genetically modified corn in China’s northeast

By Dominique Patton BEIJING (Reuters) – Farmers are illegally growing genetically modified corn in China’s northeast, said environmental non-profit Greenpeace on Wednesday, in a report that may generate further distrust of the government’s ability to ensure a safe food supply. … Continue reading

By Dominique Patton

BEIJING (Reuters) – Farmers are illegally growing genetically modified corn in China’s northeast, said environmental non-profit Greenpeace on Wednesday, in a report that may generate further distrust of the government’s ability to ensure a safe food supply.

Beijing has spent billions of dollars to develop GMO crops that it hopes will ensure food supplies for its 1.4 billion people but has not yet approved commercial cultivation amid deep-seated anti-GMO sentiment. The new findings seem to confirm concerns that Beijing will be unable to supervise the planting of GMO crops once commercial cultivation is permitted, leading to widespread contamination of the food chain with GM varieties.

In its report, Greenpeace said 93 percent of samples taken last year from corn fields in five counties in Liaoning province, part of China’s breadbasket, tested positive for GMO contamination.

9.70

UPDATE – 6 September 2013

The Colombian government has just announced that it is suspending Resolution 970, which was the subject of massive public outcry in recent weeks thanks to the huge peasant mobilisation launched on 19 August. The Resolution, adopted in 2010 and sometimes referred to as Law 970, made it illegal for Colombian farmers to save seeds in order for private companies and transnational corporations to gain monopoly control over the market.

 
Resolution 970 will be suspended for a period of two years, and this will only apply to domestically produced seeds (not imports). The government says it will use the two-year freeze to write new rules on seed use “which will not affect small farmers”.

This is NOT a reversal of policy. It is a public statement from the government. People are waiting to see it written into a document with legal force, and are reiterating calls for the Resolution to be repealed instead.

Sources (in Spanish):

On 19 August, Colombian farmers’ organisations initiated a massive nationwide strike. They blocked roads, dumped milk on cars and basically stopped producing food for the cities. The problem? Farmers are being driven out of existence by the government’s policies.

The state provides almost no support for the small-scale farming sector.
1 Instead, it embraces a social and economic model that serves the interests of a wealthy elite minority. Recent free trade agreements (FTAs) signed with the US and the EU are undercutting Colombian producers, who can’t compete with subsidised imports.
2 The Colombian government has been actively promoting land grabbing by large corporations, many of them foreign (Monica Semillas from Brazil, Merhav from Israel, Cargill from the US), to promote export-oriented agribusiness at the expense of family farming oriented towards food sovereignty.

UPDATE – 6 September 2013

The Colombian government has just announced that it is suspending Resolution 970, which was the subject of massive public outcry in recent weeks thanks to the huge peasant mobilisation launched on 19 August. The Resolution, adopted in 2010 and sometimes referred to as Law 970, made it illegal for Colombian farmers to save seeds in order for private companies and transnational corporations to gain monopoly control over the market.

 
Resolution 970 will be suspended for a period of two years, and this will only apply to domestically produced seeds (not imports). The government says it will use the two-year freeze to write new rules on seed use “which will not affect small farmers”.

This is NOT a reversal of policy. It is a public statement from the government. People are waiting to see it written into a document with legal force, and are reiterating calls for the Resolution to be repealed instead.

Sources (in Spanish):

On 19 August, Colombian farmers’ organisations initiated a massive nationwide strike. They blocked roads, dumped milk on cars and basically stopped producing food for the cities. The problem? Farmers are being driven out of existence by the government’s policies.

The state provides almost no support for the small-scale farming sector.
1 Instead, it embraces a social and economic model that serves the interests of a wealthy elite minority. Recent free trade agreements (FTAs) signed with the US and the EU are undercutting Colombian producers, who can’t compete with subsidised imports.
2 The Colombian government has been actively promoting land grabbing by large corporations, many of them foreign (Monica Semillas from Brazil, Merhav from Israel, Cargill from the US), to promote export-oriented agribusiness at the expense of family farming oriented towards food sovereignty.

Free markets

A free market is a market economy in which the forces of supply and demand are free of intervention by a government, price-setting monopolies, or other authority. A free market contrasts with a controlled market or regulated market, in which government intervenes in supply and demand through non-market methods … Continue reading

free market is a market economy in which the forces of supply and demand are free of intervention by a government, price-setting monopolies, or other authority. A free market contrasts with a controlled market or regulated market, in which government intervenes in supply and demand through non-market methods such as laws creating barriers to market entry or directly setting prices. Although free markets are commonly associated with capitalism in contemporary usage and popular culture, free markets have been advocated by market anarchistsmarket socialists, proponents of cooperatives, and advocates of profit sharing.

The definition of free market has been disputed and made complex by collectivist political philosophers and socialist economic ideas. Adam Smith discarded subjective value theory and contended that an unregulated market was prone to the rise of monopolies and was therefore not “free.”

Various forms of socialism based on, or which advocate, free markets have existed since the 19th century. Early notable socialist proponents of free-markets include Pierre-Joseph ProudhonBenjamin Tucker and the Ricardian socialists, who believed that genuinely free markets andvoluntary exchange cannot exist within the exploitative conditions of capitalism.

Léon Walras, one of the founders of the neoclassical school of economics who helped formulate the general equilibrium theory, argued that free competition could only be realized under conditions of state ownership of natural resources and land. Additionally, income taxes could be eliminated because the state would receive income to finance public services through owning such resources and enterprises.[5]

Advocates of free-market socialism, such as Jaroslav Vanek, argue that genuine free markets are not possible under conditions of private ownership over productive property because the class differences and inequalities in income and power that ensue from this arrangement enable interests of the dominant class to skew the market to their favor, either in the form of monopoly and market power, or by utilizing their wealth and resources to pass government regulations and policies that benefit their specific business interests.

Excessive disparities in income distribution emerging from private ownership are alleged by proponents of this system to lead to social instability. This requires costly corrective measures in the form of social welfare and redistributive taxation and heavy administrative costs to administer them, which weakens the incentive to work, invites dishonesty and increases the likelihood of tax evasion, thus necessitating government regulation over markets and reducing the overall efficiency of the market economy.

Friedrich Hayek popularized the classical liberal view that market economies promote spontaneous order which results in a better “allocation of societal resources than any design could achieve.”[9] According to this view, in market economies are characterized by the formation of complex transactional networks which produce and distribute goods and services throughout the economy. These networks are not designed, but nevertheless emerge as a result of decentralized individual economic decisions. The idea of spontaneous order is an elaboration on the invisible hand proposed by Adam Smith in The Wealth of Nations. Smith wrote that the individual who:

By preferring the support of domestic to that of foreign industry, he intends only his own security; and by directing that industry in such a manner as its produce may be of the greatest value, he intends only his own gain, and he is in this, as in many other cases, led by an invisible hand to promote an end which was no part of his intention. Nor is it always the worse for society that it was no part of it. By pursuing his own interest [an individual] frequently promotes that of the society more effectually than when he really intends to promote it. I have never known much good done by those who affected to trade for the [common] good.

—Adam Smith, Wealth of Nations

Smith pointed out that one does not get one’s dinner by appealing to the brother-love of the butcher, the farmer or the baker. Rather one appeals to their self-interest, and pays them for their labor.

It is not from the benevolence of the butcher, the brewer or the baker, that we expect our dinner, but from their regard to their own self-interest. We address ourselves, not to their humanity but to their self-love, and never talk to them of our own necessities but of their advantages.

—Adam Smith[10]

Supporters of this view claim that spontaneous order is superior to any order that does not allow individuals to make their own choices of what to produce, what to buy, what to sell, and at what prices, due to the number and complexity of the factors involved. They further believe that any attempt to implement central planning will result in more disorder, or a less efficient production and distribution of goods and services.

A free market is a mathematical abstraction. The concept of free market is the idea that offer and demand sets the prices of things, nothing more, and nothing less. There are no free markets anywhere in the world. Markets  in the US are far from free in the Adam Smith’s sense. The US market is heavily distorted by cartels, monopolies, subsidies, tariff and non-tariff barriers to trade, and regulations. These distortions are always in favor of the short-term interests of large corporations because they control the government trough lobbying and revolving-door politicking. A notorious and archetypal example is the GMO soybean crop which is heavily subsidized in many ways and under monopolist control of Monsanto. This situation distorts the prices of food and energy and eventually, but not very far on the future, it would be catastrophic not only for the US but for the whole human race. It might be counter intuitive but to give ever more prerogatives and power to big corporations is actually perilous to democracy and free market values, let alone the very existence of humans.

The US as a country is rich not because of free markets but because is big, it has a lot of resources, grew on the back of slave labor, and it is at the apex of an empire.

A lot of poor and destitute except a few elites is not where we might be, but where we are.

A study by the World Institute for Development Economics Research at United Nations University reports that the richest 1% of adults alone owned 40% of global assets in the year 2000, and that the richest 10% of adults accounted for 85% of the world total. The bottom half of the world adult population owned barely 1% of global wealth.
You might think that the US is rich and other countries poor because of sin against free markets and manifest destiny but actually the gap between countries is narrowing. According to current research, global income inequality peaked approximately in 1970s when world income was distributed bimodally into “rich” and “poor” countries with little overlap. Since then inequality have been rapidly decreasing, and this trend seems to be accelerating. Income distribution is now unimodal, with most people living in middle-income countries. World inequality is however increasing, possibly because of increase of within-countries inequalities

Food Safety

Published on May 23, 2013

The world’s leading Scientists, Physicians, Attorneys, Politicians and Environmental Activists expose the corruption and dangers surrounding the widespread use of Genetically Modified Organisms in the new feature length documentary, “Seeds of Death: Unveiling the Lies of GMOs”.

Senior Executive Producer / Writer / Director: Gary Null PhD
Executive Producer/Writer/Co-Director: Richard Polonetsky
Producers: Paola Bossola, Richard Gale, James Spruill, Patrick Thompson, Valerie Van Cleve
Editors: James Spruill, Patrick Thompson, Richie Williamson, Nick Palm
Music: Kevin MacLeod (Incompetech.com), Armando Guarnera
Graphics: Jay Graygor


Published on May 12, 2012
****SAVE THIS DOCUMENTARY AS AN MP4 FILE TO WATCH RATHER THAN STREAM***
1) Highlight and copy this videos URL address:
http://www.youtube.com/watch?v=5uah8L…
2) Go to www.savetube.com
3) Paste the URL you just copied into the “VID” field and then click on VIDEO.
4) It will then give you options for download, download the MP4 file. You can then watch it without waiting for it to buffer and even better, burn it to DVD for others to see.

Americans’ right to access fresh, healthy foods of their choice is under attack. Farmageddon tells the story of small, family farms that were providing safe, healthy foods to their communities and were forced to stop, sometimes through violent ac-tion, by agents of misguided government bureaucracies, and seeks to figure out why.

Filmmaker Kristin Canty’s quest to find healthy food for her four children turned into an educational journey to discover why access to these foods was being threatened. What she found were policies that favor agribusiness and factory farms over small family-operated farms selling fresh foods to their communities. Instead of focusing on the source of food safety problems — most often the industrial food chain — policymakers and regulators implement and enforce solutions that target and often drive out of business small farms that have proven themselves more than capable of producing safe, healthy food, but buckle under the crushing weight of government regulations and excessive enforcement actions.

Farmageddon highlights the urgency of food freedom, encouraging farmers and consumers alike to take action to preserve individuals’ rights to access food of their choice and farmers’ rights to produce these foods safely and free from unreasona-bly burdensome regulations. The film serves to put policymakers and regulators on notice that there is a growing movement of people aware that their freedom to choose the foods they want is in danger, a movement that is taking action with its dollars and its voting power to protect and preserve the dwindling number of family farms that are struggling to survive.


Dear Friend,
Late last year the FDA quietly took a major step toward approving the “frankenfish,” AquaBounty’s genetically modified salmon.
Its approval would be a radical move by the FDA — the first genetically modified animal ever to enter our food supply. It’s no wonder the FDA posted its final review, clearing the way for approval, on the Friday before the Christmas holiday, when few people would notice.
The FDA is now taking public comments on its study, which is expected to lead to approval of the frankenfish. This is our last chance to keep GMO salmon off our grocery store shelves, and stop the dangerous trend of introducing GM animals into our food supply.
AquaBounty’s frankenfish is an Atlantic salmon, spliced with genes from an eel pout and growth hormone from a Chinook salmon. The result is a salmon that produces growth hormone year-round and grows twice as fast. The risks are myriad.
The fish hasn’t been proven safe for humans. But the FDA is preparing to approve it based on a limited, flawed and inadequate study — even thought the same study identified elevated allergy-causing potential,1 and elevated levels of the IGF-1 growth hormone, which is linked to colon, prostate and breast cancers. Clearly more study is needed to determine the safety or danger of GMO salmon.2
Were GMO salmon to escape its farms into the wild, the fish would pose a serious risk to wild salmon populations. The GMO salmon consume five times more food than wild salmon, and are more aggressive. Introducing these traits into the wild population would be serious — and irreversible.3
Separate from any risks, the GMO salmon are less healthy to eat — producing less of the beneficial omega-3 fatty acids than conventional salmon — and a less efficient food source — requiring 1.5 to 8 kilograms of wild fish to produce one kilogram of conventional farmed salmon.
Worse still, without GMO labeling, these frankenfish would be totally unlabeled on store shelves, and indistinguishable from other farmed salmon, so consumers will have no way of making an informed choice.
The White House knows that the public is opposed to GMO salmon and is feeling our pressure.
A recent report even documents that the White House may have delayed the release of the FDA assessment, which was completed in May, until after the election, to avoid upsetting the president’s political base.4
Significant public opposition in this comment period is our best shot at preventing approval of GMO salmon. But this is our last chance. So now is the time to make your voice heard.
Thanks for fighting for safe food.
Elijah Zarlin, Campaign Manager 
CREDO Action from Working Assets
1. “Consumers Union Says FDA Assessment of GE Salmon Is Flawed and Inadequate,” Consumers Union, 12/21/12
2. “AquAdvantage Salmon Ready for Commerce?,” Permaculture News, 9/23/10
3. “Tell the FDA: No Frankenfish,” Organic Consumers Union
4. “White House Ends Its Interference in a Scientific Review,” Slate, 12/21/12


FOR IMMEDIATE RELEASE CONTACT:
Organic Consumers Association
Katherine Paul,
207.653.3090,
katherine@organicconsumers.org

FINLAND, Minn. – Nov. 12, 2012 – The Organic Consumers Association (OCA) is monitoring the ongoing vote count and election results for Prop 37, the California Right to Know Genetically Engineered Food Act. The OCA will contest the vote if results differ substantially from pre-election poll results or if there are reports of any voting irregularities, particularly in Orange and San Mateo Counties where paperless ballot systems make voting more vulnerable to fraud.

Prop 37 was defeated by 6 percentage points, 53% to 47%, according to the California Secretary of State on election night. However, as with every election, not every ballot had been counted as of midnight Nov. 6. On election night, there were still 3.3 million uncounted votes. As of November 11, the vote totals were 5,205,044 NO to 4,619,580 YES.

“The OCA, along with the California Right to Know Campaign and its attorneys, are closely monitoring the ongoing vote count process,” said Ronnie Cummins, Director of the OCA and OCF, which contributed more than $1 million to the Prop 37 campaign. “We will challenge the outcome if the final count indicates more YES than NO votes, or if the results are substantially different from our pre-election polls.”

State law requires county elections officials to report their final results to the Secretary of State by December 7. The Secretary of State has until December 14 to certify the results of the election.

The OCA hired Lake Research Partners to conduct pre-election polling for Prop 37. The final results of the polling are not yet available.

“Win or lose, Prop 37 is just the beginning,” said Cummins. “We’ve put GMO labeling on the national map, and we’ve put Big Ag and Big Food on notice: This movement is stronger than ever, and it’s not going away.”

Activists in Washington State have already collected more than half of the signatures they need to put a similar GMO labeling initiative on the ballot there in 2013. Plans are also in the works to reignite legislative attempts in Vermont and Connecticut, where laws don’t provide for citizens ballot initiatives.

The Organic Consumers Association (OCA) is an online and grassroots non-profit 501(c)3 public interest organization campaigning for health, justice, and sustainability.

The Organic Consumers Fund is a 501(c)4 allied organization of the Organic Consumers Association, focused on grassroots lobbying and legislative action.


FDA Acts on Food Safety Bill by Judith McGeary, Esq. – May 20, 2011 http://www.ftcldf.org/federal/111_Cong-S510.htm http://www.govtrack.us/congress/bill.xpd?bill=s111-510 http://www.ftcldf.org/fda-acts-on-food-safety-bill.htm The Food and Drug Administration (FDA) recently issued the first new rules under the Food Safety Modernization Act (FSMA), meeting the initial deadlines imposed by the Act. The first rule addresses prior notice of food shipments imported from other countries. Under current law, anyone who is importing food that is subject to FDA’s jurisdiction (i.e. anything except meat, poultry, or egg products) must submit prior notification to the FDA [See 21 C.F.R. § 1.278-1.279]. The FSMA added the new requirement that such notice include “any country to which the article has been refused entry” [FSMA Sec. 304]. The FDA’s new rule amends the regulations accordingly. The second rule addresses the standard for FDA to administratively detain food. Administrative detention is a limited enforcement power — the agency can detain an article of food for no more than 30 days [See 21 C.F.R. § 1.379]. The purpose of the detention is to keep the food out of commerce while the FDA institutes a seizure or injunction action. The FSMA lowered the standard necessary for FDA to administratively detain food, from “credible evidence” that the food “presents a threat of serious adverse health consequences of death” to “reason to believe” that the food is “adulterated or misbranded.” The FDA’s recent interim rule incorporates the new, lower standard. http://youtu.be/OddINatuAXw http://youtu.be/b27EFldZ17k http://www.ftcldf.org/fda-acts-on-food-safety-http://www.govtrack.us/congress/billtext.xpd?bill=h111-875 H. R. 875 http://www.govtrack.us/congress/bill.xpd?bill=s111-510 http://www.ftcldf.org/fda-acts-on-food-safety-bill.htmhttp://www.ftcldf.org/federal/111_Cong-S510.htm [111th Congress Public Law 353]
[From the U.S. Government Printing Office]

[[Page 124 STAT. 3885]]

Public Law 111-353
111th Congress

An Act

To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of the food supply. <>

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <>
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

(a) <> Short Title.–This Act may be cited
as the “FDA Food Safety Modernization Act”.

(b) References.–Except as otherwise specified, whenever in this Act
an amendment is expressed in terms of an amendment to a section or other
provision, the reference shall be considered to be made to a section or
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(c) Table of Contents.–The table of contents for this Act is as
follows:

Sec. 1. Short title; references; table of contents.

TITLE I–IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

Sec. 101. Inspections of records.
Sec. 102. Registration of food facilities.
Sec. 103. Hazard analysis and risk-based preventive controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce safety.
Sec. 106. Protection against intentional adulteration.
Sec. 107. Authority to collect fees.
Sec. 108. National agriculture and food defense strategy.
Sec. 109. Food and Agriculture Coordinating Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of food.
Sec. 112. Food allergy and anaphylaxis management.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance relating to post harvest processing
of raw oysters.
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.

TITLE II–IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY
PROBLEMS

Sec. 201. Targeting of inspection resources for domestic facilities,
foreign facilities, and ports of entry; annual report.
Sec. 202. Laboratory accreditation for analyses of foods.
Sec. 203. Integrated consortium of laboratory networks.
Sec. 204. Enhancing tracking and tracing of food and recordkeeping.
Sec. 205. Surveillance.
Sec. 206. Mandatory recall authority.
Sec. 207. Administrative detention of food.
Sec. 208. Decontamination and disposal standards and plans.
Sec. 209. Improving the training of State, local, territorial, and
tribal food safety officials.
Sec. 210. Enhancing food safety.

[[Page 124 STAT. 3886]]

Sec. 211. Improving the reportable food registry.

TITLE III–IMPROVING THE SAFETY OF IMPORTED FOOD

Sec. 301. Foreign supplier verification program.
Sec. 302. Voluntary qualified importer program.
Sec. 303. Authority to require import certifications for food.
Sec. 304. Prior notice of imported food shipments.
Sec. 305. Building capacity of foreign governments with respect to food
safety.
Sec. 306. Inspection of foreign food facilities.
Sec. 307. Accreditation of third-party auditors.
Sec. 308. Foreign offices of the Food and Drug Administration.
Sec. 309. Smuggled food.

TITLE IV–MISCELLANEOUS PROVISIONS

Sec. 401. Funding for food safety.
Sec. 402. Employee protections.
Sec. 403. Jurisdiction; authorities.
Sec. 404. Compliance with international agreements.
Sec. 405. Determination of budgetary effects.

TITLE I–IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

SEC. 101. INSPECTIONS OF RECORDS.

(a) In General.–Section 414(a) (21 U.S.C. 350c(a)) is amended–
(1) by striking the heading and all that follows through
“of food is” and inserting the following: “Records
Inspection.–
“(1) Adulterated food.–If the Secretary has a reasonable
belief that an article of food, and any other article of food
that the Secretary reasonably believes is likely to be affected
in a similar manner, is”;
(2) by inserting “, and to any other article of food that
the Secretary reasonably believes is likely to be affected in a
similar manner,” after “relating to such article”;
(3) by striking the last sentence; and
(4) by inserting at the end the following:
“(2) Use of or exposure to food of
concern. <> –If the Secretary believes that
there is a reasonable probability that the use of or exposure to
an article of food, and any other article of food that the
Secretary reasonably believes is likely to be affected in a
similar manner, will cause serious adverse health consequences
or death to humans or animals, each person (excluding farms and
restaurants) who manufactures, processes, packs, distributes,
receives, holds, or imports such article shall, at the request
of an officer or employee duly designated by the Secretary,
permit such officer or employee, upon presentation of
appropriate credentials and a written notice to such person, at
reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records
relating to such article and to any other article of food that
the Secretary reasonably believes is likely to be affected in a
similar manner, that are needed to assist the Secretary in
determining whether there is a reasonable probability that the
use of or exposure to the food will cause serious adverse health
consequences or death to humans or animals.
“(3) Application.–The requirement under paragraphs (1) and
(2) applies to all records relating to the manufacture,
processing, packing, distribution, receipt, holding, or
importation of such article maintained by or on behalf of such
person

[[Page 124 STAT. 3887]]

in any format (including paper and electronic formats) and at
any location.”.

(b) Conforming Amendment.–Section 704(a)(1)(B) (21 U.S.C.
374(a)(1)(B)) is amended by striking “section 414 when” and all that
follows through “subject to” and inserting “section 414, when the
standard for records inspection under paragraph (1) or (2) of section
414(a) applies, subject to”.
SEC. 102. REGISTRATION OF FOOD FACILITIES.

(a) Updating of Food Category Regulations; Biennial Registration
Renewal.–Section 415(a) (21 U.S.C. 350d(a)) is amended–
(1) in paragraph (2), by–
(A) striking “conducts business and” and inserting
“conducts business, the e-mail address for the contact
person of the facility or, in the case of a foreign
facility, the United States agent for the facility,
and”; and
(B) inserting “, or any other food categories as
determined appropriate by the Secretary, including by
guidance” after “Code of Federal Regulations”;
(2) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively; and
(3) by inserting after paragraph (2) the following:
“(3) Biennial registration renewal. <> –During the period beginning on October 1 and ending
on December 31 of each even-numbered year, a registrant that has
submitted a registration under paragraph (1) shall submit to the
Secretary a renewal registration containing the information
described in paragraph (2). The Secretary shall provide for an
abbreviated registration renewal process for any registrant that
has not had any changes to such information since the registrant
submitted the preceding registration or registration renewal for
the facility involved.”.

(b) Suspension of Registration.–
(1) In general.–Section 415 (21 U.S.C. 350d) is amended–
(A) in subsection (a)(2), by inserting after the
first sentence the following: “The registration shall
contain an assurance that the Secretary will be
permitted to inspect such facility at the times and in
the manner permitted by this Act.”;
(B) by redesignating subsections (b) and (c) as
subsections (c) and (d), respectively; and
(C) by inserting after subsection (a) the following:

“(b) Suspension of Registration.–
“(1) In general.–If the Secretary determines that food
manufactured, processed, packed, received, or held by a facility
registered under this section has a reasonable probability of
causing serious adverse health consequences or death to humans
or animals, the Secretary may by order suspend the registration
of a facility–
“(A) that created, caused, or was otherwise
responsible for such reasonable probability; or
“(B)(i) that knew of, or had reason to know of,
such reasonable probability; and
“(ii) packed, received, or held such food.

[[Page 124 STAT. 3888]]

“(2) Hearing on suspension. <> –The
Secretary shall provide the registrant subject to an order under
paragraph (1) with an opportunity for an informal hearing, to be
held as soon as possible but not later than 2 business days
after the issuance of the order or such other time period, as
agreed upon by the Secretary and the registrant, on the actions
required for reinstatement of registration and why the
registration that is subject to suspension should be reinstated.
The Secretary shall reinstate a registration if the Secretary
determines, based on evidence presented, that adequate grounds
do not exist to continue the suspension of the registration.
“(3) Post-hearing corrective action plan; vacating of
order.–
“(A) Corrective action plan.–If, after providing
opportunity for an informal hearing under paragraph (2),
the Secretary determines that the suspension of
registration remains necessary, the Secretary shall
require the registrant to submit a corrective action
plan to demonstrate how the registrant plans to correct
the conditions found by the
Secretary. <> The Secretary shall
review such plan not later than 14 days after the
submission of the corrective action plan or such other
time period as determined by the Secretary.
“(B) Vacating of order.–Upon a determination by
the Secretary that adequate grounds do not exist to
continue the suspension actions required by the order,
or that such actions should be modified, the Secretary
shall promptly vacate the order and reinstate the
registration of the facility subject to the order or
modify the order, as appropriate.
“(4) Effect of suspension.–If the registration of a
facility is suspended under this subsection, no person shall
import or export food into the United States from such facility,
offer to import or export food into the United States from such
facility, or otherwise introduce food from such facility into
interstate or intrastate commerce in the United States.
“(5) Regulations.–
“(A) In general.–The Secretary shall promulgate
regulations to implement this subsection. The Secretary
may promulgate such regulations on an interim final
basis.
“(B) Registration requirement.–The Secretary may
require that registration under this section be
submitted in an electronic format. Such requirement may
not take effect before the date that is 5 years after
the date of enactment of the FDA Food Safety
Modernization Act.
“(6) Application date. <> —
Facilities shall be subject to the requirements of this
subsection beginning on the earlier of–
“(A) the date on which the Secretary issues
regulations under paragraph (5); or
“(B) 180 days after the date of enactment of the
FDA Food Safety Modernization Act.
“(7) No delegation.–The authority conferred by this
subsection to issue an order to suspend a registration or vacate
an order of suspension shall not be delegated to any officer or
employee other than the Commissioner.”.
(2) <> Small entity
compliance policy guide.–Not later than 180 days after the
issuance of the regulations promulgated

[[Page 124 STAT. 3889]]

under section 415(b)(5) of the Federal Food, Drug, and Cosmetic
Act (as added by this section), the Secretary shall issue a
small entity compliance policy guide setting forth in plain
language the requirements of such regulations to assist small
entities in complying with registration requirements and other
activities required under such section.
(3) Imported food.–Section 801(l) (21 U.S.C. 381(l)) is
amended by inserting “(or for which a registration has been
suspended under such section)” after “section 415”.

(c) <> Clarification of Intent.–
(1) Retail food establishment.–The Secretary shall amend
the definition of the term “retail food establishment” in
section in 1.227(b)(11) of title 21, Code of Federal Regulations
to clarify that, in determining the primary function of an
establishment or a retail food establishment under such section,
the sale of food products directly to consumers by such
establishment and the sale of food directly to consumers by such
retail food establishment include–
(A) the sale of such food products or food directly
to consumers by such establishment at a roadside stand
or farmers’ market where such stand or market is located
other than where the food was manufactured or processed;
(B) the sale and distribution of such food through a
community supported agriculture program; and
(C) the sale and distribution of such food at any
other such direct sales platform as determined by the
Secretary.
(2) Definitions.–For purposes of paragraph (1)–
(A) the term “community supported agriculture
program” has the same meaning given the term
“community supported agriculture (CSA) program” in
section 249.2 of title 7, Code of Federal Regulations
(or any successor regulation); and
(B) the term “consumer” does not include a
business.

(d) Conforming Amendments.–
(1) Section 301(d) (21 U.S.C. 331(d)) is amended by
inserting “415,” after “404,”.
(2) Section 415(d), as redesignated by subsection
(b), <> is amended by adding at the end
before the period “for a facility to be registered, except with
respect to the reinstatement of a registration that is suspended
under subsection (b)”.
SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

(a) In General.–Chapter IV (21 U.S.C. 341 et seq.) is amended by
adding at the end the following:
“SEC. 418. <> HAZARD ANALYSIS AND RISK-BASED
PREVENTIVE CONTROLS.

“(a) In General.–The owner, operator, or agent in charge of a
facility shall, in accordance with this section, evaluate the hazards
that could affect food manufactured, processed, packed, or held by such
facility, identify and implement preventive controls to significantly
minimize or prevent the occurrence of such hazards and provide
assurances that such food is not adulterated under section 402 or
misbranded under section 403(w), monitor the performance of those
controls, and maintain records of this monitoring as a matter of routine
practice.

[[Page 124 STAT. 3890]]

“(b) Hazard Analysis.–The owner, operator, or agent in charge of a
facility shall–
“(1) identify and evaluate known or reasonably foreseeable
hazards that may be associated with the facility, including–
“(A) biological, chemical, physical, and
radiological hazards, natural toxins, pesticides, drug
residues, decomposition, parasites, allergens, and
unapproved food and color additives; and
“(B) hazards that occur naturally, or may be
unintentionally introduced; and
“(2) identify and evaluate hazards that may be
intentionally introduced, including by acts of terrorism; and
“(3) develop a written analysis of the hazards.

“(c) Preventive Controls.–The owner, operator, or agent in charge
of a facility shall identify and implement preventive controls,
including at critical control points, if any, to provide assurances
that–
“(1) hazards identified in the hazard analysis conducted
under subsection (b)(1) will be significantly minimized or
prevented;
“(2) any hazards identified in the hazard analysis
conducted under subsection (b)(2) will be significantly
minimized or prevented and addressed, consistent with section
420, as applicable; and
“(3) the food manufactured, processed, packed, or held by
such facility will not be adulterated under section 402 or
misbranded under section 403(w).

“(d) Monitoring of Effectiveness.–The owner, operator, or agent in
charge of a facility shall monitor the effectiveness of the preventive
controls implemented under subsection (c) to provide assurances that the
outcomes described in subsection (c) shall be achieved.
“(e) Corrective Actions. <> –The owner,
operator, or agent in charge of a facility shall establish procedures to
ensure that, if the preventive controls implemented under subsection (c)
are not properly implemented or are found to be ineffective–
“(1) appropriate action is taken to reduce the likelihood
of recurrence of the implementation failure;
“(2) all affected food is evaluated for safety; and
“(3) all affected food is prevented from entering into
commerce if the owner, operator or agent in charge of such
facility cannot ensure that the affected food is not adulterated
under section 402 or misbranded under section 403(w).

“(f) Verification.–The owner, operator, or agent in charge of a
facility shall verify that–
“(1) the preventive controls implemented under subsection
(c) are adequate to control the hazards identified under
subsection (b);
“(2) the owner, operator, or agent is conducting monitoring
in accordance with subsection (d);
“(3) the owner, operator, or agent is making appropriate
decisions about corrective actions taken under subsection (e);
“(4) the preventive controls implemented under subsection
(c) are effectively and significantly minimizing or preventing
the occurrence of identified hazards, including through the use
of environmental and product testing programs and other
appropriate means; and

[[Page 124 STAT. 3891]]

“(5) there is documented, periodic reanalysis of the plan
under subsection (i) to ensure that the plan is still relevant
to the raw materials, conditions and processes in the facility,
and new and emerging threats.

“(g) Recordkeeping. <> –The owner, operator,
or agent in charge of a facility shall maintain, for not less than 2
years, records documenting the monitoring of the preventive controls
implemented under subsection (c), instances of nonconformance material
to food safety, the results of testing and other appropriate means of
verification under subsection (f)(4), instances when corrective actions
were implemented, and the efficacy of preventive controls and corrective
actions.

“(h) Written Plan and Documentation.–The owner, operator, or agent
in charge of a facility shall prepare a written plan that documents and
describes the procedures used by the facility to comply with the
requirements of this section, including analyzing the hazards under
subsection (b) and identifying the preventive controls adopted under
subsection (c) to address those hazards. Such written plan, together
with the documentation described in subsection (g), shall be made
promptly available to a duly authorized representative of the Secretary
upon oral or written request.
“(i) Requirement To Reanalyze. <> –The owner,
operator, or agent in charge of a facility shall conduct a reanalysis
under subsection (b) whenever a significant change is made in the
activities conducted at a facility operated by such owner, operator, or
agent if the change creates a reasonable potential for a new hazard or a
significant increase in a previously identified hazard or not less
frequently than once every 3 years, whichever is earlier. Such
reanalysis shall be completed and additional preventive controls needed
to address the hazard identified, if any, shall be implemented before
the change in activities at the facility is operative. Such owner,
operator, or agent shall revise the written plan required under
subsection (h) if such a significant change is made or document the
basis for the conclusion that no additional or revised preventive
controls are needed. The Secretary may require a reanalysis under this
section to respond to new hazards and developments in scientific
understanding, including, as appropriate, results from the Department of
Homeland Security biological, chemical, radiological, or other terrorism
risk assessment.

“(j) Exemption for Seafood, Juice, and Low-acid Canned Food
Facilities Subject to HACCP.–
“(1) In general.–This section shall not apply to a
facility if the owner, operator, or agent in charge of such
facility is required to comply with, and is in compliance with,
1 of the following standards and regulations with respect to
such facility:
“(A) The Seafood Hazard Analysis Critical Control
Points Program of the Food and Drug Administration.
“(B) The Juice Hazard Analysis Critical Control
Points Program of the Food and Drug Administration.
“(C) The Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers standards of
the Food and Drug Administration (or any successor
standards).
“(2) Applicability.–The exemption under paragraph (1)(C)
shall apply only with respect to microbiological hazards that
are regulated under the standards for Thermally Processed

[[Page 124 STAT. 3892]]

Low-Acid Foods Packaged in Hermetically Sealed Containers under
part 113 of chapter 21, Code of Federal Regulations (or any
successor regulations).

“(k) Exception for Activities of Facilities Subject to Section
419.–This section shall not apply to activities of a facility that are
subject to section 419.
“(l) Modified Requirements for Qualified Facilities.–
“(1) Qualified facilities.–
“(A) In general.–A facility is a qualified
facility for purposes of this subsection if the facility
meets the conditions under subparagraph (B) or (C).
“(B) Very small business.–A facility is a
qualified facility under this subparagraph–
“(i) if the facility, including any
subsidiary or affiliate of the facility, is,
collectively, a very small business (as defined in
the regulations promulgated under subsection (n));
and
“(ii) in the case where the facility is a
subsidiary or affiliate of an entity, if such
subsidiaries or affiliates, are, collectively, a
very small business (as so defined).
“(C) <> Limited annual
monetary value of sales.–
“(i) In general.–A facility is a qualified
facility under this subparagraph if clause (ii)
applies–
“(I) to the facility, including any
subsidiary or affiliate of the facility,
collectively; and
“(II) to the subsidiaries or
affiliates, collectively, of any entity
of which the facility is a subsidiary or
affiliate.
“(ii) Average annual monetary value.–This
clause applies if–
“(I) during the 3-year period
preceding the applicable calendar year,
the average annual monetary value of the
food manufactured, processed, packed, or
held at such facility (or the collective
average annual monetary value of such
food at any subsidiary or affiliate, as
described in clause (i)) that is sold
directly to qualified end-users during
such period exceeded the average annual
monetary value of the food manufactured,
processed, packed, or held at such
facility (or the collective average
annual monetary value of such food at
any subsidiary or affiliate, as so
described) sold by such facility (or
collectively by any such subsidiary or
affiliate) to all other purchasers
during such period; and
“(II) the average annual monetary
value of all food sold by such facility
(or the collective average annual
monetary value of such food sold by any
subsidiary or affiliate, as described in
clause (i)) during such period was less
than $500,000, adjusted for inflation.
“(2) Exemption.–A qualified facility–
“(A) shall not be subject to the requirements under
subsections (a) through (i) and subsection (n) in an
applicable calendar year; and
“(B) shall submit to the Secretary–

[[Page 124 STAT. 3893]]

“(i)(I) documentation that demonstrates that
the owner, operator, or agent in charge of the
facility has identified potential hazards
associated with the food being produced, is
implementing preventive controls to address the
hazards, and is monitoring the preventive controls
to ensure that such controls are effective; or
“(II) documentation (which may include
licenses, inspection reports, certificates,
permits, credentials, certification by an
appropriate agency (such as a State department of
agriculture), or other evidence of oversight), as
specified by the Secretary, that the facility is
in compliance with State, local, county, or other
applicable non-Federal food safety law; and
“(ii) <> documentation, as
specified by the Secretary in a guidance document
issued not later than 1 year after the date of
enactment of this section, that the facility is a
qualified facility under paragraph (1)(B) or
(1)(C).
“(3) Withdrawal; rule of construction.–
“(A) In general.–In the event of an active
investigation of a foodborne illness outbreak that is
directly linked to a qualified facility subject to an
exemption under this subsection, or if the Secretary
determines that it is necessary to protect the public
health and prevent or mitigate a foodborne illness
outbreak based on conduct or conditions associated with
a qualified facility that are material to the safety of
the food manufactured, processed, packed, or held at
such facility, the Secretary may withdraw the exemption
provided to such facility under this subsection.
“(B) Rule of construction.–Nothing in this
subsection shall be construed to expand or limit the
inspection authority of the Secretary.
“(4) Definitions.–In this subsection:
“(A) Affiliate.–The term `affiliate’ means any
facility that controls, is controlled by, or is under
common control with another facility.
“(B) Qualified end-user.–The term `qualified end-
user’, with respect to a food, means–
“(i) the consumer of the food; or
“(ii) a restaurant or retail food
establishment (as those terms are defined by the
Secretary for purposes of section 415) that–
“(I) is located–
“(aa) in the same State as
the qualified facility that sold
the food to such restaurant or
establishment; or
“(bb) not more than 275
miles from such facility; and
“(II) is purchasing the food for
sale directly to consumers at such
restaurant or retail food establishment.
“(C) Consumer.–For purposes of subparagraph (B),
the term `consumer’ does not include a business.
“(D) Subsidiary.–The term `subsidiary’ means any
company which is owned or controlled directly or
indirectly by another company.

[[Page 124 STAT. 3894]]

“(5) Study.–
“(A) In general.–The Secretary, in consultation
with the Secretary of Agriculture, shall conduct a study
of the food processing sector regulated by the Secretary
to determine–
“(i) the distribution of food production by
type and size of operation, including monetary
value of food sold;
“(ii) the proportion of food produced by each
type and size of operation;
“(iii) the number and types of food
facilities co-located on farms, including the
number and proportion by commodity and by
manufacturing or processing activity;
“(iv) the incidence of foodborne illness
originating from each size and type of operation
and the type of food facilities for which no
reported or known hazard exists; and
“(v) the effect on foodborne illness risk
associated with commingling, processing,
transporting, and storing food and raw
agricultural commodities, including differences in
risk based on the scale and duration of such
activities.
“(B) Size.–The results of the study conducted
under subparagraph (A) shall include the information
necessary to enable the Secretary to define the terms
`small business’ and `very small business’, for purposes
of promulgating the regulation under subsection (n). In
defining such terms, the Secretary shall include
consideration of harvestable acres, income, the number
of employees, and the volume of food harvested.
“(C) Submission of report.–Not later than 18
months after the date of enactment the FDA Food Safety
Modernization Act, the Secretary shall submit to
Congress a report that describes the results of the
study conducted under subparagraph (A).
“(6) No preemption.–Nothing in this subsection preempts
State, local, county, or other non-Federal law regarding the
safe production of food. Compliance with this subsection shall
not relieve any person from liability at common law or under
State statutory law.
“(7) Notification to consumers.–
“(A) In general.–A qualified facility that is
exempt from the requirements under subsections (a)
through (i) and subsection (n) and does not prepare
documentation under paragraph (2)(B)(i)(I) shall–
“(i) with respect to a food for which a food
packaging label is required by the Secretary under
any other provision of this Act, include
prominently and conspicuously on such label the
name and business address of the facility where
the food was manufactured or processed; or
“(ii) with respect to a food for which a food
packaging label is not required by the Secretary
under any other provisions of this Act,
prominently and conspicuously display, at the
point of purchase, the name and business address
of the facility where the

[[Page 124 STAT. 3895]]

food was manufactured or processed, on a label,
poster, sign, placard, or documents delivered
contemporaneously with the food in the normal
course of business, or, in the case of Internet
sales, in an electronic notice.
“(B) No additional label.–Subparagraph (A) does
not provide authority to the Secretary to require a
label that is in addition to any label required under
any other provision of this Act.

“(m) Authority With Respect to Certain Facilities.–The Secretary
may, by regulation, exempt or modify the requirements for compliance
under this section with respect to facilities that are solely engaged in
the production of food for animals other than man, the storage of raw
agricultural commodities (other than fruits and vegetables) intended for
further distribution or processing, or the storage of packaged foods
that are not exposed to the environment.
“(n) Regulations.–
“(1) In general. <> –Not later than 18
months after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall promulgate regulations–
“(A) to establish science-based minimum standards
for conducting a hazard analysis, documenting hazards,
implementing preventive controls, and documenting the
implementation of the preventive controls under this
section; and
“(B) to define, for purposes of this section, the
terms `small business’ and `very small business’, taking
into consideration the study described in subsection
(l)(5).
“(2) Coordination.–In promulgating the regulations under
paragraph (1)(A), with regard to hazards that may be
intentionally introduced, including by acts of terrorism, the
Secretary shall coordinate with the Secretary of Homeland
Security, as appropriate.
“(3) Content.–The regulations promulgated under paragraph
(1)(A) shall–
“(A) provide sufficient flexibility to be
practicable for all sizes and types of facilities,
including small businesses such as a small food
processing facility co-located on a farm;
“(B) comply with chapter 35 of title 44, United
States Code (commonly known as the `Paperwork Reduction
Act’), with special attention to minimizing the burden
(as defined in section 3502(2) of such Act) on the
facility, and collection of information (as defined in
section 3502(3) of such Act), associated with such
regulations;
“(C) acknowledge differences in risk and minimize,
as appropriate, the number of separate standards that
apply to separate foods; and
“(D) not require a facility to hire a consultant or
other third party to identify, implement, certify, or
audit preventative controls, except in the case of
negotiated enforcement resolutions that may require such
a consultant or third party.
“(4) Rule of construction.–Nothing in this subsection
shall be construed to provide the Secretary with the authority
to prescribe specific technologies, practices, or critical
controls for an individual facility.

[[Page 124 STAT. 3896]]

“(5) Review.–In promulgating the regulations under
paragraph (1)(A), the Secretary shall review regulatory hazard
analysis and preventive control programs in existence on the
date of enactment of the FDA Food Safety Modernization Act,
including the Grade `A’ Pasteurized Milk Ordinance to ensure
that such regulations are consistent, to the extent practicable,
with applicable domestic and internationally-recognized
standards in existence on such date.

“(o) Definitions.–For purposes of this section:
“(1) Critical control point.–The term `critical control
point’ means a point, step, or procedure in a food process at
which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce such hazard to an
acceptable level.
“(2) Facility.–The term `facility’ means a domestic
facility or a foreign facility that is required to register
under section 415.
“(3) Preventive controls.–The term `preventive controls’
means those risk-based, reasonably appropriate procedures,
practices, and processes that a person knowledgeable about the
safe manufacturing, processing, packing, or holding of food
would employ to significantly minimize or prevent the hazards
identified under the hazard analysis conducted under subsection
(b) and that are consistent with the current scientific
understanding of safe food manufacturing, processing, packing,
or holding at the time of the analysis. Those procedures,
practices, and processes may include the following:
“(A) Sanitation procedures for food contact
surfaces and utensils and food-contact surfaces of
equipment.
“(B) Supervisor, manager, and employee hygiene
training.
“(C) An environmental monitoring program to verify
the effectiveness of pathogen controls in processes
where a food is exposed to a potential contaminant in
the environment.
“(D) A food allergen control program.
“(E) A recall plan.
“(F) Current Good Manufacturing Practices (cGMPs)
under part 110 of title 21, Code of Federal Regulations
(or any successor regulations).
“(G) Supplier verification activities that relate
to the safety of food.”.

(b) <> Guidance Document.–The Secretary
shall issue a guidance document related to the regulations promulgated
under subsection (b)(1) with respect to the hazard analysis and
preventive controls under section 418 of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)).

(c) <> Rulemaking.–
(1) Proposed rulemaking.–
(A) In general. <> –Not later than 9 months after
the date of enactment of this Act, the Secretary of
Health and Human Services (referred to in this
subsection as the “Secretary”) shall publish a notice
of proposed rulemaking in the Federal Register to
promulgate regulations with respect to–
(i) activities that constitute on-farm packing
or holding of food that is not grown, raised, or
consumed

[[Page 124 STAT. 3897]]

on such farm or another farm under the same
ownership for purposes of section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350d), as amended by this Act; and
(ii) activities that constitute on-farm
manufacturing or processing of food that is not
consumed on that farm or on another farm under
common ownership for purposes of such section 415.
(B) Clarification.–The rulemaking described under
subparagraph (A) shall enhance the implementation of
such section 415 and clarify the activities that are
included as part of the definition of the term
“facility” under such section 415. Nothing in this Act
authorizes the Secretary to modify the definition of the
term “facility” under such section.
(C) Science-based risk analysis.–In promulgating
regulations under subparagraph (A), the Secretary shall
conduct a science-based risk analysis of–
(i) specific types of on-farm packing or
holding of food that is not grown, raised, or
consumed on such farm or another farm under the
same ownership, as such packing and holding
relates to specific foods; and
(ii) specific on-farm manufacturing and
processing activities as such activities relate to
specific foods that are not consumed on that farm
or on another farm under common ownership.
(D) Authority with respect to certain facilities.–
(i) In general.–In promulgating the
regulations under subparagraph (A), the Secretary
shall consider the results of the science-based
risk analysis conducted under subparagraph (C),
and shall exempt certain facilities from the
requirements in section 418 of the Federal Food,
Drug, and Cosmetic Act (as added by this section),
including hazard analysis and preventive controls,
and the mandatory inspection frequency in section
421 of such Act (as added by section 201), or
modify the requirements in such sections 418 or
421, as the Secretary determines appropriate, if
such facilities are engaged only in specific types
of on-farm manufacturing, processing, packing, or
holding activities that the Secretary determines
to be low risk involving specific foods the
Secretary determines to be low risk.
(ii) Limitation. <> —
The exemptions or modifications under clause (i)
shall not include an exemption from the
requirement to register under section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350d), as amended by this Act, if applicable, and
shall apply only to small businesses and very
small businesses, as defined in the regulation
promulgated under section 418(n) of the Federal
Food, Drug, and Cosmetic Act (as added under
subsection (a)).
(2) Final regulations.–Not later than 9 months after the
close of the comment period for the proposed rulemaking under
paragraph (1), the Secretary shall adopt final rules with
respect to–

[[Page 124 STAT. 3898]]

(A) activities that constitute on-farm packing or
holding of food that is not grown, raised, or consumed
on such farm or another farm under the same ownership
for purposes of section 415 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350d), as amended by this
Act;
(B) activities that constitute on-farm manufacturing
or processing of food that is not consumed on that farm
or on another farm under common ownership for purposes
of such section 415; and
(C) the requirements under sections 418 and 421 of
the Federal Food, Drug, and Cosmetic Act, as added by
this Act, from which the Secretary may issue exemptions
or modifications of the requirements for certain types
of facilities.

(d) Small Entity Compliance Policy Guide. <> –Not later than 180 days after the issuance of the
regulations promulgated under subsection (n) of section 418 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the
Secretary shall issue a small entity compliance policy guide setting
forth in plain language the requirements of such section 418 and this
section to assist small entities in complying with the hazard analysis
and other activities required under such section 418 and this section.

(e) Prohibited Acts.–Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
“(uu) The operation of a facility that manufactures, processes,
packs, or holds food for sale in the United States if the owner,
operator, or agent in charge of such facility is not in compliance with
section 418.”.
(f) <> No Effect on HACCP Authorities.–
Nothing in the amendments made by this section limits the authority of
the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to
revise, issue, or enforce Hazard Analysis Critical Control programs and
the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers standards.

(g) <> Dietary
Supplements.–Nothing in the amendments made by this section shall apply
to any facility with regard to the manufacturing, processing, packing,
or holding of a dietary supplement that is in compliance with the
requirements of sections 402(g)(2) and 761 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).

(h) <> Updating Guidance Relating to Fish
and Fisheries Products Hazards and Controls. <> –The
Secretary shall, not later than 180 days after the date of enactment of
this Act, update the Fish and Fisheries Products Hazards and Control
Guidance to take into account advances in technology that have occurred
since the previous publication of such Guidance by the Secretary.

(i) <> Effective Dates.–
(1) General rule.–The amendments made by this section shall
take effect 18 months after the date of enactment of this Act.
(2) <> Flexibility
for small businesses.–Notwithstanding paragraph (1)–
(A) the amendments made by this section shall apply
to a small business (as defined in the regulations
promulgated under section 418(n) of the Federal Food,
Drug, and Cosmetic Act (as added by this section))
beginning on the

[[Page 124 STAT. 3899]]

date that is 6 months after the effective date of such
regulations; and
(B) the amendments made by this section shall apply
to a very small business (as defined in such
regulations) beginning on the date that is 18 months
after the effective date of such regulations.
SEC. 104. <> PERFORMANCE STANDARDS.

(a) In General. <> –The Secretary shall, in
coordination with the Secretary of Agriculture, not less frequently than
every 2 years, review and evaluate relevant health data and other
relevant information, including from toxicological and epidemiological
studies and analyses, current Good Manufacturing Practices issued by the
Secretary relating to food, and relevant recommendations of relevant
advisory committees, including the Food Advisory Committee, to determine
the most significant foodborne contaminants.

(b) Guidance Documents and Regulations.–Based on the review and
evaluation conducted under subsection (a), and when appropriate to
reduce the risk of serious illness or death to humans or animals or to
prevent adulteration of the food under section 402 of the Federal Food,
Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent the spread by food
of communicable disease under section 361 of the Public Health Service
Act (42 U.S.C. 264), the Secretary shall issue contaminant-specific and
science-based guidance documents, including guidance documents regarding
action levels, or regulations. Such guidance, including guidance
regarding action levels, or regulations–
(1) <> shall apply to products or
product classes;
(2) shall, where appropriate, differentiate between food for
human consumption and food intended for consumption by animals
other than humans; and
(3) shall not be written to be facility-specific.

(c) No Duplication of Efforts.–The Secretary shall coordinate with
the Secretary of Agriculture to avoid issuing duplicative guidance on
the same contaminants.
(d) Review.–The Secretary shall periodically review and revise, as
appropriate, the guidance documents, including guidance documents
regarding action levels, or regulations promulgated under this section.
SEC. 105. STANDARDS FOR PRODUCE SAFETY.

(a) In General.–Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 103, is amended by adding at the end the following:
“SEC. 419. <> STANDARDS FOR PRODUCE SAFETY.

“(a) Proposed Rulemaking.–
“(1) In general.–
“(A)
Rulemaking. <> —
Not later than 1 year after the date of enactment of the
FDA Food Safety Modernization Act, the Secretary, in
coordination with the Secretary of Agriculture and
representatives of State departments of agriculture
(including with regard to the national organic program
established under the Organic Foods Production Act of
1990), and in consultation with the Secretary of
Homeland Security, shall publish a notice of proposed
rulemaking to establish science-based minimum standards
for the safe production and harvesting of those types of
fruits

[[Page 124 STAT. 3900]]

and vegetables, including specific mixes or categories
of fruits and vegetables, that are raw agricultural
commodities for which the Secretary has determined that
such standards minimize the risk of serious adverse
health consequences or death.
“(B) Determination by secretary.–With respect to
small businesses and very small businesses (as such
terms are defined in the regulation promulgated under
subparagraph (A)) that produce and harvest those types
of fruits and vegetables that are raw agricultural
commodities that the Secretary has determined are low
risk and do not present a risk of serious adverse health
consequences or death, the Secretary may determine not
to include production and harvesting of such fruits and
vegetables in such rulemaking, or may modify the
applicable requirements of regulations promulgated
pursuant to this section.
“(2) Public input.–During the comment period on the notice
of proposed rulemaking under paragraph (1), the Secretary shall
conduct not less than 3 public meetings in diverse geographical
areas of the United States to provide persons in different
regions an opportunity to comment.
“(3) Content.–The proposed rulemaking under paragraph (1)
shall–
“(A) provide sufficient flexibility to be
applicable to various types of entities engaged in the
production and harvesting of fruits and vegetables that
are raw agricultural commodities, including small
businesses and entities that sell directly to consumers,
and be appropriate to the scale and diversity of the
production and harvesting of such commodities;
“(B) include, with respect to growing, harvesting,
sorting, packing, and storage operations, science-based
minimum standards related to soil amendments, hygiene,
packaging, temperature controls, animals in the growing
area, and water;
“(C) consider hazards that occur naturally, may be
unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism;
“(D) take into consideration, consistent with
ensuring enforceable public health protection,
conservation and environmental practice standards and
policies established by Federal natural resource
conservation, wildlife conservation, and environmental
agencies;
“(E) in the case of production that is certified
organic, not include any requirements that conflict with
or duplicate the requirements of the national organic
program established under the Organic Foods Production
Act of 1990, while providing the same level of public
health protection as the requirements under guidance
documents, including guidance documents regarding action
levels, and regulations under the FDA Food Safety
Modernization Act; and
“(F) define, for purposes of this section, the
terms `small business’ and `very small business’.
“(4) Prioritization.–The Secretary shall prioritize the
implementation of the regulations under this section for
specific fruits and vegetables that are raw agricultural
commodities

[[Page 124 STAT. 3901]]

based on known risks which may include a history and severity of
foodborne illness outbreaks.

“(b) Final Regulation.–
“(1) In general. <> –Not later than 1
year after the close of the comment period for the proposed
rulemaking under subsection (a), the Secretary shall adopt a
final regulation to provide for minimum science-based standards
for those types of fruits and vegetables, including specific
mixes or categories of fruits or vegetables, that are raw
agricultural commodities, based on known safety risks, which may
include a history of foodborne illness outbreaks.
“(2) Final regulation.–The final regulation shall–
“(A) provide for coordination of education and
enforcement activities by State and local officials, as
designated by the Governors of the respective States or
the appropriate elected State official as recognized by
State statute; and
“(B) include a description of the variance process
under subsection (c) and the types of permissible
variances the Secretary may grant.
“(3) Flexibility for small
businesses. <> —
Notwithstanding paragraph (1)–
“(A) the regulations promulgated under this section
shall apply to a small business (as defined in the
regulation promulgated under subsection (a)(1)) after
the date that is 1 year after the effective date of the
final regulation under paragraph (1); and
“(B) the regulations promulgated under this section
shall apply to a very small business (as defined in the
regulation promulgated under subsection (a)(1)) after
the date that is 2 years after the effective date of the
final regulation under paragraph (1).

“(c) Criteria.–
“(1) In general.–The regulations adopted under subsection
(b) shall–
“(A) set forth those procedures, processes, and
practices that the Secretary determines to minimize the
risk of serious adverse health consequences or death,
including procedures, processes, and practices that the
Secretary determines to be reasonably necessary to
prevent the introduction of known or reasonably
foreseeable biological, chemical, and physical hazards,
including hazards that occur naturally, may be
unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism, into fruits
and vegetables, including specific mixes or categories
of fruits and vegetables, that are raw agricultural
commodities and to p

Published on May 23, 2013

The world’s leading Scientists, Physicians, Attorneys, Politicians and Environmental Activists expose the corruption and dangers surrounding the widespread use of Genetically Modified Organisms in the new feature length documentary, “Seeds of Death: Unveiling the Lies of GMOs”.

Senior Executive Producer / Writer / Director: Gary Null PhD
Executive Producer/Writer/Co-Director: Richard Polonetsky
Producers: Paola Bossola, Richard Gale, James Spruill, Patrick Thompson, Valerie Van Cleve
Editors: James Spruill, Patrick Thompson, Richie Williamson, Nick Palm
Music: Kevin MacLeod (Incompetech.com), Armando Guarnera
Graphics: Jay Graygor


Published on May 12, 2012
****SAVE THIS DOCUMENTARY AS AN MP4 FILE TO WATCH RATHER THAN STREAM***
1) Highlight and copy this videos URL address:
http://www.youtube.com/watch?v=5uah8L…
2) Go to www.savetube.com
3) Paste the URL you just copied into the “VID” field and then click on VIDEO.
4) It will then give you options for download, download the MP4 file. You can then watch it without waiting for it to buffer and even better, burn it to DVD for others to see.

Americans’ right to access fresh, healthy foods of their choice is under attack. Farmageddon tells the story of small, family farms that were providing safe, healthy foods to their communities and were forced to stop, sometimes through violent ac-tion, by agents of misguided government bureaucracies, and seeks to figure out why.

Filmmaker Kristin Canty’s quest to find healthy food for her four children turned into an educational journey to discover why access to these foods was being threatened. What she found were policies that favor agribusiness and factory farms over small family-operated farms selling fresh foods to their communities. Instead of focusing on the source of food safety problems — most often the industrial food chain — policymakers and regulators implement and enforce solutions that target and often drive out of business small farms that have proven themselves more than capable of producing safe, healthy food, but buckle under the crushing weight of government regulations and excessive enforcement actions.

Farmageddon highlights the urgency of food freedom, encouraging farmers and consumers alike to take action to preserve individuals’ rights to access food of their choice and farmers’ rights to produce these foods safely and free from unreasona-bly burdensome regulations. The film serves to put policymakers and regulators on notice that there is a growing movement of people aware that their freedom to choose the foods they want is in danger, a movement that is taking action with its dollars and its voting power to protect and preserve the dwindling number of family farms that are struggling to survive.


Dear Friend,
Late last year the FDA quietly took a major step toward approving the “frankenfish,” AquaBounty’s genetically modified salmon.
Its approval would be a radical move by the FDA — the first genetically modified animal ever to enter our food supply. It’s no wonder the FDA posted its final review, clearing the way for approval, on the Friday before the Christmas holiday, when few people would notice.
The FDA is now taking public comments on its study, which is expected to lead to approval of the frankenfish. This is our last chance to keep GMO salmon off our grocery store shelves, and stop the dangerous trend of introducing GM animals into our food supply.
AquaBounty’s frankenfish is an Atlantic salmon, spliced with genes from an eel pout and growth hormone from a Chinook salmon. The result is a salmon that produces growth hormone year-round and grows twice as fast. The risks are myriad.
The fish hasn’t been proven safe for humans. But the FDA is preparing to approve it based on a limited, flawed and inadequate study — even thought the same study identified elevated allergy-causing potential,1 and elevated levels of the IGF-1 growth hormone, which is linked to colon, prostate and breast cancers. Clearly more study is needed to determine the safety or danger of GMO salmon.2
Were GMO salmon to escape its farms into the wild, the fish would pose a serious risk to wild salmon populations. The GMO salmon consume five times more food than wild salmon, and are more aggressive. Introducing these traits into the wild population would be serious — and irreversible.3
Separate from any risks, the GMO salmon are less healthy to eat — producing less of the beneficial omega-3 fatty acids than conventional salmon — and a less efficient food source — requiring 1.5 to 8 kilograms of wild fish to produce one kilogram of conventional farmed salmon.
Worse still, without GMO labeling, these frankenfish would be totally unlabeled on store shelves, and indistinguishable from other farmed salmon, so consumers will have no way of making an informed choice.
The White House knows that the public is opposed to GMO salmon and is feeling our pressure.
A recent report even documents that the White House may have delayed the release of the FDA assessment, which was completed in May, until after the election, to avoid upsetting the president’s political base.4
Significant public opposition in this comment period is our best shot at preventing approval of GMO salmon. But this is our last chance. So now is the time to make your voice heard.
Thanks for fighting for safe food.
Elijah Zarlin, Campaign Manager 
CREDO Action from Working Assets
1. “Consumers Union Says FDA Assessment of GE Salmon Is Flawed and Inadequate,” Consumers Union, 12/21/12
2. “AquAdvantage Salmon Ready for Commerce?,” Permaculture News, 9/23/10
3. “Tell the FDA: No Frankenfish,” Organic Consumers Union
4. “White House Ends Its Interference in a Scientific Review,” Slate, 12/21/12


FOR IMMEDIATE RELEASE CONTACT:
Organic Consumers Association
Katherine Paul,
207.653.3090,
katherine@organicconsumers.org

FINLAND, Minn. – Nov. 12, 2012 – The Organic Consumers Association (OCA) is monitoring the ongoing vote count and election results for Prop 37, the California Right to Know Genetically Engineered Food Act. The OCA will contest the vote if results differ substantially from pre-election poll results or if there are reports of any voting irregularities, particularly in Orange and San Mateo Counties where paperless ballot systems make voting more vulnerable to fraud.

Prop 37 was defeated by 6 percentage points, 53% to 47%, according to the California Secretary of State on election night. However, as with every election, not every ballot had been counted as of midnight Nov. 6. On election night, there were still 3.3 million uncounted votes. As of November 11, the vote totals were 5,205,044 NO to 4,619,580 YES.

“The OCA, along with the California Right to Know Campaign and its attorneys, are closely monitoring the ongoing vote count process,” said Ronnie Cummins, Director of the OCA and OCF, which contributed more than $1 million to the Prop 37 campaign. “We will challenge the outcome if the final count indicates more YES than NO votes, or if the results are substantially different from our pre-election polls.”

State law requires county elections officials to report their final results to the Secretary of State by December 7. The Secretary of State has until December 14 to certify the results of the election.

The OCA hired Lake Research Partners to conduct pre-election polling for Prop 37. The final results of the polling are not yet available.

“Win or lose, Prop 37 is just the beginning,” said Cummins. “We’ve put GMO labeling on the national map, and we’ve put Big Ag and Big Food on notice: This movement is stronger than ever, and it’s not going away.”

Activists in Washington State have already collected more than half of the signatures they need to put a similar GMO labeling initiative on the ballot there in 2013. Plans are also in the works to reignite legislative attempts in Vermont and Connecticut, where laws don’t provide for citizens ballot initiatives.

The Organic Consumers Association (OCA) is an online and grassroots non-profit 501(c)3 public interest organization campaigning for health, justice, and sustainability.

The Organic Consumers Fund is a 501(c)4 allied organization of the Organic Consumers Association, focused on grassroots lobbying and legislative action.


FDA Acts on Food Safety Bill by Judith McGeary, Esq. – May 20, 2011 http://www.ftcldf.org/federal/111_Cong-S510.htm http://www.govtrack.us/congress/bill.xpd?bill=s111-510 http://www.ftcldf.org/fda-acts-on-food-safety-bill.htm The Food and Drug Administration (FDA) recently issued the first new rules under the Food Safety Modernization Act (FSMA), meeting the initial deadlines imposed by the Act. The first rule addresses prior notice of food shipments imported from other countries. Under current law, anyone who is importing food that is subject to FDA’s jurisdiction (i.e. anything except meat, poultry, or egg products) must submit prior notification to the FDA [See 21 C.F.R. § 1.278-1.279]. The FSMA added the new requirement that such notice include “any country to which the article has been refused entry” [FSMA Sec. 304]. The FDA’s new rule amends the regulations accordingly. The second rule addresses the standard for FDA to administratively detain food. Administrative detention is a limited enforcement power — the agency can detain an article of food for no more than 30 days [See 21 C.F.R. § 1.379]. The purpose of the detention is to keep the food out of commerce while the FDA institutes a seizure or injunction action. The FSMA lowered the standard necessary for FDA to administratively detain food, from “credible evidence” that the food “presents a threat of serious adverse health consequences of death” to “reason to believe” that the food is “adulterated or misbranded.” The FDA’s recent interim rule incorporates the new, lower standard. http://youtu.be/OddINatuAXw http://youtu.be/b27EFldZ17k http://www.ftcldf.org/fda-acts-on-food-safety-http://www.govtrack.us/congress/billtext.xpd?bill=h111-875 H. R. 875 http://www.govtrack.us/congress/bill.xpd?bill=s111-510 http://www.ftcldf.org/fda-acts-on-food-safety-bill.htmhttp://www.ftcldf.org/federal/111_Cong-S510.htm [111th Congress Public Law 353]
[From the U.S. Government Printing Office]

[[Page 124 STAT. 3885]]

Public Law 111-353
111th Congress

An Act

To amend the Federal Food, Drug, and Cosmetic Act with respect to the
safety of the food supply. <>

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <>
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

(a) <> Short Title.–This Act may be cited
as the “FDA Food Safety Modernization Act”.

(b) References.–Except as otherwise specified, whenever in this Act
an amendment is expressed in terms of an amendment to a section or other
provision, the reference shall be considered to be made to a section or
other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(c) Table of Contents.–The table of contents for this Act is as
follows:

Sec. 1. Short title; references; table of contents.

TITLE I–IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

Sec. 101. Inspections of records.
Sec. 102. Registration of food facilities.
Sec. 103. Hazard analysis and risk-based preventive controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce safety.
Sec. 106. Protection against intentional adulteration.
Sec. 107. Authority to collect fees.
Sec. 108. National agriculture and food defense strategy.
Sec. 109. Food and Agriculture Coordinating Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of food.
Sec. 112. Food allergy and anaphylaxis management.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance relating to post harvest processing
of raw oysters.
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.

TITLE II–IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY
PROBLEMS

Sec. 201. Targeting of inspection resources for domestic facilities,
foreign facilities, and ports of entry; annual report.
Sec. 202. Laboratory accreditation for analyses of foods.
Sec. 203. Integrated consortium of laboratory networks.
Sec. 204. Enhancing tracking and tracing of food and recordkeeping.
Sec. 205. Surveillance.
Sec. 206. Mandatory recall authority.
Sec. 207. Administrative detention of food.
Sec. 208. Decontamination and disposal standards and plans.
Sec. 209. Improving the training of State, local, territorial, and
tribal food safety officials.
Sec. 210. Enhancing food safety.

[[Page 124 STAT. 3886]]

Sec. 211. Improving the reportable food registry.

TITLE III–IMPROVING THE SAFETY OF IMPORTED FOOD

Sec. 301. Foreign supplier verification program.
Sec. 302. Voluntary qualified importer program.
Sec. 303. Authority to require import certifications for food.
Sec. 304. Prior notice of imported food shipments.
Sec. 305. Building capacity of foreign governments with respect to food
safety.
Sec. 306. Inspection of foreign food facilities.
Sec. 307. Accreditation of third-party auditors.
Sec. 308. Foreign offices of the Food and Drug Administration.
Sec. 309. Smuggled food.

TITLE IV–MISCELLANEOUS PROVISIONS

Sec. 401. Funding for food safety.
Sec. 402. Employee protections.
Sec. 403. Jurisdiction; authorities.
Sec. 404. Compliance with international agreements.
Sec. 405. Determination of budgetary effects.

TITLE I–IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS

SEC. 101. INSPECTIONS OF RECORDS.

(a) In General.–Section 414(a) (21 U.S.C. 350c(a)) is amended–
(1) by striking the heading and all that follows through
“of food is” and inserting the following: “Records
Inspection.–
“(1) Adulterated food.–If the Secretary has a reasonable
belief that an article of food, and any other article of food
that the Secretary reasonably believes is likely to be affected
in a similar manner, is”;
(2) by inserting “, and to any other article of food that
the Secretary reasonably believes is likely to be affected in a
similar manner,” after “relating to such article”;
(3) by striking the last sentence; and
(4) by inserting at the end the following:
“(2) Use of or exposure to food of
concern. <> –If the Secretary believes that
there is a reasonable probability that the use of or exposure to
an article of food, and any other article of food that the
Secretary reasonably believes is likely to be affected in a
similar manner, will cause serious adverse health consequences
or death to humans or animals, each person (excluding farms and
restaurants) who manufactures, processes, packs, distributes,
receives, holds, or imports such article shall, at the request
of an officer or employee duly designated by the Secretary,
permit such officer or employee, upon presentation of
appropriate credentials and a written notice to such person, at
reasonable times and within reasonable limits and in a
reasonable manner, to have access to and copy all records
relating to such article and to any other article of food that
the Secretary reasonably believes is likely to be affected in a
similar manner, that are needed to assist the Secretary in
determining whether there is a reasonable probability that the
use of or exposure to the food will cause serious adverse health
consequences or death to humans or animals.
“(3) Application.–The requirement under paragraphs (1) and
(2) applies to all records relating to the manufacture,
processing, packing, distribution, receipt, holding, or
importation of such article maintained by or on behalf of such
person

[[Page 124 STAT. 3887]]

in any format (including paper and electronic formats) and at
any location.”.

(b) Conforming Amendment.–Section 704(a)(1)(B) (21 U.S.C.
374(a)(1)(B)) is amended by striking “section 414 when” and all that
follows through “subject to” and inserting “section 414, when the
standard for records inspection under paragraph (1) or (2) of section
414(a) applies, subject to”.
SEC. 102. REGISTRATION OF FOOD FACILITIES.

(a) Updating of Food Category Regulations; Biennial Registration
Renewal.–Section 415(a) (21 U.S.C. 350d(a)) is amended–
(1) in paragraph (2), by–
(A) striking “conducts business and” and inserting
“conducts business, the e-mail address for the contact
person of the facility or, in the case of a foreign
facility, the United States agent for the facility,
and”; and
(B) inserting “, or any other food categories as
determined appropriate by the Secretary, including by
guidance” after “Code of Federal Regulations”;
(2) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively; and
(3) by inserting after paragraph (2) the following:
“(3) Biennial registration renewal. <> –During the period beginning on October 1 and ending
on December 31 of each even-numbered year, a registrant that has
submitted a registration under paragraph (1) shall submit to the
Secretary a renewal registration containing the information
described in paragraph (2). The Secretary shall provide for an
abbreviated registration renewal process for any registrant that
has not had any changes to such information since the registrant
submitted the preceding registration or registration renewal for
the facility involved.”.

(b) Suspension of Registration.–
(1) In general.–Section 415 (21 U.S.C. 350d) is amended–
(A) in subsection (a)(2), by inserting after the
first sentence the following: “The registration shall
contain an assurance that the Secretary will be
permitted to inspect such facility at the times and in
the manner permitted by this Act.”;
(B) by redesignating subsections (b) and (c) as
subsections (c) and (d), respectively; and
(C) by inserting after subsection (a) the following:

“(b) Suspension of Registration.–
“(1) In general.–If the Secretary determines that food
manufactured, processed, packed, received, or held by a facility
registered under this section has a reasonable probability of
causing serious adverse health consequences or death to humans
or animals, the Secretary may by order suspend the registration
of a facility–
“(A) that created, caused, or was otherwise
responsible for such reasonable probability; or
“(B)(i) that knew of, or had reason to know of,
such reasonable probability; and
“(ii) packed, received, or held such food.

[[Page 124 STAT. 3888]]

“(2) Hearing on suspension. <> –The
Secretary shall provide the registrant subject to an order under
paragraph (1) with an opportunity for an informal hearing, to be
held as soon as possible but not later than 2 business days
after the issuance of the order or such other time period, as
agreed upon by the Secretary and the registrant, on the actions
required for reinstatement of registration and why the
registration that is subject to suspension should be reinstated.
The Secretary shall reinstate a registration if the Secretary
determines, based on evidence presented, that adequate grounds
do not exist to continue the suspension of the registration.
“(3) Post-hearing corrective action plan; vacating of
order.–
“(A) Corrective action plan.–If, after providing
opportunity for an informal hearing under paragraph (2),
the Secretary determines that the suspension of
registration remains necessary, the Secretary shall
require the registrant to submit a corrective action
plan to demonstrate how the registrant plans to correct
the conditions found by the
Secretary. <> The Secretary shall
review such plan not later than 14 days after the
submission of the corrective action plan or such other
time period as determined by the Secretary.
“(B) Vacating of order.–Upon a determination by
the Secretary that adequate grounds do not exist to
continue the suspension actions required by the order,
or that such actions should be modified, the Secretary
shall promptly vacate the order and reinstate the
registration of the facility subject to the order or
modify the order, as appropriate.
“(4) Effect of suspension.–If the registration of a
facility is suspended under this subsection, no person shall
import or export food into the United States from such facility,
offer to import or export food into the United States from such
facility, or otherwise introduce food from such facility into
interstate or intrastate commerce in the United States.
“(5) Regulations.–
“(A) In general.–The Secretary shall promulgate
regulations to implement this subsection. The Secretary
may promulgate such regulations on an interim final
basis.
“(B) Registration requirement.–The Secretary may
require that registration under this section be
submitted in an electronic format. Such requirement may
not take effect before the date that is 5 years after
the date of enactment of the FDA Food Safety
Modernization Act.
“(6) Application date. <> —
Facilities shall be subject to the requirements of this
subsection beginning on the earlier of–
“(A) the date on which the Secretary issues
regulations under paragraph (5); or
“(B) 180 days after the date of enactment of the
FDA Food Safety Modernization Act.
“(7) No delegation.–The authority conferred by this
subsection to issue an order to suspend a registration or vacate
an order of suspension shall not be delegated to any officer or
employee other than the Commissioner.”.
(2) <> Small entity
compliance policy guide.–Not later than 180 days after the
issuance of the regulations promulgated

[[Page 124 STAT. 3889]]

under section 415(b)(5) of the Federal Food, Drug, and Cosmetic
Act (as added by this section), the Secretary shall issue a
small entity compliance policy guide setting forth in plain
language the requirements of such regulations to assist small
entities in complying with registration requirements and other
activities required under such section.
(3) Imported food.–Section 801(l) (21 U.S.C. 381(l)) is
amended by inserting “(or for which a registration has been
suspended under such section)” after “section 415”.

(c) <> Clarification of Intent.–
(1) Retail food establishment.–The Secretary shall amend
the definition of the term “retail food establishment” in
section in 1.227(b)(11) of title 21, Code of Federal Regulations
to clarify that, in determining the primary function of an
establishment or a retail food establishment under such section,
the sale of food products directly to consumers by such
establishment and the sale of food directly to consumers by such
retail food establishment include–
(A) the sale of such food products or food directly
to consumers by such establishment at a roadside stand
or farmers’ market where such stand or market is located
other than where the food was manufactured or processed;
(B) the sale and distribution of such food through a
community supported agriculture program; and
(C) the sale and distribution of such food at any
other such direct sales platform as determined by the
Secretary.
(2) Definitions.–For purposes of paragraph (1)–
(A) the term “community supported agriculture
program” has the same meaning given the term
“community supported agriculture (CSA) program” in
section 249.2 of title 7, Code of Federal Regulations
(or any successor regulation); and
(B) the term “consumer” does not include a
business.

(d) Conforming Amendments.–
(1) Section 301(d) (21 U.S.C. 331(d)) is amended by
inserting “415,” after “404,”.
(2) Section 415(d), as redesignated by subsection
(b), <> is amended by adding at the end
before the period “for a facility to be registered, except with
respect to the reinstatement of a registration that is suspended
under subsection (b)”.
SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

(a) In General.–Chapter IV (21 U.S.C. 341 et seq.) is amended by
adding at the end the following:
“SEC. 418. <> HAZARD ANALYSIS AND RISK-BASED
PREVENTIVE CONTROLS.

“(a) In General.–The owner, operator, or agent in charge of a
facility shall, in accordance with this section, evaluate the hazards
that could affect food manufactured, processed, packed, or held by such
facility, identify and implement preventive controls to significantly
minimize or prevent the occurrence of such hazards and provide
assurances that such food is not adulterated under section 402 or
misbranded under section 403(w), monitor the performance of those
controls, and maintain records of this monitoring as a matter of routine
practice.

[[Page 124 STAT. 3890]]

“(b) Hazard Analysis.–The owner, operator, or agent in charge of a
facility shall–
“(1) identify and evaluate known or reasonably foreseeable
hazards that may be associated with the facility, including–
“(A) biological, chemical, physical, and
radiological hazards, natural toxins, pesticides, drug
residues, decomposition, parasites, allergens, and
unapproved food and color additives; and
“(B) hazards that occur naturally, or may be
unintentionally introduced; and
“(2) identify and evaluate hazards that may be
intentionally introduced, including by acts of terrorism; and
“(3) develop a written analysis of the hazards.

“(c) Preventive Controls.–The owner, operator, or agent in charge
of a facility shall identify and implement preventive controls,
including at critical control points, if any, to provide assurances
that–
“(1) hazards identified in the hazard analysis conducted
under subsection (b)(1) will be significantly minimized or
prevented;
“(2) any hazards identified in the hazard analysis
conducted under subsection (b)(2) will be significantly
minimized or prevented and addressed, consistent with section
420, as applicable; and
“(3) the food manufactured, processed, packed, or held by
such facility will not be adulterated under section 402 or
misbranded under section 403(w).

“(d) Monitoring of Effectiveness.–The owner, operator, or agent in
charge of a facility shall monitor the effectiveness of the preventive
controls implemented under subsection (c) to provide assurances that the
outcomes described in subsection (c) shall be achieved.
“(e) Corrective Actions. <> –The owner,
operator, or agent in charge of a facility shall establish procedures to
ensure that, if the preventive controls implemented under subsection (c)
are not properly implemented or are found to be ineffective–
“(1) appropriate action is taken to reduce the likelihood
of recurrence of the implementation failure;
“(2) all affected food is evaluated for safety; and
“(3) all affected food is prevented from entering into
commerce if the owner, operator or agent in charge of such
facility cannot ensure that the affected food is not adulterated
under section 402 or misbranded under section 403(w).

“(f) Verification.–The owner, operator, or agent in charge of a
facility shall verify that–
“(1) the preventive controls implemented under subsection
(c) are adequate to control the hazards identified under
subsection (b);
“(2) the owner, operator, or agent is conducting monitoring
in accordance with subsection (d);
“(3) the owner, operator, or agent is making appropriate
decisions about corrective actions taken under subsection (e);
“(4) the preventive controls implemented under subsection
(c) are effectively and significantly minimizing or preventing
the occurrence of identified hazards, including through the use
of environmental and product testing programs and other
appropriate means; and

[[Page 124 STAT. 3891]]

“(5) there is documented, periodic reanalysis of the plan
under subsection (i) to ensure that the plan is still relevant
to the raw materials, conditions and processes in the facility,
and new and emerging threats.

“(g) Recordkeeping. <> –The owner, operator,
or agent in charge of a facility shall maintain, for not less than 2
years, records documenting the monitoring of the preventive controls
implemented under subsection (c), instances of nonconformance material
to food safety, the results of testing and other appropriate means of
verification under subsection (f)(4), instances when corrective actions
were implemented, and the efficacy of preventive controls and corrective
actions.

“(h) Written Plan and Documentation.–The owner, operator, or agent
in charge of a facility shall prepare a written plan that documents and
describes the procedures used by the facility to comply with the
requirements of this section, including analyzing the hazards under
subsection (b) and identifying the preventive controls adopted under
subsection (c) to address those hazards. Such written plan, together
with the documentation described in subsection (g), shall be made
promptly available to a duly authorized representative of the Secretary
upon oral or written request.
“(i) Requirement To Reanalyze. <> –The owner,
operator, or agent in charge of a facility shall conduct a reanalysis
under subsection (b) whenever a significant change is made in the
activities conducted at a facility operated by such owner, operator, or
agent if the change creates a reasonable potential for a new hazard or a
significant increase in a previously identified hazard or not less
frequently than once every 3 years, whichever is earlier. Such
reanalysis shall be completed and additional preventive controls needed
to address the hazard identified, if any, shall be implemented before
the change in activities at the facility is operative. Such owner,
operator, or agent shall revise the written plan required under
subsection (h) if such a significant change is made or document the
basis for the conclusion that no additional or revised preventive
controls are needed. The Secretary may require a reanalysis under this
section to respond to new hazards and developments in scientific
understanding, including, as appropriate, results from the Department of
Homeland Security biological, chemical, radiological, or other terrorism
risk assessment.

“(j) Exemption for Seafood, Juice, and Low-acid Canned Food
Facilities Subject to HACCP.–
“(1) In general.–This section shall not apply to a
facility if the owner, operator, or agent in charge of such
facility is required to comply with, and is in compliance with,
1 of the following standards and regulations with respect to
such facility:
“(A) The Seafood Hazard Analysis Critical Control
Points Program of the Food and Drug Administration.
“(B) The Juice Hazard Analysis Critical Control
Points Program of the Food and Drug Administration.
“(C) The Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers standards of
the Food and Drug Administration (or any successor
standards).
“(2) Applicability.–The exemption under paragraph (1)(C)
shall apply only with respect to microbiological hazards that
are regulated under the standards for Thermally Processed

[[Page 124 STAT. 3892]]

Low-Acid Foods Packaged in Hermetically Sealed Containers under
part 113 of chapter 21, Code of Federal Regulations (or any
successor regulations).

“(k) Exception for Activities of Facilities Subject to Section
419.–This section shall not apply to activities of a facility that are
subject to section 419.
“(l) Modified Requirements for Qualified Facilities.–
“(1) Qualified facilities.–
“(A) In general.–A facility is a qualified
facility for purposes of this subsection if the facility
meets the conditions under subparagraph (B) or (C).
“(B) Very small business.–A facility is a
qualified facility under this subparagraph–
“(i) if the facility, including any
subsidiary or affiliate of the facility, is,
collectively, a very small business (as defined in
the regulations promulgated under subsection (n));
and
“(ii) in the case where the facility is a
subsidiary or affiliate of an entity, if such
subsidiaries or affiliates, are, collectively, a
very small business (as so defined).
“(C) <> Limited annual
monetary value of sales.–
“(i) In general.–A facility is a qualified
facility under this subparagraph if clause (ii)
applies–
“(I) to the facility, including any
subsidiary or affiliate of the facility,
collectively; and
“(II) to the subsidiaries or
affiliates, collectively, of any entity
of which the facility is a subsidiary or
affiliate.
“(ii) Average annual monetary value.–This
clause applies if–
“(I) during the 3-year period
preceding the applicable calendar year,
the average annual monetary value of the
food manufactured, processed, packed, or
held at such facility (or the collective
average annual monetary value of such
food at any subsidiary or affiliate, as
described in clause (i)) that is sold
directly to qualified end-users during
such period exceeded the average annual
monetary value of the food manufactured,
processed, packed, or held at such
facility (or the collective average
annual monetary value of such food at
any subsidiary or affiliate, as so
described) sold by such facility (or
collectively by any such subsidiary or
affiliate) to all other purchasers
during such period; and
“(II) the average annual monetary
value of all food sold by such facility
(or the collective average annual
monetary value of such food sold by any
subsidiary or affiliate, as described in
clause (i)) during such period was less
than $500,000, adjusted for inflation.
“(2) Exemption.–A qualified facility–
“(A) shall not be subject to the requirements under
subsections (a) through (i) and subsection (n) in an
applicable calendar year; and
“(B) shall submit to the Secretary–

[[Page 124 STAT. 3893]]

“(i)(I) documentation that demonstrates that
the owner, operator, or agent in charge of the
facility has identified potential hazards
associated with the food being produced, is
implementing preventive controls to address the
hazards, and is monitoring the preventive controls
to ensure that such controls are effective; or
“(II) documentation (which may include
licenses, inspection reports, certificates,
permits, credentials, certification by an
appropriate agency (such as a State department of
agriculture), or other evidence of oversight), as
specified by the Secretary, that the facility is
in compliance with State, local, county, or other
applicable non-Federal food safety law; and
“(ii) <> documentation, as
specified by the Secretary in a guidance document
issued not later than 1 year after the date of
enactment of this section, that the facility is a
qualified facility under paragraph (1)(B) or
(1)(C).
“(3) Withdrawal; rule of construction.–
“(A) In general.–In the event of an active
investigation of a foodborne illness outbreak that is
directly linked to a qualified facility subject to an
exemption under this subsection, or if the Secretary
determines that it is necessary to protect the public
health and prevent or mitigate a foodborne illness
outbreak based on conduct or conditions associated with
a qualified facility that are material to the safety of
the food manufactured, processed, packed, or held at
such facility, the Secretary may withdraw the exemption
provided to such facility under this subsection.
“(B) Rule of construction.–Nothing in this
subsection shall be construed to expand or limit the
inspection authority of the Secretary.
“(4) Definitions.–In this subsection:
“(A) Affiliate.–The term `affiliate’ means any
facility that controls, is controlled by, or is under
common control with another facility.
“(B) Qualified end-user.–The term `qualified end-
user’, with respect to a food, means–
“(i) the consumer of the food; or
“(ii) a restaurant or retail food
establishment (as those terms are defined by the
Secretary for purposes of section 415) that–
“(I) is located–
“(aa) in the same State as
the qualified facility that sold
the food to such restaurant or
establishment; or
“(bb) not more than 275
miles from such facility; and
“(II) is purchasing the food for
sale directly to consumers at such
restaurant or retail food establishment.
“(C) Consumer.–For purposes of subparagraph (B),
the term `consumer’ does not include a business.
“(D) Subsidiary.–The term `subsidiary’ means any
company which is owned or controlled directly or
indirectly by another company.

[[Page 124 STAT. 3894]]

“(5) Study.–
“(A) In general.–The Secretary, in consultation
with the Secretary of Agriculture, shall conduct a study
of the food processing sector regulated by the Secretary
to determine–
“(i) the distribution of food production by
type and size of operation, including monetary
value of food sold;
“(ii) the proportion of food produced by each
type and size of operation;
“(iii) the number and types of food
facilities co-located on farms, including the
number and proportion by commodity and by
manufacturing or processing activity;
“(iv) the incidence of foodborne illness
originating from each size and type of operation
and the type of food facilities for which no
reported or known hazard exists; and
“(v) the effect on foodborne illness risk
associated with commingling, processing,
transporting, and storing food and raw
agricultural commodities, including differences in
risk based on the scale and duration of such
activities.
“(B) Size.–The results of the study conducted
under subparagraph (A) shall include the information
necessary to enable the Secretary to define the terms
`small business’ and `very small business’, for purposes
of promulgating the regulation under subsection (n). In
defining such terms, the Secretary shall include
consideration of harvestable acres, income, the number
of employees, and the volume of food harvested.
“(C) Submission of report.–Not later than 18
months after the date of enactment the FDA Food Safety
Modernization Act, the Secretary shall submit to
Congress a report that describes the results of the
study conducted under subparagraph (A).
“(6) No preemption.–Nothing in this subsection preempts
State, local, county, or other non-Federal law regarding the
safe production of food. Compliance with this subsection shall
not relieve any person from liability at common law or under
State statutory law.
“(7) Notification to consumers.–
“(A) In general.–A qualified facility that is
exempt from the requirements under subsections (a)
through (i) and subsection (n) and does not prepare
documentation under paragraph (2)(B)(i)(I) shall–
“(i) with respect to a food for which a food
packaging label is required by the Secretary under
any other provision of this Act, include
prominently and conspicuously on such label the
name and business address of the facility where
the food was manufactured or processed; or
“(ii) with respect to a food for which a food
packaging label is not required by the Secretary
under any other provisions of this Act,
prominently and conspicuously display, at the
point of purchase, the name and business address
of the facility where the

[[Page 124 STAT. 3895]]

food was manufactured or processed, on a label,
poster, sign, placard, or documents delivered
contemporaneously with the food in the normal
course of business, or, in the case of Internet
sales, in an electronic notice.
“(B) No additional label.–Subparagraph (A) does
not provide authority to the Secretary to require a
label that is in addition to any label required under
any other provision of this Act.

“(m) Authority With Respect to Certain Facilities.–The Secretary
may, by regulation, exempt or modify the requirements for compliance
under this section with respect to facilities that are solely engaged in
the production of food for animals other than man, the storage of raw
agricultural commodities (other than fruits and vegetables) intended for
further distribution or processing, or the storage of packaged foods
that are not exposed to the environment.
“(n) Regulations.–
“(1) In general. <> –Not later than 18
months after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall promulgate regulations–
“(A) to establish science-based minimum standards
for conducting a hazard analysis, documenting hazards,
implementing preventive controls, and documenting the
implementation of the preventive controls under this
section; and
“(B) to define, for purposes of this section, the
terms `small business’ and `very small business’, taking
into consideration the study described in subsection
(l)(5).
“(2) Coordination.–In promulgating the regulations under
paragraph (1)(A), with regard to hazards that may be
intentionally introduced, including by acts of terrorism, the
Secretary shall coordinate with the Secretary of Homeland
Security, as appropriate.
“(3) Content.–The regulations promulgated under paragraph
(1)(A) shall–
“(A) provide sufficient flexibility to be
practicable for all sizes and types of facilities,
including small businesses such as a small food
processing facility co-located on a farm;
“(B) comply with chapter 35 of title 44, United
States Code (commonly known as the `Paperwork Reduction
Act’), with special attention to minimizing the burden
(as defined in section 3502(2) of such Act) on the
facility, and collection of information (as defined in
section 3502(3) of such Act), associated with such
regulations;
“(C) acknowledge differences in risk and minimize,
as appropriate, the number of separate standards that
apply to separate foods; and
“(D) not require a facility to hire a consultant or
other third party to identify, implement, certify, or
audit preventative controls, except in the case of
negotiated enforcement resolutions that may require such
a consultant or third party.
“(4) Rule of construction.–Nothing in this subsection
shall be construed to provide the Secretary with the authority
to prescribe specific technologies, practices, or critical
controls for an individual facility.

[[Page 124 STAT. 3896]]

“(5) Review.–In promulgating the regulations under
paragraph (1)(A), the Secretary shall review regulatory hazard
analysis and preventive control programs in existence on the
date of enactment of the FDA Food Safety Modernization Act,
including the Grade `A’ Pasteurized Milk Ordinance to ensure
that such regulations are consistent, to the extent practicable,
with applicable domestic and internationally-recognized
standards in existence on such date.

“(o) Definitions.–For purposes of this section:
“(1) Critical control point.–The term `critical control
point’ means a point, step, or procedure in a food process at
which control can be applied and is essential to prevent or
eliminate a food safety hazard or reduce such hazard to an
acceptable level.
“(2) Facility.–The term `facility’ means a domestic
facility or a foreign facility that is required to register
under section 415.
“(3) Preventive controls.–The term `preventive controls’
means those risk-based, reasonably appropriate procedures,
practices, and processes that a person knowledgeable about the
safe manufacturing, processing, packing, or holding of food
would employ to significantly minimize or prevent the hazards
identified under the hazard analysis conducted under subsection
(b) and that are consistent with the current scientific
understanding of safe food manufacturing, processing, packing,
or holding at the time of the analysis. Those procedures,
practices, and processes may include the following:
“(A) Sanitation procedures for food contact
surfaces and utensils and food-contact surfaces of
equipment.
“(B) Supervisor, manager, and employee hygiene
training.
“(C) An environmental monitoring program to verify
the effectiveness of pathogen controls in processes
where a food is exposed to a potential contaminant in
the environment.
“(D) A food allergen control program.
“(E) A recall plan.
“(F) Current Good Manufacturing Practices (cGMPs)
under part 110 of title 21, Code of Federal Regulations
(or any successor regulations).
“(G) Supplier verification activities that relate
to the safety of food.”.

(b) <> Guidance Document.–The Secretary
shall issue a guidance document related to the regulations promulgated
under subsection (b)(1) with respect to the hazard analysis and
preventive controls under section 418 of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)).

(c) <> Rulemaking.–
(1) Proposed rulemaking.–
(A) In general. <> –Not later than 9 months after
the date of enactment of this Act, the Secretary of
Health and Human Services (referred to in this
subsection as the “Secretary”) shall publish a notice
of proposed rulemaking in the Federal Register to
promulgate regulations with respect to–
(i) activities that constitute on-farm packing
or holding of food that is not grown, raised, or
consumed

[[Page 124 STAT. 3897]]

on such farm or another farm under the same
ownership for purposes of section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350d), as amended by this Act; and
(ii) activities that constitute on-farm
manufacturing or processing of food that is not
consumed on that farm or on another farm under
common ownership for purposes of such section 415.
(B) Clarification.–The rulemaking described under
subparagraph (A) shall enhance the implementation of
such section 415 and clarify the activities that are
included as part of the definition of the term
“facility” under such section 415. Nothing in this Act
authorizes the Secretary to modify the definition of the
term “facility” under such section.
(C) Science-based risk analysis.–In promulgating
regulations under subparagraph (A), the Secretary shall
conduct a science-based risk analysis of–
(i) specific types of on-farm packing or
holding of food that is not grown, raised, or
consumed on such farm or another farm under the
same ownership, as such packing and holding
relates to specific foods; and
(ii) specific on-farm manufacturing and
processing activities as such activities relate to
specific foods that are not consumed on that farm
or on another farm under common ownership.
(D) Authority with respect to certain facilities.–
(i) In general.–In promulgating the
regulations under subparagraph (A), the Secretary
shall consider the results of the science-based
risk analysis conducted under subparagraph (C),
and shall exempt certain facilities from the
requirements in section 418 of the Federal Food,
Drug, and Cosmetic Act (as added by this section),
including hazard analysis and preventive controls,
and the mandatory inspection frequency in section
421 of such Act (as added by section 201), or
modify the requirements in such sections 418 or
421, as the Secretary determines appropriate, if
such facilities are engaged only in specific types
of on-farm manufacturing, processing, packing, or
holding activities that the Secretary determines
to be low risk involving specific foods the
Secretary determines to be low risk.
(ii) Limitation. <> —
The exemptions or modifications under clause (i)
shall not include an exemption from the
requirement to register under section 415 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350d), as amended by this Act, if applicable, and
shall apply only to small businesses and very
small businesses, as defined in the regulation
promulgated under section 418(n) of the Federal
Food, Drug, and Cosmetic Act (as added under
subsection (a)).
(2) Final regulations.–Not later than 9 months after the
close of the comment period for the proposed rulemaking under
paragraph (1), the Secretary shall adopt final rules with
respect to–

[[Page 124 STAT. 3898]]

(A) activities that constitute on-farm packing or
holding of food that is not grown, raised, or consumed
on such farm or another farm under the same ownership
for purposes of section 415 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350d), as amended by this
Act;
(B) activities that constitute on-farm manufacturing
or processing of food that is not consumed on that farm
or on another farm under common ownership for purposes
of such section 415; and
(C) the requirements under sections 418 and 421 of
the Federal Food, Drug, and Cosmetic Act, as added by
this Act, from which the Secretary may issue exemptions
or modifications of the requirements for certain types
of facilities.

(d) Small Entity Compliance Policy Guide. <> –Not later than 180 days after the issuance of the
regulations promulgated under subsection (n) of section 418 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the
Secretary shall issue a small entity compliance policy guide setting
forth in plain language the requirements of such section 418 and this
section to assist small entities in complying with the hazard analysis
and other activities required under such section 418 and this section.

(e) Prohibited Acts.–Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
“(uu) The operation of a facility that manufactures, processes,
packs, or holds food for sale in the United States if the owner,
operator, or agent in charge of such facility is not in compliance with
section 418.”.
(f) <> No Effect on HACCP Authorities.–
Nothing in the amendments made by this section limits the authority of
the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to
revise, issue, or enforce Hazard Analysis Critical Control programs and
the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers standards.

(g) <> Dietary
Supplements.–Nothing in the amendments made by this section shall apply
to any facility with regard to the manufacturing, processing, packing,
or holding of a dietary supplement that is in compliance with the
requirements of sections 402(g)(2) and 761 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa-1).

(h) <> Updating Guidance Relating to Fish
and Fisheries Products Hazards and Controls. <> –The
Secretary shall, not later than 180 days after the date of enactment of
this Act, update the Fish and Fisheries Products Hazards and Control
Guidance to take into account advances in technology that have occurred
since the previous publication of such Guidance by the Secretary.

(i) <> Effective Dates.–
(1) General rule.–The amendments made by this section shall
take effect 18 months after the date of enactment of this Act.
(2) <> Flexibility
for small businesses.–Notwithstanding paragraph (1)–
(A) the amendments made by this section shall apply
to a small business (as defined in the regulations
promulgated under section 418(n) of the Federal Food,
Drug, and Cosmetic Act (as added by this section))
beginning on the

[[Page 124 STAT. 3899]]

date that is 6 months after the effective date of such
regulations; and
(B) the amendments made by this section shall apply
to a very small business (as defined in such
regulations) beginning on the date that is 18 months
after the effective date of such regulations.
SEC. 104. <> PERFORMANCE STANDARDS.

(a) In General. <> –The Secretary shall, in
coordination with the Secretary of Agriculture, not less frequently than
every 2 years, review and evaluate relevant health data and other
relevant information, including from toxicological and epidemiological
studies and analyses, current Good Manufacturing Practices issued by the
Secretary relating to food, and relevant recommendations of relevant
advisory committees, including the Food Advisory Committee, to determine
the most significant foodborne contaminants.

(b) Guidance Documents and Regulations.–Based on the review and
evaluation conducted under subsection (a), and when appropriate to
reduce the risk of serious illness or death to humans or animals or to
prevent adulteration of the food under section 402 of the Federal Food,
Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent the spread by food
of communicable disease under section 361 of the Public Health Service
Act (42 U.S.C. 264), the Secretary shall issue contaminant-specific and
science-based guidance documents, including guidance documents regarding
action levels, or regulations. Such guidance, including guidance
regarding action levels, or regulations–
(1) <> shall apply to products or
product classes;
(2) shall, where appropriate, differentiate between food for
human consumption and food intended for consumption by animals
other than humans; and
(3) shall not be written to be facility-specific.

(c) No Duplication of Efforts.–The Secretary shall coordinate with
the Secretary of Agriculture to avoid issuing duplicative guidance on
the same contaminants.
(d) Review.–The Secretary shall periodically review and revise, as
appropriate, the guidance documents, including guidance documents
regarding action levels, or regulations promulgated under this section.
SEC. 105. STANDARDS FOR PRODUCE SAFETY.

(a) In General.–Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 103, is amended by adding at the end the following:
“SEC. 419. <> STANDARDS FOR PRODUCE SAFETY.

“(a) Proposed Rulemaking.–
“(1) In general.–
“(A)
Rulemaking. <> —
Not later than 1 year after the date of enactment of the
FDA Food Safety Modernization Act, the Secretary, in
coordination with the Secretary of Agriculture and
representatives of State departments of agriculture
(including with regard to the national organic program
established under the Organic Foods Production Act of
1990), and in consultation with the Secretary of
Homeland Security, shall publish a notice of proposed
rulemaking to establish science-based minimum standards
for the safe production and harvesting of those types of
fruits

[[Page 124 STAT. 3900]]

and vegetables, including specific mixes or categories
of fruits and vegetables, that are raw agricultural
commodities for which the Secretary has determined that
such standards minimize the risk of serious adverse
health consequences or death.
“(B) Determination by secretary.–With respect to
small businesses and very small businesses (as such
terms are defined in the regulation promulgated under
subparagraph (A)) that produce and harvest those types
of fruits and vegetables that are raw agricultural
commodities that the Secretary has determined are low
risk and do not present a risk of serious adverse health
consequences or death, the Secretary may determine not
to include production and harvesting of such fruits and
vegetables in such rulemaking, or may modify the
applicable requirements of regulations promulgated
pursuant to this section.
“(2) Public input.–During the comment period on the notice
of proposed rulemaking under paragraph (1), the Secretary shall
conduct not less than 3 public meetings in diverse geographical
areas of the United States to provide persons in different
regions an opportunity to comment.
“(3) Content.–The proposed rulemaking under paragraph (1)
shall–
“(A) provide sufficient flexibility to be
applicable to various types of entities engaged in the
production and harvesting of fruits and vegetables that
are raw agricultural commodities, including small
businesses and entities that sell directly to consumers,
and be appropriate to the scale and diversity of the
production and harvesting of such commodities;
“(B) include, with respect to growing, harvesting,
sorting, packing, and storage operations, science-based
minimum standards related to soil amendments, hygiene,
packaging, temperature controls, animals in the growing
area, and water;
“(C) consider hazards that occur naturally, may be
unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism;
“(D) take into consideration, consistent with
ensuring enforceable public health protection,
conservation and environmental practice standards and
policies established by Federal natural resource
conservation, wildlife conservation, and environmental
agencies;
“(E) in the case of production that is certified
organic, not include any requirements that conflict with
or duplicate the requirements of the national organic
program established under the Organic Foods Production
Act of 1990, while providing the same level of public
health protection as the requirements under guidance
documents, including guidance documents regarding action
levels, and regulations under the FDA Food Safety
Modernization Act; and
“(F) define, for purposes of this section, the
terms `small business’ and `very small business’.
“(4) Prioritization.–The Secretary shall prioritize the
implementation of the regulations under this section for
specific fruits and vegetables that are raw agricultural
commodities

[[Page 124 STAT. 3901]]

based on known risks which may include a history and severity of
foodborne illness outbreaks.

“(b) Final Regulation.–
“(1) In general. <> –Not later than 1
year after the close of the comment period for the proposed
rulemaking under subsection (a), the Secretary shall adopt a
final regulation to provide for minimum science-based standards
for those types of fruits and vegetables, including specific
mixes or categories of fruits or vegetables, that are raw
agricultural commodities, based on known safety risks, which may
include a history of foodborne illness outbreaks.
“(2) Final regulation.–The final regulation shall–
“(A) provide for coordination of education and
enforcement activities by State and local officials, as
designated by the Governors of the respective States or
the appropriate elected State official as recognized by
State statute; and
“(B) include a description of the variance process
under subsection (c) and the types of permissible
variances the Secretary may grant.
“(3) Flexibility for small
businesses. <> —
Notwithstanding paragraph (1)–
“(A) the regulations promulgated under this section
shall apply to a small business (as defined in the
regulation promulgated under subsection (a)(1)) after
the date that is 1 year after the effective date of the
final regulation under paragraph (1); and
“(B) the regulations promulgated under this section
shall apply to a very small business (as defined in the
regulation promulgated under subsection (a)(1)) after
the date that is 2 years after the effective date of the
final regulation under paragraph (1).

“(c) Criteria.–
“(1) In general.–The regulations adopted under subsection
(b) shall–
“(A) set forth those procedures, processes, and
practices that the Secretary determines to minimize the
risk of serious adverse health consequences or death,
including procedures, processes, and practices that the
Secretary determines to be reasonably necessary to
prevent the introduction of known or reasonably
foreseeable biological, chemical, and physical hazards,
including hazards that occur naturally, may be
unintentionally introduced, or may be intentionally
introduced, including by acts of terrorism, into fruits
and vegetables, including specific mixes or categories
of fruits and vegetables, that are raw agricultural
commodities and to provide reasonable assurances that
the produce is not adulterated under section 402;
“(B) provide sufficient flexibility to be
practicable for all sizes and types of businesses,
including small businesses such as a small food
processing facility co-located on a farm;
“(C) comply with chapter 35 of title 44, United
States Code (commonly known as the `Paperwork Reduction
Act’), with special attention to minimizing the burden
(as defined in section 3502(2) of such Act) on the
business, and collection of information (as defined in
section 3502(3) of such Act), associated with such
regulations;

[[Page 124 STAT. 3902]]

“(D) acknowledge differences in risk and minimize,
as appropriate, the number of separate standards that
apply to separate foods; and
“(E) not require a business to hire a consultant or
other third party to identify, implement, certify,
compliance with these procedures, processes, and
practices, except in the case of negotiated enforcement
resolutions that may require such a consultant or third
party; and
“(F) permit States and foreign countries from which
food is imported into the United States to request from
the Secretary variances from the requirements of the
regulations, subject to paragraph (2), where the State
or foreign country determines that the variance is
necessary in light of local growing conditions and that
the procedures, processes, and practices to be followed
under the variance are reasonably likely to ensure that
the produce is not adulterated under section 402 and to
provide the same level of public health protection as
the requirements of the regulations adopted under
subsection (b).
“(2) Variances.–
“(A) Requests for variances.–A State or foreign
country from which food is imported into the United
States may in writing request a variance from the
Secretary. Such request shall describe the variance
requested and present information demonstrating that the
variance does not increase the likelihood that the food
for which the variance is requested will be adulterated
under section 402, and that the variance provides the
same level of public health protection as the
requirements of the regulations adopted under subsection
(b). The Secretary shall review such requests in a
reasonable timeframe.
“(B) Approval of variances.–The Secretary may
approve a variance in whole or in part, as appropriate,
and may specify the scope of applicability of a variance
to other similarly situated persons.
“(C) Denial of variances.–The Secretary may deny a
variance request if the Secretary determines that such
variance is not reasonably likely to ensure that the
food is not adulterated under section 402 and is not
reasonably likely to provide the same level of public
health protection as the requirements of the regulation
adopted under subsection (b). <>
The Secretary shall notify the person requesting such
variance of the reasons for the denial.
“(D) Modification or revocation of a variance.–The
Secretary, after notice and an opportunity for a
hearing, may modify or revoke a variance if the
Secretary determines that such variance is not
reasonably likely to ensure that the food is not
adulterated under section 402 and is not reasonably
likely to provide the same level of public health
protection as the requirements of the regulations
adopted under subsection (b).

“(d) Enforcement. <> –The Secretary may
coordinate with the Secretary of Agriculture and, as appropriate, shall
contract and coordinate with the agency or department designated by the
Governor of each State to perform activities to ensure compliance with
this section.

“(e) Guidance.–

[[Page 124 STAT. 3903]]

“(1) In
general. <> –Not
later than 1 year after the date of enactment of the FDA Food
Safety Modernization Act, the Secretary shall publish, after
consultation with the Secretary of Agriculture, representatives
of State departments of agriculture, farmer representatives, and
various types of entities engaged in the production and
harvesting or importing of fruits and vegetables that are raw
agricultural commodities, including small businesses, updated
good agricultural practices and guidance for the safe production
and harvesting of specific types of fresh produce under this
section.
“(2) Public meetings.–The Secretary shall conduct not
fewer than 3 public meetings in diverse geographical areas of
the United States as part of an effort to conduct education and
outreach regarding the guidance described in paragraph (1) for
persons in different regions who are involved in the production
and harvesting of fruits and vegetables that are raw
agricultural commodities, including persons that sell directly
to consumers and farmer representatives, and for importers of
fruits and vegetables that are raw agricultural commodities.
“(3) Paperwork reduction.–The Secretary shall ensure that
any updated guidance under this section will–
“(A) provide sufficient flexibility to be
practicable for all sizes and types of facilities,
including small businesses such as a small food
processing facility co-located on a farm; and
“(B) acknowledge differences in risk and minimize,
as appropriate, the number of separate standards that
apply to separate foods.

“(f) Exemption for Direct Farm Marketing.–
“(1) In general.–A farm shall be exempt from the
requirements under this section in a calendar year if–
“(A) during the previous 3-year period, the average
annual monetary value of the food sold by such farm
directly to qualified end-users during such period
exceeded the average annual monetary value of the food
sold by such farm to all other buyers during such
period; and
“(B) the average annual monetary value of all food
sold during such period was less than $500,000, adjusted
for inflation.
“(2) Notification to consumers.–
“(A) In general.–A farm that is exempt from the
requirements under this section shall–
“(i) with respect to a food for which a food
packaging label is required by the Secretary under
any other provision of this Act, include
prominently and conspicuously on such label the
name and business address of the farm where the
produce was grown; or
“(ii) with respect to a food for which a food
packaging label is not required by the Secretary
under any other provision of this Act, prominently
and conspicuously display, at the point of
purchase, the name and business address of the
farm where the produce was grown, on a label,
poster, sign, placard, or documents delivered
contemporaneously with the

[[Page 124 STAT. 3904]]

food in the normal course of business, or, in the
case of Internet sales, in an electronic notice.
“(B) No additional label.–Subparagraph (A) does
not provide authority to the Secretary to require a
label that is in addition to any label required under
any other provision of this Act.
“(3) Withdrawal; rule of construction.–
“(A) In general.–In the event of an active
investigation of a foodborne illness outbreak that is
directly linked to a farm subject to an exemption under
this subsection, or if the Secretary determines that it
is necessary to protect the public health and prevent or
mitigate a foodborne illness outbreak based on conduct
or conditions associated with a farm that are material
to the safety of the food produced or harvested at such
farm, the Secretary may withdraw the exemption provided
to such farm under this subsection.
“(B) Rule of construction.–Nothing in this
subsection shall be construed to expand or limit the
inspection authority of the Secretary.
“(4) Definitions.–
“(A) Qualified end-user.–In this subsection, the
term `qualified end-user’, with respect to a food
means–
“(i) the consumer of the food; or
“(ii) a restaurant or retail food
establishment (as those terms are defined by the
Secretary for purposes of section 415) that is
located–
“(I) in the same State as the farm
that produced the food; or
“(II) not more than 275 miles from
such farm.
“(B) Consumer.–For purposes of subparagraph (A),
the term `consumer’ does not include a business.
“(5) No preemption.–Nothing in this subsection preempts
State, local, county, or other non-Federal law regarding the
safe production, harvesting, holding, transportation, and sale
of fresh fruits and vegetables. Compliance with this subsection
shall not relieve any person from liability at common law or
under State statutory law.
“(6) Limitation of effect.–Nothing in this subsection
shall prevent the Secretary from exercising any authority
granted in the other sections of this Act.

“(g) Clarification.–This section shall not apply to produce that
is produced by an individual for personal consumption.
“(h) Exception for Activities of Facilities Subject to Section
418.–This section shall not apply to activities of a facility that are
subject to section 418.”.
(b) Small Entity Compliance Policy Guide. <> –Not later than 180 days after the issuance of regulations
under section 419 of the Federal Food, Drug, and Cosmetic Act (as added
by subsection (a)), the Secretary of Health and Human Services shall
issue a small entity compliance policy guide setting forth in plain
language the requirements of such section 419 and to assist small
entities in complying with standards for safe production and harvesting
and other activities required under such section.

(c) Prohibited Acts.–Section 301 (21 U.S.C. 331), as amended by
section 103, is amended by adding at the end the following:

[[Page 124 STAT. 3905]]

“(vv) The failure to comply with the requirements under section
419.”.
(d) <> No Effect on HACCP Authorities.–
Nothing in the amendments made by this section limits the authority of
the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to
revise, issue, or enforce product and category-specific regulations,
such as the Seafood Hazard Analysis Critical Controls Points Program,
the Juice Hazard Analysis Critical Control Program, and the Thermally
Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
standards.
SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.

(a) In General.–Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 105, is amended by adding at the end the following:
“SEC. 420. <> PROTECTION AGAINST INTENTIONAL
ADULTERATION.

“(a) Determinations.–
“(1) In general.–The Secretary shall–
“(A) conduct a vulnerability assessment of the food
system, including by consideration of the Department of
Homeland Security biological, chemical, radiological, or
other terrorism risk assessments;
“(B) consider the best available understanding of
uncertainties, risks, costs, and benefits associated
with guarding against intentional adulteration of food
at vulnerable points; and
“(C) <> determine the types
of science-based mitigation strategies or measures that
are necessary to protect against the intentional
adulteration of food.
“(2) Limited distribution.–In the interest of national
security, the Secretary, in consultation with the Secretary of
Homeland Security, may determine the time, manner, and form in
which determinations made under paragraph (1) are made publicly
available.

“(b) Regulations. <> –Not later than 18 months
after the date of enactment of the FDA Food Safety Modernization Act,
the Secretary, in coordination with the Secretary of Homeland Security
and in consultation with the Secretary of Agriculture, shall promulgate
regulations to protect against the intentional adulteration of food
subject to this Act. Such regulations shall–
“(1) specify how a person shall assess whether the person
is required to implement mitigation strategies or measures
intended to protect against the intentional adulteration of
food; and
“(2) specify appropriate science-based mitigation
strategies or measures to prepare and protect the food supply
chain at specific vulnerable points, as appropriate.

“(c) Applicability.–Regulations promulgated under subsection (b)
shall apply only to food for which there is a high risk of intentional
contamination, as determined by the Secretary, in consultation with the
Secretary of Homeland Security, under subsection (a), that could cause
serious adverse health consequences or death to humans or animals and
shall include those foods–
“(1) for which the Secretary has identified clear
vulnerabilities (including short shelf-life or susceptibility to
intentional contamination at critical control points); and

[[Page 124 STAT. 3906]]

“(2) in bulk or batch form, prior to being packaged for the
final consumer.

“(d) Exception.–This section shall not apply to farms, except for
those that produce milk.
“(e) Definition.–For purposes of this section, the term `farm’ has
the meaning given that term in section 1.227 of title 21, Code of
Federal Regulations (or any successor regulation).”.
(b) Guidance Documents.–
(1) In general. <> –Not later than 1 year
after the date of enactment of this Act, the Secretary of Health
and Human Services, in consultation with the Secretary of
Homeland Security and the Secretary of Agriculture, shall issue
guidance documents related to protection against the intentional
adulteration of food, including mitigation strategies or
measures to guard against such adulteration as required under
section 420 of the Federal Food, Drug, and Cosmetic Act, as
added by subsection (a).
(2) Content.–The guidance documents issued under paragraph
(1) shall–
(A) include a model assessment for a person to use
under subsection (b)(1) of section 420 of the Federal
Food, Drug, and Cosmetic Act, as added by subsection
(a);
(B) include examples of mitigation strategies or
measures described in subsection (b)(2) of such section;
and
(C) specify situations in which the examples of
mitigation strategies or measures described in
subsection (b)(2) of such section are appropriate.
(3) Limited distribution.–In the interest of national
security, the Secretary of Health and Human Services, in
consultation with the Secretary of Homeland Security, may
determine the time, manner, and form in which the guidance
documents issued under paragraph (1) are made public, including
by releasing such documents to targeted audiences.

(c) <> Periodic Review.–The Secretary of
Health and Human Services shall periodically review and, as appropriate,
update the regulations under section 420(b) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), and the guidance documents
under subsection (b).

(d) Prohibited Acts.–Section 301 (21 U.S.C. 331 et seq.), as
amended by section 105, is amended by adding at the end the following:
“(ww) The failure to comply with section 420.”.
SEC. 107. AUTHORITY TO COLLECT FEES.

(a) Fees for Reinspection, Recall, and Importation Activities.–
Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is amended by
adding at the end the following:

“PART 6–FEES RELATED TO FOOD

“SEC. 743. <> AUTHORITY TO COLLECT AND
USE FEES.

“(a) In General.–
“(1) Purpose and authority.–For fiscal year 2010 and each
subsequent fiscal year, the Secretary shall, in accordance with
this section, assess and collect fees from–
“(A) the responsible party for each domestic
facility (as defined in section 415(b)) and the United
States agent

[[Page 124 STAT. 3907]]

for each foreign facility subject to a reinspection in
such fiscal year, to cover reinspection-related costs
for such year;
“(B) the responsible party for a domestic facility
(as defined in section 415(b)) and an importer who does
not comply with a recall order under section 423 or
under section 412(f) in such fiscal year, to cover food
recall activities associated with such order performed
by the Secretary, including technical assistance,
follow-up effectiveness checks, and public
notifications, for such year;
“(C) each importer participating in the voluntary
qualified importer program under section 806 in such
year, to cover the administrative costs of such program
for such year; and
“(D) each importer subject to a reinspection in
such fiscal year, to cover reinspection-related costs
for such year.
“(2) Definitions.–For purposes of this section–
“(A) the term `reinspection’ means–
“(i) with respect to domestic facilities (as
defined in section 415(b)), 1 or more inspections
conducted under section 704 subsequent to an
inspection conducted under such provision which
identified noncompliance materially related to a
food safety requirement of this Act, specifically
to determine whether compliance has been achieved
to the Secretary’s satisfaction; and
“(ii) with respect to importers, 1 or more
examinations conducted under section 801
subsequent to an examination conducted under such
provision which identified noncompliance
materially related to a food safety requirement of
this Act, specifically to determine whether
compliance has been achieved to the Secretary’s
satisfaction;
“(B) the term `reinspection-related costs’ means
all expenses, including administrative expenses,
incurred in connection with–
“(i) arranging, conducting, and evaluating
the results of reinspections; and
“(ii) assessing and collecting reinspection
fees under this section; and
“(C) the term `responsible party’ has the meaning
given such term in section 417(a)(1).

“(b) Establishment of Fees.–
“(1) In general. <> –Subject to subsections (c)
and (d), the Secretary shall establish the fees to be collected
under this section for each fiscal year specified in subsection
(a)(1), based on the methodology described under paragraph (2),
and shall publish such fees in a Federal Register notice not
later than 60 days before the start of each such year.
“(2) Fee methodology.–
“(A) Fees.–Fees amounts established for
collection–
“(i) under subparagraph (A) of subsection
(a)(1) for a fiscal year shall be based on the
Secretary’s estimate of 100 percent of the costs
of the reinspection-related activities (including
by type or level of reinspection activity, as the
Secretary determines applicable) described in such
subparagraph (A) for such year;

[[Page 124 STAT. 3908]]

“(ii) under subparagraph (B) of subsection
(a)(1) for a fiscal year shall be based on the
Secretary’s estimate of 100 percent of the costs
of the activities described in such subparagraph
(B) for such year;
“(iii) under subparagraph (C) of subsection
(a)(1) for a fiscal year shall be based on the
Secretary’s estimate of 100 percent of the costs
of the activities described in such subparagraph
(C) for such year; and
“(iv) under subparagraph (D) of subsection
(a)(1) for a fiscal year shall be based on the
Secretary’s estimate of 100 percent of the costs
of the activities described in such subparagraph
(D) for such year.
“(B) Other considerations.–
“(i) Voluntary qualified importer program.–
In establishing the fee amounts under subparagraph
(A)(iii) for a fiscal year, the Secretary shall
provide for the number of importers who have
submitted to the Secretary a notice under section
806(c) informing the Secretary of the intent of
such importer to participate in the program under
section 806 in such fiscal year.
“(II) Recoupment.–In establishing
the fee amounts under subparagraph
(A)(iii) for the first 5 fiscal years
after the date of enactment of this
section, the Secretary shall include in
such fee a reasonable surcharge that
provides a recoupment of the costs
expended by the Secretary to establish
and implement the first year of the
program under section 806.
“(ii) Crediting of fees.–In establishing the
fee amounts under subparagraph (A) for a fiscal
year, the Secretary shall provide for the
crediting of fees from the previous year to the
next year if the Secretary overestimated the
amount of fees needed to carry out such
activities, and consider the need to account for
any adjustment of fees and such other factors as
the Secretary determines appropriate.
“(iii) Published
guidelines. <> –Not later than
180 days after the date of enactment of the FDA
Food Safety Modernization Act, the Secretary shall
publish in the Federal Register a proposed set of
guidelines in consideration of the burden of fee
amounts on small business. Such consideration may
include reduced fee amounts for small businesses.
The Secretary shall provide for a period of public
comment on such guidelines. The Secretary shall
adjust the fee schedule for small businesses
subject to such fees only through notice and
comment rulemaking.
“(3) Use of fees.–The Secretary shall make all of the fees
collected pursuant to clause (i), (ii), (iii), and (iv) of
paragraph (2)(A) available solely to pay for the costs referred
to in such clause (i), (ii), (iii), and (iv) of paragraph
(2)(A), respectively.

“(c) Limitations.–
“(1) In general.–Fees under subsection (a) shall be
refunded for a fiscal year beginning after fiscal year 2010
unless the amount of the total appropriations for food safety

[[Page 124 STAT. 3909]]

activities at the Food and Drug Administration for such fiscal
year (excluding the amount of fees appropriated for such fiscal
year) is equal to or greater than the amount of appropriations
for food safety activities at the Food and Drug Administration
for fiscal year 2009 (excluding the amount of fees appropriated
for such fiscal year), multiplied by the adjustment factor under
paragraph (3).
“(2) Authority.–If–
“(A) the Secretary does not assess fees under
subsection (a) for a portion of a fiscal year because
paragraph (1) applies; and
“(B) at a later date in such fiscal year, such
paragraph (1) ceases to apply,
the Secretary may assess and collect such fees under subsection
(a), without any modification to the rate of such fees,
notwithstanding the provisions of subsection (a) relating to the
date fees are to be paid.
“(3) Adjustment factor.–
“(A) In general.–The adjustment factor described
in paragraph (1) shall be the total percentage change
that occurred in the Consumer Price Index for all urban
consumers (all items; United States city average) for
the 12-month period ending June 30 preceding the fiscal
year, but in no case shall such adjustment factor be
negative.
“(B) Compounded basis.–The adjustment under
subparagraph (A) made each fiscal year shall be added on
a compounded basis to the sum of all adjustments made
each fiscal year after fiscal year 2009.
“(4) Limitation on amount of certain fees.–
“(A) In general.–Notwithstanding any other
provision of this section and subject to subparagraph
(B), the Secretary may not collect fees in a fiscal year
such that the amount collected–
“(i) under subparagraph (B) of subsection
(a)(1) exceeds $20,000,000; and
“(ii) under subparagraphs (A) and (D) of
subsection (a)(1) exceeds $25,000,000 combined.
“(B) Exception.–If a domestic facility (as defined
in section 415(b)) or an importer becomes subject to a
fee described in subparagraph (A), (B), or (D) of
subsection (a)(1) after the maximum amount of fees has
been collected by the Secretary under subparagraph (A),
the Secretary may collect a fee from such facility or
importer.

“(d) Crediting and Availability of Fees.–Fees authorized under
subsection (a) shall be collected and available for obligation only to
the extent and in the amount provided in appropriations Acts. Such fees
are authorized to remain available until expended. Such sums as may be
necessary may be transferred from the Food and Drug Administration
salaries and expenses account without fiscal year limitation to such
appropriation account for salaries and expenses with such fiscal year
limitation. The sums transferred shall be available solely for the
purpose of paying the operating expenses of the Food and Drug
Administration employees and contractors performing activities
associated with these food safety fees.
“(e) Collection of Fees.–
“(1) In general.–The Secretary shall specify in the
Federal Register notice described in subsection (b)(1) the time

[[Page 124 STAT. 3910]]

and manner in which fees assessed under this section shall be
collected.
“(2) Collection of unpaid fees. <> –In
any case where the Secretary does not receive payment of a fee
assessed under this section within 30 days after it is due, such
fee shall be treated as a claim of the United States Government
subject to provisions of subchapter II of chapter 37 of title
31, United States Code.

“(f) Annual Report to Congress.–Not later than 120 days after each
fiscal year for which fees are assessed under this section, the
Secretary shall submit a report to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, to include a description of
fees assessed and collected for each such year and a summary description
of the entities paying such fees and the types of business in which such
entities engage.
“(g) Authorization of Appropriations.–For fiscal year 2010 and
each fiscal year thereafter, there is authorized to be appropriated for
fees under this section an amount equal to the total revenue amount
determined under subsection (b) for the fiscal year, as adjusted or
otherwise affected under the other provisions of this section.”.
(b) Export Certification Fees for Foods and Animal Feed.–
(1) Authority for export certifications for food, including
animal feed.–Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is
amended–
(A) in the matter preceding clause (i), by striking
“a drug” and inserting “a food, drug”;
(B) in clause (i) by striking “exported drug” and
inserting “exported food, drug”; and
(C) in clause (ii) by striking “the drug” each
place it appears and inserting “the food, drug”.
(2) Clarification of certification.–Section 801(e)(4) (21
U.S.C. 381(e)(4)) is amended by inserting after subparagraph (B)
the following new subparagraph:
“(C) For purposes of this paragraph, a
certification by the Secretary shall be made on such
basis, and in such form (including a publicly available
listing) as the Secretary determines appropriate.”.
(3) Limitations on the use and amount of fees.–Paragraph
(4) of section 801(e) (21 U.S.C. 381(e)) is amended by adding at
the end the following:
“(D) With regard to fees pursuant to subparagraph
(B) in connection with written export certifications for
food:
“(i) Such fees shall be collected and
available solely for the costs of the Food and
Drug Administration associated with issuing such
certifications.
“(ii) Such fees may not be retained in an
amount that exceeds such costs for the respective
fiscal year.”
SEC. 108. <> NATIONAL AGRICULTURE AND FOOD
DEFENSE STRATEGY.

(a) Development and Submission of Strategy.–
(1) In general. <> –Not later
than 1 year after the date of enactment of this Act, the
Secretary of Health and Human Services and the Secretary of
Agriculture, in coordination with the Secretary of Homeland
Security, shall prepare and transmit

[[Page 124 STAT. 3911]]

to the relevant committees of Congress, and make publicly
available on the Internet Web sites of the Department of Health
and Human Services and the Department of Agriculture, the
National Agriculture and Food Defense Strategy.
(2) Implementation plan.–The strategy shall include an
implementation plan for use by the Secretaries described under
paragraph (1) in carrying out the strategy.
(3) Research.–The strategy shall include a coordinated
research agenda for use by the Secretaries described under
paragraph (1) in conducting research to support the goals and
activities described in paragraphs (1) and (2) of subsection
(b).
(4) Revisions. <> –Not later than 4 years
after the date on which the strategy is submitted to the
relevant committees of Congress under paragraph (1), and not
less frequently than every 4 years thereafter, the Secretary of
Health and Human Services and the Secretary of Agriculture, in
coordination with the Secretary of Homeland Security, shall
revise and submit to the relevant committees of Congress the
strategy.
(5) Consistency with existing plans.–The strategy described
in paragraph (1) shall be consistent with–
(A) the National Incident Management System;
(B) the National Response Framework;
(C) the National Infrastructure Protection Plan;
(D) the National Preparedness Goals; and
(E) other relevant national strategies.

(b) Components.–
(1) In general.–The strategy shall include a description of
the process to be used by the Department of Health and Human
Services, the Department of Agriculture, and the Department of
Homeland Security–
(A) to achieve each goal described in paragraph (2);
and
(B) to evaluate the progress made by Federal, State,
local, and tribal governments towards the achievement of
each goal described in paragraph (2).
(2) Goals.–The strategy shall include a description of the
process to be used by the Department of Health and Human
Services, the Department of Agriculture, and the Department of
Homeland Security to achieve the following goals:
(A) Preparedness goal.–Enhance the preparedness of
the agriculture and food system by–
(i) conducting vulnerability assessments of
the agriculture and food system;
(ii) mitigating vulnerabilities of the system;
(iii) improving communication and training
relating to the system;
(iv) developing and conducting exercises to
test decontamination and disposal plans;
(v) developing modeling tools to improve event
consequence assessment and decision support; and
(vi) preparing risk communication tools and
enhancing public awareness through outreach.
(B) Detection goal.–Improve agriculture and food
system detection capabilities by–
(i) identifying contamination in food products
at the earliest possible time; and

[[Page 124 STAT. 3912]]

(ii) conducting surveillance to prevent the
spread of diseases.
(C) Emergency response goal.–Ensure an efficient
response to agriculture and food emergencies by–
(i) immediately investigating animal disease
outbreaks and suspected food contamination;
(ii) preventing additional human illnesses;
(iii) organizing, training, and equipping
animal, plant, and food emergency response teams
of–
(I) the Federal Government; and
(II) State, local, and tribal
governments;
(iv) designing, developing, and evaluating
training and exercises carried out under
agriculture and food defense plans; and
(v) ensuring consistent and organized risk
communication to the public by–
(I) the Federal Government;
(II) State, local, and tribal
governments; and
(III) the private sector.
(D) Recovery goal.–Secure agriculture and food
production after an agriculture or food emergency by–
(i) working with the private sector to develop
business recovery plans to rapidly resume
agriculture, food production, and international
trade;
(ii) conducting exercises of the plans
described in subparagraph (C) with the goal of
long-term recovery results;
(iii) rapidly removing, and effectively
disposing of–
(I) contaminated agriculture and
food products; and
(II) infected plants and animals;
and
(iv) decontaminating and restoring areas
affected by an agriculture or food emergency.
(3) Evaluation.–The Secretary, in coordination with the
Secretary of Agriculture and the Secretary of Homeland Security,
shall–
(A) develop metrics to measure progress for the
evaluation process described in paragraph (1)(B); and
(B) <> report on the progress
measured in subparagraph (A) as part of the National
Agriculture and Food Defense strategy described in
subsection (a)(1).

(c) Limited Distribution.–In the interest of national security, the
Secretary of Health and Human Services and the Secretary of Agriculture,
in coordination with the Secretary of Homeland Security, may determine
the manner and format in which the National Agriculture and Food Defense
strategy established under this section is made publicly available on
the Internet Web sites of the Department of Health and Human Services,
the Department of Homeland Security, and the Department of Agriculture,
as described in subsection (a)(1).
SEC. 109. <>
FOOD AND AGRICULTURE COORDINATING
COUNCILS.

The Secretary of Homeland Security, in coordination with the
Secretary of Health and Human Services and the Secretary of Agriculture,
shall within 180 days of enactment of this Act, and annually thereafter,
submit to the relevant committees of Congress,

[[Page 124 STAT. 3913]]

and make publicly available on the Internet Web site of the Department
of Homeland Security, a report on the activities of the Food and
Agriculture Government Coordinating Council and the Food and Agriculture
Sector Coordinating Council, including the progress of such Councils
on–
(1) facilitating partnerships between public and private
entities to help coordinate and enhance the protection of the
agriculture and food system of the United States;
(2) providing for the regular and timely interchange of
information between each council relating to the security of the
agriculture and food system (including intelligence
information);
(3) identifying best practices and methods for improving the
coordination among Federal, State, local, and private sector
preparedness and response plans for agriculture and food
defense; and
(4) recommending methods by which to protect the economy and
the public health of the United States from the effects of–
(A) animal or plant disease outbreaks;
(B) food contamination; and
(C) natural disasters affecting agriculture and
food.
SEC. 110. <> BUILDING DOMESTIC CAPACITY.

(a) In General.–
(1) Initial report.–The Secretary, in coordination with the
Secretary of Agriculture and the Secretary of Homeland Security,
shall, not later than 2 years after the date of enactment of
this Act, submit to Congress a comprehensive report that
identifies programs and practices that are intended to promote
the safety and supply chain security of food and to prevent
outbreaks of foodborne illness and other food-related hazards
that can be addressed through preventive activities. Such report
shall include a description of the following:
(A) Analysis of the need for further regulations or
guidance to industry.
(B) Outreach to food industry sectors, including
through the Food and Agriculture Coordinating Councils
referred to in section 109, to identify potential
sources of emerging threats to the safety and security
of the food supply and preventive strategies to address
those threats.
(C) Systems to ensure the prompt distribution to the
food industry of information and technical assistance
concerning preventive strategies.
(D) Communication systems to ensure that information
about specific threats to the safety and security of the
food supply are rapidly and effectively disseminated.
(E) Surveillance systems and laboratory networks to
rapidly detect and respond to foodborne illness
outbreaks and other food-related hazards, including how
such systems and networks are integrated.
(F) Outreach, education, and training provided to
States and local governments to build State and local
food safety and food defense capabilities, including
progress implementing strategies developed under
sections 108 and 205.

[[Page 124 STAT. 3914]]

(G) The estimated resources needed to effectively
implement the programs and practices identified in the
report developed in this section over a 5-year period.
(H) The impact of requirements under this Act
(including amendments made by this Act) on certified
organic farms and facilities (as defined in section 415
(21 U.S.C. 350d).
(I) Specific efforts taken pursuant to the
agreements authorized under section 421(c) of the
Federal Food, Drug, and Cosmetic Act (as added by
section 201), together with, as necessary, a description
of any additional authorities necessary to improve
seafood safety.
(2) Biennial reports.–On a biennial basis following the
submission of the report under paragraph (1), the Secretary
shall submit to Congress a report that–
(A) reviews previous food safety programs and
practices;
(B) outlines the success of those programs and
practices;
(C) identifies future programs and practices; and
(D) includes information related to any matter
described in subparagraphs (A) through (H) of paragraph
(1), as necessary.

(b) Risk-based Activities.–The report developed under subsection
(a)(1) shall describe methods that seek to ensure that resources
available to the Secretary for food safety-related activities are
directed at those actions most likely to reduce risks from food,
including the use of preventive strategies and allocation of inspection
resources. The Secretary shall promptly undertake those risk-based
actions that are identified during the development of the report as
likely to contribute to the safety and security of the food supply.
(c) Capability for Laboratory Analyses; Research.–The report
developed under subsection (a)(1) shall provide a description of methods
to increase capacity to undertake analyses of food samples promptly
after collection, to identify new and rapid analytical techniques,
including commercially-available techniques that can be employed at
ports of entry and by Food Emergency Response Network laboratories, and
to provide for well-equipped and staffed laboratory facilities and
progress toward laboratory accreditation under section 422 of the
Federal Food, Drug, and Cosmetic Act (as added by section 202).
(d) Information Technology.–The report developed under subsection
(a)(1) shall include a description of such information technology
systems as may be needed to identify risks and receive data from
multiple sources, including foreign governments, State, local, and
tribal governments, other Federal agencies, the food industry,
laboratories, laboratory networks, and consumers. The information
technology systems that the Secretary describes shall also provide for
the integration of the facility registration system under section 415 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), and the prior
notice system under section 801(m) of such Act (21 U.S.C. 381(m)) with
other information technology systems that are used by the Federal
Government for the processing of food offered for import into the United
States.
(e) Automated Risk Assessment.–The report developed under
subsection (a)(1) shall include a description of progress toward

[[Page 124 STAT. 3915]]

developing and improving an automated risk assessment system for food
safety surveillance and allocation of resources.
(f) Traceback and Surveillance Report.–The Secretary shall include
in the report developed under subsection (a)(1) an analysis of the Food
and Drug Administration’s performance in foodborne illness outbreaks
during the 5-year period preceding the date of enactment of this Act
involving fruits and vegetables that are raw agricultural commodities
(as defined in section 201(r) (21 U.S.C. 321(r)) and recommendations for
enhanced surveillance, outbreak response, and traceability. Such
findings and recommendations shall address communication and
coordination with the public, industry, and State and local governments,
as such communication and coordination relates to outbreak
identification and traceback.
(g) Biennial Food Safety and Food Defense Research Plan.–The
Secretary, the Secretary of Agriculture, and the Secretary of Homeland
Security shall, on a biennial basis, submit to Congress a joint food
safety and food defense research plan which may include studying the
long-term health effects of foodborne illness. Such biennial plan shall
include a list and description of projects conducted during the previous
2-year period and the plan for projects to be conducted during the
subsequent 2-year period.
(h) Effectiveness of Programs Administered by the Department of
Health and Human Services.–
(1) In general. <> –To determine whether
existing Federal programs administered by the Department of
Health and Human Services are effective in achieving the stated
goals of such programs, the Secretary shall, beginning not later
than 1 year after the date of enactment of this Act–
(A) conduct an annual evaluation of each program of
such Department to determine the effectiveness of each
such program in achieving legislated intent, purposes,
and objectives; and
(B) <> submit to Congress a report
concerning such evaluation.
(2) Content.–The report described under paragraph (1)(B)
shall–
(A) include conclusions concerning the reasons that
such existing programs have proven successful or not
successful and what factors contributed to such
conclusions;
(B) include recommendations for consolidation and
elimination to reduce duplication and inefficiencies in
such programs at such Department as identified during
the evaluation conduct under this subsection; and
(C) <> be made publicly
available in a publication entitled “Guide to the U.S.
Department of Health and Human Services Programs”.

(i) Unique Identification Numbers.–
(1) In general. <> –Not later than
1 year after the date of enactment of this Act, the Secretary,
acting through the Commissioner of Food and Drugs, shall conduct
a study regarding the need for, and challenges associated with,
development and implementation of a program that requires a
unique identification number for each food facility registered
with the Secretary and, as appropriate, each broker that imports
food into the United States. Such study shall include an
evaluation of the costs associated with development and
implementation

[[Page 124 STAT. 3916]]

of such a system, and make recommendations about what new
authorities, if any, would be necessary to develop and implement
such a system.
(2) Report.–Not later than 15 months after the date of
enactment of this Act, the Secretary shall submit to Congress a
report that describes the findings of the study conducted under
paragraph (1) and that includes any recommendations determined
appropriate by the Secretary.
SEC. 111. SANITARY TRANSPORTATION OF FOOD.

(a) In General. <> –Not later than 18 months after the date of enactment of this
Act, the Secretary shall promulgate regulations described in section
416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b)).

(b) Food Transportation Study.–The Secretary, acting through the
Commissioner of Food and Drugs, shall conduct a study of the
transportation of food for consumption in the United States, including
transportation by air, that includes an examination of the unique needs
of rural and frontier areas with regard to the delivery of safe food.
SEC. 112. <> FOOD ALLERGY AND ANAPHYLAXIS
MANAGEMENT.

(a) Definitions.–In this section:
(1) Early childhood education program.–The term “early
childhood education program” means–
(A) a Head Start program or an Early Head Start
program carried out under the Head Start Act (42 U.S.C.
9831 et seq.);
(B) a State licensed or regulated child care program
or school; or
(C) a State prekindergarten program that serves
children from birth through kindergarten.
(2) ESEA definitions.–The terms “local educational
agency”, “secondary school”, “elementary school”, and
“parent” have the meanings given the terms in section 9101 of
the Elementary and Secondary Education Act of 1965 (20 U.S.C.
7801).
(3) School.–The term “school” includes public–
(A) kindergartens;
(B) elementary schools; and
(C) secondary schools.
(4) Secretary.–The term “Secretary” means the Secretary
of Health and Human Services.

(b) Establishment of Voluntary Food Allergy and Anaphylaxis
Management Guidelines.–
(1) Establishment.–
(A) In general. <> –Not later than
1 year after the date of enactment of this Act, the
Secretary, in consultation with the Secretary of
Education, shall–
(i) develop guidelines to be used on a
voluntary basis to develop plans for individuals
to manage the risk of food allergy and anaphylaxis
in schools and early childhood education programs;
and
(ii) make such guidelines available to local
educational agencies, schools, early childhood
education programs, and other interested entities
and individuals to be implemented on a voluntary
basis only.

[[Page 124 STAT. 3917]]

(B) Applicability of ferpa.–Each plan described in
subparagraph (A) that is developed for an individual
shall be considered an education record for the purpose
of section 444 of the General Education Provisions Act
(commonly referred to as the “Family Educational Rights
and Privacy Act of 1974”) (20 U.S.C. 1232g).
(2) Contents.–The voluntary guidelines developed by the
Secretary under paragraph (1) shall address each of the
following and may be updated as the Secretary determines
necessary:
(A) Parental obligation to provide the school or
early childhood education program, prior to the start of
every school year, with–
(i) documentation from their child’s physician
or nurse–
(I) supporting a diagnosis of food
allergy, and any risk of anaphylaxis, if
applicable;
(II) identifying any food to which
the child is allergic;
(III) describing, if appropriate,
any prior history of anaphylaxis;
(IV) listing any medication
prescribed for the child for the
treatment of anaphylaxis;
(V) detailing emergency treatment
procedures in the event of a reaction;
(VI) listing the signs and symptoms
of a reaction; and
(VII) assessing the child’s
readiness for self-administration of
prescription medication; and
(ii) a list of substitute meals that may be
offered to the child by school or early childhood
education program food service personnel.
(B) The creation and maintenance of an individual
plan for food allergy management, in consultation with
the parent, tailored to the needs of each child with a
documented risk for anaphylaxis, including any
procedures for the self-administration of medication by
such children in instances where–
(i) the children are capable of self-
administering medication; and
(ii) such administration is not prohibited by
State law.
(C) Communication strategies between individual
schools or early childhood education programs and
providers of emergency medical services, including
appropriate instructions for emergency medical response.
(D) Strategies to reduce the risk of exposure to
anaphylactic causative agents in classrooms and common
school or early childhood education program areas such
as cafeterias.
(E) The dissemination of general information on
life-threatening food allergies to school or early
childhood education program staff, parents, and
children.
(F) Food allergy management training of school or
early childhood education program personnel who
regularly come into contact with children with life-
threatening food allergies.

[[Page 124 STAT. 3918]]

(G) The authorization and training of school or
early childhood education program personnel to
administer epinephrine when the nurse is not immediately
available.
(H) The timely accessibility of epinephrine by
school or early childhood education program personnel
when the nurse is not immediately available.
(I) The creation of a plan contained in each
individual plan for food allergy management that
addresses the appropriate response to an incident of
anaphylaxis of a child while such child is engaged in
extracurricular programs of a school or early childhood
education program, such as non-academic outings and
field trips, before- and after-school programs or
before- and after-early child education program
programs, and school-sponsored or early childhood
education program-sponsored programs held on weekends.
(J) Maintenance of information for each
administration of epinephrine to a child at risk for
anaphylaxis and prompt notification to parents.
(K) Other elements the Secretary determines
necessary for the management of food allergies and
anaphylaxis in schools and early childhood education
programs.
(3) Relation to state law.–Nothing in this section or the
guidelines developed by the Secretary under paragraph (1) shall
be construed to preempt State law, including any State law
regarding whether students at risk for anaphylaxis may self-
administer medication.

(c) School-based Food Allergy Management Grants.–
(1) In general.–The Secretary may award grants to local
educational agencies to assist such agencies with implementing
voluntary food allergy and anaphylaxis management guidelines
described in subsection (b).
(2) Application.–
(A) In general.–To be eligible to receive a grant
under this subsection, a local educational agency shall
submit an application to the Secretary at such time, in
such manner, and including such information as the
Secretary may reasonably require.
(B) Contents.–Each application submitted under
subparagraph (A) shall include–
(i) an assurance that the local educational
agency has developed plans in accordance with the
food allergy and anaphylaxis management guidelines
described in subsection (b);
(ii) a description of the activities to be
funded by the grant in carrying out the food
allergy and anaphylaxis management guidelines,
including–
(I) how the guidelines will be
carried out at individual schools served
by the local educational agency;
(II) how the local educational
agency will inform parents and students
of the guidelines in place;
(III) how school nurses, teachers,
administrators, and other school-based
staff will be made aware of, and given
training on, when applicable, the
guidelines in place; and

[[Page 124 STAT. 3919]]

(IV) any other activities that the
Secretary determines appropriate;
(iii) an itemization of how grant funds
received under this subsection will be expended;
(iv) a description of how adoption of the
guidelines and implementation of grant activities
will be monitored; and
(v) an agreement by the local educational
agency to report information required by the
Secretary to conduct evaluations under this
subsection.
(3) Use of funds.–Each local educational agency that
receives a grant under this subsection may use the grant funds
for the following:
(A) Purchase of materials and supplies, including
limited medical supplies such as epinephrine and
disposable wet wipes, to support carrying out the food
allergy and anaphylaxis management guidelines described
in subsection (b).
(B) In partnership with local health departments,
school nurse, teacher, and personnel training for food
allergy management.
(C) Programs that educate students as to the
presence of, and policies and procedures in place
related to, food allergies and anaphylactic shock.
(D) Outreach to parents.
(E) Any other activities consistent with the
guidelines described in subsection (b).
(4) Duration of awards.–The Secretary may award grants
under this subsection for a period of not more than 2 years. In
the event the Secretary conducts a program evaluation under this
subsection, funding in the second year of the grant, where
applicable, shall be contingent on a successful program
evaluation by the Secretary after the first year.
(5) Limitation on grant funding.–The Secretary may not
provide grant funding to a local educational agency under this
subsection after such local educational agency has received 2
years of grant funding under this subsection.
(6) Maximum amount of annual awards.–A grant awarded under
this subsection may not be made in an amount that is more than
$50,000 annually.
(7) Priority.–In awarding grants under this subsection, the
Secretary shall give priority to local educational agencies with
the highest percentages of children who are counted under
section 1124(c) of the Elementary and Secondary Education Act of
1965 (20 U.S.C. 6333(c)).
(8) Matching funds.–
(A) In general.–The Secretary may not award a grant
under this subsection unless the local educational
agency agrees that, with respect to the costs to be
incurred by such local educational agency in carrying
out the grant activities, the local educational agency
shall make available (directly or through donations from
public or private entities) non-Federal funds toward
such costs in an amount equal to not less than 25
percent of the amount of the grant.

[[Page 124 STAT. 3920]]

(B) Determination of amount of non-federal
contribution.–Non-Federal funds required under
subparagraph (A) may be cash or in kind, including
plant, equipment, or services. Amounts provided by the
Federal Government, and any portion of any service
subsidized by the Federal Government, may not be
included in determining the amount of such non-Federal
funds.
(9) Administrative funds.–A local educational agency that
receives a grant under this subsection may use not more than 2
percent of the grant amount for administrative costs related to
carrying out this subsection.
(10) Progress and evaluations.–At the completion of the
grant period referred to in paragraph (4), a local educational
agency shall provide the Secretary with information on how grant
funds were spent and the status of implementation of the food
allergy and anaphylaxis management guidelines described in
subsection (b).
(11) Supplement, not supplant.–Grant funds received under
this subsection shall be used to supplement, and not supplant,
non-Federal funds and any other Federal funds available to carry
out the activities described in this subsection.
(12) Authorization of appropriations.–There is authorized
to be appropriated to carry out this subsection $30,000,000 for
fiscal year 2011 and such sums as may be necessary for each of
the 4 succeeding fiscal years.

(d) Voluntary Nature of Guidelines.–
(1) In general.–The food allergy and anaphylaxis management
guidelines developed by the Secretary under subsection (b) are
voluntary. Nothing in this section or the guidelines developed
by the Secretary under subsection (b) shall be construed to
require a local educational agency to implement such guidelines.
(2) Exception.–Notwithstanding paragraph (1), the Secretary
may enforce an agreement by a local educational agency to
implement food allergy and anaphylaxis management guidelines as
a condition of the receipt of a grant under subsection (c).
SEC. 113. NEW DIETARY INGREDIENTS.

(a) In General.–Section 413 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 350b) is amended–
(1) by redesignating subsection (c) as subsection (d); and
(2) by inserting after subsection (b) the following:

“(c) Notification.–
“(1) In general.–If the Secretary determines that the
information in a new dietary ingredient notification submitted
under this section for an article purported to be a new dietary
ingredient is inadequate to establish that a dietary supplement
containing such article will reasonably be expected to be safe
because the article may be, or may contain, an anabolic steroid
or an analogue of an anabolic steroid, the Secretary shall
notify the Drug Enforcement Administration of such
determination. Such notification by the Secretary shall include,
at a minimum, the name of the dietary supplement or article, the
name of the person or persons who marketed the product or made

[[Page 124 STAT. 3921]]

the submission of information regarding the article to the
Secretary under this section, and any contact information for
such person or persons that the Secretary has.
“(2) Definitions.–For purposes of this subsection–
“(A) the term `anabolic steroid’ has the meaning
given such term in section 102(41) of the Controlled
Substances Act; and
“(B) the term `analogue of an anabolic steroid’
means a substance whose chemical structure is
substantially similar to the chemical structure of an
anabolic steroid.”.

(b) Guidance. <> —
Not later than 180 days after the date of enactment of this Act, the
Secretary shall publish guidance that clarifies when a dietary
supplement ingredient is a new dietary ingredient, when the manufacturer
or distributor of a dietary ingredient or dietary supplement should
provide the Secretary with information as described in section 413(a)(2)
of the Federal Food, Drug, and Cosmetic Act, the evidence needed to
document the safety of new dietary ingredients, and appropriate methods
for establishing the identify of a new dietary ingredient.
SEC. 114. <> REQUIREMENT FOR GUIDANCE
RELATING TO POST HARVEST PROCESSING OF RAW
OYSTERS.

(a) In General. <> –Not later than 90
days prior to the issuance of any guidance, regulation, or suggested
amendment by the Food and Drug Administration to the National Shellfish
Sanitation Program’s Model Ordinance, or the issuance of any guidance or
regulation by the Food and Drug Administration relating to the Seafood
Hazard Analysis Critical Control Points Program of the Food and Drug
Administration (parts 123 and 1240 of title 21, Code of Federal
Regulations (or any successor regulations), where such guidance,
regulation or suggested amendment relates to post harvest processing for
raw oysters, the Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a report which
shall include–
(1) an assessment of how post harvest processing or other
equivalent controls feasibly may be implemented in the fastest,
safest, and most economical manner;
(2) the projected public health benefits of any proposed
post harvest processing;
(3) the projected costs of compliance with such post harvest
processing measures;
(4) the impact post harvest processing is expected to have
on the sales, cost, and availability of raw oysters;
(5) criteria for ensuring post harvest processing standards
will be applied equally to shellfish imported from all nations
of origin;
(6) an evaluation of alternative measures to prevent,
eliminate, or reduce to an acceptable level the occurrence of
foodborne illness; and
(7) the extent to which the Food and Drug Administration has
consulted with the States and other regulatory agencies, as
appropriate, with regard to post harvest processing measures.

(b) Limitation.–Subsection (a) shall not apply to the guidance
described in section 103(h).

[[Page 124 STAT. 3922]]

(c) Review and Evaluation.–Not later than 30 days after the
Secretary issues a proposed regulation or guidance described in
subsection (a), the Comptroller General of the United States shall–
(1) review and evaluate the report described in (a) and
report to Congress on the findings of the estimates and analysis
in the report;
(2) compare such proposed regulation or guidance to similar
regulations or guidance with respect to other regulated foods,
including a comparison of risks the Secretary may find
associated with seafood and the instances of those risks in such
other regulated foods; and
(3) evaluate the impact of post harvest processing on the
competitiveness of the domestic oyster industry in the United
States and in international markets.

(d) Waiver.–The requirement of preparing a report under subsection
(a) shall be waived if the Secretary issues a guidance that is adopted
as a consensus agreement between Federal and State regulators and the
oyster industry, acting through the Interstate Shellfish Sanitation
Conference.
(e) Public Access.–Any report prepared under this section shall be
made available to the public.
SEC. 115. <> PORT SHOPPING.

<> Until the date on which the Secretary
promulgates a final rule that implements the amendments made by section
308 of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, (Public Law 107-188), the Secretary shall notify
the Secretary of Homeland Security of all instances in which the
Secretary refuses to admit a food into the United States under section
801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) so
that the Secretary of Homeland Security, acting through the Commissioner
of Customs and Border Protection, may prevent food refused admittance
into the United States by a United States port of entry from being
admitted by another United States port of entry, through the
notification of other such United States ports of entry.
SEC. 116. <> ALCOHOL-RELATED FACILITIES.

(a) In General.–Except as provided by sections 102, 206, 207, 302,
304, 402, 403, and 404 of this Act, and the amendments made by such
sections, nothing in this Act, or the amendments made by this Act, shall
be construed to apply to a facility that–
(1) under the Federal Alcohol Administration Act (27 U.S.C.
201 et seq.) or chapter 51 of subtitle E of the Internal Revenue
Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain a
permit or to register with the Secretary of the Treasury as a
condition of doing business in the United States; and
(2) under section 415 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350d) is required to register as a
facility because such facility is engaged in manufacturing,
processing, packing, or holding 1 or more alcoholic beverages,
with respect to the activities of such facility that relate to
the manufacturing, processing, packing, or holding of alcoholic
beverages.

(b) Limited Receipt and Distribution of Non-alcohol
Food. <> –Subsection (a) shall not apply to a
facility engaged in the receipt and distribution of any non-alcohol
food, except that such paragraph shall apply to a facility described in
such paragraph

[[Page 124 STAT. 3923]]

that receives and distributes non-alcohol food, provided such food is
received and distributed–
(1) in a prepackaged form that prevents any direct human
contact with such food; and
(2) in amounts that constitute not more than 5 percent of
the overall sales of such facility, as determined by the
Secretary of the Treasury.

(c) Rule of Construction.–Except as provided in subsections (a) and
(b), this section shall not be construed to exempt any food, other than
alcoholic beverages, as defined in section 214 of the Federal Alcohol
Administration Act (27 U.S.C. 214), from the requirements of this Act
(including the amendments made by this Act).

TITLE II–IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY
PROBLEMS

SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC
FACILITIES, FOREIGN FACILITIES, AND PORTS
OF ENTRY; ANNUAL REPORT.

(a) Targeting of Inspection Resources for Domestic Facilities,
Foreign Facilities, and Ports of Entry.–Chapter IV (21 U.S.C. 341 et
seq.), as amended by section 106, is amended by adding at the end the
following:
“SEC. 421. <> TARGETING OF INSPECTION
RESOURCES FOR DOMESTIC FACILITIES, FOREIGN
FACILITIES, AND PORTS OF ENTRY; ANNUAL
REPORT.

“(a) Identification and Inspection of Facilities.–
“(1) Identification.–The Secretary shall identify high-
risk facilities and shall allocate resources to inspect
facilities according to the known safety risks of the
facilities, which shall be based on the following factors:
“(A) The known safety risks of the food
manufactured, processed, packed, or held at the
facility.
“(B) The compliance history of a facility,
including with regard to food recalls, outbreaks of
foodborne illness, and violations of food safety
standards.
“(C) The rigor and effectiveness of the facility’s
hazard analysis and risk-based preventive controls.
“(D) Whether the food manufactured, processed,
packed, or held at the facility meets the criteria for
priority under section 801(h)(1).
“(E) Whether the food or the facility that
manufactured, processed, packed, or held such food has
received a certification as described in section 801(q)
or 806, as appropriate.
“(F) Any other criteria deemed necessary and
appropriate by the Secretary for purposes of allocating
inspection resources.
“(2) Inspections.–
“(A) In general. <> —
Beginning on the date of enactment of the FDA Food
Safety Modernization Act, the Secretary shall increase
the frequency of inspection of all facilities.

[[Page 124 STAT. 3924]]

“(B) Domestic high-risk
facilities. <> –The Secretary shall
increase the frequency of inspection of domestic
facilities identified under paragraph (1) as high-risk
facilities such that each such facility is inspected–
“(i) not less often than once in the 5-year
period following the date of enactment of the FDA
Food Safety Modernization Act; and
“(ii) not less often than once every 3 years
thereafter.
“(C) Domestic non-high-risk
facilities. <> –The Secretary shall
ensure that each domestic facility that is not
identified under paragraph (1) as a high-risk facility
is inspected–
“(i) not less often than once in the 7-year
period following the date of enactment of the FDA
Food Safety Modernization Act; and
“(ii) not less often than once every 5 years
thereafter.
“(D) <> Foreign facilities.–
“(i) Year 1.–In the 1-year period following
the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall inspect not
fewer than 600 foreign facilities.
“(ii) Subsequent years.–In each of the 5
years following the 1-year period described in
clause (i), the Secretary shall inspect not fewer
than twice the number of foreign facilities
inspected by the Secretary during the previous
year.
“(E) Reliance on federal, state, or local
inspections.–In meeting the inspection requirements
under this subsection for domestic facilities, the
Secretary may rely on inspections conducted by other
Federal, State, or local agencies under interagency
agreement, contract, memoranda of understanding, or
other obligation.

“(b) Identification and Inspection at Ports of Entry.–The
Secretary, in consultation with the Secretary of Homeland Security,
shall allocate resources to inspect any article of food imported into
the United States according to the known safety risks of the article of
food, which shall be based on the following factors:
“(1) The known safety risks of the food imported.
“(2) The known safety risks of the countries or regions of
origin and countries through which such article of food is
transported.
“(3) The compliance history of the importer, including with
regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.
“(4) The rigor and effectiveness of the activities
conducted by the importer of such article of food to satisfy the
requirements of the foreign supplier verification program under
section 805.
“(5) Whether the food importer participates in the
voluntary qualified importer program under section 806.
“(6) Whether the food meets the criteria for priority under
section 801(h)(1).

[[Page 124 STAT. 3925]]

“(7) Whether the food or the facility that manufactured,
processed, packed, or held such food received a certification as
described in section 801(q) or 806.
“(8) Any other criteria deemed necessary and appropriate by
the Secretary for purposes of allocating inspection resources.

“(c) Interagency Agreements With Respect to Seafood.–
“(1) In general.–The Secretary of Health and Human
Services, the Secretary of Commerce, the Secretary of Homeland
Security, the Chairman of the Federal Trade Commission, and the
heads of other appropriate agencies may enter into such
agreements as may be necessary or appropriate to improve seafood
safety.
“(2) Scope of agreements.–The agreements under paragraph
(1) may include–
“(A) cooperative arrangements for examining and
testing seafood imports that leverage the resources,
capabilities, and authorities of each party to the
agreement;
“(B) coordination of inspections of foreign
facilities to increase the percentage of imported
seafood and seafood facilities inspected;
“(C) standardization of data on seafood names,
inspection records, and laboratory testing to improve
interagency coordination;
“(D) coordination to detect and investigate
violations under applicable Federal law;
“(E) a process, including the use or modification
of existing processes, by which officers and employees
of the National Oceanic and Atmospheric Administration
may be duly designated by the Secretary to carry out
seafood examinations and investigations under section
801 of this Act or section 203 of the Food Allergen
Labeling and Consumer Protection Act of 2004;
“(F) the sharing of information concerning observed
non-compliance with United States food requirements
domestically and in foreign nations and new regulatory
decisions and policies that may affect the safety of
food imported into the United States;
“(G) conducting joint training on subjects that
affect and strengthen seafood inspection effectiveness
by Federal authorities; and
“(H) outreach on Federal efforts to enhance seafood
safety and compliance with Federal food safety
requirements.

“(d) Coordination.–The Secretary shall improve coordination and
cooperation with the Secretary of Agriculture and the Secretary of
Homeland Security to target food inspection resources.
“(e) Facility. <> –For purposes of this
section, the term `facility’ means a domestic facility or a foreign
facility that is required to register under section 415.”.

(b) Annual Report.–Section 1003 (21 U.S.C. 393) is amended by
adding at the end the following:
“(h) Annual Report Regarding Food.–Not later than February 1 of
each year, the Secretary shall submit to Congress a report, including
efforts to coordinate and cooperate with other Federal agencies with
responsibilities for food inspections, regarding–
“(1) information about food facilities including–

[[Page 124 STAT. 3926]]

“(A) the appropriations used to inspect facilities
registered pursuant to section 415 in the previous
fiscal year;
“(B) the average cost of both a non-high-risk food
facility inspection and a high-risk food facility
inspection, if such a difference exists, in the previous
fiscal year;
“(C) the number of domestic facilities and the
number of foreign facilities registered pursuant to
section 415 that the Secretary inspected in the previous
fiscal year;
“(D) the number of domestic facilities and the
number of foreign facilities registered pursuant to
section 415 that were scheduled for inspection in the
previous fiscal year and which the Secretary did not
inspect in such year;
“(E) the number of high-risk facilities identified
pursuant to section 421 that the Secretary inspected in
the previous fiscal year; and
“(F) the number of high-risk facilities identified
pursuant to section 421 that were scheduled for
inspection in the previous fiscal year and which the
Secretary did not inspect in such year.
“(2) information about food imports including–
“(A) the number of lines of food imported into the
United States that the Secretary physically inspected or
sampled in the previous fiscal year;
“(B) the number of lines of food imported into the
United States that the Secretary did not physically
inspect or sample in the previous fiscal year; and
“(C) the average cost of physically inspecting or
sampling a line of food subject to this Act that is
imported or offered for import into the United States;
and
“(3) information on the foreign offices of the Food and
Drug Administration including–
“(A) the number of foreign offices established; and
“(B) the number of personnel permanently stationed
in each foreign office.

“(i) Public Availability of Annual Food Reports. <> –The Secretary shall make the reports required under
subsection (h) available to the public on the Internet Web site of the
Food and Drug Administration.”.

(c) <> Advisory Committee Consultation.–
In allocating inspection resources as described in section 421 of the
Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the
Secretary may, as appropriate, consult with any relevant advisory
committee within the Department of Health and Human Services.
SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.

(a) In General.–Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 201, is amended by adding at the end the following:
“SEC. 422. <> LABORATORY ACCREDITATION FOR
ANALYSES OF FOODS.

“(a) Recognition of Laboratory Accreditation.–
“(1) In general. <> –Not later than 2
years after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall–
“(A) establish a program for the testing of food by
accredited laboratories;
“(B) <> establish a publicly
available registry of accreditation bodies recognized by
the Secretary and laboratories

[[Page 124 STAT. 3927]]

accredited by a recognized accreditation body, including
the name of, contact information for, and other
information deemed appropriate by the Secretary about
such bodies and laboratories; and
“(C) require, as a condition of recognition or
accreditation, as appropriate, that recognized
accreditation bodies and accredited laboratories report
to the Secretary any changes that would affect the
recognition of such accreditation body or the
accreditation of such laboratory.
“(2) Program requirements.–The program established under
paragraph (1)(A) shall provide for the recognition of laboratory
accreditation bodies that meet criteria established by the
Secretary for accreditation of laboratories, including
independent private laboratories and laboratories run and
operated by a Federal agency (including the Department of
Commerce), State, or locality with a demonstrated capability to
conduct 1 or more sampling and analytical testing methodologies
for food.
“(3) Increasing the number of qualified laboratories.–The
Secretary shall work with the laboratory accreditation bodies
recognized under paragraph (1), as appropriate, to increase the
number of qualified laboratories that are eligible to perform
testing under subparagraph (b) beyond the number so qualified on
the date of enactment of the FDA Food Safety Modernization Act.
“(4) Limited distribution.–In the interest of national
security, the Secretary, in coordination with the Secretary of
Homeland Security, may determine the time, manner, and form in
which the registry established under paragraph (1)(B) is made
publicly available.
“(5) Foreign laboratories.–Accreditation bodies recognized
by the Secretary under paragraph (1) may accredit laboratories
that operate outside the United States, so long as such
laboratories meet the accreditation standards applicable to
domestic laboratories accredited under this section.
“(6) Model laboratory standards.–The Secretary shall
develop model standards that a laboratory shall meet to be
accredited by a recognized accreditation body for a specified
sampling or analytical testing methodology and included in the
registry provided for under paragraph (1). In developing the
model standards, the Secretary shall consult existing standards
for guidance. The model standards shall include–
“(A) methods to ensure that–
“(i) appropriate sampling, analytical
procedures (including rapid analytical
procedures), and commercially available techniques
are followed and reports of analyses are certified
as true and accurate;
“(ii) internal quality systems are
established and maintained;
“(iii) procedures exist to evaluate and
respond promptly to complaints regarding analyses
and other activities for which the laboratory is
accredited; and
“(iv) individuals who conduct the sampling
and analyses are qualified by training and
experience to do so; and
“(B) any other criteria determined appropriate by
the Secretary.

[[Page 124 STAT. 3928]]

“(7) Review of recognition.–To ensure compliance with the
requirements of this section, the Secretary–
“(A) shall periodically, and in no case less than
once every 5 years, reevaluate accreditation bodies
recognized under paragraph (1) and may accompany
auditors from an accreditation body to assess whether
the accreditation body meets the criteria for
recognition; and
“(B) shall promptly revoke the recognition of any
accreditation body found not to be in compliance with
the requirements of this section, specifying, as
appropriate, any terms and conditions necessary for
laboratories accredited by such body to continue to
perform testing as described in this section.

“(b) Testing Procedures.–
“(1) In general.–Not later than 30 months after the date
of enactment of the FDA Food Safety Modernization Act, food
testing shall be conducted by Federal laboratories or non-
Federal laboratories that have been accredited for the
appropriate sampling or analytical testing methodology or
methodologies by a recognized accreditation body on the registry
established by the Secretary under subsection (a)(1)(B) whenever
such testing is conducted–
“(A) by or on behalf of an owner or consignee–
“(i) in response to a specific testing
requirement under this Act or implementing
regulations, when applied to address an identified
or suspected food safety problem; and
“(ii) as required by the Secretary, as the
Secretary deems appropriate, to address an
identified or suspected food safety problem; or
“(B) on behalf of an owner or consignee–
“(i) in support of admission of an article of
food under section 801(a); and
“(ii) under an Import Alert that requires
successful consecutive tests.
“(2) Results of testing.–The results of any such testing
shall be sent directly to the Food and Drug Administration,
except the Secretary may by regulation exempt test results from
such submission requirement if the Secretary determines that
such results do not contribute to the protection of public
health. Test results required to be submitted may be submitted
to the Food and Drug Administration through electronic means.
“(3) Exception. <> –The Secretary
may waive requirements under this subsection if–
“(A) a new methodology or methodologies have been
developed and validated but a laboratory has not yet
been accredited to perform such methodology or
methodologies; and
“(B) the use of such methodology or methodologies
are necessary to prevent, control, or mitigate a food
emergency or foodborne illness outbreak.

“(c) Review by Secretary.–If food sampling and testing performed
by a laboratory run and operated by a State or locality that is
accredited by a recognized accreditation body on the registry
established by the Secretary under subsection (a) result in a State
recalling a food, the Secretary shall review the sampling and testing

[[Page 124 STAT. 3929]]

results for the purpose of determining the need for a national recall or
other compliance and enforcement activities.
“(d) No Limit on Secretarial Authority.–Nothing in this section
shall be construed to limit the ability of the Secretary to review and
act upon information from food testing, including determining the
sufficiency of such information and testing.”.
(b) Food Emergency Response Network. <> –The Secretary, in coordination with
the Secretary of Agriculture, the Secretary of Homeland Security, and
State, local, and tribal governments shall, not later than 180 days
after the date of enactment of this Act, and biennially thereafter,
submit to the relevant committees of Congress, and make publicly
available on the Internet Web site of the Department of Health and Human
Services, a report on the progress in implementing a national food
emergency response laboratory network that–
(1) provides ongoing surveillance, rapid detection, and
surge capacity for large-scale food-related emergencies,
including intentional adulteration of the food supply;
(2) coordinates the food laboratory capacities of State,
local, and tribal food laboratories, including the adoption of
novel surveillance and identification technologies and the
sharing of data between Federal agencies and State laboratories
to develop national situational awareness;
(3) provides accessible, timely, accurate, and consistent
food laboratory services throughout the United States;
(4) develops and implements a methods repository for use by
Federal, State, and local officials;
(5) responds to food-related emergencies; and
(6) is integrated with relevant laboratory networks
administered by other Federal agencies.
SEC. 203. <> INTEGRATED CONSORTIUM OF
LABORATORY NETWORKS.

(a) In General. <> –The Secretary of Homeland
Security, in coordination with the Secretary of Health and Human
Services, the Secretary of Agriculture, the Secretary of Commerce, and
the Administrator of the Environmental Protection Agency, shall maintain
an agreement through which relevant laboratory network members, as
determined by the Secretary of Homeland Security, shall–
(1) agree on common laboratory methods in order to reduce
the time required to detect and respond to foodborne illness
outbreaks and facilitate the sharing of knowledge and
information relating to animal health, agriculture, and human
health;
(2) identify means by which laboratory network members could
work cooperatively–
(A) to optimize national laboratory preparedness;
and
(B) to provide surge capacity during emergencies;
and
(3) engage in ongoing dialogue and build relationships that
will support a more effective and integrated response during
emergencies.

(b) Reporting Requirement. <> –The Secretary of
Homeland Security shall, on a biennial basis, submit to the relevant
committees of Congress, and make publicly available on the Internet Web
site of the Department of Homeland Security, a report on the progress of
the integrated consortium of laboratory networks, as established under
subsection (a), in carrying out this section.

[[Page 124 STAT. 3930]]

SEC. 204. <> ENHANCING TRACKING AND TRACING
OF FOOD AND RECORDKEEPING.

(a) Pilot Projects.–
(1) In general.–Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the “Secretary”),
taking into account recommendations from the Secretary of
Agriculture and representatives of State departments of health
and agriculture, shall establish pilot projects in coordination
with the food industry to explore and evaluate methods to
rapidly and effectively identify recipients of food to prevent
or mitigate a foodborne illness outbreak and to address credible
threats of serious adverse health consequences or death to
humans or animals as a result of such food being adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 342) or misbranded under section 403(w) of such Act
(21 U.S.C. 343(w)).
(2) Content.–The Secretary shall conduct 1 or more pilot
projects under paragraph (1) in coordination with the processed
food sector and 1 or more such pilot projects in coordination
with processors or distributors of fruits and vegetables that
are raw agricultural commodities. The Secretary shall ensure
that the pilot projects under paragraph (1) reflect the
diversity of the food supply and include at least 3 different
types of foods that have been the subject of significant
outbreaks during the 5-year period preceding the date of
enactment of this Act, and are selected in order to–
(A) develop and demonstrate methods for rapid and
effective tracking and tracing of foods in a manner that
is practicable for facilities of varying sizes,
including small businesses;
(B) develop and demonstrate appropriate
technologies, including technologies existing on the
date of enactment of this Act, that enhance the tracking
and tracing of food; and
(C) inform the promulgation of regulations under
subsection (d).
(3) Report. <> –Not later than 18
months after the date of enactment of this Act, the Secretary
shall report to Congress on the findings of the pilot projects
under this subsection together with recommendations for
improving the tracking and tracing of food.

(b) Additional Data Gathering.–
(1) In general.–The Secretary, in coordination with the
Secretary of Agriculture and multiple representatives of State
departments of health and agriculture, shall assess–
(A) the costs and benefits associated with the
adoption and use of several product tracing
technologies, including technologies used in the pilot
projects under subsection (a);
(B) the feasibility of such technologies for
different sectors of the food industry, including small
businesses; and
(C) whether such technologies are compatible with
the requirements of this subsection.
(2) Requirements.–To the extent practicable, in carrying
out paragraph (1), the Secretary shall–

[[Page 124 STAT. 3931]]

(A) evaluate domestic and international product
tracing practices in commercial use;
(B) consider international efforts, including an
assessment of whether product tracing requirements
developed under this section are compatible with global
tracing systems, as appropriate; and
(C) <> consult with a diverse
and broad range of experts and stakeholders, including
representatives of the food industry, agricultural
producers, and nongovernmental organizations that
represent the interests of consumers.

(c) Product Tracing System.–The Secretary, in consultation with the
Secretary of Agriculture, shall, as appropriate, establish within the
Food and Drug Administration a product tracing system to receive
information that improves the capacity of the Secretary to effectively
and rapidly track and trace food that is in the United States or offered
for import into the United States. Prior to the establishment of such
product tracing system, the Secretary shall examine the results of
applicable pilot projects and shall ensure that the activities of such
system are adequately supported by the results of such pilot projects.
(d) Additional Recordkeeping Requirements for High Risk Foods.–
(1) In general. <> —
In order to rapidly and effectively identify recipients of a
food to prevent or mitigate a foodborne illness outbreak and to
address credible threats of serious adverse health consequences
or death to humans or animals as a result of such food being
adulterated under section 402 of the Federal Food, Drug, and
Cosmetic Act or misbranded under section 403(w) of such Act, not
later than 2 years after the date of enactment of this Act, the
Secretary shall publish a notice of proposed rulemaking to
establish recordkeeping requirements, in addition to the
requirements under section 414 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title
21, Code of Federal Regulations (or any successor regulations),
for facilities that manufacture, process, pack, or hold foods
that the Secretary designates under paragraph (2) as high-risk
foods. The Secretary shall set an appropriate effective date of
such additional requirements for foods designated as high risk
that takes into account the length of time necessary to comply
with such requirements. Such requirements shall–
(A) relate only to information that is reasonably
available and appropriate;
(B) be science-based;
(C) not prescribe specific technologies for the
maintenance of records;
(D) ensure that the public health benefits of
imposing additional recordkeeping requirements outweigh
the cost of compliance with such requirements;
(E) be scale-appropriate and practicable for
facilities of varying sizes and capabilities with
respect to costs and recordkeeping burdens, and not
require the creation and maintenance of duplicate
records where the information is contained in other
company records kept in the normal course of business;

[[Page 124 STAT. 3932]]

(F) minimize the number of different recordkeeping
requirements for facilities that handle more than 1 type
of food;
(G) to the extent practicable, not require a
facility to change business systems to comply with such
requirements;
(H) allow any person subject to this subsection to
maintain records required under this subsection at a
central or reasonably accessible location provided that
such records can be made available to the Secretary not
later than 24 hours after the Secretary requests such
records; and
(I) include a process by which the Secretary may
issue a waiver of the requirements under this subsection
if the Secretary determines that such requirements would
result in an economic hardship for an individual
facility or a type of facility;
(J) be commensurate with the known safety risks of
the designated food;
(K) take into account international trade
obligations;
(L) not require–
(i) a full pedigree, or a record of the
complete previous distribution history of the food
from the point of origin of such food;
(ii) records of recipients of a food beyond
the immediate subsequent recipient of such food;
or
(iii) product tracking to the case level by
persons subject to such requirements; and
(M) include a process by which the Secretary may
remove a high-risk food designation developed under
paragraph (2) for a food or type of food.
(2) Designation of high-risk foods.–
(A) In general. <> –Not later than
1 year after the date of enactment of this Act, and
thereafter as the Secretary determines necessary, the
Secretary shall designate high-risk foods for which the
additional recordkeeping requirements described in
paragraph (1) are appropriate and necessary to protect
the public health. Each such designation shall be based
on–
(i) the known safety risks of a particular
food, including the history and severity of
foodborne illness outbreaks attributed to such
food, taking into consideration foodborne illness
data collected by the Centers for Disease Control
and Prevention;
(ii) the likelihood that a particular food has
a high potential risk for microbiological or
chemical contamination or would support the growth
of pathogenic microorganisms due to the nature of
the food or the processes used to produce such
food;
(iii) the point in the manufacturing process
of the food where contamination is most likely to
occur;
(iv) the likelihood of contamination and steps
taken during the manufacturing process to reduce
the possibility of contamination;
(v) the likelihood that consuming a particular
food will result in a foodborne illness due to
contamination of the food; and

[[Page 124 STAT. 3933]]

(vi) the likely or known severity, including
health and economic impacts, of a foodborne
illness attributed to a particular food.
(B) List of high-risk foods. <> –At the time the Secretary promulgates the
final rules under paragraph (1), the Secretary shall
publish the list of the foods designated under
subparagraph (A) as high-risk foods on the Internet
website of the Food and Drug
Administration. <> The Secretary may update the
list to designate new high-risk foods and to remove
foods that are no longer deemed to be high-risk foods,
provided that each such update to the list is consistent
with the requirements of this subsection and notice of
such update is published in the Federal Register.
(3) Protection of sensitive information.–In promulgating
regulations under this subsection, the Secretary shall take
appropriate measures to ensure that there are effective
procedures to prevent the unauthorized disclosure of any trade
secret or confidential information that is obtained by the
Secretary pursuant to this section, including periodic risk
assessment and planning to prevent unauthorized release and
controls to–
(A) prevent unauthorized reproduction of trade
secret or confidential information;
(B) prevent unauthorized access to trade secret or
confidential information; and
(C) maintain records with respect to access by any
person to trade secret or confidential information
maintained by the agency.
(4) Public input.–During the comment period in the notice
of proposed rulemaking under paragraph (1), the Secretary shall
conduct not less than 3 public meetings in diverse geographical
areas of the United States to provide persons in different
regions an opportunity to comment.
(5) Retention of records.–Except as otherwise provided in
this subsection, the Secretary may require that a facility
retain records under this subsection for not more than 2 years,
taking into consideration the risk of spoilage, loss of value,
or loss of palatability of the applicable food when determining
the appropriate timeframes.
(6) Limitations.–
(A) Farm to school programs.–In establishing
requirements under this subsection, the Secretary shall,
in consultation with the Secretary of Agriculture,
consider the impact of requirements on farm to school or
farm to institution programs of the Department of
Agriculture and other farm to school and farm to
institution programs outside such agency, and shall
modify the requirements under this subsection, as
appropriate, with respect to such programs so that the
requirements do not place undue burdens on farm to
school or farm to institution programs.
(B) Identity-preserved labels with respect to farm
sales of food that is produced and packaged on a farm.–
The requirements under this subsection shall not apply
to a food that is produced and packaged on a farm if–

[[Page 124 STAT. 3934]]

(i) the packaging of the food maintains the
integrity of the product and prevents subsequent
contamination or alteration of the product; and
(ii) the labeling of the food includes the
name, complete address (street address, town,
State, country, and zip or other postal code), and
business phone number of the farm, unless the
Secretary waives the requirement to include a
business phone number of the farm, as appropriate,
in order to accommodate a religious belief of the
individual in charge of such farm.
(C) Fishing vessels.–The requirements under this
subsection with respect to a food that is produced
through the use of a fishing vessel (as defined in
section 3(18) of the Magnuson-Stevens Fishery
Conservation and Management Act (16 U.S.C. 1802(18)))
shall be limited to the requirements under subparagraph
(F) until such time as the food is sold by the owner,
operator, or agent in charge of such fishing vessel.
(D) Commingled raw agricultural commodities.–
(i) Limitation on extent of tracing.–
Recordkeeping requirements under this subsection
with regard to any commingled raw agricultural
commodity shall be limited to the requirements
under subparagraph (F).
(ii) Definitions.–For the purposes of this
subparagraph–
(I) the term “commingled raw
agricultural commodity” means any
commodity that is combined or mixed
after harvesting, but before processing;
(II) the term “commingled raw
agricultural commodity” shall not
include types of fruits and vegetables
that are raw agricultural commodities
for which the Secretary has determined
that standards promulgated under section
419 of the Federal Food, Drug, and
Cosmetic Act (as added by section 105)
would minimize the risk of serious
adverse health consequences or death;
and
(III) the term “processing” means
operations that alter the general state
of the commodity, such as canning,
cooking, freezing, dehydration, milling,
grinding, pasteurization, or
homogenization.
(E) Exemption of other foods.–The Secretary may, by
notice in the Federal Register, modify the requirements
under this subsection with respect to, or exempt a food
or a type of facility from, the requirements of this
subsection (other than the requirements under
subparagraph (F), if applicable) if the Secretary
determines that product tracing requirements for such
food (such as bulk or commingled ingredients that are
intended to be processed to destroy pathogens) or type
of facility is not necessary to protect the public
health.
(F) Recordkeeping regarding previous sources and
subsequent recipients.–In the case of a person or food
to which a limitation or exemption under subparagraph
(C), (D), or (E) applies, if such person, or a person
who

[[Page 124 STAT. 3935]]

manufactures, processes, packs, or holds such food, is
required to register with the Secretary under section
415 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350d) with respect to the manufacturing,
processing, packing, or holding of the applicable food,
the Secretary shall require such person to maintain
records that identify the immediate previous source of
such food and the immediate subsequent recipient of such
food.
(G) Grocery stores. <> –With
respect to a sale of a food described in subparagraph
(H) to a grocery store, the Secretary shall not require
such grocery store to maintain records under this
subsection other than records documenting the farm that
was the source of such food. The Secretary shall not
require that such records be kept for more than 180
days.
(H) Farm sales to consumers.–The Secretary shall
not require a farm to maintain any distribution records
under this subsection with respect to a sale of a food
described in subparagraph (I) (including a sale of a
food that is produced and packaged on such farm), if
such sale is made by the farm directly to a consumer.
(I) Sale of a food.–A sale of a food described in
this subparagraph is a sale of a food in which–
(i) the food is produced on a farm; and
(ii) the sale is made by the owner, operator,
or agent in charge of such farm directly to a
consumer or grocery store.
(7) No impact on non-high-risk foods.–The recordkeeping
requirements established under paragraph (1) shall have no
effect on foods that are not designated by the Secretary under
paragraph (2) as high-risk foods. Foods described in the
preceding sentence shall be subject solely to the recordkeeping
requirements under section 414 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350c) and subpart J of part 1 of title
21, Code of Federal Regulations (or any successor regulations).

(e) Evaluation and Recommendations.–
(1) Report.–Not later than 1 year after the effective date
of the final rule promulgated under subsection (d)(1), the
Comptroller General of the United States shall submit to
Congress a report, taking into consideration the costs of
compliance and other regulatory burdens on small businesses and
Federal, State, and local food safety practices and
requirements, that evaluates the public health benefits and
risks, if any, of limiting–
(A) the product tracing requirements under
subsection (d) to foods identified under paragraph (2)
of such subsection, including whether such requirements
provide adequate assurance of traceability in the event
of intentional adulteration, including by acts of
terrorism; and
(B) the participation of restaurants in the
recordkeeping requirements.
(2) Determination and recommendations.–In conducting the
evaluation and report under paragraph (1), if the Comptroller
General of the United States determines that the limitations
described in such paragraph do not adequately protect the public
health, the Comptroller General shall submit

[[Page 124 STAT. 3936]]

to Congress recommendations, if appropriate, regarding
recordkeeping requirements for restaurants and additional foods,
in order to protect the public health.

(f) Farms.–
(1) Request for information.–Notwithstanding subsection
(d), during an active investigation of a foodborne illness
outbreak, or if the Secretary determines it is necessary to
protect the public health and prevent or mitigate a foodborne
illness outbreak, the Secretary, in consultation and
coordination with State and local agencies responsible for food
safety, as appropriate, may request that the owner, operator, or
agent of a farm identify potential immediate recipients, other
than consumers, of an article of the food that is the subject of
such investigation if the Secretary reasonably believes such
article of food–
(A) is adulterated under section 402 of the Federal
Food, Drug, and Cosmetic Act;
(B) presents a threat of serious adverse health
consequences or death to humans or animals; and
(C) was adulterated as described in subparagraph (A)
on a particular farm (as defined in section 1.227 of
chapter 21, Code of Federal Regulations (or any
successor regulation)).
(2) Manner of request. <> –In making a
request under paragraph (1), the Secretary, in consultation and
coordination with State and local agencies responsible for food
safety, as appropriate, shall issue a written notice to the
owner, operator, or agent of the farm to which the article of
food has been traced. The individual providing such notice shall
present to such owner, operator, or agent appropriate
credentials and shall deliver such notice at reasonable times
and within reasonable limits and in a reasonable manner.
(3) Delivery of information requested.–The owner, operator,
or agent of a farm shall deliver the information requested under
paragraph (1) in a prompt and reasonable manner. Such
information may consist of records kept in the normal course of
business, and may be in electronic or non-electronic format.
(4) Limitation.–A request made under paragraph (1) shall
not include a request for information relating to the finances,
pricing of commodities produced, personnel, research, sales
(other than information relating to shipping), or other
disclosures that may reveal trade secrets or confidential
information from the farm to which the article of food has been
traced, other than information necessary to identify potential
immediate recipients of such food. <>
Section 301(j) of the Federal Food, Drug, and Cosmetic Act and
the Freedom of Information Act shall apply with respect to any
confidential commercial information that is disclosed to the
Food and Drug Administration in the course of responding to a
request under paragraph (1).
(5) Records.–Except with respect to identifying potential
immediate recipients in response to a request under this
subsection, nothing in this subsection shall require the
establishment or maintenance by farms of new records.

[[Page 124 STAT. 3937]]

(g) No Limitation on Commingling of Food.–Nothing in this section
shall be construed to authorize the Secretary to impose any limitation
on the commingling of food.
(h) Small Entity Compliance Guide. <> –Not later
than 180 days after promulgation of a final rule under subsection (d),
the Secretary shall issue a small entity compliance guide setting forth
in plain language the requirements of the regulations under such
subsection in order to assist small entities, including farms and small
businesses, in complying with the recordkeeping requirements under such
subsection.

(i) Flexibility for Small
Businesses. <> —
Notwithstanding any other provision of law, the regulations promulgated
under subsection (d) shall apply–
(1) to small businesses (as defined by the Secretary in
section 103, not later than 90 days after the date of enactment
of this Act) beginning on the date that is 1 year after the
effective date of the final regulations promulgated under
subsection (d); and
(2) to very small businesses (as defined by the Secretary in
section 103, not later than 90 days after the date of enactment
of this Act) beginning on the date that is 2 years after the
effective date of the final regulations promulgated under
subsection (d).

(j) Enforcement.–
(1) Prohibited acts.–Section 301(e) (21 U.S.C. 331(e)) is
amended by inserting “; or the violation of any recordkeeping
requirement under section 204 of the FDA Food Safety
Modernization Act (except when such violation is committed by a
farm)” before the period at the end.
(2) Imports.–Section 801(a) (21 U.S.C. 381(a)) is amended
by inserting “or (4) the recordkeeping requirements under
section 204 of the FDA Food Safety Modernization Act (other than
the requirements under subsection (f) of such section) have not
been complied with regarding such article,” in the third
sentence before “then such article shall be refused
admission”.
SEC. 205. <> SURVEILLANCE.

(a) Definition of Foodborne Illness Outbreak.–In this Act, the term
“foodborne illness outbreak” means the occurrence of 2 or more cases
of a similar illness resulting from the ingestion of a certain food.
(b) Foodborne Illness Surveillance Systems.–
(1) In general.–The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, shall enhance
foodborne illness surveillance systems to improve the
collection, analysis, reporting, and usefulness of data on
foodborne illnesses by–
(A) coordinating Federal, State and local foodborne
illness surveillance systems, including complaint
systems, and increasing participation in national
networks of public health and food regulatory agencies
and laboratories;
(B) facilitating sharing of surveillance information
on a more timely basis among governmental agencies,
including the Food and Drug Administration, the
Department of Agriculture, the Department of Homeland
Security, and State and local agencies, and with the
public;

[[Page 124 STAT. 3938]]

(C) developing improved epidemiological tools for
obtaining quality exposure data and microbiological
methods for classifying cases;
(D) augmenting such systems to improve attribution
of a foodborne illness outbreak to a specific food;
(E) expanding capacity of such systems, including
working toward automatic electronic searches, for
implementation of identification practices, including
fingerprinting strategies, for foodborne infectious
agents, in order to identify new or rarely documented
causes of foodborne illness and submit standardized
information to a centralized database;
(F) allowing timely public access to aggregated, de-
identified surveillance data;
(G) at least annually, publishing current reports on
findings from such systems;
(H) establishing a flexible mechanism for rapidly
initiating scientific research by academic institutions;
(I) integrating foodborne illness surveillance
systems and data with other biosurveillance and public
health situational awareness capabilities at the
Federal, State, and local levels, including by sharing
foodborne illness surveillance data with the National
Biosurveillance Integration Center; and
(J) other activities as determined appropriate by
the Secretary.
(2) Working group.–The Secretary shall support and maintain
a diverse working group of experts and stakeholders from
Federal, State, and local food safety and health agencies, the
food and food testing industries, consumer organizations, and
academia. <> Such
working group shall provide the Secretary, through at least
annual meetings of the working group and an annual public
report, advice and recommendations on an ongoing and regular
basis regarding the improvement of foodborne illness
surveillance and implementation of this section, including
advice and recommendations on–
(A) the priority needs of regulatory agencies, the
food industry, and consumers for information and
analysis on foodborne illness and its causes;
(B) opportunities to improve the effectiveness of
initiatives at the Federal, State, and local levels,
including coordination and integration of activities
among Federal agencies, and between the Federal, State,
and local levels of government;
(C) improvement in the timeliness and depth of
access by regulatory and health agencies, the food
industry, academic researchers, and consumers to
foodborne illness aggregated, de-identified surveillance
data collected by government agencies at all levels,
including data compiled by the Centers for Disease
Control and Prevention;
(D) key barriers at Federal, State, and local levels
to improving foodborne illness surveillance and the
utility of such surveillance for preventing foodborne
illness;
(E) the capabilities needed for establishing
automatic electronic searches of surveillance data; and
(F) specific actions to reduce barriers to
improvement, implement the working group’s
recommendations, and

[[Page 124 STAT. 3939]]

achieve the purposes of this section, with measurable
objectives and timelines, and identification of resource
and staffing needs.
(3) Authorization of appropriations.–To carry out the
activities described in paragraph (1), there is authorized to be
appropriated $24,000,000 for each fiscal years 2011 through
2015.

(c) Improving Food Safety and Defense Capacity at the State and
Local Level.–
(1) In general. <> –The Secretary shall
develop and implement strategies to leverage and enhance the
food safety and defense capacities of State and local agencies
in order to achieve the following goals:
(A) Improve foodborne illness outbreak response and
containment.
(B) Accelerate foodborne illness surveillance and
outbreak investigation, including rapid shipment of
clinical isolates from clinical laboratories to
appropriate State laboratories, and conducting more
standardized illness outbreak interviews.
(C) Strengthen the capacity of State and local
agencies to carry out inspections and enforce safety
standards.
(D) Improve the effectiveness of Federal, State, and
local partnerships to coordinate food safety and defense
resources and reduce the incidence of foodborne illness.
(E) Share information on a timely basis among public
health and food regulatory agencies, with the food
industry, with health care providers, and with the
public.
(F) Strengthen the capacity of State and local
agencies to achieve the goals described in section 108.
(2) Review. <> –In developing of the
strategies required by paragraph (1), the Secretary shall, not
later than 1 year after the date of enactment of the FDA Food
Safety Modernization Act, complete a review of State and local
capacities, and needs for enhancement, which may include a
survey with respect to–
(A) staffing levels and expertise available to
perform food safety and defense functions;
(B) laboratory capacity to support surveillance,
outbreak response, inspection, and enforcement
activities;
(C) information systems to support data management
and sharing of food safety and defense information among
State and local agencies and with counterparts at the
Federal level; and
(D) other State and local activities and needs as
determined appropriate by the Secretary.

(d) Food Safety Capacity Building Grants.–Section 317R(b) of the
Public Health Service Act (42 U.S.C. 247b-20(b)) is amended–
(1) by striking “2002” and inserting “2010”; and
(2) by striking “2003 through 2006” and inserting “2011
through 2015”.
SEC. 206. MANDATORY RECALL AUTHORITY.

(a) In General.–Chapter IV (21 U.S.C. 341 et seq.), as amended by
section 202, is amended by adding at the end the following:

[[Page 124 STAT. 3940]]

“SEC. 423. <> MANDATORY RECALL AUTHORITY.

“(a) Voluntary Procedures. <> –If the
Secretary determines, based on information gathered through the
reportable food registry under section 417 or through any other means,
that there is a reasonable probability that an article of food (other
than infant formula) is adulterated under section 402 or misbranded
under section 403(w) and the use of or exposure to such article will
cause serious adverse health consequences or death to humans or animals,
the Secretary shall provide the responsible party (as defined in section
417) with an opportunity to cease distribution and recall such article.

“(b) Prehearing Order To Cease Distribution and Give Notice.–
“(1) In general.–If the responsible party refuses to or
does not voluntarily cease distribution or recall such article
within the time and in the manner prescribed by the Secretary
(if so prescribed), the Secretary may, by order require, as the
Secretary deems necessary, such person to–
“(A) immediately cease distribution of such
article; and
“(B) as applicable, immediately notify all
persons–
“(i) manufacturing, processing, packing,
transporting, distributing, receiving, holding, or
importing and selling such article; and
“(ii) to which such article has been
distributed, transported, or sold, to immediately
cease distribution of such article.
“(2) Required additional information.–
“(A) In general.–If an article of food covered by
a recall order issued under paragraph (1)(B) has been
distributed to a warehouse-based third party logistics
provider without providing such provider sufficient
information to know or reasonably determine the precise
identity of the article of food covered by a recall
order that is in its possession, the notice provided by
the responsible party subject to the order issued under
paragraph (1)(B) shall include such information as is
necessary for the warehouse-based third party logistics
provider to identify the food.
“(B) Rules of construction.–Nothing in this
paragraph shall be construed–
“(i) to exempt a warehouse-based third party
logistics provider from the requirements of this
Act, including the requirements in this section
and section 414; or
“(ii) to exempt a warehouse-based third party
logistics provider from being the subject of a
mandatory recall order.
“(3) Determination to limit areas affected.–If the
Secretary requires a responsible party to cease distribution
under paragraph (1)(A) of an article of food identified in
subsection (a), the Secretary may limit the size of the
geographic area and the markets affected by such cessation if
such limitation would not compromise the public health.

“(c) Hearing on Order. <> –The Secretary shall
provide the responsible party subject to an order under subsection (b)
with an opportunity for an informal hearing, to be held as soon as
possible, but not later than 2 days after the issuance of the order,

[[Page 124 STAT. 3941]]

on the actions required by the order and on why the article that is the
subject of the order should not be recalled.

“(d) Post-hearing Recall Order and Modification of Order.–
“(1) Amendment of order.–If, after providing opportunity
for an informal hearing under subsection (c), the Secretary
determines that removal of the article from commerce is
necessary, the Secretary shall, as appropriate–
“(A) amend the order to require recall of such
article or other appropriate action;
“(B) specify a timetable in which the recall shall
occur;
“(C) require periodic reports to the Secretary
describing the progress of the recall; and
“(D) provide notice to consumers to whom such
article was, or may have been, distributed.
“(2) Vacating of order.–If, after such hearing, the
Secretary determines that adequate grounds do not exist to
continue the actions required by the order, or that such actions
should be modified, the Secretary shall vacate the order or
modify the order.

“(e) Rule Regarding Alcoholic Beverages.–The Secretary shall not
initiate a mandatory recall or take any other action under this section
with respect to any alcohol beverage until the Secretary has provided
the Alcohol and Tobacco Tax and Trade Bureau with a reasonable
opportunity to cease distribution and recall such article under the
Alcohol and Tobacco Tax and Trade Bureau authority.
“(f) Cooperation and Consultation.–The Secretary shall work with
State and local public health officials in carrying out this section, as
appropriate.
“(g) Public Notification.–In conducting a recall under this
section, the Secretary shall–
“(1) <> ensure that a press
release is published regarding the recall, as well as alerts and
public notices, as appropriate, in order to provide
notification–
“(A) of the recall to consumers and retailers to
whom such article was, or may have been, distributed;
and
“(B) that includes, at a minimum–
“(i) the name of the article of food subject
to the recall;
“(ii) a description of the risk associated
with such article; and
“(iii) to the extent practicable, information
for consumers about similar articles of food that
are not affected by the recall;
“(2) consult the policies of the Department of Agriculture
regarding providing to the public a list of retail consignees
receiving products involved in a Class I recall and shall
consider providing such a list to the public, as determined
appropriate by the Secretary; and
“(3) <> if available, publish on the
Internet Web site of the Food and Drug Administration an image
of the article that is the subject of the press release
described in (1).

“(h) No Delegation.–The authority conferred by this section to
order a recall or vacate a recall order shall not be delegated to any
officer or employee other than the Commissioner.

[[Page 124 STAT. 3942]]

“(i) Effect.–Nothing in this section shall affect the authority of
the Secretary to request or participate in a voluntary recall, or to
issue an order to cease distribution or to recall under any other
provision of this Act or under the Public Health Service Act.
“(j) Coordinated Communication.–
“(1) In general.–To assist in carrying out the
requirements of this subsection, the Secretary shall establish
an incident command operation or a similar operation within the
Department of Health and Human Services that will operate not
later than 24 hours after the initiation of a mandatory recall
or the recall of an article of food for which the use of, or
exposure to, such article will cause serious adverse health
consequences or death to humans or animals.
“(2) Requirements.–To reduce the potential for
miscommunication during recalls or regarding investigations of a
food borne illness outbreak associated with a food that is
subject to a recall, each incident command operation or similar
operation under paragraph (1) shall use regular staff and
resources of the Department of Health and Human Services to–
“(A) ensure timely and coordinated communication
within the Department, including enhanced communication
and coordination between different agencies and
organizations within the Department;
“(B) ensure timely and coordinated communication
from the Department, including public statements,
throughout the duration of the investigation and related
foodborne illness outbreak;
“(C) identify a single point of contact within the
Department for public inquiries regarding any actions by
the Secretary related to a recall;
“(D) coordinate with Federal, State, local, and
tribal authorities, as appropriate, that have
responsibilities related to the recall of a food or a
foodborne illness outbreak associated with a food that
is subject to the recall, including notification of the
Secretary of Agriculture and the Secretary of Education
in the event such recalled food is a commodity intended
for use in a child nutrition program (as identified in
section 25(b) of the Richard B. Russell National School
Lunch Act (42 U.S.C. 1769f(b))); and
“(E) conclude operations at such time as the
Secretary determines appropriate.
“(3) Multiple recalls.–The Secretary may establish
multiple or concurrent incident command operations or similar
operations in the event of multiple recalls or foodborne illness
outbreaks necessitating such action by the Department of Health
and Human Services.”.

(b) Search Engine. <> –Not later than 90 days after the date of enactment of this
Act, the Secretary shall modify the Internet Web site of the Food and
Drug Administration to include a search engine that–
(1) is consumer-friendly, as determined by the Secretary;
and
(2) provides a means by which an individual may locate
relevant information regarding each article of food subject to a
recall under section 423 of the Federal Food, Drug, and

[[Page 124 STAT. 3943]]

Cosmetic Act and the status of such recall (such as whether a
recall is ongoing or has been completed).

(c) Civil Penalty.–Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) is
amended by inserting “or any person who does not comply with a recall
order under section 423” after “section 402(a)(2)(B)”.
(d) Prohibited Acts.–Section 301 (21 U.S.C. 331 et seq.), as
amended by section 106, is amended by adding at the end the following:
“(xx) The refusal or failure to follow an order under section
423.”.
(e) GAO Review.–
(1) In general. <> –Not later
than 90 days after the date of enactment of this Act, the
Comptroller General of the United States shall submit to
Congress a report that–
(A) identifies State and local agencies with the
authority to require the mandatory recall of food, and
evaluates use of such authority with regard to
frequency, effectiveness, and appropriateness, including
consideration of any new or existing mechanisms
available to compensate persons for general and specific
recall-related costs when a recall is subsequently
determined by the relevant authority to have been an
error;
(B) identifies Federal agencies, other than the
Department of Health and Human Services, with mandatory
recall authority and examines use of that authority with
regard to frequency, effectiveness, and appropriateness,
including any new or existing mechanisms available to
compensate persons for general and specific recall-
related costs when a recall is subsequently determined
by the relevant agency to have been an error;
(C) considers models for farmer restitution
implemented in other nations in cases of erroneous
recalls; and
(D) makes recommendations to the Secretary regarding
use of the authority under section 423 of the Federal
Food, Drug, and Cosmetic Act (as added by this section)
to protect the public health while seeking to minimize
unnecessary economic costs.
(2) Effect of review. <> –If the
Comptroller General of the United States finds, after the review
conducted under paragraph (1), that the mechanisms described in
such paragraph do not exist or are inadequate, then, not later
than 90 days after the conclusion of such review, the Secretary
of Agriculture shall conduct a study of the feasibility of
implementing a farmer indemnification program to provide
restitution to agricultural producers for losses sustained as a
result of a mandatory recall of an agricultural commodity by a
Federal or State regulatory agency that is subsequently
determined to be in error. <> The Secretary of
Agriculture shall submit to the Committee on Agriculture of the
House of Representatives and the Committee on Agriculture,
Nutrition, and Forestry of the Senate a report that describes
the results of the study, including any recommendations.

(f) <> Annual Report to Congress.–
(1) In general.–Not later than 2 years after the date of
enactment of this Act and annually thereafter, the Secretary of
Health and Human Services (referred to in this subsection as the
“Secretary”) shall submit a report to the Committee

[[Page 124 STAT. 3944]]

on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of Representatives
on the use of recall authority under section 423 of the Federal
Food, Drug, and Cosmetic Act (as added by subsection (a)) and
any public health advisories issued by the Secretary that advise
against the consumption of an article of food on the ground that
the article of food is adulterated and poses an imminent danger
to health.
(2) Content.–The report under paragraph (1) shall include,
with respect to the report year–
(A) the identity of each article of food that was
the subject of a public health advisory described in
paragraph (1), an opportunity to cease distribution and
recall under subsection (a) of section 423 of the
Federal Food, Drug, and Cosmetic Act, or a mandatory
recall order under subsection (b) of such section;
(B) the number of responsible parties, as defined in
section 417 of the Federal Food, Drug, and Cosmetic Act,
formally given the opportunity to cease distribution of
an article of food and recall such article, as described
in section 423(a) of such Act;
(C) the number of responsible parties described in
subparagraph (B) who did not cease distribution of or
recall an article of food after given the opportunity to
cease distribution or recall under section 423(a) of the
Federal Food, Drug, and Cosmetic Act;
(D) the number of recall orders issued under section
423(b) of the Federal Food, Drug, and Cosmetic Act; and
(E) a description of any instances in which there
was no testing that confirmed adulteration of an article
of food that was the subject of a recall under section
423(b) of the Federal Food, Drug, and Cosmetic Act or a
public health advisory described in paragraph (1).
SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.

(a) In General.–Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) is
amended by–
(1) striking “credible evidence or information indicating”
and inserting “reason to believe”; and
(2) striking “presents a threat of serious adverse health
consequences or death to humans or animals” and inserting “is
adulterated or misbranded”.

(b) Regulations.– <> Not later
than 120 days after the date of enactment of this Act, the Secretary
shall issue an interim final rule amending subpart K of part 1 of title
21, Code of Federal Regulations, to implement the amendment made by this
section.

(c) <> Effective Date.–The amendment made
by this section shall take effect 180 days after the date of enactment
of this Act.
SEC. 208. <> DECONTAMINATION AND DISPOSAL
STANDARDS AND PLANS.

(a) In General.–The Administrator of the Environmental Protection
Agency (referred to in this section as the “Administrator”), in
coordination with the Secretary of Health and Human Services, Secretary
of Homeland Security, and Secretary of Agriculture, shall provide
support for, and technical assistance to, State, local, and tribal
governments in preparing for, assessing, decontaminating, and recovering
from an agriculture or food emergency.

[[Page 124 STAT. 3945]]

(b) Development of Standards.–In carrying out subsection (a), the
Administrator, in coordination with the Secretary of Health and Human
Services, Secretary of Homeland Security, Secretary of Agriculture, and
State, local, and tribal governments, shall develop and disseminate
specific standards and protocols to undertake clean-up, clearance, and
recovery activities following the decontamination and disposal of
specific threat agents and foreign animal diseases.
(c) Development of Model Plans.–In carrying out subsection (a), the
Administrator, the Secretary of Health and Human Services, and the
Secretary of Agriculture shall jointly develop and disseminate model
plans for–
(1) the decontamination of individuals, equipment, and
facilities following an intentional contamination of agriculture
or food; and
(2) the disposal of large quantities of animals, plants, or
food products that have been infected or contaminated by
specific threat agents and foreign animal diseases.

(d) Exercises. <> –In carrying out subsection (a),
the Administrator, in coordination with the entities described under
subsection (b), shall conduct exercises at least annually to evaluate
and identify weaknesses in the decontamination and disposal model plans
described in subsection (c). Such exercises shall be carried out, to the
maximum extent practicable, as part of the national exercise program
under section 648(b)(1) of the Post-Katrina Emergency Management Reform
Act of 2006 (6 U.S.C. 748(b)(1)).

(e) Modifications.–Based on the exercises described in subsection
(d), the Administrator, in coordination with the entities described in
subsection (b), shall review and modify as necessary the plans described
in subsection (c) not less frequently than biennially.
(f) Prioritization.–The Administrator, in coordination with the
entities described in subsection (b), shall develop standards and plans
under subsections (b) and (c) in an identified order of priority that
takes into account–
(1) highest-risk biological, chemical, and radiological
threat agents;
(2) agents that could cause the greatest economic
devastation to the agriculture and food system; and
(3) agents that are most difficult to clean or remediate.
SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND
TRIBAL FOOD SAFETY OFFICIALS.

(a) Improving Training.–Chapter X (21 U.S.C. 391 et seq.) is
amended by adding at the end the following:
“SEC. 1011. <> IMPROVING THE TRAINING OF
STATE, LOCAL, TERRITORIAL, AND TRIBAL
FOOD SAFETY OFFICIALS.

“(a) Training.–The Secretary shall set standards and administer
training and education programs for the employees of State, local,
territorial, and tribal food safety officials relating to the regulatory
responsibilities and policies established by this Act, including
programs for–
“(1) scientific training;
“(2) training to improve the skill of officers and
employees authorized to conduct inspections under sections 702
and 704;
“(3) training to achieve advanced product or process
specialization in such inspections;

[[Page 124 STAT. 3946]]

“(4) training that addresses best practices;
“(5) training in administrative process and procedure and
integrity issues;
“(6) training in appropriate sampling and laboratory
analysis methodology; and
“(7) training in building enforcement actions following
inspections, examinations, testing, and investigations.

“(b) Partnerships With State and Local Officials.–
“(1) In general.–The Secretary, pursuant to a contract or
memorandum of understanding between the Secretary and the head
of a State, local, territorial, or tribal department or agency,
is authorized and encouraged to conduct examinations, testing,
and investigations for the purposes of determining compliance
with the food safety provisions of this Act through the officers
and employees of such State, local, territorial, or tribal
department or agency.
“(2) Content.–A contract or memorandum described under
paragraph (1) shall include provisions to ensure adequate
training of such officers and employees to conduct such
examinations, testing, and investigations. The contract or
memorandum shall contain provisions regarding reimbursement.
Such provisions may, at the sole discretion of the head of the
other department or agency, require reimbursement, in whole or
in part, from the Secretary for the examinations, testing, or
investigations performed pursuant to this section by the
officers or employees of the State, territorial, or tribal
department or agency.
“(3) Effect.–Nothing in this subsection shall be construed
to limit the authority of the Secretary under section 702.

“(c) Extension Service.–The Secretary shall ensure coordination
with the extension activities of the National Institute of Food and
Agriculture of the Department of Agriculture in advising producers and
small processors transitioning into new practices required as a result
of the enactment of the FDA Food Safety Modernization Act and assisting
regulated industry with compliance with such Act.
“(d) National Food Safety Training, Education, Extension, Outreach
and Technical Assistance Program.–
“(1) In general. <> —
In order to improve food safety and reduce the incidence of
foodborne illness, the Secretary shall, not later than 180 days
after the date of enactment of the FDA Food Safety Modernization
Act, enter into one or more memoranda of understanding, or enter
into other cooperative agreements, with the Secretary of
Agriculture to establish a competitive grant program within the
National Institute for Food and Agriculture to provide food
safety training, education, extension, outreach, and technical
assistance to–
“(A) owners and operators of farms;
“(B) small food processors; and
“(C) small fruit and vegetable merchant
wholesalers.
“(2) Implementation.–The competitive grant program
established under paragraph (1) shall be carried out in
accordance with section 405 of the Agricultural Research,
Extension, and Education Reform Act of 1998.

“(e) Authorization of Appropriations.–There are authorized to be
appropriated such sums as may be necessary to carry out this section for
fiscal years 2011 through 2015.”.

[[Page 124 STAT. 3947]]

(b) National Food Safety Training, Education, Extension, Outreach,
and Technical Assistance Program.–Title IV of the Agricultural
Research, Extension, and Education Reform Act of 1998 is amended by
inserting after section 404 (7 U.S.C. 7624) the following:
“SEC. 405. <> NATIONAL FOOD SAFETY TRAINING,
EDUCATION, EXTENSION, OUTREACH, AND
TECHNICAL ASSISTANCE PROGRAM.

“(a) In General. <> –The Secretary shall award
grants under this section to carry out the competitive grant program
established under section 1011(d) of the Federal Food, Drug, and
Cosmetic Act, pursuant to any memoranda of understanding entered into
under such section.

“(b) Integrated Approach.–The grant program described under
subsection (a) shall be carried out under this section in a manner that
facilitates the integration of food safety standards and guidance with
the variety of agricultural production systems, encompassing
conventional, sustainable, organic, and conservation and environmental
practices.
“(c) Priority.–In awarding grants under this section, the
Secretary shall give priority to projects that target small and medium-
sized farms, beginning farmers, socially disadvantaged farmers, small
processors, or small fresh fruit and vegetable merchant wholesalers.
“(d) Program Coordination.–
“(1) In general.–The Secretary shall coordinate
implementation of the grant program under this section with the
National Integrated Food Safety Initiative.
“(2) Interaction.–The Secretary shall–
“(A) in carrying out the grant program under this
section, take into consideration applied research,
education, and extension results obtained from the
National Integrated Food Safety Initiative; and
“(B) in determining the applied research agenda for
the National Integrated Food Safety Initiative, take
into consideration the needs articulated by participants
in projects funded by the program under this section.

“(e) Grants.–
“(1) In general.–In carrying out this section, the
Secretary shall make competitive grants to support training,
education, extension, outreach, and technical assistance
projects that will help improve public health by increasing the
understanding and adoption of established food safety standards,
guidance, and protocols.
“(2) Encouraged features.–The Secretary shall encourage
projects carried out using grant funds under this section to
include co-management of food safety, conservation systems, and
ecological health.
“(3) Maximum term and size of grant.–
“(A) In general.–A grant under this section shall
have a term that is not more than 3 years.
“(B) Limitation on grant funding.–The Secretary
may not provide grant funding to an entity under this
section after such entity has received 3 years of grant
funding under this section.

“(f) Grant Eligibility.–

[[Page 124 STAT. 3948]]

“(1) In general.–To be eligible for a grant under this
section, an entity shall be–
“(A) a State cooperative extension service;
“(B) a Federal, State, local, or tribal agency, a
nonprofit community-based or non-governmental
organization, or an organization representing owners and
operators of farms, small food processors, or small
fruit and vegetable merchant wholesalers that has a
commitment to public health and expertise in
administering programs that contribute to food safety;
“(C) an institution of higher education (as defined
in section 101(a) of the Higher Education Act of 1965
(20 U.S.C. 1001(a))) or a foundation maintained by an
institution of higher education;
“(D) a collaboration of 2 of more eligible entities
described in this subsection; or
“(E) such other appropriate entity, as determined
by the Secretary.
“(2) Multistate partnerships.–Grants under this section
may be made for projects involving more than 1 State.

“(g) Regional Balance.–In making grants under this section, the
Secretary shall, to the maximum extent practicable, ensure–
“(1) geographic diversity; and
“(2) diversity of types of agricultural production.

“(h) Technical Assistance.–The Secretary may use funds made
available under this section to provide technical assistance to grant
recipients to further the purposes of this section.
“(i) Best Practices and Model Programs.–Based on evaluations of,
and responses arising from, projects funded under this section, the
Secretary may issue a set of recommended best practices and models for
food safety training programs for agricultural producers, small food
processors, and small fresh fruit and vegetable merchant wholesalers.
“(j) Authorization of Appropriations.–For the purposes of making
grants under this section, there are authorized to be appropriated such
sums as may be necessary for fiscal years 2011 through 2015.”.
SEC. 210. ENHANCING FOOD SAFETY.

(a) Grants To Enhance Food Safety.–Section 1009 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 399) is amended to read as
follows:
“SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY.

“(a) In General.–The Secretary is authorized to make grants to
eligible entities to–
“(1) undertake examinations, inspections, and
investigations, and related food safety activities under section
702;
“(2) train to the standards of the Secretary for the
examination, inspection, and investigation of food
manufacturing, processing, packing, holding, distribution, and
importation, including as such examination, inspection, and
investigation relate to retail food establishments;
“(3) build the food safety capacity of the laboratories of
such eligible entity, including the detection of zoonotic
diseases;
“(4) build the infrastructure and capacity of the food
safety programs of such eligible entity to meet the standards as
outlined in the grant application; and

[[Page 124 STAT. 3949]]

“(5) take appropriate action to protect the public health
in response to–
“(A) a notification under section 1008, including
planning and otherwise preparing to take such action; or
“(B) a recall of food under this Act.

“(b) Eligible Entities; Application.–
“(1) In general. <> –In this section,
the term `eligible entity’ means an entity–
“(A) that is–
“(i) a State;
“(ii) a locality;
“(iii) a territory;
“(iv) an Indian tribe (as defined in section
4(e) of the Indian Self-Determination and
Education Assistance Act); or
“(v) a nonprofit food safety training entity
that collaborates with 1 or more institutions of
higher education; and
“(B) that submits an application to the Secretary
at such time, in such manner, and including such
information as the Secretary may reasonably require.
“(2) Contents.–Each application submitted under paragraph
(1) shall include–
“(A) an assurance that the eligible entity has
developed plans to engage in the types of activities
described in subsection (a);
“(B) a description of the types of activities to be
funded by the grant;
“(C) an itemization of how grant funds received
under this section will be expended;
“(D) a description of how grant activities will be
monitored; and
“(E) an agreement by the eligible entity to report
information required by the Secretary to conduct
evaluations under this section.

“(c) Limitations.–The funds provided under subsection (a) shall be
available to an eligible entity that receives a grant under this section
only to the extent such entity funds the food safety programs of such
entity independently of any grant under this section in each year of the
grant at a level equal to the level of such funding in the previous
year, increased by the Consumer Price Index. Such non-Federal matching
funds may be provided directly or through donations from public or
private entities and may be in cash or in-kind, fairly evaluated,
including plant, equipment, or services.
“(d) Additional Authority.–The Secretary may–
“(1) award a grant under this section in each subsequent
fiscal year without reapplication for a period of not more than
3 years, provided the requirements of subsection (c) are met for
the previous fiscal year; and
“(2) award a grant under this section in a fiscal year for
which the requirement of subsection (c) has not been met only if
such requirement was not met because such funding was diverted
for response to 1 or more natural disasters or in other
extenuating circumstances that the Secretary may determine
appropriate.

[[Page 124 STAT. 3950]]

“(e) Duration of Awards.–The Secretary may award grants to an
individual grant recipient under this section for periods of not more
than 3 years. In the event the Secretary conducts a program evaluation,
funding in the second year or third year of the grant, where applicable,
shall be contingent on a successful program evaluation by the Secretary
after the first year.
“(f) Progress and Evaluation.–
“(1) In general.–The Secretary shall measure the status
and success of each grant program authorized under the FDA Food
Safety Modernization Act (and any amendment made by such Act),
including the grant program under this section. A recipient of a
grant described in the preceding sentence shall, at the end of
each grant year, provide the Secretary with information on how
grant funds were spent and the status of the efforts by such
recipient to enhance food safety. To the extent practicable, the
Secretary shall take the performance of such a grant recipient
into account when determining whether to continue funding for
such recipient.
“(2) No duplication.–In carrying out paragraph (1), the
Secretary shall not duplicate the efforts of the Secretary under
other provisions of this Act or the FDA Food Safety
Modernization Act that require measurement and review of the
activities of grant recipients under either such Act.

“(g) Supplement Not Supplant.–Grant funds received under this
section shall be used to supplement, and not supplant, non-Federal funds
and any other Federal funds available to carry out the activities
described in this section.
“(h) Authorization of Appropriations.–For the purpose of making
grants under this section, there are authorized to be appropriated such
sums as may be necessary for fiscal years 2011 through 2015.”.
(b) Centers of Excellence.–Part P of the Public Health Service Act
(42 U.S.C. 280g et seq.) is amended by adding at the end the following:
“SEC. 399V-5. <> FOOD SAFETY INTEGRATED
CENTERS OF EXCELLENCE.

“(a) In General. <> –Not later than
1 year after the date of enactment of the FDA Food Safety Modernization
Act, the Secretary, acting through the Director of the Centers for
Disease Control and Prevention and in consultation with the working
group described in subsection (b)(2), shall designate 5 Integrated Food
Safety Centers of Excellence (referred to in this section as the
`Centers of Excellence’) to serve as resources for Federal, State, and
local public health professionals to respond to foodborne illness
outbreaks. The Centers of Excellence shall be headquartered at selected
State health departments.

“(b) Selection of Centers of Excellence.–
“(1) Eligible entities.–To be eligible to be designated as
a Center of Excellence under subsection (a), an entity shall–
“(A) be a State health department;
“(B) partner with 1 or more institutions of higher
education that have demonstrated knowledge, expertise,
and meaningful experience with regional or national food
production, processing, and distribution, as well as
leadership in the laboratory, epidemiological, and
environmental detection and investigation of foodborne
illness; and

[[Page 124 STAT. 3951]]

“(C) provide to the Secretary such information, at
such time, and in such manner, as the Secretary may
require.
“(2) Working group. <> –Not later than
180 days after the date of enactment of the FDA Food Safety
Modernization Act, the Secretary shall establish a diverse
working group of experts and stakeholders from Federal, State,
and local food safety and health agencies, the food industry,
including food retailers and food manufacturers, consumer
organizations, and academia to make recommendations to the
Secretary regarding designations of the Centers of Excellence.
“(3) Additional centers of excellence.–The Secretary may
designate eligible entities to be regional Food Safety Centers
of Excellence, in addition to the 5 Centers designated under
subsection (a).

“(c) Activities.–Under the leadership of the Director of the
Centers for Disease Control and Prevention, each Center of Excellence
shall be based out of a selected State health department, which shall
provide assistance to other regional, State, and local departments of
health through activities that include–
“(1) providing resources, including timely information
concerning symptoms and tests, for frontline health
professionals interviewing individuals as part of routine
surveillance and outbreak investigations;
“(2) providing analysis of the timeliness and effectiveness
of foodborne disease surveillance and outbreak response
activities;
“(3) providing training for epidemiological and
environmental investigation of foodborne illness, including
suggestions for streamlining and standardizing the investigation
process;
“(4) establishing fellowships, stipends, and scholarships
to train future epidemiological and food-safety leaders and to
address critical workforce shortages;
“(5) training and coordinating State and local personnel;
“(6) strengthening capacity to participate in existing or
new foodborne illness surveillance and environmental assessment
information systems; and
“(7) conducting research and outreach activities focused on
increasing prevention, communication, and education regarding
food safety.

“(d) Report to Congress.–Not later than 2 years after the date of
enactment of the FDA Food Safety Modernization Act, the Secretary shall
submit to Congress a report that–
“(1) describes the effectiveness of the Centers of
Excellence; and
“(2) provides legislative recommendations or describes
additional resources required by the Centers of Excellence.

“(e) Authorization of Appropriations.–There is authorized to be
appropriated such sums as may be necessary to carry out this section.
“(f) No Duplication of Effort.–In carrying out activities of the
Centers of Excellence or other programs under this section, the
Secretary shall not duplicate other Federal foodborne illness response
efforts.”.
SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY.

(a) In General.–Section 417 (21 U.S.C. 350f) is amended–

[[Page 124 STAT. 3952]]

(1) by redesignating subsections (f) through (k) as
subsections (i) through (n), respectively; and
(2) by inserting after subsection (e) the following:

“(f) Critical Information. <> –Except with
respect to fruits and vegetables that are raw agricultural commodities,
not more than 18 months after the date of enactment of the FDA Food
Safety Modernization Act, the Secretary may require a responsible party
to submit to the Secretary consumer-oriented information regarding a
reportable food, which shall include–
“(1) a description of the article of food as provided in
subsection (e)(3);
“(2) as provided in subsection (e)(7), affected product
identification codes, such as UPC, SKU, or lot or batch numbers
sufficient for the consumer to identify the article of food;
“(3) contact information for the responsible party as
provided in subsection (e)(8); and
“(4) any other information the Secretary determines is
necessary to enable a consumer to accurately identify whether
such consumer is in possession of the reportable food.

“(g) Grocery Store Notification.–
“(1) Action by secretary.–The Secretary shall–
“(A) prepare the critical information described
under subsection (f) for a reportable food as a
standardized one-page summary;
“(B) <> publish such one-page summary
on the Internet website of the Food and Drug
Administration in a format that can be easily printed by
a grocery store for purposes of consumer notification.
“(2) Action by grocery store.–A notification described
under paragraph (1)(B) shall include the date and time such
summary was posted on the Internet website of the Food and Drug
Administration.

“(h) <> Consumer Notification.–
“(1) In general. <> –If a grocery
store sold a reportable food that is the subject of the posting
and such establishment is part of chain of establishments with
15 or more physical locations, then such establishment shall,
not later than 24 hours after a one page summary described in
subsection (g) is published, prominently display such summary or
the information from such summary via at least one of the
methods identified under paragraph (2) and maintain the display
for 14 days.
“(2) List of conspicuous
locations. <> –Not more than 1 year after
the date of enactment of the FDA Food Safety Modernization Act,
the Secretary shall develop and publish a list of acceptable
conspicuous locations and manners, from which grocery stores
shall select at least one, for providing the notification
required in paragraph (1). Such list shall include–
“(A) posting the notification at or near the
register;
“(B) providing the location of the reportable food;
“(C) providing targeted recall information given to
customers upon purchase of a food; and
“(D) other such prominent and conspicuous locations
and manners utilized by grocery stores as of the date of
the enactment of the FDA Food Safety Modernization Act
to provide notice of such recalls to consumers as
considered appropriate by the Secretary.”.

[[Page 124 STAT. 3953]]

(b) Prohibited Act.–Section 301 (21 U.S.C. 331), as amended by
section 206, is amended by adding at the end the following:
“(yy) The knowing and willful failure to comply with the
notification requirement under section 417(h).”.
(c) Conforming Amendment.–Section 301(e) (21 U.S.C. 331(e)) is
amended by striking “417(g)” and inserting “417(j)”.

TITLE III–IMPROVING THE SAFETY OF IMPORTED FOOD

SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.

(a) In General.–Chapter VIII (21 U.S.C. 381 et seq.) is amended by
adding at the end the following:
“SEC. 805. <> FOREIGN SUPPLIER VERIFICATION
PROGRAM.

“(a) In General.–
“(1) Verification requirement.–Except as provided under
subsections (e) and (f), each importer shall perform risk-based
foreign supplier verification activities for the purpose of
verifying that the food imported by the importer or agent of an
importer is–
“(A) produced in compliance with the requirements
of section 418 or section 419, as appropriate; and
“(B) is not adulterated under section 402 or
misbranded under section 403(w).
“(2) Importer defined.–For purposes of this section, the
term `importer’ means, with respect to an article of food–
“(A) the United States owner or consignee of the
article of food at the time of entry of such article
into the United States; or
“(B) in the case when there is no United States
owner or consignee as described in subparagraph (A), the
United States agent or representative of a foreign owner
or consignee of the article of food at the time of entry
of such article into the United States.

“(b) Guidance.–Not later than 1 year after the date of enactment
of the FDA Food Safety Modernization Act, the Secretary shall issue
guidance to assist importers in developing foreign supplier verification
programs.
“(c) Regulations.–
“(1) In general.–Not later than 1 year after the date of
enactment of the FDA Food Safety Modernization Act, the
Secretary shall promulgate regulations to provide for the
content of the foreign supplier verification program established
under subsection (a).
“(2) Requirements.–The regulations promulgated under
paragraph (1)–
“(A) shall require that the foreign supplier
verification program of each importer be adequate to
provide assurances that each foreign supplier to the
importer produces the imported food in compliance with–
“(i) processes and procedures, including
reasonably appropriate risk-based preventive
controls, that provide the same level of public
health protection as those required under section
418 or section 419 (taking into

[[Page 124 STAT. 3954]]

consideration variances granted under section
419), as appropriate; and
“(ii) section 402 and section 403(w).
“(B) shall include such other requirements as the
Secretary deems necessary and appropriate to verify that
food imported into the United States is as safe as food
produced and sold within the United States.
“(3) Considerations.–In promulgating regulations under
this subsection, the Secretary shall, as appropriate, take into
account differences among importers and types of imported foods,
including based on the level of risk posed by the imported food.
“(4) Activities.–Verification activities under a foreign
supplier verification program under this section may include
monitoring records for shipments, lot-by-lot certification of
compliance, annual on-site inspections, checking the hazard
analysis and risk-based preventive control plan of the foreign
supplier, and periodically testing and sampling shipments.

“(d) Record Maintenance and Access. <> —
Records of an importer related to a foreign supplier verification
program shall be maintained for a period of not less than 2 years and
shall be made available promptly to a duly authorized representative of
the Secretary upon request.

“(e) Exemption of Seafood, Juice, and Low-acid Canned Food
Facilities in Compliance With HACCP.–This section shall not apply to a
facility if the owner, operator, or agent in charge of such facility is
required to comply with, and is in compliance with, 1 of the following
standards and regulations with respect to such facility:
“(1) The Seafood Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
“(2) The Juice Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
“(3) The Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers standards of the Food and Drug
Administration (or any successor standards).

<> The exemption under paragraph (3) shall apply
only with respect to microbiological hazards that are regulated under
the standards for Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers under part 113 of chapter 21, Code of
Federal Regulations (or any successor regulations).

“(f) Additional Exemptions. <> –The Secretary, by notice published in the Federal
Register, shall establish an exemption from the requirements of this
section for articles of food imported in small quantities for research
and evaluation purposes or for personal consumption, provided that such
foods are not intended for retail sale and are not sold or distributed
to the public.

“(g) Publication of List of Participants. <> —
The Secretary shall publish and maintain on the Internet Web site of the
Food and Drug Administration a current list that includes the name of,
location of, and other information deemed necessary by the Secretary
about, importers participating under this section.”.

(b) Prohibited Act.–Section 301 (21 U.S.C. 331), as amended by
section 211, is amended by adding at the end the following:
“(zz) The importation or offering for importation of a food if the
importer (as defined in section 805) does not have in place

[[Page 124 STAT. 3955]]

a foreign supplier verification program in compliance with such section
805.”.
(c) Imports.–Section 801(a) (21 U.S.C. 381(a)) is amended by adding
“or the importer (as defined in section 805) is in violation of such
section 805” after “or in violation of section 505”.
(d) <> Effective Date.–The amendments made
by this section shall take effect 2 years after the date of enactment of
this Act.
SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.

Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 301, is
amended by adding at the end the following:
“SEC. 806. <> VOLUNTARY QUALIFIED IMPORTER
PROGRAM.

“(a) In General. <> –Beginning not later than 18
months after the date of enactment of the FDA Food Safety Modernization
Act, the Secretary shall–
“(1) establish a program, in consultation with the
Secretary of Homeland Security–
“(A) to provide for the expedited review and
importation of food offered for importation by importers
who have voluntarily agreed to participate in such
program; and
“(B) consistent with section 808, establish a
process for the issuance of a facility certification to
accompany food offered for importation by importers who
have voluntarily agreed to participate in such program;
and
“(2) <> issue a guidance document
related to participation in, revocation of such participation
in, reinstatement in, and compliance with, such program.

“(b) Voluntary Participation.–An importer may request the
Secretary to provide for the expedited review and importation of
designated foods in accordance with the program established by the
Secretary under subsection (a).
“(c) Notice of Intent To Participate.–An importer that intends to
participate in the program under this section in a fiscal year shall
submit a notice and application to the Secretary of such intent at the
time and in a manner established by the Secretary.
“(d) Eligibility.–Eligibility shall be limited to an importer
offering food for importation from a facility that has a certification
described in subsection (a). In reviewing the applications and making
determinations on such applications, the Secretary shall consider the
risk of the food to be imported based on factors, such as the following:
“(1) The known safety risks of the food to be imported.
“(2) The compliance history of foreign suppliers used by
the importer, as appropriate.
“(3) The capability of the regulatory system of the country
of export to ensure compliance with United States food safety
standards for a designated food.
“(4) The compliance of the importer with the requirements
of section 805.
“(5) The recordkeeping, testing, inspections and audits of
facilities, traceability of articles of food, temperature
controls, and sourcing practices of the importer.
“(6) The potential risk for intentional adulteration of the
food.
“(7) Any other factor that the Secretary determines
appropriate.

[[Page 124 STAT. 3956]]

“(e) Review and Revocation. <> –Any importer
qualified by the Secretary in accordance with the eligibility criteria
set forth in this section shall be reevaluated not less often than once
every 3 years and the Secretary shall promptly revoke the qualified
importer status of any importer found not to be in compliance with such
criteria.

“(f) False Statements.–Any statement or representation made by an
importer to the Secretary shall be subject to section 1001 of title 18,
United States Code.
“(g) Definition.–For purposes of this section, the term `importer’
means the person that brings food, or causes food to be brought, from a
foreign country into the customs territory of the United States.”.
SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR FOOD.

(a) In General.–Section 801(a) (21 U.S.C. 381(a)) is amended by
inserting after the third sentence the following: “With respect to an
article of food, if importation of such food is subject to, but not
compliant with, the requirement under subsection (q) that such food be
accompanied by a certification or other assurance that the food meets
applicable requirements of this Act, then such article shall be refused
admission.”.
(b) Addition of Certification Requirement.–Section 801 (21 U.S.C.
381) is amended by adding at the end the following new subsection:
“(q) Certifications Concerning Imported Foods.–
“(1) In general.–The Secretary may require, as a condition
of granting admission to an article of food imported or offered
for import into the United States, that an entity described in
paragraph (3) provide a certification, or such other assurances
as the Secretary determines appropriate, that the article of
food complies with applicable requirements of this Act. Such
certification or assurances may be provided in the form of
shipment-specific certificates, a listing of certified
facilities that manufacture, process, pack, or hold such food,
or in such other form as the Secretary may specify.
“(2) Factors to be considered in requiring certification.–
The Secretary shall base the determination that an article of
food is required to have a certification described in paragraph
(1) on the risk of the food, including–
“(A) known safety risks associated with the food;
“(B) known food safety risks associated with the
country, territory, or region of origin of the food;
“(C) a finding by the Secretary, supported by
scientific, risk-based evidence, that–
“(i) the food safety programs, systems, and
standards in the country, territory, or region of
origin of the food are inadequate to ensure that
the article of food is as safe as a similar
article of food that is manufactured, processed,
packed, or held in the United States in accordance
with the requirements of this Act; and
“(ii) the certification would assist the
Secretary in determining whether to refuse or
admit the article of food under subsection (a);
and

[[Page 124 STAT. 3957]]

“(D) information submitted to the Secretary in
accordance with the process established in paragraph
(7).
“(3) Certifying entities.–For purposes of paragraph (1),
entities that shall provide the certification or assurances
described in such paragraph are–
“(A) an agency or a representative of the
government of the country from which the article of food
at issue originated, as designated by the Secretary; or
“(B) such other persons or entities accredited
pursuant to section 808 to provide such certification or
assurance.
“(4) Renewal and refusal of certifications.–The Secretary
may–
“(A) require that any certification or other
assurance provided by an entity specified in paragraph
(2) be renewed by such entity at such times as the
Secretary determines appropriate; and
“(B) refuse to accept any certification or
assurance if the Secretary determines that such
certification or assurance is not valid or reliable.
“(5) Electronic submission.–The Secretary shall provide
for the electronic submission of certifications under this
subsection.
“(6) False statements.–Any statement or representation
made by an entity described in paragraph (2) to the Secretary
shall be subject to section 1001 of title 18, United States
Code.
“(7) Assessment of food safety programs, systems, and
standards.–If the Secretary determines that the food safety
programs, systems, and standards in a foreign region, country,
or territory are inadequate to ensure that an article of food is
as safe as a similar article of food that is manufactured,
processed, packed, or held in the United States in accordance
with the requirements of this Act, the Secretary shall, to the
extent practicable, identify such inadequacies and establish a
process by which the foreign region, country, or territory may
inform the Secretary of improvements made to such food safety
program, system, or standard and demonstrate that those controls
are adequate to ensure that an article of food is as safe as a
similar article of food that is manufactured, processed, packed,
or held in the United States in accordance with the requirements
of this Act.”.

(c) Conforming Technical Amendment.–Section 801(b) (21 U.S.C.
381(b)) is amended in the second sentence by striking “with respect to
an article included within the provision of the fourth sentence of
subsection (a)” and inserting “with respect to an article described in
subsection (a) relating to the requirements of sections 760 or 761,”.
(d) <> No Limit on Authority.–Nothing in
the amendments made by this section shall limit the authority of the
Secretary to conduct inspections of imported food or to take such other
steps as the Secretary deems appropriate to determine the admissibility
of imported food.
SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

(a) In General.–Section 801(m)(1) (21 U.S.C. 381(m)(1)) is amended
by inserting “any country to which the article has been refused
entry;” after “the country from which the article is shipped;”.

[[Page 124 STAT. 3958]]

(b) Regulations. <> –Not later
than 120 days after the date of enactment of this Act, the Secretary
shall issue an interim final rule amending subpart I of part 1 of title
21, Code of Federal Regulations, to implement the amendment made by this
section.

(c) <> Effective Date.–The amendment made
by this section shall take effect 180 days after the date of enactment
of this Act.
SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH RESPECT TO
FOOD SAFETY.

(a) In General. <> –The Secretary shall, not later
than 2 years of the date of enactment of this Act, develop a
comprehensive plan to expand the technical, scientific, and regulatory
food safety capacity of foreign governments, and their respective food
industries, from which foods are exported to the United States.

(b) Consultation.–In developing the plan under subsection (a), the
Secretary shall consult with the Secretary of Agriculture, Secretary of
State, Secretary of the Treasury, the Secretary of Homeland Security,
the United States Trade Representative, and the Secretary of Commerce,
representatives of the food industry, appropriate foreign government
officials, nongovernmental organizations that represent the interests of
consumers, and other stakeholders.
(c) Plan.–The plan developed under subsection (a) shall include, as
appropriate, the following:
(1) Recommendations for bilateral and multilateral
arrangements and agreements, including provisions to provide for
responsibility of exporting countries to ensure the safety of
food.
(2) Provisions for secure electronic data sharing.
(3) Provisions for mutual recognition of inspection reports.
(4) Training of foreign governments and food producers on
United States requirements for safe food.
(5) Recommendations on whether and how to harmonize
requirements under the Codex Alimentarius.
(6) Provisions for the multilateral acceptance of laboratory
methods and testing and detection techniques.

(d) Rule of Construction.–Nothing in this section shall be
construed to affect the regulation of dietary supplements under the
Dietary Supplement Health and Education Act of 1994 (Public Law 103-
417).
SEC. 306. INSPECTION OF FOREIGN FOOD FACILITIES.

(a) In General.–Chapter VIII (21 U.S.C. 381 et seq.), as amended by
section 302, is amended by inserting at the end the following:
“SEC. 807. <> INSPECTION OF FOREIGN FOOD
FACILITIES.

“(a) Inspection.–The Secretary–
“(1) may enter into arrangements and agreements with
foreign governments to facilitate the inspection of foreign
facilities registered under section 415; and
“(2) shall direct resources to inspections of foreign
facilities, suppliers, and food types, especially such
facilities, suppliers, and food types that present a high risk
(as identified by the Secretary), to help ensure the safety and
security of the food supply of the United States.

[[Page 124 STAT. 3959]]

“(b) Effect of Inability To Inspect.–Notwithstanding any other
provision of law, food shall be refused admission into the United States
if it is from a foreign factory, warehouse, or other establishment of
which the owner, operator, or agent in charge, or the government of the
foreign country, refuses to permit entry of United States inspectors or
other individuals duly designated by the Secretary, upon request, to
inspect such factory, warehouse, or other establishment. For purposes of
this subsection, such an owner, operator, or agent in charge shall be
considered to have refused an inspection if such owner, operator, or
agent in charge does not permit an inspection of a factory, warehouse,
or other establishment during the 24-hour period after such request is
submitted, or after such other time period, as agreed upon by the
Secretary and the foreign factory, warehouse, or other establishment.”.
(b) <> Inspection by the Secretary of
Commerce.–
(1) In general.–The Secretary of Commerce, in coordination
with the Secretary of Health and Human Services, may send 1 or
more inspectors to a country or facility of an exporter from
which seafood imported into the United States originates. The
inspectors shall assess practices and processes used in
connection with the farming, cultivation, harvesting,
preparation for market, or transportation of such seafood and
may provide technical assistance related to such activities.
(2) Inspection report.–
(A) In general.–The Secretary of Health and Human
Services, in coordination with the Secretary of
Commerce, shall–
(i) prepare an inspection report for each
inspection conducted under paragraph (1);
(ii) provide the report to the country or
exporter that is the subject of the report; and
(iii) <> provide a 30-day
period during which the country or exporter may
provide a rebuttal or other comments on the
findings of the report to the Secretary of Health
and Human Services.
(B) Distribution and use of report.–The Secretary
of Health and Human Services shall consider the
inspection reports described in subparagraph (A) in
distributing inspection resources under section 421 of
the Federal Food, Drug, and Cosmetic Act, as added by
section 201.
SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS.

Chapter VIII (21 U.S.C. 381 et seq.), as amended by section 306, is
amended by adding at the end the following:
“SEC. 808. <> ACCREDITATION OF THIRD-PARTY
AUDITORS.

“(a) Definitions.–In this section:
“(1) Audit agent.–The term `audit agent’ means an
individual who is an employee or agent of an accredited third-
party auditor and, although not individually accredited, is
qualified to conduct food safety audits on behalf of an
accredited third-party auditor.
“(2) Accreditation body.–The term `accreditation body’
means an authority that performs accreditation of third-party
auditors.
“(3) Third-party auditor.–The term `third-party auditor’
means a foreign government, agency of a foreign government,

[[Page 124 STAT. 3960]]

foreign cooperative, or any other third party, as the Secretary
determines appropriate in accordance with the model standards
described in subsection (b)(2), that is eligible to be
considered for accreditation to conduct food safety audits to
certify that eligible entities meet the applicable requirements
of this section. A third-party auditor may be a single
individual. A third-party auditor may employ or use audit agents
to help conduct consultative and regulatory audits.
“(4) Accredited third-party auditor.–The term `accredited
third-party auditor’ means a third-party auditor accredited by
an accreditation body to conduct audits of eligible entities to
certify that such eligible entities meet the applicable
requirements of this section. An accredited third-party auditor
may be an individual who conducts food safety audits to certify
that eligible entities meet the applicable requirements of this
section.
“(5) Consultative audit.–The term `consultative audit’
means an audit of an eligible entity–
“(A) to determine whether such entity is in
compliance with the provisions of this Act and with
applicable industry standards and practices; and
“(B) the results of which are for internal purposes
only.
“(6) Eligible entity.–The term `eligible entity’ means a
foreign entity, including a foreign facility registered under
section 415, in the food import supply chain that chooses to be
audited by an accredited third-party auditor or the audit agent
of such accredited third-party auditor.
“(7) Regulatory audit.–The term `regulatory audit’ means
an audit of an eligible entity–
“(A) to determine whether such entity is in
compliance with the provisions of this Act; and
“(B) the results of which determine–
“(i) whether an article of food manufactured,
processed, packed, or held by such entity is
eligible to receive a food certification under
section 801(q); or
“(ii) whether a facility is eligible to
receive a facility certification under section
806(a) for purposes of participating in the
program under section 806.

“(b) Accreditation System.–
“(1) Accreditation bodies.–
“(A) Recognition of accreditation bodies.–
“(i) In general. <> –Not
later than 2 years after the date of enactment of
the FDA Food Safety Modernization Act, the
Secretary shall establish a system for the
recognition of accreditation bodies that accredit
third-party auditors to certify that eligible
entities meet the applicable requirements of this
section.
“(ii) Direct accreditation.–If, by the date
that is 2 years after the date of establishment of
the system described in clause (i), the Secretary
has not identified and recognized an accreditation
body to meet the requirements of this section, the
Secretary may directly accredit third-party
auditors.
“(B) Notification.–Each accreditation body
recognized by the Secretary shall submit to the
Secretary a

[[Page 124 STAT. 3961]]

list of all accredited third-party auditors accredited
by such body and the audit agents of such auditors.
“(C) Revocation of recognition as an accreditation
body.–The Secretary shall promptly revoke the
recognition of any accreditation body found not to be in
compliance with the requirements of this section.
“(D) Reinstatement. <> –The
Secretary shall establish procedures to reinstate
recognition of an accreditation body if the Secretary
determines, based on evidence presented by such
accreditation body, that revocation was inappropriate or
that the body meets the requirements for recognition
under this section.
“(2) Model accreditation standards. <> —
Not later than 18 months after the date of enactment of the FDA
Food Safety Modernization Act, the Secretary shall develop model
standards, including requirements for regulatory audit reports,
and each recognized accreditation body shall ensure that third-
party auditors and audit agents of such auditors meet such
standards in order to qualify such third-party auditors as
accredited third-party auditors under this section. In
developing the model standards, the Secretary shall look to
standards in place on the date of the enactment of this section
for guidance, to avoid unnecessary duplication of efforts and
costs.

“(c) Third-party Auditors.–
“(1) Requirements for accreditation as a third-party
auditor.–
“(A) Foreign governments.–Prior to accrediting a
foreign government or an agency of a foreign government
as an accredited third-party auditor, the accreditation
body (or, in the case of direct accreditation under
subsection (b)(1)(A)(ii), the Secretary) shall perform
such reviews and audits of food safety programs,
systems, and standards of the government or agency of
the government as the Secretary deems necessary,
including requirements under the model standards
developed under subsection (b)(2), to determine that the
foreign government or agency of the foreign government
is capable of adequately ensuring that eligible entities
or foods certified by such government or agency meet the
requirements of this Act with respect to food
manufactured, processed, packed, or held for import into
the United States.
“(B) Foreign cooperatives and other third
parties.–Prior to accrediting a foreign cooperative
that aggregates the products of growers or processors,
or any other third party to be an accredited third-party
auditor, the accreditation body (or, in the case of
direct accreditation under subsection (b)(1)(A)(ii), the
Secretary) shall perform such reviews and audits of the
training and qualifications of audit agents used by that
cooperative or party and conduct such reviews of
internal systems and such other investigation of the
cooperative or party as the Secretary deems necessary,
including requirements under the model standards
developed under subsection (b)(2), to determine that
each eligible entity certified by the cooperative or
party has systems and standards in use to ensure that
such entity or food meets the requirements of this Act.

[[Page 124 STAT. 3962]]

“(2) Requirement to issue certification of eligible
entities or foods.–
“(A) In general.–An accreditation body (or, in the
case of direct accreditation under subsection
(b)(1)(A)(ii), the Secretary) may not accredit a third-
party auditor unless such third-party auditor agrees to
issue a written and, as appropriate, electronic food
certification, described in section 801(q), or facility
certification under section 806(a), as appropriate, to
accompany each food shipment for import into the United
States from an eligible entity, subject to requirements
set forth by the Secretary. Such written or electronic
certification may be included with other documentation
regarding such food shipment. The Secretary shall
consider certifications under section 801(q) and
participation in the voluntary qualified importer
program described in section 806 when targeting
inspection resources under section 421.
“(B) Purpose of certification.–The Secretary shall
use certification provided by accredited third-party
auditors to–
“(i) determine, in conjunction with any other
assurances the Secretary may require under section
801(q), whether a food satisfies the requirements
of such section; and
“(ii) determine whether a facility is
eligible to be a facility from which food may be
offered for import under the voluntary qualified
importer program under section 806.
“(C) Requirements for issuing certification.–
“(i) In general. <> –An
accredited third-party auditor shall issue a food
certification under section 801(q) or a facility
certification described under subparagraph (B)
only after conducting a regulatory audit and such
other activities that may be necessary to
establish compliance with the requirements of such
sections.
“(ii) Provision of certification.–Only an
accredited third-party auditor or the Secretary
may provide a facility certification under section
806(a). Only those parties described in 801(q)(3)
or the Secretary may provide a food certification
under 301(g).
“(3) Audit report submission requirements.–
“(A) Requirements in general.–As a condition of
accreditation, not later than 45 days after conducting
an audit, an accredited third-party auditor or audit
agent of such auditor shall prepare, and, in the case of
a regulatory audit, submit, the audit report for each
audit conducted, in a form and manner designated by the
Secretary, which shall include–
“(i) the identity of the persons at the
audited eligible entity responsible for compliance
with food safety requirements;
“(ii) the dates of the audit;
“(iii) the scope of the audit; and
“(iv) any other information required by the
Secretary that relates to or may influence an
assessment of compliance with this Act.

[[Page 124 STAT. 3963]]

“(B) Records.–Following any accreditation of a
third-party auditor, the Secretary may, at any time,
require the accredited third-party auditor to submit to
the Secretary an onsite audit report and such other
reports or documents required as part of the audit
process, for any eligible entity certified by the third-
party auditor or audit agent of such auditor. Such
report may include documentation that the eligible
entity is in compliance with any applicable registration
requirements.
“(C) Limitation.–The requirement under
subparagraph (B) shall not include any report or other
documents resulting from a consultative audit by the
accredited third-party auditor, except that the
Secretary may access the results of a consultative audit
in accordance with section 414.
“(4) Requirements of accredited third-party auditors and
audit agents of such auditors.–
“(A) Risks to public
health. <> –If, at any time during
an audit, an accredited third-party auditor or audit
agent of such auditor discovers a condition that could
cause or contribute to a serious risk to the public
health, such auditor shall immediately notify the
Secretary of–
“(i) the identification of the eligible
entity subject to the audit; and
“(ii) such condition.
“(B) Types of audits.–An accredited third-party
auditor or audit agent of such auditor may perform
consultative and regulatory audits of eligible entities.
“(C) Limitations.–
“(i) In general.–An accredited third party
auditor may not perform a regulatory audit of an
eligible entity if such agent has performed a
consultative audit or a regulatory audit of such
eligible entity during the previous 13-month
period.
“(ii) Waiver.–The Secretary may waive the
application of clause (i) if the Secretary
determines that there is insufficient access to
accredited third-party auditors in a country or
region.
“(5) Conflicts of interest.–
“(A) Third-party auditors.–An accredited third-
party auditor shall–
“(i) not be owned, managed, or controlled by
any person that owns or operates an eligible
entity to be certified by such auditor;
“(ii) in carrying out audits of eligible
entities under this section, have procedures to
ensure against the use of any officer or employee
of such auditor that has a financial conflict of
interest regarding an eligible entity to be
certified by such auditor; and
“(iii) <> annually make
available to the Secretary disclosures of the
extent to which such auditor and the officers and
employees of such auditor have maintained
compliance with clauses (i) and (ii) relating to
financial conflicts of interest.
“(B) Audit agents.–An audit agent shall–
“(i) not own or operate an eligible entity to
be audited by such agent;

[[Page 124 STAT. 3964]]

“(ii) in carrying out audits of eligible
entities under this section, have procedures to
ensure that such agent does not have a financial
conflict of interest regarding an eligible entity
to be audited by such agent; and
“(iii) <> annually make
available to the Secretary disclosures of the
extent to which such agent has maintained
compliance with clauses (i) and (ii) relating to
financial conflicts of interest.
“(C) Regulations. <> –The
Secretary shall promulgate regulations not later than 18
months after the date of enactment of the FDA Food
Safety Modernization Act to implement this section and
to ensure that there are protections against conflicts
of interest between an accredited third-party auditor
and the eligible entity to be certified by such auditor
or audited by such audit agent. Such regulations shall
include–
“(i) requiring that audits performed under
this section be unannounced;
“(ii) a structure to decrease the potential
for conflicts of interest, including timing and
public disclosure, for fees paid by eligible
entities to accredited third-party auditors; and
“(iii) appropriate limits on financial
affiliations between an accredited third-party
auditor or audit agents of such auditor and any
person that owns or operates an eligible entity to
be certified by such auditor, as described in
subparagraphs (A) and (B).
“(6) Withdrawal of accreditation.–
“(A) In general.–The Secretary shall withdraw
accreditation from an accredited third-party auditor–
“(i) if food certified under section 801(q)
or from a facility certified under paragraph
(2)(B) by such third-party auditor is linked to an
outbreak of foodborne illness that has a
reasonable probability of causing serious adverse
health consequences or death in humans or animals;
“(ii) following an evaluation and finding by
the Secretary that the third-party auditor no
longer meets the requirements for accreditation;
or
“(iii) following a refusal to allow United
States officials to conduct such audits and
investigations as may be necessary to ensure
continued compliance with the requirements set
forth in this section.
“(B) Additional basis for withdrawal of
accreditation.–The Secretary may withdraw accreditation
from an accredited third-party auditor in the case that
such third-party auditor is accredited by an
accreditation body for which recognition as an
accreditation body under subsection (b)(1)(C) is
revoked, if the Secretary determines that there is good
cause for the withdrawal.
“(C) Exception. <> –The
Secretary may waive the application of subparagraph
(A)(i) if the Secretary–
“(i) conducts an investigation of the
material facts related to the outbreak of human or
animal illness; and

[[Page 124 STAT. 3965]]

“(ii) reviews the steps or actions taken by
the third party auditor to justify the
certification and determines that the accredited
third-party auditor satisfied the requirements
under section 801(q) of certifying the food, or
the requirements under paragraph (2)(B) of
certifying the entity.
“(7) Reaccreditation. <> –The Secretary
shall establish procedures to reinstate the accreditation of a
third-party auditor for which accreditation has been withdrawn
under paragraph (6)–
“(A) if the Secretary determines, based on evidence
presented, that the third-party auditor satisfies the
requirements of this section and adequate grounds for
revocation no longer exist; and
“(B) in the case of a third-party auditor
accredited by an accreditation body for which
recognition as an accreditation body under subsection
(b)(1)(C) is revoked–
“(i) <> if the third-party
auditor becomes accredited not later than 1 year
after revocation of accreditation under paragraph
(6)(A), through direct accreditation under
subsection (b)(1)(A)(ii) or by an accreditation
body in good standing; or
“(ii) under such conditions as the Secretary
may require for a third-party auditor under
paragraph (6)(B).
“(8) Neutralizing costs. <> –The
Secretary shall establish by regulation a reimbursement (user
fee) program, similar to the method described in section 203(h)
of the Agriculture Marketing Act of 1946, by which the Secretary
assesses fees and requires accredited third-party auditors and
audit agents to reimburse the Food and Drug Administration for
the work performed to establish and administer the accreditation
system under this section. The Secretary shall make operating
this program revenue-neutral and shall not generate surplus
revenue from such a reimbursement mechanism. Fees authorized
under this paragraph shall be collected and available for
obligation only to the extent and in the amount provided in
advance in appropriation Acts. Such fees are authorized to
remain available until expended.

“(d) Recertification of Eligible
Entities. <> –An eligible entity shall apply for
annual recertification by an accredited third-party auditor if such
entity–
“(1) intends to participate in voluntary qualified importer
program under section 806; or
“(2) is required to provide to the Secretary a
certification under section 801(q) for any food from such
entity.

“(e) False Statements.–Any statement or representation made–
“(1) by an employee or agent of an eligible entity to an
accredited third-party auditor or audit agent; or
“(2) by an accredited third-party auditor to the Secretary,

shall be subject to section 1001 of title 18, United States Code.
“(f) Monitoring.–To ensure compliance with the requirements of
this section, the Secretary shall–
“(1) <> periodically, or at least once
every 4 years, reevaluate the accreditation bodies described in
subsection (b)(1);

[[Page 124 STAT. 3966]]

“(2) <> periodically, or at least once
every 4 years, evaluate the performance of each accredited
third-party auditor, through the review of regulatory audit
reports by such auditors, the compliance history as available of
eligible entities certified by such auditors, and any other
measures deemed necessary by the Secretary;
“(3) at any time, conduct an onsite audit of any eligible
entity certified by an accredited third-party auditor, with or
without the auditor present; and
“(4) take any other measures deemed necessary by the
Secretary.

“(g) Publicly Available Registry.–The Secretary shall establish a
publicly available registry of accreditation bodies and of accredited
third-party auditors, including the name of, contact information for,
and other information deemed necessary by the Secretary about such
bodies and auditors.
“(h) Limitations.–
“(1) No effect on section 704 inspections.–The audits
performed under this section shall not be considered inspections
under section 704.
“(2) No effect on inspection authority.–Nothing in this
section affects the authority of the Secretary to inspect any
eligible entity pursuant to this Act.”.
SEC. 308. <> FOREIGN OFFICES OF THE FOOD AND
DRUG ADMINISTRATION.

(a) In General. <> –The Secretary shall
establish offices of the Food and Drug Administration in foreign
countries selected by the Secretary, to provide assistance to the
appropriate governmental entities of such countries with respect to
measures to provide for the safety of articles of food and other
products regulated by the Food and Drug Administration exported by such
country to the United States, including by directly conducting risk-
based inspections of such articles and supporting such inspections by
such governmental entity.

(b) Consultation.–In establishing the foreign offices described in
subsection (a), the Secretary shall consult with the Secretary of State,
the Secretary of Homeland Security, and the United States Trade
Representative.
(c) Report.–Not later than October 1, 2011, the Secretary shall
submit to Congress a report on the basis for the selection by the
Secretary of the foreign countries in which the Secretary established
offices, the progress which such offices have made with respect to
assisting the governments of such countries in providing for the safety
of articles of food and other products regulated by the Food and Drug
Administration exported to the United States, and the plans of the
Secretary for establishing additional foreign offices of the Food and
Drug Administration, as appropriate.
SEC. 309. <> SMUGGLED FOOD.

(a) In General. <> –Not later than 180
days after the enactment of this Act, the Secretary shall, in
coordination with the Secretary of Homeland Security, develop and
implement a strategy to better identify smuggled food and prevent entry
of such food into the United States.

(b) Notification to Homeland Security. <> –Not
later than 10 days after the Secretary identifies a smuggled food that
the Secretary believes would cause serious adverse health consequences

[[Page 124 STAT. 3967]]

or death to humans or animals, the Secretary shall provide to the
Secretary of Homeland Security a notification under section 417(n) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f(k)) describing
the smuggled food and, if available, the names of the individuals or
entities that attempted to import such food into the United States.

(c) Public Notification.–If the Secretary–
(1) identifies a smuggled food;
(2) reasonably believes exposure to the food would cause
serious adverse health consequences or death to humans or
animals; and
(3) reasonably believes that the food has entered domestic
commerce and is likely to be consumed,

the Secretary shall promptly issue a press release describing that food
and shall use other emergency communication or recall networks, as
appropriate, to warn consumers and vendors about the potential threat.
(d) Effect of Section.–Nothing in this section shall affect the
authority of the Secretary to issue public notifications under other
circumstances.
(e) Definition.–In this subsection, the term “smuggled food”
means any food that a person introduces into the United States through
fraudulent means or with the intent to defraud or mislead.

TITLE IV–MISCELLANEOUS PROVISIONS

SEC. 401. FUNDING FOR FOOD SAFETY.

(a) In General.–There are authorized to be appropriated to carry
out the activities of the Center for Food Safety and Applied Nutrition,
the Center for Veterinary Medicine, and related field activities in the
Office of Regulatory Affairs of the Food and Drug Administration such
sums as may be necessary for fiscal years 2011 through 2015.
(b) Increased Number of Field Staff.–
(1) In general.–To carry out the activities of the Center
for Food Safety and Applied Nutrition, the Center for Veterinary
Medicine, and related field activities of the Office of
Regulatory Affairs of the Food and Drug Administration, the
Secretary of Health and Human Services shall increase the field
staff of such Centers and Office with a goal of not fewer than–
(A) 4,000 staff members in fiscal year 2011;
(B) 4,200 staff members in fiscal year 2012;
(C) 4,600 staff members in fiscal year 2013; and
(D) 5,000 staff members in fiscal year 2014.
(2) Field staff for food defense.–The goal under paragraph
(1) shall include an increase of 150 employees by fiscal year
2011 to–
(A) provide additional detection of and response to
food defense threats; and
(B) detect, track, and remove smuggled food (as
defined in section 309) from commerce.

[[Page 124 STAT. 3968]]

SEC. 402. EMPLOYEE PROTECTIONS.

Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391
et seq.), as amended by section 209, is further amended by adding at the
end the following:
“SEC. 1012. <> EMPLOYEE PROTECTIONS.

“(a) In General.–No entity engaged in the manufacture, processing,
packing, transporting, distribution, reception, holding, or importation
of food may discharge an employee or otherwise discriminate against an
employee with respect to compensation, terms, conditions, or privileges
of employment because the employee, whether at the employee’s initiative
or in the ordinary course of the employee’s duties (or any person acting
pursuant to a request of the employee)–
“(1) provided, caused to be provided, or is about to
provide or cause to be provided to the employer, the Federal
Government, or the attorney general of a State information
relating to any violation of, or any act or omission the
employee reasonably believes to be a violation of any provision
of this Act or any order, rule, regulation, standard, or ban
under this Act, or any order, rule, regulation, standard, or ban
under this Act;
“(2) testified or is about to testify in a proceeding
concerning such violation;
“(3) assisted or participated or is about to assist or
participate in such a proceeding; or
“(4) objected to, or refused to participate in, any
activity, policy, practice, or assigned task that the employee
(or other such person) reasonably believed to be in violation of
any provision of this Act, or any order, rule, regulation,
standard, or ban under this Act.

“(b) Process.–
“(1) In general. <> –A person who
believes that he or she has been discharged or otherwise
discriminated against by any person in violation of subsection
(a) may, not later than 180 days after the date on which such
violation occurs, file (or have any person file on his or her
behalf) a complaint with the Secretary of Labor (referred to in
this section as the `Secretary’) alleging such discharge or
discrimination and identifying the person responsible for such
act. <> Upon receipt of such a complaint,
the Secretary shall notify, in writing, the person named in the
complaint of the filing of the complaint, of the allegations
contained in the complaint, of the substance of evidence
supporting the complaint, and of the opportunities that will be
afforded to such person under paragraph (2).
“(2) Investigation.–
“(A) In
general. <> –Not later
than 60 days after the date of receipt of a complaint
filed under paragraph (1) and after affording the
complainant and the person named in the complaint an
opportunity to submit to the Secretary a written
response to the complaint and an opportunity to meet
with a representative of the Secretary to present
statements from witnesses, the Secretary shall initiate
an investigation and determine whether there is
reasonable cause to believe that the complaint has merit
and notify, in writing, the complainant and the person
alleged to have

[[Page 124 STAT. 3969]]

committed a violation of subsection (a) of the
Secretary’s findings.
“(B) Reasonable cause found; preliminary order.–If
the Secretary concludes that there is reasonable cause
to believe that a violation of subsection (a) has
occurred, the Secretary shall accompany the Secretary’s
findings with a preliminary order providing the relief
prescribed by paragraph (3)(B). <> Not
later than 30 days after the date of notification of
findings under this paragraph, the person alleged to
have committed the violation or the complainant may file
objections to the findings or preliminary order, or
both, and request a hearing on the record. The filing of
such objections shall not operate to stay any
reinstatement remedy contained in the preliminary order.
Any such hearing shall be conducted expeditiously. If a
hearing is not requested in such 30-day period, the
preliminary order shall be deemed a final order that is
not subject to judicial review.
“(C) Dismissal of complaint.–
“(i) Standard for complainant.–The Secretary
shall dismiss a complaint filed under this
subsection and shall not conduct an investigation
otherwise required under subparagraph (A) unless
the complainant makes a prima facie showing that
any behavior described in paragraphs (1) through
(4) of subsection (a) was a contributing factor in
the unfavorable personnel action alleged in the
complaint.
“(ii) Standard for employer.–Notwithstanding
a finding by the Secretary that the complainant
has made the showing required under clause (i), no
investigation otherwise required under
subparagraph (A) shall be conducted if the
employer demonstrates, by clear and convincing
evidence, that the employer would have taken the
same unfavorable personnel action in the absence
of that behavior.
“(iii) Violation standard.–The Secretary may
determine that a violation of subsection (a) has
occurred only if the complainant demonstrates that
any behavior described in paragraphs (1) through
(4) of subsection (a) was a contributing factor in
the unfavorable personnel action alleged in the
complaint.
“(iv) Relief standard.–Relief may not be
ordered under subparagraph (A) if the employer
demonstrates by clear and convincing evidence that
the employer would have taken the same unfavorable
personnel action in the absence of that behavior.
“(3) Final order.–
“(A) In general. <> –Not later
than 120 days after the date of conclusion of any
hearing under paragraph (2), the Secretary shall issue a
final order providing the relief prescribed by this
paragraph or denying the complaint. At any time before
issuance of a final order, a proceeding under this
subsection may be terminated on the basis of a
settlement agreement entered into by the Secretary, the
complainant, and the person alleged to have committed
the violation.

[[Page 124 STAT. 3970]]

“(B) Content of order.–If, in response to a
complaint filed under paragraph (1), the Secretary
determines that a violation of subsection (a) has
occurred, the Secretary shall order the person who
committed such violation–
“(i) to take affirmative action to abate the
violation;
“(ii) to reinstate the complainant to his or
her former position together with compensation
(including back pay) and restore the terms,
conditions, and privileges associated with his or
her employment; and
“(iii) to provide compensatory damages to the
complainant.
“(C) Penalty.–If such an order is issued under
this paragraph, the Secretary, at the request of the
complainant, shall assess against the person against
whom the order is issued a sum equal to the aggregate
amount of all costs and expenses (including attorneys’
and expert witness fees) reasonably incurred, as
determined by the Secretary, by the complainant for, or
in connection with, the bringing of the complaint upon
which the order was issued.
“(D) Bad faith claim.–If the Secretary finds that
a complaint under paragraph (1) is frivolous or has been
brought in bad faith, the Secretary may award to the
prevailing employer a reasonable attorneys’ fee, not
exceeding $1,000, to be paid by the complainant.
“(4) Action in court.–
“(A) In general. <> –If the
Secretary has not issued a final decision within 210
days after the filing of the complaint, or within 90
days after receiving a written determination, the
complainant may bring an action at law or equity for de
novo review in the appropriate district court of the
United States with jurisdiction, which shall have
jurisdiction over such an action without regard to the
amount in controversy, and which action shall, at the
request of either party to such action, be tried by the
court with a jury. The proceedings shall be governed by
the same legal burdens of proof specified in paragraph
(2)(C).
“(B) Relief.–The court shall have jurisdiction to
grant all relief necessary to make the employee whole,
including injunctive relief and compensatory damages,
including–
“(i) reinstatement with the same seniority
status that the employee would have had, but for
the discharge or discrimination;
“(ii) the amount of back pay, with interest;
and
“(iii) compensation for any special damages
sustained as a result of the discharge or
discrimination, including litigation costs, expert
witness fees, and reasonable attorney’s fees.
“(5) Review.–
“(A) In general.–Unless the complainant brings an
action under paragraph (4), any person adversely
affected or aggrieved by a final order issued under
paragraph (3) may obtain review of the order in the
United States Court of Appeals for the circuit in which
the violation, with respect to which the order was
issued, allegedly occurred or the circuit in which the
complainant resided on the

[[Page 124 STAT. 3971]]

date of such violation. <> The
petition for review must be filed not later than 60 days
after the date of the issuance of the final order of the
Secretary. Review shall conform to chapter 7 of title 5,
United States Code. The commencement of proceedings
under this subparagraph shall not, unless ordered by the
court, operate as a stay of the order.
“(B) No judicial review.–An order of the Secretary
with respect to which review could have been obtained
under subparagraph (A) shall not be subject to judicial
review in any criminal or other civil proceeding.
“(6) Failure to comply with order.–Whenever any person has
failed to comply with an order issued under paragraph (3), the
Secretary may file a civil action in the United States district
court for the district in which the violation was found to
occur, or in the United States district court for the District
of Columbia, to enforce such order. In actions brought under
this paragraph, the district courts shall have jurisdiction to
grant all appropriate relief including, but not limited to,
injunctive relief and compensatory damages.
“(7) Civil action to require compliance.–
“(A) In general.–A person on whose behalf an order
was issued under paragraph (3) may commence a civil
action against the person to whom such order was issued
to require compliance with such order. The appropriate
United States district court shall have jurisdiction,
without regard to the amount in controversy or the
citizenship of the parties, to enforce such order.
“(B) Award.–The court, in issuing any final order
under this paragraph, may award costs of litigation
(including reasonable attorneys’ and expert witness
fees) to any party whenever the court determines such
award is appropriate.

“(c) Effect of Section.–
“(1) Other laws.–Nothing in this section preempts or
diminishes any other safeguards against discrimination,
demotion, discharge, suspension, threats, harassment, reprimand,
retaliation, or any other manner of discrimination provided by
Federal or State law.
“(2) Rights of employees.–Nothing in this section shall be
construed to diminish the rights, privileges, or remedies of any
employee under any Federal or State law or under any collective
bargaining agreement. The rights and remedies in this section
may not be waived by any agreement, policy, form, or condition
of employment.

“(d) Enforcement.–Any nondiscretionary duty imposed by this
section shall be enforceable in a mandamus proceeding brought under
section 1361 of title 28, United States Code.
“(e) Limitation.–Subsection (a) shall not apply with respect to an
employee of an entity engaged in the manufacture, processing, packing,
transporting, distribution, reception, holding, or importation of food
who, acting without direction from such entity (or such entity’s agent),
deliberately causes a violation of any requirement relating to any
violation or alleged violation of any order, rule, regulation, standard,
or ban under this Act.”.

[[Page 124 STAT. 3972]]

SEC. 403. <> JURISDICTION; AUTHORITIES.

Nothing in this Act, or an amendment made by this Act, shall be
construed to–
(1) alter the jurisdiction between the Secretary of
Agriculture and the Secretary of Health and Human Services,
under applicable statutes, regulations, or agreements regarding
voluntary inspection of non-amenable species under the
Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.);
(2) alter the jurisdiction between the Alcohol and Tobacco
Tax and Trade Bureau and the Secretary of Health and Human
Services, under applicable statutes and regulations;
(3) limit the authority of the Secretary of Health and Human
Services under–
(A) the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) as in effect on the day before the
date of enactment of this Act; or
(B) the Public Health Service Act (42 U.S.C. 301 et
seq.) as in effect on the day before the date of
enactment of this Act;
(4) alter or limit the authority of the Secretary of
Agriculture under the laws administered by such Secretary,
including–
(A) the Federal Meat Inspection Act (21 U.S.C. 601
et seq.);
(B) the Poultry Products Inspection Act (21 U.S.C.
451 et seq.);
(C) the Egg Products Inspection Act (21 U.S.C. 1031
et seq.);
(D) the United States Grain Standards Act (7 U.S.C.
71 et seq.);
(E) the Packers and Stockyards Act, 1921 (7 U.S.C.
181 et seq.);
(F) the United States Warehouse Act (7 U.S.C. 241 et
seq.);
(G) the Agricultural Marketing Act of 1946 (7 U.S.C.
1621 et seq.); and
(H) the Agricultural Adjustment Act (7 U.S.C. 601 et
seq.), reenacted with the amendments made by the
Agricultural Marketing Agreement Act of 1937; or
(5) alter, impede, or affect the authority of the Secretary
of Homeland Security under the Homeland Security Act of 2002 (6
U.S.C. 101 et seq.) or any other statute, including any
authority related to securing the borders of the United States,
managing ports of entry, or agricultural import and entry
inspection activities.
SEC. 404. <> COMPLIANCE WITH INTERNATIONAL
AGREEMENTS.

Nothing in this Act (or an amendment made by this Act) shall be
construed in a manner inconsistent with the agreement establishing the
World Trade Organization or any other treaty or international agreement
to which the United States is a party.
SEC. 405. DETERMINATION OF BUDGETARY EFFECTS.

The budgetary effects of this Act, for the purpose of complying with
the Statutory Pay-As-You-Go Act of 2010, shall be determined by
reference to the latest statement titled “Budgetary Effects of PAYGO
Legislation” for this Act, submitted for printing in the

[[Page 124 STAT. 3973]]

Congressional Record by the Chairman of the Senate Budget Committee,
provided that such statement has been submitted prior to the vote on
passage.

Approved January 4, 2011.

LEGISLATIVE HISTORY–H.R. 2751:
—————————————————————————

CONGRESSIONAL RECORD:
Vol. 155 (2009):
June 9, considered and passed House.
Vol. 156 (2010):
Dec. 19, considered and passed
Senate, amended.
Dec. 21, House concurred in Senate
amendments.

GMO Arctic Apple

“I don’t care about spots on my apples, just leave me the birds and the bees,” sang Joni Mitchell in 1970. But if the U.S. Department of Agriculture approves the new GMO “Arctic Apple,” you’ll end up with spotless apples that could not only be toxic, but also potentially dangerous for the environment.

We have no idea what long-term effects the Arctic Apple could have on bee pollinators, or the people – including children – who eat them. They’re intended for the fresh-sliced apple market, but could find their way into the produce aisle shelves and into juice, juice-sweetened snacks, applesauce and baby foods, all of which are mostly consumed by children. And no labeling would be required.
The Department of Agriculture has opened a comment period on the Arctic Apple. We need to urge the agency to keep these apples off store shelves.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click here to add your public comment.
If this unlabeled, potentially dangerous fruit succeeds in making it to market, it will only be the first of many. If there are long-term consequences to eating genetically modified fruit we won’t find out under our current regulatory climate until much too late, because like other GMO foods, these apples are likely to be approved without any public, peer-reviewed study of their long-term effects.
The Department of Agriculture shouldn’t let food producers experiment further on us in its quest to make a minor cosmetic improvement to a fruit intended for mass human consumption.
The apple growers’ industry associations representing over 60 percent of commercial orchards have already come out against GMO apples.1 Many are concerned about reduced consumer confidence in the apple market, while some organic growers are concerned that pollen contamination from GMO orchards could endanger their organic certification.2
McDonald’s and Gerber have even said they won’t carry the apples in the foreseeable future.3
We need to act now – before these apples hit the shelves at our local grocery stores – to amplify the outcry against this frankenfood.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click the link below to add your public comment:
http://act.credoaction.com/go/2847?t=5&akid=9548.5084505.tuGACR
Thank you for standing up for safe food.
Becky Bond, Political Director
CREDO Action from Working Assets

Submit a public comment:
  1. Wenonah Hauter, “One Genetically Engineered Apple Spoils the Bunch,” The Dr. Oz Show, August 3, 2012.
  2. Andrew Pollack, “That Fresh Look, Genetically Buffed,” The New York Times, July 12, 2012.
  3. Connor Adams Sheets, “GMO Apples Rejected By McDonald’s, Gerber As Washington Labeling Defeat Neared,” The International Business Times, November 7, 2013.

“I don’t care about spots on my apples, just leave me the birds and the bees,” sang Joni Mitchell in 1970. But if the U.S. Department of Agriculture approves the new GMO “Arctic Apple,” you’ll end up with spotless apples that could not only be toxic, but also potentially dangerous for the environment.

We have no idea what long-term effects the Arctic Apple could have on bee pollinators, or the people – including children – who eat them. They’re intended for the fresh-sliced apple market, but could find their way into the produce aisle shelves and into juice, juice-sweetened snacks, applesauce and baby foods, all of which are mostly consumed by children. And no labeling would be required.
The Department of Agriculture has opened a comment period on the Arctic Apple. We need to urge the agency to keep these apples off store shelves.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click here to add your public comment.
If this unlabeled, potentially dangerous fruit succeeds in making it to market, it will only be the first of many. If there are long-term consequences to eating genetically modified fruit we won’t find out under our current regulatory climate until much too late, because like other GMO foods, these apples are likely to be approved without any public, peer-reviewed study of their long-term effects.
The Department of Agriculture shouldn’t let food producers experiment further on us in its quest to make a minor cosmetic improvement to a fruit intended for mass human consumption.
The apple growers’ industry associations representing over 60 percent of commercial orchards have already come out against GMO apples.1 Many are concerned about reduced consumer confidence in the apple market, while some organic growers are concerned that pollen contamination from GMO orchards could endanger their organic certification.2
McDonald’s and Gerber have even said they won’t carry the apples in the foreseeable future.3
We need to act now – before these apples hit the shelves at our local grocery stores – to amplify the outcry against this frankenfood.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click the link below to add your public comment:
http://act.credoaction.com/go/2847?t=5&akid=9548.5084505.tuGACR
Thank you for standing up for safe food.
Becky Bond, Political Director
CREDO Action from Working Assets

Submit a public comment:
  1. Wenonah Hauter, “One Genetically Engineered Apple Spoils the Bunch,” The Dr. Oz Show, August 3, 2012.
  2. Andrew Pollack, “That Fresh Look, Genetically Buffed,” The New York Times, July 12, 2012.
  3. Connor Adams Sheets, “GMO Apples Rejected By McDonald’s, Gerber As Washington Labeling Defeat Neared,” The International Business Times, November 7, 2013.

GMO Arctic Apple

“I don’t care about spots on my apples, just leave me the birds and the bees,” sang Joni Mitchell in 1970. But if the U.S. Department of Agriculture approves the new GMO “Arctic Apple,” you’ll end up with spotless apples that could not only be toxic, but also potentially dangerous for the environment.

We have no idea what long-term effects the Arctic Apple could have on bee pollinators, or the people – including children – who eat them. They’re intended for the fresh-sliced apple market, but could find their way into the produce aisle shelves and into juice, juice-sweetened snacks, applesauce and baby foods, all of which are mostly consumed by children. And no labeling would be required.
The Department of Agriculture has opened a comment period on the Arctic Apple. We need to urge the agency to keep these apples off store shelves.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click here to add your public comment.
If this unlabeled, potentially dangerous fruit succeeds in making it to market, it will only be the first of many. If there are long-term consequences to eating genetically modified fruit we won’t find out under our current regulatory climate until much too late, because like other GMO foods, these apples are likely to be approved without any public, peer-reviewed study of their long-term effects.
The Department of Agriculture shouldn’t let food producers experiment further on us in its quest to make a minor cosmetic improvement to a fruit intended for mass human consumption.
The apple growers’ industry associations representing over 60 percent of commercial orchards have already come out against GMO apples.1 Many are concerned about reduced consumer confidence in the apple market, while some organic growers are concerned that pollen contamination from GMO orchards could endanger their organic certification.2
McDonald’s and Gerber have even said they won’t carry the apples in the foreseeable future.3
We need to act now – before these apples hit the shelves at our local grocery stores – to amplify the outcry against this frankenfood.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click the link below to add your public comment:
http://act.credoaction.com/go/2847?t=5&akid=9548.5084505.tuGACR
Thank you for standing up for safe food.
Becky Bond, Political Director
CREDO Action from Working Assets

Submit a public comment:
  1. Wenonah Hauter, “One Genetically Engineered Apple Spoils the Bunch,” The Dr. Oz Show, August 3, 2012.
  2. Andrew Pollack, “That Fresh Look, Genetically Buffed,” The New York Times, July 12, 2012.
  3. Connor Adams Sheets, “GMO Apples Rejected By McDonald’s, Gerber As Washington Labeling Defeat Neared,” The International Business Times, November 7, 2013.

“I don’t care about spots on my apples, just leave me the birds and the bees,” sang Joni Mitchell in 1970. But if the U.S. Department of Agriculture approves the new GMO “Arctic Apple,” you’ll end up with spotless apples that could not only be toxic, but also potentially dangerous for the environment.

We have no idea what long-term effects the Arctic Apple could have on bee pollinators, or the people – including children – who eat them. They’re intended for the fresh-sliced apple market, but could find their way into the produce aisle shelves and into juice, juice-sweetened snacks, applesauce and baby foods, all of which are mostly consumed by children. And no labeling would be required.
The Department of Agriculture has opened a comment period on the Arctic Apple. We need to urge the agency to keep these apples off store shelves.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click here to add your public comment.
If this unlabeled, potentially dangerous fruit succeeds in making it to market, it will only be the first of many. If there are long-term consequences to eating genetically modified fruit we won’t find out under our current regulatory climate until much too late, because like other GMO foods, these apples are likely to be approved without any public, peer-reviewed study of their long-term effects.
The Department of Agriculture shouldn’t let food producers experiment further on us in its quest to make a minor cosmetic improvement to a fruit intended for mass human consumption.
The apple growers’ industry associations representing over 60 percent of commercial orchards have already come out against GMO apples.1 Many are concerned about reduced consumer confidence in the apple market, while some organic growers are concerned that pollen contamination from GMO orchards could endanger their organic certification.2
McDonald’s and Gerber have even said they won’t carry the apples in the foreseeable future.3
We need to act now – before these apples hit the shelves at our local grocery stores – to amplify the outcry against this frankenfood.
Tell the USDA: Reject GMO apples – they’re unnecessary and potentially dangerous. Click the link below to add your public comment:
http://act.credoaction.com/go/2847?t=5&akid=9548.5084505.tuGACR
Thank you for standing up for safe food.
Becky Bond, Political Director
CREDO Action from Working Assets

Submit a public comment:
  1. Wenonah Hauter, “One Genetically Engineered Apple Spoils the Bunch,” The Dr. Oz Show, August 3, 2012.
  2. Andrew Pollack, “That Fresh Look, Genetically Buffed,” The New York Times, July 12, 2012.
  3. Connor Adams Sheets, “GMO Apples Rejected By McDonald’s, Gerber As Washington Labeling Defeat Neared,” The International Business Times, November 7, 2013.

Monsanto

Published time: April 04, 2013 16:34
Edited time: April 05, 2013 12:28  

 
Monsanto on Wednesday reported that its net income rose 22 percent to $1.48 billion, or $2.74 a share, in a one-year period. The profit increase, which occurred in the three-month period through February, marked a new record for the lucrative biotech company. Revenue rose 15 percent to $5.47 billion, much of which came from the sales of genetically modified corn seeds, particularly those sold in emerging markets like Brazil, Argentina, and other Latin American countries.


Monsanto’s seed business, particularly its genetically engineered corn, cotton and soybeans, increased by more than 10 percent in the second quarter. The seeds repel bugs and are resistant to weed-killers, making them popular among farmers trying to yield more produce.
The profit spike exceeded expectations and Wall Street predictions and may have widened the gap between Monsanto and other seed businesses. The company’s shares also rose 89 cents, closing at $104.51 on Wednesday. Over the past years, the shares have risen by about 10 percent.
“So our bottom line business outlook today means the momentum that we anticipated in our first quarter has clearly carried through into even stronger business results for the second quarter,” said CEO Hugh Grant, on a call with analysts, as reported by the Associated Press.
And the company only predicts to be making more money this year: Monsanto expects $2 billion in free cash flow in 2013 and will become “more aggressive” in returning cash to shareholders through dividends and “opportunistic” share purchases,” Chief Financial Officer Pierre Courduroux said during the call with analysts.
But it’s not just the corporation’s seeds that are spiking revenue: the company also sells crop chemicals, which saw a 37 percent increase in sales. The herbicide Roundup, a popular weed killer, jumped by 73 percent to $371 million.
News of the company’s financial success comes just days after US President Barack Obama signeda bill into law that protects the billion-dollar corporation from any sort of litigation. Known by critics as the ‘Monsanto Protection Act’, section 734 of the Agricultural Appropriations Bill gives biotech companies immunity in regards to the production and sale of genetically modified seeds. The company would therefore have free reign to sell genetically engineered products the long-term effects of which remain unknown, without the prospect of facing a lawsuit for it.
Nationwide, Americans from the far right and the far left have united in their condemnation of the provision that benefits Monsanto, and a petition against the provision generated more than 250,000 signatures. Critics claim the legislation allows the company to bypass the court system and continue to dominate the US seed industry.


Published time: July 23, 2013 17:14
Edited time: July 24, 2013 18:12

Biotech giant Monsanto has been awarded yet another victory by the federal government thanks to a recent Environmental Protection Agency decision to allow larger traces of the herbicide glyphosate in farm-grown foods.

Despite a number of studies linking exposure to the chemical with diseases including types of cancer, the EPA is increasing the amount of glyphosate allowed in oilseed and food crops.

The EPA announced their plans on May 1 and allowed critics two months to weigh in and object to the ruling. Following little opposition, though, the EPA is on path to soon approve of levels of glyphosate being found in crops several times over the current concentration.

Glyphosate, a weed-killing chemical developed by Monsanto in 1970, is the key ingredient in the company’s “Roundup” label of herbicides. In the decades since, Monsanto has created and patented a number of genetically-modified organisms and genetically-engineered crops resisted to glyphosate that are sold worldwide under the company’s “Roundup Ready” brand. Those GMO products are then planted in fields where glyphosate, namely Roundup, is used en masse to eliminate weeds from taking over harvest. With scientists linking that chemical to cancerous diseases, though, critics decry the EPA decision and caution it could do more harm than good.

Through the EPA’s new standards, the amount of allowable glyphosate in oilseed crops such as flax, soybeans and canola will be increased from 20 parts per million (ppm) to 40 ppm, which GM Watch acknowledged is over 100,000 times the amount needed to induce breast cancer cells. Additionally, the EPA is increasing limits on allowable glyphosate in food crops from 200 ppm to 6,000 ppm.

Just last month, The Cornucopia Institute concluded a study by finding glyphosate “exerted proliferative effects in human hormone-dependent breast cancer.” A similar study released in April concluded that “glyphosate enhances the damaging effects of other food borne chemical residues and environmental toxins.”

“Negative impact on the body is insidious and manifests slowly over time as inflammation damages cellular systems throughout the body,” independent scientist Anthony Samsel and MIT’s Stephanie Seneff concluded in the April study. “Consequences are most of the diseases and conditions associated with a Western diet, which include gastrointestinal disorders, obesity, diabetes, heart disease, depression, autism, infertility, cancer and Alzheimer’s disease.”

Dr. Don M. Huber, emeritus professor of plant pathology at Purdue University, found in yet another examination that “Glyphosate draws out the vital nutrients of living things,” in turn removing most nutritional value from GMO foods.

A press release issued by the group Beyond Pesticides criticized the decision as well. “Given that alternative methods of growing food and managing weeds are available, like those that exist in organic agriculture, it is unreasonable for EPA to increase human exposures to Roundup,” they wrote.

In the past, Monsanto has long-defended their use of the chemical. “We are very confident in the long track record that glyphosate has,” Jerry Stainer, Monsanto’s executive vice president of sustainability, stated previously. “It has been very, very extensively studied.”


Published time: September 25, 2013 01:55
Edited time: September 26, 2013 17:41  

In its short-term government-funding bill, the US Senate will propose an end to a budget provision that protects genetically-modified seeds from litigation despite possible health risks.
Called “The Monsanto Protection Act” by opponents, the budget rider shields biotech behemoths like Monsanto, Cargill and others from the threat of lawsuits and bars federal courts from intervening to force an end to the sale of a GMO (genetically-modified organism) even if the genetically-engineered product causes damaging health effects.

The US House of Representatives approved a three-month extension to the rider in their own short-term FY14 Continuing Resolution spending bill, which was approved last week by the lower chamber.

The Senate version of the legislation will make clear the provision expires on Sept. 30, the end of the current fiscal year.


Published time: October 17, 2013 03:53

A lobbying group for major US manufacturers has violated Washington state campaign finance law while opposing a ballot initiative that would require labeling genetically-modified foods, according to a lawsuit filed by the state attorney general Wednesday.
The Grocery Manufacturers of America (GMA) ran afoul of state law in collecting and spending $7.2 million against ballot initiative 522 – which voters will consider in November – while not disclosing the individual donors funneling contributions to the organization, alleged State Attorney General Bob Ferguson.
“Truly fair elections demand all sides follow the rules by disclosing who their donors are and how much they are spending to advocate their views,” Ferguson said in a statement.
The measure would require the proper labeling of goods which contain ingredients with genetically-modified organisms (GMOs), as well as the labeling of seeds and seed products containing GMOs sold in the state.
With over $7 million spent, GMA is the largest donor to the “No on I-522” campaign. GMA and other opponents have raised over $17 million, spending $13 million thus far, in the effort to block labeling.
The “Yes on I-522” campaign has raised around $5.5 million in support of the labeling. They believe it is crucial for the public’s right to know what is in their food and say the labeling is a positive move considering the numerous questions surrounding the safety of GMOs to human health.
Ferguson’s office alleges GMA set up a “Defense of Brands Strategic Account” and asked its numerous high-powered members to contribute money in an effort to oppose the ballot initiative.
In the process of spending the money, GMA shielded contributors’ identification from public disclosures, the lawsuit alleges.

GMA has a total of 300 member organizations in its ranks.
The attorney general is seeking a temporary restraining order to force GMA to comply with disclosure laws. In addition, civil penalties are included in the suit.
GMA claimed to be surprised by the developments, though it did not say if it asked members to fund the drive to oppose I-522, which would have required a political action committee and disclosure of donors.
“GMA takes great care to understand and comply with all state election and campaign finance laws,” the organization said. “GMA will review its actions in Washington state and relevant statutes and continue to cooperate with state authorities to fully resolve the issue as promptly as possible.”
Supporters of the ballot initiative pushed a similar claim that was rejected by a Thurston County judge, who said the matter needed to go through the state Public Disclosure Commission, which Ferguson is representing in the suit filed Wednesday.
Washington’s consideration of a GMO labeling measure comes one year after a similar measure was rejected by California voters after companies like Monsanto contributed $44 million for “No on Prop 37.”
Proponents of the California labeling measure only raised $7.3 million in defeat.
Monsanto has contributed about $5 million in opposition to Washington’s I-522. Corporate giants Bayer, Dupont, BASF, and Dow have also contributed to block labeling.
In June, Connecticut became the first state to pass a labeling bill, though legislative requirements demand it would only go into effect once four states – including one adjacent to the state – passes similar regulations.


Published time: October 11, 2013 06:16
Edited time: October 11, 2013 07:22

Joining six continents, 52 countries and over 500 cities, ‘March against Monsanto’ is planning its second mass rally Saturday against the biotech giant and genetically modified food. A number of Agent Orange victims are expected to join the protest.

“Saturday is a big day of action against Monsanto. We took our lights out to a local cornfield. Monsanto is bad for our food and bad for our planet,” the March against Monsanto’s movement posted on its Facebook page.

The rallies, which come four days ahead of World Food Day on Oct. 16, will call on millions of activists to boycott “Monsanto’s predatory business,” genetically modified organisms (GMOs) and other harmful pesticides, which threaten “health, fertility and longevity.”

On October, 5, Movement against Monsanto launched a global ‘Twitter storm’ asking people to tweet and post certain hashtags as frequently as possible.


Monsanto is a multinational agricultural biotechnology corporation headquartered in Creve Coeur, Missouri. With the exception of weapons manufacturers and other private military firms, there is perhaps no corporation that provides such a dramatic example of corporate influence over government. Not only does Monsanto spend a staggering $8 million a year lobbying government officials (imagine 80 full-time lobbyists each paid $100,000 a year), but many former Monsanto executives hold key positions in the FDA, EPA and USDA, where they have made favorable regulatory decisions regarding Monsanto products.
One of those products, recombinant bovine somatotropin, commonly known as “bovine growth hormone” (rBGH), is a synthetic hormone injected into cows to increase milk production. It also increases the levels a substance called IGF-1 in their milk, which is then passed on to humans. Elevated blood serum levels of IGF-1 have been linked in numerous studies to breast, colon and prostate cancer. For this reason, Canada, Australia, New Zealand, Japan and all 27 European Union countries have banned the use of rBGH. The FDA’s highly controversial 1993 decision approving rBGH was overseen by former Monsanto attorney, Michael R. Taylor, who was serving as the FDA’s Deputy Commissioner of Policy at the time. After the decision Taylor left the FDA and again joined Monsanto, becoming the company’s chief lobbyist and Vice President for Public Policy. He has since gone back and forth between Monsanto and various government positions in the FDA and the USDA, highlighting the “revolving door syndrome” that has become a hallmark of corporate-government collusion.
Monsanto’s genetically modified (GM) crops consist primarily of those modified to be resistant to the herbicide Roundup (another Monsanto product) and those modified to contain within their cells the biological pesticide called Bacillus thuringiensis (or Bt). Widespread health and environmental concerns over both these types of GM plants are based on numerous scientific studies and have resulted in many countries banning GM crops entirely. In the European Union a moratorium on new GM crops has been in effect since 1998 and strict labeling is required on all genetically modified food products approved before the moratorium. Monsanto has spent millions of dollars pressuring EU officials to allow the introduction of GM foods into Europe, and—more significantly—recent Wikileaks documents reveal U.S. State Department officials also pressuring EU officials on Monsanto’s behalf.
Monsanto’s actions run the gamut of illegality and dirty tricks, and include the attempted bribery of Canadian officials; the intentional dumping of toxic waste into the environment; and the filing of hundreds of lawsuits alleging “patent infringement” against small farmers whose crops became contaminated with their patented genes, etc. Mass protests against Monsanto have spread to dozens of countries around the world and have included civil disobedience actions like the burning of experimental crop fields and the nonviolent occupation of Monsanto facilities.

References and external links:

http://www.corporatewatch.org/?lid=209
http://www.guardian.co.uk/world/2011/jan/03/wikileaks-us-eu-gm-crops
http://www.businessweek.com/ap/financialnews/D9RL51J81.htm
http://www.thelancet.com/journals/lancet/article…
http://www.ejnet.org/bgh/igf-1science.html
http://www.dailymail.co.uk/news/article-1082559/The-GM-genocide…
http://www.biolsci.org/v05p0706.htm
http://news.bbc.co.uk/2/hi/americas/2961284.stm
http://www.nytimes.com/1998/10/25/magazine/playing-god…
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods…
http://video.google.com/videoplay?docid=6262083…
http://facebook.com/geneticcrimesunit
http://www.facebook.com/occupymonsanto

Published time: April 04, 2013 16:34
Edited time: April 05, 2013 12:28  

 
Monsanto on Wednesday reported that its net income rose 22 percent to $1.48 billion, or $2.74 a share, in a one-year period. The profit increase, which occurred in the three-month period through February, marked a new record for the lucrative biotech company. Revenue rose 15 percent to $5.47 billion, much of which came from the sales of genetically modified corn seeds, particularly those sold in emerging markets like Brazil, Argentina, and other Latin American countries.


Monsanto’s seed business, particularly its genetically engineered corn, cotton and soybeans, increased by more than 10 percent in the second quarter. The seeds repel bugs and are resistant to weed-killers, making them popular among farmers trying to yield more produce.
The profit spike exceeded expectations and Wall Street predictions and may have widened the gap between Monsanto and other seed businesses. The company’s shares also rose 89 cents, closing at $104.51 on Wednesday. Over the past years, the shares have risen by about 10 percent.
“So our bottom line business outlook today means the momentum that we anticipated in our first quarter has clearly carried through into even stronger business results for the second quarter,” said CEO Hugh Grant, on a call with analysts, as reported by the Associated Press.
And the company only predicts to be making more money this year: Monsanto expects $2 billion in free cash flow in 2013 and will become “more aggressive” in returning cash to shareholders through dividends and “opportunistic” share purchases,” Chief Financial Officer Pierre Courduroux said during the call with analysts.
But it’s not just the corporation’s seeds that are spiking revenue: the company also sells crop chemicals, which saw a 37 percent increase in sales. The herbicide Roundup, a popular weed killer, jumped by 73 percent to $371 million.
News of the company’s financial success comes just days after US President Barack Obama signeda bill into law that protects the billion-dollar corporation from any sort of litigation. Known by critics as the ‘Monsanto Protection Act’, section 734 of the Agricultural Appropriations Bill gives biotech companies immunity in regards to the production and sale of genetically modified seeds. The company would therefore have free reign to sell genetically engineered products the long-term effects of which remain unknown, without the prospect of facing a lawsuit for it.
Nationwide, Americans from the far right and the far left have united in their condemnation of the provision that benefits Monsanto, and a petition against the provision generated more than 250,000 signatures. Critics claim the legislation allows the company to bypass the court system and continue to dominate the US seed industry.


Published time: July 23, 2013 17:14
Edited time: July 24, 2013 18:12

Biotech giant Monsanto has been awarded yet another victory by the federal government thanks to a recent Environmental Protection Agency decision to allow larger traces of the herbicide glyphosate in farm-grown foods.

Despite a number of studies linking exposure to the chemical with diseases including types of cancer, the EPA is increasing the amount of glyphosate allowed in oilseed and food crops.

The EPA announced their plans on May 1 and allowed critics two months to weigh in and object to the ruling. Following little opposition, though, the EPA is on path to soon approve of levels of glyphosate being found in crops several times over the current concentration.

Glyphosate, a weed-killing chemical developed by Monsanto in 1970, is the key ingredient in the company’s “Roundup” label of herbicides. In the decades since, Monsanto has created and patented a number of genetically-modified organisms and genetically-engineered crops resisted to glyphosate that are sold worldwide under the company’s “Roundup Ready” brand. Those GMO products are then planted in fields where glyphosate, namely Roundup, is used en masse to eliminate weeds from taking over harvest. With scientists linking that chemical to cancerous diseases, though, critics decry the EPA decision and caution it could do more harm than good.

Through the EPA’s new standards, the amount of allowable glyphosate in oilseed crops such as flax, soybeans and canola will be increased from 20 parts per million (ppm) to 40 ppm, which GM Watch acknowledged is over 100,000 times the amount needed to induce breast cancer cells. Additionally, the EPA is increasing limits on allowable glyphosate in food crops from 200 ppm to 6,000 ppm.

Just last month, The Cornucopia Institute concluded a study by finding glyphosate “exerted proliferative effects in human hormone-dependent breast cancer.” A similar study released in April concluded that “glyphosate enhances the damaging effects of other food borne chemical residues and environmental toxins.”

“Negative impact on the body is insidious and manifests slowly over time as inflammation damages cellular systems throughout the body,” independent scientist Anthony Samsel and MIT’s Stephanie Seneff concluded in the April study. “Consequences are most of the diseases and conditions associated with a Western diet, which include gastrointestinal disorders, obesity, diabetes, heart disease, depression, autism, infertility, cancer and Alzheimer’s disease.”

Dr. Don M. Huber, emeritus professor of plant pathology at Purdue University, found in yet another examination that “Glyphosate draws out the vital nutrients of living things,” in turn removing most nutritional value from GMO foods.

A press release issued by the group Beyond Pesticides criticized the decision as well. “Given that alternative methods of growing food and managing weeds are available, like those that exist in organic agriculture, it is unreasonable for EPA to increase human exposures to Roundup,” they wrote.

In the past, Monsanto has long-defended their use of the chemical. “We are very confident in the long track record that glyphosate has,” Jerry Stainer, Monsanto’s executive vice president of sustainability, stated previously. “It has been very, very extensively studied.”


Published time: September 25, 2013 01:55
Edited time: September 26, 2013 17:41  

In its short-term government-funding bill, the US Senate will propose an end to a budget provision that protects genetically-modified seeds from litigation despite possible health risks.
Called “The Monsanto Protection Act” by opponents, the budget rider shields biotech behemoths like Monsanto, Cargill and others from the threat of lawsuits and bars federal courts from intervening to force an end to the sale of a GMO (genetically-modified organism) even if the genetically-engineered product causes damaging health effects.

The US House of Representatives approved a three-month extension to the rider in their own short-term FY14 Continuing Resolution spending bill, which was approved last week by the lower chamber.

The Senate version of the legislation will make clear the provision expires on Sept. 30, the end of the current fiscal year.


Published time: October 17, 2013 03:53

A lobbying group for major US manufacturers has violated Washington state campaign finance law while opposing a ballot initiative that would require labeling genetically-modified foods, according to a lawsuit filed by the state attorney general Wednesday.
The Grocery Manufacturers of America (GMA) ran afoul of state law in collecting and spending $7.2 million against ballot initiative 522 – which voters will consider in November – while not disclosing the individual donors funneling contributions to the organization, alleged State Attorney General Bob Ferguson.
“Truly fair elections demand all sides follow the rules by disclosing who their donors are and how much they are spending to advocate their views,” Ferguson said in a statement.
The measure would require the proper labeling of goods which contain ingredients with genetically-modified organisms (GMOs), as well as the labeling of seeds and seed products containing GMOs sold in the state.
With over $7 million spent, GMA is the largest donor to the “No on I-522” campaign. GMA and other opponents have raised over $17 million, spending $13 million thus far, in the effort to block labeling.
The “Yes on I-522” campaign has raised around $5.5 million in support of the labeling. They believe it is crucial for the public’s right to know what is in their food and say the labeling is a positive move considering the numerous questions surrounding the safety of GMOs to human health.
Ferguson’s office alleges GMA set up a “Defense of Brands Strategic Account” and asked its numerous high-powered members to contribute money in an effort to oppose the ballot initiative.
In the process of spending the money, GMA shielded contributors’ identification from public disclosures, the lawsuit alleges.

GMA has a total of 300 member organizations in its ranks.
The attorney general is seeking a temporary restraining order to force GMA to comply with disclosure laws. In addition, civil penalties are included in the suit.
GMA claimed to be surprised by the developments, though it did not say if it asked members to fund the drive to oppose I-522, which would have required a political action committee and disclosure of donors.
“GMA takes great care to understand and comply with all state election and campaign finance laws,” the organization said. “GMA will review its actions in Washington state and relevant statutes and continue to cooperate with state authorities to fully resolve the issue as promptly as possible.”
Supporters of the ballot initiative pushed a similar claim that was rejected by a Thurston County judge, who said the matter needed to go through the state Public Disclosure Commission, which Ferguson is representing in the suit filed Wednesday.
Washington’s consideration of a GMO labeling measure comes one year after a similar measure was rejected by California voters after companies like Monsanto contributed $44 million for “No on Prop 37.”
Proponents of the California labeling measure only raised $7.3 million in defeat.
Monsanto has contributed about $5 million in opposition to Washington’s I-522. Corporate giants Bayer, Dupont, BASF, and Dow have also contributed to block labeling.
In June, Connecticut became the first state to pass a labeling bill, though legislative requirements demand it would only go into effect once four states – including one adjacent to the state – passes similar regulations.


Published time: October 11, 2013 06:16
Edited time: October 11, 2013 07:22

Joining six continents, 52 countries and over 500 cities, ‘March against Monsanto’ is planning its second mass rally Saturday against the biotech giant and genetically modified food. A number of Agent Orange victims are expected to join the protest.

“Saturday is a big day of action against Monsanto. We took our lights out to a local cornfield. Monsanto is bad for our food and bad for our planet,” the March against Monsanto’s movement posted on its Facebook page.

The rallies, which come four days ahead of World Food Day on Oct. 16, will call on millions of activists to boycott “Monsanto’s predatory business,” genetically modified organisms (GMOs) and other harmful pesticides, which threaten “health, fertility and longevity.”

On October, 5, Movement against Monsanto launched a global ‘Twitter storm’ asking people to tweet and post certain hashtags as frequently as possible.


Monsanto is a multinational agricultural biotechnology corporation headquartered in Creve Coeur, Missouri. With the exception of weapons manufacturers and other private military firms, there is perhaps no corporation that provides such a dramatic example of corporate influence over government. Not only does Monsanto spend a staggering $8 million a year lobbying government officials (imagine 80 full-time lobbyists each paid $100,000 a year), but many former Monsanto executives hold key positions in the FDA, EPA and USDA, where they have made favorable regulatory decisions regarding Monsanto products.
One of those products, recombinant bovine somatotropin, commonly known as “bovine growth hormone” (rBGH), is a synthetic hormone injected into cows to increase milk production. It also increases the levels a substance called IGF-1 in their milk, which is then passed on to humans. Elevated blood serum levels of IGF-1 have been linked in numerous studies to breast, colon and prostate cancer. For this reason, Canada, Australia, New Zealand, Japan and all 27 European Union countries have banned the use of rBGH. The FDA’s highly controversial 1993 decision approving rBGH was overseen by former Monsanto attorney, Michael R. Taylor, who was serving as the FDA’s Deputy Commissioner of Policy at the time. After the decision Taylor left the FDA and again joined Monsanto, becoming the company’s chief lobbyist and Vice President for Public Policy. He has since gone back and forth between Monsanto and various government positions in the FDA and the USDA, highlighting the “revolving door syndrome” that has become a hallmark of corporate-government collusion.
Monsanto’s genetically modified (GM) crops consist primarily of those modified to be resistant to the herbicide Roundup (another Monsanto product) and those modified to contain within their cells the biological pesticide called Bacillus thuringiensis (or Bt). Widespread health and environmental concerns over both these types of GM plants are based on numerous scientific studies and have resulted in many countries banning GM crops entirely. In the European Union a moratorium on new GM crops has been in effect since 1998 and strict labeling is required on all genetically modified food products approved before the moratorium. Monsanto has spent millions of dollars pressuring EU officials to allow the introduction of GM foods into Europe, and—more significantly—recent Wikileaks documents reveal U.S. State Department officials also pressuring EU officials on Monsanto’s behalf.
Monsanto’s actions run the gamut of illegality and dirty tricks, and include the attempted bribery of Canadian officials; the intentional dumping of toxic waste into the environment; and the filing of hundreds of lawsuits alleging “patent infringement” against small farmers whose crops became contaminated with their patented genes, etc. Mass protests against Monsanto have spread to dozens of countries around the world and have included civil disobedience actions like the burning of experimental crop fields and the nonviolent occupation of Monsanto facilities.

References and external links:

http://www.corporatewatch.org/?lid=209
http://www.guardian.co.uk/world/2011/jan/03/wikileaks-us-eu-gm-crops
http://www.businessweek.com/ap/financialnews/D9RL51J81.htm
http://www.thelancet.com/journals/lancet/article…
http://www.ejnet.org/bgh/igf-1science.html
http://www.dailymail.co.uk/news/article-1082559/The-GM-genocide…
http://www.biolsci.org/v05p0706.htm
http://news.bbc.co.uk/2/hi/americas/2961284.stm
http://www.nytimes.com/1998/10/25/magazine/playing-god…
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods…
http://video.google.com/videoplay?docid=6262083…
http://facebook.com/geneticcrimesunit
http://www.facebook.com/occupymonsanto

Monsanto’s GMO sweet corn

Published on Aug 1, 2013
14 year old Rachel Parent debates Kevin O’Leary on the issue of Genetically Modified Food
Donate to the cause at Rachel’s website: http://www.gmo-news.com
Canadian Biotechnology Action Network: www.cban.ca
petition for mandatory GMO food labelling: http://www.avaaz.org/en/petition/Brin…
O’Leary knocks himself out: http://youtu.be/OFS035Kdo-s
Rachel’s challenge to O’Leary: https://www.youtube.com/watch?v=0XcXK…
original broadcast on CBC: If you want to see CBC’s “The Lang O’Leary Exchange” with the commercials: http://www.cbc.ca/player/News/TV+Show…


Take Action!
Clicking here will automatically add your name to this to Walmart CEO Mike Duke:
“Walmart: Live up to your commitment to consumer safety, and reject Monsanto’s untested and potentially toxic genetically-modified sweet corn before it’s planted this spring.”

Automatically add your name:

Take action now!

CREDO Action | more than a network, a movement.

Dear Friend,
This spring, Monsanto’s GMO sweet corn — their first product for direct human consumption — will be getting planted for the first time.
Then it will be sold, unlabeled, in a grocery store near you.
What would it take to stop it? It would take the largest food retailer in the country rejecting Monsanto’s untested, potentially toxic corn.
In response to pressure from more than 250,000 CREDO Activists and others last fall, Trader Joes, Whole Foods and General Mills all committed not to sell Monsanto’s sweet corn.1
But not Walmart.
Walmart, wrote to us that “nothing is more important than the safety and satisfaction of our customers.” But that’s just not consistent with selling this unlabeled GMO sweet corn, which contains three genetic modifications — including the insecticide Bt — and hasn’t been tested to prove it is safe for humans to eat.2
Walmart could make a powerful statement for consumer safety by rejecting Monsanto’s GMO sweet corn, but they won’t do it unless we put very public pressure on the company.
This corn is Monsanto’s first foray into designing GMO foods that could wind up whole on your plate. If it’s successful, we can be sure that it will just be the beginning for Monsanto, who already produces roughly 90% of GMO seeds around the globe.
As the largest food retailer, and even the largest seller of organic foods, Walmart can set an important precedent that could keep Monsanto’s GMO sweet corn, and any future GMO foods, from taking root.
If Walmart really means that nothing is more important than their customers safety then they need to take a stand now.
Click below to automatically sign the petition:
http://act.credoaction.com/r/?r=5535403&id=35505-5154581-RZHw_fx&t=10
Thanks for fighting for safe and healthy food.
Elijah Zarlin, Campaign Manager
CREDO Action from Working Assets


Thanks for taking action.

Here are some ways you can spread the word to make sure Walmart takes a stand against Monsanto’s sweet corn.

If you are on Facebook, click here to post the petition to your Wall.

If you have a Twitter account, click here to automatically tweet:
Tell @Walmart: Stand up for consumer safety and reject Monsanto’s untested, unlabeled GMO sweet corn: http://bit.ly/yVOW5j @CREDOMobile #gmo

You can also send the following e-mail to your friends and family. Spreading the word is critical, but please only pass this message along to those who know you — spam hurts our campaign.

Thanks for all you do.

–The CREDO Action Team

Here’s a sample message to send to your friends:

Subject: Tell Walmart: Don’t sell Monsanto’s potentially toxic GMO sweet corn
Dear Friend,

This spring, Monsanto’s GMO sweet corn — their first product for direct human consumption — will be getting planted for the first time.

Then it will be sold, unlabeled, in a grocery store near you.

To stop it, we’ll need significant opposition from food sellers to this untested, potentially toxic product. Walmart is the largest food retailer in the country, but they have no plans to reject Monsanto’s GMO sweet corn.

I just signed a petition urging Walmart to take a stand for consumer safety, and reject Monsanto’s GMO sweet corn before it’s planted. You can add your name here:

http://act.credoaction.com/campaign/walmart_no_gmo/?r_by=35505-5154581-RZHw_fx&rc=confemail

Published on Aug 1, 2013
14 year old Rachel Parent debates Kevin O’Leary on the issue of Genetically Modified Food
Donate to the cause at Rachel’s website: http://www.gmo-news.com
Canadian Biotechnology Action Network: www.cban.ca
petition for mandatory GMO food labelling: http://www.avaaz.org/en/petition/Brin…
O’Leary knocks himself out: http://youtu.be/OFS035Kdo-s
Rachel’s challenge to O’Leary: https://www.youtube.com/watch?v=0XcXK…
original broadcast on CBC: If you want to see CBC’s “The Lang O’Leary Exchange” with the commercials: http://www.cbc.ca/player/News/TV+Show…


Take Action!
Clicking here will automatically add your name to this to Walmart CEO Mike Duke:
“Walmart: Live up to your commitment to consumer safety, and reject Monsanto’s untested and potentially toxic genetically-modified sweet corn before it’s planted this spring.”

Automatically add your name:

Take action now!

CREDO Action | more than a network, a movement.

Dear Friend,
This spring, Monsanto’s GMO sweet corn — their first product for direct human consumption — will be getting planted for the first time.
Then it will be sold, unlabeled, in a grocery store near you.
What would it take to stop it? It would take the largest food retailer in the country rejecting Monsanto’s untested, potentially toxic corn.
In response to pressure from more than 250,000 CREDO Activists and others last fall, Trader Joes, Whole Foods and General Mills all committed not to sell Monsanto’s sweet corn.1
But not Walmart.
Walmart, wrote to us that “nothing is more important than the safety and satisfaction of our customers.” But that’s just not consistent with selling this unlabeled GMO sweet corn, which contains three genetic modifications — including the insecticide Bt — and hasn’t been tested to prove it is safe for humans to eat.2
Walmart could make a powerful statement for consumer safety by rejecting Monsanto’s GMO sweet corn, but they won’t do it unless we put very public pressure on the company.
This corn is Monsanto’s first foray into designing GMO foods that could wind up whole on your plate. If it’s successful, we can be sure that it will just be the beginning for Monsanto, who already produces roughly 90% of GMO seeds around the globe.
As the largest food retailer, and even the largest seller of organic foods, Walmart can set an important precedent that could keep Monsanto’s GMO sweet corn, and any future GMO foods, from taking root.
If Walmart really means that nothing is more important than their customers safety then they need to take a stand now.
Click below to automatically sign the petition:
http://act.credoaction.com/r/?r=5535403&id=35505-5154581-RZHw_fx&t=10
Thanks for fighting for safe and healthy food.
Elijah Zarlin, Campaign Manager
CREDO Action from Working Assets


Thanks for taking action.

Here are some ways you can spread the word to make sure Walmart takes a stand against Monsanto’s sweet corn.

If you are on Facebook, click here to post the petition to your Wall.

If you have a Twitter account, click here to automatically tweet:
Tell @Walmart: Stand up for consumer safety and reject Monsanto’s untested, unlabeled GMO sweet corn: http://bit.ly/yVOW5j @CREDOMobile #gmo

You can also send the following e-mail to your friends and family. Spreading the word is critical, but please only pass this message along to those who know you — spam hurts our campaign.

Thanks for all you do.

–The CREDO Action Team

Here’s a sample message to send to your friends:

Subject: Tell Walmart: Don’t sell Monsanto’s potentially toxic GMO sweet corn
Dear Friend,

This spring, Monsanto’s GMO sweet corn — their first product for direct human consumption — will be getting planted for the first time.

Then it will be sold, unlabeled, in a grocery store near you.

To stop it, we’ll need significant opposition from food sellers to this untested, potentially toxic product. Walmart is the largest food retailer in the country, but they have no plans to reject Monsanto’s GMO sweet corn.

I just signed a petition urging Walmart to take a stand for consumer safety, and reject Monsanto’s GMO sweet corn before it’s planted. You can add your name here:

http://act.credoaction.com/campaign/walmart_no_gmo/?r_by=35505-5154581-RZHw_fx&rc=confemail

The ingenuity of looting

India-U.S. Fight on Basmati Rice Is Mostly Settled
By SARITHA RAI
Published: August 25, 2001

A Texas company’s attempt to patent a type of basmati rice became a touchstone for anti-globalization protest in the 1990’s. But the long-simmering issue was largely settled this week, when the United States granted a narrower patent to the company, Ricetec of Alvin, Tex.

The United States originally granted the patent in 1997, touching a nerve in India, leading to a challenge by the Indian government and igniting demonstrations against what was termed a piracy of emerging nations’ indigenous products.

After this week’s decision, the Indian government said it saw no reason for further dispute. The new patent is limited to a few variants of the rice and will not hamper export of its own basmati product, the government concluded.

Still, scientists in India are complaining about future problems while evaluating the impact, and opposition politicians are agitating for further action.

The protests in the late 1990’s were led by Vandana Shiva, who called Ricetec’s claim to basmati rice absurd. She termed the limited scope of the final patent largely a success. But, she warned, ”the battle against Ricetec is just the beginning of India’s battle against bio-piracy and theft of indigenous plant wealth.”

For most Indians, the basmati controversy went beyond the economic impact of one product. Basmati, an aromatic rice used in virtually every Indian kitchen, is considered a national heritage. The long-grain rice, whose grains remain petal-soft and separate after cooking, grows in the Punjab region in the north, and across the border in Pakistan.

In 1997, the United States initially granted a broad basmati patent to Ricetec, which developed several strains of rice marketed under various names as similar to basmati. Of the 20 claims made by the company, most related to the rice plant, with others covering the grain and farming methods.

The American decision created an uproar as bitter Indians expressed frustration that successive governments had let India lose claim to basmati, which had never been trademarked. India and its rival Pakistan said they would fight the patent, calling it a threat to the economic survival of thousands of farmers in the subcontinent. More than 50,000 people demonstrated in front of the United Sates Embassy against the patent.

At the World Trade Organization conference in Seattle, India protested the agreement on trade-related intellectual property rights, which had led to a spate of patents for western companies, including for basmati rice. Another coalition denounced the basmati rice patent at the Seattle meeting, and called on W.T.O. members to accept that the rights of farmers and communities precede intellectual property rights.

At the Summit of the Americas in Quebec, activists protested against the prospect of intellectual property protection that would work to the advantage of multinationals involved in genetic engineering of agricultural products — like basmati developed over hundreds of years — at the expense of small farmers in developing countries.

For years, India largely ignored any claim or legal protection for growers and marketers of basmati. A bill has been introduced to recognize produce as belonging to a specific geographical area, but it is still pending before a panel of the Parliament. Given that basmati is not patented by geographic location even within India, the country’s international patent appeal appears weak.

For over two decades ”basmati” has been used in the United States to describe long-grain aromatic rice grown domestically. This usage went unchallenged by India, so much so that the patent claims were under the plea of ”long usage” provided for in trade-related intellectual property rights.

The premium grain stacked up in American supermarkets under brand names like Calmati, which comes from California, and Texmati and Kasmati, which are marketed by Ricetec.

Indian basmati exporters dismiss these varieties as basmati imitations. The distinct aroma and the texture of basmati comes from the Indian soil irrigated by waters from the Himalayan rivers, they say.

India urged the United States Patent and Trade Office in April 2000 to re-examine certain Ricetec claims that India felt posed a threat to Indian basmati exports to the United States. In hundreds of pages of scientific evidence, India argued that its basmati varieties already had the characteristics claimed as unique by Ricetec.

India protested Ricetec’s claim to the term basmati, and insisted that the appellation should be reserved for rice grown in a specific region in India. The argument is much like the one that has been used successfully to limit Champagne to France and Scotch whiskey to Scotland.

Ricetec subsequently withdrew some 15 claims. The American patent office just issued a patent on the claims dealing with three strains of the rice developed by the company.

While the government said it was satisfied, opposition politicians stalled proceedings in the Indian Parliament demanding that the government challenge the patent.

On Tuesday, the commerce minister, Digvijay Singh, tried to pacify members of Parliament, saying Ricetec had received only a varietal patent so it could sell its rice as a superior strain of basmati. India could also develop its own different strains of basmati, he said.

Ms. Shiva, the protester, saw the narrowing of the patent as a significant accomplishment. ”What remains is a farmers’ battle, because Ricetec’s strains have been bred from traditional Indian and Pakistani basmati varieties,” she said. Activists will continue to urge the government to pursue a trademark battle for the basmati name.

But scientists, including Dr. S. A. Siddiq of the Indian Council of Agricultural Research, remain skeptical about India’s ability to thwart piracy of traditional basmati strains. ”India exports a million tons of basmati a year, and India is complacent because the Ricetec patent does not hinder that,” Dr. Siddiq said.

The issue goes beyond mere protection of trade and export of the rice. ”The basmati patent came so suddenly that India has just woken up to the threat to its traditional plant wealth,” Dr. Siddiq said. ”We have to get our laws in place.”

Ms. Shiva says that allowing multinational companies to patent indigenous produce and knowledge is a theft and has resulted in the revoking of a European patent for the traditional Indian neem tree. Patent fights are on for medicinal turmeric and tamarind.

”Granting exclusive patent rights amounts to stealing economic options of daily survival from the developing world,” Ms. Shiva said.


The Mayacoba Bean is a case of biopiracy, where Larry Procter, a Colorado executive in the bean industry cultivated yellow beans he bought in Mexico on vacation for which he received a US patent two years later on all yellow beans of this variety. Larry’s company, Pod-Ners, admits that its Enola bean, (named after Larry Proctor’s wife), is a descendant of the traditional Mexican bean from the Andes, the Mayacoba, but that it has a better yellow color and a more consistent shape. By obtaining a patent and a U.S. Plant Variety Protection Certificate, he secured what amounted to a legal monopoly over yellow beans sold in the United States. Under the terms of the patent, he can therefore sue anyone in the United States who sells or grows a bean that he considered to be his particular shade of yellow. Procter also profits from yellow beans imported from Mexico by imposing on them a six cent-per-pound royalty. As a result, both farmers in the United States and particularly in Northern Mexico have suffered great economic hardship. The case has stimulated great debate over whether traditional knowledge and/or genetic resources should be patentable in the first place. As the number of patents filed by large corporations for native crops increases, activists become more concerned about the adverse effects of these patents on developing countries and particularly indigenous people.


THE SBMATE PATENT:
AMERICAN INGENUITY OR LOOTING OF A TANZANIAN RESOURCE?

CHARLOTTE HINKLE

April 10, 2011

Today’s pirates don’t come with eye patches and daggers clenched in their teeth, but with sharp suits and claiming intellectual property rights. So those rich countries which take seeds away from their poorer neighbors and then try to patent them are guilty of theftplain and simple: biopirates by another name.

–New Scientist

National and international regulation of all areas of bioscience must strike a
balance between promoting innovation and addressing public concerns.

– British BioIndustry Association

I. THE SBMATE CONTROVERSY

A. Introduction

Issued on September 1, 2009, the U.S. Patent for the sorghum aluminum tolerance
gene, SbMATE, is assigned to the United States of America and the Brazilian
Agricultural Research Corporation.3 This patent is notable because it has enormous
commercial potential,4 yet its ownership and scope are controversial. In fact, critics believe that the SbMATE patent is a “biopiracy” patent, in which biological material from a developing country was used to develop a patent without creating any ownership rights for the developing country.5 It is argued that the SbMATE gene comes from a Tanzanian farmers’ variety of sorghum and, furthermore, that the SbMATE patent will harm Tanzanians.6 At the very least, the SbMATE patent story demonstrates the complexity of both patentable subject matter and biopiracy determinations.

B. The Importance of the SbMATE Gene and the SbMATE Patent

The SbMATE gene used in the SbMATE patent was developed from sorghum, which is a type of domesticated grass.8 Sorghum is important in agriculture, and is considered the fifth most important cereal crop grown in the world,9 as certain varieties
of sorghum are used to make food products and food items.10 Sorghum is also a notably hardy crop, as it may be grown with limited water and generally without the application of fertilizer or other food inputs. Because of these features, sorghum is generally grown in harsh environments where other crops grow or yield poorly.

Sorghum is particularly important to the developing world in Asia and Africa
because it is an vital food staple that, along with millet, is “the principle source of energy, protein, vitamins and minerals for millions of the poorest people . . .” In fact, sorghum is referred to as a “course grain” or a “poor people’s crop” because it is consumed mostly by disadvantaged groups.

The demand for sorghum is not as high as it might be because removing the pericarp, or hull, requires a lot of manual labor. Furthermore, sorghum flour “may have taste, texture, and consistency characteristics that are less appealing than those of maize or wheat flours.” Because of such problems, sorghum is not usually traded on international markets.

The SbMATE gene that is found in some varieties of sorghum is particularly desirable because it enables plants to grow in aluminum-rich soil, which is normally toxic to crops.18 As noted in the patent for SbMATE, aluminum toxicity “is a primary limitation for crop production in developing countries,” and “reduces food security in parts of the world where it is most tenuous.” Crops such as wheat, rice, and maize are unable to grow in aluminum-rich soil because aluminum in such soil takes a chemical form that is toxic to them. This toxicity both “stunts the growth of crop plant roots and inhibits the uptake of key minerals.” In contrast, the SbMATE gene allows crops to neutralize the toxic effects of aluminum at their root tips, so that crops with the gene can grow normally.

The inventors of the SbMATE patent also believe that the SbMATE gene can help prevent phosphorus deficiency, which limits crop production in such soils and is
associated with acidic soils.23 It is believed that a transporter like SbMATE “can
facilitate the efflux of citric acid from roots [and may] significantly increase the ability of crop plants to acquire [phosphate] from acid soils . . . .”

The U.S. patent application for SbMATE was filed on May 17, 2007, and was assigned to both the United States of America, as represented by the Secretary of Agriculture, and the Brazilian Agricultural Research Corporation. The inventors of the patent were listed as government researchers from the U.S. Department of Agriculture, the Brazilian Agricultural Research Foundation (Embrapa), and Texas A&M
University. The Patent Cooperation Treaty (PCT) application for the SbMATE patent
was filed almost a year later on May 9, 2008, and the applicants listed on it were similar to those listed on the U.S. patent, although the PCT Application also included The Texas A & M University System for all countries except the U.S.

National phase processing for the PCT application was requested for Australia and the European Patent Office. Tanzania was not mentioned anywhere in either the U.S. patent or the PCT application.

The inventors of the U.S. patent stated that “the single locus …identified as
controlling aluminum tolerance … [was] developed from two highly [aluminum] tolerant
sorghum cultivars.” These cultivars are listed as SC283 and a recombinant inbred
population created from SC283.32 When the patent inventors described the research done with these cultivars, they cited to findings in a 2004 research paper by some of the patent’s listed inventors.

The authors of this research paper worked for institutions such as the U.S.
Department of Agriculture, Cornell University, Texas A & M University, and the
Brazilian Agricultural Research Foundation (Embrapa). The research paper stated that
the authors used two Al tolerant sorghum inbred lines, SC283 and SC566-14.35 The
paper further stated that the SC283 line was collected in Tanzania, while the SC566 line was collected in Nigeria. The SC283 Tanzanian sorghum line mentioned in the paper is a relatively common Tanzanian farmers’ variety of sorghum that is also known internationally as either IS7173 or Msumbji.

C. Expectations for the SbMATE Patent

Among other claims, the SbMATE patent claims isolated and recombinant DNA sequences, a transgenic seed and plant, and a method of producing the genetically
transformed plant.38 Both the U.S. patent and the PCT application state that “SbMATE
can work across species to enhance tolerance to [aluminum] in other important crops
grown in localities worldwide.”

More specifically, it is stated in the patent that the SbMATE patent technology
can be used to create genetically modified versions of crops such as maize, wheat, and rice, so that these crops may also grow in aluminum rich and acidic soils. As the inventors of the SbMATE patent noted, aluminum toxicity is “the primary limitation for crop production in developing countries, including 38% of the farmland in Southeast Asia, 31% in Latin America, and 20% of the arable lands in East Asia and Sub-Saharan Africa.” Because of this potential to increase crop growth in so many areas, there has been commercial interest in licensing the SbMATE patent. For example, both Dow Chemical and Oji Paper, Japan’s second largest paper products producer, have sought to license SbMATE.

While the SbMATE gene has enormous commercial potential,43 widespread commercial use is years away. In the meantime, there is a lingering concern that such
biological patents will “threaten the ability of developing countries to build their own industries, and feed and treat their people.” Opponents of patents like SbMATE argue that developing countries must pay a high price for patented products that are reintroduced into their countries while simultaneously being unable to use “intellectual property framework to protect against the piracy of their own indigenous and local resources and knowledge.”

Defenders of Tanzania’s rights to the SbMATE gene are upset that, while the SC283 line of sorghum was used to isolate the SbMATE gene, no rights to the gene or related patents were conferred to Tanzania. The SC283 variety of sorghum is not the
only aluminum tolerant variety of sorghum; there are aluminum tolerant sorghums from
other areas of Africa as well, such as the Nigerian SC566-14 line mentioned in the
research paper. Some critics further argue that genes from sorghum varieties
originating from Ethiopia, Sudan, and Uganda are also “encompassed” by the U.S.
patent. Still, the possible “theft” of Tanzania’s rights to the SbMATE is written about the most.

II. GENERAL PROBLEM OF DEVELOPED COUNTRIES & COMPANIES PATENTING “INVENTIONS” INDIGENOUS TO DEVELOPING COUNTRIES

A. Historical Perspective

The term “biopiracy” is somewhat ambiguous. The term is most often used today
to describe “when multinational corporations profit from the medicinal and agricultural uses of plants known to indigenous or native societies and fail to compensate those communities,” but the term can also apply when more developed nations or societies are the “pirates,” or when profiting occurs from new uses of non-indigenous plants.

Currently, biopiracy is most likely to occur when “knowledge is patented by ‘expatriate scientists and resident inventors with access to industrial country patent offices,’” although biopiracy can occur in many other ways as well.

The World Intellectual Property Organization (WIPO) considers biopiracy to be both a trade abuse and a threat to biodiversity. There is a concern that taking a country’s indigenous plants without its permission undermines its statehood, as “the
undoubted powers of states to regulate access to and the use of plant life forms within their domains has always remained an inherent aspect of statehood.”56 The number of “takings” involved underscores the seriousness of the problem. For example, one study found that by 1996 the base compound in most of the top 150 plant-derived pharmaceuticals corresponded with traditional medical knowledge. 57

Furthermore, there is a very real concern that biopiracy “delegitimizes the profound intellectual input of local farmers onto the improvement of plants.”58

Accusations of “biopiracy patents” are not new.59 The following examples of natural rubber, rosy periwinkle, and the Enola Bean Patent demonstrate how the term biopiracy is applied to different types of situations and has evolved throughout history. 60

These are only a few examples of the larger cultural clash that can result over the
exploitation of non-indigenous plant material. At its core, biopiracy “encapsulates a strong moral and ethical dimension, which is entrenched on the demise of cultural
linkages between communities and their assets, from which communities have contributed in nurturing and sustaining their assets.”

Natural Rubber

Authors often use the story of natural rubber as a famous example of possible
biopiracy, although the alleged taking does not include the taking of traditional
knowledge. 62 In the mid–1800s natural rubber was produced primarily from wild trees in the Amazon basin.63 During the Industrial Revolution, the value of this raw rubber grew as demand for it in Europe and North America rapidly increased.64 By 1876, Brazil controlled ninety-five percent of the global trade,65 and its Amazon River cities became “the centers of an extremely lucrative, near-global monopoly.” 66

To overcome the Brazilian monopoly, the British Royal Botanical Gardens sent a
botanist to collect Amazon seeds.67 The botanist collected over 70,000 rubber tree
seeds,68 which were used to establish rubber plantations in the British colony of Ceylon and other plantations in South East Asia.69 These British plantations “broke” the Brazilian monopoly on natural rubber,70 which eventually collapsed.71

This rubber “piracy” is still remembered in some parts of Brazil today.72

Rosy Periwinkle

The story of rosy periwinkle (Catharanthus roseus) is another example of alleged
biopiracy. The plant is found in Madagascar, and is the source of the two powerful
cancer fighting drugs vincristine and vinblastine.73 Both drugs were isolated, tested, and marketed by Eli Lilly beginning in the 1950s and, eventually, vincristine generated substantial profits for the company. 74 Madagascar did not profit from the development or sale of either of the drugs, while many authors have argued it should have.75

However, there is another perspective on the rosy periwinkle biopiracy story.

Despite concerns about the improper treatment of Madagascar, it is not clear if rosy
periwinkle is native to Madagascar or just first described there.76 Furthermore, while rosy periwinkle may have originated in Madagascar, it was naturalized in other parts of the world long before Eli Lilly studied it, and the first specimens used by Eli Lilly actually came from India.77 Today the rosy periwinkle is truly an international plant, as it is cultivated on all six continents and is integrated into folk healing traditions in countries as diverse as England, Vietnam, and Dominica.78

Also, while “indigenous and peasant communities strongly suggested bioactivity,”
the flower’s use as the source of a cancer drug was previously unknown and was
expensive for Eli Lilly to discover.79 Therefore, while numerous authors once argued
that Madagascar was unfairly denied revenues from Eli Lilly’s drugs, the rosy periwinkle story is now considered, “a weak case for those who argue that the pharmaceutical industry has reaped great profits by exploiting the ethnobotanical knowledge of particular nations . . . .”80

The Enola Bean Patent

A more recent example of possible biopiracy is the Enola bean. The alleged
“theft” of an indigenous resource began when an American executive, Larry Proctor,
traveled to Mexico and brought back a bag of yellow colored beans.81 In April of 1999, after two years of a selective breeding program using the beans, Proctor obtained a patent on the resulting beans.82 Proctor stated that these patented beans had a distinctively yellow color that held true across generations, and he named them Enola beans after his wife.83 While it was admitted that the Enola bean is a descendent from the traditional Mexican bean Mayacoba,84 it was argued that the Enola bean is unique.85

In Mexico, farmers have grown yellow colored beans since the Aztecs, and
agronomists registered the Mayacoba bean as a variety of the yellow bean in 1978.86

By the time of the Enola patent, Mexican farmers were exporting yellow beans, including Mayacoba, to the U.S., and annual sales in the U.S. were reported at about $50 million dollars.87

After the Enola bean patent was issued, Proctor monitored imports of Mexican
yellow beans.88 He believed that Mexican farmers were possibly infringing on the Enola patent by selling yellow beans to companies in the United States, and he stated that Mexican farmers were likely raising Enola beans and selling them as Mayacoba.89 At the request of his company, U.S. Customs officials stopped bean shipments from Mexico to search for any beans with the same color as Enola beans.90

Proctor also monitored U.S. sales of yellow beans. He filed suit against sixteen
small U.S. bean seed companies that sold Mexican yellow beans for infringing on the
Enola patent, also accusing them of illegally growing and selling Enola beans.91

Furthermore, he charged licensing fees of up to six cents a pound for the right to sell yellow beans in the United States.92 All of these actions had a large effect on the Mexican yellow bean industry.93 After the Enola bean patent was issued, Mexican export sales of yellow beans dropped over ninety percent, which had a severe economic impact on farmers in northern Mexico.94

The Enola bean patent was most controversial because a number of organizations
believed that the patent was improvidently granted.95 These organizations maintained
that despite its consistent yellow coloration, the Enola bean failed to meet the basic patent requirement of novelty over Mexican yellow beans and, therefore, the Enola bean was unpatentable.96

Less than a year after the Enola bean patent was issued, the Colombia-based
International Center for Tropical Agriculture (CIAT), with support from the Food and
Agriculture Association, filed a request for reexamination of the Enola bean patent.97

CIAT claimed it that maintained “some 260 bean samples with yellow seeds, and six
accessions [that were] ‘substantially identical’ to claims made in Proctor’s patent.”98

After several years of re-examinations, the U.S. Patent and Trademark Association
revoked the Enola Patent in April of 2008.99 Despite the ultimate invalidation of the Enola bean patent, opponents of the patent believe that the invalidation took too long to occur, and allowed “the owner of a flagrantly unjust patent to legally monopolize markets and destroy competition for close to half the 20-year patent term.”100 This inability of the U.S. patent system to quickly invalidate an improvidently granted patent is often cited as a failure of the U.S. patent system, and a concern for future “biopiracy patents.”101

Perhaps because the Enola bean patent is so often cited as a “biopiracy,” a few authors have wrote adamant defenses of the Enola bean patent while its validity was being determined.102

B. Acquiring a U.S. Patent

Patent law in the United States is grounded in the United States Constitution,
which gives Congress the power “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their
respecting Writings and Discoveries.”103

A patent grant gives the owner the right to exclude others “from making, using,
offering to sell, or selling the invention within the United States, or importing the invention into the United States.”104 In other words, the United States provides the inventor the right to exclude others from the invention for a limited period of time, so that the inventor has an economic incentive to disclose her invention; furthermore, in exchange for a patent, the inventor provides the public with the knowledge of how to create the invention in her patent application.105

Section 101 of the Patent Act defines patentable subject matter as:

Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefore, subject to the
conditions and requirements of this title. 106

The Supreme Court has determined that the wide language of this section means
that “Congress plainly contemplated that the patent laws be given wide scope.” 107

While the patent laws do give “a wide scope” as to what is patentable, there are limits, and the court has provided three specific exceptions.108 Laws of nature, physical phenomena, and abstract ideas are not patentable.109 The Court has noted that while these exceptions are not clearly stated in the text, “these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years.”110

Determinations of patentability can be subtle and sometimes appear contradictory.
For instance, while discoveries that are “only some of the handiwork of nature” have
been held not patentable,111 a bacterium was held patentable because it had
“markedly different characteristics from any found in nature” and had “the potential for significant utility.”112 Even if a discovery meets the requirements of § 101 of the Patent Act, in order for it “to receive patent protection, [it] must be novel, § 102, nonobvious, § 103, and fully and particularly described,
§ 112.”113 These requirements are thought to “serve a critical role in adjusting the tension . . . between stimulating innovation by protecting inventors and impeding progress by granting patents when not justified by statutory design.” 114

Still, the United States’ patent law has been criticized for impeding progress by
not sufficiently recognizing already existing traditional knowledge known in other
countries. United States patent law explicitly prohibits the patenting of an invention when another inventor has already “patented or described [the invention] in a printed publication in this or a foreign country,” however, United States patent laws only prohibit the patenting of an “invention known or used by others in this country.”115 Therefore, United States patent law does not explicitly prohibit the patenting of an invention known or used by others in a foreign country and, subsequently, has been criticized for not recognizing other countries’ traditional knowledge that has not been published.116 Still, the United States has policy reasons for using this language.117 However, this omission of non-recorded knowledge of inventions known in other countries is different from what most other countries require.118 Additionally, arguments that controversial patents are
valid because previous knowledge of the invention in a foreign country was not published incite further criticism of United States patent law.119

As outlined below, United States patents for genes, plants, and seeds are also
controversial,120 but U.S. patent law has developed in such a way that all three are
currently patentable in at least some form. However, as outlined below, there have been challenges to the future patentability of genes, plants, and seeds, and such challenges have implications for future controversies that are similar to the SbMATE controversy.

U.S. Plant Patents

The United States Plant Patent Act of 1930121 introduced a type of patent
specifically for plants known as a “plant patent.”122 These patents protect developers of new varieties of asexual propagated plants,123 such as apple trees and rose bushes.124

Because plant patents can only be issued for asexually-propagated plants, they are limited in scope. Furthermore, the patent rights derived from such patents are limited to “plants that are asexually reproduced from the patentee’s plants . . . [so that] independent creation is a valid defense.”125 Allowing independent creation as a valid defense against patent infringement is an unusual limitation on the rights of the patent holder, as most patent holders can pursue infringement actions against anyone who uses the patented invention, even if the alleged infringer created the invention independently.

In 1970, the United States Plant Variety Protection Act126 (“PVPA”) established
plant variety protection certificates issued by the United States Department of
Agriculture.127 These certificates give developers of new varieties of seed-propagated plants patent-like rights, although they cannot be granted for first generation hybrid plants.128 The certificates confer to a breeder the right to prevent others from selling, reproducing, importing, or exporting a plant, and the right to stop others from producing a hybrid or different variety of the plant.129 They provide protection for slightly longer than a patent; plant variety protection certificates provide protection for twenty years from the date of issuance, instead of the standard patent protection term of twenty years from the date of filing.130 The certificates are limited in scope because there is an
exception from infringement liability for experimentation using a protected variety.131

Also, farmers may legally save seeds from protected varieties and use these seeds in the production of crops without infringement.132

In 1985 in Ex parte Hibberd,133 the Board of Patent Appeals and Interferences
held that a variety of maize was patentable, despite initial rejections that the subject matter was beyond the scope of 35 U.S.C. § 101 and ought to be protected under the Plant Patent Act or the Plant Variety Protection Act.134 Since this case was decided, it has been cited for the proposition that utility patents can be issued on plants, in spite of other intellectual property protections available to inventors of such plants by the Plant Patent Act and the Plant Variety Protection Act.135

Subsequently, in 2001, in J.E.M. Ag Supply v. Pioneer Hi-Bred International,136
the Supreme Court affirmed the patentability of sexually reproducing hybrid plants, even if they are not genetically modified.137 In J.E.M, the Supreme Court also held that breeders had the right to obtain “dual protection” for new breeds of plants under both the PVPA and the Patent Act.138

These cases are significant. They increased the methods of protection available
for some types of plants, and gave some inventors a range of options not generally
available to patent holders. While most inventions can only be protected by a single
patent, transgenic plant holders can chose to apply for multiple patents or to not use any patents.

Generally, inventors prefer to protect transgenic plants with utility patents
because “the utility patent can apply to the method used to engineer a plant, the genetic sequences that are inserted, and the plant that results.”139 In contrast, plant patents protect “only a single plant or genome”140 and do not provide protection against independently created plants.141 Also, while plant patents and plant variety protection certificates can prevent only the unlawful proliferation of a variety and cannot prevent the use of plant materials for breeding purposes, utility patents can both prevent seed increases by reproduction of the same variety and protect breeders from unauthorized use of protected plant varieties for breeding and research.142 The same plant may be protected by both a utility patent and a plant patent,143 and a plant variety protection certificate.144

U.S. Gene Patents

Patents on genes are not generally allowed until a DNA product has been isolated
and purified.145 Patents on such isolated and purified products prevent others from
“mak[ing], us[ing], offer[ing] to sell, or sell[ing] [patented genes] within the United States, or import[ing] [patented genes] into the United States.”146

Biotechnology companies argue that genes, plants and seeds should be patentable so that companies will have enough confidence to invest the time and money necessary to develop such products.147

Still, a recent district court ruling held patents for isolated DNA containing breast cancer susceptibility genes invalid.148 This district court noted that “[i]n light of DNA’s unique qualities as a physical embodiment of information, none of the structural differences . . . between native . . . DNA and the isolated . . . DNA claimed in the patentsin-suit render the claimed DNA ‘markedly different,’”149 and that “the time may come when the use of DNA for molecular and diagnostic purposes may not require purification.”150 The district court further noted that “Supreme Court precedent has established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.”151

This decision has led to questions about other patents on human genes, which has
led to doubt about a larger number of U.S. patents, as over 40,000 patents on 2,000
human genes are said to exist.152 The language of the decision also questions the
patentability of other types of genes, as much of the logic regarding the patentability of human genes applies to the patentability of genes in general.153

The district court’s decision has been criticized for relying on older cases and
failing to cite relevant Federal Circuit cases.154 However, the decision may be indicative of a new trend. Soon after the decision, the Department of Justice submitted a friend-of-the-court brief that contradicted the long-standing stance of the PTO and stated that genes should not be eligible for patents because they are a product of nature.155

Ultimately, the patentability of genes remains a controversial subject.156 Despite
its brief, the government suggested that changing gene patent laws “would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops . . . could still be patented.”157

C. International Patent Law

International patent law has been significantly influenced by the U.S. Supreme
Court decision in Diamond v. Chakrabarty,158 which held that a live, human-made microorganism is patentable subject matter.159 International gene and plant patenting has also been affected by international trade and patent harmonization agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the General Agreement on Trade and Tariffs (GATT), and the North American Free Trade Agreement (NAFTA).160 In both the developed and developing countries that signed these agreements, “genes . . . are considered patentable material if they meet general patent criteria and are demonstrated to be new creations (e.g., artificial genes) or are isolated from nature and identified . . . and shown to have a particular function and use.”161

While TRIPS does not require plant patents, it specifically requires the protection
of plant varieties “either by patents or by an effective sui generis system or by any combination thereof.”162 The term “sui generis” is not well defined and its meaning is debated.163 It is generally thought that it “enables member countries to design their own system of protection for plant varieties” if they do not issue plant patents; however, it is not clear what is sufficient to qualify as a “sui generis system.”164

The TRIPS agreement also did not define “invention.” The United Nations has
noted that this exclusion allows WTO “member countries relatively free to draw the line between patentable ‘discoveries’ and actual inventions in the patent field,”165 thereby preserving some autonomy for WTO member countries as they implement their patent laws.

Still, many WTO member countries have changed their patent laws to conform to
the TRIPS agreement because, as member countries, they are bound to adhere to
TRIPS.166 For example, prior to joining TRIPS, the Indian patent system followed the
1970 Indian Patent Act, which prevented patent claims for “substances intended for use, or capable as being used as food or medicine or drug.”167 This patent exception was broad and the Indian Patent Act defined food as “any article of nourishment.”168

However, the India patent system changed after India joined WIPO and had to comply
with the TRIPS agreement. Patents are now granted for seeds, plants, micro-organisms, cells and even [genetically modified] organisms and animals.”169 Similarly, it is argued that prior to Australia, Canada, and Ireland joining WIPO, attempts by agribusiness to introduce legislation similar to TRIPS were rebuffed in all three countries.170

In fact, Australian patent laws have changed to such an extent that, like the U.S,
Australia now allows inventors to patent individual plant varieties.171 While plant
varieties are not patentable in many European countries, a plant characterized by a
particularly gene, instead of by its genome, is patentable in most of Europe.172

Furthermore, in much of Europe, transgenic plants are patentable only if they are not restricted to a specific plant variety but represent a broader plant grouping.173 In the past, developing countries have responded with attempts “to restrict and even prohibit the patenting of plants.”174

The issuance of intellectual property rights over genetic material in native species
has been defended for two reasons. It has been argued that:

[i]n addition to more fairly distributing the gains from recombinant genetic
products based on those species, it . . . also gives[s] developing countries
an incentive to protect rainforests and other genetically rich areas . . . the
granting of property rights over a resource can be expected to lead to more
efficient use of a resource.175

In 1993, the landmark Convention for Biological Diversity (CBD) Treaty went into force, which attempted to address global biodiversity conservation.176 The CBD
Treaty is dedicated to the objectives of conservation of biological diversity, sustainable use of the components of biological diversity, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.177 This third objective acknowledges the concerns of developing countries, and the CBD Treaty “recognizes the sovereign rights of states to determine through national legislation the conditions for access to the biological resources in their territories.”178

Recently, developing countries have attempted to alter the TRIPS patent requirements in order to address biopiracy concerns, although these attempts are unlikely to be successful.179 One recently proposed amendment suggested a requirement that patent applications that “use or are based upon genetic resources or traditional knowledge disclose the source, as well as the country of source.”180

Another proposed amendment to TRIPS would require that patent applications “must include evidence of prior informed consent of any materials used from another country and satisfaction of the [Convention of Biological Diversity] mandate that access to genetic resources be subject to prior informed consent . . . .”181

Neither of these amendments is likely to be successful for many reasons, including the fact that amendments to TRIPS require broad consensus among WTO members, and that such proposals have little support among Western countries.182

Developing countries have attempted more local reform as well. Against a movement toward broader international intellectual property regimes, developing countries have implemented national systems to regulate use of their own indigenous plants and knowledge. For example, in 1999 the Indian government created an online database of documented traditional knowledge in response to concerns that traditional knowledge was being “misappropriated in the form of patents on non-original innovations.”183 The government specifically cites concerns about patents on inventions that use Indian plants such as basmati rice, hoodia, and kava, and the government’s desire to prevent such “bio-prospecting” patents in the future.184 It is hoped the database will break “the format and language barrier and mak[e traditional knowledge] accessible to patent examiners at International Patent Offices for the purpose of carrying out search and examination.”185

SbMATE and the African Perspective

In spite of the ongoing controversy regarding the patentability of genes and
plants, at least some of the claims in the SbMATE patent are likely to remain valid even if gene patents and general plant patents are held invalid. The SbMATE patent claims include not only isolated and recombinant DNA sequences and a transgenic seed and plant, but also a method of producing the genetically transformed plant.186 Such transgenic organisms and methods for their production are unlikely to be invalidated as unpatentable subject matter.187

The continued patentability of transgenic organisms and methods of their production is discouraging to many Africans. Africans are concerned that biopiracy is costing Africa a lot of benefits.188 There is a general sentiment that “the existing system
of intellectual property rights and patents does not accommodate non-western systems of knowledge ownership and access.”189 There is also a concern that the system treats “knowledge as a commodity owned by an individual or company with the goal of trade.”

Furthermore, there is concern among “scholars, activists, and indigenous peoples [] that the patent system has not been sensitive to the dignity, rights and worldviews of indigenous and traditional people.”190

Western intellectual property protections have been criticized because developing
countries must pay a high price for patented products that are reintroduced into their countries while simultaneously being unable to use the “intellectual property framework to protect against the piracy of their own indigenous and local resources and knowledge.”191 Patents are accused of reflecting “the arrogance of Western
civilization.”192 Another complaint is that the “creativity, ingenuity and invention which an efficient patent system should nurture and encourage is being undermined by patents that are creating patent thickets so dense that they are adding costs to medical and scientific research and, in some instances, hindering it all together.”193

In 2000, in response to such concerns and in accordance with the CBD Treaty, the
African Union formally endorsed legislation that sought to protect biological resources “including agricultural genetic resources by requiring, among other things, that ‘any access to any biological resources . . . shall be subject to application’ and refused to recognize any patent for life forms of biological processes.”194 This legislation, known as the Law on the Rights of Local Communities, Farmers, Breeders and Access, attempts to “provide[] a framework for the recognition of the innovative and creative efforts of African societies.” 195

The law still exists as a model law, although it has not been formally adopted.196

This type of model law is unlikely to be adopted in African countries, such as Tanzania, because they are members of the World Trade Organization197 and, therefore, must adhere to minimum intellectual property standards under TRIPS.198

Still, there is an ongoing concern that patents that claim living organisms and
genes, such as the SbMATE patent, are patents for discoveries of nature, and as such
should not be patentable.199 It is argued that the TRIPS requirement of a minimum,
uniformly applicable intellectual property standard, “is a reflection of the trends in economic globalization, which promotes a private profit oriented approach within an economic and proprietary framework” that will result in “dire consequences for countries in the South.”200 Additionally, critics argue that the TRIPS requirement “of patenting of life forms and biodiversity will erode the sovereign power of [] Third World [countries]”, such as Tanzania, “to their resources and will generate ethical problems to the patenting of life.” 201

III. THE “INTERNATIONAL SEED TREATY”

The International Treaty on Plant Genetic Resources for Food and Agriculture
(ITPGRFA),202 popularly known as the International Seed Treaty, and hereinafter
referred to as such, went into force in June of 2004.203 Its aims include:

[R]ecognizing the enormous contributions of farmers to the diversity of
crops that feed the world; establishing a global system to provide farmers, plant breeders and scientists with access to plant genetic materials; [and]
ensuring that recipients share benefits they derive from the use of these
genetic materials with the countries where they have been originated.204

The International Seed Treaty was fostered by the Food and Agricultural
Organization (FAO) of the United Nations, and the Treaty remains under its control.205

The FAO encouraged the Treaty because of “unease about intellectual property regimes
that reward formal breeders while ignoring the contributions . . . of farmers to the
development and conservation of the very plant genetic sources on which breeders
depend.”206 The FAO maintains that genetic resources have a lot of value and that in the last thirty years more than three-quarters of increased crop productivity is the result of breeding.207

The Treaty provides “a strong and elaborate shape to the concept of farmers’ rights.” Furthermore, the Treaty is consistent with the theory that “the ownership
approach is simply contrary to communities’ traditional ways of life, which promote the common ownership of their [traditional knowledge] associated with their seeds . . . .”208

The Treaty sets up a Multilateral System from which resources can be obtained
for use and conservation in research, breeding, and training.209 If a commercial product is developed using resources from the multilateral system and may not be used without restriction by others for further research and breeding, the Treaty provides for payment of an equitable share of the resulting monetary benefits.210

If a product is developed that others may use without restriction, payment is considered voluntary.211

Much of the Treaty is about the germoplasm collection of Consultative Group on
International Agricultural Research (CGIAR)’s Future Harvest Centers. This
germoplasm collection is thought to contain about 560,000 accessions of crop diversity and is considered invaluable because it contains diverse farmers’ landraces212 and local varieties, and they are held in trust for the international community.213 The treaty calls upon International Agricultural Research Centers (IARCs) of CGIAR to “sign agreements with the Governing Body with regard to such [] collections.”214 A large amount of this material and other regional collections are placed into the International Network.215

Sorghum is included under the list of Food Crops covered by the treaty.216 It is
listed as a food crop that falls under the Multilateral System, which “include[s] all plant genetic resources for food and agriculture . . . that are under the management and control of the Contracting Parties and in the public domain.”217 The Treaty further states that “Contracting Parties also agree to encourage natural and legal persons within their jurisdiction who hold plant genetic resources for food and agriculture listed in [the Treaty] to include such plant genetic resources . . . in the Multilateral System.218

The International Seed Treaty came into effect on June 29, 2004, and there are
now 127 parties to the Treaty.219 Of the countries involved in the SbMATE controversy, Brazil was the first to sign the Treaty on June 10, 2002 and further ratified it on May 22, 2006.220 The United States of America was second to sign on November 1, 2002.221

Tanzania did not accede to the International Seed Treaty until April 30, 2004.222
The International Seed Treaty has been criticized because it does not clarify what
enforcement procedures will be used to ensure that farmers’ rights will be respected223 or even how benefits from the commercial use of the genetic materials will be shared.224

The treaty itself advocates arbitration between contracting parties for the settlement of disputes.225

IV. ANALYSIS TO DETERMINE IF THE UNITED STATES DID VIOLATE THE INTERNATIONAL SEED TREATY

Defenders of Tanzania’s right to the SbMATE patent contend that the patent and
attempts to license the patent contradict the goals of the treaty.226 Indeed one of the aims of the treaty is stated to be “ensuring that recipients share benefits they derive from the use of these genetic materials with the countries where they have been originated.”227

However, as has been noted by other authors, it is difficult to claim that the
SbMATE patent directly violated the International Seed Treaty. The SC283 sorghum
strain used in the invention of the SbMATE patent is available at a center, the
International Crop Research Institute for the Semi-Arid Tropics (ICRISAT), under the
label of Msumbiji or SB117.228 This center supplies germoplasm under agreement with
the FAO’s International Seed Treaty,229 so any material acquired through the center
would be subject to the International Seed Treaty’s rules. Therefore, if the researchers who invented the SbMATE patent innovation had used SC283 sorghum from the center, they would have broken the Treaty’s requirement that “recipients share benefits they derive from the use of these genetic materials with the countries where they have been originated.”230 The SbMATE patent would also have violated Article 12.3.d that “recipients shall not claim any intellectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components . . . .”231

However, the ICRISAT center is unlikely to have been the source of the material
used to obtain the SbMATE patent. Instead, Texas A & M is thought to have held
samples of SC283 long before the International Seed Treaty was ratified, and there is no evidence that the Texas A & M sorghum line came from any Center subject to the
International Seed Treaty.232 Hence statements that “governments . . . ignore [the
International Seed Treaty] provisions, pillag[e] the coffers of CGIAR and sell[] them to Dow Chemical and other wealthy country concerns” 233 are inaccurate and misleading exaggerations.

While the International Seed Treaty predates both the U.S. patent and the PCT
application, neither falls under the authority of the International Seed Treaty, for neither encompasses material covered by the Treaty. However, it is worth noting that while the SbMATE patent and the PCT application may not directly violate the Treaty, they do appear to create the type of problem that the International Seed Treaty was designed to address.

As earlier noted, the FAO encouraged the Treaty because of “unease about
intellectual property regimes that reward formal breeders while ignoring the contributions. . . of farmers to the development and conservation of the very plant genetic sources on which breeders depend.”234 While statements such as, “permitting the SbMATE patent to stand and for the private sector to profit from it, would signal a new open hunting season on privatization of the vast collection of farmers’ varieties of food crops held by the CGIAR” are inaccurate, they do demonstrate how farmers in developing countries feel misled and unprotected by the Treaty.

There is a sentiment that “the genius of African farms is locked up in the vaults of
the CGIAR,”235 and that while the International Seed Treaty may not protect the plants used by Tanzanian farmers from being used to make the SbMATE patent, it should. At its center, biopiracy “encapsulates a strong moral and ethical dimension, which is entrenched on the demise of cultural linkages between communities and their assets, from which communities have contributed in nurturing and sustaining their assets.”236

Therefore, even if the SbMATE patent is proven not to violate the International Seed
Treaty, concerns about the SbMATE patent are likely to continue.

V. CONCLUSIONS

A. Outlook

Ethical concerns about patents, as well as concerns about the threat of patents to
biodiversity,237 are likely to continue in spite of the International Seed Treaty. Similar to the plant lines used in the SbMATE patent, any plant lines that have already been acquired will not be covered under the International Seed Treaty.238 Therefore, it is likely that there are other germoplasms that are listed among the 560,000 accessions of crop diversity available in CGIAR239 that were also acquired outside of the CGIAR regime and may be patented despite the International Seed Treaty.

In spite of these problems, the International Seed Treaty has been credited with
“providing access to, as well as the conservation and sustainable use of, plant genetic resources on the one hand and the fair and equitable sharing of benefits derived from their use on the other.” 240 Presumably the Treaty will become more important over time, as plants subject to the Treaty are used to develop further innovations in agriculture and medicine.

In the meantime, there are other proposed improvements to intellectual property
systems intended to provide additional protection for developing countries’ genetic
resources.241 For example, there are suggestions for developing more sui generis systems of intellectual property, which are thought to be a more “fair” way to protect genetic sequence rights.242 Another proposed improvement is having more developing countries adopt the Indian Traditional Knowledge Digital Library model, which lists online the known uses of indigenous plants by developing countries, to prevent the issuance of new patents for previously known uses of plants.243

In addition to the protection provided by proposed improvements to intellectual
property laws, it is hoped that over time intellectual property systems in both developing and developed countries will become more advanced so that they provide better and more clear protection of genetic resources in general.244 It is also hoped that intellectual property systems will be more effective at protecting developing countries’ rights, after there is an increased understanding in developing countries of how intellectual property systems work and more people are taught how to use such systems to their advantage.245

B. Lessons Learned

As the historical examples of “biopiracy” have shown, determinations of biopiracy are not easy, and intellectual property systems are generally not well suited for
making such determinations. In fact, patent systems in particular are not usually
designed to address problems of “theft” of indigenous resources, and systems that are designed to address such concerns are often distinct from intellectual property systems.

When alleged “biopiracy patents” occur, generally the problem is a failure to create
protections against the taking of indigenous material, the failure to adequately publicize traditional knowledge,247 or the failure to properly reward cultures for the use of their indigenous material. The problem is usually not that an intellectual property system granted a patent per se. For example, while the United States patent system may be criticized for allowing patents on inventions that are known, but not described in published material in foreign countries, generally in objectionable cases such knowledge is either known in the United States, published somewhere or fails to meet the nonobvious requirement.248 Therefore, most biopiracy analysis should be determined without implicating intellectual property systems, particularly patent systems, and should instead focus primarily on the original “taking” and use of indigenous material.

For example, in the case of the possible biopiracy of Brazilian natural rubber, no
intellectual property rights were involved, let alone patent rights.249 Still, many authors have argued that the rubber was “biopirated.” In the case of the Enola beans, a patent was issued in spite of biopiracy concerns, although it was eventually invalidated250 because the beans were considered obvious; intellectual property law does not reward inventions that are simply “takings.”251 Finally, in the case of the rosy periwinkle the “invention” was not taken directly from an indigenous country and was in fact novel, so the patent should be valid.252 Although the SbMATE patent involves a more obvious “taking” from an indigenous country than the rosy periwinkle did, the “invention” is also treated as a “novel” invention, and as such is considered patentable.

While there are increasingly greater protections for developing countries’ resources, disagreements similar to the SbMATE controversy will continue. Intellectual property law, particularly in the United States, has accepted genetically modified plants as novel and patentable inventions.253 While genetically modified plants may use traits from other plants, patents are granted to incentivize the work and skill that is required to create genetically modified plants and to incentivize the release of information to the public about how to create the genetically modified plant.254 Researchers already have strains of many plants from around the world and will undoubtedly use these plants to create genetically modified plants. Countries such as the United States will continue to
grant patents on these genetically modified plants as long as such patents conform to patent laws.

International intellectual property systems have largely followed the U.S. example
that living organisms are patentable.255 Like all other countries, developing countries are required to adopt WIPO intellectual property protection requirements if they wish to join the WTO.256 For better or worse, this mandate limits how developing countries may approach intellectual property.

While patent laws may change so that patents can no longer be granted for genes
and for some types of plants, patents that cover genetically modified plants, such as the SbMATE patent, are likely to continue. There are undoubtedly critics who believe that plants should never be patentable, critics who believe that intellectual property laws should not incentivize the creation of genetically modified plants, and critics who believe that patents should never be obtained on inventions that use material from a foreign country without the foreign country’s permission. However, most patent laws are created to incentivize broad innovation and are not designed to meet these particular objectives.

Furthermore, the International Seed Treaty was not designed to completely
address any of these concerns. The Treaty was never designed to encompass or address
all past takings, and it is not clear where in history “the biopiracy clock” should start.

Since plants such as the rosy periwinkle now exist throughout the globe,257 tracing their “theft” is impossible. Indeed, it is almost equally impossible to determine when all the strains of plants like SC283 sorghum were taken from their indigenous countries.

Moreover, any intellectual property system that does address these concerns will appear radically different from the system currently in place.

Under current intellectual property law, the SbMATE patent represents American
ingenuity, and not the “looting” of a Tanzanian resource. While the use of the SC283
sorghum line must appear to some Tanzanians much like the theft of the Elgin marbles
fr

India-U.S. Fight on Basmati Rice Is Mostly Settled
By SARITHA RAI
Published: August 25, 2001

A Texas company’s attempt to patent a type of basmati rice became a touchstone for anti-globalization protest in the 1990’s. But the long-simmering issue was largely settled this week, when the United States granted a narrower patent to the company, Ricetec of Alvin, Tex.

The United States originally granted the patent in 1997, touching a nerve in India, leading to a challenge by the Indian government and igniting demonstrations against what was termed a piracy of emerging nations’ indigenous products.

After this week’s decision, the Indian government said it saw no reason for further dispute. The new patent is limited to a few variants of the rice and will not hamper export of its own basmati product, the government concluded.

Still, scientists in India are complaining about future problems while evaluating the impact, and opposition politicians are agitating for further action.

The protests in the late 1990’s were led by Vandana Shiva, who called Ricetec’s claim to basmati rice absurd. She termed the limited scope of the final patent largely a success. But, she warned, ”the battle against Ricetec is just the beginning of India’s battle against bio-piracy and theft of indigenous plant wealth.”

For most Indians, the basmati controversy went beyond the economic impact of one product. Basmati, an aromatic rice used in virtually every Indian kitchen, is considered a national heritage. The long-grain rice, whose grains remain petal-soft and separate after cooking, grows in the Punjab region in the north, and across the border in Pakistan.

In 1997, the United States initially granted a broad basmati patent to Ricetec, which developed several strains of rice marketed under various names as similar to basmati. Of the 20 claims made by the company, most related to the rice plant, with others covering the grain and farming methods.

The American decision created an uproar as bitter Indians expressed frustration that successive governments had let India lose claim to basmati, which had never been trademarked. India and its rival Pakistan said they would fight the patent, calling it a threat to the economic survival of thousands of farmers in the subcontinent. More than 50,000 people demonstrated in front of the United Sates Embassy against the patent.

At the World Trade Organization conference in Seattle, India protested the agreement on trade-related intellectual property rights, which had led to a spate of patents for western companies, including for basmati rice. Another coalition denounced the basmati rice patent at the Seattle meeting, and called on W.T.O. members to accept that the rights of farmers and communities precede intellectual property rights.

At the Summit of the Americas in Quebec, activists protested against the prospect of intellectual property protection that would work to the advantage of multinationals involved in genetic engineering of agricultural products — like basmati developed over hundreds of years — at the expense of small farmers in developing countries.

For years, India largely ignored any claim or legal protection for growers and marketers of basmati. A bill has been introduced to recognize produce as belonging to a specific geographical area, but it is still pending before a panel of the Parliament. Given that basmati is not patented by geographic location even within India, the country’s international patent appeal appears weak.

For over two decades ”basmati” has been used in the United States to describe long-grain aromatic rice grown domestically. This usage went unchallenged by India, so much so that the patent claims were under the plea of ”long usage” provided for in trade-related intellectual property rights.

The premium grain stacked up in American supermarkets under brand names like Calmati, which comes from California, and Texmati and Kasmati, which are marketed by Ricetec.

Indian basmati exporters dismiss these varieties as basmati imitations. The distinct aroma and the texture of basmati comes from the Indian soil irrigated by waters from the Himalayan rivers, they say.

India urged the United States Patent and Trade Office in April 2000 to re-examine certain Ricetec claims that India felt posed a threat to Indian basmati exports to the United States. In hundreds of pages of scientific evidence, India argued that its basmati varieties already had the characteristics claimed as unique by Ricetec.

India protested Ricetec’s claim to the term basmati, and insisted that the appellation should be reserved for rice grown in a specific region in India. The argument is much like the one that has been used successfully to limit Champagne to France and Scotch whiskey to Scotland.

Ricetec subsequently withdrew some 15 claims. The American patent office just issued a patent on the claims dealing with three strains of the rice developed by the company.

While the government said it was satisfied, opposition politicians stalled proceedings in the Indian Parliament demanding that the government challenge the patent.

On Tuesday, the commerce minister, Digvijay Singh, tried to pacify members of Parliament, saying Ricetec had received only a varietal patent so it could sell its rice as a superior strain of basmati. India could also develop its own different strains of basmati, he said.

Ms. Shiva, the protester, saw the narrowing of the patent as a significant accomplishment. ”What remains is a farmers’ battle, because Ricetec’s strains have been bred from traditional Indian and Pakistani basmati varieties,” she said. Activists will continue to urge the government to pursue a trademark battle for the basmati name.

But scientists, including Dr. S. A. Siddiq of the Indian Council of Agricultural Research, remain skeptical about India’s ability to thwart piracy of traditional basmati strains. ”India exports a million tons of basmati a year, and India is complacent because the Ricetec patent does not hinder that,” Dr. Siddiq said.

The issue goes beyond mere protection of trade and export of the rice. ”The basmati patent came so suddenly that India has just woken up to the threat to its traditional plant wealth,” Dr. Siddiq said. ”We have to get our laws in place.”

Ms. Shiva says that allowing multinational companies to patent indigenous produce and knowledge is a theft and has resulted in the revoking of a European patent for the traditional Indian neem tree. Patent fights are on for medicinal turmeric and tamarind.

”Granting exclusive patent rights amounts to stealing economic options of daily survival from the developing world,” Ms. Shiva said.


The Mayacoba Bean is a case of biopiracy, where Larry Procter, a Colorado executive in the bean industry cultivated yellow beans he bought in Mexico on vacation for which he received a US patent two years later on all yellow beans of this variety. Larry’s company, Pod-Ners, admits that its Enola bean, (named after Larry Proctor’s wife), is a descendant of the traditional Mexican bean from the Andes, the Mayacoba, but that it has a better yellow color and a more consistent shape. By obtaining a patent and a U.S. Plant Variety Protection Certificate, he secured what amounted to a legal monopoly over yellow beans sold in the United States. Under the terms of the patent, he can therefore sue anyone in the United States who sells or grows a bean that he considered to be his particular shade of yellow. Procter also profits from yellow beans imported from Mexico by imposing on them a six cent-per-pound royalty. As a result, both farmers in the United States and particularly in Northern Mexico have suffered great economic hardship. The case has stimulated great debate over whether traditional knowledge and/or genetic resources should be patentable in the first place. As the number of patents filed by large corporations for native crops increases, activists become more concerned about the adverse effects of these patents on developing countries and particularly indigenous people.


THE SBMATE PATENT:
AMERICAN INGENUITY OR LOOTING OF A TANZANIAN RESOURCE?

CHARLOTTE HINKLE

April 10, 2011

Today’s pirates don’t come with eye patches and daggers clenched in their teeth, but with sharp suits and claiming intellectual property rights. So those rich countries which take seeds away from their poorer neighbors and then try to patent them are guilty of theftplain and simple: biopirates by another name.

–New Scientist

National and international regulation of all areas of bioscience must strike a
balance between promoting innovation and addressing public concerns.

– British BioIndustry Association

I. THE SBMATE CONTROVERSY

A. Introduction

Issued on September 1, 2009, the U.S. Patent for the sorghum aluminum tolerance
gene, SbMATE, is assigned to the United States of America and the Brazilian
Agricultural Research Corporation.3 This patent is notable because it has enormous
commercial potential,4 yet its ownership and scope are controversial. In fact, critics believe that the SbMATE patent is a “biopiracy” patent, in which biological material from a developing country was used to develop a patent without creating any ownership rights for the developing country.5 It is argued that the SbMATE gene comes from a Tanzanian farmers’ variety of sorghum and, furthermore, that the SbMATE patent will harm Tanzanians.6 At the very least, the SbMATE patent story demonstrates the complexity of both patentable subject matter and biopiracy determinations.

B. The Importance of the SbMATE Gene and the SbMATE Patent

The SbMATE gene used in the SbMATE patent was developed from sorghum, which is a type of domesticated grass.8 Sorghum is important in agriculture, and is considered the fifth most important cereal crop grown in the world,9 as certain varieties
of sorghum are used to make food products and food items.10 Sorghum is also a notably hardy crop, as it may be grown with limited water and generally without the application of fertilizer or other food inputs. Because of these features, sorghum is generally grown in harsh environments where other crops grow or yield poorly.

Sorghum is particularly important to the developing world in Asia and Africa
because it is an vital food staple that, along with millet, is “the principle source of energy, protein, vitamins and minerals for millions of the poorest people . . .” In fact, sorghum is referred to as a “course grain” or a “poor people’s crop” because it is consumed mostly by disadvantaged groups.

The demand for sorghum is not as high as it might be because removing the pericarp, or hull, requires a lot of manual labor. Furthermore, sorghum flour “may have taste, texture, and consistency characteristics that are less appealing than those of maize or wheat flours.” Because of such problems, sorghum is not usually traded on international markets.

The SbMATE gene that is found in some varieties of sorghum is particularly desirable because it enables plants to grow in aluminum-rich soil, which is normally toxic to crops.18 As noted in the patent for SbMATE, aluminum toxicity “is a primary limitation for crop production in developing countries,” and “reduces food security in parts of the world where it is most tenuous.” Crops such as wheat, rice, and maize are unable to grow in aluminum-rich soil because aluminum in such soil takes a chemical form that is toxic to them. This toxicity both “stunts the growth of crop plant roots and inhibits the uptake of key minerals.” In contrast, the SbMATE gene allows crops to neutralize the toxic effects of aluminum at their root tips, so that crops with the gene can grow normally.

The inventors of the SbMATE patent also believe that the SbMATE gene can help prevent phosphorus deficiency, which limits crop production in such soils and is
associated with acidic soils.23 It is believed that a transporter like SbMATE “can
facilitate the efflux of citric acid from roots [and may] significantly increase the ability of crop plants to acquire [phosphate] from acid soils . . . .”

The U.S. patent application for SbMATE was filed on May 17, 2007, and was assigned to both the United States of America, as represented by the Secretary of Agriculture, and the Brazilian Agricultural Research Corporation. The inventors of the patent were listed as government researchers from the U.S. Department of Agriculture, the Brazilian Agricultural Research Foundation (Embrapa), and Texas A&M
University. The Patent Cooperation Treaty (PCT) application for the SbMATE patent
was filed almost a year later on May 9, 2008, and the applicants listed on it were similar to those listed on the U.S. patent, although the PCT Application also included The Texas A & M University System for all countries except the U.S.

National phase processing for the PCT application was requested for Australia and the European Patent Office. Tanzania was not mentioned anywhere in either the U.S. patent or the PCT application.

The inventors of the U.S. patent stated that “the single locus …identified as
controlling aluminum tolerance … [was] developed from two highly [aluminum] tolerant
sorghum cultivars.” These cultivars are listed as SC283 and a recombinant inbred
population created from SC283.32 When the patent inventors described the research done with these cultivars, they cited to findings in a 2004 research paper by some of the patent’s listed inventors.

The authors of this research paper worked for institutions such as the U.S.
Department of Agriculture, Cornell University, Texas A & M University, and the
Brazilian Agricultural Research Foundation (Embrapa). The research paper stated that
the authors used two Al tolerant sorghum inbred lines, SC283 and SC566-14.35 The
paper further stated that the SC283 line was collected in Tanzania, while the SC566 line was collected in Nigeria. The SC283 Tanzanian sorghum line mentioned in the paper is a relatively common Tanzanian farmers’ variety of sorghum that is also known internationally as either IS7173 or Msumbji.

C. Expectations for the SbMATE Patent

Among other claims, the SbMATE patent claims isolated and recombinant DNA sequences, a transgenic seed and plant, and a method of producing the genetically
transformed plant.38 Both the U.S. patent and the PCT application state that “SbMATE
can work across species to enhance tolerance to [aluminum] in other important crops
grown in localities worldwide.”

More specifically, it is stated in the patent that the SbMATE patent technology
can be used to create genetically modified versions of crops such as maize, wheat, and rice, so that these crops may also grow in aluminum rich and acidic soils. As the inventors of the SbMATE patent noted, aluminum toxicity is “the primary limitation for crop production in developing countries, including 38% of the farmland in Southeast Asia, 31% in Latin America, and 20% of the arable lands in East Asia and Sub-Saharan Africa.” Because of this potential to increase crop growth in so many areas, there has been commercial interest in licensing the SbMATE patent. For example, both Dow Chemical and Oji Paper, Japan’s second largest paper products producer, have sought to license SbMATE.

While the SbMATE gene has enormous commercial potential,43 widespread commercial use is years away. In the meantime, there is a lingering concern that such
biological patents will “threaten the ability of developing countries to build their own industries, and feed and treat their people.” Opponents of patents like SbMATE argue that developing countries must pay a high price for patented products that are reintroduced into their countries while simultaneously being unable to use “intellectual property framework to protect against the piracy of their own indigenous and local resources and knowledge.”

Defenders of Tanzania’s rights to the SbMATE gene are upset that, while the SC283 line of sorghum was used to isolate the SbMATE gene, no rights to the gene or related patents were conferred to Tanzania. The SC283 variety of sorghum is not the
only aluminum tolerant variety of sorghum; there are aluminum tolerant sorghums from
other areas of Africa as well, such as the Nigerian SC566-14 line mentioned in the
research paper. Some critics further argue that genes from sorghum varieties
originating from Ethiopia, Sudan, and Uganda are also “encompassed” by the U.S.
patent. Still, the possible “theft” of Tanzania’s rights to the SbMATE is written about the most.

II. GENERAL PROBLEM OF DEVELOPED COUNTRIES & COMPANIES PATENTING “INVENTIONS” INDIGENOUS TO DEVELOPING COUNTRIES

A. Historical Perspective

The term “biopiracy” is somewhat ambiguous. The term is most often used today
to describe “when multinational corporations profit from the medicinal and agricultural uses of plants known to indigenous or native societies and fail to compensate those communities,” but the term can also apply when more developed nations or societies are the “pirates,” or when profiting occurs from new uses of non-indigenous plants.

Currently, biopiracy is most likely to occur when “knowledge is patented by ‘expatriate scientists and resident inventors with access to industrial country patent offices,’” although biopiracy can occur in many other ways as well.

The World Intellectual Property Organization (WIPO) considers biopiracy to be both a trade abuse and a threat to biodiversity. There is a concern that taking a country’s indigenous plants without its permission undermines its statehood, as “the
undoubted powers of states to regulate access to and the use of plant life forms within their domains has always remained an inherent aspect of statehood.”56 The number of “takings” involved underscores the seriousness of the problem. For example, one study found that by 1996 the base compound in most of the top 150 plant-derived pharmaceuticals corresponded with traditional medical knowledge. 57

Furthermore, there is a very real concern that biopiracy “delegitimizes the profound intellectual input of local farmers onto the improvement of plants.”58

Accusations of “biopiracy patents” are not new.59 The following examples of natural rubber, rosy periwinkle, and the Enola Bean Patent demonstrate how the term biopiracy is applied to different types of situations and has evolved throughout history. 60

These are only a few examples of the larger cultural clash that can result over the
exploitation of non-indigenous plant material. At its core, biopiracy “encapsulates a strong moral and ethical dimension, which is entrenched on the demise of cultural
linkages between communities and their assets, from which communities have contributed in nurturing and sustaining their assets.”

Natural Rubber

Authors often use the story of natural rubber as a famous example of possible
biopiracy, although the alleged taking does not include the taking of traditional
knowledge. 62 In the mid–1800s natural rubber was produced primarily from wild trees in the Amazon basin.63 During the Industrial Revolution, the value of this raw rubber grew as demand for it in Europe and North America rapidly increased.64 By 1876, Brazil controlled ninety-five percent of the global trade,65 and its Amazon River cities became “the centers of an extremely lucrative, near-global monopoly.” 66

To overcome the Brazilian monopoly, the British Royal Botanical Gardens sent a
botanist to collect Amazon seeds.67 The botanist collected over 70,000 rubber tree
seeds,68 which were used to establish rubber plantations in the British colony of Ceylon and other plantations in South East Asia.69 These British plantations “broke” the Brazilian monopoly on natural rubber,70 which eventually collapsed.71

This rubber “piracy” is still remembered in some parts of Brazil today.72

Rosy Periwinkle

The story of rosy periwinkle (Catharanthus roseus) is another example of alleged
biopiracy. The plant is found in Madagascar, and is the source of the two powerful
cancer fighting drugs vincristine and vinblastine.73 Both drugs were isolated, tested, and marketed by Eli Lilly beginning in the 1950s and, eventually, vincristine generated substantial profits for the company. 74 Madagascar did not profit from the development or sale of either of the drugs, while many authors have argued it should have.75

However, there is another perspective on the rosy periwinkle biopiracy story.

Despite concerns about the improper treatment of Madagascar, it is not clear if rosy
periwinkle is native to Madagascar or just first described there.76 Furthermore, while rosy periwinkle may have originated in Madagascar, it was naturalized in other parts of the world long before Eli Lilly studied it, and the first specimens used by Eli Lilly actually came from India.77 Today the rosy periwinkle is truly an international plant, as it is cultivated on all six continents and is integrated into folk healing traditions in countries as diverse as England, Vietnam, and Dominica.78

Also, while “indigenous and peasant communities strongly suggested bioactivity,”
the flower’s use as the source of a cancer drug was previously unknown and was
expensive for Eli Lilly to discover.79 Therefore, while numerous authors once argued
that Madagascar was unfairly denied revenues from Eli Lilly’s drugs, the rosy periwinkle story is now considered, “a weak case for those who argue that the pharmaceutical industry has reaped great profits by exploiting the ethnobotanical knowledge of particular nations . . . .”80

The Enola Bean Patent

A more recent example of possible biopiracy is the Enola bean. The alleged
“theft” of an indigenous resource began when an American executive, Larry Proctor,
traveled to Mexico and brought back a bag of yellow colored beans.81 In April of 1999, after two years of a selective breeding program using the beans, Proctor obtained a patent on the resulting beans.82 Proctor stated that these patented beans had a distinctively yellow color that held true across generations, and he named them Enola beans after his wife.83 While it was admitted that the Enola bean is a descendent from the traditional Mexican bean Mayacoba,84 it was argued that the Enola bean is unique.85

In Mexico, farmers have grown yellow colored beans since the Aztecs, and
agronomists registered the Mayacoba bean as a variety of the yellow bean in 1978.86

By the time of the Enola patent, Mexican farmers were exporting yellow beans, including Mayacoba, to the U.S., and annual sales in the U.S. were reported at about $50 million dollars.87

After the Enola bean patent was issued, Proctor monitored imports of Mexican
yellow beans.88 He believed that Mexican farmers were possibly infringing on the Enola patent by selling yellow beans to companies in the United States, and he stated that Mexican farmers were likely raising Enola beans and selling them as Mayacoba.89 At the request of his company, U.S. Customs officials stopped bean shipments from Mexico to search for any beans with the same color as Enola beans.90

Proctor also monitored U.S. sales of yellow beans. He filed suit against sixteen
small U.S. bean seed companies that sold Mexican yellow beans for infringing on the
Enola patent, also accusing them of illegally growing and selling Enola beans.91

Furthermore, he charged licensing fees of up to six cents a pound for the right to sell yellow beans in the United States.92 All of these actions had a large effect on the Mexican yellow bean industry.93 After the Enola bean patent was issued, Mexican export sales of yellow beans dropped over ninety percent, which had a severe economic impact on farmers in northern Mexico.94

The Enola bean patent was most controversial because a number of organizations
believed that the patent was improvidently granted.95 These organizations maintained
that despite its consistent yellow coloration, the Enola bean failed to meet the basic patent requirement of novelty over Mexican yellow beans and, therefore, the Enola bean was unpatentable.96

Less than a year after the Enola bean patent was issued, the Colombia-based
International Center for Tropical Agriculture (CIAT), with support from the Food and
Agriculture Association, filed a request for reexamination of the Enola bean patent.97

CIAT claimed it that maintained “some 260 bean samples with yellow seeds, and six
accessions [that were] ‘substantially identical’ to claims made in Proctor’s patent.”98

After several years of re-examinations, the U.S. Patent and Trademark Association
revoked the Enola Patent in April of 2008.99 Despite the ultimate invalidation of the Enola bean patent, opponents of the patent believe that the invalidation took too long to occur, and allowed “the owner of a flagrantly unjust patent to legally monopolize markets and destroy competition for close to half the 20-year patent term.”100 This inability of the U.S. patent system to quickly invalidate an improvidently granted patent is often cited as a failure of the U.S. patent system, and a concern for future “biopiracy patents.”101

Perhaps because the Enola bean patent is so often cited as a “biopiracy,” a few authors have wrote adamant defenses of the Enola bean patent while its validity was being determined.102

B. Acquiring a U.S. Patent

Patent law in the United States is grounded in the United States Constitution,
which gives Congress the power “to promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their
respecting Writings and Discoveries.”103

A patent grant gives the owner the right to exclude others “from making, using,
offering to sell, or selling the invention within the United States, or importing the invention into the United States.”104 In other words, the United States provides the inventor the right to exclude others from the invention for a limited period of time, so that the inventor has an economic incentive to disclose her invention; furthermore, in exchange for a patent, the inventor provides the public with the knowledge of how to create the invention in her patent application.105

Section 101 of the Patent Act defines patentable subject matter as:

Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefore, subject to the
conditions and requirements of this title. 106

The Supreme Court has determined that the wide language of this section means
that “Congress plainly contemplated that the patent laws be given wide scope.” 107

While the patent laws do give “a wide scope” as to what is patentable, there are limits, and the court has provided three specific exceptions.108 Laws of nature, physical phenomena, and abstract ideas are not patentable.109 The Court has noted that while these exceptions are not clearly stated in the text, “these exceptions have defined the reach of the statute as a matter of statutory stare decisis going back 150 years.”110

Determinations of patentability can be subtle and sometimes appear contradictory.
For instance, while discoveries that are “only some of the handiwork of nature” have
been held not patentable,111 a bacterium was held patentable because it had
“markedly different characteristics from any found in nature” and had “the potential for significant utility.”112 Even if a discovery meets the requirements of § 101 of the Patent Act, in order for it “to receive patent protection, [it] must be novel, § 102, nonobvious, § 103, and fully and particularly described,
§ 112.”113 These requirements are thought to “serve a critical role in adjusting the tension . . . between stimulating innovation by protecting inventors and impeding progress by granting patents when not justified by statutory design.” 114

Still, the United States’ patent law has been criticized for impeding progress by
not sufficiently recognizing already existing traditional knowledge known in other
countries. United States patent law explicitly prohibits the patenting of an invention when another inventor has already “patented or described [the invention] in a printed publication in this or a foreign country,” however, United States patent laws only prohibit the patenting of an “invention known or used by others in this country.”115 Therefore, United States patent law does not explicitly prohibit the patenting of an invention known or used by others in a foreign country and, subsequently, has been criticized for not recognizing other countries’ traditional knowledge that has not been published.116 Still, the United States has policy reasons for using this language.117 However, this omission of non-recorded knowledge of inventions known in other countries is different from what most other countries require.118 Additionally, arguments that controversial patents are
valid because previous knowledge of the invention in a foreign country was not published incite further criticism of United States patent law.119

As outlined below, United States patents for genes, plants, and seeds are also
controversial,120 but U.S. patent law has developed in such a way that all three are
currently patentable in at least some form. However, as outlined below, there have been challenges to the future patentability of genes, plants, and seeds, and such challenges have implications for future controversies that are similar to the SbMATE controversy.

U.S. Plant Patents

The United States Plant Patent Act of 1930121 introduced a type of patent
specifically for plants known as a “plant patent.”122 These patents protect developers of new varieties of asexual propagated plants,123 such as apple trees and rose bushes.124

Because plant patents can only be issued for asexually-propagated plants, they are limited in scope. Furthermore, the patent rights derived from such patents are limited to “plants that are asexually reproduced from the patentee’s plants . . . [so that] independent creation is a valid defense.”125 Allowing independent creation as a valid defense against patent infringement is an unusual limitation on the rights of the patent holder, as most patent holders can pursue infringement actions against anyone who uses the patented invention, even if the alleged infringer created the invention independently.

In 1970, the United States Plant Variety Protection Act126 (“PVPA”) established
plant variety protection certificates issued by the United States Department of
Agriculture.127 These certificates give developers of new varieties of seed-propagated plants patent-like rights, although they cannot be granted for first generation hybrid plants.128 The certificates confer to a breeder the right to prevent others from selling, reproducing, importing, or exporting a plant, and the right to stop others from producing a hybrid or different variety of the plant.129 They provide protection for slightly longer than a patent; plant variety protection certificates provide protection for twenty years from the date of issuance, instead of the standard patent protection term of twenty years from the date of filing.130 The certificates are limited in scope because there is an
exception from infringement liability for experimentation using a protected variety.131

Also, farmers may legally save seeds from protected varieties and use these seeds in the production of crops without infringement.132

In 1985 in Ex parte Hibberd,133 the Board of Patent Appeals and Interferences
held that a variety of maize was patentable, despite initial rejections that the subject matter was beyond the scope of 35 U.S.C. § 101 and ought to be protected under the Plant Patent Act or the Plant Variety Protection Act.134 Since this case was decided, it has been cited for the proposition that utility patents can be issued on plants, in spite of other intellectual property protections available to inventors of such plants by the Plant Patent Act and the Plant Variety Protection Act.135

Subsequently, in 2001, in J.E.M. Ag Supply v. Pioneer Hi-Bred International,136
the Supreme Court affirmed the patentability of sexually reproducing hybrid plants, even if they are not genetically modified.137 In J.E.M, the Supreme Court also held that breeders had the right to obtain “dual protection” for new breeds of plants under both the PVPA and the Patent Act.138

These cases are significant. They increased the methods of protection available
for some types of plants, and gave some inventors a range of options not generally
available to patent holders. While most inventions can only be protected by a single
patent, transgenic plant holders can chose to apply for multiple patents or to not use any patents.

Generally, inventors prefer to protect transgenic plants with utility patents
because “the utility patent can apply to the method used to engineer a plant, the genetic sequences that are inserted, and the plant that results.”139 In contrast, plant patents protect “only a single plant or genome”140 and do not provide protection against independently created plants.141 Also, while plant patents and plant variety protection certificates can prevent only the unlawful proliferation of a variety and cannot prevent the use of plant materials for breeding purposes, utility patents can both prevent seed increases by reproduction of the same variety and protect breeders from unauthorized use of protected plant varieties for breeding and research.142 The same plant may be protected by both a utility patent and a plant patent,143 and a plant variety protection certificate.144

U.S. Gene Patents

Patents on genes are not generally allowed until a DNA product has been isolated
and purified.145 Patents on such isolated and purified products prevent others from
“mak[ing], us[ing], offer[ing] to sell, or sell[ing] [patented genes] within the United States, or import[ing] [patented genes] into the United States.”146

Biotechnology companies argue that genes, plants and seeds should be patentable so that companies will have enough confidence to invest the time and money necessary to develop such products.147

Still, a recent district court ruling held patents for isolated DNA containing breast cancer susceptibility genes invalid.148 This district court noted that “[i]n light of DNA’s unique qualities as a physical embodiment of information, none of the structural differences . . . between native . . . DNA and the isolated . . . DNA claimed in the patentsin-suit render the claimed DNA ‘markedly different,’”149 and that “the time may come when the use of DNA for molecular and diagnostic purposes may not require purification.”150 The district court further noted that “Supreme Court precedent has established that products of nature do not constitute patentable subject matter absent a change that results in the creation of a fundamentally new product.”151

This decision has led to questions about other patents on human genes, which has
led to doubt about a larger number of U.S. patents, as over 40,000 patents on 2,000
human genes are said to exist.152 The language of the decision also questions the
patentability of other types of genes, as much of the logic regarding the patentability of human genes applies to the patentability of genes in general.153

The district court’s decision has been criticized for relying on older cases and
failing to cite relevant Federal Circuit cases.154 However, the decision may be indicative of a new trend. Soon after the decision, the Department of Justice submitted a friend-of-the-court brief that contradicted the long-standing stance of the PTO and stated that genes should not be eligible for patents because they are a product of nature.155

Ultimately, the patentability of genes remains a controversial subject.156 Despite
its brief, the government suggested that changing gene patent laws “would have limited impact on the biotechnology industry because man-made manipulations of DNA, like methods to create genetically modified crops . . . could still be patented.”157

C. International Patent Law

International patent law has been significantly influenced by the U.S. Supreme
Court decision in Diamond v. Chakrabarty,158 which held that a live, human-made microorganism is patentable subject matter.159 International gene and plant patenting has also been affected by international trade and patent harmonization agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the General Agreement on Trade and Tariffs (GATT), and the North American Free Trade Agreement (NAFTA).160 In both the developed and developing countries that signed these agreements, “genes . . . are considered patentable material if they meet general patent criteria and are demonstrated to be new creations (e.g., artificial genes) or are isolated from nature and identified . . . and shown to have a particular function and use.”161

While TRIPS does not require plant patents, it specifically requires the protection
of plant varieties “either by patents or by an effective sui generis system or by any combination thereof.”162 The term “sui generis” is not well defined and its meaning is debated.163 It is generally thought that it “enables member countries to design their own system of protection for plant varieties” if they do not issue plant patents; however, it is not clear what is sufficient to qualify as a “sui generis system.”164

The TRIPS agreement also did not define “invention.” The United Nations has
noted that this exclusion allows WTO “member countries relatively free to draw the line between patentable ‘discoveries’ and actual inventions in the patent field,”165 thereby preserving some autonomy for WTO member countries as they implement their patent laws.

Still, many WTO member countries have changed their patent laws to conform to
the TRIPS agreement because, as member countries, they are bound to adhere to
TRIPS.166 For example, prior to joining TRIPS, the Indian patent system followed the
1970 Indian Patent Act, which prevented patent claims for “substances intended for use, or capable as being used as food or medicine or drug.”167 This patent exception was broad and the Indian Patent Act defined food as “any article of nourishment.”168

However, the India patent system changed after India joined WIPO and had to comply
with the TRIPS agreement. Patents are now granted for seeds, plants, micro-organisms, cells and even [genetically modified] organisms and animals.”169 Similarly, it is argued that prior to Australia, Canada, and Ireland joining WIPO, attempts by agribusiness to introduce legislation similar to TRIPS were rebuffed in all three countries.170

In fact, Australian patent laws have changed to such an extent that, like the U.S,
Australia now allows inventors to patent individual plant varieties.171 While plant
varieties are not patentable in many European countries, a plant characterized by a
particularly gene, instead of by its genome, is patentable in most of Europe.172

Furthermore, in much of Europe, transgenic plants are patentable only if they are not restricted to a specific plant variety but represent a broader plant grouping.173 In the past, developing countries have responded with attempts “to restrict and even prohibit the patenting of plants.”174

The issuance of intellectual property rights over genetic material in native species
has been defended for two reasons. It has been argued that:

[i]n addition to more fairly distributing the gains from recombinant genetic
products based on those species, it . . . also gives[s] developing countries
an incentive to protect rainforests and other genetically rich areas . . . the
granting of property rights over a resource can be expected to lead to more
efficient use of a resource.175

In 1993, the landmark Convention for Biological Diversity (CBD) Treaty went into force, which attempted to address global biodiversity conservation.176 The CBD
Treaty is dedicated to the objectives of conservation of biological diversity, sustainable use of the components of biological diversity, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.177 This third objective acknowledges the concerns of developing countries, and the CBD Treaty “recognizes the sovereign rights of states to determine through national legislation the conditions for access to the biological resources in their territories.”178

Recently, developing countries have attempted to alter the TRIPS patent requirements in order to address biopiracy concerns, although these attempts are unlikely to be successful.179 One recently proposed amendment suggested a requirement that patent applications that “use or are based upon genetic resources or traditional knowledge disclose the source, as well as the country of source.”180

Another proposed amendment to TRIPS would require that patent applications “must include evidence of prior informed consent of any materials used from another country and satisfaction of the [Convention of Biological Diversity] mandate that access to genetic resources be subject to prior informed consent . . . .”181

Neither of these amendments is likely to be successful for many reasons, including the fact that amendments to TRIPS require broad consensus among WTO members, and that such proposals have little support among Western countries.182

Developing countries have attempted more local reform as well. Against a movement toward broader international intellectual property regimes, developing countries have implemented national systems to regulate use of their own indigenous plants and knowledge. For example, in 1999 the Indian government created an online database of documented traditional knowledge in response to concerns that traditional knowledge was being “misappropriated in the form of patents on non-original innovations.”183 The government specifically cites concerns about patents on inventions that use Indian plants such as basmati rice, hoodia, and kava, and the government’s desire to prevent such “bio-prospecting” patents in the future.184 It is hoped the database will break “the format and language barrier and mak[e traditional knowledge] accessible to patent examiners at International Patent Offices for the purpose of carrying out search and examination.”185

SbMATE and the African Perspective

In spite of the ongoing controversy regarding the patentability of genes and
plants, at least some of the claims in the SbMATE patent are likely to remain valid even if gene patents and general plant patents are held invalid. The SbMATE patent claims include not only isolated and recombinant DNA sequences and a transgenic seed and plant, but also a method of producing the genetically transformed plant.186 Such transgenic organisms and methods for their production are unlikely to be invalidated as unpatentable subject matter.187

The continued patentability of transgenic organisms and methods of their production is discouraging to many Africans. Africans are concerned that biopiracy is costing Africa a lot of benefits.188 There is a general sentiment that “the existing system
of intellectual property rights and patents does not accommodate non-western systems of knowledge ownership and access.”189 There is also a concern that the system treats “knowledge as a commodity owned by an individual or company with the goal of trade.”

Furthermore, there is concern among “scholars, activists, and indigenous peoples [] that the patent system has not been sensitive to the dignity, rights and worldviews of indigenous and traditional people.”190

Western intellectual property protections have been criticized because developing
countries must pay a high price for patented products that are reintroduced into their countries while simultaneously being unable to use the “intellectual property framework to protect against the piracy of their own indigenous and local resources and knowledge.”191 Patents are accused of reflecting “the arrogance of Western
civilization.”192 Another complaint is that the “creativity, ingenuity and invention which an efficient patent system should nurture and encourage is being undermined by patents that are creating patent thickets so dense that they are adding costs to medical and scientific research and, in some instances, hindering it all together.”193

In 2000, in response to such concerns and in accordance with the CBD Treaty, the
African Union formally endorsed legislation that sought to protect biological resources “including agricultural genetic resources by requiring, among other things, that ‘any access to any biological resources . . . shall be subject to application’ and refused to recognize any patent for life forms of biological processes.”194 This legislation, known as the Law on the Rights of Local Communities, Farmers, Breeders and Access, attempts to “provide[] a framework for the recognition of the innovative and creative efforts of African societies.” 195

The law still exists as a model law, although it has not been formally adopted.196

This type of model law is unlikely to be adopted in African countries, such as Tanzania, because they are members of the World Trade Organization197 and, therefore, must adhere to minimum intellectual property standards under TRIPS.198

Still, there is an ongoing concern that patents that claim living organisms and
genes, such as the SbMATE patent, are patents for discoveries of nature, and as such
should not be patentable.199 It is argued that the TRIPS requirement of a minimum,
uniformly applicable intellectual property standard, “is a reflection of the trends in economic globalization, which promotes a private profit oriented approach within an economic and proprietary framework” that will result in “dire consequences for countries in the South.”200 Additionally, critics argue that the TRIPS requirement “of patenting of life forms and biodiversity will erode the sovereign power of [] Third World [countries]”, such as Tanzania, “to their resources and will generate ethical problems to the patenting of life.” 201

III. THE “INTERNATIONAL SEED TREATY”

The International Treaty on Plant Genetic Resources for Food and Agriculture
(ITPGRFA),202 popularly known as the International Seed Treaty, and hereinafter
referred to as such, went into force in June of 2004.203 Its aims include:

[R]ecognizing the enormous contributions of farmers to the diversity of
crops that feed the world; establishing a global system to provide farmers, plant breeders and scientists with access to plant genetic materials; [and]
ensuring that recipients share benefits they derive from the use of these
genetic materials with the countries where they have been originated.204

The International Seed Treaty was fostered by the Food and Agricultural
Organization (FAO) of the United Nations, and the Treaty remains under its control.205

The FAO encouraged the Treaty because of “unease about intellectual property regimes
that reward formal breeders while ignoring the contributions . . . of farmers to the
development and conservation of the very plant genetic sources on which breeders
depend.”206 The FAO maintains that genetic resources have a lot of value and that in the last thirty years more than three-quarters of increased crop productivity is the result of breeding.207

The Treaty provides “a strong and elaborate shape to the concept of farmers’ rights.” Furthermore, the Treaty is consistent with the theory that “the ownership
approach is simply contrary to communities’ traditional ways of life, which promote the common ownership of their [traditional knowledge] associated with their seeds . . . .”208

The Treaty sets up a Multilateral System from which resources can be obtained
for use and conservation in research, breeding, and training.209 If a commercial product is developed using resources from the multilateral system and may not be used without restriction by others for further research and breeding, the Treaty provides for payment of an equitable share of the resulting monetary benefits.210

If a product is developed that others may use without restriction, payment is considered voluntary.211

Much of the Treaty is about the germoplasm collection of Consultative Group on
International Agricultural Research (CGIAR)’s Future Harvest Centers. This
germoplasm collection is thought to contain about 560,000 accessions of crop diversity and is considered invaluable because it contains diverse farmers’ landraces212 and local varieties, and they are held in trust for the international community.213 The treaty calls upon International Agricultural Research Centers (IARCs) of CGIAR to “sign agreements with the Governing Body with regard to such [] collections.”214 A large amount of this material and other regional collections are placed into the International Network.215

Sorghum is included under the list of Food Crops covered by the treaty.216 It is
listed as a food crop that falls under the Multilateral System, which “include[s] all plant genetic resources for food and agriculture . . . that are under the management and control of the Contracting Parties and in the public domain.”217 The Treaty further states that “Contracting Parties also agree to encourage natural and legal persons within their jurisdiction who hold plant genetic resources for food and agriculture listed in [the Treaty] to include such plant genetic resources . . . in the Multilateral System.218

The International Seed Treaty came into effect on June 29, 2004, and there are
now 127 parties to the Treaty.219 Of the countries involved in the SbMATE controversy, Brazil was the first to sign the Treaty on June 10, 2002 and further ratified it on May 22, 2006.220 The United States of America was second to sign on November 1, 2002.221

Tanzania did not accede to the International Seed Treaty until April 30, 2004.222
The International Seed Treaty has been criticized because it does not clarify what
enforcement procedures will be used to ensure that farmers’ rights will be respected223 or even how benefits from the commercial use of the genetic materials will be shared.224

The treaty itself advocates arbitration between contracting parties for the settlement of disputes.225

IV. ANALYSIS TO DETERMINE IF THE UNITED STATES DID VIOLATE THE INTERNATIONAL SEED TREATY

Defenders of Tanzania’s right to the SbMATE patent contend that the patent and
attempts to license the patent contradict the goals of the treaty.226 Indeed one of the aims of the treaty is stated to be “ensuring that recipients share benefits they derive from the use of these genetic materials with the countries where they have been originated.”227

However, as has been noted by other authors, it is difficult to claim that the
SbMATE patent directly violated the International Seed Treaty. The SC283 sorghum
strain used in the invention of the SbMATE patent is available at a center, the
International Crop Research Institute for the Semi-Arid Tropics (ICRISAT), under the
label of Msumbiji or SB117.228 This center supplies germoplasm under agreement with
the FAO’s International Seed Treaty,229 so any material acquired through the center
would be subject to the International Seed Treaty’s rules. Therefore, if the researchers who invented the SbMATE patent innovation had used SC283 sorghum from the center, they would have broken the Treaty’s requirement that “recipients share benefits they derive from the use of these genetic materials with the countries where they have been originated.”230 The SbMATE patent would also have violated Article 12.3.d that “recipients shall not claim any intellectual property or other rights that limit the facilitated access to the plant genetic resources for food and agriculture, or their genetic parts or components . . . .”231

However, the ICRISAT center is unlikely to have been the source of the material
used to obtain the SbMATE patent. Instead, Texas A & M is thought to have held
samples of SC283 long before the International Seed Treaty was ratified, and there is no evidence that the Texas A & M sorghum line came from any Center subject to the
International Seed Treaty.232 Hence statements that “governments . . . ignore [the
International Seed Treaty] provisions, pillag[e] the coffers of CGIAR and sell[] them to Dow Chemical and other wealthy country concerns” 233 are inaccurate and misleading exaggerations.

While the International Seed Treaty predates both the U.S. patent and the PCT
application, neither falls under the authority of the International Seed Treaty, for neither encompasses material covered by the Treaty. However, it is worth noting that while the SbMATE patent and the PCT application may not directly violate the Treaty, they do appear to create the type of problem that the International Seed Treaty was designed to address.

As earlier noted, the FAO encouraged the Treaty because of “unease about
intellectual property regimes that reward formal breeders while ignoring the contributions. . . of farmers to the development and conservation of the very plant genetic sources on which breeders depend.”234 While statements such as, “permitting the SbMATE patent to stand and for the private sector to profit from it, would signal a new open hunting season on privatization of the vast collection of farmers’ varieties of food crops held by the CGIAR” are inaccurate, they do demonstrate how farmers in developing countries feel misled and unprotected by the Treaty.

There is a sentiment that “the genius of African farms is locked up in the vaults of
the CGIAR,”235 and that while the International Seed Treaty may not protect the plants used by Tanzanian farmers from being used to make the SbMATE patent, it should. At its center, biopiracy “encapsulates a strong moral and ethical dimension, which is entrenched on the demise of cultural linkages between communities and their assets, from which communities have contributed in nurturing and sustaining their assets.”236

Therefore, even if the SbMATE patent is proven not to violate the International Seed
Treaty, concerns about the SbMATE patent are likely to continue.

V. CONCLUSIONS

A. Outlook

Ethical concerns about patents, as well as concerns about the threat of patents to
biodiversity,237 are likely to continue in spite of the International Seed Treaty. Similar to the plant lines used in the SbMATE patent, any plant lines that have already been acquired will not be covered under the International Seed Treaty.238 Therefore, it is likely that there are other germoplasms that are listed among the 560,000 accessions of crop diversity available in CGIAR239 that were also acquired outside of the CGIAR regime and may be patented despite the International Seed Treaty.

In spite of these problems, the International Seed Treaty has been credited with
“providing access to, as well as the conservation and sustainable use of, plant genetic resources on the one hand and the fair and equitable sharing of benefits derived from their use on the other.” 240 Presumably the Treaty will become more important over time, as plants subject to the Treaty are used to develop further innovations in agriculture and medicine.

In the meantime, there are other proposed improvements to intellectual property
systems intended to provide additional protection for developing countries’ genetic
resources.241 For example, there are suggestions for developing more sui generis systems of intellectual property, which are thought to be a more “fair” way to protect genetic sequence rights.242 Another proposed improvement is having more developing countries adopt the Indian Traditional Knowledge Digital Library model, which lists online the known uses of indigenous plants by developing countries, to prevent the issuance of new patents for previously known uses of plants.243

In addition to the protection provided by proposed improvements to intellectual
property laws, it is hoped that over time intellectual property systems in both developing and developed countries will become more advanced so that they provide better and more clear protection of genetic resources in general.244 It is also hoped that intellectual property systems will be more effective at protecting developing countries’ rights, after there is an increased understanding in developing countries of how intellectual property systems work and more people are taught how to use such systems to their advantage.245

B. Lessons Learned

As the historical examples of “biopiracy” have shown, determinations of biopiracy are not easy, and intellectual property systems are generally not well suited for
making such determinations. In fact, patent systems in particular are not usually
designed to address problems of “theft” of indigenous resources, and systems that are designed to address such concerns are often distinct from intellectual property systems.

When alleged “biopiracy patents” occur, generally the problem is a failure to create
protections against the taking of indigenous material, the failure to adequately publicize traditional knowledge,247 or the failure to properly reward cultures for the use of their indigenous material. The problem is usually not that an intellectual property system granted a patent per se. For example, while the United States patent system may be criticized for allowing patents on inventions that are known, but not described in published material in foreign countries, generally in objectionable cases such knowledge is either known in the United States, published somewhere or fails to meet the nonobvious requirement.248 Therefore, most biopiracy analysis should be determined without implicating intellectual property systems, particularly patent systems, and should instead focus primarily on the original “taking” and use of indigenous material.

For example, in the case of the possible biopiracy of Brazilian natural rubber, no
intellectual property rights were involved, let alone patent rights.249 Still, many authors have argued that the rubber was “biopirated.” In the case of the Enola beans, a patent was issued in spite of biopiracy concerns, although it was eventually invalidated250 because the beans were considered obvious; intellectual property law does not reward inventions that are simply “takings.”251 Finally, in the case of the rosy periwinkle the “invention” was not taken directly from an indigenous country and was in fact novel, so the patent should be valid.252 Although the SbMATE patent involves a more obvious “taking” from an indigenous country than the rosy periwinkle did, the “invention” is also treated as a “novel” invention, and as such is considered patentable.

While there are increasingly greater protections for developing countries’ resources, disagreements similar to the SbMATE controversy will continue. Intellectual property law, particularly in the United States, has accepted genetically modified plants as novel and patentable inventions.253 While genetically modified plants may use traits from other plants, patents are granted to incentivize the work and skill that is required to create genetically modified plants and to incentivize the release of information to the public about how to create the genetically modified plant.254 Researchers already have strains of many plants from around the world and will undoubtedly use these plants to create genetically modified plants. Countries such as the United States will continue to
grant patents on these genetically modified plants as long as such patents conform to patent laws.

International intellectual property systems have largely followed the U.S. example
that living organisms are patentable.255 Like all other countries, developing countries are required to adopt WIPO intellectual property protection requirements if they wish to join the WTO.256 For better or worse, this mandate limits how developing countries may approach intellectual property.

While patent laws may change so that patents can no longer be granted for genes
and for some types of plants, patents that cover genetically modified plants, such as the SbMATE patent, are likely to continue. There are undoubtedly critics who believe that plants should never be patentable, critics who believe that intellectual property laws should not incentivize the creation of genetically modified plants, and critics who believe that patents should never be obtained on inventions that use material from a foreign country without the foreign country’s permission. However, most patent laws are created to incentivize broad innovation and are not designed to meet these particular objectives.

Furthermore, the International Seed Treaty was not designed to completely
address any of these concerns. The Treaty was never designed to encompass or address
all past takings, and it is not clear where in history “the biopiracy clock” should start.

Since plants such as the rosy periwinkle now exist throughout the globe,257 tracing their “theft” is impossible. Indeed, it is almost equally impossible to determine when all the strains of plants like SC283 sorghum were taken from their indigenous countries.

Moreover, any intellectual property system that does address these concerns will appear radically different from the system currently in place.

Under current intellectual property law, the SbMATE patent represents American
ingenuity, and not the “looting” of a Tanzanian resource. While the use of the SC283
sorghum line must appear to some Tanzanians much like the theft of the Elgin marbles
from Greece, there is no complete system in place to compensate developing countries
for any use of their indigenous plants in the creation of new patentable inventions. The International Seed Treaty attempts to remedy these problems in the future and reward those farmer cultures that developed useful plants like SC283 sorghum. It does not seek to correct all past “takings.” Therefore, the International Seed Treaty does not address potential problems caused by the SbMATE patent. In addition, for the foreseeable future patents accused of being “biopiracy patents,” such as the SbMATE patent, are likely to remain valid.