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are waiting to see it written into a document with legal force, and are reiterating calls for the Resolution to be repealed instead.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.

sedition

In law, sedition is overt conduct, such as speech and organization, that is deemed by the legal authority to tend toward insurrection against the established order. Sedition often includes subversion of a constitution and incitement of discontent (or resistance) to … Continue reading

In law, sedition is overt conduct, such as speech and organization, that is deemed by the legal authority to tend toward insurrection against the established order. Sedition often includes subversion of a constitution and incitement of discontent (or resistance) to lawful authority. Sedition may include any commotion, though not aimed at direct and open violence against the laws. Seditious words in writing are seditious libel. A seditionist is one who engages in or promotes the interests of sedition.

Typically, sedition is considered a subversive act, and the overt acts that may be prosecutable under sedition laws vary from one legal code to another. Where the history of these legal codes has been traced, there is also a record of the change in the definition of the elements constituting sedition at certain points in history. This overview has served to develop a sociological definition of sedition as well, within the study of state persecution.

The term sedition in its modern meaning first appeared in the Elizabethan Era (c. 1590) as the “notion of inciting by words or writings disaffection towards the state or constituted authority”. “Sedition complements treason and martial law: while treason controls primarily the privileged, ecclesiastical opponents, priests, and Jesuits, as well as certain commoners; and martial law frightens commoners, sedition frightens intellectuals.”

In 1798, President John Adams signed into law the Alien and Sedition Acts, the fourth of which, the Sedition Act or “An Act for the Punishment of Certain Crimes against the United States” set out punishments of up to two years of imprisonment for “opposing or resisting any law of the United States” or writing or publishing “false, scandalous, and malicious writing” about the President or the U.S. Congress (though not the office of the Vice-President, then occupied by Adams’ political opponent Thomas Jefferson). This Act of Congress was allowed to expire in 1801 after Jefferson’s election to the Presidency.

Political cartoon by Art Young, The Masses, 1917.

In the Espionage Act of 1917, Section 3 made it a federal crime, punishable by up to 20 years of imprisonment and a fine of up to $10,000, to willfully spread false news of the American army and navy with an intent to disrupt their operations, to foment mutiny in their ranks, or to obstruct recruiting. This Act of Congress was amended Sedition Act of 1918, which expanded the scope of the Espionage Act to any statement criticizing the Government of the United States. These Acts were upheld in 1919 in the case of Schenck v. United States, but they were largely repealed in 1921, leaving laws forbidding foreign espionage in the United States and allowing military censorship of sensitive material.

In 1940, the Alien Registration Act, or “Smith Act“, was passed, which made it a federal crime to advocate or to teach the desirability of overthrowing the United States Government, or to be a member of any organization which does the same. It was often used against Communist Party organizations. This Act was invoked in three major cases, one of which against the Socialist Worker’s Party in Minneapolis in 1941, resulting in 23 convictions, and again in what became known as the Great Sedition Trial of 1944 in which a number of pro-Nazi figures were indicted but released when the prosecution ended in a mistrial. Also, a series of trials of 140 leaders of the Communist Party USA also relied upon the terms of the “Smith Act”—beginning in 1949—and lasting until 1957. Although the U.S. Supreme Court upheld the convictions of 11 CPUSA leaders in 1951 in Dennis v. United States, that same Court reversed itself in 1957 in the case of Yates v. United States, by ruling that teaching an ideal, no matter how harmful it may seem, does not equal advocating or planning its implementation. Although unused since at least 1961, the “Smith Act” remains a Federal law.

There was, however, a brief attempt to use the sedition laws against protesters of the Vietnam War. On October 17, 1967, two demonstrators, including then Marin County resident Al Wasserman, while engaged in a ‘sit in’ at the Army Induction Center in Oakland, Ca., were arrested and charged with sedition by deputy US. Marshall Richard St. Germain. U.S. Attorney Cecil Poole changed the charge to trespassing. Poole said, “three guys (according to Mr. Wasserman there were only 2) reaching up and touching the leg of an inductee, and that’s conspiracy to commit sedition? That’s ridiculous!” The inductees were in the process of physically stepping on the demonstrators as they attempted to enter the building, and the demonstrators were trying to protect themselves from the inductees’ feet. Attorney Poole later added, “We’ll decide what to prosecute, not marshals.”[25]

In 1981, Oscar López Rivera, a Puerto Rican Nationalist and Vietnam war veteran, was convicted and sentenced to 70 years in prison for seditious conspiracy and various other offenses. He was among the 16 Puerto Rican nationalists offered conditional clemency by U.S. President Bill Clinton in 1999, but he rejected the offer. His sister, Zenaida López, said he refused the offer because on parole, he would be in “prison outside prison.” López Rivera is said to be “among the longest held political prisoners in the history of Puerto Rico and in the world.” He has been jailed for 32 years, 8 months, and 24 days.[26]

In 1987 fourteen white supremacists were indicted by a federal grand jury on charges filed by the U.S. Department of Justice against a seditious conspiracy between July 1983 and March 1985. Some alleged conspirators were serving time for overt acts, such as the crimes committed by The Order. Others such as Louis Beam and Richard Butler were charged for their speech seen as spurring on the overt acts by the others. In April 1988, a federal jury in Arkansas acquitted all the accused of charges of seditious conspiracy.[27]

On October 1, 1995, Omar Abdel-Rahman and nine others were convicted of seditious conspiracy.[28]

Laura Berg, a nurse at a U.S. Department of Veterans Affairs hospital in New Mexico was investigated for sedition in September 2005[29] after writing a letter[30][31] to the editor of a local newspaper, accusing several national leaders of criminal negligence. Though their action was later deemed unwarranted by the director of Veteran Affairs, local human resources personnel took it upon themselves to request an FBI investigation. Ms. Berg was represented by the ACLU.[32] Charges were dropped in 2006.[33]

On March 28, 2010, nine members of the Hutaree militia were arrested and charged with crimes including seditious conspiracy.

Sedition is a punishable offense under Article 94 of the Uniform Code of Military Justice.

Volksverhetzung (“incitement of the people”) is a legal concept unique to Germany. It is sometimes loosely translated as sedition,[36] although the law bans the incitement of hatred against a segment of the population. Segment of the population meaning, for example, a race or religion.

 

the Disposition Matrix

July 11, 2014

Just a few weeks ago, during a commencement address to West Point’s graduating cadets, President Obama spoke to the importance of greater transparency “about both the basis of our counter-terrorism actions and the manner in which they are carried out.”
President Obama also made similar comments about drone transparency last year, but the Obama administration hasn’t yet matched the president’s words with action by publicly disclosing meaningful information about its targeted operations and its use of drone strikes.
The U.S. secret drone war is damaging our reputation abroad and arguably inspiring new terrorists instead of thwarting them. Human rights and civil rights groups have uncovered evidence of hundreds of civilian deaths unreported by the U.S. government in Iraq, Afghanistan, Yemen, Pakistan and Somalia.1,2 Our government must be transparent about whom it is targeting with drones, and why, in order to shed light on whether or not the U.S. government is violating international law.
Even CIA Director John Brennan has said, the United States “need[s] to acknowledge publicly” any mistaken killings and should “make public the overall numbers of civilian deaths resulting from U.S. strikes targeting al-Qa’ida.”
With the Obama administration currently considering the use of drone strikes in Iraq, which would undoubtedly lead to civilian casualties, now is the perfect time to demand transparency on the civilians killed by previous U.S. drone strikes abroad.
The public has an inalienable right to know whom their government is targeting and at what collateral cost. Now is the time to have a national conversation about the U.S. drone strike program and to demand far greater transparency from the Obama administration.
Thank you for your support.
Rick Rosenthal, CREDO Activist
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  1. Everything We Know So Far About Drone Strikes,” ProPublica, February 5, 2013
  2. The Toll Of 5 Years Of Drone Strikes: 2,400 Dead,” Huffington Post, January 23, 2014


Oct 27 2013, 9:55 AM ET

(The Atlantic) -Two new reports issued this week by Amnesty International and Human Rights Watch detailed dozens of civilian deaths caused by drone strikes in Pakistan and Yemen. Classified documents obtained by the Washington Post suggest that CIA officials who carry out the strikes make little effort to track civilian deaths.
“There is a lot more pressure building” on President Barack Obama, Sarah Holewinski, head of the Center for Civilians in Conflict, a group pushing for greater transparency in drone strikes, told me this week. “He’s going to have to look at these legal questions.”


There is a serious terrorist threat to the United States. The administration is under enormous pressure to prevent attacks. But there are ways to safeguard the United States without sparking such a serious backlash abroad and at home.
Holewinski called on the Obama administration to implement its promise to move command of drone operations from the CIA to the American military. She said the shift, which Obama announced this spring, is going “very, very slowly.”
Military control is one step toward a key goal: greater transparency in countries where drone strikes are enormously unpopular. Keeping the drone strikes as a covert CIA-run program makes accountability and determining the true number of civilian deaths impossible, she said.
If strikes are commanded by the military and disclosed publicly, reports of civilian casualties could be investigated under military law and compensation paid to victims — as now happens in Afghanistan.
Holewinski also urged the administration to disclose targeting rules that it has refused to make public. How are civilians defined? And how are civilian casualties assessed? What is the legal definition of an individual who can be targeted?
She credited the administration for a decrease in drone strikes since Obama promised one in May. But, she insisted, the targeting process needs to be far more transparent.


The secrecy veiling Obama’s drone war

By Daphne Eviatar
January 4, 2013

It’s rare for a judge to express regret over her own ruling.  But that’s what happened Wednesday, when Judge Colleen McMahon of the U.S. District Court for the Southern District of New York reluctantly ruled that the Obama administration does not need to provide public justification for its deadly drone war.

The memos requested by two New York Times reporters and the American Civil Liberties Union, McMahon wrote, “implicate serious issues about the limits on the power of the Executive Branch under the Constitution and laws of the United States, and about whether we are indeed a nation of laws, not of men.” Still, the Freedom of Information Act allows the executive branch to keep many things secret.
In this case, McMahon ruled, the administration’s justifications for the killing of select individuals — including American citizens — without so much as a hearing, constitute an internal “deliberative process” by the government that need not be disclosed.
McMahon did not hide her disappointment. “The Alice-in-Wonderland nature of this pronouncement is not lost on me,” she wrote, “but after careful and extensive consideration, I find myself stuck in a paradoxical situation in which I cannot solve a problem because of contradictory constraints and rules – a veritable Catch-22.” She explained, “I can find no way around the thicket of laws and precedents that effectively allow the Executive Branch of our government to proclaim as perfectly lawful certain actions that seem on their face incompatible with our Constitution and laws, while keeping the reasons for their conclusion a secret.”
The judge’s lament may have, in part, been induced by the striking discord between the looking-glass world in which she found herself, and the hopes that President Barack Obama had first generated for a newly transparent government.
That continued once he was in office. In a Dec. 29, 2009 executive order, Obama said: “Our democratic principles require that the American people be informed of the activities of their government.” He insisted “our nation’s progress depends on the free flow of information both within the government and to the American people.”
He sent an accompanying memo to the heads of all executive branch agencies:

“Transparency promotes accountability and provides information for citizens about what their government is doing. Information maintained by the federal government is a national asset.”

That was before Obama embarked on a secret, exponential expansion of the deadly drone war. Or at least, before most Americans were aware of it.
Since 2009, there have been more than 300 bombings by remote-controlled U.S. drones in Pakistan, Yemen and Somalia. During the entire Bush administration, there were just 51.
Thousands of people have reportedly been killed by the “unmanned aerial vehicles.”

Though U.S. officials claim the number of civilian deaths has been minimal, independent studies show otherwise. Ultimately, it’s impossible to know how many people have been killed, or who they were, because the government doesn’t release that information.
This all stands in stark contrast to the heady early days of the Obama presidency.
Back in 2009, overruling the objections of six former CIA directors, Obama released the legal memos created by the Bush administration to justify the use of torture and other “enhanced interrogation techniques” on suspected terrorists.
Today, he insists on hiding memos that justify the secret killing of suspected terrorists – and, as in the case of Anwar al-Awlaki, the killing of their children.
The government has made a point of saying that these killings were all lawful and justified, trotting out senior administration officials to make those claims in a series of speeches over the last two years.
As McMahon noted, “it is not surprising that the government feels somewhat defensive.” After all, “some Americans question the power of the executive to make a unilateral and unreviewable decision to kill an American citizen who is not actively engaged in armed combat operations against this country. Their concern rests on the text of the Constitution and several federal statutes, and is of a piece with concerns harbored by the Framers of our unique form of government.”
The ACLU has already vowed to appeal McMahon’s decision. But its success is far from certain.  It’s also unclear whether any court will ever require the government to release the memos documenting its legal rationale for these secret extrajudicial killings. McMahon’s decision, however, highlights why Obama should release them nonetheless.
Demands for the memos have been mounting ever since The New York Times first revealed that administration lawyers had documented their justification for the Awlaki killing in 2010.
Both U.S. citizens and foreign allies, whom the U.S. government strongly relies on in fighting its “war on terror,” have been skeptical of the program’s legality for years.  This has stymied intelligence-sharing with foreign governments, such as Germany, and infuriated local populations in Pakistan and Yemen, whose support is critical to defeating Al Qaeda and the Taliban.
It has also undermined Obama’s reputation — making it easier for critics to say he’s no better than his predecessor. It could even tarnish his legacy as a president, for he took office promising shiny reforms after a particularly dark chapter in U.S. history.
McMahon herself noted that there is no reason to believe at this point that releasing the memos would endanger national security, because any “intelligence sources and methods” could be redacted. On the contrary, explaining under what circumstances Washington believes targeted killing would be lawful could both quell critics’ claims of U.S. lawlessness and delineate the rules the United States wants other countries to follow.
To the extent that the memos reflect internal deliberations rather than the administration’s final decisions, the Justice Department can make that clear. Obama can also explain where U.S. policy stands now.
It would be a brave and principled move on Obama’s part. It would also go a long way toward developing global confidence that, despite past mistakes, Washington is waging its fight against terrorism in accordance with the rule of law.
If Obama instead continues to take refuge in the courts, he may be able to claim a minor legal victory. But the president will have lost a far more important battle.


In April of 2012, Saadiq Long, a 43-year-old African-American Muslim who now lives in Qatar, purchased a ticket on KLM Airlines to travel to Oklahoma, the state where he grew up. Long, a 10-year veteran of the US Air Force, had learned that the congestive heart failure from which his mother suffers had worsened, and she was eager to see her son. He had last seen his mother and siblings more than a decade ago, when he returned to the US in 2001, and spent months saving the money to purchase the ticket and arranging to be away from work.

The day before he was to travel, a KLM representative called Long and informed him that the airlines could not allow him to board the flight. That, she explained, was because the US Department of Homeland Security (DHS) had placed Long on its “no-fly list”, which bars him from flying into his own country.

Long has now spent the last six months trying to find out why he was placed on this list and what he can do to get off of it. He has had no success, unable to obtain even the most basic information about what caused his own government to deprive him of this right to travel.

He has no idea when he was put on this list, who decided to put him on it, or the reasons for his inclusion. He has never been convicted of any crime, never been indicted or charged with a crime, and until he was less than 24 hours away from boarding that KLM flight back to his childhood home, had received no notice that his own government prohibited him from flying.

As his mother’s health declines, he remains effectively barred from returning to see her. “My mother is much too sick to come visit me, as she has difficulty now even walking very short distances,” Long told me in an interview Sunday in Doha, the sleek, booming capital city of America’s close Gulf ally, where the former Senior Airman and Staff Sergeant has lived for several years.

“I don’t understand how the government can take away my right to travel without even telling me,” he said. What is most mystifying to him is that he has spent the last decade living and working, usually teaching English, in three countries that have been very close and compliant US allies: Egypt, United Arab Emirates, and now Qatar. “If the US government wanted me to question or arrest or prosecute me, they could have had me in a minute. But there are no charges, no accusations, nothing.”

As compelling as Long’s story is, it is extremely common. Last year in Washington, I met a 19-year-old Somali-American Muslim, born and raised in the US, who saved money from a summer job to purchase a ticket to travel for the first time to Somalia to visit family members he had never met. When he went to the ticket counter to check-in, he was informed that he was barred from flying and suffered the humiliation of having to return home with his luggage and then trying to explain to his employer, family and friends why he did not travel.

Like Long, that American teenager was never convicted or even charged with any crime, and was mystified and angry that his own government secretly placed him on this list, though he remains too afraid to speak out without anonymity. “I’m scared that if I do, it’ll only get worse,” he told me.

Like so many post-9/11 civil liberties abridgments aimed primarily at Muslims, this no-fly-list abuse has worsened considerably during the Obama presidency. In February, Associated Press learned that “the Obama administration has more than doubled, to about 21,000 names, its secret list of suspected terrorists who are banned from flying to or within the United States, including about 500 Americans.”

Worse, the Obama administration “lowered the bar for being added to the list”. As a result, reported AP, “now a person doesn’t have to be considered only a threat to aviation to be placed on the no-fly list” but can be included if they “are considered a broader threat to domestic or international security”, a vague status determined in the sole and unchecked discretion of unseen DHS bureaucrats.

But the worst cases are those like Long’s: when the person is suddenly barred from flying when they are outside of the US, often on the other side of the world. As a practical matter, that government act effectively exiles them from their own country. “Obviously, I can’t get to Oklahoma from Qatar if I can’t fly,” said Long. “Trying to take a boat would take weeks away from work just for the travel alone, and it’s not affordable. If I can’t fly, then I can’t go back home.”

Gadeir Abbas, a lawyer with the Council on American-Islamic Relations (CAIR) now working on Long’s case, told me:

“What is happening to Saadiq happens to American Muslims with alarming regularity. Every few weeks I hear of another Muslim citizen who cannot return to the country of which he is a citizen.

“It is as if the US has created a system of secret law whereby certain behaviors – being Muslim seems to be one of them – trigger one’s placement on government watch lists that separate people from their families, end careers, and poison personal relationships. All of this done without any due process.”

The ACLU has spent years challenging the constitutionality of the no-fly list in court. Representing 15 US citizens and permanent residents who have been placed on the list, , including four military veterans, the civil liberties group scored a possibly significant victory this June when the 9th Circuit of Appeals reinstated their lawsuit, which a lower court judge had dismissed, and allowed the case to proceed. ACLU lawyer Nusrat Choudhury, who argued the case, told me:

“The No Fly List bars thousands of people from commercial air travel without any opportunity to learn about or refute the basis for their inclusion on the list. The result is a vast and growing list of individuals who, on the basis of error or innuendo, have been deemed too dangerous to fly but who are too harmless to arrest. Some have been stranded abroad when they suddenly found themselves unable to board planes.

“None of these Americans have ever been told why they are on the No Fly List or given a reasonable opportunity to get off it. But, the Constitution requires the government to provide our clients a fair chance to clear their names.”

Long’s case is both typical yet particularly compelling. Strictly on humanitarian grounds, it is outright cruel to deny a person who has been convicted of no crime the ability to see his ailing mother.

Beyond the constitutional and humanitarian questions, Long was confounded by what seems to be the utterly irrational reasoning on which the no-fly list is based. As it bars him only from flying, he remains technically free to board a cruise ship to the US, one that would be filled with American civilians. Every US citizen has the constitutional right to enter the country, so he is technically free to visit the US or return there to live if he is able to get back, to visit crowded streets and shopping malls, to board trains, in essence to do anything but fly.

“It makes no sense, so it’s obvious this is meant as some kind of punishment, but for what?”, he asked. “If they are so afraid of me, they can just put a law enforcement agent on the plane to escort me back home.”

After learning he had been barred from flying, Long sought assistance from the US Embassy in Doha. “After many follow-up calls to the embassy,” he recounted, “they finally gave me ‘assistance’ in the form of the website to DHS and instructions to file a complaint.” On 15 May, he filed a formal complaint with DHS and received a so-called “redress control number” with a promise to review his case within 7-10 business days. Almost six months later, he is still in Doha waiting for an answer, still harboring hope that he will receive clearance to return home to visit his sick mother.

Abbas, the CAIR lawyer, told me: “It makes my stomach churn what the US does to American Muslims while they travel.” Unfortunately, he said, the political reality of this issue tracks the familiar pattern of Muslims being denied the most basic rights: “there is zero political will to alter the use of endless secret watchlists that terrorize the Muslim community and make none of us any safer.”

Abbas worked last year on the truly wrenching case of Gulet Mohamed, the then-18-year-old Somali-American who, while visiting Kuwait, was detained at the behest of the Obama administration, and beaten and tortured by Kuwaiti authorities while he was interrogated for two weeks. Once the Kuwaitis were done with him and wanted to release him, Mohamed – who, to date, has never been charged with any crime – faced a horrible dilemma: at some point when he was traveling, the US government placed him on a no-fly list, meaning that he could no longer stay in Kuwait, but also could not return to the US, stuck in lawless limbo.

When he was in Kuwaiti detention, Gulet was able to use a cell phone illicitly obtained by a fellow detainee, and his family arranged for him to call me and the New York Times’ Mark Mazzetti to recount his story. I spent an hour on the phone with him, and still vividly recall the terror and visceral fear of the American teeanger as he tried to understand why his own government first arranged for his detention and beating, and then barred him from returning to the country where he was born and had lived his whole life, even when the Kuwaitis were eager to release him. That is the tyranny of the no-fly list.

“Our litigation in Gulet Mohamed’s case seeks to establish what I think is the very modest proposition that the US cannot actively obstruct a citizen’s movement into the US from abroad,” said Abbas. As modest – and self-evident – a proposition as that is, it is one the US courts have not recognized in the context of no-fly lists.

Saddiq Long has now purchased another ticket to travel to the US on 8 November, less than a week from now, in the hope that the US government will allow him to fly. “If he isn’t allowed to fly home on the 8th,” said Abbas, “we will plan on mobilizing people to contact the Special Agent in Charge of the FBI field office in Oklahoma City. The FBI controls these lists and his intervention could end Saadiq’s predicament.”

For now, Long can do nothing other than wait and hope that his own country, which he served for a decade in the armed forces, will deign to allow him to return. Secret deprivation of core rights, no recourse, no due process, no right even to learn what has been done to you despite zero evidence of wrongdoing: that is the life of many American Muslims in the post-9/11 world. Most significantly, it gets progressively worse, not better, as the temporal distance from 9/11 grows.


Series: Glenn Greenwald on security and liberty

The Washington Post has a crucial and disturbing story this morning by Greg Miller about the concerted efforts by the Obama administration to fully institutionalize – to make officially permanent – the most extremist powers it has exercised in the name of the war on terror.
Based on interviews with “current and former officials from the White House and the Pentagon, as well as intelligence and counterterrorism agencies”, Miller reports that as “the United States‘ conventional wars are winding down”, the Obama administration “expects to continue adding names to kill or capture lists for years” (the “capture” part of that list is little more than symbolic, as the US focus is overwhelmingly on the “kill” part). Specifically, “among senior Obama administration officials, there is broad consensus that such operations are likely to be extended at least another decade.” As Miller puts it: “That timeline suggests that the United States has reached only the midpoint of what was once known as the global war on terrorism.”
In pursuit of this goal, “White House counterterrorism adviser John O Brennan is seeking to codify the administration’s approach to generating capture/kill lists, part of a broader effort to guide future administrations through the counterterrorism processes that Obama has embraced.” All of this, writes Miller, demonstrates “the extent to which Obama has institutionalized the highly classified practice of targeted killing, transforming ad-hoc elements into a counterterrorism infrastructure capable of sustaining a seemingly permanent war.”
The Post article cites numerous recent developments reflecting this Obama effort, including the fact that “CIA Director David H Petraeus is pushing for an expansion of the agency’s fleet of armed drones”, which “reflects the agency’s transformation into a paramilitary force, and makes clear that it does not intend to dismantle its drone program and return to its pre-September 11 focus on gathering intelligence.” The article also describes rapid expansion of commando operations by the US Joint Special Operations Command (JSOC) and, perhaps most disturbingly, the creation of a permanent bureaucratic infrastructure to allow the president to assassinate at will:

“JSOC also has established a secret targeting center across the Potomac River from Washington, current and former U.S. officials said. The elite command’s targeting cells have traditionally been located near the front lines of its missions, including in Iraq and Afghanistan. But JSOC created a ‘national capital region’ task force that is a 15-minute commute from the White House so it could be more directly involved in deliberations about al-Qaeda lists.”

The creepiest aspect of this development is the christening of a new Orwellian euphemism for due-process-free presidential assassinations: “disposition matrix”. Writes Miller:

“Over the past two years, the Obama administration has been secretly developing a new blueprint for pursuing terrorists, a next-generation targeting list called the ‘disposition matrix’.
“The matrix contains the names of terrorism suspects arrayed against an accounting of the resources being marshaled to track them down, including sealed indictments and clandestine operations. US officials said the database is designed to go beyond existing kill lists, mapping plans for the ‘disposition’ of suspects beyond the reach of American drones.”

The “disposition matrix” has been developed and will be overseen by the National Counterterrorism Center (NCTC). One of its purposes is “to augment” the “separate but overlapping kill lists” maintained by the CIA and the Pentagon: to serve, in other words, as the centralized clearinghouse for determining who will be executed without due process based upon how one fits into the executive branch’s “matrix”. As Miller describes it, it is “a single, continually evolving database” which includes “biographies, locations, known associates and affiliated organizations” as well as “strategies for taking targets down, including extradition requests, capture operations and drone patrols”. This analytical system that determines people’s “disposition” will undoubtedly be kept completely secret; Marcy Wheeler sardonically said that she was “looking forward to the government’s arguments explaining why it won’t release the disposition matrix to ACLU under FOIA”.
This was all motivated by Obama’s refusal to arrest or detain terrorist suspects, and his resulting commitment simply to killing them at will (his will). Miller quotes “a former US counterterrorism official involved in developing the matrix” as explaining the impetus behind the program this way: “We had a disposition problem.”
The central role played by the NCTC in determining who should be killed – “It is the keeper of the criteria,” says one official to the Post – is, by itself, rather odious. As Kade Crockford of the ACLU of Massachusetts noted in response to this story, the ACLU has long warned that the real purpose of the NCTC – despite its nominal focus on terrorism – is the “massive, secretive data collection and mining of trillions of points of data about most people in the United States”.
In particular, the NCTC operates a gigantic data-mining operation, in which all sorts of information about innocent Americans is systematically monitored, stored, and analyzed. This includes “records from law enforcement investigations, health information, employment history, travel and student records” – “literally anything the government collects would be fair game”. In other words, the NCTC – now vested with the power to determine the proper “disposition” of terrorist suspects – is the same agency that is at the center of the ubiquitous, unaccountable surveillance state aimed at American citizens.
Worse still, as the ACLU’s legislative counsel Chris Calabrese documented back in July in a must-read analysis, Obama officials very recently abolished safeguards on how this information can be used. Whereas the agency, during the Bush years, was barred from storing non-terrorist-related information about innocent Americans for more than 180 days – a limit which “meant that NCTC was dissuaded from collecting large databases filled with information on innocent Americans” – it is now free to do so. Obama officials eliminated this constraint by authorizing the NCTC “to collect and ‘continually assess’ information on innocent Americans for up to five years”.
And, as usual, this agency engages in these incredibly powerful and invasive processes with virtually no democratic accountability:

“All of this is happening with very little oversight. Controls over the NCTC are mostly internal to the DNI’s office, and important oversight bodies such as Congress and the President’s Intelligence Oversight Board aren’t notified even of ‘significant’ failures to comply with the Guidelines. Fundamental legal protections are being sidestepped. For example, under the new guidelines, Privacy Act notices (legal requirements to describe how databases are used) must be completed by the agency that collected the information. This is in spite of the fact that those agencies have no idea what NCTC is actually doing with the information once it collects it.
“All of this amounts to a reboot of the Total Information Awareness Program that Americans rejected so vigorously right after 9/11.”

It doesn’t require any conspiracy theorizing to see what’s happening here. Indeed, it takes extreme naiveté, or wilful blindness, not to see it.
What has been created here – permanently institutionalized – is a highly secretive executive branch agency that simultaneously engages in two functions: (1) it collects and analyzes massive amounts of surveillance data about all Americans without any judicial review let alone search warrants, and (2) creates and implements a “matrix” that determines the “disposition” of suspects, up to and including execution, without a whiff of due process or oversight. It is simultaneously a surveillance state and a secretive, unaccountable judicial body that analyzes who you are and then decrees what should be done with you, how you should be “disposed” of, beyond the reach of any minimal accountability or transparency.
The Post’s Miller recognizes the watershed moment this represents: “The creation of the matrix and the institutionalization of kill/capture lists reflect a shift that is as psychological as it is strategic.” As he explains, extra-judicial assassination was once deemed so extremist that very extensive deliberations were required before Bill Clinton could target even Osama bin Laden for death by lobbing cruise missiles in East Africa. But:

Targeted killing is now so routine that the Obama administration has spent much of the past year codifying and streamlining the processes that sustain it.

To understand the Obama legacy, please re-read that sentence. As Murtaza Hussain put it when reacting to the Post story: “The US agonized over the targeted killing Bin Laden at Tarnak Farms in 1998; now it kills people it barely suspects of anything on a regular basis.”
The pragmatic inanity of the mentality driving this is self-evident: as I discussed yesterday (and many other times), continuous killing does not eliminate violence aimed at the US but rather guarantees its permanent expansion. As a result, wrote Miller, “officials said no clear end is in sight” when it comes to the war against “terrorists” because, said one official, “we can’t possibly kill everyone who wants to harm us” but trying is “a necessary part of what we do”. Of course, the more the US kills and kills and kills, the more people there are who “want to harm us”. That’s the logic that has resulted in a permanent war on terror.
But even more significant is the truly radical vision of government in which this is all grounded. The core guarantee of western justice since the Magna Carta was codified in the US by the fifth amendment to the constitution: “No person shall . . . be deprived of life, liberty, or property, without due process of law.” You simply cannot have a free society, a worthwhile political system, without that guarantee, that constraint on the ultimate abusive state power, being honored.
And yet what the Post is describing, what we have had for years, is a system of government that – without hyperbole – is the very antithesis of that liberty. It is literally impossible to imagine a more violent repudiation of the basic blueprint of the republic than the development of a secretive, totally unaccountable executive branch agency that simultaneously collects information about all citizens and then applies a “disposition matrix” to determine what punishment should be meted out. This is classic political dystopia brought to reality (despite how compelled such a conclusion is by these indisputable facts, many Americans will view such a claim as an exaggeration, paranoia, or worse because of this psychological dynamic I described here which leads many good passive westerners to believe that true oppression, by definition, is something that happens only elsewhere).
In response to the Post story, Chris Hayes asked: “If you have a ‘kill list’, but the list keeps growing, are you succeeding?” The answer all depends upon what the objective is.
As the Founders all recognized, nothing vests elites with power – and profit – more than a state of war. That is why there were supposed to be substantial barriers to having them start and continue – the need for a Congressional declaration, the constitutional bar on funding the military for more than two years at a time, the prohibition on standing armies, etc. Here is how John Jay put it in Federalist No 4:

“It is too true, however disgraceful it may be to human nature, that nations in general will make war whenever they have a prospect of getting anything by it; nay, absolute monarchs will often make war when their nations are to get nothing by it, but for the purposes and objects merely personal, such as thirst for military glory, revenge for personal affronts, ambition, or private compacts to aggrandize or support their particular families or partisans. These and a variety of other motives, which affect only the mind of the sovereign, often lead him to engage in wars not sanctified by justice or the voice and interests of his people.”

In sum, there are factions in many governments that crave a state of endless war because that is when power is least constrained and profit most abundant. What the Post is reporting is yet another significant step toward that state, and it is undoubtedly driven, at least on the part of some, by a self-interested desire to ensure the continuation of endless war and the powers and benefits it vests. So to answer Hayes’ question: the endless expansion of a kill list and the unaccountable, always-expanding powers needed to implement it does indeed represent a great success for many. Read what John Jay wrote in the above passage to see why that is, and why few, if any, political developments should be regarded as more pernicious.

Detention policies

Assuming the Post’s estimates are correct – that “among senior Obama administration officials, there is broad consensus that such operations are likely to be extended at least another decade” – this means that the war on terror will last for more than 20 years, far longer than any other American war. This is what has always made the rationale for indefinite detention – that it is permissible to detain people without due process until the “end of hostilities” – so warped in this context. Those who are advocating that are endorsing nothing less than life imprisonment – permanent incarceration – without any charges or opportunities to contest the accusations.
That people are now dying at Guantanamo after almost a decade in a cage with no charges highlights just how repressive that power is. Extend that mentality to secret, due-process-free assassinations – something the US government clearly intends to convert into a permanent fixture of American political life – and it is not difficult to see just how truly extremist and anti-democratic “war on terror” proponents in both political parties have become.

UPDATE

As I noted yesterday, Afghan officials reported that three Afghan children were killed on Saturday by NATO operations. Today, reports CNN, “missiles blew up part of a compound Wednesday in northwest Pakistan, killing three people – including one woman” and added: “the latest suspected U.S. drone strike also injured two children.” Meanwhile, former Obama press secretary and current campaign adviser Robert Gibbs this week justified the US killing of 16-year-old American Abdulrahaman Awlaki, killed by a US drone in Yemen two weeks after his father was, on the ground that he “should have a far more responsible father”.
Also yesterday, CNN profiled Abu Sufyan Said al-Shihri, alleged to be a top al-Qaida official in Yemen. He pointed out “that U.S. drone strikes are helping al-Qaida in Yemen because of the number of civilian deaths they cause.” Ample evidence supports his observation.
To summarize all this: the US does not interfere in the Muslim world and maintain an endless war on terror because of the terrorist threat. It has a terrorist threat because of its interference in the Muslim world and its endless war on terror.

UPDATE II

The Council on Foreign Relations’ Micah Zenko, writing today about the Post article, reports:

“Recently, I spoke to a military official with extensive and wide-ranging experience in the special operations world, and who has had direct exposure to the targeted killing program. To emphasize how easy targeted killings by special operations forces or drones has become, this official flicked his hand back over and over, stating: ‘It really is like swatting flies. We can do it forever easily and you feel nothing. But how often do you really think about killing a fly?'”

That is disturbingly consistent with prior reports that the military’s term for drone victims is “bug splat”. This – this warped power and the accompanying dehumanizing mindset – is what is being institutionalized as a permanent fixture in American political life by the current president.

UPDATE III

At Wired, Spencer Ackerman reacts to the Post article with an analysis entitled “President Romney Can Thank Obama for His Permanent Robotic Death List”. Here is his concluding paragraph:

“Obama did not run for president to preside over the codification of a global war fought in secret. But that’s his legacy. . . . Micah Zenko at the Council on Foreign Relations writes that Obama’s predecessors in the Bush administration ‘were actually much more conscious and thoughtful about the long-term implications of targeted killings’, because they feared the political consequences that might come when the U.S. embraces something at least superficially similar to assassination. Whoever follows Obama in the Oval Office can thank him for proving those consequences don’t meaningfully exist — as he or she reviews the backlog of names on the Disposition Matrix.”

It’s worth devoting a moment to letting that sink in.

July 11, 2014

Just a few weeks ago, during a commencement address to West Point’s graduating cadets, President Obama spoke to the importance of greater transparency “about both the basis of our counter-terrorism actions and the manner in which they are carried out.”
President Obama also made similar comments about drone transparency last year, but the Obama administration hasn’t yet matched the president’s words with action by publicly disclosing meaningful information about its targeted operations and its use of drone strikes.
The U.S. secret drone war is damaging our reputation abroad and arguably inspiring new terrorists instead of thwarting them. Human rights and civil rights groups have uncovered evidence of hundreds of civilian deaths unreported by the U.S. government in Iraq, Afghanistan, Yemen, Pakistan and Somalia.1,2 Our government must be transparent about whom it is targeting with drones, and why, in order to shed light on whether or not the U.S. government is violating international law.
Even CIA Director John Brennan has said, the United States “need[s] to acknowledge publicly” any mistaken killings and should “make public the overall numbers of civilian deaths resulting from U.S. strikes targeting al-Qa’ida.”
With the Obama administration currently considering the use of drone strikes in Iraq, which would undoubtedly lead to civilian casualties, now is the perfect time to demand transparency on the civilians killed by previous U.S. drone strikes abroad.
The public has an inalienable right to know whom their government is targeting and at what collateral cost. Now is the time to have a national conversation about the U.S. drone strike program and to demand far greater transparency from the Obama administration.
Thank you for your support.
Rick Rosenthal, CREDO Activist
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  1. Everything We Know So Far About Drone Strikes,” ProPublica, February 5, 2013
  2. The Toll Of 5 Years Of Drone Strikes: 2,400 Dead,” Huffington Post, January 23, 2014


(The Atlantic) -Two new reports issued this week by Amnesty International and Human Rights Watch detailed dozens of civilian deaths caused by drone strikes in Pakistan and Yemen. Classified documents obtained by the Washington Post suggest that CIA officials who carry out the strikes make little effort to track civilian deaths.
“There is a lot more pressure building” on President Barack Obama, Sarah Holewinski, head of the Center for Civilians in Conflict, a group pushing for greater transparency in drone strikes, told me this week. “He’s going to have to look at these legal questions.”


There is a serious terrorist threat to the United States. The administration is under enormous pressure to prevent attacks. But there are ways to safeguard the United States without sparking such a serious backlash abroad and at home.
Holewinski called on the Obama administration to implement its promise to move command of drone operations from the CIA to the American military. She said the shift, which Obama announced this spring, is going “very, very slowly.”
Military control is one step toward a key goal: greater transparency in countries where drone strikes are enormously unpopular. Keeping the drone strikes as a covert CIA-run program makes accountability and determining the true number of civilian deaths impossible, she said.
If strikes are commanded by the military and disclosed publicly, reports of civilian casualties could be investigated under military law and compensation paid to victims — as now happens in Afghanistan.
Holewinski also urged the administration to disclose targeting rules that it has refused to make public. How are civilians defined? And how are civilian casualties assessed? What is the legal definition of an individual who can be targeted?
She credited the administration for a decrease in drone strikes since Obama promised one in May. But, she insisted, the targeting process needs to be far more transparent.


The secrecy veiling Obama’s drone war

By Daphne Eviatar
January 4, 2013

It’s rare for a judge to express regret over her own ruling.  But that’s what happened Wednesday, when Judge Colleen McMahon of the U.S. District Court for the Southern District of New York reluctantly ruled that the Obama administration does not need to provide public justification for its deadly drone war.

The memos requested by two New York Times reporters and the American Civil Liberties Union, McMahon wrote, “implicate serious issues about the limits on the power of the Executive Branch under the Constitution and laws of the United States, and about whether we are indeed a nation of laws, not of men.” Still, the Freedom of Information Act allows the executive branch to keep many things secret.
In this case, McMahon ruled, the administration’s justifications for the killing of select individuals — including American citizens — without so much as a hearing, constitute an internal “deliberative process” by the government that need not be disclosed.
McMahon did not hide her disappointment. “The Alice-in-Wonderland nature of this pronouncement is not lost on me,” she wrote, “but after careful and extensive consideration, I find myself stuck in a paradoxical situation in which I cannot solve a problem because of contradictory constraints and rules – a veritable Catch-22.” She explained, “I can find no way around the thicket of laws and precedents that effectively allow the Executive Branch of our government to proclaim as perfectly lawful certain actions that seem on their face incompatible with our Constitution and laws, while keeping the reasons for their conclusion a secret.”
The judge’s lament may have, in part, been induced by the striking discord between the looking-glass world in which she found herself, and the hopes that President Barack Obama had first generated for a newly transparent government.
That continued once he was in office. In a Dec. 29, 2009 executive order, Obama said: “Our democratic principles require that the American people be informed of the activities of their government.” He insisted “our nation’s progress depends on the free flow of information both within the government and to the American people.”
He sent an accompanying memo to the heads of all executive branch agencies:

“Transparency promotes accountability and provides information for citizens about what their government is doing. Information maintained by the federal government is a national asset.”

That was before Obama embarked on a secret, exponential expansion of the deadly drone war. Or at least, before most Americans were aware of it.
Since 2009, there have been more than 300 bombings by remote-controlled U.S. drones in Pakistan, Yemen and Somalia. During the entire Bush administration, there were just 51.
Thousands of people have reportedly been killed by the “unmanned aerial vehicles.”

Though U.S. officials claim the number of civilian deaths has been minimal, independent studies show otherwise. Ultimately, it’s impossible to know how many people have been killed, or who they were, because the government doesn’t release that information.
This all stands in stark contrast to the heady early days of the Obama presidency.
Back in 2009, overruling the objections of six former CIA directors, Obama released the legal memos created by the Bush administration to justify the use of torture and other “enhanced interrogation techniques” on suspected terrorists.
Today, he insists on hiding memos that justify the secret killing of suspected terrorists – and, as in the case of Anwar al-Awlaki, the killing of their children.
The government has made a point of saying that these killings were all lawful and justified, trotting out senior administration officials to make those claims in a series of speeches over the last two years.
As McMahon noted, “it is not surprising that the government feels somewhat defensive.” After all, “some Americans question the power of the executive to make a unilateral and unreviewable decision to kill an American citizen who is not actively engaged in armed combat operations against this country. Their concern rests on the text of the Constitution and several federal statutes, and is of a piece with concerns harbored by the Framers of our unique form of government.”
The ACLU has already vowed to appeal McMahon’s decision. But its success is far from certain.  It’s also unclear whether any court will ever require the government to release the memos documenting its legal rationale for these secret extrajudicial killings. McMahon’s decision, however, highlights why Obama should release them nonetheless.
Demands for the memos have been mounting ever since The New York Times first revealed that administration lawyers had documented their justification for the Awlaki killing in 2010.
Both U.S. citizens and foreign allies, whom the U.S. government strongly relies on in fighting its “war on terror,” have been skeptical of the program’s legality for years.  This has stymied intelligence-sharing with foreign governments, such as Germany, and infuriated local populations in Pakistan and Yemen, whose support is critical to defeating Al Qaeda and the Taliban.
It has also undermined Obama’s reputation — making it easier for critics to say he’s no better than his predecessor. It could even tarnish his legacy as a president, for he took office promising shiny reforms after a particularly dark chapter in U.S. history.
McMahon herself noted that there is no reason to believe at this point that releasing the memos would endanger national security, because any “intelligence sources and methods” could be redacted. On the contrary, explaining under what circumstances Washington believes targeted killing would be lawful could both quell critics’ claims of U.S. lawlessness and delineate the rules the United States wants other countries to follow.
To the extent that the memos reflect internal deliberations rather than the administration’s final decisions, the Justice Department can make that clear. Obama can also explain where U.S. policy stands now.
It would be a brave and principled move on Obama’s part. It would also go a long way toward developing global confidence that, despite past mistakes, Washington is waging its fight against terrorism in accordance with the rule of law.
If Obama instead continues to take refuge in the courts, he may be able to claim a minor legal victory. But the president will have lost a far more important battle.


In April of 2012, Saadiq Long, a 43-year-old African-American Muslim who now lives in Qatar, purchased a ticket on KLM Airlines to travel to Oklahoma, the state where he grew up. Long, a 10-year veteran of the US Air Force, had learned that the congestive heart failure from which his mother suffers had worsened, and she was eager to see her son. He had last seen his mother and siblings more than a decade ago, when he returned to the US in 2001, and spent months saving the money to purchase the ticket and arranging to be away from work.

The day before he was to travel, a KLM representative called Long and informed him that the airlines could not allow him to board the flight. That, she explained, was because the US Department of Homeland Security (DHS) had placed Long on its “no-fly list”, which bars him from flying into his own country.

Long has now spent the last six months trying to find out why he was placed on this list and what he can do to get off of it. He has had no success, unable to obtain even the most basic information about what caused his own government to deprive him of this right to travel.

He has no idea when he was put on this list, who decided to put him on it, or the reasons for his inclusion. He has never been convicted of any crime, never been indicted or charged with a crime, and until he was less than 24 hours away from boarding that KLM flight back to his childhood home, had received no notice that his own government prohibited him from flying.

As his mother’s health declines, he remains effectively barred from returning to see her. “My mother is much too sick to come visit me, as she has difficulty now even walking very short distances,” Long told me in an interview Sunday in Doha, the sleek, booming capital city of America’s close Gulf ally, where the former Senior Airman and Staff Sergeant has lived for several years.

“I don’t understand how the government can take away my right to travel without even telling me,” he said. What is most mystifying to him is that he has spent the last decade living and working, usually teaching English, in three countries that have been very close and compliant US allies: Egypt, United Arab Emirates, and now Qatar. “If the US government wanted me to question or arrest or prosecute me, they could have had me in a minute. But there are no charges, no accusations, nothing.”

As compelling as Long’s story is, it is extremely common. Last year in Washington, I met a 19-year-old Somali-American Muslim, born and raised in the US, who saved money from a summer job to purchase a ticket to travel for the first time to Somalia to visit family members he had never met. When he went to the ticket counter to check-in, he was informed that he was barred from flying and suffered the humiliation of having to return home with his luggage and then trying to explain to his employer, family and friends why he did not travel.

Like Long, that American teenager was never convicted or even charged with any crime, and was mystified and angry that his own government secretly placed him on this list, though he remains too afraid to speak out without anonymity. “I’m scared that if I do, it’ll only get worse,” he told me.

Like so many post-9/11 civil liberties abridgments aimed primarily at Muslims, this no-fly-list abuse has worsened considerably during the Obama presidency. In February, Associated Press learned that “the Obama administration has more than doubled, to about 21,000 names, its secret list of suspected terrorists who are banned from flying to or within the United States, including about 500 Americans.”

Worse, the Obama administration “lowered the bar for being added to the list”. As a result, reported AP, “now a person doesn’t have to be considered only a threat to aviation to be placed on the no-fly list” but can be included if they “are considered a broader threat to domestic or international security”, a vague status determined in the sole and unchecked discretion of unseen DHS bureaucrats.

But the worst cases are those like Long’s: when the person is suddenly barred from flying when they are outside of the US, often on the other side of the world. As a practical matter, that government act effectively exiles them from their own country. “Obviously, I can’t get to Oklahoma from Qatar if I can’t fly,” said Long. “Trying to take a boat would take weeks away from work just for the travel alone, and it’s not affordable. If I can’t fly, then I can’t go back home.”

Gadeir Abbas, a lawyer with the Council on American-Islamic Relations (CAIR) now working on Long’s case, told me:

“What is happening to Saadiq happens to American Muslims with alarming regularity. Every few weeks I hear of another Muslim citizen who cannot return to the country of which he is a citizen.

“It is as if the US has created a system of secret law whereby certain behaviors – being Muslim seems to be one of them – trigger one’s placement on government watch lists that separate people from their families, end careers, and poison personal relationships. All of this done without any due process.”

The ACLU has spent years challenging the constitutionality of the no-fly list in court. Representing 15 US citizens and permanent residents who have been placed on the list, , including four military veterans, the civil liberties group scored a possibly significant victory this June when the 9th Circuit of Appeals reinstated their lawsuit, which a lower court judge had dismissed, and allowed the case to proceed. ACLU lawyer Nusrat Choudhury, who argued the case, told me:

“The No Fly List bars thousands of people from commercial air travel without any opportunity to learn about or refute the basis for their inclusion on the list. The result is a vast and growing list of individuals who, on the basis of error or innuendo, have been deemed too dangerous to fly but who are too harmless to arrest. Some have been stranded abroad when they suddenly found themselves unable to board planes.

“None of these Americans have ever been told why they are on the No Fly List or given a reasonable opportunity to get off it. But, the Constitution requires the government to provide our clients a fair chance to clear their names.”

Long’s case is both typical yet particularly compelling. Strictly on humanitarian grounds, it is outright cruel to deny a person who has been convicted of no crime the ability to see his ailing mother.

Beyond the constitutional and humanitarian questions, Long was confounded by what seems to be the utterly irrational reasoning on which the no-fly list is based. As it bars him only from flying, he remains technically free to board a cruise ship to the US, one that would be filled with American civilians. Every US citizen has the constitutional right to enter the country, so he is technically free to visit the US or return there to live if he is able to get back, to visit crowded streets and shopping malls, to board trains, in essence to do anything but fly.

“It makes no sense, so it’s obvious this is meant as some kind of punishment, but for what?”, he asked. “If they are so afraid of me, they can just put a law enforcement agent on the plane to escort me back home.”

After learning he had been barred from flying, Long sought assistance from the US Embassy in Doha. “After many follow-up calls to the embassy,” he recounted, “they finally gave me ‘assistance’ in the form of the website to DHS and instructions to file a complaint.” On 15 May, he filed a formal complaint with DHS and received a so-called “redress control number” with a promise to review his case within 7-10 business days. Almost six months later, he is still in Doha waiting for an answer, still harboring hope that he will receive clearance to return home to visit his sick mother.

Abbas, the CAIR lawyer, told me: “It makes my stomach churn what the US does to American Muslims while they travel.” Unfortunately, he said, the political reality of this issue tracks the familiar pattern of Muslims being denied the most basic rights: “there is zero political will to alter the use of endless secret watchlists that terrorize the Muslim community and make none of us any safer.”

Abbas worked last year on the truly wrenching case of Gulet Mohamed, the then-18-year-old Somali-American who, while visiting Kuwait, was detained at the behest of the Obama administration, and beaten and tortured by Kuwaiti authorities while he was interrogated for two weeks. Once the Kuwaitis were done with him and wanted to release him, Mohamed – who, to date, has never been charged with any crime – faced a horrible dilemma: at some point when he was traveling, the US government placed him on a no-fly list, meaning that he could no longer stay in Kuwait, but also could not return to the US, stuck in lawless limbo.

When he was in Kuwaiti detention, Gulet was able to use a cell phone illicitly obtained by a fellow detainee, and his family arranged for him to call me and the New York Times’ Mark Mazzetti to recount his story. I spent an hour on the phone with him, and still vividly recall the terror and visceral fear of the American teeanger as he tried to understand why his own government first arranged for his detention and beating, and then barred him from returning to the country where he was born and had lived his whole life, even when the Kuwaitis were eager to release him. That is the tyranny of the no-fly list.

“Our litigation in Gulet Mohamed’s case seeks to establish what I think is the very modest proposition that the US cannot actively obstruct a citizen’s movement into the US from abroad,” said Abbas. As modest – and self-evident – a proposition as that is, it is one the US courts have not recognized in the context of no-fly lists.

Saddiq Long has now purchased another ticket to travel to the US on 8 November, less than a week from now, in the hope that the US government will allow him to fly. “If he isn’t allowed to fly home on the 8th,” said Abbas, “we will plan on mobilizing people to contact the Special Agent in Charge of the FBI field office in Oklahoma City. The FBI controls these lists and his intervention could end Saadiq’s predicament.”

For now, Long can do nothing other than wait and hope that his own country, which he served for a decade in the armed forces, will deign to allow him to return. Secret deprivation of core rights, no recourse, no due process, no right even to learn what has been done to you despite zero evidence of wrongdoing: that is the life of many American Muslims in the post-9/11 world. Most significantly, it gets progressively worse, not better, as the temporal distance from 9/11 grows.


Series: Glenn Greenwald on security and liberty

The Washington Post has a crucial and disturbing story this morning by Greg Miller about the concerted efforts by the Obama administration to fully institutionalize – to make officially permanent – the most extremist powers it has exercised in the name of the war on terror.
Based on interviews with “current and former officials from the White House and the Pentagon, as well as intelligence and counterterrorism agencies”, Miller reports that as “the United States‘ conventional wars are winding down”, the Obama administration “expects to continue adding names to kill or capture lists for years” (the “capture” part of that list is little more than symbolic, as the US focus is overwhelmingly on the “kill” part). Specifically, “among senior Obama administration officials, there is broad consensus that such operations are likely to be extended at least another decade.” As Miller puts it: “That timeline suggests that the United States has reached only the midpoint of what was once known as the global war on terrorism.”
In pursuit of this goal, “White House counterterrorism adviser John O Brennan is seeking to codify the administration’s approach to generating capture/kill lists, part of a broader effort to guide future administrations through the counterterrorism processes that Obama has embraced.” All of this, writes Miller, demonstrates “the extent to which Obama has institutionalized the highly classified practice of targeted killing, transforming ad-hoc elements into a counterterrorism infrastructure capable of sustaining a seemingly permanent war.”
The Post article cites numerous recent developments reflecting this Obama effort, including the fact that “CIA Director David H Petraeus is pushing for an expansion of the agency’s fleet of armed drones”, which “reflects the agency’s transformation into a paramilitary force, and makes clear that it does not intend to dismantle its drone program and return to its pre-September 11 focus on gathering intelligence.” The article also describes rapid expansion of commando operations by the US Joint Special Operations Command (JSOC) and, perhaps most disturbingly, the creation of a permanent bureaucratic infrastructure to allow the president to assassinate at will:

“JSOC also has established a secret targeting center across the Potomac River from Washington, current and former U.S. officials said. The elite command’s targeting cells have traditionally been located near the front lines of its missions, including in Iraq and Afghanistan. But JSOC created a ‘national capital region’ task force that is a 15-minute commute from the White House so it could be more directly involved in deliberations about al-Qaeda lists.”

The creepiest aspect of this development is the christening of a new Orwellian euphemism for due-process-free presidential assassinations: “disposition matrix”. Writes Miller:

“Over the past two years, the Obama administration has been secretly developing a new blueprint for pursuing terrorists, a next-generation targeting list called the ‘disposition matrix’.
“The matrix contains the names of terrorism suspects arrayed against an accounting of the resources being marshaled to track them down, including sealed indictments and clandestine operations. US officials said the database is designed to go beyond existing kill lists, mapping plans for the ‘disposition’ of suspects beyond the reach of American drones.”

The “disposition matrix” has been developed and will be overseen by the National Counterterrorism Center (NCTC). One of its purposes is “to augment” the “separate but overlapping kill lists” maintained by the CIA and the Pentagon: to serve, in other words, as the centralized clearinghouse for determining who will be executed without due process based upon how one fits into the executive branch’s “matrix”. As Miller describes it, it is “a single, continually evolving database” which includes “biographies, locations, known associates and affiliated organizations” as well as “strategies for taking targets down, including extradition requests, capture operations and drone patrols”. This analytical system that determines people’s “disposition” will undoubtedly be kept completely secret; Marcy Wheeler sardonically said that she was “looking forward to the government’s arguments explaining why it won’t release the disposition matrix to ACLU under FOIA”.
This was all motivated by Obama’s refusal to arrest or detain terrorist suspects, and his resulting commitment simply to killing them at will (his will). Miller quotes “a former US counterterrorism official involved in developing the matrix” as explaining the impetus behind the program this way: “We had a disposition problem.”
The central role played by the NCTC in determining who should be killed – “It is the keeper of the criteria,” says one official to the Post – is, by itself, rather odious. As Kade Crockford of the ACLU of Massachusetts noted in response to this story, the ACLU has long warned that the real purpose of the NCTC – despite its nominal focus on terrorism – is the “massive, secretive data collection and mining of trillions of points of data about most people in the United States”.
In particular, the NCTC operates a gigantic data-mining operation, in which all sorts of information about innocent Americans is systematically monitored, stored, and analyzed. This includes “records from law enforcement investigations, health information, employment history, travel and student records” – “literally anything the government collects would be fair game”. In other words, the NCTC – now vested with the power to determine the proper “disposition” of terrorist suspects – is the same agency that is at the center of the ubiquitous, unaccountable surveillance state aimed at American citizens.
Worse still, as the ACLU’s legislative counsel Chris Calabrese documented back in July in a must-read analysis, Obama officials very recently abolished safeguards on how this information can be used. Whereas the agency, during the Bush years, was barred from storing non-terrorist-related information about innocent Americans for more than 180 days – a limit which “meant that NCTC was dissuaded from collecting large databases filled with information on innocent Americans” – it is now free to do so. Obama officials eliminated this constraint by authorizing the NCTC “to collect and ‘continually assess’ information on innocent Americans for up to five years”.
And, as usual, this agency engages in these incredibly powerful and invasive processes with virtually no democratic accountability:

“All of this is happening with very little oversight. Controls over the NCTC are mostly internal to the DNI’s office, and important oversight bodies such as Congress and the President’s Intelligence Oversight Board aren’t notified even of ‘significant’ failures to comply with the Guidelines. Fundamental legal protections are being sidestepped. For example, under the new guidelines, Privacy Act notices (legal requirements to describe how databases are used) must be completed by the agency that collected the information. This is in spite of the fact that those agencies have no idea what NCTC is actually doing with the information once it collects it.
“All of this amounts to a reboot of the Total Information Awareness Program that Americans rejected so vigorously right after 9/11.”

It doesn’t require any conspiracy theorizing to see what’s happening here. Indeed, it takes extreme naiveté, or wilful blindness, not to see it.
What has been created here – permanently institutionalized – is a highly secretive executive branch agency that simultaneously engages in two functions: (1) it collects and analyzes massive amounts of surveillance data about all Americans without any judicial review let alone search warrants, and (2) creates and implements a “matrix” that determines the “disposition” of suspects, up to and including execution, without a whiff of due process or oversight. It is simultaneously a surveillance state and a secretive, unaccountable judicial body that analyzes who you are and then decrees what should be done with you, how you should be “disposed” of, beyond the reach of any minimal accountability or transparency.
The Post’s Miller recognizes the watershed moment this represents: “The creation of the matrix and the institutionalization of kill/capture lists reflect a shift that is as psychological as it is strategic.” As he explains, extra-judicial assassination was once deemed so extremist that very extensive deliberations were required before Bill Clinton could target even Osama bin Laden for death by lobbing cruise missiles in East Africa. But:

Targeted killing is now so routine that the Obama administration has spent much of the past year codifying and streamlining the processes that sustain it.

To understand the Obama legacy, please re-read that sentence. As Murtaza Hussain put it when reacting to the Post story: “The US agonized over the targeted killing Bin Laden at Tarnak Farms in 1998; now it kills people it barely suspects of anything on a regular basis.”
The pragmatic inanity of the mentality driving this is self-evident: as I discussed yesterday (and many other times), continuous killing does not eliminate violence aimed at the US but rather guarantees its permanent expansion. As a result, wrote Miller, “officials said no clear end is in sight” when it comes to the war against “terrorists” because, said one official, “we can’t possibly kill everyone who wants to harm us” but trying is “a necessary part of what we do”. Of course, the more the US kills and kills and kills, the more people there are who “want to harm us”. That’s the logic that has resulted in a permanent war on terror.
But even more significant is the truly radical vision of government in which this is all grounded. The core guarantee of western justice since the Magna Carta was codified in the US by the fifth amendment to the constitution: “No person shall . . . be deprived of life, liberty, or property, without due process of law.” You simply cannot have a free society, a worthwhile political system, without that guarantee, that constraint on the ultimate abusive state power, being honored.
And yet what the Post is describing, what we have had for years, is a system of government that – without hyperbole – is the very antithesis of that liberty. It is literally impossible to imagine a more violent repudiation of the basic blueprint of the republic than the development of a secretive, totally unaccountable executive branch agency that simultaneously collects information about all citizens and then applies a “disposition matrix” to determine what punishment should be meted out. This is classic political dystopia brought to reality (despite how compelled such a conclusion is by these indisputable facts, many Americans will view such a claim as an exaggeration, paranoia, or worse because of this psychological dynamic I described here which leads many good passive westerners to believe that true oppression, by definition, is something that happens only elsewhere).
In response to the Post story, Chris Hayes asked: “If you have a ‘kill list’, but the list keeps growing, are you succeeding?” The answer all depends upon what the objective is.
As the Founders all recognized, nothing vests elites with power – and profit – more than a state of war. That is why there were supposed to be substantial barriers to having them start and continue – the need for a Congressional declaration, the constitutional bar on funding the military for more than two years at a time, the prohibition on standing armies, etc. Here is how John Jay put it in Federalist No 4:

“It is too true, however disgraceful it may be to human nature, that nations in general will make war whenever they have a prospect of getting anything by it; nay, absolute monarchs will often make war when their nations are to get nothing by it, but for the purposes and objects merely personal, such as thirst for military glory, revenge for personal affronts, ambition, or private compacts to aggrandize or support their particular families or partisans. These and a variety of other motives, which affect only the mind of the sovereign, often lead him to engage in wars not sanctified by justice or the voice and interests of his people.”

In sum, there are factions in many governments that crave a state of endless war because that is when power is least constrained and profit most abundant. What the Post is reporting is yet another significant step toward that state, and it is undoubtedly driven, at least on the part of some, by a self-interested desire to ensure the continuation of endless war and the powers and benefits it vests. So to answer Hayes’ question: the endless expansion of a kill list and the unaccountable, always-expanding powers needed to implement it does indeed represent a great success for many. Read what John Jay wrote in the above passage to see why that is, and why few, if any, political developments should be regarded as more pernicious.

Detention policies

Assuming the Post’s estimates are correct – that “among senior Obama administration officials, there is broad consensus that such operations are likely to be extended at least another decade” – this means that the war on terror will last for more than 20 years, far longer than any other American war. This is what has always made the rationale for indefinite detention – that it is permissible to detain people without due process until the “end of hostilities” – so warped in this context. Those who are advocating that are endorsing nothing less than life imprisonment – permanent incarceration – without any charges or opportunities to contest the accusations.
That people are now dying at Guantanamo after almost a decade in a cage with no charges highlights just how repressive that power is. Extend that mentality to secret, due-process-free assassinations – something the US government clearly intends to convert into a permanent fixture of American political life – and it is not difficult to see just how truly extremist and anti-democratic “war on terror” proponents in both political parties have become.

UPDATE

As I noted yesterday, Afghan officials reported that three Afghan children were killed on Saturday by NATO operations. Today, reports CNN, “missiles blew up part of a compound Wednesday in northwest Pakistan, killing three people – including one woman” and added: “the latest suspected U.S. drone strike also injured two children.” Meanwhile, former Obama press secretary and current campaign adviser Robert Gibbs this week justified the US killing of 16-year-old American Abdulrahaman Awlaki, killed by a US drone in Yemen two weeks after his father was, on the ground that he “should have a far more responsible father”.
Also yesterday, CNN profiled Abu Sufyan Said al-Shihri, alleged to be a top al-Qaida official in Yemen. He pointed out “that U.S. drone strikes are helping al-Qaida in Yemen because of the number of civilian deaths they cause.” Ample evidence supports his observation.
To summarize all this: the US does not interfere in the Muslim world and maintain an endless war on terror because of the terrorist threat. It has a terrorist threat because of its interference in the Muslim world and its endless war on terror.

UPDATE II

The Council on Foreign Relations’ Micah Zenko, writing today about the Post article, reports:

“Recently, I spoke to a military official with extensive and wide-ranging experience in the special operations world, and who has had direct exposure to the targeted killing program. To emphasize how easy targeted killings by special operations forces or drones has become, this official flicked his hand back over and over, stating: ‘It really is like swatting flies. We can do it forever easily and you feel nothing. But how often do you really think about killing a fly?'”

That is disturbingly consistent with prior reports that the military’s term for drone victims is “bug splat”. This – this warped power and the accompanying dehumanizing mindset – is what is being institutionalized as a permanent fixture in American political life by the current president.

UPDATE III

At Wired, Spencer Ackerman reacts to the Post article with an analysis entitled “President Romney Can Thank Obama for His Permanent Robotic Death List”. Here is his concluding paragraph:

“Obama did not run for president to preside over the codification of a global war fought in secret. But that’s his legacy. . . . Micah Zenko at the Council on Foreign Relations writes that Obama’s predecessors in the Bush administration ‘were actually much more conscious and thoughtful about the long-term implications of targeted killings’, because they feared the political consequences that might come when the U.S. embraces something at least superficially similar to assassination. Whoever follows Obama in the Oval Office can thank him for proving those consequences don’t meaningfully exist — as he or she reviews the backlog of names on the Disposition Matrix.”

It’s worth devoting a moment to letting that sink in.

women in Islam

The Iraqi Council of Representatives will vote to legalise Forced Child Marriage1.
The specifics of the legislation (part of the Jaafari Personal Status Law) are terrifying:

  • There will no longer be a minimum age to legally marry (it’s currently 18) but the law provides policies for divorcing a 9-year-old girl;
  • A girl’s father would legally be able to accept a marriage proposal on her behalf; and
  • The girl would be legally prohibited from resisting her husband’s advances and leaving the home without his permission.

It’s a recipe for a life in domestic and sexual slavery.

The law was sent to the Council of Representatives yesterday, and the vote could happen any time now. To prevent Iraq’s girls from becoming vulnerable to forced child marriage it is crucial that we act now.

Currently, Iraq has one of the most progressive policies on women’s rights in the Middle East — setting the legal marriage age at 18 and prohibiting forced marriage2.

Any minute now, the Iraqi Council of Representatives will vote to legalise forced child marriage. 1
The specifics of the legislation (part of the Jaafari Personal Status Law) are terrifying:
  • There will no longer be a minimum age to legally marry (it’s currently 18) but the law provides policies for divorcing a 9-year-old;
  • A girl’s father would legally be able to accept a marriage proposal; and
  • The girl would be legally prohibited from resisting her husband’s advances and leaving the home without his permission.
It’s a recipe for a life in domestic and sexual slavery.
Currently, Iraq has one of the most progressive policies on women’s rights in the Middle East — setting the legal marriage age at 18 and prohibiting forced marriage.2
Brave Iraqi women have been fighting against removing the minimum age for marriage, for their sake and for the sake of their daughters. Last month on International Women’s Day, countless women attended demonstrations in Baghdad protesting the Jaafari Personal Status Law. They called it the “Day of Mourning”.3
We may not have much time to stop Iraq from legalising forced child marriage and a lifetime of domestic and sexual slavery for girls and women. Call on the the Iraqi Council of Representatives to vote “no” to the Jaafari Personal Status Law today.


PUBLISHED: 14:41 GMT, 24 January 2013 | UPDATED: 14:42 GMT, 24 January 2013

Saudi Arabia’s feared morality police say they will not punish men who walk around in their underwear – but women still face harsh punishments if they violate strict laws on women’s dress codes.

The Commission for the Promotion of Virtue and Prevention of Vice has denied reports of a ban to counter the controversial trend of young men frequenting shopping malls in their undershirts and long pyjamas.

Women, however, are still expected to cover their body with a cloak, head covering and a veil according to the country’s strict Islamic laws.


Friday, 15 March, 2002, 12:19 GMT  

Saudi police ‘stopped’ fire rescue
 
Saudi Arabia’s religious police stopped schoolgirls from leaving a blazing building because they were not wearing correct Islamic dress, according to Saudi newspapers.

In a rare criticism of the kingdom’s powerful “mutaween” police, the Saudi media has accused them of hindering attempts to save 15 girls who died in the fire on Monday.

An inquiry was launched by the Saudi government in wake of the deaths. The investigation was led by Abdul Majeed, the governor of Makkah. The Interior Minister, Prince Nayef, promised that those responsible for the deaths would be held accountable.[7] Nayef, at the time, stated that the deaths didn’t happen as a result of the fire, but rather the stampede caused by the panic. He acknowledged the presence of two mutaween and that they went there to prevent “mistreatment” of the girls. He asserted that they didn’t interfere with the rescue efforts and only arrived after everyone had left the building.[7]
On March 25, the inquiry concluded that while the fire had been caused by a stray cigarette, the religious educational authorities responsible for the school had neglected the safety of the pupils.[3] The inquiry found that the clerics had ignored warnings that overcrowding of the school could cause a fatal stampede. It also found that there was a lack of fire extinguishers and alarms in the building. Accordingly, the cleric in charge of the school was fired, and his office was merged with the Ministry of Education. The report dismissed allegations that the mutaween (of CPVPV) had prevented the girls from fleeing or made the death toll worse.[3]
Many newspapers welcomed the merger of the agency responsible for girls’ education with the Ministry of Education. Previously, the agencies had been separate and girls’ education had been in the hands of the religious establishment. The newspapers saw the merger as a step towards “reform”.


Elham Asghari is an Iranian swimmer who began swimming at the age of five. She holds several national open-water swimming records. Elham swims wearing a full-body swimsuit she designed that fully adheres to Iran’s Islamic dress code for women. She says the suit hinders her performance and causes her pain, adding a hefty six kilograms to her weight in water. Still she wears it in order to pursue her lifelong dream of being an open-water swimmer.
Achieving that dream has not been without its challenges for Elham. In Iran women are only allowed to swim in gender-segregated pools and are banned from participating in international swimming competitions. During a previous open-water record-attempt, Iranian police chased Elham in a boat in order to stop her from swimming. The propellers on the police boat sliced her legs and hip.
Elham broke her previous 20km open-water record, in June of 2013, by completing a swim in the Caspian Sea in just over eight hours. She swam in a private, women-only beach to avoid another run in with the police. Yet, Iranian officials have refused to recognize her record, stating that her swimming costume, which she had worn when setting her previous records, was illegal because “the feminine characteristics of her body were visible when she came out of the water.

As an Iranian-American woman living in the United States, I feel it is my duty to raise the publics’ awareness on the issue at hand. I’m asking the International Swimming Federation (FINA) to require the Iranian Swimming Federation to register the record Elham Asghari rightfully earned.
Elham Asghari is a talented, accomplished athlete who has worked tirelessly as an open-water swimmer. She continues to face obstacles and challenges that most athletes would never have to deal with on a daily basis. Like any other athlete she deserves to be recognized for her accomplishments. Please join me in asking FINA to help get Elham’s record recognized.


(CNN) — Women stood at the forefront of the Arab Spring, taking to the streets shoulder to shoulder with men in an effort to overturn oppressive old orders.

But while their efforts have seen dictators ousted and reforms introduced, the greater rights for women many hoped would emerge from the upheaval have not materialized.

Indeed, says Lebanese activist Diala Haidar, the rise of political Islam throughout the region in the wake of the uprising has raised the specter of hard-won gains for women being lost.

Haidar and four other women’s rights activists across the region started a campaign, The Uprising of Women in the Arab World, on Facebook in October 2011, to highlight injustices against women throughout the region.

“The Arab Spring took place under the banner of freedom, dignity and equality, and the three can’t be established if women are left behind,” said Haidar, 28, a laboratory supervisor.

“At every stage of history we have been given the excuse, ‘It’s not the time to discuss women’s issues — we are at war, it’s a revolution,’ or whatever. It’s our time to say ‘We need our rights,'” she added.


RIYADH — Denied the right to travel without consent from their male guardians and banned from driving, women in Saudi Arabia are now monitored by an electronic system that tracks any cross-border movements.

Since last week, Saudi women’s male guardians began receiving text messages on their phones informing them when women under their custody leave the country, even if they are travelling together.

Manal al-Sherif, who became the symbol of a campaign launched last year urging Saudi women to defy a driving ban, began spreading the information on Twitter, after she was alerted by a couple.


International Olympic Committee rules require that countries allow both men and women to compete as a prerequisite for their participation in the Olympic Games. Saudia Arabia, a country that has never sent a female athlete to the games, has been warned of this, promised to correct the situation, and then sort of did nothing for awhile and hoped that no one would notice.

Now, one human rights group says enough is enough and is encouraging the IOC to bar the Middle Eastern Kingdom from the Games, on account of the fact that they’re clearly dragging their feet on this. In a letter to the IOC on Wednesday, the organization demanded Saudi Arabia be barred from the upcoming London Olympic Games if they fail to send a lady to compete.

For awhile, it looked as though Saudi Arabia would actually comply with the IOC’s warning. Equestrian Dalma Rushdi Malhas competed for the kingdom in the 2010 Youth Olympic Games, where she took home a bronze medal. Some analysts believed that she had the best chance to qualify for the Olympics, but now, it seems that the country’s all-male equestrian team is deep into training in Europe— without her.

Further, Olympic rules have bent over backward to allow countries with fewer highly trained athletes to send participants to the games by offering universality slots in many track and field and swimming events. The slots are reserved for countries that can’t produce any athletes that meet the qualifying standards. Saudi Arabia has not opted to fill any of those slots with female athletes.

A spokesperson from the IOC rejected the call for a Saudi ban, saying that the Games don’t issue ultimatums or deadlines to countries who wish to participate, that Malhas’s participation in the Youth Olympic Games was a positive sign that Saudi Arabia was serious about including ladies.

But Human Rights Watch isn’t not so sure this is the case. Girls and boys are strictly segregated in the country, and all girls schools do not offer any sort of physical education, exercise, or sports teams. For a Saudi woman to have any hope of training, she’d have to do it in another country. Saudi Arabia was never serious about including women in sport, and may never be.

Ban Urged on Saudi Arabia over Discrimination [NYT]

The Iraqi Council of Representatives will vote to legalise Forced Child Marriage1.
The specifics of the legislation (part of the Jaafari Personal Status Law) are terrifying:

  • There will no longer be a minimum age to legally marry (it’s currently 18) but the law provides policies for divorcing a 9-year-old girl;
  • A girl’s father would legally be able to accept a marriage proposal on her behalf; and
  • The girl would be legally prohibited from resisting her husband’s advances and leaving the home without his permission.

It’s a recipe for a life in domestic and sexual slavery.

The law was sent to the Council of Representatives yesterday, and the vote could happen any time now. To prevent Iraq’s girls from becoming vulnerable to forced child marriage it is crucial that we act now.

Currently, Iraq has one of the most progressive policies on women’s rights in the Middle East — setting the legal marriage age at 18 and prohibiting forced marriage2.

Any minute now, the Iraqi Council of Representatives will vote to legalise forced child marriage. 1
The specifics of the legislation (part of the Jaafari Personal Status Law) are terrifying:
  • There will no longer be a minimum age to legally marry (it’s currently 18) but the law provides policies for divorcing a 9-year-old;
  • A girl’s father would legally be able to accept a marriage proposal; and
  • The girl would be legally prohibited from resisting her husband’s advances and leaving the home without his permission.
It’s a recipe for a life in domestic and sexual slavery.
Currently, Iraq has one of the most progressive policies on women’s rights in the Middle East — setting the legal marriage age at 18 and prohibiting forced marriage.2
Brave Iraqi women have been fighting against removing the minimum age for marriage, for their sake and for the sake of their daughters. Last month on International Women’s Day, countless women attended demonstrations in Baghdad protesting the Jaafari Personal Status Law. They called it the “Day of Mourning”.3
We may not have much time to stop Iraq from legalising forced child marriage and a lifetime of domestic and sexual slavery for girls and women. Call on the the Iraqi Council of Representatives to vote “no” to the Jaafari Personal Status Law today.


|

Saudi Arabia’s feared morality police say they will not punish men who walk around in their underwear – but women still face harsh punishments if they violate strict laws on women’s dress codes.

The Commission for the Promotion of Virtue and Prevention of Vice has denied reports of a ban to counter the controversial trend of young men frequenting shopping malls in their undershirts and long pyjamas.

Women, however, are still expected to cover their body with a cloak, head covering and a veil according to the country’s strict Islamic laws.


Friday, 15 March, 2002, 12:19 GMT  

Saudi police ‘stopped’ fire rescue
 
Saudi Arabia’s religious police stopped schoolgirls from leaving a blazing building because they were not wearing correct Islamic dress, according to Saudi newspapers.

In a rare criticism of the kingdom’s powerful “mutaween” police, the Saudi media has accused them of hindering attempts to save 15 girls who died in the fire on Monday.

An inquiry was launched by the Saudi government in wake of the deaths. The investigation was led by Abdul Majeed, the governor of Makkah. The Interior Minister, Prince Nayef, promised that those responsible for the deaths would be held accountable.[7] Nayef, at the time, stated that the deaths didn’t happen as a result of the fire, but rather the stampede caused by the panic. He acknowledged the presence of two mutaween and that they went there to prevent “mistreatment” of the girls. He asserted that they didn’t interfere with the rescue efforts and only arrived after everyone had left the building.[7]
On March 25, the inquiry concluded that while the fire had been caused by a stray cigarette, the religious educational authorities responsible for the school had neglected the safety of the pupils.[3] The inquiry found that the clerics had ignored warnings that overcrowding of the school could cause a fatal stampede. It also found that there was a lack of fire extinguishers and alarms in the building. Accordingly, the cleric in charge of the school was fired, and his office was merged with the Ministry of Education. The report dismissed allegations that the mutaween (of CPVPV) had prevented the girls from fleeing or made the death toll worse.[3]
Many newspapers welcomed the merger of the agency responsible for girls’ education with the Ministry of Education. Previously, the agencies had been separate and girls’ education had been in the hands of the religious establishment. The newspapers saw the merger as a step towards “reform”.


Elham Asghari is an Iranian swimmer who began swimming at the age of five. She holds several national open-water swimming records. Elham swims wearing a full-body swimsuit she designed that fully adheres to Iran’s Islamic dress code for women. She says the suit hinders her performance and causes her pain, adding a hefty six kilograms to her weight in water. Still she wears it in order to pursue her lifelong dream of being an open-water swimmer.
Achieving that dream has not been without its challenges for Elham. In Iran women are only allowed to swim in gender-segregated pools and are banned from participating in international swimming competitions. During a previous open-water record-attempt, Iranian police chased Elham in a boat in order to stop her from swimming. The propellers on the police boat sliced her legs and hip.
Elham broke her previous 20km open-water record, in June of 2013, by completing a swim in the Caspian Sea in just over eight hours. She swam in a private, women-only beach to avoid another run in with the police. Yet, Iranian officials have refused to recognize her record, stating that her swimming costume, which she had worn when setting her previous records, was illegal because “the feminine characteristics of her body were visible when she came out of the water.

As an Iranian-American woman living in the United States, I feel it is my duty to raise the publics’ awareness on the issue at hand. I’m asking the International Swimming Federation (FINA) to require the Iranian Swimming Federation to register the record Elham Asghari rightfully earned.
Elham Asghari is a talented, accomplished athlete who has worked tirelessly as an open-water swimmer. She continues to face obstacles and challenges that most athletes would never have to deal with on a daily basis. Like any other athlete she deserves to be recognized for her accomplishments. Please join me in asking FINA to help get Elham’s record recognized.


(CNN) — Women stood at the forefront of the Arab Spring, taking to the streets shoulder to shoulder with men in an effort to overturn oppressive old orders.

But while their efforts have seen dictators ousted and reforms introduced, the greater rights for women many hoped would emerge from the upheaval have not materialized.

Indeed, says Lebanese activist Diala Haidar, the rise of political Islam throughout the region in the wake of the uprising has raised the specter of hard-won gains for women being lost.

Haidar and four other women’s rights activists across the region started a campaign, The Uprising of Women in the Arab World, on Facebook in October 2011, to highlight injustices against women throughout the region.

“The Arab Spring took place under the banner of freedom, dignity and equality, and the three can’t be established if women are left behind,” said Haidar, 28, a laboratory supervisor.

“At every stage of history we have been given the excuse, ‘It’s not the time to discuss women’s issues — we are at war, it’s a revolution,’ or whatever. It’s our time to say ‘We need our rights,'” she added.


RIYADH — Denied the right to travel without consent from their male guardians and banned from driving, women in Saudi Arabia are now monitored by an electronic system that tracks any cross-border movements.

Since last week, Saudi women’s male guardians began receiving text messages on their phones informing them when women under their custody leave the country, even if they are travelling together.

Manal al-Sherif, who became the symbol of a campaign launched last year urging Saudi women to defy a driving ban, began spreading the information on Twitter, after she was alerted by a couple.


International Olympic Committee rules require that countries allow both men and women to compete as a prerequisite for their participation in the Olympic Games. Saudia Arabia, a country that has never sent a female athlete to the games, has been warned of this, promised to correct the situation, and then sort of did nothing for awhile and hoped that no one would notice.

Now, one human rights group says enough is enough and is encouraging the IOC to bar the Middle Eastern Kingdom from the Games, on account of the fact that they’re clearly dragging their feet on this. In a letter to the IOC on Wednesday, the organization demanded Saudi Arabia be barred from the upcoming London Olympic Games if they fail to send a lady to compete.

For awhile, it looked as though Saudi Arabia would actually comply with the IOC’s warning. Equestrian Dalma Rushdi Malhas competed for the kingdom in the 2010 Youth Olympic Games, where she took home a bronze medal. Some analysts believed that she had the best chance to qualify for the Olympics, but now, it seems that the country’s all-male equestrian team is deep into training in Europe— without her.

Further, Olympic rules have bent over backward to allow countries with fewer highly trained athletes to send participants to the games by offering universality slots in many track and field and swimming events. The slots are reserved for countries that can’t produce any athletes that meet the qualifying standards. Saudi Arabia has not opted to fill any of those slots with female athletes.

A spokesperson from the IOC rejected the call for a Saudi ban, saying that the Games don’t issue ultimatums or deadlines to countries who wish to participate, that Malhas’s participation in the Youth Olympic Games was a positive sign that Saudi Arabia was serious about including ladies.

But Human Rights Watch isn’t not so sure this is the case. Girls and boys are strictly segregated in the country, and all girls schools do not offer any sort of physical education, exercise, or sports teams. For a Saudi woman to have any hope of training, she’d have to do it in another country. Saudi Arabia was never serious about including women in sport, and may never be.

Ban Urged on Saudi Arabia over Discrimination [NYT]

the scariest place on earth

March 18, 2014 – 7:28 PM

– See more at: http://cnsnews.com/news/article/patrick-goodenough/north-korean-born-prison-camp-my-favorite-word-freedom#sthash.040mlHnp.dpuf

According to a comprehensive study by the Committee for Human Rights in North Korea (PDF, 5.2 MB), as many as 200,000 North Koreans are incarcerated on political grounds. Former inmates have testified of routine beatings, systematic torture, forced abortions, infanticide and executions,
The report describes the Kwan-li-so as “political penal labor colonies, where North Koreans suspected of wrong-doing and wrong-thinking, along with up to three generations of family members are summarily deported without trial to disappear into fenced-in and heavily guarded mountainous areas where they are subjected to forced labor in mines, logging, state farming and factory work, for mostly lifetime duration.”

– See more at: http://cnsnews.com/news/article/patrick-goodenough/north-korean-born-prison-camp-my-favorite-word-freedom#sthash.040mlHnp.dpuf


Published: 21 December, 2012, 11:18

South Korea’s President-elect Park Geun-hye promises more openness with the North. But a resumption of the ‘Sunshine’ policy is unlikely as she makes demands Pyongyang will find impossible to meet.

The ever-changing political landscapes of the Korean Peninsula never fails to offer stark contrasts. To the north, a sombre December is spent mourning the forefathers of the communist dynasty under the rule of a boy-king and his advisers. To the south, voters have elected the nation’s first female president, the daughter of South Korea’s iconic former leader, Park Chung-hee.

While their circumstances and rise to power could not be more dissimilar, both Kim Jong-un and Park Geun-hye derive some degree of public support through channelling nostalgia for their parent’s legacies. In South Korea, one of the world’s most rapidly ageing societies, Park relied heavily on the elderly for her support base, who associate her with the economic prosperity of her father’s rule, in much the same way as northerners regard the times of Kim Il-sung. As the new president prepares to take office in February 2013, many among South Korea’s left leaning youth see Park Geun-hye as an enabler of status quo conservatism veiled behind a thin liberal facade.

Park is widely credited with resuscitating the legitimacy of the ruling Saenuri party, which has garnered record-setting disapproval ratings under incumbent President Lee Myung-bak. Money laundering scandals, tax evasion, and accusations of embezzlement have followed the outgoing President Lee, who has come down hard on dissenters by jailing activists and artists who have criticized his rule. Lee is also responsible for dismantling Seoul’s liberal approach to North Korea as seen through the “Sunshine Policy” of previous administrations, at the cost of nearly reigniting the Korean war after a series of provocative live fire exchanges in disputed territorial waters in 2010 that saw the North shell the South’s Yeonpyeong island, and the sinking of a South Korean naval vessel.

Despite running on the conservative ticket, Park has steered clear of openly advocating Lee’s hardline on Pyongyang in her campaign rhetoric. Although an unpredictable North Korea looms just 70km from Seoul, domestic economic issues are the most immediate focus of the South Korean voter.
­Leading a ‘Chaebol Republic’

An odious brand of crony-corporatism has prevailed in the South Korean economy, spearheaded by the chaebol, large-scale conglomerates like Hyundai, LG, and Samsung. While these recognizable brands have indeed brought much wealth and opportunity to the southern half of the peninsula, Koreans on the lower end of the economic food chain feel neglected by the nation’s mega-corporations and the wealthy political elite. Prior to taking office, President Lee ran the Hyundai Engineering and Construction conglomerate, and has pardoned the chairs of Samsung and Hyundai Motors from jail over convictions for fraud. Park’s opponent, the liberal Moon Jae-in of the Democratic United Party, has accused the country’s conglomerate-dominated economic model of being the main contributing factor to economic inequality, blaming Park’s father with developing the corporatist economic model still prevalent today.

The defeated Moon Jae-in spoke of increasing taxation on the wealthy and providing small businesses with economic protection from the chaebol. President Lee’s passing of a free-trade agreement with the United States enraged many working class people and farmers who fear the flooding of Korean markets with cheap foreign agricultural products. Moon publicly voiced his disapproval of the trade regime and vowed to re-negotiate it; this position resonated well with young leftists, but popular disdain for establishment parties like Moon’s Democratic United Party proved to be a major obstacle for the left.

Park, on the other hand, has toed the party line of President Lee by championing economic and diplomatic ties with Washington, while resisting calls for taxing the chaebol in fear of hampering their growth. Park has played more of a centrist role than one would expect from a conservative ticket by advocating college tuition cuts, maternity assistance, free school lunches, and other social welfare programs, but has come under fire for being unable to answer basic questions about minimum wage figures during a debate, prompting tough statements from the Korean Confederation of Trade Unions:

“It is terribly discouraging when a person who wants to become president does not even know the country’s minimum wage, which is a minimal right for survival and the first step toward a welfare state.”
Park’s ‘Trustpolitik’ & Inter-Korean relations

­The failures of Lee Myung-bak’s loathed tenure are none more apparent than in the field of inter-Korean relations. As Kim Jong-un consolidates power in Pyongyang and toys with introducing the seedlings of economic reform, it is high time for a change in attitude from the Blue House in Seoul toward more amenable relations between the two Koreas. Although Park has publically stood clear of Lee’s tough stance, a closer look at her foreign policy signifies more acquiesce than divergence from the status quo. In a 2011 article published by Park in the Council on Foreign Relation’s Foreign Affairs website titled, “A New Kind of Korea,” the incoming president talks of adopting a policy of “trustpolitik,” aimed at developing a minimum level of trust between the two Koreas. Just as it exists under the current leadership of President Lee, the cornerstone of Park’s policy revolves around Pyongyang abandoning its nuclear program and de-weaponizing, or suffering the consequences.

Park is setting herself up to fail, and having visited Pyongyang in person to negotiate with Kim Jong-il, one would assume she would be less naïve on the issue of Pyongyang’s nuclear program and the importance it holds to North Koreans. After the death of Kim Il-sung in 1994, his son oversaw general economic mismanagement and a series of natural disasters that led to widespread starvation. To legitimize his tenure, Kim Jong il introduced Songun politics, a military-first policy aimed at appeasing the military and building up national defenses. The attainment of a “nuclear deterrent” has been trumpeted as a major accomplishment in domestic North Korean propaganda, despite very little concrete evidence of the capability of these weapons, or the status of Pyongyang’s nuclear program.

It is unrealistic to expect Pyongyang to give up its nuclear program, primarily because achieving the status of a nuclear state, proven or not, is Kim Jong-il’s main “accomplishment.” The upper echelons of leadership in the Korean Worker’s Party surely hold dear the lessons of Gaddafi after dismantling Libya’s nuclear program. Pyongyang continues to pursue provocative missile tests and belligerent rhetoric because they view this as a means of ensuring their security, the fact that the Pyongyang power-dynasty has moved into a third generation is proof enough that this policy has worked for them. Park has spoken of taking a middle-of-the-road approach, and proposed an inter-Korean dialogue with Kim Jong-un. These are goals that represent a more practical shift, but if Park’s policy rests solely on being open to Pyongyang only if they disarm, the incoming administration will find itself mired in President Lee’s legacy of tension. In line with the militarism of her conservative party, Park has spoken of plans to create an East Asian military alliance and appears willing to continue the hardline against Pyongyang:

“Asian states must slow down their accelerating arms build-up, reduce military tensions, and establish a cooperative security regime that would complement existing bilateral agreements and help resolve persistent tensions in the region.”

“South Korea must first demonstrate, through a robust and credible deterrent posture, that it will no longer tolerate North Korea’s increasingly violent provocations. It must show Pyongyang that the North will pay a heavy price for its military and nuclear threats. This approach is not new, but in order to change the current situation, it must be enforced more vigorously than in the past.”

In contrast to Park, Moon Jae-in’s Democratic United Party has touted a return to the “Sunshine Policy,” and has advocated restarting unconditional aid to Pyongyang. The conservative political elite in Seoul fails to realize that relations with North Korea can more effectively be cooled not by pursuing hardline policies and provocative military drills, but by bolstering inter-Korean economic ties, tourism, and exchange. Kim Jong-un can only begin to dismantle the military-first policy by offering some alternative whereby he maintains his legitimacy – that could potentially be by increasing economic opportunity, raising standards of living, and developing North Korea’s economy. Seoul would be in a much better position to negotiate if they had a hand in mutually beneficial economic development with the North. Park’s ambitions of creating a “cooperative security regime” with Asian states (presuming North Korea is excluded) will certainly not help convince Pyongyang to disarm. An “Asian NATO” is counterproductive and would only make Pyongyang more unpredictable – as long as Seoul’s ballistic missiles are capable of hitting any part of North Korea, expecting Pyongyang to commit political suicide by disarming is simply not realistic.
Korea at the crossroads

The incoming South Korean administration has lots of problems on its hands; managing an ageing population with some of the world’s lowest birth rates, tackling increasing prostitution rates, high suicide rates and other social ills, and coping with an economic slowdown in China, the nation’s biggest export market. South Korea’s economic development has lifted millions out of poverty and into the economic space of high earners in the span of a few decades. It would be foolish for Park to pursue the foreign policy of her predecessor and risk reigniting a Korean war and all that would come with it; enormous civilian casualty rates, an unprecedented refugee crisis, along with the destruction of the South Korean economy. All signs point to Park Geun-hye continuing along the same economic trajectory as the incumbent President Lee, perhaps with a greater emphasis on social welfare programs. The next five years will be critical for inter-Korean relations. In attempting to emerge from her father’s shadow, one would hope that she could address the faults in the economic system her father helped create by reducing income disparity, and also learn from his mistakes by allowing free and open political dissent and total freedom of expression.

­Nile Bowie for RT

The statements, views and opinions expressed in this column are solely those of the author and do not necessarily represent those of RT.


Published: 23 January, 2013, 06:50

Stressing its condemnation of North Korea’s recent rocket launch, the UN Security Council has unanimously approved a resolution expanding existing sanctions against Pyongyang. In response, the communist state vowed to step up its nuclear deterrence.

On Tuesday the council once again reiterated its demand that North Korea abandon its nuclear program, and “deplored” Pyongyang’s violations of previous resolutions.

December’s rocket launch put a satellite into orbit, but is suspected of being part of a covert program to develop ballistic missiles capable of carrying warheads.

The new resolution contains “important new sanctions on its companies and government agencies, including North Korea’s space agency, which was responsible for the launch, a bank and on North Korean individuals. It also updates current lists of nuclear and ballistic missile technology banned for transfer” to and from North Korea, said US Ambassador to the UN Susan Rice.

In retaliation for the move, Pyongyang has threatened to step up its nuclear deterrence and pull out from the process of denuclearization of the Korean Peninsula.

“We will take measures to boost and strengthen our defensive military power including nuclear deterrence,” its foreign ministry said in a statement carried by state news agency KCNA.

For the first time in four years, the move against Pyongyang was backed by its main regional ally China. China’s support makes the resolution binding, unlike previous Security Council statements, which were unenforceable.

“We believe that action taken by the Council should be prudent, measured, proportionate, and conducive to stability,” Chinese Ambassador Li Baodong said after the vote, as quoted by AP.

UN Secretary-General Ban Ki-moon welcomed the adoption of the resolution, saying in a statement: “Speaking with one voice, the Security Council reiterated its firm stance that the DPRK’s pursuit of nuclear weapons, including means of delivery, is unacceptable.”


By Ju-min Park and Choonsik Yoo | Reuters
1/23/2013

SEOUL (Reuters) – North Korea said on Thursday it would carry out further rocket launches and a nuclear test that would target the United States, dramatically stepping up its threats against a country it called its “enemy”.

The announcement by the country’s top military body came a day after the United Nations Security Council agreed a U.S.-backed resolution to censure and sanction the country for a rocket launch in December that breached U.N. rules.

“We are not disguising the fact that the various satellites and long-range rockets that we will fire and the high-level nuclear test we will carry out are targeted at the United States,” North Korea’s National Defence Commission said, according to state news agency KCNA.

North Korea is believed by South Korea and other observers to be “technically ready” for a third nuclear test, and the decision to go ahead rests with leader Kim Jong-un who pressed ahead with the December rocket launch in defiance of the U.N. sanctions.

“Whether North Korea tests or not is up to North Korea,” Glyn Davies, the top U.S. envoy for North Korean diplomacy, said in the South Korean capital of Seoul as KCNA released its statement.

“We hope they don’t do it. We call on them not to do it,” Davies said. “This is not a moment to increase tensions on the Korean peninsula.”

The North was banned from developing missile and nuclear technology under sanctions dating from its 2006 and 2009 nuclear tests.

The concern now is that Pyongyang, whose only major diplomatic ally, China, endorsed the latest U.N. resolution, could undertake a third nuclear test using highly enriched uranium for the first time, opening a second path to a bomb.

Its previous tests have been viewed as limited successes and used plutonium, of which the North has limited stocks.

North Korea gave no time-frame for the coming test and often employs harsh rhetoric in response to U.N. and U.S. actions.

Its long-range rockets are not seen as capable of reaching the United States mainland and it is not believed to have the technology to mount a nuclear warhead on a long-range missile.

“The UNSC (Security Council) resolution masterminded by the U.S. has brought its hostile policy towards the Democratic Peoples Republic of Korea (North Korea) to its most dangerous stage,” the commission was quoted as saying.

(Writing by David Chance; Editing by Raju Gopalakrishnan)


President Barack Obama is due to visit the demilitarised zone (DMZ) on South Korea’s border with the North on Sunday before a nuclear summit in Seoul.

The United States president’s trip to the area separating the north and south on the Korean peninsula comes amidst increased tension over Pyongyang’s plan to launch a rocket next month.

His visit will be a show of support for South Korea, said the White House.

There are currently about 28,500 US soldiers stationed in the area.

North and South Korea technically remain at war because their three-year conflict ended in an armistice in 1953 and no peace treaty was signed. The US has since stationed troops in South Korea.

The 4km(2.5-mile)-wide DMZ is probably the most heavily guarded border area in the world. Former US President Bill Clinton described it as ”the scariest place on earth” when he visited in the 1990s.

Mr Obama, who is expected to renew pressure on Pyongyang to abandon its nuclear ambitions, will also meet South Korea’s President Lee Myung-bak ahead of the summit starting on Monday.

The three-day Nuclear Security Summit involves more than 53 leaders from nations and international organisations.

Mr Obama is also due to meet Chinese President Hu Jintao and is widely expected to urge him to draw on Beijing’s influence for nuclear negotiations with Pyongyang.
‘Grave provocation’

North Korea’s announcement last week that it will launch a rocket carrying a satellite to mark its late leader Kim Il-sung’s birth centenary in April drew widespread criticism.

The move is seen as violating UN Security Council resolutions passed after a similar launch in 2009.

South Korea said the launch would be a “grave provocation” and Japan urged the North to “exercise restraint”.

Japan, particularly concerned as the 2009 rocket was launched over the country, said the move would ”interfere with our effort toward a dialogue”.

Last month, Pyongyang agreed to suspend long-range missile tests as part of a deal for the US to supply 240,000 tonnes of food aid to North Korea.

The US has said that the planned launch could violate the agreement and affect the resumption of food aid.

The North said that the ”working satellite” launch is an opportunity for ”putting the country’s technology of space use for peaceful purposes on a higher stage”.

At the nuclear summit dedicated to reducing the threats of nuclear terrorism, the North Korean issue will loom large, along with that of Iran’s nuclear programme.

March 18, 2014 – 7:28 PM

– See more at: http://cnsnews.com/news/article/patrick-goodenough/north-korean-born-prison-camp-my-favorite-word-freedom#sthash.040mlHnp.dpuf

According to a comprehensive study by the Committee for Human Rights in North Korea (PDF, 5.2 MB), as many as 200,000 North Koreans are incarcerated on political grounds. Former inmates have testified of routine beatings, systematic torture, forced abortions, infanticide and executions,
The report describes the Kwan-li-so as “political penal labor colonies, where North Koreans suspected of wrong-doing and wrong-thinking, along with up to three generations of family members are summarily deported without trial to disappear into fenced-in and heavily guarded mountainous areas where they are subjected to forced labor in mines, logging, state farming and factory work, for mostly lifetime duration.”

– See more at: http://cnsnews.com/news/article/patrick-goodenough/north-korean-born-prison-camp-my-favorite-word-freedom#sthash.040mlHnp.dpuf


Published: 21 December, 2012, 11:18

South Korea’s President-elect Park Geun-hye promises more openness with the North. But a resumption of the ‘Sunshine’ policy is unlikely as she makes demands Pyongyang will find impossible to meet.

The ever-changing political landscapes of the Korean Peninsula never fails to offer stark contrasts. To the north, a sombre December is spent mourning the forefathers of the communist dynasty under the rule of a boy-king and his advisers. To the south, voters have elected the nation’s first female president, the daughter of South Korea’s iconic former leader, Park Chung-hee.

While their circumstances and rise to power could not be more dissimilar, both Kim Jong-un and Park Geun-hye derive some degree of public support through channelling nostalgia for their parent’s legacies. In South Korea, one of the world’s most rapidly ageing societies, Park relied heavily on the elderly for her support base, who associate her with the economic prosperity of her father’s rule, in much the same way as northerners regard the times of Kim Il-sung. As the new president prepares to take office in February 2013, many among South Korea’s left leaning youth see Park Geun-hye as an enabler of status quo conservatism veiled behind a thin liberal facade.

Park is widely credited with resuscitating the legitimacy of the ruling Saenuri party, which has garnered record-setting disapproval ratings under incumbent President Lee Myung-bak. Money laundering scandals, tax evasion, and accusations of embezzlement have followed the outgoing President Lee, who has come down hard on dissenters by jailing activists and artists who have criticized his rule. Lee is also responsible for dismantling Seoul’s liberal approach to North Korea as seen through the “Sunshine Policy” of previous administrations, at the cost of nearly reigniting the Korean war after a series of provocative live fire exchanges in disputed territorial waters in 2010 that saw the North shell the South’s Yeonpyeong island, and the sinking of a South Korean naval vessel.

Despite running on the conservative ticket, Park has steered clear of openly advocating Lee’s hardline on Pyongyang in her campaign rhetoric. Although an unpredictable North Korea looms just 70km from Seoul, domestic economic issues are the most immediate focus of the South Korean voter.
­Leading a ‘Chaebol Republic’

An odious brand of crony-corporatism has prevailed in the South Korean economy, spearheaded by the chaebol, large-scale conglomerates like Hyundai, LG, and Samsung. While these recognizable brands have indeed brought much wealth and opportunity to the southern half of the peninsula, Koreans on the lower end of the economic food chain feel neglected by the nation’s mega-corporations and the wealthy political elite. Prior to taking office, President Lee ran the Hyundai Engineering and Construction conglomerate, and has pardoned the chairs of Samsung and Hyundai Motors from jail over convictions for fraud. Park’s opponent, the liberal Moon Jae-in of the Democratic United Party, has accused the country’s conglomerate-dominated economic model of being the main contributing factor to economic inequality, blaming Park’s father with developing the corporatist economic model still prevalent today.

The defeated Moon Jae-in spoke of increasing taxation on the wealthy and providing small businesses with economic protection from the chaebol. President Lee’s passing of a free-trade agreement with the United States enraged many working class people and farmers who fear the flooding of Korean markets with cheap foreign agricultural products. Moon publicly voiced his disapproval of the trade regime and vowed to re-negotiate it; this position resonated well with young leftists, but popular disdain for establishment parties like Moon’s Democratic United Party proved to be a major obstacle for the left.

Park, on the other hand, has toed the party line of President Lee by championing economic and diplomatic ties with Washington, while resisting calls for taxing the chaebol in fear of hampering their growth. Park has played more of a centrist role than one would expect from a conservative ticket by advocating college tuition cuts, maternity assistance, free school lunches, and other social welfare programs, but has come under fire for being unable to answer basic questions about minimum wage figures during a debate, prompting tough statements from the Korean Confederation of Trade Unions:

“It is terribly discouraging when a person who wants to become president does not even know the country’s minimum wage, which is a minimal right for survival and the first step toward a welfare state.”
Park’s ‘Trustpolitik’ & Inter-Korean relations

­The failures of Lee Myung-bak’s loathed tenure are none more apparent than in the field of inter-Korean relations. As Kim Jong-un consolidates power in Pyongyang and toys with introducing the seedlings of economic reform, it is high time for a change in attitude from the Blue House in Seoul toward more amenable relations between the two Koreas. Although Park has publically stood clear of Lee’s tough stance, a closer look at her foreign policy signifies more acquiesce than divergence from the status quo. In a 2011 article published by Park in the Council on Foreign Relation’s Foreign Affairs website titled, “A New Kind of Korea,” the incoming president talks of adopting a policy of “trustpolitik,” aimed at developing a minimum level of trust between the two Koreas. Just as it exists under the current leadership of President Lee, the cornerstone of Park’s policy revolves around Pyongyang abandoning its nuclear program and de-weaponizing, or suffering the consequences.

Park is setting herself up to fail, and having visited Pyongyang in person to negotiate with Kim Jong-il, one would assume she would be less naïve on the issue of Pyongyang’s nuclear program and the importance it holds to North Koreans. After the death of Kim Il-sung in 1994, his son oversaw general economic mismanagement and a series of natural disasters that led to widespread starvation. To legitimize his tenure, Kim Jong il introduced Songun politics, a military-first policy aimed at appeasing the military and building up national defenses. The attainment of a “nuclear deterrent” has been trumpeted as a major accomplishment in domestic North Korean propaganda, despite very little concrete evidence of the capability of these weapons, or the status of Pyongyang’s nuclear program.

It is unrealistic to expect Pyongyang to give up its nuclear program, primarily because achieving the status of a nuclear state, proven or not, is Kim Jong-il’s main “accomplishment.” The upper echelons of leadership in the Korean Worker’s Party surely hold dear the lessons of Gaddafi after dismantling Libya’s nuclear program. Pyongyang continues to pursue provocative missile tests and belligerent rhetoric because they view this as a means of ensuring their security, the fact that the Pyongyang power-dynasty has moved into a third generation is proof enough that this policy has worked for them. Park has spoken of taking a middle-of-the-road approach, and proposed an inter-Korean dialogue with Kim Jong-un. These are goals that represent a more practical shift, but if Park’s policy rests solely on being open to Pyongyang only if they disarm, the incoming administration will find itself mired in President Lee’s legacy of tension. In line with the militarism of her conservative party, Park has spoken of plans to create an East Asian military alliance and appears willing to continue the hardline against Pyongyang:

“Asian states must slow down their accelerating arms build-up, reduce military tensions, and establish a cooperative security regime that would complement existing bilateral agreements and help resolve persistent tensions in the region.”

“South Korea must first demonstrate, through a robust and credible deterrent posture, that it will no longer tolerate North Korea’s increasingly violent provocations. It must show Pyongyang that the North will pay a heavy price for its military and nuclear threats. This approach is not new, but in order to change the current situation, it must be enforced more vigorously than in the past.”

In contrast to Park, Moon Jae-in’s Democratic United Party has touted a return to the “Sunshine Policy,” and has advocated restarting unconditional aid to Pyongyang. The conservative political elite in Seoul fails to realize that relations with North Korea can more effectively be cooled not by pursuing hardline policies and provocative military drills, but by bolstering inter-Korean economic ties, tourism, and exchange. Kim Jong-un can only begin to dismantle the military-first policy by offering some alternative whereby he maintains his legitimacy – that could potentially be by increasing economic opportunity, raising standards of living, and developing North Korea’s economy. Seoul would be in a much better position to negotiate if they had a hand in mutually beneficial economic development with the North. Park’s ambitions of creating a “cooperative security regime” with Asian states (presuming North Korea is excluded) will certainly not help convince Pyongyang to disarm. An “Asian NATO” is counterproductive and would only make Pyongyang more unpredictable – as long as Seoul’s ballistic missiles are capable of hitting any part of North Korea, expecting Pyongyang to commit political suicide by disarming is simply not realistic.
Korea at the crossroads

The incoming South Korean administration has lots of problems on its hands; managing an ageing population with some of the world’s lowest birth rates, tackling increasing prostitution rates, high suicide rates and other social ills, and coping with an economic slowdown in China, the nation’s biggest export market. South Korea’s economic development has lifted millions out of poverty and into the economic space of high earners in the span of a few decades. It would be foolish for Park to pursue the foreign policy of her predecessor and risk reigniting a Korean war and all that would come with it; enormous civilian casualty rates, an unprecedented refugee crisis, along with the destruction of the South Korean economy. All signs point to Park Geun-hye continuing along the same economic trajectory as the incumbent President Lee, perhaps with a greater emphasis on social welfare programs. The next five years will be critical for inter-Korean relations. In attempting to emerge from her father’s shadow, one would hope that she could address the faults in the economic system her father helped create by reducing income disparity, and also learn from his mistakes by allowing free and open political dissent and total freedom of expression.

­Nile Bowie for RT

The statements, views and opinions expressed in this column are solely those of the author and do not necessarily represent those of RT.


Published: 23 January, 2013, 06:50

Stressing its condemnation of North Korea’s recent rocket launch, the UN Security Council has unanimously approved a resolution expanding existing sanctions against Pyongyang. In response, the communist state vowed to step up its nuclear deterrence.

On Tuesday the council once again reiterated its demand that North Korea abandon its nuclear program, and “deplored” Pyongyang’s violations of previous resolutions.

December’s rocket launch put a satellite into orbit, but is suspected of being part of a covert program to develop ballistic missiles capable of carrying warheads.

The new resolution contains “important new sanctions on its companies and government agencies, including North Korea’s space agency, which was responsible for the launch, a bank and on North Korean individuals. It also updates current lists of nuclear and ballistic missile technology banned for transfer” to and from North Korea, said US Ambassador to the UN Susan Rice.

In retaliation for the move, Pyongyang has threatened to step up its nuclear deterrence and pull out from the process of denuclearization of the Korean Peninsula.

“We will take measures to boost and strengthen our defensive military power including nuclear deterrence,” its foreign ministry said in a statement carried by state news agency KCNA.

For the first time in four years, the move against Pyongyang was backed by its main regional ally China. China’s support makes the resolution binding, unlike previous Security Council statements, which were unenforceable.

“We believe that action taken by the Council should be prudent, measured, proportionate, and conducive to stability,” Chinese Ambassador Li Baodong said after the vote, as quoted by AP.

UN Secretary-General Ban Ki-moon welcomed the adoption of the resolution, saying in a statement: “Speaking with one voice, the Security Council reiterated its firm stance that the DPRK’s pursuit of nuclear weapons, including means of delivery, is unacceptable.”


By Ju-min Park and Choonsik Yoo | Reuters
1/23/2013

SEOUL (Reuters) – North Korea said on Thursday it would carry out further rocket launches and a nuclear test that would target the United States, dramatically stepping up its threats against a country it called its “enemy”.

The announcement by the country’s top military body came a day after the United Nations Security Council agreed a U.S.-backed resolution to censure and sanction the country for a rocket launch in December that breached U.N. rules.

“We are not disguising the fact that the various satellites and long-range rockets that we will fire and the high-level nuclear test we will carry out are targeted at the United States,” North Korea’s National Defence Commission said, according to state news agency KCNA.

North Korea is believed by South Korea and other observers to be “technically ready” for a third nuclear test, and the decision to go ahead rests with leader Kim Jong-un who pressed ahead with the December rocket launch in defiance of the U.N. sanctions.

“Whether North Korea tests or not is up to North Korea,” Glyn Davies, the top U.S. envoy for North Korean diplomacy, said in the South Korean capital of Seoul as KCNA released its statement.

“We hope they don’t do it. We call on them not to do it,” Davies said. “This is not a moment to increase tensions on the Korean peninsula.”

The North was banned from developing missile and nuclear technology under sanctions dating from its 2006 and 2009 nuclear tests.

The concern now is that Pyongyang, whose only major diplomatic ally, China, endorsed the latest U.N. resolution, could undertake a third nuclear test using highly enriched uranium for the first time, opening a second path to a bomb.

Its previous tests have been viewed as limited successes and used plutonium, of which the North has limited stocks.

North Korea gave no time-frame for the coming test and often employs harsh rhetoric in response to U.N. and U.S. actions.

Its long-range rockets are not seen as capable of reaching the United States mainland and it is not believed to have the technology to mount a nuclear warhead on a long-range missile.

“The UNSC (Security Council) resolution masterminded by the U.S. has brought its hostile policy towards the Democratic Peoples Republic of Korea (North Korea) to its most dangerous stage,” the commission was quoted as saying.

(Writing by David Chance; Editing by Raju Gopalakrishnan)


President Barack Obama is due to visit the demilitarised zone (DMZ) on South Korea’s border with the North on Sunday before a nuclear summit in Seoul.

The United States president’s trip to the area separating the north and south on the Korean peninsula comes amidst increased tension over Pyongyang’s plan to launch a rocket next month.

His visit will be a show of support for South Korea, said the White House.

There are currently about 28,500 US soldiers stationed in the area.

North and South Korea technically remain at war because their three-year conflict ended in an armistice in 1953 and no peace treaty was signed. The US has since stationed troops in South Korea.

The 4km(2.5-mile)-wide DMZ is probably the most heavily guarded border area in the world. Former US President Bill Clinton described it as ”the scariest place on earth” when he visited in the 1990s.

Mr Obama, who is expected to renew pressure on Pyongyang to abandon its nuclear ambitions, will also meet South Korea’s President Lee Myung-bak ahead of the summit starting on Monday.

The three-day Nuclear Security Summit involves more than 53 leaders from nations and international organisations.

Mr Obama is also due to meet Chinese President Hu Jintao and is widely expected to urge him to draw on Beijing’s influence for nuclear negotiations with Pyongyang.
‘Grave provocation’

North Korea’s announcement last week that it will launch a rocket carrying a satellite to mark its late leader Kim Il-sung’s birth centenary in April drew widespread criticism.

The move is seen as violating UN Security Council resolutions passed after a similar launch in 2009.

South Korea said the launch would be a “grave provocation” and Japan urged the North to “exercise restraint”.

Japan, particularly concerned as the 2009 rocket was launched over the country, said the move would ”interfere with our effort toward a dialogue”.

Last month, Pyongyang agreed to suspend long-range missile tests as part of a deal for the US to supply 240,000 tonnes of food aid to North Korea.

The US has said that the planned launch could violate the agreement and affect the resumption of food aid.

The North said that the ”working satellite” launch is an opportunity for ”putting the country’s technology of space use for peaceful purposes on a higher stage”.

At the nuclear summit dedicated to reducing the threats of nuclear terrorism, the North Korean issue will loom large, along with that of Iran’s nuclear programme.

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.

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Published on Mar 25, 2013

Cody R Wilson has figured out how to print a semi-automatic rifle from the comfort of his own home. Now he’s putting all the information online so that others will join him.

This is a story about the rapid evolution of a technology that has forced the American legal system to play catch up. Cody Wilson, a 25 year old University of Texas Law student, is an advocate for the open source production of firearms using 3D printing technology. This makes him a highly controversial figure on both sides of the gun control issue. MOTHERBOARD sat down with Cody in Austin, Texas to talk about the constitution, the legal system, and to watch him make and test-fire a 3D-printed gun.

Check out our podcast with Cody here: http://bit.ly/VICE-Podcast-Cody-Wilson

Produced By Erin Lee Carr
Edited by Chris O’Coin

Read more on MOTHERBOARD here: http://motherboard.vice.com/read/clic…

To find out more about what the ATF says about 3D-printed guns, read this: http://motherboard.vice.com/blog/the-…


Published on May 15, 2013

How does the Liberator works ?
The 3d printed gun (all made of plastic with a printer) designed by Defense Distributed is here modeled and animated with Solidworks to show its functionality.
Springs are not animated properly,


Published on May 7, 2013

Defense Distributed has made good on their promise to produce and fire the world’s first fully 3D-printed gun. Anthony looks at the impact this might have on our lives.

Read More:

Meet The “Liberator”: Test-Firing The World’s First Fully 3D-Printed Gun
http://www.forbes.com/sites/andygreen…
“Before “three” arrives, a shot reverberates across the overcast central Texas landscape.”

Defense Distributed
http://defdist.org/

World’s First 3D-Printed Gun Fired on Video
http://mashable.com/2013/05/06/3d-pri…
“Can guns really be 3D-printed? The answer to that question is a simple yes. If you don’t believe it, just watch Cody Wilson, the man behind the world’s first 3D-printed gun, firing the weapon on video.”

First 3D-Printed Gun Fired
http://www.telegraph.co.uk/news/world…
“A gun has been produced using a 3D-printer in a world first that has prompted concerns that the regulation of firearms may soon be impossible.”

DEFCAD Liberator
http://defcad.org/liberator/

What You Need To Know About The Liberator 3D-Printed Pistol
http://techcrunch.com/2013/05/06/what…
“Now that we have confirmation that the Liberator 3D-printed pistol can be fired without destroying the body, let’s address what this means for 3D printed weapons and, presumably, homemade weapons in general.”

3-D Printer Company Seizes Machine From Desktop Gunsmith
http://www.wired.com/dangerroom/2012/…
“Cody Wilson planned in the coming weeks to make and test a 3-D printed pistol.”

Published on May 13, 2013
Inventor of 3D Printer Guns Shut Down By Government – Cody Wilson’s Interview with Jacari Jackson

Cody Wilson’s on the air anouncement of the 3D Guns Printer guns anouncement can be seen on the video here: http://youtu.be/m5an-j3D190

You can check out the Liberator being shot for the first time on YouTube here: http://youtu.be/drPz6n6UXQY

Cody Wilson – Inventor of 3D Printer Guns Gets Shut Down By Government

3D printing guru Cody Wilson of Defense Distributed announced that the US Office of Defense Trade Controls Compliance, Enforcement Division (DTCC/END) had sent him a letter requesting the group remove all data supposedly in violation of the Arms Export Control Act from public access immediately on his website at http://defcad.org.

The State Department’s Office of Defense Trade Controls (DTCC) have shut down the Austin Texas based 3D printing company.

“I think information will be free, and it wants to be.” Cody said May 9th, 2012 when the State Department’s Office of Defense Trade Controls Compliance (DTCC) Enforcement Division had issued a take down notice to Austin-based 3D gun printing company Defense Distributed declaring the group’s open distribution of 3D gun part files on the Internet potentially violated export laws explicit in the International Traffic in Arms Regulations, or ITAR.

The notice came just days after the group finally managed a fully-functional gun using mainly parts printed from a 3D printer, and aimed to have Defense Distributed take down the offending files and cite their “procedures for determining proper jurisdiction of technical data,” data which, at this point the DTCC says, could be in violation of § 127.1 of the ITAR.

“As an arms manufacturer, we registered ITAR, but we thought since Defense Distributed would be a non-profit software company; we could not have to register for ITAR because we were just a software company and not interested in actual trade of arms, and then number 2, we could basically claim a public domain exemption from the ITAR and we wouldn’t have to ask permission to put the files up for download.”

Gun-related files, Wilson claims, are already regulated and must be permitted before they can be distributed online, but since the beginning, the group has tried to avoid asking government for permission, not to flout the laws, but because they believed they met public domain exemptions.

According to Wilson, the fact that the DTCC cites specific pieces of the ITAR is an indication that they may plan to bring criminal prosecutions of civil penalties against the group.

“So it’s not a good day for the project, but it was expected, and we released, especially the Liberator, in such a good way that it’s definitely online forever and, especially with news of this censorship, I don’t think it will ever disappear. So that’s a success even if Defense Distributed or DefCad is somehow indefinitely shut down.”

Wilson says the group knew what they were up against long before the project even started by studying the case of Phil Zimmermann, the inventor of the Pretty Good Privacy (PGP) encryption program who in 1993 was under investigation by the United States Customs Service.

Similarly, in that case, law enforcement wanted to see if Zimmermann’s software violated federal arms-export laws because the technology could be considered a munition in that, being readily available online, it made it too difficult to determine what kinds of files, transactions and emails were being exchanged and what countries they came from and went to.
As was the case with Zimmermann, Wilson hoped the popularization and widespread distribution of his group’s gun files would lead the State Department to reconsider, if not altogether dump, an investigative effort.

“And to me, I understand that this software seems more closely related to guns so it might be a different case, but the parallels seemed pretty strong. At the end of the day, these are just bits, they’re not actual bombs.”

The frantic rush to regulate the data was no doubt accelerated by Defense Distributed’s recent successes — printable 30-round AR magazines and lower receivers that could withstand more than 650 rounds and of course their latest conquest, the single-shot pistol known as the Liberator.

http://youtu.be/H9MsYlnJVkM

Published on Mar 25, 2013

Cody R Wilson has figured out how to print a semi-automatic rifle from the comfort of his own home. Now he’s putting all the information online so that others will join him.

This is a story about the rapid evolution of a technology that has forced the American legal system to play catch up. Cody Wilson, a 25 year old University of Texas Law student, is an advocate for the open source production of firearms using 3D printing technology. This makes him a highly controversial figure on both sides of the gun control issue. MOTHERBOARD sat down with Cody in Austin, Texas to talk about the constitution, the legal system, and to watch him make and test-fire a 3D-printed gun.

Check out our podcast with Cody here: http://bit.ly/VICE-Podcast-Cody-Wilson

Produced By Erin Lee Carr
Edited by Chris O’Coin

Read more on MOTHERBOARD here: http://motherboard.vice.com/read/clic…

To find out more about what the ATF says about 3D-printed guns, read this: http://motherboard.vice.com/blog/the-…


Published on May 15, 2013

How does the Liberator works ?
The 3d printed gun (all made of plastic with a printer) designed by Defense Distributed is here modeled and animated with Solidworks to show its functionality.
Springs are not animated properly,


Published on May 7, 2013

Defense Distributed has made good on their promise to produce and fire the world’s first fully 3D-printed gun. Anthony looks at the impact this might have on our lives.

Read More:

Meet The “Liberator”: Test-Firing The World’s First Fully 3D-Printed Gun
http://www.forbes.com/sites/andygreen…
“Before “three” arrives, a shot reverberates across the overcast central Texas landscape.”

Defense Distributed
http://defdist.org/

World’s First 3D-Printed Gun Fired on Video
http://mashable.com/2013/05/06/3d-pri…
“Can guns really be 3D-printed? The answer to that question is a simple yes. If you don’t believe it, just watch Cody Wilson, the man behind the world’s first 3D-printed gun, firing the weapon on video.”

First 3D-Printed Gun Fired
http://www.telegraph.co.uk/news/world…
“A gun has been produced using a 3D-printer in a world first that has prompted concerns that the regulation of firearms may soon be impossible.”

DEFCAD Liberator
http://defcad.org/liberator/

What You Need To Know About The Liberator 3D-Printed Pistol
http://techcrunch.com/2013/05/06/what…
“Now that we have confirmation that the Liberator 3D-printed pistol can be fired without destroying the body, let’s address what this means for 3D printed weapons and, presumably, homemade weapons in general.”

3-D Printer Company Seizes Machine From Desktop Gunsmith
http://www.wired.com/dangerroom/2012/…
“Cody Wilson planned in the coming weeks to make and test a 3-D printed pistol.”

Published on May 13, 2013
Inventor of 3D Printer Guns Shut Down By Government – Cody Wilson’s Interview with Jacari Jackson

Cody Wilson’s on the air anouncement of the 3D Guns Printer guns anouncement can be seen on the video here: http://youtu.be/m5an-j3D190

You can check out the Liberator being shot for the first time on YouTube here: http://youtu.be/drPz6n6UXQY

Cody Wilson – Inventor of 3D Printer Guns Gets Shut Down By Government

3D printing guru Cody Wilson of Defense Distributed announced that the US Office of Defense Trade Controls Compliance, Enforcement Division (DTCC/END) had sent him a letter requesting the group remove all data supposedly in violation of the Arms Export Control Act from public access immediately on his website at http://defcad.org.

The State Department’s Office of Defense Trade Controls (DTCC) have shut down the Austin Texas based 3D printing company.

“I think information will be free, and it wants to be.” Cody said May 9th, 2012 when the State Department’s Office of Defense Trade Controls Compliance (DTCC) Enforcement Division had issued a take down notice to Austin-based 3D gun printing company Defense Distributed declaring the group’s open distribution of 3D gun part files on the Internet potentially violated export laws explicit in the International Traffic in Arms Regulations, or ITAR.

The notice came just days after the group finally managed a fully-functional gun using mainly parts printed from a 3D printer, and aimed to have Defense Distributed take down the offending files and cite their “procedures for determining proper jurisdiction of technical data,” data which, at this point the DTCC says, could be in violation of § 127.1 of the ITAR.

“As an arms manufacturer, we registered ITAR, but we thought since Defense Distributed would be a non-profit software company; we could not have to register for ITAR because we were just a software company and not interested in actual trade of arms, and then number 2, we could basically claim a public domain exemption from the ITAR and we wouldn’t have to ask permission to put the files up for download.”

Gun-related files, Wilson claims, are already regulated and must be permitted before they can be distributed online, but since the beginning, the group has tried to avoid asking government for permission, not to flout the laws, but because they believed they met public domain exemptions.

According to Wilson, the fact that the DTCC cites specific pieces of the ITAR is an indication that they may plan to bring criminal prosecutions of civil penalties against the group.

“So it’s not a good day for the project, but it was expected, and we released, especially the Liberator, in such a good way that it’s definitely online forever and, especially with news of this censorship, I don’t think it will ever disappear. So that’s a success even if Defense Distributed or DefCad is somehow indefinitely shut down.”

Wilson says the group knew what they were up against long before the project even started by studying the case of Phil Zimmermann, the inventor of the Pretty Good Privacy (PGP) encryption program who in 1993 was under investigation by the United States Customs Service.

Similarly, in that case, law enforcement wanted to see if Zimmermann’s software violated federal arms-export laws because the technology could be considered a munition in that, being readily available online, it made it too difficult to determine what kinds of files, transactions and emails were being exchanged and what countries they came from and went to.
As was the case with Zimmermann, Wilson hoped the popularization and widespread distribution of his group’s gun files would lead the State Department to reconsider, if not altogether dump, an investigative effort.

“And to me, I understand that this software seems more closely related to guns so it might be a different case, but the parallels seemed pretty strong. At the end of the day, these are just bits, they’re not actual bombs.”

The frantic rush to regulate the data was no doubt accelerated by Defense Distributed’s recent successes — printable 30-round AR magazines and lower receivers that could withstand more than 650 rounds and of course their latest conquest, the single-shot pistol known as the Liberator.

http://youtu.be/H9MsYlnJVkM

Pledge of Allegiance

The Pledge of Allegiance of the United States is an expression of loyalty to the federal flag and the republic of the United States of America, originally composed by Francis Bellamy in 1892 and formally adopted by Congress as the … Continue reading

The Pledge of Allegiance of the United States is an expression of loyalty to the federal flag and the republic of the United States of America, originally composed by Francis Bellamy in 1892 and formally adopted by Congress as the pledge in 1942.[1] The Pledge has been modified four times since its composition, with the most recent change adding the words “under God” in 1954.

Congressional sessions open with the recital of the Pledge, as do government meetings at local levels, and meetings held by many private organizations. It is also commonly recited in school at the beginning of every school day, although the Supreme Court has ruled on several occasions that students cannot be compelled to recite the Pledge, or punished for not doing so.

According to the United States Flag Code, the Pledge of Allegiance reads:[2]

I pledge allegiance to the flag of the United States of America, and to the republic for which it stands, one nation under God, indivisible, with liberty and justice for all.

According to the Flag Code, the Pledge “should be rendered by standing at attention facing the flag with the right hand over the heart. Members of the Armed Forces and veterans who are present and not in uniform may render the military salute. Persons in uniform should remain silent, face the flag, and render the military salute”.[2] 

The Pledge of Allegiance was written in 1892 by Francis Bellamy (1855–1931), who was a Baptist minister, a Christian socialist, and the cousin of socialist utopian novelist Edward Bellamy (1850–1898). The original “Pledge of Allegiance” was published in the September 8 issue of the popular children’s magazine The Youth’s Companion as part of the National Public-School Celebration of Columbus Day, a celebration of the 400th anniversary of Christopher Columbus‘s arrival in the Americas. The event was conceived and promoted by James B. Upham, a marketer for the magazine, as a campaign to instill the idea of American nationalism by selling flags to public schools and magazines to students.[3][4][5][6]

Bellamy’s original Pledge read as follows:[7]

I pledge allegiance to my Flag and the Republic for which it stands, one nation indivisible, with liberty and justice for all.


The Pledge was supposed to be quick and to the point. Bellamy designed it to be recited in 15 seconds. As a socialist, he had initially also considered using the words equality and fraternity[6] but decided against it – knowing that the state superintendents of education on his committee were against equality for women and African Americans.[8]