The Food Safety Law: The Way Forward

By James J. Gormley

The biggest food-industry-related issue of the 2009-2010 Congress was S. 510/HR 2751, the Food Safety Modernization Act (FSMA or Public Law 111-353).

Advocacy and political positioning on the FSMA exemplified both successes that can be achieved via industry-consumer collaboration and yet, ultimately, likewise the failure of such a collaboration to achieve more than the political version of NIMBY (not in my back yard) accomplishments.

What trade groups failed to realize:

1. While the FSMA does provide some improved food-safety system measures, its over-reliance on recordkeeping and documentation that features a Hazard Analysis and Critical Control Point (HACCP) algorithmic/risk-based approach to food safety, and an under-reliance on on-site physical inspections, does nothing to address the core problems in this country’s food-safety system: filthy factory farms and disgusting slaughterhouses.
2. While these groups are patting each other on the back for being representatives of the regulated industry that have a “seat at the table,” their members’ raw material suppliers are being saddled with a dizzyingly complex and expensive system of paperwork and systems, onerous requirements whose impact is already being felt by companies that are attempting to be forward-compliant.
3. If the FDA abuses its now expanded powers, legitimate manufacturers (and classes of products) will be swept up in its allegations of adulteration, contamination and misbranding.
4. The organic trade groups will regret their effusive praise if raw milk and raw milk cheeses (a cottage industry and gourmet food segment) are taken off the market.
5. Although all trade groups claim that consumer benefit and consumer safety are at the very core of everything they support, including this law, they disregarded the fact that consumer health freedom organizations — groups which truly represent consumer interests — were completely opposed to S. 510 and HR 2751 and that tens of thousands of letters were sent to Congress demanding that this bill not pass in its current form (this is on top of over 20,000 letters to the White House calling for its veto).

Regardless, once trade groups and some conservative consumer groups saw that farms and dietary supplement finished products were ostensibly excluded from HR 2751, most parties claimed victory and applauded the bill’s passage despite the fact that very troubling provisions remain in the law, such as:

Reasonable probability and reasonable belief: According to Section 423, if there is a “reasonable probability” that an article of food is adulterated under section 402 or misbranded under section 403, the U.S. Food and Drug Administration will offer the manufacturer an “opportunity to cease distribution and recall such article.”

DANGER: The FDA has often called products misbranded based on the flimsiest of bases; it has also challenged the GRAS status of certain ingredients (or the data behind NDI filings) as a back-door attempt to go after certain combination supplements. The FDA has also made clear its regulatory animus regarding raw milk products (milk, cheeses). The FDA could very well attempt to use its expanded recall authority to effectively go on a “witch hunt” against certain products or classes or products that it cannot hurt through existing law.

Section 113 (new dietary ingredients) re anabolic steroids: One example of where dietary supplements were not totally excluded from HR 2751 is Section 113, wherein there is a proviso to notify the U.S. Drug Enforcement Administration (DEA) if dietary supplements contain anabolic steroids, which could be excellent if judiciously applied — this was something I am pleased to note that I personally created a campaign on via Citizens for Health and various calls to action.
POTENTIAL DANGER: Nevertheless, the FDA merely needs to suspect that a supplement “may contain” an anabolic steroid or anabolic steroid analogue in order to refer a dietary supplement for DEA enforcement, which does open the door to potential targeting of legitimate manufacturers along with the fly-by-night operators.

Section 207. Administrative detention of food. In the final version of HR 2751, “credible evidence” was changed to “reason to believe” for suspected adulterated or contaminated food to be quarantined.

DANGER: Now the FDA does not even need credible evidence in order to impound food; all the agency needs to have is a gut feeling that food is dangerous, and it can be quarantined. While this might help in cases of intentional poisoning of the food supply, it does provide the FDA a great deal of additional discretionary authority.

Section 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 (WTO) or any other treaty or international agreement to which the U.S. is a party (e.g., General Agreement on Tariffs and Trade [GATT], NAFTA, the Uruguay Rounds, Codex).

DANGER: This is dangerous ground even if it was intended as a pro forma thruway. As an example of unintended, sovereignty-endangering consequences of nations including such language, one commentator claims that in Canada’s new Bill C-36, Health Canada has proposed that the powers provided to Parliament should be forfeited so that Canada can “honor its international agreements and commitments”! The FDA has not provided any explanation, much less a good reason, as to why sovereign U.S. domestic laws and regulations would need to be consistent, or not inconsistent, with international treaties and agreements.

Section 420. Limited distribution. “In the interest of national security, the Secretary of HHS, in consultation with the Secretary of Homeland Security, may determine the time, manner and form in which the guidance documents […] are made public, including by releasing such documents to targeted audiences.”

DANGER: If the U.S. government does not care to release the very instructions and guidance needed by suppliers and producers in order to properly comply with the requirements, the government does not have to, if cloaked under the usual catch-all blanket of “national security.” Obviously, in this way many food producers would likely fail if the requirements (and related compliance guidance) are a secret until inspection. This is similar to a teacher handing you a graded final exam despite the fact that you were denied the course, the textbook, the studying and the very exam questions themselves. Talk about setting food producer and ingredient suppliers up for failure!

The FSMA’s fate
Passage of this bill won’t change much unless the bill is funded. In this economic environment, it will be difficult to get the $1.4 billion required to implement this bill without some revenue generator, which this bill does not include. There has already been talk from Republicans in the House that they will not fund the bill. The government is currently under a continuing resolution (CR) which expires on March 4. So one of the first challenges for the new Congress is how they handle the Fiscal Year 2011 budget. Therefore, it is unlikely that anyone will get an increase in this environment. Some lobbying from states is also anticipated since they’ll be able to seek a variance from the produce safety standards as long as they can show that they have procedures in place to reach the same goals.

The way forward

Effective health-freedom advocacy in 112th Congress. On the good side, the Republican-controlled House bodes well for anti-big-government, anti-big-spending, fiscally conservative efforts, including efforts to de-fund “Obamacare” (which will encounter stiff opposition in the Senate) and the FSMA (which is winnable).

One thing to keep in mind: Many old-school, good government Democrats vote anti-supplement because they honestly believe that, in so doing, they are protecting consumers. Some of the anti-supplement co-sponsors are also anti-GMO.

Therefore, approaches to the good-government Dems (called goo-goos) should not attack them as being anti-supplement but should, instead, make it clear that most measures which hurt consumer access to supplements and supplement information also hurts consumers themselves. We must drive home one of Benjamin Franklin’s many truths:

“The man who trades freedom for security does not deserve nor will he ever receive either.”

Good Intentions Do Not A Good Bill Make; President Obama Must Veto This Bill

By James J. Gormley

President Obama is waiting to hear from you, your neighbors, your brothers, your sisters, your parents — and all of America — as to whether to sign the "food safety bill" into law.

If you agree with all of the problems we have identified with this bill — or even with most of them — I ask you to please go to the White House comment page and ask the President to veto this bill.

It’s not that the bill is meant to disrupt the American Way of Life or forever change the fabric of our great nation. It is not badly intentioned. It even has some decent provisions in it. On top of that, dietary supplements were ostensibly excluded, as were farms and small food-service operations.

The problem is not what was intended, or what FDA Commissioner Hamburg believes is in this bill. The problem is that the bill’s advocates and many of its supporters were all sold a bill of goods.

The fact is that FSMA will do very little to improve food safety; and, in truth, by obscuring the real core of our nation’s food safety problems with layer upon layer of HACCP requirements, and food allergenicity protections and food safety recordkeeping plans — and all of the $1.4 billion worth of stuff (red tape and feel good busywork) in this bill — this bill would actually make things worse.

Why? Because while Dr. Hamburg and the bill’s cheerleaders are busy shaking hands, and slapping each other on the back as to what an amazing bill this is (which it is not), the disgusting factory farms and filthy slaughterhouses in this country — which are the real problems with our food supply, let’s face it — will not be made any less filthy by this $1.4 billion boondoggle.

What are the remaining problems with this bill that make it un-signable?

If the FDA (Secretary of the HHS) has a “reasonable belief” or feels there is a “reasonable probability” that a food is unsafe, records inspections must be carried out and foods can be quarantined. The FDA has a long and sordid history of abusing this power by making assumptions that hurt food producers, and ultimately consumers.

The FDA already believes (without a shred of evidence) that raw milk and raw milk cheeses are unsafe — wouldn’t this be the perfect opportunity for the FDA to close down a cottage industry towards which it has always held such animus?

Now while it is potentially good that the bill includes a proviso (in Section 113) calling for dietary supplement products (that’s why I said ostensibly excludes, above) that may contain (or may be) anabolic steroids to be referred to the DEA, the problem is that that it is way too vague: "may contain" is not definitive enough by a long stretch, which opens the doors for the FDA to believe that many supplements “may contain” anabolic steroids, and hurt legitimate manufacturers in the process.

Section 423 offers manufactuers an opportunity to voluntarily take a product off the market and recall it if the FDA feels that there is a “reasonable probability” that an article of food is misbranded. Well, here we go again; the FDA has time and again greatly overarched in its authority in these areas, often calling products “misbranded” for the smallest mistake in a nutrition facts or product label.

Section 404 insists that nothing in the bill shall in any way be inconsistent with the World Trade Organization or any other international treaty or agreement to which the U.S. is a party! Okay, again, can anyone explain why (I ask why) domestic, sovereign, internal U.S. laws and regulations need to be consistent with international treaties and agreements (such as Codex)?

Section 420 calls for limited distribution of the guidance documents that food producers would need in order to comply with this law in the interests of “national security.” This says that although food facilties will be required to comply with this new law, if the U.S. government does not feel like releasing instructions and guidance on how to properly comply with the requirements, it does not have to, if blanketed under the usual sacred cow of “national security.” Outrageous!

FDA Commissioner Margaret A. Hamburg MD truly believes that the Food Safety Modernization Act (FSMA) is the greatest thing ever. Sadly, it is not worthy of the President’s signature and was railroaded through Congress under suspended rules and other legislative sleight of hand.

I ask you to tell President Obama to please veto this bill; we will work together on coming up with an alternative bill in 2011 that will be signature-worthy.

"Food Safety" Bill In Desperate Need of a Presidential Veto

By James J. Gormley

As you may know, the so-called Food Safety and Modernization Act cleared the U.S. House of representatives by a vote of 215 to 144 less than two days after Senate Republicans gave a surprise “victory” to the legislation’s advocates by allowing legilsators to move the package by questionable, legislative sleight-of-hand, otherwise called unanimous consent.

"This legislation is the product of a flawed process," said Rep. Frank Lucas, the top Republican on the House Agriculture Committee, as reported by FarmPolicy.com. "It gives the Food and Drug Administration lots of additional authorities with no accountability.” (Listen to Congressman Lucas’ comments here.)

Rep. Jack Kingston of Georgia, the ranking GOP member on the appropriations subcommittee that oversees the FDA, told The Washington Post that the number of cases of food-borne illnesses in the country does not justify the $1.4 billion the new law is estimated to cost over the first five years.

"We're going to have to evaluate everything and set priorities at a time of reduced appropriations for all the different discretionary programs," Rep. Tom Latham (R-Iowa) told the Post.

Latham serves on the FDA appropriations subcommittee and, along with Kingston and the panel's two other Republicans, voted against the food safety bill. The food safety legislation "is going to have to compete with everything else," he told the Post.

The Act would cost American taxpayers $825 million in 2011 alone ($1.4 billion over the first five years) and does not even touch the root causes of the U.S.’s food safety problems — such as factory-farming — which were highlighted in both a 2009 campaign by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and by a letter to 99 U.S. senators by the Ranchers-Cattlemen Action Legal Fund (R-CALF USA).

In fact, the legislation, at it stands now, is saddled with an extreme overreliance on a risk algorithm-based approach to food safety, referred to as Hazard Analysis & Critical Control Point (HACCP) and an under-reliance on old-fashioned, on-site physical inspections.

This bill, despite its name and intent, would not make this country's food supply more safe, but less safe.

If this bill were to become law, it would be a multi-billion dollar boondoggle that would make our food safety system much more complex, more focused on hazards analysis than on physical inspections and no less beset by dirty factory farms and filthy slaughterhouses than it was before.

Please ask President Obama to veto this legislation so that consumers — not industry lobbyists and agri-business cronies — can develop a true food safety bill that will improve this country’s food-safety system, not bog it down with paperwork, smoke and mirrors.

Food Safety for 2010: the Good, the Bad … and the Ugly

By James J. Gormley  
courtesy of NOW Foods
In October, we alerted you to serious worries about Senate Bill (S.) 510. Now that we have just started the New Year, let’s take a look back at the whole food safety picture in 2009 and how things are shaping up for 2010.

Here’s a partial run-down on some of the biggest food safety news stories of 2009:

1. Starting in January 2009, a giant peanut manufacturing corporation began voluntary recalls of up to 3,918 products made with peanut butter and peanut paste that reportedly caused nine deaths and 714 confirmed cases of Salmonella in 46 states.
2. In June and July of 2009, a fast-food restaurant in Milan, Illinois had two workers infected with hepatitis A working at the eatery; in addition to workers and customers getting sick, 10,000 people were exposed by the time the situation was under control.
3. Beginning in July (going through December), two mammoth meat manufacturers (based in Denver, Colo. and Fresno, Calif.) recalled 1.314 million pounds of beef due to concerns that it was contaminated with three strains of antibiotic-resistant Salmonella.
4. On September 1st, the Washington Post alerted us to the case of a Nevadan woman severely injured by chocolate-chip cookie dough contaminated with E. coli 0157:H7.
5. On October 4th the New York Times’ Michael Moss reported that a children’s dance instructor from Minnesota was partially paralyzed from E. coli 0157:H7 in hamburgers she ate. The meat originated in massive slaughterhouses in Nebraska, Texas, Uruguay, and a South Dakota firm that treats fat trimmings with ammonia to kill bacteria.
6. In December 2009, a series of articles in USA Today uncovered that Jack in the Box, Burger King and Costco are “are far more rigorous”─up to 10 times more stringent─ in checking for dangerous bacteria than is the USDA in setting standards for beef served to our children via the National School Lunch Program.

And lest these cases create the impression that contamination only relates to beef or peanut butter, ConsumerReports.org posted “The 10 riskiest foods overseen by the FDA,”  which lists the top ten offending foods. In decreasing order of “riskiness,” the article listed (somewhat surprisingly) the following 10 foods and food products: leafy greens; eggs; tuna; oysters; potatoes; cheese; ice cream; tomatoes; sprouts; and berries.

What do 2009’s food-safety outbreaks mean to us?
What the outbreaks in 2009 (and, for that matter over the last 19 years) mean is this: Food production by gargantuan factories and slaughterhouses is questionable; one marked by potentially unsanitary practices and stopgap remedial treatments that don’t work well .

As to food safety bills on Capitol Hill, here’s where things stand as of this writing:

• H.R. 759, or the Food and Drug Administration Globalization Act of 2009, sponsored by Congressman John Dingell (Mich.); 10 co-sponsors; introduced January 28th, 2009; referred to House Committee on Energy and Commerce on January 29, 2009.
• H.R. 875, or the Food Safety Modernization Act of 2009, sponsored by Congresswoman Rosa DeLauro (Conn.); 40 co-sponsors; introduced February 4th, 2009; referred to House Subcommittee on Livestock, Dairy and Poultry on April 23rd, 2009.
• H.R. 1332, or the Safe Food Enforcement, Assessment, Standards, and Targeting (FEAST) Act of 2009, sponsored by Congressman Jim Costa (Calif.); 30 co-sponsors; introduced March 5, 2009; executive comment requested from the FDA and the USDA on April 23rd, 2009.
• H.R. 2749, or the Food Safety Enhancement Act of 2009, sponsored by Congressman John Dingell; 5 co-sponsors; passed under suspended rules on July 30, 2009.
• Senate Bill (S.) 510, or the FDA Food Safety Modernization Act, sponsored by Senator Richard Durbin (Ill.); 15 co-sponsors; placed on Senate Legislative Calendar under General Orders (No. 247).

There are a couple of issues in these bills that stand out like sore thumbs. As to H.R. 875, this bill calls for the creation of yet another agency with another “czar”, the Food Safety Administration; not a welcome addition to fans of limited or more efficient government.

As to H.R. 2749, which passed the House already, this column has previously noted problems associated with this bill, including registration fees for food facilities and powers to “restrict the movement of food” by effectively quarantining (i.e., shutting down) a town, city or region. These aggressive new police powers should be reserved for demonstrable risks to public safety, not given freely as a blanket trust and authority granted to unelected agency bureaucrats.

On the positive side, thanks to grassroots advocacy organization new language in S. 510 exempts safe dietary supplements and organics while softening language relating to the threat of harmonization with Codex Alimentarius; however, there are still some areas of concern.

What will be the legislative fate of these bills?
Since H.R. 759 is considered the flagship House food-safety bill by Congresswoman DeLauro (who is the sponsor of H.R. 875, above) and since Congressman Dingell is the sponsor of H.R. 759 and of the House Bill which was last introduced but which passed first, I foresee two scenarios.

One strong probability is that all of the other House food-safety bills will fall by the wayside, since H.R. 2749 already passed and since S. 510 is likely to pass in the full Senate this year or early next.

A second possibility is that portions of H.R. 875 and 1332 will either make it into negotiations on the Senate side for S. 510─not very likely since H.R. 2749 has already passed─ or will be incorporated into this year’s agriculture appropriations bill, more likely since Congresswoman DeLauro was the sponsor of the 2009 “agriculture bill” that passed in October 2009.

Gormley Take-Away: Senate Bill 510 will likely be the “last man standing” in terms of food-safety bills in the remainder of this current 111th legislative session of Congress─ and perhaps in the first half of next year’s 112th session─and we do need to be vigilant on this bill before it becomes law.   Nevertheless, regardless of whatever food-safety bills are introduced or debated in 2010, we must push for increasing support of local food production (including food co-ops and community supported agriculture [CSA]). We also need food manufacturers to take more responsibility for ensuring the safety of the foods they produce by the use and enforcement of existing audited GMP and HACCP systems, backed up by testing. This will continue to keep the public safe and prevent Congress from setting up overly broad enforcement mechanisms without fixing the underlying problems.

Senate Bill 510: The $825 Million Dollar Folly

By James J. Gormley

courtesy of NOW Foods

Are you a backyard grower of heirloom tomatoes you sell on your own property or at a local farmer’s market? If so, you will be in for a whopper of a surprise if Senator Durbin’s Senate Bill 510 (S.B. 510) passes: you may be receiving a visit from inspectors.

Products not grown according to designated standards will be considered adulterated and your business records will be subject to warrantless searches by inspectors from the U.S. Food and Drug Administration (FDA), all this without any evidence that you have violated any law.

Wonder why the National Guard or Federal agents have effectively imposed martial law by quarantining your town? Under S.B. 510’s House counterpart bill, H.R. 2749 (Section 133b, “Authority to Prohibit or Restrict the Movement of Food”), sponsored by Congressman Dingell, the Secretary of Health and Human Services will have the power to prohibit all movement of all food within a geographic area, whether the food is in your grandmother’s grocery bag in her Toyota Hybrid or on a flatbed. No court order will be needed, just a phone call to the appropriate state official and a public announcement will be sufficient.

Upset that raw milk or raw milk cheeses (like feta) are no longer available in the U.S.? This could well happen thanks to the “performance standards” powers that would be granted to the FDA by S.B. 510, especially since the agency has made it clear that it is vehemently opposed to the consumption of raw milk products.

Amazed that U.S. food safety regulations strangely match those of other countries? Well, Section 306 of S.B. 510 would require “Recommendations to harmonize requirements under the Codex Alimentarius.”

And what about food supplement manufacturers, suppliers, distributors and health food stores? Will they be ensnared in this bill’s draconian, 1984-esque net? Very possibly so.

This all may seem far-fetched, but theoretically, this new law would give the government all this authority.

S.B. 510 (which would cost Americans $825 million in 2010 alone) and the House of Representatives version of this bill, H.R. 2749, which did pass under suspended rules, do not address the root causes of the U.S.'s food safety problems, which were highlighted in both a recent campaign by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and by a letter to 99 U.S. senators by the Ranchers-Cattlemen Action Legal Fund (R-CALF USA).

According to Citizens for Health (http://www.citizens.org/), if this proposed law is enacted it would:

• Undermine DSHEA and move the U.S. one step closer to harmonizing our standards under Codex with those of supplement-restrictive regimes like the European Union. (DSHEA, or the Dietary Supplement Health and Education Act, asserts that supplements are food and are safe for consumption unless proven otherwise – ensuring that millions of Americans are able to enjoy access to safe, effective and affordable dietary supplements).

• Give the FDA unprecedented control over farms and direct-to-consumer distributors. If passed, the bills would charge facilities an annual $500 registration fee, require additional record keeping, and expand FDA authority to quarantine geographic areas for alleged food safety problems – all without significantly improving food safety.

• Cost U.S. taxpayers billions of dollars ($825 million in 2010 alone) while providing fewer physical inspections and less food safety overall.

• Harm U.S. organic farmers by imposing overlapping regulations.

• Hurt food supplements and health-food stores by imposing standards that are already covered by the AER (Adverse Event Reporting) Law, cGMPs (current Good Manufacturing Practices) and food facility registration.

• Cripple local food co-ops, farm stands, independent ranchers and artisanal food producers by imposing unnecessary standards and unfair bureaucratic burdens.

Clearly, S. 510, while purporting to increase food safety would actually leave consumers more vulnerable to foodborne disease since the FDA would be required to use a risky, risk-based food safety system rather than doing old-fashioned, effective physical, on-site inspections in plants, factory farms and slaughterhouses, where the actual food safety concerns are.

Furthermore, the U.S. has abrogated its duty to inspect and enforce food safety standards, both here and abroad, by allowing processing plants to regulate themselves under a failed system; and it has embraced policies that have driven independent U.S. farmers and ranchers out of business and replaced them with corporate-owned, industrialized food production units that are known to cut food safety corners to maximize corporate profits.

So what do we need to do?

Click here for an opportunity to send a letter opposing S.B. 510 as it is currently written.

Gormley Take Away: As of this writing, our nation is over $11.8 trillion in debt. Let’s not add $825 million more (actually several trillion dollar over the next few years) for a bureaucratic monster to be foisted upon an already deeply flawed U.S. food-safety system. S.B. 510 is sadly, and ironically, not about food safety, although I wish it were. It’s about food madness, pure and simple, and it must be fixed … or stopped.