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 some 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 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.”