Food Safety

Food Safety Bill Threatens Natural Health Options

The FDA Food Safety Modernization Act contains dangerous provisions that threaten access to natural health options.
Most worrisome, the senate bill (S. 510) contains a reference to Codex Alimentarius. Senator Hatch has made clear to ANH-USA that the call to ask FDA to review Codex standards does not signal any intention to move in a different direction on the Dietary Supplement Health and Education Act (DSHEA), the legislation that currently governs access to dietary supplements. In his opening remarks for the mark up of “FDA Food Safety Modernization Act” on November 18, 2009, Senator Harkin mirrored this message. As the senate moves forward with this legislation, Senators Harkin and Hatch have promised to see what can be done to make absolutely clear this legislation is not intended to impact our access to high quality, potent dietary supplements.
This is a tremendous show of support from Senators Harkin and Hatch, but we are still concerned that the inclusion of Codex language in this bill will be used to support future US harmonization. As they say, the road to hell is paved with good intentions. The bill still includes a Codex provision that absolutely must be removed by amendment in order to protect free choice about supplements.
We know the senate understands the severity of this provision. They have attempted to satisfy concern with amended language, but the new language, requiring “Recommendations on whether and how to harmonize requirements under the Codex Alimentarius” (§306, p. 116) would still create an unacceptable slippery slope toward U.S. harmonization with Codex.
Why are we so concerned? Because this legislative language would be used as a basis for U.S. harmonization when the U.S. evaluates whether or not to harmonize. As a member of Codex, the U.S. is required to go through this process. Essentially, if we are recommending to other countries that they should harmonize, it is difficult to then say that we should be exempted from our own logic.
Codex was initially developed to establish international food safety standards, regulate ingredients of food products, and determine permissible level of contaminants in food products. However, there is great concern that utilizing Codex Alimentarius will result in the loss of control over U.S. domestic food safety standards and compromise access to higher dose dietary supplements.
Codex is still in the “risk assessment” phase and hasn’t proceeded to the point where actual nutrient value recommendations for supplements are issued. However, they are using the same process recommended by the World Health Organization and used by the EU in determining their standards. The EU has advanced past the risk assessment and on to the risk management phase. Using the methods currently being built into European guidelines, the maximum limit for beta carotene would be the amount found in half a large carrot, while that for selenium would be no more than what is typically available in one third of a Brazil nut! The end result, should the U.S. harmonize and use these standards in place of those that currently allow access to higher dose dietary supplements would be an utter loss of the ability to maintain a healthy lifestyle using vitamins.
What else is wrong with this bill? It gives unbridled authority to the FDA to regulate farmers without holding FDA accountable for its actions. FDA is empowered with the sole control over recalls, seizures, detentions and quarantines. The summer of 2008 tomato debacle is a clear example of an FDA knee jerk reaction that financially ruined innocent food producers. Dramatically increasing FDA’s authority with no corresponding increase in oversight of the agency defies all common sense—especially in light of FDA’s history. An indemnification provision is needed to protect food operations wrongly subjected to a food recall and will ensure FDA is held accountable for its actions.
The FDA Food Modernization Act also commingles small farms and processors into the same category as large agribusiness operations and creates complicated regulations intended for multi-sourced supply chains that cross national and international boundaries is a direct attack on the sustainability of a smaller operation. The ‘one-size fits all’ found in S.510 has significant economic implications and will financially destroy direct market produce growers that sell their produce at farm stands, for example, trying to comply with a commercial standard. A categorical exemption for direct farm-to-consumer operations is a must!
It’s important to note that as worrisome as these provision are, the house version of this bill, passed in 2009, is much more severe in its impact on small farmers and the dietary supplements industry.
Why does this matter? Because after the senate passes their version of the Food Safety bill, the house and senate will go to conference, where they will work behind closed doors to combine the senate and house versions of this bill. This means that it’s even more critical to knock out the detrimental aspects of the senate bill to ensure that the compromise conference bill is less of a compromise on our part.
What are the most troubling aspects of the house bill?
(1) Increases jail sentences (from three to ten years) and fines (to $100,000 for individuals and $7.5 million for corporations) for “adulterating” or “misbranding” food or supplements.
If a vitamin company cites scientific, peer-reviewed studies in support of a health benefit of a product, this would be deemed misbranding and subject the product to recall from the market. Likewise, as defined in the current Good Manufacturing Practices, even minor paperwork violations could, per the FDA, represent adulterating.
(2) Imposes new fees on food operations of all sizes.
The new fee, $500, is identical for all, from the very smallest to the largest. Farms are exempt, but if the farmer makes some sauerkraut, he or she pays. And all the fees collected from the tiny operations represent another nice subsidy for the agri-businesses.
(3) Imposes record keeping, hazard analysis, food safety plans, and more on farms as well as businesses, small and large.
(4) Gives FDA control of farming standards and practices.
(5) Permits the FDA to Conduct Random, Warrantless Searches.
(6) Ignores the recommendations of a government report on the failings of the FDA and the urgent need for reform at the Agency.
ANH-USA is currently negotiating with senate staff regarding some of our concerns in the food safety bill and have put our grassroots action item on hold pending more favorable modifications to the legislative language. Check back frequently for the latest updates and any new action alerts.

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