I am writing to you as your constituent and as a member of Citizens for Health, the voice of the natural health consumer. I understand that S. 510, the FDA Food Safety Modernization Act, will come before you for consideration very soon. I urge you to oppose the bill if it comes before you for a vote, and to oppose any efforts to circumvent the full legislative process by attaching the Senate language to another bill.
Naturally, I support efforts to ensure the safety of what we eat and drink; however S. 510 would ultimately make our food less safe, not more. In addition, the bill would do so at the expense of health food retailers, manufacturers, and consumers of natural foods.
These are my concerns:
1) What the bill says: If the Secretary of Health and Human Services (HHS) 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 health consequences, then the source would have to give HHS agents access to all of its records.
My concerns: Simply believing there's a potential hazard isn't enough - there should be proof before HHS intrudes upon the livelihood of our health food retailers and manufacturers. Taking it a step further: What constitutes "reasonable," and by whom is it determined? There needs to be evidence, and it needs to be clear and definitive.
2) What the bill says: It mandates use of Hazard Analysis and Critical Control Points (HACCP) as a means of identifying sources of contamination.
My concern: HACCP is a risk-based algorithmic approach to food safety that allows many shortcuts and involves a monumental amount of expensive paperwork and recordkeeping with NO improvements in on-site, physical inspections.
3) What the bill says: If the Secretary determines...that there is a reasonable probability that an article of food is adulterated or misbranded...the Secretary shall provide the responsible party an opportunity to cease distribution and recall such an article.
My concern: Similar to #1 above, what level of evidence will constitute "reasonable" probability? In addition, the words "adulterated" and "misbranded" have been applied by the FDA so liberally over the years that they've become watered down as descriptors of contamination.
And, the biggest problem of all with S. 510:
4) What the bill says: "Nothing in 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 U.S. is a party."
My concern: No other countries ensure that all of their internal regulations are consistent with WTO or any other treaty or international agreement - so why should the United States sacrifice its sovereignty? I am additionally concerned about what might happen to the affordability of - and especially my access to - the products and services I choose to maintain my health and wellness if the United States is required to harmonize with the WTO, SPS, the Uruguay Rounds, and Codex.
The bottom line: If the above problems and deficiencies are not fixed or eliminated immediately from S. 510, then it must not pass. What constitutes reasonable belief and reasonable probability will be moving targets, moved up or down by the FDA at will. By further emphasizing the risky HAACP algorithmic approach to food safety consumers will be less safe since there will a greater reliance on mathematical and statistical hazards models and less reliance on physical, on-site inspections. Furthermore, the sovereignty of U.S. law and regulation will be further undermined and compromised by referencing international standards and bodies in internal U.S. statutes.
I strongly urge you to vote "No" on S. 510 or any efforts to attach it to another bill. Thank you for your prompt attention to this matter, and I look forward to your reply.
Kenneth M. Howard, Director
Abundant Living Information Services
502 So. State, Suite #900
Orem, UT 84058