News of cuts in the U.S. Food and Drug Administration’s draft food safety rules the Food Safety Modernization Act (FSMA) stunned food safety advocates when it was revealed this week that the White House Office of Management and Budget (OMB) gutted the FSMA on the q.t.
Food Chemical News broke the story that cuts made by the OMB to the FSMA include striking out requirements for food companies to test for microbial contamination of environments and finished food products, as well as rules for companies to maintain supplier verification programs and track consumer complaints, allow FDA investigator’s ability to copy records to demonstrate compliance, you know, stuff that generally helps to keep food safe.
Battle-weary food safety advocates were given a glimpse of a tiny light burning at the end of the food safety tunnel – the FSMA. The great change that was to reform the creaky, old, and outdated food safety laws, badly in need of updating. Now, they find their budding hope for a future with a safer food supply has been snuffed out by the OMB. What is left of the FSMA is a shrivelled up, toothless, sorry excuse for a food safety act.
Faith-based food safety
“Testing is crucial to verify that your control programs are working, to have some data that says, ‘yes, what we’re doing works.’ Otherwise, you’re just guessing,” food safety expert Doug Powell, of Barfblog, told HuffPost in January 2013. “It’s not much better than astrology. It’s faith-based food safety.”
Meanwhile, the FDA recently updated its FSMA page to include a FAQ section. For those of you who have, mercifully, been spared the arduous task of deciphering the nomenclature of government regulatory speak, the FAQs may prove useful. Then again they may not. I picked out the choice segments relating to pet food and animal feed, naturally. Here goes:
Food Safety Modernization Act Frequently Asked Questions:
Do all sections of the law apply to pet food as well?
Yes. However, FDA is expressly authorized to modify the preventive controls requirements for facilities that are solely engaged in the production of animal foods or to exempt those facilities entirely from the preventive controls requirements. FDA would need to promulgate a regulation to accomplish such a modification or exemption.
When I think of the Food Safety Modernization Act, I only think of food that people consume. What is the Federal-State Integration team doing about food for animals?
The Federal-State Integration team realizes the importance of improving animal food regulations and standards along with human food. The Federal-State Integration team has members from the Center of Veterinary Medicine at FDA and is partnering with organizations such as the Association of American Feed Control Officials to ensure that food for animals is safe.
What constitutes a “reasonable belief” that food is affected in a similar manner in the context of FDA records access?
Decisions regarding whether FDA “reasonably believes” a food is affected in similar manner so as to either be adulterated and present a threat of serious adverse health consequences or death to humans or animals or to pose a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death to humans or animals will be made on a case-by-case basis because such decisions are fact-specific.
Does the FSMA Domestic Facility Risk Categorization approach apply to all registered facilities, i.e., food and animal feed facilities?
To date, FDA has only categorized facilities manufacturing food for human consumption as high-risk and non-high-risk under the framework established by FSMA. FDA has existing risk models that are used to prioritize work within each program operated at by the Center for Veterinary Medicine. The Agency is currently working to update these models based on the framework established by FSMA.
When may FDA suspend the registration of a facility registered under section 415 of the FD&C Act?
Under section 415(b) of the FD&C Act, if FDA determines that food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:
- Created, caused or was otherwise responsible for such reasonable probability; OR
- Knew of or had reason to know of such reasonable probability AND packed, received or held such food.
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