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Documents Show White House Edits to FSMA Rules

Food Chemical News is reporting that documents released on regulations.gov on Feb. 28 reveal cuts made by the White House Office of Management and Budget (OMB) to the implementing regulatory package for the Food Safety Modernization Act (FSMA).

Those apparent cuts 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.

Congress passed the FSMA in 2010 and it was signed into law by President Obama during the first week of 2011.   Implementing regulations drafted by the Food and Drug Administration (FDA) went through an unusually lengthy review by OMB that consumed all of 2012.

Food Safety News has put out a number of requests for more comments from the FDA and various consumer groups and industry stakeholders. Expect more detailed coverage of the release in the coming week.

We encourage readers to review the documents here and comment on anything of interest in our comment section.

© Food Safety News
  • billmarler

    Can some explain what background the White House Office of Management and Budget (OMB) has with food safety?

  • Oginikwe

    At almost 3,000 pages, most of us will have to get back to you.

    One thing does jump out: actual reported food-borne illnesses are listed as 10,948 from 166 outbreaks from 2003-2008, while estimates are 3,835,803 illnesses even as illnesses are 5,461,731 just from the norovirus. That doesn’t make sense. Am I reading that incorrectly? And, what’s with the 38,000,000 as “unidentified”?

    If they’re not going to maintain supplier verifications then how do they intend to do tracebacks?

  • Peter Hurley

    Below is one of the deletions from Tab B Compared NPRM Part 2 of 3 on p.108 of 251.
    Remeber this is a recomendation that has been DELETED.

    Deleted: Proposed § 110.150(e)(1)(i) and (ii) would require that the owner, operator, or agent in charge of a facility establish and implement written procedures to conduct finished product testing (proposed § 110.150(e)(1)(i)) and environmental monitoring (proposed § 110.150(e)(1)(ii)). We are proposing to require that written procedures be established and implemented for finished product testing and environmental monitoring because these procedures are essential to understanding whether the finished product testing and environmental monitoring are adequate to verify that the preventive controls are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur. Proposed § 110.150(e)(1)(iii

    Nice job on gutting something good White House OMB.

  • Peter Hurley

    DELETED: p 107:251 Tab B compared NPRM 2 of 3.

    Because of the importance of environmental monitoring in identifying situations in which contamination of food from the environment may occur, it would be reasonable to review the results of the tests on the day that they are received. As discussed in section XII.G.5.c of this document, the frequency of finished product verification testing would depend on the food and the hazards reasonably likely to occur in the food. Similar to the results for environmental monitoring, it would be reasonable to review the results of the tests on the day that they are received.