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Documents Show OMB Weakened FDA’s Food Safety Rules

The White House Office of Management and Budget significantly weakened the U.S. Food and Drug Administration’s draft food safety rules, documents posted on the Federal Register last week show. The hundreds of pages of documents, first discovered and reported by Food and Chemical News (subscription only) on Friday, confirm what food safety insiders had suspected – that OMB’s lengthy review stripped product and environmental testing requirements, among other provisions that FDA sought, from the preventive controls rule.

“Based on FDA’s original language, as revealed in the documents placed online by HHS, the agency did favor environmental monitoring for pathogens reasonably likely to occur as well as scientifically valid finished product testing, when appropriate based on risk, to assess whether the preventive controls significantly minimize or prevent the hazards,” Joan Murphy reported in Food Chemical News. “If environmental monitoring were to identify the presence of a pathogen, the facility would follow certain corrective action steps, according to the original proposal.”

Looking at the documents, which were apparently posted online by Health and Human Services to satisfy a 1993 executive order on transparency, it is clear that OMB eliminated such requirements in their edits to the proposal. Instead, testing is mentioned in an appendix, and the agency asks for comments.

While Food Safety Modernization Act watchers had speculated about such changes, seeing such edits in a track-change format offers a rare, detailed look at OMB’s review process. (The standard practice for economically significant regulations is to go through review at OMB’s Office of Information and Regulatory Affairs, but exactly what changes are made by the agency are often not disclosed.)

David Plunkett, a senior food safety attorney at the Center for Science in the Public Interest, said he wasn’t surprised that testing was one of the issues holding up the rules while they were under White House review.

“It’s OMB once again protecting corporate bottom lines at the expense of protection for public health,” said Plunkett. “Testing is critical to verification. I don’t think a preventive food safety system can be effective without it. Unfortunately, OMB bean counting of the wrong costs results in a less effective prevention program and ultimately continuing food safety problems.”

“We totally predicted that was what happened based on reading the rule and have been saying that since the rule came out – all about getting it out the door with acceptable political economics and now look for the private sector to weigh in,” said David Acheson, former associate commissioner of foods at FDA, now a consultant at Leavitt Partners.

As Food Chemical News reported, the changes OMB made to the proposed rules were “too numerous to cite,” but included eliminating requirements for maintaining a supplier approval and verification program or requirements to review complaints from consumers or customers that might be related to a company’s food safety plan, and striking a mention of an FDA investigator’s ability to copy records to demonstrate compliance. “Similar changes can be found between the draft of the proposed produce safety regulation and a large majority of the preamble is rewritten from the FDA draft,” the report noted.

OMB also added a year to the date by which farms would have to comply with the new rule. According to the documents, FDA had proposed allowing very small businesses three years to comply with the rule, small businesses two years and all other companies one year. During its review, OMB changed the time allowed for compliance to four years for very small businesses, three years for small businesses and two years for all other farms.

Why were all these changes made? “Undoubtedly election-year politics,” according to Marion Nestle, food politics expert, author, and professor at New York University.

“The election is over,” Nestle wrote on her blog Food Politics on Monday. “The FDA needs to do its job. Let’s get these items reinserted. The safety of Americans is at stake here.”

Food Safety News invites readers to review and weigh in on the documents, which can be viewed here.

The FDA did not respond to requests for comment.

This article has been updated to add comments.

© Food Safety News
  • http://twitter.com/RustyBrown47 Russell La Claire

    Interesting that some of the basic needs of the FDA in the food arena are already in place in the drug/device portions of the Agency. Copying records? Environmental monitoring? Very basic. Unfortunate that OMB has allowed industry to once again stymie even the simplest change to make the food change better.