The U.S. White House Office of Management and Budget has revised the Food and Drug Administration's draft food safety rules, according to documents posted on the Federal Register the week of March 18.
Some food safety experts have expressed concerns that the changes weaken the rules. The Office of Management and Budget review stripped product and environmental testing requirements, among other provisions that the FDA sought, from the preventive controls rule. "Based on the FDA's original language, as revealed in the documents placed online by Health and Human Services, 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," said Joan Murphy 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 seems that the Office of Management and Budget eliminated such requirements in their edits to the proposal. Instead, testing is mentioned in an appendix, and the agency asks for comments.
Other changes 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, according to Food Chemical News. "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," said the report.
The Office of Management and Budget also added a year to the date by which farms would have to comply with the new rule. According to the documents, the 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, the Office of Management and Budget 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.
