On September 19, 2014, FDA released four supplementary notices of proposed rule-makings (SNPRMs), revised versions of four of the proposed rules it released previously as part of its implementation of the Food Safety Modernization Act (FSMA) of 2011. The agency committed to revise the originally proposed rules after receiving significant feedback from industry stakeholders about various aspects of each rule.
SNPRMs Released on September 19, 2014
The four SNPRMs will be published in the Federal Register on September 29, 2014, which will start the clock on the 75-day comment period for each of the SNPRMs. The comment period would end on Saturday, December 13, although FDA may adjust the date so the comment period ends on Friday, December 12, or on Monday, December 15, as they have done in the past.
Notable Revisions on Preventive Controls for Human Food
The proposed revisions to the rules are largely consistent with what was expected, and with what FDA indicated it would change, though there are several key variations. The most notable is the proposed revision to the rule for preventive controls for human food that would include product testing, environmental monitoring and domestic supplier verification requirements in the regulatory text of the rule. The inclusion of these requirements in the preamble and appendix of the original proposed rule sparked significant controversy, and their inclusion in the regulatory text of the revised rule is likely to do so again. FDA says it "is now providing an opportunity for input on specific language and seeking comment on whether to include it in the final rule."
Other Notable Revisions
Other notable revisions to the four proposed rules include:
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Making water quality standards more flexible and clarifying the scope of "covered farms" in the produce safety rule.
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Exempting farms that pack or hold food for other farms from the preventive controls rule.
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Revising animal feed CGMP regulations to be more flexible and better aligned with current practices; proposing product testing, environmental monitoring and supplier verification requirements for public comment; and requesting comment on whether feed mills associated with fully vertically integrated farming operations should be required to register as food facilities under the animal feed rule.
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Proposing a more comprehensive evaluation of food and supplier risks and requiring supplier verification activities that are a hybrid of the two options originally presented in the FSVP rule.
The fact sheets for each of the SNPRMs can be found here, under "Proposed Rules."