When to Expect the Overdue FSMA Proposed Rules
January 4, 2012, was the one-year anniversary of the enactment of the Food Safety Modernization Act. This also means that it was the due date for a number of provisions for which FDA was to have completed an action “not later than 1 year after the date of enactment.”
FDA has made some noteworthy accomplishments in the year since FSMA became law, and earlier this month the Agency published a One-Year Progress Report, noting the most significant of these.
For example, FDA reported that it has:
- issued interim final rules on criteria for administrative detention and used this authority three times; issued interim final rules on prior notice of imported food.
- issued guidance to the seafood industry on food safety hazards and to the dietary supplement industry regarding new dietary ingredients.
- conducted extensive domestic and foreign outreach to all stakeholders to receive input in developing the proposed preventive control rules.
- established the Produce Safety Alliance and the Food Safety Preventive Controls Alliance.
- met the FSMA mandate for foreign food safety inspections, and is well on its way to meeting the 5-year inspection frequency mandate for high-risk domestic food facilities.
- continued to build State-Federal and global partnerships
In addition, FDA completed initial implementation steps for a consumer-friendly web search for recalls; guidance to seafood industry on food safety hazards; administrative detention of foods; and prior notice of imported food.
What has not been publicized is that FDA has also fulfilled its mandate to write proposed rules for the Produce Safety Regulation (Section 105); Hazard Analysis and Risk-Based Preventive Controls (Section 103); Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals (Section 103); and Foreign Supplier Verification Program (Section 301).
However, while each of these rules were completed by FDA long before the January deadline and submitted between Nov. 22 and Dec. 9, 2011, to the Office of Management and Budget (OMB), all four are still Pending Review.
It may be helpful to put this all in context of the process by which a rule makes its way through the review process. After FDA has drafted a proposed rule, it first is typically reviewed and approved by the Department of Health and Human Services, of which FDA is an Agency. From HHS, it is then passed on to OMB. OMB reports directly to the President and is responsible for assessing “economic and other impacts” of major regulations. During the process OMB reviews the rules from an economic perspective with a core mission “to serve the President of the United States in implementing his vision across the Executive Branch.” OMB is tasked to carry out this mission, in relation to rulemaking, through: “Coordination and review of all significant Federal regulations by executive agencies, to reflect Presidential priorities and to ensure that economic and other impacts are assessed as part of regulatory decision-making, along with review and assessment of information collection requests.”
Our conversations with FDA indicate that the Agency is hopeful that by the beginning of February, at least some of these items will have moved off the desk of OMB and begun to move forward through the rulemaking process. However, as anyone who has been part of this process understands the “ball” is not in FDA’s court at this point and effectively the FDA has no control on when these proposed rules will see the light of day. As we discussed in our Nov. 9, 2011, newsletter, rulemaking involves:
- Notice of Proposed Rulemaking (NPRM), Advance Notice of Proposed Rulemaking, or Interim Final Rule
- Public Comment
- Final Rule
So whenever these proposed rules emerge, it is then time for industry to provide comments to help shape what the final version will look like.
While it would be nice if OMB would issue a timeline, that is a totally unrealistic expectation. With 163 rules listed as “pending review” with OMB, we can only hope to see action in the near term so that the food industry can focus on understanding the new requirements. Although having an understanding of the review process does not move it any faster, it at least allows any frustration of missed deadlines to be directed toward an appropriate place.