The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS). After highlighting the most significant priorities, we provide charts for each agency that provide additional details on their plans. More information can be found by clicking on the blue link next to each item, which will take you to a specific page about each agenda item on OMB's website.
We want to caution that the dates included in the Unified Agenda are not commitments to act on or by the date shown and simply indicate the agencies' aspirations (note, for example, that dates for some planned actions have already passed). Rather than focusing on projected dates, the Unified Agenda is a valuable tool to identify the substantive issues the agencies consider to be priorities for rulemaking.
FDA's current priorities include the following:
- FDA has completed the seven major
rulemakings under the FDA Food Safety Modernization Act (FSMA) and
the agency has turned its efforts to more discrete actions to fine
tune the regulations. FDA's agenda for future FSMA-related
- Streamlining the written assurance requirements that apply when a manufacturer/processor or importer of food identifies a hazard requiring a preventive control, but does not control the hazard (e.g., 21 CFR § 117.136). FDA plans to conduct parallel rulemakings for the Preventive Controls for Human Food (November 2019), Preventive Controls for Animal Food (July 2020), and Foreign Supplier Verification Programs (November 2019) rules, but the Unified Agenda does not include similar plans for the Produce Safety rule;
- Clarifying changes to the food facility registration requirements, including revising the definition of "farm" (April 2020);
- Proposing a regulation on laboratory accreditation, which will enable FDA to recognize accreditation bodies that will accredit laboratories performing analyses of food under certain circumstances. This proposed rule was published on November 4, 2019; see Hogan Lovells Memorandum dated November 12, 2019;
- Proposing a regulation to revise certain requirements currently applying to produce that satisfies criteria for an exemption from the Produce Safety rule because that produce will receive commercial processing to adequately reduce the presence of microorganisms of public health significance (March 2020); and
- Enhancing traceability requirements by proposing additional recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that are designated as high-risk foods, as required by consent decree (September 2020).
- FDA plans to reopen the comment period for a proposed rule to provide for the use of fluid ultrafiltered milk in the manufacturer of standardized cheeses and related cheese products (November 2019).
- FDA plans to issue a proposed rule to update the agency's regulations to remove all mention of partially hydrogenated oils (PHOs) and to revoke all prior sanctioned uses. This action follows FDA's declaratory order in June 2015 announcing the agency's determination that there no longer is a consensus among qualified experts that PHOs are Generally Recognized as Safe (GRAS) for any use in human food and FDA's denial of a food additive petition in May 2018 requesting that the regulations be amended to provide for the safe use of PHOs in certain food applications (March 2020).
- FDA plans to issue a proposed rule to update the definition for the implied nutrient content claim "healthy" to be consistent with current nutrition science and federal dietary guidelines (November 2019).
- FDA plans to issue a final rule to add a second methodology for the analysis of sulfites in foods, which FDA states will improve the speed and efficiency in FDA testing for sulfites in food for enforcement activities (October 2020).
- FDA pushed back the reopening of the comment period for a proposed rule relating to modernizing food standards of identity (January 2020). The agency also plans to promulgate proposed rules to revoke the current standards of identity for French dressing and frozen cherry pie (May 2020 for both rules). FDA plans to finalize a rule amending the standard for yogurt and revoking the standards for lowfat and nonfat yogurt (May 2020).
- FDA plans to issue a final rule on fluoride levels in bottled water (April 2020). The proposed rule would revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride that exceeds 0.7 milligrams per liter (mg/L).
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