OMB Releases Spring 2018 Unified Agenda of Regulatory Actions
The Office of Management and Budget (OMB) recently released the Spring 2018 Unified Agenda of Regulatory Actions for federal agencies, 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), 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. 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 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 rulemakings includes: 1. Extending the compliance dates for the agricultural water provisions of the Produce Safety rule for covered produce other than sprouts; 2. Removing 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); 3. Clarifying changes to the food facility registration requirements, including revising the definition of "farm;" and 4. 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.
FDA will reopen the comment period for a proposed rule relating to modernizing food standards of identities.
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FDA plans to issue a proposed rule to amend its regulations on the type size requirement for calorie declarations for Front of Pack (FOP) labeling in glass front vending machines.
FDA also plans on finalizing several other regulations, including: 1. An amendment to FDA's regulation authorizing the use of health claims regarding the relationship between soy protein and coronary heart disease; and 2. A rule that would establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients.
The priorities for agencies within the U.S. Department of Agriculture (USDA) include the following:
AMS plans to finalize the proposed rule issued earlier this month to establish the national mandatory bioengineered food disclosure standard. The Unified Agenda states that the agency plans to finalize the proposal in July 2018, the statutory deadline for finalizing the rulemaking, but this timing is unlikely given that comments on the proposal are not due until July 3, 2018.
FSIS has announced several initiatives to modernize inspection systems and to eliminate or streamline regulations. For example, FSIS is currently accepting comments (due June 13, 2018) on a proposed rule to transition egg products manufacturing from a command and control system to a Hazard Analysis and Critical Control Point (HACCP) program. FSIS plans to finalize in 2019 a proposal to modernize swine slaughter inspection.
FSIS estimates it will issue a final rule in September 2018 that would allow China to export to the U.S. poultry products from birds slaughtered in China. Currently, China only may export to the U.S. poultry products manufactured in China but slaughtered in the U.S. or other eligible countries.
In November 2017, FNS issued an interim final rule extending flexibilities for certain requirements for milk, whole grains, and sodium under FNS Child Nutrition Programs through school year 2018-2019. FNS plans to finalize the regulation in December 2018.
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We will continue to monitor the Federal Register for agency actions and will keep you notified of items of interest. Please contact us if you have any questions.
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Spring 2018 Regulatory Agendas: Summary of Selected Items Relating to Food Regulation
FDA:
Stage of Rulemaking Proposed Rule Stage
Subject
Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size
Estimated Date NPRM 05/2018
Proposed
Proposed Rule to Revise the Allowable Level NPRM
Rule Stage of Fluoride Added to Bottled Water
06/2018
Proposed Rule Stage Proposed Rule Stage
Proposed Rule Stage
Proposed Rule Stage
Laboratory Accreditation for Analyses of Foods The Food and Drug Administration Food Safety Modernization Act; Removing Written Assurance Requirements From the Customer Provisions in Certain Implementing Rules Food Standards: General Principles and Food Standards Modernization (Reopening of Comment Period)
Permanent Listing of Color Additive Lakes
NPRM 09/2018 NPRM 11/2018
NPRM Comment Period Reopened 12/2018 NPRM 12/2018
Proposed Rule Stage
Proposed Rule Stage
Proposed Rule Stage
Food Additives: Food Contact Substance Notification That Is No Longer Effective
Investigational New Drug Applications Requirements for Conventional Foods, Dietary Supplements, and Cosmetics
Amendments to Registration of Food Facilities
NPRM 12/2018
NPRM 04/2019
NPRM 04/2019
Final Rule Stage
Food Labeling: Revision of the Nutrition and Final Rule Supplement Facts Labels and Serving Sizes 05/2018 of Foods
Final Rule Stage
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, Extension of Compliance Dates for Subpart E
Final Action 06/2018
RIN 0910AH83
0910AI03
0910AH31 0910AH77
Change in Status? NPRM Changed from Mar. to May 2018 First Time in Unified Agenda No
NPRM Changed from Aug. to Nov. 2018
0910AC54
Moved from LTA List to Proposed Rule Stage
0910AH80
0910AI01 0910AH07
0910AH82
0910AH92
0910AH93
NPRM Changed from Aug. to Dec. 2018 First Time in Unified Agenda Moved from LTA List to Proposed Rule Stage Moved from LTA List to Proposed Rule Stage
Moved from Proposed Rule Stage to Final Rule Stage No
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Stage of Rulemaking Final Rule Stage
Final Rule Stage Final Rule Stage
Final Rule Stage
Final Rule Stage
Final Rule Stage
Final Rule Stage Long-Term Actions
Subject Label Requirement for Food That Has Been Refused Admission Into the United States
Crabmeat; Amendment of Common or Usual Name Import Tolerances for Residues of Unapproved New Animal Drugs in Food
New Animal Drugs: Updating Tolerances for Residues of New Animal Drugs in Food
Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods
Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
Amendment to Add a New Method for the Analysis of Sulfites in Foods Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
Estimated Date NPRM Withdrawal 08/2018
Direct Final Rule 11/2018
Final Rule 12/2018
Final Action 12/2018
Final Rule 12/2018
Final Action 02/2019
Direct Final Rule 03/2019
Final Action 09/2019
RIN 0910AF61
0910AI04 0910AF78
0910AG17
0910AH00
0910AH51
0910AI02 0910AH43
Change in Status?
Final Action July 2018 Changed to Withdrawal of NPRM Aug. 2018
First Time in Unified Agenda
Final Rule Changed from Aug. to Dec. 2018 Final Action Changed from Aug. to Dec. 2018 Final Rule Changed from Oct. to Dec. 2018
Moved from Proposed Rule Stage to Final Rule Stage First Time in Unified Agenda Moved from Proposed Rule Stage to LTA List
FSIS:
Stage of Rulemaking Proposed Rule Stage
Subject
Allowing Pet Food and Other Uninspected Articles to be Prepared in an Official Establishment Outside the Hours of Operation Under Inspection
Proposed Rule Stage Proposed Rule Stage
Eliminating Unnecessary Requirements for Hog Carcass Cleaning
Eliminating the Requirement That Livestock Carcasses be Marked "U.S. Inspected and Passed" at the Time of Inspection When Carcasses Are to be Further Processed Within the Same Establishment
Estimated Date NPRM 05/2018
NPRM 05/2018 NPRM 05/2018
RIN 0583AD66
0583AD68 0583AD69
Change in Status? NPRM Changed from Mar. to May 2018 No
No
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Stage of Rulemaking
Proposed Rule Stage
Subject Egg Products Inspection Regulations
Proposed Rule Stage
Proposed Rule Stage
Final Rule Stage
Publication Method for Lists of Foreign Countries Eligible to Export Meat, Poultry, and Egg Products to the United States Changes to Accreditation of Non-Federal Laboratories for Analytical Testing of Meat, Poultry, and Processed Egg Products Elimination of Trichina Control Regulations and Consolidation of Thermally Processed, Commercially Sterile Regulations
Final Rule Stage
Final Rule Stage
Eligibility of the People's Republic of China (PRC) for the Importation Into the United States of Poultry Products From Birds Slaughtered in the PRC
Modernization of Swine Slaughter Inspection
Long-Term Actions
Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed
Estimated Date NPRM Comment Period End 06/13/2018 NPRM 08/2018
NPRM 09/2018
Final Action 05/2018
RIN 0583AC58
0583AD72
0583AD70
0583AD59
Final Action 09/2018
0583AD64
Final Rule 04/2019
0583AD62
Next Action 0583Undetermined AD56
Change in Status? NPRM Issued Feb. 2018
First Time in Unified Agenda First Time in Unified Agenda Final Rule Dec. 2017 Changed to Final Action May 2018 Final Action Changed from Mar. to Sep. 2018 Moved from Proposed Rule Stage to Final Rule Stage No
APHIS:
Stage of Rulemaking Proposed Rule Stage
Subject
National Poultry Improvement Plan and Auxiliary Provisions
Proposed Branding Requirements for Bovines Imported Rule Stage Into the United States From Mexico
Proposed National List of Reportable Animal Diseases Rule Stage
Estimated Date
NPRM 04/09/2018; NPRM Comment Period End 05/09/2018 NPRM 04/12/2018; NPRM Comment Period End 06/11/2018
NPRM 11/2018
RIN
0579AE37
Change in Status? First Time in Unified Agenda
0579- First Time AE38 in Unified
Agenda
0579- First Time AE39 in Unified
Agenda
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Stage of Rulemaking Proposed Rule Stage
Final Rule Stage
Subject
Establishment of Regulations for the Evaluation and Recognition of the Animal Health Status of Compartments Bovine Spongiform Encephalopathy and Scrapie; Importation of Small Ruminants and Their Germplasm, Products, and Byproducts
Estimated Date NPRM 11/2018
Final Rule 07/2018
Final Rule Stage
Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables
Final Rule 07/2018
Final Rule Stage
Conditions for Payment of Highly Pathogenic Final Rule
Avian Influenza Indemnity Claims
10/2018
RIN 0579AE43 0579AD10
0579AD71
0579AE14
Change in Status?
First Time in Unified Agenda
Final Rule Changed from Feb. to July 2018 Final Rule Changed from Dec. 2017 to July 2018 Moved from LTA List to Final Rule Stage
FNS:
Stage of Rulemaking Proposed Rule Stage
Subject
Providing Regulatory Flexibility for Retailers in the Supplemental Nutrition Assistance Program (SNAP)
Final Rule Stage Final Rule Stage
Revisions and Clarifications in Requirements for the Processing of Donated Foods Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements
Estimated Date NPRM 09/2018
RIN
0584AE61
Final Action 05/2018 Interim Final Rule Effective 07/01/2018; Final Action 12/2018
0584AE38 0584AE53
Change in Status? NPRM Changed from Jan. to Sep. 2018 No
No
AMS:
Stage of Rulemaking Proposed Rule Stage
Proposed Rule Stage
Subject
NOP; Proposed Amendments to the National List of Allowed and Prohibited Substances for October 2017 Recommendations (Livestock and Handling) National Bioengineered Food Disclosure Standard
Estimated Date NPRM 04/2018
NPRM 05/2018; Final Action 07/2018
RIN
0581AD78
Change in Status? First Time in Unified Agenda
0581AD54
NPRM Changed from Dec. 2017 to May 2018
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Stage of Rulemaking Proposed Rule Stage
Proposed Rule Stage
Proposed Rule Stage
Subject NOP; Proposed Amendments to the National List of Allowed and Prohibited Substances for October 2017 Recommendations (Livestock and Handling) NOP; Amendments to the National List of Allowed and Prohibited Substances (Crops, Livestock and Handling)
NOP; Strengthening Organic Enforcement
Estimated Date NPRM 04/2018
NPRM Comment Period Reopened End 05/14/2018; Final Rule 07/2018 NPRM 03/2019
RIN
0581AD78
Change in Status?
First Time in Unified Agenda
0581- No AD60
0581AD09
NPRM Changed from Sep. 2014 to Mar. 2019
