Federal Register Update – November 16 – 18, 2022

November 16, 2022

Federal Register

Food and Drug Administration

Rules

Requirements for Additional Traceability Records for Certain Foods

Filed on: 11/15/2022 at 11:15 am

Scheduled Pub. Date: 11/21/2022

FR Document: 2022-24417  PDF 597 Pages (1.26 MB)  Permalink

Notices

Environmental Assessments; Availability, etc.: Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Draft Amended

Filed on: 11/16/2022 at 8:45 am

Scheduled Pub. Date: 11/17/2022

FR Document: 2022-25001  PDF 7 Pages (84.3 KB)  Permalink

Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, Canada; Draft Amended; Meeting

Filed on: 11/16/2022 at 8:45 am

Scheduled Pub. Date: 11/17/2022

FR Document: 2022-25002  PDF 9 Pages (110 KB)  Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances: Sulfur Dioxide

Filed on: 11/16/2022 at 8:45 am

Scheduled Pub. Date: 11/17/2022

FR Document: 2022-25014  PDF 12 Pages (121 KB)  Permalink

Proposed Rules

Pesticide Petitions: Residues of Pesticide Chemicals in or on Various Commodities

Filed on: 11/16/2022 at 8:45 am

Scheduled Pub. Date: 11/17/2022

FR Document: 2022-25071  PDF 6 Pages (107 KB)  Permalink

FDA

FDA Advances the New Era of Smarter Food Safety, Finalizing Foundational Rule to Improve Traceability of Contaminated Foods

FDA Roundup: November 15, 2022

FDA Outlines Strategy to Enhance the Safety of Powdered Infant Formula

FDA Announces the Final Rule for Food Traceability Under FSMA

Warning Letters

Posted DateIssue DateCompanyIssuing OfficeSubject
11/15/202210/26/2022Lucero Produce II Corp.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
11/15/202210/18/2022HolleHippos LLCDivision of Southeast ImportsForeign Supplier Verification Program (FSVP)

USDA

FACT SHEET: One Year of the Bipartisan Infrastructure Law at USDA

Biden-Harris Administration, Trout Unlimited Invest up to $40 Million to Restore Watersheds on National Forests

AMS

USDA Restricts PACA Violators in California and Nevada From Operating in the Produce Industry

GAO

Food Safety: FDA Oversight of Substances Used in Manufacturing, Packaging, and Transporting Food Could Be Strengthened

Performance and Accountability Report, Fiscal Year 2022

Twitter

@FrankYiannasFDA

  • Today, the US FDA announced an unprecedented advancement in foodborne illness prevention through finalization of the Food Traceability Rule.
  • This rule lays the foundation for even greater end-to-end food traceability across the food system that we’re working on as part of our New Era of Smarter Food Safety.
  • Together, we ARE creating a safer, smarter, & more transparent food system that will benefit consumers, food producers, and the planet.

@SecVilsack

  • For too long, American infrastructure has fallen behind, with rural & historically underserved communities suffering the most. The Bipartisan Infrastructure Law has provided @USDA with the resources to create a more resilient, equitable economy that works for everyone.

@FDAFood

  • Recording available of part 3 of webinars providing in-depth information about the Infant Formula Transition Plan for Exercise of Enforcement Discretion. This webinar focus: “Originally Quality Factor Requirement– Sufficient Biological Quality of Protein.”
  • OUTBREAK REMINDER: @US_FDA is still investigating the multistate outbreak of E. coli O121:H19 infections linked to Earth Grown frozen #falafel. Check your freezer! Do not eat, sell, or serve the recalled product.
  • Available today, the @US_FDA’s final rule “Requirements for Additional Traceability Records for Certain Foods.”  This rule more effectively traces contaminated food through the food supply whether sourced in the U.S. or abroad. #FSMA
  • Released today, the outline of @US_FDA’s strategy to help prevent cronobacter sakazakii Illnesses associated with consumption of powdered infant formula. Over the next several months the Agency intends to work with stakeholders to finalize this strategy.

@FDArecalls

November 17, 2022

Federal Register

Agricultural Marketing Service

Proposed Rules

Decrease of Assessment Rate for Texas Oranges and Grapefruit

Filed on: 11/17/2022 at 8:45 am

Scheduled Pub. Date: 11/18/2022

FR Document: 2022-25123  PDF 10 Pages (105 KB)  Permalink

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Country of Origin Labeling

Filed on: 11/17/2022 at 8:45 am

Scheduled Pub. Date: 11/18/2022

FR Document: 2022-25079  PDF 4 Pages (92.6 KB)  Permalink

Pecans Grown in Multiple States

Filed on: 11/17/2022 at 8:45 am

Scheduled Pub. Date: 11/18/2022

FR Document: 2022-25076  PDF 4 Pages (95 KB)  Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

                Electronic Import Inspection

Filed on: 11/17/2022 at 8:45 am

Scheduled Pub. Date: 11/18/2022

FR Document: 2022-25171  PDF 3 Pages (88.4 KB)  Permalink

Food Safety Certification for Specialty Crops Program (FSCSC)

Filed on: 11/17/2022 at 8:45 am

Scheduled Pub. Date: 11/18/2022

FR Document: 2022-25143  PDF 5 Pages (94.4 KB)  Permalink

Environmental Protection Agency

Rules

                Pesticide Tolerances: Cyclaniliprole

Filed on: 11/17/2022 at 8:45 am

Scheduled Pub. Date: 11/18/2022

FR Document: 2022-25185  PDF 11 Pages (132 KB)  Permalink

Food Safety and Inspection Service

Notices

Expansion of Shiga Toxin-Producing Escherichia coli Testing to Additional Raw Beef Products

Filed on: 11/17/2022 at 8:45 am

Scheduled Pub. Date: 11/18/2022

FR Document: 2022-25140  PDF 32 Pages (208 KB)  Permalink

FDA

Focusing on Prevention to Safeguard Infant Formula

FDA Spurs Innovation for Human Food from Animal Cell Culture Technology

FDA Completes First Pre-Market Consultation for Human Food Made Using Animal Cell Culture Technology

FSIS

Tyson Fresh Meats, Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination

USDA

USDA Invests $21.6M in Small Business-Led Innovations

CVM

FDA Releases Draft Amended Environmental Assessment for AquAdvantage Salmon and Announces Virtual Public Meeting

Twitter

@USDAFoodSafety

  • #Alert Tyson Fresh Meats, Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination https://bit.ly/3O9Pbt3

@FDAanimalhealth

@DrCaliff_FDA

November 18, 2022

Federal Register

Food and Drug Administration

Proposed Rules

Filing of Food Additive Petition: Cargill, Inc.

Filed on: 11/18/2022 at 8:45 am

Scheduled Pub. Date: 11/21/2022

FR Document: 2022-25310  PDF 4 Pages (100 KB)  Permalink

Food and Nutrition Service

Proposed Rules

Special Supplemental Nutrition Program for Women, Infants, and Children: Revisions in the Women, Infants, and Children Food Packages

Filed on: 11/18/2022 at 8:45 am

Scheduled Pub. Date: 11/21/2022

FR Document: 2022-24705  PDF 196 Pages (721 KB)  Permalink

FDA

FDA’s Cybersecurity Modernization Action Plan

FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease

FDA Issues Warning Letters to Companies Selling Dietary Supplements that Claim to Treat Cardiovascular Disease

FDA to Hold Webinar on the Food Traceability Final Rule

Recalls

DateBrandDescriptionProduct TypeRecall ReasonCompany
11/17/2022FudgeamentalsChocolate fudge bitesFood & Beverages, Allergens, Chocolate/Cocoa ProductUndeclared walnutsFudgeamentals
11/17/2022Green Day ProduceEnoki MushroomsFood & BeveragesPotential to be contaminated with Listeria MonocytogenesGreen Day Produce
11/17/2022Healthy Sense and People’s ChoiceDaily multi vitamin with Iron and Women’s daily vitamin with ironFood & BeveragesDue to Vitamin A, B12, C, E and Pantothenic Acid being lower than declaredMason Vitamins Inc.

Warning Letters

Posted DateIssue DateCompanyIssuing OfficeSubject
11/17/202211/14/2022Healthy Trends Worldwide, LLCCenter for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded
11/17/202211/14/2022Chambers’ ApothecaryCenter for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded
11/17/202211/14/2022iwiCenter for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded
11/17/202211/14/2022BergaMet North America LLCCenter for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded
11/17/202211/14/2022Essential ElementsCenter for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded
11/17/202211/14/2022Calroy Health Sciences, LLCCenter for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded
11/17/202211/14/2022Anabolic Laboratories IncCenter for Food Safety and Applied Nutrition (CFSAN)New Drug/Misbranded

OMB

AGENCY: HHS-FDARIN: 0910-ZB40Status: Concluded
TITLE:Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)
STAGE: NoticeECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 11/14/2022LEGAL DEADLINE: None  
** COMPLETED: 11/17/2022COMPLETED ACTION: Consistent without Change

USDA

USDA Proposes Science-Driven Updates to Foods Provided Through WIC

Twitter

@FrankYiannasFDA

  • FDA commends the recipients of @IntFreshProduce’s Root Cause Analysis award. Organizations like these reflect a strong food safety culture and ultimately are helping us all to broaden our understanding of the drivers of contamination. https://theproducenews.com/headlines/ifpa-announces-winners-root-cause-analysis-award
  • The FDA recently issued the Food Traceability Final Rule. On Dec 7th, the FDA is holding a webinar to explain the rule, answer your questions, & listen to any concerns you might have. Please plan to join us!

@USDAFoodSafety

  • The deadline to submit comments on our proposed framework for controlling Salmonella in poultry has been extended to 12/16. View the notice for more details

@FDAfood

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