Federal Register Update – November 16 – 18, 2022
November 16, 2022
Federal Register
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 Date | Issue Date | Company | Issuing Office | Subject |
| 11/15/2022 | 10/26/2022 | Lucero Produce II Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| 11/15/2022 | 10/18/2022 | HolleHippos LLC | Division of Southeast Imports | Foreign Supplier Verification Program (FSVP) |
USDA
FACT SHEET: One Year of the Bipartisan Infrastructure Law at USDA
AMS
USDA Restricts PACA Violators in California and Nevada From Operating in the Produce Industry
GAO
Performance and Accountability Report, Fiscal Year 2022
@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
- Big Sky Bread Company Issues Allergy Alert on Undeclared Milk in Chocolate Chunk Granola and Chocolate Chunk Peanut Butter Chip Granola https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/big-sky-bread-company-issues-allergy-alert-undeclared-milk-chocolate-chunk-granola-and-chocolate
- Boston Baking Issues Allergy Alert on Undeclared Pecans in “Boston Baking Mini Cinnamon Crumb Cakes” https://fda.gov/safety/recalls-market-withdrawals-safety-alerts/boston-baking-issues-allergy-alert-undeclared-pecans-boston-baking-mini-cinnamon-crumb-cakes
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
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
USDA
USDA Invests $21.6M in Small Business-Led Innovations
CVM
@USDAFoodSafety
- #Alert Tyson Fresh Meats, Inc. Recalls Raw Ground Beef Products Due to Possible Foreign Matter Contamination https://bit.ly/3O9Pbt3
@FDAanimalhealth
- Today #FDA issued a draft amended Environmental Assessment for AquAdvantage Salmon, an Atlantic salmon with an intentionally altered genome. FDA approved an application concerning the salmon in 2015
- The Environmental Assessment evaluates the potential risk the salmon or its eggs would pose to the U.S. environment if it were to escape confinement: https://federalregister.gov/public-inspection/2022-25001/environmental-assessments-availability-etc-production-of-aquadvantage-salmon-at-the-bay-fortune-and
- #FDA is also announcing a virtual public meeting on Dec. 15 where the public can provide input on the draft amended EA.
@DrCaliff_FDA
- The world is experiencing a food revolution and the FDA is committed to supporting innovation in the food supply. Today we are announcing that we have completed our first pre-market consultation of a human food made from cultured animal cells. https://fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology
November 18, 2022
Federal Register
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
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 to Hold Webinar on the Food Traceability Final Rule
Recalls
| Date | Brand | Description | Product Type | Recall Reason | Company |
| 11/17/2022 | Fudgeamentals | Chocolate fudge bites | Food & Beverages, Allergens, Chocolate/Cocoa Product | Undeclared walnuts | Fudgeamentals |
| 11/17/2022 | Green Day Produce | Enoki Mushrooms | Food & Beverages | Potential to be contaminated with Listeria Monocytogenes | Green Day Produce |
| 11/17/2022 | Healthy Sense and People’s Choice | Daily multi vitamin with Iron and Women’s daily vitamin with iron | Food & Beverages | Due to Vitamin A, B12, C, E and Pantothenic Acid being lower than declared | Mason Vitamins Inc. |
Warning Letters
| Posted Date | Issue Date | Company | Issuing Office | Subject |
| 11/17/2022 | 11/14/2022 | Healthy Trends Worldwide, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/17/2022 | 11/14/2022 | Chambers’ Apothecary | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/17/2022 | 11/14/2022 | iwi | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/17/2022 | 11/14/2022 | BergaMet North America LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/17/2022 | 11/14/2022 | Essential Elements | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/17/2022 | 11/14/2022 | Calroy Health Sciences, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
| 11/17/2022 | 11/14/2022 | Anabolic Laboratories Inc | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
OMB
| AGENCY: HHS-FDA | RIN: 0910-ZB40 | Status: 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: Notice | ECONOMICALLY SIGNIFICANT: No | |
| RECEIVED DATE: 11/14/2022 | LEGAL DEADLINE: None | |
| ** COMPLETED: 11/17/2022 | COMPLETED ACTION: Consistent without Change |
USDA
USDA Proposes Science-Driven Updates to Foods Provided Through WIC
@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.
- 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
- To submit questions in advance, visit the registration page https://fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/webinar-food-traceability-final-rule-12072022… or send questions to FSMA204Traceability@fda.hhs.gov