In This Week’s Edition:
- FDA Publishes Guidance on Refusal of Inspection by a Foreign Food Establishment or Foreign Government
- Public Meeting; National Advisory Committee on Microbiological Criteria for Foods
- FDA Publishes Guidance on FSMA Laboratory Accreditation Rule
- USDA Announcement on WIC Funding
- FSIS Rule on Appeals of Agency Inspection Decisions or Actions
- FDA Releases Guidance on Use of Tracers in Animal Food
- USDA Farmer Assistance Payments
- FSIS Directive on Verifying Food Safety Practices
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FDA Publishes Guidance on Refusal of Inspection by a Foreign Food Establishment or Foreign Government
FDA is announcing the availability of a final guidance for industry entitled “Refusal of Inspection by a Foreign Food Establishment or Foreign Government.” The guidance will provide information for foreign food establishments subject to FDA inspection, as well as foreign governments, on when FDA may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection as provided in the Federal Food, Drug, and Cosmetic Act.
Public Meeting; National Advisory Committee on Microbiological Criteria for Foods
This notice is announcing that the National Advisory Committee on Microbiological Criteria for Foods will hold a public meeting of the full Committee on November 15, 2022. The Committee will discuss and vote on adopting the following report: Enhancing Salmonella Control in Poultry Products. An update on the Cyclospora cayetanensis charge will also be provided and FDA will issue an additional work charge on Cronobacter spp. in Powdered Infant Formula to the Committee.
FDA Publishes Guidance on FSMA Laboratory Accreditation Rule
FDA is announcing the availability of a guidance for industry entitled “Laboratory Accreditation for Analyses of Foods: What You Need to Know About the FDA Regulation: Guidance for Industry–Small Entity Compliance Guide.” The small entity compliance guide is intended to help small entities comply with the final rule entitled “Laboratory Accreditation for Analyses of Foods.”
USDA Announcement on WIC Funding
USDA announces progress in several modernization and innovation efforts for WIC. Efforts include the award of nearly $53 million across three major grants funded by the American Rescue Plan Act of 2021.
FSIS Rule on Appeals of Agency Inspection Decisions or Actions
FSIS is amending its regulations to establish a uniform time period requirement for the filing of appeals of certain Agency inspection decisions or actions.
FDA Releases Guidance on Use of Tracers in Animal Food
FDA is announcing the availability of a final guidance for industry entitled “Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds.” Tracers are ingredients added to animal food, medicated feed, and Type A medicated articles to identify a particular product. This final guidance replaces Compliance Policy Guide Sec. 680.100 “Tracers in Animal Feed.”
USDA Farmer Assistance Payments
USDA announced that distressed borrowers with qualifying USDA farm loans have received nearly $800 million in assistance, as part of the $3.1 billion in assistance for distressed farm loan borrowers provided through Section 22006 of the Inflation Reduction Act (IRA). The IRA directed USDA to expedite assistance to distressed borrowers of direct or guaranteed loans administered by USDA’s Farm Service Agency whose operations face financial risk.
FSIS Directive on Verifying Food Safety Practices
This directive instructs Enforcement, Investigations and Analysis Officers (EIAOs) and EIAO-trained Public Health Veterinarians on how to conduct Food Safety Assessments (FSAs) within seven production days. This directive also provides instructions on how to document FSAs using the FSA tools in the FSA Module in the Public Health Information System. The FSA tools are a series of questionnaires that guide the EIAO in gathering information to assess the establishment’s food safety system. FSIS is reissuing this directive to clarify instructions, add egg products, add new FSA tools, and remove outdated information.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of E.coli O121:H19 linked to Frozen Falafels (reference #1115), FDA has initiated traceback and sample collection and analysis.
- For the outbreak of E. coli O157:H7 in an unidentified product (reference #1081), the FDA investigation has closed.
- For the outbreak of Salmonella Senftenberg in an unidentified product (reference #1087), the case count has increased from 33 to 34 cases.
- For the outbreak of Cyclospora cayetanensis in an unidentified product (reference #1084), the case count has increased from 42 to 43 case.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foreign establishments refusing FDA inspection, foreign processors not in compliance with juice HACCP, and more.
FDA Warning Letters
Cloud Hempistry |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Island Ecig & Vape Co |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Beijing Xinggu Lvsan Technology Co., Ltd. Formerly known as Beijing Lvsan Technology Co., Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug/Misbranded |
Tobacco Paradise LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
American Cleaning Solutions |
CGMP/Finished Pharmaceuticals/Adulterated |
Forcemech International LLC |
CGMP/QSR/Medical Devices/Adulterated |
South Pork Ranch Equipment LLC |
Unapproved New Animal Drug/Adulterated |
Thai Union Group PLC |
Seafood HACCP/CGMP for Foods/Adulterated |