Food Industry Regulatory Update August 2, 2024

August 2, 2024

In This Week’s Edition:

USDA Policy to Reduce Salmonella
FDA to Hold Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food
FDA Alerts Parents and Caregivers to Cronobacter Safety Concerns with Crecelac Goat Milk Infant Formula
Fresh Tomatoes From Mexico; Institution of a Five-Year Review
U.S. Department of Agriculture Announces Key Staff Appointments and Promotions
FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2025
FSMA Third-Party Certification Program User Fee Rate for Fiscal Year 2025
FSMA Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2025
Plant Protection and Quarantine Releases 2023 Annual Report
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 Targets Walmart and Amazon Again for Third-Party Fulfillment of Violative Products

USDA Policy to Reduce Salmonella

USDA’s FSIS issued a comprehensive proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products. The proposal would establish final product standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 colony forming units (CFU) per gram/ml and any detectable level of at least one of the Salmonella serotypes of public health significance from entering commerce. The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I,4,[5],12: and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen. The proposal would also require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination throughout the slaughter system.

FDA to Hold Public Meeting on the Development of an Enhanced Systematic Process for FDA’s Post-Market Assessment of Chemicals in Food

The FDA will host a public meeting to share the agency’s enhanced systematic process for post-market assessment of chemicals in food and hear stakeholder perspectives on this proposal. This information will help inform FDA’s thinking and further the development of the process. The webinar will take place Wednesday, September 25, 2024. Limited in-person attendance and virtual attendance available

FDA Alerts Parents and Caregivers to Cronobacter Safety Concerns with Crecelac Goat Milk Infant Formula

After conducting an abbreviated nutrient analysis of Crecelac Infant Powdered Goat Milk Infant Formula, the FDA found both elevated levels of potassium and chloride and low levels of Vitamin A. The potassium and chloride levels were significantly above the levels permitted in infant formula in the U.S. and could lead to kidney and/or heart problems if the infant formula is used for an extended period of time. In addition, low Vitamin A intake could lead to vision loss from a Vitamin A deficiency if the infant formula is used for an extended period of time.

Fresh Tomatoes From Mexico; Institution of a Five-Year Review

The International Trade Commission has given notice that it has instituted a review pursuant to the Tariff Act of 1930, as amended, to determine whether termination of the suspended investigation on fresh tomatoes from Mexico would be likely to lead to continuation or recurrence of material injury. Interested parties may submit data for the ITC to consider in its review.

U.S. Department of Agriculture Announces Key Staff Appointments and Promotions

USDA announced the names of individuals who hold senior staff positions in Washington, D.C.:

Carlton Bridgeforth has been promoted to White House Liaison in the Office of the Secretary.
Hunter Henderson has been promoted to Chief of Staff of the Farm Service Agency.
Alyssa Charney has been promoted to Senior Advisor for Farm Production and Conservation.
Victoria Maloch has been promoted to Chief of Staff for Marketing and Regulatory Programs.
Will Clement has been appointed Senior Advisor for Strategic Communications in the Office of Communications.

FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2025

FDA is announcing the fiscal year 2025 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Food Safety Modernization Act.

FSMA Third-Party Certification Program User Fee Rate for Fiscal Year 2025

FDA is announcing the fiscal year 2025 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Food Safety Modernization Act. FDA is also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.

FSMA Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2025

FDA is announcing the fiscal year 2025 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program that is authorized by the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Food Safety Modernization Act. This fee is effective on August 1, 2024, and will remain in effect through September 30, 2025.

Plant Protection and Quarantine Releases 2023 Annual Report

See USDA’s Plant Protection and Quarantine’s 2023 annual report here.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

A new outbreak of Cyclospora cayetanensis illnesses (ref #1237) linked to a not yet identified product has been added to the table. FDA has initiated traceback.
A new outbreak of Cyclospora cayetanensis illnesses (ref #1239) linked to a not yet identified product has been added to the table. FDA has initiated traceback.
For the outbreak of Salmonella Irumu (ref #1235) linked to a not yet identified product, the case count has increased from 31 to 32.
For the outbreak of Salmonella Typhimurium (ref #1234) linked to a not yet identified product, FDA has initiated sample collection.
For the investigation of illnesses (ref #1233) linked to Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies, the advisory has been updated to include additional illnesses and a list of retailers that may have received recalled product.
For the investigation of Listeria monocytogenes (ref #1232) illnesses, the outbreak has ended and FDA’s investigation has closed. Based on CDC’s epidemiological investigation, ill people reported eating salad mixes before becoming sick. CDC, FDA, and state and local partners conducted epidemiologic and traceback investigations and collected and analyzed finished product and environmental samples. All samples collected as part of the investigation were reported as negative for Listeria monocytogenes. The products making people sick in this outbreak are off the market and past shelf life. There is no ongoing risk to the public.

CORE Investigation Table

FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.

FDA Import Alerts

The latest FDA import alerts include human and animal foods that are imported from foreign suppliers by importers who are not in compliance with FSVP, raw agricultural products for pesticides, and more.