Food Industry Regulatory Update November 4, 2024
In This Week’s Edition:
- FDA Food Code Supplement
- First Pre-Harvest Water Treatment Registered by EPA
- FDA Starts Next Phase of Sodium Reduction Efforts
- FDA Issues Final Compliance Policy Guide for Scombrotoxin-forming Fish and Fishery Products
- Food Distribution Programs: Improving Access and Parity
- FDA Human Foods Program: FY 2025 Priority Deliverables
- FDA Update on Phthalates in Food Packaging and Food Contact Applications
- Importation of Fresh Soursop Fruit From Mexico Into the U.S.
- 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 Food Code Supplement
FDA has published the Supplement to the 2022 Food Code. The Supplement updates the 2022 Food Code with recommendations made by regulatory officials, industry, academia, and consumers at the 2023 Biennial Meeting of the Conference for Food Protection.
The Food Code and its Supplement provide government and industry with practical, science-based controls for reducing the risk of foodborne illness in retail and foodservice establishments of all types. The Food Code and the Supplement are joint projects by the FDA, the Centers for Disease Control and Prevention, and the United States Department of Agriculture (USDA) – Food Safety and Inspection Service (FSIS).
Some highlights in the Supplement to the 2022 Food Code include:
- Adding new provisions addressing disinfection of food contact, nonfood-contact and equipment surfaces;
- Expanding and clarifying how and when containers can be refilled and reused in a food establishment;
- Addressing food protection with new provisions that improve awareness of food defense measures;
- Building on the concept of Food Safety Management Systems and Active Managerial Control by defining the terms, including new provisions that speak to when a Food Safety Management System is required;
- Updating testing requirements for reinstatement of food employees diagnosed with an illness from STEC, Shigella, or Nontyphoidal Salmonella to include culture-independent diagnostic tests; and
- Enhancing information regarding sushi rice acidification with a dedicated section in Annex 6 Food Processing Criteria addressing risks and controls.
First Pre-Harvest Water Treatment Registered by EPA
The U.S. Food and Drug Administration (FDA), in collaboration with the Environmental Protection Agency (EPA), announces the successful EPA registration of the first antimicrobial product using the revised efficacy protocol for pre-harvest agricultural water. This registration marks the first ever approval of a treatment for use against foodborne pathogens, such as Salmonella and E. coli, in the agricultural water used to grow produce. The registration was made following ongoing work to develop and refine an efficacy protocol to support registration. Prior to this registration, chemical applications for use in pre-harvest agricultural water were limited to treatment for the management of algae and biofilm formation or produce rot, but this approval sets a critical standard for reducing the presence of human pathogens directly.
FDA Starts Next Phase of Sodium Reduction Efforts
FDA has issued new, voluntary targets for sodium reduction in foods in a draft guidance that serves as Phase II of the agency’s ongoing work. The new targets build on the final, voluntary sodium reduction goals issued in 2021, now referred to as Phase I, to further reduce diet-related diseases associated with consuming high levels of sodium.
FDA Issues Final Compliance Policy Guide for Scombrotoxin-forming Fish and Fishery Products
FDA is announcing the availability of a final Compliance Policy Guide (CPG) intended to provide the FDA’s current thinking on the adulteration of fish and fishery products with Scombrotoxin.
The CPG, titled “Sec. 540.525 Scombrotoxin-forming Fish and Fishery Products – Decomposition and Histamine Compliance Policy Guide” will assist the FDA in addressing adulteration associated with decomposition and histamine identified during surveillance sampling and testing. It also will increase consumer protections related to scombrotoxin fish poisoning by lowering the levels of histamine in fish at which the FDA indicates that it may take action.
Food Distribution Programs: Improving Access and Parity
This final rule considers public comments submitted in response to the proposed rule revising the Commodity Supplemental Food Program, the Food Distribution Program on Indian Reservations, The Emergency Food Assistance Program, and USDA Foods disaster response regulations. This final rule is intended to make access and parity improvements in USDA’s food distribution programs to support access for eligible populations and streamline requirements for program operators.
FDA Human Foods Program: FY 2025 Priority Deliverables
FDA’s Human Foods Program (HFP) released its 2025 Priority Deliverables, which highlights activities the HFP plans to focus on during its first year following a reorganization of the program’s design and responsibilities that went into effect on October 1, 2024. These priority deliverables are being shared while the HFP works on a more comprehensive multi-year strategic plan to advance its vision and mission.
FDA Update on Phthalates in Food Packaging and Food Contact Applications
FDA is responding to the objection that we received from the Environmental Defense Fund, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, and Healthy Babies Bright Futures on the final rule that amended the food additive regulations to no longer provide for the use of 25 plasticizers that the petition identified as ortho-phthalates because these food additive uses have been permanently abandoned. After reviewing the objection, FDA has concluded that the objection does not provide a basis for modifying FDA’s final rule amending the food additive regulations.
Importation of Fresh Soursop Fruit From Mexico Into the U.S.
FDA is advising the public of their decision to authorize the importation of fresh soursop fruit (Annona muricata), also known as guanabana, from Mexico into the continental United States. Based on findings of a pest risk analysis, which FDA made available to the public for review and comment through a previous notice, FDA has determined that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh soursop fruit from Mexico.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- A new outbreak E. coli O26:H11 (ref #1272) linked to a not yet identified product has been added to the table.
- For the outbreak of E. coli O157:H7 (ref #1270) the advisory has been updated to provide investigational updates and include more cases. A specific ingredient has not yet been confirmed as the source of the outbreak, but most sick people report eating McDonald’s Quarter Pounder burgers. Taylor Farms has initiated a voluntary recall of some onions sent to food service customers. FDA is working to determine if the slivered onions on Quarter Pounder burgers are the likely source of contamination. FDA has initiated an onsite inspection and sample collection.
- For the outbreak of Listeria monocytogenes (ref #1268) linked to a not yet identified product, the case count has increased from three to four cases.
- For the outbreak of Salmonella Thompson (ref #1262) linked to a not yet identified product, the case count has increased from 25 to 27 cases.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foods containing illegal/undeclared colors, foods containing undeclared major allergens or fail to properly label major allergens.
FDA Food Industry Warning Letters
| Future Best Trading Inc. |
| Foreign Supplier Verification Program (FSVP) |
| Paso Real Produce LLC |
| Foreign Supplier Verification Program (FSVP) |