The US Food and Drug Administration updated the Mycotoxins in Domestic and Imported Human Foods Compliance Program to include the monitoring of additional mycotoxins of regulatory interest in human foods, specifically T-2/HT-2 toxins and zearalenone. The updated compliance program also reflects the transition by FDA regulatory laboratories to a multi-mycotoxin method for analysis in human foods, which will allow the agency to obtain results for multiple mycotoxins in a single sample analysis. The new data gained by the compliance program update will support enforcement actions, risk assessments, and international activities, as well as provide information on mycotoxin incidence, extent of contamination, and co-occurrence. These changes do not affect the FDA’s surveillance of mycotoxins in animal food.

T-2/HT-2 toxins are mycotoxins produced by Fusarium molds. These toxins are found in contaminated grains, such as wheat, rye, oat, and barley. Contamination generally occurs when these foods are not stored and/or dried properly. If T-2 and HT-2 are found in foods, they may cause human health issues such as high fever, gastrointestinal problems, and hemorrhage.

Zearalenone is a mycotoxin also produced by Fusarium molds. It has been found in contaminated grains, such as corn, oats, wheat, sorghum, and rice. Contamination generally occurs when these foods are not stored and/or dried properly. If zearalenone is found in food, it may cause reproductive issues in humans.

The updated Mycotoxins in Domestic and Imported Human Foods Compliance Program and information on mycotoxins, including how the FDA monitors them in foods, can be found at https://www.fda.gov/food/natural-toxins-food/mycotoxins. For more information about the FDA Center for Veterinary Medicine’s oversight of mycotoxins in animal food, visit Chemical Contaminants in Animal Food.

The US Food and Drug Administration (FDA) is announcing the availability of an updated guidance for industry entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide” (SECG). This update aims to assist small entities in complying with the revised requirements related to pre-harvest agricultural water for covered produce (other than sprouts) under the Produce Safety Rule.

The SECG reflects changes made to the Produce Safety Rule by the May 2024 final rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water”. Compliance dates for the pre-harvest agricultural water requirements for covered produce (other than sprouts) begin on April 7, 2025, with date staggering based on farm size.

Additional Information

FDA’s Food Safety Guidance Documents

FSMA Final Rule on Produce Safety

FSMA Final Rule on Pre-Harvest Agricultural Water

Federal Register Notice

News from AAFC’s Market Access Secretariat

On September 10, 2024, the United States Department of Agriculture (USDA) released an updated Guideline to Strengthen Substantiation of Animal-Raising and Environment-Related Claims on Meat and Poultry Labels. This Guideline is intended to provide information related to such claims on meat or poultry product labels. These labels bearing such claim(s) may only be used on products if they have been reviewed and approved by the USDA’s Food Safety and Inspection Service (FSIS). You can access the Guideline document by clicking on this link: FSIS Guideline on Substantiating Animal-Raising or Environment-Related Labeling Claims.

This guideline is not directly linked to the voluntary “Product of USA” final rule, although it touches on voluntary claims on meat and poultry products.

Comments on the Guideline can be submitted directly to the USDA through the Federal Register or by mail. Comments must be received on or before November 12, 2024, to be assured of consideration.

News from AAFC’s Market Access Secretariat

In recent months, the Canadian Food and Inspection Agency (CFIA) was made aware of industry concerns related to an import requirement by the Ministry of Health in Malaysia that Canadian pork shipments be free from any beta-agonist. We are pleased to confirm that an agreement has been reached between the CFIA and the Ministry of Health in Malaysia.

Effective now, an additional statement will be included in the CFIA certificate for the export of pork and pork products including offal to Malaysia (Annex E2), noting that products in the shipment have been produced from pigs raised under the Canadian Ractopamine Free Pork Certification Program and do not contain any other beta-agonists, as they are not authorized for use in pigs in Canada.

Should you have any further questions, please reach out to your CFIA local office.

News from Canadian Food Inspection Agency

The CFIA has been made aware by the Canadian Industry that notices are circulating announcing that, starting immediately, all wood packaging materials exported from Canada to the USA now need to be heat treated or fumigated as per the ISPM 15 requirements. The notice states that this change is due to the recent Avian Influenza outbreak and that every truck entering the US will undergo inspections to ensure that the pallet standards are met.

The CFIA confirmed with the US authorities that this information is false. No changes have been made to the requirements.

In 2005, an exemption was established for the movement of wood packaging between the US and Canada (wood packaging materials do not need to be treated and stamped). To be exempt, the wood packaging must be accompanied by export/shipping documents clearly stating that any unmarked wood packaging in the shipment was:

• produced in either the US and/or Canada (as the case may be), and
• manufactured with wood originating from either Canada or the US

This exemption applies only to the Continental United States. Wood packaging imported from or exported to Hawaii and US territories is not included in the exemption and thus need to bear the ISPM 15 mark.

If you need further information, please contact your local CFIA office.