Food Industry Regulatory Update August 6, 2021

In this Week’s Edition:

FDA Issues Letter to Industry on Fluorinated Polyethylene Food Contact Containers
FDA Compliance Date for the Final Rule on Gluten-Free Labeling of Fermented and Hydrolyzed Foods Approaching
USDA General Counsel Confirmed
National Organic Program Renews Exemptions for Substances
FSIS Updates Directive for Verification Activities for High Pressure Processing, Irradiation and Microwave Tempering
FDA Update on Cyclospora Outbreak Investigation
FSIS Updates COVID-19 Procedures for Inspection Activities
AMS Proposes Terminating South Texas Onion Marketing Order
ERS Seeking Comment on Aquaculture Strategic Plans
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
FDA Warning Letters

FDA Issues Letter to Industry on Fluorinated Polyethylene Food Contact Containers

FDA has issued a letter reminding industry that only certain fluorinated polyethylene containers are authorized for food contact use. The agency took this step to ensure that manufacturers that produce, distribute, or use these types of containers are aware of FDA’s regulation pertaining to the requirements for fluorinating polyethylene containers used with food (21 CFR 177.1615).

Fluorination allows for improved chemical barrier properties in containers. Recently, based on testing performed by the Environmental Protection Agency (EPA), the FDA has become aware that certain per- and polyfluoroalkyl substances (PFAS) can form and migrate from some fluorinated high-density polyethylene (HDPE – a type of polyethylene) containers. EPA’s testing was conducted on containers that are not regulated by the FDA (containers intended to hold mosquito-controlling pesticides not approved for direct use on food crops). The type of PFAS detected are called perfluoroalkyl carboxylic acids (PFCAs), several of which are associated with adverse health effects. Analytical studies indicate that PFCAs can result from fluorination processes that are not compliant with FDA’s regulations.

While the FDA has no evidence that these alternative fluorination processes are used to manufacture food containers, the agency is encouraging manufacturers and distributors to consult with the FDA regarding the regulatory status of any manufacturing processes used for fluorinated polyethylene containers intended for use with food. More details here.

FDA Compliance Date for the Final Rule on Gluten-Free Labeling of Fermented and Hydrolyzed Foods Approaching

On August 13, 2020, the U.S. Food and Drug Administration released a final rule to establish compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. In both fermented and hydrolyzed foods, protein strands have been broken down into smaller strands or individual amino acids. The rule is designed to protect individuals with celiac disease — a hereditary, chronic inflammatory disorder of the small intestine — who are advised to avoid all sources of gluten in their diet to protect against adverse health effects associated with consumption of gluten for those with the disease. The compliance date for the rule is August 13, 2021. More information here.

USDA General Counsel Confirmed

Janie Simms Hipp has been confirmed to serve as General Counsel of the United States Department of Agriculture. More information here.

National Organic Program Renews Exemptions for Substances

Details here.

FSIS Updates Directive for Verification Activities for High Pressure Processing, Irradiation and Microwave Tempering

More information here.

FDA Update on Cyclospora Outbreak Investigation

The update is here.

FSIS Updates COVID-19 Procedures for Inspection Activities

The notice announces that to reduce the risk of COVID-19 infection for FSIS employees, FSIS will now expect official meat and poultry establishments, egg products plants, and all other facilities where FSIS provides inspection services, such as voluntary inspection service, to follow recent guidance from the Centers for Disease Control (CDC) and require their employees or contractors to wear masks when IPP are present, if the establishment is located in a county with “substantial” or “high” community transmission of COVID-19. For the purposes of this notice, official establishments, egg products plants, and all other facilities where inspection is provided are collectively referred to as “establishments.”