By JIM RUTLEDGE
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has begun accepting public comments on new food safety rules to help the owners and operators of food facilities meet certain registration requirements.
The requirements to register food facilities are new provisions added to the Federal Food, Drug and Cosmetic Act (FD&C) under the Food Safety Modernization Act (FSMA) of 2011. The latest rules also give increased muscle to the FDA’s ability to respond quickly to food-related emergencies and food poison outbreaks.
The new rules apply to all U.S. facilities engaged in the manufacturing or processing, packaging or the storing of foods for human and animal consumption. For certain-sized facilities that handle animal foods, however, the FDA has extended its deadlines and inspection timeframes for operators to come into compliance with the new rules and regulations, the agency announced this month.
Small-sized animal food facilities – firms with fewer than 500 employees – needed to come into compliance with the hazard analysis provisions and risk-based preventive controls regulations by Sept. 17, with the FDA delaying facility inspections until next fall. Initially, inspections were set to begin in January 2019.
A month ago, the FDA issued its supplemental draft guidance for food facility registration, establishing a new set of guidelines that require companies to provide the FDA “with assurances that they will be permitted to inspect their facilities; remind operators that facilities are required to renew their registration every other year; and that the FDA now has the authority to suspend a facilities registration.”
The draft guidelines, the agency says, are intended to “clarify” the government’s thinking about registration requirements for facilities that share physical space with multiple companies for food storage or use commercial communal kitchens.
The agency began accepting electronic or written comments on the proposed guidelines on August 20. The deadline for submission of comments is Oct. 19.
The FDA has also updated its webpage “Registration of Food Facilities” at www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration that includes a flowchart meant to help facilities determine if they are considered a retail food establishment, which would mean that they are exempt from food facility regulations and not required to register.
As a reminder, the agency said the 2018 biennial registration renewal period begins Oct. l and concludes Dec. 31. To register and find more information, facility owners and operators should visit the webpage.
The FDA’s decision to extend its deadlines and inspection timetable for certain-size animal food facilities was met with support from the American Feed Industry Assoc. (AFIA).
“Throughout the rulemaking process, the AFIA has asked the agency to take a staggered approach to implementation, to allow the industry time to focus on current good manufacturing practice (CGMP) implementation and also to receive the necessary guidance to properly implement the hazard analysis and risk-base prevention controls (HA/PC) requirements,” said Leah Wilkinson, AFIA’s vice president of public policy and education.
“The AFIA applauds the agency for continuing to offer this staggered approach and flexibility as the industry implements these broad, sweeping regulations.”
The FDA also said it intends to delay compliance for very small animal food businesses, those with sales less than $2.5 million annually, from the requirements applicable to qualified facilities until the fall of 2020.
As of Sept. 17, all three-size facilities of animal food businesses must comply with at least one portion of the FSMA regulations. Very small facilities must comply with the CGMPs for the first time.
Large-size facilities came into compliance with the HA/PA regulations last September, and the FDA will soon focus its inspections on CGMP provisions for all-size facilities. Prevention controls inspections will only affect large-size facilities.
The government said while the FDA has delayed inspections, compliance with the rules and regulations per the compliance dates is still required for all animal food manufacturing facilities. Should an animal food safety event occur, the FDA stated it reserves the right to take regulatory action.
With regard to providing comments on the draft guidelines, the public is invited to submit online at www.regulations.gov to docket folder FDA-2012-D-1002.
Mailed comments, referencing the docket number, should be sent to: Division of Dockets Management (AFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.