FSMA: Recent FDA Revisions & Deadlines
In response to comments collected regarding the major proposed Food Safety Modernization Act (FSMA) regulations, the U.S. Food and Drug Administration (FDA) revised four of the seven rules that the agency proposed in 2013. On September 19, 2014, FDA proposed revisions to the following proposed rules: produce safety, preventive controls for human food, preventive controls for animal food, and the foreign supplier verification program. Below are some of the proposed revisions.
FDA’s revisions offer more flexible agricultural water safety criteria. The agency updated the microbial quality standard for water and is allowing for naturally occurring microbial die-off. FDA is also proposing a tiered water testing system through which the frequency of testing will be dependent on the contamination risk of the water source.
FDA is removing its proposed minimum-time interval of nine-months between the application of untreated biological soil amendments of animal origin (such as raw manure) and crop harvesting. The agency is conducting further research on this matter before making a final decision on a new time interval. FDA is also ridding of its proposed 45-day minimum application interval for compost, including compost manures.
FDA is proposing to base farm sizes (small business, very small business, etc.) on produce sales rather than food sales, which combined sales of all foods produced on the farm. The agency is proposing to exempt farms with $25,000 or less in produce sales from the produce safety rules.
Preventive Controls for Human Food
FDA’s revisions state that a farm will no longer be required to register as a food facility if it simply packs or holds raw agricultural commodities grown on another farm under a different ownership. Farms under this qualification would be subject to produce safety rules rather than preventive controls for human foods. FDA updated its Food Facility Registration Guidance in November 2014 to inform the industry that FDA does not intend to prioritize enforcing registration requirements for farms such as these as the rule-making process continues.
FDA is proposing that a “very small business” be defined as a firm with less than $1 million in total annual sales of human food, adjusted for inflation.
The proposed revisions would allow FDA to withdraw (and re-instate) an exemption for a qualified food facility for specified reasons regarding food safety. FDA would be required to notify the exempt facility in advance of the withdrawal, give the facility a chance to respond, and provide the facility an additional 60 days to comply with the full requirements for hazard analysis and risk-based preventive controls.
FDA is proposing that facilities be required to conduct product and environmental testing (appropriate for the nature of that specific facility) to verify implementation and effectiveness of preventative controls. Facilities would also be required to implement certain supplier controls when necessary to ensure identified hazards are controlled before the facility receives products from the supplier.
Preventive Controls for Animal Food
FDA is proposing that current good manufacturing practices (CGMPs) provide more flexibility for the variety of types animal food facilities and establish standards for producing safe animal food.
FDA is also proposing that human food processors that are already in compliance with FDA human food safety requirements would not need to implement additional preventive controls when supplying a by-product for animal food, unless the by-product is further processed. These human food processors would not need to implement additional CGMP regulations either, except for CGMPs proposed to prevent physical and chemical contamination when holding and distributing the by-product.
FDA is proposing that a “very small business” be defined as a firm with less than $2.5 million in total annual sales of animal food, adjusted for inflation.
As with the preventive controls for human food, FDA would have the power to withdraw an animal food firm from exemption. Animal food firms would also be subject to the product testing, environment monitoring, and supplier control requirements.
Foreign Supplier Verification Program
FDA is proposing that importers be required to conduct a broader evaluation of food and foreign supplier risks. Importers would need to consider factors such as the nature of hazards in food, the supplier’s food safety procedures, processes, practices, and performance history, and more.
FDA is proposing that importers be required to conduct annual on-site auditing of a supplier when there is reason to believe that a hazard will cause serious injuries or death to humans or animals. An importer would only be allowed to use a different verification activity for such a supplier if the importer could establish that the activity would provide adequate control of the hazard.
FDA will begin accepting comments on these proposed revisions on Monday, September 29, 2014, and will continue to accept comments for the following 75 days. At a recent conference, Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, said not to expect an extension for this comment period due to the court-ordered deadlines for FDA to issue the final rules. FDA is required to issue final rules by:
- August 30, 2015 for preventive controls for human food and preventive controls for animal food
- October 31, 2015 for produce safety, the foreign supplier verification program, and third-party accreditation
- March 31, 2016 for sanitary transport
- May 31, 2016 for intentional adulteration
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