While the major provisions of the FSMA rules are being implemented as planned, the FDA said the compliance date extensions and clarifications are part of the agency’s continuing efforts to make the rules as practical as possible while still protecting public health. The FDA said the final rule addresses technical issues and better aligns compliance dates across the four rules.
After the FSMA was signed into law in January 2011, the FDA went to work on writing regulations for enforcement and came up with seven major rules. The final regulations were published on Sept. 17, 2015, and included requirements for Current Good Manufacturing Practices (CGMPs), hazard analysis and risk-based preventive controls as well as supply-chain programs.
While CGMPs have long existed for the production of human food, this is the first time that most animal food producers will be subject to CGMPs, according to an Aug. 24 blog on FDA Voice.
Two CGMP and preventive controls rules – together with the five other foundational rules that will be implemented over the next several years to strengthen FDA oversight of produce, imported foods, sanitary transportation and intentional adulteration – are designed to implement the preventive and risk-based food safety system mandated under FSMA, the National Grain and Feed Association (NGFA) said.
The changes announced in the final rule affect the compliance dates for certain provisions in the following four sets of FDA rules: the two CGMP and preventive controls rules for human and animal food; the foreign supplier verification programs (FSVP) rule; and the produce safety rule. The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for the FDA to resolve specified issues, NGFA said.
The two draft guidance documents when finalized will help domestic and foreign facilities comply with key requirements in the Preventive Controls for Animal Food rule, which covers all animal food, including animal feed and pet food. One of those documents provides direction on ways to comply with the rule’s CGMP requirements, which are baseline food safety and sanitation standards for animal food facilities, according to an Aug. 24 blog on FDA Voice. This draft guidance also provides information on provisions related to the CGMP requirements, such as qualifications and training of personnel.
The regulatory provisions in the final FSMA rules remain unchanged. Compliance dates are fast approaching for large food facilities that produce human and animal foods.
Animal food companies (including feed and pet food manufacturers), other than small and very small businesses, need to come into compliance with CGMPs under the current good manufacturing practice, hazard analysis, and risk-based preventive controls for animal food rule by Sept. 19, and with preventive controls by Sept. 18, 2017.
The FDA issued a draft guidance document, available for public comment starting Aug. 24, that includes five chapters of what will be a multi-chapter guidance document designed to help businesses comply with the human food CGMP and preventive controls rule. The draft guidance explains the FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls for human food, and includes a discussion about establishing a food safety plan. The NGFA said it has been advised that the forthcoming guidance document for animal food likely may be similar in several respects to the human food guidance.
|Richard Sellers, senior vice-president of public policy and education for AFIA.|
The compliance date for firms with more than 500 employees is Sept. 19 — less than one month away — for CGMP compliance,” said Richard Sellers, senior vice-president of public policy and education for the American Feed Industry Association (AFIA). “Industry needs adequate time to review this document and determine if their facilities are in compliance with FDA's interpretation of this rule as explained in this document. The tardy nature of the guidance makes this task near impossible to achieve.”
The FSMA applies to domestic and foreign facilities that manufacture, process, pack or hold animal feed and/or pet food, and ingredients used in such products. In general, this means the FSMA covers facilities that are required to register with the FDA under the agency’s existing facility registration regulations implemented as part of the Bioterrorism Act.