Among other things, FSMA specifies a July 3 effective date for requirements that grain, feed, feed ingredient, grain processing, milling and other sectors of the commercial food and feed industry conduct hazard analyses and implement preventive controls. The law also establishes a Jan. 3, 2013 effective date for facilities to establish foreign supplier verification procedures. However, FDA as yet has not proposed or obtained public comment on regulations spelling out the compliance requirements for these provisions that will apply to various industry sectors. The agency has said it is planning to issue two distinct sets of proposed rules concerning the hazard analysis and preventive control requirements, one for human food and another for animal feed and pet food.
The American Feed Industry Association (AFIA), National Grain and Feed Association (NGFA) and National Oilseed Processors Association (NOPA) on June 20 had written to FDA Deputy Commissioner for Foods Michael Taylor requesting that FDA exercise enforcement discretion in enforcing these provisions of FSMA until final regulations are issued and an appropriate implementation period is provided. The three organizations expressed concern about FDA’s pending plans to enforce these statutory provisions “given that proposed rules implementing these sections have not even been promulgated yet.” AFIA, NGFA and NOPA requested clarification from the agency on its intentions and plans regarding such enforcement as soon as possible so that they could provide guidance to their member companies and affiliated state and regional associations.
In a response dated Aug. 10, Deputy Commissioner Taylor wrote that FDA will “expect to enforce compliance” with the hazard analysis, preventive control and foreign supplier verification provisions of FSMA within the “timeframes that will be described in the final rules.” He also noted that the agency “is committed to full and timely implementation” of these provisions of the law.
Taylor’s letter does remind facilities that compliance with existing good manufacturing practice regulations, such as those applying to medicated animal feed, and other food and feed safety-related provisions of the Federal Food, Drug and Cosmetic Act remain in effect and are subject to inspection and enforcement by FDA.
AFIA, NGFA and NOPA said they are notifying companies within their respective memberships about FDA’s enforcement policy stance.