Three U.S. grain, animal feed and feed ingredient processing organizations commended the Food and Drug Administration for clarifying its enforcement policy for implementing several key sections of the Food Safety Modernization Act, which was signed into law in January 2011.
The law includes Section 418, which requires manufacturers that process or pack feed products to conduct a hazard analysis at each facility for hazards that are "reasonably foreseen," and to minimize the hazards. According to a white paper from the American Feed Industry Association, Richard Sellers, vice president of feed regulation and nutrition at AFIA, estimates the regulations will cost to the industry in excess of $1 billion.
The FSMA specified a July 3 effective date for the hazard requirement. 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.
AFIA, in conjunction with the National Grain and Feed Association and National Oilseed Processors Association, wrote a letter to FDA Deputy Commissioner for Foods Michael Taylor requesting that FDA exercise 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, 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.