FDA previously had amended and reissued for additional public comment key portions of the three originally proposed rules implementing major sections of the Food Safety Modernization Act (FSMA). FDA reissued the proposed rules on September 19 because public comments received on its initial proposals from the NGFA and other stakeholders led the agency to make significant changes to certain key provisions.
The proposed rules are very significant to NGFA member companies involved in supplying commodities or ingredients for or manufacturing and distributing human food, animal feed, pet food and feed ingredients, as well as those involved in the storage of raw agricultural commodities, such as grains and oilseeds. In addition, the proposed requirements would affect companies engaged in importing foreign food/feed products, including grains and oilseeds.
FDA's three proposed rules would establish requirements for current good manufacturing practice (CGMP) and preventive controls for animal feed and pet food, CGMP and preventive controls for human food, and foreign supplier verification programs for food/feed products imported into the United States. The proposed rules contain several common regulatory concepts, which FDA intends to use to form the cornerstones of the new FSMA-mandated food safety requirements.
The NGFA's statements conveyed the following positions urging FDA to issue final regulations that:
Provide a clear exemption for low-risk storage and packing activities of raw agricultural commodities other than fruits and vegetables
Establish realistic and practical CGMP requirements for animal feed and pet food
Allow hazards to be controlled in a manner commensurate with risk
Provide facilities and importers sufficient flexibility when verifying the safety of food/feed received from foreign and domestic suppliers
Contain Revised Requirements to Reduce Compliance costs
Stagger compliance dates for CGMP and preventive control requirements