WASHINGTON, D.C., U.S. — The National Grain and Feed Association (NGFA) on Dec. 15 submitted extensive comments to the U.S. Food and Drug Administration (FDA) recommending the agency make major changes to three reproposed rules that would establish safety requirements for human food, animal feed and pet food.
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 Sept. 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.
Below highlights portions of NGFA's statements:
• Supplemental Notice of Proposed Rule Making - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food and Animals.
• Proposed Rule - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.
• Supplemental Notice of Proposed Rule Making - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.
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 U.S. 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: The NGFA strongly supported FDA's revisions to its proposed rules that would clearly exempt from its requirements facilities that are solely engaged in storing raw agricultural commodities other than fruits and vegetables, such as grain elevators.
However, the NGFA also stressed that FDA's revised proposals failed to provide a clear exemption for facilities engaged in packing of raw agricultural commodities other than fruits and vegetables that are intended for further distribution or processing. The NGFA's statement urged the agency's final regulations to do so, since packing activities often are inherent to the distribution process associated with grains and oilseeds, and represent a negligible risk to public health.
• Establish Realistic and Practical CGMP Requirements for Animal Feed and Pet Food: The NGFA urged FDA to make many significant changes to its proposed rule, which would make the final requirements realistic and practical for the full range and scope of facilities that will need to comply with the regulation. In addition, the NGFA stressed that unless such revisions are made, the final regulation would add unnecessary requirements that would cause industry to expend millions of dollars towards complying with regulatory obligations that are not needed to ensure the safety of animal feed and pet food.
• Allow Hazards to be Controlled in a Manner Commensurate with Risk: The NGFA generally supported revisions to the proposed rules that would provide for a preventive control framework whereby facilities have the flexibility to make appropriate decisions pertaining to the level of management necessary to control a given hazard. However, the NGFA recommended that FDA make several additional revisions to its proposed requirements that would provide more flexibility to facilities to control hazards in a manner that is effective and efficient for their individual operations.
• Provide Facilities and Importers Sufficient Flexibility when Verifying the Safety of Food/Feed received from Foreign and Domestic Suppliers: The NGFA urged FDA to not overemphasize the role of supplier audits when issuing its final regulations. The NGFA said requiring mandatory supplier audits would be much too prescriptive, since audits only offer a "snapshot" of a supplier's food/feed safety performance at a given time.
In addition, the NGFA emphasized that FDA's regulations must appropriately recognize the complex and comingled nature in which raw agricultural commodities and other bulk ingredients move through the supply chain. As such, the NGFA said FDA's final requirements pertaining to supplier programs must not impose untenable traceability standards and appropriately reflect the risk posed by the food, feed or raw agricultural commodity.
•Contain Revised Requirements to Reduce Compliance Costs: The NGFA's statement emphasized that its own analysis conducted to evaluate the economic impact of FDA's proposed regulations found the agency's estimated cost of compliance to be vastly underestimated.
FDA's preliminary regulatory impact analysis for the proposed rule estimated an annualized compliance cost of $93.45 million for the entire animal feed and pet food industries, which equates to an annual cost ranging from $13,200 to $18,300 per affected facility. However, NGFA's economic analysis, which focused exclusively on the cost to animal feed facilities, resulted in an estimated annualized cost of $430.33 million to $722.65 million, or an annual cost per facility ranging from $56,385 to $127,715.
Further, NGFA urged FDA to produce empirical evidence of the benefits associated with the requirements before issuing a final rule. NGFA stated its belief that such empirical evidence would prove the costs of the proposed rule far exceed the anticipated benefits. In addition, the NGFA said a more limited regulation would accomplish FSMA's goals more effectively, while imposing a significantly lower economic burden upon the regulated industry.
• Stagger Compliance Dates for CGMP and Preventive Control Requirements: The NGFA strongly recommended that FDA provide a sufficient time period following publication of its final regulations to allow affected facilities to come into compliance with the rule's requirement.
Further, since the CGMP regulation will establish new baseline requirements for all affected animal feed and pet food facilities - many of which that have not previously been subject to such requirements - the NGFA stated it is necessary and appropriate for FDA to provide facilities with adequate time to first come into compliance with the CGMP regulation before being expected to comply with the preventive controls regulation. As such, the NGFA recommended that FDA provide facilities one additional year after being required to comply with FDA's final CGMP requirements before being required to comply with the agency's final preventive controls regulation.
FDA is under court order to issue both its final CGMP and preventive controls rules for human food and animal feed/pet food by Aug. 30, and its final rule for foreign supplier verification programs by Oct. 31. The NGFA believes it is unlikely that the agency will publish its final rule much before the prescribed deadlines.