The NGFA has partnered with other trade associations to urge that the Food and Drug Administration (FDA) extend the deadlines for submitting comments to the agency pertaining to three major proposed rules affecting the grain, feed and processing industry.
The NGFA and other groups requested the comment period extensions in response to the recent court settlement reach by FDA in a lawsuit filed by consumer groups concerning deadlines for finalizing the food and feed safety rules required to be issued by the agency under the Food Safety Modernization Act (FSMA). The settlement extends and staggers the final FSMA rule deadlines beyond the June 2015 deadline previously set by the U.S. District Court of Northern California. In addition, the settlement declared, “the deadlines originally provided for the close of comment periods [for proposed rules] are no longer operative.”
Animal Feed/Pet Food Proposed Rule: In a request submitted on March 4, the NGFA, American Feed Industry Association (AFIA), National Renderers Association and Pet Food Institute (PFI) jointly requested that FDA extend the comment deadline for its proposed rule for current good manufacturing practice (CGMPs) and preventive controls for animal feed and pet food to June 30, a 91-day extension from the current March 31 deadline. In making the request, the four organizations said that since FDA no longer is subject to a court-imposed deadline for closing the comment period, the extension is warranted to provide the feed industry additional time to prepare comments on the significant and complex issues raised by the proposed rule.
The extension request also noted that one or more of the signatory organizations plan to ask that FDA re-propose the rule and seek additional comments, given the extent and gravity of changes likely to be submitted in response to the agency’s original proposal. The NGFA currently is among those planning to request a re-proposal.
Among other things, these FDA-proposed regulations would require facilities that manufacture, process, pack or store animal feed and/or pet food to:
Comply with a new set of CGMPs, which up to this time have applied only to facilities manufacturing medicated feeds. The proposed animal feed and pet food CGMPs would address potential risks to animal and human health. As proposed by FDA, the feed/pet food CGMPs generally would closely mirror updated CGMPs applicable to human food.
Conduct an analysis of hazards reasonably likely to occur that could pose a danger to human or animal health, and develop preventive controls to prevent or minimize the potential for such hazards to occur that could cause products to be adulterated or misbranded.
Develop and implement a written animal feed/pet food safety plan that incorporates the preventive controls, and which would be required to be reviewed and updated periodically, as well as made available to FDA upon request.
Intentional Adulteration (Food Defense) Proposed Rule: In addition, the NGFA, AFIA, PFI and the National Oilseed Processors Association (NOPA) on March 5 joined to submit a request to FDA to extend the comment period for the agency’s proposed regulations for intentional adulteration of food. The request urged FDA to reschedule to June 30 the current March 31 comment deadline. In the statement, the organizations again stressed that FDA no longer is subject to a court-imposed deadline for closing the comment period, and said the extension is warranted to provide the industry additional time to prepare comments on the numerous issues raised by the proposed rule.
FDA’s proposed rule for intentional adulteration of food was issued on Dec. 24, and would require affected facilities to develop and implement a written food defense plan that addresses significant vulnerabilities in their operations to protect against incidents intended to cause large-scale public harm. FDA’s proposal would exempt animal feed and pet food products from the intentional adulteration rule. For most other operations, the determination as to whether the FDA proposal would apply is based upon the facility’s operation. For instance, the proposal would exempt the storage of all types of foods, except storage of food in liquid storage tanks. However, FDA uses the same narrow definition of storage as proposed previously in its proposed FSMA regulations for human and animal feed/pet food – in that the exemption would be negated if the facility engages in many types of activities associated with storage, such as screening, cleaning, drying and fumigation. The NGFA in its previous and future comments to FDA is urging that this definition be expanded in a way that encompasses such activities.
Further, a grain processing facility may be subject to the proposed intentional adulteration regulations if it is involved in one or more “key activity types” identified by FDA, including liquid storage and handling. The other three “key activity types” identified by FDA are: 1) bulk liquid receiving and loading; 2) secondary ingredient handling (the step where ingredients other than the primary ingredient of the food are handled before being combined with the primary ingredient); and 3) mixing and similar activities.
The proposed provisions for the food defense plan would require facilities to:
Identify and implement mitigation procedures and/or practices to provide assurances that food safety vulnerabilities will be minimized or prevented so that products will not be adulterated.
Monitor and verify that the implemented mitigation procedures and/or practices are being performed and are effective in controlling the food safety vulnerabilities.
Train personnel and supervisors in food defense awareness and in their responsibilities for implementing mitigation practices/procedures.
Establish and maintain records, including the written food defense plan, records documenting monitoring and verification activities, and training of personnel.
Designation of High-Risk Foods for Product Tracing: Finally, NGFA, PFI, AFIA and NRA on March 6 submitted a request to extend the comment period for 90 days on a third set of FDA-proposed FSMA regulations, which would establish methodology FDA would use to designate “high-risk foods” (potentially including animal feed and pet food) for which additional recordkeeping requirements would apply to assist in product tracing and tracking in the event of a foodborne illness outbreak.
NGFA Devoting Major Effort to Shape Outcome of FSMA-Proposed Rules: Several NGFA committees actively are engaged in reviewing the proposed rules and developing NGFA comments to submit to FDA on each of these and other FSMA-related proposed regulations. NGFA also is collaborating closely with AFIA, NOPA, NRA, PFI and other organizations in developing consensus industry views on the proposals. In addition, the NGFA is engaged in active communication with the National Association of State Departments of Agriculture, as well as agricultural producer and livestock/poultry organizations that share many of the same concerns over FDA’s proposals.
Contact NGFA Vice President of Feed Services David Fairfield at dfairfield@ngfa.org or (712) 243-4035 with questions or for more information.
By Dave Fairfield, Vice President of Feed Services