FDA issued its proposed rule on Oct. 29, 2013, in response to the new food/feed safety regulations mandated by the Food Safety Modernization Act (FSMA).
The NGFA expressed serious concerns that FDA's proposed rule in several important respects is inconsistent with the statutory framework provided by FSMA, and would add unnecessary requirements and costs that would cause industry to direct scarce resources toward complying with regulatory obligations that would not enhance the safety of animal feed and pet food.
In citing such specific concerns, the NGFA strongly recommended that FDA make numerous significant changes to its proposed rule so its final requirements will conform to FSMA's statutory language and provide sufficient flexibility to allow facilities to adopt animal feed and pet food safety practices that are practical and effective for their specific, individual operations. Among other things, the NGFA urged FDA to:
• Provide a Clear Exemption for Low-Risk Storage and Packing Activities of Raw Agricultural Commodities (Other than Fruits and Vegetables)
As expressly authorized by FSMA, FDA proposed to exempt from the rule's requirements facilities that are "solely engaged in the storage" of raw agricultural commodities intended for further distribution and processing - other than fruits and vegetables that Congress expressly made ineligible for the exemption. However, the proposed rule also contained language that would negate the exemption for facilities like grain elevators if they undertake various practices traditionally associated with the safe and effective storage of raw agricultural commodities, such as screening, cleaning, conditioning and fumigating.
The NGFA urged FDA to modify its rule to state that facilities solely engaged in the storage and packing of raw agricultural commodities, other that fruits and vegetables, intended for further distribution or processing are exempt from the regulations' requirements.
• Establish CGMP Requirements for Animal Feed and Pet Food that Differ Significantly from those Established for Human Food
The NGFA said it was proper and scientifically justified for FDA to distinguish between the necessary manufacturing and distribution practices and conditions for human food versus animal feed and pet food, and provided a rewritten draft for the agency's consideration. In addition, the NGFA stated that the provisions established within FDA's CGMPs regulation should be appropriate and reasonable for the full range and scope of facilities that will need to comply with the requirements.
• Not Mandate HACCP within its Regulation
The NGFA urged FDA to develop preventive control requirements that allow for the use of appropriate controls that are commensurate with the nature of the associated animal feed and pet food safety hazard, instead of mandating that each hazard be addressed in a prescribed and extremely burdensome manner similar to what would be required to manage a critical control point within a formal hazard analysis and critical control (HACCP) plan.
• Not Establish Additional Requirements Without Proposing Codified Language for Stakeholder Comment
Within FDA's proposal, the agency sought comment on whether to establish requirements for several additional preventive controls and verification measures not mandated by FSMA and for which the agency did not propose codified language.