NGFA Recommends Major Revisions to FDA Proposed Animal Feed and Pet Food Rule Under FSMA
Date Posted: April 4, 2014
The National Grain and Feed Association (NGFA) on March 31 submitted an extensive statement spanning more than 100 pages to the U.S. Food and Drug Administration (FDA) recommending that the agency make major changes to its proposed rule that would establish current good manufacturing practices (CGMPs) and hazard analysis and risk-based preventive controls requirements for facilities that manufacture and distribute animal feed and pet food.
FDA issued its proposed rule on Oct. 29 in response to the new food/feed safety regulations mandated by the Food Safety Modernization Act (FSMA).
The proposed rule is very significant to NGFA-member companies involved in the production and distribution of animal feed and pet food, as well as those involved in the storage of raw agricultural commodities, such as grains and oilseeds, since such products may be distributed for use in such products.
The NGFA’s Feed Legislative and Regulatory Affairs Committee spearheaded the development of NGFA’s statement.
In doing so, the committee received broad input through a review process that involved several other NGFA committees and working groups established to evaluate the proposed rule.
As such, the statement represents the collective consensus of more than 70 NGFA-member companies that were involved directly in the review of the proposed regulations.
In addition, NGFA led a coalition of other animal feed- and pet food-related trade associations to evaluate the proposed rule and, to the degree possible, gain alignment on major issues.
In its statement, the NGFA stated that it shares FDA’s goal of promoting and ensuring the production and distribution of safe and wholesome animal feed and pet food, and that FSMA embodies many of the well-recognized, science- and risk-based principles already employed through much of the industry to ensure the safety of such products.
However, the NGFA expressed serious concerns that FDA’s proposed rule in several important respects is not consistent with the statutory framework provided by FSMA, and that the agency’s proposal would add unnecessary requirements and costs that would cause industry to direct scarce resources toward complying with regulatory obligations that will not serve to benefit the safety of animal feed and pet food.
Accordingly, the NGFA strongly recommended that FDA make numerous significant changes to its proposed rule so that 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 other than fruits and vegetables intended for further distribution and processing.
However, the proposed rule also contained language that would negate the exemption for such facilities if they undertake various practices traditionally associated with the safe and effective storage of raw agricultural commodities, such as screening, cleaning, conditioning and fumigating.
In its statement, the NGFA commended FDA for its intent to exempt grain elevators from the rule’s requirements, since such an exemption would represent an appropriate risk-based approach that accurately reflects the level of animal feed and pet food safety risk associated with the operations at such facilities.
However, the NGFA stated that essentially no grain elevators would qualify for the exemption because such facilities are not just engaged in storage, but also perform other activities related to the effective holding and distribution of raw agricultural commodities, such as screening, cleaning, conditioning and fumigating.
As such, the NGFA strongly urged FDA to revise its proposed definition for storage so that it also encompasses activities performed for the safe or effective storage of raw agricultural commodities, other than fruits and vegetables, that are intended for further distribution or processing.
Further, FDA proposed within its rule that facilities engaged in packing of raw agricultural commodities, other than fruits and vegetables, that are intended for further distribution or processing would not be exempt from the proposed requirements.
In contrast, the NGFA believes that such packing activities are an extension of the distribution process associated with raw agricultural commodities, such as grains and oilseeds, and represent a minimal risk to public health.
Accordingly, 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 CGMPs Requirements for Animal Feed and Pet Food that Differ Significantly from those Established for Human Food:
FDA’s proposed rule would establish an overarching set of CGMP requirements that generally would apply to all facilities required to register under the Bioterrorism Act that are involved in manufacturing and distributing animal feed and pet food.
In proposing to do so, FDA stated its belief that CGMPs similar to those for human food are appropriate for animal feed and pet food.
In response, the NGFA strongly stated its belief that CGMPs similar to those established for human food are not appropriate for animal feed and pet food.
In doing so, the NGFA said that a clear distinction between necessary manufacturing and distribution practices and conditions for human foods in comparison to animal feed and pet food is proper and has a sound scientific basis, and that the CGMPs to be established by FDA for animal feed and pet food should appropriately reflect this fact.
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.
As such, the NGFA urged FDA to make numerous and extensive revisions to its proposed requirements to better reflect the operations associated with the vast majority of facilities that will be affected by its regulations.
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.
In doing so, the NGFA stated its belief that FDA’s proposed preventive controls regulation clearly is not aligned with the statutory language of FSMA that provided authority to the agency to promulgate hazard analysis and preventive controls requirements.
As such, the NGFA strongly recommended that FDA adhere to the legal framework provided by FSMA and within its regulation to provide flexibility for management oversight of hazards and preventive controls that is tailored to each facility’s operation and appropriately reflects the animal feed/pet food safety risk that may be present.
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.
Specifically, FDA asked for comments concerning the appropriateness of establishing additional requirements for:
1) raw material and finished product testing;
2) environmental monitoring;
3) domestic supplier approval and verification programs;
4) review of customer complaints; and
5) submission of facility profile information to the agency.
In response, the NGFA expressed serious concern about the procedural process by which FDA may choose to establish such requirements within its regulation.
The NGFA stated its belief that FDA is obligated under the Administrative Procedures Act to give stakeholders ample opportunity to review any additional requirements before FDA incorporates such requirements into its final regulation.
As such, the NGFA urged FDA to publish proposed codified language pertaining to any additional requirements for which the agency is interested, and expressly provide for appropriate stakeholder review and comment if it seeks to establish such requirements within its final regulation.
Stagger Compliance Dates for CGMPs 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 CGMPs 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 that it is necessary and appropriate for FDA to provide facilities with adequate time to first come into compliance with the CGMPs 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 be in compliance with FDA’s final CGMPs requirements before being required to comply with the agency’s final preventive controls regulation.
Should Modify and Re-Propose the Regulation for Further Comment:
The NGFA expressed its belief that FDA should make many significant changes to its proposed rule so that 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.
In addition, the NGFA stated that FDA suggested establishing additional requirements for several major areas within its final regulations, but did not propose codified language on which to provide comment.
Therefore, the NGFA recommended that FDA make available for public comment a second draft of the proposed regulation that reflects the agency’s views after reviewing stakeholders’ comments on its proposed rule.
The NGFA said that making available a second draft through a re-proposal would provide stakeholders with another opportunity to offer informed and meaningful comment on the requirements that FDA foresees within its final rule.
Further, the NGFA stated its belief that FDA has the ability and authority to re-propose the regulations and still comply with the court-ordered deadline to publish a final rule by Aug. 30, 2015.
NGFA Economic Analysis of Costs Associated with Proposed Rule:
NGFA’s statement also 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 (PRIA) estimated the proposed rule would result in a cost of between $14,700 and $20,100 per facility, or $128.75 million annually for the entire animal feed and pet food industry.
However, the NGFA’s economic analysis found the proposed rule annually would cost almost $65,000 per facility in additional labor alone, or more than $500 million annually for the entire industry.
The NGFA also emphasized that its estimate excludes the costs of additional requirements being considered by FDA for inclusion in the final rule, and the potential costs that grain elevators would incur if such facilities are not provided a clear exemption from the final rule’s requirements.
Further, the NGFA urged FDA to produce empirical evidence of the benefits associated with the requirements before issuing a final rule. The 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 that a more limited regulation that hues more closely to the statutory language of FSMA would accomplish the goals of FSMA more effectively, while imposing a significantly lower economic burden upon the regulated industry.
FDA Proposal of Additional/Modified Requirements Expected:
The NGFA anticipates that FDA will issue proposed requirements within the coming months for several additional preventive controls and verification measures not mandated by FSMA and for which the agency did not offer codified language within its proposed regulations, including those for:
1) domestic supplier approval and verification programs;
2) product testing;
3) environmental monitoring; and
4) review of complaint files.
In addition, it is anticipated that FDA will re-propose requirements associated with facilities that store and distribute raw agricultural commodities, such as grains and oilseeds, and facilities involved in manufacturing human food that also distribute co-products for use in animal feed and pet food.
Timeline for Finalizing Regulations:
FDA is obligated by court order to issue its final CGMPs and preventive controls rule for animal feed and pet food by Aug. 30, 2015.
The NGFA believes it is unlikely that the agency will publish its final rule much before the prescribed deadline.
For more information, call 202-289-0873.