March 31, 2014

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD 20852

Federal Docket: FDA-2011-N-0922

Dear Sir or Madam:

Pennsylvania Farm Bureau (PFB) is pleased to offer its comments on the proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.”

PFB is a general farm organization, made up of more than 58,000 members, providing legislative support, information, and services to Pennsylvania's farmers and rural families since 1950. Our organization includes 54 local organizations (county Farm Bureaus) that actively operate in 64 of Pennsylvania’s 67 counties. PFB is the state affiliate of the American Farm Bureau Federation (AFBF), an organization representing more than six million member families throughout the United States. In addition to the comments we are offering today, we want to affirm our support of any comments to be filed by AFBF on this topic, and would request that such comments be treated as part of the comments contained herein.

General Comments: Preventive Controls for Animal Food  

PFB fully supports, and its members are committed to, producing safe and affordable food for consumers in Pennsylvania, the United States, and around the world—and ensuring that food for animals is similarly safe and affordable is an important part of that mission. American consumers deserve to have confidence that the food animals eat is safe and that the best science is used to ensure that the most wholesome product possible is produced and offered. With those goals in mind, PFB believes that regulations governing animal food safety should have tangible, measureable benefits that outweigh the costs they impose.

With the preceding general comments in mind, PFB wishes to offer the following specific comments on the preventive controls rule for animal food, as well as the attendant rulemaking process.

1. FDA should allow for a second comment period on the preventive controls for animal food rule following its review of the initial round of comments, in order to allow stakeholders the opportunity to comment on the inevitable changes that will be made to the rule to reflect the initial comments received.  

PFB appreciates the extension of the comment period that FDA has provided for several of the proposed rules related to the Food Safety Management Act (FSMA), which will help to ensure that affected entities have time to provide meaningful comments on their provisions, as well as the second comment period promised by the agency after the initial rounds of comments are considered and those rules re-drafted. The likelihood that the comments received will be sufficiently substantive as to require significant changes to the preventive controls for animal food rule leads PFB to believe that another comment period will be needed to further evaluate those changes. Without an additional comment period to respond to any changes, farmers may find the solutions so difficult to understand as to render them completely unworkable. 2

Finally, PFB also encourages FDA to release any second drafts of the proposed rules simultaneously to allow for sufficient review of all the rules together, and to align the second comment periods for each of these rules. This strategy would help ensure the success of each individual rule and FSMA as a whole.

2. FDA must make a clear distinction between the proposed rules for animal food and human food and recognize that not all practices and preventive controls for human food are appropriate for animal feed and pet food.  

In considering FSMA, it is important to recognize that both the intent and, sometimes, the language used in the statue require a separation of the proposed animal food and human food safety rules. With this in mind, PFB is concerned that FDA has failed to clearly delineate the human food safety rules from the animal food safety rules as Congress intended. While FDA has indeed drafted separate animal and human food rules, the tone and approach of each appears to be largely based on the dynamics of the human food industry. In its comments, AFBF noted that the animal food proposed rule uses language such as “sanitary,” “hand-washing” and “utensils”—terms not commonly used in the feed industry—and that the mechanisms necessary to ensure safety may differ, depending on how the food is sold (some pet food is canned as is human food, while a great deal of livestock food is sold in bulk quantities).

Current good manufacturing processes (CGMPs) similar to human food are not appropriate for animal feed and pet food. 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 based on sound science. Clearly, the innate hygienic standards of humans exceed the hygienic standards of livestock, poultry and other animals. Further, animal feed is typically fed in a way that exposes the product to the hygienic conditions associated with the animal’s environment.

It is obvious and reasonable that the hygienic safety standards necessary for the manufacture and distribution of human foods should rightfully exceed the hygienic safety standards for animal feed and pet food, and the raw materials and ingredients used in these products. Therefore, the requirements with the proposed CGMPs for animal feed and pet food should appropriately reflect this fact.

With regard to preventive controls, although PFB supports the use of prudent, appropriate and risk-based practices to assure the safety of animal feed and pet food, we believe that FDA’s proposed preventive controls regulation is not aligned with Congressional intent when the agency was given authority under FSMA to promulgate hazard analysis and risk-based preventive controls requirements. The regulation proposed by FDA would establish an extremely burdensome, complex framework unnecessary to ensure feed safety. The preventive controls provisions in the current proposal would require excessive and unnecessary management control and oversight of potential products safety hazards that is not commensurate with the risk posed by the vast majority of potential hazards associated with animal feed. Perhaps even more significant, the requirements would divert limited resources away from industry practices that have and continue to effectively ensure the safety of such products.

FDA proposes to define “preventive control” as “those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.” PFB believes these core aspects of FDA’s proposed regulation would essentially require that all preventive controls implemented for hazards identified as being “reasonably likely to occur” be managed in a manner similar to a “critical control point” that has been established within a formal hazard analysis and critical control point (HACCP) plan. This is not consistent with the intent of Congress when FDA was provided authority under FSMA to promulgate a hazard analysis and risk-based preventive controls

regulation. The statutory language within FSMA does not mandate that covered animal feed and pet food facilities implement regulatory HACCP plans. Had Congress intended to provide FDA the authority to promulgate formal HACCP regulations through FSMA, it could have done so within the statutory language it crafted. Further, the statute does not mandate that animal feed and pet food facilities address all hazards that are “reasonably likely to occur” in the same demanding and burdensome manner that would be required of a critical control point within a formal HACCP plan.

In contrast, any preventive controls regulation should follow the FSMA statutory language to provide for implementation of a range of preventive controls (not just at critical control points) as needed to control those hazards. The level of rigor used to manage the range of necessary preventive controls should be commensurate with the nature of the risk and the type of controls being used, with only critical control points receiving the most rigorous management oversight. Further, it is extremely important that FDA’s regulation account for likelihood and severity to be considered in any scientific hazard analysis, consistent with international standards.

PFB strongly urges FDA to follow more closely the legal framework provided by FSMA and within its regulation provide flexibility for management oversight of hazards and preventive controls that is tailored to each facility’s operation and commensurate with the nature of animal feed/pet food safety risk that may be present. Indeed, FSMA instructs FDA, when developing such regulations, to provide “sufficient flexibility to be practical for all types and sizes of facilities,” acknowledge the differences in risk that exist between different types of foods and facilities, and not prescribe specific practices, technologies or critical controls for individual facilities. FSMA itself is non-prescriptive, stating that preventive controls “may include,” but certainly are not limited to, such measures as supplier verification, CGMPs, training, sanitation, hygiene practices and environmental monitoring, among others. With this in mind, any regulations addressing hazard analysis and preventive controls need to be science- and risk-based, non-prescriptive, and provide sufficient flexibility to allow facilities to adopt practices that are practical and effective for their specific, individual operations.

It also is important to stress that both CGMPs prerequisite programs and HACCP-based principles expressly are recognized in FSMA as acceptable means for achieving the performance-based goal of minimizing or preventing hazards that could cause animal feed and pet food to be adulterated or misbranded. FSMA clearly does not mandate that food facilities adopt regulatory HACCP plans.

Therefore, PFB believes that FDA’s codified regulation should mirror the non-prescriptive, flexible and risk-based language used in FSMA. However, we also believe that it is important for the agency to provide some frame of reference concerning the type(s) of hazards that various industry sectors should consider addressing, as well as illustrative examples of effective preventive controls and appropriate points in the supply chain where those controls can be implemented to have the greatest positive impact on significantly minimizing or preventing targeted hazards.

3. FDA should build on existing relationships at the state level and assign states a lead role in implementation of the preventive controls for animal food rule, rather than expend scarce resources at the federal level to establish potentially duplicative inspection processes.  

As a preferred alternative to the expenditure of considerable FDA resources to establish qualified inspection personnel, we urge FDA to utilize partnerships with existing well-trained regulators already knowledgeable about farm practices. In particular, we encourage more cooperative agreements with state departments of agriculture that are closer to the farm level and have a strong history of largely successful inspection processes. 4

The Pennsylvania Department of Agriculture (PDA) has institutional knowledge and experience in the regulation of animal food manufacturing operations. FDA must collaborate with PDA on the development of joint work-planning, inspection, compliance, enforcement and emergency response programs/strategies. At the same time, successful implementation of the rule will not be possible without integration of state agency resources into inspection, compliance and enforcement programs. FDA must provide resources to PDA to build capacity and capability to conduct the specialized preventive controls inspections required by the rule.

4. FDA must include sufficient funding for education and outreach in its budget for FSMA.  

An essential component of strengthening the federal-state relationships discussed in the preceding comment is the adequacy of funding for technical assistance that will provide producers a meaningful and feasible opportunity to comply with the heightened standards to be imposed. FDA must provide significant outreach and education to both industry and state regulatory agencies with jurisdiction over the production of animal food. The failure to provide significant outreach will result in inconsistent implementation by industry and inconsistent compliance & enforcement by regulatory agencies, including FDA.

FDA must engage national associations, as well as land grant universities, safety alliances, extension centers, and other education partners in the development of outreach and education programs. FDA must also provide resources to support universities and cooperative extension programs to conduct research necessary to support the validation requirements of the rule. This should include support not only for the research but also the outreach to industry that will be an important component of successful implementation.

Finally, FDA must improve the manner in which it shares information with national associations. FDA must commit to improving the processes, frequency and timeliness of sharing information such as inspection reports, pending compliance actions, food-borne illness outbreak investigations, reportable food registry reports, facility registration data (including any revocations) and import alerts with state regulatory agencies.

5. FDA should modify the definitions of “farm,” “harvest” and “ownership” so as to properly convey their meanings in the context of modern farming practices.  

The current definition of “farm” was created to provide an exemption from the food facility registration requirement of the Bioterrorism Act of 2002 and did not seek to define farming in a way that resembled farming practices for the purposes of food safety. In order to create an integrated food safety system, it is now critical that FDA create a definition that describes farming operations as they exist and operate, in order to properly regulate farm products under regulations designed for the farm. FDA should take advantage of this opportunity to redefine “farm,” “harvest” and “ownership” in a manner that resembles modern farming, contracting and marketing practices in order to best achieve the goal of public health protection.

PFB appreciates FDA’s recognition of farms as appropriately exempt from facility registration generally and this rule specifically. However, the farm definition appears to be too limited to encompass other normal farm activities, including feed manufacturing on a limited scale. In its comments, AFBF noted that particularly in geographically isolated areas or locations where only a small number of farms are present, it is not unusual for a farm to add value to grains and other feedstuffs grown on its operation by mixing animal feed that can then be sold to neighboring livestock farms. This practice is mutually beneficial for the farmers growing the grain as well as those needing feed for their livestock. In many of these scenarios, it would be impractical or even impossible for a grain producer to diversify into livestock solely to utilize his own grain, and likewise a livestock producer may not have the ability to produce his own feedstuffs. For areas that lack sufficient retail feed distribution (for example, Alaska), purchasing feed from a neighboring farm may be the only source of livestock feed.

While small, on-farm feed manufacturers would clearly be defined as qualified facilities and therefore subject to modified requirements, they would still be subject to CGMP requirements. This appears inappropriate given the extremely low risk presented by limited sales of feed direct to the “consumer”—in this case, the owner of the livestock for whom the feed is intended. FDA should fully exempt, in a manner similar to the farm exemption, these direct marketing situations where qualified facilities are selling the majority of their products directly to the end user.

AFBF believes there is ample statutory justification for this exemption. In its comments, it references Section 103(c)(1)(C) of FSMA, which requires that in issuing the proposed rule the Secretary conduct a science-based risk analysis of:

 “Specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; and

 Specific on-farm manufacturing and processing activities as such activities related to specific foods that are not consumed on that farm or on another farm under common ownership.”

As part of the rulemaking, the Secretary is required to consider the results of the science-based risk analysis and exempt certain facilities from the requirements in sections 418 and 421 of the FD&C Act or modify those requirements, as the Secretary determines appropriate, if such facilities are only engaged in specific types of on-farm manufacturing, processing, packing or holding activities the Secretary determines to be low risk, and involving specific foods that the Secretary determines to be low risk. On-farm feed manufacturing by a qualified facility that is utilizing low-risk feedstuffs clearly meets the requirements for full exemption. It is reasonable to apply Congressional intent to continue that exemption if the feed, otherwise exempt, is then sold directly to the consumer feeding it to his or her own livestock.

Finally, PFB appreciates FDA exempting very small businesses from the animal food preventive controls requirements and including only sales of animal food in its calculation to define a very small business for purposes of this rule, and we encourage FDA to adopt the $2.5 million total annual sales threshold for a very small business.

6. FDA’s definition of “holding” applicable to facilities storing raw agricultural commodities (RACs) other than fruits and vegetables should be expanded to better reflect the legislative intent of FSMA and the actual level of food safety risk associated with operations at such facilities.  

FDA’s proposed definition for “holding” that would apply to facilities storing RACs other than fruits and vegetables does not reflect the regulatory flexibility provided for within the statutory language of FSMA, nor does it appropriately recognize the minimal level of food safety risk associated with the operations at such facilities. In addition, subjecting such facilities to CGMPs and preventive controls requirements simply because activities are inherently performed to safely and effectively store RACs does not constitute sound food safety policy. PFB strongly urges FDA to revise its extremely narrow definition to better reflect both science-based risk and congressional intent.

A relatively simple solution is to apply to facilities the same language currently used to appropriately define “holding” for farms and farm mixed-type facilities. For example, facilities holding RACs other than fruits and vegetables may combine or “blend” different lots of the commodity when preparing the commodity for further distribution so as to meet desired quality specifications of the customer. This “blending” activity does not constitute manufacturing or processing since such activity in no way transforms the RAC into a processed food. In addition, the resulting lot of RAC is still intended for further distribution or processing. Therefore, such 6

blending activities performed on RACs rightfully should be encompassed within those activities recognized by FDA within its “holding” definition.

7. The definition of “packing” in the proposed rule is not risk-based, and such activities associated with RACs, other than fruits and vegetables intended for further distribution or processing, should be excluded from its CGMP and preventive controls requirements.  

FDA’s proposal to include “packing” of all RACs in its feed rule represents a one-size-fits-all approach that is not risk-based. As justification for its proposal, FDA cites examples of foodborne illness outbreaks and contamination events associated with fresh produce and other RACs, and expresses that the agency continues to be concerned about sanitation practices at establishments that pack RACs. In addition, FDA states that packing of RACs has been implicated as a likely source of contamination in multi-state foodborne illness outbreaks associated with such products. The concerns cited by FDA pertain to certain produce, not other RACs, such as grains and oilseeds. FDA has noted the minimal public health risk associated with those activities that pertain to the storage of RACs other than fruits and vegetables that are intended for further distribution or processing.

FDA has authority to exempt from regulation packing of RACs other than fruits and vegetables that are intended for further distribution or processing. Facilities solely engaged in the storage of such commodities also distribute them, and in many situations, packing is involved in this distribution process. Therefore, it is reasonable to conclude that the authority granted to FDA to exempt such facilities from regulation may be applied to all activities that are inherent to storing RACs other than fruits and vegetables that are intended for further distribution or processing.

Based on the minimal level of public health risk and the authority provided to the agency, PFB strongly recommends that FDA exclude “packing” activities associated with RACs other than fruits and vegetables intended for further distribution or processing from the CGMPs and preventive controls requirements of the feed safety rule.

8. Seed conditioning facilities should be exempt from the proposed rule due to the extremely low food safety risk their products present.  

The CGMPs and preventive controls requirements in the proposed rule present considerable compliance challenges for seed conditioning facilities, but the required changes would have no significant impact on the safety of animal feed because the products are inherently safe to begin with. Essentially, a benefit from risk reduction is not possible because the product itself is of such negligible risk.

If FDA does not provide a straightforward exemption for seed conditioning facilities, PFB encourages FDA to recognize in the regulation that the only activity seed conditioning facilities engage in regarding “food” is “storage” for a RAC for further distribution or processing. Such recognition, particularly under the corrected definition of “holding” previously referenced in our comments above, would allow these businesses to comply with more appropriate, reasonable requirements.

9. Recordkeeping requirements deemed necessary under this rule must adequately protect the privacy and confidentiality of individual farm businesses.  

Public disclosure of records as specified in the preventive controls rule for animal food is not in alignment with the records disclosure provisions found in the seafood and juice HACCP regulations. Both the food safety programs for juice and for fish and fishery products make records not subject to disclosure unless previously disclosed or otherwise made sufficiently generic. These same requirements should be applied to all other food

facilities subject to the proposed preventive control rule. FDA should preserve the privacy of information maintained as a result of the regulation unless otherwise made publicly available.

10. Equality in enforcement of the proposed preventive controls rule for animal food must be maintained between domestic and foreign producers.  

FDA maintains that the animal food preventive controls rule applies equally to both foreign and domestic suppliers; therefore, FDA must ensure that the rules are applied equally to both domestic and foreign producers with parity and consistency in enforcement. Domestic facilities should not be placed at an unfair disadvantage in competing against products sourced from foreign suppliers.

It is true that imported foods present a distinct challenge to FDA; enforcement can be impacted by limitations in FDA jurisdiction overseas. As a result, parity and equal enforcement of the regulations may require FDA to adopt different enforcement mechanisms. Regardless, FDA must assure that the regulation of imported foods is consistent with the regulation of domestic food.

11. The inclusion of vertically integrated livestock production operations under the proposed rule will likely have the effect of increasing costs to producers and consumers alike.  

The majority of this nation’s poultry, hogs and cattle are produced under production contracts with vertically integrated livestock production companies. Typically in these contract situations, the integrator provides the animal feed for the growers to ensure uniform production. As proposed, the animal feed manufactured by the integrator for use by the contract growers would be subject to regulation under the rule due to the definition of farm and ownership. The feed produced under these types of arrangements has not traditionally been subject to routine oversight for good manufacturing practices and preventive controls as proposed in this rule. While improvements to food safety are desirable, under the proposed rule as drafted, the inclusion of these types of operations will have a significant economic impact on the animal production industry which will either be absorbed by the industry or translated to the consumer.

12. FDA should consider adding a provision to allow flexibility in the application of the rule to co-product manufacturers—for both food and non-food products.  

The proposed animal food rule defines animal food to mean food for animals other than man and includes raw materials and ingredients. Included under the scope of this rule would be product derived from the manufacture of food for humans; the waste or co-product from human food production would be considered food for animals if it is used in whole or in part in the production of an animal food. If that is to be the case, FDA needs to provide guidance on how co-product will be regulated under this rule and associated enforcement strategy.

The human food manufacturing industry has a well-established practice of selling or giving away co-product for direct feeding to animals or for use as an animal food ingredient. These materials are recognized as a valuable and nutritious ingredient in animal food and are widely used in the production of animal food—from pet food to livestock feed.

For example, one commonly used livestock feed additive—brewers’ spent grains—is a natural by-product of the fermenting process, which is already regulated to ensure safety. Brewers have quality controls built into the entire brewing process, from the movement of barley and other grains, hops and other ingredients in beer from farm through product testing, integrity, and traceability. There are federal, state and internal brewery safeguards built in at every step throughout the U.S. supply chain, including the handling of spent grains. Even the grain used in brewing meets strict food requirements, which generally exceed feed requirements. The food safety risk 8

that the grains used in brewing and the resulting spent grains will contain mycotoxins, mold or blight is minimal given the industry’s high standards and testing practices.

Brewers’ spent grain is micro-biologically stable at the point of production, and the speed with which brewers ship spent grains to farmers and ranchers further enhances safety. It goes quickly from production to farmers and ranchers in close proximity to the brewery, who promptly feed it to their livestock. The entire process generally takes less than 24 hours.

In its comments, AFBF notes that if small craft brewers were required to comply with the full extent of this rule, their cost of landfilling or compliance would be up to an estimated $10 per barrel. Even larger producers, with the advantage of economies of scale over which to spread these costs, believe they would face a minimum increase of $3 per barrel. In addition, the loss of this safe and nutritious livestock feed source would cause considerable difficulties for livestock producers who utilize spent grains.

While co-product is recognized and accepted for use as an animal food ingredient under existing processes established by AAFCO and FDA that includes a review of safety and efficacy, the facility generating co-product has never before been subject to this level of regulatory oversight, including both good manufacturing practices and preventive controls requirements. Under this proposed rule, the co-product manufacturer (which typically is a human food manufacturer) must address the hazards present in their co-product, putting them under the scope of both the human and animal food preventive controls rules. The additional expense of this added layer of regulatory oversight may force some human food manufacturers to reluctantly send this product to landfill.

While some co-product has known risk, other co-product has little known or reasonably foreseeable risk. Yet all co-product is treated equally under the proposed animal food rule, with little acknowledgement of the obvious differences in risk. It should be recognized that while co-product is a large component of animal food, there are few to no reports of co-product being identified as a source of a human or animal food illness outbreak. Additionally, because the co-product producer may not know the intended species for the co-product they sell, a comprehensive hazard analysis is virtually impossible.

FDA should therefore consider the addition of an alternative-type provision to allow flexibility in the application of the rule to co-product manufacturers. The utilization of an alternative process would mitigate the burden on certain co-product manufacturers and would provide a streamlined path to compliance to those facilities that manufacture a low-risk product. Prior to issuing a final rule, FDA needs to re-evaluate the impact of co-product regulation on both the human and animal food manufacturing industries.

Questions also exist as to whether FDA has considered the impact of this regulation on co-product derived from non-food sources, such as the co-product derived from fuel ethanol production. The industry may not be aware of the potential extent of regulation it may be subject to under this proposed rule. Clarification is needed from FDA as to how this rule will be applied to animal food raw materials and ingredients derived from non-food crops or processes.

13. Produce farms could face additional regulation under the proposed rule.  

This rule has the potential to add another level of regulation to produce farms. In a matter of years, a farm could potentially go from no routine inspection and regulatory oversight to potentially having three types of inspectors on the farm to verify compliance with three different federal regulations. For example, a produce farm with annual sales above $25,000 that grows tomatoes for the table market would be subject to the proposed produce safety rule. If that farm brings in tomatoes from a neighboring farm and washes them prior to packing, it would be subject to the proposed human food preventive controls rule as an on-farm mixed-type facility. And if this

same farm sells culled or blemished tomatoes to a feed ingredient processor, feed mill or animal feeding operation, it may also be subject to the animal food preventive controls rule.

14. FDA should provide additional guidance on determining the value of sales or size of business for facilities covered under the rule.  

The proposed animal food preventive controls rule significantly differs from the human preventive controls rule in regard to food sales that must be considered in determining facility size. Under the animal food rule, only animal food sales must be considered, while in the human rule, all food sales must be considered (including human and animal). PDA is of the opinion that this difference will create a great deal of confusion and be virtually impossible for regulators to confirm during inspection.

The same confusion exists in determining whether or not a facility is a small business. The small business size is based on the number of employees; a facility subject to the animal food rule must only consider the employees or portions of employee time spent on the manufacture of an animal food. Again, this will create confusion for both industry and regulators.

FDA should provide additional guidance on determining the value of sales or size of business for facilities covered under the rule. The “average annual monetary value of animal food sold” can be interpreted in many ways, such as the value of the food or the value of the sales of the food. While it is presumed that the value of food and the value of sales of food would be identical, the figures are not in some cases. For co-product that is given away and not “sold,” FDA has indicated that the firm must somehow quantify value of animal food sales in terms of tax benefit or offset of disposal costs. The use of such subjective parameters to determine business size will result in ambiguous and inconsistent determination of business size and result in similarly haphazard application of the rule.

15. No language requiring environmental monitoring by industry should be included in the proposed rule until the economic impact to industry has been analyzed and made available for public comment.  

FDA should not include any requirement for environmental monitoring until the economic impact on industry has been analyzed and provided, along with proposed language, for public comment. Environmental sampling has not been widely utilized in animal food manufacturing and as such there exists very little data to justify any public health benefit realized through the inclusion of an environmental monitoring program. A better approach would be for FDA to encourage industry, through guidance, to utilize environmental testing as a best practice rather than incorporate environmental testing into the final rule as a requirement.

16. FDA must make available for public comment the proposed language, as well as an economic impact analysis, prior to the inclusion of any provisions requiring finished product testing.  

Finished product testing for contaminants and pathogens is not routinely conducted by the animal food manufacturing industry, and there will be significant cost to industry to implement such a program. Under the concepts of preventive controls, hazards reasonably likely to occur should be mitigated through the implementation of preventive controls, monitoring, corrective action and verification programs. Effectively implemented, these programs should minimize the need for finished product testing. Responding to non-compliant results will require a significant amount of federal and state resources and will perpetuate the current reactive regulatory response mode and impede efforts to shift efforts to prevention. 10

17. There should be no domestic supplier verification provision in the final rule without public comment on proposed language and an attendant economic impact analysis.  

FDA has publicly stated that it is strongly considering the inclusion of a domestic supplier verification program in the animal food preventive controls rule and is seeking comments on such provision. While supplier verification is recognized as an important component of a food safety system, it is ill-advised to include a domestic supplier verification provision in the final rule without public comment on proposed language and economic impact analysis. If this provision is necessary to satisfy both FSMA and FDA’s international obligations, the requirement should be developed and made available for comment separate from the issuance of the animal (or human) preventive controls final rule.

18. FDA should create and maintain a readily accessible repository of validated processes, scientific and technical information prior to incorporating a validation requirement into the final rule.  

The absence of existing validated processes will impact the ability of regulated industry to comply. The rule is also silent on the process for conducting studies, or the process that the FDA will utilize to approve or accept the validation data and/or studies.

19. Given the breadth and complexity of the proposed animal food safety rule and the other proposed rules pertaining to FSMA, as well as the continued uncertain economic outlook, a thorough cost-benefit analysis is needed to make certain that the benefits of any new provisions outweigh their costs.  

PFB supports utilizing sound science and a risk-based approach to strengthen the nation’s food- and animal-feed safety systems. However, while we understand the need for continuous food/feed safety improvement, the farm-level impact on producers must be considered in any new regulations, especially given the breadth and complexity of the rules proposed pertaining to FSMA. Furthermore, given the scarcity of public and private resources, it is increasingly important to target these limited resources in a manner that achieves the greatest result for all accountable parties. Commitment to a robust cost-benefit analysis of any preventive controls rule is necessary to ensure that the cost of enhanced measures does not outweigh the benefits.

The cost of this rule to farmers and the feed industry has the potential to be substantial. In its comments, AFBF referenced a study commissioned by the United Soybean Board prior to publication of the proposed rule found the cost of compliance with the statutory requirements $265 million, $65 million more than FDA has estimated in the rule. In addition, the National Grain and Feed Association has analyzed the economic impact of this rule in a document which was attached as an appendix to AFBF’s comments. FDA should thoroughly review these analyses when evaluating potential changes that may be published in a second proposed or final rule, and we join with AFBF in encouraging FDA to consider holding a special comment period for the purpose of reviewing and adjusting its overall economic analysis of the combined rules’ impacts.


PFB is committed to improving food safety in a targeted, scientific, and risk-based manner, and its members look forward to continuing our working partnership with FDA to promote food safety.


Grant Gulibon
Director, Regulatory Affairs