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November 22, 2013
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane Room 1061
Rockville, MD 20852

Federal Docket: FDA-2011-N-0921

Re: Proposed Rule "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food"

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 Human Food.”

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 comments to be filed by AFBF on this topic, and would request that AFBF’s comments be treated as part of the comments contained herein.

General Comments: Preventive Controls  

The FDA states that the primary benefit of this rule, which revises the FDA’s current good manufacturing practice (CGMP) regulations regarding the manufacturing, processing, packing, or holding of human food, would be a decrease in the expected incidence of illnesses caused by the manufacturing, processing, packing or holding practices of human food. The rule adds preventive controls provisions as required by the FDA Food Safety Modernization Act (FSMA) that apply generally to facilities under the FDA’s current food safety regulations, and it updates and revises certain requirements of the CGMP regulations, which were last updated in 1986.

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. American consumers deserve to have confidence that their food is safe and that the best science is used to ensure that the most wholesome product possible is produced and offered. PFB and its members strongly support food safety because they have the same desire as other consumers to have a safe, abundant and affordable food supply, and they also have an economic interest because the demand for their products is determined by consumer confidence.

With those goals in mind, PFB believes that regulations governing food safety should have tangible, measureable benefits that outweigh the costs they impose. However, FDA has admitted that it is unable to quantify health benefits derived from this rule, and instead has developed a qualitative assessment that describes how implementing this rule would likely reduce the level of foodborne illness. FDA thus does not conduct an in-depth benefit-cost analysis of this major revision of our nation’s food safety regulations.

FDA has two similar rules in place for seafood and juice that, by now, should have generated ample evidence as to how well these two rules have reduced the rate of foodborne disease. Both are Hazard Analysis Critical Control Point (HACCP) rules, and the most logical one to study is the rule for seafood. FDA promised in the final rule to analyze that rule and determine if it had been effective, but the promised analysis for the seafood rule has not been done, but it should be done before implementing HACCP for all other foods under FDA’s jurisdiction. The measure of the seafood HACCP program’s success would be the first indicator of the likely 2

effectiveness of this program for other foods. Even before that, the FDA needs a baseline risk assessment that attributes different pathogens and other contaminants both to specific food categories as well as to failures at the processing level—failures that this proposed rule is intended to address. Finally, the FDA needs to consider a wider set of alternatives within a model of an optimal level of food safety that can be quantitatively assessed through conventional benefit-cost analysis.

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

1. FDA should allow for a second comment period on the produce 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 provided for the produce rule, which will help to ensure that affected entities have time to provide meaningful comments on its provisions. However, the scope and complexity of issues that FDA is attempting to address through its proposed food safety regulations are, by their very nature, extremely challenging for this agency to understand and appreciate the effects and unintended consequences to farmers and others engaged in food production in merely one round of public review. The likelihood that the comments received will be sufficiently substantive as to require significant changes to the 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.

The Food Safety Management Act (FSMA) provides FDA with new enforcement authority. While FDA does currently have the authority to conduct limited farm investigations, it has little experience with raw farm commodities and with how they proceed to market. Given the complexity of the proposed rules, the current process of responding to comments on this draft rule with a final rule as the next step does not allow FDA to craft a sound and operable food safety program. An interim step, such as a second draft rule or interim final rule, is needed to work through the regulatory process with adequate stakeholder input.

Finally, PFB would note that during much of the comment period for the produce safety and preventive controls for human food rules, three of the remaining rules recognized by FDA as the core of its risk-based framework were not available for public inspection. Because all five rules contain overlapping provisions that together affect our members both directly and indirectly, it is critical that they be evaluated in context and as a complete package. We encourage FDA to release a second draft of the produce safety, preventive controls for human food and animal feed, foreign supplier verification program and third-party audit certification rules simultaneously to allow for sufficient review of all the rules together, and the second comment periods for each of these rules should also be aligned. This strategy would help ensure the success of each individual rule and FSMA as a whole.

2. FDA should build on existing relationships at the state level and assign states a lead role in implementation of the produce 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.

In its comments on the rule, the Pennsylvania Department of Agriculture (PDA) has expressed its concern over the lack of information it has received from FDA on how future cooperation will take place, and has questioned the lack of direction (provided FDA will delegate authority to the states) or willingness to identify the opportunity or protocols for credentialing of state personnel to conduct inspections. To those questions, we would add the following: If a state is unable to actively support one or more FSMA requirements, will FDA be able to adequately implement the rules with its own inspectors?

Exactly how inspections will be carried out and the structure of federal-state relationships must be established in order to ensure uniform enforcement among the states. We request that FDA provide answers to the preceding questions in order to clarify its position on compliance efforts that will result from the proposed rule.

3. 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. In a like manner, additional resources are by far the greatest component needed to create a more thorough and effective education of personnel engaged in production and delivery of farm and food products. The federal-state-local scope of USDA’s National Institute for Food and Agriculture, agricultural universities and extension professionals offers excellent infrastructure, but the budgets of these entities are insufficient to take on new efforts.

We strongly encourage FDA to direct FSMA funding to this partnership and others like it that are already well-suited and ideally positioned to disseminate educational programming and curriculum. FDA and other federal agencies should recognize the scope of the educational effort needed and work diligently to secure the funds that provide adequate financial and technical support to produce safety alliances, extension centers, and other education partners need to provide locally appropriate outreach and training.

4. FDA must ensure that proper training on FSMA is available for inspection staff, industry trainers, and farm owners and employees.  

One of the most important ways FDA can demonstrate commitment to establish a produce safety rule that best ensures effective but feasible regulation of growers is through developing world-class training programs for inspection staff. Inspectors must be thoroughly trained in a manner that is consistent and uniform, such that all inspectors are able and willing to enforce rules competently and fairly.

It is imperative that FDA inspectors to be engaged in the regulation and administration of the new standards understand that a farm is vastly different than a food manufacturing facility. FDA must train inspectors to understand routine, acceptable on-farm practices. Training relevant FDA staff at all levels regarding production of horticultural crops for sale as food will be critical to ensuring that the produce safety rule is not applied in a manner that is arbitrary or inconsistent or is non-responsive to the natural, practical and financial limitations that producers on-the-farm face in management of health and safety risks.

FDA must develop rigorous training programs with on-farm modules to educate inspectors on the multitude of ways covered raw agricultural commodities (RACs) are produced. Diligence and long term effort by the agency in adhering to ongoing education and updating guidance documents as crop production practices evolve will engender confidence in the regulated community. Applying regulations against a background of understanding of typical and routine horticultural production, harvesting and handling methods is vitally important to ensure the uninterrupted flow of fruits and vegetables into our nation’s food supply. 4

At the same time, FDA should partner with the states to develop a working relationship for implementation of the produce safety regulation and outline other activities to ensure compliance. In its comments on the produce rule, PDA has indicated that it has not received information regarding how such coordination will occur. Training and education must take place for regulators conducting inspections; for regulators and organizations providing industry training; for farm owners as appropriate; and for farm employees according to the proposed rule, which must be shared with farmers and trainers. PDA also suggested that during the first several years after the regulation is finalized and farms are beginning to phase into compliance, education, rather than enforcement should be FDA’s priority. PDA’s rationale for this recommendation is that education will result in better-informed producers who will understand what is necessary to comply with the regulations, and that early outreach and education will be more effective in achieving the goal of a safer food supply than early enforcement efforts that may be inconsistent and confusing to producers and regulators alike. These important enforcement efforts can then be built on a foundation of well-coordinated producer education.

5. FDA should seek to coordinate its efforts under FSMA with those of other regulatory agencies in order to minimize conflict with existing regulations.  

FDA should coordinate with the Department of Agriculture (USDA) in the development and administration of any food safety guidelines related to fresh produce. In its comments, AFBF expressed its appreciation for the technical expertise that USDA personnel previously provided FDA, as well as FDA employees, shared with its state affiliates and directly with individual Farm Bureau members. USDA’s career staff offers a wealth of expertise and, in many cases, practical experience to inform FDA’s efforts.

Institutional relationships between state and federal food safety personnel will also need to be developed to successfully implement FSMA, particularly the produce safety rule. We encourage FDA to heavily consult state and local food regulatory agencies that are willing to participate in the implementation of FSMA (as PDA has indicated it is willing to do) and integration of state and federal food safety systems, and to pursue mutually workable strategies for future collaboration. PDA is a valuable resource that should be utilized in any contact with, outreach to or education for growers.

The expanded scope of regulation brought on by FSMA will take considerable thought, training, learning, education and communication by all parties in order to successfully implement. The Rapid Response Team (RRT) concept supported by the FDA and implemented by states serves as a model for effective integrated response where federal and state regulators work together to ensure alignment with national priorities, including the FSMA and an Integrated Food Safety System (IFSS). These RRTs should serve as an example of states successfully implementing federal objectives and achieving common outcomes through federal-state cooperation and relationships.

6. FDA should modify the definitions of “farm” and “facility” to reflect how they exist and operate, in order to tailor regulation of farm products to reflect the realities and limitations of on-farm management of food safety risks.  

The current definition of farm first appeared word for word in the Federal Register over ten years ago on October 10, 2003 (68 FR 58961), under the definitions promulgated after the Bioterrorism Act of 2002 (BTA). The original definition of farm created under the auspices of an exemption from the food facility registration requirement of the BTA did not seek to define farming in a way that resembled farming practices for the purposes of food safety. The BTA only sought to identify farming operations as a means to exempt farms from the food facility registration requirement under §415 of the Federal Food, Drug and Cosmetic Act (FD&C). Consequently, many farms have been operating outside the definition of a farm since that definition came into effect.

Increasingly, the term “facility” has significant meaning for farms. In addition to the registration requirement referenced above, facilities are now subject to the FSMA Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (preventive controls for human food) rule. The definition of a farm is a primary determinant of whether a farming operation is regulated as a producer of RACs under the produce safety rule, or as a facility under the preventive controls for human food rule. Consequently, the definition of a farm and its appropriate exemption from facility status has new significance.

As currently written, activities conducted by a farm on a farm’s own RACs are classified differently from activities conducted by that same farm on RACs produced off the farm. Therefore, the definition of farm places thousands of farms under the preventive controls rule on the basis of only minimal pack, hold, and harvest activities, none of which change the status of a RAC and or increase the food safety risk to the RAC.

Until now, the FDA has not actively pursued enforcement actions against farms that pack or hold RACs grown on another farm for a failure to register as a food facility. However, the regulations will expand the scope of farms to be subject to heightened food safety standards to both produce growers (proposed Part 112) and to food facilities (proposed Part 117), FDA has an obligation to resolve the ambiguity. FDA should better clarify the definition of a farm to align the degree of imposition of regulatory requirements on farms with the degree of food safety risk that farms and farm activities genuinely pose to public consumers.

In order to create an integrated food safety system, it is now critical that FDA define farming operations as they exist and operate, in order to properly regulate farm products under regulations designed for the farm. Farms that handle farm products should be addressed as farms under the produce rule, rather than as food facilities.

7. FDA’s proposal to implement dual safety standards for “mixed-type facilities” will be economically burdensome for the agricultural industry and is not based in sound science.  

According to the proposed rule, a “farm mixed-type facility” is an “establishment that grows or harvests crops or raises animals and may conduct other activities within the farm definition, but also conducts activities that require the establishment be registered as a food facility” (78 Fed. Reg. 3541). The proposal’s produce safety regulations only apply to the “farm” activities, and the regulations proposed in Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (“preventive control rules”) apply to the “non-farm” activities (78 Fed. Reg. 3646, Jan. 16, 2013). Thus, farmers are left with the extremely confusing obligation to determine whether any of their activities trigger the preventive control rules. The distinctions proposed are nonsensical, and the agency provides no evidence that such divisions promote public safety.

The proposal defines “harvesting” as an activity traditionally performed by farms for the purpose of removing raw agricultural commodities (RACs) on the farm on which they were grown or raised, or another farm under the same ownership. For example, “gathering, washing, trimming of outer leaves, removing of stems and husks from, sifting, filtering, threshing, shelling, and cooling” RACs on a farm or another farm under the same ownership are listed as examples (78 Fed. Reg. 3646, Jan. 16, 2013).

However, these very same harvesting activities, if performed on Farmer A’s farm to Farmer B’s RACs, would be considered “manufacturing,” thus exposing Farmer A to both the proposed produce safety regulations and preventive control rules (See 78 Fed. Reg. 3542). In other words, Farmer A’s farm would be considered a mixed-type facility. The same is also true for activities like the packaging of RACs, which turns a farm into a mixed-type facility if performed on produce not grown on that farm. Again, FDA’s proposal provides no credible scientific basis for such incongruous distinctions. 6

In its comments on the proposed rule, PDA particularly notes that FDA’s proposed definition of “harvesting” does not reflect the realities of modern farm practices, nor is there a scientific basis for the distinctions it creates (making certain farms “mixed-type facilities” that really are not), and that it does not take into account the role played by cooperation and resource sharing among farmers to grow, harvest and market their products. Such cooperation and resource-sharing provides multiple cost-efficiency benefits to producers and consumers alike.

The absence of a credible scientific basis for creating a class of “mixed-type facility” of farm subject to heightened regulatory standards goes directly to the question of regulatory jurisdiction that Congress intended FDA to exercise under the Food Safety Management Act on farming operations. Looking to the plain language of the Act, it is clear that Congress did not contemplate safety standards for farms that would ignore the actual farm structure in practice. In fact, FSMA expressly recognizes that the regulations should provide “sufficient flexibility to be practicable for all sizes and types of businesses” and “acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods” (FSMA § 105). Mandating that washing or packaging the neighboring farm’s tomatoes makes a farm a mixed-type facility directly contradicts the Act’s requirement that the regulations provide sufficient flexibility and acknowledge risk variances. The proposal is simply illogical, and violates the spirit of what Congress envisioned through enactment of FSMA to regulate. The tomatoes have not been sliced or modified in any way and the produce safety standards would still apply to the farm washing or packaging the produce.

The Act also expressly states the intent of Congress that the regulations should “not require a business to hire a consultant or other third party to identify, implement, certify, compliance with these procedures, processes, and practices” (FSMA § 105). The distinctions in the proposal between what constitutes a mixed-type facility are so utterly confusing that there is no doubt that farmers will be forced to hire third-party consultants to merely determine whether they are a mixed-type facility (and, then again to implement them). Even more, the proposal’s safety standards can improve food safety only to the extent that producers and processors comply with the standards. The ambiguities embedded in the proposal make compliance nearly impossible and any attempt oppressively expensive.

FDA does not have jurisdiction to regulate mixed-type farm facilities as proposed without first demonstrating a science-based need for such heightened standards. The proposal’s economic burden to the farming industry is so great that without such evidence, the implementation of dual safety standards for mixed-type farm facilities is arbitrary and capricious.

We understand that the FDA definition of facility (21 CFR 1.227(b)(2)) includes “mobile facility” and that in-field handling and packaging of fresh produce may be perceived as “processing”, subject to the preventive controls rule. PFB opposes such definition for activities such as “top and tail”, “core in field” and “clean and core”, as such activities should only be considered harvesting; i.e., not scientifically different from the FDA provision that harvesting includes “trimming of outer leaves of.” The hazard evaluation of such products is not different from raw, intact produce that is harvested without trimming and is subsequently trimmed in a building as part of farming. In both cases, the produce harvesting, post-harvest water quality, equipment and tool sanitation and worker health and hygiene provisions of the proposed produce safety rule would all apply and provide adequate protection of public health.

We remain concerned that farms with minimal processing (e.g. washing) or handling of produce not grown on their own farm will be swept into the preventive controls rule. It is important for FDA to understand that crop failure, weather disaster, and simple need for variety mean that sometimes farmers must handle, hold and pack fruits and vegetables that are not their own. This is often necessary to be able to fulfill already negotiated contracts and obligations, as well as meet the consumer demand when circumstances outside of the farmers’ control serve to reduce their crop output. Farmers should, and will, provide the same strict adherence to food safety protocols as they do to their own produce, and should not be required to comply with both rules simply

because a minor portion of the crop they are selling came from a different farm. If a farm is handling a majority of its own produce and operating under the produce safety rule, they should not be required to comply with the preventive controls rule in addition.

In summary, the size of the operation or its location in the supply chain is scientifically irrelevant to whether it is covered by the produce safety or preventive controls rules. The hazards and controls identified by FDA in the proposed produce safety rule can apply equally as well—with strong protection of public health—to packing/repacking operations as they do to an on-farm operation, provided that both operations are limited to handling, holding, packing or packaging raw, intact produce. Based on the discussion above, Farm Bureau also opposes the concept of a “farm mixed-type facility” under this preventive controls rule.

8. FDA should clarify what it means by the “same ownership” of a farm.  

Under farm activities regulated by the proposed produce rule and the preventive controls rule, ownership of RACs largely determines the extent of the regulation. If a RAC is grown on differing land tracts but “under the same ownership,” the handling of that product would be subject to the standards that would normally apply to farm and be covered under the preventive controls rule, but if the RAC is grown on land tracts and the operation is not considered to be “under the same ownership,” it will be considered “high-risk” and therefore be subject to much more stringent regulation.

In its comments, PDA points out that there are farms that are owned under different names, but are operated as a single entity using the same equipment. There are also cases of individually owned, jointly operated farms on which the ownership of farm inputs and outputs is divided among several owners. In order to clear up any confusion in such a situation, PDA suggested that FDA adopt a more precise interpretation than “same ownership” which better reflects the operational function of the farm and avoids unnecessary regulatory activity.

9. FDA has inappropriately grouped very low-risk produce packing and handling facilities together with food processing facilities under the proposed rule.  

PFB understands that FSMA defines the term “facility” to mean “a domestic facility or a foreign facility that is required to register under section 415” and that it is FDA’s intent that “conducting activities outside the definition of ‘farm’ triggers the requirements in the section 415 registration regulations and, thus, brings the facility within the scope of section 418 of the FD&C Act.” That is, FDA intends a sharp division between “facilities” subject to the preventive controls rule and “farms” subject to the produce safety rule, based on the section 415 registration regulations. However, this is an artificial restriction, neither science- nor risk-based. We contend that the Congressional intent of FSMA is met if registered facilities that handle, hold, pack or package raw, intact produce are covered by the relevant requirements of the produce safety rule instead of the preventive controls rule.

FDA has specifically identified these processes as low-risk in the preamble that states: “Small and very small on-farm businesses conducting these low risk activities would be exempt from most of the rule’s requirements. We would define the low-risk activities that qualify for the exemption, including the specific foods to which they relate (such as repacking intact fruits and vegetables…”)

Although inappropriately restricting the proposed exemption to companies based on size, FDA has nonetheless characterized repacking (and, thus, packing) intact fruits and vegetables as “low-risk.” Activities such as packing or repacking intact fruits and vegetables that are considered low-risk for small and very small on-farm businesses are also low-risk for larger operations. FDA should extend this exemption to all facilities that 8

handle, hold, pack or package raw, intact produce, recognizing that these operations are clearly covered by the relevant requirements of the produce safety rule instead of the preventive controls rule.

We believe that FSMA provides authority for such exemptions and modifications to the requirements of section 418 of the FD&C Act. These include provisions related to activities of facilities subject to section 419 of the FD&C Act (Standards for Produce Safety). FDA clearly intends that the proposed produce safety rule provides “standards for the safe… packing, and holding of produce on farms.” We therefore contend that the standards in the proposed produce safety rule—particularly the personnel qualifications and training requirements in proposed subpart C, health and hygiene requirements in proposed subpart D, and the requirements for equipment, tools, buildings, and sanitation in proposed subpart L—are more than adequate for the safe holding, handling and packing of raw, intact fresh produce, regardless of the commodity, size of the operation or source of the produce.

10. PFB appreciates FDA’s expressed intent to further define “retail food establishments” which are not required to register or comply with the proposed preventive controls rule to include farm and roadside stands.  

Including farm and roadside stands among the “retail food establishments” that are not required to register or comply with the proposed preventive controls rule is important to ensure that farm markets which handle some produce that is not grown on their own property but used only for retail sale at their own market will not fall under the Preventive Controls rule. Such clarification to the definition should be made immediately so there is no ambiguity where farm markets, roadside stands, or Community Supported Agriculture (CSA) subscription businesses must technically comply, all the while being told they will be exempt in the future. Furthermore, FDA should not place any income or value limitation on such businesses, nor require that a farm market, farmers’ market or CSA use only produce or products grown on its own property, in order to be defined as a retail food establishment exempt from the Preventive Controls rule.

11. PFB proposes that FDA specifically exempt produce auctions from the preventive controls rule to ensure that undue burden is not placed upon these entities.  

Produce auctions are a unique, entrepreneurial enterprise started by the Amish community to provide a marketplace for their products, and Pennsylvania is well-known as a state with a significant number of Amish residents. Over the last several years, produce auctions have expanded to numerous states and now include growers outside the plain community as well. Much like a farmers’ market, the auction does not take individual ownership of any products. The auction does not process, manufacture, pack or package any products. The auction does not even hold products in any sense, except for possibly to display them for a few minutes as they are sold on the auction block from grower to purchaser.

These are typically open-air marketplaces, much like farmers’ markets. Even so, the produce auctions and their leadership have worked with participating growers to ensure adherence to strict food safety practices. The auction also takes pains to ensure that food is handled safely by growers at each auction location.

Produce auctions clearly do not engage in any activities covered by the preventive controls rule. However, they have been previously misunderstood to fall within the Bioterrorism Act’s facility registration requirement. A simple misunderstanding of their business should not subject produce auctions to the new rule.

12. The proposed labeling requirement for qualified facilities that opt to use state or local inspection as evidence of compliance appears to be in excess of what is currently in place for food in packaged form.  

Under Section 117.201(d), such qualified facilities must include the name and complete address of the location where the food was manufactured and processed, including the street address and post office box, city, state and zip code. This requirement exceeds what is already present for food in packaged form (21 CFR 101.5), and these differences will create confusion for regulators and producers alike. While these differences do not appear to provide any additional food safety benefit or public health protection, they will add costs to producers in terms of redesign and reprinting of labels in order to comply with the proposed rule. FDA should clarify its reasoning for including this provision in the proposed rule.

13. FDA should recognize the Pasteurized Milk Ordinance (PMO) as currently implemented in all 50 states as meeting the requirements of the preventive control rule.  

In its comments, PDA not only suggested the above, but also strongly recommended that FDA exempt PMO-regulated facilities from FSMA’s preventive controls provisions specified in Part 117 of the preventive controls rule. PDA also expressed its concern that FDA has not completed a sufficient review of the PMO as required under FSMA Section 103(n)(5). Congress required that review to ensure that the FSMA regulations were consistent with the PMO in place at the time the FSMA regulations were drafted. Because of that required review, any determination made by FDA about the sufficiency of the PMO to protect public health should be shared for public comment—but no such information has been forthcoming from FDA.

Changing the regulatory system to mandate compliance with the preventive controls rule would have a substantial economic impact on both PDA and Pennsylvania’s dairy industry, while adding no public health protection. Both PDA and Pennsylvania’s dairy industry do not support this unnecessary duplication of effort for those reasons. PFB urges FDA to consider the well-established efficiency and effectiveness of this program and provide an exemption for the Grade “A” milk industry from the preventive control provisions (subpart C) of Section 117.

14. The compliance dates for “very, very small” and other facilities are not the same under the produce rule and preventive controls rule. The lack of coordination between the two will cause confusion for producers and regulators alike.  

If both the final produce rule and the final preventive controls rule are released at the same time, a great deal of confusion will likely result. There are inconsistencies between the compliance dates in the two rules as currently drafted. In its comments, PDA suggested that FDA consider a process that would permit “small” and “very small” farms (as defined under the produce rule) that are also on-farm mixed-type facilities subject to both rules a compliance period extension of 12 months by notifying FDA in writing. By permitting only these facilities to apply for the compliance extension, only a small percentage of facilities will be eligible, and the extension will allow farmers to plan accordingly (implementing the produce rule first, and then implementing the preventive controls rule).

15. Public disclosure and recordkeeping requirements under the proposed rule should be aligned with those in other risk-based preventive programs, and the use of electronic records should not be required for small and very small businesses.  

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. 10

At the same time, while expensive food safety verification software is available and may not impose a burden on larger firms, the same is not the case for “small” and “very small” operations, and an exemption from the electronic records requirement should be available to those entities.

16. Recordkeeping requirements deemed necessary under this rule should provide non-electronic alternatives and adequately protect the privacy and confidentiality of individual farm businesses.  

Records and other documentation should not increase production costs for diversified farmers, most of whom operate small businesses. Producers currently maintain a plethora of records, yet most farms do not have the technical or financial resources available to make their record-keeping systems interoperable with government or others in the food chain.

According to USDA’s National Agricultural Statistics Service (NASS), 70 percent of farms have access to a computer, 68 percent own or lease a computer and 40 percent of U.S. farms use a computer for farm business in 2013. NASS also concludes that 2/3 of U.S. farms have Internet access, but some farms still rely on dial-up access. Therefore, if recordkeeping is determined necessary, there must be acceptable, basic alternatives to an electronic format.

The privacy and confidentiality of individual farm businesses must be considered in the development of new regulations. Any recordkeeping requirements must be accompanied by assurance that information accessed by federal government authorities in regards to food safety protocols will remain confidential.

17. FDA should consider additional factors in evaluating its justification for the proposed rule.  

A major underlying theme of FDA’s justification for developing the proposed preventive controls rule as it has is that consumers and producers in the food marketplace, due to imperfect or insufficient information about food safety risks, do not make decisions that lead to the optimal level of food safety. Put another way, FDA argues that a lack of information about the dangers posed by unsafe food on the part of producers and consumers may lead to underproduction and underconsumption of foods that are, in FDA’s view, produced without sufficient controls in place to prevent foodborne illness, adulteration, or contamination. FDA then concludes that market incentives are not strong enough to provide for an optimal level of food safety, and that additional regulatory authority is necessary to correct what they perceive to be imperfections in the food marketplace.

This view of food consumer and producer behavior, however, fails to account for several critical incentives that both consumers and producers have to strive for an optimal level of food safety. As noted in the introductory section of these comments, farmers have the same desire as other consumers to have a safe, abundant and affordable food supply, and they also have an economic interest in safe food because the demand for their products is determined by consumer confidence. They have substantial incentives to have food safety programs in place, and more and more producers have been incorporating food safety into vertical contracts. Consumers also have a wealth of information available to them regarding recalls and other food safety issues on the numerous Internet sites dedicated to food safety topics, and they also have access to the legal system, which can award compensation in cases where unsafe food causes harm (a fact that the FDA acknowledges only in part, as it claims that consumers in such cases cannot always pinpoint the exact source of contamination).

In sum, the FDA’s contention seems to be that despite food consumers’ access to a wide variety of information about food safety risks and producers’ incentives to bring safe food to market, neither the marketplace nor the legal system provide enough economic incentives to guarantee safe food, and that “the Government may (emphasis added) be able to improve social welfare through targeted regulation.” However, the FDA makes no effort to determine exactly how far removed the current state of food safety is from what it would consider to be

optimal, nor does it define what it would consider to be that optimal level of food safety or attempt to quantify whether or not the current state of food safety is getting better or worse relative to the optimal level. This is necessary information in evaluating whether or not the proposed regulation is the most appropriate course of action, and FDA should provide additional evidence supporting the above and other assertions it makes in support of the need for it.

18. While FDA has stated that alternative compliance methods are available under the proposed rule, more alternatives are needed that better account for the probable risk associated with a given activity.  

As noted in the preceding section, FDA has not adequately assessed how far the current state of food safety deviates from the optimal level. Without doing so, the best possible and appropriate regulatory solution is difficult to craft. The alternatives that FDA does present in the proposed rule are applications of the same regulation to three different thresholds of firm size (annual revenues of $250,000, $500,000 and $1,000,000). Each requires all affected processors to meet minimum standards that are narrowly applied. The animating principle of this approach is to try to guard against whatever future problems may arise, but without accounting for the probability that any of those problems may actually occur.

PFB supports improving the food safety regulatory process for consumers and producers via additional science-based inspection, as well as the research and development of scientifically-based rapid testing procedures and tools. However, PFB believes that inspections should be targeted according to risk. Using the approach embodied in FDA’s proposal amounts to regulating every product, everywhere heavily because there may be a problem somewhere, with some product, at some unspecified point in the future. This is an unnecessary and ultimately inefficient and ineffective use of scarce public and private resources, because not all products and facilities present the same (or even significant) risks. If these differential risk probabilities are taken into account, different regulatory designs may emerge depending on the risk for which mitigation is sought—designs that may little resemble the three options presented by FDA under the proposed rule.

To that end, FDA would be better served by focusing on options that increase the probability that processors producing contaminated food in outbreaks are identified, thus creating greater incentives for food safety by raising processor awareness of the costs of outbreaks (costs of recalls, loss of sales, and lawsuits, in particular). Such an approach focuses attention and resources on facilities with problems, which can be more quickly identified by other entities in the food marketplace. It would also allow recalls to be better targeted at the problem processors and allow investigations to proceed and improve conditions at those facilities. A targeted approach along these lines is superior to the one enshrined in the proposed rule.

19. FDA does not have enough information to conduct a complete estimate the benefits of the proposed rule.  

To determine the likely benefits of the proposed rule, FDA attempted to estimate the total economic burden of the illnesses that could potentially be prevented by it. It estimated that there are one million illnesses caused by FDA-regulated food products that would fall under the scope of the proposed rule each year, with an estimated monetary cost of nearly $2 billion. However, FDA acknowledges that it cannot determine the share of the illnesses addressed by the proposed rule. In particular, FDA admits that many illnesses are the result of improper food handling in the home or in a food service setting, and those types of cases would not fall under the proposed rule. There are a number of different steps at which food can become contaminated between the producer and the consumer, so even if a given food product was safe at the farmer/processor level, there is no way to know how safe it will remain as it travels through the food market continuum—and there is little evidence that the proposed regulations will help to address food safety risks beyond the level of farms. 12

Conclusion  

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.

Sincerely,

Grant Gulibon

Director, Regulatory Affairs