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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

Re: Proposed Rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption  

Federal Docket: FDA-2011-N-0921  

Pennsylvania Farm Bureau (PFB) is pleased to offer its comments on produce safety as the Food and Drug Administration (FDA) develops standards for the growing, harvesting, packing and holding of produce for human consumption.

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 Produce Safety Comments  

PFB’s members are keenly aware and involved in voluntary promotion of sound food safety practices, and appreciate the opportunity to provide input on how food safety is regulated. We believe that although the U.S. food production system is among the best in the world, efforts to feasibly improve the quality and safety or food production are important and worthwhile.

PFB recognizes that food systems, due to their biological nature, will never be risk free. But even as the food safety environment has encountered increasing levels of change, in large part due to changes in Americans’ dietary habits and choices, foodborne illness statistics have improved. The U.S. now imports food from more than 150 different countries through more than 300 ports of entry. About half of the fresh fruits eaten in America are grown outside of the country, and these imports allow consumers to enjoy their favorite produce year-round. Exports and imports of food products allows for a more varied and customized diet suited to today’s consumer preferences. International trade of food products gives our farmers and other food producers the opportunity to sell their goods abroad—but it also creates challenges for FDA to ensure that the safety of food products moving interstate and internationally meets reasonable health and safety standards that US consumers have grown to expect.

At the same time that the changes referenced above have taken place, the number of people involved in the food preparation process has also increased. Approximately 50 cents of every food dollar today is spent on foods prepared outside the home in places like restaurants, vending machines, and schools. This development increases the need to ensure adequate training for food service workers across the country and to consider the

potential widespread impact of deliberate contamination of the food supply. As the supply chain gets longer, there are more opportunities (both accidental and intentional) for the introduction of public health threats.

With the preceding general comments in mind, PFB wishes to offer the following specific comments on the produce 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? 3

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.

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. 5

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.

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.

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. Foreign and domestic producers should be subject to the same level of regulation under the proposed rule, and there should be no “means-tested” regulatory exception provided.  

Increased federal standards will place United States producers at a competitive disadvantage with foreign producers if the same standards are not aggressively enforced on imports. In its comments, PDA stated that if imposition of the proposed produce rule’s standards on domestically produced food products is necessary to ensure a safe food supply, the same standards should be equally applied and enforced on imported food products to ensure the same level of food safety. 7

Another provision of the proposed rule which will put numerous domestic producers at a disadvantage relative to foreign producers is means-testing, notably the proposed regulatory exception based solely on size for growers with farm sales of $25,000 per year or less. While we believe that few, if any, domestic growers would qualify for this exemption, its consequences for imports are dramatic. The amount of farm production required to reach the equivalent of $25,000 (U.S.) is vastly different in numerous foreign countries, many of which are serious produce exporters to the United States. In its comments, AFBF cited the example of Chinese apple production, which leads the world, but is the product of many small farms, several of which make less than $25,000 (U.S.) per year. Under the small farm exemptions in the proposed rule, the vast majority of apples imported from China would be exempt from the proposed rule, putting United States producers at a significant competitive disadvantage in their own domestic markets, creating a widely divergent and unpredictable level of food safety regulation for United States consumers. In many cases, inclusion of this exemption in its current form will mislead the consuming public on the actual degree to which imported food products have been subjected to the regulations’ food safety protocols.

10. Any new rules should be integrated with the existing GAP and other processes in order to minimize conflicts, overlap and paperwork.  

The existing guidance for Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) have provided a sound and effective basis in the types of activities to be performed by fresh produce growers, packers, and shippers that foster food quality and safety and reduce safety and health risks. The proposed produce safety standards should be coordinated with already established and related certifications to minimize conflicts, overlap and paperwork – and the cost associated with these activities. We strongly encourage FDA to interact extensively with the retail community and promote the adoption of any final produce safety rule as a uniform standard. FDA must make every effort to gain acceptance from the marketing chain through standardization of produce safety regulations and third-party audits. Growers are suffering from “audit fatigue” due to the multitude of requirements already in place from handlers, retailers, and in some cases, state authorities. Rather than causing growers to face additional, and sometimes contradictory, rules and the associated paperwork, FDA should simplify the process with regulations that are easily understand by retailers and can be agreed upon to make produce safety a non-competitive issue, as it is in the meat and poultry industry.

While we understand that growers already certified through GAP or the Leafy Greens Marketing Agreement (LGMA) will be in compliance with the produce safety rule, we encourage FDA to clarify the consistent interaction of these standards in a final rule. Furthermore, we encourage FDA interaction with the retail community to promote the adoption of a uniform public/private standard. If FDA establishes national standards, we would expect the agency to encourage wide adoption of those standards in the marketplace, in addition to regulatory compliance. As we noted in the previous paragraph, no one benefits when growers are forced to conduct multiple audits (currently, often with different standards) in order to have options for marketing their produce.

11. A standard procedure for updating FDA exemptions should be developed.  

Because food safety is size-neutral, all growers of covered produce should meet necessary standards. However, the financial interest of a large grower to implement practices and systems to reduce or limit liability should not overburden smaller growers with unnecessary practices that would drive them out of business. AFBF noted in its comments that it does not support size-based exemptions, which led it to oppose the “Tester amendment” during the legislative process that created FSMA. While FDA must implement the statutory requirement,

serious concerns remain about the potential for this provision to disrupt the safety of the commercial food supply.

In formal comments submitted three years prior to enactment of FSMA, AFBF urged FDA to focus regulatory actions and resources on those commodities or commodity groups that have experienced higher occurrences of human foodborne illness. Despite Congressional intent in directing FDA to concentrate FSMA rulemaking on those commodities, FDA rejected this approach.

FDA should reconsider standards that take into account the relative risks and comparative benefits associated with individual commodity groups. FDA should initially propose regulations for only those commodities that historically have experienced more extreme levels of microbial contamination. If these regulations can be successfully implemented and enforced, it would be then appropriate to conduct a thorough analysis of whether other commodities pose the level of food safety risk to the public as would justify expansion of FSMA regulations to those commodities.

Although we do not believe FDA should regulate all produce for reasons described in the previous paragraph, if FDA retains lists of covered and exempt produce, the factors that cause a specific commodity to be listed must be clearly explained and justified by risk status. FDA must also establish a process for review of the lists and clarify whether and how a commodity can move from one list to another.

As we noted, appropriate produce safety standards should reflect risk, and therefore should account for inherent differences in such factors as growing methods (i.e., imposition of less stringent standards for those grown off the ground) and marketing purposes (i.e., avoidance of duplicative regulatory standards for foods customarily cooked by consumers and must be cooked before consumption to ensure the food’s safety). We commend FDA for clearly excluding grains from the proposed rule and for exempting produce that is rarely consumed raw or that will be commercially processed with subsequent thermal processing. FDA’s exemption for personal or on-farm consumption is also appropriate.

In its comments, PDA recommended the development of a formal process for adding products to the list of exemptions in the future as they are found to be low risk, which would include the criteria for removing products from the list if new information becomes available about risk or consumption patterns.

12. 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. NAAS 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.

13. The agricultural water quality standards proposed in the rule are unrealistic and will cause severe harm to numerous farm operations.  

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In its comments, PDA calls for FDA to take more time to set relevant water quality standards for agricultural water, as more research is needed to determine exactly what is appropriate as a safety standard for agricultural water. In the preamble to the proposed rule, the FDA indicated its use of the EPA recreational water quality standards for agricultural water used during the growing activities for covered produce (other than sprouts), which are only written as guidance to the states for recreational water quality. Such recreation typically includes activities in which a person is immersed in or ingests water, or has a high degree of bodily contact with the water. These activities differ significantly from how water is used by farmers (for instance, the water quality standards for swimmers are irrelevant to what the standard should be for produce irrigation). These standards have not been finalized in regulation by EPA, which researched and established the standard.

PDA further states in its comments that the use of current recreational water quality standards with regard to agricultural water is not supported for that use by any scientific data of which it is aware. This makes the recreational water quality standards proposed by FDA an inappropriate measure for food safety—yet compliance to the rules is tightly focused on meeting these EPA limits and discontinuation of water usage is required when it does not meet these standards. The results of the testing necessary will have a significant impact on the produce industry, and if valid scientific data is not available to support that use of these water quality standards is appropriate, they represent an undue burden on growers. A better solution would be to focus more resources on the prevention of contamination in the first place, test to verify compliance, while at the same time researching what would be an appropriate standard for agricultural water quality.

PDA also expressed concern that the proposed E. coli standard is much higher than the World Health Organization (WHO) standard for minimum water quality—4 times stricter. Until import standards are enforceable, higher requirements serve to put domestic producers at a disadvantage while still allowing substandard produce to enter the United States. Challenges against the United States under various World Trade Organization (WTO) agreements could be made if its standards are not based in food safety science.

14. The term “growing season” needs to be clarified, as it varies by region and by crop.  

15. PFB strongly encourages FDA to change the minimum application interval for raw soil amendments of biological origin from the proposed 270 days to 120 days.  

FDA’s proposed minimum application interval for raw soil amendments of biological origin is 270 days between application and harvest, when the covered product is reasonably likely to contact the soil after application. This standard will be extremely difficult to meet for many growers. As a result, it could have significant negative impacts on the geographical diversity of produce production as well as diversification of individual farms into a combination of produce and livestock. The current accepted standard is 120 days between application of soil amendments and harvest, and PFB strongly encourages FDA to change the minimum application interval to 120 days.

The reason for FDA’s proposed rejection of the 120 day standard in favor of 270 days is unclear, since the 120-day standard has not posed microbial contamination problems and FDA provides no scientific basis to justify 270 days. The consequences to farmers, on the other hand, are very clear. The 270 day standard would essentially prohibit farmers in cooler climates with a shorter growing season from applying raw soil amendments. For example, the growing season in northern Pennsylvania is shorter than in the state’s southern region. It would also severely restrict or eliminate farmers’ ability to pasture animals on fallow fields outside the growing season. Growers who combine livestock and plant-based production in an integrated system report

multiple benefits, including maximized nutrient cycles, balanced production systems, economic diversification, land clearing and weed control.

Furthermore, Section 419(a)(3)(e) of the FD&C explicitly states that the new produce safety standards for organic produce cannot “include any requirements that conflict with or duplicate the requirements of the National Organic Program.” The proposed 270 day standard clearly violates this statute as it is inconsistent with NOP regulations in 7 CFR 205.203(c)(2) that require 120 days between application and harvest.

16. The monthly testing requirement is particularly onerous to Pennsylvania’s mushroom industry.  

From both a time and cost perspective, monthly testing would be difficult for Pennsylvania’s mushroom industry, given that the mushroom growing season lasts only two to three months. In its comments, PDA stated that environmental swabbing once per crop cycle is more appropriate, so that it can be completed before and after a crop season and avoid creating too many challenges during the growing season.

17. FDA should consider additional scientific studies and include provisions in the final rule that recognize the comparatively low and variable risk levels associated with various animal species relative to the contamination of produce.  

It is important for FDA to recognize that wildlife interactions with produce cannot realistically be prevented by the best efforts of the farmer. FDA should also be mindful that dogs and cats are “working animals” on many farms, providing benefits in the area of pest control. Additional clarification of what FDA is trying to accomplish in this area is needed, and more flexible criteria need to be established that are realistic to the presence of wildlife and undomesticated animals in farm areas and is more responsive to farmers’ practical inability to prevent regular occurrences of animals on farms.

18. PFB commends FDA for establishing alternatives and variances to offer options for meeting standards, but all standards should be eligible and the list of entities able to request variances should be expanded.  

PFB commends FDA for establishing variances and alternatives that offer options for growers of all size in all geographic regions to meet standards. However, the alternatives are limited to agricultural water and biological soil amendments. Variances are likewise restricted to state and foreign governments.

At a minimum, alternatives must be allowed for all standards and FDA should broaden the entities eligible to request variances to include commodity groups, regional organizations, and other coalitions of growers with a common unifying characteristic. Allowing petitions for variances from parties other than state governments would also considerably decrease the burden currently placed solely on state agencies.

Under the proposed rule, a farmer may establish an alternative provided they “have adequate scientific data or information to support a conclusion that an alternative would provide the same level of public health protection as the applicable requirement established in this part.” Similarly, a government may petition FDA for a variance in light of local growing conditions if they provide a statement that the variance is reasonably likely to ensure that the produce is not adulterated under the FD&C and “provide the same level of public health protection as the requirements” of the rule. However, the risk model employed by FDA to derive the standards for water and application intervals for biological soil amendments is unknown. FDA must provide this risk model in order for a farmer or government to determine that an alternative or variance provides the same level of public health protection.

FDA should establish criteria for how information supplied in support of variances will be evaluated. PFB is very concerned that the science that appears to be needed to support the approval of alternatives and variances does not exist or would be extremely difficult to obtain. The lack of peer-reviewed scientific information will 11

hamper the practicality and usefulness of these flexible options to meet FDA’s regulatory demands as currently proposed. We support the use of industry-generated scientific data conducted through accredited or university laboratories. Data sets, methodology and analysis should be publicly shared so that other stakeholders can access and leverage results.

19. A cost-benefit analysis of any new produce safety standard is necessary to ensure that the cost of enhanced measures does not outweigh the benefits.  

PFB supports utilizing sound science and a risk-based approach to strengthen the nation’s food and animal feed safety systems. However, too many new standards may unnecessarily complicate the marketplace without increasing the overall safety of the food supply. While we acknowledge the potential benefit of continuous effort to improve farm safety, the farm-level impact on producers must be considered in any new food safety regulations. Furthermore, in an era of tight budgets for everyone in the food chain, it is increasingly important to target limited resources in a manner that achieves the greatest result for all accountable parties.

20. FDA must also prioritize a communications effort to educate the public on proper food handling.  

In numerous comments to FDA, PFB has repeatedly stressed the importance of recognizing food safety as a shared responsibility between growers, the marketing chain, retailers, food service, and consumers. Safe handling procedures must be observed at each and every step, concluding with food preparation and consumption. The final responsibility ultimately rests with the consumer. Therefore, in order for any food safety regulation to be effective, FDA must also prioritize a communications effort to educate the public on proper food handling.

Conclusion  

Pennsylvania Farm Bureau is committed to improving produce safety in a targeted, scientific, and risk-based manner, and its members look forward to continuing our working partnership with FDA to promote the safety of fresh produce.

Sincerely,

Grant Gulibon
Director, Regulatory Affairs