Commenting on Food Safety Regulation

Last Friday, the public comment period closed for the Food and Drug Administration’s proposed produce rule[i]. When finalized, the rule will establish mandatory standards for growing produce—i.e. fresh fruits, vegetables, and nuts—intended to improve food safety and protect public health.  The agency released the proposed rule in January 2013 as one stage[ii] in implementing the Food Safety Modernization Act (FSMA), which President Obama signed into law on January 4, 2011.

To give you a sense of the scope of this law, FSMA enacts an expansion of federal authority on the same order of magnitude as the big environmental protection laws of the late 60s and early 70s—the Clean Air and Water Acts, for example, or the Endangered Species Act. However, in addition to its progressive promise to better protect public health, FSMA also opens the door for misapplication of government authority: if poorly implemented, it could be an agricultural version of the Patriot Act. The produce rule, in particular, has the potential to discriminate against small-scale organic farms and to impede ecologically-based farming practices. And that is why I and thousands of others are trying to convince FDA to amend it. In the rest of the post, I will briefly discuss the background of the rule, explain how the Federal administrative process for such rules works, and will conclude with the comments that I submitted to FDA.

Major reform of the nation’s food safety regulatory system has been brewing for the past decade or so[iii]. The tipping point came with a series of deadly and high-profile outbreaks, in particular a 2006 multi-state outbreak of E. coli O157:H7 that killed 5 people and sickened another 200. This and other outbreaks triggered a wave of industry and government reforms. This is a long story that I won’t get into here, but SF Gate published a nice summary of the basic plot this past weekend that will catch you up to speed.

But let’s return to the closing of the public comment period. If you are not familiar with the way Federal law works, the short version is that most legislation merely provides a general framework, the details of which have to be worked out by one or more Federal agencies through a process known as rulemaking. Agencies belong to the executive branch of government, and ultimately answer to the President. Examples include the FDA, USDA, EPA, and so forth.

However, an agency such as FDA does not have complete freedom to work out the details of a law such as FSMA as it wishes. Rather, the agency must comply with a whole series of legal requirements, some of which are included in the law itself and others of which come from administrative law, a corpus of laws that set universal requirements for any rulemaking. One of the most important administrative laws is the Administrative Procedures Act of 1946 (APA). The APA requires that any time an agency intends to alter an existing regulation or introduce a new one, it must publish a notice of proposed rulemaking in the Federal Register. This publication marks the start of a period (generally three months) during which any member of the public—including individual citizens, organizations, and even other agencies or other nation-states—may submit comments on the proposed rule to the agency. The agency is required by law to respond to each and every comment; this does not mean that the agency has to follow or agree with every comment, but it must at least justify its response. Once all comments have been addressed and the agency has revised the draft rule accordingly, it will release a final rule that will then be the law of the land.

The public comment phase of rulemaking is a critical part of American government, as it is one of the few ways that the public can participate directly in the governance of the country. It is also a key avenue to educate regulatory agencies about the potential impacts or oversights that a rule might have. For the produce rule, 13,390 comments were submitted to the FDA between January and November of 2013. One of those comments is mine, which I will share with you here to give a sense of what participating in a rulemaking process in this manner might look like. (Note that the version I submitted to FDA was on Berkeley letterhead—formality matters with these things!).

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To whom it may concern:

I am writing to comment on the FDA’s proposed rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (hereafter, the rule) in my capacity as a PhD candidate in Environmental Science, Policy and Management at the University of California, Berkeley, where I am researching and writing my dissertation on US food safety governance and risk regulation. The US National Science Foundation (NSF) currently funds my research in this area, and in collaboration with an interdisciplinary team of ecologists and social scientists I have another grant application in review with NSF to study socio-ecological dynamics of food safety practices on California leafy greens farms.

From this vantage point, I express my hope that FDA will take the opportunity presented by the mandates of the Food Safety Modernization Act to demonstrate to the American people that the United States government can engage in sensible, well-reasoned, and participatory modes of regulation that effectively protect the public from food borne hazards while equitably distributing the costs and benefits of such protection. Toward that end, I raise five points:

1. The rule must be more flexible and scale-appropriate. The Food Safety Modernization Act (FSMA) directs FDA to “provide sufficient flexibility to be practicable for all sizes and types of businesses” (21 USC §350h[c][1][B]) and to “be appropriate to the scale and diversity of the production and harvesting of such commodities” (21 USC §350h[a][3][A]). The current rule does not reflect this mandate, and the “qualified exemption” provided in §112.5 is insufficient (see comment #2). The rule must recognize that there are many different types of farms in this country, operating in many different contexts. The geography, culture, marketing channels, consumer preferences, and labor situations vary dramatically, as does the risk profile for food safety. If the rule does not provide scale-appropriate requirements for all of the different types of farms and contexts in which they operate, it will hurt farmers, rural communities, and local ecosystems. If this happens, the rule will fail to benefit the public good.

I would like to give you a sense of how this rule appears to a small-scale, Latino farmer in California, who has worked very hard for many years and even gone back to school to learn how to start up his own fruit and vegetable farm, which sells to markets in and around the San Francisco Bay Area. I provide a direct quote from Javier, whom I met at a focus group meeting[iv] convened for immigrant farmers affiliated with the Agriculture and Land-Based Training Association (ALBA) to share their experiences in complying with food safety requirements. I have translated it from the original Spanish:

“Food safety is first and foremost a worry. Or, if you want, a risk. I worry not only for me as a farmer, but also for the recipient who is going to eat the food. And this worry includes many things: the cost, the time it takes to fill out all the papers, all the demands that are out there, and there are no differences [in what is demanded] between small and large. This is what has us upset… there is no difference between a large company and a tiny one, and the large company has all these resources to pay someone to do that, and we don’t have the resources… <pointing to other farmers in the room> He knows what he has to do. She knows what she has to do. Ensure that the product goes from the field to the crate in a safe manner. We don’t have a problem there. The problem we have is the bureaucracy and the cost. This is the problem.”

To reiterate, the ten farmers at the focus group meeting discussed in great detail the many concrete steps they take to ensure that their products will not make one of their customers sick. They understand and practice the appropriate risk prevention methods: regularly washing hands with soap and water, wearing gloves, sanitizing equipment, carefully inspecting the fields, packing houses, and other farm facilities, and so on. Yet the expected amount of record-keeping, laboratory testing, paperwork, and audit costs imposes an extensive burden on the farmers, and they do not believe these bureaucratic requirements actually contribute to making the food any safer for their customers.

FDA should, in greater collaboration with food producers of all backgrounds from across the country, revise the rule to set multiple equivalent standards at each stage of farm production―soil amendment, irrigation, equipment sanitization, worker education and hygiene, record-keeping, harvest, etc.—that are appropriate for different farm types and contexts. Merely allowing producers to “establish alternatives” (§112.12) to the baseline standards provided they have “adequate scientific data or information” (see comment #3) does not provide sufficient flexibility and is not appropriate. The provision at §112.12 places the burdens and costs of identifying and proving the viability of alternative measures on producers, when it is clear from the language of the law as quoted above that Congress intended FDA to take a lead role in identifying viable alternatives.

2. The rule must not inadvertently create the misconception that some farms are unsafe because they have been exempted from the requirements. I recently had the opportunity to speak with Kathleen Merrigan, a US Deputy Secretary of Agriculture who stepped down earlier this year, when she visited the Berkeley campus. She emphasized that the rule must not create a category of farm that is publicly perceived to be exempt from food safety regulation, and I strongly agree. Doing so risks unduly damaging the reputation of these producers and may undermine the integrity of this rule by creating the appearance of a double standard. Rather than simply grant small farms that sell direct and locally a “qualified exemption”, per §112.5, from the universal requirements laid out in Subparts B through O, FDA should foster further dialogue with these farmers to collaboratively develop a set of food safety requirements, possibly including voluntary risk prevention practices to comply with 21 USC §350h(f), that best suits their particular risk profiles and also takes advantage of their operational strengths. Many small farms are operated with a degree of substantive, effective care—daily oversight over the farm by owners and top managers or hand harvesting―that is unique to their scale of operation. These practices of care should be recognized as valid and legitimate risk-prevention measures in the same way that water quality tests (Subpart N), treatment of biological soil amendments (Subpart F), or worker hygiene training (Subpart D) are for larger-scale farming operations.

3. The FDA must take on greater responsibility for identifying and evaluating alternative risk prevention methods. The burdens and costs of producing “adequate scientific data” in support of alternative methods of risk-prevention, per §112.12, should not fall solely on producers, some of whom may not be able to bear these costs because of their limited resources. FDA should work with other government agencies, scientists, and stakeholders to identify and scientifically evaluate other methods of risk-prevention and protection of public health. For example, FDA could take the lead in evaluating the risk-prevention potential of shorter or less centralized supply chains. A shorter supply chain (i.e. measured as time from harvest to consumption), such as for a farmers market or a consumer supported agriculture (CSA) arrangement, in principle reduces the risk of a consumer contracting an illness from produce: less time in storage and transit translates to less time for pathogens to incubate. Similarly, a non-centralized supply chain that does not process or mix produce in large batches (such as ready-to-eat bagged salad mixes) in principle reduces the risk that contamination will lead to an outbreak, and also in principle reduces the possible magnitude of an outbreak if one were to occur.[v] In addition, FDA should clarify what is meant by “adequate scientific data,” specifically detailing what criteria will be used, and by whom, to judge its adequacy. Lastly, the standards referenced in the rule should be shown to adhere to the same criteria once defined .

4. The rule should avoid an overly narrow definition of safety, and acknowledge potential tradeoffs of food safety with other demands on produce. The rule must recognize that there are many different, and at times competing, qualities that the American public expects from fresh produce. Furthermore, there is no one universal definition of safe food that everyone will agree on. A low risk of pathogen contamination is important to many people, but so are environmental sustainability, support for rural livelihoods, fair and just labor practices, nutritional content, local sourcing, reasonable prices, organic production, and a product that tastes good, to name a few. The rule must explicitly take into account the potential impacts that pathogen-oriented risk prevention standards may have on these other qualities. For example, §112.31(b)(1) directs farm operators to exclude a sick employee from work “until the person’s health condition no longer presents a risk to public health,” but provides no instruction that indicates that the health and well-being of the employee should also be a concern. Preventing a worker from earning money at the same time that he or she is sick, and may have to pay medical bills, could have severe consequences for the worker and his or her family. Not only is this bad for the worker, but it may also encourage workers to hide symptoms of illness, perversely introducing additional risk to public health. FDA must recognize that it will not serve the American public to have pathogen-free produce if at the same time ecosystems are degraded, small-scale farmers are forced out of business, and the healthfulness (nutritional) and quality (aesthetic) of the end-product is ignored.

5. The rule should not unduly burden producers for whom English is not a primary language. Many farmers in America do not speak English as a first language, and neither do their customers. Promulgating and enforcing the rule in an inaccessible manner, for example by failing to communicate in a language in which producers are fluent, will unduly discriminate against these farmers. Research on the experiences of Hmong farmers in California’s San Joaquin Valley, for example, shows that culturally inappropriate labor regulations can produce racialized discrimination against immigrant farmers[vi]. Studies in progress by the same researchers have uncovered preliminary evidence that assessment of compliance with food safety standards may also be racialized, not least because of language-based communication barriers. In addition to my first comment, I add that at a minimum FDA must ensure that the rule, and all associated forms, instructions, and avenues of assistance are readily available in any language and format that a farmer or producer needs. In addition, FDA should include a clause in Subpart Q (Compliance and Enforcement) with a statement to the effect that all compliance and enforcement actions will be conducted in a language in which the farmer or producer in question is fluent.

I would like to conclude by urging FDA to recognize that American farmers care about the quality and safety of their produce, and want to grow safe food for their customers. FDA’s mission, as mandated in the Food Safety Modernization Act, is best served by a more cooperative approach to facilitating the adoption of better food safety practices among farmers. The proposed produce rule as written adopts a command-and-control approach to food safety that will likely lead to an antagonistic relationship between FDA and producers. Less emphasis on filling out paperwork and more emphasis on actually practicing better agriculture could go a long way toward ameliorating this antagonism. I end by noting that establishing trust and mutual respect between FDA and produce farmers will be necessary to adaptively build domestic capacity for food safety, as required by Sec. 110 of the FSMA (21 USC §2204).

 


[i] For brevity’s sake, this is the short title by which most people refer to the rule. The official name of the rule is Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. You can find the full Federal Register (78 FR 11: 3504) notice here: http://caff.org/wp-content/uploads/2012/08/FSMA-produce-rule-from-Fed-Reg.pdf.

[ii] FDA has issued at least eight rules, some proposed and some final, related to implementation of the FSMA. It has also issued a number of “Guidance for Industry” documents, which serve as sources of standard, authoritative information for the private sector. One such guidance document from 1998, the Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, provides the official scientific basis for much of the regulatory developments surrounding food safety for produce.

[iii] The US Government Accountability Office (GAO) has added “Revamping Federal Oversight of Food Safety” to its “High Risk List,” basically the office’s list of priorities for government action and remediation. The GAO has been issuing reports on the topic since at least 2001. In addition, President Obama created the President’s Food Safety Working Group in 2009. Its initial report concluded,

 “Unfortunately, the nation’s food safety system is anything but flexible and coordinated. Our system is hamstrung by outdated laws, insufficient resources, suboptimal management structures, and poor coordination across agencies and with States and localities. At least a dozen Federal agencies, implementing at least 30 different laws, have roles in overseeing the safety of the nation’s food supply. This approach was not rationally designed. Rather, it developed in fits and starts as the nation’s attention turned to one crisis after another. Building a new system will require recognizing the critical importance of a closely coordinated system.”

[iv] The focus group was held on November 8, 2013 in Salinas, California.

[v] DeLind, L., & Howard, P. (2008). Safe at any scale? Food scares, food regulation, and scaled alternatives. Agriculture and Human Values, 25(3), 301-317.

[vi] Minkoff-Zern, L.-A., Peluso, N., Sowerwine, J., & Getz, C. (2011). Race and Regulation: Asian Immigrants in California Agriculture. In A. H. Alkon & J. Agyeman (Eds.), Cultivating Food Justice: Race, Class, and Sustainability (pp. 65): MIT Press.

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One Response to Commenting on Food Safety Regulation

  1. Erik Nelson

    First of all, I really enjoy reading your posts. They are always insightful and meaningful. I would like to comment on your fifth point. It seems to me a topic separate from your other points. I understand how it would be beneficial for those immigrant or ESL farmers. I don’t understand how it is the government’s responsibility to provide this for those farmers. Should the burden of communication be put on the government? I understand it is a common practice of some municiple governments and even state governments to provide services in multiple languages. This seems outside the responsibility of the federal government however. Perhaps it is something that can be addressed through education and not so much in this forum. Either way, I really enjoyed your post!

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