Balancing Food Safety and Burdens on Small Farms

Vol. 28 No. 2

Ms. Beyranevand is the associate director of the Center for Agriculture and Food Systems and an associate professor of law at Vermont Law School.

In response to the concerns raised by journalists, like Upton Sinclair in The Jungle, and our country’s first group of true food safety advocates, Congress enacted the Pure Food and Drugs Act in 1906 to ensure the safety and purity of the food supply in the United States. The law represented the nation’s initial sweeping attempt at food safety regulation and later evolved into the current Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. §§ 301–399. While some might argue that the regulation of our food system has come a long way from the horrors described by journalists, food scientists, and advocates in the early 1900s, the United States currently spends approximately $152 billion per year in aggregate health care costs to address foodborne illness, according to Dr. Robert Scharff, a former Food and Drug Administration (FDA) economist. See Robert L. Scharff, Health Related Costs from Foodborne Illness in the United States (Mar. 3, 2010). Beyond the economic costs, the FDA estimates that one in six Americans will suffer a foodborne illness, and, of those people, 130,000 individuals will be hospitalized with 3,000 people dying as a result of contracting the illness. See Food and Drug Administration, FDA Proposes New Food Safety Standards for Foodborne Illness Prevention and Food Safety (Jan. 4, 2013). Some suggest these statistics reflect the problems inherent to our highly industrialized food system, which relies heavily on the mass production and importation of food creating apparent issues regarding traceability and accountability. According to the most recent figures of the United States Department of Agriculture (USDA), the United States imported almost $106 billion worth of food in 2012. See USDA Economic Research Service, Summary Data on Food Import Values for 14 Food Categories, Annual Data Since 1999 (Mar. 29, 2013). Yet, the FDA estimates that it inspected less than 1 percent of those goods. See FDA Consumer Health Information, Ensuring the Safety of Imported Products: Q&A with David Elder (Oct. 19, 2010).

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In part because of food safety concerns, but also for a host of other reasons, consumers have expressed tremendous and increasing support for the development of sustainable local food systems. The number of farmer’s markets in the United States increased 92 percent from 1998 to 2009 while direct-to-consumer sales (those where the farmer sells directly to the consumer) increased 120 percent from 1997 to 2007. See USDA Economic Research Service, Local Food Systems: Concepts, Impacts, and Issues (May 2010). Studies support these assumptions and suggest that a greater emphasis on these local food systems can substantially reduce the incidence and severity of foodborne illness, as centralized production can provide for shorter supply chains, easier traceability, and enhanced consumer awareness. See Brian Halweil, Home Grown: The Case for Local Food in a Global Market (2002).

A complete transition back to the local food sheds of the early 1900s is unlikely given the increasing globalization of food markets and production, and experts have legitimate concerns that such a dramatic reshaping of our agriculture system alone will have the effect of eradicating the problem of foodborne illness. Accordingly, because of the urgent need to enact some national standards to address both the tremendous costs and risks posed by foodborne illness given our dominant modes of food production, Congress passed the Food Safety Modernization Act (FSMA) in 2010. 21 U.S.C. § 2201. Included among the many provisions of the legislation are exemptions for “small farms,” which are those that average annual gross revenue of less than $500,000 and sell a majority of their products directly to consumers, restaurants, and grocery stores either within the same state or within a 275 mile radius of the farm. See 21 U.S.C. § 350h(f); 21 U.S.C. § 350g(l). Proponents of the exemptions included small farmers and food producers, consumers that favor local food systems, and political activists who distrust big government. In support of the exemptions, they argue that the amendments do not create exemptions from the food safety provisions under the law, but rather simply provide alternatives that take into account farm size. On the other hand, critics of the legislation suggest that implicit in the exemption of these tens of thousands of farms from the food safety requirements under FSMA is the assumption that small means safer, which is not borne out in the scientific literature. In relying on what opponents would consider flawed reasoning, critics of the small farms exemptions claim that Congress has essentially failed in its duty to fully and adequately protect the food supply while at the same time creating additional difficulties for the exempted individuals.

Regardless of whether one finds the exemptions or the reasoning behind them appropriate, ultimately, they are problematic to those affected for several reasons. First, small farmers are left with a great deal of uncertainty regarding whether and what regulations will apply to them under the new system. Moreover, because the exemptions allow for a significant percentage of products from these farms to be sold to large distributors, the benefits of traceability become less meaningful as the relationship between the producer and the consumer becomes more attenuated. Additionally, failure to comply with food safety requirements may foreclose the opportunity to enter those markets altogether. Finally, because the regulations exclude so many farms, state and local governments, as well as the exempted small farms themselves, will ultimately bear the burden of addressing issues of food safety for those exempted farms by developing suitable mechanisms that strike a balance between ensuring consumer safety, shielding farmers from liability, and not overburdening small farmers and producers.

FSMA’s Small Farm Exemptions

Deemed by the FDA as “the most sweeping reform of our food safety laws in more than 70 years,” President Obama signed the FSMA into law on January 4, 2011. FDA website. The law, as originally proposed, drew the attention of many diverse sets of interest groups, some of which formed unlikely coalitions to lobby for specific changes to the bill’s provisions in order to protect small farmers and businesses. Known as the Tester-Hagan amendments, the exemptions for small farmers were incorporated into the bill’s language at the behest of small farm groups and food safety advocates who thought that FSMA’s registration, monitoring, and safety requirements were simply too onerous for small farms and businesses. In addition to incorporating these exemptions, however, Congress also included a provision requiring the FDA to study foodborne illness as related to the size and type of the farm or operation. 21 U.S.C. § 350g(l)(5). Ostensibly, once the studies are complete, the agency will revisit the exemptions to determine whether they are in need or amendment or rescission.

Following the amendment’s proposal, groups such as the Center for Science in the Public Interest, the Consumers Union, Food and Water Watch, and the Pew Charitable Trusts drafted a strongly worded letter to Senator Tester (D-MT) in opposition on the basis that the exemptions for small farms failed to achieve the intended protections. In other words, legislators should have considered other mechanisms by which to ensure food safety while at the same time balancing the needs of small farmers and businesses. Specifically, their criticisms focused on the fact that an exempted farm could sell contaminated produce directly to a school or nursing home where children and the elderly, populations that are particularly susceptible to foodborne illness, would be exposed. See Coalition Letter Regarding the Food Safety Modernization Act, Apr. 20, 2010. Alternatively, under the proposed amendment, contaminated produce from an exempted farm could be commingled with and contaminate large quantities of regulated produce rendering the requirements for larger farms meaningless. Id. Finally, the same exemptions that apply to American small farms under the exemptions would also apply to foreign small farms that may not follow similar agricultural practices to American small farms. Id.

In January 2013, the FDA issued its proposed regulations after the Center for Food Safety sued the agency for failing to meet the deadlines imposed by Congress in FSMA. See Order Re. Cross-Motions for Summary Judgment, Ctr. for Food Safety v. Hamburg, C 12-4529 PJH, 2013 WL 1741816 (N.D. Cal. Apr. 22, 2013). In the court’s order, Judge Hamilton concurred with the agency’s argument that developing regulations without careful consideration where the issues involved greatly impact public safety simply to meet a specific deadline that fails to consider the enormity of the task is irresponsible. Id. at 6. The resulting regulations, however, appear to have suffered exactly the fate the agency claimed they would in the sense that they represent an incomplete and arguably ill-conceived set of rules that have not been judiciously drafted to fully and sufficiently address the magnitude of the issues involved.

Produce Safety Under FSMA

Of particular concern to food safety advocates regarding the proposed small farm exemptions are the proposed Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, 78 Fed. Reg. 3503 (Jan. 16. 2013). This concern is rooted in the fact that 46 percent of all foodborne illnesses from 1998 to 2008 were attributable to produce consumption with leafy greens, in particular, accounting for more illnesses than any other commodity. See Centers for Disease Control, Attribution of Foodborne Illness, USA, 1998–2008, Emerg. Infect. Dis. (2013). The FDA has also determined that contaminated produce was responsible for more than 14,000 illnesses and thirty-four deaths between 1996 and 2010. See FDA, Fact Sheet on the FSMA Proposed Rule for Produce: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (2013). This concern is compounded by the fact that the USDA recommends that half the current American plate consist of fruits and vegetables, so that consumption of produce in this country is only likely to increase.

Under the provisions for small farms, the proposed rules reiterate the exemptions set forth in FSMA basing the definitions of farm size on “the average annual monetary value of food sold.” 78 Fed. Reg. at 3544. For small farms, this annual value is $500,000 per year, whereas for very small farms this value is $250,000. Id. at 3545. The FDA estimates that the proposed exempted small farms make up 18 percent of gross revenue from food sales by produce farms, while the proposed exempted very small farms make up 12 percent according to “sales class breaks” included in information generally available from the USDA. Id. Under the proposed rule, these farms would be exempted from the produce safety standards so long as the annual monetary value of produce sold to qualified end users exceeded sales to other purchasers but did not exceed the amounts mentioned above. Id. at 3549. Qualified end users are those that are “located (i) in the same State as the farm that produced the food; or (ii) not more than 275 miles from such farm” irrespective of whether this distance crosses international borders. Id. at 3548. The agency provides the following example:

if a [Community Supported Agriculture (CSA)] farm has an average annual monetary value of food sold during the relevant 3-year period of less than $500,000; and 25% of the monetary value of its sales comes from sales to individual consumers enrolled in the CSA, 50% of the monetary value of its sales comes from sales to restaurants in the same state as the farm, and 25% of the monetary value of its sales comes from sales to other buyers who are not qualified end-users; the CSA farm would be eligible for the qualified exemption.

Id. at 3550.

To ensure some level of accountability, the rules require the farms that meet the above qualifications to include a label on the product that displays the name and address of the farm. Id. For foods that do not have a label, this information must be displayed at the point of purchase. Id.

Food safety advocates are troubled by these provisions, for obvious reasons. First, an exempted farm can still sell just under half of its produce to a large distributor or any party that does not meet the definition of a qualified end user. In the unfortunate case where that farm has taken minimal or no safety precautions, its produce could either directly injure consumers or become commingled with other produce from large farms causing harm to consumers. Additionally, these exemptions rely, in part, on the belief that states and localities may be better situated to regulate food safety for small and very small farms taking into account the unique needs of their particular regions. As the agency has stated, part of what it is attempting to accomplish through the standards is a preliminary set of rules that can be adapted and amended, as necessary, while using partnerships at the state and local levels to aid small and very small farms in developing food safety programs that are consistent with the FDA’s good agricultural practices (GAP) guide should the agency later issue rules that apply to those farms. Id. at 3556. At this point, however, many states and local health departments are ill-equipped to manage food safety standards or develop sufficient programs for small and very small farms. While FSMA includes provisions to build partnerships with states, localities, and other entities, concerns abound regarding how states will receive adequate financial and technical assistance to create robust food safety standards that comport with the statute’s mandates given the fact that the FDA has insufficient funding to fully implement the law. From the small farm’s perspective, the exemptions under FSMA and its rules may provide some relief from what might appear to be a myriad of burdensome and complex federal requirements, but, ultimately, they fail to protect these farms from liability should their products cause a foodborne illness outbreak.

Protecting Small Farmers from Liability

As recognized by the FDA,“[e]xperience at farming does not necessarily convey knowledge of food safety, particularly that of microbial food safety hazards.” Id. at 3556. Taking this into consideration, the fact that a farm is small may provide some inherent safety mechanisms in the sense that it is often far easier for farmers to take more precautions, note when products may have become contaminated, and trace specific products back to a single source. However, the fact that a farm is small, in and of itself, does not necessarily make that farm immune to food safety issues. Given the complexities of FSMA, and food safety more generally, the FDA has recognized that it will be necessary for the agency to partner with state and local agencies, extension programs, farmers’ groups, and others to provide education and outreach to farmers. In particular, the agency has chosen to focus on providing education and outreach resources to small and very small farms. Id. at 3608.

For farmers who conduct most of their direct sales at farmers’ markets, there are differing levels of protection in place depending on the state or locality. Generally, states rely on local health departments or the operators of farmers’ markets to ensure the safety of the products sold there. Local health officials might perform inspections, or the farmers’ markets themselves may have specific rules or regulations in place for vendors. For example, in Indiana, farmers’ markets are considered temporary food establishments meaning the local health departments issue permits for farmers’ market vendors that require compliance with local health ordinances and regulations. See Christa Hofmann, Jennifer Dennis, A. Scott Gilliam, & Shirley Vargas, Food Safety Regulations for Farmers’ Markets (Mar. 2007). Because the products sold at farmers’ markets have the potential to be risky depending on how safely they were produced, handled and transported, experts recommend that farmers’ market operators should determine what products they will allow for sale and include rules to that effect in the market’s bylaws. Id. In essence, while small farmers may not be governed under the food safety standards set forth in FSMA, they may be subject to state and local regulations if they intend to sell their products at local farmers’ markets. Unfortunately, however, this level of regulation is not necessarily the standard leaving the farmer solely responsible for developing the mechanisms to ensure the safety of his or her products. Moreover, some farmers are reluctant to support any requirements or regulations governing sales at farmers’ markets that they consider overly burdensome or onerous. For those markets where farmers govern the requirements that pertain to vendors, there may be none that address the issue of food safety.

Voluntary Safety Practices for Small Farms

As an alternative to regulation, Londa Nwadike, formerly of the University of Vermont Extension Program, suggests that following food safety practices, advertising to consumers that the farm has some sort of food safety certification, or engaging in voluntary measures to ensure the safety of the products sold can act as marketing tools that attract and retain customers. See Cookson Beecher, Farmers Market Vendors, Managers Get Up to Speed on Food Safety ABCs, Food Safety News (Apr. 15, 2013). Moreover, food safety measures incorporated at the storage, preparation, and transportation levels are neither overly burdensome nor exorbitantly expensive. Id. When farmers ignore such measures and foodborne illness outbreaks occur from products purchased at a farmer’s market, it has the effect of shaking consumer confidence not just in the particular vendor but in the market as a whole. Id. While many suggest that such instances of outbreaks are unlikely, there are reported instances of these types of outbreaks and likely many that go unreported or unrecognized by the consumer. Taking that a step further, because some studies suggest that direct to consumer sales from smaller farms have the potential to ensure a greater level of food safety, it benefits the farmers to take measures and precautions, whether required or not, to protect their business and reputation.

Beyond adopting voluntary measures, following good agricultural practices, and obeying local and state regulations, small farmers should also consider obtaining product liability insurance. Currently, liability insurance is required by some grocery stores, large distributors, farmers’ markets, property owners, and other customers. Generally, even the farmers who sell products through a CSA or some other direct sales mechanism should consider product liability insurance to protect themselves in the unfortunate event that someone gets sick. The costs of liability insurance vary widely depending on the amount of coverage but can be as low as a couple hundred dollars per year or as expensive as several thousand. Food safety advocates recognize that following food safety practices is likely to provide some assurance that the products are safe, yet those measures are not foolproof. To date, both farmers’ markets and farmers have been reluctant to either require or purchase such insurance because the policies can be cost prohibitive for very small farmers that have slim profit margins.

Given the rising rates of new farmers with little to no experience, it is even more pertinent to consider different options to ensure the safety of their food products and aid in the viability of the business. There are some creative options small farmers might consider to ensure food safety and protect themselves from liability. Currently, a number of nonprofit organizations are working with coalitions of small farmers to develop programs that include food safety standards appropriate to the farms involved and provide group product liability insurance at a lower rate. In many instances, these programs are almost fully funded by the organization so the costs to participating farmers are minimal. Farmers could also consider developing their own cooperative models whereby they seek the assistance of the state and local organizations or agencies to develop appropriate food safety standards and attempt to secure group product liability insurance at a lower rate for participating.

Ultimately, while small farmers may be breathing a sigh of relief at the small farms exemptions under FSMA, they are not relieved of the burden to provide safe products for their own sake. While FSMA may exempt small farms from following specific food safety standards, those farms should consider following some variation of these measures anyway, in addition to securing product liability insurance to protect against an event of foodborne illness. To keep the rates of consumer support for local food systems rising, these measures are not just useful, they are necessary.


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