American Journal of Law & Medicine

The Implementation of the Food Safety Modernization Act and the Strength of the Sustainable Agriculture Movement

In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug Administration (FDA) rules to implement the Act threatened to weaken this victory for small farm groups, however, prompting a loud response from small farmers (1) and local food proponents.

The FDA's second set of proposed rules, issued in September 2014 in response to these and other complaints, were, perhaps surprisingly, responsive to small farmers' concerns. Using comments submitted to the FDA, this article explores the responses of the agriculture industry and public health organizations, as well as small farm groups, consumers of local food, and sustainable agriculture interests (which, for simplicity, I alternately describe as comprising the "sustainable agriculture" or "small farm" movement), to three aspects of the FDA's proposed rules--involving manure application, on-farm packing activities, and exemptions for very small farms--to assess the strength of the sustainable agriculture movement. The rules involving manure application and on-farm packing, it turns out, reveal little about the independent political strength of the local food movement, as large industry groups also objected to these provisions. But for the third issue discussed here--exemptions for very small farms--the interests of sustainable agriculture groups were directly opposed to both industry and public health organizations, and yet prevailed. This suggests that the high salience of locavore and "slow food" issues might have allowed relatively small, dispersed interests to overcome traditional obstacles to political organization, and that the sustainable agriculture movement has indeed become an effective political force.


Food is--not surprisingly, given its necessity and ubiquity--at the heart of multiple, important health issues affecting the American public. One is foodborne disease: The Centers for Disease Control and Prevention (CDC) estimates that pathogens borne by contaminated foods sicken millions, and kill thousands, each year. (2) Another is obesity--more than one-third of Americans are obese, contributing to a variety of conditions including heart disease, stroke, and diabetes--and other maladies associated with a poor diet. (3) To combat the former problem, Congress passed the FDA Food Safety Modernization Act (FSMA) in 2011, "the most sweeping reform of our food safety laws in more than 70 years," (4) granting the Food and Drug Administration (FDA) broad new authority to prevent and detect contamination in most aspects (5) of food production. Among other requirements, the Act directed the FDA to publish standards for produce safety within one year of the FSMA's enactment--rules that would "establish science-based minimum standards for the safe production and harvesting" of raw fruits and vegetables to "minimize the risk of serious adverse health consequences or death." (6) These standards were to address "soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water," and implementation would be prioritized for "raw agricultural products." (7) Since the FSMA was first proposed in Congress, however, there have been fears that the legislation will slow the move away from over-consumption of heavily processed foods that many believe is essential to improving the quality of American diets and ending the obesity epidemic. By imposing new and costly burdens on small producers, some warned, the FSMA would reduce access to fresh, local produce and other minimally-processed foods from farmers' markets, Community Supported Agriculture (CSAs), and farm sales. (8)

Due to these competing concerns, as well as the lobbying efforts of consumer groups, the food industry, and local agriculture proponents, exemptions for small producers from the FSMA's requirements have been, and will continue to be, extremely contentious. Efforts by small-farm advocates led to the introduction of the Tester-Hagan Amendment to the FSMA, which "provides an exemption from the produce safety standards if a farm can demonstrate a previous three-year average gross income of less than $500,000 and over 50% of sales were to [consumers, restaurants, or retailers within a certain geographic region]." (9) This amendment was harshly criticized by both food safety proponents and the agriculture industry, who observed that food safety issues can arise on farms of any size, but it was ultimately adopted. (10) The fight did not end there, however. The enacted version of the FSMA left the FDA significant discretion in crafting rules and exemptions while directing the agency to

   ... provide sufficient flexibility to be applicable to various
   types of entities engaged in the production and harvesting of
   fruits and vegetables that are raw agricultural commodities,
   including small businesses and entities that sell directly to
   consumers, and be appropriate to the scale and diversity of the
   production and harvesting of such commodities."

After holding a variety of hearings and issuing updates on progress, the FDA finally issued rules in January 2013. (12) The "Produce Rule"--"Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption"--focused on produce that is generally consumed raw and aimed to minimize health risks of food by preventing "the introduction of known or reasonably foreseeable biological hazards into or onto produce." (13) To avoid the contamination of food, the FDA proposed regulations including personnel training standards; limits on the type of water used to irrigate crops; standards for the use of soil amendments, manure, and sewage on crops; and rules regarding food packing and building sanitation. (14) The FDA also proposed a rule on "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (the "Preventive Controls Rule") in January 2013. (15) Many provisions of the proposed Preventive Controls Rule related to Section 418 of the Food, Drug & Cosmetic Act, which, as amended by the FSMA, required the FDA to issue regulations for conducting hazard analyses of food handling and to implement preventive controls, among other actions. (16) The FDA's proposed rules therefore addressed practices associated with managing, packing, and holding human foods, such as bagging and canning foods, and concerns about unsanitary conditions within these processes. (17) Under the rules, covered facilities were to register with the FDA and "have and implement a written food safety plan" indicating safety hazards at the facility and associated preventive controls, monitoring, corrective action, and verification, as well as a recall plan for when preventive measures were inadequate to protect consumer safety. (18)

These proposed rules generated a great deal of comment and criticism from small farm and sustainable agriculture groups and consumers of local food. (19) They objected to, inter alia: proposed restrictions on the use of manure fertilizer, which is essential to organic farming; the inclusion of animal feed and other non-produce in the calculation of food sales limits for various exemptions, which potentially limits the ability of existing non-produce farms to experiment with growing produce; differing requirements for on-farm packing and holding of agricultural products based on the ownership of the agricultural products; required documentation for operations qualifying under the Tester-Hagan formula and the potential application of these documentation requirements to small-scale pickling and canning operations; and procedures for the withdrawal of exemptions. (20) As National Sustainable Agriculture Coalition (NSAC) Policy Specialist Sophia Kruszewski put it, the "rules must not only ensure a safe food supply, but also that family farms can thrive and that consumers can access foods that are safe, healthy, and sustainably produced, including fresh food from local producers." (21)

The FDA issued revised proposed rules addressing some of these concerns in September 2014. (22) These rules, which are now available for further public comment, suggest that the small farm movement has a relatively great amount of lobbying power. Indeed, post-revision, NSAC is "cautiously optimistic . …

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