The draft Produce Safety and Preventive Controls (for handling facilities) regulations are the first steps towards implementing the Food Modernization Safety Act (FSMA) of 2010. When finalized, the FSMA will provide FDA with unprecedented authority to regulate produce farmers, handlers and distributors operating domestically or shipping into the United States. From setting quality standards for agricultural water to restrictions on applying manure, from imposing rules to maintain farmworker hygiene and exclude wildlife from fields and facilities, FDA will oversee the production and handling of fresh fruits and vegetables literally from farm to fork.
The FSMA and FDA’s current draft regulations are predicated on the belief that reducing the risk from food borne pathogens requires a highly technical, centrally managed system based on universal enforcement of scientifically-validated standards. This is the same understanding that underlies other federal and state food safety programs, such as those mandating the pasteurization of fresh milk prior to sale and maintenance of Hazard Analysis and Critical Control Points (HACCP) plans for meat processing facilities. We have seen a clear connection between these regulatory programs and the aggressive concentration of the dairy and meat sectors which has resulted in countless small farmers exiting production. Does FSMA implementation foretell a similar fate for local fruit and vegetable producers and handlers?
Sustainable food advocates were acutely sensitive to this risk as FSMA moved through Congress and came away generally satisfied with the protections ultimately included in the law. There are two variables – annual sales volume and whether the produce is sold to an end user or a “middle man” such as a processor or wholesaler – that determine farmers’ compliance requirements. The fact that FSMA acknowledges a distinction between selling to end users (whether directly to consumers or to restaurants, schools and other institutions which process and serve immediately) and the wholesale market testifies to the increasing if still limited leverage that local and sustainable food proponents now exercise in Washington, DC.
First of all produce that is rarely consumed raw such as potatoes and winter squash, is not covered by FDA’s current draft, and produce farmers who gross less than $25,000 annually are completely exempt. More significantly from a commercial perspective, the proposal provides a partial exemption for fruit and vegetable farmers who average less than $500,000 in annual gross sales of which more than half of the product sold is sold to ‘qualified end users,’ defined as consumers and restaurants or retailers either in-state or within 275 miles of the farm or facility. Qualifying farms will be exempt from the proposed produce safety standards and will be not be subjected to mandatory inspection, although FDA retains authority to inspect based on potential safety concerns. Farms that qualify under this exemption will, however, be subject to significant recordkeeping requirements including their production and handling practices as well as identifying their qualified end users.
However FDA crafts it final regulations, anyone who grows, handles or markets fresh fruits and vegetables is going to see the way they do business change, and possibly quite seriously. Here are some general precepts which can contribute to common-sense solutions which will benefit farmers and consumers alike:
- Pathogen reduction cannot be the exclusive objective for a food safety standard. Setting the reduction, or worse yet elimination, of all potentially hazardous food pathogens as the sole benchmark of success is an invitation for the ends to justify the means. For example, eliminating all wildlife habitat is not an acceptable strategy for managing risk for pathogens potentially spread by wild animals. At the farm level, protecting against food borne pathogens requires a site-specific approach that is not compatible with the controlled, uniform environments for which HACCP is suited. The Wild Farm Alliance does excellent work on assessing the compatibility of wild habitat and agricultural production from the food safety perspective.
- We cannot test our way to acceptable food safety. Dependence on testing protocols, no matter how well designed and enforced, cannot protect against systemic lapses and breakdowns that result in illnesses attributable to food borne pathogens. Testing must be a component of an effective food safety program but it can never replace intelligent and responsible human oversight at every stage of the production, handling and consumption processes. Excessive dependence on testing is also fast track for depleting the invaluable resources of time and money from small operations and creating an unnecessary economy of scale for larger operations.
- Concentration in and of itself carries tremendous risk. There are many ways in which scale drives risk. For example, pooling produce from multiple farms can result in contamination of the entire load if even one of the sources has an inadequate safety program. Food safety is only one of several obvious reasons why we should be especially concerned that the United States is increasingly importing its fruits and vegetables from overseas. (How about irreversible loss of farm land for another reason?)
- No raw food product is inherently risky in and of itself. While every food presents a unique set of food safety challenges, it’s equally true that we are capable of managing risk appropriately. Creating excessive barriers to the production and marketing of certain products, such as salad mix, which are recognized to present unique challenges, is simply avoiding problem for which viable solutions exist.
- Overextended regulation and intervention will harm all players in the food system. Bear in mind that there are actually two steps to complying with a regulation: complying with the specific provision and subsequently documenting that compliance. It is often the second step, which involves the application, inspection, testing and recordkeeping and routine contact with the regulatory authority which swamps the actual measures necessary to satisfy the regulation itself. It is imperative that FDA avoid establishing regulations which overburden and subsequently choke out the small and medium sized producers who are driving the local food movement.
Public input will have a significant impact as FDA moves forward on finalizing the Produce Safety and Preventive Controls proposals and forthcoming components of the FSMA, such as the provisions for imported fruits and vegetables. Local and sustainable agriculture advocates played a significant role in shaping the underlying law and continued engagement is crucial to insure that this perspective is reflected in the final regulations. Among many other organizations tracking the FSMA implementation process, the National Sustainable Agriculture Coalition provides useful updates. The FDA public comment period closes on September 16, 2013.
Mark Keating has worked in the organic, sustainable and local food movements since 1982. His work experience includes commercial food service, farm labor, retail sales and marketing, state and federal civil service, non-profit advocacy, academia, journalism and conducting organic inspections. While working for the USDA National Organic Program between 1999 and 2002 Mark helped draft the national organic standards for crop and livestock production. He spent two more years with the USDA Marketing Services Branch working to develop and promote farmers markets. Mark also worked for the NOP in 2010. An inveterate believer that organically raised and locally distributed food offers the surest path to human health and planetary survival, Mark, his wife and their daughter live alongside the Pequest River in New Jersey, the Garden State.