Implementing the Food Modernization Safety Act

In my previous post, I sketched the enormous stakes involved as the U.S. Food and Drug Administration (FDA) re-writes federal food safety regulations for fresh fruits and vegetables. It might be more appropriate to say “writes” such regulations, since the current laws, which date to 1938, are structured as guidance and significantly limit FDA’s enforcement authority. That will fundamentally change once FDA completes drafting new regulations to implement the Food Safety Modernization Act (FSMA). The public can review and comment on the first sections of FDA’s proposed regulations through September 16.

Whatever final form they take, these regulations will greatly expand FDA’s authority to determine how commercial produce farmers and vendors operate. FDA will oversee where, when and how manure may be used as a fertilizer, determine which records farmers must maintain to document compliance and set the fees and conditions for on-farm inspections. For the first time, FDA will have the same mandatory recall authority for fruits and vegetables which USDA currently exercises with meat, poultry and egg products.

The incentives for enhancing produce safety are obvious: food borne pathogens pose serious, even lethal health risks and fresh fruits and vegetables are recognized vectors for their transmission. Driven by concerns about consumer safety and litigation, many large produce distributors and retailers already require farmers to comply with a process-based, third-party verified safety program comparable to FSMA. At the same time, fresh produce is a principle catalyst behind the renaissance of local and sustainable food systems blossoming across the United States which is creating dynamic new marketing opportunities for existing and new entry farmers. Whether shipped around the world or raised on a neighboring CSA, fresh produce inevitably entails some food safety risks, but sensibly managing those risks will look nothing alike.

How will the FSMA’s sweeping expansion of federal authority, developed for an industrial-scale, global production and distribution network, affect the rights of small and medium-sized farmers who reach their customers through produce auction houses, farmers markets and farm-to-school programs? Will the mushrooming legwork and paperwork necessary to document compliance drive these operations out of the system and perhaps out of business as other federal agricultural regulatory initiatives have? How effectively and responsibly will FDA exercise its authority over the more than 100,000 separate entities which it estimates will have to fully comply with FSMA requirements? We’ll dedicate this post to outlining the nuts and bolts of the current draft FSMA regulations and shift to a broader analysis of their implications for food safety and local food systems next time.

The FDA’s current proposal covers the first two components of FSMA: Standards for Produce Production (Produce Rule), and Food Safety Measures for Facilities that Process Food for Human Consumption (Preventive Controls Rule). Both rules address food safety risks from microbial pathogens such as E. coli O157:H7, Salmonella and Listeria and have no bearing on health concerns related to residues from pesticides, antibiotics or genetically modified organisms. The rules do not affect the application of composted human manure, referred to legally as biosolids, which remains under EPA jurisdiction. The Produce Rule establishes science – based minimum standards for the field-based growing, harvesting, packing, and holding of produce while the Preventive Controls Rule applies to requirements for handling facilities that manufacture, process, pack, or hold human food. When fully implemented, the FSMA will require that imported produce comply with the requirements in the Produce and Preventive Control Rules, but FDA has yet to propose how such compliance will be enforced.

Historically, the FDA has relied on a surveillance-based approach to food borne illness in which it monitored specific outbreaks and then worked backwards to identify the source of contamination before removing any remaining potentially contaminated produce from the marketplace. The Agency currently possess the authority to inspect all field- or facility-based food operations without prior notice, but a historical lack of resources has meant that such inspections have been infrequent and haphazard. In a major shift, the Produce and Preventive Control Rules will feature a preventive approach in which farms must comply with minimum (as determined by FDA) safety standards and handling operations must develop and implement a written preventive control plans. This new model parallels the Hazard Analysis of Critical Control Points (HACCP) system which USDA uses to identify, isolate and correct food safety non-compliances in the meat processing facilities it inspects.

The Produce Rule will only apply to fruits and vegetables normally consumed raw, such as apples, carrots, lettuce, onions, and tomatoes and exempts items such as potatoes and squash which are typically cooked. It identifies high-risk categories for potential contamination of crops by food borne pathogens including agricultural water, biological soil amendments of animal origin, farmworker health and hygiene, domesticated and wild animals. The Produce Rule uses the term biological soil amendments of animal origin to refer to manure-based fertilizers and establishes different requirements for using such materials depending on whether or not they have been composted or otherwise treated to reduce pathogens. FDA specifically states that its proposed regulations will not conflict with the compost and raw manure standards which USDA enforces on certified organic operations. The Produce Rule also includes a rigid protocol for producing edible sprouts including sanitizing treatment of seed before sprouting and testing of spent irrigation water for pathogens because FDA has long targeted these foods as a high risk vector for food borne pathogens.

It is likely that, in addition to pure processing facilities, many farms covered by the Produce Rule will also have to comply with the Preventive Controls Rule. Under the Preventive Controls Rule, a facility must maintain a written food safety plan, and to keep records of preventive controls, monitoring, corrective actions, and verification. Only an individual qualified either through training or experience could write such plans would require updating every three years, or more frequently if there are problems. As with farms which raise fruits and vegetables, food processing facilities would receive more frequent and thorough inspection by FDA under the proposal.

That’s an awful lot of information to digest and reflects just the tiniest tip of the iceberg behind FDA’s Produce and Preventive Control Rules which run to a combined 1,200 pages. You do have until September 16 to share your perspective with FDA, so your summer reading should be covered. Next time we’ll take a look at who will be covered when the FSMA takes effect – the sustainable agriculture community successfully lobbied to have broad exemptions included – and wrap up with some comments about public policy versus personal choice as tools for safeguarding our food supply.

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.