By Cheryl Wixson, P.E.
On January 4, 2013, the FDA released for public comment its proposed rule for preventing foodborne illnesses from foods eaten by humans. As part of the Food Safety Modernization Act (FSMA), this proposed rule aims to establish science-based, minimum standards for growing, harvesting, packing and holding produce in its raw or natural (unprocessed) state on domestic and foreign farms.
In this proposed rule, produce means fruits and vegetables grown for human consumption, including, for example, spinach, lettuce, cantaloupe, tomatoes, mushrooms, onions, peppers, cabbage, strawberries, citrus and walnuts. These standards do not apply to produce that is rarely consumed raw (potatoes and other roots), produce for personal or on-farm consumption, and produce that receives commercial processing (corn, green beans, paste tomatoes).
Not all farms will be covered by this rule. As required by Congress, farms would be partially exempt if their food sales average less than $500,000 per year during the last three years and at least 51 percent of their sales are to qualified end users – i.e., directly to consumers (CSAs, farmers’ markets, farm stands), restaurants or retail food establishments in the same state as the farm or not more than 275 miles from the farm.
If a farm qualifies for this partial exemption, certain labeling requirements apply. If a label is required on the food, it must include the name and address of the farm where the produce was grown. If a label is not required on the food, the name and address of the farm where the produce was grown must be displayed at the point of sale, such as a poster or sign at the farmers’ market. The FDA is also proposing that the smallest farms –those with an average annual value of food sold during the previous three-year period of $25,000 or less – would not be covered.
Farms that do not qualify for partial exemptions are required to register with FDA under FDA’s current food facility registration regulations. These facilities include manufacturers, processors, warehouses, storage tanks and grain elevators. FDA may withdraw certain exemptions if it deems that is necessary to protect the public health and prevent or control a foodborne illness outbreak.
Highlights of the Proposed Rule
The FDA is proposing to establish science-based minimum standards for safely growing, harvesting, packing and holding produce on farms. The proposed rule identifies five areas or routes in which produce could become contaminated with pathogens: agricultural water, biological soil amendments of animal origin (manure and compost), worker health and hygiene, domesticated and wild animals, and equipment, tools and buildings.
The rule has two major features. First, it contains new provisions requiring hazard analysis and risk-based preventive controls. Second, it would revise the existing Current Good Manufacturing Practice requirements to include hazard analysis and risk-based preventive controls for human food.
The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems, which were pioneered by the food industry and are required by FDA for juice and seafood. Facility operators would be required to understand hazards that are reasonably likely to occur in their operations and to institute preventive controls to minimize these hazards. Although this proposed rule aligns well with HACCP, it differs slightly in that preventive controls may be required at points other than critical control points, and critical limits would not be required for all preventive controls.
Each covered facility would be required to write and implement a written food safety plan. The plan would include a flow chart of the processes and a hazard analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility. Preventive controls must be identified and implemented to assure that hazards likely to occur will be significantly minimized or prevented. Monitoring procedures assure that preventive controls are consistently performed and documented. Corrective actions that would be used if preventive controls were not properly implemented must be described, as must verification activities to ensure that preventive controls are consistently implemented and are effective. Required recordkeeping includes records of preventive controls, monitoring, corrective actions, verification, and a written farm food safety plan.
A qualified individual would be required to prepare the food safety plan, develop the hazard analysis, validate preventive controls, review records and reanalyze the food safety plan. To be qualified, an individual must successfully complete training in accordance with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system.
What does this mean for producers, farmers and certified organic growers?
The good news is that MOFGA anticipated that the FDA would require a science-based approach to farm food safety, so we developed educational materials on Farm Food Safety Basics. For three years we have led these workshops for producers and growers. To help growers keep records efficiently, we used NOP guidelines for the Organic Farm Plan to develop MOFGA’s template for a HACCP-based farm food safety plan.
Comparing the FDA’s proposed rule with MOFGA’s template shows differences in two areas: agricultural water testing, and manure and compost management. The FDA rule proposes that agricultural water be tested for pathogens at the start of the growing season and every three months after that, which could mean up to four water tests per year.
The FDA rule concerning applying composted manure to crops intended for consumption in a raw state differs from NOP standards, with a longer waiting period and more stringent production applications. Eric Sideman, MOFGA’s organic crop specialist, is studying this further.
Interestingly, the proposed FDA rule does not require a “verified” food safety plan, only that one exists. This allows an opportunity for discussion with markets that now require GAP certification and the potential for certified organic growers to access these markets.
What Can You Do?
First, become familiar with the proposed rule. Read the Fact Sheet on the Food Safety Modernization Act Proposed Rule for Produce: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, at
www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm and the Overview of Proposed Rule under Food Safety Modernization Act for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, at www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm.
Second, comment to the FDA on the rule by April 30, 2013, particularly regarding exemptions for small farms and farms that sell directly to the consumer. These exemptions, for which Russell Libby and others worked hard, are important for a majority of small, diversified farms and need to be supported.
Lastly, educate yourself, your workers and your consumers. A science-based approach to farm food safety is in everyone’s best interest.
Cheryl Wixson, P.E., is MOFGA’s agricultural engineer and food safety specialist. For more information and a copy of MOFGA’s sample Farm Food Safety Plan, please contact her at Cheryl@mofga.org or 207- 852-0899.