As part of its implementation of the Food Safety Modernization Act (FSMA), on January 16, 2013, the US Food and Drug Administration (FDA) published two proposed regulations that will significantly impact farmers. Many farmers, especially those with smaller operations, may believe that the FSMA rules do not apply to them. However, that is not necessarily true. Farmers should be aware of whether and how the proposed regulations will apply to their businesses before the rules take effect and while they still have an opportunity to submit comments to FDA.
One of the proposed FSMA rules (the Produce Rule) applies to the growing, harvesting, packing, and holding of produce. (More details about the requirements of the Produce Rule can be found in FDA’s summary and FAQ.) The other proposed rule (the Preventive Controls Rule) concerns the use of current good manufacturing practice, hazard analysis, and risk-based preventive controls in facilities that manufacture, process, pack, or hold food for consumption. (More details can be found in FDA’s summaryand FAQ on the Preventive Controls Rule.)
Which Farms Would Have To Comply With The Produce Rule?
In general, the Produce Rule applies to a farm with total food sales of more than $25,000 on average, per year during the previous three years. However, a farm would have a “qualified exemption” from most requirements of the Produce Rule if, during the preceding three calendar years:
- More than half of its food sales (as measured by monetary value) are directly to (1) consumers and/or (2) restaurants or food retailers located in the same state or not more than 275 miles from the farm; AND
- Its total food sales are less than $500,000 on average, per year.
A farm with a qualified exemption still would have to comply with requirements regarding labeling and point of purchase identification of the name and address of the farm where produce was grown. Moreover, FDA could withdraw a qualified exemption if a farm is linked to a foodborne illness or if FDA otherwise determines that it is necessary to protect public health.
In addition, even if a farm is covered by the Produce Rule, its requirements would not apply to produce that is:
- Rarely consumed raw (for example, beets, eggplant, potatoes);
- Raised for personal or on-farm consumption; or
- With certain documentation, intended for commercial processing, such as canning, involving a kill step.
Which Farms Would Have To Comply With The Preventive Controls Rule?
The Preventive Controls Rule applies to a farm if it must be registered as a “facility” under the Food, Drug and Cosmetic Act — that is, generally, if it manufactures, processes, packs, or holds food for consumption in the United States. In general, farms are exempt from the facility registration requirement and, therefore, also would be exempt from the proposed Preventive Controls Rule. But FDA’s definition of “farm” activities excludes certain practices commonly occurring on farms.
Under FDA’s definition, the following on-farm activities would be exempt from the rule:
- Raising of animals, including seafood;
- Growing crops;
- Harvesting crops and other raw agricultural commodities (for example, eggs), including gathering, washing, trimming outer leaves, removing stems and husks, threshing, shelling, and cooling such commodities produced on the farm or another farm under the same ownership;
- Packing or holding food that is grown, raised, or consumed on the farm or another farm under the same ownership; and
- Manufacturing or processing food for consumption on the farm or another farm under the same ownership.
Thus, a farm would not be exempt (and the Preventive Controls Rule would apply) if the farm performs harvesting activities, packing, or holding raw agricultural commodities raised on other farms not under common ownership. In addition, the rule would apply if a farm manufactures or processes food not consumed on the farm. Importantly, FDA construes “manufacturing/processing” broadly to include not only activities commonly thought of as processing — such as cutting, coring, chopping, canning, cooking, milling, salting, and smoking — but also, with regard to food raised on other farms, activities like washing, sorting, and stickering/labeling. (See Table 4 of the proposed regulations.)
The Preventive Controls Rule has two parts: (1) updating the existing Current Good Manufacturing Practice (CGMP) regulations to require protections against cross-contamination from allergens, among other things; and (2) extensive new requirements for hazard analysis and risk-based preventive controls, including implementation of written food safety plans. If a farm is required to register as a facility, it must comply with the CGMP regulations. In addition, a farm required to register as a facility must comply with the hazard analysis and risk-based preventive controls requirements unless it meets one of the following exemptions:
- It is a small business (less than 500 employees) or very small business (FDA has not decided whether it will define this as less than $250,000; less than $500,000; or less than $1 million in total annual food sales) and conducts low-risk on-farm manufacturing/processing, packing, or holding activities;
- It manufactures products covered by other regulations (juice, seafood, dietary supplements, alcoholic beverages, or low-acid canned foods), in which case it must comply with those regulations;
- Its non-farming activities solely involve storing raw agricultural commodities other than fruits and vegetables intended for further distribution or processing; or
- Its non-farming activities solely involve storing packaged food that is not exposed to the environment.
Finally, a farm required to register as a facility may be exempted from most of the hazard analysis and risk-based preventive controls requirements if it fits the definition of a “qualified facility”:
- More than half of its sales (as measured by value) are directly to (1) consumers and/or (2) restaurants or food retailers located in the same state or not more than 275 miles from the farm; AND its total food sales are less than $500,000 on average, per year; OR
- It is a very small business (again, FDA has not decided whether this will be defined as less than $250,000; less than $500,000; or less than $1 million in total annual food sales).
Under the proposed rule, a “qualified facility” still would have to certify to FDA that it is eligible for “qualified facility” status and either: (1) notify FDA that it is addressing hazards through preventive controls and monitoring; or (2) notify FDA that it complies with applicable local regulations, and notify consumers of the name and business address of the facility where the food was manufactured or processed.
As FDA has not yet finalized the FSMA regulations, the requirements and exemptions are subject to change. Interested parties have the opportunity to influence the final regulations by submitting comments to FDA before September 16, 2013.