New Proposed FSMA Regulations: From Farm to Fork

Recognizing that smaller businesses may need more time to comply with the requirements, compliance dates would be phased in based on business size. “Very small businesses” that are not exempt would have three years to comply after publication of the final rule, “small businesses” would have two years to comply, and all other businesses would have one year to comply after publication of the final rule. To help the industry, particularly small and mid-sized businesses, comply with the new requirements, the FDA helped establish a Food Safety Preventive Controls Alliance to develop a core training curriculum and to disseminate information on hazards and controls.

Standards for the Growing, Harvesting, Packing and Holding of Produce

FDA’s second set of proposed rules would establish minimum safety standards for the production and harvesting of fruits and vegetables on farms. The FDA’s proposal builds upon prior produce safety activities by the FDA and the produce industry to establish standards and best practices, such as the Leafy Greens Marketing Agreements in California and ­Arizona and the Model Code for Produce Safety. In developing the rules, FDA considered both the commodity and the practices associated with growing, harvesting, packing and holding the produce as well as how produce will be used and consumed after it leaves the farm. The resulting rules are designed to allow growers flexibility in their approach to on-farm food safety, with the ability to implement food safety practices appropriate to the scale of production and type of agricultural practices used.

The rules focus on agricultural practices and propose new standards in working, training, and health and hygiene; agricultural water; biological soil amendments; animals in growing areas; equipment, tools, and buildings; and specific standards for sprouts. They cover most fruits and vegetables while they are in their raw or natural state, including herbs and tree nuts, but exempt certain categories that create less risk. They do not apply to 1) produce rarely consumed raw, such as artichokes, asparagus, or potatoes; 2) produce for personal or on-farm consumption; 3) produce that is not a Raw Agricultural Commodity; and 4) produce intended for commercial processing with a “kill step” that will adequately reduce microorganisms of public health concern. Unlike preventive controls, the new produce safety rules will require minimal recordkeeping. Growers would be required to document that certain of the standards are being met, but the rule would not require duplication of records already kept for other purposes.

The proposed rules provide that farms may establish alternatives to certain requirements related to water and biological soil amendments if the alternative is scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing food safety risks. In addition, states or foreign countries may request a variance from some or all of the rules if required by local growing conditions, provided the same level of public health is assured.

Certain farms would be subject to modified requirements. For example, farms and farm “mixed-type facilities” with average annual sales under $25,000 would not be covered under the new rules. These farms, however, will continue to be covered under the adulteration provisions and other applicable provisions of the Federal Food, Drug and Cosmetic Act. Farm mixed-type facilities (farms that are also engaged in activities outside the definition of “farm” that require food facility registration), may be subject to both the proposed produce safety rules and the preventive controls rules, such as an establishment that both grows and processes fresh-cut produce.

Similar to the proposed preventive controls, FDA proposes staggered compliance dates depending on the size of the farm. “Very small farms” would have four years from the effective date to comply, “small farms” would have three years to comply, and other covered farms would have two years to comply. In all cases, the time period for compliance would be extended for some water requirements.

Timeline for Implementation and Compliance

The effective date for both proposed rules is 60 days after the final rules are published in the Federal Registry. FDA continues to seek comments on the proposed rules through May 16, 2013. According to FDA, it will be at least a year before the final rules are published. Until then, food growers, manufacturers and distributors will have time to develop plans, policies, and procedures to conform to the new rules. FDA recognizes that partnership with the food industry is essential to the success of the proposed rules and will continue to provide technical assistance and outreach through public meetings, presentations, listening sessions, and guidance documents.