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New Proposed FSMA Regulations: From Farm to Fork
by Sarah Brew and Courtney Lawrence
A fter much anticipation and delay, on January 4, 2013, the Food and Drug Administration (FDA) released two proposed regulations under the Food Safety Modernization Act (FSMA) that will have a significant impact on food growers and producers: 1) Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food; and 2) Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption. The new rules are part of FDA’s overarching efforts to shift food safety focus from reactive to preventive. FDA met with farmers, industry, consumer groups, the international community, and other key stakeholders to develop new regulations that are practical and not “one-size-fits all.”
CGMP & Hazard Analysis & Risk-Based Preventive Controls
FDA’s proposals would add a new set of regulations implementing the Hazard Analysis and Risk-Based Preventive Controls provision of the FSMA. The new rules focus on preventing problems that can cause foodborne illness through two changes: Revisions to the existing CGMP and the addition of preventive controls.
Revisions to the CGMPs. The proposed rule would update or delete certain requirements in the existing CGMPs and generally “modernize” the language of the CGMPs. It would clarify that existing CGMP provisions requiring protection against contamination of food also require protection against cross-contact of food by allergens. Provisions directed to preventing contamination of food and food contact substances would also include preventing contamination of food packaging materials. Certain other CGMP provisions would be deleted, including provisions recommending temperatures for maintaining refrigerated, frozen, or hot foods. In addition, FDA is requesting comment on whether it should mandate training for food production facility employees and supervisors.
Preventive Controls. The proposed rule would require facilities of a certain size to develop formal, written food safety plans to prevent and correct food safety issues. Specifically, a facility would be required to evaluate “known or reasonably foreseeable” hazards; identify and implement preventive controls to address these hazards; monitor performance of the preventive controls; establish corrective action procedures when needed; and verify that the preventive controls are adequate to control the hazards identified. The preventive controls would include, as appropriate, process controls, allergen controls, sanitation controls, and a written recall plan. In all respects, FDA intends each facility’s food safety plan to be tailored to fit the facility and the risks associated with the facility’s food.
Food facilities are also required to document actions taken under the food safety plan, and those documents must be made promptly available to the FDA upon oral or written request (such as during an inspection), and to reanalyze the plan at least every three years. In addition, food facilities are required to appoint a “qualified individual” to prepare and oversee the food safety plan. The proposed preventive controls align with Hazard Analysis and Critical Control Points (HACCP) systems, but the new rule differs in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls.
The tentative proposed rule does not include requirements that companies engage in either environmental monitoring or finished product testing. However, FDA continues to seek comments on these provisions, and FDA recently indicated such provisions would be in the final rule.
The tentative proposed rule does not include requirements that companies engage in either environmental monitoring or finished product testing.
In general, with some exceptions, the preventive control provisions would apply to facilities that manufacture, process, pack, or hold human food and are required to register with the FDA under Section 415 of the Federal Food, Drug and Cosmetic Act. Activities within the definition of “farm” would not be subject to the proposed preventive controls. The proposed rules provide exemptions for certain facilities and for certain activities. For example, very small facilities or activities subject to and in compliance with existing HACCP regulations for seafood and juice are exempt from the requirements for preventive controls. In addition, the FDA is proposing modified preventive control requirements in certain circumstances, such as modified requirements for warehouses solely engaged in the storage of packaged food that is not exposed to the environment. Modified requirements would also apply to “qualified facilities” (a very small business or one with three-year average annual sales of less than $500,000, with more than half of sales going directly to consumers or to restaurants/retail food establishments in the same state or within 275 miles).
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.
Brew is a partner at Faegre Baker Daniels in Minneapolis and leads the firm’s nationally ranked Food Litigation and Regulation practice. She represents companies involved in all aspects of food production and distribution. Lawrence is an associate at Faegre Baker Daniels, practicing in food and agriculture litigation and regulation. She previously worked for an international producer and marketer of food, agricultural, financial, and industrial products and services.