On January 16, 2013, the Food and Drug Administration (“FDA”) published in the Federal Register two long-awaited proposed rules to implement the Food Safety Modernization Act (“FSMA”) – a law intended to shift food safety in the United States from a primarily reactive to a more preventative system. The proposed rules, entitled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food” (“Preventative Controls Rule”) and “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” (“Produce Rule”), carry significant new implications for a broad range of participants in the food industry. The Preventative Controls Rule is available here (78 Fed. Reg. 3646). The Produce Rule is available here (78 Fed. Reg. 3504).
Pre-publication drafts were released on January 4, 2013 – the second anniversary of FSMA’s enactment – but today’s publication in the Federal Register initiates the four-month deadline within which interested parties may submit comments on FDA’s proposals and potentially influence the final regulations. Several additional proposed FSMA regulations addressing importer foreign supplier verification, preventative controls for the animal feed industry, and an accreditation system for third-party auditors, remain due for publication and are expected shortly. Affected stakeholders should monitor the developments and consider actively participating in the rulemaking process.
Preventative Controls Rule
1. Food Safety Plans
Under the proposed Preventative Controls Rule, covered food facilities would be required to create and maintain written plans that (1) identify potential food safety hazards; (2) establish preventative controls to address potential hazards; (3) implement monitoring procedures to verify that the preventative controls are working; (4) outline how to correct any problems that may arise; and (5) comply with mandatory recordkeeping requirements. Preventative controls that may be required as part of the food safety plans include process controls, allergen controls, sanitation controls, and employee training. The proposed rule would also require facilities that identify known or foreseeable hazards to establish written recall plans.
The requirements would apply to facilities that manufacture, process, pack or hold human food (including foreign facilities that export to the United States) – facilities otherwise required to register with FDA under the Federal Food, Drug and Cosmetic Act. Farms that do not manufacture or process food (other than food consumed on the farm) would not be covered by the Preventative Controls Rule. The rule would also exempt facilities such as grain elevators or warehouses that store only raw agricultural commodities (other than fruits and vegetables) destined for further distribution or processing; facilities that store only packaged food that is not exposed to the environment; facilities that manufacture, process, pack or hold dietary supplements or alcoholic beverages; facilities subject to the seafood or juice hazard analysis critical control point regulations; and facilities subject to the low-acid canned food regulation.
3. Qualified Facilities and Reduced Requirements
Additionally, the proposed rule would apply reduced requirements to certain “qualified facilities” that (1) are very small businesses or (2) had average food sales of less than $500,000 per year during the preceding three-year period, and that make the majority of their sales to either consumers, or restaurants or retail food establishments located within the same state or 275 miles of the facility and purchasing the food for sale directly to consumers. FDA proposes three alternative definitions for very small businesses: businesses with less than $250,000, $500,000, or $1,000,000 of total annual sales of food.
4. Effective Date
Compliance would be required of businesses, other than small and very small businesses, within one year from the date the final rule is published in the Federal Register. Small businesses – proposed to mean businesses with fewer than 500 employees – would have two years to comply, while very small businesses would have three years to comply.
1. Science-Based Standards
The Produce Rule would set science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. The proposed standards relate to identified routes of microbial contamination, including (1) agricultural water; (2) biological soil amendments of animal origin; (3) health and hygiene; (4) animals in the growing area; (5) equipment, tools, and buildings; and (6) sprouts (the only commodity-specific standards). For example, the proposed rule would impose time interval restrictions between the application of animal-originated soil amendments and crop harvest. Another of the many proposed standards would require that agricultural water systems be inspected at the beginning of each growing season, and periodic analytical testing of agricultural water.
The Produce Rule would cover fruits and vegetables in their raw or natural (unprocessed) state (including produce imported from foreign countries). The rule would not apply to a defined list of specific fruits and vegetables that are rarely consumed raw, nor would it apply to produce grown for personal consumption, or destined for commercial processing that will reduce microorganisms of public health concern (e.g., “kill-step” processing). Additionally, the proposed rule would exempt farms with average annual food sales of $25,000 or less during the preceding three-year period. A partial exemption would be available for farms with average annual food sales of less than $500,000 during the previous three years, and that make the majority of their sales to either consumers, or restaurants or retail food establishments located within the same state or 275 miles of the farm. A state or foreign country could request a variance from any standards, if the state or country determines that a variance is necessary in light of local growing conditions, and the standards proposed under the variance will provide the same level of public health protection as the requirements of the Produce Rule.
3. Effective Date
The Produce Rule would become effective 60 days after a final rule is published in the Federal Register. Compliance deadlines would be staggered in accordance with monetary sales values. Very small businesses – proposed to mean facilities with average annual food sales of less than $250,000 during the previous three years – would have four years from the effective date to comply with most requirements. Small businesses – proposed to mean facilities with average annual food sales of less than $500,000 during the previous three years – would have three years to comply with most requirements. All other businesses would have two years to comply with most requirements. All covered entities would have an additional two years within which to comply with some water quality requirements.
Rulemaking Process and Submitting Comments
FDA is now accepting comments on the Preventative Controls Rule and the Produce Rule, and will consider revising those rules based on comments received. Comments must be submitted by May 16, 2013, although there is a possibility that this deadline could be extended. Stakeholders who may be affected should carefully review the proposed rules and consider submitting comments, particularly with respect to proposals that appear contentious, arbitrary, unclear, or which may have significant unintended consequences. FDA has requested input from the food and agriculture industry, and this four-month period represents a critical opportunity to understand and potentially influence the provisions included in the final rules.
Attorneys from Downey Brand’s Food & Agriculture Practice Group are closely monitoring FDA’s ongoing implementation of FSMA. If you would like to discuss the issues or implications for your business, including your opportunity to comment on the proposed regulations, please contact Dale Stern or Graham St. Michel at Downey Brand.