Earlier today, FDA finalized the first set of major rules implementing the Food Safety Modernization Act (FSMA) – regulations addressing current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for human and animal food.  These long-delayed rules, commonly referred to as the preventive controls rules, establish science-based preventive controls for facilities involved in the production, packaging, handling, and storage of human and animal foods.  The rules will be formally published in the Federal Register on September 17, 2015.

The timing of the proposed rules indicates that FDA is committed to releasing the major FSMA rules in compliance with court-ordered timelines – meaning the remaining FSMA rules can all be expected by the spring of 2016.  As a result, there may be much work to be done by food and beverage companies to achieve compliance with new FSMA requirements.  Companies involved in human and animal food production should take note of the rules and carefully evaluate their new compliance obligations.  Many companies will need to re-evaluate relationships with suppliers and vendors to ensure that they are well positioned to facilitate FSMA compliance.

We anticipate that many food and beverage companies have already begun the process of ensuring that they will have compliant food safety systems in place when the rules take effect.  Companies that have not yet begun this process still have time to catch up, considering the delayed compliance dates, but they should get started right away, beginning with a careful review of the new preventive controls requirements.

History of the Preventive Controls Rules

The preventive controls rules are a key element of the new regulatory framework established by the FSMA, which was signed into law over four years ago.  The FSMA was intended to strengthen the U.S. food safety system by enhancing FDA’s ability to prevent, rather than merely respond to, food safety problems like microbial and chemical contamination.  Delay in implementing the FSMA resulted in a court order mandating that FDA issue the preventive controls rules by the end of August 2015, with other rules due throughout the fall of 2015 and spring of 2016.

Overview of Mandatory Preventive Control Requirements

The preventive controls rules for human and animal foods are at the heart of the FSMA framework for improving food safety.  They broadly require food facilities to establish and implement written preventive controls plans to identify, control, and prevent hazards that could put the food supply at risk.  To do so, food facilities will be required to:

• Evaluate the hazards that could affect food safety;
• Specify what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards;
• Specify how the facility will monitor these controls to ensure they are working;
• Maintain routine records of the monitoring; and
• Specify what actions the facility will take to correct problems that arise.

Among other things, food production facilities will now be required to control for all significant hazards (most reasonably foreseeable hazards), conduct product testing and environmental monitoring, apply supplier evaluation programs, and implement expanded recordkeeping requirements.

Effective Date and Staggered Compliance Dates

The preventive controls rules become effective 60 days after publication in the Federal Register.  Companies involved in the production of human food are generally required to comply with the rule by September 17, 2016.  Small businesses and very small businesses are not required to comply with the rule until September 17, 2017 and September 17, 2018, respectively.  Companies involved in the production of food for animals are generally required to comply with the current good manufacturing practice provisions of the rule by September 17, 2016 and the preventive controls provisions of the rule by September 17, 2017.  These compliance dates are extended by one year for small businesses and two years for very small businesses.

For More Information

As Polsinelli continues an in-depth review and analysis of the preventive controls rules, applying our experience and perspective on the legal issues facing food and agriculture clients, we will provide more detailed information about the rule – identifying areas of significant impact, likely questions and areas of concern, ambiguities, significant regulatory nuances, and likely FDA expectations.