On September 10, 2015, the U.S. Food and Drug Administration (FDA) made public two final Food Safety Modernization Act (FSMA) rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (the “Final Rules”). The Final Rules, scheduled for publication in the Federal Register on September 17, arguably represent the cornerstones of the landmark food safety law. The original proposed rules were issued in January 2013; after extensive industry comment, supplemental rules were released in September 2014. FDA’s release of the Final Rules meets court-ordered deadlines stemming from an August 2012 lawsuit for “unreasonable delay,” filed by the Center for Food Safety.
The agency’s stated approach to addressing comments and finalizing the rules was to focus on specific changes to current good manufacturing practices (CGMP) to reflect current practices in the manufacturing, processing, packing and holding of human food. The substance of the Final Rules is largely unchanged from the proposed and supplemental rules. The revisions generally clarify the supplemental rules, including the provisions on hazard analysis, preventive controls and establishment of a supply chain program. There are, however, material changes to key definitions for “hazard,” “qualified individual,” “farm” and “holding.” Finally, compliance deadlines for most provisions in the Final Rule for food for animals have been extended for certain qualified businesses.
Overview of the Final Rules
The Final Rules include requirements that facilities required to register with FDA establish and maintain food safety plans, perform hazard analyses and establish preventive controls to mitigate hazards. Facilities will be required to perform various preventive controls management activities, including product testing, supplier verification and environmental monitoring. The rules also establish new CGMP requirements for manufacturing, processing, packaging and holding both human food and food for animals.
The Final Rules make product testing and environmental monitoring optional as verification activities, requiring them only when appropriate to the specific food, facility, nature of the preventive control and the role of that control in the facility’s food safety system. Environmental monitoring would be required, for example, if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control. The Final Rule maintains the requirement that an onsite audit be conducted as the supplier verification activity when the hazard being controlled by the supplier is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans. FDA also maintained the exemption from this requirement if the receiving facility provides written documentation that other equally suitable verification activities provide adequate assurance that hazards are being controlled.
A notable change in the Final Rules is the establishment of a supply chain program. In response to public comments, and with the goal of drafting language that aligns with hazard analysis requirements, the FDA re-wrote requirements for supplier verification that are detailed across multiple sections of the Final Rule. Facilities identifying hazards from receiving raw materials and ingredients must implement written procedures requiring that ingredients are received only from approved suppliers; these facilities must also establish, conduct and document ongoing supplier verification activities. The Final Rule clarifies what factors must be considered in approving a supplier, and defining appropriate supplier verification activities, which include sampling, testing and onsite supplier audits.
There are notable changes to definitions for key terms throughout the Final Rules. For instance, FDA broadened its definition of a “hazard” to include agents that have “the potential to cause illness or injury in humans or animals,” shifting from defining a hazard as “reasonably likely to cause illness or injury.” The definition of a “farm” was also revised to denote two types of farms — a primary production farm, and a secondary activities farm — and to distinguish between farms devoted mainly to growing crops and livestock, and those devoted mainly to harvesting, the latter of which would include processing activities covered under FSMA. Finally, FDA refined the nomenclature describing trained food safety personnel from “qualified individual” to “Preventive Controls Qualified Individual,” altering the definition by specifying the qualifications necessary to administer risk-based preventive controls.
Final Rules require facilities to maintain food safety plans, including hazard analysis and appropriate preventive controls; and updates CGMP
Flexibility granted in application of verification activities, based on what activity is most appropriate to the food, facility and preventive control in question
Establish the Supply Chain Program to implement supplier verification methods for both Human Food and Animal Food
Clarify the scope of “farm” to distinguish between “primary production” and “secondary activities”
CGMPs for Human Food
The Final Rule for human food, in a notable change from the supplemental rule, now explicitly addresses allergen cross-contact by incorporating stakeholder comments and FDA’s longstanding position that CGMP must include its consideration. For example, one provision of the Final Rule requires that good employee hygiene practices include wearing outer garments suitable to the operation in a manner that protects against allergen cross-contact and against the contamination of food, food-contact surfaces or food-packaging materials.
The Final Rules also entirely remove nonbinding provisions of the CGMP (i.e., those provisions using “should” or “compliance may be achieved by”). FDA views some of those provisions “as more appropriately included in guidance” and intends to transfer them (such as the recommendation to inspect raw materials on receipt to ensure that their condition has not contributed to allergen cross-contact, contamination or deterioration). But FDA has also now made some previously nonbinding provisions fully enforceable, such as those for educating and training personnel engaged in manufacturing, processing, packing or holding food.
Allergen cross-contamination must be incorporated as part of CGMP
Some previously nonbinding recommendations found in regulations will be transferred to guidance documents
Other previously nonbinding recommendations will now carry the force of law
CGMPs for Animal Food
Overall, the Final Rule for animal food contains few surprises, but does incorporate clarifying language and modified definitions. One area of clarification stems from sanitation requirements regarding storage of bulk feed commonly stored outdoors. In response to industry concerns over potentially costly mandatory requirements, FDA has clarified that plants may protect against food contamination by “using protective coverings where necessary and appropriate.” FDA has not attempted to specify those circumstances, giving industry much more flexibility in determining when such expenditures are truly necessary.
Finally, FDA clarified its “holding” exemption, removing bulk grain storage facilities from FSMA’s regulatory scheme. Industry stakeholders commented repeatedly throughout the rulemaking process that grain storage facilities (e.g., elevators) should be exempt. The Final Rules establish a carve-out for those facilities which engage solely in storing raw agricultural commodities, therefore exempting a large and important portion of the animal feed supply chain. FDA clarified that holding activities include the drying/dehydrating and blending of the same raw commodity. However, if a holding facility also incorporates a process that transforms the raw commodity into processed food, the facility will be subject to FSMA CGMP requirements. This means that grain elevators with integrated feed mill operations will be subject to FSMA requirements, despite the fact the elevator conducts holding activities. Grain holding facilities will need to examine their operations carefully to ensure they fall under the holding exemption.
Final Rules allow for flexibility in controlling for hazards in bulk animal food commonly stored outdoors
Grain storage facilities devoted to only storing grain are exempt from FSMA’s CGMP requirements
Storage facilities that have integrated operations (such as feed mills) will not fall under FSMA’s “holding” exemption
Compliance Dates and Outlook
The Final Rules will be become effective 60 days after their publication on September 17, 2015, in the Federal Register; however, compliance dates respective to company sizes are staggered. In the Final Rule for animal food, FDA extended compliance dates by one year for businesses other than small and very small businesses — now, they will have one year after the date of publication to comply with the CGMP requirements and two years to comply with preventive controls and supply-chain requirements. Deadlines for small and very small businesses are likewise extended for one year. Under the Final Rule for human food, FDA established effective and compliance dates as proposed, for the most part. Both rules, however, establish separate compliance dates for the supply-chain program provisions, based mainly on when suppliers to receiving facilities are required to comply with preventive controls requirements.
The next regulations implementing FSMA — final rules on foreign supplier verification and third-party accreditation programs — should be released by October 31, 2015. Final rules thereafter are required to be released on March 31, 2016, (sanitary transportation) and May 31, 2016 (intentional adulteration).
Funding remains a key concern regarding FDA’s implementation of FSMA’s final rules. FDA is expected to continue to advocate for additional funding for FSMA implementation, particularly as Congress debates government funding past September 30. FDA has been granted additional funding each year, though the agency says it still has a shortfall of roughly $276 million. The Obama administration has requested roughly $109 million for FSMA implementation activities, though Congress is expected to appropriate only about half that amount.
The release of the Final Rules detailing CGMPs and Hazard Analysis and Risk Based Preventive Controls for both Human and Animal Food represent the cornerstone of FSMA implementation. These Rules perhaps signify FDA’s most impactful steps in shifting the U.S. food safety paradigm from reactive to preventive. Over the course of the past two years, FDA has held numerous public comment sessions and assessed thousands of stakeholder comments on proposed FSMA rules. FDA was notably responsive, granting additional flexibility where it was asked, aligning CGMP for human food and food for animals with those best practices currently being exercised by industry stakeholders, and generally providing additional clarity on provisions where explanation was requested. FDA’s enforcement of these Final Rules, along with subsequent rules set for future release, will have significant, long-lasting regulatory, economic and legal impacts on the human and animal food industry.