The Food and Drug Administration (FDA) has released two major, final rules to implement the FDA Food Safety Modernization Act (FSMA). The final rules are:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; and
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.
FDA also has published two qualitative risk assessments (RAs), which accompany the final rules, related to manufacturing, processing, packing, and holding activities for human/animal food when such activities are conducted on farms:
- Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; and
- Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm.
These final rules and notices of the availability of the RAs will be published in the Federal Register on September 17, 2015.
FDA has posted fact sheets and other materials explaining the final rules on its website. See generally The Law, Rules & Guidance; FSMA Webinars & Interviews; Frequently Asked Questions. FDA also has announced that it will host three webinars on the Preventive Controls final rules. The first webinar, on September 15, will include information on who is covered by the rules and the final definition of “farm.” The other two webinars, on September 16 & 17 will discuss the significant provisions of the Preventive Controls for Human Food and the Preventive Controls for Animal Food final rules, respectively. FDA also has scheduled a public meeting about the Preventive Controls final rules to be held in Chicago on October 20, 2015.
FDA, in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health, created in September 2011 the Food Safety Preventive Controls Alliance to develop training courses and technical information on preventing contamination for both human and animal food during production. The training course being developed by the Alliance will serve as the standardized curriculum referred to in the definition of “preventive controls qualified individual” in the final rules. The technical information being developed by the Alliance will help industry — particularly small- and medium-size companies — comply with the new Preventive Controls final rules.
Finally, FDA intends to issue several guidance documents on specific requirements in the final rules, such as hazard analysis, preventive controls, environmental monitoring, allergen controls, and validation of process controls. The agency also intends to launch a Food Safety Technical Assistance Network.
This posting is intended to provide a brief summary of the highlights of the two final rules released today. Full analyses of these lengthy and detailed regulations will be issued in separate, subsequent OFW Law memoranda.
Preventive Controls for Human Food
The final rule largely reflects the January 2013 original proposed rule as modified by the September 2014 supplemental proposed rule, but with modifications and a few new requirements in response to public input. For example, additional flexibility has been built into key requirements, including supply chain controls, and the definition of “farms” — which are exempt from preventive controls requirements.
The final rule creates certain new requirements for the production of human food by registered food facilities, and revises previous requirements, in three key ways:
- First, the final rule modernizes FDA’s long-standing current good manufacturing practice (CGMP) regulations, which govern the manufacturing, processing, packing, or holding of human food. Importantly, it imposes minimum training requirements for all employees involved in manufacturing, processing, packing, or holding food (including temporary and seasonal employees). All such employees must be “qualified individuals” (i.e., must have education, training, or experience appropriate to perform their assigned duties) and must receive training in the principles of food hygiene and food safety.
- Second, the final rule requires that covered facilities establish and implement hazard analysis and risk-based preventive controls for human food. In general, these requirements apply to establishments that are required to register with FDA as a food “facility.” This portion of the final rule requires registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the control of those hazards, unless an exemption applies. Facilities must also monitor their preventive controls, conduct verification activities to ensure the preventive controls are effective, take appropriate corrective actions, and maintain records documenting these actions.
- Third, the final rule clarifies the scope of the exemption for farms in FDA’s current food facility registration regulations, and makes corresponding revisions to FDA’s current regulations for the establishment, maintenance, and availability of records. These revisions affect who is subject to the existing regulations for registration and recordkeeping, as well as the new requirements for hazard analysis and risk-based preventive controls established in the final rule. The definition of “farm” now includes both “primary production farms” and “secondary activities farms,” the latter being an off-farm operation engaged in harvesting, packing or holding raw agricultural commodities in which the primary production farm that provides most of the raw agricultural commodities owns a majority interest.
The new preventive controls requirements, implementing section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), include the following requirements:
- Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The final rule sets requirements for a written food safety plan that includes:
- Hazard analysis;
- Preventive controls; and
- Oversight and management of preventive controls, including:
- Monitoring,
- Corrective actions and corrections, and
- Verification.
- A covered facility also would be required to maintain associated records and have a recall plan.
- The definition of a “farm” is clarified to cover two types of farm operations:
- Primary Production Farm, and
- Secondary Activities Farm.
- Operations defined as farms are not subject to the preventive controls final rule.
- Primary Production and Secondary Activities Farms conducting activities on produce covered by the Produce Safety final rule will be required to comply with that final rule.
- The supply chain program is made more flexible, with separate compliance dates established.
Preventive Controls for Animal Food
The final rule has elements of both the original and supplemental proposals, in addition to new requirements that are the outgrowth of public input received during the comment period for both preventive controls proposals.
The final rule establishes new requirements for the production of animal food by registered food facilities in two ways:
- First, the final rule creates new CGMP regulations that specifically address the manufacturing, processing, packing, and holding of food for animals. These requirements apply to establishments that are required to register with FDA as a food “facility.”
- Second, the final rule requires covered facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. As with the CGMPs, these requirements apply to establishments that are required to register with FDA as a food facility. This portion of the rule requires registered animal food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the control of those hazards, unless an exemption applies. Facilities must also monitor their preventive controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions.
The final rule establishes CGMP provisions to ensure the safety and suitability of animal food. Specifically, the final rule establishes requirements in the following areas:
- Personnel;
- Plant and grounds;
- Sanitation;
- Water supply and plumbing;
- Equipment and utensils;
- Plant operations;
- Holding and distribution; and
- Holding and distribution of human food by-products for use as animal food.
The final rule also implements the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the final rule provides for the following:
- Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan that includes:
- Hazard analysis;
- Preventive controls; and
- Oversight and management of preventive controls, including:
- Monitoring,
- Corrective actions and corrections, and
- Verification.
- A covered facility also would be required to maintain associated records and have a recall plan.
- The supply chain program is made more flexible, with separate compliance dates established.
- The definition of a “farm” is clarified in the Preventive Controls for Human Food final rule to cover two types of farm operations (i.e., Primary Production Farm and Secondary Activities Farm). Operations meeting the definition of “farm” are not subject to the preventive controls final rule.
- Feed mills associated with farms (vertically integrated operations) are not covered.
Effective Date and Compliance Dates
The Preventive Controls final rules will become effective on November 16, 2015; however, covered entities will be permitted to come into compliance at future, staggered dates, depending on a variety of factors.
Under the Preventive Controls for Human Food final rule, most businesses (other than small businesses, very small businesses, and businesses subject to the Pasteurized Milk Ordinance) will have 1 year after the date of publication to come into compliance (i.e., September 17, 2016). Businesses may have more time to comply with the supply chain control requirements.
Under the Preventive Controls for Animal Food final rule, most businesses will have 1 year after the date of publication (i.e., September 17, 2016) to comply with the CGMP requirements, and 2 years after publication (i.e., September 17, 2017) to comply with preventive controls and supply chain requirements.
