A Reminder to our Friends in the Food Distribution Industry: Compliance Dates for FDA Food Safety Regulations Fast Approaching
Health Law Alert 08/25/16 Theodore M. Sullivan
Food & Drug Administration (FDA) has published several regulations in the past year that impact the United States food distribution industry, and the compliance date for two of these regulations is next month (September). The particular regulations that apply to a food distribution entity will depend on the nature of the entity's operations and the types of food products it stores and distributes.
Specifically, food distribution entities required to register one or more facilities with FDA must comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Final Rule (PCHF Rule), and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Final Rule (PCAF Rule) by September 17, 2016, unless otherwise exempt. For example, if a food distribution entity has storage warehouses that are required to be registered with the FDA as "food facilities" because the warehouses "hold" food, the PCHF and PCAF Rules may significantly impact these facilities' compliance obligations.
In addition, most food transportation entities will need to comply with the Sanitary Transportation of Human and Animal Food Final Rule (Sanitary Transportation Rule) by April 6, 2017, unless otherwise exempt. Therefore, entities that "ship," "load," "receive," or "carry by motor vehicle or railroad," food for consumption in the U.S. will soon need to be familiar with the compliance requirements under the Sanitary Transportation Rule.
Each of these Rules is discussed in more detail below.
FSMA and its Regulations Applicable to the Food Distribution Industry
These Rules were passed by FDA as part of its efforts to implement the Food Safety Modernization Act (FSMA) of 2011. The purpose of the FSMA is to ensure the safety of the United States' food supply by shifting the regulatory focus to preventing contamination rather than responding after the fact. To achieve the goal of improving food safety, the FSMA called for the implementation of certain foundational regulations. FDA published these seven FSMA Final Rules between September 2015 and May 2016. The entities to which each regulation applies, as well as effective dates for compliance, vary by regulation.
Pre-Packaged Food Exemptions
Because the FSMA and its implementing regulations are focused solely on "food safety," certain types of activities and food products may limit the scope of a food distribution entity's compliance obligations under the new FSMA regulations. For example, under the PCHF and PCAF Rules, food facilities that are solely engaged in the storage of "unexposed packaged food" are exempt from the hazard analysis and risk-based preventive controls (HARPC) requirements of these rules. However, food facilities must comply with modified requirements if the unexposed packaged food requires temperature control for food safety purposes (TCS food).
Likewise, the Sanitary Transportation Rule does not apply to food that is completely enclosed by a container, unless the food is TCS food. TCS food generally means food that must be refrigerated to prevent adulteration; frozen food is typically not considered TCS food.
HARPC Requirements and Modified Requirements for TCS Food
For FDA-registered food facilities that must comply with the HARPC requirements of the PCHF and PCAF Rules in September, one of the key requirements is for the facility to develop a food safety plan under the supervision of a "preventive controls qualified individual." The food safety plan must contain the following provisions:
- Written Hazard Analysis;
- Written Preventive Controls;
- Written Supply-Chain Program;
- Written Recall Plan;
- Written Procedures for Monitoring and Implementation of the Preventive Controls;
- Written Corrective Action Plan Procedures; and
- Written Verification Procedures.
A food safety plan must be "facility specific," and take into account the equipment and layout of each facility, even if the activities at a company's multiple facilities are similar. Unless a facility is exempt from the HARPC requirements (e.g., the pre-packaged food exemption applies), the facility must establish a food safety plan that covers "all the foods" the facility manufactures, processes, packs, or holds. The good news is that if a food facility handles both human food and animal food, the facility will be deemed compliant with the HARPC requirements of the PCAF Rule if it is compliant with the HARPC requirements of the PCHF Rule. The one caveat is that the food safety plan must include a hazard analysis for the animal food. For more information about the HARPC requirements under the PCHF Rule, see 21 C.F.R. Part 117, Subpart C.
If a food facility only stores unexposed packaged food, but some of the food is TCS food, then the facility must comply with modified requirements of the PCHF or PCAF Rules. Although a food safety plan will not be required in such a case, the facility will need to ensure a preventive controls qualified individual oversees the temperature control requirements. For more information about the modified requirements for TCS food, see 21 C.F.R. § 117.206.
In addition to implementing the HARPC requirements, the PCHF and PCAF Rules also address the Current Good Manufacturing Practice (CGMP) requirements. The PCHF Rule updates the CGMPs that have been in place since 1986 for human food, and the PCAF Rule establishes CGMPs for the first time for animal food. Because these provisions are part of the PCHF and PCAF Rules, the compliance date for businesses, other than small and very small businesses, is also September 17, 2016. These CGMP requirements will apply even to food facilities that are otherwise exempt from complying with the HARPC requirements of the PCHF or PCAF Rules (e.g., a food facility must comply with the CGMPs even if the pre-packaged food exemption applies). However, similar to the HARPC requirements, a food facility that handles both human food and animal food will be deemed compliant with the CGMPs for animal food if it is compliant with CGMPs for human food. For more information about the CGMP requirements under the PCHF Rule, see 21 C.F.R. Part 117, Subpart B.
Sanitary Transportation Requirements
While food transportation entities that are not required to register as an FDA food facility will not need to worry about complying with the PCHF and PCAF Rules in September, they still must be aware of the sanitary transportation compliance obligations that will be required, as applicable, in April 2017. Actual compliance responsibilities will depend on an entity's specific activities with respect to the transport of certain food products (i.e., whether the entity is a "shipper," "loader," "carrier," or "receiver"). A transportation entity may be subject to the requirements of the Sanitary Transportation Rule in multiple capacities, depending on the types of transportation activities in which a business is involved. If shippers, loaders, carriers, and receivers are under common ownership or operational control as a single legal entity, the entity may conduct transportation operations in conformance with "common, integrated written procedures" that ensure the sanitary transportation of food that is consistent with the requirements for each type of entity subject to the Rule.
This Rule is significant to the food distribution industry because it is the only FSMA regulation directly applicable to "carriers." However, the scope is limited to food transported by motor vehicle or railroad. Thus, a carrier of food by ship, barge, plane, or other mode of transportation is not subject to the Sanitary Transportation Rule. Finally, FDA has clarified that brokers and third-party logistics providers (3PLs) may be subject to compliance with the Sanitary Transportation Rule as a "shipper."
However, there are a number of exemptions to the Sanitary Transportation Rule. One exemption is for a "parcel delivery service," meaning carriers that deliver individual food packages to consumers. A second exemption is for the transportation of food completely enclosed by a container, except a food that requires temperature control for safety.
Stay tuned for our upcoming Client Alert on the relevant compliance requirements for each type of entity subject to the Sanitary Transportation Rule (i.e., shippers, loaders, carriers, and receivers).
While this summary focuses on the FSMA regulations most likely to impact the food distribution industry, FDA has implemented seven FSMA foundational regulations, with varying applicability and compliance dates. For more information on these FSMA regulations, including those applicable to farms, importers, and auditors, please refer to the FSMA Rules & Guidance for Industry. If you are interested in more information about the FSMA generally, the FDA has provided a list of Frequently Asked Questions on FSMA.
In addition to the seven FSMA foundational regulations, the FDA has also recently published the Amendments to Registration of Food Facilities Final Rule. This regulation, effective September 12, 2016, modifies a number of aspects of the food facility registration process, including requiring additional information on the registration. This regulation also will require all FDA food facilities to register electronically by January 4, 2020.