Rundown of Key Aspects to FSMA

Editor’s Note: This third and final article in a series reviewing the evolution of food law highlights the most important aspects of six rules of FSMA.

Understanding the below six rules will help you better incorporate the Food Safety Modernization Act (FSMA) into your food safety program. Here’s what you need to know.

Preventive Controls for Food for Animals
The Preventive Controls for Food for Animals final rule has staggered dates of compliance for both the current Good Manufacturing Practices (cGMPs) and the preventive controls (PCs) rule, beginning Sept. 18, 2017 with full implementation by Sept. 17, 2019. Larger entities falling under this body of legislation were required to comply with the new cGMPs in September 2016 and will be held to the PCs rule beginning Sept. 18, 2017. The due date for full compliance by all entities is September 17, 2019. There are several definitions of exempted businesses, but the details concerning these exemptions are beyond the scope of this article, so please refer to the regulations for more information on this topic. The PCs for Food for Animals rule (published in 21 CFR 507 Subpart B) establishes baseline cGMP standards for producing safe food for a broad range of animals.

The cGMPs for food for animals are very similar to those for human foods, with a few unique provisions, including water supply and plumbing, plant operations, and holding and distribution of human food by-products for use as animal food. The regulations also contain very similar requirements to the PCs for Human Food final rule, including the requirements for the development of a food safety plan that contains: 1) a comprehensive hazard analysis of the products and processes, 2) establishment of PCs, 3) monitoring procedures for PCs, 4) verification and validation activities for established PCs, and 5) a recall plan.

Accredited Third-Party Certification
The Accredited Third-Party Certification rule defines requirements for the development of a voluntary program for the accreditation of third-party certification bodies to conduct regulatory food safety audits and issue certifications of foreign facilities. The accredited certification body’s auditor will act on behalf of the FDA as a regulatory authority when performing unannounced audits of the eligible foreign supplier/importer. If the supplier’s food safety programs are acceptable, the supplier will be issued a certificate of compliance that may qualify it to be eligible for the Voluntary Qualified Importer Program, which allows importers expedited review and entry of products into the U.S. The rule also describes the requirements for recognized accredited certification bodies to perform these audits as well as the agency’s ability to directly accredit third-party certification bodies if none have been recognized within two years of implementing this program. The body of regulation is found in CFR Parts 1, 11, and 16.

Foreign Supplier Verification
The Foreign Supplier Verification Programs (FSVP) rule is quite revolutionary and puts a great deal more responsibility on importers to “verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.”An FSVP is required for each food brought into the U.S. and the respective supplier of that food. Importers must conduct a comprehensive hazard analysis of each raw material and a risk assessment of the respective foreign supplier. Based on performance and risk of the imported food, a list of approved suppliers, supplier verification, and corrective action activities must be documented. The program’s written procedures must include a provision for receiving product from unapproved vendors on a temporary basis. Foreign supplier verification activities may include annual onsite audits of the supplier’s facility, sampling and testing of product, or reliance on another entity to perform verification activities, as long as the importer is familiar with the relevant documentation. Annual onsite audits are “generally required when there is reasonable probability of exposure to an identified hazard that may result in a serious adverse health consequence or death to humans or animals (called a SAHCODHA hazard).”