One of the most notable pieces of federal legislation addressing food safety in the past century, the FDA Food Safety Modernization Act (FSMA), was enacted on Jan. 4, 2011 — amending section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Companies that manufacture, process, pack, or store food, including coffee, must comply.
The FSMA requires companies in the United States with these food facilities to submit additional registration information to the FDA. It also requires companies to renew the registration on a biennial basis, providing the FDA with authority to suspend the registration of a food facility in certain circumstances.
With key deadlines looming (see the first question with Rick Barham below), business owners may still have questions about FSMA requirements. Despite the attention that the legislation has received in the media in recent years, many companies may not realize that the compliance deadlines for FDA’s Preventive Controls Rules have already passed, or are not aware of the new requirements.
The FDA-focused consultancy Registrar Corp recently published an article on the current status of FSMA discussing what’s required now, future compliance deadlines, and FDA’s enforcement to date. In addition to highlighting the major rules, the article provides an important update on the FDA registration process. All registered food facilities must renew their registrations between Oct. 1 and Dec. 31 of this year.
We asked Rick Barham, the Director of Food Safety for Registrar Corp, to shed some light on the legislation requirements and upcoming deadlines.
DCN: What’s required for businesses to be in compliance with the FSMA?
Rick Barham: Businesses that meet the definition of a “qualified facility” are subject to modified requirements of the Preventive Controls for Human Food rule. These facilities are not required comply with Subpart C and G, Food Safety Plan and Supply Chain Program, respectively, of the regulation if they meet the necessary criteria. The modified requirements require the business to attest to their status as a qualified facility.
The Preventive Controls compliance deadline for very small human food businesses is Sept. 17, 2018. Very small businesses may choose to comply by either implementing a HARPC Food Safety Plan and Supply Chain Program or by submitting the qualified facility attestation with FDA, which allows them to forgo the former option.
Very small businesses that are manufacturing, processing, packing, or holding food before Sept. 17, 2018, must submit their first qualified facility attestation to FDA by Dec. 17, 2018. The modified requirements for very small businesses are outlined in §117.201 of the Code of Federal Regulations.
Companies must first calculate the average annual sales and market value of foods manufactured, packed or held — including subsidiaries and affiliates — in the preceding three years to determine if they are eligible. Once they have determined their qualified facility status, they may submit a qualified facility attestation to the FDA electronically using the FDA Unified Registration and Listing System (FURLs) beginning Oct. 1, 2018, or by mail using Form FDA 3942a (currently only available as a draft; FDA states that it plans to make the final forms available in advance of the Sept. 17 compliance deadline. FDA will request all calculations and financial supporting documents.
When submitting this qualified facility attestation, the company must attest that it meets the definition of a qualified facility under the Preventive Controls Rule and:
- It has identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or
- It is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight.
Once a facility has submitted its initial attestation, it must re-submit attestation during the biennial food facility registration renewal period (every even-numbered year between Oct. 1 and Dec. 31).
Who needs to be concerned with this legislation?
Most food facilities that manufacture, process, pack, or store food must comply with the Preventive Controls. The qualified facility attestation is voluntary. See section “Who Qualifies for the Exemption” on our blog.
What’s the cost?
There is no cost to submit qualified facility attestation.
How much time does it take?
The FDA estimates in the Federal Register that facilities will spend about 30 minutes reporting their status as a qualified facility to FDA every two years. Of course, this does not seem to consider the time it will take to gather the necessary supporting records.
What are the implications for not updating?
Very small human food businesses that do not implement a HARPC Food Safety Plan and Supply Chain Program, nor submit Qualified Facility Attestation, will be non-compliant with the Preventive Controls Rule, a prohibited act that may subject them to civil or criminal penalties under the Food, Drug, and Cosmetic Act.
For exporters, this may also affect relationships with U.S. buyers, as many U.S. importers will consider their foreign suppliers’ compliance with Preventive Controls when approving suppliers under their Foreign Supplier Verification Programs (FSVPs).
Is it a relatively simple process for already registered facilities?
It is hard to say being that this is a new requirement, although it will depend on the submitter’s familiarity with the FDA Unified Registration and Listing System (FURLs), English fluency, and the availability of the necessary supporting records.