FSMA: What's Happening in 2015?

Four years have passed since FDA’s Food Safety Modernization Act (FSMA) became law. Amending the Federal Food, Drug, and Cosmetic Act (FDCA), FSMA aims to increase the safety of the food supply in the United States by mandating a more proactive, preventive approach to food safety and providing FDA with expanded regulatory and enforcement authorities.

Since 2011, FDA has shouldered a heavy workload to issue all of the regulations, guidance documents, reports, and studies that are required to implement FSMA in accordance with FSMA’s statutory timetable. So far, FDA has succeeded in issuing proposed regulations and supplemental proposed regulations to implement the core provisions of FSMA, but the agency has been unable to meet a number of rulemaking deadlines nonetheless. As a result of FDA’s settlement of a case challenging implementation delays, FDA is required to issue final regulations implementing fundamental FSMA provisions in 2015 and 2016.

The FSMA amendments to the FDCA introduce significant change to the food safety provisions of the statute. Globalization and the dramatic growth in the share of the U.S. food and dietary supplement market that is imported from foreign suppliers inspired a number of FSMA provisions designed to help ensure that all food and dietary supplement products marketed in the United States comply with FDCA safety and labeling requirements. The FSMA amendments touch virtually all products that are marketed in the United States that qualify as “food,” as defined by the FDCA, including food that meets the “dietary supplement” definition.

FDA regulatory requirements under the FSMA amendments apply to all food in the same way, without regard to the distinctions between dietary supplements and other categories of food. FSMA does require FDA to account for dietary supplement status in a few key areas, however. For example, dietary supplements that are manufactured in compliance with the rigorous current Good Manufacturing Practice (cGMP) requirements established by FDA regulations in 21 CFR Part 111 are not required to comply with the new “hazard analysis risk-based preventive control” (“preventive control” or “HARPC”) requirements, which require most other food manufacturers to establish and implement written, facility-specific hazard analysis and risk-based preventive control plans that are designed to identify and control potential food safety risk factors. FDA is establishing these requirements under FDCA Section 418, but has yet to issue final rules.

Despite criticism from public interest groups for falling behind FSMA’s implementation timetable, last year proved to be another significant year for the agency. In 2014, FDA issued one final rule, one proposed rule, four supplemental proposed rules, and a number of updated guidance documents to the industry.

2014 Actions

Proposed Rule on Sanitary Transportation of Human and Animal Food¹

January 2014 –FDA issued a proposed rule that would require those who transport food to use sanitary transportation practices to ensure the safety of food. The rule would establish criteria-e.g., conditions and practices, training, and recordkeeping-for the sanitary transport of food. FDA issued this proposed rule under the Sanitary Food Transportation Act of 2005 and as directed by Section 111(a) of FSMA.

FDA received comments through July 30, 2014.

Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of FSMA²

February 2014 –As its first step in meeting its requirement to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary, FDA issued a draft methodological approach to identifying high-risk foods. The draft approach is based on an analysis of chemical and microbial hazards related to food and considers the historical public health significance of the food with respect to outbreaks and cases of foodborne disease, as well as food processing–related factors.

FDA received comments through May 22, 2014.

Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers³

March 2014 –FDA published its third version of guidance on the requirements under the Information Required in Prior Notice of Imported Foods (Section 304 of FSMA). The guidance is updated with a list of answers to questions FDA frequently receives.

FDA receives comments on guidance at any time.

Final Rule on the Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements⁴

April 2014 –FDA issued a final rule that adopted, without change, the interim final rule that set forth standards regarding FDA’s expanded authority to access records relating to articles of food that FDA reasonably believes are likely to be affected by a suspect article of food. This rule implements Section 101 of FSMA.

Effective April 4, 2014.

Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small-Entity Compliance Guide⁵

April 2014 –FDA issued updated guidance pertaining to the final rule on the establishment, maintenance, and availability of records. The document describes in lay terms who must establish and maintain records, how the records must be maintained, how and why FDA will access records, and what will happen if the required records are not established and maintained.

FDA receives comments on guidance at any time.

Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act⁶

April 2014 –FDA issued updated guidance pertaining to FDA’s authority to access and copy records under Sections 414 and 704 of the FDCA, which, in light of FSMA, expands FDA’s access to records. FDA’s access now extends beyond records relating to the specific suspect article of food to records relating to any other article of food that FDA reasonably believes is likely to be affected.

FDA receives comments on guidance at any time.

Proposed Supplemental Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals⁷

September 2014 –FDA issued a supplemental proposed rule on foreign supplier verification programs that revises the agency’s original proposal to provide more flexibility in determining verification measures based on food and supplier risks. FDA combines the proposed requirement that an importer conduct a compliance status review of each food to be imported and each foreign supplier being considered with the proposed requirement than an importer analyze the hazards in each food to create a more comprehensive evaluation of food and supplier risks. The Proposed Supplemental Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals would implement Section 301 of FSMA.

FDA received comments through January 27, 2014.

Proposed Supplemental Rule for Preventive Controls for Human Food⁸

September 2014 –FDA issued a supplemental proposed rule on preventive controls for human food revising its original proposal to be more flexible and less burdensome by no longer requiring farmers to register as food facilities merely because they pack or hold raw agriculture commodities grown on another farm under a different ownership. The proposed rule also defines exempt“very small business[es]” as firms with less than $1 million in total annual sales, among other things. The Proposed Supplemental Rule for Preventive Controls for Human Food would implement Section 103 of FSMA.

FDA received comments through December 15, 2014.

Proposed Supplemental Rule for Preventive Controls for Animal Food⁹

September 2014 –FDA issued a supplemental proposed rule on preventive controls for animal food that revises the agency’s original proposal to be more flexible and less burdensome by making cGMP regulations more applicable to animal food. It also defines exempt “very small business[es]” as firms with less than $2.5 million in sales. The Proposed Supplemental Rule for Preventive Controls for Animal Food would implement Section 103 of FSMA.

FDA received comments through December 15, 2014.

Proposed Supplemental Rule for Produce Safety¹⁰

September 2014 –FDA issued a supplemental proposed rule on produce safety that revises its original proposal to be more flexible and less burdensome in the areas of water-quality standards and testing, among other things. FDA proposes revisions to the microbial standard for water to reflect data that supports the 2012 Environmental Protection Agency recreational-water criteria. FDA also proposes that farms with an average annual monetary value of produce sales of $25,000 or less will not be covered by the rule. The Proposed Supplemental Rule for Produce Safety would implement Section 105 of FSMA.

FDA received comments through December 15, 2014.

2015 Actions

FDA is slated to finalize a number of core FSMA rules this year. In settling a case with the Center for Food Safety challenging the agency’s rulemaking delays, FDA agreed to deadlines that push the final implementation of FSMA into 2016.¹¹ According to the new timeline, FDA should release five final rules in 2015 and two final rules in 2016. (See below).

August 30, 2015
Preventive controls for human food

August 30, 2015
Preventive controls for animal food

October 31, 2015
Produce safety standards

October 31, 2015
Foreign Supplier Verification Program

October 31, 2015
Accreditation of third-party auditors

March 31, 2016
Sanitary transportation of food

May 31, 2016
Intentional adulteration and food defense

References

1. 79 Fed. Reg. 7005 (Feb. 5, 2014) (To be codified at 21 CFR pt. 1).
2. Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA, USFDA, Feb. 2014, http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm380210.htm.
3. Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers, USFDA, Mar. 2014, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm078911.htm.
4. 79 Fed. Reg. 18799 (Apr. 4, 2014) (Codified at 21 CFR pt. 1).
5. Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records; Small Entity Compliance Guide, USFDA, Apr. 2014, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm391329.htm.
6. Draft Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act, USFDA, Apr. 2014, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm292745.htm.
7. 79 Fed. Reg. 58573 (Sept. 29, 2014) (To be codified at 21 CFR pt. 1).
8. 79 Fed. Reg. 58523 (Sept. 29, 2014) (To be codified at 21 CFR pt. 1).
9. 79 Fed. Reg. 58475 (Sept. 29, 2014) (To be codified at 21 CFR pt. 1).
10. 79 Fed. Reg. 58433 (Sept. 29, 2014) (To be codified at 21 CFR pt. 1).
11. Center for Food Safety v. Hamburg, 4:12-cv-04529-PJH (February 20, 2014) (Consent Decree).

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