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A Few Food Safety Modernization Act (FSMA) Compliance Dates Extended

On August 24, the US Food and Drug Administration (FDA or Agency) issued a final rule (Final Rule) that extends and clarifies the compliance dates for a limited subset of Food Safety Modernization Act (FSMA) requirements in four of the seven foundational rules part of FDA’s FSMA implementation.1 The four rules include

  • Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (Preventive Control Rules) for Human and Animal Foods;2

  • Foreign Supplier Verification Programs (FSVP);3 and

  • Produce Safety.4

The Agency decided to extend the dates to address industry concerns about the practicality of complying with such dates and to better align them with the other FSMA rules. Generally, FDA granted an additional two years to comply.

The below table provides the updated compliance dates for the subset of FSMA requirements. Given the dates’ variability among the four rules, the earliest compliance date is listed.

FSMA Rules Extension

FSMA Rule(s)

Topic/Provision

Earliest Compliance Date

Preventive Control Rules

Facilities solely engaged in packing and/or holding that produce raw agricultural commodities

January 26, 2018

Facilities that would qualify as secondary activities farms except for the ownership of the facility

January 26, 2018

Preventive Control Rule for Human Food

Facilities that color raw agricultural commodities

January 26, 2018

National Conference on Interstate Milk Shipments facilities producing Grade “A” milk and milk products to comply with CGMP requirements

September 17, 2018

Preventive Control Rules,

FSVP, and

Produce Safety

Provisions concerning customer assurances when controls are applied downstream in the distribution chain

September 19, 2018

Preventive Control Rule for Animal Food

Off-farm facilities solely engaged in cotton ginning that provide products without further processing for use as animal food

May 28, 2019

FSVP

Importation of food contact substances

May 28, 2019

 

Amaru Sanchez contributed to this post.


1https://www.gpo.gov/fdsys/pkg/FR-2016-08-24/pdf/2016-20176.pdf
2https://www.gpo.gov/fdsys/pkg/FR-2015-09-17/pdf/2015-21920.pdf (Human Food); see also
https://www.gpo.gov/fdsys/pkg/FR-2015-09-17/pdf/2015-21921.pdf (Animal Food).
3https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28158.pdf
4https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28159.pdf

Copyright © 2020 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume VI, Number 242

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About this Author

Robert Hibbert, Civil litigation attorney, Morgan Lewis
Partner

Robert G. Hibbert advises clients in the food and agricultural industries on federal regulation, particularly relating to the US Department of Agriculture (USDA), as well as the US Food and Drug Administration (FDA). Clients seek his counsel on labeling, advertising, recalls, food safety compliance, animal health, and new product development issues. Bob’s experience with civil litigation in federal court includes successful challenges to the scope of USDA jurisdiction and authority over major segments of the food processing industry.

202-739-5611