FSMA Final Rules and Guidance

 

Final Rule

Rule Final Status Point of Contact General Compliance Period Small Business Compliance Very Small Business Compliance

Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense)1

This rule is intended to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. This rule applies to both domestic and foreign facilities that are required to register under section 415 of the FD&C Act.

May 27, 2016 Ryan Newkirk, Center for Food Safety and Applied Nutrition, FDA May 27, 2019 May 27, 2020 May 27, 2021
Sanitary Transportation of Human and Animal Food (Sanitary Transportation)2

This rule is intended to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport.

April 6, 2016 Michael Kashtock, Center for Food Safety and Applied Nutrition, FDA April 6, 2017 April 6, 2018 N/A
Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications (Accredited Third-Party Certification)

This rule is intended to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA).

November 27, 2015 Charlotte A. Christin, Office of Foods and Veterinary Medicine, FDA N/A N/A N/A
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs (FSVP))3

This rule is intended to require importers to verify that food they import into the United States Is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FDA&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling.

November 27, 2015 Brian Pendleton, Office of Policy, FDA May 27, 2017 N/A N/A

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety)4

This rule is intended to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, by establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.

November 27, 2015 Samir Assar, Center for Food Safety and Applied Nutrition, FDA

January 26, 20175

January 26, 20186

January 26, 2018

January 26, 2019

January 26, 2019

January 26, 2020

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food)7

The rule is intended to modernize requirements for current good manufacturing practices (cGMPs) and for domestic and foreign facilities that are subject to Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food.

September 17, 2015 Jenny Scott, Center for Food Safety and Applied Nutrition, FDA  September 17, 2016 September 17, 2017 September 17, 2018

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Food for Animals)8

This rule is intended to establish requirements for the current good manufacturing practice (cGMP) for food for animals and for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals.

September 17, 2015 Kim Young, Center for Veterinary Medicine, FDA September 17, 20169

September 17, 201710

September 17, 2017

September 17, 2018

September 17, 2018

September 17, 2019

1Small businesses: a business employing fewer than 500 persons; Very small businesses: a business that has less than $10,000,000 in total annual sales of human food.

2 Small businesses: a business employing fewer than 500 persons and having less than $27.5 million in annual receipts.

3 For the importation of food that is also subject to the preventive controls and produce safety rules, the importer would be required to comply with FSVP regulations six months after the foreign supplier is required to comply with preventive controls or produce safety regulations. If importers are subject to the supply-chain program requirements in those rules, the compliance date for FSVP vary (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm) 

4 Small businesses: a business that has more than $250,000 but no more than $500,000 in produce sales; Very small businesses, those with more than $25,000 but no more than $250,000 in annual produce sales.

5 For covered activities involving sprouts

6 For covered activities, except for those involving sprouts
7 Small Businesses: a business employing fewer than 500 persons; Very small businesses: a business that has less than $1 million in total annual sales of human food. Compliance dates vary depending on requirements of the supply chain program (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm).
8 Small Businesses: a business employing fewer than 500 persons; Very small businesses: a business averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food. Compliance dates vary depending on requirements of the supply chain program (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm)

9 cGMP compliance date

10 PC compliance date

 

Guidance

Guidance Final Status Point of Contact
FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act

The FDA is announcing the availability of a draft guidance for industry entitled “FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act.” This draft guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled “Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.”

April 4, 2014 William Correll, Office of
Compliance, Center for Food Safety and Applied Nutrition, FDA
Questions and Answers Regarding Food Facility Registration (Sixth Edition)

The FDA is announcing the availability of a guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (5th Edition).” The guidance provides updated information pertaining to registration of human and animal food facilities under the FD&C Act, as amended by FSMA on January 4, 2011.

November 19, 2014 William Correll, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA
Questions and Answers Regarding Establishment and Maintenance of Records by Persons who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)

The FDA is announcing the availability of a guidance entitled “Questions and Answers Regarding Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5).” This guidance provides updated information pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by FSMA of January 4, 2011.

February 23, 2012 William Correll, Office of
Compliance, Center for Food Safety and Applied Nutrition, FDA
What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide

FDA prepared this guidance to restate the legal requirements in section 304(h) of the FD&C Act 21 U.S.C. 334(h), as amended by section 207 of FSMA.

October 25, 2011 William Correll, Office of
Compliance, Center for Food Safety and Applied Nutrition, FDA