FSMA Rules

The Food Safety Modernization Act (FSMA) gives the U.S. Food and Drug Administration (FDA) authority to regulate food from farm to fork, which enables the FDA to better protect the public by strengthening the food safety system. The goal is to prevent foodborne outbreaks before they occur by taking proactive measures and shifting from a reactionary approach to a proactive approach. FSMA has created seven new federal rules that address produce, human food, animal food, transportation, and imported food.

The Produce Safety Rule is currently the only rule regulated by ISDA, more information about the other six rules can be found below.

FDA’s FSMA Rules – FAQ

Key Facts About Preventive Controls for Animal Food

Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.

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Fact Sheet

This FDA fact sheet contains key requirements for the final rule on Preventive Controls for Animal Food.

FSMA-Final Rule on Preventive Controls for Animal Food

Code of Federal Regulations

Code of Federal Regulations Title 21-Food and Drugs, Chapter 1- Food and Drugs Administration Department of Health and Human Services Subchapter A – General, Part 1 General Enforcement Regulations.

Key Facts About Preventive Controls for Human Food

Preventive controls are steps that you, a domestic or foreign food facility, must
take to reduce or eliminate food safety hazards.
The rule also incorporates the Current Good Manufacturing Practice (CGMP)
requirements, which have been updated.

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Fact Sheet

This FDA fact sheet contains key requirements for the final rule on Preventive Controls for Human Food.

Key Facts about Preventive Controls for Human Food

Code of Federal Regulations

Code of Federal Regulations Title 21—Food and Drugs, Chapter 1 – Food and Drugs Administration Department of Health and Human Services Subchapter A – General, Part 1 General Enforcement Regulations

Key Facts About Accredited Third-Party Certification

The FDA Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification was finalized in November 2015. The rule establishes a voluntary program for the accreditation of third-party certification bodies, also known as third-party auditors, to conduct food safety audits and issue certifications of foreign entities and the foods for humans and animals they produce. These requirements are intended to help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.

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Fact Sheet

his FDA fact sheet contains key requirements for the final rule Accredited Third-Party Certification.

FSMA-Final Rule on Accredited Third-Party Certification

Code of Federal Regulations

Accredited Third Party Certification Program

Accredited Third-Party Certification is a voluntary program in which FDA recognizes “accreditation bodies” that will have the responsibility of accrediting third-party “certification bodies.” The certification bodies will conduct food safety audits and issue certifications of foreign food facilities.

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Key Facts About Foreign Supplier Verification Programs

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.

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Fact Sheet

The FDA is committed to helping ensure that importers can meet the FSP requirements. In order to facilitate compliance, FDA will provide guidance, outreach, and training.

KEY REQUIREMENTS_ Final Rule on Foreign Supplier Verification Programs

Key Facts About Mitigation Strategies to Protect Food Against Intentional Adulteration

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Fact Sheet

This FDA fact sheet contains key requirements for the final rule for Mitigation Strategies to Protect Food Against Intentional Adulteration.

FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration

Code of Federal Regulations

Code of Federal Regulations Title 21-Food and Drugs, Chapter 1- Food and Drugs Administration Department of Health and Human Services Subchapter A – General, Part 1 General Enforcement Regulations.

Key Facts About Sanitary Transportation of Human and Animal Food

The FDA Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation.

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Fact Sheet

This FDA fact sheet contains key requirements for the final rule on Sanitary Transportation of Human and Animal Food.

Final Rule on Sanitary Transportation of Human and Animal Food

Code of Federal Regulations

Code of Federal Regulations Title 21-Food and Drugs, Chapter 1- Food and Drugs Administration Department of Health and Human Services Subchapter A – General, Part 1 General Enforcement Regulations.

Pesticides

Animal Industries

Plant Industries

Agricultural Inspections

Market Development

Laboratories

Food Safety (FSMA)

FDA’s FSMA Rules – FAQ