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NC State Extension

Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) of 2011 can be difficult to implement because it is so far-reaching. These pages explain some of the components of the rules that impact food for animals.

This page provides information about what FSMA is and how North Carolina and NC State Extension have responded to new rules and regulations prompted by FSMA.

About FSMA

The Food Safety Modernization Act (FSMA) is one of the most sweeping regulations to affect the feed industry in the last 75 years. It was passed in January of 2011 and led to the U.S. Food and Drug Administration (FDA) developing regulations under Title 21 of the CFR. Subchapters A and E of Chapter 1 of Title 21 apply to animal food manufacturing.

A great resource is the FDA video Safe Animal Feed (5:11) that emphasizes the role animal food manufacturers play in maintaining a safe food supply in the United States.

FSMA has led to inspections of facilities for Current Good Manufacturing Practice (CGMP) and the development of a written food safety plan with a hazard analysis and any risk-based preventive controls. For an overview of how FSMA led to various FDA regulations, see our diagram below.

tree diagram showing the hierarchical relationship between the Food Safety Modernization Act (FSMA) and CFR 21, including the Preventive Controls for Animal Food (PCAF) rule

FSMA is a documentation rule. It’s important to remember: If it isn’t written down, you can’t prove that it happened.

Blue square with text If it isn't written down, you can't prove that it happened

In general, facilities that are required to register under the Bioterrorism Act of 2002 are required to comply with FSMA.

Establishments, including farms, that are not required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) are not required to comply with any part of the rule. Get more information on our PCAF: Exemptions page.

FSMA in North Carolina

North Carolina has been proactive in preparing for the new food safety regulations introduced by the Food Safety Modernization Act (FSMA).

These new regulations focus on shifting food safety structures from a reactive to a proactive system. For the first time, feed manufacturing facilities are subject to Current Good Manufacturing Practice (CGMP) inspections by the FDA (these are in addition to medicated feed CGMP inspections).

Each state is unique, so inspections may be performed by FDA inspectors or state agencies that are contracted through the FDA. The North Carolina Department of Agriculture and Consumer Services (NCDA&CS) will be performing CGMP and Hazard Analysis inspections in the state of North Carolina as contractors for the FDA.

Facilities should anticipate being inspected for multiple regulations at a time, if applicable, such as Bovine Spongiform Encephalopathy (BSE), Veterinary Feed Directive and Medicated Feed regulations.

Inspections can last several days and multiple investigators may show up. This is not unusual, as investigators are also learning how to implement these new regulations.

FSMA and NC State Extension

As part of the proactive nature of the new regulations, NC State Extension hired an Area Specialized Agent for animal food safety. Marissa Herchler joined the feed milling program in August 2016 and has been working to provide training, resources and guidance for North Carolina animal food manufacturers.

FSMA Training Resources from NC State Extension

NC State Extension facilitates Preventive Controls for Animal Food courses. These courses offer an on-demand schedule once enough people have expressed interest in attending the course. Anyone interested in participating in a Preventive Controls for Animal Food course and becoming a Preventive Controls Qualified Individual (PCQI) should contact Marissa Herchler Cohen.

In addition to the Preventive Controls for Animal Food PCQI course, NC State Extension offers a free qualified individual training course focusing on animal food safety and personal hygiene to help meet the training requirements of the FSMA Preventive Controls for Animal Food rule. For more information about this training course, visit our FSMA Qualified Individual Animal Food Safety Training page. Contact Marissa Herchler Cohen with any questions about this course.

For more information about courses, programs and support available from NC State Feed Milling Extension, contact Marissa Herchler Cohen.

For additional information contact

Marissa Herchler Cohen
NC State University
Cooperative Extension Service
Prestage Department of Poultry Science
234 D Scott Hall
Raleigh, NC 27695-7608

E-mail: marissa_cohen@ncsu.edu
Phone: +1 919.515.5396