Food Safety Modernization Act (FSMA) Introduction

The Food Safety Modernization Act (FSMA) is made of seven rules that apply to Human and/or Animal Food as follows:

Rules applicable to Animal Food Rules NOT applicable to Animal Food
Preventive Controls for Animal Food Preventive Controls for Human Food
Foreign Supplier Verification Program Produce Safety
Accredited Third-Party Certification Intentional Adulteration
Sanitary Transportation

This site focuses on Preventive Controls for Animal Food 21 CFR 507 and  Sanitary Transportation 21 CFR Part 1 and 11. 

The purpose of the Food Safety Modernization Act is to improve the safety of food fed to animals and humans.

Who must comply with the Food Safety Modernization Act?

  • The short answer to this question is all facilities required to register under the Bioterrorism Act of 2002. This begs the question:

Who must comply with the Bioterrorism Act of 2002?

  • You must register your facility if you are the owner, operator, or agent in charge of a facility, engaged in the manufacturing / processing, packing, or holding of food for consumption in the United States.

As with all regulations, look to the definition of the words for further clarity… To simplify the reading and understanding of the law I have taken out the legalese that makes the law seem more difficult than it is. As always, refer to 21 CFR 507 for the exact definition.

Define Facility: any establishment, which is under one owner, at one general physical location. A facility may consist of one or more contiguous structures, and a single building may house more than one facility if the facilities are under separate ownership.

Define one owner: individuals, partnerships, LLC, Corporations responsible for a business entity.

Define food: Food include: Fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods.

For the remainder of this document I have changed “food” to “feed” as it applies to our industry.

Define manufacturing/processing: means making feed from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating feed, including feed crops or ingredients.

Define packing:  placing feed into a container (bulk, tote, bag) other than placing the feed into a container that directly contacts the feed and that the consumer receives.  Includes re-packing and activities performed incidental to packing or re-packing a feed.

Define holding: storage of feed and also includes activities performed incidental to storage of a feed (e.g., activities performed for the safe or effective storage of that feed, such as fumigating feed during storage, and drying/dehydrating raw agricultural commodities). Holding also includes activities performed as a practical necessity for the distribution of that food (such as blending of the same raw agricultural commodity and breaking down pallets). Holding facilities could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage tanks.

Are there any exceptions from complying with the rule?

Short answer is yes. All laws have exemptions but there are also reporting requirements that go along with those exemptions. Exemption does not mean you do nothing, you must apply for exemption.  I will not describe the types of exemptions available. I recommend you seek legal guidance to determine your eligibility for exemption.

Therefore, CFD recommends that all members and customers registered under the bioterrorism act embark on the path to compliance not only because it is the law but it will have a positive impact on your business.