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U.S. Department of Health and Human Services

Animal & Veterinary

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GRAS Grows at CVM

By Geoff Wong, Team Leader, Ingredient Safety Team, Division of Animal Feeds
Alfan Dangin, Paralegal Specialist, and Dr. Melanie McLean, Senior Writer/Editor, Communications
Lee Korb, Regulatory Counsel, Office of Surveillance & Compliance

The Federal Food, Drug, and Cosmetic Act (the Act) defines a food additive as any substance that is found in food.  A food additive is either added intentionally or is present because of the way the food is made or packaged.1 However, a substance found in food that is Generally Recognized As Safe, or GRAS, is not considered a food additive. 

On June 4, 2010, FDA’s CVM announced a voluntary pilot program that changes the way a company may inform CVM that it has made a GRAS determination.  In the past, a company that determined the use of an ingredient in animal feed was GRAS could petition CVM to affirm its GRAS determination.  The company’s petition included comprehensive data for CVM to review.  If the data supported the company’s GRAS determination, CVM affirmed that the ingredient was GRAS by issuing a regulation, published in the Code of Federal Regulations, listing the ingredient as GRAS.

Under the pilot program, a company that determines the use of an ingredient in animal feed is GRAS can submit a “GRAS notice” to CVM.  The GRAS notice is a summary of the data and information the company used to make its GRAS determination for the use of the feed ingredient.  CVM evaluates the notice to see if there is sufficient basis for the company’s GRAS determination.  If there is sufficient basis, CVM issues a letter stating the Center has no questions at this time about the company’s GRAS determination.  If there is insufficient basis, CVM issues a letter stating that the Center has questions about the GRAS determination.

Strong evidence of safety is required to determine the use of a substance is GRAS.  Also, the evidence of safety must be generally known and accepted by the scientific community.  This general recognition by qualified scientists is called the “common knowledge element.”  There are two components of the common knowledge element, and both are necessary for a substance to be GRAS:

  • The data and information used to establish safety must be generally available.  Typically, this is information published in peer-reviewed scientific journals; and
  • There must be consensus among the qualified scientists that the substance is safe for its intended use in animal feed.

History of GRAS

Congress added the definition of a food additive to the Act in 1958.  GRAS substances were exempt from the definition, and therefore, not considered food additives.  Also in 1958, FDA created a list of substances that are GRAS when used as indicated and made using good manufacturing practices.  However, FDA acknowledged the difficulty in including all GRAS substances in the list.

In the late 1960s, FDA established the process of reviewing data submitted by a company and affirming that the use of the substance was GRAS.  This process is called the “petition affirmation process.”

1997 Proposed Rule

In April 1997, FDA issued a proposed rule calling for a new program to replace the petition affirmation process.  CVM’s voluntary pilot program is a result of the proposed rule. 

For years, only FDA’s Center for Food Safety and Applied Nutrition (CFSAN) accepted GRAS notices under the proposed rule.  CVM did not because of resource constraints.  However, CVM recently established the Ingredient Safety Team in the Division of Animal Feeds (DAF).  With the help of other groups at CVM, the Ingredient Safety Team is starting to evaluate GRAS notices under the 1997 proposed rule.

The Pilot Program

In CVM’s pilot program, a company submits a GRAS notice that summarizes the data and information used to support the GRAS determination for the use of a feed ingredient.  The summary includes information about:

  • The substance;
  • The animal species that the feed containing the substance is intended for;
  • How the substance will be used (the conditions of use); and
  • The legal basis for the GRAS determination.  The legal basis is either a scientific argument or a “common use prior to 1958” argument.  In the common use argument, the company shows the substance is safe by proving that it was commonly used in food before 1958.   

If the substance will be used in feed for food-producing animals, like cattle, pigs, and chickens, the GRAS notice addresses human food safety.  That is, the notice shows that food products made from animals that ate the animal feed containing the substance are safe for people to eat.   

“The petition affirmation process did not offer companies a way to simply notify CVM of a GRAS determination.  But under the pilot program, a company can do just that,” explained Dr. Sharon Benz, director of DAF.  CVM hopes the more efficient process will encourage companies to notify CVM of their GRAS determinations.

Before submitting a GRAS notice, companies may contact DAF to discuss the pilot program.  GRAS notices submitted to CVM and the Center’s responses to the notices will be posted on CVM’s Web site.  For more information about the pilot program, please visit:  http://www.fda.gov/AnimalVeterinary/Products/AnimalFoodFeeds/ GenerallyRecognizedasSafeGRASNotifications/default.htm.

1For the complete definition of a food additive, please see the Code of Federal Regulations (CFR) at 21 CFR 570.3(e)