Agency Response Letter GRAS Notice No. GRN 000021
CFSAN/Office of Premarket Approval
July 29, 1999
Melvin W. VandenBerg
2325 North Loop Drive
Ames, IA 50010
Re: GRAS Notice No. GRN 000021
Dear Mr. VandenBerg:
The Food and Drug Administration (FDA) is responding to the notice, dated April 22, 1999, that you submitted in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received this notice on April 26, 1999 and designated it as GRAS Notice No. GRN 000021.
Your notice states that AMPC, Inc. has determined through scientific procedures that pork collagen is GRAS for use as a binder and purge reducing additive in meat or meat type products at a level of 1 - 3.5%.
According to your notice, pork collagen is a concentrated collagen protein prepared from pork fatty tissues. In the notice, you equate pork collagen protein to commonly consumed concentrated collagen proteins from fatty tissue such as fried pork rinds, cracklings, bacon, rendered beef fat tissue solids, pork greaves, and partially defatted pork fatty tissue. You have provided an analysis of pork collagen and of "pork tissue" from which it is prepared. These analytical data show that the amino acid profile provided for pork collagen is similar to that for "pork tissue," indicating that the protein was relatively unchanged by processing. The notice provides a description of the mechanical and thermal process for producing pork collagen from "dehydrated pork fatty tissue." This process is similar to the mechanical processes for producing regenerated collagen or collagen fiber from the corium layer of purified cowhides.
As you discussed with FDA staff during a telephone conversation on July 12, 1999, the specifications that you propose for pork collagen do not include a specification for lead. At this time, the available data would support a lead specification of less than 1.25 ppm. Given FDA's interest in achieving the lowest possible levels of lead in food, it is our understanding that AMPC is committed to analyzing further lots of pork collagen to obtain additional data that would support a lead specification for pork collagen of less than 1 ppm.
Based on the information provided by AMPC, as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of AMPC that pork collagen is GRAS for use as a binder and purge reducing additive in meat or meat type products at a level of 1-3.5%. The agency has not, however, made its own determination regarding the GRAS status of the notified use of pork collagen. As always, it is the continuing responsibility of AMPC, Inc. to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
FDA consulted with the Labeling and Additives Policy Division (LAPD) of the Food Safety and Inspection Service, United States Department of Agriculture, regarding the use of pork collagen in meat or meat-type products. With the exception of the implications of meat product standards, LAPD did not identify any concerns regarding the suitability of the intended use of pork collagen in meat or meat-type products. LAPD requested that we advise you to seek regulatory guidance regarding whether the use of pork collagen in meat or meat-type products requires rulemaking under the statutes that FSIS implements. You should direct your inquiry to Dr. Robert Post, Director, LAPD, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, 300 12th Street, SW, Room 602, Washington, DC 20250-3700. The telephone number for LAPD is (202) 205-0279 and the FAX number is (202) 205-3625.
In accordance with proposed 21 CFR 170.36(f), we have placed a copy of this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), in a file that is available for public review and copying in the public reading room of the agency's Freedom of Information Staff.
Alan M. Rulis, Ph.D.
Office of Premarket Approval
Center for Food Safety and Applied Nutrition
cc: Dr. Robert Post, Director, LAPD
Office of Policy, Program Development and Evaluation
Food Safety and Inspection Service
300 12th Street, SW, Room 602
Washington, DC 20250-3700