02-6124. Use of Transglutaminase Enzyme and Pork Collagen as Binders in Certain Meat and Poultry Products

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Affirmation of effective date for direct final rule.

SUMMARY:

On October 31, 2001, the Food Safety and Inspection Service (FSIS) published a direct final rule “Use of Transglutaminase Enzyme and Pork Collagen as Binders in Certain Meat and Poultry Products” in the Federal Register. This direct final rule notified the public of FSIS's intention to amend the Federal meat and poultry products inspection regulations to permit the use of one or both of these substances, in limited amounts, as binders in certain standardized meat and poultry products. This direct final rule also announced the Agency's intention to prescribe labeling requirements when tranglutaminase enzyme (TG enzyme) is used to fabricate or reform cuts of meat or poultry. FSIS received one comment in response to the direct final rule. However, the comment was not an adverse comment or notice of intent to submit an adverse comment. Therefore, FSIS is affirming the December 31, 2001, effective date for this direct final rule.

EFFECTIVE DATE:

December 31, 2001.

FOR FURTHER INFORMATION CONTACT:

Robert C. Post, Ph.D., Director, Labeling and Consumer Protection Staff, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250-3700; [phone]

SUPPLEMENTARY INFORMATION:

Background

On October 31, 2001, FSIS published a direct final rule “Use of Transglutaminase Enzyme and Pork Collagen as Binders in Certain Meat and Poultry Products” (66 FR 54912). This direct final amended the Federal meat inspection regulations to permit the use of pork collagen and TG enzyme, in limited amounts, as binders in certain standardized meat food products and amended the poultry products inspection regulations to permit the use of TG enzyme, in limited amounts, in certain standardized poultry products. This direct final rule also amended the meat and poultry products inspection regulations to require that, when TG enzyme is used to fabricate or reform cuts of meat or poultry, the resulting product bear labeling to indicate that it has been formed from pieces of whole muscle meat, or that it has been reformed from a single cut. This direct final was in response to petitions submitted to the Agency by Ajinomoto, U.S.A., Inc. and AMPC, Corp.

On December 3, 2001, FSIS received a comment from Hogan & Hartson, L.L.P. on behalf of Ajinomoto USA, Inc., in response to the rulemaking. The commenter, also one of the petitioners, requested that FSIS provide clarification on the scope of the direct final rule. Specifically, Ajinomoto requested that FSIS clarify that the Agency intended to allow the use of TG enzyme in cured pork products under 9 CFR 319.104 when it published the direct final rule. The commenter noted that in its petition it had specifically requested that the standard of identity for cured pork products under 9 CFR 319.104 be amended to provide for the use of TG enzyme as a binder and provided data in support of this request. The commenter also expressed full support for the rule and stated that the comment was not intended to be an adverse comment but rather a clarification on the scope of the final rule.

When it began development of the direct final rule, FSIS had determined that, based on the data submitted by Ajinomoto, TG enzyme was suitable for use as a binder in sausages as provided under part 319 of title 9. While the rule was under development, Ajinomoto submitted additional data to support the use of TG enzyme in other standardized products, including cured pork products under 9 CFR 319.140. Upon review of the additional data, FSIS determined that, in addition to sausages as provided under part 319, TG enzyme was suitable for use in restructured meats (9 CFR 319.15(d)), roast beef parboiled and steam roasted (9 CFR 319.104) cooked sausages (9 CFR 319.180) and poultry rolls (9 CFR 381.159), and incorporated these findings into the direct final rule. However, when it incorporated these products in the direct final rule, the Agency was still reviewing the data submitted on the use of TG enzyme in cured pork products defined under 9 CFR 319.104. Thus, the direct final rule does not provide for the use of TG enzyme in these products. FSIS ultimately determined that TG enzyme is suitable for use as a binder in cured pork products under 9 CFR 319.104. In response to the commenter's request to clarify the scope of the direct final rule, the rule, as published, is not intended to provide for the use of TG enzyme in cured pork products under 9 CFR 319.104. However, because FSIS ultimately found that TG enzyme is suitable for use as a binder in these standardized products, the Agency intends to publish another direct final rule to permit such a use.

Because FSIS did not receive any adverse comments or notice of intent to submit adverse comments in response to the direct final rule, the effective date remains as December 31, 2001.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce the meeting and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via fax to over 300 organizations and individuals. In addition, the update is available on-line through the FSIS web page located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at [phone].

Done at Washington, DC, on: March 11, 2002.

Margaret O'K Glavin,

Acting Administrator.