03-10392. Approving Ingredients Used in the Production of Meat and Poultry Products: Use of Any Safe and Suitable Binder or Antimicrobial Agent in Meat and Poultry Products With Standards of Identity or Composition

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Direct final rule.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is amending its regulations to permit the use of any safe and suitable binder or antimicrobial agent in the production of meat and poultry products that are subject to a standard of identity or composition that provides for the use of such ingredients. The use of these ingredients must be consistent with any limitations or conditions of use prescribed in applicable FSIS or Food and Drug Administration (FDA) regulations. This direct final rule will provide establishments with greater flexibility in formulating meat and poultry products.

DATES:

This rule will be effective June 30, 2003 unless FSIS receives written adverse comments that are within the scope of this rulemaking or written notice of the intent to submit adverse comments that are within the scope of this rulemaking on or before May 29, 2003.

If we receive such comment, we will publish a timely withdrawal in the Federal Register informing the public that this rule will not take effect.

ADDRESSES:

Submit adverse comments or notice of intent to submit adverse comments within the scope of this rulemaking to: FSIS Docket Clerk, Docket No. 01-032DF, Room 102, Cotton Annex Building, 300 12th Street, SW., Washington, DC 20250-3700. Any comments received will be available for public inspection in the FSIS Docket Room from 8:30 a.m. to 4:30 p.m., Monday through Friday. Copies of this direct final rule are available on the Internet at http://www.fsis.usda.gov.

FOR FURTHER INFORMATION CONTACT:

Robert C. Post, Ph.D., Director, Labeling and Consumer Protection Staff, Room 602, 1400 Independence Avenue, SW., Room 602 Cotton Annex, Washington, DC 20250-3700, 202-205-0279.

SUPPLEMENTARY INFORMATION:

Background

On December 23, 1999, FSIS published in the Federal Register, a final rule entitled, “Food Ingredients and Sources of Radiation Listed or Approved for Use in the Production of Meat and Poultry Products.” The final rule provided a comprehensive background regarding the status of food ingredients and sources of radiation currently listed in Titles 9 and 21 of the CFR, and explained the process by which FDA and FSIS would be working together regarding future requests for approvals of ingredients to be used in meat and poultry products, which are under USDA jurisdiction.

After publishing that rule, the two agencies entered into a memorandum of understanding (MOU) that outlines the responsibilities of each Agency during the joint review of new ingredients or new uses of previously approved ingredients. Under the Federal Food, Drug and Cosmetic Act (FFDCA), FDA has the responsibility for determining the safety of ingredients. FSIS has authority under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to determine whether new ingredients, or new uses of previously approved ingredients, are suitable for their intended use in meat and poultry products. The final rule and MOU are available on the internet at: http://www.fsis.usda.gov/​oppde/​larc.

As used in this rule, the term “safe and suitable” has the same meaning as in FDA regulations (21 CFR 130.3(d)) and as is applied in the MOU between the two Agencies. A safe and suitable ingredient is one that: (1) Performs an appropriate technical function in the food in which it is used; (2) is used at the lowest level necessary to achieve its intended purpose in that food; and (3) is currently approved or listed in FDA regulations as a food additive (21 CFR parts 172-180); GRAS substance (21 CFR parts 182 and 184); Prior-Sanctioned Food Ingredient (21 CFR part 181); Color Additive (21 CFR part 70); or is a self-determined GRAS ingredient for which FDA has provided FSIS with a written no objection opinion regarding the safety of the use of the substance in meat and poultry products and for which FSIS has determined the use to be suitable (per an acceptability determination described in the MOU).

Under current regulations, a person wishing to use an FDA-approved ingredient that FSIS has determined to be suitable for use in meat and poultry products, such as an antimicrobial agent or binder, in a product for which there exists a regulatory standard that does not provide for the use of the ingredient, must petition FSIS to amend the standard. Evaluation of the petition for the proposed ingredient use and the rulemaking to amend the standard may take two years or more.

FSIS receives approximately 2 to 3 petitions annually for uses of newly approved or new uses of approved antimicrobials or binders. A recent example of this was the 1999 petition to allow the use of transglutaminase enzyme and pork collagen for use in limited amounts as binders in certain standardized meat and poultry products, which led to an October 31, 2001, final rule (66 FR 54912). Without amending specific product standards of identity, the use of the approved ingredient is limited to non-standardized products only.

The Final Rule

FSIS is amending the general requirements of the regulations governing standards of identity and composition for meat and poultry products (9 CFR 319.1 and 381.155). A standard of identity prescribes the manner of preparation and the ingredients of a product that is to be called by a certain name. A standard of composition prescribes the quantity of ingredients, such as the minimum meat or poultry content, of a product. Numerous specific standards of identity and composition for meat and poultry products are set out in the regulations (9 CFR 319, subparts A-U and 381, subpart P). FSIS is adding to the general requirements a provision that will permit the use of any binder or antimicrobial agent if FDA and FSIS have found the ingredients to be safe and suitable in the production of products that are subject to such standards, and if the standards and other applicable regulations already allow the use of these types of ingredients in the preparation or processing of the products.

FSIS has determined that conducting rulemaking to amend individual food standards of identity to permit the addition of new ingredients on a case by case basis is not an efficient use of Agency resources and results in unnecessary delays for the use of safe and suitable binders and antimicrobial agents by meat and poultry establishments. Therefore, the objectives to be accomplished by this direct final rule is to provide for efficient use of Agency resources and to provide establishments greater flexibility in the formulation of meat and poultry products with a standard of identity and composition in 9 CFR parts 319 and 381 which already permit the use of ingredients of these types.

With the implementation of this direct final rule, establishments that prepare or process meat or poultry food products for which a standard of identity or composition provides for the use of binders or antimicrobial agents will be able to choose from a larger number of antimicrobial agents or binders than at present when formulating their products. Even though the standardized products will be permitted to contain these new antimicrobial agents or binders, the products will continue to be identified by the same standardized product names. The establishments thus would benefit from continued consumer acceptance of their products.

Executive Order 12988

This direct final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This direct final rule: (1) Preempts all state and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

Executive Order 12866 and Regulatory Flexibility Act

This direct final rule has been reviewed under Executive Order 12866. It has been determined to be not significant for purposes of E.O. 12866 and therefore, has not been reviewed by the Office of Management and Budget (OMB).

Effect on Small Entities

Costs associated with this direct final rule will be voluntary. Establishments can be expected to assume such costs only if it would be profitable for them to do so. The direct final rule will not mandate any changes in the way meat food or poultry products are produced or labeled. The rule will increase the availability to establishments of antimicrobial agents and binders that may be added to standardized meat food and poultry products without prolonged regulation development processes to amend food standards. Establishments that choose to prepare or process products that contain antimicrobial agents or binders will continue to incur the normal costs of production, labeling, and marketing.

This direct final rule will not impose any new requirement on small entities but will provide them with greater flexibility in the use in their products of antimicrobial agents and binders. The decision to use a new antimicrobial agent or binder in the production of standardized meat and poultry products is strictly voluntary. The rule could benefit as many as 1,150 federally inspected establishments. Most of these establishments—almost 900—are small operations, each employing fewer than 500 persons. If States operating meat or poultry inspection programs for products in intrastate commerce that are “equal to” the Federal program for products in interstate commerce issue similar regulatory amendments, an additional 1,100 establishments could benefit. Nearly all the State-inspected establishments are small business entities.

Paperwork Requirements

Abstract: Establishments choosing to take advantage of the flexibility of this rule by changing their product formulations to include different antimicrobial agents or binders would have to change their labels. In most cases, the label changes will be subject to the provisions for generically approved labeling in 9 CFR 317.5 and 381.133 because the changes will apply to products with standards of identity. That means that the label changes would not entail prior review and approval by FSIS before the new labels could be used. In most cases, the changes involved will be limited to changes in the statement of ingredients. A small percentage of the establishments affected by this rule may find that they need to revise and revalidate their HACCP plans.

Estimate of Burden: FSIS estimates that it will take at most one hour to develop a modified label. As many as 300 federally inspected establishments, principally establishments that manufacture products that are heat-treated, not-fully-cooked, and not shelf-stable would be more likely to consider changes, such as the addition or substitution of an antimicrobial agent, that might entail a reassessment of their HACCP plans. For example, an establishment wishing to add an antimicrobial to its product formulation, or substitute another approved antimicrobial for one that the establishment is already using, may have determined that such a change in product formulation would improve product safety. If so, FSIS estimates that it may take up to two hours for an establishment to reassess its HACCP plan as a result of a formulation change.

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 direct final rule, FSIS will announce it and make copies of this Federal Register publication available through the FSIS Constituent Update. FSIS provides a weekly Constituent Update, which is communicated via Listserv, a free e-mail subscription service. 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 Listserv 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 the Listserv and Web page, FSIS is able to provide information to a much broader, more diverse audience.

For more information contact the Congressional and Public Affairs Office, at [phone]. To be added to the free e-mail subscription service (Listserv) go to the “Constituent Update” page on the FSIS Web site at http://www.fsis.usda.gov/​oa/​update/​update.htm. Click on the “Subscribe to the Constituent Update Listserv” link, then fill out and submit the form.

List of Subjects

9 CFR Part 319

• Food Standards
• Meat Inspection

9 CFR Part 381

• Food Standards
• Poultry Inspection

For the reasons set out in the preamble, FSIS is amending 9 CFR part 319 and part 381 as follows:

PART 319—DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

Subpart A—General

1. The authority for Part 319 continues to read as follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

2. Section 319.1 is amended by designating the existing text as paragraph (a) and by adding a new paragraph (b) as follows:

§ 319.1

Labeling and preparation of standardized products.

(a) * * *

(b) Any binder or antimicrobial agent that has been found to be safe and suitable by the Food and Drug Administration and the Food Safety and Inspection Service may be used in the production of meat products with standards of identity in this part, where the product standards and applicable Federal regulations already permit the use of these types of ingredients.

PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS

Subpart P—Definitions and Standards of Identity or Composition

3. The authority for Part 381 continues to read as follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18, 2.53.

4. Section 381.155 is amended by adding a new paragraph (b) to read as follows:

§ 381.155

General.

* * * * *

(b) Any binder or antimicrobial agent that has been found to be safe and suitable by the Food and Drug Administration and the Food Safety and Inspection Service may be used in the production of poultry products with standards of identity in this part, where the product standards and applicable Federal regulations already permit the use of these types of ingredients.

Done at Washington, DC on: April 21, 2003.

Garry L. McKee,

Administrator.