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Federal Register, Vol. 54, No. 75, April 20, 1989 (Rule) 21 CFR Part 58

AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES; Food and Drug

Administration; Food and Drug Administration.

DOC TYPE: Rules and Regulations
CFR: 21 CFR Part 58
NUMBER: Docket No. 89N-0054
Effective May 22, 1989; written comments by May 22, 1989.

CONTACT: Paul D. Lepore, Division of Compliance Policy
(HFC-230), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-2390.

Written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.

Final rule.

The Food and Drug Administration (FDA) is amending its regulations on good laboratory practice (GLP) for nonclinical laboratory studies to confirm the FDA policy that testing facilities are to use humane procedures for animal identification and experimentation. The agency has determined that toe clipping for animal identification is a potentially painful procedure and its use in animal studies should be discouraged. The amendment will not affect the intent of the regulatory requirements, which is to assure that animals used in nonclinical laboratory studies are appropriately identified.

In the Federal Register of December 22, 1978 (43 FR 59986), FDA published final regulations regarding GLP for nonclinical laboratory studies. These regulations, codified at 21 CFR Part 58, prescribe GLP for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with these regulations is intended to assure the quality and integrity of the safety data filed under provisions of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. (See 21 CFR 58.1(a).) The GLP regulations were amended in a final rule published on September 4, 1987 (52 FR 33768).

Section 58.90(d) of the GLP regulations provides, in pertinent part, that ''Warm-blooded animals, excluding suckling rodents, used in laboratory procedures * * * shall receive appropriate identification (e.g., tattoo, toe clip, color code, ear tag, ear punch, etc.) * * *.''

The need for requiring appropriate identification of the animals was discussed in the preamble to the proposed rule (November 19, 1976; 41 FR 51206 at 51214) and in the preamble to the final rule (December 22, 1978; 43 FR 59986 at 60004, par. 157). FDA has determined that appropriate identification is necessary to preclude animal mixups during a study. Such mixups in test animal identification could affect the validity of the study results. Paragraph 157 of the preamble to the final rule advised that, because of the varied nature of the tests and the test systems that could be used in a study, the precise manner of animal identification is left to the discretion of the test facility.

Elsewhere in the preamble to the final rule (par. 150), the agency stated that the humane care of test animals is a recognized and accepted scientific and ethical responsibility that is encouraged by various agency guidelines and the Animal Welfare Act. The agency also stated that the promulgation of the GLP regulations should foster the humane treatment of animals used in nonclinical laboratory studies.

In light of the foregoing, FDA listed in Sec. 58.90(d) examples of methods of animal identification which were considered to be appropriate and humane. At that time, toe clipping was considered to be appropriate and humane. Since then, an increasing number of veterinarians for laboratory animals have determined that toe clipping is potentially painful and that its use should be discouraged.

As a result, the Interagency Research Animal Committee, a group consisting of representatives from Federal agencies involved in the care, use, and conservation of animals used in biomedical research and testing, has recommended that a scientist wishing to use toe clipping of animals as a method of animal identification should obtain the approval of each facility's institutional animal care and use committee (the committee). Before giving its consent, the committee should be convinced that no other method of identifying the animals would be appropriate. The committee should also be convinced that anesthesia and antisepsis would be used so that the toe clipping procedure would be humane and conform to accepted veterinary procedures. The Interagency Research Animal Committee did not recommend prohibiting the use of toe clipping entirely, but did recommend restricting its use to situations where this method of identification is necessary. The interagency committee also recommended procedures for performing toe clipping if it is to be done.

FDA accepts the recommendations of the Interagency Research Animal Committee and believes that the use of toe clipping of animals in nonclinical laboratory studies should be discouraged in accordance with that group's recommendations. Accordingly, FDA is removing the words ''toe clip'' from the second parenthetical expression in Sec. 58.90(d). The amendment will eliminate the impression given by the current regulation that toe clipping is an approved and humane method of animal identification. The amendment will not affect the responsibility of testing facilities to use appropriate and humane methods of animal identification.

Under section 553(b) of the Administrative Procedure Act (5 U.S.C. 553(b) and FDA's administrative practices and procedures regulations (21 CFR 10.40(e)), the Commissioner finds that notice and public procedure for amending 21 CFR 58.90(d) are unnecessary and contrary to the public interest. FDA believes that this amendment will help to promote the humane treatment of laboratory animals. However, by removing one example from the list of examples of methods of identification given parenthetically in Sec.58.90(d), the agency is neither adding nor removing a regulatory requirement. That is, the substantive requirements of the GLP regulations are unchanged by this amendment. Therefore, the Commissioner finds good cause to proceed directly to a final rule.

Although the agency is publishing this final rule without an opportunity for prior notice and comment as a proposed rule, FDA is providing for comment on this final rule in accordance with Sec. 10.40(e)(1) of the agency's regulations (21 CFR 10.40(e)(1)).

Economic Impact

In accordance with Executive Order 12291, FDA has analyzed the potential economic effects of this final rule. The agency has determined that the rule is not a major rule as defined by the Order.

Environmental Impact

The agency has determined under 21 CFR 25.24(a)(10) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

Comments

Interested persons may, on or before May 22, 1989, submit to the Dockets Management Branch (address above) written comments regarding this proposal. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 58 Laboratories, Reporting and Recordkeeping requirements.

Therefore, under the Public Health Service Act as amended by the Radiation Control for Health and Safety Act of 1968 and under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, Part 58 is amended to read as follows:

PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

1. The authority citation for 21 CFR Part 58 is revised to read as follows:

Authority: Secs. 306, 402(a), 406, 408, 409, 502, 503, 505, 506, 507, 510, 512-516, 518-520, 701(a), 706, 801, Pub. L. 717, 52 Stat. 1045-1046 as amended, 1049-1053 as amended, 1055, 1058 as amended, 55 Stat. 851 as amended, 59 Stat. 463 as amended, 68 Stat. 511-517 as amended, 72 Stat. 1785-1788 as amended, 76 Stat. 794 as amended, 82 Stat. 343-351, 90 Stat. 539-574 (21 U.S.C. 336, 342(a), 346, 346a, 348, 352, 353, 355, 356, 357, 360, 360b-360f, 360h-360j, 371(a), 376, 381); secs. 215, 351, 354-360F, Pub. L. 410, 58 Stat. 690, 702 as amended, 82 Stat. 1173-1186 as amended (42 U.S.C. 216, 262, 263b-263n); 21 CFR 5.11.

Sec. 58.90 Amended

2. Section 58.90 Animal care is amended in paragraph (d) by removing the words ''toe clip,'' from the second parenthetical expression.

Dated: April 4, 1989.

Alan L. Hoeting