[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Proposed Rules]
[Pages 31468-31469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15725]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 500

[Docket No. 95N-0417]


Carcinogenicity Testing of Compounds Used in Food-Producing 
Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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[[Page 31469]]

SUMMARY: The Food and Drug Administration (FDA) is proposing to revise 
the regulation that sets forth the requirements for the carcinogenicity 
testing of compounds used in food-producing animals to allow the agency 
and sponsors greater flexibility when choosing the types of studies 
used for testing the carcinogenicity of compounds used in food-
producing animals. FDA is proposing to revise the study requirements 
because FDA recognizes that advances in models used to assess the 
carcinogenicity of compounds have been made. The specific requirement 
that a sponsor must conduct oral, chronic, dose-response studies would 
be deleted under the proposed regulation. Sponsors would have more 
options for testing the carcinogenicity of compounds used in food-
producing animals. This proposal implements the goals stated by the 
National Performance Review.

DATES: Written comments by September 3, 1996.

ADDRESSES: Written comments to the Dockets Managements Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. Comments should be identified with the docket 
number found in brackets in the heading of this document. Received 
comments may be seen at the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Margaret A. Miller, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0205.

SUPPLEMENTARY INFORMATION: Section 500.80(b) (21 CFR 500.80(b)) sets 
forth the requirements for the carcinogenicity testing of compounds 
used in food-producing animals. Specifically, the regulation states, 
``The bioassays that a sponsor conducts must be oral, chronic, dose-
response studies and must be designed to assess carcinogenicity and to 
determine the quantitative aspects of any carcinogenic response.''
    At the time that this regulation was written, a chronic study was 
considered to be the standard test for carcinogenicity. However, FDA 
recognizes that advances in models used to assess carcinogenicity have 
been made in recent years. For example, scientists now agree that, 
depending on the compound, a chronic study (as required under current 
regulations) may not measure the appropriate time point necessary to 
assess carcinogenicity. Study designs other than chronic may result in 
a better evaluation of the compound. Thus, FDA is proposing to remove 
the requirement for oral, chronic, dose-response studies to allow 
sponsors the option of using other study designs when assessing 
carcinogenicity of compounds used for food-producing animals.
    This proposal is aligned with the goals stated by the National 
Performance Review. This proposed rule is a result of the President's 
directive to conduct a comprehensive review of all rules to identify 
those that are obsolete and burdensome and to delete or revise them. 
The agency has determined that this rule is in need of revision as 
described herein.

I. Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has determined that this action is 
categorically excluded under 21 CFR 25.24(a)(8). The procedure for 
testing the carcinogenicity of compounds used for food-producing 
animals is being revised. This revision will not cause an increase in 
the existing level of use or cause a change in the intended uses of the 
product or its substitutes. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

II. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the proposed rule would clarify FDA policy 
and simplify the process for submitting certain applications, the 
agency certifies that the proposed rule will not have a significant 
economic impact on a substantial number of small entities. Therefore, 
under the Regulatory Flexibility Act, no further analysis is required.

III. Paperwork Reduction Act of 1995

    The agency has determined that this proposed rule contains no 
collection of information requirements under the Paperwork Reduction 
Act of 1995 (44 U.S.C. chapter 35).

IV. Federalism

    FDA has analyzed this proposal in accordance with the principles 
and criteria set forth in Executive Order 12612 and has determined that 
this proposal does not warrant the preparation of a Federalism 
Assessment.

V. Request for Comments

    Interested persons may, on or before September 3, 1996 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 are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

List of Subjects in 21 CFR Part 500

    Animal drugs, Animal feeds, Cancer, Labeling, Polychlorinated 
biphenyls (PCB's).
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
500 is amended as follows:

Part 500--General

    1. The authority citation for 21 CFR part 500 continues to read as 
follows:

    Authority: Secs. 201, 301, 402, 403, 409, 501, 502, 503, 512, 
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 
342, 343, 348, 351, 352, 353, 360b, 371).

Sec. 500.80  [Amended]

    2. Section 500.80 Scope of this subpart is amended in paragraph (b) 
by removing the phrase ``must be oral, chronic, dose-response studies 
and.''

    Dated: June 13, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-15725 Filed 6-19-96; 8:45 am]
BILLING CODE 4160-01-F