[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Rules and Regulations]
[Pages 66982-66983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33483]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
regulations that set forth the requirements for the carcinogenicity 
testing of compounds used in food-producing animals. The amended 
regulations will eliminate the specific requirement that a sponsor must 
conduct oral, chronic, dose-response studies. This action is intended 
to allow FDA and sponsors greater flexibility in choosing the types of 
studies used for testing the carcinogenicity of compounds used in food-
producing animals. The increased flexibility will make it easier and 
more economical for sponsors to complete required testing. These 
actions are part of FDA's continuing effort to achieve the objectives 
set forth in the President's ``National Performance Review'' 
initiative, which is intended to provide a comprehensive review of all 
rules in order to identify those that are obsolete and burdensome and 
to delete or revise them.

EFFECTIVE DATE: February 23, 1998.

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: 

I. Background

    In the Federal Register of June 20, 1996 (61 FR 31468), FDA 
proposed to revise the requirements for the carcinogenicity testing of 
compounds used in food-producing animals as set forth in Sec. 500.80(b) 
(21 CFR 500.80(b)) of the new animal drug approval regulations. The 
second sentence of Sec. 500.80(b) of the existing 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.'' The 
proposed rule would revise the existing language to eliminate the words 
``must be oral, chronic, dose-response studies and'' * * *.
    When the existing regulation was issued, a chronic study was the 
standard test for carcinogenicity. However, advances in models used to 
assess carcinogenicity have been made in recent years. For example, 
scientists now agree that a chronic study, as required under current 
regulations, may not measure the appropriate time point necessary to 
assess carcinogenicity for some compounds. Study designs other than a 
chronic study may result in a better evaluation of the compound in a 
number of cases.
    FDA recognized these scientific advances by proposing to remove the 
requirement for oral, chronic, dose-response studies so that sponsors 
would have the option of using other study designs when assessing the 
carcinogenicity of compounds used for food-producing animals. This 
proposed change would allow FDA and sponsors greater flexibility in 
choosing types of studies for testing the carcinogenicity of compounds 
used in food-producing animals, making it more economical and

[[Page 66983]]

easier for sponsors. No comments were received on the proposed rule.

II. Conclusion

    Because the agency has determined that the underlying rationale in 
support of the amendment remains sound and because no comments or other 
information were received suggesting any modification, the revisions 
set forth in the proposed rule have not been modified in the final 
rule. Accordingly, the final rule deletes the specific requirement that 
required a sponsor to conduct oral, chronic, dose-response studies.
    As stated in the proposal, this revision is consistent with the 
goals of the President's National Performance Review. The agency's 
actions are part of its continuing effort to achieve the objectives set 
forth in that initiative, which is intended to provide a comprehensive 
review of all rules in order to identify those that are obsolete and 
burdensome and to delete or revise them.

III. Environmental Impact

    FDA has carefully considered the potential environmental effects of 
this action and has determined that this action is categorically 
excluded under 21 CFR 25.30(h). This action revises the requirements 
for testing the carcinogenicity of compounds used for food-producing 
animals, but 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), 
and under the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 
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, and distributive impacts and equity). The Regulatory 
Flexibility Act requires agencies to examine the economic impact of a 
rule on small entities. The Unfunded Mandates Reform Act requires 
agencies to prepare an assessment of anticipated costs and benefits 
before enacting any rule that may result in an expenditure in any one 
year by State, local and tribal governments, in the aggregate, or by 
the private sector, of $100,000,000 (adjusted annually for inflation).
    This amendment to the regulations setting forth the requirements 
for the carcinogenicity testing of compounds used in food-producing 
animals will eliminate the specific requirement that a sponsor must 
conduct oral, chronic, dose-response studies, giving the agency and 
sponsors greater flexibility in choosing the types of studies used for 
testing the carcinogenicity of compounds used in food-producing 
animals. The resultant expanded flexibility will make it easier and 
less costly for sponsors to complete required testing.
    FDA concludes that this final rule is consistent with the 
principles set forth in the Executive order and in these two statutes. 
In addition, the agency has determined that this rule is not a 
significant regulatory action as defined by the Executive order and so 
is not subject to review under the Executive order. Because the final 
rule does not impose a mandate that results in an expenditure of $100 
million or more by State, local, and tribal governments in the 
aggregate, or by the private sector in any one year, a written 
statement and economic analysis are not required as prescribed under 
section 202(a) of the Unfunded Mandates Reform Act of 1995.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the rule will clarify FDA policy and 
simplify the process for submitting certain applications, the agency 
certifies that the 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.

V. Paperwork Reduction Act of 1995

    FDA has determined that this rule contains no collection of 
information requirements under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520).

VI. Federalism

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

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: 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) 
in the second sentence by removing the phrase ``must be oral, chronic, 
dose-response studies and''.

    Dated: December 17, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-33483 Filed 12-22-97; 8:45 am]
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