[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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