[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Rules and Regulations]
[Pages 26077-26078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12450]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1240

[Docket No. 97P-0418]


Revocation of Lather Brushes Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revoking its 
regulation pertaining to the treatment, sterilization, handling, 
storage, marking, and inspection of lather brushes. FDA is revoking 
this regulation because the regulation is no longer necessary to 
protect the public health.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Policy Development and 
Coordination Staff (HF-23), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3380.

DATES: This final rule is effective June 11, 1998.
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 20, 1997 (62 FR 54398), FDA 
proposed to revoke a regulation pertaining to the treatment, 
sterilization, handling, storage, marking, and inspection of lather 
brushes. The preamble to the proposal explained that the lather brush 
regulation was originally published in 1949 by the Federal Security 
Agency and was intended to prevent cases of cutaneous anthrax through 
lather brushes made from animal hair or bristles. A Government 
reorganization transferred the Federal Security Agency's functions to 
the then-Department of Health, Education, and Welfare (now known as the 
Department of Health and Human Services), and responsibility for the 
rule was later assigned, in 1975, to FDA. The rule was codified at 
Sec. 1240.70 (21 CFR 1240.70).
    FDA proposed to revoke the regulation because it was unaware of any 
reliance on the lather brush requirements or of any current concerns 
associated with lather brushes and because the regulation was no longer 
necessary to protect the public health. The proposal also noted that 
the then-Center for Disease Control (now the Centers for Disease 
Control and Prevention) revoked a similar lather brush regulation in 
1985 on the grounds that no case of cutaneous anthrax in the United 
States had been associated with lather brushes since 1930.
    FDA received no comments on the proposal. Consequently, this final 
rule revokes Sec. 1240.70.

II. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
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 final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
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 final rule eliminates certain 
manufacturing requirements for lather brushes, the agency certifies 
that the final 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. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

[[Page 26078]]

List of Subjects in 21 CFR Part 1240

    Communicable diseases, Public health, Travel restrictions, Water 
supply.
    Therefore, under the Public Health Service Act and under the 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1240 is amended as follows:

PART 1240--CONTROL OF COMMUNICABLE DISEASES

    1. The authority citation for part 1240 continues to read as 
follows:

    Authority: 42 U.S.C. 216, 243, 264, 271.

Sec. 1240.70  [Removed]

    2. Section 1240.70 Lather brushes is removed.

    Dated: May 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-12450 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F