[Federal Register Volume 62, Number 202 (Monday, October 20, 1997)]
[Proposed Rules]
[Pages 54398-54399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27694]


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Proposed Rules
                                                Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 62, No. 202 / Monday, October 20, 1997 / 
Proposed Rules

[[Page 54398]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1240

[Docket No. 97N-0418]


Revocation of Lather Brushes Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

DATES: Written comments by January 5, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 19, 1949 (14 FR 278), the 
Federal Security Agency issued a regulation to prohibit ``interstate 
traffic'' in lather brushes unless the brushes complied with 42 CFR 
71.151 or with certain requirements in 42 CFR 72.21. 42 CFR 71.151 
barred importation of lather brushes made from animal hair or bristles, 
unless the brushes were permanently marked with the manufacturer's name 
or identifying mark and a U.S. medical officer had determined that the 
brushes were free of anthrax spores. The regulation also directed 
medical officers to sample brushes from each shipment, subject them to 
laboratory analysis, and to issue a certificate if the shipment 
appeared to be free of spores. If the shipment contained anthrax 
spores, the shipment would be denied entry into the United States.
    The Federal Security Agency was abolished in a reorganization in 
1953, and its functions were transferred to the then newly-created 
Department of Health, Education, and Welfare. The department later 
became the Department of Health and Human Services.
    42 CFR 72.21, which applied primarily to lather brushes 
manufactured in the United States, established specific treatment, 
sterilization, handling, storage, and marking requirements for these 
products; and it required that persons engaged in processing or 
handling of hair or bristles for use in lather brushes, as well as 
persons manufacturing lather brushes, permit inspections by authorized 
representatives of the Surgeon General. The rule was transferred, 
without change, from title 42 to title 21 of the Code of Federal 
Regulations on February 6, 1975 (40 FR 5620), and, as a result, became 
Sec. 1240.70 (21 CFR 1240.70).
    In the Federal Register of August 9, 1983 (48 FR 36143 at 36144), 
the Centers for Disease Control (CDC), now known as the Centers for 
Disease Control and Prevention, proposed to revoke various foreign 
quarantine regulations, including 42 CFR 71.151. The preamble to that 
proposal explained that:
    The proposed regulations will no longer require lather brushes 
made from animal hair or bristles, imported into the United States, 
to carry identifying markings or to be certified as treated and 
stored to prevent possible contamination with spores of Bacillus 
anthracis. No case of cutaneous anthrax in the United States has 
been associated with lather brushes since 1930, and the continuation 
of existing requirements is unnecessary to protect the public 
health. Should the importation of anthrax in lather brushes become a 
threat to public health in the future, inspection and control 
measures authorized under provisions of the regulations will be 
implemented.
 CDC revoked 42 CFR 71.151 on January 11, 1985 (50 FR 1516), without 
any further discussion.
    In the Federal Register of June 12, 1989 (54 FR 24890), FDA issued 
a final rule amending various regulations to correct outdated cross-
references and typographical errors and to make other corrections. This 
rule revised Sec. 1240.70, without explanation, to eliminate the 
reference to 42 CFR 71.151. Yet, in all other respects, Sec. 1240.70 
has remained essentially unchanged since 1949.
    Recently, FDA has been reexamining its regulations to determine 
whether any are obsolete or no longer necessary. One regulation that 
caught the agency's attention is Sec. 1240.70. The agency is unaware of 
any reliance on the lather brush requirements in this regulation or of 
any current concerns associated with lather brushes. Additionally, 
CDC's decision to remove 42 CFR 71.151 because no case of cutaneous 
anthrax in the United States has been associated with lather brushes 
since 1930 suggests that Sec. 1240.70 also is no longer necessary to 
protect the public health. Consequently, FDA is proposing to revoke 
this regulation.

II. Analysis of Impacts

    FDA has examined the impacts of the proposed 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). The agency believes that this proposed rule is consistent 
with the principles identified in the Executive Order. In addition, the 
proposed rule is not a significant regulatory action as defined by 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. The proposed rule, if finalized, would eliminate 
certain manufacturing requirements for lather brushes. Consequently, 
the proposed rule would not impose any additional regulatory burdens on 
small entities, and so, 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

[[Page 54399]]

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. Request for Comments

    Interested persons may, on or before January 5, 1998, 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 1240

    Communicable diseases, Public health, Travel restrictions, Water 
supply.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 1240 be amended as follows:

PART 1240--CONTROL OF COMMUNICABLE DISEASES

    1. The authority citation for 21 CFR 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: October 10, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-27694 Filed 10-17-97; 8:45 am]
BILLING CODE 4160-01-F