[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
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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
