[Federal Register Volume 63, Number 42 (Wednesday, March 4, 1998)]
[Proposed Rules]
[Pages 10722-10723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5416]
Federal Register / Vol. 63, No. 42 / Wednesday, March 4, 1998 /
Proposed Rules
[[Page 10722]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300605A; FRL-5776-2]
RIN 2070-AD20
Pesticides; FFDCA Jurisdiction over Food Packaging Impregnated
with an Insect Repellent Transferred to FDA
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
Summary: Elsewhere in today's Federal Register, EPA is issuing a direct
final rule which gives the Food and Drug Administration (FDA) sole
jurisdiction under the Federal Food, Drug, and Cosmetic Act (FFDCA) for
food packaging (e.g., paper and paperboard, coatings, adhesives, and
polymers) which is impregnated with an insect repellent. To effectuate
that transfer, the rule excepts certain inert ingredients from the
definitions of ``pesticide chemical'' and ``pesticide chemical
residue.'' Specifically, the exception applies to those inert
ingredients that are the components of the food packaging (e.g., paper
and paperboard, coatings, adhesives, and polymers) which is impregnated
with an insect repellent. Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA still regulates the food packaging
material impregnated with an insect repellent as an inert ingredient of
the pesticide product. EPA is issuing the action as a direct final rule
without prior proposal because the Agency believes that the action is
not controversial and will not result in any adverse comments. A
detailed rationale for the promulgation of the rule is set forth in the
direct final rule, along with the details of the rule. With this
corresponding action, EPA is providing an opportunity for the public to
submit adverse comment on this issue. If no relevant adverse comment is
submitted in response to this proposed rule, the direct final rule will
become effective without any further action by the Agency. If, however,
a relevant adverse comment is received during the comment period, the
direct final rule will be withdrawn and the public comments received
will be addressed in a subsequent final rule, or EPA may request
additional public comments. Any parties interested in commenting on
this action should do so at this time.
DATES: Comments must be received on or before April 3, 1998.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, deliver comments to:
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Follow the
instructions under Unit II. of this document. No Confidential Business
Information (CBI) should be submitted through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. A copy of the comment that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential will be included in the
public docket by EPA without prior notice.
FOR FURTHER INFORMATION CONTACT: By mail: Robert Torla, Biopesticides
and Pollution Prevention Division, Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: 5th Floor
Crystal Station, 2800 Crystal Drive, Arlington, VA, (703) 308-8098;
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
For detailed information about the action, see the direct final
rule which is published elsewhere in today's Federal Register.
II. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number ``300605'' (including comments and data submitted electronically
as described below). A public version of this record, including
printed, paper versions of electronic comments, which does not include
any information claimed as CBI, is available for inspection from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
official rulemaking record is located at the Virginia address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at: opp-
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number ``OPP-300605.'' Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
III. Regulatory Assessment Requirements
As an exception, this action does not impose any regulatory
obligations. Under Executive Order 12866 entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993), it has been determined that
this proposed rule is not ``significant'' and is not subject to OMB
review. This proposed rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et. seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). In addition, this action
does not involve any standards that would require Agency consideration
pursuant to section 12(d) of the National Technology Transfer and
Advancement Act (NTTAA) (Pub. L. 104-113).
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the
Agency hereby certifies that this regulatory action will not have a
significant economic impact on a substantial number of small entities,
because this regulatory action is an exemption and imposes no
regulatory obligations. EPA will provide this information to the Small
Business Administration's office of Advocacy upon request.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides
[[Page 10723]]
and pests, Reporting and recordkeeping requirements.
Dated: February 23, 1998.
Carol M. Browner,
Administrator.
[FR Doc. 98-5416 Filed 3-3-98; 8:45 am]
BILLING CODE 6560-50-F