[Federal Register Volume 60, Number 70 (Wednesday, April 12, 1995)]
[Proposed Rules]
[Pages 18560-18562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8732]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 8F3646 and FAP 8H5558/P611; FRL-4947-3]
RIN 2070-AC18
Sethoxydim; Pesticide Tolerance and Feed Additive Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to increase the established pesticide tolerance
for the combined residues of the herbicide sethoxydim (2-[1-
(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-
one) and its metabolites containing the 2-cyclohexen-1-one moiety
(calculated as the herbicide) in or on the raw agricultural commodity
sugar beet roots to 1.0 part per million (ppm) and to increase the
established feed additive regulation on the animal feed commodity
sugarbeet molasses to 10.0 ppm. The BASF Corp. requested these
regulations to establish the maximum permissible levels for residues of
the pesticide in or on the above commodities.
DATES: Comments, identified by the document control number, [PP 8F3646
and FAP 8H5558/P611], must appear on or before May 12, 1995.
ADDRESSES: By mail, submit written comments to: Public Response and
[[Page 18561]] Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW, Washington, DC 20460. In person, bring comments to: Rm.
1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (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 may be disclosed publicly by EPA without prior notice. All
written comments will be available for public inspection in Rm. 1132 at
the address given above, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product
Manager (PM-25), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 241, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6027; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal
Register of October 12, 1988 (53 FR 39783 and 39785), which announced
that BASF Corp., P.O. Box 13528, Research Triangle Park, NC 27709-3528,
had submitted pesticide petition (PP) 8F3646 and a feed additive
petition (FAP) 8H5558 to EPA. Pesticide petition 8F3646 requests that
the Administrator, pursuant to section 408(d) of the Federal Food, Drug
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), amend 40 CFR part 180 by
establishing a tolerance for the combined residues of the herbicide
sethoxydim (2-[1-ethoxyimino)butyl]-5- [2-(ethylthio)propyl]-3-hydroxy-
2-cyclohexen-1-one) and its metabolites containing the 2-cyclohexen-1-
one moiety (calculated as the herbicide)) in or on the raw agricultural
commodity (RAC) sugarbeet roots at 1.0 part per million (ppm). Feed
additive petition 8H5558 requests that the Administrator, pursuant to
section 409(e) of FFDCA (21 U.S.C. 348), amend 40 CFR part 186 by
establishing a feed additive regulation for the combined residues of
the herbicide sethoxydim and its metabolites containing the 2-
cyclohexen-1-one moiety (calculated as the herbicide) in or on the
animal feed sugar beet molasses at 5.0 ppm.
There were no comments or requests for referral to an advisory
committed received in response to these notices.
The petitioner subsequently amended the notice for FAP 8H5558 by
submitting a revised Section F proposing to increase the established
feed additive regulation to permit residues of sethoxydim in the animal
feed sugar beet molasses at 10.0 ppm. Because the 10.0 ppm has not been
proposed previously and because it has been longer than 5 years since
the original proposal, the tolerances of 1.0 ppm on sugar beet roots
and 10.0 ppm on sugar beet molasses are being proposed for 30 days to
allow for public comment.
The information submitted in the petitions and other relevant
material have been evaluated. The pesticide is useful for the purpose
for which the tolerances are sought. The toxicological data and other
information considered in support of PP 8F3646 and FAP 8H5558 are
discussed in the final rule referring to pesticide petitions (PP)
9F3855, 2F4121, and 4F4413, which appears elsewhere in the ``Rules and
Regulations'' section of this issue of the Fedral Register.
The reference dose (RfD) based on a NOEL of 8.86 mg/kg/day in the
1-year feeding study in dogs and an uncertainty factor of 100 was
calculated to be 0.09 mg/kg bwt/ day. The theoretical maximum residue
contribution (TMRC) for existing tolerances for the overall U.S.
population is 0.032904 mg/kg bwt/day or 36.5% of the RfD. The current
action will increase the TMRC by 0.000299 mg/kg bwt/day. These
tolerances and previously established tolerances utilize 36.8% of the
RfD for the overall U.S. population. For U.S. subgroup populations,
nonnursing infants and children aged 1 to 6, the current action and
previously established tolerances utilize, respectively, a total of
63.136 and 74.318% of the RfD, assuming that residue levels are at the
established tolerances and that 100% of the crop is treated.
Based on the information and the data considered, the Agency has
determined that the tolerances established by amending 40 CFR part 180
would protect the public health, and the establishment of a feed
additive regulation by amending 40 CFR part 186 would be safe.
Therefore, it is proposed that they be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide under the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended, which contains any of the ingredients
listed herein, may request within 30 days after publication of this
document in the Federal Register that this rulemaking proposal as it
relates to the section 408 tolerance be referred to an Advisory
Committee in accordance with section 408(e) of the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number [PP 8F3646 and FAP 8H5558/P611]. All written
comments filed in response to these petitions will be available in the
Public Response and Program Resources Branch, at the address given
above from 8 a.m. to 4 p.m., Monday through Friday, except legal
holidays.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order, i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB). Under section 3(f), the order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect of
the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities (also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President`s priorities, or the
principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance
requirements, or establishing or raising food/feed additive regulations
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950). [[Page 18562]]
List of Subjects in 40 CFR Parts 180 and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Feed additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: March 30, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that chapter I of title 40 of the Code of
Federal Regulations be amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as follow:
Authority: 21 U.S.C. 346a and 371.
b. In Sec. 180.412(a), by amending the table therein by revising
the entry for sugar beet, roots, to read as follows:
Sec. 180.412 2-[1-(Ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexen-1-one; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Part per
Commodity million
------------------------------------------------------------------------
* * * * *
Sugar beet, roots.......................................... 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read follows:
Authority: 21 U.S.C. 348.
b. In Sec. 186.2800, by revising the section heading and
introductory text and by amending the table therein by revising the
entry for sugar beet molasses, to read as follows:
Sec. 186.2800 2-[1-(Ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexen-1-one.
Tolerances are established for the combined residues of the
herbicide 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one and its metabolites containing the 2-cyclohexen-1-one
moiety (calculated as the herbicide) in or on the following
commodities:
------------------------------------------------------------------------
Part per
Food million
------------------------------------------------------------------------
* * * * *
Sugar beet molasses........................................ 10.0
* * * * *
------------------------------------------------------------------------
[FR Doc. 95-8732 Filed 4-11-95; 8:45 am]
BILLING CODE 6560-50-F