[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]



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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.

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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
                                                                        
                  *        *        *        *        *                 
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* * * * *

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
                                                                        
                  *        *        *        *        *                 
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[FR Doc. 95-8732 Filed 4-11-95; 8:45 am]
BILLING CODE 6560-50-F