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sethoxydim (Poast) Proposed Tolerance 3/96

[Federal Register: March 1, 1996 (Volume 61, Number 42)]
[Notices]               
[Page 8185-8203]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9F3804/P646: FRL-5351-8]
RIN 2070-AB18
Sethoxydim; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document 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-cyclohexene-1-
one) and its metabolite containing the 2-cyclohexene-1-one (calculated 
as the herbicide) in or on the raw agricultural commodities (RACs): 
apricots, cherries (sweet and sour), nectarines, and peaches at 0.2 
part per million (ppm). These regulations to establish the maximum 
permissible levels for residues of the pesticide in or on the above 
commodities were requested in petitions submitted by BASF Corporation.
DATES: Comments, identified by the docket control number [PP 9F3804/
P646], must appear on or before April 1, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and 
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. Information submitted as a 
comment concerning this notice 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 4:30 p.m., Monday through Friday, excluding legal 
holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in Word Perfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [PP 9F3804/P646]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Electronic 
comments on this proposed rule may be filed online at many Federal 
Depository Libraries. Additional information on electronic submissions 
can be found below in this document.
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, telephone number, and e-mail address: Rm 241, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 305-6027; e-mail:
               taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal 
Register of January 9, 1990 (54 FR 779), which announced that BASF 
Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-3528, had 
submitted pesticide petition (PP) 9F3804 and a food additive petition 
(FAP) 8H 5559 to EPA. Pesticide Petition 9F3804 requests that the 
Administrator, pursuant to section 408 (d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346 a(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-cyclohexene-1-one) and its metabolites containing the 2-cyclohexene-
1-one moiety (calculated as the herbicide) in or on the crop grouping 
stone fruits at 0.2 part per million (ppm). Food additive petition 
8H5559 requests that the Administrator, pursuant to section 408 of 
FFDCA (21 U.S.C. 348), amend 40 CFR part 186 by establishing a food 
additive regulation for the combined residues of the herbicide 
sethoxydim; 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-
2-cyclohexene-1-one) and its metabolites containing the 2-cyclohexene-
1-one moiety (calculated as the herbicide) in or on the processed food 
dried prunes at 0.4 ppm.
    There were no comments or requests for referral to an advisory 
committee received in response to these notices.
    The petitioner subsequently amended these notices by submitting a 
revised section F withdrawing the proposed food additive tolerance on 
dried prunes at 0.4 ppm (8H5559) and proposing that tolerances for 
residues of the herbicide be established for the raw agricultural 
commodities (RACs) apricots at 0.2 ppm, cherries (sweet and sour) at 
0.2 ppm, nectarines at 0.2 ppm, and peaches at 0.2 ppm. Because the 0.2 
ppm tolerances on apricots, cherries (sweet and sour), nectarines at 
0.2 ppm and peaches have not been proposed previously and because it 
has been longer than five (5) years since the original proposal, the 
tolerances of 0.2 ppm on apricots, cherries (sweet and sour, 
nectarines, and peaches 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 9F3804 in the final rule 
referring to PP 4F4344, appear elsewhere in today's issue of the 
Federal 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 37% of the RfD. The current 
action will increase the TMRC by 0.000061 mg/kg bwt/day. These 
tolerances and previously established tolerances utilize 37.67% 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 64 
and 74.319% 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. Therefore, it is proposed that these 
tolerances 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 
docket control number [PP 9F3804/P646]. 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 
4:30 p.m., Monday through Friday, except legal holidays.
    A record has been established for this rulemaking under docket 
number [PP 9F3804/P646] (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 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
                    opp-docket@epamail.epa.gov
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official rulemaking, as well as the public version, as 
described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will also include all comments submitted 
directly in writing. The official rulemaking record is the paper record 
maintained at the address in "ADDRESSES" at the beginning of this 
document.
    Under Executive Order 12866 (58 FR 51735, October 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 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).
List of Subjects in 40 CFR Part 180
    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.
    Dated: February 20, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is proposed to be amended as follows:
PART 180--[AMENDED]
    1. The authority citation for part 180 continues to read as follows:
    Authority: 21 U.S.C. 346a and 371.
    2. In Sec. 180.412(a), by amending the table therein by adding and 
alphabetically inserting the new entries for apricots, cherries (sweet 
and sour), nectarines, and peaches to read as follows:
Sec. 180.412   2-[1-(Ethoxyimino)butyl]-5-[2-(ethiothio)propyl]-3-
hydroxy-2-cyclohexene-1-one; tolerances for residues.
    (a)  *  *  *
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                   Commodity                        Parts per million   
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                  *        *        *        *        *       
Apricots.......................................            0.2
                                                              
                  *        *        *        *        *       
Cherries (sweet and sour)......................            0.2
                                                              
                  *        *        *        *        *       
Nectarines.....................................            0.2
Peaches........................................            0.2
                                                              
                  *        *        *        *        *       
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