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prosulfuron (Exceed) Proposed Tolerance 4/96

[Federal Register: April 17, 1996 (Volume 61, Number 75)]
[Notices]               
[Page 16782-16784]
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DEPARTMENT OF TRANSPORTATION
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4469/P650; FRL-5357-5]
RIN 2070-AB18
Prosulfuron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish time-limited tolerances for residues 
of the herbicide prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-yl)-3-[2-
(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea in or on the raw 
agricultural commodities cereal grains group (except rice and wild 
rice), grain at 0.01 part per million (ppm); cereal grains group 
(except rice and wild rice), forage at 0.10 ppm; cereal grains group 
(except rice and wild rice), fodder at 0.01 ppm, cereal grains group 
(except rice and wild rice), straw at 0.02 ppm; and cereal grains group 
(except rice and wild rice), hay at 0.20 part per million (ppm). The 
Agency has not completed the regulatory assessment of our science 
findings; therefore, the Agency is proposing these tolerances with an 
expiration date.
DATES:  Written comments, identified by the docket number [PP 5F4469/
P650] should be submitted to EPA by May 17, 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 Highway, 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 should not be submitted 
through e-mail. Information marked as CBI 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 WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [PP 5F4469/P650]. 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), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 245, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA 22202, 703-305-6800, e-mail: 
                    taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice of filing published in 
the Federal Register of (60 FR 27505, May 24, 1995) which requested 
tolerances for residues of the herbicide prosulfuron, 1-(4-methoxy-6-
methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea 
in or on the raw agricultural commodities cereal grains (except rice/
wild rice) group at 0.02 part per million (ppm), and cereal grains, 
forage, fodder and straw (except rice/wild rice) group at 0.02 part per 
million (ppm). The petitioner subsequently amended this petition by 
submitting a revised section F which proposed tolerances in or on the 
raw agricultural commodities cereal grains group (except rice and wild 
rice), grain at 0.01 part per million (ppm); cereal grains group 
(except rice and wild rice), forage at 0.10 ppm; cereal grains group 
(except rice and wild rice), fodder at 0.01 ppm; cereal grains group 
(except rice and wild rice), straw at 0.02 ppm; and cereal grains group 
(except rice and wild rice), hay at 0.20 part per million (ppm). These 
tolerances with an expiration date are required by EPA to allow the 
petitioner, Ciba-Geigy Corp. to submit additional data concerning the 
method trial, plant metabolism and ruminant metabolism data. The 
petitioner has submitted a method trial and it has been validated by an 
independent laboratory. Additional time is being required to complete 
review of this method trial and allow additional time to complete and 
submit the required plant and animal metabolism data and new 
developmental rabbit study with an accompanying overview (discussion of 
all the rabbit developmental data, yet to be submitted by the 
registrant).
    There were no comments or requests for referral to an advisory 
committee received in response to the notice of filing.
    The data submitted in the petition and other relevant material have 
been evaluated. The toxicology data listed below were considered in 
support of this tolerance.
    1. Several acute toxicology studies placing technical grade 
prosulfuron in Toxicity Category III, and an acute neurotoxicity study 
in rats at dose levels of 0, 10, 250, 500, or 1,000 mg/kg with a NOEL 
of 10 mg/kg based on reduced motor activity and body temperature in 
males and impaired righting reflex in females. A 90 day neurotoxicity 
study in rats demonstrated NOELs of >5,000 ppm in females and 10,000 
ppm in males and 200 ppm for systemic toxicity.
    2. A 1-year feeding study with dogs fed dosages of 0, 0.33, 1.95, 
18.6 or 41.0 mg/kg/day (males) and 0, 0.31, 1.84, 20.2, or 48.8 mg/kg/
day (females). The NOEL was 1.84 mg/kg/day based on hematologic and 
clinical chemistry effects and incidence of lipofuscin accumulation in 
the liver at 18.6 mg/kg/day.
    3. An 18-month carcinogenicity study in mice fed dosages of 0, 
1.71, 81.4, 410 or 832 mg/kg/day (males), and 0, 2.11, 100, 508 or 
1,062 mg/kg/day (females). There was no evidence of carcinogenic 
effects up to 1,062 mg/kg/day, the highest dose tested (HDT).
    4. A 2-year chronic feeding/carcinogenicity study in rats fed 
dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or 
205.8 mg/kg/day (females). There was uncertain evidence of 
carcinogenicity with slight increases in the incidence of mammary gland 
adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase 
in incidence of benign testicular interstital cell tumors at 79.9 and 
160.9 mg/kg/day (significant trend only). A systemic NOEL of 7.9 mg/kg/
day was based on decreased body weight and body weight gain, 
hematopoietic effects (males), and possibly increased serum GGT and 
decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/
day.
    5. A multigeneration reproduction study with rats fed dosages of 0, 
0.67, 13.3, 136 or 278 (males), and 0, 0.76, 15.3, 152 or 311 mg/kg/day 
(females) with a reproductive and a systemic NOEL of 13.3 mg/kg/day 
based on decreased mean body weights and body weight gain observed at 
136 mg/kg/day for both pups (at 200 ppm beginning during lactation) and 
parental animals.
    6. A developmental toxicity study in rats at dose levels of 0, 5, 
50, 200 and 400 mg/kg/day by gavage. The developmental NOEL was 200 mg/
kg/day based on a statistically significant elevation of combined 
skeletal findings at 400 mg/kg/day, and maternal toxicity NOEL of 200 
mg/kg/day, based on marginal effects on body weight gain at 400 mg/kg/
day.
    7. A developmental toxicity study in rabbits at dose levels of 0, 
1.0, 10 and 100 mg/kg/day by gavage with no indications of developmental 
toxixicy at dose levels up to 100 mg/kg/day. A new rabbit developmental study 
has received preliminary evaluation. Based upon this evaluation, the maternal 
NOEL appears to be 20 mg/kg/day. The developmental NOEL can not be determined 
without a complete evaluation of this study. However, it is unlikely that the 
NOEL would be less than 20 mg/kg/day in this study. A data gap remains for the 
rabbit developmental until this study, all other as yet unsubmitted 
deveopmental studies (both rangefinding and definitive) and an accompanying 
overview (discussion of all the rabbit developmental data, yet to be submitted 
by the registrant) has been completely evaluated and approved by the Agency.
    8. Three acceptable mutagenicity studies were reviewed for 
prosulfuron. These include assays with Salmonella typhimurium strains 
TA1535 TA1537, TA98, and TA100 or E. coli WP2 uvrA exposed in either 
the presence or absence of mammalian metabolic activation; unscheduled 
DNA synthesis (UDS) in primary rat hepatocytes; and a structural 
chromosomal aberration micronucleus test in mice. All these tests were 
negative for mutagenicity.
    The prosulfuron Reference Dose (RfD) was established at 0.02 mg/kg/
day based on a NOEL of 1.84 mg/kg bwt/day on the 1-year dog chronic 
feeding study with an uncertainty factor of 100. The theoretical 
maximum residue contribution (TMRC) for tolerances on the cereal grains 
group, straw, forage and hay, and milk, meat and meat by-products 
utilizes 1.5% of the RfD for the total U.S. population. The most highly 
exposed subgroups, children (1 to 6) and non-nursing infants (less than 
one year old), utilize 4.4% of the RfD.
    The HED RfD/Peer Review Committee classified this chemical as a 
Class D oncogen based on the conclusion that there was uncertain 
evidence of carcinogenicity with slight increases in the incidence of 
mammary gland adenocarcinomas in female rats at 95.7 and 205.8 mg/kg/
day, but significant only at 95.7 mg/ kg/day, a slight increase in 
incidence of benign testicular interstital cell tumors in rats at 79.9 
and 160.9 mg/kg/day, and no evidence of carcinogenicity in mice.
    The committee also decided that prosulfuron was not associated with 
any significant reproductive or develpmental toxicity under the 
conditions of testing. However, this evaluation does not include 
evaluation of the new rabbit developmental study (already at EPA) or 
any other rabbit developmental studies that have been conducted but not 
yet submitted by the registrant.
    Data which are desirable include the submission of stability data 
(storage and chemical), information on accuracy of the method used to 
verify the certified limits, experimental details of all solubility 
determinations, and additional plant and ruminant metabolism data.
    Based on the information cited above, the Agency has determined 
that when used in accordance with good agricultural practice, this 
ingredient is useful and the tolerances will protect the public health. 
Therefore, EPA is proposing to establish the tolerances as described 
below.
    Any person who has registered or submitted an application for 
registration of a pesticide, under the Federal Insecticide, Fungicide, 
and Rodenticide Act (FIFRA), as amended, which contains any of the 
active ingredients listed herein, may request within 30 days after 
publication of this notice in the Federal Register that this rulemaking 
proposal be referred to an Advisory Committee in accordance with 
section 408(e) of the Federal Food, Drug, and Cosmetic Act.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
docket number [PP 5F4469/P650]. All written comments filed in response 
to this petition will be available in the Public Response and Program 
Resources Branch, at the Virginia address given above from 8 a.m. to 
4:30 p.m., Monday throught Friday, except legal holidays.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any or all of that information as 
"Confidential Business Information'' (CBI). EPA will not disclose 
information so marked, except in accordance with procedures set forth 
in 40 CFR part 2. A second copy of such comments, with the CBI deleted, 
must also be submitted for inclusion in the public record. EPA may 
publicly disclose without prior notice information not marked 
confidential.
    EPA has established a record for this proposed rule under docket 
number [PP-5F4469/P650] (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 4:00 p.m., Monday through Friday, except 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
    The official record for this proposed rule, 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 place the paper copies in the 
official proposed rule record which will also include all comments 
submitted directly in writing. The official proposed rule record is the 
paper record maintained at the "ADDRESSES'' listed at the beginning of 
this document.
    The Office of Management and Budget has exempted this rule from the 
requirements of section 3 of Executive Order 12866.
    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 food 
additive regulations or establishing exemptions from tolerance 
requirements 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: April 3, 1996.
Susan Lewis,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR part 180 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. By revising Sec. 180.481 to read as follows:
Sec. 180.481   Prosulfuron; tolerances for residues.
    Tolerances that expire on December 31, 1999 are being established for 
residues of the herbicide prosulfuron 1-(4-methoxy-6-methyl-triazin-2-yl)-3-
[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea in or on the following raw 
agricultural commodities:
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                                                                  Parts 
                           Commodity                               per  
                                                                 million
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Cereal grains group (except rice and wild rice), grain.........    0.01 
Cereal grains group (except rice and wild rice), forage........    0.10 
Cereal grains group (except rice and wild rice), fodder........    0.01 
Cereal grains group (except rice and wild rice), straw.........    0.02 
Cereal grains group (except rice and wild rice), hay...........    0.20 
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