[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Rules and Regulations]
[Pages 14637-14639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8145]



40 CFR Part 60
CFR Correction
    In title 40 of the Code of Federal Regulations, part 60, revised as 
of July 1, 1995, make the following correction:
Sec. 60.62  [Corrected]
    On page 127, in Sec. 60.62 remove paragraph (a)(3).
BILLING CODE 1505-01-D
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR PART 180

[PP 4F4322/R2217; FRL-5356-4]
RIN 2070-AB78


Pesticide Tolerance for Tribenuron Methyl

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: This rule establishes tolerances for residues of the herbicide 
tribenuron methyl (methyl-2[[[[N-(4-methoxy-6-methyl-1,3,5-triazin-2-
yl) methylamino] carbonyl]amino]sulfonyl] benzoate) in or on the raw 
agricultural commodities (RACs) hay of grass forage, fodder and hay 
group (excluding Bermudagrass) at 0.10 ppm; and forage grass forage, 
fodder and hay group (excluding Bermudagrass) at 0.10 ppm. This 
regulation to establish a maximum permissible level for residues of 
tribenuron methyl was requested in a petition submitted by E.I. DuPont 
de Nemours Company, Inc. Agricultural Products, Walker Mill, Barley 
Mill Plaza, P.O. Box 80038. Wilmington, DE 19880-0038.
EFFECTIVE DATE: April 3, 1996.
ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [PP 4F4322/R2217], may be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. A copy of any objections and hearing requests 
filed with the Hearing Clerk should be identified by the docket number 
and submitted 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 copies of objections and hearing requests to Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees 
accompanying objections shall be labeled ``Tolerance Petition Fees'' 
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. An electronic 
copy of objections and hearing requests filed with the Hearing Clerk 
may be submitted to OPP by sending electronic mail (e-mail) to: opp-
[email protected]
    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [PP 4F4322/R2217]. No 
Confidential Business Information (CBI) should be submitted through e-
mail. Copies of electronic objections and hearing requests on this rule 
may be filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found in the SUPPLEMENTARY 
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne Miller, Product 
Manager (23) Registration Division (7505C), Office of Pesticide 
Programs. Environmental Protection Agency, 401 M St. SW., Washington, 
DC 20460. Office location and telephone number: Rm. 237, CM #2, 1921 
Jefferson Davis Highway, Arlington, VA 22202, 703-305-6224.
SUPPLEMENTARY INFORMATION: EPA issued a notice of filing, published in 
the Federal Register of July 13, l994 (59 FR 35719), which announced 
that DuPont, Agricultural Products, Walker's Mill, Barley Mill Plaza 
P.O. Box 80038, Wilmington, DE had submitted a pesticide petition, PP 
4F4322, to EPA requesting that the Administrator, pursuant to section 
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d), establish tolerances for combined residues of the herbicide 
tribenuron methyl (methyl-2[[[[N-(4-methoxy-6-methyl 1,3,5-triazin-2-
yl) methylamino] carbonyl]amino]sulfonyl]benzoate in or on grass, seed; 
grass seed straw; grass, seed cleanings (screenings) at 0.04 ppm. A 
second notice of filing was issued on February 1, l996, published in 
the Federal Register (61 FR 3696), which announced that DuPont had 
amended the petition by revising the requested tolerances to read: in 
or on the raw agricultural commodities hay of grass forage, fodder and 
hay group (excluding Bermudagrass) at 0.10 ppm; forage of grass forage, 
fodder and hay group (excluding Bermudagrass) at 0.10 ppm and forage 
regrowth at 0.10 ppm. The analytical method for determining residues is 
high performance liquid

[[Page 14638]]

chromatography with photo-conductivity detection.
    There were no comments received in response to the notices of 
filing. The scientific data submitted in the petition and other 
relevant material have been evaluated. The toxicological data 
considered in support of the proposed tolerances include:
    1. The following acute studies with tribenuron methyl (DPX-L5300):
        Acute Oral, Rat: LD50 >5,000 mg/kg, Toxicity Category IV.
        Acute Dermal, Rabbit: LC50 >2000 mg/kg, Toxicity Category 
IV.
        Acute Inhalation, Rat: >6.7 mg/L/4hr, Toxicity Category IV.
        Primary Eye Irritation, Rabbit: Toxicity Category IV.
        Primary Dermal Irritation, Guinea Pig: Toxicity Category IV.
        Dermal Sensitiation, Guinea Pig: nonsensitizing.
    2. A 3-month feeding study, Rat: No-observed-effect-level (NOEL) = 
7/8 mg/kg/day and Lowest effect level (LEL) = 118/135 mg/kg/day. 
Toxicity observed: decreased body weight gain, food consumption and 
food efficiency; decreased absolute heart, liver, and kidney weights; 
increased relative brain, heart, liver, kidney, testes, and spleen 
weights; decreased serum glucose and globulin; no histopathologic 
lesions; likely cachexia.
    3. A 3-month feeding study, Dog: NOEL = 73.3/78.0 mg/kg/day (HDT).
    4. A 28-day dermal, Rabbit; The limit dose, 1,000 mg/kg/day, 
resulted in serious toxicity and death, NOEL and LEL could not be 
defined. Toxicity included treatment site lesions, hypokinesia, 
decreased body weights and food consumption, and kidney pathology, but 
the cause of death could not be determined. Although the study was Core 
Supplementary, another study is not needed. Worker expsure is expected 
to be 4 to 5 orders of magnitude less than the limit dose.
    5. Chronic feeding, Dog: NOEL (females) = 0.79 mg/kg/day, NOEL 
(males) = 8.16 mg/kg/day; LEL (males) = 8.18 mg/kg/day, with elevated 
serum bilirubin, AST, and urinary volume, and LEL (females) = 52.02 mg/
kg/day with increased serum creatinine, bilirubin, AST, and globulin, 
decreased body weight gain of 18.2%.
    6. Carcinogenicity, Mouse: NOEL (males) = 3 mg/kg/day and LEL 
(males) = 30 mg/kg/day, with bilateral seminiferous degeneration and 
oligospermia. Although frank toxicity was not observed in the females, 
Health Effects Division (HED) peer review judged the dose levels to be 
adequate. There was no evidence of carcinogenicity.
    7. Developmental toxicity, Rat: Maternal NOEL = 20 mg/kg/day; 
Maternal LEL = 125 mg/kg/day, with decreased maternal body weight gain 
and food consumption; Developmental NOEL = 20 mg/kg/day; Developmental 
LEL = 125 mg/kg/day, with decreased body weight; at 500 mg/kg/day (HDT) 
there were increased resorptions, fetal deaths, and incomplete 
ossification.
    8. Developmental toxicity, Rabbit: Maternal NOEL = 20 mg/kg/day, 
Maternal LEL = 80 mg/kg/day (HDT - decreased food consumption, 
increased abortions); Developmental NOEL = 20 mg/kg/day, Development 
LEL = 80 mg/kg/day (HDT - 10% decrease in body weight compared to 
controls, not statistically significant). Abortions were increased at 
89 mg/kg/day. No terata were observed.
    9. 2-generation reproduction, Rat: Paternal NOEL = 2.0 mg/kg/day, 
Paternal LEL = 21.0 mg/kg/day, with decreased body weight gain in F1a 
adult females; Reproductive NOEL = 2.5 mg/kg/day, Reproductive LEL = 25 
mg/kg/day, with decreased body weight gain during lactation for F1b and 
F2b pups.
    10. Chronic feeding/carcinogenicity, Rat: NOEL = 0.95/1.2 mg/kg/
day, LEL = 10/13 mg/kg/day, with decreased body weight gain in both 
sexes. Statistically significant increase in mammary gland 
adenocarcinomas in female rats at 76 mg/kg/day, HDT. Health Effects 
Division Peer Review Committee classified tribenuron methyl a Category 
C (possible human carcinogen) under EPA's cancer assessment guidelines.
    11. Gene mutation: Ames Assay: Negative for Salmonella strains 
TA97, TA98, TA100 and TA1535 with and without metabolic activation.
    12. Structural chromosome: Micronucleus Assay in Mouse Bone Marrow. 
Negative at a cytotoxic dose. In vivo Cytogenetic Assay in Rat. 
Negative.
    13. Other genotoxic effects: In vitro Point Mutation in CHO Cells. 
Negative.
    14. Unscheduled DNA synthesis in rats. Negative.
    15. Metabolism: Rats given a single dose of 20 or 1,800 mg/kg 
excreted 99% or 97%, respectively, of radiolabel within 96 hours. The 
major route of excretion is the urine (2 to 4 times the amount excreted 
in feces). No more than 1% of radiolabel was found in any one tissue or 
organ 7 days. Major metabolites in the urine and feces included 
metsulfuron methyl, saccharin, and O-dimethyl triazine amine. The two 
major metabolic routes are the demethylation of the carbamoyl methyl 
group and the hydrolysis of the carbamate moiety.
    16. Estrogenic Activity in Rats: Weak estrogenic activity was 
observed in female rats.
    The Reference Dose (RfD) is established at 0.008 mg/kg/day, based 
on the 1 year dog feeding study NOEL of 0.79 mg/kg/day and an 
uncertainty factor of 100. The NOEL is taken from a 1 year feeding 
study in dogs which demonstrated as an effect elevated serum bilirubin 
and AST levels. The result from the EPA Dietary Risk Evaluation System 
for chronic analysis of dietary risk from all raw agricultural 
commodities (RACs) for which tolerances have been established (40 CFR 
180.451) was published (FRL-4759-4) in the Federal Register (59 FR 
17755, April 14, l994). Based on the information published the 
Theoretical Maximum Residue Contribution (TMRC) for the general 
population is now estimated to be 7.8  x  10-5 mg/kg bwt/day, or 
1% of the RfD (viz. 0.97). The addition of forage and hay of grasses 
associated with the use of tribenuron methyl in the culture of grass 
seeds in the states of Washington, Oregon and Idaho under a regional 
registration will not increase the risk by more than a fraction of 1%, 
because of the low potential for transfer of residues of tribenuron 
methyl in ruminants. In a lactating goat study with labeled tribenuron 
methyl at a level of 6.7 ppm there was a total of 0.5% of the 
administered dose found in the assayed tissues and organs. Based on 
this low potential for transfer of residues to tissues, the Agency has 
concluded that feeding studies and animal tolerances for tribenuron 
methyl are not required. The proposed tolerances for grass RACs are at 
the same level as established for barley, oats, and wheat straw in 
ruminant diets, the proposed tolerances for the grass RACs will not 
increase the dietary burden for residues of tribenuron methyl in 
ruminants. Therefore no tolerances are needed for secondary residues in 
animal tissues and in milk. There are no human dietary RACs associated 
with the proposed registration of tribenuron methyl for use in the 
production of grass seed.
    Tribenuron methyl is considered a class C carcinogen with no 
Q* established for quantification of potency. EPA considers the 
cancer risk from exposure to tribenuron methyl from use as registered 
under the Federal Insecticide, Fungicide and Rodenticide Act as amended 
to be negligible.
    The petitioner requested a petition for tolerances with regional 
registration based on the claim that the pesticide would not be used in 
grass seed production areas other than in the state of Washington, 
Oregon, and Idaho,

[[Page 14639]]
because of the culture practices in those state. Residue chemistry data 
supporting this regulatory action were limited to data from the Pacific 
Northwestern states mentioned above.
    An adequate analytical method, high performance liquid 
chromatography with photo-conductivity detection, is available for 
enforcement purposes.
    There are presently no actions pending against the continued 
registration of this chemical. The pesticide is considered useful for 
the purpose for which the tolerances are being sought.
    Based on the information and data considered, the Agency has 
determined that the tolerances established by amending 40 CFR 180.451 
will protect the public health. Therefore the tolerances are 
established as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register,file 
written objections to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed with 
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy 
of the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines tht the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issue(s) in the manner sought by the requestor would be 
adequate to justify the action requested (40 CFR 178.32).
    EPA has established a record for this rulemaking under docket 
number [PP-4F4322/R2217] (including any comments and data submitted 
electronically). 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 may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.
    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 on 
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 
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: March 22, 1996.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is 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. 180.451 by revising the section heading to read as set 
forth below, designating the existing text as paragraph (a), and by 
adding a new paragraph (b), to read as follows:


Sec. 180.451  Tribenuron methyl; tolerances for residues.

    (a) *       *      *      
    (b) Tolerances with regional registration, as defined in 
Sec. 180.1(n) are established for residues of the herbicide tribenuron 
methyl (methyl-2-[[[[N-(4-methoxy-6-methyl-1,3,5- triazin-2-yl) 
methylamino] carbonyl]amino]sulfonyl]benzoate) in or on the following 
raw agricultural commodities:

------------------------------------------------------------------------
                                                                  Parts 
                           Commodity                               per  
                                                                 million
------------------------------------------------------------------------
Grass forage, fodder and hay group (except Bermudagrass);               
 forage........................................................    0.10 
Grass forage, fodder and hay group (except Bermudagrass); hay..    0.10 
------------------------------------------------------------------------


[FR Doc. 96-8145 Filed 4-2-96; 8:45 am]
BILLING CODE 6560-50-F