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sulfonium Pesticide Tolerance 3/96

[Federal Register: March 8, 1996 (Volume 61, Number 47)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9F3796, 5E4479, 4F4343, 0F3890, 0F3860 and 1F3950/R2212; FRL-5353-4]
RIN 2070-AB78
Pesticide Tolerances for Sulfonium, trimethyl-salt with N-
  (phosphonomethyl)glycine (1:1)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes permanent tolerances for residues of the 
herbicide sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine 
(1:1) [formerly glyphosate-trimesium/ sulfosate] in or on the raw 
agricultural commodities almond hulls, imported bananas, the citrus 
fruit group, grapes and the tree nut group. In addition, this 
regulation establishes a two year time-limited tolerance for residues 
of this herbicide on the raw agricultural commodities corn, and 
animals. The regulations to establish a maximum permissible level for 
residues of the herbicide was requested in several petitions submitted 
by Zeneca AG Products.

EFFECTIVE DATE: This regulation becomes effective March 8, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 9F3796, 5E4479, 4F4343, 0F3890, 0F3860 and 
1F3950/R2212], 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 document control 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 copy 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-docket@epamail.epa.gov

    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 9F3796, 5E4479, 
4F4343, 0F3890, 0F3860 and 1F3950/R2212]. 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 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 and telephone number: Rm. 241, CM #2, 1921 Jefferson Davis Highway, 
Arlington, VA 22202 (703) 305-6027; e-mail:
                taylor.robert@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued the following notices (PF-643; 
FRL-4986-8), published in the Federal Register of November 15, 1995, 
(60 FR 57422) which announced that Zeneca AG Products, 1800 Concord 
Pike, P.O. Box 15458, Wilmington, DE 19850-5458, had submitted 
pesticide petitions 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 a tolerance for the residues of the 
herbicide sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine 
(1:1) [formerly glyphosate-trimesium/ sulfosate, in or on certain raw 
agricultural commodities:
    1. PP 0F3890. Originaly published in the Federal Register of 
January 16, 1991 (56 FR 1632), the notice proposed establishing a 
regulation to permit residues of the herbicide sulfonium, trimethyl-
salt with N-(phosphonomethyl)glycine (1:1) in or on the citrus fruit 
group at 0.5 ppm. The November 15, 1995 notice amended this petition by 
proposing a regulation to permit residues in or on the raw agricultural 
commodities citrus fruits at 0.05 ppm.
    2. PP 1F3950. Originally published in the Federal Register of April 
3, 1991 (56 FR 13642), the notice proposed establishing a regulation to 
permit residues of the herbicide sulfonium, trimethy-salt with N-
(phosphonomethyl)glycine (1:1) in or on grapes at 0.2 ppm. The November 
15, 1995 notice amended the petition by proposing to establish a 
regulation to permit the residues of the herbicide in or on raw 
agricultural commodity grapes at 0.1 ppm.
    3. PP 4F4343. Proposed establishing a regulation to permit residues 
of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) in or on the tree nut group at 0.05 ppm 
and almond hulls at 2.00 ppm (of which no more than 0.5 ppm is 
trimethylsulfonium). However, based on the available residue data, the 
appropriate tolerance for almond hulls is 1.0 ppm (of which no more 
than 0.3 ppm is trimethylsulfonium). Zeneca AG Products have 
resubmitted a revised Section F for this petition.
    4. PP 9F3796. Published in the Federal Register of April 12, 1990, 
(55 FR 13829), the notice proposed establishing a regulation to permit 
residues of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) in or on corn grain at 0.1 parts per 
million (ppm) and corn forage and corn fodder at 0.2 ppm.
    5. PP 5E4479. Proposed establishing a regulation to permit residues 
of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) in or on imported bananas at 0.05 parts 
per million (ppm).
    6. PP 9F3796. Originally published in the Federal Register of April 
12, 1990, (55 FR 13829), the notice proposed establishing a regulation 
to permit residues of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) in or on corn grain at 0.1 parts per 
million (ppm) and corn forage and corn fodder at 0.2 ppm. This petition 
was amended by the November 15, 1995 notice by proposing to establish 
tolerances in or on corn grain at 0.2 ppm (of which no more than 0.10 
is trimethylsulfonium); corn fodder at 0.3 ppm (of which no more than 
0.20 is trimethylsulfonium); and corn forage at 0.1 ppm.
    7.  PP 0F3860. Published in the Federal Register of November 15, 
1995 (60 FR 57423), the notice proposed establishing a regulation to 
permit residues of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) in or on the raw agricultural 
commodities for animals as part of the soybean petition for milk and 
meat at 0.2 ppm, meat by-products at 1.00 ppm, fat at 0.10 ppm of 
cattle, goats, hogs, horses and sheep; eggs at 0.02 ppm, poultry fat, 
poultry liver and poultry meat at 0.05 ppm; and poultry meat by-
products (except liver) at 0.10 ppm.
    There were no comments or requests for referral to an advisory 
committee received in response to these 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 tolerance include:
    1. Several acute toxicology studies placing technical grade 
sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine (1:1) in 
Toxicity Category III and Toxicity Category IV.
    2. A subchronic feeding study with dogs fed dosage levels of 0, 2, 
10 and 50 milligrams/kilogram/day (mg/kg/day) with no observable effect 
level (NOEL) of 10 mg/kg/day.
    3. A chronic feeding/carcinogenicity study in male and female rats 
fed dosage levels of 0, 100, 500 and 1000 ppm (0, 4.2, 21.2 or 41.8 mg/
kg/day in males and 0, 5.4, 27.0 or 55.7 mg/kg/day in females) with no 
carcinogenic effects observed under the conditions of the study at dose 
levels up to and including the 1000 ppm highest dose tested (HDT) and a 
systemic NOEL of 1000 ppm. There were no biologically significant 
effects observed in the study. The study was considered to be 
acceptable because the highest dose level tested was approaching one 
half of what would be considered an adequate dose level for 
carcinogenicity testing and because there was no indication of any 
carcinogenic response to warrant repeat of the study. This assessment 
was based on toxic effects observed in the subchronic and reproductive 
toxicity studies in rats at higher dose levels.
    4. A chronic feeding/carcinogenicity study in male and female mice 
fed dosage levels of 0, 100, 1000 and 8,000 ppm (0, 11.7, 118 or 991 
mg/kg/day in males and 0, 16, 159 or 1,341 mg/kg/day in females) with 
no carcinogenic effects observed under the conditions of the study at 
dose levels up to and including the 8000 ppm HDT (highest dose may have 
been excessive) and systemic NOEL of 1000 ppm based on decreases in 
body weight and feed consumption (both sexes), increases in the 
incidences of white matter degeneration in the lumbar spinal cord 
(males only), and increased incidences of duodenal epithelial 
hyperplasia (females only).
    5. A developmental toxicity study in rats given doses of 0, 30, 100 
and 333 mg/kg/day with a developmental NOEL of 100 mg/kg/day based on 
significant decreases in fetal body weight, and a maternal NOEL of 100 
mg/kg/day based on undetermined deaths of 2 dams at HDT; decreases in 
body weight, body weight gain and feed intake; and increased 
salivation, chromorhinorrhea and lethargy (HDT).
    6. A developmental toxicity study in rabbits given doses of 0, 10, 
40 and 100 mg/kg/day with a developmental NOEL of 40 mg/kg/day based on 
4 abortions and a reduction in the number of live fetuses/doe. In 
addition, there were only 7 litters available for examination. This was 
not a sufficiently high number of animals to absolutely conclude that 
no developmental toxicity was occuring at the highest dose level. The 
maternal NOEL was 40 mg/kg/day based on 6 deaths/17 pregnant does, 4 
abortions in 11 survivors and decreased body weight, body weight gain, 
food consumption.
    7. A two generation reproduction study in rats fed dosage rates of 
0, 150, 800 and 2,000 ppm (0, 6.1, 35.0 or 88.5 mg/kg/day in males and 
0, 8.0, 41.0 or 98.0 mg/kg/day in females) with a reproductive/
developmental NOEL of 150 ppm based on decreased litter size in the F0a 
and F1b litters at 2,000 ppm and on decreased mean pup weights during 
lactation in the second litters at 800 ppm and in all litters at 2000 ppm; and 
a systemic NOEL of 150 ppm based on reduced feed intake, body weights and body 
weight gains and reduced absolute and sometimes relative thymus, heart, liver 
and kidney weights.
    8. Mutagenicity data included two Ames tests with Salmonella 
typhimurium; a sex linked recessive lethal test with Drosophila 
melanoga; a forward mutation (mouse lymphoma) test; an in vivo bone 
marrow cytogenetics test in rats; a micronucleus assay in mice; an in 
vitro chromosomal aberration test in Chinese hamster ovary cells (CHO) 
(no aberrations were observed either with or without S9 activation and 
there were no increases in sister chromatid exchanges); and a 
morphological transformation test in mice (all negative).
    The reference dose (RfD) based on a chronic dog feeding study (NOEL 
of 10 mg/kg body weight (bwt)/day) and using a hundred-fold safety 
factor is calculated to be 0.1 mg/kg bwt/day. The theoretical maximum 
residue contribution (TMRC) for all proposed tolerances (almond hulls; 
imported bananas; citrus fruit group; corn; eggs; grapes; fat/meat by-
products/meat of cattle, goats, hogs, horses and sheep; pome fruit 
group; poultry fat,liver, meat by-products and meat; soybeans; stone 
fruit group; tree nut group; and wheat; and food additive regulations 
(prunes, raisins and soybean hulls) is 0.019825 mg/kg/day or 19.825 
percent of the RfD for the overall U.S. population. For U.S. subgroup 
populations, nonnursing infants and children 1 to 6 years of age, the 
current action, previously proposed tolerances and food additive 
regulations utilize a total of 0.044625 mg/kg/day and 44.625 percent of 
the RfD, assuming that residue levels are at the established tolerance 
levels and that 100 percent of the crop is treated.
    The RfD/Peer Review Committee, in a consensus review dated July 26, 
1994, classified sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) as a Group E carcinogen based on no 
evidence of carcinogenicity in rat and mouse studies.
    An adequate analytical method, gas chromatography for the cation 
and liquid chromatography for the anion and its metabolite AMPA, is 
available for enforcement purposes and will be published in the 
Pesticide Analytical Manual (PAM), Vol. II.
    There are presently no actions pending against the continued 
registration of this chemical.
    Based on the information and data considered, the Agency has 
determined that the tolerances established by amending 40 CFR part 180 
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 that 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).
    A record has been established for this rulemaking under the docket 
number [PP 9F3796, 5E4479, 4F4343, 0F3890, 0F3860 and 1F3950/R2212] 
(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 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.
    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 rule-making record 
which 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 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. 9-354, 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: February 23, 1996.

Peter Caulkins,
Acting 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. Section 180.489, is added to subpart C to read as follows:


Sec. 180.489  Sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine 
(1:1); tolerances for residues.

    (a) Tolerances are established for residues of the herbicideSulfonium, 
trimethyl-salt with N-(phosphonomethyl)glycine (1:1)in or on the following raw 
agricultural products:


------------------------------------------------------------------------
                                                              Parts per 
                        Commodities                            million  
------------------------------------------------------------------------
Almond, hulls, (of which no more than 0.3 ppm is                     
 trimethylsulfonium).......................................     1.00
Bananas (imported only)/a..................................     0.05
Citrus fruit group,........................................     0.05
Grapes,....................................................     0.10
Tree nut group,............................................     0.05 
------------------------------------------------------------------------
/a There are no U.S. registrations as of the date of publication of the  
  tolerance in the Federal Register.                                    


    (b) Time-limited tolerances to expire March 9, 1998, are established for 
the residues of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) in or on the following raw agricultural 
commodities:


------------------------------------------------------------------------
                                                              Parts per 
                        Commodities                            million  
------------------------------------------------------------------------
Cattle, fat................................................     0.10
Cattle, mbyp...............................................     1.00
Cattle, meat...............................................     0.20
Corn, fodder (of which no more than 0.20 ppm is                     
 trimethylsulfonium).......................................     0.30
Corn, forage...............................................     0.10
Corn, grain (of which no more than 0.10 is                          
 trimethylsulfonium).......................................     0.20
Eggs.......................................................     0.02
Goats, fat.................................................     0.10
Goats, mbyp................................................     1.00
Goats, meat................................................     0.20
Hogs, fat..................................................     0.10
Hogs, mbyp.................................................     1.00
Hogs, meat.................................................     0.20
Horses, fat................................................     0.10
Horses, mbyp...............................................     1.00
Horses, meat...............................................     0.20
Milk.......................................................     0.20
Poultry, fat...............................................     0.05
Poultry, liver.............................................     0.05
Poultry, mbyp..............................................     0.10
Poultry, meat..............................................     0.05
Sheep, fat.................................................     0.10
Sheep, mbyp................................................     1.00
Sheep, meat................................................     0.20
------------------------------------------------------------------------