[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Rules and Regulations]
[Pages 9352-9355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5537]
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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)
[[Page 9353]]
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
[[Page 9354]]
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).
[[Page 9355]]
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
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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
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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
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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
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[FR Doc. 96-5537 Filed 3-7-96; 8:45 am]
BILLING CODE 6560-50-F
