[Federal Register Volume 61, Number 70 (Wednesday, April 10, 1996)]
[Rules and Regulations]
[Pages 15896-15900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8945]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[PP 0F3860, 3F4238; FAP 6H5740 and 6H5742/R2227; FRL-5361-1]
RIN 2070-AB78
Sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine (1:1)
(formerly glyphosate-trimesium/sulfosate); Pesticide Tolerances and
Food/Feed Additive Regulations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes permanent tolerances for the
residues of the herbicide sulfonium, trimethyl- salt with N-
(phosphonomethyl)glycine (1:1) (formerly glyphosate- trimesium/
sulfosate) in or on the raw agricultural commodity stone fruit group
and a food additive regulation for the processed commodity prunes. In
addition, this regulation establishes a 2-year time limited tolerance
for the residue of this herbicide in or on the raw agricultural
commodities soybean forage, soybean
[[Page 15897]]
aspirated grain fractions, soybean hay, and soybean seed and
establishes a feed additive regulation for this herbicide in or on
soybean hulls. The regulations to establish maximum permissible levels
for residues of the pesticide in or on the commodities were requested
in petitions submitted by Zeneca Ag Products.
EFFECTIVE DATE: This regulation becomes effective April 10, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 0F3860 and 3F4238; FAP 6H5740 and 6H5742/
R2227], 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 a copy of objections and hearing requests to Rm. 1132 CM #2, 1921
Jefferson Davis Highway, 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 0F3860 and 3F4238;
FAP 6H5740 and 6H5742/]. 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.
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.
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 in the
Federal Register which announced that Zeneca Ag Products, 1800 Concord
Pike, P.O. Box 15458, Wilmington, DE 19850-5458, had submitted
pesticide petitions (PP 0F3860 and 3F4238) and food additive petitions
(FAP) 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), amend 40 CFR part 180 by establishing tolerances for residues
of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1), in or on certain raw agricultural
commodities (RACs).
1. FAPs 6H5740 and 6H5742. FAPs 6H5740 and 6H5742 requests that the
Administrator, pursuant to section 409(e) of the FFDCA (21 U.S.C. 348),
amend 40 CFR part 185 by establishing food additive regulations for the
residues of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl) glycine (1:1) in or on the processed food
commodities: prunes, (of which no more than 0.05 ppm is
trimethylsulfonium) at 0.2 ppm and soybean, hulls (of which no more
than 2 ppm is trimethylsulfonium) at 7.0 ppm.
2. PP 0F3860. Published in the Federal Register (PF-638; FRL-4986-
8) of November 15, 1995 (60 FR 57423), the notice proposed establishing
a regulation to permit the residues of the herbicide sulfonium,
trimethyl-salt with N-(phosphonomethyl) glycine (1:1) in or on the raw
agricultural commodities soybean forage at 2.00 ppm (of which no more
than 1 ppm is trimethylsulfonium (TMS)), soybean aspirated grain
fractions at 210.0 ppm (of which no more than 60 ppm is TMS), soybean
hay at 5.00 ppm (of which no more than 2 ppm is TMS) and soybean seed
at 3.00 ppm (of which no more than 1 ppm is TMS).
3. PP 3F4238. Published in the Federal Register (PF-581; FRL-4645-
7) of October 21, 1993 (58 FR 54355), 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 stone fruit group at 0.05 ppm.
4. PP 6H5740. Published in the Federal Register (PF-642; FRL-4992-
9) of January 31, 1996 (61 FR 3401), the notice proposed establishing a
regulation to permit residues of the herbicide, sulfonium, trimethyl-
salt with N-(phosphonomethyl) glycine (1:1) in or on feed commodity
soybean hulls at 7.0 ppm (of which no more than 2 ppm is TMS).
5. PP 6H5742. Published in the Federal Register (PF-642; FRL-4992-
9) of January 31, 1996 (61 FR 3401), the notice proposed establishing a
regulation to permit the residues of the herbicide, sulfonium,
trimethyl-salt with N-(phosphonomethyl)glycine (1:1) in or on the
processed commodity prunes at 0.2 ppm (of which no more than 0.05 ppm
is TMS).
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 petitions and other relevant
material have been evaluated. The toxicological data considered in
support of the tolerances 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 a 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 1,000 parts per million (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 1,000 ppm highest
dose tested (HDT) and a systemic NOEL of 1,000 ppm. There were no
biologically significant effects observed
[[Page 15898]]
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, 1,000, 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 8,000 ppm HDT (highest dose may
have been excessive) and systemic NOEL of 1,000 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 two dams at HDT;
decreases in bodyweight, bodyweight 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 four abortions and a reduction in the number of live fetuses/doe. In
addition, there were only seven litters available for examination. This
was not a sufficiently high number of animals to absolutely conclude
that no developmental toxicity was occurring 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 with rats fed dosage rates
of 0, 150, 800, and 2,000 ppm (0, 6.1, 35 or 88.5 mg/kg/day in males
and 0, 8, 41 or 98 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 2,000
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;
bananas; citrus fruit group; corn; eggs; grapes; fat, meat by-products,
meat of cattle, goats, hogs, horses and sheep; pome fruit group;
poultry fat, poultry liver, poultry meat by-products and poultry meat;
soybeans; stone fruit group; tree nut group; and wheat; and food
regulations (prunes, raisins, and soybean hulls) is 0.019760 mg/kg/day
or 19.760 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 the food
additive regulations utilize a total of 0.044461 mg/kg/day and 44.461
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: 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 the methodology 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
would protect the public health, and the establishment of food additive
regulations by amending 40 CFR part 185 would be safe. 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
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 docket
number [PP 0F3860 and 3F4238; FAP 6H5740 and 6H5742/R2227] (including
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 all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking
[[Page 15899]]
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, 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, 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
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
40 CFR Part 185
Environmental protection, Food additive, Pesticides and pests
Dated: March 27, 1996.
Sstephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, title 40 of the Code of Federal Regulations is amended
as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. Section 180.489 is amended by adding an entry for stone fruit
group to the table in paragraph (a), and by revising paragraph (b) to
read as follows:
Sec. 180.489 Sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine
(1:1); tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodities million
------------------------------------------------------------------------
* * * * *
Stone fruit group.......................................... 0.05
------------------------------------------------------------------------
(b) Time-limited tolerances 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 Expiration date
------------------------------------------------------------------------
Cattle, fat....................... 0.10 March 9, 1998
Cattle, mbyp...................... 1.00 Do.
Cattle, meat...................... 0.20 Do.
Corn, fodder (of which no more
than 0.20 ppm is
trimethylsulfonium).............. 0.30 Do.
Corn, forage...................... 0.10 Do.
Corn, grain (of which no more than
0.10 is trimethylsulfonium)...... 0.20 Do.
Eggs.............................. 0.02 Do.
Goats, fat........................ 0.10 Do.
Goats, mbyp....................... 1.00 Do.
Goats, meat....................... 0.20 Do.
Hogs, fat......................... 0.10 Do.
Hogs, mbyp........................ 1.00 Do.
Hogs, meat........................ 0.20 Do.
Horses, fat....................... 0.10 Do.
Horses, mbyp...................... 1.00 Do.
Horses, meat...................... 0.20 Do.
Milk.............................. 0.20 Do.
Poultry, fat...................... 0.05 Do.
Poultry, liver.................... 0.05 Do.
Poultry, mbyp..................... 0.10 Do.
Poultry, meat..................... 0.05 Do.
Sheep, fat........................ 0.10 Do.
Sheep, mbyp....................... 1.00 Do.
Sheep, meat....................... 0.20 Do.
Soybean, forage (of which no more
than 1 ppm is trimethylsulfonium) 2.00 April 10, 1998
Soybean, aspirated grain fractions
(of which no more than 60 ppm is
trimethylsulfonium).............. 210.00 Do.
Soybean, hay (of which no more
than 2 ppm is trimethylsulfonium) 5.00 Do.
Soybean, seed (of which no more
than 1 ppm is trimethylsulfonium) 3.00 Do.
------------------------------------------------------------------------
[[Page 15900]]
PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b. In Sec. 185.5375, the table in paragraph (a) is amended by
adding entries for prunes, and soybean, hulls to read as follows:
Sec. 185.5375 Sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1).
(a) * * *
------------------------------------------------------------------------
Parts per
Commodities million
------------------------------------------------------------------------
Prunes, (of which no more than 0.05 ppm is
trimethylsulfonium)....................................... 0.2
* * * * *
Soybean, hulls (of which no more than 2 ppm is
trimethylsulfonium)....................................... 7.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 96-8945 Filed 4-9-96; 8:45 am]
BILLING CODE 6560-50-F
