sulfonium Food Additive Regulation 3/96
[Federal Register: March 8, 1996 (Volume 61, Number 47)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 185
[FAP 1H5606/R2211; FRL-5353-3]
Food Additive Regulation for Sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) (formerly glyphosate-trimesium/sulfosate)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: These regulations establish a food additive regulation for the
residues of the herbicide sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1) (formerly glyphosate-trimesium/
sulfosate) in or on the processed commodity raisins. The regulation to
establish maximum permissible levels for residues of the pesticide in
or on the commodity was requested in a petition submitted by Zeneca AG
EFFECTIVE DATE: This regulation becomes effective March 8, 1996.
ADDRESSES: Written objections and hearing requests, identified by the document
control number, [FAP 1H5606/R2211], 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:
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 [FAP 1H5606/R2211] .
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
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:
SUPPLEMENTARY INFORMATION: EPA issued a notice (PF-638; 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 a food additive
petition (FAP) 1H5606 to EPA requesting that the Administrator,
pursuant to section 409(e) of the FFDCA (21 U.S.C. 348), amend 40 CFR
part 185 by establishing a food additive regulation for the residues of
the herbicide sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine
(1:1) (formerly glyphosate-trimesium/sulfosate), in or on the processed
food commodity raisins at 0.20 ppm (of which no more than 0.05 ppm is
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 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 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 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 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
and food consumption.
7. A 2-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;
imported bananas; citrus fruit group; corn; eggs; grapes; fat/meat by-
products/meat of cattles, 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 0.019760 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 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 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 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 establishment of a food additive regulation by
amending 40 CFR part 185 will be safe. Therefore, the tolerance is
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 [FAP 1H5606/R2211] (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.
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
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
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 in 40 CFR Part 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additive, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: February 23, 1996.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I, part 185 of title 40 of the Code of Federal
Regulations is amended as follows:
1. In part 185:
a. The authority citation for part 185 continues to read as follows:
Authority: 21 U.S.C. 346a and 348.
b. By adding Sec. 185.5375, Sulfonium, trimethyl-salt with N-
(phosphonomethyl)glycine (1:1), to read as follows:
Sec. 185.5375 Sulfonium, trimethyl-salt with N-
(a) Food additive regulation is established for residues of the
herbicide sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine
(1:1) (formerly glyphosate-trimesium/sulfosate) in or on the following
Raisins (of which no more than 0.05 ppm is