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sulfonium Food Additive Regulation 3/96

[Federal Register: March 8, 1996 (Volume 61, Number 47)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 185
[FAP 1H5606/R2211; FRL-5353-3]
RIN 2070-AB78
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.
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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 
Products.

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:
                  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 [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 
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 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 
trimethylsulfonium).
    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 
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 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.

Peter Caulkins,

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:

PART 185--[AMENDED]

    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-
(phosphonomethyl)glycine (1:1).

    (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 
processed commodities:

------------------------------------------------------------------------
                                                              Parts per 
                        Commodities                            million  
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Raisins (of which no more than 0.05 ppm is                              
 trimethylsulfonium........................................     0.20
                                                                        
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    (b) [Reserved]