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sulfonium Pesticide Tolerance and Food Additive Regulation 4/96

[Federal Register: April 10, 1996 (Volume 61, Number 70)]
[Proposed Rules]
[Page 15915-15917]
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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 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 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 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.
                                                                        
------------------------------------------------------------------------



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
                                                                   
                  *        *        *        *        *            
------------------------------------------------------------------------

* * * * *