[Federal Register Volume 59, Number 248 (Wednesday, December 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31927]


[Federal Register: December 28, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 3F4193/R2097; FRL-4926-9]
RIN 2070-AB78


Pesticide Tolerances for Halosulfuron

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes tolerances for residues of the herbicide 
halosulfuron in or on the raw agricultural commodities corn, field 
grain at 0.1 part per million (ppm); corn, field forage at 0.3 ppm; 
corn, field fodder at 1.5 ppm; grain sorghum (milo) grain at 0.1 ppm; 
grain sorghum (milo) forage at 0.1 ppm; grain sorghum (milo) fodder/
stover at 0.1 ppm; and meat and meat byproducts (cattle, goats, hogs, 
horses, and sheep) at 0.1 ppm. The regulation also establishes 
tolerances to permit indirect or inadvertent residues when present as a 
result of application to field corn and/or grain sorghum (milo) in or 
on soybean seed at 0.5 ppm; soybean forage at 0.5 ppm; soybean hay at 
0.5 ppm; wheat grain at 0.1 ppm; wheat forage at 0.1 ppm; and wheat 
straw at 0.2 ppm. Monsanto Co. requested these regulations to establish 
maximum permissible levels for residues of the herbicide.

EFFECTIVE DATE: This regulation becomes effective December 28, 1994.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 3F4193/R2097], 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.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product 
Manager (PM-23), Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 237, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-7830.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of November 2, 1994 (59 FR 54910), which announced 
that Monsanto Co. had submitted pesticide petition (PP) 3F4193 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 tolerances for residues of the herbicide halosulfuron (methyl 
5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonylaminosulfonyl-3-chloro-
1-methyl-1H-pyrazole-4-carboxylate, and its metabolites determined as 
3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid and expressed 
as parent equivalents), in or on the raw agricultural commodities corn, 
field grain at 0.1 part per million (ppm); corn, field forage at 0.3 
ppm; corn, field fodder at 1.5 ppm; grain sorghum (milo) grain at 0.1 
ppm; grain sorghum (milo) forage at 0.1 ppm; grain sorghum (milo) 
fodder/stover at 0.1 ppm; and meat and meat byproducts (cattle, goats, 
hogs, horses, and sheep) at 0.1 ppm. The petition also requested that 
EPA establish tolerances to permit indirect or inadvertent residues 
when present as a result of application to field corn and/or grain 
sorghum (milo) in or on soybean seed at 0.5 ppm; soybean forage at 0.5 
ppm; soybean hay at 0.5 ppm; wheat grain at 0.1 ppm; wheat forage at 
0.1 ppm; and wheat straw at 0.2 ppm. This notice was published as an 
amendment to the original notice that was published in the Federal 
Register of October 21, 1993 (58 FR 54354).
    There were no comments received in response to the 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. Acute toxicological studies placing the technical-grade 
halosulfuron in Toxicity Category III.
    2. A 90-day feeding study in rats resulted in a lowest-observed-
effect level (LOEL) of 497 mg/kg/day in males and 640 mg/kg/day in 
females, and a no-observed-effect level (NOEL) of 116 mg/kg/day in 
males and 147 mg/kg/day in females.
    3. A 21-day dermal toxicity study in rats resulted in a NOEL of 100 
mg/kg/day in males and greater than 1,000 mg/kg/day in females. The 
only treatment-related effect was a decrease in body weight gain of the 
1,000 mg/kg/day group in males.
    4. A 1-year chronic oral study in dogs resulted in a LOEL of 40 mg/
kg/day based on decreased weight gain and a NOEL of 10 mg/kg/day for 
systemic toxicity.
    5. A 78-week carcinogenicity study was performed on mice. Males in 
the 971.6 mg/kg/day group had decreased body weight gains and an 
increased incidence of microconcretion/ mineralization in the testis 
and epididymis. No treatment-related effects were noted in females. 
Based on these results, a LOEL of 971.9 mg/kg/day was established in 
males and NOEL's of 410 mg/kg/day in males and 1,214.6 mg/kg/day in 
females were established. The study showed no evidence of 
carcinogenicity.
    6. A combined chronic toxicity/carcinogenicity study in rats 
resulted in a LOEL of 225.2 mg/kg/day in males and 138.6 mg/kg/day in 
females based on decreased body weight gains, and a NOEL of 108.3 mg/
kg/day in males and 56.3 mg/kg/day in females. The study showed no 
evidence of carcinogenicity.
    7. A developmental toxicity study in rats resulted in a 
developmental LOEL of 750 mg/kg/day, based on decreases in mean litter 
size and fetal body weight, and increases in resorptions, resorptions/
dam, postimplantation loss and in fetal and litter incidences of soft 
tissue and skeletal variations, and a developmental NOEL of 250 mg/kg/
day. Maternal LOEL was 750 mg/kg/day based on increased incidence of 
clinical observations, reduced body weight gains, and reduced food 
consumption and food efficiency. The maternal NOEL was 250 mg/kg/day.
    8. A developmental toxicity study in rabbits resulted in a 
developmental LOEL of 150 mg/kg/day, based on decreased mean litter 
size and increases in resorptions, resorptions/dam and postimplantation 
loss, and a developmental NOEL of 50 mg/kg/day. The maternal LOEL was 
150 mg/kg/day based on reduced body weight gain and reduced food 
consumption and food efficiency. The maternal NOEL was 50 mg/kg/day.
    9. A dietary two-generation reproduction study in rats resulted in 
parental toxicity at 223.2 mg/kg/day in males and 261.4 mg/kg/day in 
females in the form of decreased body weights, decreased body weight 
gains, and reduced food consumption during the premating period. Very 
slight effects were noted in body weight of the offspring at this dose. 
This effect was considered to be developmental toxicity (developmental 
delay) rather than a reproductive effect. No effects were noted on 
reproductive or other developmental toxicity parameters. The systemic/
developmental toxicity LOEL was 223.2 mg/kg/day in males and 261.4 mg/
kg/day in females; the systemic/developmental toxicity NOEL was 50.4 
mg/kg/day in males and 58.7 mg/kg/day in females. The reproductive LOEL 
was greater than 223.2 mg/kg/day in males and 261.4 mg/kg/day in 
females; the reproductive NOEL was equal to or greater than 223.2 mg/
kg/day in males and 261.4 mg/kg/day in females.
    10. Bacterial/mammalian microsomal mutagenicity assays were 
performed and found not to be mutagenic.
    11. Two mutagenicity studies were performed to test gene mutation 
and found to produce no chromosal aberrations or gene mutations in 
cultured Chinese hamster ovary cells.
    12. An in vivo mouse micronucleus assay did not cause a significant 
increase in the frequency of micronucleated polychromatic erythrocytes 
in bone marrow cells.
    13. A mutagenicity study was performed on rats and found not to 
induce unscheduled DNA synthesis in primary rat hepatocytes.
    14. A metabolism study in rats resulted in the administered dose 
being absorbed rapidly and incompletely. Most of the test article was 
eliminated by urine and feces within 72 hours, and appeared to be 
independent of dose and sex.
    The Office of Pesticide Programs' Health Effects Division's 
Carcinogenicity Peer Review Committee (CPRC) has classified 
halosulfuron in Group E (no evidence of carcinogenicity) under the 
Agency's ``Guidelines for Carcinogen Risk Assessment'' published in the 
Federal Register of September 24, 1986 (51 FR 33992). In its 
evaluation, CPRC gave consideration to body weight gain changes and 
changes in hematological and blood chemistry parameters in the 1-year 
feeding study in dogs.
    The Reference Dose (RfD) is established at 0.1 mg/kg/day, based on 
a NOEL of 10 mg/kg/day from the 1-year feeding study in dogs and an 
uncertainty factor of 100. The Theoretical Maximum Residue Contribution 
(TMRC) from the current action is estimated at 0.00051 mg/kg of body 
weight/day for the general population, and utilizes less than 1% of the 
RfD for the U.S. population. The TMRC for the most exposed subgroups is 
0.00117 mg/kg body weight/day for nonnursing infants (less than 1 year 
old) and 0.00101 mg/kg body weight/day for children (1 to 6 years old), 
or 1 percent of the RfD for both groups. Therefore, no appreciable risk 
is expected from chronic dietary intake since the RfD is not exceeded 
for either the general population or any subgroup.
    The nature of the residue is adequately understood for the purposes 
of the tolerance.
    An adequate analytical method, gas chromatography with an electron-
capture detector, is available for enforcement purposes.
    The field corn and grain sorghum (milo) enforcement methodology has 
been submitted to the Food and Drug Administration for publication in 
the Pesticide Analytical Manual, Vol. II (PAM II). Because of the long 
lead time for publication of the method in PAM II, the analytical 
methodology is being made available in the interim to anyone interested 
in pesticide enforcement when requested from: Calvin Furlow, Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202, (703)-305-5232.
    Any secondary residues occurring in meat byproducts will fall 
within existing tolerances for these commodities. Tolerances were not 
deemed necessary on milk, eggs, meat, or fat.
    The pesticide is considered useful for the purpose for which the 
tolerances are sought and capable of achieving the intended physical or 
technical effect. There are currently no actions pending against the 
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).
    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 
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 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

Dated: December 15, 1994.

Daniel M. Barolo,
Director, 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. By adding new Sec. 180.479, to read as follows:


Sec. 180.479   Halosulfuron; tolerances for residues.

    (a) Tolerances. Tolerances are established for residues of the 
herbicide halosulfuron, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] 
carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, and 
its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-
carboxylic acid and expressed as parent equivalents, in or on the raw 
agricultural commodities listed below.

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Cattle, mbyp...............................................          0.1
Corn, field, fodder........................................          1.5
Corn, field, forage........................................          0.3
Corn, field, grain.........................................          0.1
Goats, mbyp................................................          0.1
Hogs, mbyp.................................................          0.1
Horses, mbyp...............................................          0.1
Sheep, mbyp................................................          0.1
Sorghum, grain, fodder/stover..............................          0.1
Sorghum, grain, forage.....................................          0.1
Sorghum, grain, grain......................................          0.1
------------------------------------------------------------------------

    (b) Indirect or inadvertent tolerances. Tolerances are established 
for indirect or inadvertent residues of the herbicide halosulfuron, 
methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonylaminosulfonyl-3-
chloro-1-methyl-1H-pyrazole-4-carboxylate, and its metabolites 
determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid 
and expressed as parent equivalents, in or on the following raw 
agricultural commodities when present therein as a result of the 
application of halosulfuron to growing crops:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Soybean, forage............................................          0.5
Soybean, hay...............................................          0.5
Soybean, seed..............................................          0.5
Wheat, forage..............................................          0.1
Wheat, grain...............................................          0.1
Wheat, straw...............................................          0.2
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[FR Doc. 94-31927 Filed 12-27-94; 8:45 am]
BILLING CODE 6560-50-F