[Federal Register Volume 60, Number 90 (Wednesday, May 10, 1995)]
[Rules and Regulations]
[Pages 24788-24790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11667]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4336/R2133; FRL-4953-8]
RIN 2070-AB78
Pesticide Tolerances for Prosulfuron
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes time-limited tolerances, to expire on
December 31, 1995, for residues of the herbicide prosulfuron, 1-(4-
methoxy-6-methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-
phenylsulfonyl]-urea, in or on the raw agricultural commodities corn
(fodder, forage, grain and fresh [including sweet kernels plus cobs
with husks removed]) at 0.01 part per million (ppm), milk at 0.01 part
per million (ppm), and fat, kidney, liver, meat, and meat byproducts of
cattle, goats, hogs, horses, and sheep at 0.05 part per million (ppm).
Ciba-Geigy Corp. requested this regulation pursuant to the Federal
Food, Drug and Cosmetic Act (FFDCA). The regulation establishes maximum
permissible levels for residues of the herbicide in or on the
commodities.
EFFECTIVE DATE: This regulation becomes effective May 10, 1995.
ADDRESSES:Written objections and hearing requests, identified by the
document control number, [PP 4F4336/R2133] maybe submitted to the
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. Fees accompanying objections shall be
labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 36277M,
Pittsburgh, PA 15251. A copy of objections and hearing request 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.
A copy of objections and requests for hearings filed with the
Hearing Clerk may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Copies and
requests for hearings must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
objections and requests for hearings will also be accepted on disks in
WordPerfect in 5.1 file format or ASCII file format. All copies of
objections and requests for hearings in electronic form must be
identified by the docket number [PP 4F4336/R2133]. No Confidential
Business Information (CBI) should be submitted through e-mail.
Electronic copies of objections and requests for hearings 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 (H7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 245, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)-305-6800; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of November 2, 1994 (59 FR 54907), which announced
that the Ciba-Geigy Corp., P.O. Box 18300, Greensboro, NC 27419-8300,
had submitted a pesticide petition, PP 4F4336, to EPA proposing to
amend 40 CFR part 180 by establishing a tolerance under section 408 of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a, for the
residues the herbicide prosulfuron, 1-(4-methoxy-6-methyl-triazin-2-
yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea, in or on corn,
forage at 0.02 ppm; corn, fodder at 0.02 ppm; corn, grain at 0.02 ppm;
corn, fresh (including sweet kernels plus cobs with husks removed) at
0.02 ppm; milk at 0.02 ppm; meat byproducts, kidney and liver of
cattle, goats, hogs, horses, and sheep at 0.10 ppm; poultry, fat,
kidney, liver, meat and meat byproducts at 0.10 ppm; and eggs at 0.10
ppm.
The petitioner subsequently amended the petition by lowering the
tolerances and withdrawing poultry from the list of proposed
tolerances. A notice was not filed since there is less risk to man and
the environment.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data listed [[Page 24789]] below were
considered in support of this tolerance.
1. Several acute toxicology studies placing technical-grade
prosulfuron in Toxicity Category III, and an acute neurotoxicity study
in rats at dose levels of 0, 10, 250, 500, or 1,000 mg/kg with an NOEL
of 10 mg/kg based on reduced motor activity and body temperature in
males and impaired righting reflex in females. A 90-day neurotoxicity
study in rats demonstrated NOELs of greater than 5,000 ppm in females
and 10,000 ppm in males.
2. A 1-year feeding study with dogs fed dosages of 0, 0.33, 1.95,
18.6, or 41.0 mg/kg/day (males) and 0, 0.31, 1.84, 20.2, or 48.8 mg/kg/
day (females). The NOEL was 1.84 mg/kg/day based on hematologic and
clinical chemistry effects and incidence of lipofuscin accumulation in
the liver at 18.6 mg/kg/day.
3. An 18-month carcinogenicity study in mice fed dosages of 0,
1.71, 81.4, 410 or 832 mg/kg/day (males), and 0, 2.11, 100, 508 or
1,062 mg/kg/day (females). There was no evidence of carcinogenic
effects up to 1,062 mg/kg/day, the highest dose tested (HDT).
4. A 2-year chronic feeding/carcinogenicity study in rats fed
dosages of 0, 0.4, 7.9, 79.9 or 160.9 (males), and 0, 0.5, 9.2, 95.7 or
205.8 mg/kg/day (females). There was uncertain evidence of
carcinogenicity with slight increases in the incidence of mammary gland
adenocarcinomas in females at 95.7 and 205.8 mg/kg/day, slight increase
in incidence of benign testicular interstital cell tumors at 79.9 and
160.9 mg/kg/day (significant trend only). A systemic NOEL of 7.9 mg/kg/
day was based on decreased body weight and body weight gain,
hematopoietic effects (males), and possibly increased serum GGT and
decreased liver, kidney and adrenal weights (females) at 79.9 mg/kg/
day.
5. A three-generation reproduction study with rats fed dosages of
0, 0.67, 13.3, 136, or 278 (males), and 0, 0.76, 15.3, 152 or 311 mg/
kg/day (females) with a reproductive and a systemic NOEL of 13.3 mg/kg/
day based on decreased mean body weights and body weight gain observed
at 136 mg/kg/day for both pups and parental animals.
6. A developmental toxicity study in rats at dose levels of 0, 5,
50, 200 and 400 mg/kg/day by gavage. The developmental NOEL was 200 mg/
kg/day based on a statistically significant elevation of combined
skeletal findings at 400 mg/kg/day, and maternal toxicity NOEL of 200
mg/kg/day, based on marginal effects on body weight gain at 400 mg/kg/
day.
7. A developmental toxicity study in rabbits at dose levels of 0,
1.0, 10 and 100 mg/kg/day by gavage with no indications of
developmental toxixicy at dose levels up to 100 mg/kg/day. The
registrant was required to submit another study at higher doses to
establish the NOEL and LEL for maternal and developmental toxicity. A
new study is being conducted, and this deficiency is not considered
sufficient to affect registration.
8. Three acceptable mutagenicity studies were reviewed for
prosulfuron. These include assays with Salmonella typhimurium strains
TA1535, TA1537, TA98, and TA100 or E. coli WP2 uvrA exposed in either
the presence or absence of mammalian metabolic activation; unscheduled
DNA synthesis (UDS) in primary rat hepatocytes; and a structural
chromosomal aberration micronucleus test in mice. All these tests were
negative for mutagenicity.
The prosulfuron Reference Dose (RfD) was established at 0.02 mg/kg/
day based on the 1-year dog chronic feeding study with an uncertainty
factor of 100. The theoretical maximum residue contribution (TMRC) for
tolerances on corn grain, straw and forage, and milk, meat and meat
byproducts utilizes 1.4% of the RfD for the total U.S. population. The
most highly exposed subgroups, children (ages 1 to 6) and nonnursing
infants (less than 1-year old), utilize 4.3% of the RfD.
The HED RfD/Peer Review Committee classified this chemical as a
Class D oncogen based on the conclusion that there was uncertain
evidence of carcinogenicity with slight increases in the incidence of
mammary gland adenocarcinomas in female rats at 95.7 and 205.8 mg/kg/
day, but significant only at 95.7 mg/ kg/day, a slight increase in
incidence of benign testicular interstital cell tumors in rats at 79.9
and 160.9 mg/kg/day, and no evidence in carcinogenicity in mice.
The committee also decided that prosulfuron was not associated with
any significant reproductive or develpmental toxicity under the
conditions of testing.
This pesticide is useful for the purposes for which the tolerances
are sought. The nature of the residues is adequately understood for the
purposes of establishing these tolerances. An analytical method, HPLC
with column switching, is available for determination of residues of
prosulfuron in corn and has been validated by an independent
laboratory. The field residue and radio-labeled field metabolism
studies submitted to the Agency indicate that there are no residues in
corn grain, forage or fodder following application of prosulfuron. In
addition, as noted above, the TMRC for the most highly exposed
subgroups utilizes only 4.3% of the RFD. Therefore, this time limited
tolerance is being issued prior to the completion of the method
validation process by the EPA laboratory. Because of this, the Agency
has set an expiration date of December 31, 1995 for the tolerance.
Adequate analytical methodology, HPLC with UV detection, for animal
tissues is available for enforcement purposes. Because of the long lead
time from establishing these tolerances to publication the enforcement
methodology is being made available in the interim to anyone interested
in pesticide enforcement when requested by mail from: Calvin Furlow,
Public Response 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. 1130A, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202.
Required data include a repeat of the developmental study in
rabbits, the submission of stability data (storage and chemical),
information on accuracy of the method used to verify the certified
limits, experimental details of all solubility determinations,
additional corn and ruminant metabolism data, and completion of method
trial.
There are currently no actions pending against the registration of
this chemical. Any secondary residues occurring in meat, milk, and meat
byproducts will be covered by the proposed tolerances in these
commodities. Based on the data and information submitted above, the
Agency has determined that the establishment of tolerances by amending
40 CFR part 180 will protect the public health. Therefore, EPA is
establishing the tolerances as described below.
Any person adversely affected by this regulation may, within 30
days after the date of publication in the Federal Register, file
written objections with the Hearing Clerk, Environmental Protection
Agency, 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
[[Page 24790]] requestor's contentions on each issue, 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 a 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 4F4336/R2133] (including objections and hearing requests
submitted electronically as described below). 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 Rm. 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.
Written objections and requests for hearings, identified by the
document control number [PP 4F4336/R2133], may be submitted to the
Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708, 401 M
St., SW., Washington, DC 20460.
A copy of electronic objections and requests for hearings filed
with the Hearing Clerk can be sent directly to EPA at:
opp-D[email protected]
A copy of electronic objections and requests for hearings filed
with the Hearing Clerk must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
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 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 objections and hearing requests 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 review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defies a ``signficant regulatory action'' as an action that
is likely to result in 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 referred to as ``economically
significant''); (2) creating serious inconsistancy 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 the rights and obligations of recipients
thereof; 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 the 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: May 3, 1995.
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. 180.481, to read as follows:
Sec. 180.481 Prosulfuron; tolerances for residues.
Time-limited tolerances, to expire on December 31, 1995, are
established for residues of the herbicide prosulfuron, 1-(4-methoxy-6-
methyl-triazin-2-yl)-3-[2-(3,3,3-trifluoropyl)-phenyl-sulfonyl]-urea,
in or on the following raw agricultural commodities:
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Parts per
Commodity million Expiration date
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Cattle, fat............... 0.05............ Dec. 31, 1995.
Cattle, kidney............ 0.05............ Do.
Cattle, liver............. 0.05............ Do.
Cattle, meat.............. 0.05............ Do.
Cattle, mbyp.............. 0.05............ Do.
Corn, fodder.............. 0.01............ Do.
Corn, forage.............. 0.01............ Do.
Corn, grain and fresh
(including sweet kernels
plus cobs with husks
removed)................. 0.01............ Do.
Goats, fat................ 0.05............ Do.
Goats, kidney............. 0.05............ Do.
Goats, liver.............. 0.05............ Do.
Goats, meat............... 0.05............ Do.
Goats, mbyp............... 0.05............ Do.
Hogs, fat................. 0.05............ Do.
Hogs, kidney.............. 0.05............ Do.
Hogs, liver............... 0.05............ Do.
Hogs, meat................ 0.05............ Do.
Hogs, mbyp................ 0.05............ Do.
Horses, fat............... 0.05............ Do.
Horses, kidney............ 0.05............ Do.
Horses, liver............. 0.05............ Do.
Horses, meat.............. 0.05............ Do.
Horses, mbyp.............. 0.05............ Do.
Milk...................... 0.01............ Do.
Sheep, fat................ 0.05............ Do.
Sheep, kidney............. 0.05............ Do.
Sheep, liver.............. 0.05............ Do.
Sheep, meat............... 0.05............ Do.
Sheep, mbyp............... 0.05............ Do.
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[FR Doc. 95-11667 Filed 5-8-95; 1:34 pm]
BILLING CODE 6560-50-F