[Federal Register Volume 61, Number 55 (Wednesday, March 20, 1996)]
[Rules and Regulations]
[Pages 11311-11313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6438]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4390/R2215; FRL-5354-3]
Pesticide Tolerance for Cadre
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of the
new herbicide, (AC 263,222) (+)-2-[4,5-dihydro-4-methyl-4-(1-
methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methyl-3-pyridinecarboxylic acid
applied as its ammonium salt and its metabolite (+)-2-[4,5- dihydro-4-
methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-hydromethyl-3-
pyridinecarboxylic acid both free and conjugated, in or on peanut nut
meat at 0.1 ppm. The regulation to establish a maximum permissible
level for the residues of the herbicide was requested in petitions
submitted by American Cyanamid Company.
EFFECTIVE DATE: This regulation becomes effective March 20, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket number, [PP 4F4390/R2215], may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Room M3708, 401 M St., SW.,
Washington, DC 20460. A copy of any objections and hearing request
filed with the Hearing Clerk should be identified by the docket number
and submitted to: Public Response and Program Resources Branch, Field
Operations Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20450.
In person, bring copy of objections and hearing request to: Room 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
4F4390/R2215]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of 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), 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.
[[Page 11312]]
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register on (August 17, 1995) (FRL-4963-7), which announced
that the American Cyanamid Company, P.O. Box 400, Princeton, NJ 08543-
0400, had submitted pesticide petition, PP 4F4390 to EPA requesting
that the Administrator, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 34a(d), amend 40 CFR part
180, by establishing a regulation to permit residues of the herbicide,
(+)-2-[4,5-dihydro-4-methyl-4-(1- methylethyl)-5-oxo-1H-imidazol-2-yl]-
5-methyl-3-pyridinecarboxylic acid applied as its ammonium salt and its
metabolite (+)-2-[4,5- dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-
imidazol-2-yl]-5- hydromethyl-3-pyridinecarboxylic acid both free and
conjugated, in or on the raw agricultural commodity (RAC), peanut
nutmeat at 0.1 part per million ppm.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
Discussion of Toxicology Data
The scientific data submitted in the petition and all other
relevant material have been evaluated. The toxicology data listed below
were considered in support of this tolerance.
1. An acute oral toxicity study in rats utilizing AC 263,222 as the
test material resulted in a LD50 of greater than 5,000 mg/kg
(males and females).
2. An acute dermal toxicity study in rabbits utilizing AC 263,222
as the test material resulted in a LD50 of greater than 2,000 mg/
kg (males and females).
3. An acute inhalation toxicity study in rats utilizing AC 263,222
as the test material resulted in a LC50 of greater than 5.52 mg/
liter (males and females).
4. In a 21-day dermal study in rabbits, AC 263,222 was applied at
dose levels of 0, 250, 500 or 1,000 mg/kg/day. The no-observed-effect-
level (NOEL) was 1,000 mg/kg/day for both systemic toxicity and dermal
irritation. The lowest observed effect level (LEL) was not determined
(greater than 1,000 mg/kg/day).
5. In a 3-month subchronic feeding study, AC 263,222 was
administered in the diet to male and female Sprague-Dawley rats at dose
levels of 0, 5,000, 10,000 or 20,000 ppm (0, 386, 760 or 1,522 mg/kg/
day in males and 0, 429, 848 or 1,728 mg/kg/day in females). No
treatment-related effects were observed. The NOEL was 20,000 ppm. The
LEL was not determined (greater than 20,000 ppm).
6. A 2-year combined chronic feeding/carcinogenicity study was
conducted with rats. AC 263,222 was administered in the diet to male
and female Sprague-Dawley rats at dose levels of 0, 5,000, 10,000 or
20,000 ppm (0, 253, 505 or 1,029 mg/kg/day in males and 0, 308, 609 or
1,237 mg/kg/day in females). No treatment-related effects were observed
and no increase in tumors was observed at any dose level. The NOEL for
both male and female rats was 20,000 ppm. A LEL was not determined
(greater than 20,000 ppm).
7. In a 1-year chronic feeding study, AC 263,222 was administered
in the diet to male and female beagle dogs at dose levels of 0, 5,000,
20,000 or 40,000 ppm (0, 137, 501 or 1,141 mg/kg/day in males and 0,
180, 534 or 1,092 mg/kg/day in females). The NOEL was not determined in
this study (below 5,000 ppm). The LEL was 5,000 ppm, based on slight
degeneration/necrosis and lymphocyte/macrophage infiltration in
skeletal muscle in males and females and slightly decreased creatinine
levels in females.
8. An 18-month carcinogenicity study was conducted with mice. AC
263,222 was administered in the diet to male and female CD-1 mice at
dose levels of 0, 1,750, 3,500 or 7,000 ppm (0, 271, 551 or 1,134 mg/
kg/day in males and 0, 369, 733 or 1,422 mg/kg/day in females). No
treatment-related effects were observed and no increase in tumors was
observed at any dose level. The NOEL for both male and female mice was
7,000 ppm. A LEL was not determined (greater than 7,000 ppm).
9. A developmental toxicity study was conducted with rats. AC
263,222 was administered orally by gavage to pregnant Sprague-Dawley
rats at dose levels of 0, 250, 500 or 1,000 mg/kg/day during gestation
days 6 to 15. The maternal NOEL was 1,000 mg/kg/day. The maternal LEL
was not determined (greater than 1,000 mg/kg/day). The developmental
NOEL was 1,000 mg/kg/day. The developmental LEL was not determined
(greater than 1,000 mg/kg/day).
10. In a developmental toxicity study with rabbits, AC 263,222 was
administered orally by gavage to pregnant rabbits at dose levels of 0,
175, 350, 500 or 700 mg/kg/day during gestation days 7 to 19. The
maternal NOEL was 350 mg/kg/day. The maternal LEL was 500 mg/kg/day,
based on decreased body weight gain and decreased food consumption. The
developmental NOEl was 500 mg/kg/day. The developmental LEL was not
determined (greater than 500 mg/kg/day).
11. A reproduction study was conducted with rats. AC 263,222 was
administered in the diet for 2 generations to Sprague-Dawley rats at
dose levels of 0, 5,000, 10,000 or 20,000 ppm (equivalent to premating
dose levels of 0, 301, 605 or 1,205 mg/kg/day in males and to premating
dose levels of 0, 378, 737 or 1,484 mg/kg/day in females). The NOEL for
both parents and offspring in the study was 20,000 ppm. A LEL was not
determined (greater than 20,000 ppm).
12. Mutagenicity data included an Ames assay in S. typhimurium TA
strains and E. coli WP2 (negative with and without metabolic
activation), a forward mutation assay in CHO/HGPRT cells (negative with
and without metabolic activation), an in vitro chromosomal aberration
assay in CHO cells (negative with and without metabolic activation) and
an in vivo bone marrow cytogenetic assay in rats (negative).
13. A metabolism study was conducted in which the absorption,
distribution, metabolism and excretion of 14C-AC 263,222 was
studied in male and female rats. Radioactivity was rapidly absorbed and
excreted, mostly in less than 6 hours. The major route of excretion was
the urine. No significant bioaccumulation occurred in tissues. Less
than 6% of the administered dose was metabolized, the majority of
radioactivity appearing in the urine as unchanged parent compound.
The Reference Dose (RfD) for AC 263,222 is 0.50 mg/kg/day. This
value is based on the LEL of 5,000 ppm (137 mg/kg/day in males and 180
mg/kg/day in females) determined in the 1-year chronic feeding study in
dogs. An uncertainty factor (UF) of 300 was applied to the NOEL based
on the following: an UF of 100 to account for inter-species
extrapolation and intra-species variability and an additional UF of 3
to account for the lack of a NOEL in the study.
Nature of the Residue and Analytical Method
The nature of the AC 263,222 residue in plants ruminants is
adequately understood. The residues of concern are the parent AC
263,222 and its hydroxymethyl metabolite, AC 263,284.
An adequately validated HPLC residue analytical method has been
presented to gather the magnitude of the residue data for AC 263,222
and its metabolite AC 263,284 ranging from 0.1 ppm to 5 pm in peanut
hulls and nutmeats. This method, M 2253.01, is suitable to enforce the
tolerances of 0.1 ppm.
[[Page 11313]]
The nature of the residue in poultry has not been defined. It has
been concluded that there is no reasonable expectation of finite AC
263,222 residues occurring in poultry from this use.
Since there are very low residues in peanuts and a livestock
feeding and grazing restriction on the AC 263,222 treated peanut hay,
there is no need to have cattle and poultry feeding studies; nor is
there any need for secondary tolerances of AC 263,222 and its
hydroxymethyl metabolite in meat, milk, poultry, and eggs in this
petition only.
Risk Assessment
The DRES chronic analysis used the Reference Dose (RfD) of 0.50 mg/
kg/day, based upon results in the 1-year chronic feeding study in dogs.
For chronic dietary exposure from the new use of AC 263,222 on
peanuts the TMRC for the general U.S. population and the most highly
exposed subgroups are as follows (as percent of the Reference Dose):
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U.S. population............................................ 0.0015%
Children (1-6 Years Old)................................... 0.0047%
Children (6-12 Years Old).................................. 0.0034%
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An acute dietary risk assessment is not required for AC 263,222.
The pesticide is considered useful for the purpose for which the
tolerance is sought. Based on the information and data considered, the
Agency has determined that the tolerance established by amending 40 CFR
part 180 will protect the public health. 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 and/or request a hearing 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 fees provided 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, and the requestor's
contentions on each such issue, and a summary of the evidence relied
upon by the objection (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 on 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, 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
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: March 5, 1996.
Penelope A. Fenner-Crisp,
Acting Director, Office of Pesticide Programs.
Therefore, chapter I of title 40 Code of Federal Regulations 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 Sec. 180.490 to subpart C, to read as follows:
Sec. 180.490 Cadre, tolerance for residues.
Tolerance is established for residues of the herbicide; (+)-2-[4,5-
dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-5-methyl-3-
pyridinecarboxylic acid applied as its ammonium salt and its metabolite
(+)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl]-
5-hydromethyl-3-pyridinecarboxylic acid both free and conjugated; in or
on the following raw agricultural commodity:
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Parts
Commodities per
million
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Peanut nutmeat 0.1
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[FR Doc. 96-6438 Filed 3-19-96; 8:45 am]
BILLING CODE 6560-50-F
