[Federal Register Volume 61, Number 102 (Friday, May 24, 1996)]
[Proposed Rules]
[Pages 26149-26152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13022]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP4E4420 and 6E4638/P656; FRL-5370-2]
RIN 2070-AC18
Metolachlor; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA proposes to establish time-limited tolerances for residues
of the herbicide metolachlor and its metabolites in or on the raw
agricultural commodities pepper, and forage and hay of the grass
forage, fodder and hay crop group (excluding Bermudagrass). The
proposed regulation to establish maximum permissible levels for
residues of the herbicide was requested in petitions submitted by the
Interregional Research Project No. 4 (IR-4). The tolerances would
expire on December 31, 1998.
DATES: Comments, identified by the docket number [PP 4E4420 and 6E4638/
P656], must be received on or before June 24, 1996.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202. Comments and data
may also be submitted to OPP by sending electronic mail (e-mail) to:
opp-docket@epamail.epa.gov.
[[Page 26150]]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number [PP 4E4420 and 6E4638/P656]. Electronic
comments on this proposed rule may be filed online at many Federal
Depository Libraries. Additional information on electronic submissions
can be found in the ``SUPPLEMENTARY INFORMATION'' section of 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). 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 Virginia address
given above, from 8 a .m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460.
Office location and telephone number: Sixth Floor, Crystal Station #1,
2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8783; e-
mail: jamerson.hoyt@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petitions (PP) 4E4420 and 6E4638 to EPA on behalf of the named
Agricultural Experiment Stations. These petitions request that the
Administrator, pursuant to section 408(e) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), amend 40 CFR 180.368 by
establishing tolerances for combined residues (free and bound) of the
herbicide metolachlor [2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-
methoxy-1- methylethyl)acetamide], and its metabolites, determined as
the derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5-methyl-3-morpholinone, each expressed
as the parent compound, in or on certain raw agricultural commodities
as follows:
1. PP 4E4420. Petition submitted on behalf of the Experimental
Stations of Arkansas, Florida, Georgia, Oklahoma, South Carolina, and
Texas proposing a time-limited tolerance for pepper at 0.5 part per
million (ppm).
IR-4 also proposed that the established tolerances for combined
residues of metolachlor and its metabolites on bell pepper at 0.1 ppm,
chili pepper at 0.5 ppm, Cubanelle pepper at 0.1 ppm, and tabasco
pepper at 0.5 ppm be removed. The established metolachlor tolerances
for these varieties of pepper are no longer needed, since the proposed
tolerance for pepper will apply to all varieties of pepper. The
commodity term ``pepper'' is defined in 40 CFR 180.1(h) to include all
varieties of pepper.
2. PP 6E4638. Petition submitted on behalf of the Experimental
Station of Oregon proposing time-limited tolerances for forage at 10
ppm and hay at 0.2 ppm of the grass forage, fodder and hay crop group
(excluding Bermudagrass). IR-4 proposed the tolerances in support of
regional registration for use of metolachlor on grass grown for seed in
Idaho, Oregon and Washington. The use of metolachlor on grass grown for
seed will be limited to production areas in Idaho, Oregon, and
Washington based on the geographical representation of the residue data
submitted. Additional residue data will be required to expand the area
of usage. Persons seeking geographically broader registration should
contact the Agency's Registration Division at the address provided
above. EPA is establishing these tolerances with an expiration date of
December 31, 1998, to allow IR-4 time to submit additional residue data
in support of permanent tolerances for pepper and the grass forage,
fodder, and hay crop group (excluding Bermudagrass). IR-4 has agreed to
provide magnitude of residue data from three additional field trials
for bell pepper, and five additional field trials for grass forage and
hay.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerance include:
1. A 1-year feeding study with dogs fed diets containing 0, 100,
300, or 1,000 ppm (equivalent to 3.5, 9.7 or 32.7 mg/kg/day for males
and 3.6, 9.7 or 33.0 mg/kg/day for females) with a systemic no-observed
effect level (NOEL) of 300 ppm (9.7 mg/kg/day) based on decreased body
weight in females.
2. A 2-year feeding/carcinogenicity study with rats fed diets
containing 0, 30, 300, 1,000, or 3,000 ppm (equivalent to 0, 1.5, 15,
50, or 150 mg/kg/day) with a compound related increase in liver
adenomas and combined adenomas/carcinomas in female rats at the high
dose level. This study, which was performed by Industrial Biotest, was
classified as supplemental data due to inadequate clinical chemistry
determination and dietary preparation records.
3. A 2-year feeding/carcinogenicity study with rats fed diets
containing 0, 30, 300, or 3,000 ppm (equivalent to 0, 1.5, 15, or 150
mg/kg/day) with a systemic NOEL of 300 ppm based on decreased body
weight at the 3,000 ppm dose level. A statistically significant
increase in liver neoplasia was found in female rats at the 3,000 ppm
dose level.
4. A 2-year carcinogenicity study in mice fed diets containing 0,
300, 1,000 and 3,000 ppm (highest dose level equivalent to 428 mg/kg/
day) with no treatment related carcinogenic effects observed under the
conditions of the study.
5. A second 2-year carcinogenicity study in mice fed diets
containing 0, 300, 1,000 or 3,000 ppm with no treatment related
carcinogenic effects observed under the conditions of the study.
6. A 2-generation reproduction study in rats fed diets containing
0, 30, 300 or 1,000 ppm with a reproductive NOEL of 300 ppm (equivalent
to 23.5 to 26 mg/kg/day) based on reduced pup weights in the F1a and
F2a litters at the 1,000 ppm dose level (equivalent to 75.8 to 85.7 mg/
kg/day). The NOEL for parental toxicity is equal to or greater than the
1,000 ppm dose level.
7. A developmental toxicity study in rabbits given gavage doses at
0, 36, 120 or 360 mg/kg/day on gestation days 6 through 18. The NOEL
for maternal toxicity was established at 120 mg/kg/day based on
lacrimation, miosis, reduced food consumption and body weight gain.
There was no developmental toxicity observed under the conditions of
the study.
8. A second developmental toxicity study in rats given gavage doses
of 0, 30, 100, 300, or 1,000 mg/kg/day on gestation days 6-15. The
NOEL's for maternal and developmental toxicity were established at 300
mg/kg/day. The NOEL for maternal toxicity was based on deaths,
salivation, lacrimation, convulsions, reduced body weight and food
consumption at the 1,000 mg/kg/day dose level. The NOEL for
developmental toxicity was based on
[[Page 26151]]
reduced mean fetal body weight, reduced number of implantations/dam
with resulting decreased litter size, and a slight increase in
resorptions/dam with resulting increase in post-implantation loss.
9. Metolachlor was not found to be mutagenic in any tests.
Mutagenicity data include gene mutation assays in Salmonella and mouse
lymphoma cells; structural chromosome aberration tests including an in
vivo micronucleus assay in Chinese hamsters and a dominant lethal assay
in mice; and other genotoxic activity tests including DNA damage/repair
assays in rat hepatocytes and in human fibroblasts, and an in vivo/in
vitro unscheduled DNA synthesis assay.
10. Several metabolism studies have been performed with metolachlor
and the available data indicate the compound is readily absorbed after
oral dosing and excreted in approximately equal amounts in urine and
feces.
Metolachlor was evaluated by the Office of Pesticide Programs'
Health Effects Division, Carcinogenicity Peer Review Committee (CPRC)
in 1991 and classified as a Group C (possible carcinogen) with a
recommendation for the quantification of estimated potential human risk
using a linearized low-dose extrapolation (Q*). This
recommendation was based on the finding of liver tumors in female rats
at the 3,000 ppm dose level in both rat studies and the apparent
induction of a small number of nasal turbinate tumors in both sexes of
rats at the 3,000 ppm dose level. Nasal turbinate tumors have also been
associated with dietary administration of acetochlor and alachlor,
structurally related herbicides that are classified as Group B2
carcinogens (probable human carcinogens).
The Carcinogenicity Peer Review Committee's decision was presented
to the FIFRA Scientific Advisory Panel on September 18, 1991. The Panel
concluded that liver tumors were benign and hyperplasia were evident in
rats of both sexes. The Panel also concluded that the occurrence of
nasal turbinate tumors in rats was low and not statistically
significant, but of concern since metolachlor is structurally related
to acetochlor and alachlor. The Panel considered the carcinogenicity
evidence to be minimal but sufficient for the classification of
metolachlor as a Group C carcinogen.
The CPRC met on July 27, 1994, to revaluate the weight-of-the-
evidence on metolachlor, with particular reference to its
carcinogenicity, based on newly submitted metabolism and mutagenicity
studies. The registrant submitted data to show that the metabolism of
metolachlor is substantially different from the metabolism of
acetochlor and alachlor. Metolachlor does not metabolize to form a
reactive quinone imine, which is presumed to be the carcinogenic
metabolite of acetochlor and alachlor. There was also no evidence for
mutagenic potential of metolachlor. Based on these data and in
consideration of the full weight-of-the-evidence, the CPRC concluded
that the classification of metolachlor should remain as a Group C
carcinogen, but recommended that the Reference Dose (RfD) should be
used for quantification of human risk.
The RfD is established at 0.1 mg/kg of body weight (bwt)/day, based
on a NOEL of 9.7 mg/kg/day from the 1-year feeding study with dogs and
an uncertainty factor of 100. Available information on anticipated
residues and/or percent of crop treated were used to estimate the
Anticipated Residue Contribution (ARC) from residues of metolachlor in
the human diet. The ARC from established tolerances and the proposed
tolerances for pepper and forage and hay of the grass, forage, fodder
and hay group is estimated at 0.0006 mg/kg bwt/day and utilizes 0.6
percent of the RfD for the U.S. population. The ARC for non-nursing
infants (the subgroup most highly exposed) utilizes 2 percent of the
RfD. EPA generally has no concern for exposures below 100 percent of
the RfD and concludes that the proposed uses of metolachlor on pepper
and grass grown for seed pose negligible dietary cancer risks to
humans.
Adequate analytical methods are available for enforcement purposes.
The methods are listed in the Pesticide Analytical Manual, Vol. II (PAM
II). The qualitative nature of the residues in plants and animals is
adequately understood. The established tolerances for milk and meat,
fat, kidney, liver and meat byproducts of livestock are adequate to
cover secondary residues resulting from the proposed use on grass grown
for seed. There are no livestock feed commodities associated with
pepper.
There are presently no actions pending against the continued
registration of this chemical. The pesticide is considered useful for
the purpose for which the tolerances are sought.
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. Therefore, it is proposed that the
tolerances be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number [PP 4E4420 and 6E4638/P656].
A record has been established for this rulemaking under docket
number [PP 4E4420 and 6E4638/P656] (including comments and data
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 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.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments 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 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
[[Page 26152]]
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.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub.L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (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 explaining the factual basis for this
determination 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 10, 1996.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be 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. In Sec. 180.368, by removing ``peppers, bell'' from the table in
paragraph (a), by revising the table in paragraph (c) and by adding a
new paragraph (d) to read as follows:
Sec. 180.368 Metolachlor; tolerances for residues.
* * * * *
(c)* * *
------------------------------------------------------------------------
Parts per
Commodity million Expiration date
------------------------------------------------------------------------
Onions, dry bulb.................. 1.0 .......................
Grass forage, fodder and hay group
(excluding Bermudagrass), forage. 10 December 31, 1998
Grass forage, fodder and hay group
(excluding Bermudagrass), hay.... 0.2 December 31, 1998
------------------------------------------------------------------------
(d) A time-limited tolerance is established for the combined
residues (free and bound) of the herbicide metolachlor [2-chloro-N-(2-
ethyl-6-methylphenyl)-N-(2-methoxy-1-methylethyl)acetamide], and its
metabolites, determined as the derivatives, 2-[(2-ethyl-6-
methylphenyl)amino]-1-propanol and 4-(2-ethyl-6-methylphenyl)-2-
hydroxy-5-methyl-3-morpholinone, each expressed as the parent compound
in or on the following raw agricultural commodity:
------------------------------------------------------------------------
Parts per
Commodity million Expiration date
------------------------------------------------------------------------
Pepper............................ 0.5 December 31, 1998
------------------------------------------------------------------------
[FR Doc. 96-13022 Filed 5-23-96; 8:45 am]
BILLING CODE 6560-50-F
