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metolachlor (Dual) Proposed Tolerance 5/96

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.
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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.
    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 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<SUP>*). 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 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