[Federal Register Volume 60, Number 137 (Tuesday, July 18, 1995)]
[Proposed Rules]
[Pages 36768-36770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17129]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0F3834/P621; FRL-4964-6]
Quizalofop-P Ethyl Ester; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for the residues of the
herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-
chloroquinoxalin-2-yl)oxy)phenoxyl])-propanoate], and its acid
metabolite quizalofop-p [R-(2-[4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy]) propanoic acid], and the S enantiomers of both the
ester and the acid, all expressed as quizalofop-p-ethyl ester, in or on
the raw agricultural commodity lentils at 0.05 part per million (ppm).
The regulation was requested by the E.I. du Pont de Nemours & Co.,
Inc., and establishes the maximum permissible level for residues of the
herbicide in or on lentils.
DATES: Comments, identified by the document control number [PP 0F3834/
P621], must be received on or before August 17, 1995.
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 Hwy., Arlington, VA 22202. Information submitted
as a comment concerning this document may be claimed confidential by
marking any part or all of that information as Confidental Business
Information'' (CBI). Information so marked will not be diclosed except
in accordance withm 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 avialable for public notice. All written comments will be
avialable for public inspection in Rm. 1132 at the address given above,
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.
Comments and data may also be submitted electronically 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [PP 0F3834/P621]. No Confidential Business
Information (CBI) should be submitted through e-mail. Electronic
comments on this proposed 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), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 241, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6027; e-mail:
taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of February 22, 1990 (55 FR 6311), which announced
that the E.I. du Pont de Nemours & Co., Inc., Walkers Mill Bldg.,
Barley Mill Plaza, Wilmington, DE 19880, had submitted pesticide
petition (PP) 1F3951 to EPA proposing that under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 346a), 40 CFR 180.441 be amended by
establishing a regulation to permit the combined residues of the
herbicide quizalofop ethyl (ethyl-(2-[4-(6-chloroquinoxalin-2yl-
oxy)phenoxy] propanoate)), its metabolite 2-[4-(6-chloroquinoxalin-2-
yloxy)phenoxy] propanoic acid, and conjugates, all
[[Page 36769]]
expressed as quizalofop ethyl, in or on lentils, dry beans, and dry
peas at 0.05 ppm.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
The petitioner subsequently amended the petition and proposed to
establish a tolerance for residues of the herbicide quizalofop-p ethyl
ester [ethyl (R)-(2-[4-((6-chloroquinoxalin-2-yl)oxy)phenoxy])-
propanoate] and its acid metabolite quizalop-p-[R-(2-[4-((6-
chloroquinoxalin-2-yl)oxy)phenoxy]) propanoic acid], and the S
enantiomers of both the ester and acid, all expressed as quizalofop-p
ethyl ester, in or on the raw agricultural commodity lentils at 0.05
ppm.
The petitioner withdrew the proposals for dry beans and dry peas at
0.05 ppm. Because it has been longer than 5 years since the original
proposal, the tolerance of 0.05 ppm for lentils is being proposed for
30 days to allow for public comment.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data listed below considered in support
of this tolerance.
1. Several acute toxicology studies placing technical-grade
quizalofop ethyl in toxicity Category III.
2. An 18-month carcinogenicity study with CD-1 mice fed dosages of
0, 0.2, 1.5, 12, and 48 mg/kg/day with no carcinogenic effects observed
under the conditions of the study at levels up to and including 12 mg/
kg/day and a marginal increase in the incidence of hepatocellular
tumors at 48 mg/kg/day HDT (highest dose tested), which exceeded the
maximum tolerated dose (MTD).
3. A 2-year chronic toxicity/carcinogenicity study in rats fed
dosages of 0, 0.9, 3.7, and 15.5 mg/kg/day for males and 0, 1.1, 4.6,
and 18.6 mg/kg/day for females, with no carcinogenic effects observed
under the conditions of the study at levels up to and including 18.6 g/
kg/day (HDT) and a systemic NOEL of 0.9 mg/kg/day based on altered red
cell parameters and slight/minimal centrilobular enlargement of the
liver at 3.7 mg/kg/day.
4. A 1-year feeding study in dogs fed dosages of 0., 0.625, 2.5,
and 10 mg/kg/day with NOEL of 10 mg/kg/day (HDT).
5. A developmental toxicity study in rats fed dosage levels of 0,
30, 100, and 300 mg/kg/day (HDT), with a maternal toxicity NOEL of 30
mg/kg/day and a developmental toxicity NOEL of greater than 300 mg/kg/
day (HDT).
6. A developmental toxicity study in rabbits fed dosage levels of
0, 7, 20, and 60 mg/kg/day with no developmental effects noted at 60
mg/kg/day (HDT), and a maternal toxicity NOEL of 20 mg/kg/day based on
decreases in food consumption and body weight gain at 60 mg/kg/day
(HDT).
7. A two-generation reproduction study in rats fed dosages of 1,
1.25, 5, and 20 mg/kg/day with a reproductive (developmental) NOEL of
1.25 mg/kg/day based on an increase in liver weight and increase in the
incidence of eosinophillic changes in the liver at 5.0 mg/kg/day and a
parental NOEL of 5.0 mg/kg/day based on decreased body weight and
premating weight gain in males at 20 mg/kg/day (HDT).
8. Mutagenicity data included gene mutation assays with E. coli and
S. typhimurium (negative); DNA damage assays with B. subtillis
(negative) and a chromosomal aberration test in Chinese hamster cells
(negative).
The Carcinogenicity Peer Review Committed (CPRC) of HED has
evaluated the rat and mouse cancer studies on quizalofop along with
other relevant short- term toxicity studies, mutagencity studies, and
structure-activity relationships. The CPRC concluded, after three
meetings and an evaluation by the OPP Science Advisory Panel, that the
classification should be a category D (not classifiable as to human
cancer potential). No new cancer studies were required.
The Category D classification is based on an approximate doubling
in the incidence of male mice liver tumors between controls and the
high dose. This finding was not considered strong enough to warrant the
finding of a Category C (possible human carcinogen) since the increase
was of marginal statistical significance, occurred at a high dose which
exceeded the predicted MTD, and occurred in a study in which the
concurrent control for liver tumors was somewhat low as compared to the
historical controls, while the high dose control group was at the upper
end of previous historical control groups.
Based on the NOEL of 0.9 mg/kg/bwt/day in the 2-year rat feeding
study, and using a hundredfold uncertainty factor, the reference dose
(RfD) for quazalofop ethyl is calculated to be 0.009 mg/kg/bwt/day. The
theoretical maximum residue contribution (TMRC) is 0.000218 mg/kg/bwt/
day for existing tolerances for the overall U.S. population. The
current action will increase the TMRC by less than 0.000001 mg/kg/bwt/
day. These tolerances and previously established tolerances utilize a
total of 2.4 % of the RfD for the overall U.S. populations, with all
exposure coming from published uses. For U.S. subgroup populations,
nonnursing infants and children aged 1 to 6 years, the current action
and previously established tolerances utilize, respectively a total of
10.2 percent and 5.76 percent of the RfD, with all exposure coming from
previously established tolerances, assuming that residue levels are at
the established tolerances and that 100 percent of the crop is tested.
The nature of the residue is adequately understood, and an adequate
analytical methodology (high-pressure liquid chromatography using
either ultraviolet or fluorescence detection) is available for
enforcement purposes in Vol. II of the Food and Drug Administration
Pesticide Analytical Method (PAM II, Method I). There are currently no
actions pending against the registration of this chemical. No secondary
residues are expected to occur in meat, milk, poultry, or eggs from
this use.
Based on the information cited above, the Agency has determined
that when used in accordance with good agricultural practice, this
ingredient is useful and that the tolerance establised by amending 40
CFR part 180 will protect the public health. It is proposed, therefore,
that the tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration a pesticide, under the Fedral 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 document in the Federal Register that this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the Federal Food, Drug, and Cosmetic Act.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number [PP 0F3834/P621]. All written comments filed in
response to this petition will be available in the Public Response and
Program Resources Branch, at the address given above from 8 a.m. to
4:30 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP 0F3834/P621] (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
[[Page 36770]]
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.
The Office of Management and Budget has exempted this rule from the
requirements of Executive Order 12866. 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 food additive regulations or raising
tolerance levels or food additive regulations 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
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
Dated: June 28, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.441, by revising paragraph (c), to read as follows:
Sec. 180.441 Quizalofop ethyl; tolerances for residues.
* * * * *
(c) Tolerances are established for the combined residues of the
herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-
chloroquinoxalin-2-yl)oxy)phenoxyl)-propanoate], and its acid
metabolite quizalofop-p [R-(2-(4((6-chloroquinoxalin-2-yl)oxy)phenoxy])
propanoic acid], and the S enatiomers of both the ester and the acid,
all expressed as quizalofop-p-ethyl ester, in or on the following raw
agricultural commodities:
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Parts per
Commodity million
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Cottonseed................................................. 0.05
Lentils.................................................... 0.05
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[FR Doc. 95-17129 Filed 7-17-95; 8:45 am]
BILLING CODE 6560-50-F
