[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Proposed Rules]
[Pages 31079-31081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15595]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 6E4652/P664; FRL-5377-1]
RIN 2070-AC18
Quizalofop ethyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for the combined residues
of the herbicide quizalofop-p ethyl ester, its acid metabolite
quizalofop-p, and the S enantiomers of both the ester and the acid, all
expressed as quizalofop-p-ethyl ester, in or on the raw agricultural
commodities peppermint tops and spearmint tops. The proposed regulation
to establish maximum permissible levels for residues of the herbicide
was requested in a petition submitted by the Interregional Research
Project No. 4 (IR-4).
DATES: Comments, identified by the docket number [PP 6E4652/P664], must
be received on or before July 19, 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 6E4652/P664]. 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
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
petition (PP) 6E4652 to EPA on behalf of the Oregon Agricultural
Experiment Station.
This petition requests 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 180.441 by establishing tolerances for the
combined residues of the herbicide quizalofop-p ethyl ester [ethyl (R)-
(2-[4-((6-chloroquinoxalin- 2-yl)oxy)phenoxyl] propionate], 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 commodities peppermint tops and spearmint tops at
2 parts per million (ppm).
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
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 diets
containing 0, 2, 10, 80 and 320 ppm (equivalent to 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 80 ppm. There was
an elevated incidence of hepatocellular adenomas and carcinomas
combined in CD-1 male mice at the 320 ppm dose level, which exceeded
the maximum tolerated dose (MTD).
3. A 2-year chronic toxicity/carcinogenicity study in rats fed
diets containing 0, 25, 100 and 400 ppm (equivalent to 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. The NOEL for systemic toxicity is established at 25
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ppm (0.9 mg/kg/day) based on red blood cell destruction in males, and
slight/minimal centrilobular enlargement of the liver in females at the
100 ppm dose level.
4. A 1-year feeding study in dogs fed diets containing 0, 0.625,
2.5, and 10 mg/kg/day with a 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, with no developmental effects observed
under the conditions of the study. The NOEL for maternal toxicity is
established at 30 mg/kg/day.
6. A developmental toxicity study in rabbits fed dosage levels of
0, 7, 20, and 60 mg/kg/day with no developmental effects observed under
the conditions of the study. The NOEL for maternal toxicity is
established at 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 diets containing
0, 25, 100 and 400 ppm (equivalent to 0, 1.25, 5, and 20 mg/kg/day)
with a NOEL for developmental toxicity at 25 ppm based on an increase
in liver weight and an increase in the incidence of eosinophillic
changes in the liver at 100 ppm. The NOEL for parental toxicity is
established at 100 ppm based on decreased body weight and premating
weight gain in males at the 400 ppm dose level.
8. Mutagenicity data included gene mutation assays with E. coli and
S. typhimurium (negative); DNA damage assays with B. subtilis
(negative); and a chromosomal aberration test in Chinese hamster cells
(negative).
OPP's Health Effects Division, Carcinogenicity Peer Review
Committee (CPRC) has evaluated the rat and mouse cancer studies for
quizalofop ethyl along with other relevant short-term toxicity studies,
mutagenicity studies, and structure-activity relationships. The CPRC
has classified quizalofop ethyl as a Group D carcinogen (not
classifiable as to human cancer potential). The Group 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 classification of a Category C
(possible human carcinogen); 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. No new cancer studies are required for quizalofop ethyl
at this time.
The Reference Dose (RfD) for quizalofop ethyl is calculated at
0.009 mg/kg of body weight/day. The RfD is based on the NOEL of 0.9 mg/
kg/day from the 2-year rat feeding study, and an uncertainty factor of
100. The theoretical maximum residue contribution (TMRC) from existing
tolerances and the proposed tolerance for mint tops utilizes 5 percent
of the RfD for the overall U.S. population and 18.5 percent of the RfD
for non-nursing infants (the population subgroup most highly exposed).
EPA generally has no concern for dietary exposures below 100 percent of
the RfD.
The nature of the residue in plants is adequately understood. An
adequate analytical method (HPLC-UV) is available for enforcement
purposes. Prior to its publication in the Pesticide Analytical Manual,
Volume II (PAM II), the enforcement method is being made available in
the interim to anyone who is interested in pesticide residue
enforcement from: By mail, Calvin Furlow, Public Response and 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: Crystal
Mall #2, Rm 1128, 1921 Jefferson Davis Hwy., Arlington, VA 22202
(703)305-5805.
There is no reasonable expectation that secondary residues will
occur in milk, eggs, or meat of livestock and poultry since there are
no significant livestock feed commodities associated with this action.
Data submitted with the petition demonstrate that residues of
quizalofop ethyl do not concentrate in mint oil. The proposed
tolerances for peppermint and spearmint tops is adequate to cover
residues in mint oil.
There are presently no actions pending against the continued
registration of this chemical. 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
would protect the public health. Therefore, it is proposed that the
tolerance 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 6E4652/P664].
A record has been established for this rulemaking under docket
number [PP 6E4652/P664] (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 Virginia 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
[[Page 31081]]
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 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: June 10, 1996.
Stephen L. Johnson,
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. 180.441, 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] propionate], 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 following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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Cottonseed................................................. 0.05
Peppermint, tops........................................... 2
Spearmint, tops............................................ 2
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[FR Doc. 96-15595 Filed 6-18-96; 8:45 am]
BILLING CODE 6560-50-F
