[Federal Register Volume 61, Number 82 (Friday, April 26, 1996)]
[Proposed Rules]
[Pages 18536-18538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10385]
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DEPARTMENT OF TRANSPORTATION
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4590/P652; FRL-5363-5]
RIN 2070-AB18
Quizalofop Ethyl; Proposed Tolerance for Residues on Pineapple
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 and 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 commodity
pineapple. The proposed regulation to establish a maximum permissible
level 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 5E4590/P652], must
be received on or before May 28, 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 5E4590/P652]. 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
petition (PP) 5E4590 to EPA on behalf of the Agricultural Experiment
Station of Hawaii. 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 a
tolerance for 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-2yl)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
pineapple at 0.1 part per million (ppm). IR-4 proposed that use of
quizalofop ethyl on pineapple be limited to Hawaii 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.
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. 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 no-observed-effect-level (NOEL) for systemic toxicity is
established at 25 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, the highest dose
tested (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 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
[[Page 18537]]
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 a uncertainty factor of
100. The theoretical maximum residue contribution (TMRC) from existing
tolerances and the proposed tolerance for pineapple utilizes 2.5
percent of the RfD for the overall U.S. population and 10.6 percent of
the RfD for non-nursing infants (the population most highly exposed).
EPA generally has no concern for dietary exposures below 100 percent of
the RfD.
The nature of the residues in livestock is adequately understood. A
bovine feeding study using quizalofop ethyl ester shows that finite
residues will occur from the feeding of treated commodities or their
processed feed items. The established tolerances in milk, and in fat,
meat, and meat byproducts of cattle, goats, and hogs, horses and sheep
are adequate to cover secondary residues resulting from this use on
pineapple. Food and feed tolerances are not required in association
with this action. EPA concludes that the results of a pineapple
processing study show that residues of quizalofop-p ethyl ester do not
concentrate in the processed commodities juice or wet pulp (pineapple
process residue) .
The nature of the residue in pineapple is adequately understood for
the purposes of this tolerance. 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, telephone: 703-305-5805.
There are presently no actions pending against the continued
registration of this chemical.
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.
A record has been established for this rulemaking under docket
number [PP 5E4590/P652] (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 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.
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 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
[[Page 18538]]
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: April 16, 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. 180.441, by adding a new paragraph (d), to read as
follows:
Sec. 180.441 Quizalofop ethyl; tolerances for residues.
* * * * *
(d) Tolerances with regional registration, as defined in
Sec. 180.1(n), are established for the combined residues of the
herbicide quizalofop-p ethyl ester [ethyl (R)-(2-[4-((6-
chloroquinoxalin-2-yl)oxy)phenoxy)-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 following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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* * * * *
Pineapple.................................................. 0.1
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[FR Doc. 96-10385 Filed 4-25-96; 8:45 am]
BILLING CODE 6560-50-F
