[Federal Register Volume 61, Number 116 (Friday, June 14, 1996)]
[Rules and Regulations]
[Pages 30171-30175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15040]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186

[PP3F4268, FAP5720/R2247; FRL-5375-6]


Quizalofop-P Ethyl Ester; Pesticide Tolerance and Feed Additive 
Regulation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document increases the current tolerance for cotton seeds 
to 0.1 part per million (ppm) 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 enantiomers of both the ester and the acid, all expressed as 
quizalofop-p-ethyl ester; establishes time limited tolerances with an 
expiration date for quizalofop-p-ethyl ester in or on the raw 
agricultural commodities legume vegetables (succulent or dried) group 
at 0.25 ppm, foliage of legume vegetables (except soybeans) at 3.0 ppm, 
sugarbeet root at 0.1 ppm, sugarbeet top at 0.5 ppm; and establishes a 
time limited feed additive tolerance with an expiration date for 
quizalofop-p-ethyl ester for sugarbeet molasses at 0.2 ppm. Because 
there has been insufficient time since the imposition of the additional 
data requirements for specific geographical representation for 
sugarbeet and bean field trials to generate the necessary residue data 
and additional time is necessary to further refine a revised analytical 
method and complete the tolerance method validation (TMV), the Agency 
is granting the tolerances for legume vegetables (succulent and dried) 
group, foliage of legume vegetables (except soybeans), sugarbeet top 
and sugarbeet root with a 3-year expiration date]. E.I. du Pont de 
Nemours Co., requested these tolerances and feed additive regulations 
in petitions submitted to the EPA pursuant to the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

EFFECTIVE DATE: These regulations become effective June 14, 1996.

ADDRESSES: Written objection and hearing requests, identified by the 
document control number, [PP3F4268, FAP5H5720/R2247], may be submitted 
to: Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708, 
401 M St., SW., Washington DC 20460. Fees accompanying objections shall 
be labeled ``Tolerance Fees'' and forwarded to: EPA Headquarters 
Accounting Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
PA 15251. A copy of any objections and hearing request filed with the 
Hearing Clerk may also be identified by the document control number and 
submitted 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 a copy of objections and hearing requests to: Rm. 
1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. A copy of 
objections and hearing requests filed with the Hearing Clerk may also 
be submitted electronically by sending electronic mail (e-mail) to: 
<a href="/cdn-cgi/l/email-protection#7f100f0f521b101c141a0b3f1a0f1e121e1613511a0f1e51181009"><span class="__cf_email__" data-cfemail="7e110e0e531a111d151b0a3e1b0e1f131f1712501b0e1f50191108">[email protected]</span></a>.
    Copies of objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.

[[Page 30172]]

copies of objections and hearing requests will also be acceptable on 
disks in Word Perfect 5.1 file format or ASCII file format. All copies 
of objections and hearing requests electronic form must be identified 
by the docket number [PP3F4268, FAP5H5720/R2247]. No Confidential 
Business Information (CBI) should be submitted through e-mail. 
Electronic copies of objections and hearing requests on this rule may 
be filed online at many Federal Depository Libraries. Additional 
information on electronic submission 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, telephone number, and e-mail address: Rm. 
241, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 703-305-6027; e-
mail: <a href="/cdn-cgi/l/email-protection#0e7a6f7762617c207c616c6b7c7a4e6b7e6f636f6762206b7e6f20696178"><span class="__cf_email__" data-cfemail="8cf8edf5e0e3fea2fee3eee9fef8cce9fcede1ede5e0a2e9fceda2ebe3fa">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register August 17, 1995 (60 FR 42884) (FRL-4963-7), 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) 3F4268 to EPA proposing that 40 CFR part 180 be amended 
by establishing a regulation to permit the combined residues of the 
herbicide quizalofop-p-ethyl ester (ethyl R-2-(4-(6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoic acid) and the S enantiomers of the ester and 
acid, all expressed as quizolofop-p-ethyl ester, in or on the raw 
agricultural commodities legume vegetable (succulent or dried) group at 
0.3 ppm, foilage of legume vegetables (except soybeans and bean hay) at 
0.7 ppm; sugar beet root at 0.1 ppm; sugar beet top at 0.5 ppm and 
cottonseed at 0.1 ppm. Dupont also submitted feed additive petition 
(FAP) 5H5720 proposing to amend 40 CFR part 186 by establishing a 
regulation to permit residues of the herbicide quizalofop-p-ethyl ester 
[ethyl R-2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid, and 
the senantiomers of the ester and the acid all expressed as quizalofop-
p-ethyl ester, in or on the animal feed sugar beet molasses at 0.2 ppm.
    No comments or requests for referral to an advisory committee were 
received in response to these notices of filing.
    Subsequently, the petitioner amended these petitions by submitting 
revised section Fs. Amended filing notices were published in the 
Federal Register of September 13, 1995 (60 FR 47577) (FRL-4975-3), 
proposing these changes.
    PP 3F4268. DuPont amended this petition by proposing a regulation 
to permit the combined residues of the herbicide quizalofop-p-ethyl 
ester and its acid metabolite, quizalofop-p-[R-(4-((6-chloroquinoxalin-
2-yl)oxy)phenoxy)propanoic acid), and the S enantiomers of the ester 
and the acid all expressed as quizalofop-p-ethyl ester in or on the 
following raw agricultural commodities (RACs): cotton seed at 0.1 ppm, 
legume vegetable (succulent or dried) group at 0.3 ppm; foliage of 
legume vegetable (except soybeans and bean hay) at 0.7 ppm; sugar beet 
root at 0.1 ppm; and sugar beet top at 0.5 ppm.
    FAP 5H5720. DuPont amended this petition by proposing that 40 CFR 
part 186 be amended by establishing a regulation to permit the combined 
residues of the herbicide quizalofop-p-ethyl ester and its acid 
metabolite quizalofop-p-(R-(2-(4-(6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoic acid and the S-enantiomers of the ester and 
the acid, all expressed as quizalofop-p-ethyl ester, in or on the feed 
commodity sugar beet molasses at 0.5 ppm.
    The Agency received one comment opposing the tolerances stated in 
the amended filing notices published September 13, 1995. The 
commenter's opposition to the tolerances was based upon toxicological 
concerns including the concept of ``NOEL'' (no observed effect level); 
the use of animal testing to represent human reaction to potentially 
toxic substances (pesticides); the indications of a link between 
pesticide exposure and Parkinson's Disease (PD).
    The Agency has reviewed the comment and decided to proceed with 
these tolerances. The Agency, made the decision that a wide variety of 
toxicological studies would serve as the basis for determining if a 
pesticide could be requested and used without an reasonable risk. It is 
true that animal models do not and cannot predict every human reaction 
to pesticides, but the general consensus is that they offer the best 
information as to what a pesticide might do to humans. Usually, the 
Agency requires and reviews long-term studies in rodents and non-
rodents to determine a dose which causes no observed adverse effects. 
The NOEL is divided by an uncertainty factor-often at least 100-to 
arrive at doses or exposures that should not cause harmful effects on 
humans. This is a long established procedure and EPA believes is 
protective of public health.
    The Agency understands that the testing of one pesticide does not 
predict all the possible adverse interactions with other pesticides--or 
for that matter other drugs or environmental pollutants. The Agency is 
exploring ways of testing the interactions of pesticides having a 
similar toxicity endpoint, but progress in that area is slow. The 
commenter presented no evidence showing quizalofop-p-ethyl ester would 
interact with other pesticides.
    With reference to the indications of a link between pesticide 
exposure and Parkinson's disease, the Agency is aware that many 
researchers are investigating the potential reaction of pesticide 
exposures to chronic neurological diseases including Parkinson`s 
Disease, and additional research is need to study this important area. 
Available studies in humans or animals have not yet established any 
relationship between pesticide exposures and Parkinson's Disease.
    During the course of the review of these petitions, the Agency 
determined that the tolerances proposed for cottonseed, legume 
vegetables (succulent of dried), foliage of legume vegetables (except 
soybean and bean hay), and the proposed feed additive regulation for 
sugarbeet molasses need revisions. The petitioner subsequently 
submitted a revised section F proposing that tolerances be 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 acid, all expressed as 
quizalofop-p-ethyl ester in or on the following raw agricultural 
commodities: cottonseed at 0.1 ppm; legume vegetable (succulent or 
dried) group at 0.25 ppm; foliage of legume vegetables (except 
soybeans) at 3.0 ppm; sugar beet root at 0.1 ppm; and sugar beet top at 
0.5 ppm. A revised section F was submitted for FAP 5H5720 proposing the 
establishment of a feed additive tolerance 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 enantioners of the ester and the acid, all expressed 
as quizalofop-p-ethyl ester be established on sugarbeet molasses at 0.2 
ppm. The 3.0 ppm tolerance for foliage of legume vegetables was 
previously proposed under PP 5F4545 on February 1, 1996 (61 FR 3696) 
(FRL-4994-3). The proposed tolerance for sugarbeet molasses was 
previously proposed.

[[Page 30173]]

    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, 0.3, 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). (Please see the discussion by the HED 
Carcinogenicity Peer Review Committee.)
    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 eosinophilic 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 Committee (CPRC) of HED has 
evaluated the rat and mouse cancer studies on quizalofop along with 
other relevant short-term toxicity studies, mutagenicity 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 first CPRC review tentatively concluded that quizalofop should 
be classified as a Category B2 (probable human carcinogen). That 
classification was based on liver tumors in female rats, ovarian tumors 
in female mice, and liver tumors in male mice. This classification was 
downgraded to a Category C (possible human carcinogen) at a second CPRC 
review. The change in classification was due to a reexamination of the 
liver tumors in female rats and ovarian tumors in female mice. The 
first peer review had found a statistically significant positive trend 
for liver carcinomas in female rats. Subsequent to this conclusion the 
tumor data was reevaluated, and the reevaluation showed a reduced 
number of carcinomas. Although there remained a statistically 
significant positive trend for carcinomas in the study, the CPRC 
concluded that the carcinomas were not biologically significant given 
the few carcinomas identified (one at the mid-dose and two at the high 
dose). Noting that this level of carcinomas was within historical 
levels, the CPRC concluded that administration of quizalofop did not 
appear to be associated with the liver carcinomas.
    As to the ovarian tumors in female mice, the CPRC had first 
attached importance to the fact that these tumors were statistically 
significant at the high dose as compared to historical control values 
although statistically significant when compared to concurrent 
controls. However, review of further historical control data showed 
that the level of ovarian tumors in the quizalofop study was similar to 
the background rate in several other studies. Given this information 
and that the quizalofop study showed no hyperplasia of the ovary, no 
signs of endocrine activity related to ovarian function, and no dose 
response relationship, the CPRC concluded that the ovarian tumors were 
probably not compound-related.
    The findings of the second CPRC review were presented to EPA's 
Scientific Advisory Panel (SAP). The SAP concurred with the CPRC 
conclusion that the liver tumors in female rats and the ovary tumors in 
female mice showed no evidence of carcinogenicity. However, the SAP 
disagreed with CPRC's classification of quizalofop as a Category C 
based on the liver tumors in male mice. The SAP concluded that the 
mouse liver tumors did support such a classification because the tumors 
occurred at a dose above the maximum-tolerated dose (MTD) and because 
they were not statistically significant if a ``p'' value of less than 
.01 was used instead of a ``p'' value of less than .05. The SAP 
believed that such greater statistical rigor was appropriate for 
variable tumor endpoints such as male mouse liver tumors.
    Following the SAP review, the CPRC changed the classification for 
quizalofop to Category D. 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.
    EPA has found the evidence on the carcinogenicity of quizalofop-p-
ethyl ester in animals to be equivocal and therefore concludes that 
quizalofop-p-ethyl ester does not induce cancer in animals within the 
meaning of the Delaney clause. Important to this conclusion was the 
following evidence: (1) The only statistically significant tumor 
response that appears compound-related was seen at a single dose in a 
single sex in a single species; (2) the response was only marginally 
statistically significant; (3) the response was only significant when 
benign and malignant tumors were combined; (4) the tumors were in the 
male mouse liver; (5) the tumors were within historical controls; and 
(6) the mutagenicity studies were negative. Although in some 
circumstances a finding of animal carcinogenicity could be made despite 
any one, or even several, of the six factors noted, the combination of 
all of these factors here cast sufficient doubt on the reproducibility 
of the response in the high dose male mouse that EPA concludes the 
evidence on carcinogenicity is equivocal.
    Based on the NOEL of 0.9 mg/kg/bwt/day in the 2-year rat feeding 
study, and using a hundred-fold uncertainty factor, the reference dose 
(RFD) for quiazalofop ethyl is calculated to be 0.009 mg/kg/

[[Page 30174]]

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 
0.000260 mg/kg/bwt/day. These tolerances and previously established 
tolerances utilize a total of 5.3 percent of the RFD for the overall 
U.S. populations, with all exposure coming from published uses. For 
U.S. subgroup populations, non-nursing infants and children aged 1 to 6 
years, the current action and previously established tolerances 
utilize, respectively a total of 18.8 percent and 11.9 percent of the 
RfD, assuming that residue levels are at the established tolerances and 
that 100 percent of the crop is tested.
    Data desirable but lacking for this chemical include additional 
sugarbeet and bean residue field trials and completion of a tolerance 
method validation (TMV) for a revised analytical method. The additional 
residue data are needed in response to a recent change in EPA 
guidelines. The Agency is granting the tolerances for legume vegetables 
(succulent or dried) group, foliage of legume vegetables (except 
soybeans), sugarbeet root and sugarbeet top with a 3-year expiration 
date to allow the petitioner, E.I. duPont de Nemours and Company to 
gather additional residue data and to further refine the analytical 
method and allow the Agency to complete the TMV.
    The nature of the residue in plants and livestock is adequately 
understood. An adequate amount of geographically represenative crop 
field reidue data were presented which show that the proposed 
tolerances should not be exceeded when quizalofop-p ethyl ester is 
formulated into ASSURE II and used as directed. An adequate analytical 
method (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. Any secondary residues expected to occur 
in milk, eggs, and meat, fat, and meat byproducts of cattle, goats, 
hogs, horses, sheep, and poultry will be covered by existing 
tolerances.
    The pesticide is considered useful for the purpose for which the 
regulation is sought and is capable of achieving the intended physical 
or technical effect.
    Based on the information cited above, the Agency has determined 
that the establishment of tolerances by amending 40 CFR part 180 will 
protect the public health, and the establishment of feed additive 
regulations by amending 40 CFR part 186 will be safe. Therefore, EPA is 
establishing the tolerances and feed additive regulation as set forth 
below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections with the Hearing Clerk, at the address given above, 
40 CFR 178.20. A copy of the objections and/or hearing requests filed 
with the Hearing Clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections. 40 
CFR 178.25. Each objection must be accompanied by the fee prescribed by 
40 CFR 180.33 (i). If a hearing is requested, the objections must 
include a statement of the factual issue(s) on which the hearing is 
requested, the requestor`s contentions on each such issue, and a 
summary of any evidence relied upon by the objector. 40 CFR 178.27. A 
request for a hearing will be granted if the Administrator determines 
that the material submitted shows the following: There is a genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more issues in favor of the requestor, taking into 
account uncontested claims or facts to the contrary; and resolution of 
the factual issue(s) in the manner sought by the requestor would be 
adequate to justify the action requested. 40 CFR 178.32.
    A record has been established for this rulemaking under docket 
number [PP3F4268, FAP5H5720/R2247] (including objections and hearing 
requests 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 Rm. 
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.
    Written objections and hearing requests, identified by the document 
control number [PP3F4268, FAP5H5720/R2247] may be submitted to the 
Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708, 401 M 
St., SW., Washington, DC 20460. A copy of electronic objections and 
hearing requests filed with the Hearing Clerk can be sent directly to 
EPA at: <a href="/cdn-cgi/l/email-protection#422d32326f262d21292736022732232f232b2e6c2732236c252d34"><span class="__cf_email__" data-cfemail="87e8f7f7aae3e8e4ece2f3c7e2f7e6eae6eeeba9e2f7e6a9e0e8f1">[email protected]</span></a>.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk 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 any objections and hearing requests 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 objections and hearing requests 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, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under Section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in 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, completion, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities (also referred to 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 the rights and obligation of recipients 
thereof; 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 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

[[Page 30175]]

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.

List of Subjects in 40 CFR Part 186

    Environmental protection, Animals feeds, Pesticides and pests.
    Dated: May 29, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    b. In 180.441, by revising paragraph (c) and adding paragraph (d) 
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)phenoxy)propanoate], and its acid metabolite 
quizalofop-p [R-(2-(4-((6-quinoxalin-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;

                                                                        
------------------------------------------------------------------------
                 Commodity                        Parts per million     
------------------------------------------------------------------------
cottonseed................................  0.1                         
lentils...................................  0.05                        
------------------------------------------------------------------------

    (d) Time limited tolerances to expire on June 14, 1999 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 it 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:

                                                                        
------------------------------------------------------------------------
                Commodities                       Parts per million     
------------------------------------------------------------------------
foliage of legume vegetables (except        3.0                         
 soybeans).                                                             
legume vegetables (succulent or dried)      0.25                        
 group.                                                                 
sugarbeet, root...........................  0.1                         
sugarbeet, top............................  0.5                         
------------------------------------------------------------------------

PART 186--[AMENDED]

    2. In part 186:
    a. The authority for part 186 continues to read as follows:

    Authority: 21 U.S.C. 342, 348, and 701.

    b. In 186.5250, by redesignating the existing paragraph and table 
as paragraph (a) and adding paragraph (b) to read as follows:


Sec. 186.5250   Quizalofop ethyl.

    *    *    *    *    *
    (b) A feed additive regulation to expire (insert date 3 years from 
date of publication in the Federal Register) is established to permit 
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 the ester and 
the acid, all expressed as quizalofop-p-ethyl ester in or on sugar beet 
molasses at 0.2 part per million (ppm)

[FR Doc. 96-15040 Filed 6-13-96; 8:45 am]
BILLING CODE 6560-50-F

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