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Quinoxyfen (DOW, IR-4). May 30, 2003. Pesticide Tolerance Petition. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/May/Day-30/p13562.htm
[Federal Register: May 30, 2003 (Volume 68, Number 104)]
[Notices]
[Page 32497-32501]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my03-67]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0071; FRL-7295-7]
Quinoxyfen; Notice of Filing a Pesticide Petition to Establish a
Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket ID number OPP-2003-0071, must be
received on or before June 30, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:
[[Page 32498]]
(703) 308-3194]; e-mail address: brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
¥ Crop production (NAICS 111)
¥ Animal production (NAICS 112)
¥ Food manufacturing (NAICS 311)
¥ Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2003-0071. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although, a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This
docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The docket telephone number is (703)
305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although, not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA
dockets. Information claimed as CBI and other information whose
disclosure is restricted by statute, which is not included in the
official public docket, will not be available for public viewing in
EPA's electronic public docket. EPA's policy is that copyrighted
material will not be placed in EPA's electronic public docket but will
be available only in printed, paper form in the official public docket.
To the extent feasible, publicly available docket materials will be
made available in EPA's electronic public docket. When a document is
selected from the index list in EPA dockets, the system will identify
whether the document is available for viewing in EPA's electronic
public docket. Although, not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.
EPA intends to work towards providing electronic access to all of the
publicly available docket materials through EPA's electronic public
docket.
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or on paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also, include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2003-0071. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address or other contact
information unless you provide it in the body of your comment.
[[Page 32499]]
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP-2003-0071. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0071.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2003-0071. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket, and EPA's
electronic public docket without prior notice. If you have any
questions about CBI, or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows, proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: May 19, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petitions
The petitioner summary of the pesticide petitions is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the Interregional Research Project Number (IR-4), and
represents the view of the petitioner. The petition summary announces
the availability of a description of the analytical methods available
to EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
Interregional Research Project Number (IR-4)
PP 1E6302 and 2E6474
EPA has received pesticide petitions (1E6302 and 2E6474) from the
Interregional Research Project Number (IR-4), 681 U.S. Highway
#1 South, North Brunswick, NJ 08902 proposing, pursuant to
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part
180 by establishing tolerances for residues of quinoxyfen 5,7-dichloro-
4-quinolyl 4-fluorophenyl ether in or on the following raw agricultural
commodities: Grape at 0.70 parts per million (ppm) (1E6302), hop, dried
at 5 ppm (1E6302), and cherry at 0.4 ppm (2E6474). EPA has determined
that the petitions contain data or information regarding the elements
set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully
evaluated the sufficiency of the submitted data at this time or whether
the data support granting of the petitions. Additional data may be
needed before EPA rules on the petitions. This notice includes a
summary of the petitions prepared by the registrant, Dow AgroSciences
LLC, Indianapolis, IN 46268.
A. Residue Chemistry
1. Plant metabolism. The nature of residues is adequately
understood for the purposes of these tolerances. Based on the findings
from these studies, quinoxyfen is the primary residue in all crops and
therefore, the only residue of concern. Metabolites were present at low
levels (<10% of total radioactive residue).
Grape vineyard, cherry orchards, and hops are not normally rotated
to succeeding crops, therefore, concerns on the residues in rotational
crops are minimal. Nonetheless, a confined rotational crop study was
conducted with quinoxyfen which confirmed
[[Page 32500]]
minimal carryover of residues (> 0.003 [mu]ug/g) to succeeding crops.
2. Analytical method. A practical analytical method for detecting
and measuring levels of quinoxyfen in or on cherries, hops, grapes and
its products allows monitoring of residues at or above the tolerances
set for these crops. The analytical method uses capillary gas
chromatography and mass selective detection (GC-MSD) with limits of
quantitation (LOQ) of 0.01 parts per million (ppm) for cherries,
grapes, grape juice, raisins and 0.05 ppm for hops. An independent
laboratory has validated the method using hops, which is typically the
more difficult matrix to analyze.
3. Magnitude of residues. The magnitude of residues for grape,
hops, and cherry is adequately understood.
B. Toxicological Profile
1. Acute toxicity. Quinoxyfen technical has low acute toxicity. The
acute oral lethal dose (LD)50 in rats was >5,000 milligrams/
kilogram (mg/kg) whereas, the dermal (LD)50 in rabbits was
>2,000 mg/kg. The acute inhalation lethal concentration
(LC)50 in rats was greater than the highest attainable
aerosol concentration (3.38 mg/L). Quinoxyfen produced no dermal
irritation and only mild eye irritation in rabbits. A guinea pig dermal
sensitization study conducted by the modified Buehler method found no
sensitization, whereas a study conducted by the Magnusson and Kligman
maximization test showed a positive sensitization reaction.
Formulations of quinoxyfen are water based suspension concentrates that
have similar low acute toxicity. These suspension concentrates are
classified as non-sensitizer, based on the results from testing in
guinea pigs.
2. Genotoxicity. Quinoxyfen was negative for genotoxicity when
tested in in vitro and in vivo systems.
3. Reproductive and developmental toxicity. Quinoxyfen did not have
any effect on reproductive parameters at dose levels that induced
treatment-related effects in parental rats. Transient decreases in pup
body weights were seen prior to weaning, but dietary concentrations
were targeted for adults and consumption of treated diets by the pups
resulted in dose levels to the pups approximately 3-fold higher than in
adults. Post-weaning weights were comparable to controls. A teratogenic
potential for quinoxyfen was not demonstrated in either rats or rabbits
at dose levels that induced maternal toxicity.
4. Subchronic and chronic toxicity. Quinoxyfen caused increased
liver weights and microscopic hepatocellular hypertrophy when given at
sufficiently high dose levels in rats and mice for 13 weeks; no effects
were observed in the subchronic dog study at the highest dose tested.
Very high dietary levels were associated with slight hepatocellular
necrosis. Similar increases in liver weights were seen in chronic
studies. In addition, increased kidney weights, and an increase in the
incidence of chronic progressive glomerulonephropathy, were seen after
24 months in female rats given high dose levels of quinoxyfen. Chronic
toxicity seen in dogs included liver effects as noted above, along with
regenerative anemia at high dose levels.
Using the Guidelines for Carcinogen Risk Assessment published
September 24, 1986 (51 FR 33992), it is proposed that quinoxyfen be
classified as Group E for carcinogenicity (no evidence of
carcinogenicity) based on the results of studies in two species. Dow
AgroSciences believes there was no evidence of carcinogenicity in an
18-month mouse feeding study and a 24-month rat feeding study at any
dosage tested.
5. Animal metabolism. Quinoxyfen is rapidly absorbed, extensively
metabolized and rapidly eliminated in the urine and feces. Studies
conducted with 14C-quinoxyfen, labeled in either the phenyl
ring or the quinoline ring, indicated extensive cleavage of the diaryl
ether linkage. There were no substantive differences in the metabolism
and disposition of quinoxyfen between males and females, or between
single or repeated exposure. Parent quinoxyfen was not found in the
urine; although, it was identified in the feces. The major metabolites
found in urine and/or feces included: (1) Acid-labile conjugates of the
phenyl ring moiety (4-FP) and quinoline ring moiety (DCHQ); (2) lesser
quantities of free 4-FP and DCHQ; and (3) isomers of fluorophenyl-ring
hydroxy-quinoxyfen, both free and glucuronide and/or sulfate
conjugates. Trace quantity of the 3-OH metabolite was also identified
in the urine and feces of rats.
6. Metabolite toxicology. The nature of residue studies of
quinoxyfen in plants indicated that the majority of applied
radiolabeled material remained as the parent compound. Analyses from
nature of residues studies in a number of crops revealed low residues
of metabolites (<10% TRR) identified as: (1) A quinoline-ring
hydroxylated metabolite, most likely 3-OH; (2) a cyclized deschloro
photoproduct (CFBPQ); (3) 4-FP; and (4) a metabolite in which the
fluorine was replaced by a hydroxyl group. Of these metabolites, 4-FP
(formed by ether bridge cleavage), and DCHQ (corresponding to the other
half of the molecule), as well as trace quantities of 3-OH, have been
identified in rat urine and/or feces. These data suggest that most
metabolites formed in plants are similarly formed in mammals and are of
little toxicologic concern, based on the existing data for quinoxyfen.
7. Neurotoxicity. Quinoxyfen has been shown to have no
neurotoxicologic potential based on acute and subchronic studies.
8. Endocrine disruption. There is no evidence from any studies to
suggest that quinoxyfen has an effect on any endocrine system.
C. Aggregate Exposure
1. Dietary exposure. Potential dietary exposure and risk assessment
was estimated using DEEM (Dietary Exposure Evaluation Model, Version
7.76) with USDA food consumption data continuing survey of food intake
by individuals (CSFII) Survey 1994-1998.
i. Food--a. Acute No acute dietary risk for quinoxyfen was
evaluated since no appropriate toxicity endpoint attributable to a
single dose could be identified. Therefore, an acute reference dose was
not established.
b. Chronic. The dietary exposure assessment was performed using a
conservative approach (Tier I) and the estimated theoretical maximum
residue contribution (TMRC) was based on the proposed tolerances for
quinoxyfen on or in grapes, hops, and cherries with the assumption that
100% of these crops were treated with quinoxyfen.
ii. Drinking water. Based on the rapid degradation of quinoxyfen in
water and its high tendency to sorb to soils, no surface water or
ground water contamination is expected. This agrees with EPA Tier 1
modeling using SciGrow and GENEEC which estimated concentration of
quinoxyfen at 0.006 [mu]g/L in ground water and 241 [mu]g/L in surface
water, respectively.
2. Non-dietary exposure. Quinoxyfen is not currently registered for
non-crop uses. Therefore, aggregate exposure to quinoxyfen will not
include non-dietary, non-occupational exposures.
D. Cumulative Effects
The potential for cumulative effects of quinoxyfen and other
substances that have a common mechanism of toxicity is also considered.
Quinoxyfen is a member of the quinoline class of fungicides. No
information is available to determine whether quinoxyfen has a common
mechanism of toxicity with other pesticides. Therefore, it is
appropriate to consider only the
[[Page 32501]]
potential risks of quinoxyfen in an aggregate exposure assessment.
E. Safety Determination
1. U.S. population. The chronic dietary exposure was evaluated
using a chronic reference dose (RfD) of 0.2 mg/kg/day based on a no
observed adverse effect level (NOAEL) of 20 mg/kg/day from chronic rat,
chronic dog, and rat reproduction studies and uncertainty factor of
100. No additional Food Quality Protecction Act (FQPA) uncertainty
factor is needed.
For the U.S. general population, the TMRC was estimated to be
0.000192 mg/kg/day. Using the conservative exposure assumptions
described in Section C. and based on the completeness and reliability
of the toxicity data, the aggregate exposure to quinoxyfen utilizes
0.1% of the RfD for the U.S. population. EPA generally has no concern
for exposures below 100% of the RfD because the RfD represents the
level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. Thus, there
is a reasonable certainty that no harm will result from aggregate
exposure to quinoxyfen residues from the proposed uses.
2. Infants and children. FFDCA section 408 provides that EPA may
apply an additional safety factor for infants and children in the case
of threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base. Based on the current toxicological
data requirements, the data base for quinoxyfen relative to prenatal
and postnatal effects for children is complete.
In assessing the potential for additional sensitivity of infants
and children to residues of quinoxyfen, data from developmental
toxicity studies in rats and rabbits and a 2-generation reproduction
study in the rat are considered. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from pesticide exposure during prenatal development.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability and potential
systemic toxicity of mating animals and on various parameters
associated with the well-being of offspring.
The population subgroup with the highest potential exposure are
children (1-6 yrs old) with TMRC of 0.00071 mg/kg/day. Using the
conservative exposure assumptions previously described in Section C.
the percent RfD utilized by the potential aggregate exposure to
quinoxyfen residues is about 0.4% for children (1-6 yrs old), the
population subgroup with highest potential exposure. Quinoxyfen had no
effect on reproduction or embryo-fetal development at any dosage
tested. Therefore, no additional FQPA uncertainty factor is needed.
Based on the completeness and reliability of the toxicity data and the
conservative exposure assessment, Dow AgroSciences concludes that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to quinoxyfen residues from proposed
uses.
The drinking water level of concern (DWLOC) for the general U.S.
population and children 1-6 years old (population subgroup with the
highest potential exposure) was calculated to be 6,993 [mu]g/L and
1,993 [mu]g/L, respectively. The DWLOCs are substantially greater than
the estimated residue concentration in ground water or surface water;
therefore, exposure to quinoxyfen would not result in unacceptable
levels of aggregate human health risk.
F. International Tolerances
There are no codex maximum residue levels established for residues
of quinoxyfen on grapes, hops, and cherries.
[FR Doc. 03-13562 Filed 5-29-03; 8:45 am]
BILLING CODE 6560-50-S