Quinoxyfen; Pesticide Tolerance, 50350-50354 [E6-14065]
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50350
Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Rules and Regulations
Coordinators requested a temporary
deviation from the current operating
regulation for the new Woodrow Wilson
Memorial (I–95) Bridge set out in 33
CFR 117.255(c).
Though good progress has been made
regarding commissioning of the north
and south drawbridges (both now
carrying I–95 vehicle traffic), the
coordinators are requesting an
additional two months of 10 a.m.-to-2
p,.m. restriction of bridge operation to
proceed with commissioning activities
through October 26, 2006. From a riveruser standpoint, the coordinators have
received no requests from boaters or
mariners to open during the 10 a.m. to
2 p.m. time frame since the restriction
was issued in late June 2006. In fact, no
requests have been received for an
opening of the new bridge at all since
July 3, 2006. Finally, the coordinators
have received no complaints on the 10
a.m. to 2 p.m. restriction.
The coordinators requested that the
new Outer Loop portion of the new
drawbridge not be available for
openings for vessels each day between
the hours of 10 a.m. to 2 p.m. from
Monday, August 26 through October 24,
2006 or until the bridge is properly
commissioned, whichever comes first.
The temporary deviation will only affect
vessels with mast heights of 75 feet or
greater as the existing drawbridge is able
to open in accordance with the current
operating regulations set out in 33 CFR
117.255(a). Management of the Federal
and auxiliary channels will continue to
be closely coordinated between the
coordinators for the construction of the
new Woodrow Wilson Bridge Project,
the Coast Guard and vessels requesting
transit through the construction zone.
Further more, all affected vessels with
mast heights greater than 75 feet will be
able to receiver an opening of the new
drawbridge in the ‘‘off-peak’’ vehicle
traffic hours (evening and overnight) in
accordance with 33 CFR 117.255(c).
Maintaining the new drawbridge in the
closed-to-navigation position each day
from 10 a.m. to 2 p.m. on August 26,
2006 through October 24, 2006 will help
reduce the impact to vehicular traffic
during this phase of new bridge
construction.
The Coast Guard has informed the
known users of the waterway of the
closure period for the bridge so that
these vessels can arrange their transits
to minimize any impact caused by the
temporary deviation.
In accordance with 33 CFR 117.35(c),
this work will be performed with all due
speed in order to return the bridge to
normal operation as soon as possible.
This deviation from the operating
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regulations is authorized under 33 CFR
117.35.
Dated: August 17, 2006
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, Fifth
Coast Guard District.
[FR Doc. 06–7132 Filed 8–24–06; 8:45 am]
BILLING CODE 4910–15–M
FOR FURTHER INFORMATION CONTACT:
Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–7610; e–mail address:
jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0167; FRL–8088–8]
Quinoxyfen; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of quinoxyfen in
or on commodities: lettuce, head and
lettuce, leaf; melon, subgroup 9A;
pepper, bell and pepper, nonbell; and
strawberry. The Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection
Act of 1996 (FQPA).
DATES: This regulation is effective
August 25, 2006. Objections and
requests for hearings must be received
on or before October 24, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0167. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The 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.
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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), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
32532), e.g., agricultural workers;
commercial applicators; farmers;
greenhouse, nursery, and floriculture
workers; residential users.
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 Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e–CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
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opptsfrs/home/guidelin.htm
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–0167 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before October 24, 2006.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2006–0167, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on–
line instructions for submitting
comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of April 21,
2006 (71 FR 20667) (FRL–8056–4), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP 3E6755; 5E6969;
and 5E6970) by the Interregional
Research Project #4 (IR–4), 681 U.S.
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Highway #1 South, North Brunswick, NJ
08902–3390. The petitions requested
that 40 CFR 180.588 be amended by
establishing tolerances for residues of
the fungicide quinoxyfen, (5,7–
dichloro–4–(4–fluorophenoxy)
quinoline in or on the raw agricultural
commodities: eggplant at 1.0 parts per
million (ppm) (PP 3E6755); peppers
(bell and non–bell) at 1.0 ppm (PP
3E6755); melon subgroup 9A at 0.1 ppm
(PP 5E6969); lettuce, head and leaf at
17.0 ppm (PP 5E6970); and strawberry
at 0.8 ppm (PP 5E6970). That notice
included a summary of the petition
prepared by Dow AgroSciences, the
registrant. There were no comments
received in response to the notice of
filing.
Upon completing review of the
current quinoxyfen database, the
Agency concluded that the appropriate
tolerance levels for quinoxyfen residues
in or on pending crops should be
established as follow: Lettuce, head at
7.0 ppm; lettuce, leaf at 19 ppm; melon,
subgroup 9A at 0.08 ppm; pepper, bell
at 0.35 ppm; pepper, non–bell at 1.7
ppm; and strawberry at 0.90 ppm. The
Agency concluded that there are
insufficient data to establish a tolerance
for quinoxyfen residues in or on
eggplant, at this time.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA–PEST/1997/
November/Day–26/p30948.htm.
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III. Aggregate Risk Assessment and
Determination of Safety
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action. EPA has sufficient data to assess
the hazards of and to make a
determination on aggregate exposure,
consistent with section 408(b)(2) of
FFDCA, for a tolerance for residues of
quinoxyfen on lettuce, head at 7.0 ppm;
lettuce, leaf at 19 ppm; melon (subgroup
9A) at 0.08 ppm; pepper, bell at 0.35
ppm; pepper, non–bell at 1.7 ppm; and
strawberry at 0.90 ppm. EPA’s
assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the toxic effects caused by
quinoxyfen as well as the no–observed–
adverse–effect–level (NOAEL) and the
lowest–observed–adverse–effect–level
(LOAEL) from the toxicity studies can
be found in the Federal Register of
September 29, 2003 (68 FR 55858)
(FRL–7318–2), under docket ID number
EPA–HQ–OPP–2003–0218, to which the
reader may refer for additional
information.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which no adverse
effects are observed (the NOAEL) from
the toxicology study identified as
appropriate for use in risk assessment is
used to estimate the toxicological level
of concern (LOC). However, the lowest
dose at which adverse effects of concern
are identified (the LOAEL) is sometimes
used for risk assessment if no NOAEL
was achieved in the toxicology study
selected. An uncertainty factor (UF) is
applied to reflect uncertainties inherent
in the extrapolation from laboratory
animal data to humans and in the
variations in sensitivity among members
of the human population as well as
other unknowns.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold hazards such as cancer. The
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Q* approach assumes that any amount
of exposure will lead to some degree of
cancer risk, estimates risk in terms of
the probability of occurrence of
additional cancer cases. More
information can be found on the general
principles EPA uses in risk
characterization at https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for quinoxyfen used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of September 29,
2003 (68 FR 55858) (FRL–7318–2),
under docket ID number EPA–HQ–
OPP–2003–0218, to which the reader
may refer for additional information.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.588) for the
residues of quinoxyfen, in or on a
variety of raw agricultural commodities.
Permanent tolerances are established for
residues of quinoxyfen per se in/on
cherry, sweet and cherry, tart at 0.30
ppm; grape at 0.60 ppm; and dried hop
cones at 3.0 ppm. In addition, timelimited tolerances are established under
Section 18 emergency exemptions for
residues of quinoxyfen per se in/on
pumpkin; squash, winter; and
vegetables, curcubit, subgroup 9A. Risk
assessments were conducted by EPA to
assess dietary exposures from
quinoxyfen in food as follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a one-day or
single exposure.
There were no toxic effects
attributable to a single dose. Therefore,
an endpoint of concern was not
identified to quantitate acute-dietary
risk to the general population or to the
subpopulation females 13-50 years old.
As a result, no acute risk is expected
from exposure to quinoxyfen.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
(DEEM-FCIDTM), Version 2.03, which
incorporates food consumption data as
reported by respondents in the USDA
1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated
exposure to the chemical for each
commodity.
The following assumptions were
made for the chronic exposure
assessments: An unrefined, Tier 1
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chronic dietary (food and water)
exposure assessment using tolerancelevel residues and assuming 100% crops
treated for all proposed commodities,
and default DEEM Version 7.76
processing factors for all commodities.
iii. Cancer. Quinoxyfen is classified as
‘‘not likely to be carcinogenic to
humans,’’ based on the lack of evidence
of carcinogenicity in rat and mice
studies. Therefore, an exposure
assessment for the purpose of evaluating
cancer risk is not needed.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring exposure data to complete a
comprehensive dietary exposure
analysis and risk assessment for
quinoxyfen in drinking water. Because
the Agency does not have
comprehensive monitoring data,
drinking water concentration estimates
are made by reliance on simulation or
modeling taking into account data on
the physical characteristics of
quinoxyfen. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water.
Typically EPA evaluates the potential
for human exposure to pesticides in
drinking water through an assessment of
available surface water and ground
water monitoring data and modeling.
For quinoxyfen, no monitoring data
were available for use in this drinking
water assessment. Therefore, potential
human exposures to quinoxyfen were
evaluated through modeling.
The Agency used the FQPA Index
Reservoir Screening Tool (FIRST) to
calculate the surface water Estimated
Exposure Concentrations (EECs) and the
screening model SCI-GROW to calculate
the groundwater EECs. The Agency
considered residues of quinoxyfen per
se, plus a metabolite, 3-OH quinoxyfen,
in modeling studies. To do this, aerobic
soil metabolism and aerobic aquatic
metabolism half-lives determined for
the parent compound in the guideline
studies were recalculated using
concentration data for the parent
compound plus 3-OH quinoxyfen when
the latter compound was present.
Additionally, the Agency was restricted
to the use of soil adsorption coefficients
determined only for the parent
compound; however, other available
information from the guideline studies
indicates that 3-OH quinoxyfen has
mobility in soil similar to that of the
parent compound. Because
hydroxylation (the addition of the 3-OH)
could increase its mobility relative to
quinoxyfen, this metabolite has the
potential to reach drinking water
sources in significant quantities.
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For the surface water and
groundwater assessments, EECs were
determined using a maximum annual
application rate for cherries of 0.55 lb
a.i./A (five applications of 0.114 lb a.i./
A/application).
Based on the FIRST and SCI-GROW
models, the estimated environmental
concentrations (EECs) of quinoxyfen for
chronic exposures are estimated to be
0.84 ppb for surface water and 0.006
ppb for ground water. Model estimates
of drinking water concentrations were
directly entered into the dietary
exposure model (DEEM-FCID).
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Quinoxyfen is not registered for use on
any sites that would result in residential
exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
Unlike other pesticides for which EPA
has followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
quinoxyfen and any other substances
and quinoxyfen does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
not assumed that quinoxyfen has a
common mechanism of toxicity with
other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1.In general. Section 408 of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
infants and children in the case of
threshold effects to account for prenatal
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and postnatal toxicity and the
completeness of the data base on
toxicity and exposure unless EPA
determines based on reliable data that a
different margin of safety will be safe for
infants and children. Margins of safety
are incorporated into EPA risk
assessments either directly through use
of a MOE analysis or through using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk to humans. In applying
this provision, EPA either retains the
default value of 10X when reliable data
do not support the choice of a different
factor, or, if reliable data are available,
EPA uses a different additional safety
factor value based on the use of
traditional uncertainty factors and/or
special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity.
There is no quantitative or qualitative
evidence of increased susceptibility of
rat and rabbit fetuses to in utero
exposure in developmental studies.
There is evidence of increased
quantitative susceptibility (minimal
decrease in F1a pup weights) in the rat
multi-generation reproduction study,
but the concern is low since: (1) The
effects in pups are well-characterized
with a clear NOAEL; (2) the pup effects
are minimal at the LOAEL and only
noted in the first-generation offspring;
and (3) the doses and endpoints selected
for regulatory purposes would address
the concerns of the pup effects noted in
the rat reproduction study. Therefore,
there are no residual uncertainties for
prenatal/postnatal toxicity in this study.
3. Conclusion. There is a complete
toxicity data base for quinoxyfen and
exposure data are complete or are
estimated based on data that reasonably
account for potential exposures. There
are no residual uncertainties for
prenatal/postnatal toxicity. No
additional safety factor is needed for
data base uncertainties. No clinical sign
of neurotoxicity or neuropathology was
seen in the data base, including acute
and subchronic neurotoxicity studies. A
developmental neurotoxicity study is
not required. Therefore, EPA
determined that the 10X SF to protect
infants and children should be reduced
to 1X.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. An endpoint of concern
was not identified to quantitate acutedietary risk to the general population or
to the subpopulation females 13-50
years old. As a result, no acute risk is
expected from exposure to quinoxyfen.
2. Chronic risk. Using the exposure
assumptions described in this unit for
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chronic exposure, EPA has concluded
that exposure to quinoxyfen from (food
+ water) will utilize 1.3% of the cPAD
for the U.S. population, <1% of the
cPAD for infants <1 year old), and 2.0%
of the cPAD for children (1 to 2 years
old) the subpopulation at greatest
exposure. There are no residential uses
for quinoxyfen that result in chronic
residential exposure to quinoxyfen.
3. Short-term risk. Short-term
aggregate exposure takes into account
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Quinoxyfen is not registered for use on
any sites that would result in residential
exposure. Therefore, the aggregate risk
is the sum of the risk from food and
water, which do not exceed the
Agency’s level of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level). Quinoxyfen is not
registered for use on any sites that
would result in residential exposure.
Therefore, the aggregate risk is the sum
of the risk from food and water, which
do not exceed the Agency’s level of
concern.
5. Aggregate cancer risk for U.S.
population. Quinoxyfen has been
classified as ‘‘not likely to be
carcinogenic to humans.’’ Therefore,
quinoxyfen is not expected to pose a
cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, and to infants and children
from aggregate exposure to quinoxyfen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A practical analytical method is
available to monitor and enforce the
tolerances of quinoxyfen residues in
crops. The analytical method uses
capillary gas chromatography and mass
spectrometry detector (GC-MSD) with
limits of quantitation (LOQ) of
approximately 0.01 ppm. The method is
adequate for collecting data and
enforcing tolerances for quinoxyfen
residues in/on the subject crops. There
are no livestock feed items associated
with these petitions, therefore, data
collection and tolerance enforcement
methods for livestock commodities are
not required.
B. International Residue Limits
There are no Mexican, Canadian or
Codex maximum residue limits (MRLs)
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50353
established for quinoxyfen in/on crops
considered in this action. Therefore, no
compatibility issues exist for these
tolerances.
V. Conclusion
Therefore, the tolerance is established
for residues of quinoxyfen, 5,7-dichloro4-(4-fluorophenoxy) quinoline in or on
lettuce, head at 7.0 ppm and lettuce, leaf
at 19 ppm; melon, subgroup 9A at 0.08
ppm; pepper, bell at 0.35 ppm; pepper,
nonbell at 1.7 ppm; and strawberry at
0.90 ppm. .
VI. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has
been exempted from review under
Executive Order 12866 due to its lack of
significance, this rule is not subject to
Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This final rule does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104-4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section
12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
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50354
Federal Register / Vol. 71, No. 165 / Friday, August 25, 2006 / Rules and Regulations
Agency has determined that this action
will not have a substantial direct effect
on States, on the relationship between
the national government and the States,
or on the distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this rule
does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive
Order 13175, requires EPA to develop
an accountable process to ensure
‘‘meaningful and timely input by tribal
officials in the development of
regulatory policies that have tribal
implications.’’ ‘‘Policies that have tribal
implications’’ is defined in the
Executive order to include regulations
that have ‘‘substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
rule will not have substantial direct
effects on tribal governments, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
VerDate Aug<31>2005
15:27 Aug 24, 2006
Jkt 208001
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
kresoxim-methyl in or on vegetable,
cucurbit, group 9. Interregional
Research Project No. 4 requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended
by the Food Quality Protection Act of
1996 (FQPA).
DATES: This regulation is effective
August 25, 2006. Objections and
requests for hearings must be received
on or before October 24, 2006, and must
be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
List of Subjects in 40 CFR Part 180
ADDRESSES: EPA has established a
Environmental protection,
docket for this action under docket
Administrative practice and procedure,
identification (ID) number EPA–HQ–
Agricultural commodities, Pesticides
OPP–2006–0333. All documents in the
and pests, Reporting and recordkeeping
docket are listed in the index for the
requirements.
docket. Although listed in the index,
some information is not publicly
Dated: August 16, 2006.
available, e.g., Confidential Business
Lois Rossi,
Information (CBI) or other information
Director, Registration Division, Office of
whose disclosure is restricted by statute.
Pesticide Programs.
Certain other material, such as
I Therefore, 40 CFR chapter I is
copyrighted material, is not placed on
amended as follows:
the Internet and will be publicly
available only in hard copy form.
PART 180—[AMENDED]
Publicly available docket materials are
I 1. The authority citation for part 180
available in the electronic docket at
continues to read as follows:
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Authority: 21 U.S.C. 321(q), 346a and 371.
Regulatory Public Docket in Rm. S-4400,
I 2. Section 180.588 is amended by
One Potomac Yard (South Building),
alphabetically adding commodities to
2777 S. Crystal Drive, Arlington, VA.
the table in paragraph (a) to read as
The Docket Facility is open from 8:30
follows:
a.m. to 4 p.m., Monday through Friday,
§ 180.588 Quinoxyfen; tolerances for
excluding legal holidays. The Docket
residues.
telephone number is (703) 305-5805.
(a) * * *
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division
Commodity
Parts per million
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
*
*
*
*
*
Lettuce, head ..................
7.0 Pennsylvania Ave., NW., Washington,
Lettuce, leaf ....................
19 DC 20460-0001; telephone number:
Melon, subgroup 9A .......
0.08 (703) 305-6463; e-mail address:
Pepper, bell ....................
0.35 madden.barbara@epa.gov.
Pepper, nonbell ..............
Strawberry ......................
1.7
0.90
[FR Doc. E6–14065 Filed 8–24–06; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0333; FRL–8088–1]
Kresoxim-methyl; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes a
tolerance for combined residues of
Frm 00036
Fmt 4700
I. General Information
A. Does this Action Apply to Me?
BILLING CODE 6560–50–S
PO 00000
SUPPLEMENTARY INFORMATION:
Sfmt 4700
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), e.g.,
agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS 112),
e.g., cattle ranchers and farmers, dairy
cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311),
e.g., agricultural workers; farmers;
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Agencies
[Federal Register Volume 71, Number 165 (Friday, August 25, 2006)]
[Rules and Regulations]
[Pages 50350-50354]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14065]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0167; FRL-8088-8]
Quinoxyfen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
quinoxyfen in or on commodities: lettuce, head and lettuce, leaf;
melon, subgroup 9A; pepper, bell and pepper, nonbell; and strawberry.
The Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 25, 2006. Objections and
requests for hearings must be received on or before October 24, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0167. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The 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.
FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; e-mail address: jackson.sidney@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), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly
[[Page 50351]]
to the guidelines at https://www.epa.gpo/opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0167 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 24, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0167, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 21, 2006 (71 FR 20667) (FRL-8056-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
3E6755; 5E6969; and 5E6970) by the Interregional Research Project
4 (IR-4), 681 U.S. Highway 1 South, North Brunswick,
NJ 08902-3390. The petitions requested that 40 CFR 180.588 be amended
by establishing tolerances for residues of the fungicide quinoxyfen,
(5,7-dichloro-4-(4-fluorophenoxy) quinoline in or on the raw
agricultural commodities: eggplant at 1.0 parts per million (ppm) (PP
3E6755); peppers (bell and non-bell) at 1.0 ppm (PP 3E6755); melon
subgroup 9A at 0.1 ppm (PP 5E6969); lettuce, head and leaf at 17.0 ppm
(PP 5E6970); and strawberry at 0.8 ppm (PP 5E6970). That notice
included a summary of the petition prepared by Dow AgroSciences, the
registrant. There were no comments received in response to the notice
of filing.
Upon completing review of the current quinoxyfen database, the
Agency concluded that the appropriate tolerance levels for quinoxyfen
residues in or on pending crops should be established as follow:
Lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon, subgroup 9A
at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and
strawberry at 0.90 ppm. The Agency concluded that there are
insufficient data to establish a tolerance for quinoxyfen residues in
or on eggplant, at this time.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of quinoxyfen on
lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon (subgroup 9A)
at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and
strawberry at 0.90 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by quinoxyfen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the Federal
Register of September 29, 2003 (68 FR 55858) (FRL-7318-2), under docket
ID number EPA-HQ-OPP-2003-0218, to which the reader may refer for
additional information.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The
[[Page 50352]]
Q* approach assumes that any amount of exposure will lead to some
degree of cancer risk, estimates risk in terms of the probability of
occurrence of additional cancer cases. More information can be found on
the general principles EPA uses in risk characterization at https://
www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for quinoxyfen used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 29, 2003 (68 FR 55858)
(FRL-7318-2), under docket ID number EPA-HQ-OPP-2003-0218, to which the
reader may refer for additional information.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.588) for the residues of quinoxyfen, in or on a
variety of raw agricultural commodities. Permanent tolerances are
established for residues of quinoxyfen per se in/on cherry, sweet and
cherry, tart at 0.30 ppm; grape at 0.60 ppm; and dried hop cones at 3.0
ppm. In addition, time-limited tolerances are established under Section
18 emergency exemptions for residues of quinoxyfen per se in/on
pumpkin; squash, winter; and vegetables, curcubit, subgroup 9A. Risk
assessments were conducted by EPA to assess dietary exposures from
quinoxyfen in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one-day or single exposure.
There were no toxic effects attributable to a single dose.
Therefore, an endpoint of concern was not identified to quantitate
acute-dietary risk to the general population or to the subpopulation
females 13-50 years old. As a result, no acute risk is expected from
exposure to quinoxyfen.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), Version 2.03, which
incorporates food consumption data as reported by respondents in the
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII), and accumulated exposure to the chemical for each
commodity.
The following assumptions were made for the chronic exposure
assessments: An unrefined, Tier 1 chronic dietary (food and water)
exposure assessment using tolerance-level residues and assuming 100%
crops treated for all proposed commodities, and default DEEM Version
7.76 processing factors for all commodities.
iii. Cancer. Quinoxyfen is classified as ``not likely to be
carcinogenic to humans,'' based on the lack of evidence of
carcinogenicity in rat and mice studies. Therefore, an exposure
assessment for the purpose of evaluating cancer risk is not needed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for quinoxyfen in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of quinoxyfen. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water.
Typically EPA evaluates the potential for human exposure to
pesticides in drinking water through an assessment of available surface
water and ground water monitoring data and modeling. For quinoxyfen, no
monitoring data were available for use in this drinking water
assessment. Therefore, potential human exposures to quinoxyfen were
evaluated through modeling.
The Agency used the FQPA Index Reservoir Screening Tool (FIRST) to
calculate the surface water Estimated Exposure Concentrations (EECs)
and the screening model SCI-GROW to calculate the groundwater EECs. The
Agency considered residues of quinoxyfen per se, plus a metabolite, 3-
OH quinoxyfen, in modeling studies. To do this, aerobic soil metabolism
and aerobic aquatic metabolism half-lives determined for the parent
compound in the guideline studies were recalculated using concentration
data for the parent compound plus 3-OH quinoxyfen when the latter
compound was present. Additionally, the Agency was restricted to the
use of soil adsorption coefficients determined only for the parent
compound; however, other available information from the guideline
studies indicates that 3-OH quinoxyfen has mobility in soil similar to
that of the parent compound. Because hydroxylation (the addition of the
3-OH) could increase its mobility relative to quinoxyfen, this
metabolite has the potential to reach drinking water sources in
significant quantities.
For the surface water and groundwater assessments, EECs were
determined using a maximum annual application rate for cherries of 0.55
lb a.i./A (five applications of 0.114 lb a.i./A/application).
Based on the FIRST and SCI-GROW models, the estimated environmental
concentrations (EECs) of quinoxyfen for chronic exposures are estimated
to be 0.84 ppb for surface water and 0.006 ppb for ground water. Model
estimates of drinking water concentrations were directly entered into
the dietary exposure model (DEEM-FCID).
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Quinoxyfen is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to quinoxyfen and any other
substances and quinoxyfen does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that quinoxyfen has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal
[[Page 50353]]
and postnatal toxicity and the completeness of the data base on
toxicity and exposure unless EPA determines based on reliable data that
a different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a MOE analysis or through using uncertainty
(safety) factors in calculating a dose level that poses no appreciable
risk to humans. In applying this provision, EPA either retains the
default value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence of increased susceptibility of rat and rabbit
fetuses to in utero exposure in developmental studies. There is
evidence of increased quantitative susceptibility (minimal decrease in
F1a pup weights) in the rat multi-generation reproduction study, but
the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the pup effects are minimal at
the LOAEL and only noted in the first-generation offspring; and (3) the
doses and endpoints selected for regulatory purposes would address the
concerns of the pup effects noted in the rat reproduction study.
Therefore, there are no residual uncertainties for prenatal/postnatal
toxicity in this study.
3. Conclusion. There is a complete toxicity data base for
quinoxyfen and exposure data are complete or are estimated based on
data that reasonably account for potential exposures. There are no
residual uncertainties for prenatal/postnatal toxicity. No additional
safety factor is needed for data base uncertainties. No clinical sign
of neurotoxicity or neuropathology was seen in the data base, including
acute and subchronic neurotoxicity studies. A developmental
neurotoxicity study is not required. Therefore, EPA determined that the
10X SF to protect infants and children should be reduced to 1X.
E. Aggregate Risks and Determination of Safety
1. Acute risk. An endpoint of concern was not identified to
quantitate acute-dietary risk to the general population or to the
subpopulation females 13-50 years old. As a result, no acute risk is
expected from exposure to quinoxyfen.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
quinoxyfen from (food + water) will utilize 1.3% of the cPAD for the
U.S. population, <1% of the cPAD for infants <1 year old), and 2.0% of
the cPAD for children (1 to 2 years old) the subpopulation at greatest
exposure. There are no residential uses for quinoxyfen that result in
chronic residential exposure to quinoxyfen.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Quinoxyfen is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Quinoxyfen is
not registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Quinoxyfen has been
classified as ``not likely to be carcinogenic to humans.'' Therefore,
quinoxyfen is not expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to quinoxyfen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A practical analytical method is available to monitor and enforce
the tolerances of quinoxyfen residues in crops. The analytical method
uses capillary gas chromatography and mass spectrometry detector (GC-
MSD) with limits of quantitation (LOQ) of approximately 0.01 ppm. The
method is adequate for collecting data and enforcing tolerances for
quinoxyfen residues in/on the subject crops. There are no livestock
feed items associated with these petitions, therefore, data collection
and tolerance enforcement methods for livestock commodities are not
required.
B. International Residue Limits
There are no Mexican, Canadian or Codex maximum residue limits
(MRLs) established for quinoxyfen in/on crops considered in this
action. Therefore, no compatibility issues exist for these tolerances.
V. Conclusion
Therefore, the tolerance is established for residues of quinoxyfen,
5,7-dichloro-4-(4-fluorophenoxy) quinoline in or on lettuce, head at
7.0 ppm and lettuce, leaf at 19 ppm; melon, subgroup 9A at 0.08 ppm;
pepper, bell at 0.35 ppm; pepper, nonbell at 1.7 ppm; and strawberry at
0.90 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the
[[Page 50354]]
Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 16, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.588 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:
Sec. 180.588 Quinoxyfen; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Lettuce, head....................................... 7.0
Lettuce, leaf........................................ 19
Melon, subgroup 9A................................... 0.08
Pepper, bell......................................... 0.35
Pepper, nonbell...................................... 1.7
Strawberry........................................... 0.90
------------------------------------------------------------------------
[FR Doc. E6-14065 Filed 8-24-06; 8:45 am]
BILLING CODE 6560-50-S