Etofenprox; Pesticide Tolerance, 75601-75605 [E8-29346]
Download as PDF
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0567; FRL–8390–9]
Etofenprox; Pesticide Tolerance
mstockstill on PROD1PC62 with RULES
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a
tolerance for residues of etofenprox (2(4-ethoxyphenyl)-2-methylpropyl 3phenoxybenzyl ether) in or on rice,
grain. Mitsui Chemical, Inc. requested
this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 12, 2008. Objections and
requests for hearings must be received
on or before February 10, 2009, 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–2008–0567. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
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 Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Kevin Sweeney, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5063; e-mail address:
sweeney.kevin@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
VerDate Aug<31>2005
16:37 Dec 11, 2008
Jkt 217001
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide 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 electronically
available documents 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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. 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–2008–0567. 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
as required by 40 CFR part 178 on or
before February 10, 2009.
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
PO 00000
Frm 00065
Fmt 4700
Sfmt 4700
75601
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–0567, 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 Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’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 Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of August 13,
2008 (73 FR 47185) (FRL– 8376–8), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 7F7215) by Mitsui
Chemicals, Inc., Shiodome City Center,
1–5–2, Higashi-Shimbashi, Minato-ku,
Tokyo, Japan 105–7117 c/o Landis
International, Inc. P.O. Box 5126, 3185
Madison Highway, Valdosta, GA 31603–
5126 USA. The petition requested that
40 CFR 180.620 be amended by
establishing tolerances for combined
residues or residues of the insecticide
etofenprox and the metabolite 2-(4ethyoxyphenyl)-2-methylpropyl 3phenoxybenzoate, in or on rice, grain at
0.01 parts per million (ppm) and rice,
straw at 0.06 ppm. That notice
referenced a summary of the petition
prepared by Mitsui Chemicals, Inc., the
registrant, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petition, EPA has
modified the tolerance expression to
include only residues of etofenprox per
se in or on rice grain of 0.01 ppm. EPA
has also concluded that a etofenprox
tolerance for rice straw is unnecessary.
The reason for these changes is
explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
E:\FR\FM\12DER1.SGM
12DER1
75602
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
mstockstill on PROD1PC62 with RULES
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....’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
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 for the petitioned-for
tolerances for residues of etofenprox in
or on rice, grain at 0.01 ppm. EPA’s
assessment of exposures and risks
associated with establishing tolerances
follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its 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.
Etofenprox has low acute toxicity
from the oral, dermal, and inhalation
routes of exposure. It is not an acute eye
or skin irritant and is not a dermal
sensitizer; however, etofenprox does
cause skin irritation after repeated
exposure. The major target organs of
etofenprox are the liver, thyroid, kidney,
and hematopoietic system.
Etofenprox was assessed in a
complete battery of subchronic, chronic,
carcinogenicity, developmental and
reproductive studies as well as acute,
subchronic, and developmental
neurotoxicity studies. Etofenprox is
classified as a synthetic pyrethroid ether
insecticide and has an excitatory
neurotoxic mode of action.
Neurotoxicity studies, including a
developmental neurotoxicity study in
VerDate Aug<31>2005
16:37 Dec 11, 2008
Jkt 217001
the rat, did show some evidence of
neurotoxic effects as is expected of a
neurotoxicant but these effects were
unremarkable.
The most sensitive target organs in the
toxicology database are the thyroid and
liver. The kidney is also a common
target organ of toxicity. There is no
evidence of carcinogenicity and
etofenprox is classified as ‘‘Not likely to
be carcinogenic to humans at doses that
do not alter rat thyroid hormone
homeostasis’’ and, therefore, no
quantitative cancer risk assessment is
required. There is no indication of
increased quantitative or qualitative
susceptibility of the developing
offspring in toxicology database for
etofenprox. Developmental effects were
seen at doses that caused maternal
toxicity. There was no evidence of
reproductive effects in the 2–generation
reproduction study in rats. Etofenprox
was negative for mutagenic/genotoxic
potential based on the results of
mutagenicity studies. There is no
evidence of immunotoxicity in the
database. Immunotoxicity studies are a
new data requirement and are required
as a condition of registration. The
toxicology database for etofenprox is
sufficient to assess human health
hazards and the Point of Departure
(POD) selected for deriving the chronic
reference dose will adequately account
for all chronic effects determined to
result from exposure to etofenprox in
chronic animal studies, including
potential immunotoxicity effects.
Specific information on the studies
received and the nature of the adverse
effects caused by etofenprox, as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies, can be found at https://
www.regulations.gov in document
Etofenprox: Human Health Risk
Assessment for Proposed Section 3 Uses
on Rice and as ULV Mosquito
Adulticide, at pages 14–29 in docket ID
number EPA–HQ–OPP–2008–0567.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological POD is identified as
the basis for derivation of reference
values for risk assessment. The POD
may be defined as the NOAEL in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, LOAEL or a Benchmark
Dose (BMD) approach is sometimes
used for risk assessment. Uncertainty/
safety factors (UFs) are used in
conjunction with the POD to take into
account uncertainties inherent in the
PO 00000
Frm 00066
Fmt 4700
Sfmt 4700
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-term, intermediate-term,
and chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for etofenprox used for
human risk assessment can be found at
https://www.regulations.gov in document
Etofenprox: Human Health Risk
Assessment for Proposed Section 3 Uses
on Rice and as ULV Mosquito
Adulticide, at pages 30–31 in docket ID
number EPA–HQ–OPP–2008–0567.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. EPA assessed dietary
exposure to etofenprox, the EPA
considered exposure under the
petitioned for tolerance on rice, grain;
the first food use of etofenprox. EPA
assessed dietary exposures from
etofenprox 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 1–day or single
exposure.
No such effects were identified in the
toxicological studies for etofenprox;
therefore, a quantitative acute dietary
exposure assessment is unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996, 1998 CSFII.
As to residue levels in food, EPA
assumed that all rice grain contained
tolerance level residues of etofenprox
E:\FR\FM\12DER1.SGM
12DER1
mstockstill on PROD1PC62 with RULES
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
and that 100 percent of the rice crop
was treated with etofenprox.
iii. Cancer. EPA classified etofenprox
as ‘‘Not likely to be carcinogenic to
humans at doses that do not alter rat
thyroid hormone homeostasis.’’ An
increased incidence of thyroid follicular
adenomas and/or carcinomas was seen
in males and females administered
etofenprox in their diet at 4,900 ppm, a
dose that was considered adequate to
assess potential for carcinogenicity. No
treatment-related tumors were seen in
male or female mice when tested at a
dose that was considered adequate to
assess carcinogenicity. The nonneoplastic toxicological evidence (i.e.
thyroid growth, thyroid hormonal
changes) indicated that etofenprox was
inducing a disruption in the thyroidpituitary hormonal status. Rats are
substantially more sensitive to humans
to the development of thyroid follicular
cell tumors in response to thyroid
hormone imbalance. There was no
mutagenicity concern for etofenprox
from in vivo or in vitro assays. The
overall weight-of-evidence was
considered sufficient to indicate that
etofenprox induces thyroid follicular
tumors through an anti-thyroid mode of
action. The Agency has determined that
quantification of human cancer risk is
not appropriate because the chronic
reference dose is protective against the
chronic effects determined to result
from exposure to etofenprox, including
potential cancer effects.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for etofenprox. Tolerance level residues
and/or 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for etofenprox in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of etofenprox.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Based on the Tier I Rice Model and
Screening Concentration in Ground
Water (SCI–GROW) models, the
estimated drinking water concentrations
(EDWCs) of etofenprox for chronic
exposure were calculated based on a
maximum application rate of 0.27
pound (lb) active ingredient (ai)/
acre(A)/year. The estimated drinking
water concentrations (EDWCs) of
etofenprox for chronic exposures for
VerDate Aug<31>2005
16:37 Dec 11, 2008
Jkt 217001
non-cancer assessments are estimated to
be 0.88 (parts per billion (ppb) for
surface water and 1.55 x 10–3 ppb for
ground water. Acute exposure (single
dose or 1–day exposure) effects were not
identified in the toxicological studies
for etofenprox; therefore, a quantitative
acute drinking water assessment is
unnecessary.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 0.88 ppb
was used to assess the contribution to
drinking water.
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).
Etofenprox is currently registered for the
following uses that could result in
residential exposures: Indoor and
outdoor (yard patio) use as an insect
fogger, indoor/outdoor crack and
crevice/spot treatment; as a cat and dog
spot-on treatment; and outdoors as a
wide-area mosquito adulticide. EPA
assessed residential exposure using the
following assumptions: Adults are
potentially exposed to etofenprox
residues during residential application
of etofenprox. Both adults and children
are potentially exposed to etofenprox
residues after application (postapplication) of etofenprox products in
residential settings. Exposure estimates
were generated for residential handlers
and individuals with potential postapplication contact with lawn, soil,
treated indoor surfaces, and treated pets
using the EPA’s Draft Standard
Operating Procedures (SOPs) for
Residential Exposure Assessment, and
dissipation or transfer data from a turf
transferable residue (TTR) study and a
pet transferrable residue study. Shortterm and intermediate-term inhalation
exposures for adults, and short-term and
intermediate-term incidental oral and
inhalation exposures for children are
anticipated. These estimates are
considered conservative, but
appropriate, since the study data were
generated at maximum application
rates.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of 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
PO 00000
Frm 00067
Fmt 4700
Sfmt 4700
75603
substances that have a common
mechanism of toxicity.’’
Etofenprox is classified as a synthetic
pyrethroid ether insecticide and is a
member of the pyrethroid class of
pesticides. EPA is not currently
following a cumulative risk approach
based on a common mechanism of
toxicity for the pyrethroids. Although
all pyrethroids alter nerve function by
modifying the normal biochemistry and
physiology of nerve membrane sodium
channels, available data show that there
are multiple types of sodium channels
and it is currently unknown whether the
pyrethroids as a class have similar
effects on all channels or whether
modifications of different types of
sodium channels would have a
cumulative effect. Nor do we have a
clear understanding of effects on key
downstream neuronal function, e.g.,
nerve excitability, or how these key
events interact to produce their
compound specific patterns of
neurotoxicity. Without such
understanding, there is no basis to make
a common mechanism of toxicity
finding. There is ongoing research by
the EPA’s Office of Research and
Development and pyrethroid registrants
to evaluate the differential biochemical
and physiological actions of pyrethroids
in mammals. When available, the
Agency will evaluate results of this
research and make a determination of
common mechanism as a basis for
assessing cumulative risk. For
information regarding EPA’s 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(b)(2)(c) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA safety factor (SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The prenatal and postnatal toxicology
database includes a developmental
toxicity studies in rabbits and rats; a 2–
generation reproduction studies in the
E:\FR\FM\12DER1.SGM
12DER1
mstockstill on PROD1PC62 with RULES
75604
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
rat; and a developmental (DNT)
neurotoxicity study in the rat. There
was no evidence of increased
quantitative or qualitative susceptibility
following in-utero and/or postnatal
exposure in the development toxicity
studies in rats or rabbits, or in the 2–
generation rat reproduction study.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for etofenprox
is complete, except for immunotoxicity
testing. Immunotoxicity studies are a
new data requirement and EPA has
determined that an additional
uncertainty factor is not required to
account for potential immunotoxicity.
The reasons for this determination are
explained as follows:
EPA began requiring functional
immunotoxicity testing of all food and
non-food use pesticides on December
26, 2007. Since this requirement went
into effect after the tolerance petition
was submitted, these studies are not yet
available for etofenprox. Due to the lack
of evidence of immunotoxicity for
etofenprox, EPA does not believe that
conducting immunotoxicity testing will
result in a NOAEL less than the NOAEL
of 3.7 milligram/kilogram/day (mg/kg/
day), which is already established as the
cRfD point of departure for etofenprox.
An additional factor (UFDB) for
database uncertainties is not needed to
account for potential immunotoxicity.
ii. There is no evidence that
etofenprox results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iii. There are no residual uncertainties
identified in the exposure databases for
the following reasons:
• The chronic dietary food exposure
assessment utilizes proposed tolerance
level residues and 100 PCT information
for all commodities. By using these
screening level assessments, actual
exposures/risk will not be
underestimated;
• EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to etofenprox in drinking water.
• EPA used similarly conservative
assumptions to assess post-application
exposure of children as well as
incidental oral exposure of toddlers.
These assessments will not
underestimate the exposure and risks
posed by etofenprox.
VerDate Aug<31>2005
16:37 Dec 11, 2008
Jkt 217001
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing
the estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, etofenprox is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to etofenprox
from food and water will utilize < 1%
of the cPAD for the general U.S.
population and all population
subgroups. Based on the explanation in
Unit III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of etofenprox is not expected.
3. Short-term-/Intermediate-term risk.
Short-term or intermediate-term
aggregate exposure takes into account
short-term or intermediate-term
residential exposure plus chronic
exposure from food and water
(considered to be a background
exposure level).
Etofenprox is currently registered for
uses that could result in short-term and
intermediate-term residential exposure
and the Agency has determined that it
is appropriate to aggregate chronic
exposure through food and water with
short-term and intermediate-term
residential exposures to etofenprox.
Since the doses and endpoints selected
for etofenprox to assess short-term and
intermediate-term exposure are
identical, the short-term and
intermediate-term risk estimates for
etofenprox are the same.
Using the exposure assumptions
described in this unit for short-term and
intermediate-term exposures, EPA has
concluded the combined short-term and
intermediate-term food, water, and
PO 00000
Frm 00068
Fmt 4700
Sfmt 4700
residential exposures aggregated result
in aggregate MOEs of 1,200 for adults
and 170 for toddlers. For adults, the
short-term/ intermediate-term aggregate
risks combined food and drinking water
exposure with short-term/intermediate
term inhalation exposure. For toddler
short-term and intermediate-term
aggregate risks, the average food and
drinking water exposure was combined
with toddler incidental oral exposures
following pet treatments and indoor
fogger applications, and inhalation
exposure following indoor fogger
applications.
4. Aggregate cancer risk for U.S.
population. The Agency has classified
etofenprox as ‘‘Not likely to be
carcinogenic to humans at doses that do
not alter thyroid hormone homeostasis.’’
The chronic reference dose will is
protective of chronic effects determined
to result from exposure to etofenprox,
including potential cancer effects.
5. 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, or to infants and children
from aggregate exposure to etofenprox
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(Liquid Chromatographic Mass
Spectrometric (LC/MS/MS) method) is
available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
The Codex Alimentarius Commission
(CODEX) has established maximum
residue levels (MRLs) for the residue of
etofenprox per se in or on pome fruits
at 1 mg/kg and potato at 0.01 mg/kg.
Currently, there are no CODEX MRLs for
rice commodities. Etofenprox is
scheduled for periodic re-evaluation by
CODEX in 2012. As discussed in this
unit, EPA has adopted a tolerance
expression for etofenprox which should
make the rice tolerances compatible
with proposed CODEX MRLs for rice
commodities.
C. Revisions to Petitioned-For
Tolerances
The petitioner proposed tolerances for
combined residues or residues of the
insecticide etofenprox and the
metabolite 2-(4-ethyoxyphenyl)-2-
E:\FR\FM\12DER1.SGM
12DER1
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Rules and Regulations
methylpropyl 3-phenoxybenzoate, in or
on rice, grain at 0.01 ppm and rice,
straw at 0.06 ppm. Although EPA has
included the metabolite 2-(4ethyoxyphenyl)-2-methylpropyl 3phenoxybenzoate in its assessment of
exposure and risk for etofenprox, EPA
has decided to exclude the metabolite
from the tolerance expression because
the metabolism and residue studies
show that the parent compound will
serve as a better indicator of potential
misuse. Limiting the tolerance
expression to the parent only also
allows for harmonization with the
proposed Codex MRLs. EPA has
determined that rice, straw is not a
significant feedstuff; therefore, a
tolerance for residues of etofenprox per
se in/on rice straw is not needed. The
tolerance has been revised to reflect the
correct commodity definition, ‘‘rice,
grain’’ and the proposed tolerance
expression has been revised to residues
of etofenprox per se in or on rice, grain
of 0.01 ppm.
mstockstill on PROD1PC62 with RULES
V. Conclusion
Therefore, a tolerance is established
for residues of etofenprox, (2-(4ethoxyphenyl)-2-methylpropyl 3phenoxybenzyl ether), in or on rice,
grain at 0.01 ppm.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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 final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., 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).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
VerDate Aug<31>2005
16:37 Dec 11, 2008
Jkt 217001
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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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).
40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
PO 00000
Frm 00069
Fmt 4700
Sfmt 4700
75605
Dated: December 4, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.620 is amended by
revising pargraph (a) to read as follows:
■
§ 180.620 Etofenprox; tolerance for
residues.
(a) General. A tolerance is established
for residues of the insecticide
etofenprox [2-(4-ethoxyphenyl)-2methylpropyl 3-phenoxybenzyl ether] in
or on the following raw agricultural
commodity:
Commodity
Parts per million
Rice, grain ......................
*
*
*
*
0.01
*
[FR Doc. E8–29346 Filed 12–11–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0217; FRL–8393–1]
Isoxaflutole; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation amends the
pesticide tolerance for isoxaflutole by
removing isoxaflutole’s benzoic acid
metabolite (RPA 203328) from the
established tolerance expression and
revising downward tolerance levels for
isoxaflutole in or on field corn. Bayer
CropScience requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
December 12, 2008. Objections and
requests for hearings must be received
on or before February 10, 2009, 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–2008–0217. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
E:\FR\FM\12DER1.SGM
12DER1
Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Rules and Regulations]
[Pages 75601-75605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29346]
[[Page 75601]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0567; FRL-8390-9]
Etofenprox; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
etofenprox (2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether) in
or on rice, grain. Mitsui Chemical, Inc. requested this tolerance under
the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 12, 2008. Objections and
requests for hearings must be received on or before February 10, 2009,
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-2008-0567. All documents in the
docket are listed in the docket index available at https://
www.regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Kevin Sweeney, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5063; e-mail address: sweeney.kevin@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 those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to
provide 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 electronically available documents 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 EPA's tolerance regulations
at 40 CFR part 180 through the Government Printing Office's e-CFR site
at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2008-0567. 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 as required by 40 CFR part 178
on or before February 10, 2009.
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 this copy, identified by docket ID number
EPA-HQ-OPP-2008-0567, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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 Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of August 13, 2008 (73 FR 47185) (FRL-
8376-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7F7215) by Mitsui Chemicals, Inc., Shiodome City Center, 1-5-2,
Higashi-Shimbashi, Minato-ku, Tokyo, Japan 105-7117 c/o Landis
International, Inc. P.O. Box 5126, 3185 Madison Highway, Valdosta, GA
31603-5126 USA. The petition requested that 40 CFR 180.620 be amended
by establishing tolerances for combined residues or residues of the
insecticide etofenprox and the metabolite 2-(4-ethyoxyphenyl)-2-
methylpropyl 3-phenoxybenzoate, in or on rice, grain at 0.01 parts per
million (ppm) and rice, straw at 0.06 ppm. That notice referenced a
summary of the petition prepared by Mitsui Chemicals, Inc., the
registrant, which is available to the public in the docket, https://
www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the tolerance expression to include only residues of
etofenprox per se in or on rice grain of 0.01 ppm. EPA has also
concluded that a etofenprox tolerance for rice straw is unnecessary.
The reason for these changes is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the
[[Page 75602]]
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....''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for the petitioned-for
tolerances for residues of etofenprox in or on rice, grain at 0.01 ppm.
EPA's assessment of exposures and risks associated with establishing
tolerances follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
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.
Etofenprox has low acute toxicity from the oral, dermal, and
inhalation routes of exposure. It is not an acute eye or skin irritant
and is not a dermal sensitizer; however, etofenprox does cause skin
irritation after repeated exposure. The major target organs of
etofenprox are the liver, thyroid, kidney, and hematopoietic system.
Etofenprox was assessed in a complete battery of subchronic,
chronic, carcinogenicity, developmental and reproductive studies as
well as acute, subchronic, and developmental neurotoxicity studies.
Etofenprox is classified as a synthetic pyrethroid ether insecticide
and has an excitatory neurotoxic mode of action. Neurotoxicity studies,
including a developmental neurotoxicity study in the rat, did show some
evidence of neurotoxic effects as is expected of a neurotoxicant but
these effects were unremarkable.
The most sensitive target organs in the toxicology database are the
thyroid and liver. The kidney is also a common target organ of
toxicity. There is no evidence of carcinogenicity and etofenprox is
classified as ``Not likely to be carcinogenic to humans at doses that
do not alter rat thyroid hormone homeostasis'' and, therefore, no
quantitative cancer risk assessment is required. There is no indication
of increased quantitative or qualitative susceptibility of the
developing offspring in toxicology database for etofenprox.
Developmental effects were seen at doses that caused maternal toxicity.
There was no evidence of reproductive effects in the 2-generation
reproduction study in rats. Etofenprox was negative for mutagenic/
genotoxic potential based on the results of mutagenicity studies. There
is no evidence of immunotoxicity in the database. Immunotoxicity
studies are a new data requirement and are required as a condition of
registration. The toxicology database for etofenprox is sufficient to
assess human health hazards and the Point of Departure (POD) selected
for deriving the chronic reference dose will adequately account for all
chronic effects determined to result from exposure to etofenprox in
chronic animal studies, including potential immunotoxicity effects.
Specific information on the studies received and the nature of the
adverse effects caused by etofenprox, 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 at https://
www.regulations.gov in document Etofenprox: Human Health Risk
Assessment for Proposed Section 3 Uses on Rice and as ULV Mosquito
Adulticide, at pages 14-29 in docket ID number EPA-HQ-OPP-2008-0567.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological POD is identified as the basis for
derivation of reference values for risk assessment. The POD may be
defined as the NOAEL in the toxicology study identified as appropriate
for use in risk assessment. However, if a NOAEL cannot be determined,
LOAEL or a Benchmark Dose (BMD) approach is sometimes used for risk
assessment. Uncertainty/safety factors (UFs) are used in conjunction
with the POD to take into account 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. Safety is assessed for acute and chronic dietary
risks by comparing aggregate food and water exposure to the pesticide
to the acute population adjusted dose (aPAD) and chronic population
adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the
POD by all applicable UFs. Aggregate short-term, intermediate-term, and
chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for etofenprox used for
human risk assessment can be found at https://www.regulations.gov in
document Etofenprox: Human Health Risk Assessment for Proposed Section
3 Uses on Rice and as ULV Mosquito Adulticide, at pages 30-31 in docket
ID number EPA-HQ-OPP-2008-0567.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. EPA assessed dietary
exposure to etofenprox, the EPA considered exposure under the
petitioned for tolerance on rice, grain; the first food use of
etofenprox. EPA assessed dietary exposures from etofenprox 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 1-day or single exposure.
No such effects were identified in the toxicological studies for
etofenprox; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996,
1998 CSFII. As to residue levels in food, EPA assumed that all rice
grain contained tolerance level residues of etofenprox
[[Page 75603]]
and that 100 percent of the rice crop was treated with etofenprox.
iii. Cancer. EPA classified etofenprox as ``Not likely to be
carcinogenic to humans at doses that do not alter rat thyroid hormone
homeostasis.'' An increased incidence of thyroid follicular adenomas
and/or carcinomas was seen in males and females administered etofenprox
in their diet at 4,900 ppm, a dose that was considered adequate to
assess potential for carcinogenicity. No treatment-related tumors were
seen in male or female mice when tested at a dose that was considered
adequate to assess carcinogenicity. The non-neoplastic toxicological
evidence (i.e. thyroid growth, thyroid hormonal changes) indicated that
etofenprox was inducing a disruption in the thyroid-pituitary hormonal
status. Rats are substantially more sensitive to humans to the
development of thyroid follicular cell tumors in response to thyroid
hormone imbalance. There was no mutagenicity concern for etofenprox
from in vivo or in vitro assays. The overall weight-of-evidence was
considered sufficient to indicate that etofenprox induces thyroid
follicular tumors through an anti-thyroid mode of action. The Agency
has determined that quantification of human cancer risk is not
appropriate because the chronic reference dose is protective against
the chronic effects determined to result from exposure to etofenprox,
including potential cancer effects.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for etofenprox. Tolerance level residues and/or 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for etofenprox in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etofenprox. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier I Rice Model and Screening Concentration in
Ground Water (SCI-GROW) models, the estimated drinking water
concentrations (EDWCs) of etofenprox for chronic exposure were
calculated based on a maximum application rate of 0.27 pound (lb)
active ingredient (ai)/acre(A)/year. The estimated drinking water
concentrations (EDWCs) of etofenprox for chronic exposures for non-
cancer assessments are estimated to be 0.88 (parts per billion (ppb)
for surface water and 1.55 x 10-\3\ ppb for ground water. Acute
exposure (single dose or 1-day exposure) effects were not identified in
the toxicological studies for etofenprox; therefore, a quantitative
acute drinking water assessment is unnecessary.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.88 ppb was used to
assess the contribution to drinking water.
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). Etofenprox is
currently registered for the following uses that could result in
residential exposures: Indoor and outdoor (yard patio) use as an insect
fogger, indoor/outdoor crack and crevice/spot treatment; as a cat and
dog spot-on treatment; and outdoors as a wide-area mosquito adulticide.
EPA assessed residential exposure using the following assumptions:
Adults are potentially exposed to etofenprox residues during
residential application of etofenprox. Both adults and children are
potentially exposed to etofenprox residues after application (post-
application) of etofenprox products in residential settings. Exposure
estimates were generated for residential handlers and individuals with
potential post-application contact with lawn, soil, treated indoor
surfaces, and treated pets using the EPA's Draft Standard Operating
Procedures (SOPs) for Residential Exposure Assessment, and dissipation
or transfer data from a turf transferable residue (TTR) study and a pet
transferrable residue study. Short-term and intermediate-term
inhalation exposures for adults, and short-term and intermediate-term
incidental oral and inhalation exposures for children are anticipated.
These estimates are considered conservative, but appropriate, since the
study data were generated at maximum application rates.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
Etofenprox is classified as a synthetic pyrethroid ether
insecticide and is a member of the pyrethroid class of pesticides. EPA
is not currently following a cumulative risk approach based on a common
mechanism of toxicity for the pyrethroids. Although all pyrethroids
alter nerve function by modifying the normal biochemistry and
physiology of nerve membrane sodium channels, available data show that
there are multiple types of sodium channels and it is currently unknown
whether the pyrethroids as a class have similar effects on all channels
or whether modifications of different types of sodium channels would
have a cumulative effect. Nor do we have a clear understanding of
effects on key downstream neuronal function, e.g., nerve excitability,
or how these key events interact to produce their compound specific
patterns of neurotoxicity. Without such understanding, there is no
basis to make a common mechanism of toxicity finding. There is ongoing
research by the EPA's Office of Research and Development and pyrethroid
registrants to evaluate the differential biochemical and physiological
actions of pyrethroids in mammals. When available, the Agency will
evaluate results of this research and make a determination of common
mechanism as a basis for assessing cumulative risk. For information
regarding EPA's 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(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database includes a developmental toxicity studies in
rabbits and rats; a 2-generation reproduction studies in the
[[Page 75604]]
rat; and a developmental (DNT) neurotoxicity study in the rat. There
was no evidence of increased quantitative or qualitative susceptibility
following in-utero and/or postnatal exposure in the development
toxicity studies in rats or rabbits, or in the 2-generation rat
reproduction study.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for etofenprox is complete, except for
immunotoxicity testing. Immunotoxicity studies are a new data
requirement and EPA has determined that an additional uncertainty
factor is not required to account for potential immunotoxicity. The
reasons for this determination are explained as follows:
EPA began requiring functional immunotoxicity testing of all food
and non-food use pesticides on December 26, 2007. Since this
requirement went into effect after the tolerance petition was
submitted, these studies are not yet available for etofenprox. Due to
the lack of evidence of immunotoxicity for etofenprox, EPA does not
believe that conducting immunotoxicity testing will result in a NOAEL
less than the NOAEL of 3.7 milligram/kilogram/day (mg/kg/day), which is
already established as the cRfD point of departure for etofenprox. An
additional factor (UFDB) for database uncertainties is not needed to
account for potential immunotoxicity.
ii. There is no evidence that etofenprox results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iii. There are no residual uncertainties identified in the exposure
databases for the following reasons:
The chronic dietary food exposure assessment utilizes
proposed tolerance level residues and 100 PCT information for all
commodities. By using these screening level assessments, actual
exposures/risk will not be underestimated;
EPA made conservative (protective) assumptions in the
ground and surface water modeling used to assess exposure to etofenprox
in drinking water.
EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by etofenprox.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etofenprox is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etofenprox from food and water will utilize < 1% of the cPAD for the
general U.S. population and all population subgroups. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of etofenprox is not expected.
3. Short-term-/Intermediate-term risk. Short-term or intermediate-
term aggregate exposure takes into account short-term or intermediate-
term residential exposure plus chronic exposure from food and water
(considered to be a background exposure level).
Etofenprox is currently registered for uses that could result in
short-term and intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic exposure
through food and water with short-term and intermediate-term
residential exposures to etofenprox. Since the doses and endpoints
selected for etofenprox to assess short-term and intermediate-term
exposure are identical, the short-term and intermediate-term risk
estimates for etofenprox are the same.
Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined
short-term and intermediate-term food, water, and residential exposures
aggregated result in aggregate MOEs of 1,200 for adults and 170 for
toddlers. For adults, the short-term/ intermediate-term aggregate risks
combined food and drinking water exposure with short-term/intermediate
term inhalation exposure. For toddler short-term and intermediate-term
aggregate risks, the average food and drinking water exposure was
combined with toddler incidental oral exposures following pet
treatments and indoor fogger applications, and inhalation exposure
following indoor fogger applications.
4. Aggregate cancer risk for U.S. population. The Agency has
classified etofenprox as ``Not likely to be carcinogenic to humans at
doses that do not alter thyroid hormone homeostasis.'' The chronic
reference dose will is protective of chronic effects determined to
result from exposure to etofenprox, including potential cancer effects.
5. 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, or to infants and children from aggregate
exposure to etofenprox residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (Liquid Chromatographic Mass
Spectrometric (LC/MS/MS) method) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
The Codex Alimentarius Commission (CODEX) has established maximum
residue levels (MRLs) for the residue of etofenprox per se in or on
pome fruits at 1 mg/kg and potato at 0.01 mg/kg. Currently, there are
no CODEX MRLs for rice commodities. Etofenprox is scheduled for
periodic re-evaluation by CODEX in 2012. As discussed in this unit, EPA
has adopted a tolerance expression for etofenprox which should make the
rice tolerances compatible with proposed CODEX MRLs for rice
commodities.
C. Revisions to Petitioned-For Tolerances
The petitioner proposed tolerances for combined residues or
residues of the insecticide etofenprox and the metabolite 2-(4-
ethyoxyphenyl)-2-
[[Page 75605]]
methylpropyl 3-phenoxybenzoate, in or on rice, grain at 0.01 ppm and
rice, straw at 0.06 ppm. Although EPA has included the metabolite 2-(4-
ethyoxyphenyl)-2-methylpropyl 3-phenoxybenzoate in its assessment of
exposure and risk for etofenprox, EPA has decided to exclude the
metabolite from the tolerance expression because the metabolism and
residue studies show that the parent compound will serve as a better
indicator of potential misuse. Limiting the tolerance expression to the
parent only also allows for harmonization with the proposed Codex MRLs.
EPA has determined that rice, straw is not a significant feedstuff;
therefore, a tolerance for residues of etofenprox per se in/on rice
straw is not needed. The tolerance has been revised to reflect the
correct commodity definition, ``rice, grain'' and the proposed
tolerance expression has been revised to residues of etofenprox per se
in or on rice, grain of 0.01 ppm.
V. Conclusion
Therefore, a tolerance is established for residues of etofenprox,
(2-(4-ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether), in or on
rice, grain at 0.01 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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).
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 4, 2008.
Debra Edwards,
Director, 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 180.620 is amended by revising pargraph (a) to read as
follows:
Sec. 180.620 Etofenprox; tolerance for residues.
(a) General. A tolerance is established for residues of the
insecticide etofenprox [2-(4-ethoxyphenyl)-2-methylpropyl 3-
phenoxybenzyl ether] in or on the following raw agricultural commodity:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Rice, grain.......................................... 0.01
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-29346 Filed 12-11-08; 8:45 am]
BILLING CODE 6560-50-S