[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Rules and Regulations]
[Page 54922-54928]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se06-12]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0613.; FRL-8089-2]
Etofenprox; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of etofenprox (2-[ethoxyphenyl]-2-methylpropyl-3-phenoxy
benzyl ether) in or on rice grain and rice straw. This action is
associated with an emergency exemption under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on rice. This regulation establishes a maximum
permissible level for residues of etofenprox in these food commodities.
The tolerances expire and are revoked on December 31, 2009.
DATES: This regulation is effective September 20, 2006. Objections and
requests for hearings must be received on or before November 20, 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-2006-0613. All documents in the
docket are listed on the regulations.gov website. 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 either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday
[[Page 54923]]
through Friday, excluding legal holidays. The Docket telephone number
is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9364; e-mail address: Sec-18-Mailbox@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 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 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 http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://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 http://www.gpoaccess.gov/ecfr
.
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-2006-0613 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 November 20, 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-2006-0613, by one of the following methods:
Federal eRulemaking Portal: http://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
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e) and (l)(6), is establishing tolerances for residues of
the insecticide etofenprox (2-[ethoxyphenyl]-2-methylpropyl-3-phenoxy
benzyl ether) or on rice grain at 0.01 parts per million (ppm) and rice
straw at 0.02 ppm. These tolerances expire and are revoked on December
31, 2009. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations (CFR).
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Etofenprox on Rice and FFDCA Tolerances
The Applicant asserts that the current emergency situation with
respect to weevil management has arisen primarily from the continuing,
and probably increasing, practice of cultivating crawfish in ponds in
close proximity to rice fields in southern Louisiana. The great
majority of crawfish ponds (at least 75%) are close enough to rice
fields to be affected by the management practices used in rice. All of
the insecticides currently registered for use against the
[[Page 54924]]
rice water weevil in Louisiana are toxic to crawfish. The use of
etofenprox for weevil control has one significant advantage over
currently used liquid products in that it is formulated as a granular
and thus there is far less potential for drift. The Applicant states
that the estimated economic loss if no effective weevil controls are
available is over 8 million dollars.
EPA has authorized under FIFRA section 18 the use of etofenprox on
rice for control of rice water weevil (Lissorhoptrus oryzophilus) in
Louisiana. After having reviewed the submission, EPA concurs that
emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of etofenprox in or on rice
grain and rice straw. In doing so, EPA considered the safety standard
in section 408(b)(2) of the FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of the FFDCA would be consistent with
the safety standard and with FIFRA section 18. Consistent with the need
to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment as provided in section 408(l)(6) of the FFDCA.
Although these tolerances expire and are revoked on December 31, 2009,
under section 408(l)(5) of the FFDCA, residues of the pesticide not in
excess of the amounts specified in these tolerances remaining in or on
rice grain or rice straw after that date will not be unlawful, provided
the pesticide is applied in a manner that was lawful under FIFRA, and
the residues do not exceed a level that was authorized by these
tolerances at the time of that application. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
etofenprox meets EPA's registration requirements for use on rice or
whether permanent tolerances for this use would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of etofenprox by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than Louisiana to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for etofenprox, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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 http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
Consistent with section 408(b)(2)(D) of the 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
etofenprox and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of etofenprox in or on rice grain at 0.01 ppm
and rice straw at 0.02 ppm. EPA's assessment of the dietary exposures
and risks associated with establishing the tolerances follows.
A. Toxicological Endpoints
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 endpoint. 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. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF)
is retained due to concerns unique to the FQPA, this additional factor
is applied to the RfD by dividing the RfD by such additional factor.
The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA SF.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for etofenprox used for human risk assessment is shown in the
following Table:
[[Page 54925]]
Doses and Toxicological Endpoints for Etofenprox
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, FQPA SF and Level of
Exposure/Scenario Interspecies, Concern for Risk Study and Toxicological
Intraspecies and any Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-49 years of Not selected NA No toxicological
age) endpoint attributable
to a single exposure
was identified in the
available toxicology
studies.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population Not selected NA No toxicological
including infants and children) endpoint attributable
to a single exposure
was identified in the
available toxicology
studies.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 3.7 mg/kg/day FQPA SF = 1x cPAD = Combined Chronic
Chronic RfD = 0.037 mg/ Chronic RfD/Special Toxicity/
kg/day. FQPA SF = 0.037 mg/kg/ Carcinogenicity Study
day. in Rat (MRID No.
40449707)
LOAEL = 25.5 mg/kg/day
based on increased
thyroid weights.
Related to increased
liver weights and
histopathology changes
in liver and thyroid
that occurred at the
higher dose.
----------------------------------------------------------------------------------------------------------------
Incidental Oral Short-Term (1 - 30 NOAEL =100 mg/kg/day LOC for MOE = 100 Developmental Toxicity
days) UF = 100............... in Rabbit (MRID No.
45210602)
LOAEL = 300 mg/kg/day
based on decreased
body weights, body
weight gains, and food
consumption (maternal
toxicity).
----------------------------------------------------------------------------------------------------------------
Incidental Oral Intermediate-Term (1 - NOAEL = 20 mg/kg/day UF LOC for MOE = 100 Subchronic Oral
6 months) = 100 Toxicity in Rat (MRID
No. 40449703)
LOAEL = 120 mg/kg/day
based on decreased
body weight gain,
increased liver and
thyroid weights with
corresponding
histopathology,
changes in hematology
and clinical
chemistry.
----------------------------------------------------------------------------------------------------------------
Dermal (All durations) NA NA No systemic toxicity
was identified in the
dermal 28-day study;
Highest Dose Tested
was 1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Inhalation (All durations) NOAEL =10.6 mg/kg/day LOC for MOE = 100 13-Week Inhalation
UF = 100............... Residential............ Toxicity in Rat (MRID
LOC for MOE = 100...... No. 40449705)
Occupational........... LOAEL = 52.3 mg/kg/day
based on organ weight
changes and
histopathological
changes in liver,
adrenals and thyroid.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classification: ``Not likely to be carcinogenic to humans at doses that
do not alter rat thyroid hormone homeostasis.''
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Any additional safety factor retained due to concerns unique to the FQPA,
NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population
adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern,
NA = Not Applicable
B. Exposure Assessment
1. Dietary exposure from food and feed uses. Risk assessments were
conducted by EPA to assess dietary exposures from etofenprox in food as
follows:
i. Acute exposure. Acute dietary 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. An acute risk assessment was not performed. No
toxicological endpoint attributable to a single (acute) dietary
exposure was identified.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 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: The concentration of etofenprox in rice commodities is
assumed at tolerance level and 100 percent of rice grown is assumed to
be treated.
iii. Cancer. Etofenprox has been classified as, ``Not likely to be
carcinogenic to humans at doses that do not alter rat thyroid hormone
homeostasis.'' In 1989, the EPA classified etofenprox as a ``Group C
Possible Human Carcinogen'' based on thyroid tumors in rats. In 1996
the EPA evaluated additional information submitted by the registrant,
Mitsui Toatsu, regarding the carcinogenic potential of etofenprox. Its
objective was to demonstrate a threshold mechanism for the thyroid
tumors in rats. In 2005, an additional 4-week dietary investigative
study on thyroid function and hepatic microsomal enzyme induction in
rats was reviewed by the EPA. In 2005, the Agency considered if the
additional study along with the previously submitted data provided
sufficient information to support re-evaluation of etofenprox's
carcinogenicity status. In consideration of these new data, and in
accordance with the EPA Final Guidelines for Carcinogen Risk
Assessment, etofenprox was classified as ``Not likely to be
[[Page 54926]]
carcinogenic to humans at doses that do not alter rat thyroid hormone
homeostasis.'' This decision was based on the following considerations:
a. Treatment-related thyroid follicular cell tumors were seen in
both male and female rats at 4,900 ppm, which was considered to be
adequate, and not excessive, to assess carcinogenicity;
b. No treatment-related tumors were seen in male or female mice
when tested at a dose that was considered adequate to assess
carcinogenicity;
c. There is no mutagenicity concern for etofenprox form in vivo or
in vitro assays;
d. The non-neoplastic toxicological evidence (i.e., thyroid growth
and thyroid hormonal changes) indicated that etofenprox was inducing a
disruption in the thyroid-pituitary hormonal status; and
e. Rats are substantially more sensitive than humans to the
development of thyroid follicular cell tumors in response to thyroid
hormone imbalance. The overall weight-of-the-evidence was considered
sufficient to indicate that etofenprox induced thyroid follicular
tumors through an antithyroid mode of action; The quantification of
carcinogenic potential is not applicable. Therefore, no risk
quantification is required.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for etofenprox 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 etofenprox. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the provisional refined rice models (Method A and B) and
SCI-GROW models, the estimated environmental concentrations (EECs) of
etofenprox for chronic exposures are estimated to be 2.5 parts per
billion (ppb) for surface water and 0.002 ppb for ground water.
The estimated drinking water concentrations (EDWCs) for etofenprox
were directly entered into the dietary exposure model DEEM-FCID\TM\.
For chronic dietary risk assessment, the annual average concentration
of 2.5 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 use on the following
residential non-dietary sites: Outdoor (yard/patio), spot-on pet
treatment, indoor foggers, and crack and crevice/spot treatment to
control a variety of crawling and flying insect pests. The residential
risk assessment was conducted using the following exposure assumptions:
Average food and drinking water exposures are aggregated with exposures
to toddlers from inhalation and hand-to-mouth activities following the
use of an indoor total-release fogger and hand-to-mouth from contact
with a companion cat treated with the etofenprox spot-on product.
Aggregate assessment for adults combines average food and water
exposures for the total U.S. population with adult handler and post
application inhalation exposures from the use of the indoor total-
release fogger. These residential uses are believed to be the ones most
likely to co-occur (comprehensive flea treatment approach), and also
present the most conservative (worst-case) scenario for potential
aggregate exposures.
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 etofenprox and any other
substances and etofenprox 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 etofenprox 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 http://www.epa.gov/pesticides/cumulative/.
C. Safety Factor for Infants and Children
1. In general. Section 408 of the 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 and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines 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.
2. Developmental toxicity studies. A prenatal developmental
toxicity study in rabbits showed no quantitative/qualitative evidence
of increased susceptibility in offspring. In the rabbit study the
developmental effects were seen at doses that resulted in maternal
deaths at the high dose. Additionally, the rabbit developmental study
showed increased abortions, decreased maternal body weights, body
weight gains and food consumption. In the rabbit study, the maternal
LOAEL (300 milligram/kilogram/day (mg/kg/day)) is equal to the
developmental LOAEL. In the 1-generation/developmental study in rats,
increased susceptibility in the offspring was not observed. In the rat
developmental study, the maternal LOAEL was equal to the developmental
LOAEL.
3. Reproductive toxicity study. The 2-generation reproduction study
in rats did not show evidence of quantitative/qualitative
susceptibility in offspring. In this study rats showed decreased pup
weights, increased thyroid, liver and kidney weights with corresponding
pathological changes in pups, and clinical signs of pups during most of
the lactation period which included body tremors, distended abdomen,
lethargy, unsteady gait, and abnormal movements. However, except for
thyroid weight in female pups, all of these effects occurred at the
highest dose tested (HDT). The effects on organ weights carried over to
the adults of both the F1 and F2 generations with
corresponding centrilobular hepatocyte enlargement and increased
thyroidal epithelial height in the HDT group of the F1
generation. At the high dose, parents (F0) had similar
effects on their organs as the pups: increased liver, thyroid, and
kidney weights with pathological changes in the kidney. The parental
LOAEL was equal to the offspring LOAEL in the 2-generation reproduction
study in rats.
[[Page 54927]]
4. Prenatal and postnatal sensitivity. There is no indication of
increased quantitative/qualitative evidence of susceptibility of the
offspring in the developmental rat or rabbit studies or in the 2-gen
reproduction study in the rat. Developmental effects were seen at doses
that caused maternal toxicity. No developmental effects were seen in
the rat 1-generation/developmental study. In the 2-generation
reproduction toxicity study, there was no evidence of quantitative and
qualitative susceptibility because the presence of toxicity in the
offspring occurred at the level of parental toxicity (increased organs
weights and associated pathological changes occurred in both the pups
and parents). In the developmental neurotoxicity study in rats, the
observed eye abnormalities associated with body injuries could not be
disassociated from possible altered treatment-related maternal behavior
that resulted in injury to the pups.
5. Conclusion. The toxicology database for etofenprox is
essentially complete. The data are sufficient for endpoint selection
for exposure/risk assessment scenarios and for evaluation of the
requirements under the Food Quality Protection Act (FQPA). Evidence of
quantitative and qualitative susceptibility of offspring were not
observed, and therefore, the FQPA 10x safety factor was reduced to 1x.
D. Aggregate Risks and Determination of Safety
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/
[fxsp0]trac/science/screeningsop.pdf.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs.
1. Acute risk. An acute risk assessment was not performed. No
toxicological endpoint attributable to a single (acute) dietary
exposure was identified. Therefore, acute risk from etofenprox exposure
to is not expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
etofenprox from food and water will utilize < 1% of the cPAD for the
U.S. population, and < 1% of the cPAD for all infants (< 1 year old), the
subpopulation at greatest exposure. Based on the use pattern, chronic
residential exposure to residues of etofenprox is not expected.
Therefore, EPA does not expect the aggregate exposure to exceed 100% of
the cPAD.
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). Etofenprox is currently
registered for use(s) that could result in short-term residential
exposure and the Agency has determined that it is appropriate to
aggregate chronic food and water and short-term exposures for
etofenprox.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential
exposures aggregated result in aggregate MOEs of 960 for adults and 350
for inhalation and 560 for incidental oral for toddlers. These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food, water and residential uses. Therefore, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Etofenprox is currently registered for use(s) that could result
in intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for etofenprox.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food, water, and
residential exposures aggregated result in aggregate MOEs of 960 for
adults and 130 for toddlers. These aggregate MOEs do not exceed the
Agency's level of concern for aggregate exposure to food, water, and
residential uses. Therefore, EPA does not expect intermediate-term
aggregate exposure to exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Etofenprox has been
classified as, ``not likely to be carcinogenic to humans at doses that
do not alter rat thyroid hormone homeostasis.'' Therefore, etofenprox
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 etofenprox residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement methodology (gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Team Leader, Emergency Response Team, Risk Integration,
Minor Use, Emergency Response Branch (7505P) 1200 Pennsylvania Ave.,
NW., Washington, DC 20460; telephone number: (703) 308-8179; e-mail
address: britten.anthony@epa.gov.
B. International Residue Limits
Etofenprox is in the CODEX system with a residue definition of
etofenprox (fat soluble), but without an MRL on rice.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
etofenprox (2-[ethoxyphenyl]-2-methylpropyl-3-phenoxy benzyl ether), in
or on rice, grain at 0.01ppm and rice, straw at 0.02 ppm.
VII. Statutory and Executive Order Reviews
This final rule establishes time-limited tolerances under section
408 of the FFDCA. 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
[[Page 54928]]
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 FIFRA section 18
exemption under section 408 of the 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 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 the 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.
VIII. 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: September 8, 2006.
James Jones,
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 added to read as follows:
Sec. 180.620 Etofenprox; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of etofenprox (2-[ethoxyphenyl]-2-
methylpropyl-3-phenoxy benzyl ether) in connection with use of the
pesticide under section 18 emergency exemptions granted by EPA. The
tolerances will expire and are revoked on the dates specified in the
following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Rice, grain................................... 0.01 12/31/09
Rice, straw................................... 0.02 12/31/09
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 06-8004 Filed 9-19-06; 8:45 am]
BILLING CODE 6560-50-S