Etofenprox; Pesticide Tolerances for Emergency Exemptions, 54922-54928 [06-8004]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Rules and Regulations]
[Pages 54922-54928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8004]


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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.

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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 https://
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 https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.

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: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    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 https://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
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                                          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
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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 https://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 https://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 https://
www.epa.gov/oppfead1/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