[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Rules and Regulations]
[Pages 32437-32443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15937]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0140; FRL-8417-4]


d-Phenothrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
insecticide d-phenothrin [(3-phenoxyphenyl)methyl] 2,2-Dimethyl-3-(2-
methyl-1-propenyl)cyclopropanecarboxylate in or on all food/feed crops 
at 0.01 parts per million (ppm) following wide-area mosquito adulticide 
applications. McLaughlin Gormley King Company requested these 
tolerances under the Federal Food, Drug and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 8, 2009. Objections and 
requests for hearings must be received on or before September 8, 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-2008-0140. All documents in the 
docket are listed in the docket index available at http://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 http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Room S-4400, One Potomac 
Yard (South Building), 2777 S. Crystal Dr., Arlington, VA 22202-4501. 
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: Carmen Rodia, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0327; fax number: (703) 308-0029; e-mail address: 
<a href="/cdn-cgi/l/email-protection#ff8d909b969ed19c9e8d929a91bf9a8f9ed1989089"><span class="__cf_email__" data-cfemail="e99b868d8088c78a889b848c87a98c9988c78e869f">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).

[[Page 32438]]

    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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 
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 EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://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-2008-0140 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 September 8, 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-2008-0140, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Avenue, NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Room S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Dr., Arlington, VA 22202-4501. 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 September 28, 2007 (72 FR 55204) (FRL-
8147-1) (EPA-HQ-OPP-2007-0880), 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 7F7251) by McLaughlin Gormley King Company, 8810 
Tenth Avenue, North, Minneapolis, MN 55427-4319.
    The petition requested that 40 CFR part 180 be amended by 
establishing permanent tolerances for residues of the insecticide d-
phenothrin, [(3-phenoxyphenyl)methyl] 2,2-Dimethyl-3-(2-methyl-1-
propenyl)cyclopropanecarboxylate), in or on all food/feed crops at 0.01 
ppm following wide-area mosquito adulticide applications. That notice 
referenced a summary of the petition prepared by McLaughlin Gormley 
King Company, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    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 the insecticide d-phenothrin in or on all 
food/feed crops at 0.01 ppm following wide-area mosquito adulticide 
treatments. 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.
    d-Phenothrin has low acute toxicity via the oral, dermal and 
inhalation routes of exposure, is only a mild eye irritant, is non-
irritating to the dermis and tests negative for skin sensitization. The 
effects on the liver are the most systemically sensitive endpoint 
following repeated oral exposure based on acceptable subchronic and 
chronic toxicity studies in rodents and dogs, specifically, increased 
liver weight, hepatocellular vacuolization and hypertrophy and, at 
higher doses, increased liver serum enzymes. Based on a 90-day 
inhalation study in rats, the most sensitive effects from repeated 
inhalation exposure are portal of entry effects (histopathological 
changes in the nasal turbinates in both sexes). This inhalation study 
also indicated histological effects on the liver, thyroid and adrenal 
which are of borderline toxicological significance alone, but which are 
supported in part by the increased organ weights and histological 
findings of similar occurrence in some oral studies. d-Phenothrin was 
not associated with any systemic toxicity up to the limit dose of 1,000 
mg/kg/day in a 3-week dermal toxicity study in rats.
    Currently, d-phenothrin is lacking acceptable neurotoxicity studies 
and these studies are considered data gaps. The only available, but 
unacceptable/non-guideline, neurotoxicity study in

[[Page 32439]]

rats indicated piloerection in animals administered at 5,000 mg/kg for 
5 consecutive days; however, the rabbit developmental study provides 
evidence of neurotoxicity. Indications of neurotoxicity from the rabbit 
developmental study include presence of spina bifida at the mid-dose of 
100 mg/kg/day, microphthalmia at 300 mg/kg/day and hydrocephaly at the 
high-dose of 500 mg/kg/day. While these neurodevelopmental effects were 
seen in only a single fetus each, the observations of spina bifida and 
microphthalmia can be considered significant because they are uncommon 
in untreated rabbits, yet they occurred together in the d-phenothrin 
rabbit development study.
    As noted, developmental effects were observed in the rabbit 
developmental study. Minimal adverse effects were observed at the 
highest dose treated in the rat developmental study. In two acceptable 
rat reproduction studies, both systemic and reproductive/offspring 
toxicity occurred at the same doses with similar effects for offspring 
and dams in each study (organ weight changes in the 1986 study and 
decreased body weight gain in the 1995 study).
    Endocrine-related effects were observed in tests which indicated 
potential estrogen, androgen and/or thyroid-mediated toxicity. d-
Phenothrin produced adrenal cortex vacuolation in the 1-year dog 
feeding study and 90-day inhalation toxicity study in rats. In 
addition, the 90-day inhalation toxicity study also resulted in 
follicular thyroid cell enlargement. Hepatocellular enlargement was 
produced in the 26-week dog feeding study, the 1-year dog feeding study 
and the 90-day inhalation study, but was not always associated with 
thyroid toxicity in these studies at the doses tested. The endpoints 
selected for chronic dietary, incidental oral and inhalation exposure 
are protective of endocrine-related effects.
    d-Phenothrin has been classified as ``Not Likely to be Carcinogenic 
to Humans.'' Rat liver tumors, namely hepatocellular carcinomas, 
occurred only at excessively toxic doses (limit dose) and were; 
therefore, discounted and mouse liver hepatocellular adenomas, which 
are common, did not achieve statistical significance (p <0.01). In 
addition, an acceptable battery of mutagenicity studies was negative 
for mutagenic potential.
    More detailed information on the studies received and the nature of 
the adverse effects caused by d-phenothrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the document 
entitled, ``d-Phenothrin (Sumithrin[reg]) Risk Assessment for 
Reregistration Eligibility Decision (RED) and Associated Section 3 
Registration Action,'' dated July 2, 2008, by going to http://www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2008-0140-0024 in that docket. Locate and 
click on the hyperlink for docket ID number EPA-HQ-OPP-2008-0140. 
Double-click on the document to view the referenced information on 
pages 50-54 of 66.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (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, the 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for d-phenothrin used for 
human risk assessment can be found in the document entitled, ``d-
Phenothrin (Sumithrin[reg]) Risk Assessment for Reregistration 
Eligibility Decision (RED) and Associated Section 3 Registration 
Action,'' dated July 2, 2008, by going to http://www.regulations.gov. 
The referenced document is available in the docket established by this 
action, which is described under ADDRESSES, and is identified as EPA-
HQ-OPP-2008-0140-0024 in that docket. Locate and click on the hyperlink 
for docket ID number EPA-HQ-OPP-2008-0140. Double-click on the document 
to view the referenced information on pages 23-24 of 66.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to d-phenothrin, EPA considered exposure under the petitioned-
for tolerances and assessed dietary exposures from d-phenothrin 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. In estimating acute dietary 
exposure, EPA conducted a screening level acute dietary and drinking 
water exposure assessment for the proposed new food use of d-phenothrin 
for all commodities and incorporated the Agency's estimated surface 
water peak concentration of 1 part per billion (ppb). An acute dietary 
exposure analysis was performed for the population subgroup females 13-
49 years old only as no acute endpoint was identified for the remaining 
population subgroups. The acute dietary assessment assumed tolerance-
level residues in plant and livestock commodities and 100 pecent crop 
treated (PCT).
    ii. Chronic exposure. In estimating chronic dietary exposure, EPA 
conducted a screening level chronic dietary and drinking water exposure 
assessment for the proposed new food use of d-phenothrin and 
incorporated the Agency's chronic or estimated surface water 
concentration of 0.0407 ppb. The assessment assumed tolerance-level 
residues in plant and livestock commodities and 100 PCT.
    iii. Cancer. As explained in Unit III.A., d-phenothrin is 
considered to be ``Not Likely to be Carcinogenic to Humans.'' As a 
result, an exposure assessment to evaluate cancer risk is not needed 
for d-phenothrin.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue information in the

[[Page 32440]]

dietary exposure assessment for d-phenothrin.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for d-phenothrin in drinking water. These simulation models 
take into account data on the physical, chemical and fate/transport 
characteristics of d-phenothrin. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of d-
phenothrin for acute exposures are estimated to be 0.1002 ppb for 
surface water and 0.00600 ppb for ground water. Chronic exposures for 
non-cancer assessments are estimated to be 0.0407 ppb for surface water 
and 0.00600 ppb for ground water. Chronic exposures for cancer 
assessments are estimated to be 0.0369 ppb for surface water and 
0.00600 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the estimated surface water peak concentration value of 1 
ppb was used to assess the contribution to drinking water. For chronic 
dietary risk assessment, the chronic or estimated surface water 
concentration value of 0.0407 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). Based on a review of 
active labels and proposed new uses, 12 residential exposure scenarios 
have been assessed for d-phenothrin. Inhalation and incidental 
ingestion exposure assessments have been conducted for the residential 
scenarios. Short-term and intermediate-term exposures are expected and 
assessed for residential handler and post-application exposure 
scenarios based on use and expected exposure patterns.
    Risk assessments were conducted for residential exposure pathways 
based on registered uses. Residential post-application exposure and 
risk to d-phenothrin was assessed using both deterministic and 
probabilistic modeling approaches.
    The residential exposure assessment includes 2 handler and 10 post-
application residential exposure scenarios. The term ``handler'' 
applies to individuals who mix, load and apply the pesticide product. 
The term ``post-application'' describes individuals who are exposed to 
pesticides after entering areas previously treated with pesticides. d-
Phenothrin products for outdoor residential use are almost exclusively 
available as aerosol sprays. There are a small number of outdoor fogger 
products containing d-phenothrin (at least one); however, due to the 
absence of scenario-specific exposure data for outdoor foggers, the 
fact that there are very few fogger products for residential outdoor 
use and the fact that assessment of aerosol sprays and mosquito ultra 
low volume (ULV) applications are likely to address risks from foggers, 
residential use of outdoor foggers was not assessed separately for this 
analysis.
    EPA assessed residential exposure using the following assumptions: 
Primary assumptions for assessing post-application exposure to use of 
foggers and aerosols in indoor residential settings were based on data 
provided by the Non-Dietary Exposure Task Force (NDETF). The NDETF was 
formed in 1996 by members of the Pyrethrin Joint Venture and Piperonyl 
Butoxide Task Force II to respond to reregistration needs and to 
produce scientifically sound data on non-dietary exposures to 
pyrethrins, the pyrethroids, piperonyl butoxide and MGK[reg] 264 
insecticide synergist.
    EPA used the AGricultural DISPersal model (AGDISP), version 
8.15.0.4, to calculate airborne concentrations of d-phenothrin from 
aerial ULV mosquito abatement spray applications. ULV sprayers disperse 
very fine aerosol droplets that stay aloft and kill flying mosquitoes 
on contact. ULV applications involve small quantities of the 
insecticide formulation in relation to the size of the area treated, 
typically less than 3 ounces per acre. AGDISP provides estimates of the 
1-hour average concentration and the downwind deposition of spray 
material released from the aircraft equipment and predicts the motion 
of spray material released, including the mean position of the material 
and the position variance about the mean as a result of turbulent 
fluctuations, providing a prediction of spray drift.
    For the AGDISP modeling for d-phenothrin, label recommendations 
were followed, but conservative assumptions were made. The resultant 
data were used to assess inhalation exposure resulting from aerial 
application of d-phenothrin as a mosquito adulticide. Deposition data 
from the AGDISP model were not used to assess post-application 
incidental oral exposure to d-phenothrin because residential 
application of d-phenothrin products outdoors to patios and lawn areas 
results in higher deposition. Therefore, post-application incidental 
oral exposures were assessed using estimated deposition from homeowner 
application of outdoor house and garden spray products.
    Air concentrations from truck-mounted ULV spray applications are 
estimated based on the SOP for residential exposure assessment for 
inhalation exposure from use of an outdoor space spray for pest 
control. The approach was modified to assume that 1% of the highest 
application rate for a truck-mounted ULV sprayer is available in the 
breathing zone of the resident. It is assumed that the full application 
rates for a truck-mounted ULV sprayer (with a 1% dilution factor) is 
available in the breathing zone of the residential bystander, i.e., an 
application rate expressed as lbs. a.i./ft<SUP>2</SUP> is converted 
into a concentration expressed in a per cubic foot (ft<SUP>3</SUP>) 
basis.
    Scenario-specific data on pyrethrins and/or permethrin from the 
NDETF studies were used to determine deposition of d-phenothrin on 
vinyl and carpet flooring following use of a total release indoor 
fogger. Given the close structural similarity of pyrethrins, permethrin 
and d-phenothrin and the similarity of use patterns for these 
chemicals, EPA believes that the NDETF pyrethrins and/or permethrin 
data provide appropriate surrogate data for d-phenothrin. Permethrin 
data were used preferentially for this assessment, if available, since 
permethrin and d-phenothrin are both synthetic pyrethroids.
    Inhalation following application of an indoor total release fogger 
was not modeled separately because the aerosol spray application 
scenario is likely to provide a more conservative exposure estimate 
and; therefore, be protective of exposures following use of a total 
release fogger. While application rates for total release foggers and 
aerosol sprays are comparable, labels for use of total release foggers 
require that the room be closed and vacated during release of the 
fogger and that the room be opened and thoroughly ventilated for a 
period of time (e.g. 30 minutes, 1 hour) prior to re-entry.
    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

[[Page 32441]]

``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    d-Phenothrin is a member of the pyrethroid class of pesticides. 
Although all pyrethroids alter nerve function by modifying the normal 
biochemistry and physiology of nerve membrane sodium channels, EPA is 
not currently following a cumulative risk approach based on a common 
mechanism of toxicity for the pyrethroids. Although all pyrethroids 
interact with sodium channels, there are multiple types of sodium 
channels and it is currently unknown whether the pyrethroids have 
similar effects on all channels and there is also no clear 
understanding of effects on key downstream neuronal function e.g., 
nerve excitability, and how these key events interact to produce their 
compound-specific patterns of neurotoxicity. There is ongoing research 
by the Agency's Office of Research and Development and pyrethroid 
registrants to evaluate the differential biochemical and physiological 
actions of pyrethroids in mammals. When available, EPA will consider 
this research and make a determination of common mechanism as a basis 
for assessing cumulative risk. 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 EPA's website at 
http://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. d-Phenothrin demonstrated 
qualitative and quantitative susceptibility in an acceptable rabbit 
developmental study. Specifically, developmental toxicity (spina 
bifida) occurred at a lower LOAEL (100 mg/kg/day) than the maternal 
LOAEL (300 mg/kg/day) for decreased body weight gain and food 
consumption. In rats, d-phenothrin was developmentally toxic only at a 
dose of 3,000 mg/kg/day. The NOAELs and LOAELs for maternal animals and 
fetuses were the same in this study. In the 1986 and 1995 rat 
reproduction studies, the NOAELs/LOAELs for both maternal and 
offspring/reproductive findings occurred at the same dose levels (both 
studies) and the types of offspring effects (organ weight changes 
(1986) and decreased mean pup weights (1995)) were also present in the 
respective maternal animals from the two studies.
    3. Conclusion. The risk assessment and FFDCA safety finding for d-
phenothrin are based on a well characterized but incomplete toxicity 
database. With the retention of the full FQPA SF of 10x, the toxicity 
database is considered adequate to evaluate the risks to infants and 
children based on the following findings:
    i. The toxicity database for d-phenothrin is incomplete for a full 
hazard assessment. The toxicity database for d-phenothrin lacks 
acceptable acute, subchronic and developmental neurotoxicity studies 
and an immunotoxicity study. There are no indications in the available 
studies that organs associated with immune function, such as the thymus 
and spleen, are affected by d-phenothrin. An immunotoxicity study is 
required, as a new data requirement under the 40 CFR part 158 data 
requirements for registration of a pesticide (food and non-food uses).
    ii. The only available neurotoxicity study in rats is an 
unacceptable/non-guideline study which demonstrated clinical signs of 
piloerection but no axonal damage. The rabbit developmental study 
provides evidence of neurotoxicity. Spina bifida at the mid-dose and 
treatment-related presence of hydrocephaly, another serious 
neurodevelopmental effect, was seen at the highest dose tested in the 
rabbit developmental study. Generally, other specific neurotoxic 
clinical signs were absent in other acute, subchronic and chronic d-
phenothrin studies in rats and dogs; however, d-phenothrin does not 
display the full spectrum of Type 1 clinical signs in rats and dogs up 
to the limit dose.
    iii. There is qualitative and quantitative evidence of increased 
susceptibility for d-phenothrin in the rabbit developmental study in 
the form of spina bifida at doses lower than those causing maternal 
toxicity. There was no evidence of increased susceptibility in the 2-
generation reproduction study in rats. There is low concern for 
quantitative and qualitative susceptibility observed in the rabbit 
developmental study because the NOAELs/LOAELs in this study are well 
characterized and are used to establish the acute Reference Dose 
(aRfD). The NOAEL (7.1 mg/kg/day) selected for the chronic Reference 
Dose (cRfD) is lower (14x) than the dose at which developmental effects 
were observed.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessment utilizes proposed 
tolerance-level or higher residues and assumes 100 PCT for all 
commodities. Use of screening level dietary assessments ensures that 
acute and chronic dietary risks will not be underestimated. The Tier 1 
drinking water assessment uses model parameters designed to provide 
conservative, health protective estimates of water concentrations. 
Post-application exposure to children was assessed using maximum 
application rates and established exposure assumptions. Based on 
standard assumptions, most residential scenarios were not of concern 
(MOEs > 1,000). For those assessments with MOEs < 1,000, a refined 
probabilistic analysis was carried out and all scenarios passed (all 
MOEs > 1,000) at the 99th percentile level.
    The FQPA 10x SF is to be retained primarily due to the absence of 
needed acute, subchronic and developmental neurotoxicity studies in 
conjunction with a finding of increased sensitivity for a neurological 
effect in the rabbit developmental study. EPA finds that an additional 
10x SF will protect the safety of infants and children because the 
neurotoxic effects were generally not seen in the d-phenothrin toxicity 
database and when those effects were seen it was at comparatively high 
doses.

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.

[[Page 32442]]

    The aggregate risk assessment integrates the assessments conducted 
for dietary/drinking water and residential exposure. Since there is 
potential for concurrent exposure via the food, water and residential 
pathways, all routes of d-phenothrin exposure have been considered.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Acute dietary exposure analysis was performed for the 
population subgroup females 13-49 years old only. No adverse effect 
resulting from a single-oral exposure was identified and no acute 
dietary endpoint was selected for the general population or other 
population subgroups. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to d-phenothrin will occupy 1.3% of the aPAD for females 13-49 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
d-phenothrin from food and water will utilize 13% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
d-phenothrin is not expected.
    3. Short-term risk. The short- and itermediate-term aggregate risk 
is the estimated risk associated with combined risks from average food 
exposures, average drinking water exposures, incidental oral exposures 
and inhalation exposures. Exposure from oral and inhalation exposure 
pathways is not aggregated for d-phenothrin because the toxicity 
endpoints for these exposure routes are not based on common specific 
target organ toxicity effects. Aggregate risk from exposure to d-
phenothrin residues from food, drinking water and incidental oral 
exposures do not present risks of concern.
    4. 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 d-phenothrin residues.
    For more detailed information on non-dietary (residential) 
exposure, including the use of the AGDISP and CARES models and the 
NDETF data as part of assessing residential exposure to d-phenothrin, 
please refer to the document entitled, ``d-Phenothrin (Sumithrin[reg]) 
Risk Assessment for Reregistration Eligibility Decision (RED) and 
Associated Section 3 Registration Action,'' dated July 2, 2008, by 
going to http://www.regulations.gov. The referenced document is 
available in the docket established by this action, which is described 
under ADDRESSES, and is identified as EPA-HQ-OPP-2008-0140-0024 in that 
docket. Locate and click on the hyperlink for docket ID number EPA-HQ-
OPP-2008-0140. Double-click on the document to view the referenced 
information on pages 31-42 of 66.
    In addition, for more detailed information on the refinements 
incorporated as part of the probabilistic assessment of d-phenothrin, 
please refer to the document entitled, ``d-Phenothrin (Sumithrin[reg]): 
Addendum to Residential Exposure Assessment,'' dated August 19, 2008, 
by going to http://www.regulations.gov. The referenced document is 
available in the docket established by this action, which is described 
under ADDRESSES, and is identified as EPA-HQ-OPP-2008-0140-0029 in that 
docket. Locate and click on the hyperlink for docket ID number EPA-HQ-
OPP-2008-0140. Double-click on the document to view the referenced 
information.

IV. Other Considerations

A. Analytical Enforcement Methodology

    No multiresidue monitoring protocol data were submitted by the 
registrant for d-phenothrin. No analytical method was recommended by 
the registrant for enforcement. However, the United States Food and 
Drug Administration (FDA) has tested d-phenothrin through their 
multiresidue protocols. d-Phenothrin is completely recovered through 
protocol 302, but only 60% remains after florisil cleanup, which is 
rarely used any more. No additional data are needed from the 
registrant.
    Adequate enforcement methodology is available to enforce the 
tolerance expression. FDA's Pacific Regional Laboratory Northwest has 
developed a gas chromatography/mass spectrometry detection (GC/MSD) 
method that recovers d-phenothrin. 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: <a href="/cdn-cgi/l/email-protection#077562746e6372626a62736f6863744762776629606871"><span class="__cf_email__" data-cfemail="e69483958f8293838b83928e898295a6839687c8818990">[email protected]</span></a>.

B. International Residue Limits

    There are currently no established CODEX, Canadian or Mexican 
maximum residue limits (MRLs) for residues of the insecticide d-
phenothrin in or on all food/feed crops following wide-area mosquito 
adulticide applications.

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide d-phenothrin ([(3-phenoxyphenyl)methyl] 2,2-Dimethyl-3-(2-
methyl-1-propenyl)cyclopropanecarboxylate).

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

[[Page 32443]]

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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 19, 2009.
Steven Bradbury,
Acting 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 180.647 is added to read as follows:


Sec.  180.647  d-Phenothrin; tolerances for residues.

    (a) General. A tolerance of 0.01 parts per million is established 
for residues of the insecticide d-phenothrin in or on all food/feed 
crops following wide-area mosquito adulticide applications.
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. E9-15937 Filed 7-7-09; 8:45 am]
BILLING CODE 6560-50-S


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