[Federal Register Volume 74, Number 56 (Wednesday, March 25, 2009)]
[Rules and Regulations]
[Pages 12601-12606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6412]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0875; FRL-8400-8]


Fenpropathrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fenpropathrin in or on almond, hulls at 4.5 parts per million (ppm); 
cherry, sweet, at 5.0 ppm; cherry, tart at 5.0 ppm; fruit, stone, crop 
group 12 (except cherry) at 1.4 ppm; nuts, tree, crop group 14 at 0.10 
ppm; pistachio at 0.10 ppm, PP 4E6867; avocado at 1.0 ppm; black sapote 
at 1.0 ppm; canistel at 1.0 ppm; maney sapote at 1.0 ppm; mango at 1.0 
ppm; papaya at 1.0 ppm; sapodilla at 1.0 ppm; star apple at 1.0 ppm, PP 
6E7066; caneberry, subgroup 13-07A at 12 ppm; and olive at 5.0 ppm, PP 
7E7298. In addition, the Agency is deleting a time-limited tolerance on 
currant at 15 ppm which had an expiration date of 12/31/2008. The 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 25, 2009. Objections and 
requests for hearings must be received on or before May 26, 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-2006-0875. 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 Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT:  Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: <a href="/cdn-cgi/l/email-protection#99f3f8faf2eaf6f7b7eaf0fdf7fce0d9fce9f8b7fef6ef"><span class="__cf_email__" data-cfemail="543e35373f273b3a7a273d303a312d143124357a333b22">[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).
    <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

[[Page 12602]]

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-2006-0875 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 May 26, 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-2006-0875, 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 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petitioned for Tolerance

    In the Federal Register of November 15, 2006, (71 FR 66520) (FRL-
8102-5), and February 6, 2008 (73 FR 6964) (FRL-8350-9), EPA issued a 
notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 4E6867, 6E7066, and 
7E7298) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ 
08540. The petitions requested that 40 CFR 180.466 be amended by 
establishing tolerances for residues of the insecticide, fenpropathrin, 
(alpha-cyano-3-phenoxy-benzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate), in or on fruit, stone, group 12 
(except cherry) at 5.0 ppm; nut, tree, group 14 at 0.10 ppm, pistachio 
at 0.10 ppm, and almond hulls at 5.0 ppm, PP 4E6867; avocado, black 
sapote, canistel, mamey sapote, mango, papaya, sapodilla, star apple at 
1.0 ppm; barley, grain at 0.30 ppm; barley, hay at 2.5 ppm; and barley, 
straw at 4.5 ppm, PP 6E7066; caneberry subgroup 13-07A at 12 ppm and 
olives at 5 ppm, PP 7E7298. That notice referenced a summary of the 
petition prepared by Valent, U.S.A., 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 filings.

    Based upon review of the data supporting the petitions listed in 
this Unit, EPA has made certain modifications including revisions to 
proposed tolerance levels, scope of proposed crop groups, existing 
tolerance levels, proposed commodity definitions, as follows: Changed 
the proposed tolerance for fruit, stone, group 12 to fruit, stone, 
group 12 (except cherry) and revised the tolerance level from 5.0 to 
1.4 ppm; established an individual tolerance for cherry, sweet at 5.0 
ppm, and cherry, tart at 5.0 ppm; changed the proposed tolerance for 
nut, tree, group 14 (including pistachio) to nut, tree, group 14; 
established an individual tolerance for pistachio at 0.10 ppm; revised 
the tolerance level for almond, hulls from 5.0 to 4.5 ppm, and 
corrected the commodity definition for caneberry, subgroup 13-07A. 
Additionally, at this time, the Agency is not making a decision on the 
proposed tolerances for barley, grain at 0.30 ppm, barley, hay at 2.5 
ppm, and barley, straw at 4.5 ppm pending submission and review of a 
barley processing study. The reasons for these changes are explained in 
Unit IV.D.

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 fenpropathrin in or on almond, hulls at 4.5 
ppm; cherry, sweet at 5.0 ppm; cherry, tart at 5.0 ppm; fruit, stone, 
group 12 at 1.4 ppm; nut, tree, group 14 at 0.10 ppm; avocado at 1.0 
ppm; black sapote at 1.0 ppm; canistel at 1.0 ppm; maney sapote at 1.0 
ppm; mango at 1.0 ppm; papaya at 1.0 ppm; sapodilla at 1.0 ppm; star 
apple at 1.0; caneberry, subgroup 13-07A at 12 ppm; olive at 5.0 ppm; 
and pistachio at 0.10 ppm. EPA's assessment of exposures and risks 
associated with establishing tolerances follows.

A. Toxicological Profile

    The database for fenpropathrin is not complete, but it does provide 
adequate information to characterize toxicity. Acute neurotoxicity, 
subchronic neurotoxicity, and developmental neurotoxicity studies have 
been submitted and reviewed since the previous risk assessment. These 
studies were classified acceptable/guideline and

[[Page 12603]]

were considered during endpoint selection.
    Fenpropathrin exhibits high toxicity through the oral and dermal 
routes of exposure. Acute inhalation toxicity has not been determined 
for fenpropathrin. Because of the chemical's low vapor pressure, 
sufficient test material could not be generated to elicit a toxic 
response during the inhalation studies. Fenpropathrin is a mild eye 
irritant, but does not cause dermal irritation in rabbits or skin 
sensitization in guinea pigs.
    Clinical signs of toxicity observed in rats and dogs following 
subchronic exposure included tremors, ataxia, salivation, and 
hypersensitivity. Decreased body weights and food consumption are more 
general responses to dietary consumption in rats and dogs. Pregnant 
rabbits exposed to fenpropathrin during a developmental study also 
exhibited neurotoxic signs including tremors, shakiness, unsteadiness, 
and flicking limbs.
    Chronic dietary exposure to fenpropathrin produced no treatment-
related effects in mice. Following chronic exposure, rats and dogs 
showed evidence of neurotoxicity that was consistent with the effects 
that were seen after subchronic exposures. There was no evidence of 
carcinogenicity in either the rat or mouse long-term dietary studies. 
Fenpropathrin is not mutagenic in bacteria or cultured mammalian cells. 
This chemical is neither clastogenic nor damaging to DNA. Fenpropathrin 
is classified as ``not likely to be carcinogenic to humans.''
    Developmental studies in rats and rabbits showed no evidence of 
increased susceptibility in fetuses as compared to maternal animals 
following exposure to fenpropathrin in utero. Maternal animals of both 
species exhibited clinical signs of neurotoxicity. In rats, reduced 
body weight gains were also present. In neither study did dose-related 
changes in fecundity, fertility, implantations, number of abortions, or 
early or late resorptions occur. The only anomaly noted for either 
species was an increased incidence of asymmetrical or incomplete 
ossification of the fifth or sixth sternebrae in rat fetuses. A two-
generation reproduction study in rats, likewise, did not show an 
increased sensitivity to fenpropathrin in pups as compared to adults.
    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by fenpropathrin as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Fenpropathrin. Human health risk 
assessment for the proposed uses on barley, stone fruit (Crop Group 
12), tree nuts (Crop Group 14), pistachio, caneberries (Crop Subgroup 
13-07A), and star apple, dated 11/26/2008'', page 13 in docket ID 
number EPA-HQ-OPP-2006-0875-0005.

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 highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (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-, intermediate-
, 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 fenpropathrin used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Fenpropathrin. Human health risk assessment for the proposed 
uses on barley, stone fruit (Crop Group 12), tree nuts (Crop Group 14), 
pistachio, caneberries (Crop Subgroup 13-07A), and star apple, dated 
11/26/2008, page 19 in docket ID number EPA-HQ-OPP-2006-0875-0005.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpropathrin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fenpropathrin 
tolerances in (40 CFR 180.466). EPA assessed dietary exposures from 
fenpropathrin 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.
    Acute dietary exposure assessments were conducted using the Dietary 
Exposure Evaluation Model (DEEM-FCID, Version 2.03), which uses food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). A partially refined acute 
probabilistic dietary exposure analysis was performed for 
fenpropathrin. As to residue levels in food, EPA's analysis was based 
on tolerance level residues for some commodities, crop field trial data 
(only for apricots, nectarines, apples, cherries, grapes, peaches, 
pears, and plums), processing factors, and the assumption of 100% 
percent crop treated for all registered and proposed commodity uses. As 
a result, the Agency considers these analyses to be refined, but not 
highly refined.
    ii. Chronic exposure. Chronic dietary exposure assessments were 
conducted using the DEEM-FCID, (Version 2.03), which uses food 
consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue 
levels in food, EPA's analysis was based on tolerance level residues 
for some commodities, crop field trial data (only for apricots, 
nectarines, apples, cherries, grapes, peaches, pears, and plums), 
processing factors, and the assumption of 100% percent crop treated for 
all registered and proposed commodity uses. As a

[[Page 12604]]

result, the Agency considers these analyses to be refined, but not 
highly refined.
    iii. Cancer. An exposure assessment to evaluate cancer risk is 
unnecessary. There is no evidence of carcinogenicity in either the rat 
or mouse long-term dietary studies. Fenpropathrin is not mutagenic in 
bacteria or cultured mammalian cells. The chemical is neither 
clastogenic nor damaging to DNA. Fenpropathrin is classified as ``not 
likely to be carcinogenic to humans.''
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    <bullet> Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    The assumption of 100% PCT was made for all registered and proposed 
commodity uses.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fenpropathrin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenpropathrin. 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 First Index Reservoir Screening Tool (FIRST) Model for 
surface water and Screening Concentration in Ground Water (SCI-GROW) 
Model for ground water, the estimated drinking water concentrations 
(EWDC) of fenpropathrin for acute exposures are estimated to be 10.3 
parts per billion (ppb) for surface water and 0.005 ppb for ground 
water. The EWDCs for chronic exposures is estimated to be 1.81 ppb for 
surface water and 0.005 ppb for ground water.
     Modeled estimates of drinking water concentrations were directly 
entered into the DEEM-FCID. For acute dietary risk assessment, the peak 
water concentration value of 10.3 ppb was used to assess the 
contribution of drinking water. For chronic dietary risk assessment, 
the annual average concentration of 1.8 ppb was used to assess the 
contribution of 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).
    Fenpropathrin is not registered for any specific use patterns that 
would result in residential exposure. No new residential uses are 
associated with the petitioned-for tolerances.
    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 considers ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found fenpropathrin to share a common mechanism of 
toxicity with any other substances, and fenpropathrin does not appear 
to produce a toxic metabolite produced by other substances.
    Fenpropathrin 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. The Agency does not have a clear 
understanding of effects on key downstream neuronal function, e.g., 
nerve excitability, nor does it understand how these key events 
interact to produce their compound-specific patterns of neurotoxicity. 
There is ongoing research by EPA and pyrethroid registrants to evaluate 
the differential biochemical and physiological actions of pyrethroids 
in mammals. When the results of the research are available, the Agency 
will consider this research and make a determination of common 
mechanism as a basis for assessing cumulative risk. Information 
regarding EPA's procedures for cumulating effects from substances found 
to have a common mechanism can be found on 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 Food Quality 
Protection Act (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. There are no concerns or 
residual uncertainties for pre-and/or post-natal toxicity resulting 
from exposure to fenpropathrin. There is no evidence (qualitative or 
quantitative) of increased susceptibility following in utero and/or 
pre-natal or post-natal exposure in adequate developmental toxicity 
studies in rats or rabbits, a 2-generation reproduction study in rats, 
and a developmental neurotoxicity study in rats.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for fenpropathrin is adequate for FQPA

[[Page 12605]]

determination. The database for fenpropathrin is not complete, but it 
does provide adequate information to characterize toxicity/endpoint 
selection for infants and children including acceptable acute 
neurotoxicity, subchronic neurotoxicity, and developmental 
neurotoxicity studies. Based on recently revised EPA Part 158 
Guidelines, an immunotoxicology study in rats must be submitted to the 
Agency. However, because there was no indication of immunotoxicity in 
the toxicity database, an additional 10x database uncertainty factor is 
not considered necessary in order to be protective of potential 
immunotoxic effects.
     ii. The toxicity data, including a developmental neurotoxicity 
study, showed no increase in qualitative or quantitative susceptibility 
in fetuses and pups with in utero and/or post-natal exposure to 
fenpropathrin.
     iii. There are no residual uncertainties identified in the 
exposure databases. Dietary food exposure assessments were performed 
based on 100% PCT, tolerance-level residues for existing and proposed 
uses, and field trial data. The exposure databases (dietary food and 
drinking water) are complete and the exposure assessment for each 
potential exposure scenario includes all metabolites and/or degradates 
of concern and does not underestimate the potential exposure for 
infants and children. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
fenpropathrin in drinking water. These assessments will not 
underestimate the exposure and risks posed by fenpropathrin.

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-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Dietary (food + water) consumption is the only source 
of exposure to fenpropathrin that is expected to result in acute 
exposure. Therefore, the acute aggregate risk estimates are equivalent 
to the acute dietary exposure discussed in Unit III. Acute aggregate 
risk is below EPA's level of concern for the general U.S. population 
and all population subgroups. Using the exposure assumptions discussed 
in this unit for acute exposure, the acute dietary exposure from food 
and water to fenpropathrin will occupy 53% of the aPAD for children 1-2 
years, 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 
fenpropathrin from food and water will utilize 41% of the cPAD for 
children 1-2 years, the population group receiving the greatest 
exposure. There are no residential uses for fenpropathrin.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fenpropathrin is not registered for any use patterns that would 
result in residential exposure. Therefore, the short-term aggregate 
risk is the sum of the risk from exposure to fenpropathrin through food 
and water and will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Fenpropathrin is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to fenpropathrin through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Aggregate cancer risk 
is not a concern because fenpropathrin is classified as ``not likely to 
be carcinogenic to humans.''
    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, or to infants and children from aggregate 
exposure to fenpropathrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There are adequate enforcement methods for fenpropathrin. The 
methods use gas chromatography using an electron capture detector (GC/
ECD), for the determination of fenpropathrin residues in/on plants (RM-
22-4, revised 5/3/93) and animals (RM-22A-1). The limit of detection 
(LOD) for Method RM-22-4 is 0.01 ppm.
     The methods 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#c8baadbba1acbdada5adbca0a7acbb88adb8a9e6afa7be"><span class="__cf_email__" data-cfemail="760413051f1203131b13021e1912053613061758111900">[email protected]</span></a>.

B. International Residue Limits

    Codex and Mexican maximum residue limits (MRLs) are established for 
residues of fenpropathrin, but no limits are listed for the crop 
commodities addressed herein. No Canadian MRLs are established for 
fenpropathrin.

C. Revisions to Petitioned-For Tolerances

    Based upon review of available data supporting these petitions, EPA 
revised the tolerance levels, added or deleted tolerances, corrected 
commodity definitions, or otherwise modified the petitions as proposed 
in the notice of filings, as follows:
     <bullet> EPA did not include cherries in the proposed tolerance on 
fruit, stone, crop group 12 because of the significant difference in 
residue levels on cherries compared to other commodities in the crop 
group. Instead, EPA established an individual tolerance for cherry, 
sweet at 5.0 ppm, and cherry, tart at 5.0 ppm.
     <bullet> Based on available field trials residue data, analyzed 
under the Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data SOP, the Agency revised the tolerance level from 5.0 to 1.4 
ppm for fruit, stone, group 12 (except cherry).
     <bullet> EPA did not include pistachios in the proposed tolerance 
on tree nuts, crop group 14 because of pistachios are not currently 
part of that crop group. Instead EPA established an individual 
tolerance for pistachios at 0.10 ppm.
     <bullet> Based on available field trials residue data, analyzed 
under the Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data SOP, the Agency revised the tolerance level for almond, 
hulls from 5.0 to 4.5 ppm.
     <bullet> Corrected commodity definition of the proposed tolerance 
on caneberry subgroup 13A to caneberry, subgroup 13-07A to reflect how 
the crop group is defined in the applicable regulations.

[[Page 12606]]

V. Conclusion

    Therefore, tolerances are established for residues of the 
insecticide, fenpropathrin, (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate), in or on almond, hulls at 4.5 ppm; 
cherry, sweet at 5.0 ppm; cherry, tart at 5.0 ppm; fruit, stone, crop 
group 12 (except cherry) at 1.4 ppm; nut, tree, crop group 14 at 0.10 
ppm; avocado at 1.0 ppm; black sapote at 1.0 ppm; canistel at 1.0 ppm; 
maney sapote at 1.0 ppm; mango at 1.0 ppm; papaya at 1.0 ppm; sapodilla 
at 1.0 ppm; star apple at 1.0; caneberry, subgroup 13-07A at 12.0 ppm; 
olive at 5.0 ppm; and pistachio at 0.10 ppm. In addition, the Agency is 
deleting a time-limited tolerance on currant at 15 ppm which had an 
expiration date of 12/31/2008.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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


    Dated: February 24, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180. 466 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) and by removing the text in 
paragraph (b) and reserving the heading.


Sec.  180.466  Fenpropathrin; tolerances for residues.

* * * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls.............................  4.5
Avocado...................................  1.0
                                * * * * *
Caneberry subgroup 13-07A.................  12
Canistel..................................  1.0
                                * * * * *
Cherry, sweet.............................  5.0
Cherry, tart..............................  5.0
                                * * * * *
Fruit, stone, crop group 12, except cherry  1.4
                                * * * * *
Mango.....................................  1.0
                                * * * * *
Nut, tree, crop group 14..................  0.10
Olive.....................................  5.0
Papaya....................................  1.0
                                * * * * *
Pistachio.................................  0.10
                                * * * * *
Sapodilla.................................  1.0
Sapote, black.............................  1.0
Sapote, mamey.............................  1.0
                                * * * * *
Star apple................................  1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E9-6412 Filed 3-24-09; 8:45 am]
BILLING CODE 6560-50-S


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