[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28721]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Fenpropathrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
fenpropathrin in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective November 28, 2012. Objections and
requests for hearings must be received on or before January 28, 2013,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2009-0644, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; email address: email@example.com.
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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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-2009-0644 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
January 28, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
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 (excluding any Confidential Business Information (CBI) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2009-0644, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of October 7, 2009 (74 FR 51597) (FRL-8792-
7), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7594)
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.466 be amended by establishing
residues of the insecticide fenpropathrin, alpha-cyano-3-phenoxy-benzyl
2,2,3,3-tetramethylcyclopropanecarboxylate, in or on acerola, feijoa,
guava, jaboticaba, passionfruit, starfruit and wax jambu at 1.5 parts
per million (ppm); longan, lychee, pulasan, rambutan and Spanish lime
at 3.0 ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop
and sugar apple, at 1.0 ppm; and tea at 2.0 ppm. That notice referenced
a summary of the petition prepared on behalf of IR-4 by Valent USA
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerances for several commodities. The Agency has
also revised the tolerance expression for all established commodities
to be consistent with current Agency policy. The reasons for these
changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the 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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 fenpropathrin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fenpropathrin
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
Fenpropathrin is a member of the pyrethroid class of insecticides.
Pyrethroids have historically been classified into two groups--Type I
and Type II, based on chemical structure and toxicological effects.
Type I pyrethroids induce in rats a syndrome consisting of aggressive
sparring, altered sensitivity to external stimuli, hyperthermia, and
fine tremors, progressing to whole-body tremors, and prostration (T-
syndrome). Type II pyrethroids, which contain an alpha-cyano moiety,
produce in rats a syndrome that includes pawing, burrowing, salivation,
hypothermia, and coarse tremors leading to choreoathetosis (CS-
syndrome). Fenpropathrin is a mixed type pyrethroid because the
biochemical responses and resulting clinical signs of neurotoxicity are
intermediate between those of Type I and Type II pyrethroids. The
adverse outcome pathway shared by pyrethroids involves the ability to
interact with voltage-gated sodium channels in the central and
peripheral nervous systems, leading to changes in neuron firing and,
Fenpropathrin exhibits high acute toxicity via the oral and dermal
routes, but low toxicity via the inhalation route of exposure.
Fenpropathrin is a mild eye irritant, but does not cause dermal
irritation or skin sensitization. Toxicological effects characteristic
of Type I pyrethroids were seen in most of the experimental toxicology
studies including the acute, subchronic, and developmental
neurotoxicity studies, subchronic studies in the rat and dog, the
chronic carcinogenicity study in the rat, the developmental studies in
the rat and rabbit, and in the 3-generation reproduction study in rats.
Tremors were the most common indication of neurotoxicity; however,
ataxia, increased sensitivity (e.g., heightened response) to external
stimuli, convulsions, and increased auditory startle response were also
In developmental toxicity studies in rats and rabbits, maternal
toxicity included neurological effects such as ataxia, sensitivity to
external stimuli, tremors in the rat, and flicking of forepaws in the
rabbit. Developmental effects were limited to incomplete or
asymmetrical ossification of sternebrae at the maternally toxic dose in
the rat. There were no developmental effects in the rabbit. There were
no indications of immunotoxicity in any of the guideline studies,
including the immunotoxicity study in rats. In a 3-generation
reproduction study in the rat, maternal and offspring effects were
observed at the mid- and high-dose. At the high dose, maternal effects
included increased deaths and clinical signs of toxicity (tremors,
muscle twitches, and increased sensitivity) during lactation. Pup
deaths were noted at this level. At the mid-dose, minimal signs of
treatment-related effects were observed for both adults and pups,
reducing concern for quantitative or qualitative sensitivity.
There was no evidence of carcinogenicity in either the rat or mouse
long-term dietary studies, nor was there any mutagenic activity in
bacteria or cultured mammalian cells. Fenpropathrin has been classified
as ``not likely to be carcinogenic to humans.''
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 the document, ``Fenpropathrin. Human Health Risk
Assessment for Section 3 Registration on Tropical Fruit and a Request
for a Tolerance without U.S. Registration on Tea'' at pp 40-45 in
docket ID number EPA-HQ-OPP-2009-0644.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
of exposure (MOE). 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 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 is shown in
the following Table.
Table--Summary of Toxicological Doses and Endpoints for Fenpropathrin for Use in Human Health Risk Assessment
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD for risk Study and toxicological
factors assessment effects
Acute dietary (General population, Wolansky BMDL1SD = 5.0 aRfD = 0.05 mg/kg/day. Wolansky BMD1SD = 6.4 mg/kg
including children >= 6 years old). mg/kg. aPAD = 0.05 mg/kg/day. based on decreased motor
UFA = 10X............. activity.
UFH = 10X.............
FQPA SF = 1X..........
Acute dietary (< 6 years old)...... Wolansky BMDL1SD = 5.0 aRfD = 0.05 mg/kg/day. Wolansky BMD1SD = 6.4 mg/kg
mg/kg. aPAD = 0.017 mg/kg/ based on decreased motor
UFA = 10X............. day.. activity.
UFH = 10X.............
FQPA SF = 3X..........
Chronic dietary (All populations).. Because of the rapid reversibility of the most sensitive neurotoxicity
endpoint used for quantifying risks, there is no increase in hazard with
increasing dosing duration. Therefore, the acute dietary endpoint is
protective of the endpoints from repeat dosing studies, including chronic
Cancer (Oral, dermal, inhalation).. Fenpropathrin has been classified as ``not likely to be carcinogenic to
humans.'' Cancer risk is not of concern.
FQPA SF = Food Quality Protection Act Safety Factor. mg/kg/day = milligram/kilogram/day. PAD = population
adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
population (intraspecies). BMD = Benchmark Dose Analysis. BMD1SD = dose level where effect is 1SD from control
value. BMDL1SD = lower 95% confidence limit of the BMD value.
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. Such effects were identified
for fenpropathrin. In estimating acute dietary exposure, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA utilized percent
crop treated (PCT) estimates and tolerance level residues,
distributions of field trial values, and distributions of Pesticide
Data Program (PDP) monitoring data.
Residue distributions were used for the commodities that made the
most significant contributions to the risk estimates. Distributions of
USDA's PDP monitoring data from 2007 through 2010 were used for
broccoli (translated to Chinese mustard cabbage and cauliflower),
watermelon, squash, oranges (translated to tangerines), apples, apple
juice, pears, blueberries (translated to huckleberries), grapes, grape
juice, and strawberries. Distributions of field trial data were used
for cherries, peaches, plums, grapefruit, raspberries, blackberries,
apricots, cabbage, papaya, olives, tomatoes, cucumbers, Brussels
sprouts, and guava. Tolerance-level residues were assumed for all other
commodities having existing or proposed tolerances. Dietary Exposure
Evaluation Model (DEEM) default processing factors were used for those
commodities for which they were available. In some cases, empirical
processing factors were used.
ii. Chronic exposure. Based on the data summarized in Unit III.A.,
there is no bincrease in hazard from repeated exposures to
fenpropathrin; the acute dietary exposure assessment is protective for
chronic dietary exposures because acute exposure levels are higher than
chronic exposure levels. Accordingly, a dietary exposure assessment for
the purpose of assessing chronic dietary risk was not conducted.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenpropathrin does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
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:
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.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
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 estimated the PCT for existing uses as follows:
Apples, 15%; apricots, 2.5%; blueberries, 2.5%; broccoli, 2.5%;
Brussels sprouts, 10%; cabbage, 2.5%; cauliflower, 2.5%; cherries, 5%;
cotton, 2.5%; cucumbers, 2.5%; grapefruit, 35%; grapes, 10%;
nectarines, 2.5%; oranges, 35%; peaches, 2.5%; pears, 10%; plums, 2.5%;
prune plums, 2.5%; squash, 2.5%; strawberries, 50%; tangerines, 15%;
tomatoes, 10%; and watermelons, 2.5%.
In most cases, EPA uses available data from U.S. Department of
Agriculture/National Agricultural Statistics Service (USDA/NASS),
proprietary market surveys, and the National Pesticide Use Database for
the chemical/crop combination for the most recent 6 to 7 years. EPA
uses an average PCT for chronic dietary risk analysis. The average PCT
figure for each existing use is derived by combining available public
and private market survey data for that use, averaging across all
observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than 1. In those cases, 1%
is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which fenpropathrin may be applied in a particular area.
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) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) 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.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 10.3 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). Fenpropathrin is not
registered for any specific use patterns that would result in
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
The Agency is required to consider the cumulative risks of
chemicals sharing a common mechanism of toxicity. The Agency has
determined that the pyrethroids and pyrethrins, including
fenpropathrin, share a common mechanism of toxicity. The members of
this group share the ability to interact with voltage-gated sodium
channels, ultimately leading to neurotoxicity. The cumulative risk
assessment for the pyrethroids/pyrethrins was published in the November
9, 2011 issue of the Federal Register (76 FR 69726) (FRL 8888-9), and
is available at http://www.regulations.gov in the public docket, EPA-
HQ-OPP-2011-0746. Further information about the determination that
pyrethroids and pyrethrins share a common mechanism of toxicity may be
found in document ID: EPA-HQ- OPP-2008-0489-0006.
The Agency has conducted a quantitative analysis of the proposed
tolerances for fenpropathrin and has determined that it will not
contribute significantly or change the overall findings presented in
the pyrethroid cumulative risk assessment. In the cumulative assessment
for pyrethroids, residential exposures were the greatest contributor to
the total exposure. As there are no residential uses for fenpropathrin,
the proposed new uses will have no impact on the residential component
of the cumulative risk estimates.
Dietary exposures make a minor contribution to the total pyrethroid
exposure. The dietary exposure assessment performed in support of the
pyrethroid cumulative assessment was much more highly refined than that
performed for the single chemical, fenpropathrin. In addition, for the
fenpropathrin risk assessment, the most sensitive apical endpoint in
the fenpropathrin database was selected to derive the POD.
Additionally, the POD selected for fenpropathrin is specific to
fenpropathrin, whereas the POD selected for the cumulative assessment
was based on common mechanism of action data that are appropriate for
all 20 pyrethroids included in the cumulative assessment. The proposed
food uses of fenpropathrin will not contribute significantly or change
the overall findings in the pyrethroid cumulative risk assessment, as
the dietary risks are a minor component of total pyrethroid cumulative
risk. For information regarding EPA's efforts to evaluate the risk of
exposure to pyrethroids, refer to http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.
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, Safety Factor (FQPA SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
2. Prenatal and postnatal sensitivity. The fenpropathrin toxicity
database includes developmental toxicity studies in rats and rabbits
and a 3-generation reproduction study in rats, and a developmental
neurotoxicity (DNT) study in rats. There was no evidence of increased
qualitative or quantitative susceptibility noted in any of these
studies. This lack of susceptibility is consistent with the results of
the guideline prenatal and postnatal testing for other pyrethroid
There are several in vitro and in vivo studies that indicate
pharmacodynamic contributions to pyrethroid toxicity are not age-
dependent. A study of the toxicity database for pyrethroid chemicals
also noted no residual uncertainties regarding age-related
sensitivities for the young, based on the absence of prenatal
sensitivity observed in 76 guideline studies for 24 pyrethroids and the
scientific literature. However, high-dose studies at LD50
doses noted that younger animals were more susceptible to the toxicity
of pyrethroids. These age-related differences in toxicity are
principally due to age-dependent pharmacokinetics; the activity of
enzymes associated with the metabolism of pyrethroids increases with
age. Nonetheless, the typical environmental exposures to pyrethroids
are not expected to overwhelm the clearance capacity in juveniles. In
support, at a dose of 4.0 milligrams/kilogram (mg/kg) for deltamethrin
(near the Wolansky study LOAEL value of 3.0 mg/kg for deltamethrin),
the change in the acoustic startle response was similar between adult
and young rats.
3. Conclusion. EPA is reducing the FQPA SF to 3X for infants and
children less than 6 years of age. For the general population,
including children greater than 6 years of age, EPA is reducing the
FQPA SF to 1X. The decisions regarding the FQPA SF being used are based
on the following considerations:
i. The toxicity database for fenpropathrin is not complete. While
the database is considered to be complete with respect to the guideline
toxicity studies for fenpropathrin, EPA lacks additional data to
address the potential for juvenile sensitivity to all pyrethroids. In
light of the literature studies indicating a possibility of increased
sensitivity to fenpropathrin in juvenile rats at high doses, EPA has
requested proposals for study protocols which could identify and
quantify fenpropathrin's potential juvenile sensitivity. The reasons
discussed in Unit III.D.3.ii, and the uncertainty regarding the
protectiveness of the intraspecies uncertainty factor raised by the
literature studies warrant application of an additional 3X for risk
assessments for infants and children less than 6 years of age.
ii. There is no evidence that fenpropathrin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in a 3-generation rat
reproduction study. This is consistent with the results of the
guideline pre- natal and postnatal testing for other pyrethroid
pesticides. There are, however, high dose LD50 studies
(studies assessing what dose results in lethality to 50 percent of the
tested population) in the scientific literature indicating that
pyrethroids can result in increased quantitative sensitivity in the
young. Examination of pharmacokinetic and pharmacodynamic data
indicates that the sensitivity observed at high doses is related to
pyrethroid age-dependent pharmacokinetics, the activity of enzymes
associated with the metabolism of pyrethroids. Predictive
pharmacokinetic models indicate that the differential adult-juvenile
pharmacokinetics will result in otherwise equivalent administered doses
for adults and juveniles producing a 3X greater dose at the target
organ in juveniles compared to adults.
No evidence of increased quantitative or qualitative susceptibility
was seen in the pyrethroid scientific literature related to
pharmacodynamics (the effect of pyrethroids at the target tissue) both
with regard to interspecies differences between rats and humans and to
differences between juveniles and adults. Specifically, there are in
vitro pharmacodynamic data and in vivo data indicating similar
responses between adult and juvenile rats at low doses and data
indicating that the rat is a conservative model compared to the human
based on species-specific pharmacodynamics of homologous sodium channel
isoforms in rats and humans.
In light of the high dose literature studies showing juvenile
sensitivity to pyrethroids and the absence of the requested data on
juvenile sensitivity to pyrethroids, EPA is retaining a 3X additional
safety factor as estimated by pharmacokinetic modeling. For several
reasons, EPA concludes there are reliable data showing that a 3X factor
is protective of the safety of infants and children. First, the high
doses that produced juvenile sensitivity in the literature studies are
well above normal dietary exposure levels of pyrethroids to juveniles
and these lower levels of exposure are not expected to overwhelm the
ability to metabolize pyrethroids as occurred with the high doses used
in the literature studies. This is confirmed by the lack of a finding
of increased sensitivity in prenatal and postnatal guideline studies in
any pyrethroid, including fenpropathrin, despite the relatively high
doses used in those studies. Second, the portions of both the inter-
and intraspecies uncertainty factors that account for potential
pharmacodynamic differences (generally considered to be approximately
3X for each factor) are likely to overstate the risk of inter- and
intraspecies pharmacodynamic differences given the data showing
similarities in pharmacodynamics between juveniles and adults and
between humans and rats. Finally, as indicated, pharmacokinetic
modeling only predicts a 3X difference between juveniles and adults.
iii. There are no residual uncertainties identified in the exposure
databases. Although the acute dietary exposure estimates are refined,
as described in Unit III.C.1.i., the exposure estimates will not
underestimate risk for the established and proposed uses of
fenpropathrin. The residue levels used are based on distributions of
residues from field trial data, monitoring data reflecting actual
residues found in the food supply, and tolerance-level residues for
several commodities; the use of estimated PCT information; and, when
appropriate, processing factors measured in processing studies or
default high-end factors representing the maximum concentration of
residue into a processed commodity. 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.
Further information about the reevaluation of the FQPA SF for
pyrethroids may be found in document ID: EPA-HQ-OPP-2011-0746-0011, at
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure
that an adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fenpropathrin will occupy 97% of the aPAD for children 3 to 5 years
old, the population group receiving the greatest exposure from the
dietary assessment for infants and children less than 6 years old; and
27% of the aPAD for children 6 to 12 years old, the population group
receiving the greatest exposure from the dietary assessment for the
general population other than children less than 6 years old.
2. Chronic risk. Based on the data summarized in Unit III.A., there
is no increase in hazard with increasing dosing duration. Furthermore,
chronic dietary exposures will be lower than acute exposures.
Therefore, the acute aggregate assessment is protective of potential
chronic aggregate exposures.
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). A short-term
adverse effect was identified; however, fenpropathrin is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short-term
residential exposure and acute dietary exposure has already been
assessed under the appropriately protective aPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the acute
dietary risk assessment for evaluating short-term risk for
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). Because no intermediate-term adverse effect was identified,
fenpropathrin is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fenpropathrin is not expected to pose a cancer risk 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
An adequate enforcement methodology utilizing gas chromatography
with electron capture detection (GC/ECD, Residue Method Number RM-22-4)
is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for fenpropathrin in or on tea,
green and black at 2.0 ppm. Using the Organization for Economic
Cooperation and Development (OECD) MRL calculation procedures, the
recommended U.S. tolerance for tea, dried would be 3.0 ppm. However,
for the purposes of harmonization of the U.S. tolerance with the
established Codex MRL, EPA is recommending the tolerance of 2.0 ppm for
tea, dried. The Agency considers this tolerance level to be adequate
because the highest field trial value noted for tea, dried was 1.38
C. Revisions to Petitioned-for Tolerances
Based on the data supporting the petitions, EPA revised the
proposed tolerances on acerola, feijoa, guava, jaboticaba,
passionfruit, startfruit and wax jambu from 1.5 ppm to 3.0 ppm; longan,
lychee, pulasan, rambutan, and Spanish lime from 3.0 ppm to 7.0 ppm;
and atemoya, birba, cherimoya, custard apple, ilama, soursop, and sugar
apple, from 1.0 ppm to 1.5 ppm. The Agency revised these tolerance
levels based on analysis of the residue field trial data using the OECD
tolerance calculation procedures. EPA also revised the proposed
commodity definition for tea to tea, dried in order to reflect the
Agency's commodity nomenclature.
Finally, the Agency has revised the tolerance expression to clarify
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of fenpropathrin not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
Therefore, tolerances are established for residues of
fenpropathrin, alpha-cyano-3-phenoxy-benzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate, in or on acerola, feijoa, guava,
jaboticaba, passionfruit, starfruit and wax jambu at 3.0 ppm; longan,
lychee, pulasan, rambutan and Spanish lime, at 7.0 ppm; atemoya,
biriba, cherimoya, custard apple, ilama, soursop and sugar apple, at
1.5 ppm; and tea, dried at 2.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
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
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
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) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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
Dated: November 15, 2012.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.466, paragraph (a), revise the introductory text,
alphabetically add the following commodities and footnote 1 to the
table to read as follows:
Sec. 180.466 Fenpropathrin; tolerances for residues.
(a) General. Tolerances are established for residues of
fenpropathrin, including its metabolites and degradates, in or on the
commodities in the following table. Compliance with the tolerance
levels specified below is to be determined by measuring only
fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3
* * * * *
* * * * *
* * * * *
* * * * *
Custard apple........................................... 1.5
* * * * *
* * * * *
* * * * *
* * * * *
* * * * *
* * * * *
* * * * *
Spanish lime............................................ 7.0
* * * * *
* * * * *
Sugar apple............................................. 1.5
Tea, dried \1\.......................................... 2.0
* * * * *
Wax jambu............................................... 3.0
\1\ There are no U.S. registrations as of November 28, 2012, for the use
of fenpropathrin on tea, dried.
* * * * *
[FR Doc. 2012-28721 Filed 11-27-12; 8:45 am]
BILLING CODE 6560-50-P