[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27680]
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. This regulation additionally removes
several permanent tolerances as they will be superseded by the
tolerances established by 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 20, 2013. Objections and
requests for hearings must be received on or before January 21, 2014,
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
number EPA-HQ-OPP-2012-0899, 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
FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7090; email address: [email protected].
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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OPPTS
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
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-2012-0899 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 21, 2014. 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-2012-0899, 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.html.
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 Tolerances
In the Federal Register of February 15, 2013 (78 FR 11126) (FRL-
9378-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8107) by IR-4,500 College Rd. East, Suite 201W., Princeton, NJ 08540.
The petition requested that 40 CFR 180.466 be amended by establishing
tolerances for residues of the insecticide fenpropathrin, alpha-cyano-
3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate, in or on
barley, grain at 0.04 parts per million (ppm); barley, hay at 3.0 ppm;
barley, straw at 2.0 ppm; berry, low-growing, subgroup 13-07G at 2.0
ppm; bushberry subgroup 13-07B at 3.0 ppm; fruit, citrus, group 10-10
at 2.0 ppm; fruit, pome, group 11-10 at 5.0 ppm; fruit, small vine
climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm; and
vegetable, fruiting, group 8-10 at 1.0 ppm. The petition additionally
requested the removal of the following established tolerances in 40 CFR
180.466 for fenpropathrin as they will be superseded by new tolerances,
if established: Fruit, citrus, group 10; fruit, pome, group 11;
bushberry subgroup 13B; grape; juneberry; salal; strawberry; and
vegetable, fruiting, group 8.
That document 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
determined that the established tolerance for lingonberry will also be
removed. The reason for this change is 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 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
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, which lack an alpha-cyano moiety, induce in rats a
syndrome consisting of aggressive sparring, altered sensitivity to
external stimuli, hyperthermia, and fine tremor progressing to whole-
body tremor 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, ultimately, neurotoxicity.
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 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. 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 were no indications of immunotoxicity in any of the
guideline studies, including the immunotoxicity study in rats.
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 toxicological points of departure (POD)
derived from the BMDL (statistical lower confidence limit on the dose
at the benchmark dose) from the toxicity studies can be found at http://www.regulations.gov in document ``Fenpropathrin. Human Health Risk
Assessment for the Proposed Section 3 Registration on Barley and the
Request to Update Several Existing Crop Groups with Revised Crop
Grouping Definitions'' starting at p. 12, in docket ID number EPA-HQ-
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological 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. For fenopropathrin, the PODs are developed
based on a careful analysis of the doses in each toxicological study; a
benchmark dose analysis was conducted to derive the BMDL. 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 margin 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 discussed in Unit III.B. of the final rule
published in the Federal Register of November 28, 2012 (77 FR 70902)
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 United States Department of
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). 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 (i.e., the ``risk
drivers''). Monitoring data were used for risk drivers when they were
available; however, field trial data were used for the remaining risk
drivers. Distributions of monitoring data values were used for the
following risk drivers: Apple juice, apples, blackberries, blueberries,
broccoli, cauliflower, Chinese mustard cabbage, grape juice, grapes,
huckleberries, oranges, pears, raspberries, squash, strawberries,
tangerines, and watermelon. Monitoring
data from the years 2007 through 2010, inclusive, were used. Broccoli
PDP data were translated to Chinese mustard cabbage and cauliflower.
Orange PDP data were translated to tangerines. Blueberry PDP data were
translated to blackberries, huckleberries, and raspberries. Finally,
strawberry PDP data were translated to cranberries. Distributions of
field trial data were used for apricot juice, apricots, Brussels
sprouts, cabbage, cherries, cherry juice, Chinese napa cabbage,
cucumbers, grapefruit, grapefruit juice, guava, mango, mango juice,
nectarines, olives, papaya, papaya juice, passion fruit, passion fruit
juice, peach juice, peaches, plums, prune plum juice, prune plums,
tomato juice, and tomatoes. For most processed commodities, DEEM
(Dietary Exposure Evaluation Model) 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 increase 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 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 dietary risk only
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 United States
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 6-7
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 one. 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),
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 Federal
Register of November 9, 2011 (76 FR 69726) (FRL 8888-9), and is
available at http://www.regulations.gov in docket ID number 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 number EPA-HQ-OPP-2008-0489-0006.
Fenpropathrin was included in the cumulative risk assessment for
pyrethrins and pyrethroids. The proposed new uses of fenpropathrin will
not significantly impact the cumulative assessment because, in the
cumulative assessment, residential exposure was the greatest
contributor to the total exposure. As there are no new residential uses
for the 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 total pyrethroid
exposure. The dietary exposure assessment performed in support of the
pyrethroid cumulative was much more highly refined than that performed
for the single chemical. The dietary exposure assessment for the single
chemical included conservative assumptions, using field trial data for
many commodities, including the proposed new uses with the assumption
of 100 PCT, and the most sensitive apical endpoint in the fenpropathrin
hazard database was selected to derive the POD. Additionally, the POD
selected for fenpropathrin is specific to the 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.
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
SF when reliable data available to EPA support the choice of a
2. Prenatal and postnatal sensitivity. The fenpropathrin toxicity
database includes developmental toxicity studies in the rat and rabbit,
a 3-generation reproduction study in the rat, 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 pre- and postnatal testing for other pyrethroid
High-dose LD50 studies (studies assessing what dose
results in lethality to 50% of the tested population) in the scientific
literature indicate that pyrethroids can result in increased
quantitative sensitivity in the young, specifically in the form of
neurotoxicity. 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. With otherwise
equivalent administered doses for adults and juveniles, predictive
pharmacokinetic models indicate that the differential adult-juvenile
pharmacokinetics will result in 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) with regard 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.
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 SFs being used are
based on the following considerations:
i. While the database is considered to be complete with respect to
the guideline toxicity studies for fenpropathrin, EPA lacks additional
data to fully characterize the potential for juvenile sensitivity to
neurotoxic effects of pyrethroids. In light of the literature studies
indicating a possibility of increased sensitivity in juvenile rats at
high doses, EPA identified a need, and requested proposals for,
additional non-guideline studies to evaluate the potential for
sensitivity in juvenile rats. A group of pyrethroid registrants is
currently conducting those studies. Pending the results of those
studies, however, the available toxicity studies for fenpropathrin can
be used to characterize toxic effects including potential developmental
and reproductive toxicity, immunotoxicity, and neurotoxicity.
Acceptable developmental toxicity studies in rats and rabbits,
reproduction studies in rats, neurotoxicity studies (acute, subchronic,
and developmental) in rats, and immunotoxicity studies in rats are
available. In addition, a route-specific dermal toxicity study is
available, and the inhalation study has been waived.
ii. After reviewing the extensive body of data and peer-reviewed
literature on pyrethroids, the Agency has reached a number of
conclusions regarding fetal and juvenile sensitivity for pyrethroids,
including the following:
Based on an evaluation of over 70 guideline toxicity
studies for 24 pyrethroids submitted to the Agency, including prenatal
developmental toxicity studies in rats and rabbits, and pre- and
postnatal multi-generation reproduction toxicity studies and DNTs in
rats in support of pyrethroid registrations, there is no evidence that
pyrethroids directly impact developing fetuses. None of the studies
show any indications of fetal toxicity at doses that do not cause
Increased susceptibility was seen in offspring animals in
the DNT study with the pyrethroid zeta-cypermethrin (decreased pup body
weights) and DNT and reproduction studies with another pyrethroid beta-
cyfluthrin (decreased body weights and tremors). However, the
reductions in body weight and the other non-specific effects occur at
higher doses than neurotoxicity, the effect of concern for pyrethroids.
The available developmental and reproduction guideline studies in rats
with zeta-cypermethrin did not show increased sensitivity in the young
to neurotoxic effects. Overall, findings of increased sensitivity in
juvenile animals in pyrethroid studies are rare. Therefore, the
residual concern for the postnatal effects is reduced.
High-dose LD50 studies (studies assessing what
dose results in lethality to 50% of the tested population) in the
scientific literature indicate that pyrethroids can result in increased
quantitative sensitivity to juvenile animals. 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. Furthermore, a rat physiologically-based
pharmacokinetic (PBPK) model predicts a 3-fold increase of pyrethroid
concentration in juvenile brain compared to adults at high doses.
In vitro pharmacodynamic data and in vivo data
indicate that adult and juvenile rats have similar responses to
pyrethroids at low doses and therefore juvenile sensitivity is not
expected at relevant environmental exposures. Further, data also show
that the rat is a conservative model compared to the human based on
species-specific pharmacodynamics of homologous sodium channel
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.
Taking all of this information into account, EPA has reduced the
FQPA SF for women of child-bearing age because there is no evidence in
the over 70 guideline toxicity studies submitted to the Agency that
pyrethroids directly impact developing fetuses. Additionally, none of
the studies show any indications of fetal toxicity at doses that do not
cause maternal toxicity. Because there remains some uncertainty as to
juvenile sensitivity due to the findings in the high-dose
LD50 studies, EPA is retaining a 3X FQPA SF for infants and
children less than 6 years of age. By age 6, the metabolic system is
expected to be at or near adult levels thus reducing concerns for
potential age-dependant sensitivity related to pharmacokinetics;
therefore for children over 6, 1X is appropriate. Although EPA is
seeking additional data to further characterize the potential
neurotoxicity for pyrethroids, EPA has reliable data that show that
reducing the FQPA SF to 3X will protect the safety of infants and
children less than 6 years old. These data include:
a. Data from developmental, reproductive, and DNT guideline studies
with fenpropathrin that show no sensitivity.
b. Data showing that the potential sensitivity at high doses is
likely due to pharmacokinetics.
c. A rat PBPK model predicting a 3-fold increase of pyrethroid
concentration in juvenile brain compared to adults at high doses due to
d. Data indicating that the rat is a conservative model compared to
the human based on species-specific pharmacodynamics of homologous
sodium channel isoforms.
For several reasons, EPA concludes these data show that a 3X factor
is protective of the safety of infants and children less than 6 years
of age. First, it is likely that the extensive guideline studies with
pyrethroids, which indicate that increased sensitivity in juvenile
animals in pyrethroid studies is rare, better characterize the
potential sensitivity of juvenile animals than the LD50
studies. The high doses that produced juvenile sensitivity in the
literature studies are well above normal dietary or residential
exposure levels of pyrethroids to juveniles and lower levels of
exposure anticipated from dietary and residential uses are not expected
to overwhelm the juvenile's ability to metabolize pyrethroids, as
occurred with the high doses used in the literature studies. The fact
that a greater sensitivity to the neurotoxicity of pyrethroids is not
found in guideline studies following in utero exposures (based on 76
studies for 24 pyrethroids) supports this conclusion, despite the
relatively high doses used in the studies. Second, in vitro data
indicate similar pharmacodynamic response to pyrethroids between
juvenile and adult rats. Finally, as indicated, pharmacokinetic
modeling only predicts a 3X difference between juveniles and adults.
Therefore, the FQPA SF of 3X is protective of potential juvenile
Further information about the reevaluation of the FQPA SF for
pyrethroids may be found in document ID number EPA-HQ-OPP-2011-0746-
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-, intermediate-, 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 93% of the aPAD for children 1-2 years
old, the population group receiving the greatest exposure from the
dietary assessment for infants and children less than 6 years old; and
20% 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 dose duration. Therefore, the
acute aggregate assessment is protective of potential chronic aggregate
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
Adequate enforcement methodology utilizing gas chromatography with
electron capture detector (GC/ECD), Residue Method Numbers RM-22-4
(plants) and RM-22A-1 (animals), is available to enforce the tolerance
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.
Codex has established MRLs for tomatoes, sweet peppers, dried chili
peppers, eggplant, grapes, and pome fruits. The MRLs for tomatoes,
sweet peppers, grapes, and pome fruits are harmonized with the U.S.
tolerances for the corresponding crop groups or subgroups. Codex MRLs
for dried chili peppers (10 ppm) and eggplant (0.2 ppm) cannot be
harmonized with the U.S. tolerance for the fruiting vegetable crop
group (1.0 ppm), of which those commodities are a part. The Codex MRL
for eggplant is lower than the recommended corresponding U.S.
tolerance. Because the permitted domestic use on eggplant in accordance
with the approved pesticide label results in residue levels higher than
the Codex MRLs, the U.S. tolerance cannot be harmonized (lowered) since
doing so would result in residues in excess of the approved tolerance
in spite of use consistent with label directions. Concerning dried
chili peppers, EPA, under its Residue Chemistry Test Guidelines (OPPTS
860.1000), does not set tolerances for dried chili peppers. Rather,
residues on dried chili peppers would be covered under tolerances for
non-bell peppers, which, for this chemical, are captured by the
fruiting vegetable crop group tolerance. Under that U.S. tolerance,
residues of fenpropathrin on dried chili peppers would be covered up to
1.0 ppm; residues in excess of that level would only be covered if EPA
established a separate tolerance for them. At this time, however, EPA
does not have data to support establishing a tolerance for dried chili
peppers at 10 ppm.
C. Revisions to Petitioned-For Tolerances
Based on the data submitted with the petition, EPA is also removing
the established tolerance for lingonberry. The Agency is removing this
tolerance because it will be superseded by the new tolerance for
bushberry subgroup 13-07B, established by this document. The removal
does not substantively affect whether residues of fenpropathrin may be
present on lingonberry. The new bushberry subgroup 13-07B tolerance is
at the same level as the lingonberry tolerance being removed--3.0 ppm.
Therefore, tolerances are established for residues of
fenpropathrin, alpha-cyano-3-phenoxybenzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate, in or on barley, grain at 0.04 ppm;
barley, hay at 3.0 ppm; barley, straw at 2.0 ppm; berry, low-growing,
subgroup 13-07G at 2.0 ppm; bushberry subgroup 13-07B at 3.0 ppm;
fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome, group 11-10 at 5.0
ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-
07F at 5.0 ppm; and vegetable, fruiting, group 8-10 at 1.0 ppm.
Additionally, this document removes the established tolerances of
fenpropathrin in or on fruit, citrus, group 10; fruit, pome, group 11;
bushberry subgroup 13B; grape; juneberry; lingonberry; salal;
strawberry; and vegetable, fruiting, group 8.
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
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 FFDCA section 408(d), such as the tolerances 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 7, 2013.
Daniel J. Rosenblatt,
Acting 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:
a. Remove the entries for ``Bushberry subgroup 13B,'' ``Fruit, citrus,
group 10,'' ``Fruit, pome, group 11,'' ``Grape,'' ``Juneberry,''
``Lingonberry,'' ``Salal,'' ``Strawberry,'' and ``Vegetable, fruiting,
group 8'' from the table in paragraph (a).
b. Add alphabetically the following entries to the table in paragraph
The amendments read as follows:
Sec. 180.466 Fenpropathrin; tolerances for residues.
(a) * * *
* * * * *
Barley, grain............................................. 0.04
Barley, hay............................................... 3.0
Barley, straw............................................. 2.0
Berry, low growing, subgroup 13-07G....................... 2.0
* * * * *
Bushberry subgroup 13-07B................................. 3.0
* * * * *
Fruit, citrus, group 10-10................................ 2.0
Fruit, pome, group 11-10.................................. 5.0
Fruit, small vine climbing, except fuzzy kiwifruit, 5.0
* * * * *
Vegetable, fruiting, group 8-10........................... 1.0
* * * * *
* * * * *
[FR Doc. 2013-27680 Filed 11-19-13; 8:45 am]
BILLING CODE 6560-50-P