80 FR 16296 - Deltamethrin; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 59 (March 27, 2015)

Page Range		16296-16302
FR Document		2015-06861

This regulation establishes tolerances for residues of the insecticide deltamethrin in or on all food and feed commodities from use of deltamethrin as a wide-area mosquito adulticide. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 59 (Friday, March 27, 2015)

[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16296-16302]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-06861]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0209; FRL-9924-60]

Deltamethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the
insecticide deltamethrin in or on all food and feed commodities from
use of deltamethrin as a wide-area mosquito adulticide. Bayer
CropScience requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 27, 2015. Objections and
requests for hearings must be received on or before May 26, 2015, 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-2014-0209, 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), West William Jefferson Clinton 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: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
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.

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-2014-0209 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
May 26, 2015. 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-2014-0209, 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
20460-0001.
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 Tolerance

In the Federal Register of January 28, 2015 (80 FR 4527) (FRL-9921-
60), 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
[3F8210]) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle
Park, NC 27709. The petition requested that 40 CFR 180.435 be amended
by establishing a tolerance for residues of the insecticide
deltamethrin, (1R,3R)-R-cyano(3-phenoxyphenyl)methyl 3-(2,2-
dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on food and
feed commodities at 0.05 parts per million (ppm) from use as a wide-
area mosquito adulticide. That document referenced a summary of the
petition prepared by Bayer CropScience, the registrant, which is
available in the docket, http://www.regulations.gov. One comment was
received on the notice of filing. EPA's response to the comment is
discussed 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

[[Page 16297]]

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 deltamethrin including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with deltamethrin follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Deltamethrin, a Type II pyrethroid, targets the nervous
system by disrupting the voltage-gated sodium channels, resulting in
neurotoxicity. Neurotoxicity was observed throughout the toxicity
database, and effects were seen across species, sexes, exposure
duration, and routes of administration. Clinical signs characteristic
of Type II pyrethroids, such as increased salivation, altered mobility/
gait, and tremors were the most common effects observed. Increased
sensitivity to external stimuli, abnormal vocalization, and decreased
fore- and hind-limb grip strength were also commonly observed in the
database.
Deltamethrin is rapidly absorbed following an oral dose, and
effects are typically observed within two to five hours after dosing.
For pyrethroids, as a class, the combination of rapid absorption,
metabolism, and elimination precludes accumulation and increased
potency following repeated dosing. This is also true of deltamethrin.
No observed adverse effect levels (NOAELs) for the acute and chronic
studies are similar, and the acute endpoint is protective of the
endpoints from repeat dosing studies.
A dermal risk assessment was not conducted based on the lack of
effects in a 21-day dermal study and low potential for dermal
absorption for deltamethrin. These findings are consistent with the
toxicology profile of many pyrethroids.
Deltamethrin did not have any adverse effects on fetuses or
offspring in the prenatal developmental studies in rats and rabbits.
However, potential qualitative susceptibility was observed at high
doses in the developmental neurotoxicity study (DNT) and the 2-
generation reproduction study. Symptoms included vocalization,
decreased pre- and post-weaning body weight in pups of both sexes,
decreased body weight and body weight gain in maternal animals,
hyperactivity, and excessive salivation. The increased qualitative
susceptibility in the DNT and 2-generation reproduction study was
observed at doses 10- to 20-fold higher (near lethal doses) than the
current points of departure (PODs) selected for risk assessment. At
doses near the POD, no effects on parental animals or offspring were
observed in either the DNT or 2-generation reproductive studies.
Therefore, the current PODs are protective of the observed sensitivity.
There was no evidence of immunotoxicity after deltamethrin exposure
in the toxicology database or in an immunotoxicity study in rats.
Deltamethrin is classified as ``not likely to be carcinogenic to
humans.'' There was no evidence of carcinogenicity in the combined
chronic/carcinogenicity study in rats or the carcinogenicity study in
mice. In a battery of mutagenicity studies there was no evidence of a
mutagenic effect.
The database shows that deltamethrin has moderate to minimal acute
toxicity via the oral route, moderate acute toxicity via the inhalation
route, and minimal acute toxicity via the dermal route of exposure.
Deltamethrin is minimally irritating to the eyes, non-irritating to the
skin, and is not a skin sensitizer.
The Agency is making best use of the extensive scientific knowledge
about the mode of action/adverse outcome pathway (MOA/AOP) on
pyrethroids in the risk assessments for this class of pesticides. A
significant portion of the scientific literature on pyrethroids
utilizes deltamethrin as the test chemical. In the on-going work by the
Council for the Advancement of Pyrethroid Human Risk Assessment
(CAPHRA), deltamethrin is one of two sentinel pyrethroids being used to
develop the initial, extensive database of in vitro and in vivo
toxicology studies and highly refined physiologically-based
pharmacokinetic (PBPK) models. Pharmacokinetics (PK) can be defined as
what the body does to the chemical. The underlying PK of pyrethroids is
an important determination of their toxicity because the concentration
of pyrethroid at the sodium channel relates to the extent of toxicity;
greater pyrethroid concentration translates as increased neurotoxicity.
Age-dependent PK differences have been identified for several
pyrethroids (i.e., there are differences in the ability of adults and
juveniles to metabolize pyrethroids). The enzymes that metabolize and
detoxify pyrethroids are present in rats and humans at birth, and as a
result, both juveniles and adults are able to tolerate low doses of
pyrethroids when the internal dose, or the amount of pyrethroid at the
sodium channel, is low. However, the activity of these enzymes
increases with age, conveying in adults a greater capacity to detoxify
pyrethroids compared to juveniles and the PK contribution to the FQPA
Safety Factor will be 1X for adults and children >6 years old, and 3X
for children <6 years old.
Pharmacodynamics (PD) can be defined as the changes that chemicals
cause to the body, in this case, how pyrethroids interact with the
sodium channels. In contrast to the age-related PK differences
identified for pyrethroids, pharmacodynamic contributions to pyrethroid
toxicity are not age-dependent. The occurrence and ontogeny of voltage-
gated sodium channels in humans are not well characterized compared to
those in the rat. The available data indicate that the rat is a highly-
sensitive model and extrapolations from the rat would be protective of
human health. Based on the comparable function and distribution of
sodium channels between the species, the rat is an appropriate
surrogate for the evaluation of human PD. Based on the body of data,
the Agency concludes that juvenile rats are not more sensitive than
adults with respect to pyrethroid PD, and the PD contribution to the
FQPA SF will be 1X.
The Wolansky et al. acute oral study (2006), in which decreased
motor activity was observed, provides the most robust data set for
extrapolating risk from exposure to deltamethrin. The dose used for
risk assessment was determined using a benchmark dose (BMD) analysis
using one standard deviation from the control group as the benchmark
response (BMR) as suggested for continuous endpoints in the Agency's
BMD guidance (USEPA 2012). The Wolansky acute study, endpoint, and dose
were used for all dietary (acute), non-occupational (incidental oral
and inhalation), and occupational exposure (inhalation) scenarios
because it was the most robust data set for extrapolating risk from
deltamethrin, and there is a lack of increased hazard from repeated/
chronic exposure to deltamethrin.
Specific information on the studies received and the nature of the
adverse effects caused by deltamethrin as well

[[Page 16298]]

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 Deltamethrin. Human
Health Risk Assessment for the Proposed Use of Deltamethrin as a
Mosquito Adulticide over Agricultural Crops at [page 55] in docket ID
number EPA-HQ-OPP-20[14]-[0209].

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
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 deltamethrin used for
human risk assessment is discussed in Unit III.B of the final rule
published in the Federal Register of [November 7, 2014] ([79] FR
[66294]) (FRL-9918-24).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to deltamethrin, EPA considered exposure under the petitioned-
for tolerance as well as all existing deltamethrin tolerances in 40 CFR
180.435. Acute and chronic dietary (food and drinking water) exposure
assessments were conducted using the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID) Version
3.16. This software uses 2003-2008 food consumption data from the U.S.
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). Specific
information on the dietary exposure assessment can be found at http://www.regulations.gov in document Deltamethrin. Acute and Chronic Dietary
(Food and Drinking Water) Exposure and Risk Assessment for the Proposed
Use of Deltamethrin as a Wide Area Mosquito Adulticide over
Agricultural Crops in docket ID number EPA-HQ-OPP-20[14]-[0209].
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 deltamethrin. As to residue levels in food, EPA used tolerance-
level residues for most commodities and Pesticide Data Program (PDP)
monitoring data for a number of commodities. Maximum percent crop
treated (%CT) estimates were used for some commodities. To account for
the mosquito adulticide use, the maximum residue value from the
mosquito adulticide trials was multiplied by the %CT estimate for the
adulticide use (1%) for those commodities that would only have a
residue as a result of the mosquito adulticide use. However, if the
commodity could have residues from both the agricultural and
mosquitocide uses, residue values from the adulticide trials were
included in a distribution considering the 1% CT estimate (depending on
whether the commodities were blended, nonblended, or partially
blended). Default processing factors were used for some processed
commodities and empirical factors were used for others.
ii. Chronic exposure. As to residue levels in food, EPA [used
tolerance-level residues for most commodities. The average PDP value
was used for cereal grains and milk. The average mosquito adulticide
residue value multiplied by the 1% CT estimate was used to account for
the mosquito adulticide uses. Since deltamethrin is registered for use
in food handling establishments (FHEs), one-half the FHE tolerance was
used to account for the FHE uses. The FHE tolerance is based on the
LOQ, and one-half the tolerance was used as a refinement in the dietary
assessment. For the commodities for which one-half the FHE tolerance
was used, the assumption was made that there was a 4.65% chance that a
food item consumed by a person contained deltamethrin residues as a
result of treatment at some point in an FHE. Default processing factors
were used for some processed commodities and empirical factors were
used for others.
The chronic assessment was conducted solely for the purpose of
obtaining estimates of background levels of dietary exposure for
estimating aggregate risk.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that deltamethrin 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: For
acute dietary: 2.5% for apples, cantaloupes, carrots, soybeans,
tomatoes, and watermelons; and 5% for cucumbers and pears. For chronic
dietary: 1% for

[[Page 16299]]

apples, cantaloupes, carrots, cotton, potatoes (some food forms),
pumpkins, radishes, squash, tomatoes, turnips, and watermelon; 2.5% for
cucumbers, leeks, onions, pears, and sunflowers; 4.65% (commodities
with residues resulting only from the FHE use) for: Almonds,
pistachios, potatoes (some food forms), soybeans, sweet corn, and
walnuts; 5% for canola and peppers; and 40% for globe artichokes.
In the acute and chronic assessments, the mosquito adulticide %CT
estimate of 1% was used to modify the mosquito adulticide use residue
value. Residues from the mosquito adulticide use were included for all
commodities with the exception of livestock commodities because the
livestock commodities tolerances are very conservative, and any
residues in livestock feed items resulting from the mosquito adulticide
use will not increase the established tolerance levels.
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 deltamethrin 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 deltamethrin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of deltamethrin. 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.
The estimated drinking water concentration (EDWC) of deltamethrin
for acute and chronic exposures is estimated to be 0.200 parts per
billion (ppb) for both surface water and ground water. The FIRST Model
was used to determine the surface water concentration, and the SCI-GROW
Model was used to determine the groundwater concentration. The acute
surface water EDWC and the groundwater EDWC were equivalent because, in
both cases, the value was limited by the solubility of deltamethrin.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model.
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).
Deltamethrin is currently registered for the following uses that
could result in residential exposures: Residential outdoor and indoor
sites, turf, paint additives, and pet products.
There are no residential handler exposure scenarios associated with
the proposed mosquito control use as applications are to be made by
Federal, State, Tribal or local Government Officials or the U.S.
Military. However, there is potential for residential post-application
exposure resulting from mosquito control use. Post-application
inhalation exposures and incidental oral (hand-to-mouth) contact with
residues deposited on lawn/turf from ULV truck fogger applications were
included in the quantitative risk assessment. To calculate post-
application exposure from ULV truck fogger applications, EPA used the
2012 Residential SOPs for Outdoor Fogging/Misting Systems, with minimal
modification to the well-mixed box (WMB) model. The WMB model allows
for the estimation of inhalation exposure in the breathing zones of
adults and children residing in areas being treated by ground
application of deltamethrin.
EPA also assessed handler and post-application exposures for
existing residential uses of deltamethrin (i.e., indoor, outdoor, pet,
and paint additive). A quantitative dermal assessment for residential
handlers was not conducted since no systemic toxicity associated with
dermal exposure to deltamethrin was observed. MOEs were calculated for
the inhalation route of exposure only. Adult post-application exposures
from the existing uses were not quantitatively assessed since
inhalation exposures are typically negligible in outdoor settings.
Post-application inhalation exposure for adults and children is
anticipated to be negligible for representative residential registered
uses; therefore, a quantitative post-application inhalation exposure
assessment was not performed. EPA assessed post-application incidental
oral exposures to children for representative indoor/outdoor and pet
incidental oral scenarios including hand-to-mouth, object-to-mouth,
soil ingestion, and episodic granule ingestion scenarios.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 has determined that the pyrethroids and pyrethrins share
a common mechanism of toxicity: the ability to interact with voltage-
gated sodium channels ultimately leading to neurotoxicity. The
cumulative risk assessment (CRA) for the pyrethroids/pyrethrins
(published on 11/9/2011 and available at http://www.regulations.gov;
EPA-HQ-OPP-2011-0746) did not identify cumulative risks of concern,
allowing the Agency to consider new uses for pyrethroids. Deltamethrin
was

[[Page 16300]]

included in the pyrethroid/pyrethrin CRA.
Dietary exposures make a minor contribution to the total pyrethroid
exposure. The dietary exposure assessment performed in support of the
pyrethroid CRA was much more highly refined than that performed for
deltamethrin alone. Additionally, the PODs selected for deltamethrin
are specific to deltamethrin, whereas the PODs selected for the
cumulative assessment were based on common mechanism of action data
that are appropriate for all 20 pyrethroids included in the CRA.
Dietary exposure to deltamethrin residues resulting from the proposed
wide-area mosquito adulticide use will contribute very little to the
dietary exposure to deltamethrin alone and will have an insignificant
impact on the cumulative risk assessment. No dietary, residential, or
aggregate risk estimates of concern have been identified in the single
chemical assessment.
In the cumulative assessment, residential exposure was the greatest
contributor to the total exposure. In order to determine if the
registered deltamethrin indoor and turf uses will significantly
contribute to, or change the overall findings in the pyrethroid CRA,
the Agency performed a quantitative exposure and risk assessment. This
assessment used the deltamethrin relative potency factor (RPF) as well
as the same exposure algorithms and inputs that were used in the 2011
pyrethroid CRA. In all cases, the estimated deltamethrin MOEs using the
RPF method were higher (i.e., less of a risk concern) than those used
in the 2011 pyrethroid CRA. Thus, the Agency continues to support the
previous assessment, and concludes that the registered deltamethrin
uses will not significantly contribute to the overall findings in the
2011 pyrethroid CRA, and the registered deltamethrin indoor and turf
uses will have no impact on the residential component of the cumulative
risk estimates.
For information regarding EPA's efforts to evaluate the risk of
exposure to this class of chemicals, 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 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 were no indications of
fetal toxicity in any of the guideline studies. Evidence of increased
juvenile qualitative sensitivity was observed in the DNT and 2-
generation reproduction studies at doses that were considered to be
relatively high (i.e., near lethal doses). However, at doses near the
point of departure, no effects on parental animals or offspring were
observed in either the DNT or 2-generation reproduction study and,
therefore, there is no susceptibility at these doses.
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 3X for infants and children <6 years old; and
to 1X for children >6 years old, women of child bearing age and all
adult populations. That decision is based on the following findings:
i. The database of experimental toxicology studies available for
deltamethrin is largely complete including developmental toxicity
studies in rats and rabbits, a reproduction study in rats, and acute
neurotoxicity (ACN), subchronic neurotoxicity (SCN), and developmental
neurotoxicity (DNT) studies. The database provides a robust
characterization profile for children 6 years old and older, as well as
for adults. In addition to the standard guideline studies, numerous
studies from the scientific literature that describe the
pharmacodynamic and pharmacokinetic profile of the pyrethroids in
general have been considered in this assessment. Many of these studies
were conducted with deltamethrin. A 28- or 90-day inhalation study is
not available, but the Agency determined the study is not required for
deltamethrin.
ii. As with other pyrethroids, deltamethrin causes neurotoxicity
from interaction with sodium channels leading to clinical signs of
neurotoxicity. These effects are well characterized and adequately
assessed by the body of data available to the Agency.
iii. There were no indications of fetal toxicity in any of the
guideline studies in the database, including developmental studies in
the rat and rabbit, a developmental neurotoxicity study in rats, and a
2-generation reproduction study in rats. There was evidence of
increased juvenile qualitative susceptibility at high doses observed in
both the DNT and 2-generation reproduction studies. These observations
are consistent with the findings of juvenile sensitivity in the
literature for deltamethrin. However, the observations of increased
sensitivity were at doses that were considered to be relatively high
(i.e., near lethal doses), whereas at doses near the point of
departure, no effects on parental animals or offspring were observed in
either the developmental neurotoxicity (DNT) or 2-generation
reproduction study and, therefore, there is no susceptibility at these
doses. The Agency has retained a 3X uncertainty factor to protect for
exposures of children <6 years of age based on increased quantitative
susceptibility seen in studies on pyrethroid pharmacokinetics
(primarily conducted with deltamethrin) and the increased quantitative
juvenile susceptibility observed in high dose guideline and literature
studies with deltamethrin and other pyrethroids. The Agency has no
residual uncertainties regarding age-related sensitivity for women of
child bearing age as well as for all adult populations and children >=6
years of age, based on the absence of pre-natal sensitivity observed in
76 guideline studies for 24 pyrethroids and the scientific literature.
Additionally, no evidence of increased quantitative or qualitative
susceptibility was seen in the pyrethroid scientific literature related
to pharmacodynamics.
iv. There are no residual uncertainties with regard to dietary
exposure. The dietary exposure assessments are based on high-end
residue levels for most commodities, and that account for parent and
metabolites of concern, processing factors, and percent crop treated
assumptions. Furthermore, conservative, upper-bound assumptions were
used to determine exposure through drinking water and residential
sources, such that these exposures have not been underestimated.

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-,

[[Page 16301]]

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 deltamethrin will occupy 81% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
2. Chronic risk. A chronic dietary risk assessment was not
conducted because there is no apparent increase in hazard from
repeated/chronic exposures to deltamethrin. Therefore, the acute
endpoint is protective of the endpoints from repeat dosing studies. A
chronic dietary exposure assessment was performed in order to generate
background exposure estimates to aggregate with residential exposure
estimates for the short-term aggregate risk assessment.
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). Deltamethrin
is currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to deltamethrin.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 2,500 for the
general U.S. population and of 520 for children 1-2 years old, the
population group receiving the greatest exposure. Because EPA's level
of concern for deltamethrin is an MOE of 300 or below, these MOEs are
not of concern.
4. Intermediate-term risk. Because no intermediate-term adverse
effect was identified, deltamethrin 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, deltamethrin 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 deltamethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology utilizing gas chromatography with
electron capture detection (GC/ECD), is available for enforcing
tolerances for residues of deltamethrin in plant commodities, as
described in Pesticide Analytical Manual (PAM) Volume II, Section
180.422. Another GC/ECD method (Method HRAV-22) is available for
enforcing tolerances in livestock commodities. Adequate confirmatory
method validation data have been submitted for these methods, along
with adequate independent laboratory validation (ILV) trials.
Multiresidue methods data for cis-deltamethrin and trans-
deltamethrin were previously sent to FDA. Cis-deltamethrin is
completely recovered through Methods 302 and 303, and partially
recovered through Method 304. Trans-Deltamethrin is partially recovered
through Method 303, but not recovered through Method 304.

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.
Harmonization of MRLs is not an issue for the proposed use of
deltamethrin as a wide area mosquitocide since established tolerance
levels are not changing.

C. Response to Comments

An anonymous citizen objected to the approval of the requested
tolerance for deltamethrin. The commenter expressed concerns about the
neurotoxicity of the chemical and made unsubstantiated claims that
together with all other approved toxic chemicals, use of deltamethrin
could lead to many deaths and injuries and that the Agency is harming
the American people. Under section 408 of the Federal Food, Drug and
Cosmetic Act (FFDCA) EPA is authorized to establish pesticide
tolerances where the safety standard imposed by that statute is met.
When new or amended tolerances for residues of a pesticide in food or
feed are requested, the Agency evaluates whether there is a reasonable
certainty of no harm from aggregate exposure to the pesticide chemical
residue. The risk assessment conducted by the Agency considers the
potential risks from dietary exposure and other non-occupational
exposures. The Agency also considers the available information
regarding cumulative toxicological effects of the pesticide residues
and other substances that share a common mechanism of toxicity with the
subject pesticide. Such an assessment has been conducted for
deltamethrin. Deltamethrin is a Type II pyrethroid, and as with other
pyrethroids, deltamethrin causes neurotoxicity. These effects are well
characterized and adequately assessed by the body of data available to
the Agency. The Agency is confident that it has chosen endpoints,
points of departure, and uncertainty factors, that have a strong
scientific foundation and that are protective for all human
populations. As a result, EPA concludes that the tolerances for
deltamethrin are safe.

V. Conclusion

Therefore, tolerances are established for residues of deltamethrin,
(1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylic acid
(S)-alpha-cyano-3-phenoxybenzyl ester and its major metabolites, trans-
deltamethrin (S)-alpha-cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate and alpha-R-
deltamethrin[(R)-alpha-cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate in or on all food/
feed items (other than those covered by a higher tolerance as a result
of use on growing crops) from use as a wide-area mosquito adulticide at
0.05 ppm.
Currently, a tolerance of 0.05 ppm is established for residues of
deltamethrin in or on all food/feed items (other than those covered by
a higher tolerance as a result of use on growing crops) in food/feed
handling establishments. The tolerance level does not need to be
increased for the proposed use as a mosquito adulticide; however, EPA
is revising 40 CFR 180.435 to clarify the tolerance. In addition, EPA
is removing subparagraphs (a)(2)(i), (ii), (A) and (B) as they contain
language that is more

[[Page 16302]]

appropriately enforced under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) as use directions on the label.

VI. Statutory and Executive Order Reviews

This action 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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
recordkeeping requirements.

Dated: March 18, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

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. In Sec. 180.435, paragraph (a)(2) is revised to read as:

Sec. 180.435 Deltamethrin; tolerances for residues.

(a) General. * * *
* * * * *
(2) A tolerance of 0.05 ppm is established for residues of the
insecticide deltamethrin, including its metabolites and degradates, in
or on all food/feed items (other than those covered by a higher
tolerance as a result of use on growing crops) when deltamethrin is
used in food/feed handling establishments or as a wide-area mosquito
adulticide. Compliance with the tolerance levels specified is to be
determined by measuring only deltamethrin, (1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-
3-phenoxybenzyl ester, and its major metabolites, trans-deltamethrin,
(S)-alpha-cyano-m-phenoxybenzyl(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, and alpha-R-deltamethrin, (R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the commodity.
* * * * *
[FR Doc. 2015-06861 Filed 3-26-15; 8:45 am]
BILLING CODE 6560-50-P

Document Created: 2015-12-18 11:36:58
Document Modified: 2015-12-18 11:36:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective March 27, 2015. Objections and requests for hearings must be received on or before May 26, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
Contact		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 16296
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements