
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Rules and Regulations]
[Pages 18574-18580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07816]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0087; FRL-9959-54]


Deltamethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
deltamethrin in or on orange; citrus, dried pulp; citrus, oil. Bayer 
CropScience requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 20, 2017. Objections and 
requests for hearings must be received on or before June 19, 2017, 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-2016-0087, 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: Michael L. Goodis, 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 
Publishing 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 OCSPP 
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-2016-0087 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 
June 19, 2017. 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

[[Page 18575]]

objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2016-0087, 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 October 18, 2016 (81 FR 71668) (FRL-
9952-19), 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 
5E8431) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle 
Park, NC. The petition requested that 40 CFR 180.435 be amended by 
establishing tolerances for residues of the insecticide deltamethrin, 
(S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on orange, fruit at 0.3 parts 
per million (ppm); orange, dried pulp at 3 ppm; orange, oil at 50 ppm. 
That document referenced a summary of the petition prepared by Bayer 
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the commodity definitions and tolerances as follows: ``Orange 
fruit'' proposed at 0.3 ppm shall be ``Orange'' at 0.30 ppm; ``Orange 
Dried Pulp'' at 3 ppm shall be ``Citrus, dried pulp'' at 3.0 ppm; and 
``Orange Oil'' at 50 ppm shall be ``Citrus, oil'' at 50 ppm. The reason 
for these changes 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 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 is classified as a Type II pyrethroid. Type II 
pyrethroids include an alpha-cyano moiety and induce a syndrome that 
includes pawing, burrowing, salivation, hypothermia, and coarse tremors 
leading to choreoathetosis. Neurotoxicity was observed throughout the 
database, and clinical signs characteristic of Type II pyrethroids, 
such as increased salivation, altered mobility/gait, and tremors, were 
the most common effects observed. Other observed neurotoxic effects 
included increased sensitivity to external stimuli, abnormal 
vocalization, and decreased fore- and hind-limb grip strength.
    Chronic exposure does not result in accumulation or increased 
potency as a result of deltamethrin's rapid absorption, metabolism, and 
elimination. 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-dose studies. Only single-day risk 
assessments need to be conducted for purposes of endpoint selection and 
exposure assessment.
    There were no indications of fetal toxicity in any of the guideline 
studies. Evidence of increased juvenile qualitative sensitivity was 
observed in the developmental neurotoxicity and 2-generation 
reproduction studies. 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.
    Deltamethrin is classified as ``not likely to be carcinogenic to 
humans.'' There was no evidence of carcinogenicity in either the rat or 
mouse long-term dietary studies up to the highest dose tested, nor was 
there any mutagenic activity in bacteria or cultured mammalian cells.
    Specific information on the studies received and the nature of the 
adverse effects caused by deltamethrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Deltamethrin: Human Health Risk 
Assessment for the Proposed Use of Deltamethrin on Oranges Without a 
U.S. Registration at page 24 in docket ID number EPA-HQ-OPP-2016-0087.

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

[[Page 18576]]

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for deltamethrin used for 
human risk assessment is shown in the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Deltamethrin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                  Uncertainty/   RfD, PAD, level
      Exposure scenario            Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (>=6 years old)  Wolansky         UFA = 10X......  Acute RfD =      Wolansky BMD1SD = 2.48 mg/kg
                                BMDL1SD = 1.49  UFH = 10X......   0.015 mg/kg.     based on decreased motor
                                mg/kg.          FQPA SF = 1X...  aPAD = 0.015 mg/  activity.
                                                                  kg/day.
Acute Dietary (<6 years old).  Wolansky         UFA = 10X......  Acute RfD =      Wolansky BMD1SD = 2.48 mg/kg
                                BMDL1SD = 1.49  UFH = 10X......   0.015 mg/kg.     based on decreased motor
                                mg/kg.          FQPA SF = 3X...  aPAD = 0.005 mg/  activity.
                                                                  kg/day.
                              ----------------------------------------------------------------------------------
Chronic dietary (All           A chronic endpoint is not necessary since increased toxicity is not observed with
 populations).                  repeated dosing. The acute endpoint and doses are protective of longer-term
                                exposure and risk.
                              ----------------------------------------------------------------------------------
Incidental Oral (Short-term).  Wolansky         UFA = 10X......  Residential LOC  Wolansky BMD1SD = 2.48 mg/kg
                                BMDL1SD = 1.49  UFH = 10X......   for MOE = 300.   based on decreased motor
                                mg/kg.          FQPA SF = 3X...                    activity.
                              ----------------------------------------------------------------------------------
Dermal (short-term; all        A dermal assessment was not conducted based on the lack of effects in a 21-day
 populations).                  dermal study and low potential for dermal absorption for deltamethrin.
                              ----------------------------------------------------------------------------------
* Inhalation (Short-term; >=6  Wolansky         UFA = 10X......  Residential LOC  Wolansky BMD1SD = 2.48 mg/kg
 years old).                    BMDL1SD = 1.49  UFH = 10X......   for MOE = 100.  based on decreased motor
                                mg/kg.          FQPA SF = 1X...                    activity.
* Inhalation (Short-term; <6   Wolansky         UFA = 10X......  Residential LOC  Wolansky BMD1SD = 2.48 mg/kg
 years old).                    BMDL1SD = 1.49  UFH = 10X......   for MOE = 300.   based on decreased motor
                                mg/kg.          FQPA SF = 3X...                    activity.
                              ----------------------------------------------------------------------------------
Cancer (oral, dermal,          Classification: ``Not likely to be Carcinogenic to Humans'' based on the absence
 inhalation).                   of treatment related tumors in two adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
  level of concern. * Inhalation absorption is assumed to be equivalent to oral absorption. BMD1SD = The central
  estimate of the dose that results in decreased motor activity compared to control animals based upon a 1
  standard deviation using Benchmark Dose Analysis. BMDL1SD = The 95% lower confidence limit of the central
  estimate. Wolansky = Reference to Wolansky et al. Acute Oral Toxicity in Rats, MRID #47885701.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to deltamethrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing deltamethrin tolerances in 40 
CFR 180.435. EPA assessed dietary exposures from deltamethrin 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 deltamethrin. 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 Surveys, What We Eat in America (NHANES/WWEIA). 
As to residue levels in food, EPA acute dietary exposure is partially 
refined. Residues could result from agricultural uses and adulticide 
uses. Excluding the new orange tolerances, residue-level and percent 
crop treated assumptions have not changed since the previous rule, and 
those are discussed in the final rule published in the Federal Register 
of March 27, 2015 (80 FR 16296). For oranges, EPA used field trial 
values and the empirical processing factors for orange juice and citrus 
oil. In addition, HED used a percent crop treated estimate of 9%.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from 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 USDA's NHANES/WWEIA. Although a chronic dietary endpoint 
was not identified for deltamethrin, a chronic dietary exposure 
assessment was performed to provide background exposure for aggregation 
with short-term residential exposure. Residues could result from three 
different sources: Agricultural uses, food handling establishment uses, 
and adulticide uses. Assumptions about residue levels in food and 
percent crop treated for crops

[[Page 18577]]

except for oranges have not changed since the previous rule and are 
explained in the final rule published in the Federal Register of March 
27, 2015 (80 FR 16296). For oranges, EPA used average field trial 
values and assumed 100% of imported oranges are treated with 
deltamethrin.
    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 acute exposure for existing uses 
as follows:
    Apples: 2.5%; cantaloupes: 2.5%, carrots: 2.5%, cucumbers: 5%, 
pears: 5%, soybeans: 2.5%, tomatoes: 2.5%, watermelons: 2.5%.
    The Agency estimated the PCT for chronic exposure for existing uses 
as follows:
    Almonds: 1%; apples: 1%; globe artichokes: 40%; canola: 5%; 
cantaloupes: 1%; carrots: 1%; cotton: 1%; cucumbers: 2.5%; leeks: 2.5%; 
onions: 2.5%; pears: 2.5%; peppers: 5%; pistachios: 1%; potatoes: 1%; 
pumpkin: 1%; radishes: 1%; soybeans: 1%; squash: 1%; sunflowers: 2.5%; 
sweet corn: 1%; tomatoes: 1%; turnips: 1%; walnuts: 1%; watermelons: 
1%.
    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 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%, 
except for those situations in which the maximum PCT is less than one. 
In those cases, 2.5% is used as the maximum PCT. 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.
    The Agency estimated that 9% of domestically consumed oranges would 
be treated with deltamethrin as a result of the approval of the 
tolerances on oranges. Because there is currently no domestic use of 
deltamethrin on oranges, the Agency estimated the percentage of the 
domestic consumption of oranges that are imported. This calculation is 
based on three years of data (2011-2013) from USDA's Economic Research 
Service and assumes 100 percent of imported oranges are treated with 
deltamethrin. Because it is unlikely that all imported oranges will be 
treated with deltamethrin, the Agency believes that assuming 9% of 
oranges consumed have been treated with deltamethrin will not 
underestimate deltamethrin exposure on oranges.
    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. 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST), 
Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, 
the estimated drinking water concentrations (EDWCs) of deltamethrin for 
acute exposures are estimated to be 0.20 parts per billion (ppb) for 
surface water and 0.20 ppb for ground water and chronic exposures for 
non-cancer assessments are estimated to be 0.20 ppb for surface water 
and 0.20 ppb for ground water. Both the acute and chronic surface and 
ground drinking water concentration were limited by the solubility of 
deltamethrin.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment and chronic dietary exposure 
assessment, the water concentration value of 0.20 ppb was used to 
assess the contribution to drinking water.
    Although a chronic dietary endpoint was not identified for 
deltamethrin, a chronic dietary exposure assessment was performed to 
provide background exposure for aggregation with short-term residential 
exposure.

[[Page 18578]]

    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: Indoor (spot, crack and crevice) 
and outdoor (turf, garden and trees) environments, pet collars, paint 
preservative, impregnated mosquito net, and wide area mosquito and fly 
control. EPA assessed residential exposure using the Agency's 2012 
Residential Standard Operating Procedures (SOPs) along with updates in 
policy regarding body weight in addition to the following assumptions: 
Since no treatment-related effects were observed at the limit dose, a 
dermal point of departure (POD) was not selected, and neither a handler 
nor a post-application dermal exposure assessment is required.
    i. Residential handler exposures. Short-term residential handler 
inhalation exposure is anticipated from indoor and outdoor 
environments, and paint preservatives. Because no intermediate-term 
adverse effect was identified, deltamethrin is not expected to pose an 
intermediate-term risk.
    ii. Residential post-application exposures. Post-application 
inhalation exposure for adults and children is anticipated to be 
negligible for indoor (spot, crack and crevice) and outdoor (turf, 
garden and trees) environments, pet collars and paints; therefore, a 
quantitative assessment was not performed. EPA assessed post-
application short-term 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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.''
    Deltamethrin is included in the pyrethroid/pyrethrin cumulative 
risk assessment (CRA). The new tolerances to cover residues of 
deltamethrin on imported oranges, citrus oil and citrus pulp has an 
insignificant impact on the CRA. In the cumulative assessment, 
residential exposure was the greatest contributor to the total 
exposure. Although there are residential uses for deltamethrin, the 
proposed use will have no impact on the residential component of the 
cumulative risk estimates. Dietary exposures make a minor contribution 
to the total pyrethroid exposure, and as a result, the new use on 
oranges would have an insignificant impact on the cumulative dietary 
risk.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
safety factor when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. There is no quantitative 
and/or qualitative evidence of increased susceptibility of rat or 
rabbit fetuses to in utero exposure to deltamethrin. However, potential 
qualitative susceptibility was observed at high doses in the DNT and 2-
generation reproduction study for juveniles. In addition, pyrethroid 
pharmacokinetics literature indicates an increased quantitative 
susceptibility for children less than 6 years of age.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF reduced to 1X for assessing risks to adults and children 6 
years of age and older and to 3X for assessing risks to children less 
than 6 years of age. That decision is based on the following findings:
    i. The toxicity database is considered complete for deltamethrin 
with respect to guideline studies; it includes, among other studies, 
developmental toxicity studies in rats and rabbits, a reproduction 
study in rats, and acute neurotoxicity (ACN), subchronic neurotoxicity 
(SCN), and developmental neurotoxicity (DNT) studies. Nevertheless, EPA 
lacks additional data to fully characterize the potential for juvenile 
sensitivity to many pyrethroids, including deltamethrin. For this 
assessment, EPA considered the standard guideline studies as well as 
numerous studies from the scientific literature that describe the 
pharmacodynamic (PD) and pharmacokinetic (PK) profile of the 
pyrethroids in general. Many of these studies were conducted with 
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. Evidence of increased juvenile qualitative sensitivity was 
observed in the developmental neurotoxicity and 2-generation 
reproduction studies. 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 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 less than 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 and older, 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 identified in the exposure 
databases. The dietary exposure assessments are based on reasonable to 
high-end residue levels (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

[[Page 18579]]

through drinking water and residential sources, such that these 
exposures have not been underestimated. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to deltamethrin in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
deltamethrin.

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 deltamethrin will occupy 86% of the aPAD for children 3-5 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Based on the data summarized in Unit III.A., there 
is no increase in hazard with increasing dosing duration. Furthermore, 
chronic dietary exposures will be lower than acute exposures. 
Therefore, the acute aggregate assessment is protective of potential 
chronic aggregate exposures.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). 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, including inhalation and hand-to-mouth (for 
children only), result in aggregate MOEs of 2,300 for the U.S. 
Population; 2,600 for females ages 13-49; and 490 for children 1-2 
years old. Because EPA's level of concern for deltamethrin is a MOE of 
100 for the U.S. population and females 13-49, and 300 for children 1-2 
years old or below, these MOEs are not of concern.
    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, 
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 (gas chromatography with electron 
capture detection (GC/ECD)) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for deltamethrin in or on citrus 
fruits at 0.02 ppm. These MRLs are different than the tolerances being 
established for deltamethrin in the United States. Harmonization of the 
0.30 ppm tolerance with the lower Codex MRL of 0.02 ppm is not possible 
because the maximum residue value in oranges was 0.18 ppm, which is 
considerably higher than the Codex MRL.

C. Revisions to Petitioned-For Tolerances

    The Agency added a significant figure to the proposed tolerance 
level for orange and citrus, dried pulp to prevent violative samples 
from being considered non-violative. For example, if a sample contained 
a residue level of 0.34 ppm, it would have a violative residue if the 
tolerance is set at 0.30 ppm. In addition, the Agency is revising the 
commodity terminology to be consistent with the Agency's commodity 
vocabulary.

V. Conclusion

    Therefore, tolerances are established for residues of deltamethrin, 
(S)-cyano(3-phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on orange at 0.30 ppm; citrus, 
dried pulp at 3.0 ppm; citrus, oil at 50 ppm.

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

[[Page 18580]]

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 21, 2017.
Michael Goodis,
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)(1):
0
i. Add alphabetically the entries ``Citrus, dried pulp,'' ``Citrus, 
oil,'' and ``Orange'' to the table; and
0
ii. Revise the footnote at the end of the table.
    The additions and revision read as follows:


Sec.  180.435  Deltamethrin; tolerance for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Citrus, dried pulp *.......................................          3.0
Citrus, oil *..............................................           50
 
                                * * * * *
Orange *...................................................         0.30
 
                                * * * * *
------------------------------------------------------------------------
* There are no U.S. registrations.

* * * * *
[FR Doc. 2017-07816 Filed 4-19-17; 8:45 am]
 BILLING CODE 6560-50-P


