82_FR_18649 82 FR 18574 - Deltamethrin; Pesticide Tolerances

82 FR 18574 - Deltamethrin; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 75 (April 20, 2017)

Page Range18574-18580
FR Document2017-07816

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).

Federal Register, Volume 82 Issue 75 (Thursday, April 20, 2017)
[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Rules and Regulations]
[Pages 18574-18580]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                             18574              Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Rules and Regulations

                                             received by 5:00 p.m. Eastern time on                   will require payment of the filing fee at             SUPPLEMENTARY INFORMATION:
                                             the due date; or                                        that time.
                                                                                                                                                           I. General Information
                                                (iv) They are hand-delivered by                      *     *    *    *    *
                                             commercial courier to the Congressional                                                                       A. Does this action apply to me?
                                                                                                       Dated: March 3, 2017.
                                             Courier Acceptance Site in accordance                   Suzanne M. Barnett,                                      You may be potentially affected by
                                             with § 301.2(c) of this chapter and                                                                           this action if you are an agricultural
                                                                                                     Chief Copyright Royalty Judge.
                                             received by 4:00 p.m. Eastern time on                                                                         producer, food manufacturer, or
                                             the due date.                                           Approved by:
                                                                                                                                                           pesticide manufacturer. The following
                                                (6) Any document sent by mail and                    Carla D. Hayden,
                                                                                                                                                           list of North American Industrial
                                             dated only with a business postal meter                 Librarian of Congress.                                Classification System (NAICS) codes is
                                             will be considered filed on the date it                 [FR Doc. 2017–07928 Filed 4–19–17; 8:45 am]           not intended to be exhaustive, but rather
                                             is actually received by the Library of                  BILLING CODE 1410–72–P                                provides a guide to help readers
                                             Congress.                                                                                                     determine whether this document
                                                (b) Extensions. A party seeking an                                                                         applies to them. Potentially affected
                                             extension must do so by written motion.                 ENVIRONMENTAL PROTECTION                              entities may include:
                                             Prior to filing such a motion, a party                  AGENCY                                                   • Crop production (NAICS code 111).
                                             must attempt to obtain consent from the                                                                          • Animal production (NAICS code
                                             other parties to the proceeding. An                     40 CFR Part 180                                       112).
                                             extension motion must state:                            [EPA–HQ–OPP–2016–0087; FRL–9959–54]                      • Food manufacturing (NAICS code
                                                (1) The date on which the action or                                                                        311).
                                             submission is due;                                      Deltamethrin; Pesticide Tolerances                       • Pesticide manufacturing (NAICS
                                                (2) The length of the extension sought;                                                                    code 32532).
                                                                                                     AGENCY:  Environmental Protection
                                                (3) The date on which the action or                  Agency (EPA).                                         B. How can I get electronic access to
                                             submission would be due if the                          ACTION: Final rule.                                   other related information?
                                             extension were allowed;
                                                (4) The reason or reasons why there                  SUMMARY:    This regulation establishes                  You may access a frequently updated
                                             is good cause for the delay;                            tolerances for residues of deltamethrin               electronic version of EPA’s tolerance
                                                                                                     in or on orange; citrus, dried pulp;                  regulations at 40 CFR part 180 through
                                                (5) The justification for the amount of
                                                                                                     citrus, oil. Bayer CropScience requested              the Government Publishing Office’s e-
                                             additional time being sought; and
                                                                                                     these tolerances under the Federal Food,              CFR site at http://www.ecfr.gov/cgi-bin/
                                                (6) The attempts that have been made                                                                       text-idx?&c=ecfr&tpl=/ecfrbrowse/
                                             to obtain consent from the other parties                Drug, and Cosmetic Act (FFDCA).
                                                                                                                                                           Title40/40tab_02.tpl. To access the
                                             to the proceeding and the position of the               DATES: This regulation is effective April
                                                                                                                                                           OCSPP test guidelines referenced in this
                                             other parties on the motion.                            20, 2017. Objections and requests for
                                                                                                                                                           document electronically, please go to
                                                                                                     hearings must be received on or before
                                             PART 351—PROCEEDINGS                                                                                          http://www.epa.gov/ocspp and select
                                                                                                     June 19, 2017, and must be filed in
                                                                                                                                                           ‘‘Test Methods and Guidelines.’’
                                                                                                     accordance with the instructions
                                             ■ 8. The authority citation for part 351                provided in 40 CFR part 178 (see also                 C. How can I file an objection or hearing
                                             continues to read as follows:                           Unit I.C. of the SUPPLEMENTARY                        request?
                                                 Authority: 17 U.S.C. 803.                           INFORMATION).
                                                                                                                                                             Under FFDCA section 408(g), 21
                                             ■ 9. In § 351.1, revise paragraph (b)(4) to             ADDRESSES: The docket for this action,                U.S.C. 346a, any person may file an
                                             read as follows:                                        identified by docket identification (ID)              objection to any aspect of this regulation
                                                                                                     number EPA–HQ–OPP–2016–0087, is                       and may also request a hearing on those
                                             § 351.1   Initiation of proceedings.                    available at http://www.regulations.gov               objections. You must file your objection
                                             *     *      *    *      *                              or at the Office of Pesticide Programs                or request a hearing on this regulation
                                               (b) * * *                                             Regulatory Public Docket (OPP Docket)                 in accordance with the instructions
                                               (4) Filing fee. A petition to participate             in the Environmental Protection Agency                provided in 40 CFR part 178. To ensure
                                             must be accompanied with a filing fee                   Docket Center (EPA/DC), West William                  proper receipt by EPA, you must
                                             of $150 or the petition will be rejected.               Jefferson Clinton Bldg., Rm. 3334, 1301               identify docket ID number EPA–HQ–
                                             For petitions filed electronically                      Constitution Ave. NW., Washington, DC                 OPP–2016–0087 in the subject line on
                                             through eCRB, payment must be made                      20460–0001. The Public Reading Room                   the first page of your submission. All
                                             to the Copyright Royalty Board through                  is open from 8:30 a.m. to 4:30 p.m.,                  objections and requests for a hearing
                                             the payment portal designated on eCRB.                  Monday through Friday, excluding legal                must be in writing, and must be
                                             For petitions filed by other means,                     holidays. The telephone number for the                received by the Hearing Clerk on or
                                             payment must be made to the Copyright                   Public Reading Room is (202) 566–1744,                before June 19, 2017. Addresses for mail
                                             Royalty Board by check or by money                      and the telephone number for the OPP                  and hand delivery of objections and
                                             order. If a check is subsequently                       Docket is (703) 305–5805. Please review               hearing requests are provided in 40 CFR
                                             dishonored, the petition will be                        the visitor instructions and additional               178.25(b).
                                             rejected. If the petitioner believes that               information about the docket available                  In addition to filing an objection or
                                             the contested amount of that petitioner’s               at http://www.epa.gov/dockets.                        hearing request with the Hearing Clerk
                                             claim will be $1,000 or less, the                       FOR FURTHER INFORMATION CONTACT:                      as described in 40 CFR part 178, please
pmangrum on DSK3GDR082PROD with RULES




                                             petitioner must so state in the petition                Michael L. Goodis, Registration Division              submit a copy of the filing (excluding
                                             to participate and should not include                   (7505P), Office of Pesticide Programs,                any Confidential Business Information
                                             payment of the $150 filing fee. If it                   Environmental Protection Agency, 1200                 (CBI)) for inclusion in the public docket.
                                             becomes apparent during the course of                   Pennsylvania Ave. NW., Washington,                    Information not marked confidential
                                             the proceedings that the contested                      DC 20460–0001; main telephone                         pursuant to 40 CFR part 2 may be
                                             amount of the claim is more than                        number: (703) 305–7090; email address:                disclosed publicly by EPA without prior
                                             $1,000, the Copyright Royalty Judges                    RDFRNotices@epa.gov.                                  notice. Submit the non-CBI copy of your


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                                                                Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Rules and Regulations                                       18575

                                             objection or hearing request, identified                residue in or on a food) only if EPA                  levels (NOAELs) for the acute and
                                             by docket ID number EPA–HQ–OPP–                         determines that the tolerance is ‘‘safe.’’            chronic studies are similar, and the
                                             2016–0087, by one of the following                      Section 408(b)(2)(A)(ii) of FFDCA                     acute endpoint is protective of the
                                             methods:                                                defines ‘‘safe’’ to mean that ‘‘there is a            endpoints from repeat-dose studies.
                                               • Federal eRulemaking Portal: http://                 reasonable certainty that no harm will                Only single-day risk assessments need
                                             www.regulations.gov. Follow the online                  result from aggregate exposure to the                 to be conducted for purposes of
                                             instructions for submitting comments.                   pesticide chemical residue, including                 endpoint selection and exposure
                                             Do not submit electronically any                        all anticipated dietary exposures and all             assessment.
                                             information you consider to be CBI or                   other exposures for which there is                       There were no indications of fetal
                                             other information whose disclosure is                   reliable information.’’ This includes                 toxicity in any of the guideline studies.
                                             restricted by statute.                                  exposure through drinking water and in                Evidence of increased juvenile
                                               • Mail: OPP Docket, Environmental                     residential settings, but does not include            qualitative sensitivity was observed in
                                             Protection Agency Docket Center (EPA/                   occupational exposure. Section                        the developmental neurotoxicity and 2-
                                             DC), (28221T), 1200 Pennsylvania Ave.                   408(b)(2)(C) of FFDCA requires EPA to                 generation reproduction studies.
                                             NW., Washington, DC 20460–0001.                         give special consideration to exposure                However, the observations of increased
                                               • Hand Delivery: To make special                      of infants and children to the pesticide              sensitivity were at doses that were
                                             arrangements for hand delivery or                       chemical residue in establishing a                    considered to be relatively high (i.e.,
                                             delivery of boxed information, please                   tolerance and to ‘‘ensure that there is a             near lethal doses), whereas at doses near
                                             follow the instructions at http://                      reasonable certainty that no harm will                the point of departure, no effects on
                                             www.epa.gov/dockets/contacts.html.                      result to infants and children from                   parental animals or offspring were
                                               Additional instructions on                            aggregate exposure to the pesticide                   observed in either the developmental
                                             commenting or visiting the docket,                      chemical residue . . . .’’                            neurotoxicity (DNT) or 2-generation
                                             along with more information about                          Consistent with FFDCA section                      reproduction study and, therefore, there
                                             dockets generally, is available at http://              408(b)(2)(D), and the factors specified in            is no susceptibility at these doses.
                                             www.epa.gov/dockets.                                    FFDCA section 408(b)(2)(D), EPA has                      Deltamethrin is classified as ‘‘not
                                                                                                     reviewed the available scientific data                likely to be carcinogenic to humans.’’
                                             II. Summary of Petitioned-For                                                                                 There was no evidence of
                                                                                                     and other relevant information in
                                             Tolerance                                                                                                     carcinogenicity in either the rat or
                                                                                                     support of this action. EPA has
                                                In the Federal Register of October 18,               sufficient data to assess the hazards of              mouse long-term dietary studies up to
                                             2016 (81 FR 71668) (FRL–9952–19),                       and to make a determination on                        the highest dose tested, nor was there
                                             EPA issued a document pursuant to                       aggregate exposure for deltamethrin                   any mutagenic activity in bacteria or
                                             FFDCA section 408(d)(3), 21 U.S.C.                      including exposure resulting from the                 cultured mammalian cells.
                                             346a(d)(3), announcing the filing of a                  tolerances established by this action.                   Specific information on the studies
                                             pesticide petition (PP 5E8431) by Bayer                 EPA’s assessment of exposures and risks               received and the nature of the adverse
                                             CropScience, 2 T.W. Alexander Dr.,                      associated with deltamethrin follows.                 effects caused by deltamethrin as well
                                             Research Triangle Park, NC. The                                                                               as the no-observed-adverse-effect-level
                                             petition requested that 40 CFR 180.435                  A. Toxicological Profile                              (NOAEL) and the lowest-observed-
                                             be amended by establishing tolerances                      EPA has evaluated the available                    adverse-effect-level (LOAEL) from the
                                             for residues of the insecticide                         toxicity data and considered its validity,            toxicity studies can be found at http://
                                             deltamethrin, (S)-cyano(3-                              completeness, and reliability as well as              www.regulations.gov in document
                                             phenoxyphenyl)methyl (1R,3R)-3-(2,2-                    the relationship of the results of the                Deltamethrin: Human Health Risk
                                             dibromoethenyl)-2,2-                                    studies to human risk. EPA has also                   Assessment for the Proposed Use of
                                             dimethylcyclopropanecarboxylate, in or                  considered available information                      Deltamethrin on Oranges Without a U.S.
                                             on orange, fruit at 0.3 parts per million               concerning the variability of the                     Registration at page 24 in docket ID
                                             (ppm); orange, dried pulp at 3 ppm;                     sensitivities of major identifiable                   number EPA–HQ–OPP–2016–0087.
                                             orange, oil at 50 ppm. That document                    subgroups of consumers, including
                                                                                                                                                           B. Toxicological Points of Departure/
                                             referenced a summary of the petition                    infants and children.
                                                                                                        Deltamethrin is classified as a Type II            Levels of Concern
                                             prepared by Bayer CropScience, the
                                             registrant, which is available in the                   pyrethroid. Type II pyrethroids include                  Once a pesticide’s toxicological
                                             docket, http://www.regulations.gov.                     an alpha-cyano moiety and induce a                    profile is determined, EPA identifies
                                             There were no comments received in                      syndrome that includes pawing,                        toxicological points of departure (POD)
                                             response to the notice of filing.                       burrowing, salivation, hypothermia, and               and levels of concern to use in
                                                Based upon review of the data                        coarse tremors leading to                             evaluating the risk posed by human
                                             supporting the petition, EPA has revised                choreoathetosis. Neurotoxicity was                    exposure to the pesticide. For hazards
                                             the commodity definitions and                           observed throughout the database, and                 that have a threshold below which there
                                             tolerances as follows: ‘‘Orange fruit’’                 clinical signs characteristic of Type II              is no appreciable risk, the toxicological
                                             proposed at 0.3 ppm shall be ‘‘Orange’’                 pyrethroids, such as increased                        POD is used as the basis for derivation
                                             at 0.30 ppm; ‘‘Orange Dried Pulp’’ at 3                 salivation, altered mobility/gait, and                of reference values for risk assessment.
                                             ppm shall be ‘‘Citrus, dried pulp’’ at 3.0              tremors, were the most common effects                 PODs are developed based on a careful
                                             ppm; and ‘‘Orange Oil’’ at 50 ppm shall                 observed. Other observed neurotoxic                   analysis of the doses in each
                                             be ‘‘Citrus, oil’’ at 50 ppm. The reason                effects included increased sensitivity to             toxicological study to determine the
                                             for these changes is explained in Unit                  external stimuli, abnormal vocalization,              dose at which no adverse effects are
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                                             IV.C.                                                   and decreased fore- and hind-limb grip                observed (the NOAEL) and the lowest
                                                                                                     strength.                                             dose at which adverse effects of concern
                                             III. Aggregate Risk Assessment and                         Chronic exposure does not result in                are identified (the LOAEL). Uncertainty/
                                             Determination of Safety                                 accumulation or increased potency as a                safety factors are used in conjunction
                                                Section 408(b)(2)(A)(i) of FFDCA                     result of deltamethrin’s rapid                        with the POD to calculate a safe
                                             allows EPA to establish a tolerance (the                absorption, metabolism, and                           exposure level—generally referred to as
                                             legal limit for a pesticide chemical                    elimination. No observed adverse effect               a population-adjusted dose (PAD) or a


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                                             18576              Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Rules and Regulations

                                             reference dose (RfD)—and a safe margin                     expected in a lifetime. For more                     assessing-pesticide-risks/assessing-
                                             of exposure (MOE). For non-threshold                       information on the general principles                human-health-risk-pesticides.
                                             risks, the Agency assumes that any                         EPA uses in risk characterization and a                A summary of the toxicological
                                             amount of exposure will lead to some                       complete description of the risk                     endpoints for deltamethrin used for
                                             degree of risk. Thus, the Agency                           assessment process, see http://                      human risk assessment is shown in the
                                             estimates risk in terms of the probability                 www2.epa.gov/pesticide-science-and-                  Table of this unit.
                                             of an occurrence of the adverse effect

                                                TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR DELTAMETHRIN FOR USE IN HUMAN HEALTH RISK
                                                                                         ASSESSMENT
                                                                                                                                   RfD, PAD, level
                                                                                                         Uncertainty/FQPA
                                                  Exposure scenario                Point of departure                                of concern for               Study and toxicological effects
                                                                                                           safety factors          risk assessment

                                             Acute Dietary (≥6 years old)          Wolansky              UFA = 10X ..........   Acute RfD =            Wolansky BMD1SD = 2.48 mg/kg based on de-
                                                                                    BMDL1SD =            UFH = 10X                0.015 mg/kg.          creased motor activity.
                                                                                    1.49 mg/kg.          FQPA SF = 1X           aPAD = 0.015
                                                                                                                                  mg/kg/day
                                             Acute Dietary (<6 years old)          Wolansky              UFA = 10X ..........   Acute RfD =            Wolansky BMD1SD = 2.48 mg/kg based on de-
                                                                                    BMDL1SD =            UFH = 10X                0.015 mg/kg.          creased motor activity.
                                                                                    1.49 mg/kg.          FQPA SF = 3X           aPAD = 0.005
                                                                                                                                  mg/kg/day

                                             Chronic dietary (All popu-            A chronic endpoint is not necessary since increased toxicity is not observed with repeated dosing. The acute end-
                                               lations).                           point 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 based on de-
                                                                                    BMDL1SD =            UFH = 10X                for MOE = 300.        creased motor activity.
                                                                                    1.49 mg/kg.          FQPA SF = 3X

                                             Dermal (short-term; all pop-          A dermal assessment was not conducted based on the lack of effects in a 21-day dermal study and low potential
                                               ulations).                          for dermal absorption for deltamethrin.

                                             * Inhalation (Short-term; ≥6          Wolansky              UFA = 10X ..........   Residential LOC        Wolansky BMD1SD = 2.48 mg/kg
                                                years old).                         BMDL1SD =            UFH = 10X                for MOE = 100.       based on decreased motor activity.
                                                                                    1.49 mg/kg.          FQPA SF = 1X
                                             * Inhalation (Short-term; <6          Wolansky              UFA = 10X ..........   Residential LOC        Wolansky BMD1SD = 2.48 mg/kg based on de-
                                                years old).                         BMDL1SD =            UFH = 10X                for MOE = 300.        creased motor activity.
                                                                                    1.49 mg/kg.          FQPA SF = 3X

                                             Cancer (oral, dermal, inha-           Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of treatment related tumors in two
                                               lation).                            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 begin-
                                             ning 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 ad-
                                             justed dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. * Inhalation absorption is as-
                                             sumed to be equivalent to oral absorption. BMD1SD = The central estimate of the dose that results in decreased motor activity compared to con-
                                             trol animals based upon a 1 standard deviation using Benchmark Dose Analysis. BMDL1SD = The 95% lower confidence limit of the central esti-
                                             mate. Wolansky = Reference to Wolansky et al. Acute Oral Toxicity in Rats, MRID #47885701.


                                             C. Exposure Assessment                                     consumption information from the                        ii. Chronic exposure. In conducting
                                                1. Dietary exposure from food and                       United States Department of Agriculture              the chronic dietary exposure assessment
                                             feed uses. In evaluating dietary                           (USDA) 2003–2008 National Health and                 EPA used the food consumption data
                                             exposure to deltamethrin, EPA                              Nutrition Examination Surveys, What                  from the Dietary Exposure Evaluation
                                             considered exposure under the                              We Eat in America (NHANES/WWEIA).                    Model software with the Food
                                             petitioned-for tolerances as well as all                   As to residue levels in food, EPA acute              Commodity Intake Database (DEEM–
                                             existing deltamethrin tolerances in 40                     dietary exposure is partially refined.               FCID) Version 3.16. This software uses
                                             CFR 180.435. EPA assessed dietary                          Residues could result from agricultural              2003–2008 food consumption data from
                                             exposures from deltamethrin in food as                     uses and adulticide uses. Excluding the              the USDA’s NHANES/WWEIA.
                                             follows:                                                   new orange tolerances, residue-level                 Although a chronic dietary endpoint
                                                i. Acute exposure. Quantitative acute                   and percent crop treated assumptions                 was not identified for deltamethrin, a
                                             dietary exposure and risk assessments                      have not changed since the previous                  chronic dietary exposure assessment
                                             are performed for a food-use pesticide,                    rule, and those are discussed in the final           was performed to provide background
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                                             if a toxicological study has indicated the                 rule published in the Federal Register               exposure for aggregation with short-term
                                             possibility of an effect of concern                        of March 27, 2015 (80 FR 16296). For                 residential exposure. Residues could
                                             occurring as a result of a 1-day or single                 oranges, EPA used field trial values and             result from three different sources:
                                             exposure.                                                  the empirical processing factors for                 Agricultural uses, food handling
                                                Such effects were identified for                        orange juice and citrus oil. In addition,            establishment uses, and adulticide uses.
                                             deltamethrin. In estimating acute                          HED used a percent crop treated                      Assumptions about residue levels in
                                             dietary exposure, EPA used food                            estimate of 9%.                                      food and percent crop treated for crops


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                                                                Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Rules and Regulations                                      18577

                                             except for oranges have not changed                        The Agency estimated the PCT for                   consumption information and
                                             since the previous rule and are                         chronic exposure for existing uses as                 consumption information for significant
                                             explained in the final rule published in                follows:                                              subpopulations is taken into account
                                             the Federal Register of March 27, 2015                     Almonds: 1%; apples: 1%; globe                     through EPA’s computer-based model
                                             (80 FR 16296). For oranges, EPA used                    artichokes: 40%; canola: 5%;                          for evaluating the exposure of
                                             average field trial values and assumed                  cantaloupes: 1%; carrots: 1%; cotton:                 significant subpopulations including
                                             100% of imported oranges are treated                    1%; cucumbers: 2.5%; leeks: 2.5%;                     several regional groups. Use of this
                                             with deltamethrin.                                      onions: 2.5%; pears: 2.5%; peppers: 5%;               consumption information in EPA’s risk
                                               iii. Cancer. Based on the data                        pistachios: 1%; potatoes: 1%; pumpkin:                assessment process ensures that EPA’s
                                             summarized in Unit III.A., EPA has                      1%; radishes: 1%; soybeans: 1%;                       exposure estimate does not understate
                                             concluded that deltamethrin does not                    squash: 1%; sunflowers: 2.5%; sweet                   exposure for any significant
                                             pose a cancer risk to humans. Therefore,                corn: 1%; tomatoes: 1%; turnips: 1%;                  subpopulation group and allows the
                                             a dietary exposure assessment for the                   walnuts: 1%; watermelons: 1%.                         Agency to be reasonably certain that no
                                             purpose of assessing cancer risk is                        In most cases, EPA uses available data             regional population is exposed to
                                             unnecessary.                                            from United States Department of                      residue levels higher than those
                                                                                                     Agriculture/National Agricultural                     estimated by the Agency. Other than the
                                                iv. Anticipated residue and percent                  Statistics Service (USDA/NASS),
                                             crop treated (PCT) information. Section                                                                       data available through national food
                                                                                                     proprietary market surveys, and the                   consumption surveys, EPA does not
                                             408(b)(2)(E) of FFDCA authorizes EPA                    National Pesticide Use Database for the               have available reliable information on
                                             to use available data and information on                chemical/crop combination for the most                the regional consumption of food to
                                             the anticipated residue levels of                       recent 6–7 years. EPA uses a maximum                  which deltamethrin may be applied in
                                             pesticide residues in food and the actual               PCT for acute dietary risk analysis. The              a particular area.
                                             levels of pesticide residues that have                  maximum PCT figure is the highest                       2. Dietary exposure from drinking
                                             been measured in food. If EPA relies on                 observed maximum value reported                       water. The Agency used screening-level
                                             such information, EPA must require                      within the recent 6 years of available                water exposure models in the dietary
                                             pursuant to FFDCA section 408(f)(1)                     public and private market survey data                 exposure analysis and risk assessment
                                             that data be provided 5 years after the                 for the existing use and rounded up to                for deltamethrin in drinking water.
                                             tolerance is established, modified, or                  the nearest multiple of 5%, except for                These simulation models take into
                                             left in effect, demonstrating that the                  those situations in which the maximum                 account data on the physical, chemical,
                                             levels in food are not above the levels                 PCT is less than one. In those cases,                 and fate/transport characteristics of
                                             anticipated. For the present action, EPA                2.5% is used as the maximum PCT. EPA                  deltamethrin. Further information
                                             will issue such data call-ins as are                    uses an average PCT for chronic dietary               regarding EPA drinking water models
                                             required by FFDCA section 408(b)(2)(E)                  risk analysis. The average PCT figure for             used in pesticide exposure assessment
                                             and authorized under FFDCA section                      each existing use is derived by                       can be found at http://www2.epa.gov/
                                             408(f)(1). Data will be required to be                  combining available public and private                pesticide-science-and-assessing-
                                             submitted no later than 5 years from the                market survey data for that use,                      pesticide-risks/about-water-exposure-
                                             date of issuance of these tolerances.                   averaging across all observations, and                models-used-pesticide.
                                                Section 408(b)(2)(F) of FFDCA states                 rounding to the nearest 5%, except for                  Based on the First Index Reservoir
                                             that the Agency may use data on the                     those situations in which the average                 Screening Tool (FIRST), Pesticide Root
                                             actual percent of food treated for                      PCT is less than one. In those cases, 1%              Zone Model/Exposure Analysis
                                             assessing chronic dietary risk only if:                 is used as the average PCT.                           Modeling System (PRZM/EXAMS) and
                                                • Condition a: The data used are                        The Agency estimated that 9% of                    Screening Concentration in Ground
                                             reliable and provide a valid basis to                   domestically consumed oranges would                   Water (SCI–GROW) models, the
                                             show what percentage of the food                        be treated with deltamethrin as a result              estimated drinking water concentrations
                                             derived from such crop is likely to                     of the approval of the tolerances on                  (EDWCs) of deltamethrin for acute
                                             contain the pesticide residue.                          oranges. Because there is currently no                exposures are estimated to be 0.20 parts
                                                • Condition b: The exposure estimate                 domestic use of deltamethrin on                       per billion (ppb) for surface water and
                                             does not underestimate exposure for any                 oranges, the Agency estimated the                     0.20 ppb for ground water and chronic
                                             significant subpopulation group.                        percentage of the domestic consumption                exposures for non-cancer assessments
                                                                                                     of oranges that are imported. This                    are estimated to be 0.20 ppb for surface
                                                • Condition c: Data are available on
                                                                                                     calculation is based on three years of                water and 0.20 ppb for ground water.
                                             pesticide use and food consumption in
                                                                                                     data (2011–2013) from USDA’s                          Both the acute and chronic surface and
                                             a particular area, the exposure estimate
                                                                                                     Economic Research Service and                         ground drinking water concentration
                                             does not understate exposure for the
                                                                                                     assumes 100 percent of imported                       were limited by the solubility of
                                             population in such area.
                                                                                                     oranges are treated with deltamethrin.                deltamethrin.
                                                In addition, the Agency must provide                 Because it is unlikely that all imported                Modeled estimates of drinking water
                                             for periodic evaluation of any estimates                oranges will be treated with                          concentrations were directly entered
                                             used. To provide for the periodic                       deltamethrin, the Agency believes that                into the dietary exposure model.
                                             evaluation of the estimate of PCT as                    assuming 9% of oranges consumed have                    For acute dietary risk assessment and
                                             required by FFDCA section 408(b)(2)(F),                 been treated with deltamethrin will not               chronic dietary exposure assessment,
                                             EPA may require registrants to submit                   underestimate deltamethrin exposure on                the water concentration value of 0.20
                                             data on PCT.                                            oranges.                                              ppb was used to assess the contribution
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                                                The Agency estimated the PCT for                        The Agency believes that the three                 to drinking water.
                                             acute exposure for existing uses as                     conditions discussed in Unit III.C.1.iv.                Although a chronic dietary endpoint
                                             follows:                                                have been met. With respect to                        was not identified for deltamethrin, a
                                                Apples: 2.5%; cantaloupes: 2.5%,                     Condition a, PCT estimates are derived                chronic dietary exposure assessment
                                             carrots: 2.5%, cucumbers: 5%, pears:                    from Federal and private market survey                was performed to provide background
                                             5%, soybeans: 2.5%, tomatoes: 2.5%,                     data, which are reliable and have a valid             exposure for aggregation with short-term
                                             watermelons: 2.5%.                                      basis. As to Conditions b and c, regional             residential exposure.


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                                             18578              Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Rules and Regulations

                                                3. From non-dietary exposure. The                    assessment (CRA). The new tolerances                  neurotoxicity (SCN), and developmental
                                             term ‘‘residential exposure’’ is used in                to cover residues of deltamethrin on                  neurotoxicity (DNT) studies.
                                             this document to refer to non-                          imported oranges, citrus oil and citrus               Nevertheless, EPA lacks additional data
                                             occupational, non-dietary exposure                      pulp has an insignificant impact on the               to fully characterize the potential for
                                             (e.g., for lawn and garden pest control,                CRA. In the cumulative assessment,                    juvenile sensitivity to many pyrethroids,
                                             indoor pest control, termiticides, and                  residential exposure was the greatest                 including deltamethrin. For this
                                             flea and tick control on pets).                         contributor to the total exposure.                    assessment, EPA considered the
                                                Deltamethrin is currently registered                 Although there are residential uses for               standard guideline studies as well as
                                             for the following uses that could result                deltamethrin, the proposed use will                   numerous studies from the scientific
                                             in residential exposures: Indoor (spot,                 have no impact on the residential                     literature that describe the
                                             crack and crevice) and outdoor (turf,                   component of the cumulative risk                      pharmacodynamic (PD) and
                                             garden and trees) environments, pet                     estimates. Dietary exposures make a                   pharmacokinetic (PK) profile of the
                                             collars, paint preservative, impregnated                minor contribution to the total                       pyrethroids in general. Many of these
                                             mosquito net, and wide area mosquito                    pyrethroid exposure, and as a result, the             studies were conducted with
                                             and fly control. EPA assessed residential               new use on oranges would have an                      deltamethrin.
                                             exposure using the Agency’s 2012                        insignificant impact on the cumulative                   ii. As with other pyrethroids,
                                             Residential Standard Operating                          dietary risk.                                         deltamethrin causes neurotoxicity from
                                             Procedures (SOPs) along with updates                                                                          interaction with sodium channels
                                             in policy regarding body weight in                      D. Safety Factor for Infants and                      leading to clinical signs of
                                             addition to the following assumptions:                  Children                                              neurotoxicity. These effects are well
                                             Since no treatment-related effects were                    1. In general. Section 408(b)(2)(C) of             characterized and adequately assessed
                                             observed at the limit dose, a dermal                    FFDCA provides that EPA shall apply                   by the body of data available to the
                                             point of departure (POD) was not                        an additional tenfold (10X) margin of                 Agency.
                                             selected, and neither a handler nor a                   safety for infants and children in the                   iii. Evidence of increased juvenile
                                             post-application dermal exposure                        case of threshold effects to account for              qualitative sensitivity was observed in
                                             assessment is required.                                 prenatal and postnatal toxicity and the               the developmental neurotoxicity and 2-
                                                i. Residential handler exposures.                    completeness of the database on toxicity              generation reproduction studies.
                                             Short-term residential handler                          and exposure unless EPA determines                    However, the observations of increased
                                             inhalation exposure is anticipated from                 based on reliable data that a different               sensitivity were at doses that were
                                             indoor and outdoor environments, and                    margin of safety will be safe for infants             considered to be relatively high (i.e.,
                                             paint preservatives. Because no                         and children. This additional margin of               near lethal doses), whereas at doses near
                                             intermediate-term adverse effect was                    safety is commonly referred to as the                 the point of departure, no effects on
                                             identified, deltamethrin is not expected                Food Quality Protection Act Safety                    parental animals or offspring were
                                             to pose an intermediate-term risk.                      Factor (FQPA SF). In applying this                    observed in either the DNT or 2-
                                                ii. Residential post-application                     provision, EPA either retains the default             generation reproduction study, and
                                             exposures. Post-application inhalation                  value of 10X, or uses a different                     therefore, there is no susceptibility at
                                             exposure for adults and children is                     additional safety factor when reliable                these doses. The Agency has retained a
                                             anticipated to be negligible for indoor                 data available to EPA support the choice              3X uncertainty factor to protect for
                                             (spot, crack and crevice) and outdoor                   of a different factor.                                exposures of children less than 6 years
                                             (turf, garden and trees) environments,                     2. Prenatal and postnatal sensitivity.             of age based on increased quantitative
                                             pet collars and paints; therefore, a                    There is no quantitative and/or                       susceptibility seen in studies on
                                             quantitative assessment was not                         qualitative evidence of increased                     pyrethroid pharmacokinetics (primarily
                                             performed. EPA assessed post-                           susceptibility of rat or rabbit fetuses to            conducted with deltamethrin) and the
                                             application short-term incidental oral                  in utero exposure to deltamethrin.                    increased quantitative juvenile
                                             exposures to children for representative                However, potential qualitative                        susceptibility observed in high dose
                                             indoor/outdoor and pet incidental oral                  susceptibility was observed at high                   guideline and literature studies with
                                             scenarios including hand-to-mouth,                      doses in the DNT and 2-generation                     deltamethrin and other pyrethroids. The
                                             object-to-mouth, soil ingestion, and                    reproduction study for juveniles. In                  Agency has no residual uncertainties
                                             episodic granule ingestion scenarios.                   addition, pyrethroid pharmacokinetics                 regarding age-related sensitivity for
                                             Further information regarding EPA                       literature indicates an increased                     women of child bearing age as well as
                                             standard assumptions and generic                        quantitative susceptibility for children              for all adult populations and children 6
                                             inputs for residential exposures may be                 less than 6 years of age.                             years of age and older, based on the
                                             found at http://www2.epa.gov/pesticide-                    3. Conclusion. EPA has determined                  absence of pre-natal sensitivity observed
                                             science-and-assessing-pesticide-risks/                  that reliable data show the safety of                 in 76 guideline studies for 24
                                             standard-operating-procedures-                          infants and children would be                         pyrethroids and the scientific literature.
                                             residential-pesticide.                                  adequately protected if the FQPA SF                   Additionally, no evidence of increased
                                                4. Cumulative effects from substances                reduced to 1X for assessing risks to                  quantitative or qualitative susceptibility
                                             with a common mechanism of toxicity.                    adults and children 6 years of age and                was seen in the pyrethroid scientific
                                             Section 408(b)(2)(D)(v) of FFDCA                        older and to 3X for assessing risks to                literature related to pharmacodynamics.
                                             requires that, when considering whether                 children less than 6 years of age. That                  iv. There are no residual uncertainties
                                             to establish, modify, or revoke a                       decision is based on the following                    identified in the exposure databases.
                                             tolerance, the Agency consider                          findings:                                             The dietary exposure assessments are
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                                             ‘‘available information’’ concerning the                   i. The toxicity database is considered             based on reasonable to high-end residue
                                             cumulative effects of a particular                      complete for deltamethrin with respect                levels (that account for parent and
                                             pesticide’s residues and ‘‘other                        to guideline studies; it includes, among              metabolites of concern), processing
                                             substances that have a common                           other studies, developmental toxicity                 factors, and percent crop treated
                                             mechanism of toxicity.’’                                studies in rats and rabbits, a                        assumptions. Furthermore,
                                                Deltamethrin is included in the                      reproduction study in rats, and acute                 conservative, upper-bound assumptions
                                             pyrethroid/pyrethrin cumulative risk                    neurotoxicity (ACN), subchronic                       were used to determine exposure


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                                                                Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Rules and Regulations                                        18579

                                             through drinking water and residential                  level of concern for deltamethrin is a                0.02 ppm. These MRLs are different
                                             sources, such that these exposures have                 MOE of 100 for the U.S. population and                than the tolerances being established for
                                             not been underestimated. EPA made                       females 13–49, and 300 for children 1–                deltamethrin in the United States.
                                             conservative (protective) assumptions in                2 years old or below, these MOEs are                  Harmonization of the 0.30 ppm
                                             the ground and surface water modeling                   not of concern.                                       tolerance with the lower Codex MRL of
                                             used to assess exposure to deltamethrin                    4. Intermediate-term risk.                         0.02 ppm is not possible because the
                                             in drinking water. EPA used similarly                   Intermediate-term aggregate exposure                  maximum residue value in oranges was
                                             conservative assumptions to assess post-                takes into account intermediate-term                  0.18 ppm, which is considerably higher
                                             application exposure of children as well                residential exposure plus chronic                     than the Codex MRL.
                                             as incidental oral exposure of toddlers.                exposure to food and water (considered
                                                                                                     to be a background exposure level).                   C. Revisions to Petitioned-For
                                             These assessments will not
                                                                                                     Because no intermediate-term adverse                  Tolerances
                                             underestimate the exposure and risks
                                             posed by deltamethrin.                                  effect was identified, deltamethrin is not               The Agency added a significant figure
                                                                                                     expected to pose an intermediate-term                 to the proposed tolerance level for
                                             E. Aggregate Risks and Determination of                 risk.                                                 orange and citrus, dried pulp to prevent
                                             Safety                                                     5. Aggregate cancer risk for U.S.                  violative samples from being considered
                                                EPA determines whether acute and                     population. Based on the lack of                      non-violative. For example, if a sample
                                             chronic dietary pesticide exposures are                 evidence of carcinogenicity in two                    contained a residue level of 0.34 ppm,
                                             safe by comparing aggregate exposure                    adequate rodent carcinogenicity studies,              it would have a violative residue if the
                                             estimates to the acute PAD (aPAD) and                   deltamethrin is not expected to pose a                tolerance is set at 0.30 ppm. In addition,
                                             chronic PAD (cPAD). For linear cancer                   cancer risk to humans.                                the Agency is revising the commodity
                                             risks, EPA calculates the lifetime                         6. Determination of safety. Based on               terminology to be consistent with the
                                             probability of acquiring cancer given the               these risk assessments, EPA concludes                 Agency’s commodity vocabulary.
                                             estimated aggregate exposure. Short-,                   that there is a reasonable certainty that
                                             intermediate-, and chronic-term risks                   no harm will result to the general                    V. Conclusion
                                             are evaluated by comparing the                          population, or to infants and children                  Therefore, tolerances are established
                                             estimated aggregate food, water, and                    from aggregate exposure to deltamethrin               for residues of deltamethrin, (S)-
                                             residential exposure to the appropriate                 residues.                                             cyano(3-phenoxyphenyl)methyl
                                             PODs to ensure that an adequate MOE                                                                           (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
                                                                                                     IV. Other Considerations
                                             exists.                                                                                                       dimethylcyclopropanecarboxylate, in or
                                                1. Acute risk. Using the exposure                    A. Analytical Enforcement Methodology                 on orange at 0.30 ppm; citrus, dried
                                             assumptions discussed in this unit for                     Adequate enforcement methodology                   pulp at 3.0 ppm; citrus, oil at 50 ppm.
                                             acute exposure, the acute dietary                       (gas chromatography with electron                     VI. Statutory and Executive Order
                                             exposure from food and water to                         capture detection (GC/ECD)) is available              Reviews
                                             deltamethrin will occupy 86% of the                     to enforce the tolerance expression. The
                                             aPAD for children 3–5 years old, the                                                                             This action establishes tolerances
                                                                                                     method may be requested from: Chief,
                                             population group receiving the greatest                                                                       under FFDCA section 408(d) in
                                                                                                     Analytical Chemistry Branch,
                                             exposure.                                                                                                     response to a petition submitted to the
                                                                                                     Environmental Science Center, 701
                                                2. Chronic risk. Based on the data                                                                         Agency. The Office of Management and
                                                                                                     Mapes Rd., Ft. Meade, MD 20755–5350;
                                             summarized in Unit III.A., there is no                  telephone number: (410) 305–2905;                     Budget (OMB) has exempted these types
                                             increase in hazard with increasing                      email address: residuemethods@                        of actions from review under Executive
                                             dosing duration. Furthermore, chronic                   epa.gov.                                              Order 12866, entitled ‘‘Regulatory
                                             dietary exposures will be lower than                                                                          Planning and Review’’ (58 FR 51735,
                                             acute exposures. Therefore, the acute                   B. International Residue Limits                       October 4, 1993). Because this action
                                             aggregate assessment is protective of                     In making its tolerance decisions, EPA              has been exempted from review under
                                             potential chronic aggregate exposures.                  seeks to harmonize U.S. tolerances with               Executive Order 12866, this action is
                                                3. Short-term risk. Short-term                       international standards whenever                      not subject to Executive Order 13211,
                                             aggregate exposure takes into account                   possible, consistent with U.S. food                   entitled ‘‘Actions Concerning
                                             short-term residential exposure plus                    safety standards and agricultural                     Regulations That Significantly Affect
                                             chronic exposure to food and water                      practices. EPA considers the                          Energy Supply, Distribution, or Use’’ (66
                                             (considered to be a background                          international maximum residue limits                  FR 28355, May 22, 2001) or Executive
                                             exposure level). Deltamethrin is                        (MRLs) established by the Codex                       Order 13045, entitled ‘‘Protection of
                                             currently registered for uses that could                Alimentarius Commission (Codex), as                   Children from Environmental Health
                                             result in short-term residential                        required by FFDCA section 408(b)(4).                  Risks and Safety Risks’’ (62 FR 19885,
                                             exposure, and the Agency has                            The Codex Alimentarius is a joint                     April 23, 1997). This action does not
                                             determined that it is appropriate to                    United Nations Food and Agriculture                   contain any information collections
                                             aggregate chronic exposure through food                 Organization/World Health                             subject to OMB approval under the
                                             and water with short-term residential                   Organization food standards program,                  Paperwork Reduction Act (PRA) (44
                                             exposures to deltamethrin.                              and it is recognized as an international              U.S.C. 3501 et seq.), nor does it require
                                                Using the exposure assumptions                       food safety standards-setting                         any special considerations under
                                             described in this unit for short-term                   organization in trade agreements to                   Executive Order 12898, entitled
                                             exposures, EPA has concluded the                        which the United States is a party. EPA               ‘‘Federal Actions to Address
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                                             combined short-term food, water, and                    may establish a tolerance that is                     Environmental Justice in Minority
                                             residential exposures, including                        different from a Codex MRL; however,                  Populations and Low-Income
                                             inhalation and hand-to-mouth (for                       FFDCA section 408(b)(4) requires that                 Populations’’ (59 FR 7629, February 16,
                                             children only), result in aggregate MOEs                EPA explain the reasons for departing                 1994).
                                             of 2,300 for the U.S. Population; 2,600                 from the Codex level.                                    Since tolerances and exemptions that
                                             for females ages 13–49; and 490 for                       The Codex has established MRLs for                  are established on the basis of a petition
                                             children 1–2 years old. Because EPA’s                   deltamethrin in or on citrus fruits at                under FFDCA section 408(d), such as


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                                             18580              Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Rules and Regulations

                                             the tolerance in this final rule, do not                PART 180—[AMENDED]                                                    CFR 1.5000 through 1.5004, 25.105,
                                             require the issuance of a proposed rule,                                                                                      73.1010 and 74.5, published at 81 FR
                                             the requirements of the Regulatory                      ■ 1. The authority citation for part 180                              86586, December 1, 2016, are effective
                                             Flexibility Act (RFA) (5 U.S.C. 601 et                  continues to read as follows:                                         on April 20, 2017.
                                             seq.), do not apply.                                        Authority: 21 U.S.C. 321(q), 346a and 371.                        FOR FURTHER INFORMATION CONTACT:
                                                This action directly regulates growers,                                                                                    Cathy Williams by email at
                                                                                                     ■  2. In § 180.435, paragraph (a)(1):
                                             food processors, food handlers, and food                                                                                      Cathy.Williams@fcc.gov and telephone
                                                                                                     ■  i. Add alphabetically the entries
                                             retailers, not States or tribes, nor does                                                                                     at (202) 418–2918.
                                                                                                     ‘‘Citrus, dried pulp,’’ ‘‘Citrus, oil,’’ and
                                             this action alter the relationships or                                                                                        SUPPLEMENTARY INFORMATION: This
                                                                                                     ‘‘Orange’’ to the table; and
                                             distribution of power and                                                                                                     document announces that, on April 9,
                                                                                                     ■ ii. Revise the footnote at the end of the
                                             responsibilities established by Congress                                                                                      2017, OMB approved information
                                                                                                     table.
                                             in the preemption provisions of FFDCA                                                                                         collection requirements contained in the
                                                                                                        The additions and revision read as
                                             section 408(n)(4). As such, the Agency                                                                                        Commission’s Report and Order, FCC
                                                                                                     follows:
                                             has determined that this action will not                                                                                      16–128, published at 81 FR 86586. The
                                             have a substantial direct effect on States              § 180.435 Deltamethrin; tolerance for                                 OMB Control Number is 3060–1163.
                                             or tribal governments, on the                           residues.                                                             The Commission publishes this notice
                                             relationship between the national                             (a) * * *                                                       as an announcement of the effective
                                             government and the States or tribal                           (1) * * *                                                       date of those information collection
                                             governments, or on the distribution of                                                                                        requirements.
                                             power and responsibilities among the                                    Commodity                             Parts per
                                             various levels of government or between                                                                        million        Synopsis
                                             the Federal Government and Indian                                                                                               As required by the Paperwork
                                             tribes. Thus, the Agency has determined                                                                                       Reduction Act of 1995 (44 U.S.C. 3507),
                                                                                                         *            *              *               *           *
                                             that Executive Order 13132, entitled                    Citrus, dried pulp * ....................                       3.0   the FCC is notifying the public that it
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                 Citrus, oil * .................................                 50    received OMB approval on April 9,
                                             1999) and Executive Order 13175,                                                                                              2017, for the information collection
                                             entitled ‘‘Consultation and Coordination                   *           *              *               *             *         requirements contained in 47 CFR
                                             with Indian Tribal Governments’’ (65 FR                 Orange * ....................................               0.30      1.5000 through 1.5004, 25.105, 73.1010
                                             67249, November 9, 2000) do not apply                                                                                         and 74.5, as amended, in the
                                             to this action. In addition, this action                      *               *              *           *          *         Commission’s Report and Order, FCC
                                             does not impose any enforceable duty or                     * There are no U.S. registrations.                                16–128. Under 5 CFR part 1320, an
                                             contain any unfunded mandate as                                                                                               agency may not conduct or sponsor a
                                             described under Title II of the Unfunded                *           *     *           *          *
                                                                                                     [FR Doc. 2017–07816 Filed 4–19–17; 8:45 am]
                                                                                                                                                                           collection of information unless it
                                             Mandates Reform Act (UMRA) (2 U.S.C.                                                                                          displays a current, valid OMB Control
                                                                                                     BILLING CODE 6560–50–P
                                             1501 et seq.).                                                                                                                Number. No person shall be subject to
                                                This action does not involve any                                                                                           any penalty for failing to comply with
                                             technical standards that would require                                                                                        a collection of information subject to the
                                             Agency consideration of voluntary                       FEDERAL COMMUNICATIONS                                                Paperwork Reduction Act that does not
                                             consensus standards pursuant to section                 COMMISSION                                                            display a current, valid OMB Control
                                             12(d) of the National Technology                                                                                              Number. The OMB Control Number is
                                             Transfer and Advancement Act                            47 CFR Parts 1, 25, 73, and 74                                        3060–1163.
                                             (NTTAA) (15 U.S.C. 272 note).                           [GN Docket No. 15–236; FCC 16–128]                                      The foregoing notice is required by
                                                                                                                                                                           the Paperwork Reduction Act of 1995,
                                             VII. Congressional Review Act
                                                                                                     Review of Foreign Ownership Policies                                  Public Law 104–13, October 1, 1995,
                                               Pursuant to the Congressional Review                  for Broadcast, Common Carrier and                                     and 44 U.S.C. 3507.
                                             Act (5 U.S.C. 801 et seq.), EPA will                    Aeronautical Radio Licensees                                            The total annual reporting burdens
                                             submit a report containing this rule and                                                                                      and costs for the respondents are as
                                                                                                     AGENCY:   Federal Communications                                      follows:
                                             other required information to the U.S.
                                                                                                     Commission.                                                             OMB Control Number: 3060–1163.
                                             Senate, the U.S. House of
                                             Representatives, and the Comptroller                    ACTION: Final rule; announcement of                                     OMB Approval Date: April 9, 2017.
                                             General of the United States prior to                   effective date.                                                         OMB Expiration Date: April 30, 2020.
                                             publication of the rule in the Federal                                                                                          Title: Regulations Applicable to
                                                                                                     SUMMARY:   In this document, the Federal                              Broadcast, Common Carrier and
                                             Register. This action is not a ‘‘major                  Communications Commission
                                             rule’’ as defined by 5 U.S.C. 804(2).                                                                                         Aeronautical Radio Licensees Under
                                                                                                     (Commission) announces that the Office                                Section 310(b) of the Communications
                                             List of Subjects in 40 CFR Part 180                     of Management and Budget (OMB) has                                    Act of 1934, as amended.
                                                                                                     approved, for a period of three years,                                  Form Number: N/A.
                                               Environmental protection,                             information collection requirements
                                             Administrative practice and procedure,                                                                                          Respondents: Business or other for-
                                                                                                     adopted in the Commission’s Report                                    profit entities.
                                             Agricultural commodities, Pesticides                    and Order, FCC 16–128. This document
                                             and pests, Reporting and recordkeeping                                                                                          Number of Respondents and
                                                                                                     is consistent with the Report and Order,                              Responses: 81 respondents; 81
                                             requirements.
pmangrum on DSK3GDR082PROD with RULES




                                                                                                     which stated that the Commission                                      responses.
                                               Dated: March 21, 2017.                                would publish a document in the                                         Estimated Time per Response: 2
                                             Michael Goodis,                                         Federal Register announcing OMB                                       hours–46 hours.
                                             Director, Registration Division, Office of              approval and the effective date of the                                  Frequency of Response: On-occasion
                                             Pesticide Programs.                                     rules.                                                                reporting requirement.
                                               Therefore, 40 CFR chapter I is                        DATES: This final rule is effective on                                  Obligation to Respond: Required to
                                             amended as follows:                                     April 20, 2017. The amendments to 47                                  obtain or retain benefits. The statutory


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Document Created: 2017-04-20 01:42:21
Document Modified: 2017-04-20 01:42:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation82 FR 18574 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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