[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Rules and Regulations]
[Pages 66294-66301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-26430]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0297; FRL-9918-24]


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 finfish. Center for Regulatory Services, Inc., on 
behalf of PHARMAQ AS, requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 7, 2014. Objections and 
requests for hearings must be received on or before January 6, 2015, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2014-0297, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: <a href="/cdn-cgi/l/email-protection#53011715011d3c273a303620133623327d343c25"><span class="__cf_email__" data-cfemail="feacbab8acb0918a979d9b8dbe9b8e9fd0999188">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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

[[Page 66295]]

the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2014-0297 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 6, 2015. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2014-0297, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
    <bullet> 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 May 23, 2014 (79 FR 29729) (FRL-9910-
29), 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 
3E8178) by the Center for Regulatory Services, Inc, 5200 Wolf Run 
Shoals Rd., Woodbridge, VA 22192-5755, on behalf of PHARMAQ AS, P.O. 
Box 267, Sk[oslash]yen, N-0213 Oslo, Norway. The petition requested 
that 40 CFR 180.435 be amended by establishing tolerances for residues 
of the insecticide deltamethrin, (1R, 3R)-3(2,2-dibromovinyl)-2,2-
dimethylcyclopropane-carboxylic acid (S)-alpha-cyano-3-phenoxybenzyl 
ester and its major metabolites: Trans-deltamethrin, (s)-alpha-cyano-3-
phenoxybenzyl-(1R, 3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, and alpha-R-deltamethrin, (R)-
alphacyano-3-phenoxybenzyl-(1R, 3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, in or on finfish at 0.01 parts per 
million (ppm). That document referenced a summary of the petition 
prepared by PHARMAQ AS, the registrant, which is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Based upon review of the data supporting the petition, EPA has 
revised the petition by correcting the commodity definition. The Agency 
also revised the tolerance expression for deltamethrin. The reasons for 
these changes are explained in Unit IV.D.

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, a Type II pyrethroid, targets the nervous system by 
disrupting the voltage-gated sodium channels, resulting in 
neurotoxicity. Neurotoxicity was observed throughout the toxicity 
database, and effects were seen across species, sexes, exposure 
duration, and routes of administration. Clinical signs characteristic 
of Type II pyrethroids, such as increased salivation, altered mobility/
gait, and tremors were the most common effects observed. Increased 
sensitivity to external stimuli, abnormal vocalization, and decreased 
fore- and hind-limb grip strength were also commonly observed in the 
database.
    Deltamethrin is rapidly absorbed following an oral dose, and 
effects are typically observed within 2 to 5 hours after dosing. For 
pyrethroids, as a class, the combination of rapid absorption, 
metabolism, and elimination precludes accumulation and increased 
potency following repeated dosing. This is also true of deltamethrin. 
No observed adverse effect levels (NOAELs) for the acute and chronic 
studies are similar, and the acute endpoint is protective of the 
endpoints from repeat dosing studies. The Wolansky et al. acute oral 
study (2006), provides the most robust data set for extrapolating risk 
from exposure to deltamethrin. The dose used for risk assessment was 
determined using a benchmark dose (BMD) analysis using one standard 
deviation from the control group as the benchmark response (BMR). The 
study endpoint and dose were used for all exposure scenarios.
    A dermal risk assessment was not conducted based on the lack of 
effects in a 21-day dermal study and low potential for dermal 
absorption for deltamethrin. These findings are consistent with the 
toxicology profile of many pyrethroids.

[[Page 66296]]

    Deltamethrin did not have any adverse effects on fetuses or 
offspring in the prenatal developmental studies in rats and rabbits. 
However, potential qualitative susceptibility was observed at high 
doses in the developmental neurotoxicity study (DNT) and the 2-
generation reproduction study. Symptoms included vocalization, 
decreased pre- and post-weaning body weight in pups of both sexes, 
decreased body weight and body weight gain in maternal animals, 
hyperactivity, and excessive salivation. The increased qualitative 
susceptibility in the DNT and 2-generation reproduction study was 
observed at doses 10- to 20-fold higher (near lethal doses) than the 
current points of departure (PODs) selected for risk assessment. At 
doses near the POD, no effects on parental animals or offspring were 
observed in either the DNT or 2-generation reproductive studies. 
Therefore, the current PODs are protective of the observed sensitivity.
    There was no evidence of immunotoxicity after deltamethrin exposure 
in the toxicology database or in an immunotoxicity study in rats. 
Deltamethrin is classified as ``not likely to be carcinogenic to 
humans.'' There was no evidence of carcinogenicity in the combined 
chronic/carcinogenicity study in rats or the carcinogenicity study in 
mice. In a battery of mutagenicity studies there was no evidence of a 
mutagenic effect.
    The database shows that deltamethrin has moderate to minimal acute 
toxicity via the oral route, moderate acute toxicity via the inhalation 
route, and minimal acute toxicity via the dermal route of exposure. 
Deltamethrin is minimally irritating to the eyes, non-irritating to the 
skin, and is not a skin sensitizer.
    The Agency is making best use of the extensive scientific knowledge 
about the mode of action/adverse outcome pathway (MOA/AOP) on 
pyrethroids in the risk assessments for this class of pesticides. A 
significant portion of the scientific literature on pyrethroids 
utilizes deltamethrin as the test chemical. In the on-going work by the 
Council for the Advancement of Pyrethroid Human Risk Assessment 
(CAPHRA), deltamethrin is one of two sentinel pyrethroids being used to 
develop the initial, extensive database of in vitro and in vivo 
toxicology studies and highly refined physiologically based 
pharmacokinetic (PBPK) models. Pharmacokinetics (PK) can be defined as 
what the body does to the chemical. The underlying PK of pyrethroids is 
an important determination of their toxicity because the concentration 
of pyrethroid at the sodium channel relates to the extent of toxicity; 
greater pyrethroid concentration translates as increased neurotoxicity. 
Age-dependent PK differences have been identified for several 
pyrethroids (i.e., there are differences in the ability of adults and 
juveniles to metabolize pyrethroids). The enzymes that metabolize and 
detoxify pyrethroids are present in rats and humans at birth, and as a 
result, both juveniles and adults are able to tolerate low doses of 
pyrethroids when the internal dose, or the amount of pyrethroid at the 
sodium channel, is low. However, the activity of these enzymes 
increases with age, conveying in adults a greater capacity to detoxify 
pyrethroids compared to juveniles and the PK contribution to the Food 
Quality Protection Act Safety Factor (FQPA SF) will be 1x for adults 
and children >6 years old, and 3x for children <6 years old.
    Pharmacodynamics (PD) can be defined as the changes that chemicals 
cause to the body, in this case, how pyrethroids interact with the 
sodium channels. In contrast to the age-related PK differences 
identified for pyrethroids, PD contributions to pyrethroid toxicity are 
not age-dependent. The occurrence and ontogeny of voltage-gated sodium 
channels in humans are not well characterized compared to those in the 
rat. The available data indicate that the rat is a highly sensitive 
model and extrapolations from the rat would be protective of human 
health. Based on the comparable function and distribution of sodium 
channels between the species, the rat is an appropriate surrogate for 
the evaluation of human PD. Based on the body of data, the Agency 
concludes that juvenile rats are not more sensitive than adults with 
respect to pyrethroid PD, and the PD contribution to the FQPA SF will 
be 1x.
    The Wolansky et al. acute oral study (2006), in which decreased 
motor activity was observed, provides the most robust data set for 
extrapolating risk from exposure to deltamethrin. The dose used for 
risk assessment was determined using a BMD analysis using one standard 
deviation from the control group as the BMR as suggested for continuous 
endpoints in the Agency's BMD guidance (EPA, 2012). The Wolansky et al. 
acute study, endpoint, and dose were used for all dietary (acute), non-
occupational (incidental oral and inhalation), and occupational 
exposure (inhalation) scenarios because it was the most robust data set 
for extrapolating risk from deltamethrin, and there is a lack of 
increased hazard from repeated/chronic exposure to deltamethrin.
    Specific information on the studies received and the nature of the 
adverse effects caused by deltamethrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document entitled ``Deltamethrin. Human 
Health Risk Assessment for the Proposed Use of Deltamethrin without 
U.S. Registration on Finfish'' at p. 46 in docket ID number EPA-HQ-OPP-
2014-0297.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological PODs and levels of concern to use in 
evaluating the risk posed by human exposure to the pesticide. For 
hazards that have a threshold below which there is no appreciable risk, 
the toxicological POD is used as the basis for derivation of reference 
values for risk assessment. PODs are developed based on a careful 
analysis of the doses in each toxicological study to determine the dose 
at which no adverse effects are observed (the NOAEL) and the lowest 
dose at which adverse effects of concern are identified (the LOAEL). 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for deltamethrin used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 66297]]



 Table 1--Summary of Toxicological Doses and Endpoints for Deltamethrin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (>=6 years old)....  POD = Wolansky......  Acute RfD = 0.015    Wolansky BMDL1SD = 2.48 mg/kg
                                   BMDL1SD = 1.49 mg/kg   mg/kg                based on decreased motor
                                   UFA = 10 x..........  aPAD = 0.015 mg/kg/   activity.
                                   UFH = 10 x..........   day.
                                   FQPA SF = 1 x.......
----------------------------------------------------------------------------------------------------------------
Acute dietary (<6 years old).....  POD = Wolansky......  Acute RfD = 0.015    Wolansky BMDL1SD = 2.48 mg/kg
                                   BMDL1SD = 1.49 mg/kg   mg/kg                based on decreased motor
                                   UFA = 10 x..........  aPAD = 0.005 mg/kg/   activity.
                                   UFH = 10 x..........   day.
                                   FQPA SF = 3 x.......
----------------------------------------------------------------------------------------------------------------
Chronic Dietary..................  A chronic dietary risk assessment was not conducted because there is no
                                    apparent increase in hazard from repeated/chronic exposures to deltamethrin.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   POD = Wolansky......  LOC for MOE = 300..  Wolansky BMDL1SD = 2.48 mg/kg
 30 days).                         BMDL1SD = 1.49 mg/kg                        based on decreased motor
                                   UFA = 10 x..........                        activity.
                                   UFH = 10 x..........
                                   FQPA SF = 3 x.......
----------------------------------------------------------------------------------------------------------------
* Inhalation short-term (1 to 30   POD = Wolansky......  LOC for MOE = 100..  Wolansky BMDL1SD = 2.48 mg/kg
 days; >=6 years old).             BMDL1SD = 1.49 mg/kg                        based on decreased motor
                                   UFA = 10 x..........                        activity.
                                   UFH = 10 x..........
                                   FQPA SF = 1 x.......
----------------------------------------------------------------------------------------------------------------
* Inhalation short-term (1 to 30   POD = Wolansky......  LOC for MOE = 300..  Wolansky BMDL1SD = 2.48 mg/kg
 days; <6 years old).              BMDL1SD = 1.49 mg/kg                        based on decreased motor
                                   UFA = 10 x..........                        activity.
                                   UFH = 10 x..........
                                   FQPA SF = 3 x.......
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Classification: ``Not likely to be Carcinogenic to Humans'' based on the
                                    absence of treatment related tumors in two adequate rodent carcinogenicity
                                    studies.
----------------------------------------------------------------------------------------------------------------
BMDL1SD = the 95% lower confidence limit of the central estimate of the dose that results in decreased motor
  activity compared to control animals based upon one standard deviation using Benchmark Dose Analysis. FQPA SF
  = Food Quality Protection Act Safety Factor. LOC = level of concern. Mg/kg/day = milligram/kilogram/day. MOE =
  margin of exposure. PAD = population adjusted dose (a = acute, c = chronic). POD = Point of departure: 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. RfD =
  reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
  potential variation in sensitivity among members of the human population (intraspecies).
* Inhalation toxicity is assumed to be equivalent to toxicity via the oral route.

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 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA used tolerance level residues for most commodities and 
Pesticide Data Program (PDP) monitoring data for apples, apple juice, 
apple sauce, cantaloupe, carrots, cereal grains, cucumbers, milk, 
pears, soybeans, tomatoes, and watermelons. Maximum percent crop 
treated (PCT) estimates were used for some commodities. Default 
processing factors were used for some processed commodities and 
empirical factors were used for others.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, since deltamethrin is 
registered for use in food handling establishments (FHEs), residue 
values were entered for all commodities in the Dietary Exposure 
Evaluation Model software-Food Commodity Intake Database (DEEM-

[[Page 66298]]

FCID). Tolerance level residues were used for most commodities. For 
cereal grain commodities, average monitoring data values were used. For 
milk, PDP monitoring data were used. For the commodities for which the 
only established tolerance is the FHE tolerance, a residue value of 
0.025 ppm (\1/2\ the FHE tolerance) was used. The FHE tolerance is 
based on the Limit of Quantitation (LOQ), and \1/2\ the tolerance was 
used as a refinement in the dietary assessment. For commodities with 
tolerances for agricultural uses, average PCT estimates were generally 
used. For the commodities for which \1/2\ the FHE tolerance was used, 
the assumption was made that there was a 4.65% chance that a food item 
consumed by a person contained deltamethrin residues as a result of 
treatment at some point in an FHE.
    The chronic assessment was conducted solely for the purpose of 
obtaining estimates of background levels of dietary exposure for 
estimating aggregate risk.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that deltamethrin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and 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:
    <bullet> 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.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows. For 
acute dietary: 2.5% for apples, cantaloupes, carrots, soybeans, 
tomatoes, and watermelons; 5% for cucumbers and pears. For chronic 
dietary: 1% for apples, cantaloupes, carrots, cotton, potatoes (some 
food forms), pumpkins, radishes, squash, tomatoes, turnips, and 
watermelon; 2.5% for cucumbers, leeks, onions, pears, and sunflowers; 
4.65% for the commodities for which \1/2\ the FHE tolerance was used; 
5% for canola and peppers; 40% for globe artichokes; and 100% for all 
other commodities for which direct treatment is allowed.
    In the chronic assessment, for the commodities for which \1/2\ the 
FHE tolerance was used, the assumption was made that there was a 4.65% 
chance that a food item consumed by a person contained deltamethrin 
residues as a result of treatment at some point in an FHE.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6-7 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which deltamethrin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for deltamethrin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of deltamethrin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Screening Concentration in Ground Water (SCI-GROW) 
models, the estimated drinking water concentrations (EDWCs) of 
deltamethrin for acute and chronic exposures are estimated to be 0.200 
parts per billion (ppb) for both surface water and ground water. 
Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Deltamethrin is currently registered for the following uses that 
could result in residential exposures: Residential outdoor and indoor 
sites, turf, paint additives, and pet products. EPA assessed potential 
exposures for residential handlers using several application methods 
including handwand and backpack sprayers to treat lawns, turf, and 
trees; and using shaker cans and aerosol sprays for trees and indoor 
crack and crevice applications. A quantitative dermal assessment for 
residential handlers was not conducted since no systemic toxicity 
associated with dermal exposure to deltamethrin was observed.

[[Page 66299]]

MOEs were calculated for the inhalation route of exposure only. Adult 
post-application exposures were not quantitatively assessed since no 
dermal hazard was identified for deltamethrin and inhalation exposures 
are typically negligible in outdoor settings. Furthermore, the 
inhalation exposure assessment performed for residential handlers is 
representative of worse case inhalation exposures and is considered 
protective for post-application inhalation scenarios.
    EPA assessed post-application incidental oral exposures to children 
for representative indoor/outdoor and pet incidental oral scenarios 
including hand-to-mouth, object-to-mouth, soil ingestion, and episodic 
granule ingestion scenarios. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    The Agency has determined that the pyrethroids and pyrethrins share 
a common mechanism of toxicity: The ability to interact with voltage-
gated sodium channels ultimately leading to neurotoxicity. The 
cumulative risk assessment (CRA) for the pyrethroids/pyrethrins 
(published in the Federal Register of November 9, 2011 (76 FR 69726) 
(FRL-8888-9), and available at http://www.regulations.gov; EPA-HQ-OPP-
2011-0746) did not identify cumulative risks of concern, allowing the 
Agency to consider new uses for pyrethroids. Deltamethrin was included 
in the pyrethroid/pyrethrin CRA.
    Dietary exposures make a minor contribution to the total pyrethroid 
exposure. The dietary exposure assessment performed in support of the 
pyrethroid CRA was much more highly refined than that performed for 
deltamethrin alone. Additionally, the PODs selected for deltamethrin 
are specific to deltamethrin, whereas the PODs selected for the 
cumulative assessment were based on common mechanism of action data 
that are appropriate for all 20 pyrethroids included in the CRA. 
Dietary exposure to deltamethrin residues resulting from the proposed 
import tolerance on finfish will contribute very little to the dietary 
exposure to deltamethrin alone and will have an insignificant impact on 
the cumulative risk assessment. No dietary, residential, or aggregate 
risk estimates of concern have been identified in the single chemical 
assessment.
    In the cumulative assessment, residential exposure was the greatest 
contributor to the total exposure. In order to determine if the 
registered deltamethrin indoor and turf uses will significantly 
contribute to, or change the overall findings in the pyrethroid CRA, 
the Agency performed a quantitative exposure and risk assessment. This 
assessment used the deltamethrin relative potency factor (RPF) as well 
as the same exposure algorithms and inputs that were used in the 2011 
pyrethroid CRA. In all cases, the estimated deltamethrin MOEs using the 
RPF method were higher (i.e., less of a risk concern) than those used 
in the 2011 pyrethroid CRA. Thus, the Agency continues to support the 
previous assessment, and concludes that the registered deltamethrin 
uses will not significantly contribute to the overall findings in the 
2011 pyrethroid CRA, and the proposed import tolerance for finfish will 
have no impact on the residential component of the cumulative risk 
estimates.
    For information regarding EPA's efforts to evaluate the risk of 
exposure to this class of chemicals, refer to: http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA SF. In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional SF when reliable data available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There were no indications of 
fetal toxicity in any of the guideline studies. Evidence of increased 
juvenile qualitative sensitivity was observed in the DNT and 2-
generation reproduction studies at doses that were considered to be 
relatively high (i.e., near lethal doses). However, at doses near the 
POD, no effects on parental animals or offspring were observed in 
either the DNT or 2-generation reproduction study and, therefore, there 
is no susceptibility at these doses.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 3x for infants and children <6 years old; and 
to 1x for children >6 years old, women of child bearing age and all 
adult populations. That decision is based on the following findings:
    i. The database of experimental toxicology studies available for 
deltamethrin is largely complete including developmental toxicity 
studies in rats and rabbits, a reproduction study in rats, and acute 
neurotoxicity (ACN), subchronic neurotoxicity (SCN), and DNT studies. 
The database provides a robust characterization profile for children 6 
years old and older, as well as for adults. In addition to the standard 
guideline studies, numerous studies from the scientific literature that 
describe the PD and PK profile of the pyrethroids in general have been 
considered in this assessment. Many of these studies were conducted 
with deltamethrin. A 28- or 90-day inhalation study is not available, 
but the Agency determined the study is not required for deltamethrin.
    ii. As with other pyrethroids, deltamethrin causes neurotoxicity 
from interaction with sodium channels leading to clinical signs of 
neurotoxicity. These effects are well characterized and adequately 
assessed by the body of data available to the Agency.
    iii. There were no indications of fetal toxicity in any of the 
guideline studies in the database, including developmental studies in 
the rat and rabbit, a developmental neurotoxicity study in rats, and a 
2-generation reproduction study in rats. There was evidence of 
increased juvenile qualitative susceptibility at high doses observed in 
both the DNT and 2-generation reproduction studies. These observations 
are consistent with the findings of juvenile sensitivity in the 
literature for deltamethrin. However, the observations of increased 
sensitivity were at doses that were considered to be relatively high 
(i.e., near lethal doses), whereas at doses near the point of 
departure, no effects on parental animals or offspring were observed in 
either the 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

[[Page 66300]]

children <6 years of age based on increased quantitative susceptibility 
seen in studies on pyrethroid PK (primarily conducted with 
deltamethrin) and the increased quantitative juvenile susceptibility 
observed in high dose guideline and literature studies with 
deltamethrin and other pyrethroids. The Agency has no residual 
uncertainties regarding age-related sensitivity for women of child 
bearing age as well as for all adult populations and children >=6 years 
of age, based on the absence of prenatal 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 PD.
    iv. There are no residual uncertainties with regard to dietary 
exposure. The dietary exposure assessments are based on high-end 
residue levels for most commodities, and that account for parent and 
metabolites of concern, processing factors, and percent crop treated 
assumptions. Furthermore, conservative, upper-bound assumptions were 
used to determine exposure through drinking water and residential 
sources, such that these exposures have not been underestimated.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, 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 80% of the aPAD for children 3-5 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. A chronic dietary risk assessment was not 
conducted because there is no apparent increase in hazard from 
repeated/chronic exposures to deltamethrin. Therefore, the acute 
endpoint is protective of the endpoints from repeat dosing studies. A 
chronic dietary exposure assessment was performed in order to generate 
background exposure estimates to aggregate with residential exposure 
estimates for the short-term aggregate risk assessment.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Deltamethrin 
is currently registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to deltamethrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 2,500 for the 
general U.S. population and of 530 for children 1-2 years old, the 
population group receiving the greatest exposure. Because EPA's level 
of concern for deltamethrin is a MOE of 300 or below, these MOEs are 
not of concern.
    4. Intermediate-term risk. Because no intermediate-term adverse 
effect was identified, deltamethrin is not expected to pose an 
intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, deltamethrin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to deltamethrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for deltamethrin in finfish.

C. Response to Comments

    One comment was received from the general public urging the Agency 
to tighten regulations for pesticides tolerances and uses. The 
commenter particularly addressed carcinogenic chemicals and their 
effects on children's health.
    The toxicological database for deltamethrin shows that the chemical 
does not pose a cancer risk to humans. Deltamethrin is classified as 
``Not likely to be carcinogenic to humans'' based on the absence of 
treatment related tumors in adequate rodent studies. Deltamethrin is a 
Type II pyrethroid, and as with other pyrethroids, deltamethrin causes 
neurotoxicity. These effects are well characterized and adequately 
assessed by the body of data available to the Agency. The Agency is 
confident that it has chosen endpoints, PODs, and uncertainty factors 
that are protective for all populations, including infants and 
children, and that have a strong scientific foundation. In addition, 
there are ongoing efforts to develop data to gain more information 
concerning the potential sensitivity of infants and young children to 
pyrethroids as a class. EPA has addressed the variability of 
sensitivities of the population to deltamethrin, including infants and 
children in Unit III.D.

[[Page 66301]]

D. Revisions to Petitioned-For Tolerances

    Pharmaq AS requested the establishment of a permanent tolerance, 
for residues of the insecticide deltamethrin in all imported 
commercially farmed finfish at 0.01 ppm. Since there is no commodity 
definition covering all finfish, the Agency is establishing tolerances 
of 0.01 ppm in ``fish--freshwater finfish,'' ``fish--freshwater 
finfish, farm raised,'' ``fish--saltwater finfish, other,'' and 
``fish--saltwater finfish, tuna.''
    The Agency is revising the tolerance expression to clarify that:
    1. As provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of deltamethrin not specifically mentioned.
    2. Compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of deltamethrin, 
including its metabolites and degradates in or on fish--freshwater 
finfish; fish--freshwater finfish, farm raised; fish--saltwater 
finfish, other; and fish--saltwater finfish, tuna at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 29, 2014.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.435:
0
a. Revise the introductory text of paragraph (a)(1).
0
b. Add alphabetically to the table in paragraph (a)(1) the following 
commodities.
    The amendments read as follows:


Sec.  180.435  Deltamethrin; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
deltamethrin, including its metabolites and degradates, in or on the 
commodities listed in the following table. Compliance with the 
tolerance levels specified is to be determined by measuring only 
deltamethrin, (1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl 
ester, and its major metabolites, trans-deltamethrin, (S)-alpha-cyano-
m-phenoxybenzyl(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, and alpha-R-deltamethrin, (R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fish--freshwater finfish................................            0.01
Fish--freshwater finfish, farm raised...................            0.01
Fish--saltwater finfish, other..........................            0.01
Fish--saltwater finfish, tuna...........................            0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-26430 Filed 11-6-14; 8:45 am]
BILLING CODE 6560-50-P


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