[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Rules and Regulations]
[Pages 93824-93831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29882]



40 CFR Part 180

[EPA-HQ-OPP-2016-0236; FRL-9954-47]

Bifenthrin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes time-limited tolerances for 
residues of bifenthrin in or on avocado and pomegranate. This action is 
in response to EPA's granting of an emergency exemption under the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on avocado and pomegranate.
    This regulation establishes a maximum permissible level for 
residues of bifenthrin in or on these commodities. The time-limited 
tolerances expire on December 31, 2019.

DATES: This regulation is effective December 22, 2016. Objections and 
requests for hearings must be received on or before February 21, 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-2016-0236, 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: 
[email protected].


I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).

[[Page 93825]]

    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2016-0236 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 February 21, 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 objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0236, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of bifenthrin, (2-
propenyl)-2,2-dimethylcyclopropane-carboxylate), in or on avocado at 
0.50 parts per million (ppm) and pomegranate at 0.50 ppm. These time-
limited tolerances expire on December 31, 2019.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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. . . 
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Bifenthrin on Avocado and Pomegranate and 
FFDCA Tolerances

    The California Department of Pesticide Regulations (CDPR) requested 
an emergency exemption for the use of bifenthrin on avocados to control 
the polyphagous shot hole borer (PSHB), Euwallacea sp. near fornicatus. 
PSHB is a non-native ambrosia beetle that is only known to exist in 
Israel and now California, where it is a pest for avocados and numerous 
ornamental species. According to CDPR, substantial economic damage is 
occurring and 50% of baseline net operating revenue has been documented 
due to the inadequate efficacy and short residual activity of 
registered alternatives.
    CDPR also requested an emergency exemption for the use of 
bifenthrin on pomegranate to control leaffooted plant bug (LFPB), 
Leptoglossus clypealis, L. occidentalis, and L. zonatus. LFPBs are 
highly damaging pests for pomegranates. According to CDPR, substantial 
economic damage is occurring and 32% gross revenue loss is expected due 
to registered alternatives short residual activity and ineffective 
control of adult LFPB.
    After having reviewed the submission, EPA determined that an 
emergency condition exists in California, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of bifenthrin on 
avocado for control of polyphagous shot hole borer in California. 
Additionally, EPA has authorized crisis and specific exemptions under 
FIFRA section 18 for the use of bifenthrin on pomegranate to control 
leaffooted plant bug in California.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of bifenthrin in 
or on avocados and pomegranates. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and EPA decided that the necessary 
tolerances under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent, 
non-routine situation

[[Page 93826]]

and to ensure that the resulting food is safe and lawful, EPA is 
issuing these tolerances without notice and opportunity for public 
comment as provided in FFDCA section 408(l)(6). Although these time-
limited tolerances expire on December 31, 2019, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on avocados and pomegranate 
after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by these time-limited tolerances 
at the time of that application. EPA will take action to revoke these 
time-limited tolerances earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
bifenthrin meets FIFRA's registration requirements for use on avocados 
and pomegranate or whether permanent tolerances for these uses would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerance decision serves as a basis for registration of 
bifenthrin by a State for special local needs under FIFRA section 
24(c), nor do these tolerances by themselves serve as the authority for 
persons in any State other than California to use this pesticide on the 
applicable crops under FIFRA section 18, absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for bifenthrin, contact 
the Agency's Registration Division at the address provided under FOR 

IV. 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 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 
exposures expected as a result of these emergency exemption requests 
and the time-limited tolerances for residues of bifenthrin on avocado 
at 0.50 ppm and pomegranate at 0.50 ppm. EPA's assessment of exposures 
and risks associated with establishing time-limited tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for bifenthrin used for 
human risk assessment is discussed in Table 1 of the final rule 
published in the Federal Register of September 14, 2012, 77 FR 56782 

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to bifenthrin, EPA considered exposure under the time-limited 
tolerances established by this action as well as all existing 
bifenthrin tolerances in 40 CFR 180.442. EPA assessed dietary exposures 
from bifenthrin in food as follows:
    i. Acute exposure. Acute effects were identified for bifenthrin. 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 and the Dietary Exposure Evaluation Model-Food 
Consumption Intake Database (DEEM-FCID, version 3.16). As to residue 
levels in food, EPA developed anticipated residues (ARs) based on the 
latest USDA Pesticide Data Program (PDP) monitoring data 1998-2010, 
Food and Drug Administration (FDA) data, and field trial data (FTD) for 
bifenthrin. The assessment also made use of percent crop treated (PCT) 
data where available.
    ii. Chronic exposure. EPA determined that there is no increase in 
hazard from repeat exposures to bifenthrin. Therefore, the acute 
dietary exposure assessment is protective for chronic dietary exposures 
because acute exposure levels are higher than chronic exposure levels. 
Accordingly, a dietary exposure assessment for the purpose of assessing 
chronic dietary risk was not conducted.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. Based on the data summarized in Unit 
IV.A., EPA has concluded that a nonlinear RfD approach is appropriate 
for assessing cancer risk to bifenthrin. Cancer risk was assessed using 
the same exposure estimates as discussed in Unit IV.B.1.ii., chronic 
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA

[[Page 93827]]

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 
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Alfalfa, 1%; apple, 10%; almond, 25%; artichoke, 30%; beans, green, 
50%; broccoli, 6%; cabbage, 30%; caneberries, 45%; canola/rapeseed, 3%; 
cantaloupe, 60%; carrots 10%; cauliflower, 10%; celery, 1%; corn, 5%; 
cotton, 10%; cucumbers, 15%; dry beans and peas, 1%; grape, table, 1%; 
grape, wine, 5%; honeydew, 75%; hazelnut (filberts), 5%; lettuce, 15%; 
onion, 1%; lima bean, 35%; nectarine, 3%; peanut, 5%; pea, green, 25%; 
peach, 7%; pear, 1%; pecan, 5%; pepper, 20%; pistachio, 40%; potato, 
5%; pumpkin, 40%; sorghum, 1%; soybean, 5%; squash, 20%; strawberry, 
55%; sweet corn, 50%; tomato, 20%; walnut, 25%; watermelon, 15%; wheat, 
spring, 1%; and wheat, winter, 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 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 and 
averaging across all observations. 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 assumed 100% PCT for avocado and pomegranate uses.
    The Agency believes that the three conditions discussed in Unit 
IV.B1.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 bifenthrin may be applied in a particular area.
    The previous dietary exposure assessment for use avocado relied on 
PCT estimates generated in 2011; however, recently updated bifenthrin 
PCT information (Screening Level Estimates of Agricultural Uses of 
Bifenthrin from 2005-2014; Updated Screening Level Usage Analysis 
(SLUA) report for Bifenthrin (03/24/2016)) have become available for 
consideration. When comparing the PCT estimates used previously with 
those that were updated in 2016, some individual PCT estimates 
increased, and some decreased. For most foods (e.g., apples, green 
beans, grapes, peaches) which are typically risk drivers for the 
infants and children's populations who have highest estimated risks, 
the PCT data used in the previous assessment have not increased 
significantly or at all. Crops with significant increases (> 15% CT) 
are generally not those which are typically risk drivers (e.g., 
artichokes, cabbage, canola). A significant children's food for which 
PCT increased significantly (25% to 50%CT) is green peas; however, 
since bifenthrin residues in peas are non-detectable in PDP monitoring 
data, a significant increase in estimated risks is not expected. 
Similarly, for other crops with smaller increases in PCT (almonds, 
sweet corn, peanuts, pecans, pistachios, and walnuts) detectable 
residues are not found; therefore, significant increases in dietary 
risk are not expected. While there are increases in PCT for some crops 
which are expected to lead to increased risk estimates (cucurbits, Cole 
crops, tomatoes, and some berries), the increased risk is expected to 
be small. Considering all of these factors, the updated PCT estimates 
are not expected to affect the results of the 2011 bifenthrin acute 
dietary risk assessment enough to warrant revising that assessment for 
this time limited tolerance decision. Even with the emergency use of 
bifenthrin on pomegranates, and the new PCT estimates, EPA remains 
confident that bifenthrin exposures are below the aPADs for all 
population subgroups.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for bifenthrin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of bifenthrin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), 
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 bifenthrin for 
acute exposures are estimated to be 0.0140 parts per billion (ppb) for 
surface water and 0.0030 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 0.0140 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and

[[Page 93828]]

flea and tick control on pets). Residential exposure is not anticipated 
from the use of bifenthrin on avocados and pomegranates because the 
emergency uses are restricted for use only by certified applicators and 
applicators under their direct supervision.
    However, bifenthrin is currently registered for the following uses 
that could result in residential exposures: in indoor residential/
household premises in the form of crack and crevice sprays, surface-
directed application to indoor surfaces (bed bug treatment), as a paint 
additive, dust, automobiles/recreational vehicles and termite 
treatments. Outdoor residential uses of bifenthrin include broadcast 
and spot treatments including the following: Residential lawns and 
turf; golf course turf and outdoor premises (fencerows/hedgerows, 
paths/patios) by means of liquid spray and granular products; and 
ornamental (turf, shrubs, vines, trees, ground cover). EPA assessed 
residential exposure using the following assumptions: The Agency 
combines risk values resulting from separate routes of exposure when it 
is likely they can occur simultaneously based on the use pattern and 
the behavior associated with the exposed population, and if the hazard 
associated with the points of departure is similar across routes. A 
common toxicological endpoint, neurotoxicity, exists for dermal, 
incidental oral, and inhalation routes of exposure to bifenthrin. 
Therefore, these were combined for all residential exposure scenarios 
assessed. Of the proposed and established uses with potential 
residential handler and post-application exposure, the following high-
end risk estimates were selected for use in the bifenthrin short-term 
aggregate assessment: Combined dermal and inhalation exposures to 
adults from the outdoor ornamental use and combined dermal and 
incidental oral exposures to children from contact with treated turf. 
Residential handler and post-application exposure scenarios are 
generally not combined. Although the potential exists for the same 
individual (i.e., adult) to apply a pesticide around the home and be 
exposed by re-entering a treated area in the same day, this is an 
unlikely exposure scenario. Combining these exposure scenarios would 
also be inappropriate because of the conservative nature of each 
individual assessment.
    EPA did not assess intermediate-term and chronic residential 
exposures because bifenthrin is acutely toxic and does not increase in 
potency with repeated dosing. 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 is required to consider the cumulative risks of 
chemicals sharing a common mechanism of toxicity. The Agency has 
determined that the pyrethroids and pyrethrins, including bifenthrin, 
share a common mechanism of toxicity. The members of this group share 
the ability to interact with voltage-gated sodium channels, ultimately 
leading to neurotoxicity. The cumulative risk assessment for the 
pyrethroids/pyrethrins was published on Nov. 9, 2011, and is available 
at http://www.regulations.gov in the public docket, EPA-HQ-OPP-2011-
0746. Further information about the determination that pyrethroids and 
pyrethrins share a common mechanism of toxicity may be found in 
document ID: EPA-HQ-OPP-2008-0489-0006.
    The Agency has conducted a quantitative analysis of the increased 
risk potential resulting from the section 18 use of bifenthrin on 
avocados and pomegranates; this analysis is summarized in the 
documents: ``Human Health Risk Assessment to Support Section 18 
Specific Emergency Exemption Use on Avocado'' and ``Bifenthrin. Section 
18 Request for Use on Pomegranate in California'' in docket ID number 
EPA-HQ-OPP-2016-0236. Since dietary exposures are a minor component of 
the overall pyrethroid cumulative risk, the uses on avocados and 
pomegranates will not contribute significantly or change the overall 
findings presented in the pyrethroid cumulative risk assessment. For 
information regarding EPA's efforts to evaluate the risk of exposure to 
pyrethroids, refer to https://www.epa.gov/ingredients-used-pesticide-products/pyrethrins-and-pyrethroids#reg review.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. The bifenthrin toxicity 
database includes developmental toxicity studies in rats and rabbits, a 
2-generation reproduction study in rats, and a developmental 
neurotoxicity (DNT) study in rats. Bifenthrin is neither a 
developmental nor a reproductive toxicant. In the developmental 
toxicity studies in rat and rabbit, no developmental effects of 
biological significance were noted in either species in the presence of 
maternal toxicity. In a 2-generation reproduction study in the rat, 
tremors were noted only in females of both generations with one 
parental generation rat observed to have clonic convulsions. There are 
several in vitro and in vivo studies that indicate pharmacodynamic 
contributions to pyrethroid toxicity are not age-dependent. A study of 
the toxicity database for pyrethroid chemicals also noted no residual 
uncertainties regarding age-related sensitivities for the young, based 
on the absence of prenatal sensitivity observed in 76 guideline studies 
for 24 pyrethroids and the scientific literature. However, high-dose 
studies at Lethal Dose (LD)50 doses noted that younger 
animals were more susceptible to the toxicity of pyrethroids. These 
age-related differences in toxicity are principally due to age-
dependent pharmacokinetics; the activity of enzymes associated with the 
metabolism of pyrethroids increases with age. Nonetheless, the typical 
environmental exposures to pyrethroids are not expected to overwhelm 
the clearance capacity in juveniles. In support, at a dose of 4.0 mg/kg 
deltamethrin (near the Wolansky study LOAEL value of 3.0 mg/kg for 
deltamethrin), the change in the acoustic startle response was similar 
between adult and young rats.
    3. Conclusion. The Agency is reducing the FQPA SF to 1X for adults, 
including women of child-bearing age, and children greater than 6 years 
of age, resulting in a total uncertainty factor of 100 (10x 
interspecies, 10x intraspecies, 1x FQPA). However, the Agency is 
retaining a 3X FQPA SF for children from birth to 6 years of age 
resulting in a total uncertainty factor of 300 (10x

[[Page 93829]]

interspecies, 10x intraspecies, 3x FQPA).
    EPA has determined that reliable data show that the safety of 
infants and children less than or equal to 6 years old would be 
adequately protected if the FQPA SF were retained to 3X. That decision 
is based on the following findings:
    i. The toxicity database for bifenthrin is complete.
    ii. Like other pyrethroids, bifenthrin causes clinical signs of 
neurotoxicity from interaction with sodium channels. These effects are 
adequately assessed by the available guideline and non-guideline 
studies. Bifenthrin is a Type I pyrethroid, and neurotoxic effects 
characteristic of Type I pyrethroids were observed in adults in most of 
the bifenthrin toxicity database. Specifically, muscle tremors and 
decreased motor activity were observed in adults in guideline studies 
throughout the bifenthrin toxicology database, and hind-limb flexion 
was observed in adults the dermal study. For these reasons, the tremors 
seen in juveniles in the 2-generation reproduction study are not 
considered age-dependent effects.
    iii. There is no evidence that bifenthrin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. This is consistent with the results of the guideline pre- and 
post-natal testing for other pyrethroid pesticides. There are, however, 
high dose LD50 studies (studies assessing what dose results 
in lethality to 50 percent of the tested population) in the scientific 
literature indicating that pyrethroids can result in increased 
quantitative sensitivity in the young. Examination of pharmacokinetic 
and pharmacodynamic data indicates that the sensitivity observed at 
high doses is related to pyrethroid age-dependent pharmacokinetics--the 
activity of enzymes associated with the metabolism of pyrethroids. 
Predictive pharmacokinetic models indicate that the differential adult-
juvenile pharmacokinetics will result in otherwise equivalent 
administered doses for adults and juveniles producing a 3X greater dose 
at the target organ in juveniles compared to adults. No evidence of 
increased quantitative or qualitative susceptibility was seen in the 
pyrethroid scientific literature related to pharmacodynamics (the 
effect of pyrethroids at the target tissue) both with regard to inter-
species differences between rats and humans and to differences between 
juveniles and adults. Specifically, there are in vitro pharmacodynamic 
data and in vivo data indicating similar responses between adult and 
juvenile rats at low doses and data indicating that the rat is a 
conservative model compared to the human based on species-specific 
pharmacodynamics of homologous sodium channel isoforms in rats and 
    In light of the high dose literature studies showing juvenile 
sensitivity to pyrethroids and the absence of any additional data 
indicating a lack of elevated sensitivity to juveniles relative to 
adults, EPA is retaining a 3X additional safety factor as estimated by 
pharmacokinetic modeling. For several reasons, EPA concludes there are 
reliable data showing that a 3X factor is protective of the safety of 
infants and children. First, the high doses that produced juvenile 
sensitivity in the literature studies are well above normal dietary or 
residential exposure levels of pyrethroids to juveniles and these lower 
levels of exposure are not expected to overwhelm the ability metabolize 
pyrethroids as occurred with the high doses used in the literature 
studies. This is confirmed by the lack of a finding of increased 
sensitivity in pre- and post-natal guideline studies in any pyrethroid, 
including bifenthrin, despite the relatively high doses used in those 
studies. Second, the portions of both the inter- and intraspecies 
uncertainty factors that account for potential pharmacodynamic 
differences (generally considered to be approximately 3X for each 
factor) are likely to overstate the risk of inter- and intraspecies 
pharmacodynamic differences given the data showing similarities in 
pharmacodynamics between juveniles and adults and between humans and 
rats. Finally, as indicated, pharmacokinetic modeling only predicts a 
3X difference between juveniles and adults.
    iv. There are no residual uncertainties identified in the exposure 
databases with regard to dietary (food and drinking water), and 
residential exposures. Although the acute dietary exposure estimates 
are refined, the exposure estimates will not underestimate risk for the 
established and proposed uses of bifenthrin since the residue levels 
used are based on either monitoring data reflecting actual residues 
found in the food supply, or on high-end residues from field trials 
which reflect the use patterns which would result in highest residues 
in foods. Furthermore, processing factors used were either those 
measured in processing studies, or default high-end factors 
representing the maximum concentration of residue into a processed 
commodity. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to bifenthrin 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 bifenthrin.

D. 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 bifenthrin will occupy 7% of the aPAD for the general U.S. 
population and 54% of the aPAD for infants <1 year old, the population 
group receiving the greatest exposure.
    2. Chronic risk. Based on the data summarized in Unit IV.B.ii., 
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). Bifenthrin 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 bifenthrin.
    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 250 for adults 
and 340 for children 1 < 2 years old, the most highly exposed 
population. Because EPA's level of concern (LOC) for bifenthrin is a 
MOE of 100 or less for adults and 300

[[Page 93830]]

for children 1<2, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Because no intermediate-term adverse effect 
was identified, bifenthrin is not expected to pose an intermediate-term 
risk. An intermediate-term and/or chronic aggregate risk assessment was 
not conducted because bifenthrin is acutely toxic and 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.
    5. Aggregate cancer risk for U.S. population. The acute aggregate 
assessment is protective of potential chronic aggregate exposures. For 
these same reasons, the acute aggregate assessment is also protective 
of potential cancer risk.
    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 bifenthrin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (gas chromatography/electron 
capture detection) 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: 
[email protected].

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 bifenthrin in or on avocado 
and pomegranate.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
bifenthrin, 2-methyl[1,1'-biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3-
trifluoro-1-propenyl)-2,2-dimethylcyclopropane-carboxylate), in or on 
avocado at 0.50 ppm and pomegranate at 0.50 ppm. These tolerances 
expire on December 31, 2019.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This 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).

VIII. 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: November 10, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.442, revise paragraph (b) to read as follows:

Sec.  [emsp14]180.442  Bifenthrin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for

[[Page 93831]]

residues of the bifenthrin, (2-methyl[1,1'-biphenyl]-3-yl)methyl-3-(2-
carboxylate) in or on the specified agricultural commodities, resulting 
from use of the pesticide pursuant to FIFRA section 18 emergency 
exemptions. The tolerances expire on the date specified in the table.

                                               Parts per    Expiration
                  Commodity                     million        date
Apple........................................       0.5       12/31/2018
Avocado......................................       0.50      12/31/2019
Nectarine....................................       0.5       12/31/2018
Peach........................................       0.5       12/31/2018
Pomegranate..................................       0.50      12/31/2019

* * * * *

[FR Doc. 2016-29882 Filed 12-21-16; 8:45 am]