81_FR_94070 81 FR 93824 - Bifenthrin; Pesticide Tolerances for Emergency Exemptions

81 FR 93824 - Bifenthrin; Pesticide Tolerances for Emergency Exemptions

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 246 (December 22, 2016)

Page Range93824-93831
FR Document2016-29882

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.

Federal Register, Volume 81 Issue 246 (Thursday, December 22, 2016)
[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Rules and Regulations]
[Pages 93824-93831]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29882]


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ENVIRONMENTAL PROTECTION AGENCY

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.

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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: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
    [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 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

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

II. 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-
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 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 
FURTHER INFORMATION CONTACT.

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 
(FRL-9361-6).

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

In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    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 
humans.
    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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has 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.

0
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.  180.442, 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-
chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropane-
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]
 BILLING CODE 6560-50-P



                                           93824            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations

                                           appropriate, disproportionate human                       Representatives, and the Comptroller                             reference, Intergovernmental relations,
                                           health or environmental effects, using                    General of the United States prior to                            Nitrogen dioxide, Ozone, Reporting and
                                           practicable and legally permissible                       publication of the rule in the Federal                           recordkeeping requirements.
                                           methods, under Executive Order 12898                      Register. A major rule cannot take effect                          Dated: December 6, 2016.
                                           (59 FR 7629, February 16, 1994).                          until 60 days after it is published in the
                                                                                                                                                                      Heather McTeer Toney,
                                             The SIP is not approved to apply on                     Federal Register. These actions are not
                                           any Indian reservation land or in any                                                                                      Regional Administrator, Region 4.
                                                                                                     a ‘‘major rule’’ as defined by 5 U.S.C.
                                           other area where EPA or an Indian tribe                   804(2).                                                              40 CFR part 52 is amended as follows:
                                           has demonstrated that a tribe has                            Under section 307(b)(1) of the CAA,
                                           jurisdiction. In those areas of Indian                    petitions for judicial review of these                           PART 52—APPROVAL AND
                                           country, the rules do not have tribal                     actions must be filed in the United                              PROMULGATION OF
                                           implications as specified by Executive                    States Court of Appeals for the                                  IMPLEMENTATION PLANS
                                           Order 13175 (65 FR 67249, November 9,                     appropriate circuit by February 21,
                                           2000), nor will they impose substantial                   2017. Filing a petition for
                                                                                                                                                                      ■ 1. The authority citation for part 52
                                           direct costs on tribal governments or                     reconsideration by the Administrator of
                                                                                                                                                                      continues to read as follows:
                                           preempt tribal law.                                       this final rule does not affect the finality
                                             The Congressional Review Act, 5                         of these actions for the purposes of                                 Authority: 42 U.S.C. 7401 et seq.
                                           U.S.C. 801 et seq., as added by the Small                 judicial review nor does it extend the
                                           Business Regulatory Enforcement                           time within which a petition for judicial                        Subpart Z—Mississippi
                                           Fairness Act of 1996, generally provides                  review may be filed, and shall not
                                           that before a rule may take effect, the                   postpone the effectiveness of such rule                          ■ 2. Section 52.1270(e) is amended by
                                           agency promulgating the rule must                         or action. These actions may not be                              adding a new entry ‘‘Good Neighbor
                                           submit a rule report, which includes a                    challenged later in proceedings to                               Provisions (Section 110(a)(2)(D)(i)(I)) for
                                           copy of the rule, to each House of the                    enforce its requirements. See section                            the 2010 1-hour NO2 NAAQS’’ at the
                                           Congress and to the Comptroller General                   307(b)(2).                                                       end of the table to read as follows:
                                           of the United States. EPA will submit a
                                                                                                     List of Subjects in 40 CFR Part 52                               § 52.1270      Identification of plan.
                                           report containing these actions and
                                           other required information to the U.S.                      Environmental protection, Air                                  *       *    *          *       *
                                           Senate, the U.S. House of                                 pollution control, Incorporation by                                  (e) * * *
                                                                                     EPA APPROVED MISSISSIPPI NON-REGULATORY PROVISIONS
                                                                                                 Applicable geographic             State submittal
                                                 Name of non-regulatory SIP provision                                                                                     EPA approval date                       Explanation
                                                                                                 or nonattainment area            date/effective date


                                                               *               *                          *                           *                     *                    *                      *
                                           Good      Neighbor       Provisions   (Section        Mississippi ..................            5/23/2016    12/22/16, [Insert Federal Register citation] ..........
                                            110(a)(2)(D)(i)(I) for the 2010 1-hour NO2
                                            NAAQS.



                                           [FR Doc. 2016–30641 Filed 12–21–16; 8:45 am]              commodities. The time-limited                                    information about the docket available
                                           BILLING CODE 6560–50–P                                    tolerances expire on December 31, 2019.                          at http://www.epa.gov/dockets.
                                                                                                     DATES: This regulation is effective                              FOR FURTHER INFORMATION CONTACT:
                                                                                                     December 22, 2016. Objections and                                Michael L. Goodis, Registration Division
                                           ENVIRONMENTAL PROTECTION                                  requests for hearings must be received                           (7505P), Office of Pesticide Programs,
                                           AGENCY                                                    on or before February 21, 2017, and                              Environmental Protection Agency, 1200
                                                                                                     must be filed in accordance with the                             Pennsylvania Ave. NW., Washington,
                                           40 CFR Part 180                                                                                                            DC 20460–0001; main telephone
                                                                                                     instructions provided in 40 CFR part
                                           [EPA–HQ–OPP–2016–0236; FRL–9954–47]                       178 (see also Unit I.C. of the                                   number: (703) 305–7090; email address:
                                                                                                     SUPPLEMENTARY INFORMATION).                                      RDFRNotices@epa.gov.
                                           Bifenthrin; Pesticide Tolerances for                                                                                       SUPPLEMENTARY INFORMATION:
                                                                                                     ADDRESSES: The docket for this action,
                                           Emergency Exemptions
                                                                                                     identified by docket identification (ID)                         I. General Information
                                           AGENCY:  Environmental Protection                         number EPA–HQ–OPP–2016–0236, is
                                           Agency (EPA).                                             available at http://www.regulations.gov                          A. Does this action apply to me?
                                           ACTION: Final rule.                                       or at the Office of Pesticide Programs                              You may be potentially affected by
                                                                                                     Regulatory Public Docket (OPP Docket)                            this action if you are an agricultural
                                           SUMMARY:   This regulation establishes                    in the Environmental Protection Agency                           producer, food manufacturer, or
                                           time-limited tolerances for residues of                   Docket Center (EPA/DC), West William                             pesticide manufacturer. The following
                                           bifenthrin in or on avocado and                           Jefferson Clinton Bldg., Rm. 3334, 1301                          list of North American Industrial
                                           pomegranate. This action is in response                   Constitution Ave. NW., Washington, DC                            Classification System (NAICS) codes is
                                           to EPA’s granting of an emergency                         20460–0001. The Public Reading Room                              not intended to be exhaustive, but rather
                                           exemption under the Federal                               is open from 8:30 a.m. to 4:30 p.m.,                             provides a guide to help readers
Lhorne on DSK30JT082PROD with RULES




                                           Insecticide, Fungicide, and Rodenticide                   Monday through Friday, excluding legal                           determine whether this document
                                           Act (FIFRA) authorizing use of the                        holidays. The telephone number for the                           applies to them. Potentially affected
                                           pesticide on avocado and pomegranate.                     Public Reading Room is (202) 566–1744,                           entities may include:
                                             This regulation establishes a                           and the telephone number for the OPP                                • Crop production (NAICS code 111).
                                           maximum permissible level for residues                    Docket is (703) 305–5805. Please review                             • Animal production (NAICS code
                                           of bifenthrin in or on these                              the visitor instructions and additional                          112).


                                      VerDate Sep<11>2014    15:15 Dec 21, 2016   Jkt 241001   PO 00000     Frm 00034       Fmt 4700      Sfmt 4700   E:\FR\FM\22DER1.SGM       22DER1


                                                            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations                                      93825

                                             • Food manufacturing (NAICS code                       follow the instructions at http://                       Section 18 of FIFRA authorizes EPA
                                           311).                                                    www.epa.gov/dockets/contacts.html.                    to exempt any Federal or State agency
                                             • Pesticide manufacturing (NAICS                         Additional instructions on                          from any provision of FIFRA, if EPA
                                           code 32532).                                             commenting or visiting the docket,                    determines that ‘‘emergency conditions
                                                                                                    along with more information about                     exist which require such exemption.’’
                                           B. How can I get electronic access to
                                                                                                    dockets generally, is available at http://            EPA has established regulations
                                           other related information?
                                                                                                    www.epa.gov/dockets.                                  governing such emergency exemptions
                                             You may access a frequently updated                                                                          in 40 CFR part 166.
                                           electronic version of 40 CFR part 180                    II. Background and Statutory Findings
                                           through the Government Printing                                                                                III. Emergency Exemption for
                                                                                                       EPA, on its own initiative, in                     Bifenthrin on Avocado and
                                           Office’s e-CFR site at http://                           accordance with FFDCA sections 408(e)
                                           www.ecfr.gov/cgi-bin/text-                                                                                     Pomegranate and FFDCA Tolerances
                                                                                                    and 408(l)(6) of, 21 U.S.C. 346a(e) and
                                           idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                                                                              The California Department of
                                                                                                    346a(1)(6), is establishing time-limited
                                           40tab_02.tpl. To access the OCSPP test                                                                         Pesticide Regulations (CDPR) requested
                                                                                                    tolerances for residues of bifenthrin, (2-
                                           guidelines referenced in this document                                                                         an emergency exemption for the use of
                                                                                                    methyl[1,1′-biphenyl]-3-yl)methyl-3-(2-
                                           electronically, please go to http://                                                                           bifenthrin on avocados to control the
                                                                                                    chloro-3,3,3-trifluoro-1-propenyl)-2,2-
                                           www.epa.gov/ocspp and select ‘‘Test                                                                            polyphagous shot hole borer (PSHB),
                                                                                                    dimethylcyclopropane-carboxylate), in
                                           Methods and Guidelines.’’                                                                                      Euwallacea sp. near fornicatus. PSHB is
                                                                                                    or on avocado at 0.50 parts per million
                                                                                                                                                          a non-native ambrosia beetle that is only
                                           C. How can I file an objection or hearing                (ppm) and pomegranate at 0.50 ppm.
                                                                                                                                                          known to exist in Israel and now
                                           request?                                                 These time-limited tolerances expire on
                                                                                                                                                          California, where it is a pest for
                                             Under section 408(g) of the Federal                    December 31, 2019.
                                                                                                                                                          avocados and numerous ornamental
                                           Food, Drug, and Cosmetic Act (FFDCA),                       Section 408(l)(6) of FFDCA requires                species. According to CDPR, substantial
                                           21 U.S.C. 346a, any person may file an                   EPA to establish a time-limited                       economic damage is occurring and 50%
                                           objection to any aspect of this regulation               tolerance or exemption from the                       of baseline net operating revenue has
                                           and may also request a hearing on those                  requirement for a tolerance for pesticide             been documented due to the inadequate
                                           objections. You must file your objection                 chemical residues in food that will                   efficacy and short residual activity of
                                           or request a hearing on this regulation                  result from the use of a pesticide under              registered alternatives.
                                           in accordance with the instructions                      an emergency exemption granted by                        CDPR also requested an emergency
                                           provided in 40 CFR part 178. To ensure                   EPA under FIFRA section 18. Such                      exemption for the use of bifenthrin on
                                           proper receipt by EPA, you must                          tolerances can be established without                 pomegranate to control leaffooted plant
                                           identify docket ID number EPA–HQ–                        providing notice or period for public                 bug (LFPB), Leptoglossus clypealis, L.
                                           OPP–2016–0236 in the subject line on                     comment. EPA does not intend for its                  occidentalis, and L. zonatus. LFPBs are
                                           the first page of your submission. All                   actions on FIFRA section 18 related                   highly damaging pests for
                                           objections and requests for a hearing                    time-limited tolerances to set binding                pomegranates. According to CDPR,
                                           must be in writing, and must be                          precedents for the application of FFDCA               substantial economic damage is
                                           received by the Hearing Clerk on or                      section 408 and the safety standard to                occurring and 32% gross revenue loss is
                                           before February 21, 2017. Addresses for                  other tolerances and exemptions.                      expected due to registered alternatives
                                           mail and hand delivery of objections                     Section 408(e) of FFDCA allows EPA to                 short residual activity and ineffective
                                           and hearing requests are provided in 40                  establish a tolerance or an exemption                 control of adult LFPB.
                                           CFR 178.25(b).                                           from the requirement of a tolerance on                   After having reviewed the
                                             In addition to filing an objection or                  its own initiative, i.e., without having              submission, EPA determined that an
                                           hearing request with the Hearing Clerk                   received any petition from an outside                 emergency condition exists in
                                           as described in 40 CFR part 178, please                  party.                                                California, and that the criteria for
                                           submit a copy of the filing (excluding                      Section 408(b)(2)(A)(i) of FFDCA                   approval of an emergency exemption are
                                           any Confidential Business Information                    allows EPA to establish a tolerance (the              met. EPA has authorized a specific
                                           (CBI)) for inclusion in the public docket.               legal limit for a pesticide chemical                  exemption under FIFRA section 18 for
                                           Information not marked confidential                      residue in or on a food) only if EPA                  the use of bifenthrin on avocado for
                                           pursuant to 40 CFR part 2 may be                         determines that the tolerance is ‘‘safe.’’            control of polyphagous shot hole borer
                                           disclosed publicly by EPA without prior                  Section 408(b)(2)(A)(ii) of FFDCA                     in California. Additionally, EPA has
                                           notice. Submit the non-CBI copy of your                  defines ‘‘safe’’ to mean that ‘‘there is a            authorized crisis and specific
                                           objection or hearing request, identified                 reasonable certainty that no harm will                exemptions under FIFRA section 18 for
                                           by docket ID number EPA–HQ–OPP–                          result from aggregate exposure to the                 the use of bifenthrin on pomegranate to
                                           2016–0236, by one of the following                       pesticide chemical residue, including                 control leaffooted plant bug in
                                           methods:                                                 all anticipated dietary exposures and all             California.
                                             • Federal eRulemaking Portal: http://                  other exposures for which there is                       As part of its evaluation of the
                                           www.regulations.gov. Follow the online                   reliable information.’’ This includes                 emergency exemption applications, EPA
                                           instructions for submitting comments.                    exposure through drinking water and in                assessed the potential risks presented by
                                           Do not submit electronically any                         residential settings, but does not include            residues of bifenthrin in or on avocados
                                           information you consider to be CBI or                    occupational exposure. Section                        and pomegranates. In doing so, EPA
                                           other information whose disclosure is                    408(b)(2)(C) of FFDCA requires EPA to                 considered the safety standard in
                                           restricted by statute.                                   give special consideration to exposure                FFDCA section 408(b)(2), and EPA
                                             • Mail: OPP Docket, Environmental                      of infants and children to the pesticide              decided that the necessary tolerances
Lhorne on DSK30JT082PROD with RULES




                                           Protection Agency Docket Center (EPA/                    chemical residue in establishing a                    under FFDCA section 408(l)(6) would be
                                           DC), (28221T), 1200 Pennsylvania Ave.                    tolerance and to ‘‘ensure that there is a             consistent with the safety standard and
                                           NW., Washington, DC 20460–0001.                          reasonable certainty that no harm will                with FIFRA section 18. Consistent with
                                             • Hand Delivery: To make special                       result to infants and children from                   the need to move quickly on the
                                           arrangements for hand delivery or                        aggregate exposure to the pesticide                   emergency exemption in order to
                                           delivery of boxed information, please                    chemical residue. . . .’’                             address an urgent, non-routine situation


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                                           93826            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations

                                           and to ensure that the resulting food is                 of infants and children to the pesticide              B. Exposure Assessment
                                           safe and lawful, EPA is issuing these                    chemical residue in establishing a                       1. Dietary exposure from food and
                                           tolerances without notice and                            tolerance and to ‘‘ensure that there is a             feed uses. In evaluating dietary
                                           opportunity for public comment as                        reasonable certainty that no harm will                exposure to bifenthrin, EPA considered
                                           provided in FFDCA section 408(l)(6).                     result to infants and children from                   exposure under the time-limited
                                           Although these time-limited tolerances                   aggregate exposure to the pesticide                   tolerances established by this action as
                                           expire on December 31, 2019, under                       chemical residue. . . .’’                             well as all existing bifenthrin tolerances
                                           FFDCA section 408(l)(5), residues of the                                                                       in 40 CFR 180.442. EPA assessed dietary
                                           pesticide not in excess of the amounts                     Consistent with the factors specified
                                                                                                    in FFDCA section 408(b)(2)(D), EPA has                exposures from bifenthrin in food as
                                           specified in the tolerance remaining in                                                                        follows:
                                           or on avocados and pomegranate after                     reviewed the available scientific data
                                                                                                    and other relevant information in                        i. Acute exposure. Acute effects were
                                           that date will not be unlawful, provided                                                                       identified for bifenthrin. In estimating
                                           the pesticide was applied in a manner                    support of this action. EPA has
                                                                                                    sufficient data to assess the hazards of,             acute dietary exposure, EPA used food
                                           that was lawful under FIFRA, and the                                                                           consumption information from the
                                           residues do not exceed a level that was                  and to make a determination on,
                                                                                                    aggregate exposures expected as a result              United States Department of Agriculture
                                           authorized by these time-limited                                                                               (USDA) 2003–2008 National Health and
                                           tolerances at the time of that                           of these emergency exemption requests
                                                                                                    and the time-limited tolerances for                   Nutrition Examination Survey, What We
                                           application. EPA will take action to
                                                                                                    residues of bifenthrin on avocado at                  Eat in America (NHANES/WWEIA and
                                           revoke these time-limited tolerances
                                                                                                    0.50 ppm and pomegranate at 0.50 ppm.                 the Dietary Exposure Evaluation Model-
                                           earlier if any experience with, scientific
                                                                                                    EPA’s assessment of exposures and risks               Food Consumption Intake Database
                                           data on, or other relevant information
                                                                                                                                                          (DEEM–FCID, version 3.16). As to
                                           on this pesticide indicate that the                      associated with establishing time-
                                                                                                                                                          residue levels in food, EPA developed
                                           residues are not safe.                                   limited tolerances follows.
                                             Because these time-limited tolerances                                                                        anticipated residues (ARs) based on the
                                           are being approved under emergency                       A. Toxicological Points of Departure/                 latest USDA Pesticide Data Program
                                           conditions, EPA has not made any                         Levels of Concern                                     (PDP) monitoring data 1998–2010, Food
                                           decisions about whether bifenthrin                                                                             and Drug Administration (FDA) data,
                                                                                                       Once a pesticide’s toxicological                   and field trial data (FTD) for bifenthrin.
                                           meets FIFRA’s registration requirements
                                                                                                    profile is determined, EPA identifies                 The assessment also made use of
                                           for use on avocados and pomegranate or
                                                                                                    toxicological points of departure (POD)               percent crop treated (PCT) data where
                                           whether permanent tolerances for these
                                                                                                    and levels of concern to use in                       available.
                                           uses would be appropriate. Under these
                                           circumstances, EPA does not believe                      evaluating the risk posed by human                       ii. Chronic exposure. EPA determined
                                           that this time-limited tolerance decision                exposure to the pesticide. For hazards                that there is no increase in hazard from
                                           serves as a basis for registration of                    that have a threshold below which there               repeat exposures to bifenthrin.
                                           bifenthrin by a State for special local                  is no appreciable risk, the toxicological             Therefore, the acute dietary exposure
                                           needs under FIFRA section 24(c), nor do                  POD is used as the basis for derivation               assessment is protective for chronic
                                           these tolerances by themselves serve as                  of reference values for risk assessment.              dietary exposures because acute
                                           the authority for persons in any State                   PODs are developed based on a careful                 exposure levels are higher than chronic
                                           other than California to use this                        analysis of the doses in each                         exposure levels. Accordingly, a dietary
                                           pesticide on the applicable crops under                  toxicological study to determine the                  exposure assessment for the purpose of
                                           FIFRA section 18, absent the issuance of                 dose at which no adverse effects are                  assessing chronic dietary risk was not
                                           an emergency exemption applicable                        observed (the NOAEL) and the lowest                   conducted.
                                           within that State. For additional                        dose at which adverse effects of concern                 iii. Cancer. EPA determines whether
                                           information regarding the emergency                      are identified (the LOAEL). Uncertainty/              quantitative cancer exposure and risk
                                           exemption for bifenthrin, contact the                    safety factors are used in conjunction                assessments are appropriate for a food-
                                           Agency’s Registration Division at the                    with the POD to calculate a safe                      use pesticide based on the weight of the
                                           address provided under FOR FURTHER                       exposure level—generally referred to as               evidence from cancer studies and other
                                           INFORMATION CONTACT.                                     a population-adjusted dose (PAD) or a                 relevant data. Cancer risk is quantified
                                                                                                    reference dose (RfD)—and a safe margin                using a linear or nonlinear approach. If
                                           IV. Aggregate Risk Assessment and                                                                              sufficient information on the
                                           Determination of Safety                                  of exposure (MOE). For non-threshold
                                                                                                    risks, the Agency assumes that any                    carcinogenic mode of action is available,
                                              Section 408(b)(2)(A)(i) of FFDCA                      amount of exposure will lead to some                  a threshold or nonlinear approach is
                                           allows EPA to establish a tolerance (the                 degree of risk. Thus, the Agency                      used and a cancer RfD is calculated
                                           legal limit for a pesticide chemical                     estimates risk in terms of the probability            based on an earlier noncancer key event.
                                           residue in or on a food) only if EPA                     of an occurrence of the adverse effect                If carcinogenic mode of action data are
                                           determines that the tolerance is ‘‘safe.’’               expected in a lifetime. For more                      not available, or if the mode of action
                                           Section 408(b)(2)(A)(ii) of FFDCA                                                                              data determines a mutagenic mode of
                                                                                                    information on the general principles
                                           defines ‘‘safe’’ to mean that ‘‘there is a                                                                     action, a default linear cancer slope
                                                                                                    EPA uses in risk characterization and a
                                           reasonable certainty that no harm will                                                                         factor approach is utilized. Based on the
                                                                                                    complete description of the risk
                                           result from aggregate exposure to the                                                                          data summarized in Unit IV.A., EPA has
                                                                                                    assessment process, see http://
                                           pesticide chemical residue, including                                                                          concluded that a nonlinear RfD
                                                                                                    www.epa.gov/pesticides/factsheets/
                                           all anticipated dietary exposures and all                                                                      approach is appropriate for assessing
                                           other exposures for which there is                       riskassess.htm.
                                                                                                                                                          cancer risk to bifenthrin. Cancer risk
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                                           reliable information.’’ This includes                       A summary of the toxicological                     was assessed using the same exposure
                                           exposure through drinking water and in                   endpoints for bifenthrin used for human               estimates as discussed in Unit IV.B.1.ii.,
                                           residential settings, but does not include               risk assessment is discussed in Table 1               chronic exposure.
                                           occupational exposure. Section                           of the final rule published in the                       iv. Anticipated residue and percent
                                           408(b)(2)(C) of FFDCA requires EPA to                    Federal Register of September 14, 2012,               crop treated (PCT) information. Section
                                           give special consideration to exposure                   77 FR 56782 (FRL–9361–6).                             408(b)(2)(E) of FFDCA authorizes EPA


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                                                            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations                                       93827

                                           to use available data and information on                 National Pesticide Use Database for the               CT) are generally not those which are
                                           the anticipated residue levels of                        chemical/crop combination for the most                typically risk drivers (e.g., artichokes,
                                           pesticide residues in food and the actual                recent 6–7 years. EPA uses an average                 cabbage, canola). A significant
                                           levels of pesticide residues that have                   PCT for chronic dietary risk analysis.                children’s food for which PCT increased
                                           been measured in food. If EPA relies on                  The average PCT figure for each existing              significantly (25% to 50%CT) is green
                                           such information, EPA must require                       use is derived by combining available                 peas; however, since bifenthrin residues
                                           pursuant to FFDCA section 408(f)(1)                      public and private market survey data                 in peas are non-detectable in PDP
                                           that data be provided 5 years after the                  for that use and averaging across all                 monitoring data, a significant increase
                                           tolerance is established, modified, or                   observations. EPA uses a maximum PCT                  in estimated risks is not expected.
                                           left in effect, demonstrating that the                   for acute dietary risk analysis. The                  Similarly, for other crops with smaller
                                           levels in food are not above the levels                  maximum PCT figure is the highest                     increases in PCT (almonds, sweet corn,
                                           anticipated. For the present action, EPA                 observed maximum value reported                       peanuts, pecans, pistachios, and
                                           will issue such data call-ins as are                     within the recent 6 years of available                walnuts) detectable residues are not
                                           required by FFDCA section 408(b)(2)(E)                   public and private market survey data                 found; therefore, significant increases in
                                           and authorized under FFDCA section                       for the existing use and rounded up to                dietary risk are not expected. While
                                           408(f)(1). Data will be required to be                   the nearest multiple of 5%.                           there are increases in PCT for some
                                           submitted no later than 5 years from the                   The Agency assumed 100% PCT for                     crops which are expected to lead to
                                           date of issuance of these tolerances.                    avocado and pomegranate uses.                         increased risk estimates (cucurbits, Cole
                                              Section 408(b)(2)(F) of FFDCA states                    The Agency believes that the three                  crops, tomatoes, and some berries), the
                                           that the Agency may use data on the                      conditions discussed in Unit IV.B1.iv.                increased risk is expected to be small.
                                           actual percent of food treated for                       have been met. With respect to                        Considering all of these factors, the
                                           assessing chronic dietary risk only if:                  Condition a, PCT estimates are derived                updated PCT estimates are not expected
                                              • Condition a: The data used are                      from Federal and private market survey                to affect the results of the 2011
                                           reliable and provide a valid basis to                    data, which are reliable and have a valid             bifenthrin acute dietary risk assessment
                                           show what percentage of the food                         basis. As to Conditions b and c, regional             enough to warrant revising that
                                           derived from such crop is likely to                      consumption information and                           assessment for this time limited
                                           contain the pesticide residue.                           consumption information for significant               tolerance decision. Even with the
                                              • Condition b: The exposure estimate                  subpopulations is taken into account                  emergency use of bifenthrin on
                                           does not underestimate exposure for any                  through EPA’s computer-based model                    pomegranates, and the new PCT
                                           significant subpopulation group.                         for evaluating the exposure of                        estimates, EPA remains confident that
                                              • Condition c: Data are available on                  significant subpopulations including                  bifenthrin exposures are below the
                                                                                                    several regional groups. Use of this                  aPADs for all population subgroups.
                                           pesticide use and food consumption in
                                                                                                    consumption information in EPA’s risk                    2. Dietary exposure from drinking
                                           a particular area, the exposure estimate
                                                                                                    assessment process ensures that EPA’s                 water. The Agency used screening level
                                           does not understate exposure for the
                                                                                                    exposure estimate does not understate                 water exposure models in the dietary
                                           population in such area.
                                                                                                    exposure for any significant                          exposure analysis and risk assessment
                                           In addition, the Agency must provide                     subpopulation group and allows the                    for bifenthrin in drinking water. These
                                           for periodic evaluation of any estimates                 Agency to be reasonably certain that no               simulation models take into account
                                           used. To provide for the periodic                        regional population is exposed to                     data on the physical, chemical, and fate/
                                           evaluation of the estimate of PCT as                     residue levels higher than those                      transport characteristics of bifenthrin.
                                           required by FFDCA section 408(b)(2)(F),                  estimated by the Agency. Other than the               Further information regarding EPA
                                           EPA may require registrants to submit                    data available through national food                  drinking water models used in pesticide
                                           data on PCT.                                             consumption surveys, EPA does not                     exposure assessment can be found at
                                              The Agency estimated the PCT for                      have available reliable information on                http://www.epa.gov/oppefed1/models/
                                           existing uses as follows:                                the regional consumption of food to                   water/index.htm.
                                              Alfalfa, 1%; apple, 10%; almond,                      which bifenthrin may be applied in a                     Based on the First Index Reservoir
                                           25%; artichoke, 30%; beans, green,                       particular area.                                      Screening Tool (FIRST), Pesticide Root
                                           50%; broccoli, 6%; cabbage, 30%;                           The previous dietary exposure                       Zone Model/Exposure Analysis
                                           caneberries, 45%; canola/rapeseed, 3%;                   assessment for use avocado relied on                  Modeling System (PRZM/EXAMS) and
                                           cantaloupe, 60%; carrots 10%;                            PCT estimates generated in 2011;                      Screening Concentration in Ground
                                           cauliflower, 10%; celery, 1%; corn, 5%;                  however, recently updated bifenthrin                  Water (SCI–GROW) models, the
                                           cotton, 10%; cucumbers, 15%; dry                         PCT information (Screening Level                      estimated drinking water concentrations
                                           beans and peas, 1%; grape, table, 1%;                    Estimates of Agricultural Uses of                     (EDWCs) of bifenthrin for acute
                                           grape, wine, 5%; honeydew, 75%;                          Bifenthrin from 2005–2014; Updated                    exposures are estimated to be 0.0140
                                           hazelnut (filberts), 5%; lettuce, 15%;                   Screening Level Usage Analysis (SLUA)                 parts per billion (ppb) for surface water
                                           onion, 1%; lima bean, 35%; nectarine,                    report for Bifenthrin (03/24/2016)) have              and 0.0030 ppb for ground water.
                                           3%; peanut, 5%; pea, green, 25%;                         become available for consideration.                      Modeled estimates of drinking water
                                           peach, 7%; pear, 1%; pecan, 5%;                          When comparing the PCT estimates                      concentrations were directly entered
                                           pepper, 20%; pistachio, 40%; potato,                     used previously with those that were                  into the dietary exposure model. For
                                           5%; pumpkin, 40%; sorghum, 1%;                           updated in 2016, some individual PCT                  acute dietary risk assessment, the water
                                           soybean, 5%; squash, 20%; strawberry,                    estimates increased, and some                         concentration value of 0.0140 ppb was
                                           55%; sweet corn, 50%; tomato, 20%;                       decreased. For most foods (e.g., apples,              used to assess the contribution to
                                           walnut, 25%; watermelon, 15%; wheat,                     green beans, grapes, peaches) which are               drinking water.
Lhorne on DSK30JT082PROD with RULES




                                           spring, 1%; and wheat, winter, 1%.                       typically risk drivers for the infants and               3. From non-dietary exposure. The
                                              In most cases, EPA uses available data                children’s populations who have                       term ‘‘residential exposure’’ is used in
                                           from United States Department of                         highest estimated risks, the PCT data                 this document to refer to non-
                                           Agriculture/National Agricultural                        used in the previous assessment have                  occupational, non-dietary exposure
                                           Statistics Service (USDA/NASS),                          not increased significantly or at all.                (e.g., for lawn and garden pest control,
                                           proprietary market surveys, and the                      Crops with significant increases (≤ 15%               indoor pest control, termiticides, and


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                                           93828            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations

                                           flea and tick control on pets).                          and generic inputs for residential                    and exposure unless EPA determines
                                           Residential exposure is not anticipated                  exposures may be found at: http://                    based on reliable data that a different
                                           from the use of bifenthrin on avocados                   www.epa.gov/pesticides/trac/science/                  margin of safety will be safe for infants
                                           and pomegranates because the                             trac6a05.pdf.                                         and children. This additional margin of
                                           emergency uses are restricted for use                       4. Cumulative effects from substances              safety is commonly referred to as the
                                           only by certified applicators and                        with a common mechanism of toxicity.                  Food Quality Protection Act Safety
                                           applicators under their direct                           Section 408(b)(2)(D)(v) of FFDCA                      Factor (FQPA SF). In applying this
                                           supervision.                                             requires that, when considering whether               provision, EPA either retains the default
                                              However, bifenthrin is currently                      to establish, modify, or revoke a                     value of 10X, or uses a different
                                           registered for the following uses that                   tolerance, the Agency consider                        additional SF when reliable data
                                           could result in residential exposures: in                ‘‘available information’’ concerning the              available to EPA support the choice of
                                           indoor residential/household premises                    cumulative effects of a particular                    a different factor.
                                           in the form of crack and crevice sprays,                 pesticide’s residues and’’ other                         2. Prenatal and postnatal sensitivity.
                                           surface-directed application to indoor                   substances that have a common                         The bifenthrin toxicity database
                                           surfaces (bed bug treatment), as a paint                 mechanism of toxicity.’’                              includes developmental toxicity studies
                                           additive, dust, automobiles/recreational                    The Agency is required to consider                 in rats and rabbits, a 2-generation
                                           vehicles and termite treatments.                         the cumulative risks of chemicals                     reproduction study in rats, and a
                                           Outdoor residential uses of bifenthrin                   sharing a common mechanism of                         developmental neurotoxicity (DNT)
                                           include broadcast and spot treatments                    toxicity. The Agency has determined                   study in rats. Bifenthrin is neither a
                                           including the following: Residential                     that the pyrethroids and pyrethrins,                  developmental nor a reproductive
                                           lawns and turf; golf course turf and                     including bifenthrin, share a common                  toxicant. In the developmental toxicity
                                           outdoor premises (fencerows/                             mechanism of toxicity. The members of                 studies in rat and rabbit, no
                                           hedgerows, paths/patios) by means of                     this group share the ability to interact              developmental effects of biological
                                           liquid spray and granular products; and                  with voltage-gated sodium channels,                   significance were noted in either species
                                           ornamental (turf, shrubs, vines, trees,                  ultimately leading to neurotoxicity. The              in the presence of maternal toxicity. In
                                           ground cover). EPA assessed residential                  cumulative risk assessment for the                    a 2-generation reproduction study in the
                                           exposure using the following                             pyrethroids/pyrethrins was published                  rat, tremors were noted only in females
                                           assumptions: The Agency combines risk                    on Nov. 9, 2011, and is available at                  of both generations with one parental
                                           values resulting from separate routes of                 http://www.regulations.gov in the public              generation rat observed to have clonic
                                           exposure when it is likely they can                      docket, EPA–HQ–OPP–2011–0746.                         convulsions. There are several in vitro
                                           occur simultaneously based on the use                    Further information about the                         and in vivo studies that indicate
                                           pattern and the behavior associated with                 determination that pyrethroids and                    pharmacodynamic contributions to
                                           the exposed population, and if the                       pyrethrins share a common mechanism                   pyrethroid toxicity are not age-
                                           hazard associated with the points of                     of toxicity may be found in document                  dependent. A study of the toxicity
                                           departure is similar across routes. A                    ID: EPA–HQ–OPP–2008–0489–0006.                        database for pyrethroid chemicals also
                                           common toxicological endpoint,                              The Agency has conducted a                         noted no residual uncertainties
                                           neurotoxicity, exists for dermal,                        quantitative analysis of the increased                regarding age-related sensitivities for the
                                           incidental oral, and inhalation routes of                risk potential resulting from the section             young, based on the absence of prenatal
                                           exposure to bifenthrin. Therefore, these                 18 use of bifenthrin on avocados and                  sensitivity observed in 76 guideline
                                           were combined for all residential                        pomegranates; this analysis is                        studies for 24 pyrethroids and the
                                           exposure scenarios assessed. Of the                      summarized in the documents: ‘‘Human                  scientific literature. However, high-dose
                                           proposed and established uses with                       Health Risk Assessment to Support                     studies at Lethal Dose (LD)50 doses
                                           potential residential handler and post-                  Section 18 Specific Emergency                         noted that younger animals were more
                                           application exposure, the following                      Exemption Use on Avocado’’ and                        susceptible to the toxicity of
                                           high-end risk estimates were selected                    ‘‘Bifenthrin. Section 18 Request for Use              pyrethroids. These age-related
                                           for use in the bifenthrin short-term                     on Pomegranate in California’’ in docket              differences in toxicity are principally
                                           aggregate assessment: Combined dermal                    ID number EPA–HQ–OPP–2016–0236.                       due to age-dependent pharmacokinetics;
                                           and inhalation exposures to adults from                  Since dietary exposures are a minor                   the activity of enzymes associated with
                                           the outdoor ornamental use and                           component of the overall pyrethroid                   the metabolism of pyrethroids increases
                                           combined dermal and incidental oral                      cumulative risk, the uses on avocados                 with age. Nonetheless, the typical
                                           exposures to children from contact with                  and pomegranates will not contribute                  environmental exposures to pyrethroids
                                           treated turf. Residential handler and                    significantly or change the overall                   are not expected to overwhelm the
                                           post-application exposure scenarios are                  findings presented in the pyrethroid                  clearance capacity in juveniles. In
                                           generally not combined. Although the                     cumulative risk assessment. For                       support, at a dose of 4.0 mg/kg
                                           potential exists for the same individual                 information regarding EPA’s efforts to                deltamethrin (near the Wolansky study
                                           (i.e., adult) to apply a pesticide around                evaluate the risk of exposure to                      LOAEL value of 3.0 mg/kg for
                                           the home and be exposed by re-entering                   pyrethroids, refer to https://                        deltamethrin), the change in the
                                           a treated area in the same day, this is an               www.epa.gov/ingredients-used-                         acoustic startle response was similar
                                           unlikely exposure scenario. Combining                    pesticide-products/pyrethrins-and-                    between adult and young rats.
                                           these exposure scenarios would also be                   pyrethroids#reg review.                                  3. Conclusion. The Agency is
                                           inappropriate because of the                                                                                   reducing the FQPA SF to 1X for adults,
                                           conservative nature of each individual                   C. Safety Factor for Infants and Children             including women of child-bearing age,
                                           assessment.                                                1. In general. Section 408(b)(2)(C) of              and children greater than 6 years of age,
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                                              EPA did not assess intermediate-term                  FFDCA provides that EPA shall apply                   resulting in a total uncertainty factor of
                                           and chronic residential exposures                        an additional tenfold (10X) margin of                 100 (10x interspecies, 10x intraspecies,
                                           because bifenthrin is acutely toxic and                  safety for infants and children in the                1x FQPA). However, the Agency is
                                           does not increase in potency with                        case of threshold effects to account for              retaining a 3X FQPA SF for children
                                           repeated dosing. Further information                     prenatal and postnatal toxicity and the               from birth to 6 years of age resulting in
                                           regarding EPA standard assumptions                       completeness of the database on toxicity              a total uncertainty factor of 300 (10x


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                                                            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations                                      93829

                                           interspecies, 10x intraspecies, 3x                       pharmacodynamic data and in vivo data                 processed commodity. EPA made
                                           FQPA).                                                   indicating similar responses between                  conservative (protective) assumptions in
                                              EPA has determined that reliable data                 adult and juvenile rats at low doses and              the ground and surface water modeling
                                           show that the safety of infants and                      data indicating that the rat is a                     used to assess exposure to bifenthrin in
                                           children less than or equal to 6 years old               conservative model compared to the                    drinking water. EPA used similarly
                                           would be adequately protected if the                     human based on species-specific                       conservative assumptions to assess post-
                                           FQPA SF were retained to 3X. That                        pharmacodynamics of homologous                        application exposure of children as well
                                           decision is based on the following                       sodium channel isoforms in rats and                   as incidental oral exposure of toddlers.
                                           findings:                                                humans.                                               These assessments will not
                                              i. The toxicity database for bifenthrin                  In light of the high dose literature               underestimate the exposure and risks
                                           is complete.                                             studies showing juvenile sensitivity to               posed by bifenthrin.
                                              ii. Like other pyrethroids, bifenthrin                pyrethroids and the absence of any
                                           causes clinical signs of neurotoxicity                   additional data indicating a lack of                  D. Aggregate Risks and Determination of
                                           from interaction with sodium channels.                   elevated sensitivity to juveniles relative            Safety
                                           These effects are adequately assessed by                 to adults, EPA is retaining a 3X                         EPA determines whether acute and
                                           the available guideline and non-                         additional safety factor as estimated by              chronic dietary pesticide exposures are
                                           guideline studies. Bifenthrin is a Type                  pharmacokinetic modeling. For several                 safe by comparing aggregate exposure
                                           I pyrethroid, and neurotoxic effects                     reasons, EPA concludes there are                      estimates to the acute PAD (aPAD) and
                                           characteristic of Type I pyrethroids were                reliable data showing that a 3X factor is             chronic PAD (cPAD). For linear cancer
                                           observed in adults in most of the                        protective of the safety of infants and               risks, EPA calculates the lifetime
                                           bifenthrin toxicity database.                            children. First, the high doses that                  probability of acquiring cancer given the
                                           Specifically, muscle tremors and                         produced juvenile sensitivity in the                  estimated aggregate exposure. Short-,
                                           decreased motor activity were observed                   literature studies are well above normal              intermediate-, and chronic-term risks
                                           in adults in guideline studies                           dietary or residential exposure levels of             are evaluated by comparing the
                                           throughout the bifenthrin toxicology                     pyrethroids to juveniles and these lower              estimated aggregate food, water, and
                                           database, and hind-limb flexion was                      levels of exposure are not expected to                residential exposure to the appropriate
                                           observed in adults the dermal study. For                 overwhelm the ability metabolize                      PODs to ensure that an adequate MOE
                                           these reasons, the tremors seen in                       pyrethroids as occurred with the high                 exists.
                                           juveniles in the 2-generation                            doses used in the literature studies. This               1. Acute risk. Using the exposure
                                           reproduction study are not considered                    is confirmed by the lack of a finding of              assumptions discussed in this unit for
                                           age-dependent effects.                                   increased sensitivity in pre- and post-
                                              iii. There is no evidence that                                                                              acute exposure, the acute dietary
                                                                                                    natal guideline studies in any                        exposure from food and water to
                                           bifenthrin results in increased                          pyrethroid, including bifenthrin, despite
                                           susceptibility in in utero rats or rabbits                                                                     bifenthrin will occupy 7% of the aPAD
                                                                                                    the relatively high doses used in those               for the general U.S. population and 54%
                                           in the prenatal developmental studies or                 studies. Second, the portions of both the
                                           in young rats in the 2-generation                                                                              of the aPAD for infants <1 year old, the
                                                                                                    inter- and intraspecies uncertainty                   population group receiving the greatest
                                           reproduction study. This is consistent                   factors that account for potential
                                           with the results of the guideline pre-                                                                         exposure.
                                                                                                    pharmacodynamic differences
                                           and post-natal testing for other                                                                                  2. Chronic risk. Based on the data
                                                                                                    (generally considered to be
                                           pyrethroid pesticides. There are,                                                                              summarized in Unit IV.B.ii., there is no
                                                                                                    approximately 3X for each factor) are
                                           however, high dose LD50 studies                                                                                increase in hazard with increasing
                                                                                                    likely to overstate the risk of inter- and
                                           (studies assessing what dose results in                  intraspecies pharmacodynamic                          dosing duration. Furthermore, chronic
                                           lethality to 50 percent of the tested                    differences given the data showing                    dietary exposures will be lower than
                                           population) in the scientific literature                 similarities in pharmacodynamics                      acute exposures. Therefore, the acute
                                           indicating that pyrethroids can result in                between juveniles and adults and                      aggregate assessment is protective of
                                           increased quantitative sensitivity in the                between humans and rats. Finally, as                  potential chronic aggregate exposures.
                                           young. Examination of pharmacokinetic                    indicated, pharmacokinetic modeling                      3. Short-term risk. Short-term
                                           and pharmacodynamic data indicates                       only predicts a 3X difference between                 aggregate exposure takes into account
                                           that the sensitivity observed at high                    juveniles and adults.                                 short-term residential exposure plus
                                           doses is related to pyrethroid age-                         iv. There are no residual uncertainties            chronic exposure to food and water
                                           dependent pharmacokinetics—the                           identified in the exposure databases                  (considered to be a background
                                           activity of enzymes associated with the                  with regard to dietary (food and                      exposure level). Bifenthrin is currently
                                           metabolism of pyrethroids. Predictive                    drinking water), and residential                      registered for uses that could result in
                                           pharmacokinetic models indicate that                     exposures. Although the acute dietary                 short-term residential exposure, and the
                                           the differential adult-juvenile                          exposure estimates are refined, the                   Agency has determined that it is
                                           pharmacokinetics will result in                          exposure estimates will not                           appropriate to aggregate chronic
                                           otherwise equivalent administered                        underestimate risk for the established                exposure through food and water with
                                           doses for adults and juveniles producing                 and proposed uses of bifenthrin since                 short-term residential exposures to
                                           a 3X greater dose at the target organ in                 the residue levels used are based on                  bifenthrin.
                                           juveniles compared to adults. No                         either monitoring data reflecting actual                 Using the exposure assumptions
                                           evidence of increased quantitative or                    residues found in the food supply, or on              described in this unit for short-term
                                           qualitative susceptibility was seen in                   high-end residues from field trials                   exposures, EPA has concluded the
                                           the pyrethroid scientific literature                     which reflect the use patterns which                  combined short-term food, water, and
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                                           related to pharmacodynamics (the effect                  would result in highest residues in                   residential exposures result in aggregate
                                           of pyrethroids at the target tissue) both                foods. Furthermore, processing factors                MOEs of 250 for adults and 340 for
                                           with regard to inter-species differences                 used were either those measured in                    children 1 < 2 years old, the most highly
                                           between rats and humans and to                           processing studies, or default high-end               exposed population. Because EPA’s
                                           differences between juveniles and                        factors representing the maximum                      level of concern (LOC) for bifenthrin is
                                           adults. Specifically, there are in vitro                 concentration of residue into a                       a MOE of 100 or less for adults and 300


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                                           93830            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations

                                           for children 1<2, these MOEs are not of                  organization in trade agreements to                   has determined that this action will not
                                           concern.                                                 which the United States is a party. EPA               have a substantial direct effect on States
                                              4. Intermediate-term risk.                            may establish a tolerance that is                     or tribal governments, on the
                                           Intermediate-term aggregate exposure                     different from a Codex MRL; however,                  relationship between the national
                                           takes into account intermediate-term                     FFDCA section 408(b)(4) requires that                 government and the States or tribal
                                           non-dietary, non-occupational exposure                   EPA explain the reasons for departing                 governments, or on the distribution of
                                           plus chronic exposure to food and water                  from the Codex level.                                 power and responsibilities among the
                                           (considered to be a background                             The Codex has not established a MRL                 various levels of government or between
                                           exposure level). Because no                              for bifenthrin in or on avocado and                   the Federal Government and Indian
                                           intermediate-term adverse effect was                     pomegranate.                                          tribes. Thus, the Agency has determined
                                           identified, bifenthrin is not expected to                VI. Conclusion                                        that Executive Order 13132, entitled
                                           pose an intermediate-term risk. An                                                                             ‘‘Federalism’’ (64 FR 43255, August 10,
                                           intermediate-term and/or chronic                           Therefore, time-limited tolerances are              1999) and Executive Order 13175,
                                           aggregate risk assessment was not                        established for residues of bifenthrin, 2-            entitled ‘‘Consultation and Coordination
                                           conducted because bifenthrin is acutely                  methyl[1,1′-biphenyl]-3-yl)methyl-3-(2-               with Indian Tribal Governments’’ (65 FR
                                           toxic and there is no increase in hazard                 chloro-3,3,3-trifluoro-1-propenyl)-2,2-               67249, November 9, 2000) do not apply
                                           with increasing dosing duration.                         dimethylcyclopropane-carboxylate), in                 to this action. In addition, this action
                                           Furthermore, chronic dietary exposures                   or on avocado at 0.50 ppm and                         does not impose any enforceable duty or
                                           will be lower than acute exposures.                      pomegranate at 0.50 ppm. These                        contain any unfunded mandate as
                                           Therefore, the acute aggregate                           tolerances expire on December 31, 2019.               described under Title II of the Unfunded
                                           assessment is protective of potential                    VII. Statutory and Executive Order                    Mandates Reform Act (UMRA) (2 U.S.C.
                                           chronic aggregate exposures.                             Reviews                                               1501 et seq.).
                                              5. Aggregate cancer risk for U.S.                                                                              This action does not involve any
                                                                                                       This action establishes tolerances                 technical standards that would require
                                           population. The acute aggregate                          under FFDCA sections 408(e) and
                                           assessment is protective of potential                                                                          Agency consideration of voluntary
                                                                                                    408(l)(6). The Office of Management and               consensus standards pursuant to section
                                           chronic aggregate exposures. For these                   Budget (OMB) has exempted these types
                                           same reasons, the acute aggregate                                                                              12(d) of the National Technology
                                                                                                    of actions from review under Executive                Transfer and Advancement Act
                                           assessment is also protective of                         Order 12866, entitled ‘‘Regulatory
                                           potential cancer risk.                                                                                         (NTTAA) (15 U.S.C. 272 note).
                                                                                                    Planning and Review’’ (58 FR 51735,
                                              6. Determination of safety. Based on                  October 4, 1993). Because this action                 VIII. Congressional Review Act
                                           these risk assessments, EPA concludes                    has been exempted from review under
                                           that there is a reasonable certainty that                                                                        Pursuant to the Congressional Review
                                                                                                    Executive Order 12866, this action is                 Act (5 U.S.C. 801 et seq.), EPA will
                                           no harm will result to the general                       not subject to Executive Order 13211,
                                           population, or to infants and children,                                                                        submit a report containing this rule and
                                                                                                    entitled ‘‘Actions Concerning                         other required information to the U.S.
                                           from aggregate exposure to bifenthrin                    Regulations That Significantly Affect
                                           residues.                                                                                                      Senate, the U.S. House of
                                                                                                    Energy Supply, Distribution, or Use’’ (66             Representatives, and the Comptroller
                                           V. Other Considerations                                  FR 28355, May 22, 2001) or Executive                  General of the United States prior to
                                                                                                    Order 13045, entitled ‘‘Protection of                 publication of the rule in the Federal
                                           A. Analytical Enforcement Methodology                    Children from Environmental Health                    Register. This action is not a ‘‘major
                                              An adequate enforcement                               Risks and Safety Risks’’ (62 FR 19885,                rule’’ as defined by 5 U.S.C. 804(2).
                                           methodology (gas chromatography/                         April 23, 1997). This action does not
                                           electron capture detection) is available                 contain any information collections                   List of Subjects in 40 CFR Part 180
                                           to enforce the tolerance expression.                     subject to OMB approval under the                       Environmental protection,
                                              The method may be requested from:                     Paperwork Reduction Act (PRA), 44                     Administrative practice and procedure,
                                           Chief, Analytical Chemistry Branch,                      U.S.C. 3501 et seq., nor does it require              Agricultural commodities, Pesticides
                                           Environmental Science Center, 701                        any special considerations under                      and pests, Reporting and recordkeeping
                                           Mapes Rd., Ft. Meade, MD 20755–5350;                     Executive Order 12898, entitled                       requirements.
                                           telephone number: (410) 305–2905;                        ‘‘Federal Actions to Address                             Dated: November 10, 2016.
                                           email address:                                           Environmental Justice in Minority                     Michael Goodis,
                                           residuemethods@epa.gov.                                  Populations and Low-Income                            Acting Director, Registration Division, Office
                                                                                                    Populations’’ (59 FR 7629, February 16,               of Pesticide Programs.
                                           B. International Residue Limits
                                                                                                    1994).
                                             In making its tolerance decisions, EPA                    Since tolerances and exemptions that               ■Therefore, 40 CFR chapter I is
                                           seeks to harmonize U.S. tolerances with                  are established in accordance with                    amended as follows:
                                           international standards whenever                         FFDCA sections 408(e) and 408(l)(6),                  PART 180—[AMENDED]
                                           possible, consistent with U.S. food                      such as the tolerances in this final rule,
                                           safety standards and agricultural                        do not require the issuance of a                      ■ 1. The authority citation for part 180
                                           practices. EPA considers the                             proposed rule, the requirements of the                continues to read as follows:
                                           international maximum residue limits                     Regulatory Flexibility Act (RFA) (5                       Authority: 21 U.S.C. 321(q), 346a and 371.
                                           (MRLs) established by the Codex                          U.S.C. 601 et seq.) do not apply.                     ■ 2. In § 180.442, revise paragraph (b) to
                                           Alimentarius Commission (Codex), as                         This action directly regulates growers,            read as follows:
                                           required by FFDCA section 408(b)(4).                     food processors, food handlers, and food
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                                           The Codex Alimentarius is a joint                        retailers, not States or tribes, nor does             § 180.442    Bifenthrin; tolerances for
                                           United Nations Food and Agriculture                      this action alter the relationships or                residues.
                                           Organization/World Health                                distribution of power and                             *     *     *    *     *
                                           Organization food standards program,                     responsibilities established by Congress                (b) Section 18 emergency exemptions.
                                           and it is recognized as an international                 in the preemption provisions of FFDCA                 Time-limited tolerances specified in the
                                           food safety standards-setting                            section 408(n)(4). As such, the Agency                following table are established for


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                                                            Federal Register / Vol. 81, No. 246 / Thursday, December 22, 2016 / Rules and Regulations                                       93831

                                           residues of the bifenthrin, (2-                    Authorities (AAPA) that addressed                           clarifies, based on Commission and
                                           methyl[1,1′-biphenyl]-3-yl)methyl-3-(2-            proposed § 502.204, revising and                            judicial precedent, that the standard of
                                           chloro-3,3,3-trifluoro-1-propenyl)-2,2-            renumbering § 502.156. Current                              admissibility is governed by the APA,
                                           dimethylcyclopropane-carboxylate) in               § 502.156 states ‘‘[u]nless inconsistent                    not the FRE. While the presiding officer
                                           or on the specified agricultural                   with the requirements of the                                may consider the FRE for guidance, they
                                           commodities, resulting from use of the             Administrative Procedure Act and these                      are neither controlling nor binding. In
                                           pesticide pursuant to FIFRA section 18             Rules, the Federal Rules of Evidence                        response to the AAPA’s expressed
                                           emergency exemptions. The tolerances               . . . will also be applicable.’’ As                         concern that the revised language
                                           expire on the date specified in the table.         explained in the NPRM, the proposed                         suggests a change in the presiding
                                                                                              revision is intended to simplify the                        officer’s discretion, we clarify the final
                                              Commodity             Parts per Expiration date language in the rule by restating the                       rule by replacing the language ‘‘look to
                                                                     million                  liberal Administrative Procedure Act                        the FRE for guidance’’ with the language
                                                                                              (APA) standard for admissibility and                        ‘‘consider the FRE for guidance’’ as it
                                           Apple .................        0.5    12/31/2018
                                                                                                                                                          better reflects the discretion of the
                                           Avocado ............           0.50   12/31/2019 also to provide that the presiding officer
                                           Nectarine ..........           0.5    12/31/2018 may continue to look to the Federal                           presiding officer.
                                           Peach ................         0.5    12/31/2018 Rules of Evidence (FRE) for guidance.                            The Commission recently addressed
                                           Pomegranate ....               0.50   12/31/2019      The Commission adopted the original                      the utility of applying the FRE in
                                                                                              language in § 502.156 in 1976, shortly                      proceedings before it in Tober. Pointing
                                           *      *        *       *      *                                                                               to its own precedent, the Commission
                                                                                              after the FRE went into effect. 41 FR
                                                                                                                                                          noted that it has long recognized the
                                           [FR Doc. 2016–29882 Filed 12–21–16; 8:45 am]       20585, 20588 (May 19, 1976). In the
                                                                                                                                                          liberal standards of admissibility of
                                           BILLING CODE 6560–50–P                             1975 notice proposing the language the
                                                                                                                                                          evidence in administrative proceedings
                                                                                              Commission asserted that, as a general
                                                                                                                                                          and the need for considerable relaxation
                                                                                              matter, the FRE did not appear to be
                                                                                                                                                          of the rules of evidence followed by the
                                           FEDERAL MARITIME COMMISSION                        inconsistent with the APA and that the
                                                                                                                                                          federal courts in proceedings before the
                                                                                              FRE could be of great use to the
                                                                                                                                                          Commission. Applying those standards
                                           46 CFR Part 502                                    Commission’s administrative law judges
                                                                                                                                                          to the ALJ’s exclusion of certain exhibits
                                                                                              (ALJs) in disposing of evidentiary issues
                                           [Docket No. 16–08]                                                                                             on the basis of the FRE, the Commission
                                                                                              that arise in Commission proceedings,                       held that challenged exhibits were
                                           RIN 3072–AC64                                      so long as they were consistent with the                    admissible under the APA standard and
                                                                                              requirements of the APA. 40 FR 43295,                       that ‘‘to the extent that the
                                           Rules of Practice and Procedure;                   43927 (Sep. 24, 1975). Since
                                           Presentation of Evidence in                                                                                    Commission’s rules and the APA
                                                                                              promulgation of the section, however,                       diverge from the FRE, the FRE are not
                                           Commission Proceedings                             the Commission ‘‘has recognized the                         controlling and the Commission is not
                                           AGENCY: Federal Maritime Commission.
                                                                                              liberal standards of admissibility of                       bound by their requirements.’’ Id., 549.
                                                                                              evidence in administrative proceedings                         The AAPA also states that the
                                           ACTION: Final rule                                 and has repeatedly ‘. . . identified the                    proposed rule could impact motions for
                                           SUMMARY: The Federal Maritime                      need for considerable relaxation of the                     summary judgment. It noted that in
                                           Commission is reorganizing several                 rules of evidence followed by the                           federal court, a party opposing a motion
                                           subparts of its Rules of Practice and              federal courts in proceedings before the                    on the grounds that there are material
                                           Procedure and revising its rules                   Commission.’ ’’ EuroUSA Shipping, Inc.,                     facts in genuine dispute must show that
                                           regarding presentation of evidence in              Tober Group, Inc.—Possible Violations,                      there is admissible evidence on its side
                                           Commission proceedings.                            31 S.R.R. 540, 547 (FMC 2008)                               of the asserted dispute. The AAPA
                                                                                              (hereinafter Tober) (quoting Pacific                        appears to be concerned that a loosening
                                           DATES: Effective January 27, 2016.
                                                                                              Champion Express Co., Ltd.—Possible                         of the standard may limit the utility of
                                           FOR FURTHER INFORMATION CONTACT:                   Violations, 28 S.R.R. 1102, 1105–06                         summary judgment motions. The
                                           Rachel E. Dickon, Assistant Secretary,             (ALJ 1999)). Given the divergence                           Commission addressed the admissibility
                                           Federal Maritime Commission, 800                   between the FRE and APA standards,                          of evidence in the context of motions for
                                           North Capitol Street NW., Washington,              the current section’s attempt to apply                      summary judgment in Tober. Citing the
                                           DC 20573–0001. Phone: (202) 523–5725. both standards simultaneously creates a                                  Supreme Court’s decision in Celotex
                                           Email: secretary@fmc.gov.                          tension in the regulation and could be                      Corp. v. Catrett, 477 U.S. 317, 324
                                           SUPPLEMENTARY INFORMATION: The                     confusing to parties. Accordingly, the                      (1986), the Commission stated: ‘‘While
                                           Commission is updating or reorganizing Commission is now explicitly providing                                  the nonmoving party is to show facts
                                           several subparts of 46 CFR part 502, its           that presiding officers may look to the                     that present a genuine issue worthy of
                                           Rules of Practice and Procedure, and               FRE for guidance when determining the                       trial, the nonmoving party at the
                                           substantively revising the subpart                 admissibility of evidence. The AAPA                         summary judgment stage is not required
                                           regarding how hearings are conducted               notes that current rule § 502.156, states                   to produce evidence in a form that
                                           to improve guidance concerning the                 that the FRE ‘‘will be applicable’’ to                      would be admissible at trial.’’ Id., 31
                                           presentation of evidence in Commission Commission proceedings ‘‘unless                                         S.R.R. at 549 (emphasis added). Thus,
                                           proceedings. Certain current rules are             inconsistent with’’ the requirements of                     the Commission made clear that at the
                                           also removed to clarify current practice           the APA whereas the proposed language                       summary judgment stage, the
                                           and eliminate duplication.                         provides that the presiding officer ‘‘may                   nonmoving party only needs to show
                                              On May 3, 2016, the Commission                  look to the FRE for guidance.’’ The                         facts that present a genuine issue
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                                           issued a Notice of Proposed Rulemaking AAPA inquires whether such a change                                     worthy of trial. Id. This standard is
                                           (NPRM) seeking public comment on the is intended to loosen the admissibility                                   applied to ensure that doubts are
                                           proposed amendments. 81 FR 26517.                  standard in cases before the                                resolved in favor of the nonmoving
                                           The Commission received one comment Commission, and if so, to what to                                          party. As the Commission noted, it has
                                           in response to the NPRM from the                   degree. The new rule does not loosen                        denied summary judgment even when
                                           American Association of Port                       the admissibility standards, but rather                     the nonmovant has not submitted any


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Document Created: 2016-12-21 23:52:34
Document Modified: 2016-12-21 23:52:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective 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).
ContactMichael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation81 FR 93824 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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