[Federal Register Volume 81, Number 246 (Thursday, December 22, 2016)]
[Rules and Regulations]
[Pages 93824-93831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29882]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of bifenthrin in or on avocado and pomegranate. This action is
in response to EPA's granting of an emergency exemption under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing
use of the pesticide on avocado and pomegranate.
This regulation establishes a maximum permissible level for
residues of bifenthrin in or on these commodities. The time-limited
tolerances expire on December 31, 2019.
DATES: This regulation is effective December 22, 2016. Objections and
requests for hearings must be received on or before February 21, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2016-0236, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address:
[email protected].
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:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for bifenthrin in or on avocado
and pomegranate.
VI. Conclusion
Therefore, time-limited tolerances are established for residues of
bifenthrin, 2-methyl[1,1'-biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3-
trifluoro-1-propenyl)-2,2-dimethylcyclopropane-carboxylate), in or on
avocado at 0.50 ppm and pomegranate at 0.50 ppm. These tolerances
expire on December 31, 2019.
VII. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA sections 408(e) and
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001) or Executive
Order 13045, entitled ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This
action does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
Since tolerances and exemptions that are established in accordance
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 10, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.
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