[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Rules and Regulations]
[Pages 56782-56791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22772]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-1008; FRL-9361-6]
Bifenthrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
bifenthrin in or on tea, dried; grass, forage; and grass, hay.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This
regulation additionally establishes time-limited tolerances in or on
apple, nectarine, and peach under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The time-limited
tolerances expire and are revoked on December 31, 2015. Finally, this
regulation removes time-limited tolerances on orchardgrass, forage and
orchardgrass, hay, as they will be superseded by permanent tolerances.
DATES: This regulation is effective September 14, 2012. Objections and
requests for hearings must be received on or before November 13, 2012,
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-2009-1008, 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), EPA West 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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; 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, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance
[[Page 56783]]
regulations at 40 CFR part 180 through the Government Printing Office's
e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-1008 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
November 13, 2012. 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-2009-1008, 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.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-
2), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7652)
by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 08540. The
petition requested that 40 CFR 180.442 be amended by establishing
tolerances for residues of the insecticide bifenthrin, (2-methyl [1,1'-
biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on tea (import tolerance) at 25
parts per million (ppm); and tolerances with regional registrations in
or on grass, forage at 2.5 ppm and grass, hay at 4.5 ppm. That notice
referenced a summary of the petition prepared on behalf of IR-4 by FMC
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing.
EPA's response to this comment is discussed in Unit IV.C.
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerances for several commodities and revised the
commodity definition for tea to tea, dried. The Agency has also revised
the tolerance expression for all established commodities to be
consistent with current Agency policy. The reasons for these changes
are explained in Unit IV.D.
To control the brown marmorated stink bug, EPA is also establishing
time-limited tolerances for the use of bifenthrin in or on apple,
nectarine, and peach at 0.5 ppm. These tolerances expire and are
revoked on December 31, 2015. The Agency is establishing the time-
limited tolerances in response to an informal crisis exemption request
under FIFRA section 18 on behalf of the states of Delaware, Maryland,
New Jersey, North Carolina, Pennsylvania, Virginia, and West Virginia
for the emergency use of bifenthrin to control the brown marmorated
stink bug on these commodities.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of bifenthrin in
or on apple, nectarine, and peach. In doing so, EPA considered the
safety standard in section 408(b)(2) of FFDCA, and the Agency decided
that the necessary tolerances under section 408(l)(6) of FFDCA 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 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
section 408(l)(6) of FFDCA. Although these time-limited tolerances
expire and are revoked on December 31, 2015, under section 408(l)(5) of
FFDCA, residues of the pesticide not in excess of the amounts specified
in the tolerances remaining in or on apple, nectarine, and peach 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 whether bifenthrin
meets FIFRA's registration requirements for use in or on apple,
nectarine, and peach, or whether permanent tolerances for this use
would be appropriate. Under these circumstances, EPA does not believe
that these time-limited tolerances serve as a basis for registration of
bifenthrin by a State for Special Local Needs under FIFRA section
24(c). Nor does this tolerance serve as the basis for persons in any
State other than those listed to use this pesticide on these 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.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This assessment includes exposure through drinking water
and in residential settings, but does not include occupational
exposure. Section 408(b)(2)(C) of FFDCA requires
[[Page 56784]]
EPA to give special consideration to exposure of infants and children
to the pesticide chemical residue in establishing a tolerance and to
``ensure that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to the pesticide
chemical residue.* * *''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for bifenthrin including exposure
resulting from the tolerances, including the time-limited tolerances,
established by this action. EPA's assessment of exposures and risks
associated with bifenthrin follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Bifenthrin has a low order of acute toxicity via the dermal and
inhalation routes of exposure and has moderate acute toxicity via the
oral route. It is neither an eye nor skin irritant, and it is not a
dermal sensitizer. Behavioral changes characteristic of Type I
pyrethroids, such as muscle tremors, were noted in most of the
bifenthrin experimental toxicology studies, consistent with its mode of
action of delaying the inactivatation of voltage gated sodium channels.
Additional effects seen in one or more toxicity studies for bifenthrin
included muscle twitching, decreased grip strength, altered landing
foot splay, depressed respiration, increased grooming counts, loss of
muscle coordination, staggered gait, exaggerated hind limb flexion, and
convulsions at high doses. Decreased body weight, body weight gains and
food consumption were also noted in repeat-dosing dietary studies.
Evidence of increased qualitative or quantitative susceptibility of
offspring was not observed in any of the available guideline toxicity
studies for bifenthrin.
Bifenthrin is classified as a ``possible human carcinogen'' based
on an increased incidence of urinary bladder tumors in mice. However,
EPA concluded that the bladder tumors may not be uncommon in mice and
are not likely to be malignant. Additionally, these tumors were
observed only in male mice at the highest dose tested and the incidence
was of borderline significance. No evidence of carcinogenicity was
observed in bifenthrin carcinogenicity studies in rats, and bifenthrin
was negative in five different tests for mutagenicity but was
marginally active in a forward mutation test in mouse lymphoma cells.
Overall, based on the available information, there is a low concern for
mutagenicity. Taking into account all of this information, the Agency
has determined that quantification of risk using a non-linear approach
(i.e., acute population-adjusted dose (aPAD)) will adequately account
for all chronic toxicity, including carcinogenicity that could result
from exposure to bifenthrin. While the Agency would typically use a
chronic population-adjusted dose (cPAD) to protect for cancer concerns,
use of the aPAD is protective for bifenthrin because increasing
toxicity with increasing duration of exposure is not seen for
bifenthrin. The no observed adverse effect level (NOAEL) observed in
the mouse chronic study, in which tumors were observed, is 6.7 mg/kg/
day, 2-fold higher than the points of departure (POD) used for acute
risk assessment.
Specific information on the studies received and the nature of the
adverse effects caused by bifenthrin as well as the dose at which the
motor activity change is equal to one standard deviation (SD) from the
control value (BMD1SD), and the lower 95% confidence limit
of the BMD value (the BMDL1SD), resulting from the benchmark
data (BMD) analysis of the toxicity studies can be found at http://www.regulations.gov in document, ``Bifenthrin: Human Health Risk
Assessment to Support Section 3 New Uses for a Bed Bug Treatment, Grass
Grown for Seed, Tolerances for Imported Tea, and a Section 18 Emergency
Exemption Use on Apple, Nectarine, and Peach'' at pages 62-70 in docket
ID number EPA-HQ-OPP-2009-1008.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological 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. Typically, 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 shown in Table 1. of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Bifenthrin for Use in Human Health Risk Assessment
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Point of departure
Exposure/Scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Children < 6 years BMDL1SD = 3.1 mg/kg. Acute RfD = 0.031 Wolansky et al. (2006) BMD1SD =
old). mg/kg/day. 4.1 mg/kg based on reductions in
locomotor activity; supported by
multiple guideline studies.
UFA = 10x
UFH = 10x mg/kg/day aPAD = 0.010.......
[[Page 56785]]
FQPA SF = 3x
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Acute dietary (General BMDL1SD = 3.1 mg/kg. Acute RfD = 0.031 Wolansky et al. (2006) BMD1SD =
population, including >= 6 years mg/kg/day. 4.1 mg/kg based on reductions in
old). locomotor activity; supported by
multiple guideline studies.
UFA = 10x
UFH = 10x aPAD = 0.031 mg/kg/
day.
FQPA SF = 3x
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Chronic dietary (All populations) Because of the rapid reversibility of the most sensitive neurotoxicity
endpoint used for quantifying risks, there is no increase in hazard with
increasing dosing duration. Therefore, the acute dietary endpoint is
protective of the endpoints from repeat dosing studies, including chronic
dietary exposures.
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Incidental oral short-term (1 to BMDL1SD = 3.1....... Residential: < 6 Wolansky et al. (2006).
30 days). UFA = 10x........... years old. BMD1SD = 4.1 mg/kg based on
UFH = 10x........... LOC is an MOE = 300 reductions in locomotor activity;
FQPA SF = 3x........ >= 6 years old, LOC supported by multiple guideline
is an MOE = 100.. studies.
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Dermal short-term (1 to 30 days). BMDL10 = 96.3 mg/kg/ Residential: < 6 21-day dermal study in rats.
day. years old. BMD10 = 187.0 mg/kg/day, based on
UFA = 10x........... LOC is an MOE = 300 exaggerated hind limb flexion.
UFH = 10x........... >= 6 years old, LOC
FQPA SF = 3x........ is an MOE = 100..
Occupational:
Adults, LOC is an
MOE = 100.
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Inhalation short-term (1 to 30 BMDL1SD = 3.1 mg/kg. Residential: Adults Wolansky et al. (2006).
days). UFA = 10x........... LOC is an MOE = BMD1SD = 4.1 mg/kg based on
UFH = 10x........... 1,000. reductions in locomotor activity;
FQPA SF = 30x*...... supported by multiple guideline
studies.
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Cancer (Oral, dermal, inhalation) Bifenthrin has been classified as a possible human carcinogen. Because of the
rapid reversibility of the most sensitive neurotoxicity endpoint used for
quantifying risks, there is no increase in hazard with increasing dosing
duration. Therefore, the acute dietary endpoint is protective of the
endpoints from repeat dosing studies, including cancer dietary exposures.
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FQPA SF = Food Quality Protection Act Safety Factor. FQPA SF is composed of the 3X factor for increased
quantitative susceptibility and the 10X factor for the inhalation study data gap.
LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure.
PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA =
extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of
the human population (intraspecies). BMD = benchmark dose. SD = standard deviation. BMD1SD = dose level where
effect is 1 SD from control value. BMDL1SD = lower 95% confidence limit of the BMD value. BMDL10 = dose which
has a 10% toxicity change from the controls.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to bifenthrin, EPA considered exposure under the petitioned-
for tolerances and those being established in response to the Agency
issuing section 18 emergency exemptions, 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. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for bifenthrin. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
conducted a highly-refined, acute probabilistic dietary exposure and
risk assessment for all established food uses as well as the petitioned
for tolerances and the section 18 time-limited tolerances. Anticipated
residues (ARs) were developed based on the following: USDA's Pesticide
Data Program (PDP) monitoring data from 1998-2010 for bell pepper,
blueberry, broccoli, cabbage, cauliflower, cilantro, cranberry,
cucumber, egg, eggplant, grape, grapefruit, orange, orange juice,
lettuce, pear, cantaloupe, winter squash, spinach--canned, succulent
bean, strawberry, sweet corn, sweet peas,
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tomato, watermelon and milk; the Food and Drug Administration (FDA)
2002 data for blackberry and raspberry; and field trial data for
bifenthrin. ARs were further refined using percent crop treated (PCT)
data and processing factors, where appropriate.
Additionally, the uses proposed under the section 18 emergency
exemption program have use patterns that are similar to the registered
use on pear. Therefore, the Agency relied on PDP data for pears,
including for baby food and canned products, when assessing anticipated
residues on peach, nectarine, and apple. EPA believes the use of PDP
data for pears is appropriate, as bifenthrin residues are found mainly
on the fruit surface and residues on peach, nectarine, and apple are
expected to be similar to those found on pear.
ii. Chronic exposure. Based on the data summarized in Unit III.A.,
there is no increase in hazard from repeated exposures to bifenthrin;
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
III.A., the Agency has determined that quantification of risk using a
non-linear approach (i.e., aPAD) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to bifenthrin. Additionally, since the cancer dietary
assessment assumed average residue levels and the acute assessment used
high-end residue levels, the acute dietary assessment will be
protective of any cancer effects resulting from consumption of
bifenthrin residues in foods.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
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%; 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%; peanut, 5%; pea, green, 25%; pear, 4%;
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, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data for the existing use and rounded up to the nearest multiple of 5%.
The Agency estimated the PCT for the new uses associated with the
time-limited tolerances as follows:
Apple, 10%; nectarine, 3%; and peach, 7%.
Bifenthrin is being considered for use on apple, nectarine, and
peach in Delaware, Maryland, New Jersey, North Carolina, Pennsylvania,
Virginia, and West Virginia to control the brown marmorated stink bug
under FIFRA section 18, which allows for the emergency use of a
pesticide on a site for which it is not registered.
The Agency conservatively estimated that 100 percent of the crops
in these states will be treated with bifenthrin and calculated the
national PCT given the share of utilized production or grown acreage
from the seven states likely to seek the use of bifenthrin.
EPA used data from 2010 USDA/NASS for apples and peaches. Data on
the most recent survey years, 2007-2009, were used to derive the needed
PCT estimates. The sum of the utilized production in these states was
divided by the total domestic utilized production and multiplied by 100
to determine the PCT for each of the crops for each of the named years.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations, including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's
[[Page 56787]]
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.
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 flea and tick control on pets). Bifenthrin is
currently registered for several uses that could result in residential
exposures: In indoor residential/household premises as a crack and
crevice spray, paint additive and as a dust, in or on automobiles/
recreational vehicles, and for termite treatments. Residential exposure
is also anticipated from a pending registration for bed bug treatment
use, including surface-directed application to indoor surfaces. Outdoor
residential uses of bifenthrin include broadcast and spot treatments to
residential lawns and turf; golf course turf and outdoor premises by
means of liquid spray and granular products; and ornamental uses (turf,
shrubs, vines, trees, ground cover). EPA assessed residential handler
and post-application exposures for the existing and proposed bed bug
uses of bifenthrin.
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 in the Federal Register on
November 9, 2011 (76 FR 69726) (FRL-8888-9), 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 number: EPA-HQ-OPP-2008-0489-0006.
The Agency has conducted a quantitative analysis of the proposed
bifenthrin bed bug use and has determined that it will not contribute
significantly or change the overall findings presented in the
pyrethroid cumulative risk assessment. This analysis is summarized in
the document: ``Bifenthrin: Human Health Risk Assessment to Support
Section 3 New Uses for a Bed Bug Treatment, Grass Grown for Seed,
Tolerances for Imported Tea, and a Section 18 Emergency Exemption Use
on Apple, Nectarine, and Peach'' at pages 78-81 in docket ID number
EPA-HQ-OPP-2009-1008. Further, the proposed food uses of bifenthrin
will not contribute significantly or change the overall findings in the
pyrethroid cumulative risk assessment, as the dietary risks are a minor
component of total pyrethroid cumulative risk. For information
regarding EPA's efforts to evaluate the risk of exposure to
pyrethroids, refer to http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10x) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure, unless EPA determines based on reliable data, that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10x, or uses a different additional safety factor when
reliable data are 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
[[Page 56788]]
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 LD50
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. Given different levels of uncertainty for various
risk assessment scenarios, EPA is applying different FQPA safety
factors for the protection of fetuses, infants, and children depending
on the route of exposure and the population exposed. For non-inhalation
exposure scenarios for adults (including women of child-bearing age)
and children greater than 6 years of age, EPA is reducing the FQPA
safety factor to 1X. For non-inhalation exposure scenarios for infants
and children less than six years of age, EPA is reducing the FQPA
safety factor to 3X. Finally, for inhalation exposure scenarios for all
population groups, EPA is also retaining a 10X FQPA safety factor.
Because the 3X factor for infants and children less than six years of
age and the 10X factor for inhalation exposure scenarios are in
response to different uncertainties, these safety factors have been
combined for inhalation exposure scenarios for infants and children
less than six years of age resulting in a FQPA safety factor of 30X.
That decision on the various levels of the FQPA safety factor is based
on the following considerations:
i. The toxicity database for bifenthrin is not complete. EPA lacks
additional data on immunotoxicity, inhalation toxicity, and adult-
juvenile sensitivity. Recent changes to 40 CFR part 158 imposed new
data requirements for immunotoxicity testing (OCSPP Guideline 870.7800)
for pesticide registration. The toxicology database for bifenthrin does
not show any evidence of treatment-related effects on the immune
system, and the overall weight-of-evidence suggests that this chemical
does not directly target the immune system. Therefore, the Agency does
not believe that conducting a functional immunotoxicity study will
result in a lower POD than that currently in use for overall risk
assessment, and additional safety factors are not needed to account for
a lack of this study. EPA is requiring an inhalation toxicity study for
bifenthrin because inhalation data for other pyrethroids show the
potential for the inhalation route to be more potent than the oral
route. Currently, the POD for inhalation risk assessment scenarios is
based on an oral toxicity study. Reliance on an oral study raises
uncertainty as to whether the standard safety factors are protective of
infants and children. Finally, in light of the literature studies
indicating a possibility of increased sensitivity to bifenthrin in
juvenile rats at high doses, EPA has also requested proposals for study
protocols which could identify and quantify bifenthrin's potential
juvenile sensitivity. For the reasons discussed in Unit III.D.3.ii.,
the uncertainty regarding the protectiveness of the intraspecies
uncertainty factor raised by the literature studies and the absence of
the requested data warrant application of an additional 3X for risk
assessments for infants and children under six years of age.
ii. 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 the requested data on
juvenile sensitivity to pyrethroids, 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.
iii. There are no residual uncertainties identified in the
bifenthrin databases
[[Page 56789]]
with regard to dietary (food and drinking water), and residential
exposures. Although the acute dietary exposure estimates are refined,
as described in Unit III.C.1.i., 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. Further, postapplication exposure of
children and incidental oral exposure of toddlers are based on
conservative, health-protective assumptions that also ensure exposures
are not underestimated. These assessments will not underestimate the
exposure and risks posed by bifenthrin.
Further information about the reevaluation of the FQPA safety
factor for pyrethroids may be found in document ID number: EPA-HQ-OPP-
2011-0746-0011.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. Using the assumptions discussed in this unit for
acute exposure, at the 99.9th percentile of exposure the acute dietary
exposure from food and water to bifenthrin will occupy 5% of the aPAD
for the general U.S. population and 29% of the aPAD for children 1-2
years old, the population group receiving the greatest exposure.
2. Chronic risk. Based on the data summarized in Unit III.A., there
is no increase in hazard with increasing dosing duration. Furthermore,
chronic dietary exposures will be lower than acute exposures.
Therefore, the acute aggregate assessment is protective of potential
chronic aggregate exposures.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). 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.
For children 1-2 years old, the most highly exposed children's
subgroup, using the exposure assumptions described in this unit for
short-term exposures, EPA has concluded that the combined short-term
food, water, and residential exposures result in an aggregate MOE of
330. Because EPA's level of concern for bifenthrin is a MOE of 300 or
below, this MOE is not of concern.
For adults, although the short-term dermal and inhalation risks
were estimated using the same oral POD, these exposure estimates could
not be directly combined for the adult short-term exposure assessment
because the LOCs for dermal and inhalation routes of exposure are not
the same (an MOE of < 100 defines the LOC for dermal exposure while
inhalation risk is defined by an MOE of < 1,000). Accordingly an
aggregate risk index (ARI) was required to estimate aggregate risk for
adults. EPA identifies an ARI at or below one as a risk estimate of
concern. The short-term aggregate ARI for adults is 2.0. An ARI greater
than 1 indicates risks that are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term aggregate risk assessment was not
conducted because bifenthrin is acutely toxic and does not increase in
potency with repeated dosing. Because the neurotoxicity POD used for
acute risk assessment is lower (more protective) than PODs for longer
durations of exposure and acute and short-term exposure levels are
higher than longer term exposure levels, the acute and short-term
aggregate assessments are protective for intermediate-term aggregate
risks anticipated from bifenthrin exposure.
5. Aggregate cancer risk for U.S. population. For the reasons
discussed in Unit III.A. (cancer effects are non-linear and appear at
higher doses than acute effects) and Unit III.E.2. (chronic exposures
are lower than acute exposures), the acute aggregate assessment is
protective of potential cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes with reasonable certainty that no harm will result to the
general population, or to infants and children from aggregate exposure
to bifenthrin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate method, utilizing gas chromatography with electron
capture detection (GC/ECD), is available to enforce the proposed
tolerances for plant commodities.
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 an MRL for bifenthrin. However, Codex
has proposed a 30 ppm MRL for green and black tea (fermented and
dried). The United States has recommended a tolerance on tea, dried at
30 ppm in order to harmonize with the proposed Codex MRL.
C. Response to Comments
EPA received one comment to the notice of filing that stated, in
part, that no residue should be allowed for bifenthrin. The Agency
understands the commenter's concerns and recognizes that some
individuals believe that pesticides should be banned on agricultural
crops. However, the existing
[[Page 56790]]
legal framework provided by section 408 of the FFDCA states that
tolerances may be set when persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute. This citizen's comment appears to be
directed at the underlying statute and not EPA's implementation of it;
the citizen has made no contention that EPA has acted in violation of
the statutory framework.
D. Revisions to Petitioned-for Tolerances
Based on the data supporting the petitions, EPA revised the
proposed tolerance on grass, forage from 2.5 ppm to 4.0 ppm; and grass,
hay from 4.5 ppm to 15 ppm. The Agency revised these tolerance levels
based on analysis of the residue field trial data using the
Organization for Economic Cooperation and Development (OECD) tolerance
calculation procedures. Additionally, EPA revised the proposed
tolerance on tea from 25 ppm to 30 ppm, in order to harmonize with the
proposed Codex MRL associated with the commodity. EPA also revised the
proposed commodity definition for tea to tea, dried in order to reflect
the correct commodity nomenclature.
Finally, the Agency has revised the tolerance expression to clarify
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of bifenthrin not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression.
V. Conclusion
Therefore, tolerances are established for residues of bifenthrin,
(2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on grass, forage
at 4.0 ppm; grass, hay at 15 ppm; and tea, dried at 30 ppm. This
regulation additionally establishes time-limited tolerances for
residues of bifenthrin in or on apple, nectarine, and peach at 0.5 ppm.
Finally, this regulation removes time-limited tolerances in or on
orchardgrass, forage at 2.5 ppm; and orchardgrass, hay at 4.5 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 10, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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:
0
a. Revise paragraph (a)(1) introductory text.
0
b. Add alphabetically the commodity to the table in paragraph (a)(1).
0
c. Revise the footnote to the table in paragraph (a)(1).
0
d. Revise paragraph (b).
0
e. Revise paragraph (c).
The revisions and addition read as follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
insecticide bifenthrin, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only
bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-
trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Tea, dried \1\.............................................. 30
* * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations.
* * * * *
[[Page 56791]]
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide bifenthrin, including its
metabolites and degradates, in connection with use of the pesticide
under a Section 18 emergency exemption granted by EPA. Compliance with
the tolerance levels specified below is to be determined by measuring
only bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-
3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate. These
tolerances will expire and are revoked on the dates specified in the
following table:
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Apple........................................ 0.5 12/31/2015
Nectarine.................................... 0.5 12/31/2015
Peach........................................ 0.5 12/31/2015
------------------------------------------------------------------------
(c) Tolerances with regional registrations. Tolerances with
regional registrations are established for residues of the insecticide
bifenthrin, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only bifenthrin, (2-
methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate.
------------------------------------------------------------------------
Parts per
Commodity million
-----------------------------------------------------------------------
Grass, forage............................................ 4.0
Grass, hay............................................... 15
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-22772 Filed 9-13-12; 8:45 am]
BILLING CODE 6560-50-P