[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orchardgrass, hay, as they will be superseded by permanent tolerances.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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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