
[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Rules and Regulations]               
[Page 33018-33024]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jn08-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0535; FRL-8366-4]

 
Bifenthrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes 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 food commodities bushberry subgroup 13-07B; and leafy petioles 
subgroup 4B. The Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA). In addition, this action revises previously established 
time-limited tolerances for residues of bifenthrin in or on 
orchardgrass, forage and orchardgrass, hay in response to the approval 
of a specific exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing the use of this 
insecticide on orchardgrass in the State of Oregon to control western 
orchardgrass billbug. Residue data have been submitted indicating the 
need to increase the tolerances from their original level. This 
regulation establishes maximum permissible levels of residues of 
bifenthrin in these food/feed commodities. The time-limited tolerances 
expire and are revoked on December 31, 2009.

DATES: This regulation is effective June 11, 2008. Objections and 
requests for hearings must be received on or before August 11, 2008, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0535. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-

[[Page 33019]]

OPP-2007-0535. in the subject line on the first page of your 
submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before August 11, 2008.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0535, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of August 1, 2007 (72 FR 42074) (FRL-8140-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E7227) by IR-4, 500 College Road East, Suite 201 W, 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 food commodities 
bushberry subgroup 13-B and juneberry; lingonberry; salal; aronia 
berry; blueberry, lowbush; buffalo currant; Chilean guava; European 
barberry; highbush cranberry; honeysuckle; jostaberry; native currant; 
sea buckthorn at 2.0 ppm; and leafy petioles subgroup 4-B at 3.0 ppm. 
That notice referenced a summary of the petition prepared by FMC 
Corporation, the registrant, which is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
corrected the commodity definition and utilized established new crop 
groups/subgroups outlined in the final rule for Pesticide Tolerance 
Crop Grouping Program dated December 7, 2007 (72 FR 69150) (FRL-8343-
1). The new commodity definition, Bushberry subgroup 13-07B, includes 
all proposed commodities as well as additional related commodities. 
Therefore, a separate tolerance for each commodity is not needed. Based 
on supporting data, EPA also revised the proposed tolerance level from 
2.0 to 1.8 ppm. The reasons for these changes are explained in Unit 
IV.C.
    EPA is also revising previously established time-limited tolerances 
for residues of the insecticide bifenthrin in or on orchardgrass, 
forage at 2.5 ppm and orchardgrass, hay at 4.5 ppm. These tolerances 
expire and are revoked on December 31, 2009. The Agency is establishing 
these time-limited tolerances in response to a specific emergency 
exemption request under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136p, on behalf of 
the Oregon Department of Agriculture for the emergency use of 
bifenthrin on ochardgrass grown for seed, to control the orchardgrass 
billbug.
    Oregon produces nearly all of the nation's orchardgrass seed, which 
is primarily used as a high protein pasture grass. The key pest of 
orchardgrass in Oregon is the orchardgrass billbug, which lays eggs 
into the stem where they hatch and are hard to control by insecticides. 
The effect of drought conditions in fields serves to magnify damage and 
loss associated with this pest. Significant yield losses, and 
subsequently economic losses, are expected without adequate control. 
EPA has authorized under FIFRA section 18 the use of bifenthrin on 
orchardgrass for control of orchardgrass billbug in Oregon. After 
having reviewed the submission, EPA concurs that emergency conditions 
exist for this State.
    As part of its assessment of the emergency exemption request, EPA 
assessed the potential risks presented by the residues of bifenthrin in 
or on orchardgrass, forage and orchardgrass, hay. In doing so, EPA 
considered the safety standard in section 408(b)(2) of the FFDCA, and 
EPA decided that the necessary time-limited tolerances under section 
408(1)(6) of the 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 the urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is revising these time-limited tolerances without notice and 
opportunity for public comment as provided in section 408 (1) (6) of 
the FFDCA. Although, these time-limited tolerances expire and are 
revoked on December 31, 2009, under section 408 (1) (5) of the FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on orchardgrass, forage and hay after that 
date will not be unlawful, provided the pesticide is applied in a 
manner that was lawful under FIFRA, and the residues do not exceed 
levels that were authorized by these time-limited tolerances at the 
time of application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data, or other 
relevant information on this pesticide indicates that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
bifenthrin meets EPA's registration requirements for use on 
orchardgrass, forage and hay, or whether a permanent tolerance for 
these uses would be appropriate. Under this circumstance, EPA does not 
believe that the time-limited tolerance serves as a basis for 
registration of bifenthrin by a State for special local needs under 
FIFRA section 24(c). Nor does the time-limited tolerance serve as the 
basis for any State other than Oregon to use this pesticide on these 
commodities under section 18 of FIFRA without following all provisions 
of EPA's regulations implementing FIFRA section 18 as identified in 40 
CFR part 166.

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 includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide

[[Page 33020]]

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....'' These provisions were added to the FFDCA by the Food 
Quality Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 the petitioned-for 
tolerances for residues of 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 food commodities bushberry 
subgroup 13-07B at 1.8 ppm; leafy petioles subgroup 4-B at 3.0 ppm as 
well as the time-limited tolerance for residues of bifenthrin in or on 
orchardgrass, forage at 2.5 ppm and orchardgrass, hay at 4.5 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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. Specific information on the studies received and the nature 
of the adverse effects caused by bifenthrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document entitled ``Human Health Risk 
Assessment'' in docket ID number EPA-HQ-OPP-2007-0535-0004.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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 can be found at http://www.regulations.gov in the 
Bifenthrin Human Health Risk Assessment in docket ID number EPA-HQ-OPP-
2007-0535-0004.

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 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.
    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 registered and pending food uses. Anticipated 
residues (ARs) were developed based on the latest USDA's Pesticide Data 
Program (PDP) monitoring data 1998-2005, Food and Drug Administration 
(FDA) data, or field trial data for bifenthrin. ARs were further 
refined using the latest percent crop-treated (PCT) data and processing 
factors where appropriate. For new uses and uses that have been 
registered less than five years 100 PCT was assumed.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, a refined chronic dietary 
exposure assessment was conducted for all the registered and pending 
food uses of bifenthrin using single point estimates of anticipated 
bifenthrin residues, including PCT for registered food/feed 
commodities. For new uses and uses that have been registered less than 
5 years, 100 PCT was assumed.
    iii. Cancer. There was no conclusive evidence of carcinogenic 
potential of bifenthrin in the rat. A mouse oncogenicity study provided 
some evidence for carcinogenic potential in this species. In the mouse 
oncogenicity study, high-dose (81.3 mg/kg/day) males showed a highly 
significant increased incidence of urinary bladder tumors. Other 
findings in the mouse study included a dose-related trend of increased 
combined incidences of adenoma and adenocarcinoma of the liver (males 
only), and increased incidences of bronchioalveolar adenomas and 
adenocarcinomas of the lung in females at some, but not all dose levels 
relative to their controls. The EPA has characterized bifenthrin as 
Category C (possible human carcinogen) primarily on the basis of a 
mouse study. For the purpose of risk characterization, the reference-
dose (RfD) approach should be used for quantification of human cancer 
risk.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the 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 pursuant to section 408(f)(1) 
of the FFDCA require 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

[[Page 33021]]

present action, EPA will issue such data call-ins as are required by 
section 408(b)(2)(E) of the FFDCA and authorized under section 
408(f)(1) of the FFDCA. Data will be required to be submitted no later 
than 5 years from the date of issuance of this tolerance.
    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:
    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.
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group.
     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 areas.
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 used PCT information for chronic dietary exposure as 
follows:
    Raspberries 70%; honeydew melon 55%; hops 35%; alfalfa 1%; 
blackberries 20%; cantaloupes 20%; sweet corn 20%; cabbage 15%; 
artichokes 10%; broccoli 1%; cauliflower 5%; corn 1%; cucumbers 5%; 
grapes 1%; canola/rapeseed 5%; lettuce 1%; peas, green 5%; carrots 5%; 
peppers 5%;pumpkins 15%; dry beans/peas 1%; tomatoes 5%; watermelons 
5%; onions 1%; peanuts 1%; pecans 1%; potatoes 1%; soybean 1%; squash 
5%; sweet potatoes 35%; beans, green 30%; strawberries 15%; cotton 1%; 
and lettuce 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 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 believes that the conditions listed in Unit 
III.C.1.iv.a., b., and c. 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 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 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 lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for bifenthrin in drinking water. Because 
the Agency does not have comprehensive monitoring data for drinking 
water concentrations, 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) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of bifenthrin for acute 
and chronic exposure were calculated based on a maximum application 
rate of 0.5 pound(lb) active ingredient(ai)/acre(A)/season. For both 
acute and chronic exposures, the EDWC in surface water was estimated as 
0.0140 ppb. The EDWC for both acute and chronic exposures is estimated 
to be 0.0030 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic dietary 
risk assessments, the water concentration value of 0.0140 ppb (based on 
the maximum applied rate to lettuce at 0.5 lb a.i./A/season) 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 the following residential 
non-dietary sites: Indoor and outdoor residential non-dietary sites. 
Adults are potentially exposed to bifenthrin residues during 
residential application of bifenthrin. Both adults and children are 
potentially exposed to bifenthrin residues after application (post-
application) of bifenthrin products in residential settings. Exposure 
estimates were generated for residential handlers and individuals 
potential post-application contact with lawn, soil, and treated indoor 
surfaces using the EPA's Draft Standard Operating Procedures (SOPs) for 
Residential Exposure Assessment, and dissipation data from a turf 
transferable residue (TTR) study. Short-term and intermediate-term 
dermal and inhalation exposures for adults, and short-term and 
intermediate-term dermal and incidental oral exposures for children are 
anticipated. These estimates are considered conservative, but 
appropriate, since the study data were generated at maximum application 
rates.
    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.''
     Bifenthrin is a member of the pyrethroid class of pesticides. EPA 
is not currently following a cumulative risk approach based on a common 
mechanism of toxicity for the pyrethroids. Although all pyrethroids 
alter nerve function by modifying the normal biochemistry and 
physiology of nerve membrane sodium channels, available data show that 
there are multiple types of sodium channels and

[[Page 33022]]

it is currently unknown whether the pyrethroids as a class have similar 
effects on all channels or whether modifications of different types of 
sodium channels would have a cumulative effect. Nor do we have a clear 
understanding of effects on key downstream neuronal function, e.g., 
nerve excitability, or how these key events interact to produce their 
compound specific patterns of neurotoxicity. Without such 
understanding, there is no basis to make a common mechanism of toxicity 
finding. There is ongoing research by the EPA's Office of Research and 
Development and pyrethroid registrants to evaluate the differential 
biochemical and physiological actions of pyrethroids in mammals. When 
available, the Agency will evaluate results of this research and make a 
determination of common mechanism as a basis for assessing cumulative 
risk. For information regarding EPA's procedures for cumulating effects 
from substances found to have a common mechanism on EPA's website at 
http://www.epa.gov/pesticides/cumulative/.

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 available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. EPA concluded there is not a 
concern for prenatal and/or postnatal toxicity resulting from exposure 
to bifenthrin. There was no quantitative or qualitative evidence of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
to bifenthrin in developmental toxicity studies and no quantitative or 
qualitative evidence of increased susceptibility of neonates (as 
compared to adults) to bifenthrin in a 2-generation reproduction study 
in rats. Additionally, there was no quantitative or qualitative 
evidence of increased susceptibility of neonates (as compared to 
adults) to bifenthrin in a developmental neurotoxicity study. There are 
no concerns or residual uncertainties for prenatal and/or postnatal 
toxicity following exposure to bifenthrin.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for bifenthrin is complete.
    ii. A DNT study with bifenthrin is available. This study does not 
show any evidence of increased susceptibility of offspring following 
exposure to bifenthrin. This study did not impact endpoints selected by 
the Agency for various exposure scenarios.
    iii. There is no evidence that bifenthrin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
     iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on anticipated residues and percent crop treated. These assumptions are 
based on reliable data and will not underestimate the exposure and 
risk. EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to bifenthrin in 
drinking water. EPA used similarly conservative assumptions to assess 
postapplication exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by bifenthrin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to bifenthrin will occupy 25% of the aPAD for all infants (<1 year old) 
the population group receiving the greatest exposure. Therefore, EPA 
does not expect the aggregate exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
bifenthrin from food and water will utilize 55% of the cPAD for 
children 3-5 years old the population group receiving the greatest 
exposure. Based on the use pattern, chronic residential exposure to 
residues of bifenthrin is not expected. Therefore, EPA does not expect 
the aggregate exposure to exceed 100% of the cPAD.
    3. Short- and Intermediate-term risks. Short-term and intermediate-
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 and intermediate-term residential exposure and the Agency 
has determined that it is appropriate to aggregate chronic exposure 
through food and water and short-term and intermediate-term exposures 
to bifenthrin.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded food, water, 
and residential exposures aggregated result in aggregate MOEs of 220 
for the U.S. general population, 270 for all infants < 1 year old, and 
180 for children 3-5 years old, the subpopulation at greatest exposure. 
These aggregate MOEs do not exceed the Agency's LOC for aggregate 
exposure to food, water and residential uses. Therefore, EPA does not 
expect short and intermediate-term aggregate exposures to exceed the 
Agency's LOC.
    4. Aggregate cancer risk for U.S. population. The Agency considers 
the chronic aggregate risk assessment, making use of the cPAD, to be 
protective of any aggregate cancer risk. See Unit III.C.iii.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to bifenthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC)/electron-
capture detection (ECD)) are available to enforce the tolerance 
expression. The limit of quantitation (LOQ) for these

[[Page 33023]]

methods is 0.05 ppm. 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; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian, or Mexican MRLs for bifenthrin in or 
on the proposed commodities.

C. Revisions to Petitioned-For Tolerances

    Based on evaluation of available data supporting this petition, the 
Agency revised the registrant's proposed tolerances for Bushberry, 
subgroup 13B, including proposed individual berries tolerance, from 2.0 
to 1.8 ppm and applied the corrected commodity definition, Bushberry 
subgroup 13-07B. Separate tolerances for new commodities listed in crop 
subgroup 13-07B are not required as outlined in the Pesticide Tolerance 
Crop Grouping Program Final Rule published in the Federal Register of 
December 7, 2007 (72 FR 69150) (FRL-8340-6).
    The Agency determined that adequate data are available to support 
establishing a tolerance for the bushberry subgroup 13-07B. IR-4 
petitioned for a tolerance for bushberry subgroup 13B as well as an 
individual tolerance on juneberry; lingonberry; salal; aronia berry; 
blueberry, lowbush; buffalo currant; Chilean guava; European barberry; 
highbush cranberry; honeysuckle; jostaberry; native currant; sea 
buckthorn (PP 7E7227). EPA has expanded and revised berries group 13. 
Changes to crop group 13 (berries) included adding new commodities, 
revising existing subgroups and creating new subgroups (including a 
bushberry subgroup 13-07B consisting of the commodities requested in PP 
7E7227 and cultivars, varieties, and/or hybrids of these).
    EPA indicated in the December 7, 2007 final rule as well as the 
earlier May 23, 2007 proposed rule (72 FR 28920) that, for existing 
petitions for which a Notice of Filing had been published, the Agency 
would attempt to conform these petitions to the rule. Therefore, 
consistent with this rule, EPA is establishing tolerances on Bushberry 
subgroup 13-07B. Bushberry subgroup 13-07B consists of the berries for 
which tolerances were requested in PP 7E7227, as well as, additional 
commodities not included in the original tolerance petition.
    EPA concludes it is reasonable to revise the petitioned-for 
tolerances so that they agree with the recent crop grouping revisions 
because:
    i. Although the subgroup includes several new commodities, these 
commodities were proposed as individual tolerances and are closely 
related minor crops which contribute little to overall dietary or 
aggregate exposure and risk;
    ii. Bifenthrin exposure from these added commodities was considered 
when EPA conducted the dietary and aggregate risk assessments 
supporting this action; and
    iii. the representative commodities for the revised subgroup have 
not changed.
     Bushberry subgroup 13-07B. The field trials with bifenthrin on 
blueberries, representative crop, are adequate. An adequate number of 
trials were conducted reflecting the proposed use patterns in the 
appropriate geographic regions, and the appropriate commodities were 
collected at the proposed ``pre'' harvest intervals (PHIs). Samples 
were analyzed using adequate and appropriate analytical methods. 
Tolerance levels for residues in or on bushberry (subgroup 13-07B) were 
determined using the North American Free Trade Agreement (NAFTA) 
maximum residue levels (MRL)/Tolerance Harmonization Spreadsheet.

V. Conclusion

    Therefore, tolerances are established 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 food commodities bushberry subgroup 13-07B at 1.8 ppm; and 
leafy petioles subgroup 4B at 3.0 ppm. In addition, this regulation 
revises the time-limited tolerances for residues of bifenthrin 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 section 408(d) of 
FFDCA 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, 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S.

[[Page 33024]]

Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication of this final rule in the 
Federal Register. This final rule 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: May 28, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.442 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) and by revising paragraph (b) 
to read as follows:


Sec. 180.442  Bifenthrin; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Bushberry subgroup 13-07B............................                1.8
                                * * * * *
Leafy petioles subgroup 4B...........................                3.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for the 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 connection with use of the 
pesticide under a section 18 emergency exemption granted by EPA. This 
tolerance will expire and is revoked on the date specified in the 
following table.

------------------------------------------------------------------------
                                                  Expiration/Revocation
          Commodity           Parts per million            Date
------------------------------------------------------------------------
Orchardgrass, forage........                2.5                 12/31/09
Orchardgrass, hay...........                4.5                 12/31/09
------------------------------------------------------------------------

* * * * *

[FR Doc. E8-13068 Filed 6-10-08; 8:45 am]

BILLING CODE 6560-50-S
