Document ID: EPA-HQ-OPP-2007-0471-0004
Agency: epa
Document Type: Rule
Title: Bifenthrin; Pesticide Tolerance
Posted Date: 2007-10-24T04:00Z

[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]               
[Page 60261-60266]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc07-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0471; FRL-8151-5]

 
Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
bifenthrin in or on mayhaw; vegetable, root, subgroup 1B except sugar 
beet and garden beet; beet, garden, roots; beet, garden, tops; radish, 
tops; soybean, seed; soybean, hulls; soybean, refined oil; 
groundcherry; pepino; peanut; pistachio; and grain, aspirated 
fractions. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective October 24, 2007. Objections and 
requests for hearings must be received on or before December 24, 2007, 
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-2007-0471. 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: Shaja R. Brothers, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
brothers.shaja@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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 the 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-OPP-2007-0471 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 December 24, 2007.
    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-2007-0471, 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

[[Page 60262]]

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 the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP) 
(6E7125, 6E7126, 6E7127, and 6E7128) by IR-4, 500 College Road East, 
Suite 201 W., Princeton, NJ 08540. The petitions 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 pistachio at 0.05 parts per 
million (ppm) (PP 6E7127); mayhaw at 1.4 ppm (PP 6E7125); vegetables, 
fruiting, group 8 at 0.5 ppm (PP 6E7128); peanut at 0.05 ppm (PP 
6E7127); soybean, seed at 0.2 ppm (PP 6E7128); vegetable, root, except 
sugar beet and garden beet, subgroup 1B at 0.07 ppm (PP 6E7126); beet, 
garden, roots at 0.45 ppm (PP 6E7126); and beet, garden, tops at 15 ppm 
(PP 6E7126). 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 
revised commodity definitions and/or tolerances for vegetable, root, 
except sugar beet and garden beet, subgroup 1B; soybean, hulls; 
soybean, refined oil; and vegetable, fruiting, group 8. The reason for 
these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of the 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 the 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 the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....'' These provisions were added to the FFDCA by the Food 
Quality Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors 
specified in section 408(b)(2)(D) of the 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 bifenthrin on mayhaw at 1.4 ppm; vegetable, 
root, subgroup 1B except sugar beet and garden beet at 0.10 ppm; beet, 
garden, roots at 0.45 ppm; beet, garden, tops at 15 ppm; radish, tops 
at 4.5 ppm; soybean, seed at 0.2 ppm; soybean, hulls at 0.50 ppm; 
soybean, refined oil at 0.30 ppm; groundcherry at 0.5 ppm; pepino at 
0.5 ppm; peanut at 0.05 ppm; pistachio at 0.05 ppm; and grain, 
aspirated fractions at 70 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerances follow.

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. 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.
 The referenced studies are available in the 

Bifenthrin Human Health Risk Assessment on pages 52-54 in docket ID 
number EPA-HQ-OPP-2007-0471.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from 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) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC 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 
risks by comparing aggregate 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 LOC by all 
applicable UFs. Short-term, intermediate-term, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.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 on pages 27-28 in docket ID 
number EPA-HQ-OPP-2007-0471.

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.

[[Page 60263]]

    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. 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 Tier 3, acute 
probabilistic dietary exposure and risk assessment for all supported 
(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 percent crop treated 
(%CT) data and processing factors where appropriate.
    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 supported (and pending) 
food uses of bifenthrin using single point estimates of anticipated 
bifenthrin residues field trials. ARs were further refined using %CT 
data for some food commodities.
    iii. Cancer. Bifenthrin was classified as a group ``C'' (possible 
human carcinogen). The Agency concluded that the chronic risk and 
exposure assessment, making use of the cPAD, to be protective of any 
potential carcinogenic risk. Therefore, no separate exposure assessment 
was conducted pertaining to cancer risk.
    iv. Anticipated residue and %CT 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 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 the 
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 
such 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 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 used PCT information for chronic dietary exposures as 
follows: Raspberries 70%; honeydew melon 55%; hops 35%; Brussel sprouts 
1%; blackberries 20%; cantaloupes 20%; sweet corn 20%; cabbage 15%; 
artichokes 10%; broccoli 1%; cauliflower 5%; corn 1%; cucumbers 5%; 
grapes 1%; citrus 1%; lettuce 1%; peas, green 5%; pears 1%; peppers 5%; 
pumpkins 15%; spinach 1%; tomatoes 5%; watermelons 5%; tree nuts 1%; 
squash 5%; beans, green 30%; strawberries 15%; cotton 1%; and lettuce 
1% EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of 5% except for those situations in which the average 
PCT is less than one. In those cases < 1% is used as the average and 
< 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the single maximum value 
reported overall from available federal, state, and private market 
survey data on the existing use, across all years, and rounded up to 
the nearest multiple of five percent. In most cases, EPA uses available 
data from USDA/National Agricultural Statistics Service (USDA/NASS), 
Proprietary Market Surveys, and the National Center for Food and 
Agriculture Policy (NCFAP) for the most recent six years.
    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, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate 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
.

    The environmental fate database for bifenthrin is considered 
adequate for the characterization of drinking water exposure. The 
submitted data indicate that bifenthrin is relatively persistent under 
both laboratory and field conditions. Bifenthrin is relatively immobile 
in four soils tested. Due to its low mobility, bifenthrin is not likely 
to reach subsurface soil environments (lower microbial activity) or 
ground waters. Various terrestrial field dissipation studies confirm 
that bifenthrin remains mostly in the upper soil level. Due to its low 
solubility and high level of binding it appears that bifenthrin would 
remain bound to the soils during run-off events and it may reach 
surface waters if the run-off event is accompanied by erosion.The 
drinking water estimates are based on an application to lettuce at the 
highest application rate.
    Based on the First Index Reservoir Screening Tool (FIRST), and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of bifenthrin for acute 
and chronic exposures are estimated to be 0.0140 parts per billion 
(ppb) for surface water. The EECs for acute and chronic exposures are 
estimated to be 0.003 ppb for ground water.

[[Page 60264]]

    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 (lettuce-
highest application rate (0.5 lb ai/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. 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. These estimates are considered 
conservative, but appropriate, since the study data were generated at 
maximum application rates. Short- to intermediate-term dermal and 
inhalation exposures may occur for residential handlers of bifenthrin 
products. Although residential handler risks from inhalation exposures 
to bifenthrin vapor are considered unlikely since the vapor pressure of 
bifenthrin is low, inhalation exposure was assessed during residential 
mixing, loading, and application of granular products. Adults and 
children may be potentially exposed to bifenthrin residues after 
application of bifenthrin products in residential settings. Short-term 
and intermediate-term post-application dermal exposures for adults, and 
short-term and intermediate-term post-application dermal and incidental 
oral exposures for children are anticipated. Exposure estimates were 
generated for potential contact with lawn, soil, and treated indoor 
surfaces.
    4. Cumulative effects from substances with 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 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. This research is expected to be 
completed by 2007. When available, the Agency will consider 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 of the FFDCA provides that EPA shall 
apply an additional (``10X'') tenfold 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. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    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. Further, 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 that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for bifenthrin is complete.
    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 or the developmental neurotoxicity study.
    iii. 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. Conservative ground and surface water modeling estimates were 
used. Similarly conservative Residential SOPs were used to assess post-
application exposure to 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

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC 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 the population group all 
infants <  1 year old, the highest estimated acute risk receiving the 
greatest exposure. Therefore, EPA does not expect the aggregate 
exposure to exceed 100% of the aPAD.

[[Page 60265]]

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
bifenthrin from food and water will utilize 53% of the cPAD for the 
population group children 3-5 years old, the highest estimated chronic 
risk. 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-term and intermediate-term risks. Short-term and 
intermediate-term aggregate exposures take into account 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 exposures and the Agency 
has determined that it is appropriate to aggregate chronic food and 
water and short-term and intermediate-term exposures for bifenthrin.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that 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 150 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.E.2.
    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) is available to enforce the tolerance 
expression. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex MRLs for the tolerances being requested in the 
current petition.

C. Explanation of Tolerance Revisions

    1. Vegetable, fruiting, group 8. Tolerances are established for 
residues of bifenthrin per se at 0.05 ppm in/on eggplant, at 0.15 ppm 
in/on tomato, and at 0.5 ppm in/on bell and non-bell pepper. EPA has 
determined that a fruiting vegetables crop group tolerance for residues 
of bifenthrin per se is not appropriate for the following reasons: 
Maximum residues in eggplant are more than a factor of five lower than 
the tolerance for tomatoes and the use pattern for tomato and tomatillo 
are different from the other members of the crop group in terms of the 
PHI, maximum seasonal use rate, number of applications, and interval 
between applications. However, EPA is establishing tolerances for 
residues in/on groundcherry and pepino at 0.50 ppm based on the 0.5 ppm 
tolerance for bell and non-bell pepper. As 40 CFR 180.1 indicates that 
a tolerance for residues in/on tomato applies to tomatillo, a tolerance 
for residues in/on tomatillo is not required.
    2. Vegetable, root, except sugar beet and garden beet, subgroup 1B. 
Carrot and radish are the representative commodities of the root 
vegetables, except sugar beet, crop subgroup (1B). The petitioner has 
proposed tolerances for residues of bifenthrin in/on root vegetables, 
except sugar beet, crop subgroup (1B) at 0.07 ppm. Residues of 
bifenthrin ranged from < 0.05 to 0.07 ppm in radish roots with 4 of 6 
trials showing residues levels less than the LOQ (< 0.05 ppm). Residues 
of bifenthrin were less than the LOQ (< 0.05 ppm) in/on carrots from all 
of the submitted trials (10 trials). Based upon the submitted data, EPA 
concludes a tolerance for residues of bifenthrin per se in/on root 
vegetables, except sugar beet and garden beet, crop subgroup (1B) at 
0.10 ppm is appropriate.
    3. Radish, tops. Although not proposed in the Federal Register, 
based upon the submitted data, HED concludes that a separate tolerance 
for residues of bifenthrin per se in radish, tops at 4.5 ppm is 
appropriate.
    4. Soybean, hulls and refined oil. The highest-average field trial 
(HAFT) value for residues of bifenthrin in/on soybean, seed is 0.18 
ppm. The processing factors for soybean, seeds to hulls, meal, refined 
oil, and AGF are as follows:
     Soybean, seed hulls: 0.18 ppm x 2.6 = 0.47 ppm.
     Soybean, seed meal: No concentration of residues.
     Soybean, seed refined oil: 0.18 ppm x 1.6 = 0.29 ppm.
     Soybean, seed grain, aspirated fractions: 0.18 ppm x 380 = 
68.4 ppm.
    Therefore, EPA concludes that tolerances should be established for 
residues of bifenthrin in/on soybean, seed hulls at 0.50 ppm, soybean, 
seed refined oil at 0.30 ppm and grain, aspirated fractions at 70 ppm.

V. Conclusion

    Therefore, the tolerances are established for residues of 
bifenthrin in or on mayhaw at 1.4 ppm; vegetable, root, subgroup 1B 
except sugar beet and garden beet at 0.10 ppm; beet, garden, roots at 
0.45 ppm; beet, garden, tops at 15 ppm; radish, tops at 4.5 ppm; 
soybean, seed at 0.2 ppm; soybean, hulls at 0.50 ppm; soybean, refined 
oil at 0.30 ppm; groundcherry at 0.5 ppm; pepino at 0.5 ppm; peanut at 
0.05 ppm; pistachio at 0.05 ppm; and grain, aspirated fractions at 70 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this 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,

[[Page 60266]]

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 the 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 6, 2000) do not apply to this rule. In addition, 
This 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. 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: October 10, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180. 442 is amended by alphabetically adding the following 
commodities to the table in paragraph (a)(1) to read as follows:

Sec.  180.442  Bifenthrin; tolerances for residues.

    (a) General. * * * (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Beet, garden, roots..................................               0.45
Beet, garden, tops...................................                 15
                                * * * * *
Grain, aspirated fractions...........................                 70
                                * * * * *
Groundcherry.........................................                0.5
                                * * * * *
Mayhaw...............................................                1.4
                                * * * * *
Peanut...............................................               0.05
                                * * * * *
Pepino...............................................                0.5
                                * * * * *
Pistachio............................................               0.05
                                * * * * *
Radish, tops.........................................                4.5
                                * * * * *
Soybean, hulls.......................................               0.50
Soybean, refined oil.................................               0.30
Soybean, seed........................................                0.2
                                * * * * *
Vegetable, root, subgroup 1B except sugar beet and                  0.10
 garden beet.........................................

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-20753 Filed 10-23-07; 8:45 am]

BILLING CODE 6560-50-S