[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Rules and Regulations]
[Pages 46117-46123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13058]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0366; FRL-8081-7]


Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
bifenthrin in or on Vegetable, tuberous and corm, subgroup 1C; 
Brassica, leafy greens, subgroup 5B; turnip, greens; Pea and bean, 
dried shelled, except soybean, subgroup 6C; coriander, leaves; 
coriander, dried leaves; coriander, seed and okra. Interregional 
Research Project Number 4 (IR-4) requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA). EPA is also deleting an existing 
time-limited bifenthrin tolerance that is no longer needed as a result 
of this action.

DATES: This regulation is effective August 11, 2006. Objections and 
requests for hearings must be received on or before October 10, 2006, 
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-2006-0366. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail 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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 provides 
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 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, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA

[[Page 46118]]

procedural regulations which govern the submission of objections and 
requests for hearings appear in 40 CFR part 178. 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-2006-0366 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 on or 
before October 10, 2006.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0366, 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 
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of May 10, 2006 (71 FR 27246) (FRL-8067-4), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of pesticide petitions (PP) 2E6451, 
3E6882, 2E6492, 2E6423, and 4E6843 by Interregional Research Project 
Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 
08902-3390. 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 leafy brassica 
greens, subgroup 5B at 3.0 parts per million (ppm) and turnip greens at 
3.0 ppm (2E6451); tuberous and corm vegetables, subgroup 1C at 0.1 ppm 
(3E2688); okra at 0.5 ppm (2E6492); dried shelled pea and bean (except 
soybean), subgroup 6C at 0.1 ppm (2E6423); and cilantro at 5.0 ppm 
(4E6843). That notice included a summary of the petition prepared by 
FMC, the registrant. There were no comments received in response to the 
notice of filing. The proposed tolerances were later amended as 
follows: Vegetable, tuberous and corm, subgroup 1C at 0.05 ppm 
(3E2688); Brassica, leafy greens, subgroup 5B at 3.5 ppm and turnip, 
greens at 3.5 ppm (2E6451); Pea and bean, dried shelled, except 
soybean, subgroup 6C at 0.15 ppm, coriander, leaves at 6.0 ppm, 
coriander, dried leaves at 25 ppm, and coriander, seed at 5.0 ppm 
(4E6843); okra at 0.5 ppm (2E6492). EPA is also deleting an established 
tolerance in 40 CFR 180.442(b) that is no longer needed, as a result of 
this action. The tolerance deletion under 40 CFR 180.442(b) is a time-
limited tolerance established under section 18 emergency exemptions 
that is superceded by the establishment of a general tolerance for 
bifenthrin section 40 CFR 180.442(a). The revision to 40 CFR 180.442 is 
as follows: Delete the time-limited tolerance for sweet potato, roots 
at 0.05 ppm under 40 CFR 180.442(b). The tolerance for vegetable, 
tuberous and corm, subgroup 1C at 0.05 ppm that is being established 
includes sweet potato.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of bifenthrin (2-
methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate on Brassica, leafy 
greens, subgroup 5B at 3.5 ppm; coriander, dried leaves at 25 ppm; 
coriander, leaves at 6.0 ppm; coriander, seed at 5.0 ppm; okra at 0.50 
ppm; Pea and bean, dried shelled, except soybean, subgroup 6C at 0.15 
ppm; turnip, greens at 3.5 ppm; and Vegetable, tuberous and corm, 
subgroup 1C at 0.05 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerance 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. Specific information on the studies received and the nature 
of the toxic effects caused by bifenthrin as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse 
effectlevel (LOAEL) from the toxicity studies can be found at http://www.epa.gov/fedrgstr/EPA-PEST/2003/April/Day-30/p10400.htm.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members

[[Page 46119]]

of the human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for bifenthrin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 30, 2003 (68 FR 23056) (FRL-
7304-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.442) for the 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 a variety of raw 
agricultural commodities. In addition, tolerances for livestock 
commodities have been established for the 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 egg; milk fat; 
meat, fat, and meat byproducts (mbyp) of cattle, goat, hog, horse, 
poultry and sheep. Risk assessments were conducted by EPA to assess 
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.
    The Dietary Exposure Evaluation Model (DEEM-FCID(\TM\), Version 
2.03) analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 and 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the acute exposure assessments: A Tier 3, acute probabilistic 
dietary exposure assessment was conducted for all registered and 
pending food uses and drinking water. Anticipated residues (ARs) were 
developed based on 1998-2003 USDA's Pesticide Data Program (PDP) 
monitoring data, Food and Drug Administration (FDA) data, or field 
trial data for bifenthrin. ARs were further refined using percent crop 
treated (PCT) data and processing factors where appropriate.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID(\TM\), Version 2.03), 
which incorporates food consumption data as reported by respondents in 
the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII), and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: A dietary exposure assessment was conducted for 
all registered and pending food uses and drinking water. Anticipated 
residues (ARs) were developed based on 1998-2003 USDA's Pesticide Data 
Program (PDP) monitoring data, Food and Drug Administration (FDA) data, 
or field trial data for bifenthrin. ARs were further refined using 
percent crop treated (PCT) data and processing factors where 
appropriate.
    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 percent crop treated (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 chemicals that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) 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. Following 
the initial data submission, EPA is authorized to require similar data 
on a time frame it deems appropriate. For the present action, EPA will 
issue such Data Call-Ins for information relating to anticipated 
residues as are required by FFDCA section 408(b)(2)(E) and authorized 
under FFDCA section 408(f)(1). Such Data Call-Ins 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 the Agency can make the following findings: Condition 1, 
that 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; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if 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 section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows:
    Artichokes at 10%, Blackberries at 20%, Broccoli at 1%, Cabbage at 
10%, Cantaloupe at 15%, Cauliflower at 1%, Corn at 15%, Sweet corn at 
15%, Cucumber at 5%, Brussel Sprouts at 1%, Dried Beans at 9%, Dried 
Peas at 9%, Grapes at 1%, Orange at 1%, Lettuce at 1%, Sweet peas at 
5%, Pears at 1%, Nonbell Peppers at 5%, Potatoes at 39%, Honeydew melon 
at 55%, Pumpkin and squash at <15%, Raspberry at 65%, Spinach at 1%, 
Tomato at 5%, Watermelon at 5%, Nuts (almonds, pecan, and walnuts) at 
1%, Hops at 63%, Green Beans at 25%, Sweet Bell Pepper at 5%, Okra at 
47%, Strawberry at 15%, Cotton at <1%, Sorghum < at 1%, and Soybeans at 
<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 five percent 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 United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary 
Market Surveys, and the National Center for Food and Agriculture Policy 
(NCFAP) for the most recent 6 years.

[[Page 46120]]

    EPA estimates projected percent crop treated (PPCT) for a new 
pesticide use by assuming that the PCT during the pesticide's initial 5 
years of use on a specific use site will not exceed the average PCT of 
the market leader (i.e., the one with the greatest PCT) on that site 
over the three most recent surveys. Comparisons are only made among 
pesticides of the same pesticide types (i.e., the dominant miticide on 
the use site is selected for comparison with the new miticide). The 
PCTs included in the average may be each for the same pesticide or for 
different pesticides since the same or different pesticides may 
dominate for each year selected. Typically, EPA uses USDA/NASS as the 
source for the PCT data because they are publicly available. When a 
specific use site is not surveyed by USDA/NASS, EPA uses proprietary 
data and calculates the estimated PCT.
    This estimated PPCT, based on the average PCT of the market leader, 
is appropriate for use in the chronic dietary risk assessment. This 
method of estimating a PPCT for a new use of a registered pesticide or 
a new pesticide produces a high-end estimate that is unlikely, in most 
cases, to be exceeded during the initial 5 years of actual use. The 
predominant factors that generally can be analyzed based on readily 
available information and that bear on whether the estimated PPCT could 
be exceeded are whether there are concerns with pest pressures as 
indicated in emergency exemption requests or other readily available 
information, whether the new pesticide controls a broader spectrum of 
pests than the dominant pesticide(s) and/or whether the new pesticide 
has a shorter pre-harvest interval (PHI).
    All such relevant information currently available has been 
considered for bifenthrin on dry beans/peas, potatoes and okra, and it 
is unlikely that actual PCT for bifenthrin will exceed the estimated 
PPCT for bifenthrin on each of these three crops during the next five 
years mainly because of the relatively longer PHI of bifenthrin 
relative to each of the respective leading insecticides.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure 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 physical 
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 and Screening 
Concentrations in Groundwater models, the estimated environmental 
concentrations (EECs) of bifenthrin for acute exposures are estimated 
to be 0.014 parts per billion (ppb) for surface water and 0.00300 ppb 
for ground water. The EECs for chronic exposures are estimated to be 
0.0140 ppb for surface water and 0.00300 ppb for ground water.
    The estimated drinking water concentrations (EDWCs) for bifenthrin 
were calculated based on a maximum application rate of 0.5 lb ai/A/
season. Modeled estimates of drinking water concentrations were 
directly entered into the dietary exposure model (DEEM-FCID(\TM\), 
Version 2.03). For acute dietary risk assessment, the peak water 
concentration value of 0.0140 ppb was used to access the contribution 
to drinking water. For chronic dietary risk assessment, the annual 
average concentration of 0.0140 ppb was used to access 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 both 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 
handler exposures, and potential post-application contact with lawn, 
soil, and treated indoor surfaces using the EPA's Draft Standard 
Operating Proceedures (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.
    The risk assessment was conducted using the following residential 
exposure assumptions: 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 gas/vapor are considered unlikely, since the vapor pressure 
of bifenthrin is low, inhalation exposure was assessed for aerosols/
particulates 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- and intermediate-term post-application 
dermal exposures for adults, and short- 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. 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 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.

[[Page 46121]]

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. 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 safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. EPA concluded that 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. In addition, there are no concerns or 
residual uncertainties for prenatal and/or postnatal toxicity following 
exposure to bifenthrin.
    3. Conclusion. EPA has concluded that in light of the lack of the 
developmental neurotoxicity (DNT) study the acute RfD, based on the no 
observed adverse effect level (NOAEL) of 32.8 milligrams/kilograms/day 
(mg/kg/day) be divided by an uncertainty factor (UF) of 1,000 (10X for 
interspecies extrapolation, 10X for intraspecies variations, and a 10X 
FQPA factor for an incomplete database for lack of a DNT study). EPA 
has concluded that, based on reliable data, an additional FQPA factor 
of 3X in the form of a database uncertainty factor is required for all 
repeated-dose exposure scenarios to address the lack of a developmental 
neurotoxicity study (DNT) because existing data indicate that the 
results of the DNT study might impact the current toxicology endpoint 
selection and RfDs. Further explanation for the choice of 3X is 
provided in Unit III.D. of the final rule published in the Federal 
Register of April 30, 2003 (68 FR 23056) (FRL-7304-4). An UFDB of 10X 
is applied to single dose exposure scenarios (i.e., acute RfD) to 
account for the lack of the DNT. Acceptable developmental studies in 
the rat and rabbit revealed no increased susceptibility of rat or 
rabbit fetuses following in utero exposure to bifenthrin. In addition, 
there was no evidence of increased susceptibility of young rats in the 
reproduction study with bifenthrin. There are no residual uncertainties 
in the exposure databases. The dietary food exposure assessment were 
refined using percent crop treated (CT) information, and anticipated 
residue (AR) values calculated from the available monitoring data and 
field trial results. Dietary drinking water exposure is based on 
conservative modeling estimates, and the Agency's Residential standard 
operating procedures (SOPs), in conjunction with some chemical specific 
data, were used to assess residential handler and post-application 
exposure to adults and children. These assessments will not 
underestimate the exposure and risks posed by bifenthrin.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated drinking water 
concentrations (EDWCs). The DWLOC values are not regulatory standards 
for drinking water, but are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. More information on the use 
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf. More recently the 
Agency has used another approach to estimate aggregate exposure through 
food, residential and drinking water pathways. In this approach, 
modeled surface and ground water EDWCs are directly incorporated into 
the dietary exposure analysis, along with food. This provides a more 
realistic estimate of exposure because actual body weights and water 
consumption from the CSFII are used. The combined food and water 
exposures are then added to estimated exposure from residential sources 
to calculate aggregate risks. The resulting exposure and risk estimates 
are still considered to be high end, due to the assumptions used in 
developing drinking water modeling inputs.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and 
drinking water to bifenthrin will occupy 24% of the aPAD for the U.S. 
population, 18% of the aPAD for females 13 years and older, 38% of the 
aPAD for all infants less than 1 year old, and 43% of the aPAD for 
children 3-5 years old, the subpopulation at 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 exposure to 
bifenthrin from food and drinking will utilize 10% of the cPAD for the 
U.S. population, 12% of the cPAD for All infants less than 1 year old, 
and 26% of the cPAD for children 1-2 years old, the subpopulation at 
greatest exposure. Based 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 risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Bifenthrin is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for bifenthrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential 
exposures aggregated result in aggregate MOEs of 530 for the general 
U.S. population, 380 for all infants less than 1 year old, and 350 for 
children 1-2 years old the subpopulation at greatest exposure. These 
aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food, water and residential uses. Therefore, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Bifenthrin is currently registered for use(s) that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and 
intermediate-term exposures for bifenthrin.

[[Page 46122]]

    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that food, water and 
residential exposures aggregated result in aggregate MOEs of 530 for 
the general U.S. population, 380 for all infants less than 1 year old, 
and 350 for children 1-2 years old the subpopulation at greatest 
exposure. These aggregate MOEs do not exceed the Agency's level of 
concern for aggregate exposure to food, water, and residential uses. 
Therefore, EPA does not expect intermediate-term aggregate exposure to 
exceed the Agency's level of concern.
    5. 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.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and 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 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: 
[email protected].

B. International Residue Limits

    The Codex Alimentarius Commission has established maximum residue 
limits (MRLs) for residues of bifenthrin in/on various commodities. 
Codex MRLs are expressed in terms of bifenthrin per se, as are U.S. 
tolerances. The only established Codex MRL relevant to the current 
petitions is for potato at 0.05 mg/kg. As the recommended tolerance of 
tuberous and corm vegetables is also 0.05 ppm, this tolerance is in 
harmony with the Codex MRL for potato. There are no equivalent Canadian 
or Mexican MRLs for the tolerances being requested in the current 
petition.

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 on Brassica, leafy 
greens, subgroup 5B at 3.5 ppm; coriander, dried leaves at 25 ppm; 
coriander, leaves at 6.0 ppm; coriander, seed at 5.0 ppm; okra at 0.50 
ppm; Pea and bean, dried shelled, except soybean, subgroup 6C at 0.15 
ppm; turnip, greens at 3.5 ppm; and Vegetable, tuberous and corm, 
subgroup 1C at 0.05 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 due to its lack of 
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as addedby the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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,

[[Page 46123]]

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:August 1, 2006.
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 commodities to 
the table in paragraph (a) and by removing Sweet potato, roots from the 
table in paragraph (b) to read as follows:


Sec.  180.442  Bifenthrin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
                                * * * * *
Brassica, leafy greens, subgroup 5B............................      3.5
                                * * * * *
Coriander, dried leaves........................................       25
Coriander, leaves..............................................      6.0
Coriander, seed................................................      5.0
                                * * * * *
Okra...........................................................     0.50
Pea and bean, dried shelled, expect soybean, subgroup 6C.......     0.15
                                * * * * *
Turnip, greens.................................................      3.5
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C......................     0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-13058 Filed 8-10-06; 8:45 am]
BILLING CODE 6560-50-S