[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Rules and Regulations]
[Page 46117-46123]
[DOCID:fr11au06-13]

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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.

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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<PHONE_NUMBER>.

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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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

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<PHONE_NUMBER>.

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

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.

    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.

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.

    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:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

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,

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


[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Notices]
[Pages 69254-69255]
[FR Doc No: 2015-28399]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-232, OMB Control No. 3235-0225]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 17f-4.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520) (the ``Paperwork Reduction Act''),
the Securities and Exchange Commission (the ``Commission'') is
soliciting comments on the collection of information summarized below.
The Commission plans to submit this existing collection of information
to the Office of Management and Budget for extension and approval.
    Section 17(f) (15 U.S.C. 80a-17(f)) under the Investment Company
Act of 1940 (the ``Act'') \1\ permits registered management investment
companies and their custodians to deposit the securities they own in a
system for the central handling of securities (``securities
depositories''), subject to rules adopted by the Commission.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 80a.
---------------------------------------------------------------------------

    Rule 17f-4 (17 CFR 270.17f-4) under the Act specifies the
conditions for the use of securities depositories by funds \2\ and
their custodians.
---------------------------------------------------------------------------

    \2\ As amended in 2003, rule 17f-4 permits any registered
investment company, including a unit investment trust or a face-
amount certificate company, to use a security depository. See
Custody of Investment Company Assets With a Securities Depository,
Investment Company Act Release No. 25934 (Feb. 13, 2003) (68 FR 8438
(Feb. 20, 2003)). The term ``fund'' is used in this Notice to mean a
registered investment company.

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

    The Commission staff estimates that 152 respondents (including an
estimated 81 active funds that may deal directly with a securities
depository, an estimated 50 custodians, and 21 possible securities
depositories) \3\ are subject to the requirements in rule 17f-4. The
rule is elective, but most, if not all, funds use depository custody
arrangements.\4\
---------------------------------------------------------------------------

    \3\ The Commission staff estimates that, as permitted by the
rule, an estimated 2% of all active funds may deal directly with a
securities depository instead of using an intermediary. The number
of custodians is estimated based on information from Morningstar
Direct\SM\. The Commission staff estimates the number of possible
securities depositories by adding the 12 Federal Reserve Banks and 9
active registered clearing agencies. The Commission staff recognizes
that not all of these entities may currently be acting as a
securities depository for fund securities.
    \4\ Based on responses to Item 18 of Form N-SAR (17 CFR
274.101), approximately 97 percent of funds' custodians maintain
some or all fund securities in a securities depository pursuant to
rule 17f-4.
---------------------------------------------------------------------------

    Rule 17f-4 contains two general conditions. First, a fund's
custodian must be obligated, at a minimum, to exercise due care in
accordance with reasonable commercial standards in discharging its duty
as a securities intermediary to obtain and thereafter maintain
financial assets.\5\ This obligation does not contain a collection of
information because it does not impose identical reporting,
recordkeeping or disclosure requirements. Funds and custodians may
determine the specific measures the custodian will take to comply with
this obligation.\6\ If the fund deals directly with a depository, the
depository's contract or written rules for its participants must
provide that the depository will meet similar obligations, \7\ which is
a collection of information for purposes of the Paperwork Reduction
Act. All funds that deal directly with securities depositories in
reliance on rule 17f-4 should have either modified their contracts with
the relevant securities depository, or negotiated a modification in the
securities depository's written rules when the rule was amended.
Therefore, we estimate there is no ongoing burden associated with this
collection of information.\8\
---------------------------------------------------------------------------

    \5\ Rule 17f-4(a)(1). This provision incorporates into the rule
the standard of care provided by section 504(c) of Article 8 of the
Uniform Commercial Code when the parties have not agreed to a
standard. Rule 17f-4 does not impose any substantive obligations
beyond those contained in Article 8. Uniform Commercial Code,
Revised Article 8--Investment Securities (1994 Official Text with
Comments) (``Revised Article 8'').
    \6\ Moreover, the rule does not impose any requirement regarding
evidence of the obligation.
    \7\ Rule 17f-4(b)(1)(i).
    \8\ The Commission staff assumes that new funds relying on 17f-4
would choose to use a custodian instead of directly dealing with a
securities depository because of the high costs associated with
maintaining an account with a securities depository. Thus new funds
would not be subject to this condition.
---------------------------------------------------------------------------

    Second, the custodian must provide, promptly upon request by the
fund, such reports as are available about the internal accounting
controls and financial strength of the custodian.\9\ If a fund deals
directly with a depository, the depository's contract with or written
rules for its participants must provide that the depository will
provide similar financial reports,\10\ which is a collection of
information for purposes of the Paperwork Reduction Act. Custodians and
depositories usually transmit financial reports to funds twice each
year.\11\ The Commission staff estimates that 50 custodians spend
approximately 926 hours (by support staff) annually in transmitting
such reports to funds.\12\ In addition, approximately 81 funds (i.e.,
two percent of all funds) deal directly with a securities depository
and may request periodic reports from their depository. Commission
staff estimates that depositories spend approximately 19 hours (by
support staff) annually transmitting reports to the 81 funds.\13\ The
total annual burden estimate for compliance with rule 17f-4's reporting
requirement is therefore 945 hours.\14\
---------------------------------------------------------------------------

    \9\ Rule 17f-4(a)(2).
    \10\ Rule 17f-4(b)(1)(ii).
    \11\ The estimated 50 custodians would handle requests for
reports from an estimated 3,968 fund clients (approximately 80 fund
clients per custodian) and the depositories from the remaining 81
funds that choose to deal directly with a depository. It is our
understanding based on staff conversations with industry
representatives that custodians and depositories transmit these
reports to clients in the normal course of their activities as a
good business practice regardless of whether they are requested.
Therefore, for purposes of this Paperwork Reduction Act estimate,
the Commission staff assumes that custodians transmit the reports to
all fund clients.
    \12\ (3,968 fund clients x 2 reports) = 7,936 transmissions. The
staff estimates that each transmission would take approximately 7
minutes for a total of approximately 926 hours (7 minutes x 7,936
transmissions).
    \13\ (81 fund clients who may deal directly with a securities
depository x 2 reports) = 162 transmissions. The staff estimates
that each transmission would take approximately 7 minutes for a
total of approximately 19 hours (7 minutes x 162 transmissions).
    \14\ 926 hours for custodians and 19 hours for securities
depositories.
---------------------------------------------------------------------------

    If a fund deals directly with a securities depository, rule 17f-4
requires that the fund implement internal control systems reasonably
designed to prevent an unauthorized officer's instructions (by
providing at least for the form, content, and means of giving,
recording, and reviewing all officers' instructions).\15\ All funds
that seek to rely on rule 17f-4 should have already implemented these
internal control systems when the rule was amended. Therefore, there is
no ongoing burden associated with this collection of information
requirement.\16\
---------------------------------------------------------------------------

    \15\ Rule 17f-4(b)(2).
    \16\ The Commission staff assumes that new funds relying on 17f-
4 would choose to use a custodian instead of directly dealing with a
securities depository because of the high costs associated with
maintaining an account with a securities depository. Thus new funds
would not be subject to this condition.
---------------------------------------------------------------------------

    Based on the foregoing, the Commission staff estimates that the
total annual hour burden of the rule's collection of information
requirement is 945 hours.
    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act. This estimate is not derived
from a comprehensive or even representative survey or study of the
costs of Commission rules.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid control number.
    Written comments are invited on : (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (b) the accuracy of the Commission's estimate of the burden of
the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burdens of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: November 3, 2015.
 Brent J. Fields,
Secretary.
[FR Doc. 2015-28399 Filed 11-6-15; 8:45 am]
BILLING CODE 8011-01-P


Proposed Amendments to the Proposed Amendments to the On On Road Motorcycle Regulation Road Motorcycle Regulation December 10, 1998 December 10, 1998 Sacramento, CA Sacramento, CA Air Resources Board California Environmental Protection Agency Overview Overview   Background Background   Updated Emissions Inventory Updated Emissions Inventory   Proposed Amendments Proposed Amendments   Impacts Analysis Impacts Analysis   Regulatory Alternatives Regulatory Alternatives   Issues Issues   Changes to Staff Proposal Changes to Staff Proposal   Future Activities Future Activities Why Revisit On Why Revisit On Road Motorcycles?

Road Motorcycles?

  1984 Board directive to revisit 1984 Board directive to revisit   Technical advances in 14 years Technical advances in 14 years   Cost Cost effective control levels possible effective control levels possible   Opportunity to supplement SIP Opportunity to supplement SIP measures measures Proposal Covers Only Proposal Covers Only Larger, On Larger, On Road Motorcycles Road Motorcycles New Sales Mostly from Large Motorcycles 97% What's the Current Picture?

What's the Current Picture?

Updated EMFAC7G Inventory Updated EMFAC7G Inventory 1990 1990 2010 2010 HC HC 9.6 ( tons/ day) 4.5 (

9.6 ( tons/ day) 4.5 ( tpd tpd)

NOx NOx 4.9 4.9 3.0 3.0 Total Total 14.5 14.5 7.5 7.5 What's the Current Picture?

What's the Current Picture? ( cont.)

( cont.)

Existing Standards ( last amended for ` 85 MY)

Existing Standards ( last amended for ` 85 MY)

Engine Size Engine Size HC HC only Limit ( g/ km)

only Limit ( g/ km)

700 cc +

700 cc + 1.4 1.4 280 280

 699 cc 699 cc 1.0 1.0 Staff Proposal Staff Proposal Two new standards for HC + NOx Two new standards for HC + NOx   Larger motorcycles only ( 280 cc and above)

Larger motorcycles only ( 280 cc and above)

Standard Standard HC+ NOx Limit HC+ NOx Limit Model Year Model Year Tier Tier 1 1.4 g/ km 1.4 g/ km 2004 2004 Tier Tier 2 0.8 g/ km 0.8 g/ km 2008 2008   Maintain existing corporate averaging Maintain existing corporate averaging ( no individual engine family can exceed 2.5 g/ km)

( no individual engine family can exceed 2.5 g/ km) Current Motorcycle Technologies Current Motorcycle Technologies   Carburetors on most motorcycles Carburetors on most motorcycles   Few have catalysts Few have catalysts   Some have simple pulse Some have simple pulse air air Approach for Developing Tier Approach for Developing Tier 1   Non Non catalyst for most motorcycles catalyst for most motorcycles   Reduce engine Reduce engine out emissions out emissions   Increase use of simple pulse air Increase use of simple pulse air Technologies to Meet Technologies to Meet Proposed Tier Proposed Tier 1 Standard 1 Standard   25% emission reduction 25% emission reduction   60% of bikes already at or near Tier 60% of bikes already at or near Tier 1   Carburetors retained for many models Carburetors retained for many models   Electronic fuel injection on some Electronic fuel injection on some   Catalysts generally not required Catalysts generally not required   Simple engine modifications Simple engine modifications   Expanded use of pulse air Expanded use of pulse air Approach for Developing Tier Approach for Developing Tier 2   Catalysts for some, non Catalysts for some, non catalyst for others catalyst for others   Recognize exhaust replacement primarily in Recognize exhaust replacement primarily in one sector (

one sector ( approx approx. 40% of market)

. 40% of market)

  Give manufacturers flexibility to leave Give manufacturers flexibility to leave non non catalyst bikes at 1.4 g/ km.

catalyst bikes at 1.4 g/ km.

  Remaining 60% of market could meet Remaining 60% of market could meet 0.4 g/ km 0.4 g/ km   Result = industry average of 0.8 g/ km Result = industry average of 0.8 g/ km   Other scenarios possible Other scenarios possible   60% emission reduction from 1998 models 60% emission reduction from 1998 models   Up to 60% of models projected to use Up to 60% of models projected to use ° Computer Computer controlled fuel injection controlled fuel injection ° Computer Computer controlled pulse air for cold controlled pulse air for cold start start ° 3 way catalyst & feed way catalyst & feed back control back control   More Tier More Tier 1 engine modifications 1 engine modifications Technologies to Meet Technologies to Meet Proposed Tier Proposed Tier 2 Standard 2 Standard For 2008 Corporate Averaging For 2008 Corporate Averaging Multiplier for meeting HC+ NOx limit Multiplier for meeting HC+ NOx limit Model Year Model Year 0.8 g/ km ( Tier 0.8 g/ km ( Tier 2) 0.4 g/ km 2) 0.4 g/ km 1999 1999

 2004 2004 1.5 1.5 3.0 3.0 2005 2005 1.375 1.375 2.5 2.5 2006 2006 1.25 1.25 2.0 2.0 2007 2007 1.125 1.5 1.125 1.5 2008 2008 1.0 1.0 1.0 1.0 Proposal Encourages Proposal Encourages Early and Over Early and Over Compliance Compliance Proposal Multiplies Averaging Proposal Multiplies Averaging Power of Early Power of Early Compliant Bikes Compliant Bikes Actual 2004 2008 Sales Equivalent 2008 Sales 667 727 889 800 1000 4083 units Yr 2008 Yr 2004 5000 units Yr 2008 Tier Tier 2 May Impact 2 May Impact Small Small Volume Manufacturers Volume Manufacturers Small Small Volume Manufacturer Provision Volume Manufacturer Provision   No more than 1,000 units per year in CA No more than 1,000 units per year in CA   No new requirement in 2004 No new requirement in 2004   Meet Tier Meet Tier 1 standard in 2008 1 standard in 2008   No Tier No Tier 2 standard 2 standard Projected Emission Benefits ( HC+ NOx)

Projected Emission Benefits ( HC+ NOx)

Year Year Statewide HC+ NOx Reduction Statewide HC+ NOx Reduction 2010 2010 1.3 tons/ day 1.3 tons/ day 2020 2020 2.9 tons/ day 2.9 tons/ day   assumes 34% tampering rate ( MIC)

assumes 34% tampering rate ( MIC)

  full Tier full Tier 2 benefits not expected until 2020 2 benefits not expected until 2020 due to long average lifespan of MCs (~ 14 years)

due to long average lifespan of MCs (~ 14 years)   Full model availability expected Full model availability expected   Small Small volume manufacturers volume manufacturers ° no impact until 2008 no impact until 2008   Aftermarket parts companies Aftermarket parts companies ° need to accommodate catalysts by 2008 need to accommodate catalysts by 2008 Projected Economic Impacts on Projected Economic Impacts on Small Businesses Small Businesses Proposed Proposed Increased Price Increased Price Standard Standard per Bike ( dollars)

per Bike ( dollars)

1.4 g/ km 1.4 g/ km $ 44 $ 44 0.8 g/ km*

0.8 g/ km* $ 210 $ 210 * Assumes California volume production only * Assumes California volume production only Projected Cost to Consumer Projected Cost to Consumer ( compared to 1998 MY Motorcycles)

( compared to 1998 MY Motorcycles) Proposed Proposed Cost Cost Effectiveness Effectiveness Standard Standard ( dollars/

( dollars/ lb lb HC+ NOx)

HC+ NOx)

1.4 g/ km 1.4 g/ km $ 3.00 $ 3.00 0.8 g/ km*

0.8 g/ km* $ 5.40 $ 5.40 * Assumes California volume production only * Assumes California volume production only   Cost Cost effectiveness comparable to other effectiveness comparable to other adopted regulations adopted regulations Projected Cost Projected Cost Effectiveness Effectiveness ( compared to 1998 MY Motorcycles)

( compared to 1998 MY Motorcycles)   Alternative # 1: Adopt Alternative # 1: Adopt no new standards no new standards ° achieve reductions at other categories' expense achieve reductions at other categories' expense ° inequitable; limits last amended 14 years ago inequitable; limits last amended 14 years ago   Alternative # 2: Adopt Alternative # 2: Adopt more stringent standards more stringent standards ° 0.4 g/ km HC+ NOx or lower technically feasible 0.4 g/ km HC+ NOx or lower technically feasible ° increased burden on manufacturers, consumers increased burden on manufacturers, consumers Alternative Proposals Evaluated Alternative Proposals Evaluated Alternative Proposals Evaluated ( cont.)

Alternative Proposals Evaluated ( cont.)

0 0.5 1 1.5 2 2.5 3 3.5 2010 2020 HC+

NOx Reductions,

TPD   Alternative # 3: Adopt Alternative # 3: Adopt less stringent standards less stringent standards ARB ARB MIC MIC Issues Issues   Underestimated costs Underestimated costs   Benefits offset by tampering & migration Benefits offset by tampering & migration   Small Small volume manufacturer provision volume manufacturer provision ° sales cutoff too high sales cutoff too high ° Tier Tier 2 exemption 2 exemption ° competitive advantage competitive advantage Changes to Staff Proposal Changes to Staff Proposal   Applicable to complete engine Applicable to complete engine manufacturers manufacturers   Small Small volume = 300 units per year volume = 300 units per year   Technical changes Technical changes Future Activities Future Activities   2006 progress review 2006 progress review   Tampering Tampering ° Cooperative effort with industry Cooperative effort with industry ° Quantify tampering rates Quantify tampering rates ° Determine impacts on emissions Determine impacts on emissions ° Identify ways to reduce tampering Identify ways to reduce tampering Conclusion Conclusion   All feasible reductions needed All feasible reductions needed   Current standards lag behind available Current standards lag behind available technologies technologies   Modern emission controls already used on some Modern emission controls already used on some motorbikes motorbikes   Efforts taken to address industry concerns Efforts taken to address industry concerns   Proposal is commercially & technologically Proposal is commercially & technologically feasible feasible