[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]
[Page 60261-60266]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24oc07-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0471; FRL-8151-5]
Bifenthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
bifenthrin in or on mayhaw; vegetable, root, subgroup 1B except sugar
beet and garden beet; beet, garden, roots; beet, garden, tops; radish,
tops; soybean, seed; soybean, hulls; soybean, refined oil;
groundcherry; pepino; peanut; pistachio; and grain, aspirated
fractions. Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective October 24, 2007. Objections and
requests for hearings must be received on or before December 24, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0471. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, any person may file an objection
to any aspect of this regulation and may also request a hearing on
those objections. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0471 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before December 24, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0471, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental
[[Page 60262]]
Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays). Special arrangements should be made
for deliveries of boxed information. The Docket Facility telephone
number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of August 1, 2007 (72 FR 42074) (FRL-8140-
4), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP)
(6E7125, 6E7126, 6E7127, and 6E7128) by IR-4, 500 College Road East,
Suite 201 W., Princeton, NJ 08540. The petitions requested that 40 CFR
180.442 be amended by establishing tolerances for residues of the
insecticide bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-
chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on pistachio at 0.05 parts per
million (ppm) (PP 6E7127); mayhaw at 1.4 ppm (PP 6E7125); vegetables,
fruiting, group 8 at 0.5 ppm (PP 6E7128); peanut at 0.05 ppm (PP
6E7127); soybean, seed at 0.2 ppm (PP 6E7128); vegetable, root, except
sugar beet and garden beet, subgroup 1B at 0.07 ppm (PP 6E7126); beet,
garden, roots at 0.45 ppm (PP 6E7126); and beet, garden, tops at 15 ppm
(PP 6E7126). That notice referenced a summary of the petition prepared
by FMC Corporation, the registrant, which is available to the public in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
revised commodity definitions and/or tolerances for vegetable, root,
except sugar beet and garden beet, subgroup 1B; soybean, hulls;
soybean, refined oil; and vegetable, fruiting, group 8. The reason for
these changes is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....'' These provisions were added to the FFDCA by the Food
Quality Protection Act (FQPA) of 1996.
Consistent with section 408(b)(2)(D) of the FFDCA, and the factors
specified in section 408(b)(2)(D) of the FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of bifenthrin on mayhaw at 1.4 ppm; vegetable,
root, subgroup 1B except sugar beet and garden beet at 0.10 ppm; beet,
garden, roots at 0.45 ppm; beet, garden, tops at 15 ppm; radish, tops
at 4.5 ppm; soybean, seed at 0.2 ppm; soybean, hulls at 0.50 ppm;
soybean, refined oil at 0.30 ppm; groundcherry at 0.5 ppm; pepino at
0.5 ppm; peanut at 0.05 ppm; pistachio at 0.05 ppm; and grain,
aspirated fractions at 70 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerances follow.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by bifenthrin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov.
The referenced studies are available in the
Bifenthrin Human Health Risk Assessment on pages 52-54 in docket ID
number EPA-HQ-OPP-2007-0471.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-term, intermediate-term, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
A summary of the toxicological endpoints for bifenthrin used for
human risk assessment can be found at http://www.regulations.gov in the
Bifenthrin Human Health Risk Assessment on pages 27-28 in docket ID
number EPA-HQ-OPP-2007-0471.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to bifenthrin, EPA considered exposure under the petitioned-
for tolerances as well as all existing bifenthrin tolerances in (40 CFR
180.442). EPA assessed dietary exposures from bifenthrin in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
[[Page 60263]]
In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA conducted a Tier 3, acute
probabilistic dietary exposure and risk assessment for all supported
(and pending) food uses. Anticipated residues (ARs) were developed
based on the latest USDA's Pesticide Data Program (PDP) monitoring data
1998-2005, Food and Drug Administration (FDA) data, or field trial data
for bifenthrin. ARs were further refined using percent crop treated
(%CT) data and processing factors where appropriate.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, a refined chronic dietary
exposure assessment was conducted for all the supported (and pending)
food uses of bifenthrin using single point estimates of anticipated
bifenthrin residues field trials. ARs were further refined using %CT
data for some food commodities.
iii. Cancer. Bifenthrin was classified as a group ``C'' (possible
human carcinogen). The Agency concluded that the chronic risk and
exposure assessment, making use of the cPAD, to be protective of any
potential carcinogenic risk. Therefore, no separate exposure assessment
was conducted pertaining to cancer risk.
iv. Anticipated residue and %CT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide residues that have been measured in food. If
EPA relies on such information, EPA must pursuant to section 408(f)(1)
of the FFDCA require that data be provided 5 years after the tolerance
is established, modified, or left in effect, demonstrating that the
levels in food are not above the levels anticipated. For the present
action, EPA will issue such data call-ins as are required by section
408(b)(2)(E) of the FFDCA and authorized under section 408(f)(1) of the
FFDCA. Data will be required to be submitted no later than 5 years from
the date of issuance of this tolerance. Section 408(b)(2)(F) of the
FFDCA states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if:
a. The data used are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide residue.
b. The exposure estimate does not underestimate exposure for any
significant subpopulation group.
c. Data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by FFDCA section
408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency used PCT information for chronic dietary exposures as
follows: Raspberries 70%; honeydew melon 55%; hops 35%; Brussel sprouts
1%; blackberries 20%; cantaloupes 20%; sweet corn 20%; cabbage 15%;
artichokes 10%; broccoli 1%; cauliflower 5%; corn 1%; cucumbers 5%;
grapes 1%; citrus 1%; lettuce 1%; peas, green 5%; pears 1%; peppers 5%;
pumpkins 15%; spinach 1%; tomatoes 5%; watermelons 5%; tree nuts 1%;
squash 5%; beans, green 30%; strawberries 15%; cotton 1%; and lettuce
1% EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of 5% except for those situations in which the average
PCT is less than one. In those cases < 1% is used as the average and
< 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary
risk analysis. The maximum PCT figure is the single maximum value
reported overall from available federal, state, and private market
survey data on the existing use, across all years, and rounded up to
the nearest multiple of five percent. In most cases, EPA uses available
data from USDA/National Agricultural Statistics Service (USDA/NASS),
Proprietary Market Surveys, and the National Center for Food and
Agriculture Policy (NCFAP) for the most recent six years.
The Agency believes that the conditions listed in Unit
III.C.1.iv.a., b., and c.; have been met. With respect to Condition a.,
PCT estimates are derived from Federal and private market survey data,
which are reliable and have a valid basis. The Agency is reasonably
certain that the percentage of the food treated is not likely to be an
underestimation. As to Conditions b. and c., regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which bifenthrin may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for bifenthrin in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
bifenthrin. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.
The environmental fate database for bifenthrin is considered
adequate for the characterization of drinking water exposure. The
submitted data indicate that bifenthrin is relatively persistent under
both laboratory and field conditions. Bifenthrin is relatively immobile
in four soils tested. Due to its low mobility, bifenthrin is not likely
to reach subsurface soil environments (lower microbial activity) or
ground waters. Various terrestrial field dissipation studies confirm
that bifenthrin remains mostly in the upper soil level. Due to its low
solubility and high level of binding it appears that bifenthrin would
remain bound to the soils during run-off events and it may reach
surface waters if the run-off event is accompanied by erosion.The
drinking water estimates are based on an application to lettuce at the
highest application rate.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of bifenthrin for acute
and chronic exposures are estimated to be 0.0140 parts per billion
(ppb) for surface water. The EECs for acute and chronic exposures are
estimated to be 0.003 ppb for ground water.
[[Page 60264]]
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic dietary
risk assessments, the water concentration value of 0.0140 ppb (lettuce-
highest application rate (0.5 lb ai/A/season) was used to assess the
contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Bifenthrin is currently registered for the following residential
non-dietary sites: Indoor and outdoor residential non-dietary sites.
Adults are potentially exposed to bifenthrin residues during
residential application of bifenthrin. Adults and children are
potentially exposed to bifenthrin residues after application (post-
application) of bifenthrin products in residential settings. Exposure
estimates were generated for residential handlers and individuals
potential post-application contact with lawn, soil, and treated indoor
surfaces using the EPA's Draft Standard Operating Procedures (SOPs) for
Residential Exposure Assessment, and dissipation data from a turf
transferable residue (TTR) study. These estimates are considered
conservative, but appropriate, since the study data were generated at
maximum application rates. Short- to intermediate-term dermal and
inhalation exposures may occur for residential handlers of bifenthrin
products. Although residential handler risks from inhalation exposures
to bifenthrin vapor are considered unlikely since the vapor pressure of
bifenthrin is low, inhalation exposure was assessed during residential
mixing, loading, and application of granular products. Adults and
children may be potentially exposed to bifenthrin residues after
application of bifenthrin products in residential settings. Short-term
and intermediate-term post-application dermal exposures for adults, and
short-term and intermediate-term post-application dermal and incidental
oral exposures for children are anticipated. Exposure estimates were
generated for potential contact with lawn, soil, and treated indoor
surfaces.
4. Cumulative effects from substances with a common mechanism of
toxicity. Bifenthrin is a member of the pyrethroid class of pesticides.
EPA is not currently following a cumulative risk approach based on a
common mechanism of toxicity for the pyrethroids. Although all
pyrethroids alter nerve function by modifying the normal biochemistry
and physiology of nerve membrane sodium channels, available data show
that there are multiple types of sodium channels and it is currently
unknown whether the pyrethroids as a class have similar effects on all
channels or whether modifications of different types of sodium channels
would have a cumulative effect, nor do we have a clear understanding of
effects on key downstream neuronal function, e.g., nerve excitability,
or how these key events interact to produce their compound specific
patterns of neurotoxicity. Without such understanding, there is no
basis to make a common mechanism of toxicity finding. There is ongoing
research by the EPA's Office of Research and Development and pyrethroid
registrants to evaluate the differential biochemical and physiological
actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When available, the Agency will consider this
research and make a determination of common mechanism as a basis for
assessing cumulative risk. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
on EPA's website at http://www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. EPA concluded there is not a
concern for prenatal and/or postnatal toxicity resulting from exposure
to bifenthrin. There was no quantitative or qualitative evidence of
increased susceptibility of rat or rabbit fetuses to in utero exposure
to bifenthrin in developmental toxicity studies and no quantitative or
qualitative evidence of increased susceptibility of neonates (as
compared to adults) to bifenthrin in a 2-generation reproduction study
in rats. Further, there was no quantitative or qualitative evidence of
increased susceptibility of neonates (as compared to adults) to
bifenthrin in a developmental neurotoxicity study. There are no
concerns or residual uncertainties for prenatal and/ or postnatal
toxicity following exposure to bifenthrin.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for bifenthrin is complete.
ii. There is no evidence that bifenthrin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study or the developmental neurotoxicity study.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on anticipated residues and percent crop treated. These assumptions are
based on reliable data and will not underestimate the exposure and
risk. Conservative ground and surface water modeling estimates were
used. Similarly conservative Residential SOPs were used to assess post-
application exposure to children as well as incidental oral exposure of
toddlers. These assessments will not underestimate the exposure and
risks posed by bifenthrin.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to bifenthrin will occupy 25% of the aPAD for the population group all
infants < 1 year old, the highest estimated acute risk receiving the
greatest exposure. Therefore, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD.
[[Page 60265]]
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
bifenthrin from food and water will utilize 53% of the cPAD for the
population group children 3-5 years old, the highest estimated chronic
risk. Based on the use pattern, chronic residential exposure to
residues of bifenthrin is not expected.Therefore, EPA does not expect
the aggregate exposure to exceed 100% of the cPAD.
3. Short-term and intermediate-term risks. Short-term and
intermediate-term aggregate exposures take into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Bifenthrin is currently registered for uses that could result in
short-term and intermediate-term residential exposures and the Agency
has determined that it is appropriate to aggregate chronic food and
water and short-term and intermediate-term exposures for bifenthrin.
Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food,
water, and residential exposures aggregated result in aggregate MOEs of
220 for the U.S. general population, 270 for all infants < 1 year old,
and 150 for children 3-5 years old, the subpopulation at greatest
exposure. These aggregate MOEs do not exceed the Agency's LOC for
aggregate exposure to food, water and residential uses. Therefore, EPA
does not expect short and intermediate-term aggregate exposures to
exceed the Agency's LOC.
4. Aggregate cancer risk for U.S. population. The Agency considers
the chronic aggregate risk assessment, making use of the cPAD, to be
protective of any aggregate cancer risk. See Unit III.E.2.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to bifenthrin residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography (GC)/electron-
capture detection (ECD) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Codex MRLs for the tolerances being requested in the
current petition.
C. Explanation of Tolerance Revisions
1. Vegetable, fruiting, group 8. Tolerances are established for
residues of bifenthrin per se at 0.05 ppm in/on eggplant, at 0.15 ppm
in/on tomato, and at 0.5 ppm in/on bell and non-bell pepper. EPA has
determined that a fruiting vegetables crop group tolerance for residues
of bifenthrin per se is not appropriate for the following reasons:
Maximum residues in eggplant are more than a factor of five lower than
the tolerance for tomatoes and the use pattern for tomato and tomatillo
are different from the other members of the crop group in terms of the
PHI, maximum seasonal use rate, number of applications, and interval
between applications. However, EPA is establishing tolerances for
residues in/on groundcherry and pepino at 0.50 ppm based on the 0.5 ppm
tolerance for bell and non-bell pepper. As 40 CFR 180.1 indicates that
a tolerance for residues in/on tomato applies to tomatillo, a tolerance
for residues in/on tomatillo is not required.
2. Vegetable, root, except sugar beet and garden beet, subgroup 1B.
Carrot and radish are the representative commodities of the root
vegetables, except sugar beet, crop subgroup (1B). The petitioner has
proposed tolerances for residues of bifenthrin in/on root vegetables,
except sugar beet, crop subgroup (1B) at 0.07 ppm. Residues of
bifenthrin ranged from < 0.05 to 0.07 ppm in radish roots with 4 of 6
trials showing residues levels less than the LOQ (< 0.05 ppm). Residues
of bifenthrin were less than the LOQ (< 0.05 ppm) in/on carrots from all
of the submitted trials (10 trials). Based upon the submitted data, EPA
concludes a tolerance for residues of bifenthrin per se in/on root
vegetables, except sugar beet and garden beet, crop subgroup (1B) at
0.10 ppm is appropriate.
3. Radish, tops. Although not proposed in the Federal Register,
based upon the submitted data, HED concludes that a separate tolerance
for residues of bifenthrin per se in radish, tops at 4.5 ppm is
appropriate.
4. Soybean, hulls and refined oil. The highest-average field trial
(HAFT) value for residues of bifenthrin in/on soybean, seed is 0.18
ppm. The processing factors for soybean, seeds to hulls, meal, refined
oil, and AGF are as follows:
Soybean, seed hulls: 0.18 ppm x 2.6 = 0.47 ppm.
Soybean, seed meal: No concentration of residues.
Soybean, seed refined oil: 0.18 ppm x 1.6 = 0.29 ppm.
Soybean, seed grain, aspirated fractions: 0.18 ppm x 380 =
68.4 ppm.
Therefore, EPA concludes that tolerances should be established for
residues of bifenthrin in/on soybean, seed hulls at 0.50 ppm, soybean,
seed refined oil at 0.30 ppm and grain, aspirated fractions at 70 ppm.
V. Conclusion
Therefore, the tolerances are established for residues of
bifenthrin in or on mayhaw at 1.4 ppm; vegetable, root, subgroup 1B
except sugar beet and garden beet at 0.10 ppm; beet, garden, roots at
0.45 ppm; beet, garden, tops at 15 ppm; radish, tops at 4.5 ppm;
soybean, seed at 0.2 ppm; soybean, hulls at 0.50 ppm; soybean, refined
oil at 0.30 ppm; groundcherry at 0.5 ppm; pepino at 0.5 ppm; peanut at
0.05 ppm; pistachio at 0.05 ppm; and grain, aspirated fractions at 70
ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes,
[[Page 60266]]
nor does this action alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. As such, the Agency has
determined that this action will not have a substantial direct effect
on States or tribal governments, on the relationship between the
national government and the States or tribal governments, or on the
distribution of power and responsibilities among the various levels of
government or between the Federal Government and Indian tribes. Thus,
the Agency has determined that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000) do not apply to this rule. In addition,
This rule does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 10, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180. 442 is amended by alphabetically adding the following
commodities to the table in paragraph (a)(1) to read as follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
(a) General. * * * (1) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Beet, garden, roots.................................. 0.45
Beet, garden, tops................................... 15
* * * * *
Grain, aspirated fractions........................... 70
* * * * *
Groundcherry......................................... 0.5
* * * * *
Mayhaw............................................... 1.4
* * * * *
Peanut............................................... 0.05
* * * * *
Pepino............................................... 0.5
* * * * *
Pistachio............................................ 0.05
* * * * *
Radish, tops......................................... 4.5
* * * * *
Soybean, hulls....................................... 0.50
Soybean, refined oil................................. 0.30
Soybean, seed........................................ 0.2
* * * * *
Vegetable, root, subgroup 1B except sugar beet and 0.10
garden beet.........................................
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E7-20753 Filed 10-23-07; 8:45 am]
BILLING CODE 6560-50-S