[Federal Register: February 4, 2004 (Volume 69, Number 23)]
[Rules and Regulations]
[Page 5289-5297]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe04-19]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0370; FRL-7335-6]
Bifenazate; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of bifenazate (1-methylethyl 2-(4-methoxy[1,1'-
biphenyl]-3-yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as
bifenazate) in or on potatoes. This action is in response to use of
this chemical on potatoes under an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
This regulation establishes a maximum permissible level for residues of
bifenazate in this food commodity. The tolerance will expire and is
revoked on December 31, 2006.
DATES: This regulation is effective February 4, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2003-0370,
must be received on or before April 5, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: Sec-18-Mailbox@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:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
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 Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0370. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/ A frequently updated electronic version of 40 CFR part 180 is available at http://.
[[Page 5290]]
http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for combined residues of the
insecticide bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate) in
or on potatoes at 0.05 parts per million (ppm). This tolerance will
expire and is revoked on December 31, 2006. EPA will publish a document
in the Federal Register to remove the revoked tolerance from the Code
of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18-related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
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. * *
*''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
EPA has received objections to a tolerance it established for
bifenazate on a different food commodity. The objections were filed by
the Natural Resources Defense Council (NRDC) and raised several issues
regarding aggregate exposure estimates and the additional safety factor
for the protection of infants and children. Although these objections
concern separate rulemaking proceedings under the FFDCA, EPA has
considered whether it is appropriate to establish this emergency
exemption tolerance for bifenazate while the objections are still
pending.
Factors taken into account by EPA included how close the Agency is
to concluding the proceedings on the objections, the nature of the
current action, whether NRDC's objections raised frivolous issues, and
extent to which the issues raised by NRDC had already been considered
by EPA. Although NRDC's objections are not frivolous, the other factors
all support establishing this tolerance at this time. First, the
objections proceeding is unlikely to conclude prior to when action is
necessary on this petition. NRDC's objections raise complex legal,
scientific, policy, and factual matters. EPA has published a notice
describing the nature of the NRDC's objections in more detail. This
notice offered an opportunity for the public to comment on this matter
and published in the Federal Register of June 19, 2002 (67 FR 41628)
(FRL-7167-7). EPA is now examining the extensive comments received.
Second, the nature of the current action is extremely time-sensitive
and addresses an emergency situation. Third, the issues raised by NRDC
are not new matters but questions that have been the subject of
considerable study by EPA and comment by stakeholders. Accordingly, EPA
is proceeding with establishing the tolerance for bifenazate.
III. Emergency Exemption for Bifenazate on Potatoes and FFDCA
Tolerances
The states of Oregon and Washington requested the emergency use of
bifenazate on potatoes to control an outbreak of spider mites. The use
of bifenazate on potatoes in these states took place under a section 18
crisis declaration. The states invoked the crisis authorities because
of damage that spider mites cause to the crop.
EPA assessed the potential risks presented by residues of
bifenazate in or on potatoes. In doing so, EPA considered the safety
standard in section 408(b)(2) of the FFDCA, and EPA decided that the
necessary tolerance under section 408(l)(6) of the FFDCA would be
consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment as provided in
section 408(l)(6) of the FFDCA. Although this tolerance will expire and
is revoked on December 31, 2006, under section 408(l)(5) of the FFDCA,
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on potatoes after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this tolerance at the time of that application. EPA will take action
to revoke this tolerance earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether bifenazate
meets EPA's registration requirements for use on potatoes or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of bifenazate by a State for special local needs
under FIFRA section 24(c). Nor does this tolerance serve as the basis
for
[[Page 5291]]
any States other than Oregon and Washington to use this pesticide on
this crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR
part 166. For additional information regarding the emergency exemption
for bifenazate, contact the Agency's Registration Division at the
address provided under FOR FURTHER INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
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 the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
Consistent with 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 bifenazate and to make a determination on aggregate
exposure, consistent with section 408(b)(2) of the FFDCA, for a time-
limited tolerance for combined residues of bifenazate in or on potatoes
at 0.05 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Endpoints
The dose at which no adverse effects are observed (the no observed
adverse effect level (NOAEL)) from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological endpoint. However, the lowest dose at which adverse
effects of concern are identified (the lowest observed adverse effect
level (LOAEL)) is sometimes used for risk assessment if the 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. An UF
of 100 is routinely used, 10X to account for interspecies differences
and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). The FQPA requires, in certain
circumstances, an additional safety factor for the protection of
infants and children. Where this FQPA safety factor applies, EPA
calculates an acute or chronic Population Adjusted Dose (aPAD or cPAD)
by dividing the RfD by the FQPA safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. The non-dietary risk (other
than cancer) is expressed as the margin of exposure (MOE), a ratio of
the NOAEL to estimated exposures (margin of exposure (MOE) = NOAEL/
exposure). An MOE higher than the applicable LOC would indicate that
the risk is not of concern.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for bifenazate used for human risk assessment is shown in the
following Table 1:
Table 1.--Summary of Toxicological Dose and Endpoints for Bifenazate for Use in Human Risk Assessment
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Special FQPA SF and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
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Acute dietary (general population and NA NA An acute dietary
females 13-50 years old) endpoint was not
selected based on the
absence of an
appropriate endpoint
attributed to a single
dose
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Chronic dietary; (all populations) NOAEL= 1.0 milligram/ FQPA SF = 1X LOAEL = 8.9/10.4 mg/kg/
kilogram/day (mg/kg/ cPAD = 0.01 mg/kg/day.. day M/F based on
day) UF = 100 changes in
cRfD = 0.01 mg/kg/day.. hematological and
clinical chemistry
parameters, and
histopathology in bone
marrow, liver, and
kidney in the 1-Year
Dog Feeding Study
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Incidental oral, short-term (1-30 Oral NOAEL = 10 mg/kg/ LOC for MOE [le] 100 Maternal LOAEL = 100 mg/
days) day (residential).......... kg/day based on
clinical signs,
decreased body weight
and food consumption
during the dosing
period in the Rat
Developmental Study
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Incidental oral, intermediate-term Oral NOAEL = 0.9 mg/kg/ LOC for MOE [le] 100 LOAEL = 10.4/10.7 mg/kg/
(30 days to 6 months) day (residential).......... day M/F based on
changes in hematologic
parameters in the 90-
Day Subchronic Dog
Study
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[[Page 5292]]
Short-, intermediate- and long-term Dermal NOAEL = 80 mg/kg/ LOC for MOE [le] 100 LOAEL = 400 mg/kg/day
dermal (1-30 days, 30 days to 6 day (residential).......... based on decreased
months, and 6 months to lifetime) body weight and food
consumption,
hematologic effects,
increased spleen
weight and
extramedullary
hemapoiesis in the
spleen in the 21-Day
Dermal Toxicity Study
in Rats
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Short-term inhalation (1-30 days) Oral NOAEL= 10 mg/kg/ LOC for MOE [le] 100 LOAEL = 100 mg/kg/day
day (residential).......... based on decreased
inhalation absorption body weight and food
rate = 100%. consumption in the Rat
Developmental Study
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Intermediate-term inhalation (30 days Oral NOAEL= 0.9 mg/kg/ LOC for MOE [le] 100 LOAEL = 10.4/10.7 mg/kg/
to 6 months) day (residential).......... day based on changes
(inhalation absorption in hematologic
rate = 100%). parameters in the 90-
Day Dog Feeding Study
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Long-term inhalation 6 months to Oral study NOAEL= 1.0 LOC for MOE [le] 100 LOAEL = 8.9/10.4 mg/kg/
lifetime) mg/kg/day (residential).......... day M/F based on
(inhalation absorption changes in
rate = 100%). hematological and
clinical chemistry
parameters, and
histopathology in bone
marrow, liver, and
kidney in the 1-Year
Dog Feeding Study
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Cancer (oral, dermal, inhalation) NA NA Bifenazate is
classified as ``not
likely'' to be a human
carcinogen
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B. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.572) for the combined residues of bifenazate,
(hydrazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-
methylethyl ester) and D3598 expressed as bifenazate (diazinecarboxylic
acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethylester)], in or on
apple, wet pomace; cattle, fat; cotton, gin byproducts; cotton,
undelinted seed; fruit, pome, group 11; goat, fat; grape; grape,
raisin; hog, fat; hog, dried cone; horse, fat; nectarine; peach; plum;
sheep, fat, and strawberry, and bifenazate (hydrazinecarboxylic acid,
2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethyl ester) and D3598
expressed as bifenazate (diazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethylester), A1530 (1,1'-biphenyl, 4-ol) and
A1530-sulfate expressed as A1530 (1,1'-biphenyl, 4-oxysulfonic acid) in
or on cattle, meat; cattle, meat byproducts; goat, meat; goat, meat
byproducts; hog, meat; hog, meat byproducts; horse, meat; horse, meat
byproducts; milk; sheep, meat; and sheep, meat byproducts.
Risk assessments were conducted by EPA to assess dietary exposures
from bifenazate in food as follows:
i. Acute exposure. An acute dietary reference dose (RfD) for the
females 13-50 years of age and the general population, including
infants and children, was not selected because an acute oral endpoint
attributed to a single-dose exposure could not be identified in any of
the studies in the toxicology data base, including developmental and
maternal toxicity in the developmental toxicity studies.
ii. Chronic exposure. In conducting this acute dietary risk
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM/FCIDTM) 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
assessment: The chronic dietary exposure analysis assumed tolerance
level residues and 100% crop treated for all registered and proposed
crops excluding tomato where average field trial residues were used.
DEEM (ver 7.73) default processing factors were assumed for all
commodities excluding apple juice, grape juice, wine/sherry, tomato
paste, and tomato puree. The processing factors for these commodities
were reduced to 0.23, 0.17, 0.17, 5.0, and 5.0, respectively, based on
data from processing studies.
iii. Cancer. EPA has classified bifenazate as ``not likely'' to be
a human carcinogen. Therefore, a cancer dietary exposure and risk
assessment was not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for bifenazate 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 bifenazate.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS)
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentrations in Groundwater (SCI-GROW) model is used to
predict pesticide concentrations in shallow ground water. For a
screening-level assessment for surface water, EPA will generally use
FIRST (a Tier 1 model) before using PRZM/
[[Page 5293]]
EXAMS (a Tier 2 model). The FIRST model is a subset of the PRZM/EXAMS
model that uses a specific high-end runoff scenario for pesticides.
While both FIRST and PRZM/EXAMS incorporate an index reservoir
environment, the PRZM/EXAMS model includes a percent crop area factor
as an adjustment to account for the maximum percent crop coverage
within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for estimating the highest
pesticide drinking water concentrations that might ever be encountered.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, EPA
determines the maximum permissible exposures (acute, short-term,
intermediate-term and chronic) to the pesticide in drinking water,
taking into account the expected exposure through food and residential
uses. These maximum permissible level of exposure through drinking
water are called drinking water levels of comparison (DWLOCs) and used
as a point of comparison against the model estimates of a pesticide's
concentration in water. So long as the estimated EECs from these
screening models (which are designed to estimate theoretical upper
limits on a pesticide's concentration in drinking water) do not exceed
the applicable DWLOCs, EPA concludes that exposure to the pesticide in
drinking water does not pose a risk of concern in light of total
aggregate exposure to a pesticide in food, and from residential uses.
Because DWLOCs address total aggregate exposure to bifenazate they are
further discussed in the aggregate risk sections below.
Parent bifenazate degrades rapidly in aerobic soil conditions with
a half-life of approximately 30 minutes. The first degradate formed
(D3598; half-life of 7 hours) was reported in a concentration of 95% of
the applied radioactivity . D3598 degrades to D1989 (reported at a
maximum of 26% of the applied radioactivity), which is moderately
persistent with an EPA- calculated half-life of approximately 96 days.
Photodegradation and other routes of dissipation of parent bifenazate
do not appear to be significant.
The Agency concluded that the residue of concern in drinking water
is D1989. Parent and D3598 were not included as a residue of concern in
drinking water due to the short half-lives of these compounds and the
lack of an acute dietary endpoint (toxicity of D3598 is assumed to be
equivalent to bifenazate). Since ground or surface water monitoring
data to calculate a quantitative aggregate exposure are not available,
EPA provided Tier I ground (SCI-GROW) and surface water (FIRST) EECs
for D1989. Both EEC calculations with both models were based on the
strawberry application scenario (one application at 0.75 lbs ai/acre;)
because this is the highest registered/proposed application rate). The
resulting ground and chronic surface water EECs are <0.001 ppb and 6.4
ppb, respectively.
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).
Bifenazate is currently registered for use on the following
residential non-dietary sites: Commercial application to ornamental
plants (including bedding plants, flowering plants, foliage plants,
bulb crops, perennials, trees and shrubs; not turf) and all fruit trees
which will not bear fruit for a minimum of 12 months. The proposed
label is amended to permit application by residents/homeowners. The
risk assessment was conducted using the following residential exposure
assumptions: EPA anticipates only short-term dermal and short-term
inhalation exposure from the requested residential use. The proposed
formulation is appropriate for application via pump up sprayers, garden
hose-end sprayers or similar ``homeowner'' pesticide devices. The
Agency believes that persons using a hose-end sprayer are likely to
treat a larger area per day than those using a ``pump up'' compressed
air sprayer, which in turn results in possibly greater contact with the
pesticide active ingredient per day for applicators using hose-end
sprayers. In order to avoid underestimating residential risk, exposure
from a hose-end sprayer is assessed rather than that of a compressed
air sprayer. For the treatment of shrubs and ornamentals, EPA assumed
100 gallons of finish spray are applied per day. The unit exposure
value for a residential handler using open pour mixing/loading for a
garden hose-end sprayer is 11 mg/lb handled (dermal) and 0.013 mg/lb
handled. Exposures were calculated using the Agency's draft Residential
Standard Operating Procedures.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
EPA does not have, at this time, available data to determine
whether bifenazate has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to [bifenazate]
and any other substances and bifenazate does not appear to produce a
toxic metabolite produced by other substances.For the purposes of this
tolerance action, therefore, EPA has not assumed that bifenazate has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/
.
C. Safety Factor for Infants and Children
1. In general. Section 408 of the 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 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.
2. Prenatal and postnatal sensitivity. Developmental toxicity and
reproductive toxicity studies performed with bifenazate yield no
qualitative or quantitative toxicity evidence of increased
susceptibility among rats and rabbits during in utero exposure or
during postnatal exposure.
[[Page 5294]]
3. Conclusion. There is a complete toxicity data base for
bifenazate and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Based on the
lack of increased susceptibility and the completeness of the toxicity
and exposure databases, EPA has concluded that an additional 10X safety
factor is not needed to protect infants and children.
D. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water, instead, DWLOCs indicate the
maximum pesticide concentration in drinking water that would be of no
regulatory concern in light of total aggregate exposure to a pesticide
in food and residential uses. A DWLOC represents how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational
exposure)).
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to bifenazate in drinking water (when considered along with
other sources of exposure for which EPA has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because EPA considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. Before new
uses are added in the future, EPA will reassess the potential impacts
of bifenazate on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. Because no acute oral toxicity endpoint attributed
to a single-dose exposure was identified in any of the studies in the
toxicology data base, including developmental and maternal toxicity in
the developmental toxicity studies, an acute dietary risk assessment
was not conducted.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
bifenazate from food will utilize 25% of the cPAD for the U.S.
population, 60% of the cPAD for all infants < 1 year old, 86% of the
cPAD for children 1-2 years old (the most highly exposed population
subgroup), and 17% of the cPAD for females 13-49 years old. Based on
the use pattern, chronic residential exposure to residues of bifenazate
is not expected. In addition, there is potential for chronic dietary
exposure to bifenazate in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface water and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the cPAD, as shown
in Table 2:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bifenazate
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ % cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.01 25 6.4 <0.001 260
---------------------------------------------------------------------------
All infants (<1 year old) 0.01 60 6.4 <0.001 75
---------------------------------------------------------------------------
Children (1-2 years old) 0.01 86 6.4 <0.001 14
---------------------------------------------------------------------------
Females (13-49 years old) 0.01 17 6.4 <0.001 290
----------------------------------------------------------------------------------------------------------------
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).
Bifenazate is currently registered for uses 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 bifenazate.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 2,000 for the U.S. population,
2,100 for youth 13-19 years old, 2,400 for adults 20-49 years old,
2,200 for females 13-49 years old, and 2,300 for adults 50+ years old.
These aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of bifenazate in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in Table 3:
[[Page 5295]]
Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Bifenazate
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Ground Short-Term
Population Subgroup MOE (Food + Concern Water EEC Water EEC DWLOC (ppb)
Residential) (LOC) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 2,000 100 6.4 <0.001 3,500
---------------------------------------------------------------------------
Youth (13-19 years old) 2,100 100 6.4 <0.001 3,000
---------------------------------------------------------------------------
Adults (20-49 years old) 2,400 100 6.4 <0.001 3,500
---------------------------------------------------------------------------
Females (13-49 year old) 2,200 100 6.4 <0.001 3,000
---------------------------------------------------------------------------
Adults (50+ years old) 2,300 100 6.4 <0.001 3,500
----------------------------------------------------------------------------------------------------------------
x4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Residential intermediate-term aggregate exposure (30 days to 6
months) is not expected from use of this chemical. Thus, the
intermediate-term risk for the public consista od food and water
exposures which were previously addressed.
5. Aggregate cancer risk for U.S. population. EPA has classified
bifenazate as ``not likely'' to be a human carcinogen. Therefore, a
cancer dietary exposure and risk assessment was not performed.
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 bifenazate residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (example--gas chromatography) 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
Canada, Codex, and Mexico do not have maximum residue limits (MRLs)
for residues of bifenazate in/on the proposed crop. Therefore,
harmonization is not an issue.
VI. Conclusion
Therefore, a time-limited tolerance is established for combined
residues of bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate) in
or on potatoes at 0.05 ppm. This time-limited tolerance will expire on
December 31, 2006.
VII. Objections and Hearing Requests
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. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0370 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 April 5,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at
[[Page 5296]]
tompkins.jim@epa.gov, or by mailing a request for information to Mr.
Tompkins at Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3.Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by the docket ID number OPP-2003-0370, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of the FFDCA. 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 FIFRA
section 18 exemption under section 408 of the 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 the
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.
IX. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by 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
[[Page 5297]]
and pests, Reporting and recordkeeping requirements.
Dated: January 21, 2004.
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), 346(a) and 371.
0
2. Section 180.572 is amended by alphabetically adding the following
commodity to the table in paragraph (b) to read as follows:
Sec. 180.572 Bifenazate; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Potato............................ 0.05 12/31/06
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 04-2271 Filed 2-3-04; 8:45 am]
BILLING CODE 6560-50-S