Bifenazate; Pesticide Tolerance, 51500-51505 [E6-14427]
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Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Rules and Regulations
(703) 308–3194; e-mail address:
brothers.shaja@epa.gov.
[FR Doc. 06–7248 Filed 8–29–06; 8:45 am]
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION:
I. General Information
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0327; FRL–8090–1]
Bifenazate; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
bifenazate in or on pea, garden; pea,
edible podded; vegetable, tuberous and
corm, subgroup 1C; fruit, stone, group
12, except plum; plum; cattle fat; goat
fat; hog fat; horse fat; and sheep fat.
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).
DATES: This regulation is effective
August 30, 2006. Objections and
requests for hearings must be received
on or before October 30, 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–2006–0327. 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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Shaja R. Brothers, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the FFDCA, as
amended by the FQPA, any person may
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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–2006–0327 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 30, 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–2006–0327, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on–
line instructions for submitting
comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of May 3, 2006
(71 FR 26087) (FRL–8058–6), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petitions (PP 3E6762 and
5E6992) by IR-4, 681 U.S. Highway #1
South, North Brunswick, NJ 08902. The
petition requested that 40 CFR 180.572
be amended by establishing tolerances
for combined residues of the insecticide,
bifenazate, (1 methylethyl 2-(4methoxy[1,1′-biphenyl]-3yl)hydrazinecarboxylate) and
diazinecarboxylic acid, 2-(4-methoxy-
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[1,1′-biphenyl]-3-yl), 1-methylethyl ester
(expressed as bifenazate), in or on fruit,
stone, group 12 at 2.0 parts per million
(ppm); pea, garden at 0.2 ppm; pea,
edible podded at 4.0 ppm; and
vegetable, tuberous and corm at 0.01
ppm.
PP 3E6762 proposed to amend 40 CFR
180.572 by deleting existing peach and
nectarine tolerances, and establish a
tolerance for fruit, stone (Group 12) at
2.0 ppm. Following review of the
residue chemistry data, EPA determined
that the commodity terms and
tolerances levels should be revised to
the following: Pea, garden, succulent at
0.20 ppm; vegetable, tuberous and corm,
subgroup 1C at 0.10 ppm; and fruit,
stone, group 12, except plum at 2.5
ppm. Additionally, EPA determined
subsequent revisions for existing
tolerances for plum at 0.20 ppm, and fat
of cattle, goat, hog, horse, and sheep at
0.10 ppm (previously established at 0.3
ppm (plum) and 0.1 ppm (animal fat
commodities).
EPA is also deleting established
tolerances in §180.572(a) for peach and
nectarine since they will be replaced by
the establishment of the tolerance for
residues of bifenazate on fruit, stone,
group 12, except plum. Additionally,
EPA is deleting the time-limited
tolerance for tomato under §180.572(b)
since that tolerance has expired.
The notices referenced above
included a summary of the petitions
prepared by Crompton Uniroyal
Chemical, the registrant. There were no
comments received in response to the
notice of filing.
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
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further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
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 combined of
bifenazate on pea, garden, succulent at
0.20 ppm; pea, edible podded, succulent
at 4.0 ppm; vegetable, tuberous and
corm, subgroup 1C at 0.10 ppm; fruit,
stone, group 12, except plum at 2.5
ppm; plum at 0.20 ppm; and fat of
cattle, goat, hog, horse, and sheep at
0.10 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 toxic effects caused by
bifenazate as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can
be found at www.regulations.gov
(Docket ID EPA–HQ–OPP–2006–0327–
0002, pages 10–12).
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which 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 the LOAEL of concern is
identified 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.
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The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify nonthreshold 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 https://www.epa.gov/
pesticides/health/human.htm.
A summary of the toxicological
endpoints for bifenazate used for human
risk assessment can be found at
www.regulations.gov (Docket ID EPA–
HQ–OPP–2006–0327–0002, page 15).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.572) for the
combined residues of bifenazate, in or
on a variety of raw agricultural and
livestock commodities. A tolerance is
also established for milk. Risk
assessments were conducted by EPA to
assess dietary exposures from bifenazate
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. No such effects were
identified in the toxicological studies
for bifenazate, therefore a quantitative
acute dietary exposure assessment is not
performed.
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-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 assessments: The
chronic analyses incorporated tolerancelevel residues for all commodities
excluding squash, peach, tomato, and
soybean (anticipated residues based on
average field-trial residues were
assumed) and milk (anticipated residue
was assumed). The chronic analyses
incorporated average percent crop
treated (PCT) information. DEEM (ver.
7.81) 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
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were reduced to 0.23, 0.17, 0.17, 5.0,
and 5.0, respectively, based on data
from processing studies.
iii. Cancer. Bifenazate has been
classified as ‘‘not likely’’ to be a human
carcinogen. Therefore, a cancer dietary
exposure assessment was not
performed.
iv. Anticipated residue and PCT
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
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 CallIns 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: 1% for almonds, apples,
apricots, cucumbers, pecans, peppers,
walnuts, and watermelons; 5% for
grapes, nectarines, prunes, plums, and
tomatoes; 10% for peaches and pears,
and 25% for strawberries.
EPA uses an average PCT for chronic
dietary risk analysis. The average PCT
figure for each existing use is derived by
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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.
The Agency believes that the three
conditions listed have been met. With
respect to Condition 1, 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 2 and
3, 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
bifenazate may be applied in a
particular area.
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. Further information
regarding EPA drinking water models
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used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
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 EFED-calculated halflife of approximately 96 days.
Photodegradation and other routes of
dissipation of parent bifenazate do not
appear to be significant.
EPA 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 water or surface water
monitoring data are not available, a Tier
I screening concentration in ground
water (SCI-GROW) and surface water
first index sceening tool reservoir
(FIRST) were provided for the EECs of
D1989. Both models were conducted
using the strawberry application
scenario (2 x 0.50 lbs ai/acre; 21–day
RTI; highest registered/proposed
application rate).
Based on the SCI-GROW and FIRST
models, the estimated environmental
concentrations (EECs) of bifenazate are
estimated to be 6.38 parts per billion
(ppb) for chronic surface water and
<0.001 ppb for ground water. Modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model (DEEMFCIDTM). For chronic dietary risk
assessment, the annual average
concentration of 6.38 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 nonoccupational, 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 nondietary site: Ornamentals. The risk
assessment was conducted using the
following residential exposure
assumptions: EPA anticipated only
short-term dermal and inhalation
exposure for residential handlers. The
proposed formulation was appropriate
for application via pump up sprayers,
garden hose-end sprayers, or similar
‘‘homeowner’’ pesticide devices. A
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larger area per day may be treated with
a hose-end sprayer than with a ‘‘pumpup’’ compressed-air sprayer, which in
turn results in possibly greater contact
with the active ingredient per day.
Therefore, exposure from a hose-end
sprayer was assessed rather than that of
a compressed-air sprayer. With respect
to post-application residential
exposures, no significant postapplication exposure is anticipated from
landscape ornamentals, either by
residents or professional applicators;
therefore, no residential postapplication assessment was conducted.
4. Cumulative effects from 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.’’
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 website at https://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
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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.
The developmental studies in rats and
rabbits did not demonstrate any
qualitative or quantitative in utero extra
sensitivity of fetuses to bifenazate.
Similarly, increased qualitative or
quantitativesusceptibility to offspring
was not observed from bifenazate during
prenatal or postnatal development in
the reproduction study.
3. Conclusion. The Agency evaluated
the bifenazate toxicological database in
reference to the potential for enhanced
sensitivity to infants and children.
Acceptable developmental toxicity
studies in the rat and rabbit are
available, as is an acceptable 2–
generation reproduction study in the rat.
EPA concluded that a bifenazate
developmental neurotoxicity study is
not required. EPA also concluded the
10X FQPA safety factor could be
reduced to 1X for bifenazate for the
following reasons:
i. There is no indication of
quantitative or qualitative increased
susceptibility of rats and rabbits to in
utero or postnatal exposure.
ii. A bifenazate developmental
neurotoxicity study is not required.
iii. The toxicological database, the
residue chemistry database and the
environmental fate database, are
complete for FQPA assessment.
iv. The dietary drinking water
assessment utilizes water concentration
values generated by model and
associated modeling parameters which
are designed to provide conservative,
health protective, high-end estimates of
water concentrations which will not
likely be exceeded.
v. The residential handler assessment
is based upon the residential standard
operating procedures (SOPs). The
residential SOPs are based upon
reasonable worst-case assumptions and
are not expected to underestimate risk.
These assessments of exposure are not
likely to underestimate the resulting
estimates of risk from exposure to
bifenazate.
E. Aggregate Risks and Determination of
Safety
1. Acute risk. No acute risk is
expected from exposure to bifenazate
since no acute endpoints were
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identified for the general U.S.
population (including infants and
children) or the females 13-50 years old
population subgroup.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to bifenazate from food
and water will utilize 38% of the
chronic population adjusted dose
(cPAD) for the U.S. population, 79% of
the cPAD for all infants (<1 year old),
and 94% of the cPAD for children 1-2
years old. There are no residential uses
for bifenazate that result in chronic
residential exposure to bifenazate.
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).
Bifenazate 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 bifenazate.
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 margin of
exposures (MOEs) of 1,600 for the U.S.
population, 1,900 for females 13-49
years old, and 2,000 for adults 50 years
and older. 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. Aggregate cancer risk for U.S.
population. Bifenazate has been
classified as ‘‘not likely’’ to be a human
carcinogen by any relevant route of
exposure. Therefore, bifenazate is
expected to pose at most a negligible
cancer risk.
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, and to infants and children
from aggregate exposure to bifenazate
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A method (UCC-D2341) is available
for enforcement of the currently
established plant tolerances. The
methods used in the field trial and
processing studies were similar to the
current enforcement method. Since the
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procedures are similar and adequate
method validation and concurrent
recoveries were attained in the field trial
and processing studies, EPA concludes
that the current enforcement method is
appropriate for enforcement of the
tolerances associated with this petition.
Adequate enforcement methodology
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 tuberous
and corm vegetables or succulent pea;
therefore, harmonization is not an issue
for these crops. However, Codex MRLs
are established in/on peach, nectarines,
plum, and prunes (no Canadian or
Mexican stone fruit MRLs) at 2.0 ppm.
The Codex MRL residue definition is for
bifenazate per se. The U.S. and Codex
tolerances/MRLs are not compatible
with regard to tolerance expression and
therefore, the levels can not be
harmonized.
jlentini on PROD1PC65 with RULES
V. Conclusion
Therefore, the tolerance is established
for combined residues of bifenazate, (1methylethyl 2-(4-methoxy[1,1′biphenyl]-3-yl)hydrazinecarboxylate)
and diazinecarboxylic acid, 2-(4methoxy-[1,1′-biphenyl]-3-yl), 1methylethyl ester, in or on pea, garden,
succulent at 0.20 ppm; pea, edible
podded, succulent at 4.0 ppm;
vegetable, tuberous and corm, subgroup
1C at 0.10 ppm; fruit, stone, group 12,
except plum at 2.5 ppm; plum at 0.20
ppm; and fat of cattle, goat, hog, horse,
and sheep at 0.10 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
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16:32 Aug 29, 2006
Jkt 208001
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–). 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
PO 00000
Frm 00084
Fmt 4700
Sfmt 4700
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 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
and pests, Reporting and recordkeeping
requirements.
Dated: August 23, 2006.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
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Federal Register / Vol. 71, No. 168 / Wednesday, August 30, 2006 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.572 is amended by:
i. In paragraph (a)(1), in the table, by
removing the commodities ‘‘peach’’ and
‘‘nectarine’’; revising the tolerance
levels for the commodities ‘‘cattle, fat’’;
‘‘goat, fat’’; ‘‘hog, fat’’; ‘‘horse, fat’’; and
‘‘sheep, fat’’ and by alphabetically
adding commodities ‘‘fruit, stone, group
12, except 12’’; ‘‘pea, garden,
succulent’’; ‘‘pea, edible podded,
succulent’’; and ‘‘vegetable, tuberous
and corm’’; and
ii. In paragraph (b), in the table, by
removing the commodity tomato.
The amendments read as follows.
I
§ 180.572 Bifenazate; tolerances for
residues.
(a)(1) * * *
Parts per
million
Commodity
*
*
*
*
Cattle, fat ..................................
*
*
*
*
Fruit, stone, group 12, except
plum ......................................
Goat, fat ....................................
*
*
*
*
Hog, fat .....................................
*
*
*
*
Horse, fat ..................................
*
*
*
*
Pea, garden, succulent .............
Pea, edible podded, succulent
*
*
*
*
Plum ..........................................
Sheep, fat .................................
*
*
*
*
*
0.10
*
2.5
0.10
*
0.10
*
0.10
*
0.20
4.0
*
0.20
0.10
*
Vegetable, tuberous and corm,
subgroup 1C .........................
*
*
*
*
0.10
*
This regulation is effective
August 30, 2006. Objections and
requests for hearings must be received
on or before October 30, 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–2006–0292. 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
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
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:
DATES:
FR Doc. E6–14427 Filed 8–29–06; 8:45 am
I. General Information
BILLING CODE 6560–50–S
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.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0292; FRL–8090–2]
S-metolachlor; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
jlentini on PROD1PC65 with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of Smetolachlor in or on pumpkin, and
squash, winter. 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).
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16:32 Aug 29, 2006
Jkt 208001
PO 00000
Frm 00085
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Sfmt 4700
51505
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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
www.gpoaccess.gov/ecfr. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines at https://www.epa.gpo/
opptsfrs/home/guidelin.htm
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–2006–0292 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 30, 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
E:\FR\FM\30AUR1.SGM
30AUR1
Agencies
[Federal Register Volume 71, Number 168 (Wednesday, August 30, 2006)]
[Rules and Regulations]
[Pages 51500-51505]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14427]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0327; FRL-8090-1]
Bifenazate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for combined residues
of bifenazate in or on pea, garden; pea, edible podded; vegetable,
tuberous and corm, subgroup 1C; fruit, stone, group 12, except plum;
plum; cattle fat; goat fat; hog fat; horse fat; and sheep fat.
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).
DATES: This regulation is effective August 30, 2006. Objections and
requests for hearings must be received on or before October 30, 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-2006-0327. 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 https://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: 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:
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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm.
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-2006-0327 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 30, 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-2006-0327, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of May 3, 2006 (71 FR 26087) (FRL-8058-6),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petitions (PP 3E6762
and 5E6992) by IR-4, 681 U.S. Highway 1 South, North
Brunswick, NJ 08902. The petition requested that 40 CFR 180.572 be
amended by establishing tolerances for combined residues of the
insecticide, bifenazate, (1 methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[[Page 51501]]
[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate),
in or on fruit, stone, group 12 at 2.0 parts per million (ppm); pea,
garden at 0.2 ppm; pea, edible podded at 4.0 ppm; and vegetable,
tuberous and corm at 0.01 ppm.
PP 3E6762 proposed to amend 40 CFR 180.572 by deleting existing
peach and nectarine tolerances, and establish a tolerance for fruit,
stone (Group 12) at 2.0 ppm. Following review of the residue chemistry
data, EPA determined that the commodity terms and tolerances levels
should be revised to the following: Pea, garden, succulent at 0.20 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; and fruit,
stone, group 12, except plum at 2.5 ppm. Additionally, EPA determined
subsequent revisions for existing tolerances for plum at 0.20 ppm, and
fat of cattle, goat, hog, horse, and sheep at 0.10 ppm (previously
established at 0.3 ppm (plum) and 0.1 ppm (animal fat commodities).
EPA is also deleting established tolerances in Sec. 180.572(a) for
peach and nectarine since they will be replaced by the establishment of
the tolerance for residues of bifenazate on fruit, stone, group 12,
except plum. Additionally, EPA is deleting the time-limited tolerance
for tomato under Sec. 180.572(b) since that tolerance has expired.
The notices referenced above included a summary of the petitions
prepared by Crompton Uniroyal Chemical, the registrant. There were no
comments received in response to the notice of filing.
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 the FFDCA and a complete
description of the risk assessment process, see https://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 combined of bifenazate on pea,
garden, succulent at 0.20 ppm; pea, edible podded, succulent at 4.0
ppm; vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; fruit,
stone, group 12, except plum at 2.5 ppm; plum at 0.20 ppm; and fat of
cattle, goat, hog, horse, and sheep at 0.10 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 toxic effects caused by bifenazate 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
www.regulations.gov (Docket ID EPA-HQ-OPP-2006-0327-0002, pages 10-12).
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which 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 the LOAEL of concern is identified 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 https://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for bifenazate used for
human risk assessment can be found at www.regulations.gov (Docket ID
EPA-HQ-OPP-2006-0327-0002, page 15).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.572) for the combined residues of bifenazate,
in or on a variety of raw agricultural and livestock commodities. A
tolerance is also established for milk. Risk assessments were conducted
by EPA to assess dietary exposures from bifenazate 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. No such effects were
identified in the toxicological studies for bifenazate, therefore a
quantitative acute dietary exposure assessment is not performed.
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\), 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: The chronic analyses incorporated tolerance-level residues
for all commodities excluding squash, peach, tomato, and soybean
(anticipated residues based on average field-trial residues were
assumed) and milk (anticipated residue was assumed). The chronic
analyses incorporated average percent crop treated (PCT) information.
DEEM (ver. 7.81) 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
[[Page 51502]]
were reduced to 0.23, 0.17, 0.17, 5.0, and 5.0, respectively, based on
data from processing studies.
iii. Cancer. Bifenazate has been classified as ``not likely'' to be
a human carcinogen. Therefore, a cancer dietary exposure assessment was
not performed.
iv. Anticipated residue and PCT 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 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: 1% for almonds, apples,
apricots, cucumbers, pecans, peppers, walnuts, and watermelons; 5% for
grapes, nectarines, prunes, plums, and tomatoes; 10% for peaches and
pears, and 25% for strawberries.
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.
The Agency believes that the three conditions listed have been met.
With respect to Condition 1, 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 2 and
3, 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 bifenazate may
be applied in a particular area.
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. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
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 EFED-calculated half-life of approximately 96 days.
Photodegradation and other routes of dissipation of parent bifenazate
do not appear to be significant.
EPA 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 water or surface water
monitoring data are not available, a Tier I screening concentration in
ground water (SCI-GROW) and surface water first index sceening tool
reservoir (FIRST) were provided for the EECs of D1989. Both models were
conducted using the strawberry application scenario (2 x 0.50 lbs ai/
acre; 21-day RTI; highest registered/proposed application rate).
Based on the SCI-GROW and FIRST models, the estimated environmental
concentrations (EECs) of bifenazate are estimated to be 6.38 parts per
billion (ppb) for chronic surface water and <0.001 ppb for ground
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). For chronic
dietary risk assessment, the annual average concentration of 6.38 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).
Bifenazate is currently registered for use on the following
residential non-dietary site: Ornamentals. The risk assessment was
conducted using the following residential exposure assumptions: EPA
anticipated only short-term dermal and inhalation exposure for
residential handlers. The proposed formulation was appropriate for
application via pump up sprayers, garden hose-end sprayers, or similar
``homeowner'' pesticide devices. A
[[Page 51503]]
larger area per day may be treated with a hose-end sprayer than with a
``pump-up'' compressed-air sprayer, which in turn results in possibly
greater contact with the active ingredient per day. Therefore, exposure
from a hose-end sprayer was assessed rather than that of a compressed-
air sprayer. With respect to post-application residential exposures, no
significant post-application exposure is anticipated from landscape
ornamentals, either by residents or professional applicators;
therefore, no residential post-application assessment was conducted.
4. Cumulative effects from 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.''
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 website at https://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. The developmental studies in
rats and rabbits did not demonstrate any qualitative or quantitative in
utero extra sensitivity of fetuses to bifenazate. Similarly, increased
qualitative or quantitativesusceptibility to offspring was not observed
from bifenazate during prenatal or postnatal development in the
reproduction study.
3. Conclusion. The Agency evaluated the bifenazate toxicological
database in reference to the potential for enhanced sensitivity to
infants and children. Acceptable developmental toxicity studies in the
rat and rabbit are available, as is an acceptable 2-generation
reproduction study in the rat. EPA concluded that a bifenazate
developmental neurotoxicity study is not required. EPA also concluded
the 10X FQPA safety factor could be reduced to 1X for bifenazate for
the following reasons:
i. There is no indication of quantitative or qualitative increased
susceptibility of rats and rabbits to in utero or postnatal exposure.
ii. A bifenazate developmental neurotoxicity study is not required.
iii. The toxicological database, the residue chemistry database and
the environmental fate database, are complete for FQPA assessment.
iv. The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded.
v. The residential handler assessment is based upon the residential
standard operating procedures (SOPs). The residential SOPs are based
upon reasonable worst-case assumptions and are not expected to
underestimate risk. These assessments of exposure are not likely to
underestimate the resulting estimates of risk from exposure to
bifenazate.
E. Aggregate Risks and Determination of Safety
1. Acute risk. No acute risk is expected from exposure to
bifenazate since no acute endpoints were identified for the general
U.S. population (including infants and children) or the females 13-50
years old population subgroup.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
bifenazate from food and water will utilize 38% of the chronic
population adjusted dose (cPAD) for the U.S. population, 79% of the
cPAD for all infants (<1 year old), and 94% of the cPAD for children 1-
2 years old. There are no residential uses for bifenazate that result
in chronic residential exposure to bifenazate. 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). Bifenazate 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 bifenazate.
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 margin of exposures (MOEs) of
1,600 for the U.S. population, 1,900 for females 13-49 years old, and
2,000 for adults 50 years and older. 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. Aggregate cancer risk for U.S. population. Bifenazate has been
classified as ``not likely'' to be a human carcinogen by any relevant
route of exposure. Therefore, bifenazate is expected to pose at most a
negligible cancer risk.
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, and to infants and children from aggregate
exposure to bifenazate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
A method (UCC-D2341) is available for enforcement of the currently
established plant tolerances. The methods used in the field trial and
processing studies were similar to the current enforcement method.
Since the
[[Page 51504]]
procedures are similar and adequate method validation and concurrent
recoveries were attained in the field trial and processing studies, EPA
concludes that the current enforcement method is appropriate for
enforcement of the tolerances associated with this petition.
Adequate enforcement methodology 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 tuberous and corm vegetables or
succulent pea; therefore, harmonization is not an issue for these
crops. However, Codex MRLs are established in/on peach, nectarines,
plum, and prunes (no Canadian or Mexican stone fruit MRLs) at 2.0 ppm.
The Codex MRL residue definition is for bifenazate per se. The U.S. and
Codex tolerances/MRLs are not compatible with regard to tolerance
expression and therefore, the levels can not be harmonized.
V. Conclusion
Therefore, the 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, in or on pea, garden,
succulent at 0.20 ppm; pea, edible podded, succulent at 4.0 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; fruit, stone,
group 12, except plum at 2.5 ppm; plum at 0.20 ppm; and fat of cattle,
goat, hog, horse, and sheep at 0.10 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-). 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 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 and pests, Reporting and
recordkeeping requirements.
Dated: August 23, 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:
[[Page 51505]]
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.572 is amended by:
i. In paragraph (a)(1), in the table, by removing the commodities
``peach'' and ``nectarine''; revising the tolerance levels for the
commodities ``cattle, fat''; ``goat, fat''; ``hog, fat''; ``horse,
fat''; and ``sheep, fat'' and by alphabetically adding commodities
``fruit, stone, group 12, except 12''; ``pea, garden, succulent'';
``pea, edible podded, succulent''; and ``vegetable, tuberous and
corm''; and
ii. In paragraph (b), in the table, by removing the commodity
tomato.
The amendments read as follows.
Sec. 180.572 Bifenazate; tolerances for residues.
(a)(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cattle, fat................................................ 0.10
* * * * *
Fruit, stone, group 12, except plum........................ 2.5
Goat, fat.................................................. 0.10
* * * * *
Hog, fat................................................... 0.10
* * * * *
Horse, fat................................................. 0.10
* * * * *
Pea, garden, succulent..................................... 0.20
Pea, edible podded, succulent.............................. 4.0
* * * * *
Plum....................................................... 0.20
Sheep, fat................................................. 0.10
* * * * *
Vegetable, tuberous and corm, subgroup 1C.................. 0.10
------------------------------------------------------------------------
* * * * *
FR Doc. E6-14427 Filed 8-29-06; 8:45 am
BILLING CODE 6560-50-S