[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Rules and Regulations]
[Page 51500-51505]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au06-18]
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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.
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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 http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: 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 http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
To access the OPPTS Harmonized Guidelines
referenced in this document, go directly to the guidelines at http://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: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of May 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 http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for 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
http://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 http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for bifenazate used for
human risk assessment can be found at http://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 http://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 http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. 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