Document ID: EPA-HQ-OPP-2006-0327-0003
Agency: epa
Document Type: Rule
Title: Bifenazate; Pesticide Tolerance
Posted Date: 2006-08-30T13:07:09Z

[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