[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Rules and Regulations]
[Pages 51998-52003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7313]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0035; FRL-8084-6]


Benthiavalicarb-Isopropyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the combined 
residues of benthiavalicarb-isopropyl, isopropyl[(S)-1-[[[(1R)-1-(6-
fluoro-2-benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate 
and isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] 
carbonyl]-2-methylpropyl]carbamate, in or on imported grape at 0.25 
parts per million (ppm), tomato at 0.45 ppm, and grape, raisin at 1.0 
ppm. K-I Chemical U.S.A., Inc., 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 September 1, 2006. Objections and 
requests for hearings must be received on or before October 31, 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-2005-0035. 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 Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mary Waller, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: [email protected].

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 code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather 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 FFDCA, as amended by FQPA, any person may 
file

[[Page 51999]]

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-2005-0035 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 31, 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-2005-0035, 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 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 9, 2005 (70 FR 11648) (FRL-7699-
4), 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 petition (PP 
3E6545) by K-I Chemical U.S.A., Inc., 11 Martine Ave., Suite 970, White 
Plains, NY 10606. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for the combined residues of the 
fungicide isopropyl[(S)-1-[(R)-1-(6-fluoro-1,3-benzothiazol-2-
yl)ethyl]carbamoyl-2-methylpropyl]carbamate in or on the raw 
agricultural commodity imported grapes at 0.5 ppm, grape processed 
commodities juice and wine at 0.5 ppm, imported tomato at 0.5 ppm, 
tomato processed commodities at 0.5 ppm, and tomato paste at 1.5 ppm. 
That notice included a summary of the petition prepared by K-I Chemical 
U.S.A., Inc., the registrant. One comment from a private citizen was 
received in response to the notice of filing. EPA's response to this 
comment is discussed in Unit IV.
    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 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 residues of 
benthiavalicarb-isopropyl on imported grape at 0.25 ppm, tomato at 0.45 
ppm, and grape, raisin at 1.0 ppm. EPA's assessment of exposures and 
risks associated with establishing the tolerance follows.

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 benthiavalicarb-isopropyl 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 under document ID number EPA-HQ-OPP-2005-
0035-0001.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(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 adverse effects of 
concern are identified (the LOAEL) 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/oppfead1/trac/science.
    A summary of the toxicological endpoints for benthiavalicarb-
isopropyl used for human risk assessment is shown in Table 1 of this 
unit:

[[Page 52000]]



    Table 1.--Summary of Toxicological Doses and Endpoints for Benthiavalicarb-Isopropyl for Use in Human Risk
                                                   Assessment
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                                                                  Special FQPA SF and
          Exposure/scenario               Dose used in risk       level of concern for   Study and toxicological
                                            assessment, UF          risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = N/S               FQPA SF = N/A           No studies resulted in
All populations including infants and  UF = N/A...............                            toxic effects
 children when applicable.             Acute RfD = N/A........                            attributable to one or
                                                                                          two exposures.
                                                                                          Therefore an acute
                                                                                          endpoint was not
                                                                                          selected for dietary
                                                                                          exposure.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 9.9 milligrams/    FQPA SF = 1X            Chronic oral toxicity
(All populations)....................   kilograms/day (mg/kg/   cPAD = 0.099 mg/kg/day.   in rats LOAEL = 249.6
                                        day)                                              mg/kg/day based on
                                       UF = 100...............                            nephrotoxicity and
                                       Chronic RfD = 0.099 mg/                            hepatotoxicity.
                                        kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer                                 Likely to be             Q1*= 6.2795 x 10-\2\     Based on increases in
(Oral, dermal, inhalation)...........   carcinogenic to humans                            male mouse liver
                                                                                          combined adenomas and/
                                                                                          or carcinomas and/or
                                                                                          blastomas.
----------------------------------------------------------------------------------------------------------------
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL =
  lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
  dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Benthiavalicarb-
isopropyl is a new chemical and these are the first tolerances to be 
proposed for this chemical. Risk assessments were conducted by EPA to 
assess dietary exposures from benthiavalicarb-isopropyl 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 benthiavalicarb-isopropyl; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    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), for each commodity: Estimates of percent crop imported (PCI) 
were used in place of percent crop treated (PCT) values as PCI values 
more appropriately estimate exposure to benthiavalicarb-isopropyl since 
the chemical is not being proposed for registration in the United 
States and residues will only result on imported grape and tomato 
commodities. Average field trial values of 0.06958 ppm for grapes, 
0.1133 ppm for greenhouse grown tomatoes, and 0.00767 ppm for field 
grown tomatoes were used. It is unlikely that average field trial 
values and PCI values will be exceeded in the future. Average field 
trial values almost always exceed the expected residue levels found on 
crops at the time of consumption. When field trials are performed, the 
maximum allowable application rate is used and crops are harvested at 
the minimum PHI. Samples are stored frozen until analysis to ensure 
minimal degradation of residues. However, in actual practice, growers 
will not usually use the maximum application rates for economic 
reasons. Additionally, it has been observed from previous analysis, 
that monitoring data are often one to two orders of magnitude lower 
than field trial data. Moreover, the registrant is planning on 
marketing benthiavalicarb-isopropyl in Europe only. For this risk 
assessment, PCI estimates were assumed for all imports, not just grape 
and tomato commodities from Europe. Lastly, the Agency assumes 100% of 
the imported crop will be treated. The actual PCI will likely be 
considerably lower. The following processing factors derived from 
processing studies were used: 0.47 for grapes juice, 0.97 for grape 
wine, 3.67 for raisins, 1.16 for tomato puree, and 0.49 for tomato 
juice. Default processing factors of 5.4 for tomato paste and 14.3 for 
dried tomatoes were used.
    iii. Cancer. The cancer exposure assessment was conducted using the 
same exposure assumptions as were used in the chronic exposure 
assessment.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of 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 FFDCA 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.
    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

[[Page 52001]]

FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCI information as follows: Tomatoes-36%, processed 
tomato commodities-5.8%, grapes-45%, grape juice-44%, wine-23%, and 
raisins-10%.
    The Agency believes that the three conditions listed in Unit III. 
have been met. With respect to Condition 1, PCI estimates are derived 
from the U.S. Department of Agriculture, Economic Research Service data 
which are reliable and have a valid basis. The Agency is reasonably 
certain that the percentage crop imported values will not be exceeded 
in the future. The conservative assumptions were made that 100% of the 
grape and tomato commodities imported from all over the world would be 
treated. Data for grape commodities were taken from 5 year averages and 
were compared to the annual data points of each data source. It was 
observed that crop production patterns and consumption and preferences 
were more stable and changed more slowly. For tomatoes commodities, 
data was taken from 1998 to 2004 with no increases occurring over that 
time period. It is very unlikely that estimates of import would be 
exceeded in the near future due to crop production patterns and 
consumption and preferences are more stable and change more slowly. 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 the national food consumption surveys, EPA does not have 
available information on the regional consumption of food to which 
benthiavalicarb-isopropyl may be applied in a particular area.
    2. Dietary exposure from drinking water. The proposed tolerances 
are for imported commodities only, and there are no current or proposed 
U.S. registrations for this chemical. Therefore, there is no potential 
for exposure to benthiavalicarb-isopropyl through drinking water, and a 
drinking water assessment was not performed.
    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).
    There are no products containing benthiavalicarb-isopropyl proposed 
or registered for residential use or that may be applied by commercial 
applicators to residential sites. Therefore, a residential exposure 
assessment was not performed.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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 benthiavalicarb-isopropyl 
and any other substances and benthiavalicarb-isopropyl does not appear 
to produce a toxic metabolite produced by other substances. Although 
benthiavalicarb-isopropyl is a carbamate compound, it is not a member 
of the class of insecticides known as the N-methyl carbamates for which 
the Agency is presently conducting a cumulative risk assessment. The 
substituents on the benthiavalicarb-isopropyl nitrogen atom are much 
larger than the methyl group in the insecticides. While the N-methyl 
carbamates are neurotoxicants based on their ability to inhibit the 
enzyme cholinesterase, there is no evidence of neurotoxicity or 
neuropathology in the hazard database for benthiavalicarb-isopropyl. 
Benthiavalicarb-isopropyl is also not a member of the thiocarbamate 
class of herbicides or the dithiocarbamate class of fungicides. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
benthiavalicarb-isopropyl has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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 database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. 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 UFs and/or special FQPA 
SFs, as appropriate.
    2. Prenatal and postnatal sensitivity. There are no residual 
uncertainties for pre/postnatal toxicity. Developmental studies in two 
species (both rat and rabbit) and a 2-generation reproduction study in 
rats did not show any evidence of developmental or reproductive 
toxicity. Evidence suggests that there is no concern for fetuses 
exposed to benthiavalicarb-isopropyl in utero or post-natally. There 
was no evidence of neurotoxicity throughout the entire toxicology 
database and there was an absence of adverse developmental and 
reproductive effects. A developmental neurotoxicity study is not 
necessary at this time. The Agency determined that reliable data 
support reducing the FQPA SF to 1X. This determination was based on the 
following:
     There is no evidence of increased susceptibility to 
fetuses or pups following in utero or postnatal exposure in the 
developmental toxicity studies in rats or rabbits, and in the 2-
generation rat reproduction study.
     There are no residual uncertainties concerning pre and 
postnatal toxicity and no neurotoxicity concerns.
     The toxicological database is complete for FQPA 
assessment.
     The chronic and cancer dietary food exposure assessments 
utilizes anticipated residues (ARs) calculated from average field trial 
data and worldwide estimates of PCI for most commodities. Although 
refined, the assessments are based on reliable data and will not 
underestimate exposure or risk.
     There is no potential for drinking water exposure.

[[Page 52002]]

     There is no potential for residential exposure.
    3. Conclusion. There is a complete toxicity data base for 
benthiavalicarb-isopropyl and exposure data are complete or are 
estimated based on data that reasonably accounts for potential 
exposures. EPA determined that the 10X SF to protect infants and 
children should be removed. The FQPA factor is removed because there 
are no residential uncertainties for pre/postnatal toxicity.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute endpoint was not identified in any of the 
toxicity studies. Therefore, no acute risk is expected from exposure to 
benthiavalicarb-isopropyl.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
benthiavalicarb-isopropyl from food will utilize <1 % of the cPAD for 
the U.S. population, <1 % of the cPAD for all infants <1 year old, and 
<1 % of the cPAD for children 1-2 years old, the most highly exposed 
population subgroup. There are no residential uses for benthiavalicarb-
isopropyl. There are no current or proposed U.S. registrations of 
benthiavalicarb-isopropyl and as a result there is no expectation of 
exposure through drinking water. Therefore, EPA does not expect the 
aggregate exposure (dietary) to exceed 100% of the cPAD.
    3. Aggregate cancer risk for U.S. population. Applying the cancer 
potency (Q1*) value of 0.063 (mg/kg/day)-\1\ to the exposure 
value results in a cancer risk estimate of 1.6 x 10-\6\. 
This cancer risk estimate falls within the range of 1 x 
10-\6\, the risk level considered to be negligible by EPA; 
therefore, the estimated cancer risk is below the Agency's level of 
concern.
    4. 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 benthiavalicarb-isopropyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, Gas Chromatography/Nitrogen-
Phosphorous detector (GC/NPD) Method RCC. Ho. 665943 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: [email protected].

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for benthiavalicarb-isopropyl.

C. Response to Comments

    One comment was received from a private citizen objecting to 
profiteering, animal testing, and establishing tolerances. The comments 
contained no scientific data or evidence to rebut the Agency's 
conclusion that there is a reasonable certainty that no harm will 
result from aggregate exposure to benthiavalicarb-isopropyl, including 
all anticipated dietary exposures and other exposures for which there 
is reliable information. The EPA has responded to this private 
citizen's generalized comments on numerous previous occasions, for 
example, on January 7, 2005 (70 FR 1354) (FRL-7681-9) and on October 
29, 2004 (69 FR 63096) (FRL-7691-4).

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
benthiavalicarb-isopropyl, isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2-
benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate and 
isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2-benzothiazolyl)ethyl] amino] 
carbonyl]-2-methylpropyl]carbamate, in or on imported grape at 0.25 
ppm, tomato at 0.45 ppm, and grape, raisin at 1.0 ppm. As residues do 
not concentrate in wine, the 0.25 ppm grape tolerance is adequate to 
cover residues in wine. A separate tolerance for wine is not needed. 
Based on processing factors and highest average field trial values for 
field grown tomatoes which are used for processing, separate tolerances 
are not required for processed tomato commodities.

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 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
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

[[Page 52003]]

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 25, 2006.
Anne E. Lindsay,
Acting Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.618 is added to read as follows:


Sec.  180.618  Benthiavalicarb-isopropyl; tolerance for residues.

    (a) General. Tolerances are established for the combined residues 
of benthiavalicarb-isopropyl, isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2-
benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate and 
isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] 
carbonyl]-2-methylpropyl]carbamate, in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Grape, imported................................                     0.25
Grape, raisin..................................                      1.0
Tomato.........................................                     0.45
------------------------------------------------------------------------
Note: There are no U.S. registrations as of July 30, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect of inadvertent residues. [Reserved]

[FR Doc. 06-7313 Filed 8-31-06; 8:45 am]
BILLING CODE 6560-50-S