[Federal Register: September 1, 2006 (Volume 71, Number 170)]
[Rules and Regulations]
[Page 51998-52003]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se06-10]
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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: waller.mary@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 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
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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.
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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: residuemethods@epa.gov.
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