[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Rules and Regulations]
[Pages 56388-56392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8176]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0058; FRL-8091-5]


Ethaboxam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
ethaboxam in or on grape at 6.0 parts per million (ppm), with no U.S. 
registration. Landis International, Inc., agent for LG Life Sciences, 
Ltd. requested this tolerance 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 27, 2006. Objections and 
requests for hearings must be received on or before November 27, 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-2005-0058. 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: Bryant Crowe, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0025; e-mail address: <a href="/cdn-cgi/l/email-protection#385b4a574f5d165a4a4159564c785d4859165f574e"><span class="__cf_email__" data-cfemail="7a1908150d1f541808031b140e3a1f0a1b541d150c">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
    <bullet> Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
    <bullet> Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
    <bullet> 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

[[Page 56389]]

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.

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-2005-0058 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 November 27, 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-2005-0058, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 6, 2005 (70 FR 38918) (FRL-7719-3), 
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 4E6863) 
by LG Life Sciences, Ltd., c/o Landis International, Inc., P.O. Box 
5126, Valdosta, GA 31603-5126. The petition requested that 40 CFR 
180.622 be amended by establishing a tolerance for residues of the 
fungicide ethaboxam, N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethlyamino)-
5-thiazolecarboxamide, in or on grape, grape juice, and raisins at 6.0 
ppm. That notice included a summary of the petition prepared by the 
registrant LG Life Sciences, Ltd., c/o Landis International, Inc. 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/oppfead1/trac/science.

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 residues of ethaboxam on grape 
at 6.0 ppm. Studies examining the transfer of ethaboxam to processed 
grape commodities (e.g., grape juice, raisins) show that some 
concentration of ethaboxam may occur during the production of raisins 
and grape juice; however, the supported tolerance of 6.0 ppm for grape 
is sufficient to cover the potential for residues in the processed 
commodities, and separate tolerances for these commodities are not 
needed. 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 ethaboxam 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 in the electronic 
docket (docket ID number EPA-HQ-OPP-2005-0058) for this rule at http://www.regulations.gov or http://www.epa.gov/opprd001/factsheets.

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

[[Page 56390]]

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/factsheets/riskassess.htm and http://www.epa.gov/oppfead1/trac/science.
    A summary of the toxicological endpoints for ethaboxam used for 
human risk assessment is shown in Table 1. of this unit:

      Table 1.--Summary of Toxicological Dose and Endpoints for Ethaboxam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of  NOAEL = 30 mg/kg/day     Special FQPA SF = 1      Developmental Toxicity
 age)                                  UF = 100...............  aPAD = acute RfD/         Rat LOAEL = 100 mg/kg/
                                       Acute RfD = 0.3 mg/kg/    Special FQPA SF = 0.3    day based on abnormal
                                        day.                     mg/kg/day.               liver lobation
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      NOAEL = N/A              Special FQPA SF = N/A    No appropriate endpoint
 including infants and children)       UF = N/A...............  aPAD = acute RfD/         attributable to a
                                       Acute RfD = N/A........   Special FQPA SF = N/A.   single dose
                                                                                          identified. LOAEL = N/
                                                                                          A
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 5.5 mg/kg/day     Special FQPA SF = 1      Combined Chronic/
                                       UF = 100...............  cPAD = chronic RfD/       Carcinogenicity-Rat
                                       Chronic RfD = 0.055 mg/   Special FQPA SF =        LOAEL = 16.4 mg/kg/day
                                        kg/day.                  0.055 mg/kg/day.         based on effects
                                                                                          observed in the male
                                                                                          reproductive organs
                                                                                          (testes, epididymides,
                                                                                          prostate, and seminal
                                                                                          vesicles).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      N/A                      N/A                      The Agency classified
                                                                                          ethaboxam as having
                                                                                          ``suggestive evidence
                                                                                          of carcinogenicity.''
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Risk assessments were 
conducted by EPA to assess dietary exposures from ethaboxam 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 one-day or single exposure. No such effects were 
identified in the toxicological studies for ethaboxam that pertain to 
the general population including infants and children; however, an 
effect of concern was identified for females, 13-49 years of age. 
Therefore, a quantitative acute dietary exposure assessment was 
necessary for females, 13-49 years of age.
    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 
assessment: Chronic dietary analysis is based on the tolerance level 
residues and an assumption that 100% of the crop will be treated.
    iii. Cancer. The Agency classified ethaboxam as having ``suggestive 
evidence of carcinogenicity.'' The Agency concluded that the 
quantification of carcinogenic potential is not required.
    2. Dietary exposure from drinking water. This petition is not 
associated with an application to register ethaboxam uses in the U.S. 
Ethaboxam is proposed for use on fruit commodities that may be imported 
into the U.S., thus, the source of exposure expected for ethaboxam is 
solely from residues in food. Consequently, an exposure assessment that 
includes ethaboxam residues in drinking water is not warranted at this 
time.
    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). Ethaboxam is not 
registered for use on any sites that would result in residential 
exposure.
    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 ethaboxam and any other 
substances and ethaboxam 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 ethaboxam 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.

[[Page 56391]]

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. There is evidence of 
increased qualitative susceptibility in the rat developmental and 
reproduction studies. Considering the overall toxicity profile and the 
doses and endpoints selected for risk assessment for ethaboxam, the 
degree of concern for prenatal and postnatal effects observed in the 
studies is low based on the following: The developmental/offspring 
effects observed in the studies are well characterized and occur in the 
presence of maternal toxicity; a clear NOAEL has been identified in 
both of the studies; and there are no residual uncertainties for pre-
and/or postnatal toxicity. Furthermore, the toxicology endpoint 
established for risk assessment is based on a lower NOAEL than the 
reproductive NOAEL, and thus is considered protective of developmental/
offspring effects.
    3. Conclusion. The Agency recommends that the FQPA safety factor be 
reduced to 1X because there are no/low concerns and no residual 
uncertainties with regard to pre- and post-natal toxicity. Although 
there was evidence of increased qualitative susceptibility observed in 
rat developmental and reproduction studies, the studies submitted 
adequately address questions regarding pre- and post- natal toxicity, 
and the developmental/offspring effects observed in the studies are 
well characterized (clear NOAELs established). The toxicology endpoint 
established for risk assessment is based on a lower NOAEL than the 
reproductive NOAEL, and is considered protective of the developmental/
offspring effects observed. In addition, the toxicology endpoint 
established for risk assessment is also considered protective of the 
male reproductive alterations observed in the toxicology database. 
There is a complete toxicity database for ethaboxam and exposure data 
are complete or are estimated based on data that reasonably accounts 
for potential exposures.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
ethaboxam will occupy 10% of the aPAD for the U.S. population and 4% of 
the aPAD for females 13 years and older.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to ethaboxam 
from food will utilize 6% of the cPAD for the U.S. population, 9% of 
the cPAD for all infants less than 1 year of age, and 31% of the cPAD 
for children 1-2 years of age. There are no residential uses for 
ethaboxam that result in chronic residential exposure to ethaboxam.
    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).
    Ethaboxam is not registered for use on any sites that would result 
in residential exposure or residues in drinking water. Therefore, the 
aggregate risk is the sum of the risk from food only, which does not 
exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Ethaboxam is not registered for use on any sites that would result 
in residential exposure or residues in drinking water. Therefore, the 
aggregate risk is the sum of the risk from food only, which does not 
exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. The Agency classified 
ethaboxam as having ``suggestive evidence of carcinogenicity based on 
Leydig cell tumors observed in male rats.'' The Agency has determined 
that potential human risk to Leydig cell tumorigenesis would not be 
expected at exposure levels that do not cause tumors in rats. The NOAEL 
and LOAEL selected for the chronic reference dose (cRfD) is based on 
reproductive toxicity observed at lower doses than the Leydig cell 
tumor response. Thus, the cRfD would be protective of the cancer 
effects.
    6. 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 ethaboxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (HPLC/MS) 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: <a href="/cdn-cgi/l/email-protection#f68493859f9283939b93829e999285b6938697d8919980"><span class="__cf_email__" data-cfemail="aedccbddc7cadbcbc3cbdac6c1caddeecbdecf80c9c1d8">[email protected]</span></a>.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue levels (MRLs) for ethaboxam.

V. Conclusion

    Therefore, an imported tolerance is established for residues of 
ethaboxam, N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethylamino)-5-
thiazolecarboxamide, in or on grape at 6.0 ppm. Studies examining the 
transfer of ethaboxam to processed grape commodities (e.g., grape 
juice, raisins) show that some concentration of ethaboxam may occur 
during the production of raisins and grape juice; however, the 
supported tolerance of 6.0 ppm for grape is sufficient to cover the 
potential for residues in the processed commodities, and separate 
tolerances for these commodities are not needed.

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

[[Page 56392]]

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 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: September 13, 2006.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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 180.622 is added to read as follows:


Sec.  180.622  Ethaboxam; tolerances for residues.

    (a) General. Tolerances are established for residues of ethaboxam, 
N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethlyamino)-5-thiazolecarboxamide 
in or on the following commodity:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grape\1\...................................................          6.0
------------------------------------------------------------------------
\1\ There is no U.S. registration as of September 27, 2006

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

[FR Doc. 06-8176 Filed 9-26-06; 8:45 am]
BILLING CODE 6560-50-S


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