Document ID: EPA-HQ-OPP-2005-0245-0003
Agency: epa
Document Type: Rule
Title: Fenhexamid; Pesticide Tolerance
Posted Date: 2006-08-02T13:17:46Z

[Federal Register: August 2, 2006 (Volume 71, Number 148)]
[Rules and Regulations]               
[Page 43660-43664]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au06-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0245; FRL-8079-2]

 
Fenhexamid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fenhexamid in or on nonbell pepper, pomegranate, and cilantro leaves. 
Interregional Research Project No.4 (IR-4) requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 2, 2006. Objections and 
requests for hearings must be received on or before October 2, 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-2005-0245. 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: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines 

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions

[[Page 43661]]

provided in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2005-0245 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 
2, 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-2005-0245, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of November 30, 2005 (70 FR 71838) (FRL-
7735-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
4E6859 and 4E6860) by Interregional Research Project No. 4 (IR-4), 
Technology Center of New Jersey, Rutgers, the State University of New 
Jersey, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-
3390. The petition requested that 40 CFR 180.553 be amended by 
establishing tolerances for residues of the fungicide fenhexamid, (N-
2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide in or on 
cilantro, leaves at 30.0 parts per million (ppm) (4E6859); pepper, 
nonbell at 0.02 ppm (4E6860) and pomegranate at 3.0 ppm (4E6859). That 
notice included a summary of the petition prepared by Arvesta 
Corporation, the registrant. There were no comments received in 
response to the notice of filing. Petition 4E6859 was subsequently 
amended to lower the residue level for pomegranate to 2.0 ppm.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of fenhexamid on 
cilantro, leaves at 30.0 ppm; pepper, nonbell at 0.02 ppm; and 
pomegranate at 2.0 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 fenhexamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies in the Federal Register of 
April 13, 2000 (65 FR 19842) (FRL-6553-7) *http://www.epa.gov/fedrgstr/EPA-PEST/2000/April/Day-13/p9144.htm
.

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/pesticides/health/human.htm.

    A summary of the toxicological endpoints for fenhexamid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 26, 2003 (68 FR 55513) 
(FRL-7326-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.553) for the residues of fenhexamid, in or on a 
variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from fenhexamid 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 fenhexamid; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.

[[Page 43662]]

    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: one hundred percent of proposed and registered crops are 
treated with fenhexamid, default processing factors, average (chronic) 
concentration estimates for drinking water and tolerance-level residues 
for all commodities.
    iii. Cancer. Fenhexamid is classified as ``not likely'' to be a 
human carcinogen. Therefore, a cancer dietary exposure assessment was 
not performed.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fenhexamid in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of fenhexamid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm .

    Based on the FIRST and SCI-GROW models, the estimated environmental 
concentrations (EECs) of fenhexamid for acute exposures are estimated 
to be 29 parts per billion (ppb) for surface water and 0.0007 ppb for 
groundwater. The EECs for chronic exposures are estimated to be 1.1 ppb 
for surface water and 0.0007 ppb for groundwater. Modeled estimates of 
drinking water concentrations were directly entered into the dietary 
exposure model (DEEM-FCID\TM\). For chronic dietary risk assessment, 
the annual average concentration of 1.1 ppb was used to access the 
contribution to drinking water
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Fenhexamid 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 fenhexamid and any other substances and fenhexamid 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 fenhexamid has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. In the rat and the rabbit 
developmental toxicity studies, neither quantitative nor qualitative 
evidence of increased susceptibility of fetuses to in utero exposure to 
fenhexamid was observed. In the rat reproduction study, qualitative 
susceptibility was evidenced as significantly decreased pup body 
weights in both generations during the lactation period (on lactation 
days 7, 14, and 21 in the F2 generation and lactation days 
14 and 21 in the F1 generation offspring) in the presence of 
lesser maternal toxicity (alterations in clinical chemistry parameters 
and decreased organ weights without collaborative histopathology). 
Considering the overall toxicity profile and the doses and endpoints 
selected for risk assessment for fenhexamid, the degree of concern for 
the effects observed in this study was characterized as low, noting 
that there is a clear NOAEL and well-characterized dose response for 
the offspring effects observed and that these effects occurred in the 
presence of parental toxicity. No residual uncertainties were 
identified. The NOAEL of 17 mg/kg/day from the chronic dog study used 
to establish the chronic Reference Dose (cRfD) for the General 
Population (no aRfD was established for any population subgroup) is 
lower than the NOAEL of 38.2 mg/kg/day in the reproduction study in 
which the offspring effects of concern were observed (LOAEL = 406 mg/
kg/day).
    3. Conclusion. There is a complete toxicity data base for 
fenhexamid and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X Safety Factor to protect infants and children should be 
reduced to 1X for the following reasons:
     There are no residual uncertainties for pre and/or post 
natal toxicities via the oral route since the doses selected for 
concerns for the developmental and offspring toxicities seen in the 
above mentioned studies.
     There are no residual uncertainties for pre and/or post 
natal toxicities via the dermal route since the dose/endpoint/study/
species of concern was used for dermal-risk assessment.
     The toxicology data base is complete.
     Developmental neurotoxicity studies are not required for 
fenhexamid based on the following weight-of-the-evidence 
considerations:
    i. Lack of evidence of abnormalities in the development of the 
fetal nervous system in the pre/post natal studies.
    ii. Neither brain weight nor histopathological examination of the 
nervous system was affected in the subchronic and chronic studies.

[[Page 43663]]

    iii. Decreased body temperatures observed in male rats in the acute 
neurotoxicity study were not considered to be toxicologically 
significant.
     The dietary (food) exposure assessment utilizes existing 
and proposed tolerance level residues and assumes 100% of crops treated 
with fenhexamid. The assessment is based on reliable data and is not 
expected to underestimate exposure/risk.
     Conservative assumptions are used in the drinking water 
models. The drinking water exposure assessment is not expected to 
underestimate exposure/risk.
      Fenhexamid is not registered for use sites that would 
result in residential exposure.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated drinking water 
concentrations (EDWCs). The DWLOC values are not regulatory standards 
for drinking water, but are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. More information on the use 
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.

    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface and groundwater EDWCs are 
directly incorporated into the dietary exposure analysis, along with 
food. This provides a more realistic estimate of exposure because 
actual body weights and water consumption from the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs.
    1. Acute risk. An acute risk assessment was not performed. No 
toxicological endpoint attributable to a single (acute) dietary 
exposure was identified. Therefore, acute risk from exposure to 
fenhexamid is not expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenhexamid from food and water will utilize 11% of the cPAD for the 
U.S. population, 21% of the cPAD for all infants less than 1 year old, 
and 28% of the cPAD for children 1-2 years old, the subpopulation at 
greatest exposure. There are no residential uses for fenhexamid. 
Therefore, EPA does not expect the aggregate exposure to exceed 100% of 
the cPAD
    3. Short-term risk and Intermediate-term. Short-term and 
intermediate-term aggregate exposures take into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). Fenhezamid is not registered for use on any 
sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which do not 
exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. The Agency has 
classified fenhexamid as a ``not likely'' human carcinogen based on 
lack of evidence of carcinogenicity in male and female rats as well as 
in male and female mice, and on the lack of genotoxicity in an 
acceptable battery of mutagenicity studies. Therefore, fenhexamid is 
not expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to fenhexamid.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology Bayer AG Method 00362 (HPLC - ECD) 
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

    Fenhexamid per se is the residue to be regulated in pomegranate, 
cilantro or non-bell pepper. There are no Canadian, Mexican, or Codex 
MRLs for fenhexamid ``for these crops'' , therefore, there are no 
issues for international harmonization.

V. Conclusion

    Therefore, the tolerance is established for residues of fenhexamid, 
(N-2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide, in or 
on cilantro, leaves at 30.0 ppm; pepper, nonbell at 0.02 ppm; and 
pomegranate at 2.0.

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

[[Page 43664]]

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: July 21, 2006.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

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

PART 180--AMENDED

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

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

0
2. Section 180.553 is amended by alphabetically adding commodities to 
the table in paragraph (a) to read as follows:

Sec.  180.553  Fenhexamid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Cilantro, leaves                                                    30.0
                                * * * * *
Pepper, nonbell                                                     0.02
                                * * * * *
Pomegranate                                                          2.0
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E6-12348 Filed 8-1-06; 8:45 am]

BILLING CODE 6560-50-S