[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Rules and Regulations]
[Page 54912-54917]
[DOCID:fr20se06-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0324; FRL-8093-7]

Metrafenone; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone, in or on imported grape at 0.6 parts per
million (ppm), with no U.S. registration. BASF Corporation 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 20, 2006. Objections and
requests for hearings must be received on or before November 20, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0324. 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<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

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 an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-0324 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 20, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0324, 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<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of May 10, 2006 (71 FR 27242-27243) (FRL-
8058-2), 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
4E6884) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, Research
Triangle Park, NC 27709. The petition requested that 40 CFR 180.624 be
amended by establishing a tolerance for residues of the fungicide
metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone, in or on imported table and wine grapes, at 0.5
ppm. That notice included a summary of the petition prepared by BASF
Corporation, the registrant. The registrant is seeking a tolerance on
imported grapes and its processed commodities. Following review of the
residue data, EPA has increased the tolerance level for grapes from 0.5
ppm to 0.6 ppm and concluded that tolerances are not necessary for
processed grape commodities. EPA's statistical analysis of the residue
data indicates that 0.6 ppm better represents a value that should not
be exceeded in grapes and processed grape commodities by any
application of the pesticide in conformity with its uses. Tolerances
are not necessary for processed grape commodities because residues on
those commodities are unlikely to exceed the 0.6 ppm level in the grape
tolerance. Under the FFDCA, tolerances for raw agricultural commodities
also apply to processed foods made from the raw commodities (21 U.S.C.
346a(a)(2)). Comments were received on the notice of filing. EPA's
response to these comments are discussed in Unit IV.C.
    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
.

     http://www.epa.gov/oppfead1/trac/science     http://www.epa.gov/pesticides/factsheets/riskassess.htm.

s/riskassess.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 metrafenone on
grape at 0.6 ppm with no U.S. registration. EPA's assessment of
exposures and risks associated with establishing the import 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. The toxicology database for metrafenone is complete and
adequate for selection of doses and endpoints to be used in this risk
assessment. The toxic effects caused by metrafenone are discussed in a
document entitled, Metrafenone: Human Health Risk Assessment for
Proposed Use on Grapes that can be found at http://www.regulations.gov

in the docket ID number EPA-HQ-OPP-2006-0324.

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/factsheets/riskassess.htm     http://www.epa.gov/oppfead1/trac/science.

ad1/trac/science.

human risk assessment is shown in Table 1 of this unit:

     Table 1.--Summary of Toxicological Dose and Endpoints for Metrafenone for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  Special FQPA SF and
          Exposure scenario               Dose used in risk       level of concern for   Study and toxicological
                                            assessment, UF          risk assessment              effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 25 milligram/     cPAD= cRfD/Special FQPA  Combined chronic/
(All populations)....................   kilogram/day (mg/kg/     SF                       carcinogenicity--rat
                                        day)                    Special FQPA SF = 1....  LOAEL 260 (mg/kg/day):
                                       UF=100.................  cPAD= 0.25.............   Based on
                                       Chronic RfD=0.25mg/kg/                             hepatotoxicity and
                                        day.                                              nephrotoxicity in both
                                                                                sexes.
Cancer                                  Classification: ``Suggestive Evidence of Carcinogenicity.'' The chronic
(Oral, dermal, inhalation)...........                     RfD is protective of cancer effects.
----------------------------------------------------------------------------------------------------------------
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.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
proposed (40 CFR 180.624) for the residues of metrafenone, in or on
imported table and wine Grapes. There are no registrations for use of
metrafenone in the United States. There are no major livestock feed
items associated with the use on imported grapes. Therefore, residues
in livestock commodities are not relevant to the establishment of
import tolerances for grapes. Risk assessments were conducted by EPA to
assess dietary exposures from metrafenone 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 acute reference dose was established nor was a dietary endpoint
identified in either the general population or for females aged 13-49
years. There were no appropriate studies that demonstrated evidence of
toxicity attributable to a single dose of metrafenone for these
populations. As a result, 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 U.S. Department
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII), and accumulated exposure to the
chemical for each commodity. The dietary assessment included just
grapes, the only source of residues for metrafenone. It was assumed
that 100% of all grape commodities contained tolerance level residues.
    iii. Cancer. Although metrafenone is considered to be a possible
human carcinogen, the risk assessment based on chronic effects is
considered protective of cancer effects; therefore, a

cancer dietary analysis was not performed. EPA classified metrafenone
as ``Suggestive Evidence of Carcinogenicity,'' and concluded that human
risk to liver tumorigenesis would not be expected at exposure levels
that do not cause tumors in mice. The NOAEL and LOAEL selected for the
cRfD are based on hepatotoxicity and nephrotoxicity observed at doses
lower than the liver tumor response dose. Thus, the cRfD is protective
of the cancer effects. This conclusion was based on the following
weight-of-evidence considerations:
    a. There was a treatment-related increase in hepatocellular
adenomas and adenomas plus carcinomas in male mice and only at the
highest dose tested (HDT) (limit dose) of 1,109 mg/kg/day. Although
there was an increase in the incidence of hepatocellular adenomas in
female rats, this increase occurred only at the HDT, 1,493 mg/kg/day,
which was considered by the EPA to be above the maximum tolerated dose
(MTD) and, therefore, was not relevant.
    b. There were no treatment-related tumors seen in male rats or
female mice.
    c. Metrafenone did not appear to be genotoxic.
    d. The registrant submitted three ``mode of action'' studies in
rats. The EPA considered that, because the increased incidence in
tumors in rats occurred at a dose above the MTD, these studies could
not be used to explain the mode of action. The registrant did not
submit any ``mode of action'' studies in mice. Therefore, as EPA
considered an increase in hepatocellular adenomas and adenomas plus
carcinomas to be relevant only in mice, it was determined that no
``mode of action'' studies were applicable to these tumors. EPA
indicated that the results of the mode of action studies in rats could
not be ``assumed'' to be relevant in the mouse.
    iv. Anticipated residue and percent crop treated (PCT) information.
Anticipated residues and PCT data were not used for the conservative
dietary exposure analysis.
    2. Dietary exposure from drinking water. As there are no U.S.
registrations or proposed registrations, residues are not expected in
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).
    Metrafenone 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 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 metrafenone and any other
substances and metrafenone 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 metrafenone 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 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 UFs (safety) 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. The toxicology database for
metrafenone is complete and adequate to characterize potential pre-
and/or postnatal risk for infants and children. Acceptable/guideline
studies for developmental toxicity in rats and rabbits as well as a 2-
generation reproduction study in rats were available for consideration
during endpoint selection.
    3. Conclusion. After evaluating the toxicological and exposure
data, EPA recommends that the FQPA SF be reduced to 1X because:
    i. The toxicology database is complete.
    ii. There was no evidence of increased qualitative or quantitative
susceptibility observed in the rat or rabbit developmental as well as
the rat reproduction studies; there are no residual uncertainties with
regard to pre- and postnatal toxicity.
    iii. The dietary food exposure assessment is based on EPA-
recommended tolerance-level residues and assumes 100% crop treated for
all commodities, which results in very high-end estimates of dietary
exposure.
    iv. The proposed use is for import tolerances; therefore,
residential and occupational exposures are not anticipated.

E. Aggregate Risks and Determination of Safety

    In accordance with the FQPA, EPA must consider and aggregate
pesticide exposures and risks from three major sources: Food, drinking
water, and residential exposures. In an aggregate assessment, exposures
from relevant sources are added together and compared to quantitative
estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can
be aggregated. When aggregating exposures and risks from various
sources, EPA considers both the route and duration of exposure.
    The registrant is seeking import tolerances on grapes and its
processed commodities and the risk assessment includes only dietary
exposure to metrafenone. There is no expectation that exposure to
metrafenone would occur via water consumption or residential use.
Therefore, an aggregate exposure risk assessment is equivalent to the
dietary risk assessment.
    1. Acute risk. Because there was no evidence of toxicity for
metrafenone attributable to a single dose, metrafenone is not expected
to pose an acute risk.
    2. Chronic risk. As there are no U.S. registrations or proposed
registrations, the chronic aggregate risk is equivalent to the chronic
dietary risk. Based on the exposure assumptions discussed in this unit,
the chronic exposure for the general U.S. population is 0.1% of the
cPAD. The most highly exposed population subgroup is children 1-2
years, which utilizes 0.8% of the cPAD. The dietary risk estimates are
all below EPA's level of concern.

    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. As there are no U.S.
registrations or proposed registrations for metrafenone, there will be
no exposures from residential uses or residues in drinking water.
Therefore, the aggregate risk is the risk from food (grape commodities)
only. The dietary risk estimates are all below EPA'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). As there are
no U.S. registrations or proposed registrations for metrafenone, there
will be no exposures from residential uses or residues in drinking
water. Therefore, the aggregate risk is the risk from food (grape
commodities) only. The dietary risk estimates are all below EPA's level
of concern.
    5. Aggregate cancer risk for U.S. population. EPA considers the
cRfD to be protective of the cancer effects and, as indicated in this
unit, exposure is well below this level.
    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 metrafenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has submitted gas chromatography methods with
electron capture and mass selective detection for determining residues
of metrafenone in grapes and wine. These methods are considered
adequate for tolerance enforcement purposes. In addition, there is good
recovery of metrafenone from grapes using the Food and Drug
Administration (FDA) multi-residue method protocols. The metrafenone
methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    There are no specific CODEX maximum residue limits (MRLs) for
metrafenone. Although the European Food Safety Authority has proposed a
European Union MRL of 0.5 ppm for grapes, the MRL has yet to be
harmonized between member states. The registrant is seeking import
tolerance on grapes and its processed commodities. Following review of
the residue and metabolism data, EPA has made a minor change to the
proposed tolerance. For grapes EPA expanded the tolerance level for
grapes from 0.5 ppm to 0.6 ppm.

C. Response to Comments

    One comment, dated May 10, 2006, was received from B. Sachau. Ms.
Sachau's comments regarding general exposure to pesticides 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 metrafenone, including all anticipated dietary exposures
and other exposures for which there is reliable information. This
comment as well as her comments regarding animal testing have been
responded to by the Agency on several occasions. For examples, see the
Federal Register issues of January 7, 2005 (70 FR 1349) (FRL-7691-4)
and October 29, 2004 (69 FR 63083) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerance is established for residues of
metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone, in or on grape at 0.6 ppm, with no U.S.
registration.

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 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 11, 2006.
James J. Jones,
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 180.624 is added to subpart C to read as follows:

Sec.  180.624  Metrafenone, tolerances for residues.

    (a) General. Tolerances are established for residues of
metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone, in or on the following commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grape......................................................       0.6\1\
------------------------------------------------------------------------
\1\ There is no U.S. registration on grapes as of September 20, 2006.

    (b) Section 18 emergency exemption. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-15475 Filed 9-19-06; 8:45 am]

BILLING CODE 6560-50-S