Document ID: EPA-HQ-OPP-2006-0324-0005
Agency: epa
Document Type: Rule
Title: Metrafenone; Pesticide Tolerance
Posted Date: 2006-09-20T13:01:40Z

[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Rules and Regulations]               
[Page 54912-54917]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[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-

[[Page 54913]]

4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, 
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-6129; e-mail address: 
janet.whitehurst@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

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

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

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

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file 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 (703) 305-5805.

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

[[Page 54914]]

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

[[Page 54915]]

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.

[[Page 54916]]

    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: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

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

[[Page 54917]]

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