Document ID: EPA-HQ-OPP-2005-0105-0002
Agency: epa
Document Type: Rule
Title: Fenpropimorph; Pesticide Tolerance
Posted Date: 2006-03-29T05:00Z

[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Rules and Regulations]               
[Page 15608-15612]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0105; FRL-7761-3]

 
Fenpropimorph; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
fenpropimorph in or on bananas. BASF Corporation Agricultural Products 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective March 29, 2006. Objections and 
requests for hearings must be received on or before May 30, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2005-0105. All documents in the 
docket are listed in the EDOCKET index at http://www.epa.gov/edocket. 

Although listed in the index, some information is not publicly 
available, i.e., 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 either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 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: Lana Coppolino, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0086; e-mail address: coppolino.lana@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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180 

is available at E-CFR Beta Site Two 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/
.

II. Background and Statutory Findings

    In the Federal Register of June 22, 2005 (70 FR 36155)(FRL-7710-1), 
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 7E4874) 
by BASF Corporation Agricultural Products, 26 Davis Drive, P.O. Box 
13528; Research Triangle Park, NC 27709. The petition requested that 40 
CFR 180.616 be amended by establishing a tolerance for residues of the 
fungicide fenpropimorph, (+)-cis-4-(3-((4-tert-butylphenyl))-2-
methylpropyl)-2,6-dimethylmorpholine, in or on bananas at 1.5 parts per 
million (ppm). This petition was previously published in the Federal 
Register on December 7, 1998, identified by the docket control number 
PF-848. That notice included a summary of the petition prepared by BASF 
Corporation Agricultural Products, the registrant. There were no 
comments received in response to the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 

[[Page 15609]]

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 fenpropimorph on 
bananas 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 fenpropimorph as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/opprd001/factsheets/
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/oppfead1/trac/science.

    A summary of the toxicological endpoints for fenpropimorph used for 
human risk assessment is shown in the following Table 1:

    Table 1.--Summary of Toxicological Dose and Endpoints for Fenpropimorph for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-49 years of  NOAEL = 15 mg/kg/day     Special FQPA SF = 1X     Rabbit developmental
 age)                                  UF = 100X..............  aPAD = acute RfD/         study
                                       Acute RfD = 0.15 mg/kg/   Special FQPA SF = 0.15  LOAEL = 30 mg/kg/day
                                        day.                     mg/kg/day.               based on cleft palate
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations)      NOAEL = 3.2 mg/kg/day    Special FQPA SF = 1X     One year dog and
                                       UF = 100X..............  cPAD = chronic RfD/       chronic/
                                       Chronic RfD = 0.032 mg/   Special FQPA SF =        carcinogenicity rat
                                        kg/day.                  0.032 mg/kg/day.         studies
                                                                                         LOAEL = 9-11 mg/kg/day
                                                                                          based on liver
                                                                                          histopathology
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      Classification: ``Not likely to be carcinogenic to humans.'' No increased
                                            incidences in tumors in a chronic/carcinogenicity rat study or a
                                                              carcinogenicity mouse study.
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. This final rule 
establishes the first tolerance for residues of fenpropimorph. There 
are no registered uses in the United States, therefore, the only 
expected exposure is from imported foods. Risk assessments were 
conducted by EPA to assess dietary exposures from fenpropimorph 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.
    The Dietary Exposure Evaluation Model (DEEMTM-FDIC) 
Version 2.03 analysis evaluated the individual food consumption 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 following assumptions were made for the acute exposure 
assessments: The DEEMTM-FCID assessment was based on 
tolerance-level residues in banana commodities, a processing factor of 
3.9 for dried banana commodities, and 100% crop treated (CT) 
assumptions. An acute dietary dose and an endpoint attributable to a 
single dose were identified for only one population subgroup, females 
ages 13 through 49. An appropriate endpoint attributable to a single 
exposure was not identified for the general population.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM software with the FCID, Version 2.03, 
which incorporates food consumption data as reported by respondents in 
the USDA 1994-1996, and 1998 Nationwide CSFII, and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: The DEEM-FCID assessment was 
based on tolerance-level residues in banana commodities, a processing 
factor of 3.9 for dried banana commodities, and 100% CT assumptions.
    iii. Cancer. The Agency classified fenpropimorph as ``not likely to 
be carcinogenic to humans.'' There were no increased incidences of 
benign or malignant tumors in either a rat chronic/carcinogenicity or a 
mouse carcinogenicity study. Therefore, a quantitative cancer exposure 
assessment was unnecessary.
    2. Dietary exposure from drinking water. There is no expectation 
that

[[Page 15610]]

fenpropimorph residues would occur in surface water or ground water 
sources of drinking water. Fenpropimorph is proposed for use only on 
imported bananas, the sole anticipated exposure route for the U.S 
population is via dietary (food) exposure. There are no registered uses 
of fenpropimorph in the United States.
    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). Fenpropimorph 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 fenpropimorph and any 
other substances and fenpropimorph 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 fenpropimorph 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 
margin of exposure analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional safety factor value based on the use of 
traditional UFs and/or special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Although there is evidence 
for increased qualitative susceptibility in the developmental rat and 
rabbit studies, the Agency concluded that there is a low degree of 
concern (and no residual uncertainty) because:
    i. The increased susceptibility was seen at the LOAELs of 160 
milligrams/kilogram/day (mg/kg/day) in the rat study and at 30 mg/kg/
day in the rabbit study (NOAELs were 40 and 15 mg/kg/day for the rat 
and rabbit studies, respectively);
    ii. Cleft palate was not reported in a second rabbit developmental 
study with doses up to 36 mg/kg/day;
    iii. No mention was made of cleft palate in another developmental 
rat study at doses up to 160 mg/kg/day (however, there were no visceral 
or skeletal examinations of fetuses/pups);
    iv. At doses up to 2.79 mg/kg/day in a 2-generation reproduction 
study in rats, cleft palate was not reported;
    v. Developmental effects were observed only in the presence of 
maternal toxicity; and
    vi. The doses selected for acute and chronic dietary exposure and 
risk assessment were considerably lower than the doses at which 
developmental effects were observed.
    3. Conclusion. Based on the review of the toxicology database, the 
Agency recommends that the Special FQPA Safety Factor (10X) be removed 
(reduced to 1X). This recommendation is applicable to all population 
subgroups for all exposure routes and durations, and is based on the 
following factors:
    i. There is a complete toxicity data base.
    ii.There is a low degree of concern for the qualitative 
susceptibility in developmental rat and rabbit studies, because the 
fetal effects were observed only in the presence of maternal toxicity.
    iii. There is no concern for prenatal/postnatal toxicity since no 
off-spring toxicity was seen in the 2 generation reproduction study.
    iv. The endpoints of concern are addressed in this risk assessment.
    v. The dietary exposure assessment assumed tolerance level residues 
and 100% CT.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
fenpropimorph will occupy 2.6% of the acute population adjusted dose 
(aPAD) for females ages 13 through 49. An appropriate endpoint 
attributable to a single exposure was not identified for the general 
population nor any of the other population subgroup. Aggregate risk is 
limited to dietary exposure (food only). EPA does not expect the 
aggregate exposure to exceed 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
fenpropimorph from food will utilize 2.2% of the cPAD for the U.S. 
population, 9.1% of the cPAD for all infants < 1 year, and 11% of the 
cPAD for children 1-2 years, the population subgroup having the higest 
exposure.Aggregate risk is limited to dietary exposure (food only). EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD.
    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).
    Fenpropimorph is not registered for use on any sites that would 
result in residential exposure, and there is no expectation that 
fenpropimorph residues would occur via drinking water consumption. 
Therefore, the aggregate risk is the sum of the risk from food only, 
which does not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fenpropimorph is not registered for use on any sites that would 
result in residential exposure, and there is no expectation that 
fenpropimorph residues would occur via drinking water consumption. 
Therefore, the aggregate risk is the sum of the risk from food only, 
which does not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Fenpropimorph has not 
been shown to be carcinogenic. Therefore, fenpropimorph is not expected 
to pose a cancer risk.

[[Page 15611]]

    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 fenpropimorph residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The proposed method is adequate for collecting data on residues in 
bananas. Adequate method validation data were submitted. The method has 
been adequately radiovalidated, and has undergone a marginally 
successful independent laboratory validation (ILV) trial. The 
petitioner has been requested to submit acceptable recovery data from 
bananas using other suggested methods.
    The method, gas chromatography with nitrogen-phosphorous detection 
(GC/NPD), is available to enforce the tolerance expression. The method 
may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no established Mexican or Canadian maximum residue limits 
(MRLs) for fenpropimorph residues. There are Codex MRLs established for 
fenpropimorph residues in various commodities, including an MRL of 2 
mg/kg in bananas.

V. Conclusion

    Therefore, the tolerance is established for residues of 
fenpropimorph, [rel-(2R,6S)-4-[3-[4-(1,1-dimethylethyl)phenyl]-2-
methylpropyl]-2,6-dimethylmorpholine], in or on banana at 2.0 ppm with 
no U.S. registration.

VI. Objections and Hearing Requests

    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. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2005-0105 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 March 30, 
2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    2. Mail your written request to: Office of the Hearing Clerk 
(1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number EPA-HQ-OPP-2005-0105, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. You may also send an 
electronic copy of your request via e-mail to: opp-docket@epa.gov. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. 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,

[[Page 15612]]

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.

VIII. 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: March 20, 2006.
James 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 180.616 is added to read as follows:

Sec.  180.616  Fenpropimorph; tolerances for residues.

    Tolerances are established for the residues of the fungicide 
fenpropimorph (rel-(2R,6S)-4-[3-[4-(1,1-dimethylethyl)phenyl]-2-
methylpropyl]-2,6-dimethylmorpholine) in or on the following commodity:

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Banana*........................................                      2.0
------------------------------------------------------------------------
*No U.S. registration as of February 10, 2006.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 06-3029 Filed 3-28-06; 8:45 am]

BILLING CODE 6560-50-S