Document ID: EPA-HQ-OPP-2005-0145-0003
Agency: epa
Document Type: Rule
Title: Boscalid; Pesticide Tolerance
Posted Date: 2006-02-08T15:29:26Z

[Federal Register: February 8, 2006 (Volume 71, Number 26)]
[Rules and Regulations]
[Page 6359-6364]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe06-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0145; FRL-7757-9]

Boscalid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro [1,1'-biphenyl]-
2-yl) in or on banana (imported), celery, and spinach. In addition,
existing tolerances are being increased on almond hulls. Finally, the
existing lettuce exception listed for the indirect or inadvertent
residues in vegetables, leafy, group 4, is being revised to include
celery and spinach, as well as lettuce. BASF requested the tolerances
on almonds and bananas, and Interregional Research Project 4
(IR-4) has proposed group tolerances on vegetable, leafy, except
brassica, Group 4 (to include celery and spinach), under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA).

[[Page 6360]]

DATES: This regulation is effective February 8, 2006. Objections and
requests for hearings must be received on or before April 10, 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-2005-0145. All documents in the
docket are listed on the http://www.regulations.gov website. (EDOCKET, EPA's

electronic public docket and comment system was replaced on November
25, 2005, by an enhanced federal-wide electronic docket management and
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) 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: Tony Kish, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9443; e-mail address: kish.tony@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/.

II. Background and Statutory Findings

    In the Federal Register of July 6, 2005 (70 FR 38911) (FRL-7721-5),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filings of pesticide petitions (PP 4F6875,
3E6791, 5E6933) by BASF Corporation, P.O. Box 13528, Research Triangle
Park, NC 27709 and IR-4. The petition requested that 180.589 be amended
by establishing a tolerance for residues of the fungicide boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro(1,1'-biphenyl)-2-yl, in or
on the raw agricultural commodity almond, hulls at 15 parts per
millions (ppm) (PP 4F6875), vegetable, leafy, except brassica, Group 4
at 50 ppm (PP 3E6791), and banana at 0.5 ppm (PP 5E6933). That notice
included a summary of the pesticide petition prepared by BASF, the
registrant. Comments were received on the notice of filing. EPA's
response to these comments is discussed in Unit IV below.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of boscalid on almond
hulls at 17 ppm, banana (imported) at 0.20 ppm, celery at 45 ppm, and
spinach at 60 ppm. IR-4 requested a 50 ppm group tolerance for
vegetable, leafy, except brassica in Group 4. However, the requested
Boscalid tolerance for this entire group is inappropriate because the
proposed 50 ppm group tolerance is substantially higher than the
existing 11 ppm tolerance for the representative lettuce member of this
group. Therefore, based on the submitted data, separate tolerances are
established for the celery and spinach members in this group. The
existing lettuce exception listed in 40 CFR 180.589(d) for indirect or
inadvertent residues in vegetables, leafy, group 4, is being revised to
include celery, and spinach, as well as lettuce. This is because of the
separate tolerances established herein for celery and spinach in 40 CFR
180.589(a). 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

[[Page 6361]]

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 boscalid as well as the no
observed adverse effect level (NOAEL) and the lowest observed adverse
effect level (LOAEL) from the toxicity studies can be found in the
Federal Register of July 30, 2003 (68 FR 44640) (FRL-7319-6).

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.
    A summary of the toxicological endpoints for boscalid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of July 30, 2003 (68 FR 44640).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.589) for the residues of boscalid, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from boscalid 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 such effects were
identified in the toxicological studies for Boscalid; therefore, 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 United States
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 chronic exposure assessments:
    The assessment was based on tolerance-level residues (in some cases
modified by DEEM (Version 7.81) default processing factors), and
assumed 100% crop treated.
    iii. Cancer. A quantitative cancer exposure assessment is not
necessary because EPA concluded that boscalid is unlikely to pose a
carcinogenic risk to humans. This conclusion was based on the following
weight of evidence considerations. First, in male Wistar rats, there
was a significant trend (but not pairwise comparison) for the combined
thyroid adenomas and carcinomas. This trend was driven by the increase
in adenomas. Second, in the female rats, there was only a borderline
significant trend for thyroid adenomas (there were no carcinomas).
Third, the mouse study was negative as were all of the mutagenic tests.
Based on this weak evidence of carcinogenic effects, the Agency
concluded that boscalid is not expected to pose a carcinogenic risk.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for boscalid in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of boscalid.
    The Agency used the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The screening concentration in ground water (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water EPA will use FIRST
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin. None of these models
include consideration of the impact processing (mixing, dilution, or
treatment) of raw water for distribution as drinking water would likely
have on the removal of pesticides from the source water. The primary
use of these models by the Agency at this stage is to provide a screen
for sorting out pesticides for which it is unlikely that drinking water
concentrations would exceed human health levels of concern. EECs
derived from these models are used to quantify drinking water exposure
and risk as a %RfD or %PAD.
    Based on the FIRST and SCI-GROW models, the estimated environmental
concentrations (EECs) of boscalid for acute exposures are estimated to
be 87.53 parts per billion (ppb) for surface water and 0.63 ppb for
ground water. The EECs for chronic exposures are estimated to be 25.77
ppb for surface water and 0.63 ppb for ground 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).
    Residential exposure to boscalid is possible on golf courses and at
``U-pick'' farms and orchards. A non-occupational dermal post-
application exposure/risk assessment for these exposusres was conducted
in the previous occupational and residential exposure (ORE) assessment
and is described in the final rule dated July 30, 2003 ( 68 FR 44640).
    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 boscalid and any other
substances and boscalid does not appear to produce a

[[Page 6362]]

toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that boscalid 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 (MOE) analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. In applying this provision, EPA either retains the default
value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional safety factor value based on the use of
traditional uncertainty factors and/or special FQPA safety factors, as
appropriate.
    2. Prenatal and postnatal sensitivity. A complete discussion of the
prenatal/postnatal sensitivity study was recently discussed in the
final rule dated July 30, 2003 (68 FR 44640). No new information has
been received to change this information. The Agency concluded that
there are no residual uncertainties for pre- and post-natal toxicity as
the degree of concern is low for susceptibility, as evidenced by the
data in the studies for the rodent and non-rodent prenatal
developmental, reproduction and fertility effects, and the acute,
subchronic and developmental neurotoxicity studies.
    3. Conclusion. There is a complete toxicity data base for boscalid
and exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. There is no evidence of
susceptibility following in utero exposure to rats and there is low
concern and no residual uncertainties in the developmental
neurotoxicity study after establishing toxicity endpoints and
traditional uncertainty factors for intraspecies variability and
interspecies extrapolation of 100X used in the risk assessment. Based
on these data and conclusions, EPA reduced the FQPA safety factor to
1X.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. As there were no toxic effects attributable to a
single dose, an endpoint of concern was not identified to quantitate
acute-dietary risk to the general population or to the subpopulation
females 13-50 years old. No acute risk is expected from exposure to
boscalid.
    2. Chronic risk. The chronic dietary exposure analysis was based on
tolerance-level residues (in some cases modified by DEEM (Version 7.81)
default processing factors), and assumes 100% crop treated. Even with
these highly conservative assumptions, the risk estimates are well
below the Agency's LOC. The most highly exposed population subgroup
from DEEM is children 1-2 years, which has an exposure estimate of
0.067 mg/kg/day, and utilizes 31% of the chronic population adjusted
dose (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). In this case, the non-
occupational uses to be aggregated with dietary exposure are the turf
use on golf courses and u-pick farms. Post-application exposures from
these uses is considered short-term, and applies to adults and youth.
Therefore, a short-term aggregate risk assessment was conducted. As all
endpoints are from the same study, exposures from different routes can
be aggregated. The exposure to residues in drinking water were included
in the dietary exposure analysis. As a result, the aggregate exposure
is the sum of two exposure values: Dietary (food + water) and
residential. The target maximum daily exposure to boscalid residues is
0.22 mg/kg/day. The sum of the food, water, and residential exposures
is 0.021 mg/kg/day. As a result, the short-term aggregate risk of
exposure to boscalid residues is below the Agency's LOC. The exposure
estimate was calculated using the general U.S. population, but is
considered to be representative of youth because youth and adults
possess similar body surface area to weight ratios and because the
dietary exposure for youth (13-19 years old) is less than that of the
general U.S. population.
    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).
    Because no intermediate term, non-occupational exposures are
anticipated from the use of Boscalid, boscalid is not expected to pose
an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the weight
of the evidence evaluation described previously herein, EPA concluded
that boscalid is not expected to pose a carcinogenic risk to humans.
    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 boscalid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography, mass
spectrometry and electron capture detection) 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 currently no International or Codex maximum residue
levels (MRLs) for boscalid.

C. Response to Comments

    One comment dated 7/9/05 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 Boscalid, 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 example, 70 FR 1349 (January 7,
2005)(FRL-7691-4); 69 FR 63083 (October 29, 2004)(FRL-7681-9).

V. Conclusion

    Therefore, tolerances are established for residues of boscalid, 3-
pyridinecarboxamide, 2-chloro-N-(4'-

[[Page 6363]]

chloro[1,1'-biphenyl]-2-yl), in or on banana (imported) at 0.20 ppm,
celery at 45 ppm and spinach at 60 ppm. The existing 3.0 ppm tolerance
on almond hulls is being increased to 17 ppm.
    IR-4 requested a 50 ppm group tolerance for vegetable, leafy,
except brassica in Group 4. However, the requested Boscalid tolerance
for this entire group is inappropriate because the proposed 50 ppm
group tolerance is substantially higher than the existing 11 ppm
tolerance for the representative lettuce member of this group.
Therefore, based on the submitted data, separate tolerances are
established for the celery and spinach members in this group.
    The existing lettuce exception listed in 40 CFR 180.589(d) for
indirect or inadvertent residues in vegetables, leafy, group 4, is
being revised to include celery, and spinach, as well as lettuce. This
is because of the separate tolerances established herein for celery and
spinach in 40 CFR 180.589(a).

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-2005-0145 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 April 10,
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.
    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.
    2. 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-2005-0145, to: Public
Information and Records Integrity Branch, Information Technology and
Resources 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, 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

[[Page 6364]]

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. 801et 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: January 30, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.589 is amended as follows:
0
a. In the table to paragraph (a)(1) by revising the entry for ``Almond,
hulls'' and alphabetically adding commodities.
0
b. In the table to paragraph (d) by revising the entry ``Vegetable,
leafy, group 4, except lettuce''.

Sec.  180.589  Boscalid; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond, hulls........................................                 17
                                * * * * *
Banana, import\1\....................................               0.20
                                * * * * *
Celery...............................................                 45
                                * * * * *
Spinach..............................................                 60
                                * * * * *
------------------------------------------------------------------------
\1\ No US registration as of January 31, 2006.

* * * * *
    (d)* * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Vegetable, leafy, group 4, except lettuce, celery and                1.0
 spinach.............................................
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 06-1170 Filed 2-7-06; 8:45 am]

BILLING CODE 6560-50-S