[Federal Register Volume 71, Number 26 (Wednesday, February 8, 2006)]
[Rules and Regulations]
[Pages 6359-6364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1170]


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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).

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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 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: [email protected].

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: [email protected].

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'-

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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: [email protected]. 
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