Document ID: EPA-HQ-OPP-2003-0246-0005
Agency: epa
Document Type: Rule
Title: Boscalid; Pesticide Tolerance
Posted Date: 2006-05-03T14:40:09Z

[Federal Register: May 3, 2006 (Volume 71, Number 85)]
[Rules and Regulations]               
[Page 25956-25961]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my06-14]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2003-0246; FRL-8064-4]

 
Boscalid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation increases the tolerance for residues of 
boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro [1,1'-biphenyl]-
2-yl) in or on strawberry; and decreases indirect or inadvertant 
tolerances on beet, garden, roots; beet, sugar, roots; radish, roots; 
turnip, roots; and vegetable, root and tuber, leaves, Group 2. BASF 
requested these revised tolerances 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 May 3, 2006. Objections and 
requests for hearings must be received on or before July 3, 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-2003-0246. All documents in the 
docket are listed on the http://www.regulations.gov web site. EDOCKET, EPA's 

electronic public docket and comment system was replaced on November 
25, 2005, by an enchanced 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.
     Important Note: OPP will be moving to a new location the 
first week of May 2006. As a result, from Friday, April 28 to Friday, 
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any 
deliveries at the Crystal Mall 2 address and this facility 
will be closed to the public. Beginning on May 8, 2006, the OPP 
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will 
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S. 
Crystal Drive, Arlington, VA 22202. The mail code for the mailing 
address will change to (7502P), but will otherwise remain the same. The 
OPP Regulatory Public Docket telephone number and hours of operation 
will remain the same after the move.

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.

[[Page 25957]]

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 February 15, 2006 (71 FR 7951) (FRL-
7759-3), 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 
5F6986) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709. The petition (EPA-HQ-OPP-2005-0145) requested that 40 CFR 
180.589 be amended by increasing the tolerance for residues of the 
fungicide boscalid, in or on the raw agricultural commodity, 
strawberry, from 1.2 parts per million (ppm) to 4.5 ppm. That notice 
included a summary of the pesticide petition prepared by BASF, the 
registrant. The original boscalid strawberry 1.2 ppm tolerance was 
published July 30, 2003 (68 FR 44640). Due to concerns about tolerance 
overages in California, BASF submitted additional field data which 
resulted in the increased tolerances herein. No comments were received 
on the notice of filing.
    In the Federal Register of March 17, 2006 (71 FR 13841) (FRL-7767-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a revised notice of filing 
for pesticide petition (PP 1F6313) by BASF Corporation, P.O. Box 13528, 
Research Triangle Park, NC 27709. The revised petition (EPA-HQ-OPP-
2003-0246) requested that 40 CFR 180.589 be amended by decreasing the 
tolerance for indirect or inadvertant residues of the fungicide 
boscalid, in or on the raw agricultural commodities beet, garden, roots 
from 1.0 ppm to 0.1 ppm; beet, sugar, roots from 1.0 ppm to 0.1 ppm; 
radish, roots from 1.0 ppm to 0.1 ppm; turnip, roots from 1.0 ppm to 
0.1 ppm; and vegetable, root and tuber, leaves, Group 2 from 1.0 ppm to 
0.1 ppm. 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.
    The original notice of filing for petition 1F6313 was published in 
the Federal Register of February 14, 2003 (68 FR 7542), and the 
resultant final rule was published July 30, 2003 (68 FR 44640) (FRL-
7319-6). As per that final rule and associated notice of pesticide 
registration, the registrant was conditionally required to submit more 
extensive field data on the vegetable, root, subgroup 1B. The submitted 
conditional data resulted in lowering the current 1.0 ppm tolerances 
established in the final rule to 0.1 ppm herein.
    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 
strawberry at 4.5 ppm; beet, garden, roots at 0.1 ppm; beet, sugar, 
roots at 0.1 ppm; radish, roots at 0.1 ppm; turnip, roots at 0.1 ppm; 
and vegetable, root and tuber, leaves, group 2 at 0.1 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 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 at (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 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 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) (FRL-
7319-6).

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

[[Page 25958]]

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 (DEEMTM/FCID), which 
incorporates food consumption data as reported by respondents in the 
U.S. Department of Agriculture 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 and 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 First 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 I model) before using PRZM/EXAMS (a Tier II 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 
(PC) area factor as an adjustment to account for the maximum PC 
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. Estimated 
Drinking Water Concentrations (EDWC's) derived from these models are 
used to quantify drinking water exposure and risk as a percent 
Reference Dose (%RFD) or percent Adjusted Dose (%PAD).
    Based on the FIRST and SCI-GROW models, the EDWC's 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 exposures was conducted 
in the previous occupational and residential exposure assessment and is 
described in the final rule in the Federal Register of July 30, 2003 
(68 FR 44640) (FRL-7319-6).
    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 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 Web site 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 UF safety in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional 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) (FRL-7319-6). No new 
information has been received to change this information. The Agency 
concluded that there are no residual uncertainties for prenatal and 
postnatal 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 account for potential exposures. There

[[Page 25959]]

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 UFs 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 is based on 
tolerance-level residues and assumes 100% crop treated. Even with these 
highly conservative assumptions, the risk estimates are well below the 
Agency's level of concern. The most highly exposed population subgroup 
from DEEM is children 1-2 years old, which has an exposure estimate of 
0.067 milligrams/kilogram/day (mg/kg/day), and utilizes 31% 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). In this case, the non-
occupational use to be aggregated with dietary exposure is the turf use 
on golf courses. 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 produces a MOE of 1,038, which does not exceed the 
Agency's level of concern (ie., MOE's less than 100 are of concern). 
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 methods may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are currently no Codex Maximun Residue Limits for boscalid.

C. Response to Comments

    Two comments were received March 17, 2006 regarding petition 1F6313 
from B. Sachau. The first comment mentioned that EPA should not just 
accept information from sponsoring companies as correct and accurate, 
and in so doing, should not just rubber stamp this information, but 
rather conduct its own studies. In response to this comment, as per 
sections 3, 5, 12, and 25 of the Federal Insecticide, Fungicide, and 
Rodenticide Act, section 408 of the FFDCA, and in 40 CFR part 158, EPA 
requires that extensive data be submitted to support pesticide 
registrations and tolerances. Further guidance for conducting 
acceptable tests are specified in the Pesticide Assessment Guidelines 
(PAGs). Submitted data are subject to the Good Laboratory Practice 
Standards in 40 CFR part 160. EPA thoroughly reviews submitted data and 
makes an independent determination as to whether they are 
scientifically acceptable. Thus, EPA does not simply accept information 
submitted from registrants as correct and accurate, without a 
comprehensive internal scientific review.
    The second comment regarded general opposition to Agency approval 
of tolerances and exemptions other than zero, and general opposition to 
any residue left on a treated crop. The Agency finds that this comment 
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 prior similar comments from B. 
Sachau have been responded to by the Agency on several occasions. For 
example, (October 29, 2004, 69 FR 63083), (January 7, 2005, 70 FR 
1349), and (June 30, 2005, 70 FR 37683).

V. Conclusion

    Therefore, tolerances are increased for residues of boscalid,3-
pyridinecarboxamide, 2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl), in or 
on strawberry from 1.2 ppm to 4.5 ppm; and decreased for indirect or 
inadvertant residues on the following crops: Beet, garden, roots from 
1.0 ppm to 0.1 ppm; beet, sugar, roots from 1.0 ppm to 0.1 ppm; radish, 
roots from 1.0 ppm to 0.1 ppm; turnip, roots from 1.0 ppm to 0.1 ppm; 
and vegetable, root and tuber, leaves, group 2 from 1.0 ppm to 0.1 ppm

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

[[Page 25960]]

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-2003-0246 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 July 3, 
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.1, 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-2003-0246, 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.

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 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.

[[Page 25961]]

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: April 24, 2006.
Lois Rossi,
Acting 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 in the table to paragraph (a)(1) by 
revising the entry for strawberry, and in the table to paragraph (d) by 
revising the entries for; beet, garden, roots; beet, sugar, roots; 
radish, roots; turnip, roots and vegetables, root and tuber, leaves, 
group 2 in the table in paragraph (d):

Sec.  180.589  Boscalid; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Strawberry.................................................          4.5
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Beet, garden, roots........................................          0.1
Beet, sugar, roots.........................................          0.1
                                * * * * *
Radish, roots..............................................          0.1
                                * * * * *
Turnip, roots..............................................          0.1
                                * * * * *
Vegetable, root and tuber, leaves, Group 2.................          0.1
------------------------------------------------------------------------

[FR Doc. 06-4158 Filed 5-2-06; 8:45 am]

BILLING CODE 6560-50-S