[Federal Register Volume 69, Number 102 (Wednesday, May 26, 2004)]
[Rules and Regulations]
[Pages 30076-30081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11780]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0090; FRL-7348-1]


Imidacloprid; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for the combined 
residues of imidacloprid, and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as the parent in or on blueberry. 
Interregional Research Project Number 4 (IR-4) requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective May 26, 2004. Objections and 
requests for hearings must be received on or before July 26, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0090. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., 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: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; 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

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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 this Document and Other Related Information?

    In addition to using EDOCKET(http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

II. Background and Statutory Findings

    In the Federal Register of February 5, 2003 (68 FR 5880) (FRL-7287-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
1E6268, 1E6254, 1E6237, 1E6225, 0E6203, 2E6403, 2E6406, 2E6409, 2E6417, 
2E6421, 2E6435, 2E6414, 2E6458, and 2E6506) by IR-4, 681 U.S. Highway 
1 South, North Brunswick, NJ 08902-3390. That notice included 
a summary of the petitions prepared by Bayer CropScience, the 
registrant. One comment was received in response to the notice of 
filing of February 5, 2003, from an individual who requested that 
information about pesticide tolerances be available in grocery stores 
next to the food labels.
    Pursuant to section 408(o), the Consumer Right to Know provision of 
the FFDCA as amended by FQPA, the Agency distributes information on the 
risks and benefits of pesticide chemical residues in or on food to 
large retail grocers for public display. Copies of this EPA brochure 
entitled, ``Pesticides and Food: What You and Your Family Need to 
Know'' (Publication No. 735-F-98-00) may be obtained at no cost (http://www.epa.gov/pesticides/food/) or viewed in its entirety at http://www.pueblo.gsa.gov/cic_text/food/pesticides-andfood/food.html.
    The petitions requested that 40 CFR 180.472 be amended by 
establishing tolerances for combined residues of the insecticide 
imidacloprid, (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine), and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as imidacloprid in or on 
blueberry at 3.5 part per million (ppm), in addition to a variety of 
raw agricultural commodities previously established in the Federal 
Register of June 13, 2003 (68 FR 35303) (FRL-7310-8). EPA received 
objections to a time-limited tolerance it established for residues of 
imidacloprid on blueberries in connection with an emergency exemption 
for such use under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), 7 U.S.C. 136 et seq. published in the Federal Register of 
January 18, 2002 (67 FR 2580) (FRL-6817-6). The objections were filed 
by the Natural Resources Defense Council (NRDC) and raised several 
issues regarding aggregate exposure estimates and the additional safety 
factor for the protection of infants and children. NRDC's objections 
raise complex legal, scientific, policy, and factual matters. Elsewhere 
in today's Federal Register EPA has denied NRDC's objections to the 
now-expired blueberry tolerance as moot. Because NRDC's objections are 
relevant to this rulemaking establishing a new tolerance on 
blueberries, EPA has treated NRDC's objections as comments on the 
petition to re-establish the blueberry tolerance and taken them into 
account in the current action. EPA's detailed response to NRDC is 
included in the document denying its objections. Individual commodity 
tolerances for other members of the bushberry subgroup (currant, 
elderberry, gooseberry and huckleberry) were established in the Federal 
Register of June 13, 2003 (68 FR 35303).
    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 FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

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 combined residues of 
imidacloprid, and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as the parent on blueberry at 3.5 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. The nature of the toxic effects caused by imidacloprid as 
well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed are discussed in Unit III.A. of the Final Rule on Imidacloprid 
Pesticide Tolerance published in the Federal Register of June 13, 2003 
(68 FR 35303).

B. Toxicological Endpoints

    A summary of the toxicological endpoints for imidacloprid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of June 13, 2003 (68 FR 35303). These 
issues are also discussed in EPA's response to the concerns voiced by 
NRDC in its objections to the prior imidacloprid blueberry tolerance. 
EPA's response is published elsewhere in today's Federal Register. 
Acute, chronic, and short-term aggregate risk assessments are

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appropriate for imidacloprid and were performed by EPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.472) for the combined residues of imidacloprid, 
in or on a variety of raw agricultural commodities. Risk assessments 
were conducted by EPA to assess dietary exposures from imidacloprid in 
a variety of raw agricultural commodities. Acute and chronic exposure 
assessments conducted by EPA to assess dietary exposures from 
imidacloprid are discussed in Unit III.C.1. of the Final Rule on 
Imidacloprid Pesticide Tolerance published in the Federal Register of 
June 13, 2003 (68 FR 35303). These issues are also discussed in EPA's 
response to the concerns voiced by NRDC in its objections to the prior 
imidacloprid blueberry tolerance. EPA's response is published elsewhere 
in today's Federal Register. The proposed tolerance for blueberry at 
3.5 ppm was included in the imidacloprid risk assessment of June 13, 
2003.
    2. Dietary exposure from drinking water. FQPA Index Reservoir 
Screening Tool (FIRST) and Screening Concentration in Groundwater (SCI-
GROW) model estimated environmental concentrations (EECs) for 
imidacloprid for acute and chronic exposures are discussed in Unit 
III.C.2. of the Final Rule on Imidacloprid Pesticide Tolerance 
published in the Federal Register of June 13, 2003 (68 FR 35303). These 
issues are also discussed in EPA's response to the concerns voiced by 
NRDC in its objections to the prior imidacloprid blueberry tolerance. 
EPA's response is published elsewhere in today's Federal Register.
    3. From non-dietary exposure. Imidacloprid is currently registered 
for use on the following residential non-dietary sites: Granular 
products for application to lawns and ornamental plants; ready-to-use 
spray for application to flowers, shrubs and house plants; plant spikes 
for application to indoor and outdoor residential potted plants; ready-
to-use potting medium for indoor and outdoor plant containers; liquid 
concentrate for application to lawns, trees, shrubs and flowers; and 
ready-to-use liquid for directed spot application to cats and dogs. In 
addition, there are numerous registered products intended for use by 
commercial applicators to residential sites. These include gel baits 
for cockroach control; products intended for commercial ornamental, 
lawn and turf pest control; products for ant control; and products used 
as preservatives for wood products, building materials, textiles and 
plastics. The non-dietary exposure assessment is discussed in the Final 
Rule on Imidacloprid Pesticide Tolerance published in Unit III.C.3. of 
the Federal Register of June 13, 2003 (68 FR 35303). These issues are 
also discussed in EPA's response to the concerns voiced by NRDC in its 
objections to the prior imidacloprid blueberry tolerance. EPA's 
response is published elsewhere in today's Federal Register.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to imidacloprid and any other 
substances and imidacloprid 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 imidacloprid 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 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. These issues are discussed 
in Unit III.D.2. of the Final Rule on Imidacloprid Pesticide Tolerance 
published in the Federal Register of June 13, 2003 (68 FR 35303). These 
issues are also discussed in EPA's response to the concerns voiced by 
NRDC in its objections to the prior imidacloprid blueberry tolerance. 
EPA's response is published elsewhere in today's Federal Register.
    3. Conclusion. There is a complete toxicity data base for 
imidacloprid and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. EPA determined 
that the 10X safety factor to protect infants and children should be 
reduced to 3X. For further discussion, see Unit III.D.3. of the Final 
Rule on Imidacloprid Pesticide Tolerance published in the Federal 
Register of June 13, 2003 (68 FR 35303) (FRL-7310-8). These issues are 
also discussed in EPA's response to the concerns voiced by NRDC in its 
objections to the prior imidacloprid blueberry tolerance. EPA's 
response is published elsewhere in today's Federal Register.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates drinking 
water levels of concerns (DWLOCs) which are used as a point of 
comparison against EECs. DWLOC values are not regulatory standards for 
drinking water. DWLOCs are theoretical upper limits on a pesticide's 
concentration in drinking water in light of total aggregate exposure to 
a pesticide in food and residential uses. In calculating a DWLOC, the 
Agency determines how much of the acceptable exposure (i.e., the PAD) 
is available for exposure through drinking water (e.g., allowable 
chronic water exposure (milligrams/kilogram/day) = chronic population 
adjusted dose - (average food + residential exposure)). This allowable 
exposure through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values

[[Page 30079]]

as used by the EPA's Office of Water are used to calculate DWLOCs: 2 
liter (L)/70 kilogram (kg) (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. The acute risk assessment for imidacloprid is 
discussed in Unit III.E.1. of the Final Rule on Imidacloprid Pesticide 
Tolerance published in the Federal Register of June 13, 2003 (68 FR 
35303).
    2. Chronic risk. The chronic risk assessment for imidacloprid is 
discussed in Unit III.E.2. of the Final Rule on Imidacloprid Pesticide 
Tolerance published in the Federal Register of June 13, 2003 (68 FR 
35303).
    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). Imidacloprid is 
currently registered for use that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic food and water and short-term 
exposures for imidacloprid. The short-term risk assessment for 
Imidacloprid is discussed in Unit III.E.3. of the Final Rule on 
Imidacloprid Pesticide Tolerance published in the Federal Register of 
June 13, 2003 (68 FR 35303).
    4. Aggregate cancer risk for U.S. population. There is no evidence 
of carcinogenicity to humans based on carcinogenicity studies in male 
and female rats and mice. The Agency concludes that pesticidal uses of 
imidacloprid are not likely to pose a cancer risk to humans.
    5. 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 imidacloprid residues. EPA's safety finding is also 
discussed in EPA's response to the concerns voiced by NRDC in its 
objections to the prior imidacloprid blueberry tolerance. EPA's 
response is published elsewhere in today's Federal Register.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of 
imidacloprid residues of concern in plant (Bayer Gas Chromatography/
Mass Spectrometry (GC/MS) Method 00200) and livestock commodities 
(Bayer GC/MS Method 00191). These methods have undergone successful EPA 
petition method validations (PMVs), and the registrant has fulfilled 
the remaining requirements for additional raw data, method validation, 
independent laboratory validation (ILV), and an acceptable confirmatory 
method (high performance liquid chromatography/ultraviolet (HPLC/UV) 
Method 00357). 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: 
[email protected].

B. International Residue Limits

    There are no established Codex, Canadian, or Mexican maximum 
residue limits (MRLs) for imidacloprid in/on blueberries.

V. Conclusion

    Therefore, the tolerance is established for combined residues of 
imidacloprid, (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine), and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as imidacloprid in or on 
blueberry at 3.5 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 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 OPP-2004-0090 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 26, 
2004.
    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 issues(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 (1900C), 
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 Rm. 104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You

[[Page 30080]]

must mail the fee to: EPA Headquarters Accounting Operations Branch, 
Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. 
Please identify the fee submission by labeling it ``Tolerance Petition 
Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2004-0090, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services 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 Unit I.B.1. 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 issues(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.

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

[[Page 30081]]

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.

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 180.472 is amended by alphabetically adding the following 
commodity to the table in paragraph (a) to read as follows:


Sec.  180.472  Imidacloprid; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Revocation/
                   Commodity                     Parts per    Expiration
                                                  million        Date
------------------------------------------------------------------------
                                * * * * *
Blueberry
                                * * * * *
                                                        3.5         None
------------------------------------------------------------------------

* * * * *

    Dated: May 11, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 04-11780 Filed 5-25-04; 8:45 am]
BILLING CODE 6560-50-S