[Federal Register Volume 68, Number 117 (Wednesday, June 18, 2003)]
[Rules and Regulations]
[Pages 36476-36480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15129]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0113; FRL-7301-1]


Bacillus Pumilus Strain QST2808; Temporary Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the 
requirement of a tolerance for residues of the Bacillus pumilus strain 
QST2808 in or on all agricultural commodities when applied/used in 
accordance with label directions. AgraQuest, Inc. submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as 
amended by the Food Quality Protection Act of 1996 (FQPA), requesting 
the temporary tolerance exemption. This regulation eliminates the need 
to establish a maximum permissible level for residues of Bacillus 
pumilus strain QST2808. The temporary tolerance exemption will expire 
on June 30, 2006.

DATES: This regulation is effective June 18, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0113, 
must be received by EPA on or before August 18, 2003.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail or through hand delivery/courier. Follow the detailed instructions 
as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Susanne Cerrelli, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8077 ; 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:
    [sbull] Crop production/Agriculture (NAICS 111)
    [sbull] Animal production (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0113. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing 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.
    2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title --40/40cfr180 --00.html, 
a beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of May 3, 2001 (66 FR 22225) (FRL-6773-9), 
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by FQPA (Public Law 104-170), announcing the filing of 
a pesticide tolerance petition (PP 1G6240), submitted by AgraQuest, 
Inc., 1530 Drew Avenue, Davis, CA 95616. This notice included a summary 
of the petition prepared by the petitioner AgraQuest, Inc. There were 
no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing a temporary exemption from the requirement of a tolerance 
for residues of Bacillus pumilus strain QST2808. Section 
408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from 
the requirement for a tolerance (the legal limit for a pesticide 
chemical residue in or on a food) only if EPA

[[Page 36477]]

determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of 
the 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 the 
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. . . .'' Additionally, section 408(b)(2)(D) 
of the FFDCA requires that 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.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity, completeness and 
reliability and the relationship of this information 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.
    Bacillus pumilus is a ubiquitous and naturally occurring bacteria 
found in soil. The results of the acute toxicology and pathogenicity 
studies required of the petitioner under section 408(d)(2)(A) of the 
FFDCA in support of its petition for a temporary exemption from the 
requirement of a tolerance for Bacillus pumilus strain QST2808 indicate 
negligible to no mammalian toxicity. In addition, no pathogenicity was 
observed in any of the tests conducted with the Bacillus pumilus strain 
QST2808 Technical product.
    The toxicology and pathogenicity data generated by AgraQuest, Inc 
in support of this temporary exemption from the requirement of a 
tolerance are summarized below.
    1. Acute oral toxicity and pathogenicity rats (OPPTS Harmonized 
Guideline 885.3050; Master Record Identification Number (MRID) 451366-
04). Fifteen male and fifteen female rats each were administered 4.1 x 
109 cfu of Bacillus pumilus strain QST2808 Technical and 
observed for 14 days. Based on the data, Bacillus pumilus strain 
QST2808 does not appear to be toxic, infective, and/or pathogenic in 
rats, when dosed at 4.1 x 109 cfu/animal. Classification: 
Acceptable; Toxicity Category IV. (C. Etsitty's Memorandum to John L. 
Kough, dated 1/7/02 (hereinafter referred to as ``BPPD Review - 1/7/
02'')).
    2. Acute dermal toxicity (OPPTS Harmonized Guideline 885.3100; MRID 
451366-05). Five male and five female rabbits were dermally treated 
with 2g/kg body weight Bacillus pumilus strain QST2808 Technical for 24 
hours and observed for the following 14 days. The acute lethal dose 
(LD50) is greater than 2,000 mg/kg. Classification: 
Acceptable; Toxicity Category III. (BPPD Review - 1/7/02).
    3. Primary eye irritation (OPPTS Harmonized Guideline 870.2400; 
MRID 452679-01). Three male rabbits each were administered 0.1 mL of 
QST2808 Technical in the everted lower lid of one eye and then observed 
for 72 hours. Based on the data, QST2808 Technical showed minimal 
effects to the eye. Classification: Acceptable; Toxicity Category IV. 
(BPPD Review - 1/7/02).
    4. Acute injection toxicity/pathogenicity (OPPTS Harmonized 
Guideline 885.3200; MRID 451366-07). Eighteen male and eighteen female 
rats each were dosed at 1.6 x 108 cfu Bacillus pumilus 
strain QST2808 Technical intravenously and monitored over a period of 
28 days. A gross necropsy was performed on all rats. Based on the data, 
the test organism was not toxic, infective, or pathogenic to rats. 
Classification: Acceptable. (BPPD Review - 1/7/02).
    5. Acute pulmonary toxicity/pathogenicity (OPPTS Harmonized 
Guideline 885.3150; MRID 451366-06). Eighteen male and eighteen female 
rats each were administered 1.6 x 108 cfu Bacillus pumilus 
strain QST2808 Technical by a single intratracheal dosage and monitored 
over a period of 35 days for clinical signs of toxicity. Necropsy 
studies showed no significant signs of abnormalities due to the test 
organism. Based on the data, Bacillus pumilus strain QST2808 was not 
toxic, infective, and/or pathogenic to rats when dosed at 1.6 x 
108 cfu/animal. Classification: Acceptable. (BPPD Review - 
1/7/02).
    6. Acute Inhalation toxicity (OPPTS Harmonized Guideline 870.1300). 
Results of the acute pulmonary toxicity/pathogenicity (MRID 451366-06) 
performed with Bacillus pumilus strain QST2808 Technical indicate that 
it is not toxic, infective, and/or pathogenic to rats when dosed at 1.6 
x 108 cfu/animal. For the purposes of this specific action, 
the Agency has determined that the acute pulmonary toxicity/
pathogenicity data are adequate to support and/or fulfill this 
particular data requirement.
    7. Primary dermal irritation (OPPTS Harmonized Guideline 870.2500; 
MRID 452679-02). Each of three male adult rabbits were treated dermally 
with 0.5 mL QST2808 Technical for 4 hours and observed for the 
following 72 hours. Based on the data, no abnormal clinical signs were 
noted. Approximately 60 minutes after patch removal, very slight 
erythema was noted on one of the three rabbits with resolution by 24 
hours. When dosed with QST2808 Technical at 0.5 mL/animal, QST2808 
Technical was essentially non-irritating. Classification: Acceptable; 
Toxicity Category IV. (BPPD Review - 1/7/02).
    8. Hypersensitivity incidents (OPPTS Harmonized Guideline 
885.3400). The registrant reported (November 1, 2000) no incidents to 
date.
    9. Immune response. There is no information to suggest that 
Bacillus pumilus strain QST2808 has an effect on the immune system. The 
submitted toxicity/pathogenicity studies in rodents indicated that 
following several routes of exposure, the immune system is still intact 
and able to process and clear the active ingredient (MRID 451366-04; 
451366-06, and 451366-07).
    Based on the data generated in accordance with the Tier I data 
requirements set forth in 40 CFR Sec.  158.740(c), the Tier II and Tier 
III data requirements were not triggered and, therefore, not required 
in connection with this action. In addition, because the Tier II and 
Tier III data requirements were not required, the residue data 
requirements set forth in 40 CFR Sec.  158.740(b) also were not 
required.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs 
EPA to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or

[[Page 36478]]

buildings (residential and other indoor uses).

A. Dietary Exposure

    Humans and animals are commonly exposed to Bacillus pumilus, a 
ubiquitous microorganism that inhabits soil. No toxicological endpoints 
were identified for Bacillus pumilus strain QST2808. The low toxicity 
and non-pathogenicity/infectivity of Bacillus pumilus strain QST2808 is 
demonstrated by the data summarized in Unit III of this action.
    1. Food. While the proposed use pattern may result in dietary 
exposure with possible residues in or on agricultural commodities, 
negligible to no risk is expected for the general population, including 
infants and children, or animals because Bacillus pumilus strain 
QST2808 technical demonstrated no pathogenicity or oral toxicity at the 
maximum doses tested, as noted above in (Unit III).
    2. Drinking water exposure. Most importantly, there is no evidence 
of adverse effects from oral, dermal, or inhalation exposure to this 
microbial agent. (See ``Unit III. Toxicological Profile'' above.) In 
addition, the potential for transfer of Bacillus pumilus strain QST2808 
to surface or ground water during run-off associated with intended use 
applications is considered minimal to non-existent, due in part to its 
percolation through and resulting capture in soil. Accordingly, the use 
of this microbial pest control agent on terrestrial plants is not 
anticipated to negatively impact the quality of drinking water.

B. Other Non-Occupational Exposure

    Based on the proposed use patterns, the potential of non-dietary 
exposures to Bacillus pumilus strain QST2808 pesticide residues for the 
general population, including infants and children, is unlikely. 
Accordingly, the Agency believes that the potential aggregate non-
occupational exposure, derived from dermal and inhalation exposure 
through the application of Bacillus pumilus strain QST2808, should fall 
well below the currently tested microbial safety levels.
    1. Dermal exposure. The potential for dermal exposure to Bacillus 
pumilus strain QST2808 pesticide residues for the general population, 
including infants and children, is unlikely because potential use sites 
are agricultural and horticultural. However, since Bacillus pumilus 
strain QST2808 is a naturally occurring bacteria in soil, there is a 
great likelihood of prior exposure for most, if not all individuals. 
Accordingly, the increase in exposure due to this proposed product 
would be negligible. Furthermore, and as demonstrated in Unit III of 
this action, the organism is of low dermal toxicity, the acute lethal 
dose (LD50) is greater than 2,000 mg/kg, and the QST2808 
Technical was essentially non-irritating (Toxicity Category IV). 
Accordingly, the risks anticipated for this route of exposure are 
considered minimal.
    2. Inhalation exposure. The potential for inhalation exposure to 
Bacillus pumilus strain QST2808 pesticide residues for the general 
population, including infants and children is unlikely because 
potential use sites are agricultural and horticultural. However, since 
Bacillus pumilus is a natural occurring bacteria in soil, there is a 
great likelihood of prior exposure for most, if not all individuals. 
Accordingly, the increase in exposure due to this proposed product 
would be negligible. Furthermore, and as demonstrated in Unit III of 
this action, the acute pulmonary toxicity/pathogenicity testing 
performed on the technical formulation did not demonstrate 
pathogenicity or toxicity of Bacillus pumilus strain QST2808. (See Unit 
III above.) Accordingly, the risks anticipated for this route of 
exposure are considered minimal.

V. Cumulative Effects

    The Agency has considered the potential for cumulative effects of 
Bacillus pumilus strain QST2808 and other substances in relation to a 
common mechanism of toxicity. These considerations include the possible 
cumulative effects of such residues on infants and children. Bacillus 
pumilus strain QST2808 is practically non-toxic to mammals. Because no 
mechanism of pathogenicity or toxicity in mammals has been identified 
for this organism (see Unit III above), no cumulative effects from the 
residues of this product with other related microbial pesticides is 
anticipated.

VI. Determination of Safety for U.S. Population, Infants and Children

    There is a reasonable certainty that no harm to the U.S. 
population, including infants and children, will result from aggregate 
exposure to residues of Bacillus pumilus strain QST2808 due to its use 
as a microbial pest control agent. This includes all anticipated 
dietary exposures and all other exposures for which there is reliable 
information. As discussed previously, Bacillus pumilus strain QST2808 
is not pathogenic or infective and is practically non-toxic to mammals. 
(See Unit III above.) Accordingly, exempting Bacillus pumilus strain 
QST 2808 from the requirement of a tolerance should be considered safe 
and pose no significant risk.
    FFDCA section 408(b)(2)(C) provides that EPA shall apply an 
additional tenfold margin of exposure (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 that a different margin of exposure 
(safety) will be safe for infants and children. Margins of exposure 
(safety) are incorporated into EPA risk assessments either directly 
through the use of a margin of exposure analysis or by using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. Due to the ubiquitous nature of Bacillus 
pumilus, residues of this microbial pesticide in or on agricultural 
commodities are not expected to significantly increase exposure to the 
U.S. population, including infants and children. Here, EPA concludes 
that the toxicity and exposure data are sufficiently complete to 
adequately address the potential for additional sensitivity of infants 
and children to residues of Bacillus pumilus strain QST2808 and that 
there is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to Bacillus pumilus strain QST2808 
residues.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the FFDCA, as amended by 
FQPA, to develop a screening program to determine whether certain 
substances (including all pesticide active and other ingredients) ``may 
have an effect in humans that is similar to an effect produced by a 
naturally-occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Following the recommendations of its 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
EPA determined that there is no scientific basis for including, as part 
of the screening program, the androgen and thyroid hormone systems in 
addition to the estrogen hormone system. EPA also adopted EDSTAC's 
recommendation that the program include evaluations of potential 
effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, 
to the extent that effects in wildlife may help determine whether a 
substance may have an effect in humans, FFDCA authority to require 
wildlife evaluations. As the science develops and resources allow, 
screening of additional hormone

[[Page 36479]]

systems may be added to the Endocrine Disruptor Screening Program 
(EDSP). When the appropriate screening and/or testing protocols being 
considered under the Agency's EDSP have been developed, Bacillus 
pumilus strain QST2808 may be subjected to additional screening and/or 
testing to better characterize effects related to endocrine disruption.
    To date, the Agency has no information to suggest that Bacillus 
pumilus strain QST2808 has an effect on the endocrine systems. 
Moreover, as is expected from a non-pathogenic microorganism that is 
practically non-toxic to mammals, the submitted toxicity/pathogenicity 
studies in rodents indicated that following several routes of exposure, 
the immune system is still intact and able to process and clear the 
active ingredient. (BPPD Review - 1/7/02).

B. Analytical Method

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation for the reasons stated 
above, including Bacillus pumilus strain QST2808's lack of mammalian 
toxicity. For the same reasons, the Agency has concluded that an 
analytical method is not required for enforcement purpose for Bacillus 
pumilus strain QST2808.

C. Codex Maximum Residue Level

    There is no Codex Alimentarius Commission Maximum Residue Level for 
Bacillus pumilus strain QST2808.

VIII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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 
the FFDCA by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the 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), 
as was provided in the old sections 408 and 409 of the 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-2003-0113 in the subject line on the 
first page of your submission. All objections and requests for hearings 
must be in writing, and must be mailed or delivered to the Hearing 
Clerk on or before August 18, 2003.
    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 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 VIII.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-2003-0113, 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).

[[Page 36480]]

IX. Statutory and Executive Order Reviews

    This final rule establishes a temporary exemption from the 
tolerance requirement for Bacillus pumilus strain QST2808 under section 
408(d) of the 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 the 
FFDCA, such as the exemption 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 the 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.

X. 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: June 3, 2003.
James Jones,
Director, Office of Pesticide Programs.

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Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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2. Section 180.1226 is added to subpart D to read as follows:


Sec.  180.1226  Bacillus pumilus strain QST2808; temporary exemption 
from the requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is 
established for residues of the microbial pesticide Bacillus pumilus 
strain QST2808 when used in or on all agricultural commodities when 
applied/used in accordance with label directions.

[FR Doc. 03-15129 Filed 6-17 -03; 8:45 am]
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