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[Federal Register Volume 69, Number 212 (Wednesday, November 3, 2004)]
[Rules and Regulations]
[Pages 63950-63954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24250]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0215; FRL-7684-4]

Bacillus Pumilus Strain QST 2808; Exemption From the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Bacillus pumilus strain QST 2808 in 
or on food 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 an exemption from the 
requirement of a tolerance. Notification that EPA had received the 
petition was published on May 5, 2004 (69 FR 25092) (FRL-7354-4). This 
regulation eliminates the need to establish a maximum permissible level 
for residues of Bacillus pumilus strain QST2808.

DATES: This regulation is effective November 3, 2004. Objections and 
requests for hearings must be received on or before January 3, 2005.

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 
identification (ID) number OPP-2004-0215. 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., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Mandula, Biopesticides and 
Pollution Prevention Division (7511C), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-7378; 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/Agriculture (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     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 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 May 5, 2004 (69 FR 25092) (FRL-7354-4), 
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 4F6926) 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 permanent exemption from the requirement of a tolerance 
for residues of Bacillus pumilus strain QST 2808. EPA previously had 
granted the petitioner a temporary exemption from the requirement of a 
tolerance for residues of Bacillus pumilus strain QST 2808, which was 
published on June 18, 2003 (68 FR 36476)(FRL-7301-1). That temporary 
exemption is set to expire June 30, 2006.
    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 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. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which require 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

[[Page 63951]]

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 strain QST 2808 is a ubiquitous and naturally 
occurring bacterium commonly found in soil. The results of the acute 
toxicology and pathogenicity studies previously submitted by the 
petitioner in support of its petition for a temporary exemption from 
the requirement of a tolerance for Bacillus pumilus strain QST 2808 
indicate negligible to no mammalian toxicity. In addition, no 
pathogenicity was observed in any of the tests conducted with the 
Bacillus pumilus strain QST 2808 Technical product. Accordingly, the 
toxicology and pathogenicity data generated by AgraQuest, Inc in 
support of the temporary exemption from the requirement of a tolerance 
also support a permanent exemption from the requirements of a 
tolerance. This data is summarized in more detail below.
    1. Acute oral toxicity and pathogenicity (OPPTS 885.3050; MRID 
451366-04). Fifteen male and fifteen female rats each were administered 
4.1 x 10\9\ colony forming unit (cfu) of B. pumilus strain QST 2808 
Technical and observed for 14 days. Based on the data, B. pumilus 
strain QST 2808 does not appear to be toxic, infective, and/or 
pathogenic in rats, when dosed at 4.1 x 10\9\ cfu/animal. 
Classification: Acceptable; Toxicity Category IV.
    2. Acute dermal toxicity (OPPTS 885.3100; MRID 451366-05). Five 
male and five female rabbits were dermally treated with 2g/kg body 
weight B. pumilus strain QST 2808 Technical for 24 hours and observed 
for the following 14 days. The acute lethal dose (LD)50 is 
greater than 2,000 mg/kg. Classification: Acceptable; Toxicity Category 
III.
    3. Primary eye irritation (OPPTS 870.2400; MRID 452679-01). Three 
male rabbits each were administered 0.1 milliliters (mL) of QST 2808 
Technical in the everted lower lid of one eye and then observed for 72 
hours. Based on the data, QST 2808 Technical showed minimal effects to 
the eye. Classification: Acceptable; Toxicity Category IV.
    4. Acute injection toxicity/pathogenicity (OPPTS 885.3200; MRID 
451366-07). Eighteen male and eighteen female rats each were dosed at 
1.6 x 10\8\ cfu Bacillus pumilus strain QST 2808 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.
    5. Acute pulmonary toxicity/pathogenicity (OPPTS 885.3150; MRID 
451366-06). Eighteen male and eighteen female rats each were 
administered 1.6 x 10\8\ cfu Bacillus pumilus strain QST 2808 Technical 
in a single intratracheal dose 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, B. 
pumilus strain QST 2808 was not toxic, infective, and/or pathogenic to 
rats when dosed at 1.6 x 10\8\ cfu/animal. Classification: Acceptable.
    6. Acute inhalation toxicity (OPPTS 870.1300). Results of the acute 
pulmonary toxicity/pathogenicity (MRID 451366-06) performed with 
Bacillus pumilus strain QST 2808 Technical indicate that it is not 
toxic, infective, and/or pathogenic to rats when dosed at 1.6 x 10\8\ 
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 870.2500; MRID 452679-02). Each 
of three male adult rabbits were treated dermally with 0.5 mL QST 2808 
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 QST 2808 
Technical at 0.5 mL/animal, QST 2808 Technical was essentially non-
irritating. Classification: Acceptable; Toxicity Category IV.
    8. Hypersensitivity incidents (OPPTS 885.3400). The registrant has 
reported no incidents to date. Nonetheless, pursuant to FIFRA section 
6(a)(2), the registrant is required to report to the Agency any future 
incidents of hypersensitivity associated with Bacillus pumilus strain 
QST 2808.
    9. Hypersensitivity study (OPPTS 870.2600; MRID 460295-09). Twenty 
female guinea pigs were dosed on shaved skin once a week for 3 weeks 
with 0.4 mL of QST 2808 Technical. When challenged 14 days after the 
last induction, no signs of sensitization appeared. Acceptable.
    10. Immune response. There is no information to suggest that B. 
pumilus strain QST 2808 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, 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 buildings 
(residential and other indoor uses). Most importantly, there is no 
evidence of adverse effects from oral, dermal, or inhalation exposure 
to this microbial agent. (See Unit III. Toxicological Profile.)

A. Dietary Exposure

    Humans and animals are commonly exposed to B. pumilus strain QST 
2808, a ubiquitous microorganism that inhabits soil. No toxicological 
endpoints were identified for B. pumilus strain QST 2808. The low 
toxicity and non-pathogenicity/infectivity of B. pumilus strain QST 
2808 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 B. pumilus strain QST 2808 
technical demonstrated no pathogenicity or oral toxicity at the maximum 
doses tested, as noted above (Unit III.).
    2. Drinking water exposure. The potential for transfer of B. 
pumilus strain QST 2808 to surface or ground water during run-off 
associated with intended use applications is considered minimal to non-
existent, due 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.

[[Page 63952]]

B. Other Non-Occupational Exposure

    Based on the proposed agricultural and horticultural use patterns, 
the potential for non-dietary exposures to B. pumilus strain QST 2808 
pesticide residues by 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 B. pumilus strain QST 
2808 as a pesticide, should fall well below EPA's currently tested 
microbial safety levels.
    1. Dermal exposure. The potential for dermal exposure to B. pumilus 
strain QST 2808 pesticide residues for the general population, 
including infants and children, is unlikely because potential use sites 
are agricultural and horticultural. However, since B. pumilus strain 
QST 2808 is a naturally occurring bacterium in soil, there is a great 
likelihood of prior exposure for most, if not all individuals. 
Accordingly, the increase in dermal exposure due to pesticidal use of 
B. pumilus strain QST 2808 would be negligible. Furthermore, and as 
demonstrated in Unit III. of this action, the organism is of low dermal 
toxicity, the acute LD50 is greater than 2,000 mg/kg, and 
the QST 2808 Technical was essentially non-irritating (Toxicity 
Category IV). Accordingly, the risks anticipated for this route of 
exposure are considered minimal.
    2. Inhalation exposure. Inhalation exposure to B. pumilus strain 
QST 2808 pesticide residues for the general population, including 
infants and children is unlikely because potential use sites are 
agricultural and horticultural. However, since B. pumilus strain QST 
2808 is a naturally occurring bacterium in soil, there is a great 
likelihood of prior exposure for most, if not all individuals. 
Accordingly, the increase in exposure due to pesticidal use of B. 
pumilus strain QST 2808 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 B. pumilus strain QST 2808. 
(See Unit III.) Accordingly, the risks anticipated for this route of 
exposure are considered minimal.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires the Agency, when 
considering whether to establish, modify, or revoke a tolerance, to 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    These considerations include the possible cumulative effects of 
such residues on infants and children.
    The Agency has considered the potential for cumulative effects of 
B. pumilus strain QST 2808 and other substances in relation to a common 
mechanism of toxicity. B. pumilus strain QST 2808 is practically non-
toxic to mammals. Because no mechanism of pathogenicity or toxicity in 
mammals has been identified for this organism (see Unit III.), no 
cumulative effects from the interaction of residues of this product 
with other related microbial pesticides are anticipated when this 
product is used as directed on the label and in accordance with good 
agricultural practices.

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 B. pumilus strain QST 2808 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, B. pumilus strain QST 2808 is not 
pathogenic or infective and is practically non-toxic to mammals. (See 
Unit III.) 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 by 1) using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans, or 2) using a margin of exposure analysis. 
Due to the ubiquitous nature of B. pumilus strain QST 2808, 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 B. pumilus strain QST 2808 and that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to B. pumilus strain QST 2808 residues. Thus, the 
Agency has determined that the additional margin of safety is not 
necessary to protect infants and children, and that not adding any 
additional margin of safety will be safe for infants and children.

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 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 QST 2808 may be subjected to 
additional screening and/or testing to better characterize effects 
related to endocrine disruption.
    To date, based on available data, the Agency has no information to 
suggest that Bacillus pumilus strain QST 2808 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 indicate 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). 
Thus, there is no

[[Page 63953]]

impact via endocrine-related effects on the Agency's safety finding set 
forth in this final rule for Bacillus pumilus strain QST 2808.

B. Analytical Method(s)

    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 QST 2808'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 QST 2808.

C. Codex Maximum Residue Level

    There is no Codex Alimentarius Commission Maximum Residue Level for 
Bacillus pumilus strain QST 2808.

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) 
of the FFDCA, 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-2004-0215 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 January 
3, 2005.
    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, 1801 S. 
Bell St., 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. 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 ADDRESSES. Mail 
your copies, identified by docket ID number OPP-2004-0215, 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 ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance 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

[[Page 63954]]

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: October 13, 2004.
James Jones,
Director, 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 180.1255 is added to subpart D to read as follows:

Sec.  180.1255  Bacillus pumilus strain QST 2808; Exemption from the 
Requirement of a Tolerance..

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Bacillus pumilus strain QST 2808 
when used in or on all agricultural commodities when applied/used in 
accordance with label directions.

[FR Doc. 04-24250 Filed 11-2-04; 8:45 am]
BILLING CODE 6560-50-S
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