FR Doc 03-19134

[Federal Register: July 30, 2003 (Volume 68, Number 146)]
[Rules and Regulations]
[Page 44635-44640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy03-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0059; FRL-7309-8]

Bacillus subtilis var. amyloliquefaciens strain FZB24; 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 subtilis var.
amyloliquefaciens strain FZB24 on all agricultural commodities when
applied/used in accordance with good agricultural use practices for
plant strengthening, growth enhancement, and plant disease suppression.
Earth BioSciences 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

[[Page 44636]]

the requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Bacillus subtilis
var. amyloliquefaciens strain FZB24.

DATES: This regulation is effective July 30, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0059,
must be received on or before September 29, 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 IX. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Robyn Rose, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9581; e-mail address: rose.robyn@epa.gov.
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
[sbull] Antimicrobial pesticides (NAICS 32561)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I 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-2003-0059. The
official public docket is intended to serve as a repository for
materials (i.e., documents and other information) submitted to the
Agency in connection with this action and/or relied upon by the Agency
in taking 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 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. To the extent that a particular document is not located in the
official public docket, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
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.
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. Once in the system, select ``search,''
then key in the appropriate docket ID number.

II. Background and Statutory Findings

In the Federal Register of October 22, 2002 (67 FR 32231) (FRL-
7275-7), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a(d), as amended by FQPA (Public Law 104-170), announcing the
filing of a pesticide tolerance petition (PP 2F06453) by Earth
BioSciences, 451 Orange St, New Haven, CT 06511. This notice included a
summary of the petition prepared by the petitioner Earth BioSciences.
There were no comments received in response to the Notice of Filing.
The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Bacillus subtilis var. amyloliquefaciens strain FZB24.
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. 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.
Earth BioSciences, formerly Taensa, Inc., conducted the toxicology
studies required under section 408(d)(2)(A) of the FFDCA to support its
petition for an exemption from the requirement of tolerance for
Bacillus subtilis var. amyloliquefaciens strain FZB24. As illustrated
below, the studies conducted indicate a low mammalian toxicity for
Bacillus subtilis var. amyloliquefaciens strain FZB24. In addition, no
pathogenicity or infectivity was observed in any of the tests conducted
with Bacillus subtilis var. amyloliquefaciens strain FZB24. All
toxicology data generated by Earth

[[Page 44637]]

BioSciences have been reviewed by the Biopesticides and Pollution
Prevention Division (``BPPD'').
Toxicology data in support of the exemption from the requirement of
a tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24
included studies with spores (technical) and with the formulated
product (water dispersible powder) as follows:
1. Acute toxicity and/or pathogenicity--i. Bacillus subtilis var.
amyloliquefaciens strain FZB24 Spores (Technical):
[sbull] Acute oral toxicity/pathogenicity in rats. ``. . . does not
appear to be toxic and/or pathogenic in rats when dosed at 1.3 x
10⁸ cfu.'' BPPD Review of Product Chemistry and Toxicity/
Pathogenicity Data Submitted by Taensa, Inc., for the Registration of
TAE-022 and TAE-022 WDG, which contains Bacillus subtilis var.
amyloliquefaciens strain FZB24 (Submission No.: S559221; DP Barcode:
254584; Master Record Identification (MRID) No's.: 447581-01 through
447581-20) (hereinafter referred to as ``BPPD Review - December 20,
1999'').
[sbull] Acute dermal toxicity/pathogenicity in rabbits. ``The
severity of irritation persisted 72 hours, and slight irritation
persisted for 10 days, and all resolved by day 11. No deaths observed.
The acute lethal dose (LD50) is greater than 2,000 mg/kg . .
. Dermal Toxicity = Toxicity III.'' (BPPD Review - December 20, 1999).
[sbull] Acute inhalation toxicity in rats. ``The inhalation
LC50 for males, females, and combined was > 0.93 mg/L.
Toxicity Category III.'' (Submission No.: S616797; DP Barcode: 283473;
MRID No's.: 456725-01 and 456725-02) (hereinafter referred to as ``BPPD
Review - April 25, 2002'')
[sbull] Acute pulmonary toxicity/pathogenicity in rats. ``. . .
does not appear to be toxic and/or pathogenic in rats, when dosed at
1.3 x 10⁸ cfu/animal. No total clearance is seen form the
lungs of treated test animals . . . showed a distinct pattern of
clearance from kidney, liver, and spleen.'' (BPPD Review - December 20,
1999).
[sbull] Acute intravenous toxicity/pathogenicity in rats. ``. . .
does not appear to be toxic and/or pathogenic in rats, when dosed at
1.7 x 10⁸ cfu/animal.'' (BPPD Review - December 20, 1999).
[sbull] Primary eye irritation. ``. . . showed no signs of
persistent irritation into day 21, when dosed at 4.7 x 10¹⁰
cfu/right eye/animal.'' (BPPD Review - December 20, 1999.) The December
20, 1999 BPPD review indicated Toxicity Category I, but was amended in
a March 7, 2000 review to Toxicity Category II based on a comparison of
test animals showing similar recovery trends and leading to
reversibility within 21 days. Addendum to Toxicity Category for TAE-
022, which contains Bacillus subtilis var. amyloliquefaciens Strain
FZB24 (Submission No.: S559221; DP Barcode: 254584; MRID No.: 447581-
14).
[sbull] Primary dermal irritation. ``. . . severity of irritations
persisted >72 hours, but resolved by day 11. Dermal irritation =
Toxicity II.'' (BPPD Review - December 20, 1999).
[sbull] Hypersensitivity testing. ``Based on the submitted data . .
. does not appear to be a sensitizer when dosed at 3.6 x
10¹⁰ cfu.'' (BPPD Review - December 20, 1999).
[sbull] Hypersensitivity incident reporting. ``No recorded or
reported hypersensitivity reaction . . . based on handling MCPA in lab
control setting, equating to 55 person years. . .'' (BPPD Review -
December 20, 1999).
[sbull] Immune response. ``There is no information to suggest that
Bacillus subtilis var. amyloliquefaciens strain FZB24 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.'' (BPPD Review - December 20, 1999).
[sbull] Potential health effects. ``Based on information given,
there are no apparent negative effects . . . Cited literature on B.
subtilis indicate and/or support the development as a biological
control. . .'' (BPPD Review - December 20, 1999).
[sbull] Growth parameters. ``. . . is shown to grow at all tested
temperatures (e.g., 30, 34, 37, and 50 [deg]C). The enumeration shows a
low 4.2 x 10¹¹ cfu/g at 37 [deg]C to a high 6.0 x
10¹¹ cfu/g at 34 [deg]C.'' (BPPD Review - December 20,
1999).
ii. Bacillus subtilis var. amyloliquefaciens strain FZB24 WDG
(Formulation):
[sbull] Acute oral LD50 toxicity in rats. ``Toxic/limit
dose . . . is greater than 2.8 g/kg body weight (6.7 x 10¹⁰
cfu/kg). . . Toxicity Category III.'' (BPPD Review - December 20,
1999).
[sbull] Acute dermal LD50 toxicity in rats. ``The
severity of irritation persisted >72 hours, but resolved by day 11. No
deaths observed. The acute dose (LD50) is greater than 2,000
mg/kg. . . . Dermal irritation = Toxicity Category II; Dermal Toxicity
= Toxicity Category III.'' (BPPD Review - December 20, 1999).
[sbull] Acute inhalation lethal concentration (LC50)
toxicity in rats (Formulation). ``. . . an acute inhalation medium
(LC50) in male and female rats is greater than 0.93 mg/L . .
. Toxicity Category III.'' (BPPD Review - April 25, 2002)
[sbull] Primary eye irritation. ``No corneal opacity, and no signs
of irritation by day 7, when dosed . . . at 3.6 x 10¹⁰ cfu/
right eye/animal. . . . Toxicity Category III.'' (BPPD Review -
December 20, 1999).
[sbull] Hypersensitivity. ``Not a sensitizer when dosed at 3.6 x
10¹⁰ cfu. No hypersensitivity incidents have been
reported.'' (BPPD Review - December 20, 1999).
Based on the data generated in accordance with the Tier I data
requirements set forth in 40 CFR 158.740(c), the Tier II and Tier III
data requirements were not triggered and, therefore, not required in
connection with this action.

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).

A. Dietary Exposure

Bacillus subtilis var. amyloliquefaciens strain FZB24 is a
naturally-occurring microorganism and widespread in the environment.
The low toxicity and non-pathogenicity/infectivity of Bacillus subtilis
var. amyloliquefaciens strain FZB24 is demonstrated by the data
summarized in this action. The end-use (formulated) product will be
applied to all agricultural commodities as a seed treatment and via
incorporation, drenching, spraying, dipping, chemigation and
hydroponics.
1. Food. While the proposed use pattern may result in dietary
exposure with possible residues on all agricultural commodities,
negligible risk is expected for the general population, as well as for
infants and children. Submitted acute toxicology tests (MRID Numbers
447581-08, 447581-09, 447581-10, 447581-11, 447581-12, 447581-13,
447581-14, 447581-16, and 456725-02) demonstrate that based upon the
use sites, use patterns, application method, use rates, low exposure,
and minimal risk of toxicity, the potential risks from dietary exposure
for both the general population and infants and children are considered
low.
2. Drinking water exposure. Although Bacillus subtilis var.
amyloliquefaciens strain FZB24 spores may be found naturally in water,
it is not known as an aquatic bacterium, and therefore is not expected
to proliferate in aquatic

[[Page 44638]]

habitats. (Earth BioSciences petition from the requirement of a
tolerance for Bacillus subtilis var.amyloliquefaciens strain FZB24,
dated May 3, 2002.) In addition, the potential for transfer of Bacillus
subtilis var. amyloliquefaciens strain FZB24 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. Most importantly, though, the risk from
consumption of drinking water containing Bacillus subtilis var.
amyloliquefaciens strain FZB24 is considered minimal as there is no
evidence of adverse effects from oral, dermal, or inhalation exposure
to this microbial agent. (See Unit III.) Accordingly, it is not
considered to be a risk to drinking water.

B. Other Non-Occupational Exposure

Based on the proposed use patterns, the potential of non-dietary
exposures to Bacillus subtilis var. amyloliquefaciens strain FZB24
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 subtilis var.
amyloliquefaciens strain FZB24, should fall well below the currently
tested microbial safety levels. (MRID Numbers 447581-10, 447581-11,
447581-12, and 456725-02).
1. Dermal exposure. Dermal exposure via the skin is a potential
route of exposure resulting from applications of Bacillus subtilis var.
amyloliquefaciens strain FZB24. Unbroken skin is a natural barrier to
microbial invasion of the human body. Dermal absorption could occur
only if the skin were cut, if the microbe were a pathogen equipped with
mechanisms for entry through or infection of the skin, or if
metabolites were produced that could be dermally absorbed. Acute dermal
toxicity/pathogenicity data resulted in irritation that persisted 72
hours, and slight irritation persisted for 10 days, and all resolved by
day 11. No deaths were observed. The acute lethal dose
(LD50) is greater than 2,000 mg/kg. (BPPD Review - December
20, 1999). Accordingly, the risks anticipated for this route of
exposure are considered minimal.
2. Inhalation exposure. Inhalation would be an additional potential
route of exposure resulting from applications of Bacillus subtilis var.
amyloliquefaciens strain FZB24. However, because the pulmonary study
showed no adverse effects (MRID Numbers 447581-12 and 456725-02) the
risks anticipated for this route of exposure are considered minimal.

V. Cumulative Effects

The Agency has considered available information on the cumulative
effects of such residues and other substances that have a common
mechanism of toxicity. These considerations included the cumulative
effects on infants and children of such residues and other substances
with a common mechanism of toxicity. Because there is no indication of
mammalian toxicity to Bacillus subtilis var. amyloliquefaciens strain
FZB24, the Agency is confident that there will not be cumulative
effects from the residues of this product on all agricultural
commodities. (See Unit III.)

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

1. U.S. population. Bacillus subtilis var. amyloliquefaciens strain
FZB24 is a naturally occurring microorganism and Bacillus subtilis var.
amyloliquefaciens is widespread in the environment. Based on the very
low levels of mammalian toxicity associated with Bacillus subtilis var.
amyloliquefaciens strain FZB24, which is demonstrated by the data
summarized above, and the history of safe use of B. subtilis, the
Agency has concluded that there is a reasonable certainty that no harm
will result from aggregate exposure to residues of Bacillus subtilis
var. amyloliquefaciens strain FZB24 to the U.S. population. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. Accordingly, exempting Bacillus
subtilis var. amyloliquefaciens strain FZB24 from the requirement of a
tolerance should be considered safe and pose no significant risk.
2. Infants and children. 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. 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 subtilis var. amyloliquefaciens strain FZB24 and
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to Bacillus subtilis var.
amyloliquefaciens strain FZB24 residues. Also, for food use of
microbial pesticides, the acute toxicity/pathogenicity studies have
allowed for the conclusion that an exemption from the requirement of a
tolerance for Bacillus subtilis var. amyloliquefaciens strain FZB24 is
appropriate and adequate to protect human health, including that of
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 Federal
Insecticide, Fungicide, and Rodenticide Act (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 subtilis var. amyloliquefaciens strain FZB24 may be subjected
to additional screening and/or testing to better characterize effects
related to endocrine disruption.
Based on available data, no endocrine system-related effects have
been identified with consumption of Bacillus subtilis var.
amyloliquefaciens strain FZB24. It is a naturally occurring bacteria
that is widespread in the environment. To date, there is no evidence to
suggest that Bacillus subtilis var. amyloliquefaciens strain FZB24

[[Page 44639]]

affects the immune system, functions in a manner similar to any known
hormone, or that it acts as an endocrine disruptor.

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 subtilis var. amyloliquefaciens strain
FZB24'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 subtilis var. amyloliquefaciens strain FZB24.

C. Codex Maximum Residue Level

There are no Codex maximum residue levels established for residues
of Bacillus subtilis var. amyloliquefaciens strain FZB24.

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 written objections and hearing requests with the
Hearing Clerk 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-2003-0059 in the subject line on the
first page of your submission. All objections and hearing requests must
be in writing, and must be mailed or delivered to the Hearing Clerk on
or before September 29, 2003.
1. Filing the request. Your objections 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 tompkins.jim@epa.gov,
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 IX.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-2003-0059, 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: opp-docket@epa.gov. 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 tolerance
requirement for Bacillus subtilis var. amyloliquefaciens strain FZB24
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

[[Page 44640]]

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 from the tolerance
requirement 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 20, 2003.
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), 346(a) and 371.

0
2. Section 180.1243 is added to subpart D to read as follows:

Sec. 180.1243 Bacillus subtilis var. amyloliquefaciens strain FZB24;
exemption from the requirement of a tolerance.

An exemption from the requirement of a tolerance for residues of
the Bacillus subtilis var. amyloliquefaciens strain FZB24 in or on all
agricultural commodities when applied/used in accordance with label
directions.
[FR Doc. 03-19134 Filed 7-29-03; 8:45 am]

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