[Federal Register Volume 68, Number 146 (Wednesday, July 30, 2003)]
[Rules and Regulations]
[Pages 44635-44640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19134]


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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: [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 (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 [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 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: [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 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]
BILLING CODE 6560-50-S