[Federal Register Volume 67, Number 224 (Wednesday, November 20, 2002)]
[Rules and Regulations]
[Pages 70012-70017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29331]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0291; FRL-7277-3]


Bacillus Cereus Strain BPO1; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Bacillus cereus strain BPO1 on raw 
and processed food when applied/used as a

[[Page 70013]]

foliar applied biological plant growth regulator intended to promote 
root mass growth, earlier fruit initiation, increased fruit retention, 
and increased nutrient utilization. Micro Flow Company 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. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of Bacillus cereus strain BPO1.

DATES: This regulation is effective November 20, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0291, 
must be received on or before January 21, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, 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] Industry (NACIS 111, 112, 311, 32532), e.g., Crop 
Production, Animal Production, Food Manufacturing, Pesticide 
Manufacturing.
    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 ID number OPP-2002-0291. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of November 21, 2001 (66 FR 58481) (FRL-
6802-1), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a(e), as amended by FQPA (Public Law 104-170), announcing the 
filing of a pesticide tolerance petition (PP 1F6324) by Micro Flow 
Company, P.O. Box 5948 Lakeland, FL 33807-5948. This notice included a 
summary of the petition prepared by the petitioner Micro Flow Company. 
There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.1181 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Bacillus cereus strain BPO1.

III. Risk Assessment

    New 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 tolerance 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 of the FFDCA (b)(2)(C) 
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.

IV. 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.
    Acute mammalian toxicity/pathogenicity studies via oral, dermal, 
inhalation, eye, intratracheal, and

[[Page 70014]]

intravenous routes were conducted with Bacillus cereus strain BPO1. No 
pathogenicity was observed. BPO1 was also tested for entero toxin 
emetic-toxin production; no toxins were detected. Bacillus cereus has 
been implicated in nosocomial infections in rare instances and in food 
poisoning incidents. In the ELISA Analysis of Enterotoxin data 
submitted, there was no evidence of diarrhoeal type enterotoxin 
production in the culture filtrates of Bacillus cereus strain BOP1 or 
the end use product. In a blood agar hemolysis assay conducted with 
BPO1, weak alpha hemolysis was observed. Based on the results of the 
studies in this unit, subchronic, reproductive, teratology, chronic, 
and mutagenicity studies were not deemed necessary.
    1. Acute oral toxicity/pathogenicity (OPPTS 870.1100; 152A-10 and 
152B-10; MRIDs 4417737-05 and 441773-06). In the acute oral toxicity 
test, five male and five female rats were treated with a split dose, 
(10 milliliters/kilograms/dose) (mL/kg) for a total of 5,000 milligrams 
(mg)/kg of Bacillus cereus strain BP01; the second dose administered 1 
hour after the first dose. Rats were weighed and observed for mortality 
or abnormalities for 14 days. No abnormalities were noted in body 
weight or weight gain throughout the study or upon necropsy. The oral 
lethal dose (LD)50 Bacillus cereus strain BP01 was 
determined to be greater than 5,000 mg/kg body weight.
    In the acute oral toxicity/pathogenicity test, 15 males and 15 
females received a dose of 1.23 x 108 colony forming units 
(CFU) of the test substance by oral gavage; nine males and nine females 
were treated with 1.23 x 108 CFU killed test substance (by 
steam sterilization). Rats were weighed on days 0, 3, 7, 14, and 18 and 
signs of toxicity were observed daily. Randomly sampled rats from each 
sex and each test group were sacrificed on days 0, 3, 7, 14, and 18 and 
examined for any macroscopic abnormalities. Samples of the kidneys, 
liver, spleen, and stomach as well as feces were homogenized and plated 
to determine the number of typical Bacillus cereus colonies after 
incubation at 30 0C for at least 18 hours. No clinical sign 
were noted throughout the study and no abnormalities were noted in any 
animal at necropsy. Two males displayed a loss in body weight from day 
0 to 3 and five females lost weight from day 7 to 14. No other 
abnormalities were noted in body weights or weight gain. Bacillus 
cereus strain BP01 is not toxic, pathogenic or infective when 1 x 
108 CFU was administered orally. A distinct clearance 
pattern was observed throughout the study.
    2. Acute dermal toxicity (OPPTS 870.1200; 152A-11; MRID 441773-07). 
Five male and five female rabbits were given a dose of 4.4 x 
1010 CFU (2 grams (g)) dermally for 24 hours and observed 
after dosing for signs of toxicity and dermal irritation for 14 days. 
No clinical signs, except dermal irritation, were noted during the 
study and no abnormalities were noted upon necropsy. Two males and five 
females displayed a loss in body weight from day 0 to day 7. All 
animals displayed a weight gain through the end of the study. All males 
and females showed slight to well defined redness through day 4; very 
slight erythema was present in up to three males and three females 
through day 11. Dermal irritation was no longer apparent by day 12. 
Slight signs of edema were apparent in two males on day 3. Edema was no 
longer present by day 4. The LD50 of Bacillus cereus strain 
BP01 is greater than 2 grams per animal. Mild to moderate dermal 
irritation was noted and was no longer present by day 13.
    3. Acute intratracheal toxicity/pathogenicity (OPPTS 885.3150; 
152A-12; MRID 441773-08). Fifty female and fifty male rats received a 
single dose of 7 x 107 (males), or 9.33 x 107 CFU 
(females) of the test substance in a volume of 0.5 mL by intratracheal 
administration; fifty females and fifty males were treated with the 
same concentration of killed test substance (by steam sterilization); 
an additional fifty males and fifty females served as controls. Rats 
were weighed weekly and observed for signs of toxicity daily. Ten rats 
of each sex from each group were sacrificed on days 0, 7, 14, 21, and 
36. Animals were examined for macroscopic abnormalities by necropsy. 
Lungs were evaluated by histopathological examination. Samples of the 
kidneys, liver, spleen, brain, mesenteric lymph nodes, blood, lungs, 
and caecum were homogenized, plated, and incubated for at least 18 
hours then examined for typical Bacillus cereus colonies. Body weight 
losses were noted in females from the test substance group, one during 
the first, second and third weeks. No other abnormalities were noted in 
body weight or weight gain throughout the study. In the group treated 
with the test substance, three females displayed a rough hair coat, two 
females showed signs of labored respiration, and one female had hunched 
posture on day 0. Clinical signs were no longer apparent by day 2. Each 
treatment group had three males and females displaying mottled, dark 
red lungs on day 0. Red to tan lesions remained on the majority of 
animals through day 21. Bacillus cereus strain BP01 is not toxic, 
pathogenic or infective to rats at an intratracheal dose of either 7 x 
108 or 9.33 x 108 CFU. A slow but typical 
clearance pattern was observed; slow clearance in the lung with 
distinct clearance pattern noted in the liver and spleen. The lesions 
present in the histopathology sections in both the killed and live test 
substance animals indicate an inflammatory response to the treatment 
due to the presence of particulate material.
    4. Acute intravenous toxicity (OPPTS 885.3200; 152A-13; MRID 
441773-09). Five male and five female rates were intravenously injected 
with either 0.5 mL of Bacillus cereus, 0.5 mL of the killed test 
substance, or kept as a naive control. The rats were weighed before 
initial dosing and weekly thereafter. Animals were observed for 
clinical signs twice daily for 14 days. All rats were examined by 
necropsy for any macroscopic abnormalities at the end of the study. One 
female displayed a loss in body weight from day 0 to day 17. No other 
abnormalities were noted in body weight or weight gain throughout the 
study. No clinical signs were reported by the testing facilty and no 
abnormalities were noted upon necropsy. Although Bacillus cereus strain 
BP01 is not toxic to rats at an intravenous dose of 2.0 x 
107 CFU, the registrant failed to submit the clearance 
portion of the study. However, this study does not need to be repeated 
because the oral and intratracheal studies demonstrated distinct 
clearance patterns.
    5. Primary eye irritation (OPPTS; 870.2400; 152A-14; MRID 441773-
10). Three male and three female, young adult, New Zealnad White 
rabbits were given a single dose of 0.1g (equivalent to 2.2 x 
109 CFU) of the microbial pest control agent (MPCA) in the 
everted lower right eyelid of each animal. The eye was gently held 
together for 2 seconds to prevent a loss of material. The left eye 
served as the control for each animal. The Draize Method was used to 
score ocular irritation and lesions at 1 hour, and 1, 2, 3, 4, and 7 
days post dosing. A 2% fluorescein solution and ultraviolet light was 
used after 24 hours to evaluate corneal epithelial damage. Slight to 
moderate redness, chemosis, and occasional discharge was observed in 
all 6 animals within 1 hour post dosing. Clinical signs were no longer 
apparent by day 3. No abnormalities were observed in any control eye 
during the study. The primary irritation scores at 24 hours post dosing 
was 4.8 when a 0.1g (2 x 109 CFU) ocular dose was 
administered.

[[Page 70015]]

 Ocular irritation was no longer present by day 3.
    6. Immunotoxicity (OPPTS 880.3800). Immune response, 
teratogenicity, virulence enhancement, and mammalian mutagenicity (40 
CFR 158.740(c)(2)(vi) through (xv), were not required since survival, 
replication, infectivity, toxicity, or persistence of the microbial 
agent was not observed in the test animals treated in the Tier I 
infectivity tests.
    7. Hypersensitivity (OPPTS 870.2600; 152-15). Incidents of 
hypersensitivity must be reported to the Agency in a timely manner. 
There have been no reports of incidents of hypersensitivity to Bacillus 
cereus since it was registered.

V. 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

    1. Food. While the suggested use pattern may result in dietary 
exposure with possible residues on food and feed, negligible risk is 
expected for both the general population, infants and children. 
Submitted acute toxicology tests confirm that based upon the use sites, 
use patterns, application method, use rates, low exposure, and lack of 
significant toxicology concerns, the potential risks, if any, to humans 
are considered negligible, therefore an exemption from the requirement 
of a tolerance is warranted. Acute exposure could occur from the 
proposed outdoor use sites but would be very low because of the low 
application rates of less than 48 fluid ounces of BP01/acre/year in 
cotton and less than 32 fluid ounces of BP01/acre/year in soybean. 
Considering the low application rates, lack of toxicity/pathogenicity, 
ubiquitous nature and natural occurrence of Bacillius cereus, no 
residue data were required.
    2. Drinking water exposure. The microorganism Bacillus cereus is 
ubiquitous in many soils throughout the world. Bacillus cereus is not 
known as an aquatic bacterium and therefore is not expected to 
proliferate in aquatic habitats. The potential exists for Bacillus 
cereus strain BPO1 to enter ground water or other drinking water 
sources, after application. Both percolation through soil and municipal 
treatment of drinking water would reduce the possibility of exposure to 
Bacillus cereus through drinking water. Moreover, Bacillus cereus 
strain BPO1 is not considered to be a risk to drinking water. The 
Agency has no drinking water exposure concerns, because exposure is 
minimal to non-existent and the demonstrated lack of toxicity or 
pathogenicity for the Bacillus cereus Strain BP01 microbe.

B. Other Non-Occupational Exposure

    The potential of non-dietary exposures to Bacillus cereus strain 
BPO1 pesticide residues for the general population, including infants 
and children, is unlikely since this is only an agricultural use 
pesticide. The Agency believes that the potential aggregate exposure, 
derived from dermal and inhalation exposure via mixing, loading, and 
applying Bacillus cereus strain BPO1, should fall well below the 
currently tested microbial safety levels.
    1. Dermal exposure. Dermal exposure via the skin would be the 
primary route of exposure for mixer/loader applications. 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. 
Submitted acute dermal toxicity data confirmed a lack of dermal 
toxicity and mild to moderate dermal irritation was only observed until 
day 13 of the study.
    2. Inhalation exposure. Inhalation would be the primary route of 
exposure for mixer/loader applications. Because the pulmonary study 
showed no adverse effects, the risks anticipated for the route of 
exposure are considered minimal.

VI. 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 this, the Agency is confident that there will not 
be cumulative effects from the registration of this product

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

    1. U.S. population. There is a reasonable certainty that no harm 
will result from aggregate exposure to the U.S. population from 
exposure to Bacillus cereus. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion based on the 
very low levels of mammalian toxicity (no toxicity at the maximum doses 
tested, Toxicity Categories III and IV for irritation) associated with 
Bacillus cereus strain BP01 and the history of safe use of Bacillus 
cereus.
    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 database 
unless EPA determines that a different margin of exposure (safety) will 
be safe for infants and children. Margins of exposure (safety) are 
often referred to as uncertainty (safety) factors. A battery of acute 
toxicity/pathogenicity studies is considered sufficient by the Agency 
to perform a risk assessment for microbial pesticides. Other strains of 
Bacillus cereus have been implicated in nosocomial infections in rare 
instances and in food poisoning incidents. In the ELISA Analysis of 
Enterotoxin test data submitted there was no evidence of diarrhoeal 
type enterotoxin production in the culture filtration of Bacillus 
cereus strain BPO1 or the end use product. Data relating to the post 
application die off of Bacillus cereus species vs. background soil 
population counts demonstrated that this organism is very stable in the 
soil and rhizosphere. 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 is appropriate 
and adequate to protect human health, including that of infants and 
children.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA is required under 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

[[Page 70016]]

scientific basis for including, as part of the 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 cereus 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 cereus strain BP01. It is 
a naturally occurring bacteria. To date, there is no evidence to 
suggest that Bacillus cereus affects the immune system, functions in a 
manner similar to any known hormone, or that it acts as an endocrine 
disruptor.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation based upon the lack of 
mammalian toxicity of Bacillus cereus and the lack of exposure with the 
plant growth regulator use pattern. For the same reasons, the Agency 
has concluded that an analytical method is not required for enforcement 
purpose for Bacillus cereus.

C. Codex Maximum Residue Level

    There are no Codex harmonization consideration since there is 
currently no codex tolerance for Bacillus cereus residues.

IX. 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-2002-0291 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 
21, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by telephone 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-2002-0291, 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

[[Page 70017]]

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).

X. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the exemption in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications '' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XI. Submission to Congress and the Comptroller General

    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 31, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.1181 is revised to read as follows:


Sec.  180.1181  Bacillus cereus strain BPO1; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance for residues of 
the Bacillus cereus strain BPO1 in or on all raw agricultural 
commodities when applied/used in accordance with label directions.
[FR Doc. 02-29331 Filed 11-19-02; 8:45 am]
BILLING CODE 6560-50-S