[Federal Register Volume 62, Number 149 (Monday, August 4, 1997)]
[Rules and Regulations]
[Pages 41874-41877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20561]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300526; FRL-5735-6]
RIN 2070-AB78


Bacillus Cereus Strain BP01; Exemption From the Requirement of a 
Tolerance.

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.

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SUMMARY: This rule establishes an exemption from the requirement of a 
tolerance for residues of the biological pesticide Bacillus cereus 
strain BP01 for use on cotton. Micro Flo Company, acting through their 
agent SRA International, submitted a petition to EPA under the Federal 
Food, Drug and Cosmetic Act as amended by the Food Quality Protection 
Act of 1996 requesting the tolerance exemption. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus cereus strain BP01 on growing crops.

DATES: This regulation is effective August 4, 1997. Objections and 
requests for hearings must be received by EPA on or before October 3, 
1997.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300526], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
requests filed with the Hearing Clerk identified by the docket control 
number, [OPP-300526], must also be submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections 
and hearing requests must be submitted as an ASCII file avoiding 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 5.1 file format or ASCII file format. All copies 
of electronic objections and hearing requests must be identified by the 
docket number [OPP-300526]. No Confidential Business Information (CBI) 
should be submitted through e-mail. Copies of electronic objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: James J. Boland, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7501W), Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location, telephone number and e-mail address: 5th 
fl., CS #1 2800 Crystal Drive, Arlington, VA 22202, (703) 308-8728, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 25, 1997 (62 
FR 34277)(FRL-5727-1) EPA issued a notice pursuant to section 408(d), 
of the Federal Food Drug & Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), 
announcing the filing of a pesticide tolerance petition by SRA 
International, 1850 M Street NW., Suite 290, Washington DC, 20036, on 
behalf of the Micro Flo Company, P.O. Box 5948, Lakeland Florida 33807-
5948. The notice contained a summary of the petition prepared by the 
petitioner and this summary contained conclusions and arguments to 
support its conclusion that the petition complied with the Food Quality 
Protection Act (FQPA) of 1996. The petition requested that 40 CFR part 
180 be amended by establishing an exemption from the requirement of a 
tolerance for residues of the biological pest control agent Bacillus 
cereus strain BP01 on growing crops.
    There were no comments or requests for referral to an advisory 
committee received in response to the notice of filing.
    The data submitted in the petition and other material have been 
evaluated. The toxicology data requirements in support of this 
exemption from the requirement of a tolerance were satisfied.

I. Risk Assessment and Statutory Findings

    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

[[Page 41875]]

``safe.'' Section 408(c)(2)(ii) 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(c)(2)(B) 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***.'' 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.

II. Toxicological Profile

    Consistent with section 408(b)(2)(D) of 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. Additionally, section 408(b)(2)(D)(v) requires 
that, when considering whether to establish, modify, or revoke a 
tolerance, 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.'' All available 
information indicates that Bacillus cereus strain BP01 when used in 
cotton will have no human toxicity based upon the lack of mammalian 
toxicity of this product and the lack of exposure with the cotton 
growth regulator use pattern. All mammalian toxicology data 
requirements have been submitted and adequately satisfy the 
requirements as set forth in 40 CFR 158.740 for microbial pesticides 
for food, non-food, domestic outdoor and forestry uses. The mammalian 
toxicology data base includes acute toxicity studies. To date, none of 
the active microbial pesticidal ingredients registered by the Agency 
have required subchronic or chronic exposure studies. Also, for food 
uses 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. The results of testing done on 
Bacillus cereus and the end use product Mepichlor/BP01 4-2 agree with 
this.

III. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 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).
    1. Dietary exposure-- a. Food. While the proposed use pattern will 
result in dietary exposure with possible residues on food and feed, 
negligible risk is expected for both the general population and 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 toxicological concerns, the potential 
risks, if any, to humans are considered negligible and 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 applications rates. The application rate is 2 to 24 fl.oz./A 
based on growth stage of the crop and previous application history. In 
considering health risk from microbial pesticides, it is important to 
recognize the ubiquitous nature of microorganisms. Most microorganisms 
are considered to be non-pathogenic for humans, despite the continual 
exposure to high numbers of a myriad of airborne, waterborne, food and 
soil associated microorganisms as well as human and mammalian commensal 
microbes on a daily basis. Bacillus cereus has been implicated in 
nosocomial infections in rare instances and in food poisoning 
incidents. The quality control procedures have ensured that the 
diarrheal enterotoxin is not present in this product. In summary, the 
Agency believes that the potential aggregate exposure, derived from 
dermal and inhalation exposure via mixing, loading and applying 
Bacillus cereus, the oral dietary exposure drinking water containing B. 
cereus strain BP01, should fall well below the currently tested 
microbial safety levels. There have been no confirmed reports of 
immediate or delayed allergic reactions to despite significant oral, 
dermal and inhalation exposure to the microbial product. Therefore, the 
lack of toxicity associated with Bacillus cereus strain BP01, data 
relating to the post application die-off of B. cereus species v 
background soil population counts of naturally occurring microbes 
provides a scientific rationale for exempting B. cereus strain BP01 
from the requirement of a tolerance.
    b. 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. Although the potential exists for a 
minimal amount of the B. cereus strain BP01 which is applied to enter 
ground water or other drinking water sources, the amount would in all 
probability be undetectable or more than several orders of magnitude 
lower than those levels which were tested and are considered necessary 
for safety. Moreover, Bacillus cereus strain BP01 is not considered to 
be a risk to drinking water. Drinking water is accordingly not being 
screened for B. cereus as a potential indicator of microbial 
contamination or as a direct pathogenic contaminant. Both percolation 
through soil and municipal treatment of drinking water would reduce the 
possibility of exposure to B. cereus strain BP01 through drinking 
water. Therefore, the potential of significant transfer to drinking 
water is minimal to nonexistent.
    2. Other non-occupational exposures. All mammalian toxicology data 
requirements have been submitted and adequately satisfy the 
requirements as set forth in 40 CFR 158.740 for microbial pesticides 
for food, non-food, domestic outdoor and forestry uses. The mammalian 
toxicology data base includes acute toxicity studies. Based on the use 
sites, use patterns, application method, use rates, low exposure, and 
lack of significant toxicological concerns, as demonstrated in the 
submitted toxicology studies, the potential risks, if any, to humans 
are considered negligible.
    a. Dermal exposure. Exposure via the skin would be the primary 
route of exposure for mixer/loader applicators. Since 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. 
Based on the application methods, the potential for dermal

[[Page 41876]]

exposure exists for pesticide handlers and applicators. The Agency is 
requiring the appropriate signal word and statements of precaution.
    b. Inhalation Exposure. Inhalation would be the primary route of 
exposure for mixer/loader applicators. The pulmonary study showed no 
adverse effects; the risks anticipated for this route of exposure are 
considered minimal.

IV. Safety Factors

    The toxicity of Bacillus sp. is well established. No tolerance is 
needed since the proposed uses do not include food/feed uses. The 
information submitted to support the acute toxicity waiver requests, 
supplemented by available public data, indicate category IV for acute 
oral toxicity, category III for acute dermal toxicity, category III for 
primary eye irritation, category IV for primary dermal irritation, and 
that Bacillus cereus strain BP01 is not a dermal sensitizer. Bacillus 
cereus has been implicated in nosocomial infections in rare instances 
and in food poisoning incidents. The quality control procedures have 
ensured that the diarrheal enterotoxin is not present in this product.

V. Infants and Children

    Consistent with section 408(b)(2)(C) of the FFDCA, EPA has assessed 
the available information about consumption patterns among infants and 
children, special susceptibility of infants and children to pesticide 
chemical residues and the cumulative effects on infants and children of 
the residues and other substances with a common mechanism of toxicity. 
A battery of acute toxicity/pathogenicity studies is considered 
sufficient by the Agency to perform a risk assessment for microbial 
pesticides. To date, none of the active microbial pesticidal 
ingredients registered by the Agency have required subchronic or 
chronic exposure studies. Also, for food uses 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. The results of testing done on B. cereus strain 
BP01 and Mepichlor/ BP01 4-2 agree with this. Quality control 
procedures in place during manufacturing ensure that harmful levels of 
contaminating microorganisms are prevented and the mammalian 
enterotoxin is not present. In considering health risk from microbial 
pesticides, it is important to keep the ubiquitous nature of 
microorganisms in mind. Most microorganisms are considered to be non-
pathogenic for humans, despite the continual exposure to high numbers 
of a myriad of airborne, waterborne, food and soil associated 
microorganisms, as well as human and mammalian commensal microbes, on a 
daily basis.

VI. Other Considerations

    1. Endocrine disrupters. There is no known metabolite that acts as 
an ``endocrine disrupter'' produced by this microorganism. As expected 
from non-pathogenic microorganism, the submitted toxicity/pathogenicity 
studies in the rodent (required for microbial pesticides) indicate that 
following several routes of exposure, the immune system is still intact 
and able to process and clear the active ingredient. Therefore, no 
adverse effects to the endocrine or immune systems are known or 
expected. The Agency is not requiring information on the endocrine 
effects of this biological pesticide at this time; Congress has allowed 
3 years after August 3, 1996, for the Agency to implement a screening 
program with respect to endocrine effects.
    2. Analytical method. The Agency proposes to establish an exemption 
from the requirement of a tolerance without any numerical limitation; 
therefore, the Agency has concluded that an analytical method is not 
required for enforcement purposes for Bacillus cereus strain BP01.

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

    For the U.S. population, including infants and children, the Agency 
has not identified any subchronic, chronic, immune, endocrine, dietary, 
or nondietary exposure issues as they may affect infants and children 
and the general population. Risks to applicators are mitigated when the 
product is used according to label directions. Therefore, EPA concludes 
that there is reasonable certainty that no harm will result to the U.S. 
population from aggregate exposure to residues of Bacillus cereus BP01 
microbial plant growth regulator including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion because, as 
discussed above, no toxicity to mammals has been observed for Bacillus 
cereus strain BP01. Thus, a tolerance for Bacillus cereus strain BP01 
is not necessary to protect the public health. Therefore, 40 CFR part 
180 is amended as set forth below.

VIII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d) as 
was provided in the old section 408 and in section 409. However, the 
period for filing objections is 60 days, rather than 30 days. EPA 
currently has procedural regulations which govern the submission of 
objections and hearing requests. These regulations will require some 
modification to reflect the new law. However, until those modifications 
can be made, EPA will continue to use those procedural regulations with 
appropriate adjustments to reflect the new law.
    Any person may, by October 3, 1997, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
hearing clerk, at the address given under the ``Addresses'' section (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the hearing clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). 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). 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). 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

[[Page 41877]]

may be disclosed publicly by EPA without prior notice.

IX. Public Docket

    A record has been established for this rulemaking under docket 
control number [OPP-300526]. A public version of this record, which 
does not include any information claimed as CBI, is available for 
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA 22202.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing request, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the Virginia address in 
Addresses at the beginning of this document.

X. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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). 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) (Pub. L. 104-4). Nor does it require any 
prior consultation as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993), or special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), 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. Nevertheless, the Agency previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

XI. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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: July 30, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.C.C. 346a and 371

    2. Section 180.1181 is added to read as follows:


Sec. 180.1181  Bacillus cereus strain BP01; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial plant regulator Bacillus cereus strain BP01 
in or on cottonseed.

[FR Doc. 97-20561 Filed 8-1-97 ; 8:45 am]
BILLING CODE 6560-50-F