[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