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Bacillus sphaericus - Tolerance Requirement Exemption 8/98

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300701; FRL-6024-2]
RIN 2070-AB78
Bacillus Sphaericus; 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 Bacillus sphaericus in or on all food
commodities when applied/used in or on all food crops. Abbott
Laboratories submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act as amended by the Food Quality Protection Act of 1996
(Pub. L. 104-170) requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Bacillus sphaericus.

DATES: This regulation is effective September 11, 1998. Objections and
requests for hearings must be received by EPA on or before November 10,
1998.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300701], 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) 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-300701], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), 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. 119,
Crystal Mall #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: opp-docket@epamail.epa.gov. 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 5.1/6.1 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300701]. 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: Willie H. Nelson, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number and e-mail address: 9th
fl., Crystal Mall #2 1921 Jefferson Davis Hwy., Arlington, VA 22202,
(703)308-8682 e-mail: Nelson.Willie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 22, 1997
(62 FR 44687) (FRL-5737-8), EPA issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide tolerance petition by Abbott
Laboratories, Sheridan Road, North Chicago, Illinois, 60064. This
notice included 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 Bacillus sphaericus.
    There were no comments received in response to the notice of
filing. the data submitted in the petition and all relevant material
have been evaluated.

I. Risk Assessment and Statutory Findings

    New section 408(b)(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(b)(2)(A)(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

[[Page 48595]]

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)
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 us 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.
    All available information and data submitted by Abbott Laboratories
in support of the pesticide petition (PP 7F4822) have been reviewed,
and indicate that there is a reasonable certainty that no harm will
result from residues of Bacillus sphaericus because of its ubiquitous
nature and its low mammalian toxicity. The toxicological data submitted
with the petition demonstrate a lack of human health issues and fully
supports the exemption from the requirement of a tolerance. The
toxicological data submitted in support of the petition were as
follows:
    1. An acute oral toxicity/pathogenicity study - was conducted with
Bacillus sphaericus technical material in rats. An oral dose of
approximately 1 x 108  colony forming units (CFUs)
administered to rats resulted in rapid clearance during the 20-day
post-treatment observation period. A pattern of clearance during the
49-day post-treatment period was established following an intratracheal
installation pf approximately 1 x 108 CFUs. Similarly, a
pattern of clearance over a 35-day post-treatment period was observed
following an intravenous dose of approximately 1 x 107 CFUs.
There were no mortalities, no evidence of pathogenicity or treatment-
related toxicity in rats given either an oral, intratracheal or
intravenous dose.
    2. An acute oral toxicity study - done on Bacillus sphaericus
technical material caused no death in rats given a dose of 5,000
milligram/kilograms (mg/kg); therefore, the acute oral LD50
was greater than 5,000 mg/kg.
    3. Acute dermal LD50 - no mortality in rabbits over the
14-day period observation period following a 2,000 mg/kg dermal
application for 24 hours; thus, the acute dermal was greater than 2,000
mg/kg.
    4. An acute inhalation study - in a 4-hour inhalation toxicity
study in rats, the maximum attainable concentration was 0.09 mg/L, with
13.3% of the particles having a mass median aerodynamic diameter of >10
microns. Since there was no mortality or clinical signs during exposure
or the 14-day observation period, the 4-day inhalation LC50
was greater than 0.09 mg/L.
    5. Dermal irritation - described as moderately irritating to
rabbits skin at 72 hours. Irritation and iridal effects following a
1,000 mg aliquot of Bacillus sphaericus being placed in the eye of
rabbits were no longer present at day 10 post-treatment.

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 groundwater or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

    The use patterns for Bacillus sphaericus on aquatic crops may
result in dietary exposure. However, in the absence of any mammalian
toxicological endpoints and the heat used during food processing, risk
from the consumption of treated commodities is not expected for neither
the general population nor infants and children.

B. Drinking Water Exposure and Risk Characterization

    Although the potential exist for Bacillus sphaericus to enter
drinking water sources, the health risk is expected to be negligible
due to: (1) The lack of any mammalian toxicological concerns associated
with Bacillus sphaericus, (2) lack of any published record of human
disease or infection caused by Bacillus sphaericus, and (3) the
municipal drinking water treatment processes.

C. Other Non-Occupational Exposure

    Non-dietary exposure is not anticipated from the use of this
microbial pesticide. Occupational exposure will be mitigated through
the use of proper personal protective equipment.

IV. Cumulative Effects

    Cumulative effects of Bacillus sphaericus have been considered.
But, Bacillus sphaericus does not exhibit a particular mechanism of
toxicity common with other agents; therefore, cumulative effects with
any other substance are not considered.

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

    Based on the information discussed above, EPA concludes that there
is reasonable certainty that no harm will result from aggregate
exposure to the U.S. population, including infants and children, to
residues of Bacillus sphaericus. This includes anticipated dietary
exposures and all other exposures for which there is reliable
information. The Agency has arrived at this conclusion because, as
discussed above, the toxicity of Bacillus sphaericus to mammals is very
low and under reasonably foreseeable circumstances, it does not pose a
risk.
    FFDCA section 408 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 pre- and post-natal toxicity
and the completeness of the database, unless EPA determines that a
different margin of exposure (safety) are often referred to as
uncertainty (safety) factors. In this instance, the Agency believes
there is reliable data to support the conclusion that Bacillus
sphaericus is practically non-toxic to mammals, including infants and
children, and, thus, a margin of exposure (safety) approach is not
needed to protect adults or infants and children.

 VI. Other Considerations

A. Endocrine Disruptors

    The Agency has no information to suggest that Bacillus sphaericus
will not adversely affect the immune systems. The Agency is not
requiring information on the endocrine effects of this microbial
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.

B. Analytical Method(s)

    The Agency is establishing an exemption from the requirement of a

[[Page 48596]]

tolerance without any numerical limitations; therefore, the Agency has
concluded that an analytical method is not required for enforcement
purposes for Bacillus sphaericus.

C. Codex Maximum Residue Level

    There are no CODEX tolerances or international tolerance exemptions
for Bacillus sphaericus at this time.

VII. 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) and
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 governs 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 November 10, 1998, 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 may
be disclosed publicly by EPA without prior notice.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket
control number [OPP-300701]. A public version of this record, including
printed, paper versions of electronic comments, 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 119 of the Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Electronic comments can be sent directly to EPA at:
    opp-docket@epamail.epa.gov

    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 requests, 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.

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    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 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 additions, since
tolerance 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. 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.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a
regulation that is not required by statute and that creates a mandate
upon a State, local or tribal government, unless the Federal government
provides the funds necessary to pay the direct compliance costs
incurred by those governments. If the mandate is unfunded, EPA must
provide to OMB a description of the extent of EPA's prior consultation
with representatives of affected State, local and tribal governments,
the nature of their concerns, copies of any written communications from
the governments, and a statement supporting the need to issue the
regulation. In addition, Executive Order 12875 requires EPA to develop
an effective process permitting elected officials and other
representatives of State, local and tribal

[[Page 48597]]

governments "to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates."
    Today's rule does not create an unfunded federal mandate on State,
local or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected and other representatives of Indian tribal governments "to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities."
    Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian Tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.

X. 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 the rule in the 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: August 21, 1998.

Stephen L. Johnson,

Deputy Director, 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. 346a and 371.

    2. Section 180.1202 is added to subpart D to read as follows:

Sec. 180.1202  Bacillus sphaericus; exemption from the requirement of a
tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the microbial pesticides, Bacillus sphaericus when used in
or on all food crops.

[FR Doc. 98-24469 Filed 9-10-98; 8:45 am]
BILLING CODE 6560-50-F