[Federal Register Volume 63, Number 176 (Friday, September 11, 1998)]
[Rules and Regulations]
[Pages 48594-48597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24469]


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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: [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 5.1/6.1 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.W[email protected].

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:
    [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 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

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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