```
[Federal Register Volume 62, Number 163 (Friday, August 22, 1997)]
[Notices]
[Pages 44687-44689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22374]

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

ENVIRONMENTAL PROTECTION AGENCY

[PF-757; FRL-5737-8]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of a pesticide 
petition (PP 7F4827), submitted by Abbott Laboratories, proposing the 
establishment of a regulation for an exemption from the requirement of 
a tolerance for residues of the microbial pesticide, active ingredient, 
Bacillus sphaericus, when used in or on all food and feed crops.
DATES: Comments, identified by the docket control number PF-757, must 
be received on or before September 22, 1997.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7506C), Information Resources and Services 
Division, Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment 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. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Willie Nelson, (PM) 90, 
Biopesticides and Pollution Prevention Division (7501W), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Rm. 5th 
floor, CS1, 2800 Crystal Drive, Arlington, VA. 22202, (703) 308-8682; 
e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions 
contain data or information regarding the elements set forth in section 
408(d)(2); however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-757] (including comments and data submitted 
electronically as described below). 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 official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    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. Comment and data 
will

[[Page 44688]]

also be accepted on disks in Wordperfect 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [PF-757] and appropriate petition number. Electronic 
comments on this notice may be filed online at many Federal Depository 
Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: August 13, 1997.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

Abbott Laboratories

PP 7F4827

    EPA has received a pesticide petition (PP 7F4827) from Abbott 
Laboratories, 1401 Sheridan Road, Dept. 28R, Bldg A1, North Chicago, IL 
60064-4000, proposing pursuant to section 408 (d) of the Federal Food, 
Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by 
establishing an exemption from the requirement of a tolerance for 
residues of the pesticide type, Bacillus sphaericus in or on the raw 
agricultural commodities.
    Pursuant to the section 408 (d)(2)(A)(i) of the FFDCA, as amended, 
Abbott Laboratories has submitted the following summary of information, 
data and arguments in support of their pesticide petition. This summary 
was prepared by Abbott Laboratories and EPA has not fully evaluated the 
merits of the petition. The summary may have been edited by EPA if the 
terminology used was unclear, the summary contained extraneous 
material, or the summary was not clear that it reflected the conclusion 
of the petitioner and to necessarily EPA.

A. Proposed Use Practices

    For the control of mosquito larvae, uniform application is 
recommended by either aerial or conventional ground equipment at rates 
up to 0.46 billion B.S. ITU/acre. Applications should occur when 
mosquito larvae are present at an interval of 1-4 weeks.

B. Product Identity/Chemistry

    1. The pesticide and corresponding residues are identified as 
Bacillus sphaericus.
    2. Bacillus sphaericus is a naturally occurring organism, and 
residues occurring at time of harvest are anticipated to approximate 
those of naturally occurring levels.
    3. Since Abbott Laboratories is proposing to establish an exemption 
from the requirement of a tolerance without numerical limitation, an 
analytical method for detecting and measuring levels of the pesticide 
residue is considered unnecessary.

C. Mammalian Toxicological Profile

    The mammalian toxicology data submitted in support of the exemption 
from the requirement for a tolerance include evaluation of toxicity, 
pathogenicity and infectivity of Bacillus sphaericus.
    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 (CFU) 
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 
instillation of approximately 1 x 108 CFU. Similarly, a 
pattern of clearance over a 35-day post-treatment period was observed 
following an intravenous dose of approximately 1 x 107 CFU. 
There were no mortalities, no evidence of pathogenicity or treatment-
related toxicity in rats given an oral, intratracheal installatin or 
intravenous dose.
    In an acute oral toxicity study, Bacillus sphaericus technical 
material caused no deaths in rats given a dose of 5,000 mg/kg; 
therefore the acute oral LD50 was greater than 5,000 mg/kg. 
There was no mortality in rabbits over the 14-day observation period 
following a 2,000 mg/kg dermal application for 24 hours; thus, the 
acute dermal LD50 was greater than 2,000 mg/kg. In a 4-hour 
acute 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 no clinical signs during exposure or the 14-day 
observation period, the 4-hour inhalation LC50 was greater 
than 0.09 mg/L. Dermal irritation of Bacillus sphaericus technical 
material was described by Abbott Laboratories as moderately irritating 
to rabbit skin at 72 hours. Irritation and iridal effects following a 
100 mg aliquot of Bacillus sphaericus placed in the eye of rabbits were 
no longer present at day 10 post-treatement.
    1. Conclusions. Based on the toxicity data summarized above, 
Bacillus sphaericus, is not pathogenic and does not demonstrate any 
systemic toxicity.
    2. Genotoxicity, reproductive and developmental toxicity, 
subchronic toxicity and chronic toxicity testing were not performed on 
this microbial pest control agent. The low acute toxicity, lack of 
survival, replication; infectivity and lack of persistence of this 
organism does not warrant need for this level of testing.

D. Aggregate Exposure

    For the purpose of assessing the potential dietary exposure under 
this exemption, Abbott considered that under this exemption, Bacillus 
sphaericus could be present on all RACs. Other potential sources of 
exposure of the general population to residues of pesticides are 
residues in drinking water and exposure from non-occupational sources. 
Based on the available studies used to assess environmental risk, and 
the fact that Bacillus sphaericus is a naturally occurring organism 
which is susceptible to chlorine treatment, exposure residues are not 
expected in drinking water. The potential for non-occupational, non-
dietary exposure to the general population is, thus, not expected to be 
significant.

E. Cumulative Effects

    Cumulative effects of Bacillus sphaericus and other substances that 
have a common mechanism of toxicity have been considered. Due to the 
lack of mammalian toxicity, it is the opinion of Abbott Laboratories 
that consideration of a common mechanism of toxicity is not appropriate 
at this time. Abbott Laboratories has concluded that toxic effects 
produced by Bacillus sphaericus would not be cumulative with those of 
any other compounds.

F. Safety Determination

    1. U.S. population. In general, Bacillus sphaericus is a naturally 
occurring organism which has undergone no genetic modifications.

[[Page 44689]]

 The low toxicity of the subject active ingredient is demonstrated by 
the data summarized above. Based on this information, it can be 
concluded that aggregate exposure to Bacillus sphaericus over a 
lifetime will not pose appreciable risks to human health. There is 
reasonable certainty that no harm will result from aggregate exposure 
to residues of Bacillus sphaericus and, consequently, exempting 
Bacillus sphaericus from the requirement of a tolerance is considered 
safe.
    2. Infants and children. It is the opinion of Abbott Laboratories 
that the toxicity and exposure data are sufficiently complete to 
adequately address the potential for additional sensitivity of infants 
and children to residues of Bacillus sphaericus. A determination of 
safety for infants and children can be made due to the insignificant 
exposure expected beyond naturally occurring background levels and the 
low acute toxicity of this microbial insecticide. It can be concluded 
with reasonable certainty that no harm will result to infants and 
children from aggregate exposure to Bacillus sphaericus residues.

G. Existing Tolerances

    Abbott Laboratories is not aware of any existing tolerances or 
tolerance exemption for Bacillus sphaericus.
[FR Doc. 97-22374 Filed 8-21-97; 8:45 am]
BILLING CODE 6560-50-F
```