[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)]
[Notices]
[Pages 34277-34278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16358]



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ENVIRONMENTAL PROTECTION AGENCY

[PF-746; FRL-5727-1]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-746, must 
be received on or before July 25, 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: James Boland, Regulatory 
Action Leader, 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) 308-8728; 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-746] (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 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-746] 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: June 16, 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.

Micro Flo Company

PP 7F4801

    EPA has received a pesticide petition (PP 7F4801) from Micro Flo 
Company, P.O. Box 5948, Lakeland FL 33807, c/o SRA International, Inc., 
1850 M St., N.W., Washington DC 20036 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 for a tolerance for residues of plant regulator Bacillus 
cereus BP01 when used in accordance with good agricultural practice as 
an active ingredient in pesticide formulations applied to growing 
crops.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Micro 
Flo has submitted the following summary of information, data, and 
arguments in support of its pesticide petition. This summary was 
prepared by Micro Flo 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 conclusions of the 
petitioner and not necessarily EPA.

A. Proposed Use Practices

    Micro Flo Company's Bacillus cereus BPO1 is a foliar-applied plant 
regulator. When combined with the plant growth regulator, mepiquat 
chloride, for use on cotton, it allows the grower to manage the cotton 
plant for short-season production leading to reduced risk of yield and 
quality loss due to delayed and prolonged harvest. Benefits derived 
from BPO1 in conjunction with mepiquat chloride include increased early 
boll retention and/or larger bolls, reduced plant height which provides 
a more open canopy, less boll rot, improved defoliation, less trash and 
lower ginning costs, better harvest efficiency and a darker leaf color. 
Micro Flo is currently exploring potential uses of BPO1 on other major 
row crops.
    BPO1 is applied from early season when the cotton is actively 
growing and not under stress, through late season on fields that cut 
out and then regrow or on fields where the cotton does not completely 
cut out. Application rates,

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depending on the cotton variety and its vigor, vary from 0.03 - 0.38 
grams BPO1/A.
    The maximum application level for BPO1 on cotton is 0.75 gram/acre/
year, with an average of 0.2 g/acre/year. For row crops (e.g., corn, 
soybeans), the maximum application will be less than 2 g/acre/
application and less than 20 g/acre/year. This tolerance exemption 
petition is for use of Bacillus cereus BPO1 up to 20 g/acre/year. There 
is a 30-day pre-harvest interval (PHI). Livestock should not be fed or 
permitted to graze on BPO1-treated cotton forage.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The ATCC 
classification of Micro Flo's Bacillus cereus BPO1 is 55675. Only 
residues of BPO1 would be present, and these residues are 
indistinguishable from naturally-occurring Bacillus cereus without 
using specific genetic testing procedures for differentiating them.
    2. Magnitude of the residue anticipated at the time of harvest and 
the method used to determine the residue. No magnitude of residue (MOR) 
studies have been conducted on BPO1 as total application rates are 
exceedingly low (Cotton: average, 0.2 g BPO1/acre/year; maximum, 0.75 
g/acre/year; Other major row crops [e.g., soybeans, corn]: <20 g BPO1/
acre/year) and it is toxicologically innocuous. The Pre-Harvest 
Interval (PHI) is currently 30 days. Bacillus cereus is indigenous and 
widespread throughout the United States and the rest of the world.
    3. Statement regarding the lack of need for an analytical method 
for detecting and measuring the levels of the pesticide residue. As 
indicated above, the naturally-occurring population of B. cereus may 
make it impossible to distinguish between natural and introduced 
microbial populations without utilizing genetic differentiation 
techniques and therefore to establish and enforce tolerances for BPO1. 
In addition, the PHI is currently 30 days.

C. Mammalian Toxicity Profile

    Acute mammalian toxicity studies via oral, dermal, inhalation, eye, 
intratracheal and intravenous routes were conducted with Bacillus 
cereus BPO1. No pathogenicity was observed. BPO1 was also tested for 
enterotoxin production; none was detected.
    In a blood agar hemolysis assay conducted with BPO1, weak alpha 
hemolysis was observed. Based on the results of the above studies, 
subchronic, reproductive, teratology, chronic and mutagenicity studies 
were not deemed necessary.

D. Aggregate Exposure

    1. Dietary exposure--a. Food. Bacillus cereus BPO1 is currently 
pending registration for use on cotton at rates up 0.75 g/A/year. Micro 
Flo Co. will, however, be evaluating BPO1 for future registration for 
use on other row crops (e.g., soybeans, corn) at rates less than 20 g/
A/year. Considering the extremely low application rates, ubiquitous 
nature and natural occurrence of Bacillus cereus, the potential dietary 
exposure to BPO1 is minuscule.
    b. Drinking water. Bacillus cereus BPO1 is prohibited on the label 
from direct application to water, although possible spray drift may 
contact drinking water. Again, considering the extremely low 
application rates, non-toxic mode of action, ubiquitous nature and 
natural occurrence of Bacillus cereus, the potential drinking water 
exposure to BPO1 is minuscule.
    2. Non-dietary exposure. There is no anticipated non-dietary 
exposure to Bacillus cereus BPO1. Contact with naturally-occurring 
populations of B. cereus is common throughout the world. Residue 
exposure through contact with cotton seeds/oil and clothing produced 
from BPO1-treated cotton has been theoretically considered; residues 
are unlikely to be present after the delinting/cleaning process.

E. Cumulative Effects

    Although there are other currently registered Bacillus products, 
some of which hold tolerance exemptions, their modes of action are 
unlike BPO1. Specifically, the other products typically produce 
enterotoxin which, when the bacteria producing it is consumed by insect 
pests, causes the pest to die. BPO1 does not produce enterotoxin, but 
instead appears to enable the target plant to more readily and 
efficiently uptake and utilize growth nutrients. BPO1 is a true growth 
regulator and to our knowledge does not have classic pesticidal 
activity. Maximum anticipated application rates are 0.75 g/A/year 
(cotton) and <20 g/A/year (major row crops including soybeans and 
corn). Based on the above, it is therefore felt that BPO1 should not be 
considered similar to existing Bacillus products.

F. Safety Determination

    1. U. S. population. Since: (a) the maximum currently sought use 
rate is 0.75 g BPO1/A/year for use on cotton (and 20 g/A/year on other 
row crops for which registration applications have not been submitted), 
(b) the associated anticipated minute residue levels are extremely 
unlikely to add appreciably to the natural, indigenous background 
levels of Bacillus cereus, (c) BPO1 does not produce enterotoxin, and 
(d) the toxicity/pathogenicity/infectivity studies show virtually no 
negative effects, BPO1 should be considered safe when used on raw 
agricultural commodities and meets the reasonable certainty of no harm 
requirement.
    2. Infants and children. As previously discussed, based on the 
minuscule quantities of BPO1 used, its lack of toxicity and 
pathogenicity, and its mode of action, it is exceedingly improbable 
that infants or children would be at greater risk to BPO1 exposure than 
would adults. BPO1 should be considered safe when used on raw 
agricultural commodities and meets the reasonable certainty of no harm 
requirement.
    3. Endocrine effects. There is no evidence that BPO1 has endocrine 
disrupter effects individually or in combination with any other 
chemical. It is unlikely to be an endocrine disrupter or to have a 
synergistic endocrine effect in combination with other chemicals.

G. Existing Tolerances

    1. Existing U.S. tolerances or exemptions from the requirement of a 
tolerance. There are no current tolerances or tolerance exemptions for 
Bacillus cereus strain BPO1.
    2. International tolerances or exemptions from the requirement of a 
tolerance. There are no Codex Maximum Residue Levels or tolerance 
exemptions for Bacillus cereus strain BPO1.
[FR Doc. 97-16358 Filed 6-24-97; 8:45 am]
BILLING CODE 6560-50-F