[Federal Register Volume 64, Number 33 (Friday, February 19, 1999)]
[Notices]
[Pages 8358-8360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4158]


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

ENVIRONMENTAL PROTECTION AGENCY

[PF-858; FRL-6057-3]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the amendment of a pesticide petition 
proposing the establishment of regulations for residues of a certain 
pesticide chemical in or on various food commodities.
DATES: Comments, identified by the docket control number PF-858, must 
be received on or before March 22, 1999.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7506C), Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 119, 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. 119 at the 
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, c/o PM 90, 
Biopesticides and Pollution Prevention Division (7501W), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: 5th floor CS1 2800 Crystal Drive, Arlington, VA. (703-308-
8097, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA has received an amendment to a pesticide 
petition as follows proposing the establishment and/or amendment of 
regulations for residues of a certain pesticide chemical 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 this 
petition contains 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, as well as the public version, 
has been established for this notice under docket control number [PF-
858] (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 5.1/6.1 file format or 
ASCII file format. All comments and data in electronic form must be 
identified by the docket control number [PF-858]. Electronic comments 
on this proposed rule may be filed online at many Federal Depository 
Libraries.

    Dated: February 9, 1999.

Janet L. Andersen,

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

Summaries of Petition

    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

[[Page 8359]]

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.

Amended Petition

    EPA has received a request from the Interregional Research Project 
Number 4 (IR-4), New Jersey Agricultural Experiment Station, Technology 
Center of New Jersey, Rutgers University, 681 U.S. Highway #1 South, 
North Brunswick, NJ 08902-3390 proposing pursuant to section 408(d) of 
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a, to amend 40 
CFR part 180 by extending the exemption from the requirement of a 
temporary tolerance for residues of the microbial pesticide Aspergillus 
flavus (A. Flavus) AF36 in or on the raw agricultural commodity cotton 
until December 30, 2001. The request for an extension of the exemption 
from temporary tolerance was submitted on behalf of the Southern 
Regional Research Center, United States Department of Agriculture, 
Agricultural Research Service, 1100 Robert E. Lee Blvd., New Orleans, 
LA 70179-0687. These extensions are requested to comply with the Food 
Quality Protection Act of 1996 and to extend the use of the 
biopesticide to a larger area. Concomitant with this notice of filing, 
EPA is issuing a notice of receipt of application for extension 
(amendment) of the Experimental use Permit 69224-EUP-1. According to 
the proposed amended application for an Experimental Use Permit 69224-
EUP-1, 200,000 pounds (90,719 kg) of the microbial pesticide are to be 
applied to a total of 20,000 acres of commercial cotton fields in 5 of 
the 15 counties in Arizona. The proposed applications are to be made in 
Yuma, LaPaz, Maricopa, Mohave and Pinal Counties.
    EPA has determined that the petition contains 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.
    As required by section 408(d) of the FFDCA, as recently amended by 
the Food Quality Protection Act, the Southern Regional Research Center, 
United States Department of Agriculture, Agricultural Research Service 
prepared a summary of the petition and authorization for the summary to 
be published in the Federal Register in a notice of the receipt of the 
petition. The summary represents the views of the Southern Regional 
Research Center, United States Department of Agriculture, Agricultural 
Research Service; EPA, as mentioned above, is in the process of 
evaluating the petition. As required by section 408(d)(3) EPA is 
including the summary as part of this notice of filing. EPA may have 
made minor edits to the summary for the purpose of clarity.

A. Proposed Use Practices

    Aspergillus flavus isolate AF36 is for application to cotton to 
reduce the incidence of aflatoxin producing strains of A. flavus and 
thereby reduce aflatoxin contamination of cottonseed. When applied just 
prior to flowering, A. flavus isolate AF36, which does not produce 
aflatoxin, competitively excludes aflatoxin producing A. flavus strains 
without increasing A. flavus in the environment in the long term. 
Sterile wheat seed colonized with A. flavus strain AF36 is applied at 
10 pounds per acre.

B. Product Identity/Chemistry

    1. The pesticide and corresponding residues are identified as A. 
flavus isolate AF36.
    2. Aspergillus flavus isolate AF36 is a naturally occurring fungus 
isolated from cottonseed produced in the Yuma Valley of Arizona. AF36 
has been shown to be naturally and consistently associated with 
commercial cotton grown in Arizona. The overall quantity of A. flavus 
at time of harvest on cottonseed grown in fields where AF36 has been 
applied (i.e. colony forming units per gram of seed) has been shown to 
be similar to levels on cottonseed grown in fields where no application 
was made. A. flavus is a widespread fungus. It is particularly well 
adapted to the hot desert regions of Arizona where it is widespread in 
the environment. The communities of A. flavus in the desert and in 
agricultural fields are naturally composed of both aflatoxin producing 
(toxigenic) and aflatoxin non-producing (atoxigenic) strains. Both 
atoxigenic and toxigenic strains have been found on essentially all 
plant material and soils in the desert valleys of Arizona. The goal of 
applications is to increase the percent of A. flavus that is the AF36 
strain and to decrease the percent of A. flavus that produces 
aflatoxins.
    3. An extension of the exemption from the requirement of a 
tolerance for residues of the microbial pesticide A. flavus AF36 in/on 
cotton is being proposed. A. flavus isolate AF36, when applied to the 
soil just prior to bloom has been shown to significantly reduce the 
levels of aflatoxin in cottonseed at harvest. Aflatoxin levels in 
cottonseed products are regulated by the Food and Drug Administration 
(FDA). FDA does not allow cottonseed products containing aflatoxin at 
20 parts per billion (ppb) or higher to be used in dairy rations. FDA 
regulations also do not allow cottonseed products containing aflatoxin 
above 300 ppb to be used for feeding beef cattle. All lots of the 
active ingredient (A. flavus isolate AF36) and the formulated product 
are monitored as part of a rigorous quality control program.Starter 
cultures of A. flavus isolate AF36 used in the production of the end-
use product are always screened for aflatoxin production using TLC and 
appropriate standards. Quality control standards are zero tolerance for 
aflatoxin production in starter cultures. A. flavus AF36 has never been 
found to produce aflatoxin. Starter cultures of A. flavus AF36 as well 
as end-use products containing this active ingredient are also 
identified to isolate by vegetative compatibility analysis. Quality 
control standards are zero tolerance for A. flavus not identified as A. 
flavus isolate AF36 in the starter cultures and in the formulated 
product.

 C. Mammalian Toxicological Profile

    An acute oral toxicity test was performed whereby a single oral 
dose of 5,000 milligrams/kilogram (mg/kg) per animal of A. flavus 
isolate AF36 colonized wheat seed was administered by gavage to five 
male and five female Sprague Dawley rats. The oral LD50 of 
A. flavus AF36 was determined to be greater than 5,000 mg/kg rat body 
weight. No clinical signs were observed during the 14 day study and no 
abnormalities or adverse effects were observed in any of the rats upon 
necropsy.
    Genotoxicity, reproductive and developmental toxicity, subchronic 
toxicity and chronic toxicity testing were not performed on this 
microbial pest control agent. This testing is not warranted, since: (1) 
A. flavus AF36 has been worked with at the Southern Regional Research 
Center for over 10 years and in commercial fields (1996 to 1998) and in 
hand picked field plots (1989 to 1994) without report of any adverse 
health effects; (2) A. flavus AF36 is widely distributed in the 
environment and its occurrence is natural; and (3) the label will 
require applicators and other handlers to wear waterproof gloves, a 
dust/mist filtering respirator with the appropriate NIOSH

[[Page 8360]]

approval prefix N-95, P-95, or R-95, coveralls, long sleeved shirt and 
long pants, and shoes plus socks so exposure should not be a problem.

D. Aggregate Exposure

    1. Dietary Exposure. Aspergillus flavus isolate AF36 is a naturally 
occurring organism, which does not produce aflatoxin and is thus safer 
than the A. flavus isolates that produce aflatoxin. Proposed uses and 
application rates will not result in increases in the total population 
of A. flavus on the mature crop beyond naturally occurring background 
levels.
    2. Food. FDA does not allow cottonseed products containing 
aflatoxin at 20 ppb or higher to be used in dairy rations. FDA 
regulations also do not allow cottonseed products above 300 ppb to be 
used for feeding beef cattle. A. flavus isolate AF36, when applied to 
the soil just prior to bloom, has been shown to significantly reduce 
the levels of aflatoxin in cottonseed at harvest. Furthermore, the 
proposed use and application rate will not increase exposure of humans 
to A. flavus by dietary means. There is minimal dietary exposure to A. 
flavus from cottonseed. There is no mechanism for A. flavus to be 
transferred from the seed to cow products and there is no evidence that 
the fungus readily contaminates meats or milk. Seed is typically 
extracted for oil with hexane and that process kills the fungus. 
Furthermore, applications of A. flavus AF36 do not increase the 
indigenous populations of A. flavus associated with the harvested crop. 
The applications merely alter the composition of the fungal community 
associated with the mature crop so that aflatoxin producing strains are 
far less frequent. The result is a much lower incidence of aflatoxins 
in the crop and in the environment associated with the developing and 
mature crop.
    3. Drinking Water. Aspergillus flavus isolate AF36 is a naturally 
occurring organism that is already widespread in the environment and is 
not considered to be a risk to drinking water. Both percolation through 
soil and municipal treatment of drinking water would reduce the 
possibility of exposure of A. flavus through the drinking water. 
Applications of A. flavus AF36 do not increase the long-term 
populations of A. flavus in the environment, and thus are not expected 
to influence the relationship of A. flavus to water sources. 
Applications merely change the composition of the A. flavus community 
so that aflatoxins are less common in the environment.
    4. Non-dietary exposure. The potential for non-occupational, non-
dietary exposure to the general population is not expected to be 
significant and is not expected to present any risk of adverse health 
effects.

E. Cumulative Exposure

    There are no other registered products containing A. flavus isolate 
AF36 or any other isolates (strains) of the microbial active 
ingredient. Data submitted show that the fungal metabolite of concern 
which is aflatoxin is not produced by A. flavus isolate AF36 in the 
crop or in artificial media in the lab. When applied prior to 
flowering, A. flavus isolate AF36 has been shown to exclude aflatoxin 
producing fungi competitively from the developing crop and to reduce 
aflatoxin contamination of cottonseed. Data show that the proposed use 
will not result in appreciable increases in the long-term population of 
A. flavus on the crop beyond naturally occurring levels. Furthermore, 
there is no expectation of cumulative effects with other pesticides.

F. Safety Considerations

    Aspergillus flavus isolate AF36 is a naturally occurring organism. 
This isolate has low toxicity as demonstrated by the acute oral 
toxicity study in rats. A. flavus is ubiquitous throughout the hot 
desert valleys in Arizona. Studies have shown that treatment of cotton 
fields just prior to flowering with sterile wheat seed colonized by A. 
flavus isolate AF36 at 10 lbs. per acre does not increase the long-term 
populations of A. flavus either on the crop at maturity or in the soil 
1 year after application. Based on this information, IR-4 is of the 
opinion that the aggregate exposure to A. flavus over a lifetime should 
not change with application of AF36, and exposure to both aflatoxin 
producing A. flavus strains and aflatoxin should decrease. This should 
be beneficial to human health. Thus, there is a reasonable certainty 
that no harm will result from aggregate exposure to A. flavus isolate 
AF36. Extending the exemption of A. flavus isolate AF36 from the 
requirement of a temporary tolerance should be considered safe and pose 
insignificant risk.

G. Existing Tolerances

     A temporary tolerance exemption on cotton in conjunction with an 
Experimental Use Permit for A. flavus isolate AF36 is currently in 
effect (61 FR 30235-30236, June 14, 1996).

[FR Doc. 99-4158 Filed 2-18-99; 8:45 am]
BILLING CODE 6560-50-F