[Federal Register Volume 69, Number 52 (Wednesday, March 17, 2004)]
[Notices]
[Pages 12659-12664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6002]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0057; FRL-7348-8]


Aspergillus flavus NRRL 21882; Notice of Filing a Pesticide 
Petition to Establish a Tolerance for a Certain Microbial Pesticide in 
or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing 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 docket identification (ID) number OPP-
2004-0057, must be received on or before April 16, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8097; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0057. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket

[[Page 12660]]

facility identified in Unit I.B.1. Once in the system, select 
``search,'' then key in the appropriate docket ID number.
    Certain types of information will not be placed in EPA's Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B.1. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0057. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0057. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0057.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2004-0057. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

[[Page 12661]]

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received 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 Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: March 8, 2004.
 Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
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.

Circle One Global, Inc.

PP 4F6815

    EPA has received a pesticide petition, 4F6815, from Circle One 
Global, Inc., One Arthur Street, P.O. Box 28, Shellman, GA 39886-0028, 
proposing pursuant to section 408(d) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to 
establish an exemption from the requirement of a tolerance for the 
microbial pesticide Aspergillus flavus NRRL 21882 on peanuts.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Circle One Global, Inc., has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Circle One Global, Inc., and EPA 
has not fully evaluated the merits of the pesticide petition. The 
summary may have been edited by EPA if the terminology used was 
unclear, the summary contained extraneous material, or the summary 
unintentionally made the reader conclude that the findings reflected 
EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices

    Aspergillus flavus NRRL 21882 is a naturally occurring fungus that 
does not produce aflatoxin even though it is an Aspergillus flavus 
fungal strain. Its application to soil around peanut plants, results in 
significant reductions in aflatoxin contamination of peanuts. The 
reduction in aflatoxin contamination is a form of biological control 
that is achieved by competitive exclusion, i.e., the nontoxigenic 
strain applied to the field exclude native, toxigenic strains from 
infecting and growing in peanuts. This benefit is realized without 
increasing the overall concentration Aspergillus flavus in the 
environment in the long term. Similarly, the total concentration of 
Aspergillus flavus found in the peanuts is not increased above 
naturally occurring levels when the product is used as directed. 
Conidia of Aspergillus flavus NRRL 21882 are coated onto the surface of 
hulled barley and this product is applied to the soil at a proposed use 
rate of 20 pound product/acre for the end use product, Afla-Guard\TM\ 
(0.002 pound active ingredient/acre). The product is applied once 
during the season, typically 40 to 80 days after planting, using a 
Gandy box or similar device fitted to a tractor. Peanuts are harvested 
approximately 2 to 3 months after the target treatment period.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
Aspergillus flavus NRRL 21882 is a non-aflatoxin-producing strain of 
Aspergillus flavus that was isolated from a peanut seed at the National 
Peanut Research Laboratory in 1991. This naturally occurring strain 
acts as a microbial pest control agent. The corresponding residues are 
Aspergillus flavus NRRL 21882. The active ingredient is cultured from 
spores originally obtained from the Agricultural Research Service (ARS) 
Patent Culture Collection in Peoria, IL. It is cultured on a selective 
isolation medium and can be identified according to the following 
criteria: Morphological characteristics; pairing nitrate-nonutilizing 
mutants with a tester strain to demonstrate it belongs to a specific 
vegetative compatibility group; and its inability to produce aflatoxins 
and/or cyclopiazonic acid. Cultures of Aspergillus flavus NRRL 21882 
have been analyzed by chloroform or chloroform methanol extraction 
followed by high-performance liquid chromatography (HPLC). These 
analyses demonstrated that Aspergillus flavus NRRL 21882 does not 
produce potential metabolites of toxicological concern such as 
aflatoxins B1, B2, G1, or G2, cyclopiazonic acid, or numerous 
metabolites reportedly produced by Aspergillus flavus strains or other 
fungi. Additionally, Aspergillus flavus NRRL 21882 was tested, 
following multiple methodologies, and found to be free of human 
pathogens.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Trials have been conducted which measure the 
percent toxic strains of total Aspergillus flavus found in peanuts when 
the product is used as directed. Typically, the percent toxic strains 
found in the treated peanuts is significantly lower than in the 
untreated peanuts. In trials conducted in 2000 and 2001, the percentage 
of toxigenic strains was 19.9 and 24.3 for the treated peanuts, vs. 
69.8 and 95.0 for the untreated, control peanuts, respectively. A 
dilution plating method (Dorner, J.W., Journal of AOAC International, 
Vol. 85, No. 4, 2002, p. 911-916) was used to quantify the Aspergillus 
flavus colonization of peanuts in these trials. These trials also 
determined that aflatoxin contamination in peanuts treated with 
Aspergillus flavus NRRL 21882 was reduced by 71.3% and 92.8% in 2000 
and 2001, respectively.

[[Page 12662]]

    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. A 
petition for exemption from tolerances is being submitted. The data 
indicate that residues of naturally occurring Aspergillus flavus 
populations on peanuts exist, and that the proposed use does not 
increase the total level of Aspergillus flavus above naturally 
occurring levels. Further, the composition of the total Aspergillus 
flavus residues on the peanuts is such that the percent of the 
toxigenic strains is decreased with use of the product. Total levels of 
fungus on peanuts, therefore, will remain unchanged while the amount of 
aflatoxin will be reduced through use of Afla-Guard\TM\.
    In addition, both the U.S. Food and Drug Administration (FDA) and 
the U.S. Department of Agriculture (USDA) set regulatory limits for 
aflatoxin in food. The FDA action level for aflatoxin in peanuts and 
peanut products is 20 parts per billion (ppb). The USDA has implemented 
a regulatory program to inspect peanuts for aflatoxin. Under this 
program, USDA inspects peanuts immediately after harvest (still in 
shell) and, using visible Aspergillus flavus as a surrogate for 
aflatoxin, segregates those with visible Aspergillus flavus to a 
category of peanuts not eligible for human consumption without 
additional processing. The USDA sets a maximum allowable aflatoxin 
level in peanuts of 15 ppb. Thus, a regulatory inspection program is 
already in place that will assure that any peanuts with visible levels 
of Aspergillus flavus NRRL 21882 will be segregated and subjected to 
further conditioning, should that be necessary.
    The potential residues of Aspergillus flavus NRRL 21882 on peanut 
hay are not expected to be any different than those which occur 
naturally and generally are low because peanut hay is not a good 
substrate for fungal growth. FDA also sets aflatoxin action levels for 
peanut products used as animal feed. These action levels range from 20 
ppb for dairy and immature animals to 300 ppb for finishing (i.e., 
feedlot) beef cattle.
    Because use of Afla-Guard\TM\ will not increase total Aspergillus 
flavus levels above background, naturally occurring levels, the 
establishment of a tolerance and an analytical method to measure the 
pesticide residues are not needed.

C. Mammalian Toxicological Profile

    1. Acute oral toxicity/pathogenicity study. An acute oral toxicity 
study was performed in which 12 male and 12 female rats were treated 
with Aspergillus flavus NRRL 21882 at a dose of 2.35-3.80 x 10\8\ 
colony forming units (CFU) per rat. In addition, three male and three 
female rats were treated with autoclaved test material, and three male 
and three female rats were treated with a sterile culture filtrate. The 
culture filtrate was included to investigate the possibility of other 
toxins being released into the agar medium by Aspergillus flavus NRRL 
21882. Animals which received the viable test material were 
sequentially sacrificed at intervals throughout the study and subjected 
to macroscopic examination. Samples of blood, tissues, intestinal 
contents, and faeces were removed for microbiological determination of 
test substance recovery. There were no treatment-related effects for 
any animal receiving either the viable test material, the autoclaved 
test material, or the sterile culture filtrate.
    2. Acute intraperitoneal toxicity/pathogenicity study. An initial 
acute intraperitoneal toxicity and pathogenicity study in the rat 
resulted in all animals receiving viable Aspergillus flavus NRRL 21882 
dying or being euthanized for humanitarian reasons. Animals treated 
with autoclaved test material also showed severe adverse effects, 
although they were not lethal. In this study, there were three groups 
of rats. Group A rats were dosed with the test substance. Group B rats 
were dosed with autoclaved test material. Group C rats were an 
untreated control group. Group A rats were given a single dose by 
intraperitoneal injection of Aspergillus flavus NRRL 21882 (5.67-6.75 x 
10\7\ viable spores). The test substance was suspended in sterile 
physiological saline with 0.1% Tween 80. Group B rats similarly 
received a single dose by intraperitoneal injection, but the test 
solution was autoclaved so the Aspergillus flavus NRRL 21882 was not 
viable. All animals from Group A died or were sacrificed due to 
clinical signs on day 5 or 6. Surviving animals were sacrificed on day 
22 and subjected to macroscopic examination.
    Samples of blood, tissues, intestinal contents, and faeces were 
removed for microbiological determination of test substance recovery. 
All surviving animals were considered to have achieved satisfactory 
body weight gains throughout the study. There were no differences from 
controls which were considered attributable to treatment. No trends 
indicative of pyrogenic response to treatment were seen in any of the 
treated groups receiving active or inactivated test material in 
comparison with the controls or pre-dose values. Macroscopic 
examination at study termination revealed nodules on the spleen, 
kidneys, and/or connective tissue in the peritoneal cavity in animal in 
Group B. No abnormalities were observed in any animal in Group C. 
Viable Aspergillus flavus NRRL 21882 was recovered from the majority of 
organs from all Group A rats that died or were sacrificed on humane 
grounds 5 or 6 days after dosing. Although numbers of viable 
Aspergillus flavus NRRL 21882 in some liver and spleen samples showed 
counts of 10\4\ to >10\5\ colony forming units/grams (unit of measure 
for bacteria) (cfu/g), this was considered to have resulted from 
accumulation of the test organism in these organs and was not 
attributable to an infective proliferation of the test organism in 
these organs.
    There was no evidence of infectivity by Aspergillus flavus NRRL 
21882 in this study. It was concluded that viable Aspergillus flavus 
NRRL 21882 caused a severe inflammatory response in the abdominal 
cavity of rats leading to death. Rats dosed with inactivated 
Aspergillus flavus NRRL 21882 also showed an inflammatory response, but 
it was sub-lethal in nature. Because the animals dosed with autoclaved 
test material also showed adverse effects in this study it was 
hypothesized that this could be the result of some interaction with the 
Tween 80 or its breakdown products, or that Aspergillus flavus NRRL 
21882 produces some toxins.
    A second acute intraperitoneal toxicity and pathogenicity study of 
Aspergillus flavus NRRL 21882 in the rat was conducted. In this study, 
the dosing solution contained only physiological saline (no Tween 80), 
and another control group of rats was added. The latter group received 
sterile culture filtrate to evaluate the possibility of endotoxin 
release by Aspergillus flavus NRRL 21882. Groups of rats (15 male and 
15 female) were given a single dose by intraperitoneal injection of 
Aspergillus flavus NRRL 21882 (1.12-1.47 x 10\7\ viable spores/rat). 
Surviving animals were sacrificed on day 22 and subjected to 
macroscopic examination.
    Samples of blood, tissues, intestinal contents and faeces were 
removed for microbiological determination of test substance recovery. 
The animals receiving viable test material were given group numbers 1 
through 5, with designated sacrifice days of 1, 4, 8, 15, and 22. The 
group that received autoclaved material consisted of two males and two 
females. The sterile culture filtrate group consisted of three males 
and three females. There was only one unscheduled death in the study 
and it was not treatment-related. In surviving animals, only two showed 
any clinical signs. One male showed

[[Page 12663]]

abnormal posture characterized by head tilting to the left on days 9 to 
22 (to study termination) and circling to the left from days 11 to 14; 
and one female showed abnormal posture characterized by head tilting to 
the right from day 16 to day 22 (to study termination). These clinical 
signs are considered to be more likely than not treatment-related, but 
only affected 2 of the 30 animals treated with viable test material. No 
clinical signs considered related to treatment were observed in any 
animal from either the autoclaved test substance or sterile culture 
filtrate groups.
    The results of the second study were dramatically different from 
those of the first. Adverse clinical effects were seen only in one male 
and one female, both of whom survived through study termination. 
Recovery of viable test material at sacrifice demonstrated clearance of 
the test material. No Aspergillus flavus NRRL 21882 was found in blood 
at any time period and on day 22 no viable test material was recovered 
from any organ or from the gastrointestinal tract (GI). The addition of 
the sterile culture filtrate demonstrated that Aspergillus flavus NRRL 
21882 did not generate endotoxins. Based on results from the second 
study, it can be concluded that the most likely explanation for the 
adverse effects in the first study was the presence of the surfactant, 
Tween 80, and not any toxicity due to Aspergillus flavus NRRL 21882. 
Further, the results from the sterile filtrate group indicate that no 
endotoxins are produced by Aspergillus flavus NRRL 21882 and therefore 
these could not have been the cause of the adverse effects seen in the 
first I.P. study.
    3. Acute pulmonary toxicity/pathogenicity study. The acute 
pulmonary toxicity/pathogenicity of Aspergillus flavus NRRL 21882 in 
the rat was assessed. Groups of rats were given a single dose by 
intratracheal instillation of the test substance (4.6-6.9 x 10\7\ 
viable spores) suspended in sterile physiological saline containing 
0.1% Tween 80. Animals were sequentially sacrificed at intervals 
throughout the study and subjected to a macroscopic examination. 
Samples of blood, tissues, intestinal contents, and faeces were removed 
for microbiological determination of the test substance recovery. One 
female in Group C was found dead on day 2. Macroscopic examination of 
this one animal revealed congestion (characterized by blood vessels 
injected) of the brain with enlarged, swollen thickened tissues and 
patchy areas of darkened and pale tissue in the lungs. Fluid contents 
were noted along the intestinal tract. There were no clinical signs 
that were considered to be associated with the test substance. All 
surviving animals were considered to have achieved satisfactory body 
weight gains throughout the study.
    There were no differences from controls which were considered to be 
attributable to the treatment. No trends indicative of pyrogenic 
response to treatment were seen in any of the treated groups receiving 
active or inactivated test material in comparison with the controls or 
pre-dose values. No abnormalities were observed in any of the terminal 
animals at the macroscopic examination at termination. Substantial 
numbers of viable Aspergillus flavus NRRL 21882 were recovered from the 
lungs of the majority of treated rats sacrificed early in the study 
period. As the study progressed it was evident, from the counts of 
viable Aspergillus flavus NRRL 21882 obtained from the lungs of treated 
rats, that Aspergillus flavus NRRL 21882 rapidly lost viability 
following intra-tracheal dosing into rats. Some clearance of 
Aspergillus flavus NRRL 21882 from the lungs of treated rats by the 
pulmonary muco-ciliary escalator system was evident from the recovery 
of viable Aspergillus flavus NRRL 21882 from faecal contents and 
faeces. At no point over the study period did any substantial increase 
in viable counts occur that may have been indicative of a proliferation 
of Aspergillus flavus NRRL 21882 within treated rats. It was concluded 
the Aspergillus flavus NRRL 21882 showed no evidence of toxicity or 
pathogenicity to rats following a single intratracheal administration.
    Based on these studies the petitioner concludes that Aspergillus 
flavus NRRL 21882 does not present either a toxicological or infectious 
risk to mammals.
    4. Data waiver requests. Data waivers were requested for the 
following toxicology studies: acute dermal toxicity/pathogenicity, 
primary dermal irritation, primary eye irritation, and immune response. 
The rationales for the waiver requests are:
    i. The active ingredient occurs naturally in the environment.
    ii. USDA researchers have been handling the product in lab and in 
field settings for many years without reports of adverse effects, even 
though some fungi in the genus Aspergillus flavus are known dermal 
sensitizers. The formulation is granular, is ground applied, and is 
used only once per season which limits exposure and thus any potential 
adverse dermal effects. Any potential dermal irritation can be 
adequately mitigated with appropriate personal protective equipment, 
which, in this case, is a long sleeved shirt, long pants, shoes, socks, 
and gloves.
    iii. At the proposed use rate of 20 pound/acre, the equivalent 
amount of active ingredient applied is only 0.002 pound/acre. Thus, 
exposure to Aspergillus flavus NRRL 21882 is not likely to exceed the 
naturally occurring, ubiquitous Aspergillus flavus in the environment.
    iv. No eye irritation effects have been reported during the several 
years of experimentation and field trials conducted by the USDA 
researchers.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Aspergillus flavus NRRL 21882 is a 
naturally occurring organism that does not produce aflatoxins and thus 
is safer than toxigenic Aspergillus flavus isolates. At the proposed 
use rate, the total population of Aspergillus flavus on the crop will 
not increase beyond naturally occurring background levels. Total levels 
of fungus on peanuts, therefore, will remain unchanged while the amount 
of aflatoxin will be reduced through use of Afla-Guard\TM\. In 
addition, USDA inspection procedures for peanuts identify peanuts with 
visible Aspergillus flavus contamination and remove these from the food 
supply. USDA has implemented these procedures for decades to manage 
aflatoxin levels in peanuts (historically using visible Aspergillus 
flavus as a surrogate for aflatoxin). USDA procedures keep levels of 
aflatoxin in peanuts and processed peanut products below USDA and FDA 
action levels. Also, subsequent processing steps in the production of 
peanut products such as peanut butter and peanut oil will kill the 
fungus. Consequently, dietary exposure to Aspergillus flavus NRRL 21882 
is expected to be quite low. The residues on peanut hay are not 
expected to be different in the treated fields than in untreated fields 
because hay is not a good substrate for fungal growth.
    ii. Drinking water. The use of Aspergillus flavus NRRL 21882 is not 
likely to increase the natural concentration of Aspergillus flavus in 
water bodies and is not considered to be a risk to drinking water. 
Although the soil concentrations of Aspergillus flavus NRRL 21882 will 
increase immediately after application, as expected, to displace the 
toxigenic strain, this effect is temporary.
    2. Non-dietary exposure. The proposed use site is limited to the 
agricultural crop peanuts. The product is applied as a granular 
formulation, using a Gandy box or similar device fitted to a tractor. 
Uptake in moisture by the granules results in growth of the

[[Page 12664]]

Aspergillus flavus NRRL 21882 in the soil. Migration of the Aspergillus 
flavus out of the treated fields is not expected. Therefore, there will 
be no non-occupational, non-dietary exposure to the general population.

E. Cumulative Exposure

    There are no other registered products containing Aspergillus 
flavus NRRL 21882. Another strain, Aspergillus flavus AF 36, is 
conditionally registered for cotton in Arizona and Texas, but is not 
registered for use on peanuts. Peanuts are grown in several states, 
chiefly in the South.

F. Safety Determination

    1. U.S. population. Aspergillus flavus NRRL 21882 is a naturally 
occurring organism. The long-term population of Aspergillus flavus in 
the environment is not increased either in the environment or in the 
crop. Thus, there is a reasonable certainty that no harm will result 
from the use of this product. In addition, there is the benefit of 
reduced aflatoxin production.
    2. Infants and children. Aspergillus flavus NRRL 21882 is a 
naturally occurring organism that does not produce aflatoxins and thus 
is safer than toxigenic Aspergillus flavus isolates. At the proposed 
use rate, the total population of Aspergillus flavus on the crop will 
not increase beyond naturally occurring background levels. Total levels 
of fungus on peanuts, therefore, will remain unchanged while the amount 
of aflatoxin will be reduced through use of Afla-Guard\TM\. In 
addition, USDA inspection procedures removes visible Aspergillus flavus 
from the food supply and food processing steps to produce peanut 
products such as peanut butter and peanut oil kill the fungus. Finally, 
toxicity studies completed on Aspergillus flavus NRRL 21882 do not 
raise risk concerns. Based on its lack of toxicity and the natural 
occurrence of Aspergillus flavus NRRL 21882, there is a reasonable 
certainty that no harm will result to infants and children from 
exposure to potential residues. The reduction in aflatoxin resulting 
from the use of this product will be a significant benefit to 
children's health.

G. Effects on the Immune and Endocrine Systems

    Aspergillus flavus NRRL 21882 is a naturally occurring organism 
which does not produce aflatoxin and is thus safer than Aspergillus 
flavus isolates producing aflatoxins. There are no reliable data to 
suggest that Aspergillus flavus NRRL 21882 affects the immune or 
endocrine systems.

H. Existing Tolerances

    There are no existing tolerances for Aspergillus flavus NRRL 21882.

I. International Tolerances

    There are no Codex maximum residue levels for Aspergillus flavus 
NRRL 21882.
[FR Doc. 04-6002 Filed 3-16-04; 8:45 am]
BILLING CODE 6560-50-S