[Federal Register Volume 69, Number 67 (Wednesday, April 7, 2004)]
[Notices]
[Pages 18370-18375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7476]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0058; FRL-7349-4]


Muscodor albus Strain QST 20799; Notice of Filing a Pesticide 
Petition to Establish an Exemption from 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 ID number OPP-2004-0058, must be 
received on or before May 7, 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 code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
     This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be

[[Page 18371]]

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. EPA Docket. EPA has established an official public docket for 
this action under docket ID number OPP-2004-0058. 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 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 the EPA 
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-2004-0058. 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-2004-0058. 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

[[Page 18372]]

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-2004-0058.
    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-2004-0058. 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.

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 22, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summary of Petition

     The petitioner's summary of the pesticide petition is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petition was prepared by AgraQuest, Inc. 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.

 AgraQuest, Inc.

 PP 3F6745

     EPA has received a pesticide petition (PP 3F6745) from AgraQuest, 
Inc., 1530 Drew Avenue, Davis, CA 95616, 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 Muscodor albus 
strain QST 20799 in or on all food commodities.
     Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
AgraQuest, Inc. has submitted the following summary of information, 
data, and arguments in support of their pesticide petition. This 
summary was prepared by AgraQuest, 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

     Muscodor albus strain QST 20799 will be the active ingredient in 
end-use products for soil treatment to control root diseases in 
greenhouse and field crops, as well as a fumigant to control post 
harvest decay in fresh fruits, vegetables and cut flowers. When 
activated with moisture, Muscodor albus strain QST 20799 produces 
volatile compounds that are lethal to plant pathogenic organisms that 
cause diseases such as root rot, damping-off and wilt. End-use product 
will be mixed with the soil, applied to seeds, bulbs and/or tubers 
prior to planting, or used to treat enclosed containers of postharvest 
fruits, vegetables and cut flowers.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Muscodor 
albus strain QST 20799 is an endophytic fungus that was originally 
isolated from the bark of a cinnamon tree in Honduras. The strain grows 
as a white sterile mycelium and does not produce asexual or sexual 
spores, or other structures such as chlamydospores or sclerotia. 
Muscodor albus strain QST 20799 works to inhibit and kill 
microorganisms by production of a number of volatiles, mainly alcohols, 
acids, and esters. Muscodor albus strain QST 20799 will be the active 
ingredient in end-use products for soil treatment to control root 
diseases in greenhouse and field crops, as well as a biofumigant to 
control post harvest decay in fresh fruits, vegetables and cut flowers.

[[Page 18373]]

     Muscodor albus strain QST 20799 works to inhibit and kill 
microorganisms by production of a number of volatiles, mainly alcohols, 
acids, and esters. Antifungal activity was found to be mainly 
associated with the production of 2-methyl-1-butanol, ethyl butyrate 
and isobutyric acid. Other compounds produced such as ethyl propionate, 
ethyl isobutyrate and methyl isobutyrate, although, less inhibitory, 
may also contribute to the antimicrobial activity. Many of these 
compounds are well known as natural constituents of fruit aromas, fresh 
leaves, wine and rum aromas, blue cheese aroma, other natural essential 
oils and olive and vegetable oil.
     Volatiles produced by Muscodor albus strain QST 20799 have a 
fungicidal rather than a fungistatic action toward most fungi. Both 
vegetative hyphae and spores of plant pathogenic fungi are killed. The 
volatiles are also bactericidal against vegetative bacterial cells. 
Most Muscodor albus strain QST 20799 volatiles are non-polar and thus 
more likely to be absorbed or attach to the cell membrane, which is the 
first cellular component exposed after the cell wall. The disruption of 
cell membrane functions is a likely explanation for such a wide and 
unspecific activity. Damage to cell membrane components can cause loss 
of electrolytes, loss of osmotic balance and impair feeding functions. 
Damage to other cellular components is less likely, as they would 
require penetration of the cytoplasm and be more likely to have a more 
specific activity. Extensive work with crop plants has demonstrated 
that Muscodor albus strain QST 20799 will not establish on treated 
plants and does not represent a risk to non-target plants. The strain 
does not have spores or any other resting stage, and the volatiles it 
produces have been shown to dissipate rapidly in soil and water.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Residues of the fungal active ingredient are not 
expected on food or feed items because the active ingredient will not 
be in direct contact with treated commodities. The volatile organic 
compounds produced by Muscodor albus strain QST 20799 were identified 
by GC-MS as follows: The most abundant compound was ethyl propionate 
followed by 3-methyl-1-butanol (or 2-methyl-1-butanol) and isobutyric 
acid, other compounds produced include ethyl butyrate, ethyl 
isobutyrate and methyl isobutyrate. Many of these compounds are well 
known as natural constituents of fruit aromas, fresh leaves, wine and 
rum aromas, blue cheese aroma, other natural essential oils and olive 
and vegetable oil. A comprehensive data base search was carried out to 
assess the reported toxicities of these compounds. Data bases include 
the registry of toxic effects of chemical substances (RTECS) and the 
hazardous substance data bank (HSDB).
     During postharvest testing with fruit in the box, levels of 
volatile organic compounds were measured using 10 grams (10g) product 
in an 11.4L box. Exposure from such treatment is at concentrations well 
below reported lethal dose (LD)50 levels for these volatile 
compounds. Further, the volatile compounds rapidly dissipate in soil 
and water. They are not expected to accumulate on food/feed 
commodities, nor to be above the background levels of these naturally 
occurring compounds. A system was set up to determine levels of 
volatile organic compounds remaining on apples after treatment. This 
demonstrated that after a 48-hour exposure of 10g Arabesque to apples 
in a 11.4 L box, only two volatile compounds could be detected in the 
rinsate of the apple skins. All others were not detectable. These two 
were at very low concentrations (2-methyl-1-butanol, 8 ppb and isobutyl 
alcohol, 10 ppb). These levels diminish even further after 24-hours 
aeration. The LD50 values reported for these compounds are 6 
orders of magnitude higher than those observed right after exposure. 
Naturally occurring levels of the volatiles in foods are higher than 
those observed after treatment with Arabesque.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. Residues 
of the fungal active ingredient are not expected on food or feed items 
because the active ingredient, Muscodor albus strain QST 20799, will 
not be in direct contact with treated commodities. As discussed 
immediately above, residue levels of the fungus will be zero because 
the microorganism has limited survivability once its carrier nutrient 
source is exhausted. The volatiles are already found naturally 
occurring in foods such as apples, mushrooms, bananas, apricots, 
grapes, wine and beer. Many of the volatile organic compounds produced 
by Arabesque are certified natural flavors and fragrances used in 
preparation of foods, cosmetics and perfumes. There are no fungal 
residues left in soil and the fungus never comes in contact with the 
postharvest produce. An analytical method for residues is not required 
for an exemption from tolerance because it is expected that, when used 
as proposed, Muscodor albus strain QST 20799 would not result in 
residues that are of toxicological concern. Volatile compounds produced 
by the active ingredient occur naturally, and dissipate rapidly in soil 
and water.

C. Mammalian Toxicological Profile

     Studies to evaluate the safety to mammals were conducted on the 
technical grade active ingredient (TGAI) are summarized as follows:
    1. Acute oral toxicity (OPPTS Harmonized Guideline 870.1100). In a 
non-GLP acute oral toxicity study on rats (three male/three female) 
using the limit dose, no effects were seen in test animals and an 
LD50 5,000 milligrams/kilogram (mg/kg) is 
proposed. All six rats gained weight during the course of the study. 
There were no mortalities during the study. At necropsy all tissues 
appeared grossly normal in all six rats. Clearance was not measured in 
this study.
    2. Acute oral toxicity/pathogenicity (OPPTS Harmonized Guideline 
885.3050). In an acute oral toxicity/pathogenicity study a dose of 0.1 
gram dry weight of mycelium (equivalent to 1 x 108 cfu/g) 
was administered to rats (15 male/15 female) via oral gavage. There 
were no adverse effects, mortalities, clinical signs or abnormal 
macroscopic findings at post-mortem. No viable Muscodor albus strain 
QST 20799 were recovered from the organs, blood, intestinal contents or 
feces from any of the treated animals during the study, and the test 
material was rated as non-toxic and non-pathogenic.
    3. Acute dermal toxicity/pathogenicity (OPPTS Harmonized Guideline 
885.3100). In an acute dermal toxicity/pathogenicity study on rabbits 
(five male/five female) using a dose of 2.0 mL/kg body weight applied 
topically, there were no dermal reactions, mortalities, significant 
clinical signs or abnormal macroscopic findings at post-mortem. An 
LD50 2,000 mg/kg was established.
    4. Acute pulmonary toxicity/pathogenicity (OPPTS Harmonized 
Guideline 885.3150). In an acute pulmonary toxicity/pathogenicity study 
on rats (23 male/23 female) using a dose of 0.3 grams/100 grams (or 3.0 
grams/kg) body weight (highest possible dose) administered by a single 
intratracheal instillation, there were three unscheduled deaths. Deaths 
were attributed to the dosing procedure and viscous nature of the test 
material. No toxicity or clinical signs related to treatment with the 
active ingredient were observed. No viable Muscodor albus strain QST 
20799 were recovered from the organs, blood, intestinal contents or 
feces from any of the treated

[[Page 18374]]

animals during the study, and the test material was rated as non-toxic 
and non-pathogenic.
    5. Primary eye irritation (OPPTS Harmonized Guideline 870.2400). In 
a primary eye irritation study on rabbits (three female) using a dose 
of 0.1 mL per eye administered topically, there was minimal irritation 
at 1 hour post dosing, but all effects cleared by 24-hours. No corneal 
opacity or iridal effects were observed. Muscodor albus strain QST 
20799 was rated ``minimally irritating'' to eyes.
    6. Hypersensitivity incidents (OPPTS Harmonized Guideline 
885.3400). The registrant has noted that no incidents of 
hypersensitivity or any other adverse effects have occurred through the 
research, development or testing of the active ingredient and its 
related end-use product. Should any hypersensitivity incidents occur, 
they will be reported per FIFRA section 6(a)(2). The above studies show 
the active ingredient is not toxic, pathogenic, infective or irritating 
to mammals. In addition, growth temperature analysis has shown that 
Muscodor albus strain QST 20799 does not grow below 5 [deg]C or above 
34 [deg]C, which would indicate that the active ingredient would be 
unlikely to infect humans or other mammals with normal body 
temperatures above 37 [deg]C.
    7. Data waiver requests. For the technical grade active ingredient 
(TGAI) and the end-use products, Arabesque, Andante and Glissade, a 
waiver has been requested for the acute intravenous injection toxicity/
pathogenicity, acute oral toxicity (limit dose), acute dermal toxicity 
(limit dose), acute inhalation toxicity (limit dose), dermal 
irritation, dermal sensitization and the conditionally required Tier 1 
data for cell culture and immune response. Rationale for waiver of 
these data requirements is based on the lack of exposure, demonstrated 
safety to mammals, in the toxicity/pathogenicity and irritation tests, 
and the known growth temperature range of the organism. A temperature 
growth study was conducted at temperatures from 5 [deg]C to 34 [deg]C. 
Growth was observed from 10 [deg]C to 30 [deg]C; no growth occurred at 
5 [deg]C or at 34 [deg]C. Therefore, it can be concluded that the 
organism will grow above 5 [deg]C and below 34 [deg]C. Since this is 
lower than the body temperature of the mammalian test animals, it is 
unlikely that the organism would survive in these studies.
     Muscodor albus strain QST 20799 produces volatile organic 
compounds that inhibit or kill several plant pathogens. The volatile 
compounds produced by the active ingredient have been evaluated in a 
risk assessment conducted by the registrant. None of these compounds 
are endotoxins and they are not toxic to humans.
     The results of toxicity testing indicates there is no risk to 
human health or the environment from Muscodor albus strain QST 20799. 
The major intended use of Muscodor albus strain QST 20799 is to 
fumigate soil and harvested crops for the purposes of disease control. 
This product will be a viable alternative to the use of soil fumigants 
and postharvest fungicides that have been demonstrated to be harmful to 
the environment and human health (e.g., methyl bromide and 1,3 
dichloropropane). There are no reports of ecological or human health 
hazards caused by Muscodor albus strain QST 20799. It does not produce 
recognized toxins, enzymes, or virulence factors normally associated 
with mammalian invasiveness or toxicity. The absence of acute toxicity 
or pathogenicity in laboratory animals demonstrates the benign nature 
of this strain. Muscodor albus strain QST 20799 has limited 
survivability once its carrier nutrient source is exhausted. Volatile 
compounds produced are not of toxicological concern and dissipate 
rapidly in the environment. The limited survival of Muscodor albus 
strain QST 20799, the rapid dissipation of the volatile compounds 
produced, and lack of acute toxicity indicate that both the hazard and 
the exposure associated with the use of Muscodor albus strain QST 20799 
are low.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure from use of Muscodor 
albus strain QST 20799, as proposed, is minimal. The major intended use 
of Muscodor albus strain QST 20799 is to fumigate soil and harvested 
crops for the purposes of disease control. Muscodor albus strain QST 
20799 has limited survivability once its carrier nutrient source is 
exhausted. For soil treatment the poor survivability of the active 
ingredient will limit any dietary exposure. For post-harvest treatment 
there is no contact between the fungus and the postharvest commodity. 
The fungus will be in a container or sachet which will allow volatiles 
to contact the food commodity. The fungus itself will not be in contact 
with the food commodity. Preliminary studies showed that no residue 
levels of concern of either the fungus or the volatiles were found on 
apples exposed to the active ingredient. As discussed above, the active 
ingredient will not be in direct contact with treated food/feed 
commodities, and naturally occurring levels of the volatiles in foods 
are higher than those observed after treatment with Arabesque.
     The results of acute oral, dermal and pulmonary toxicity/
pathogenicity testing with the TGAI, indicates there is no risk to 
human health or the environment from Muscodor albus strain QST 20799. 
There are no reports of ecological or human health hazards caused by 
Muscodor albus strain QST 20799. It does not produce recognized toxins, 
enzymes, or virulence factors normally associated with mammalian 
invasiveness or toxicity. The absence of acute toxicity or 
pathogenicity in laboratory animals demonstrates the benign nature of 
this strain. The limited survival of Muscodor albus strain QST 20799, 
the rapid dissipation of the volatile compounds produced, and lack of 
acute toxicity indicate that both the hazard and the exposure 
associated with the use of Muscodor albus strain QST 20799 are low.
     During commercial and regular use of treated food materials, 
standard practices of washing, peeling, cooking or processing fruits 
and vegetable would further reduce any possible residue of the active 
ingredient. Volatile compounds produced by Muscodor albus strain QST 
20799 are not of toxicological concern, and dissipate rapidly in the 
environment.
    ii. Drinking water. Similarly, exposure to humans from residues of 
Muscodor albus strain QST 20799 inconsumed drinking water would be 
unlikely. Muscodor albus strain QST 20799 is not known to grow or 
thrive in aquatic environments. Potential exposure to surface water 
would be negligible and exposure to drinking water (well water or 
ground water) would be impossible to distinguish from the naturally 
occurring exposure. The major intended use of Muscodor albus strain QST 
20799 is to fumigate soil and harvested crops for the purposes of 
disease control. Muscodor albus strain QST 20799 has limited 
survivability once its carrier nutrient source is exhausted. The risk 
of the microorganism passing through the soil to ground water is 
minimal to unlikely. Additionally the fungus would not tolerate the 
treatment conditions water is subjected to in a municipal drinking 
water facility (including: chlorination, pH adjustments, high 
temperatures and/or anaerobic conditions). Volatile compounds produced 
by Muscodor albus strain QST 20799 are not of toxicological concern and 
dissipate rapidly in the environment.
     The results of toxicity testing indicates there is no risk to 
human health or the environment from Muscodor albus strain QST 20799.

[[Page 18375]]

There are no reports of ecological or human health hazards caused by 
Muscodor albus strain QST 20799. It does not produce recognized toxins, 
enzymes, or virulence factors normally associated with mammalian 
invasiveness or toxicity. The absence of acute toxicity or 
pathogenicity in laboratory animals demonstrates the benign nature of 
this strain. The limited survival of Muscodor albus QST 20799, the 
rapid dissipation of the volatile compounds produced, and lack of acute 
toxicity indicate that both the potential hazard and the dietary 
exposure to human adults, infants and children associated with the use 
of Muscodor albus strain QST 20799 are low.
    2. Non-dietary exposure. The potential for non-dietary inhalation 
and dermal exposure to the general population, including infants and 
children, is unlikely as the pesticide is proposed for agricultural or 
postharvest use sites. The major intended use of Muscodor albus strain 
QST 20799 is to fumigate soil and harvested crops for the purposes of 
disease control. Muscodor albus strain QST 20799 has limited 
survivability once its carrier nutrient source is exhausted. Volatile 
compounds produced by Muscodor albus strain QST 20799 are not of 
toxicological concern and dissipate rapidly in the environment. 
Personal protective equipment (PPE) mitigates the potential for 
exposure to applicators and handlers of the proposed products, when 
used in agricultural settings.
     The results of toxicity testing indicate there is no risk to human 
health or the environment from Muscodor albus strain QST 20799. There 
are no reports of ecological or human health hazards caused by Muscodor 
albus strain QST 20799. It does not produce recognized toxins, enzymes, 
or virulence factors normally associated with mammalian invasiveness or 
toxicity. The absence of acute toxicity or pathogenicity in laboratory 
animals demonstrates the benign nature of this strain. The limited 
survival of Muscodor albus strain QST 20799, the rapid dissipation of 
the volatile compounds produced, and lack of acute toxicity indicate 
that both the hazard and the exposure associated with the use of 
Muscodor albus strain QST 20799 are low. Non-dietary exposures would 
not be expected to pose any quantifiable risk because there are no 
detectable residues of toxicological concern.

E. Cumulative Exposure

     It is expected that, when used as proposed, Muscodor albus strain 
QST 20799 would not result in residues that are of toxicological 
concern. The major intended use of Muscodor albus strain QST 20799 is 
to fumigate soil and harvested crops for the purposes of disease 
control. Muscodor albus strain QST 20799 has limited survivability once 
its carrier nutrient source is exhausted. Volatile compounds produced 
by Muscodor albus strain QST 20799 are not of toxicological concern and 
dissipate rapidly in the environment. The results of toxicity testing 
indicates there is no risk to human health or the environment from 
Muscodor albus strain QST 20799. There are no reports of ecological or 
human health hazards caused by Muscodor albus strain QST 20799. It does 
not produce recognized toxins, enzymes, or virulence factors normally 
associated with mammalian invasiveness or toxicity. The absence of 
acute toxicity or pathogenicity in laboratory animals demonstrates the 
benign nature of this strain. The limited survival of Muscodor albus 
strain QST 20799, the rapid dissipation of the volatile compounds 
produced, and lack of acute toxicity indicate that both the hazard and 
the exposure associated with the use of Muscodor albus Strain QST 20799 
are low.

F. Safety Determination

    1. U.S. population. Acute toxicity studies have shown that Muscodor 
albus strain QST 20799 is not toxic, pathogenic, infective or 
irritating to mammals. The major intended use of Muscodor albus strain 
QST 20799 is to fumigate soil and harvested crops for the purposes of 
disease control. Muscodor albus strain QST 20799 has limited 
survivability once its carrier nutrient source is exhausted. Volatile 
compounds produced by Muscodor albus strain QST 20799 are not of 
toxicological concern and dissipate rapidly in the environment. The 
results of toxicity testing indicates there is no risk to human health 
or the environment from Muscodor albus strain QST 20799. There are no 
reports of ecological or human health hazards caused by Muscodor albus 
strain QST 20799. It does not produce recognized toxins, enzymes, or 
virulence factors normally associated with mammalian invasiveness or 
toxicity. The absence of acute toxicity or pathogenicity in laboratory 
animals demonstrates the benign nature of this strain. The limited 
survival of Muscodor albus strain QST 20799, the rapid dissipation of 
the volatile compounds produced, and lack of acute toxicity indicate 
that both the hazard and the exposure associated with the use of 
Muscodor albus strain QST 20799 are low. There is a reasonable 
certainty of no harm to the general U.S. population from exposure to 
this active ingredient.
    2. Infants and children. As mentioned above, it is expected that, 
when used as proposed, Muscodor albus strain QST 20799 would not result 
in residues that are of toxicological concern. There is a reasonable 
certainty of no harm for infants and children from exposure to Muscodor 
albus strain QST 20799 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

     To date there is no evidence to suggest that Muscodor albus strain 
QST 20799 functions in a manner similar to any known hormone, or that 
it acts as an endocrine disrupter.

H. Existing Tolerances

     There is no EPA tolerance for Muscodor albus strain QST 20799.

I. International Tolerances

     There is no Codex alimentarium commission maximum residue level 
(MRL) for Muscodor albus strain QST 20799.
[FR Doc. 04-7476 Filed 4-6-04; 8:45 am]
BILLING CODE 6560-50-S