[Federal Register: April 7, 2004 (Volume 69, Number 67)]
[Notices]
[Page 18370-18375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap04-51]
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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: bacchus.shanaz@epa.gov.
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 opp-docket@epa.gov,
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