[Federal Register Volume 65, Number 148 (Tuesday, August 1, 2000)]
[Notices]
[Pages 46912-46916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19347]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-955; FRL-6595-4]


Notice of Filing of Pesticide Petitions to Establish Tolerances 
for Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

[[Page 46913]]


DATES: Comments, identified by docket control number PF-955, must be 
received on or before August 31, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-955 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Alan Reynolds, Biopesticides 
and Pollution Prevention Division (7511C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 605-0515; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-955. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-955 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected],'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-955. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified 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 
control 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.

[[Page 46914]]

II. What Action is the Agency Taking?

    EPA has received pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions contain data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petitions. Additional data 
may be needed before EPA rules on the petitions.

List of Subjects

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

    July 18, 2000.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed 
below as required by section 408(d)(3) of the FFDCA. The summaries of 
the petitions were prepared by the petitioners and represent the view 
of the petitioners. The petition summaries 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.

I. Natural Industries, Inc.

0F6163

    EPA has received a pesticide petition 0F6163 from Natural 
Industries, Inc., 6223 Theall Road, Houston, TX 77066, 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 microbial pesticide 
Streptomyces lydicus WYEC 108.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Natural Industries, Inc. has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Natural Industries, 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

    The active ingredient Streptomyces lydicus WYEC 108 is intended for 
use as a biological fungicide for the control of soil borne plant root 
rot and damping-off fungi. Fungi controlled include: Fusarium, 
Rhizoctonia, Pythium, Phytophthora, Phytomatotricum, Aphanomyces, 
Monosprascus, Armillaria and other root-decay fungi. The active 
ingredient colonizes the root system, thus out competing other harmful 
fungi, and enhances plant vitality.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
Streptomyces lydicus WYEC 108 colonizes the growing root tips of plants 
and acts as a mycoparasite of fungal root pathogens to protect plants. 
Root colonization is a form of competitive exclusion of a pathogen from 
the root system. Other mechanisms of action include the production and 
excretion of anti-fungal metabolites (e.g., antibiotics and/or low 
molecular weight anti-fungal compounds) into the rhizosphere 
surrounding the roots of colonized plants, and mycoparasitism of the 
spores and vegetative mycelium of the fungal pathogens (e.g., via 
colonization of the spores of hyphae of the fungus, followed by the 
production of lytic enzymes such as chitinase). No deleterious effects 
to plants have been observed as a result of excretion of anti-fungal 
compounds from Streptomyces lydicus WYEC 108.
    2. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. An 
analytical method for residues is not applicable. End-use products of 
Streptomyces lydicus WYEC 108 will be intended for greenhouse, nursery 
and turf grass use (food and non-food) as a soil mix or a soil drench. 
The products will be applied only to the soil, not to growing crops 
directly, and are not intended for use in irrigation systems. Residues 
of Streptomyces lydicus WYEC 108 are not expected on agricultural 
commodities.

C. Mammalian Toxicological Profile

    The active ingredient Streptomyces lydicus WYEC 108 and the end-use 
product Actinovatetm Soluble have been evaluated for 
toxicity through oral, dermal, pulmonary, and eye routes of exposure. 
The results of the studies have indicated toxicity category IV, which 
pose no significant human health risks.
    For the active ingredient, the acute pulmonary toxicity/
pathogenicity in rats is greater than 9.1 x 108 colony 
forming units (CFU) per animal and the acute injection toxicity/
pathogenicity in rats is greater than 9.33 x 108 cfu per 
animal. No pathogenic or infective effects were observed in the 
studies. For the end-use formulation, the acute oral toxicity in rats 
was greater than 5,050 milligrams per kilograms (mg/kg) (toxicity 
category IV), eye irritation in rabbits was not observed at a dose of 
0.1 milliliters (mL) (toxicity category IV) and skin irritation in 
rabbits was not observed at a dose of 0.5 mL (toxicity category IV). 
Since its discovery no incidents of hypersensitivity have been reported 
by researchers, manufacturers or users.
    A waiver is being requested for acute dermal toxicity/pathogenicity 
based on the fact that there was no toxicity or pathogenicity in the 
pulmonary and injection studies, and no effects were observed in the 
skin irritation study. Dermal toxicity or pathogenicity would not be 
expected for this active ingredient. Finally, the organism has never 
been reported as a pathogen of humans, or as causing any type of 
adverse effect to humans, in published literature or through commercial 
use.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure from use of 
Streptomyces lydicus WYEC 108, as proposed, is minimal. Streptomyces 
lydicus WYEC 108 is applied as a soil mix or soil drench. It is not 
applied to growing crops directly. Residues of Streptomyces lydicus 
WYEC 108 are not expected on agricultural commodities.
    ii. Drinking water. Similarly, exposure to humans from residues of 
Streptomyces lydicus WYEC 108 in consumed drinking water would be 
unlikely. Streptomyces lydicus WYEC 108 is a naturally-occurring soil 
microorganism found in soil types world-wide. While spores of 
Streptomyces lydicus WYEC 108 may be found in aquatic environments, 
possibly because they are washed-in from surrounding terrestrial 
habitats, they are not known to grow or thrive in aquatic environments.
    2. Non-dietary exposure. The potential for non-dietary exposure to 
the general population, including infants and children, is unlikely as 
the proposed use sites are agricultural and horticultural settings. 
However, non-

[[Page 46915]]

dietary exposures would not be expected to pose any quantifiable risk 
due to a lack of residues of toxicological concern. Person protective 
equipment mitigates the potential for exposure to applicators and 
handlers of the proposed products, when used in agricultural and 
horticultural settings.

E. Cumulative Exposure

    It is not expected that, when used as proposed, Streptomyces 
lydicus WYEC 108 would result in residues that would remain in human 
food items.

F. Safety Determination

    1. U.S. population. Streptomyces lydicus WYEC 108 is not pathogenic 
or infective to mammals. There have been no reports of toxins or 
secondary metabolites associated with the organism, and acute toxicity 
studies have shown that Streptomyces lydicus WYEC 108 is non-toxic, 
non-pathogenic, and non-irritating. Streptomyces lydicus WYEC 108 is 
applied to the soil. It is not applied to growing crops directly. 
Residues of Streptomyces lydicus WYEC 108 are not expected on 
agricultural commodities, and therefore, exposure to the general U.S. 
population, from the proposed uses, is not anticipated.
    2. Infants and children. As mentioned above, residues of 
Streptomyces lydicus WYEC 108 are not expected on agricultural 
commodities. There is a reasonable certainty of no harm for infants and 
children from exposure to Streptomyces lydicus WYEC 108 from the 
proposed uses.

G. Effects on the Immune and Endocrine Systems

    Streptomyces lydicus WYEC 108 is a naturally-occurring, non-
pathogenic soil organism. To date there is no evidence to suggest that 
Streptomyces lydicus WYEC 108 functions in a manner similar to any 
known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

    There is no U.S. EPA tolerance established for Streptomyces lydicus 
WYEC 108.

I. International Tolerances

    A Codex Alimentarium Commission Maximum Residue Level is not 
required for Streptomyces lydicus WYEC 108.

II. Encore Technologies LLC

0F6170

    EPA has received a pesticide petition 0F6170 from Encore 
Technologies LLC, 111 Cheshire Lane, Minnetonka, MN 55305, proposing 
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 to establish an exemption from the requirement of a 
tolerance for microbial pesticide Colletotrichum gloeosporioides f. sp. 
malvae.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Encore Technologies LLC has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Encore Technologies LLC 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

    Colletotrichum gloeosporioides f. sp. malvae is a naturally 
occurring fungus that is pathogenic to the weeds round-leaved mallow 
(Malva pusila), small flowered mallow (Malva parviflora), common mallow 
(Malva neglecta), and velvet leaf (Abutilon theophrasti), all of which 
are members of the family Malvaceae. The organism will infect and kill 
round-leaved and small flowered mallows at any stage of growth, from 
seedling to mature plant. Colletotrichum gloeosporioides f. sp. malvae 
causes disease lesions that will completely encircle the stems and 
petioles of mallow, causing the plant to collapse in 2 to 4 weeks.
    The end-use formulation, Mallet WP, is a two-component product. 
Mallet WP Component A consists of a 16-oz. bottle containing a water 
soluble spore nutrient and rehydrating agent that activates the spores 
prior to application. Mallet WP Component M consists of a bag 
containing a water suspendible dried fungal spore formulation of 
Colletotrichum gloeosporioides f. sp. malvae. The product is applied to 
field crops at an early stage to control target weeds.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. 
Colletotrichum gloeosporioides f. sp. malvae was originally isolated 
and characterized by Dr. Knud Mortensen, Agriculture Canada Research 
Scientist, Regina, Saskatchewan in 1982. Colletotrichum gloeosporioides 
f. sp. malvae has been reported as indigenous to the provinces of 
Saskatchewan and Manitoba, occurring as an endemic pathogen of round-
leaved mallow producing lesions on aerial parts. The active ingredient 
is registered in Canada as BioMal for control of round-leaved 
mallow in field crops. Extensive efficacy and field research trials 
were conducted in Canada, with results showing that the organism 
provided consistent and effective control over a wide variety of 
environmental conditions. Since it's discovery in 1982, there have been 
no reports of adverse effects, sensitivity or reaction of any type 
related to use or handling of this organism.
    2. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. An 
analytical method for residues is not applicable. The use of 
Colletotrichum gloeosporioides f. sp. malvae calls for application to 
field crops at an early stage for control of mallow species. 
Consequently, there is a considerable time lag between application and 
harvesting of crops. Since survival of the organism is in part 
dependent on existence of the host plant, it is unlikely that 
application will result in the presence of Colletotrichum 
gloeosporioides f. sp. malvae in food crops. Furthermore, the host weed 
species are not palatable forage for cattle or other livestock 
populations, either through direct feeding upon diseased plants, or 
indirectly through feeding upon crops that have been treated with 
Colletotrichum gloeosporioides f. sp. malvae. Residues of 
Colletotrichum gloeosporioides f. sp. malvae are not expected on 
agricultural commodities.

C. Mammalian Toxicological Profile

    The active ingredient Colletotrichum gloeosporioides f. sp. malvae 
has been evaluated for toxicity through oral, dermal, pulmonary, 
intraperitoneal, and eye routes of exposure. The results of the studies 
have indicated there are no significant human health risks.
    For the active ingredient, the acute oral toxicity/pathogenicity in 
rats is greater than 6 x 105 cfu/(g) grams, the acute dermal 
toxicity/pathogenicity in rats is greater than 4.21 x 107 
cfu/g, the acute pulmonary toxicity/pathogenicity in rats is greater 
than 4.55 x 104 cfu per animal, and the acute 
intraperitoneal toxicity/pathogenicity in rats is greater than 5.7 x 
105 cfu per animal. No pathogenic or infective effects were 
observed in the studies. Data on the end-use formulation is cited from 
the substantially similar product Collego (Colletotrichum 
gloeosporioides f. sp. aeschynomene, EPA Reg. No. 70571-1). For the 
end-use formulation, slight eye irritation in rabbits was observed at a 
dose of 0.1 mL (toxicity category IV) and skin irritation in rabbits 
was not observed at a dose of 0.5 mL (Toxicity Category IV). Since its 
discovery, no

[[Page 46916]]

incidents of hypersensitivity have been reported by researchers, 
manufacturers or users.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Dietary exposure from use of 
Colletotrichum gloeosporioides f. sp. malvae, as proposed, is minimal. 
The use of Colletotrichum gloeosporioides f. sp. malvae calls for 
application to field crops at an early stage for control of mallow 
species. Consequently, there is a considerable time lag between 
application and harvesting of crops. Since survival of the organism is 
in part dependent on existence of the host plant, it is unlikely that 
application will result in the presence of Colletotrichum 
gloeosporioides f. sp. malvae in food crops. Residues of Colletotrichum 
gloeosporioides f. sp. malvae are not expected on agricultural 
commodities.
    ii. Drinking water. Similarly, exposure to humans from residues of 
Colletotrichum gloeosporioides f. sp. malvae in consumed drinking water 
would be unlikely. Colletotrichum gloeosporioides f. sp. malvae is a 
naturally-occurring microorganism known to exist in terrestrial 
habitats in the presence of a host plant, it is not known to grow or 
thrive in aquatic environments.
    2. Non-dietary exposure. The potential for non-dietary exposure to 
the general population, including infants and children, is unlikely as 
the proposed use sites are agricultural settings. However, non-dietary 
exposures would not be expected to pose any quantifiable risk due to a 
lack of residues of toxicological concern. Person protective equipment 
mitigates the potential for exposure to applicators and handlers of the 
proposed products, when used in agricultural settings.

E. Cumulative Exposure

    It is not expected that, when used as proposed, Colletotrichum 
gloeosporioides f.sp. malvae would result in residues that would remain 
in human food items.

F. Safety Determination

    1. U.S. population. Colletotrichum gloeosporioides f. sp. malvae is 
not pathogenic or infective to mammals. There have been no reports of 
toxins or secondary metabolites associated with the organism, and acute 
toxicity studies have shown that Colletotrichum gloeosporioides f. sp. 
malvae is non-toxic, non-pathogenic, and non-irritating. Residues of 
Colletotrichum gloeosporioides f. sp. malvae are not expected on 
agricultural commodities, and therefore, exposure to the general U.S. 
population, from the proposed uses, is not anticipated.
    2. Infants and children. As mentioned above, residues of 
Colletotrichum gloeosporioides f. sp. malvae are not expected on 
agricultural commodities. There is a reasonable certainty of no harm 
for infants and children from exposure to Colletotrichum 
gloeosporioides f. sp. malvae from the proposed uses.

G. Effects on the Immune and Endocrine Systems

    Colletotrichum gloeosporioides f. sp. malvae is a naturally-
occurring, non-pathogenic microorganism. To date there is no evidence 
to suggest that Colletotrichum gloeosporioides f. sp. malvae functions 
in a manner similar to any known hormone, or that it acts as an 
endocrine disrupter.

H. Existing Tolerances

    There is no U.S. EPA Tolerance for Colletotrichum gloeosporioides 
f. sp. malvae.

I. International Tolerances

    A Codex Alimentarium Commission Maximum Residue Level is not 
required for Colletotrichum gloeosporioides f. sp. malvae.
[FR Doc. 00-19347 Filed 7-31-00; 8:45 am]
BILLING CODE 6560-50-F