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Alternaria destruens - Pesticide Petition Filing 1/01

[PF-986; FRL-6755-1]

Notice of Filing a Pesticide Petition to Establish a Tolerance
for a Certain Pesticide Chemical 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 control number PF-986, must be
received on or before February 16, 2001.

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-961 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: By mail: Sharlene Matten,
Biopesticides and Pollution Prevention Division (7511C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (703) 605-0514; e-
mail address: matten.sharlene@epa.gov.

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.

[[Page 4018]]

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-986. 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-986 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: "opp-docket@epa.gov", 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-986. 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.

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 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 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: January 5, 2001.

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

Summary of Petition

The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the view of the
petitioner. The petition summary announces the availability of a
description of the analytical methods available to EPA for the
detection and measurement of the pesticide chemical residues or an
explanation of why no such method is needed.
EPA has received a pesticide petition PP 0F6191 from Platte
Chemical Company, j419 18th Street, Greeley, CO 80632-0667, 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 Alternaria destruens.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Platte

[[Page 4019]]

Chemical Company has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This
summary was prepared by Platte Chemical Company 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.

Platte Chemical Company

PP 0F6191

A. Product Name and Proposed Use Practices

Alternaria destruens is a naturally occurring fungus that is
pathogenic to Cuscuta spp., often referred to as dodder, swamp dodder,
largeseed dodder, field dodder or small seed dodder. The active
ingredient will infect and suppress dodder at early stages of growth.
Dodder is a leafless, rootless weed that is parasitic on cranberries
and other crops, directly reducing vigor. Dodder generally germinates
in late spring, twining stems around the host to derive its nutrients
from that plant.
Two formulations of Alternaria destruens are proposed, one for the
control of emerging dodder and one for the control of dodder that has
attached to and infested the host plant. Smolder L G, a granular
product, is proposed for use on known sites of dodder infestation, as
it emerges in the spring, to suppress dodder growth and seed
production. Smolder L WP, a sprayable product, is proposed for use on
growing dodder, as spot or area treatment to control further growth.
Use sites include vegetables, fruits, field crops and non-agricultural
areas such as uncultivated rights-of-way, roadsides and fallow areas.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues.
Alternaria destruens is a naturally occurring fungus that is pathogenic
to Cuscuta spp., often referred to as dodder, swamp dodder, largeseed
dodder, field dodder or small seed dodder. The active ingredient will
infect and suppress dodder at early stages of growth. Alternaria
destruens requires adequate moisture and temperature during the
infection period (3 to 4 hours). In very dry or drought conditions,
when dew is absent, the onset of the infection process might be delayed
until moisture conditions return. Alternaria destruens has been shown
to survive in nature only on live or dead tissue of the host weed
species. Survival on soil or non-susceptible plant tissue would be
limited.
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 Alternaria
destruens calls for application to field crops at an early stage for
control of dodder 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 Alternaria
destruens in food crops. Residues of Alternaria destruens are not
expected on agricultural commodities.

C. Mammalian Toxicological Profile

The active ingredient Alternaria destruens 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, acute oral toxicity/pathogenicity in
rats is greater than 1 X 10**7 cfu/animal, acute pulmonary
toxicity/pathogenicity in rats is greater than 5 X 10**5 cfu/
animal, and acute intraperitoneal toxicity/pathogenicity in rats is
greater than 9.6 X 10**6 cfu/animal. No pathogenic or
infective effects were observed in the studies. For the end-use
wettable powder formulation, acute dermal toxicity in rats is greater
than 5,000 mg/kg (Toxicity Category IV), acute inhalation toxicity in
rats is greater than 2.03 mg/l (Toxicity Category IV), minimal eye
irritation in rabbits was observed at a dose of 0.1 ml (Toxicity
Category III) and no skin irritation in rabbits was 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.

D. Aggregate Exposure

1. Dietary exposure--i. Food. Dietary exposure from use of
Alternaria destruens, as proposed, is minimal. The use of Alternaria
destruens calls for application to field crops at an early stages for
control of dodder 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 Alternaria
destruens in food crops. Residues of Alternaria destruens are not
expected on agricultural commodities.
ii. Drinking water. Similarly, exposure to humans from residues of
Alternaria destruens in consumed drinking water would be unlikely.
Alternaria destruens 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 (PPE) 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, Alternaria
destruens would result in residues that would remain in human food
items.

F. Safety Determination

1. U.S. population. Alternaria destruens 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 Alternaria destruens is non-toxic, non-pathogenic, and
non-irritating. Residues of Alternaria destruens 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 Alternaria
destruens are not expected on agricultural commodities. There is a
reasonable certainty of no harm for infants and children from exposure
to Alternaria destruens from the proposed uses.

G. Effects on the Immune and Endocrine Systems

Alternaria destruens is a naturally-occurring microorganism. To
date there is no evidence to suggest that Alternaria destruens
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 Alternaria destruens.

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I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not
required for Alternaria destruens.

[FR Doc. 01-1353 Filed 1-16-01; 8:45 am]
BILLING CODE 6560-50-S