[Federal Register Volume 66, Number 11 (Wednesday, January 17, 2001)]
[Notices]
[Pages 4017-4020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1353]


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ENVIRONMENTAL PROTECTION AGENCY

[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: [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.

[[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: ``[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-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 107 cfu/animal, acute pulmonary 
toxicity/pathogenicity in rats is greater than 5 X 105 cfu/
animal, and acute intraperitoneal toxicity/pathogenicity in rats is 
greater than 9.6 X 106 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.

[[Page 4020]]

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