[Federal Register Volume 65, Number 169 (Wednesday, August 30, 2000)]
[Notices]
[Pages 52749-52751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22012]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-965; FRL-6739-8]


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-965, must be 
received on or before September 29, 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-965 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.

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-965. 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,

[[Page 52750]]

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-965 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-965. 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 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 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: August 17, 2000.

  Kathleen D. Knox, Acting

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.

Plant Products Company Ltd.

0F6136

    EPA has received a pesticide petition 0F6136 from Plant Products 
Co. Ltd., f314 Orenda Rd., Brampton, Ontario, Canada L6T 1G1, 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 the microbial pesticide Pseudozyma flocculosa in or on 
all raw agricultural commodities (RAC). Pursuant to section 
408(d)(2)(A)(i) of the FFDCA, as amended, Plant Products Co. Ltd. has 
submitted the following summary of information, data, and arguments in 
support of their pesticide petition. This summary was prepared by Plant 
Products Co. Ltd. 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 Pseudozyma flocculosa is formulated into the 
end use product called Sporodex WP Biological Fungicide. Sporodex is a 
wettable powder that controls powdery mildew on greenhouse-grown 
English seedless cucumbers and roses.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Pseudozyma 
flocculosa is widely distributed as a saprophytic fungal epiphyte and 
as a

[[Page 52751]]

hyperparasite of powdery mildews in Canada, the U.S., and Europe on 
aerial plant surfaces in field or greenhouse agricultural ecosystems. 
Pseudozyma flocculosa is readily isolated by standard techniques and 
will grow aerobically on most artificial substrates in liquid and solid 
fermentations with an optimal pH in the acidic pH range of 4.5-6.8. It 
assimilates glucose, lactose, maltose, myo-inositol, xylose, ethanol 
and will grow and sporulate on cellulosic, chitinous, and keratinous 
natural substrates and is hyperparasitic on powdery mildews.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. This section is not applicable, as this proposes 
an exemption from the requirement of a tolerance.
    3. 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, as this proposes an 
exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

    No evidence of pathogenicity or infectivity of Sporodex has been 
demonstrated following acute oral gavage, intraperitoneal and 
intratracheal challenge studies in rats. No toxicity has been shown 
following a single oral dose in rats. No toxicity or irritation was 
observed following a single dermal application in rabbits. Slight 
toxicity was observed following a single intraperitoneal challenge in 
rats. However, toxicity observed was due to normal immune response to 
foreign material deposited in the peritoneal cavity. Toxicity was 
observed in rats dosed by intratracheal challenge. Mortality was 
associated with the quantity of test material delivered (6 x 10\7\ 
cells or 3.2 x 10\7\ cfu) which was the highest dose deliverable. In an 
additional study, the minimum lethal dose was shown to be higher than 6 
x 10\7\ cells, which was the highest dose deliverable. Other signs of 
toxicity following intracheal challenge were associated with normal 
immune responses to foreign material in the lung. No reports of human 
toxicity have been made from those working directly with this microbe 
for the past 10 years. Conjunctival erythema was seen in five of six 
rabbits at the 1-scoring, and in two of six rabbits at the 24-hour 
scoring interval. The highest primary irritation score observed during 
the study was 1.7 (maximum possible score=110) at the 1-hour scoring 
interval. No signs of ocular irritation were observed in any rabbits at 
or following the 48-hour scoring interval. The bioactive compounds 
produced by Pseudozyma flocculosa are not known as genotoxins.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Pseudozyma flocculosa does not 
exhibit any mammalian toxicity. Therefore, any dietary exposure would 
not be harmful to humans. Also, Pseudozyma flocculosa is a naturally 
occurring, ubiquitous microorganism indigenous to the United States and 
Canada.
    ii. Drinking water. Since, the proposed use is for indoor 
application in greenhouses only, residues of Pseudozyma flocculosa are 
unlikely to occur in drinking water. Also, Psuedozyma flocculosa does 
not exhibit any mammlian toxicity, therefore any exposure through 
drinking water would not be harmful to humans.
    2. Non-dietary exposure. Plant Products Co. Ltd. believes that the 
potential for non-dietary exposure to the general population, including 
infants and children, is unlikely as the proposed use sites are 
primarily agricultural and horticultural and that non-dietary exposures 
would not be expected to pose any quantifiable risks due to lack of 
residues of toxicological concern.

E. Cumulative Exposure

    Consideration of a common mode of toxicity is not appropriate, 
given that there is no indication of mammalian toxicity of Pseudozyma 
flocculosa and no information to indicate that toxic effects would be 
cumulative with any other compounds.

F. Safety Determination

    1. U.S. population. The lack of toxicity of Pseudozyma flocculosa 
has been demonstrated by the results of acute toxicity testing in 
mammals in which Pseudozyma flocculosa caused no adverse effects when 
dosed oral and via inhalation. Thus, the aggregate exposure to 
Pseudozyma flocculosa over a lifetime should pose negligible risks to 
human health.
    2. Infants and children. Based on the lack of toxicity and low 
exposure, there is a reasonable certainty that no harm to infants, 
children, or adults will result from aggregate exposure to Pseudozyma 
flocculosa residues. Exempting Pseudozyma flocculosa from the 
requirement of a tolerance should pose no significant risk to humans or 
the environment.

G. Existing Tolerances

    Plant Products Co. Ltd. has no information to suggest that 
Pseudozyma flocculosa will adversely affect the immune or endocrine 
systems.

H. International Tolerances

    Plant Products Co. Ltd. is not aware of any tolerances, exemptions 
from tolerance or maximum residue levels issued for Pseudozyma 
flocculosa outside of the U.S.
[FR Doc. 00-22012 Filed 8-29-00; 8:45 am]
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