[Federal Register Volume 66, Number 85 (Wednesday, May 2, 2001)]
[Notices]
[Pages 21973-21976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11000]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-992; FRL-6762-8]


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.

[[Page 21974]]


DATES: Comments, identified by docket control number PF-992, must be 
received on or before June 1, 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-992 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Carol E. Frazer, PhD., 
Biopesticides and Pollution Prevention Division, Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8810; e-mail address: 
frazer.carol @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 code          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,'' ``Regulatations and Proposed Rules`` 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-992. 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-992 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-992. 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.

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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 Comestic 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: April 19, 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 
petitioners. 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 0G6222 from Nutra-Park Inc., 
formerly known as JP BioRegulators, Inc., 3230 Deming Way, Suite 125, 
Middleton, WI 53562, through Interregional Research Project Number 4 
(IR-4), Technology Centre of New Jersey, Rutgers University, 681 U.S. 
Highway #1 South, proposing pursuant to section 408(d) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 USC 346a(d), to amend 40 CFR 
part 180 to establish an amendment/expansion of an existing tolerance 
exemption for the biochemical pesticide Lysophosphatidylethanolamine, 
also known as Lyso-PE and LPE.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Nutra-Park Inc. has submitted the following summary of information, 
data, and arguments in support of their pesticide petition. This 
summary was prepared by Nutra-Park 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.

 Nutra-Park Inc.

PP 0G622

A. Product Name and Proposed Use Practices

    Lysophosphatidylethanolamine, a specific type of phospholipid, is 
used to enhance the ripening and shelf life of the following fruits: 
Apples, citrus, cranberries, grapes, nectarines, peaches, pears, 
strawberries, tomatoes, blueberries, peppers, and cherries. 
Phospholipid enhances ethylene production thus stimulating and 
promoting ripening, but does not enhance respiration so that fruit 
stays firmer and has a longer shelf life.
    Lysophosphatidylethanolamine is sprayed at the rate of 12-500 ppm 
of active ingredient. Application rate will be 50-200 gallons per acre. 
Preharvest applications are made May through October and post-harvest 
application, by dipping fruit in solution and air drying, is extended 
into December. Treatment is made either 2 weeks prior to harvest or 
within 1-4 weeks after harvest.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. The active 
ingredient is lysophosphatidylethanolamine, a specific type of 
phospholipid. The mechanism by which phospholipid enhances ripening is 
as a growth regulator. It has been observed empirically that 
phospholipid stimulates ethylene production, but not respiration of 
plant tissues although the exact mechanism is not fully understood. 
Phospholipid is present in all cells in all organisms. It is part of 
cell membranes. About 50% of the cell membrane is composed of lipid of 
which the major constituent is phospholipid. Lyso-PE (a specific member 
of the phospholipid group) is present in high quantities in food 
products containing egg yolk and meat. In dried egg yolk, Lyso-PE 
constitutes 2% of the lipids present. Lyso-PE is also found in egg 
solids, cow's milk, corn grains, corn starch, oats and wheat which are 
exempted from regulation under section 25(b)(2) of FIFRA.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. This section is not applicable, as this proposes 
a temporary 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 a 
temporary exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

    Waivers for toxicology studies have been requested for 
phospholipid. Phospholipid is a fat found in food consumed by humans 
and animals, and is non-toxic to humans and animals. Sufficient data 
exist to assess the hazards of phospholipid and to make a determination 
on aggregate exposure, consistent with section 408 (c)(2), for the 
exemptions from the requirement of a tolerance. The exposures, 
including dietary exposure, and risks associated with establishing the 
requested exemption from the requirement of a tolerance follows.
    Phospholipid is present in all cells in all organisms. It is part 
of the cell membranes. Lyso-PE (a specific phospholipid) is present in 
high quantities in food products containing egg yolk and meat. In dried 
egg yolk, the Lyso-PE constitutes 2% of the fat present. Egg solids are 
widely used in food products. In the USA, about 18 billion eggs are 
broken per year to produce egg white and egg solids. Because of this, 
all acute toxicity, genotoxicity, and subchronic toxicity studies 
normally required for biochemical pesticides are waived.

D. Aggregate Exposure

    Phospholipid is present in all cells in all organisms. It is a part 
of the cell membrane. Phospholipid is present in high quantities in 
food products containing egg yolk and meat.
    1. Dietary exposure--i. Food. It is anticipated that residues of 
phospholipid will be negligible in treated raw agricultural 
commodities. Due to the product's lack of mammalian toxicity, any 
exposure, if it occurred, will not be harmful to humans.
    ii.  Drinking water.  It is not anticipated that residues of 
phospholipid will occur in drinking water.
    2. Non-dietary exposure. Nutra-Park Inc. is not aware of any non-
dietary exposures.

E. Cumulative Exposure

    There is no anticipated potential for cumulative effects of 
phospholipid since it does not have a mode of

[[Page 21976]]

toxicity. No cumulative effects are expected with other substances.

F. Safety Determination

    1. U.S. population. The lack of toxicity of phospholipid is 
demonstrated by the above summary. Based on this information, the 
aggregate exposure to phospholipid over a lifetime should not pose 
appreciable risks to human health. There is a reasonable certainty that 
no harm will result from aggregate exposure to phospholipid residues. 
Exempting phospholipid from the requirement of a temporary tolerance 
should be considered safe and pose insignificant risk.
    Egg solids are widely used in food products. In dried egg yolk, 2% 
of the lipids are Lyso-PE.
    2. Infants and children. Egg yolks are used in a variety of foods 
including baby food and infant formula. Lyso-PE is also present in 
human breast milk. There is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to phospholipid 
residues.

G. Effects on the Immune and Endocrine Systems

    Nutra-Park Inc. has no information to suggest that phospholipid 
will adversely affect the immune or endocrine systems.

H. Existing Tolerances

    A temporary tolerance exemption on apples, citrus, cranberries, 
grapes, nectarines, peaches, pears, strawberries and tomatoes in 
conjunction with Experimental Use Permits for 
lysophosphatidylethanolamine is currently in effect (63 FR 32131) June 
12, 1998, and has been extended to June 2003.

I. International Tolerances

    Nutra-Park Inc. is not aware of any international tolerances of 
this biochemical.
[FR Doc. 01-11000 Filed 5-1-01; 8:45 am]
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