[Federal Register Volume 62, Number 237 (Wednesday, December 10, 1997)]
[Notices]
[Pages 65077-65079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32183]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-770; FRL-5749-3]


Notice of Filing of a Pesticide Petition

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 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by the docket control number PF-770, must 
be received on or before January 9, 1998.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch (7502C), Information Resources and Services 
Division, Office of Pesticides Programs, Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments 
to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under ``SUPPLEMENTARY 
INFORMATION.'' No confidential business information should be submitted 
through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information''

[[Page 65078]]

(CBI). CBI should not be submitted through e-mail. Information marked 
as CBI will not be disclosed except in accordance with procedures set 
forth in 40 CFR part 2. A copy of the comment that does not contain CBI 
must be submitted for inclusion in the public record. Information not 
marked confidential may be disclosed publicly by EPA without prior 
notice. All written comments will be available for public inspection in 
Rm. 1132 at the address given above, from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Sheila A. Moats, Regulatory 
Action Leader, Biopesticides and Pollution Prevention Division (7511W), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St. SW., Washington, DC 20460. Office location and telephone number: 
5th floor CS #1, 2800 Crystal Drive, Arlington, VA 22202, (703) 308-
1259; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition 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 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 supports 
granting of the petition. Additional data may be needed before EPA 
rules on the petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number [PF-770] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket control number [PF-770] and appropriate petition number. 
Electronic comments on this notice may be filed online at many Federal 
Depository Libraries.

List of Subjects

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

    Dated: November 26, 1997.

Janet L. Andersen,

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

Summary of the Petition

    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. EPA is publishing the petition summary verbatim without 
editing it in any way. 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.

J P BioRegulators Inc.

PP 7G4892

    EPA has received a pesticide petition (7G4892) from J P 
BioRegulators Inc, 1611 Maple St., Middleton, Wisconsin 53562, 
proposing pursuant to section 408(d) of the Federal Food, Drug and 
Cosmetic Act, 21 U.S.C. 346a, to amend 40 CFR part 180 by establishing 
an exemption from the requirement of a tolerance for residues of 
phospholipid in or on grapes, tomatoes, apples, pear, peaches, 
nectarines, citrus, cranberries, and strawberries. Pursuant to section 
408(d)(2)(A)(I) of the FFDCA, as amended, J P BioRegulators Inc., has 
submitted the following summary of information, data, and arguments in 
support of their pesticide petition. This summary was prepared by J P 
BioRegulators Inc., and EPA has not fully evaluated the merits of the 
petition. The summary may have been edited by EPA if the terminology 
used was unclear, the summary contained extraneous material, or the 
summary was not clear that is reflected the conclusion of the 
petitioner and not necessarily EPA.

A. Proposed Use Practices

    An experimental use permit and temporary tolerance for phospholipid 
is being proposed for the following sites: grapes, tomatoes, apples, 
pear, peaches, nectarines, citrus, cranberries and strawberries in 
Arizona, California, Florida, Massachusetts, Michigan, Ohio, 
Washington, West Virginia and Wisconsin on a total of 570 acres/year 
for a 3 year period.
    Phospholipid is used to enhance the ripening and shelf life of 
fruits. 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.
    Phospholipid is sprayed at the rate of 100-500 ppm Lyso PE 
(lysophosphatidylethanolamine, a specific type of phospholipid) mixed 
in water. Application rate will be 50-200 gallons per acre. Preharvest 
applications are made May through October and post harvest application 
is extended into December. Treatment is made either 2 weeks prior to 
harvest or within 1-4 weeks after harvest.

B. Product Identity/Chemistry

    The active ingredient is phospholipid (Lyso PE). 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, cows milk, corn grains, corn 
starch, oats and wheat which are exempted from regulation under 
section25(b)(2) of FIFRA.

C. Toxicological Profile

    Waivers for toxicology studies have been requested for 
phospholipid. Phospholipid is a fat found in food consumed by humans, 
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

[[Page 65079]]

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--food. It is anticipated that residues of 
phospholipid will be negligible in treated raw agricultural 
commodities. Due to the products lack of mammalian toxicity, any 
exposure if it occurred will not be harmful to humans. It is not 
anticipated that residues of phospholipid will occur in drinking water.
    2. Non-dietary exposure, non-occupational exposure. Increased non-
dietary exposure of phospholipid via lawn care, topical insect 
repellents, etc., is not applicable to this EUP application.

E. Cumulative Exposure

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

F. Endocrine Disruptors

    J P Bioregulators Inc., has no information to suggest that 
phospholipid will adversely affect the immune or endocrine systems.

G. Safety Considerations

    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 temporay 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. 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.

H. Analytical method

    An analytical method for residues is not applicable as this 
proposes an exemption from the requirement of a tolerance.

I. Existing Tolerances

    No tolerances or exemptions from the requirement of tolerance have 
been established or applied for domestically or internationally other 
than subject petition.

[FR Doc. 97-32183 Filed 12-9-97; 8:45 am]
BILLING CODE 6560-50-F