[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]
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