[Federal Register Volume 67, Number 2 (Thursday, January 3, 2002)]
[Notices]
[Pages 323-326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-113]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-1010; FRL-6773-6]
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-1010, must be
received on or before February 4, 2002.
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-1010 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Carol E. Frazer, Ph.D.,
Biopesticides and Pollution Prevention Division (7511C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (703) 308-8810; 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,'' ``Regulations 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-1010. 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-1010 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-1010. 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.
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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, Biopesticides,
Feed additives, Food additives, Pesticides and pests, Pollution
prevention, Reporting and recordkeeping requirements.
Dated: December 20, 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 petitioners 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 1F6244 from Nutra-Park Inc.,
8383 Greenway Blvd., Suite 520, Middleton, WI 53562, 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 biochemical pesticide Lysophosphatidylethanolamine (LPE) in or on
all food commodities.
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.
I. Nutra-Park Inc.
PP 1F6244
A. Product Name and Proposed Use Practices
The commercial name for the end use product containing
Lysophosphatidylethanolamine (LPE) is LPE E94; 10% Aqueous, EPA File
Symbol 70515-R. Presently, the product is being registered for use as a
pre-harvest and post-harvest ripening and shelf life enhancer for
fruits and vegetables. As a pre-harvest spray, 100 400 parts per
million (ppm) of the active ingredient is sprayed on the raw
agricultural commodities until run-off. As a post-harvest treatment,
the raw agricultural commodities are dipped into or sprayed with a
solution containing 25 100 ppm and air dried prior to storage.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. The active
ingredient LPE is a phospholipid derived from phosphatidylethanolamine
(PE) by the enzymatic removal of one fatty acid. The residues in or on
raw agricultural commodities are likely to be primarily the LPE. Small
amounts of free fatty acid, phosphate and ethanolamine may be present.
However, none of the residues would be distinguishable from the
naturally occurring moieties.
2. Magnitude of residue at the time of harvest and method used to
determine the residue. The current analytical methodology cannot
distinguish between naturally occurring residues and those residues
resulting from the application of LPE. LPE is found in large quantities
in egg yolk and meat. LPE is naturally present in small amounts in
plant tissues and other biological matrices and can account for up to
10% of the phospholipid content of cell membranes. The additional
amount of LPE as a result of its use as a ripening agent and shelf life
enhancer will not significantly add to the amount of naturally
occurring residues.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. As stated
above, the current analytical methodology cannot distinguish between
naturally occurring residues present in or on the raw agricultural
commodities and the residues resulting from application of the product.
Based on the natural occurrence of the chemical, its favorable
toxicological profile and inconsequential exposure resulting from
label-directed uses, measuring of the residues is not warranted.
C. Mammalian Toxicological Profile
Based on the available acute toxicity data, LPE technical and its
20% formulation, do not pose any acute toxicity risks. The acute
toxicity studies place LPE technical in acute toxicity category IV for
acute oral (LD50 >5,000 milligrams/kilograms (mg/kg) male
and female), inhalation (LC50 >2.5mg/L male and female),
skin irritation (dermal irritation index is 0.0), and eye irritation
(no irritation at 72 hours) and toxicity category III for acute dermal
(LD50 >2,000 mg/kg male and female). The acute toxicity
studies place the LPE 10% formulation in acute toxicity category IV for
acute oral (LD50 >5,000 mg/kg male and female), eye
irritation (no irritation at 72 hours), skin irritation (dermal
irritation index is 0.0), and inhalation (LC50 >4.63 mg/L
male and female) and toxicity category III for acute dermal
(LD50 >2,000 mg/kg male and female). Both LPE technical and
its 10% formulation cause skin sensitization in the guinea pig.
Information on the chronic effects of LPE is obtained from the open
literature. LPE and related phospholipids, such as phosphatidylcholine,
phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol,
phosphatidic acid, phosphatidylglycerol, lysophosphatidylcholine, and
lysophosphatidylserine, are synthesized by microorganisms, plants and
animals. These important biomolecules are ubiquitous in nature and have
multifunctional properties in living cells. Lysophospholipids are
continuously generated in microbial, plant and animal systems and are
readily utilized in various cell functions or used in synthesizing new
phospholipids. All phospholipids have specific roles in executing
certain cellular functions and maintaining the integrity of cellular
membranes. Furthermore, these biomolecules are of immense importance to
various food and non-food industries as safe multifunctional natural
additives/
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ingredients. Presence of hydrolytic enzymes, known as lipases,
phospholipases and lysophospholipases, in microbial (including soil
microorganisms), plant and animal (including humans) systems ensures
the biodegradation of phospholipids and their lyso counterparts into
harmless metabolites/by-products.
D. Aggregate Exposure
1. Dietary exposure--i. Food. LPE is a member of the phospholipids.
Phospholipids are a heterogeneous group of compounds that are classed
together partially on the basis of solubility and partially on the
basis of the ester phosphorus present in the compounds. Phospholipids
are found in all cellular organisms as part of the structure of the
cellular membrane.
The framework of membranes surrounding the cell and intracellular
organelles is composed of a bilayer of lipid. The basic unit of the
bilayer is a composite of phospholipids (phosphatidylcholine,
sphingomyelin, phosphatidylethanolamine, phosphatidylserine,
phosphatidylinositol). LPE is a phospholipid derived from
phosphatidylethanolamine by the enzymatic removal of one fatty acid.
Residues of LPE naturally occur in raw agricultural commodities and are
consumed daily. The level of residues of LPE in raw agricultural
commodities through the use of this product will not be significantly
increased over the level naturally occurring.
ii. Drinking water. Because of the benign nature of the compound
and because it is composed of moieties that are consumed by all
organisms, dissipation of LPE in the environment will, in all
likelihood, be through microbial mediated degradation. There is little
or no possibility of LPE leaching into the ground water. LPE may get
into surface water during a run-off event. However, microbial
degradation will rapidly remove the residues. The levels of residues
that might get into ground or surface water used for drinking water
will not be significant compared to the exposure from naturally
occurring residues of LPE.
2. Non-dietary exposure. The potential for non-dietary exposure to
the general population, including infants and children, is unlikely as
the potential use sites are commercial, agricultural, and horticultural
settings. However, non-dietary exposure would not be expected to pose
any quantifiable risk due to a lack of residues or a level of residues
present that are of no toxicological concern.
E. Cumulative Exposure
Based on its abundance in nature and long history of use by humans
without deleterious effects, there is reasonable certainty that no harm
will result from aggregate exposure to the U.S. population, including
infants and children, to residues of LPE. This includes all anticipated
dietary exposures and all other exposures for which there are reliable
information. The exposure to LPE as a result of its label directed use
on raw agricultural food or feed commodities will not result in a
significant increase in the cumulative exposure over the present
exposure, daily consumption by the human population from both naturally
occurring sources and from processed foods.
F. Safety Determination
1. U.S. population. LPE is naturally present in small amounts in
plant tissues and other biological matrices and can account for up to
10% of the phospholipid content of cell membranes. LPE is found in many
food or feed commodities such as human breast milk, cow milk, corn
grain and starch, oats and wheat. Large quantities are present in egg
yolk and meat. Based on its abundance in nature and long historical use
of the ingredient by the human population without deleterious effects,
there is reasonable certainty that no harm will result from aggregate
exposure to the U.S. population.
2. Infants and children. LPE is found in mother's milk and in cow
milk. It is also present in egg yolk and meat and corn, oats, and
wheat. These commodities do constitute a significant percentage of
infant and children diets. Based on its long consumption by infants and
children without deleterious effects, there is reasonable certainty
that no harm will result from this additional inconsequential exposure
to infants and children.
G. Effects on the Immune and Endocrine Systems
LPE is a naturally occurring residue in raw agricultural food and
feed commodities and in processed food. To date, there is no evidence
to suggest that LPE affects the immune system, functions in a manner
similar to any known hormone, or that it acts as an endocrine
disruptor.
H. Existing Tolerances
LPE is a constituent naturally found in eggs and various animal
tissue derived products (e.g., fish meal, fish oil, lard, meat meal)
already exempted from regulation under section 25(b)(2) of the Federal
Insecticide, Fungicide, and Rodenticide Act. There is a temporary
exemption from the requirement of a tolerance established specific to
LPE (40 CFR 180.1199).
I. International Tolerances
Nutra-Park Inc. is not aware of any tolerance, exemption from
tolerance, or maximum residue level issued for LPE.
[FR Doc. 02-113 Filed 1-2-02; 8:45 am]
BILLING CODE 6560-50-S