[Federal Register Volume 63, Number 113 (Friday, June 12, 1998)]
[Rules and Regulations]
[Pages 32131-32134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15597]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300672; FRL-5795-7]
RIN 2070-AB78
Phospholipid: Lyso-PE (lysophosphatidylethanolamine); Time-
Limited Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a time-limited tolerance for residues of
the biochemical phospholipid: Lyso-PE (lysophosphatidylethanolamine) on
apples, citrus, cranberries, grapes, nectarines, peaches, pears,
strawberries, and tomatoes when used to promote pre-harvest and post-
harvest ripening and extend the storage shelf life. J P BioRegulators,
Inc. submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act of
1996 (FQPA) (Pub. L. 104-170) requesting the time-limited tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of phospholipid. The tolerance will expire on June
1, 2001.
DATES: This regulation is effective June 12, 1998. Objections and
requests for hearings must be received by EPA on or before August 11,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300672], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP ``Tolerance Fees'' and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk identified
by the docket control number, [OPP-300672], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 119,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300672]. No Confidential Business Information
(CBI) should be submitted through e-mail. Copies of electronic
objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Sheila A. Moats, Regulatory
Action Leader, Biopesticides and Pollution Prevention Division (7511C),
Environmental Protection Agency, 401 M St., SW, Washington, DC 20460.
Office location, telephone number, and e-mail address: 9th fl., CM #2
1921 Jefferson Davis Hwy., Arlington, VA 22202, (703) 308-1259; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: J P BioRegulators Inc., 1611 Maple Street,
Middleton, Wisconsin 53562, has requested in pesticide petition (PP
7G4892) the establishment of a temporary exemption from the requirement
of a tolerance for residues of the biochemical phospholipid. A notice
of filing was published in the Federal Register on December 10, 1997
(62 FR 65077)(FRL-5749-3), and the notice announced that the comment
period would end on January 11, 1998; no comments were received. This
temporary exemption from the requirement of a tolerance will permit the
marketing of apples, citrus, cranberries, grapes, nectarines, peaches,
pears, strawberries, and tomatoes when treated in accordance with the
provisions of the experimental use
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permit 70515-EUP-1, which is issued under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended (Pub. L. 95-396, 92
Stat. 819; 7 U.S.C. 136). The data submitted in the petition and all
other relevant materials have been evaluated. Following in Unit II. of
this preamble is a summary of EPA's findings regarding this petition as
required by section 408(d) of the FFDCA, 21 U.S.C. 346a, as recently
amended by the FQPA, Pub. L. 104-170.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to
mean that ``there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue...'' EPA performs a number of analyses to determine the risks
from aggregate exposure to pesticide residues. First, EPA determines
the toxicity of pesticides. Second, EPA examines exposure to the
pesticide through food, drinking water, and through other exposures
that occur as a result of pesticide us in residential settings.
II. Summary
A. Proposed Use Practices
The experimental program will be conducted in the States of
Arizona, California, Florida, Massachusetts, Michigan, Ohio,
Washington, West Virginia and Wisconsin. Crops to be treated are
apples, citrus, cranberries, grapes, nectarines, peaches, pears,
strawberries, and tomatoes. Prior to use Lyso-PE
(lysophosphatidylethanolamine, a specific type of phospholipid) is
diluted with water to 1%, i.e., 10,000 ppm of the active ingredient
Lyso-PE. Next 1 to 5 gallons of the 1% Lyso-PE solution is mixed with
sufficient water to prepare 100 gallons of spray solution containing
100 to 500 ppm of active ingredient. This solution is sprayed to run-
off for pre-harvest application. The pre-harvest treatment should be
limited to one application only. For post-harvest treatment fruit will
be dipped in the solution prepared as described above for 30 minutes,
and air dry prior to storage. The rate of application for both pre and
post-harvest is equivalent to 0.083-0.14 lbs of active ingredient per
100 gallons of water. The proposed experimental use program (EUP) would
utilize 72/kg/year of formulated product. A maximum of 570 acres
located in nine states will be treated under this EUP. Lyso-PE is
intended for enhancing and ripening the shelf life of fruits.
B. Product Identity/Chemistry
The active ingredient Lysophosphatidylethanolamine (Lyso-PE), is a
phospholipid derived from phosphatidylethanolamine (PE) by the
enzymatic removal of one fatty acid. PE is found in large quantities in
egg yolk and meat. Lyso-PE 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. Lyso-PE is found in
many food commodities such as human breast milk, cow milk, corn grain
and starch, oats and wheat. The current analytical methodology cannot
distinguish between product ingredients present in or on food
commodities following application of the product, and those ingredients
that are naturally present in the food commodities. Lyso-PE is a fine
white powder, with a pH of 6 to 8. Its specific gravity is
approximately 1g/mL.
C. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
Additionally, section 408(b)(2)(D)(v) requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Waivers of data requirements for toxicology and non-target
organisms were requested and information obtained from the open
technical literature was used to support the request. Waivers were
accepted on the basis of favorable toxicological profile, the natural
occurrence of the chemical, and inconsequential exposure resulting from
label-directed uses.
D. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from groundwater or surface water and exposure
through pesticide use in gardens, lawns, or buildings (residential and
other indoor uses).
1. Dietary exposure. Dietary exposure due to topical applications
of the phospholipid Lyso-PE is difficult to estimate because of its
prevalence in nature; applications associated with the EUP would be
minuscule compared to levels found in nature. Phospholipid in the
environment is readily utilized by microorganisms. Furthermore,
phospholipid is consumed by humans in the form of eggs, milk, grains
etc. in relatively large quantities. The low toxicity, low application
rate, and the use pattern leads the Agency to conclude that residues
from the use of the phospholipid biochemical Lyso-PE will not pose a
dietary risk of concern under foreseeable circumstances. Therefore, EPA
concludes that there is a reasonable certainness of no harm from
aggregate exposure under this temporary exemption.
2. Non-dietary, non-occupational exposure. Increased non-dietary
exposure to Lyso-PE via lawn care, topical insect repellents, etc., is
not applicable to this EUP.
E. Cumulative Exposure to Substances with Common Mechanisms of Toxicity
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
Phospholipid is ubiquitous in nature. Incremental exposure
resulting from this EUP program are minuscule when compared to the
levels found naturally-occurring in food.
F. Safety Factors
Phospholipid is naturally occurring in food and is present in all
cells in all organisms. Incremental exposure to
[[Page 32133]]
phospholipid resulting from this EUP is minuscule. Considering the
negligible contributions to the environment resulting from the
application of Lyso-PE, the abundance and role of phospholipid in foods
and in cells of all living organisms and its prevalence in nature, the
Agency concludes that the application of Lyso-PE to the aforementioned
crops does not pose a dietary risk.
III. Other Considerations
A. Endocrine Disruptors
The Agency has no information to suggest that Lyso-PE will
adversely affect the immune or endocrine systems. The Agency is not
requiring information on the endocrine effects of this biochemical
pesticide at this time; Congress had allowed three years after August
3, 1996, for the Agency to implement a screening program with respect
to endocrine effects.
B. Analytical Method
An analytical method using High Performance Liquid Chromatography
(HPLC/ELSD) for determining phospholipid content in Lyso-PE the end-use
product, is available; however, because this phospholipid is found
naturally in cells of all organisms, the Agency has determined that
residue analysis would not yield meaningful results, i.e.,the analysis
would not discern whether the source of phospholipid was from cells of
organisms or the product treatment.
C. Codex Maximum Residue Level
There are no CODEX tolerances or international tolerance exemptions
for Lyso-Pe at this time.
IV. Conclusion
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 Lyso-PE. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. The Agency has arrived at this conclusion
because, as discussed above, exposure to Lyso-PE resulting from the EUP
label-directed use is inconsequential, and it is consumed daily by the
human population from both naturally-occurring sources and from
processed foods. As a result, EPA establishes a temporary exemption
from the requirement of a tolerance pursuant to FFDCA section 408(j)(3)
for Lyso-PE (lysophosphatidylethanolamine) on the condition that it be
used in accordance with the experimental use permit 70515-EUP-1, with
the following provisions:
1. The total amount of the active ingredients to be used must not
exceed the quantity authorized by the experimental use permits.
2. J P BioRegulators, Inc., must immediately notify the EPA of any
findings from the experimental use that have a bearing on safety. The
company must also keep records of production, distribution, and
performance and on request make the records available to any authorized
officer or employee of the EPA or the Food and Drug Administration
(FDA).
This temporary exemption from the requirement of a tolerance
expires and is revoked on June 1, 2001. Residues remaining in or on the
raw agricultural commodity after this expiration date will not be
considered actionable if the biochemical is legally applied during the
term of, and in accordance with, the provisions of the amended
experimental use permit and temporary exemption from the requirement of
a tolerance. This temporary exemption from the requirement of a
tolerance may be revoked if the experimental use permit is revoked or
if any experience with or scientific data on this pesticide indicate
that the tolerance is not safe.
EPA will publish a document in the Federal Register to remove the
revoked temporary exemption from the Code of Federal Regulations.
V. Objections and Hearing Requests
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section
408(d)and as was provided in the old section 408 and in section 409.
However, the period for filing objections is 60 days, rather than 30
days. EPA currently has procedural regulations which governs the
submission of objections and hearing requests. These regulations will
require some modification to reflect the new law. However, until those
modifications can be made, EPA will continue to use those procedural
regulations with appropriate adjustments to reflect the new law.
Any person may, by August 11, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
hearing clerk, at the address given under the ``Addresses'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the hearing clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issues(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). A request for
a hearing will be granted if the Administrator determines that the
material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issues(s) in the manner sought by the
requestor would be adequate to justify the action requested (40 CFR
178.32). Information submitted in connection with an objection or
hearing request may be claimed confidential 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. A copy
of the information 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.
VI. Public Record and Electronic Submissions
A record has been established for this rulemaking under docket
control number [OPP-300672]. A public version of this record, 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 public record is located in Room 119 of the Public
Information and Records Integrity Branch, Information Resources and
Services Division(7502C), Office of Pesticide Programs, Environmental
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202.
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.
The official record for this rulemaking, as well as the public
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version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing request, EPA will transfer any
copies of objections and hearing requests received electronically into
printed, paper form as they are received and will place the paper
copies in the official rulemaking record. The official rulemaking
record is the paper record maintained at the Virginia address in
Addresses at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub.L. 104-4). Nor does it require and prior
consultation as specified by Executive Order 12875, entitled Enhancing
the Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629), February 16,
1994), or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). In additions, since
tolerance exemptions that are established on the basis of a petition
under FFDCA section 408(d), such as the exemption in this final rule,
do not require the issuance of a proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
Nevertheless, the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 3, 1998.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.1199 is added to subpart D to read as follows:
Sec. 180.1199 Phospholipid: Lyso-PE (lysophosphatidylethanolamine);
temporary exemption from the requirement of a tolerance.
The phospholipid biochemical Lyso-PE
(lysophosphatidylethanolamine); is temporarily exempted from the
requirement of a tolerance for residues when used on crops including:
apples, citrus, cranberries, grapes, nectarines, peaches, pears,
strawberries, and tomatoes. This temporary exemption from the
requirement of a tolerance will permit the marketing of the food
commodities in this paragraph when treated in accordance with the
provisions of experimental use permit 70515-EUP-1, which is being
issued under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended (7 U.S.C. 136). This temporary exemption from the
requirement of a tolerance expires and is revoked on June 1, 2001. This
temporary exemption from the requirement of a tolerance may be revoked
at any time if the experimental use permit is revoked or if any
experience with or scientific data on this pesticide indicate that the
tolerance is not safe.
[FR Doc. 98-15597 Filed 6-11-98; 8:45 am]
BILLING CODE 6560-50-F