[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

[[Page 32132]]

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

[[Page 32134]]

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