[Federal Register Volume 67, Number 70 (Thursday, April 11, 2002)]
[Rules and Regulations]
[Pages 17631-17636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8829]



[[Page 17631]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301212; FRL-6821-4]
RIN 2070-AB78


Lysophosphatidylethanolamine (LPE); Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the biological pesticide 
lysophosphatidylethanolamine (LPE) on all food commodities when 
applied/used in accordance with good agricultural practices. Nutra-
Park, Inc. submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act, as amended by the Food Quality Protection Act of 
1996, requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of LPE.

DATES: This regulation is effective April 11, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301212, 
must be received by EPA, on or before June 10, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket control number 
OPP-301212 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Carol E. Frazer, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8810; and 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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301212. The official record 
consists of the documents specifically referenced in this action, 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 Hwy., 
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.

II. Background and Statutory Findings

    In the Federal Register of January 3, 2002 (67 FR 323) (FRL-6773-
6), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide tolerance petition (PP 1F6244) by JP 
BioRegulators, now called Nutra-Park Inc., 8383 Greenway Blvd., Suite 
520, Middleton, WI 53562. This notice included a summary of the 
petition prepared by the petitioner Nutra-Park, Inc. There were no 
comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.1199 be amended by 
establishing a permanent exemption from the requirement of a tolerance 
for residues of lysophosphatidylethanolamine (LPE).

III. Risk Assessment

    New section 408(c)(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(c)(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. . . .'' Additionally, section

[[Page 17632]]

408(b)(2)(D) requires that 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.''
    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 use in residential settings.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of 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.
    LPE is a phospholipid. Phospholipids are a heterogeneous group of 
compounds that are classed together partly because of their solubility, 
and partly 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 derived from phosphatidylethanolamine by 
the enzymatic removal of one fatty acid by a phospholipase. Residues of 
LPE naturally occur in raw agricultural commodities and are eaten 
regularly. For example, LPE and N-acyl LPE levels are found in the 
following foodstuffs: 13-15 mg/100 g in corn grain, 0.5-29 mg/100 g in 
rice and 15-64 mg/100 g in wheat grain; and 2.1% lipid phosphorus in 
egg yolk. LPE plus lysophosphatidylcholine (LPC) in cow milk was 7.6% 
w/w and it is found in human breast milk (Ref. 1). Residues of LPE will 
not be significantly increased in raw agricultural commodities through 
the use of this product. For example, using reasonably foreseeable 
residue levels based on application rates, the level of LPE applied to 
apples would be approximately 0.06% greater than that found naturally 
in apple pulp (Ref. 2).
    Toxicity studies submitted in support of this tolerance exemption 
are referenced below. More detailed analyses of these studies can be 
found in the specific Agency reviews of the studies (Refs. 3 and 4). In 
addition, a substantial body of information on LPE is published and 
selected copies are included in this reference (Ref. 5).
    Two toxicity studies using the same protocol were submitted for 
each category captioned below one for the technical (LPE E94T) and one 
for the end-use product (LPE-94 10% Aqueous Growth Regulator). The 
results of study reviews are combined in the summaries that follow. LPE 
E94T is covered first. Next, a reduced concentration, 35% LPE, is shown 
as representative test material for the end-use product, although it is 
not as reduced as the pending end-use product concentration (10%).
    1. Acute oral toxicity (OPPTS 870.1100; 152-10; MRIDs 452740-01 and 
452736-01). Five male and five female rats were dosed with 5,000 
milligrams/kilograms (mg/kg) of LPE E94T or 35% LPE and observed for 14 
days. All rats survived and gained weight throughout each study. LPE 
E94T caused two females to exhibit liquid feces and oily urogenital 
areas on the day of dosing (symptoms cleared by day 1 post dosing), but 
the end-use product showed no abnormal symptoms. All rats appeared 
normal during the study. Based on the data, the acute oral 
LD50 for rats was >5,000 mg/kg. Classification: Acceptable; 
Toxicity Category IV.
    2. Acute dermal toxicity (OPPTS 870.1200; 152-11; MRIDs 452740-02 
and 454361-01). Five male and five female rabbits were given 2,000 mg/
kg LPE E94T or 35% LPE dermally for 24 hours and observed for the 
following 14 days. All rabbits survived and gained weight throughout 
the study. LPE E94T caused erythema, edema, atonia, fissuring, and/or 
desquamation on some rabbits during the study, but all symptoms cleared 
by day 14. Some of the 35% LPE rabbits also exhibited very slight to 
well-defined erythema and/or desquamation symptoms that cleared by day 
14. One female had very slight erythema by day 7 through day 10 and 
desquamation by day 7 through the end of the study. The acute dermal 
LD50 for rabbits was >2,000 mg/kg. Classification: 
Acceptable; Toxicity Category III.
    3. Acute inhalation toxicity (OPPTS 870.1300; 152-12; MRIDs 452740-
05 and 452736-04). In the first study, five male and five female rats 
were exposed for four hours to nominal atmospheric concentrations of 
91.21 mg/L LPE E94T and observed for 14 days. In the second study, the 
same number and mix of animals were exposed to atmospheric 
concentrations of 35% LPE for 4 hours and observed for 14 days. All 
rats survived the study. After an initial post-exposure weight loss, 
all rats gained weight through the remainder of the study. All rats had 
wet stained fur and two males and one female had red/brown staining 
around the nose on day 1 in the LPE E94T study, while two males and one 
female had staining around the eyes on the day of exposure to the 35% 
LPE, but symptoms cleared by day 2 in both studies. One male in the 35% 
LPE study had a sore on his neck on days 2-7 and days 13-15. Gross 
necropsies in the LPE E94T study indicated that the lungs were 
unaffected, but certain other abnormalities were noted in some rats. 
The abnormalities were not likely the result of exposure to the test 
substance, and are commonly noted in lab animals. No abnormalities 
occurred in the 35% LPE study. The inhalation LC50's for 
rats was >2.50 milligram/liter (mg/L) for the LPE E94T and >4.63 for 
the 35% LPE. Classification; Acceptable; Toxicity Category IV.
    4. Primary eye irritation (OPPTS 870.2400; 152-13; MRIDs 452740-04 
and 452736-03). In the first study, three adult rabbits administered 29 
mg LPE E94T mixed in 0.1 mL water into the everted right eyelid, then 
observed for 72 hours. No corneal opacity was noted on any rabbit. All 
rabbits in the group had iritis and conjunctivitis one hour after 
instillation of LPE; all symptoms cleared by 48-hours post-
instillation. In the second study, three adult rabbits administered 0.1 
mL of undiluted test substance 35% LPE into the everted right eyelid, 
then observed for 72 hours. No corneal opacity was noted on any rabbit. 
One rabbit exhibited very mild conjunctivitis at 1-hour post-
instillation, but symptoms cleared by 24 hours. Based on the data, LPE 
E94T was considered a minimal irritant. Classification: Acceptable; 
Toxicity Category III. Based on the data for 35% LPE, this compound was 
practically non-irritating. Classification: Acceptable; Toxicity 
Category IV.
    5. Primary dermal irritation (OPPTS 870.2500; 152-14; MRIDs 452740-
03 and 452736-02). Three each adult rabbits were treated with 0.5 g of 
LPE E94T mixed with 0.95 mL water or 35% LPE dermally for 4 hours and 
observed for the following 72 hours. No irritation was noted on any 
rabbit. LPE E94T and 35% LPE were non-irritants. Classification: 
Acceptable; Toxicity Category IV.
    6. Hypersensitivity (OPPTS 870.2600; 152-15; MRIDs 454357-01 and 
452736-

[[Page 17633]]

05). Thirty-eight each adult male guinea pigs were used to test the 
potential for dermal sensitization of LPE E94T or 35% LPE by a 
Magnusson and Kligman maximization method. All animals survived and 
gained weight throughout the studies. Mild to moderate erythema and 
edema reactions with scab formation at the injection sites were noted 
on all test and control animals throughout the observation period. 
Following challenge, all treated test animals showed scattered mild 
redness to intense redness and swelling on the right side. The left 
side, treated with sterile water, showed no irritation after challenge. 
None of the control animals in either study showed irritation on either 
side 24 and 48 hours after challenge. Both LPE E94T and 35% LPE were 
extreme dermal sensitizers.
Data Waivers (Ref. 6) were requested for the following studies:
    Studies to detect genotoxicity (OPPTS 870.5300)
    Immune response (OPPTS 880.3800)
    Mammalian mutagenicity test (OPPTS 870.5195)
    90-Day feeding (1 species) (OPPTS 870.3100)
    90-Day dermal (1 species) (OPPTS 870.3250)
    90-Day inhalation (1 species) (OPPTS 870.3465)
    Teratogenicity (1 species) (OPPTS 870.3700)
    Chronic exposure (OPPTS 870.4100) (Tier III)
    Oncogencity (OPPTS 870.4200) (Tier III)
    The registrant submitted additional information to support waivers 
from the data requirements for additional acute toxicity testing, 
subchronic toxicity testing, and chronic toxicity testing (Ref. 6). The 
registrant's rationale to support the waivers is that LPE is ubiquitous 
in nature and this and related phospholipids are synthesized by 
microorganisms, plants, and animals. These compounds are also 
ubiquitous in the human diet. Also, phospholipids have specific roles 
in cellular functions and in maintaining the integrity of cell 
membranes. Much of these data regarding LPE and related phospholipids 
were submitted in support of similar waivers in conjunction with a 
temporary tolerance exemption (see 40 CFR 180.1199) (Ref. 5) for the 
use of this active ingredient under an Experimental Use Permit (EPA 
Reg. No. 70515-EUP-1). See also memo from Russell Jones, Ph.D. to 
Sheila Moats, Ph.D., October 8, 1997 (Ref. 7). The aforementioned data 
may be bridged to support the current waiver requests. In addition, 
there is a long history of consumption by humans of lipids in food and 
the Agency knows of no instance where lipids have been associated with 
any toxic effects related to the consumption of food. Due to this 
knowledge of LPE's presence and function in the human system (Ref. 1) 
and the recent acute testing, EPA believes LPE is unlikely to be 
carcinogenic or have other long-term toxic effects.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    1. Food. Because LPE is a naturally occurring fat present in all 
living organisms, there is a great likelihood of exposure to naturally 
occurring LPE for most, if not all individuals, including infants and 
children. As mentioned above, LPE is found in human breast milk, cow 
milk, corn grain, starch, oats and plant tissues and high quantities 
are found in both egg yolk and meats (Ref. 1). Thus, LPE is a normal 
part of the human diet. To date, there have been no reports of any 
hypersensitivity incidents or reports of any known adverse reactions in 
humans resulting from exposure to LPE. A gallon of end-use product can 
be produced from the LPE equivalent to that found in six eggs (Ref. 5). 
The product would then be diluted to achieve the 25-400 ppm of LPE 
proposed for final spray or dip use. Even if there is a significant 
increase in exposure to LPE due to its use as a pesticide, the battery 
of acute toxicity studies submitted by the registrant demonstrating 
very low mammalian toxicity (Toxicity Categories III and IV) indicates 
that risk associated with acute exposures by the oral, dermal and 
inhalation routes would be low to non-existent.
    2. Drinking water exposure. LPE may get into surface water during 
run-off, but dissipation of LPE in the environment will, in all 
likelihood, be through microbial mediated degradation which will 
rapidly remove the residues (Ref. 1). The levels of residues that might 
get into ground or surface water used for drinking water will not be 
high compared to the exposure from naturally occurring residues of LPE.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure to LPE pesticide residues 
for the general population, including infants and children, is unlikely 
because potential use sites are commercial, agricultural, and 
horticultural. However, because LPE is a natural fat present in all 
cellular organisms, there is a great likelihood of prior exposure for 
most, if not all, individuals. LPE is a normal part of the human diet 
and the increased exposure due to this proposed product would be 
negligible.

VI. Cumulative Effects

    The Agency has considered the cumulative effects of LPE and other 
substances in relation to a common mechanism of toxicity. These 
considerations include the possible cumulative effects of such residues 
on infants and children. There is no indication of mammalian toxicity 
at the maximum doses tested, of this or other products containing LPE.

VII. Determination of Safety for U.S. Population, Infants and 
Children

    1. U.S. population. There is reasonable certainty that no harm will 
result from aggregate exposure to residues of LPE to the U.S. 
population. This includes all anticipated dietary exposures and all 
other exposures for which there is reliable information. The Agency has 
arrived at this conclusion based on the very low levels of mammalian 
toxicity (no toxicity at the maximum doses tested, Toxicity Categories 
III and IV) associated with LPE and the long history of safe use and 
consumption of LPE.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional tenfold margin of exposure (safety) for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the data base unless EPA 
determines that a different margin of exposure (safety) will be safe 
for infants and children. Margins of exposure (safety) are often 
referred to as uncertainty (safety) factors. In this instance, based on 
all the available information, the Agency concludes that LPE is 
practically non-toxic to mammals, including infants and children. Thus, 
there are no threshold effects of concern and, as a result the 
provision requiring an additional margin of safety does not apply. 
Further, the provisions of consumption patterns, special 
susceptibility, and cumulative effects do not apply. As a result, EPA 
has not used a margin of exposure

[[Page 17634]]

(safety) approach to assess the safety of LPE.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA is required under the FFDCA as amended by FQPA to develop a 
screening program to determine whether certain substances (including 
all pesticide active and other ingredients) ``may have an effect in 
humans that is similar to an effect produced by a naturally-occurring 
estrogen, or other such endocrine effects as the Administrator may 
designate.'' Following the recommendations of its Endocrine Disruptor 
Screening and Testing Advisory Committee (EDSTAC), EPA determined that 
there is no scientific basis for including, as part of the program, the 
androgen- and thyroid hormone systems in addition to the estrogen 
hormone system. EPA also adopted EDSTAC's recommendation that the 
program include evaluations of potential effects in wildlife. For 
pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority to require wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening 
Program(EDSP). When the appropriate screening and/or testing protocols 
being considered under the Agency's Endocrine Disruptor Screening 
Program have been developed, LPE may be subjected to additional 
screening and/or testing to better characterize effects related to 
endocrine disruption.
    Based on available data, no endocrine system-related effects have 
been identified with consumption of LPE. It is a naturally occurring 
residue in raw agricultural food, feed commodities and 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.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation for the reasons stated 
above, including LPE's lack of mammalian toxicity. For the same 
reasons, the Agency has concluded that an analytical method is not 
required for enforcement purposes for LPE.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels established for residues 
of LPE.

IX. Conclusions

    Based on the toxicology data submitted, there is reasonable 
certainty no harm will result from aggregate exposure of residues of 
LPE to the U.S. population, including infants and children, when the 
proposed product is used in accordance with good agricultural 
practices. This includes all anticipated dietary exposures and all 
other exposures for which there is reliable information. The Agency has 
arrived at this conclusion based on data submitted demonstrating no 
toxicity at the maximum doses tested and the long history of safe use 
and consumption of naturally occurring LPE. As a result, EPA 
establishes an exemption from tolerance requirements pursuant to FFDCA 
408(c) and (d) for residues of LPE in or on all food commodities.

X. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301212 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before June 10, 
2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). 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). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request

[[Page 17635]]

with the Hearing Clerk as described in Unit IX.A., you should also send 
a copy of your request to the PIRIB for its inclusion in the official 
record that is described in Unit I.B.2. Mail your copies, identified by 
docket number OPP-301212, to: Public Information and Records Integrity 
Branch, Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. In person or by courier, bring a copy 
to the location of the PIRIB described in Unit I.B.2. You may also send 
an electronic copy of your request via e-mail to: [email protected]. 
Please use an ASCII file format and avoid 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 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    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).

XI. References

    1. JP BioRegulators, Inc. A Review on Lysophosphatidylethanolamine 
and Related Phospholipids, 2000.
    2. Nutra-Park Inc. Effect of LPE Applications, 2002.
    3. USEPA. Science review in support of registration of LPE E94T 
Technical and LPE-94 20% Aqueous Growth Regulator; Memo from Jones, 
Russell S., Ph.D., September 13, 2001.
    4. USEPA. Data Evaluation Record: Skin Sensitization (MRID 454357-
01), Reilly, Sheryl K., Ph.D., January 21, 2002.
    5. Palta, Jiwan, Ph.D. and Hartman, Christina L., Ph.D.: 
Phospholipid Safety Data in Support of a Petition Proposing a Temporary 
Exemption from the Requirement of a Tolerance for Phospholipid for Use 
in Grapes, Tomatoes, Apples, Pear, Peaches, Nectarines, Citrus, 
Cranberries, and Strawberries, 1997 (MRID 443399-05).
    6. JP BioRegulators, Inc.: Waiver Request from Biochemical 
Pesticides Toxicology Data Requirements, 2000.
    7. USEPA. An Experimental Use Permit (EUP) and Petition for a 
Temporary Tolerance Exemption for Phospholipid; Memo from Jones, 
Russell S., Ph.D. to Sheila Moats, Ph.D., October 8, 1997.

XII. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any other Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications '' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XIII. 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

[[Page 17636]]

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 this final rule in the Federal Register. This 
final rule 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: March 26, 2002.
James Jones,
Acting 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. 321(q), 346(a) and 371.

    2. Section 180.1199 is revised to read as follows:


Sec. 180.1199  Lysophosphatidylethanolamine (LPE); exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide lysophosphatidylethanolamine in 
or on all food commodities.

[FR Doc. 02-8829 Filed 4-10-02; 8:45 am]
BILLING CODE 6560-50-S