Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 /Rules and Regulations 32131

List of Subjects in 40 CFR Part 81

Environmental protection, Air

pollution control, Carbon monoxide,

Intergovernmental relations.

Dated: May 29, 1998.

Chuck Clarke,

Regional Administrator, Region 10.

For the reasons set forth in the

preamble, 40 CFR part 81 is amended as

follows:

PART 81—[AMENDED]

1. The authority citation for part 81

continues to read as follows:

Authority: 42 U.S.C. 7401–7671q.

2. In § 81.302, the table for ‘‘AlaskaCarbon Monoxide’’ is amended for the

Anchorage area by revising the entry for

the Anchorage area to read as follows:

§ 81.302 Alaska.

* * * * *

Alaska-Carbon Monoxide

Designated area

Designation Classification

Date 1 Type Date 1 Type

* * * * * * *

Anchorage Area:

Anchorage Election District (part) Anchorage nonattainment area

boundary.

.................... Nonattainment .. July 13, 1998 ... Serious.

* * * * * * *

1This date is November 15, 1990, unless otherwise noted.

[FR Doc. 98–15447 Filed 6–11–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300672; FRL–5795–7]

RIN 2070–AB78

Phospholipid: Lyso-PE

(lysophosphatidylethanolamine); TimeLimited Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule establishes a timelimited 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: oppdocket@epamail.epa.gov. 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:

moats.sheila@epamail.epa.gov.

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
32132 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 /Rules and Regulations

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 (LysoPE), 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 nonoccupational 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 naturallyoccurring in food.

F. Safety Factors

Phospholipid is naturally occurring in

food and is present in all cells in all

organisms. Incremental exposure to
Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 /Rules and Regulations 32133

phospholipid resulting from this EUP is

minuscule. Considering the negligible

contributions to the environment

resulting from the application of LysoPE, 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 labeldirected use is inconsequential, and it is

consumed daily by the human

population from both naturallyoccurring 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:

opp-docket@epamail.epa.gov

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
32134 Federal Register / Vol. 63, No. 113 / Friday, June 12, 1998 /Rules and Regulations

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:

§ 180.1199 Phospholipid: Lyso-PE

(lysophosphatidylethanolamine); temporary

exemption from the requirement of a

tolerance.

The phospholipid biochemical LysoPE (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

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300670; FRL–5795–3]

RIN 2070–AB78

Propamocarb hydrochloride;

Extension of Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule extends timelimited tolerances for residues of the

fungicide propamocarb hydrochloride

in or on potatoes at 0.5 part per million

(ppm); fat, meat, meatbyproducts

(except kidney and liver) of cattle, goats,

hogs, horses, and sheep; and milk at 0.1

ppm; and tomatoes at 0.5 ppm; tomato

paste at 3 ppm; and tomato puree at 1

ppm for an additional year and a half.

This action is in response to EPA’s

granting of emergency exemptions

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of the pesticide on

potatoes and tomatoes. Section 408(l)(6)

of the Federal Food, Drug, and Cosmetic

Act (FFDCA) requires EPA to establish

a time-limited tolerance or exemption

from the requirement for a tolerance for

pesticide chemical residues in food that

will result from the use of a pesticide

under an emergency exemption granted

by EPA under section 18 of FIFRA.

DATES: This regulation becomes

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–300670],

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