64006 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Proposed Rules

5. Section 63.347 is amended by

revising the introductory text in

paragraph (e)(2) and paragraph (f)(1) to

read as follows:

§ 63.347 Reporting requirements.

* * * * *

(e) * * *

(2) If the State in which the source is

located has not been delegated the

authority to implement the rule, each

time a notification of compliance status

is required under this part, the owner or

operator of an affected source shall

submit to the Administrator a

notification of compliance status, signed

by the responsible official (as defined in

§ 63.2) who shall certify its accuracy,

attesting to whether the affected source

has complied with this subpart. If the

State has been delegated the authority,

the notification of compliance status

shall be submitted to the appropriate

authority. The notification shall list for

each affected source:

* * * * *

(f) * * *

(1) If the State in which the source is

located has not been delegated the

authority to implement the rule, the

owner or operator of an affected source

shall report to the Administrator the

results of any performance test

conducted as required by § 63.7 or

§ 63.343(b). If the State has been

delegated the authority, the owner or

operator of an affected source should

report performance test results to the

appropriate authority.

* * * * *

6. Table 1 to subpart N of Part 63 is

amended by revising the entry for

‘‘63.5(a)’’ to read as follows:

TABLE 1 TO SUBPART N OF PART 63—GENERAL PROVISIONS APPLICABILITY TO SUBPART N

General provisions reference Applies to subpart N Comment

* * * * * * *

63.5(a) ................................ Yes ..................................... Except replace the term ‘‘source’’ and ‘‘stationary source’’ in § 63.5(a) (1) and (2) of

subpart A with ‘‘affected sources.’’

* * * * * * *

Subpart O—[Amended]

7. Section 63.360 is amended by

revising paragraph (f) to read as follows:

§ 63.360 Applicability.

* * * * *

(f) The owner or operator of a source,

subject to the provisions of the title 40,

chapter I, part 63 subpart O, using 1 ton

(see definition) is subject to title V

permitting requirements. These affected

sources, if not major or located at major

sources as defined under 40 CFR 70.2,

may be deferred by the applicable title

V permitting authority from title V

permitting requirements for 5 years after

the date on which the EPA first

approves a part 70 program (i.e., until

December 9, 1999). All sources

receiving deferrals shall submit title V

permit applications within 12 months of

such date (by December 9, 2000). All

sources receiving deferrals still must

meet compliance schedule as stated in

this § 63.360.

* * * * *

Subpart M—[Amended]

8. Section 63.320 is amended by

adding paragraph (k) to read as follows:

§ 63.320 Applicability.

* * * * *

(k) The owner or operator of any

source subject to the provisions of this

subpart M is subject to title V permitting

requirements. These affected sources, if

not major or located at major sources as

defined under 40 CFR 70.2, may be

deferred by the applicable title V

permitting authority from title V

permitting requirements for 5 years after

the date on which the EPA first

approves a part 70 program (i.e., until

December 9, 1999). All sources

receiving deferrals shall submit title V

permit applications within 12 months of

such date (by December 9, 2000). All

sources receiving deferrals still must

meet compliance schedule as stated in

this § 63.320.

Subpart X—[Amended]

9. Section 63.541 is amended by

adding paragraph (c) to read as follows:

§ 63.541 Applicability.

* * * * *

(c) The owner or operator of any

source subject to the provisions of the

title 40, chapter I, part 63 subpart X is

required to obtain a title V permit from

the applicable permitting authority in

which the affected source is located.

[FR Doc. 95–30260 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 5E4598/P638; FRL–4990–5]

RIN 2070–AC18

Imidacloprid; Pesticide Tolerances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

time-limited tolerance for indirect or

inadvertent combined residues of the

insecticide (1-[6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine (referred to in this

document as imidacloprid) and its

metabolites resulting from crop

rotational practices in or on the raw

agricultural commodities in the cucurbit

vegetables crop group. The proposed

regulation to establish a maximum

permissible level for residues of the

insecticide was requested in a petition

submitted by the Interregional Research

Project No. 4 (IR-4) pursuant to the

Federal Food, Drug and Cosmetic Act

(FFDCA). The time-limited tolerance

would expire on December 31, 1996.

DATES: Comments, identified by the

document control number [PP 5E4598/

P638], must be received on or before

January 12, 1996.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW,

Washington, DC 20460. In person, bring

comments to: Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA

22202. Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or ASCII file format. All
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Proposed Rules 64007

comments and data in electronic form

must be identified by the docket number

[PP 5E4425/P638]. Electronic comments

on this proposed rule may be filed

online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found

below in this document.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information.’’

CBI should not be submitted through email. Information marked as CBI will

not be disclosed except in accordance

with procedures set forth in 40 CFR part

2. A copy of the comment 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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Highway,

Arlington, VA 22202, (703)-308-8783; email: jamerson.hoyt@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

5E4598 to EPA on behalf of the

Agricultural Experiment Stations of

California, Florida, Georgia, South

Carolina, and Texas. The petition

requests that the Administrator,

pursuant to section 408(e) of the Federal

Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a(e), amend 40 CFR

180.472 by establishing a tolerance for

indirect or inadvertent, combined

residues of the insecticide imidacloprid

(1-[(6-chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine) and its

metabolites containing the 6-

chloropyridinyl moiety, all expressed as

1-[(6-chloro-3-pyridinyl)-methyl]-Nnitro-2-imidazolidinimine, resulting

from crop rotational practices in or on

the raw agricultural commodities in the

cucurbit vegetables crop group at 0.2

part per million (ppm).

The proposed tolerance will not

support registration for imidacloprid on

cucurbit vegetables. EPA will not

consider applications for section 3 or

section 24(c) registration of

imidacloprid on cucurbit vegetables

based the proposed time-limited

tolerance. The tolerance would allow

growers to produce cucurbit vegetables

in rotation with crops that are treated in

accordance with registered uses of

imidacloprid. Imidacloprid registrations

prohibit growers from planting crops

which lack an imidacloprid tolerance on

ground treated with the insecticide

within a 12-month period. In some

areas, however, it is a common practice

for growers to plant back cucurbit

vegetables (melons, squash, and

cucumbers) in fields that have been

used to produce tomatoes and peppers.

Imidacloprid is registered and

tolerances are established for the

fruiting vegetables crop group

(including tomatoes and peppers). There

are no established imidacloprid

tolerances, however, for the cucurbit

vegetables. Crop rotational studies

reviewed by EPA indicate that plantback crops grown in fields treated with

imidacloprid may contain measurable

amounts of the pesticide residue, if the

rotational crop is planted within 12

months of application of the pesticide.

Currently, growers who plan to

double crop with cucurbit vegetables

must not use imidacloprid, or they must

not plant back cucurbit vegetables in

fields treated within 12 months of

application with imidacloprid.

According to the University of Florida

Cooperative Extension Service, the

inability to double crop because of the

imidacloprid plant-back restriction will

have a serious financial impact on the

South Florida vegetable industry.

Approximately 12,000 acres in South

Florida are double cropped with

cucurbit vegetables. Much of this

acreage has been treated with

imidacloprid to control sweet potato

whitefly (silverleaf whitefly) on

tomatoes. Prior to registration of

imidacloprid on tomatoes, EPA

approved emergency exemptions under

Section 18 of Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA)

for its use in California, Florida, South

Carolina, and Texas to avert significant

economic loss from sweet potato white

fly damage.

The proposed tolerance, which would

expire on December 31, 1996, should

allow IR-4 sufficient time to submit a

permanent tolerance for imidacloprid

on cucurbit vegetables. IR-4 is

developing field residue data in support

of a permanent tolerance and

registration for use of imidacloprid on

cucurbit vegetables. The permanent

tolerance will be proposed by IR-4 to

cover residues in cucurbit vegetables

from application to the growing crop, as

well as crop rotational practices.

EPA’s policy is to consider tolerance

petitions, when requested by the

registrants or any interested parties, for

pesticide residues on replacement or

rotational crops when residues result

from pesticide carryover in soil from

treatment of previous crops. Such

tolerances will be set at levels

determined to be appropriate based on

evaluations of toxicity and residue data

submitted to the Agency by the

petitioner. Guidance on how to conduct

residue studies on rotation crops can be

found in the EPA publication ‘‘Pesticide

Reregistration Reject Rate Analysis

Residue Chemistry/Environmental Fate

Follow Up Guidance for Conducting

Rotational Crop Studies,’’ February

1993. The procedures for filing a

petition, as described in 40 CFR 180.7,

should be followed, and each petition

must be accompanied by the

appropriate fee, as specified in 40 CFR

180.33.

The toxicological data considered in

support of the proposed tolerance

include:

1. A 1-year chronic feeding study in

dogs fed diets containing 0, 200, 500, or

1,250/2,500 ppm (average intake was 0,

6.1, 15, or 41/72 milligrams (mg)/

kilogram (kg)/day) with a no-observedeffect level of 1,250 ppm based on

increased plasma cholesterol and liver

cytochrome P-450 levels in dogs at the

2,500-ppm dose level. The high dose

was increased to 2,500 ppm (72 mg/kg/

day) from week 17 onward due to lack

of toxicity at the 1,250-dose level.

2. A 2-year feeding/carcinogenicity

study in rats fed diets containing 0, 100,

300, 900, or 1,800 ppm with a NOEL for

chronic effects at 100 ppm (5.7 mg/kg/

day in males, 7.6 mg/kg/day in females)

that included decreased body weight

gain in females at 300 ppm (24.9 mg/kg/

day) and above; and increased thyroid

lesions in males at 300 ppm (16.9 mg/

kg/day) and above, and in females at

900 ppm (73 mg/kg/day) and above.

There were no apparent carcinogenic

effects under the conditions of the

study.

3. A 2-year carcinogenicity study in

mice fed diets containing 0, 100, 330,

1,000, or 2,000 ppm with a NOEL of

1,000 ppm (208 mg/kg/day in males,

274 mg/kg/day in females) based on

decreased food consumption and

decreased water intake at the 2,000-ppm

dose level. There were no apparent

carcinogenic effects observed under the

conditions of this study.

4. A three-generation reproduction

study with rats fed diets containing 0,

100, 250, or 700 ppm with a

reproductive no-observed-effect level
64008 Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Proposed Rules

(NOEL) of 100 ppm (equivalent to 8 mg/

kg/day based on decreased pup body

weight observed at the 250-ppm dose

level.

5. A developmental toxicity study in

rat given gavage doses at 0, 10, 30, or

100 mg/kg/day during gestation days 6

to 16 with a NOEL for developmental

toxicity at 30 mg/kg/day based on

increased wavy ribs observed at the 100-

mg/kg/day dose level.

6. A developmental toxicity study in

rabbits given gavage doses at 0, 8, 24, or

72 mg/kg/day during gestation days 6

through 19 with a NOEL for

developmental toxicity at 24 mg/kg/day

based on decreased body weight and

increased skeletal abnormalities

observed at the 72-mg/kg/day dose

level.

7. Imidacloprid was negative for

mutagenic effects in all but two of 23

mutagenic assays. Imidacloprid tested

positive for chromosome aberrations in

an in vitro cytogenetic study with

human lymphocytes for the detection of

induced clastogenic effects, and for

genotoxicity in an in vitro cytogenetic

assay measuring sister chromatid

exchange in Chinese hamster ovary

cells.

Dietary risk assessments for

imidacloprid indicate that there is

minimal risk from established

tolerances and the proposed tolerance

for cucurbit vegetables. A cancer risk

assessment is not appropriate for

imidacloprid since the pesticide is

assigned to ‘‘Group E’’ (no evidence of

carcinogenicity) of EPA’s cancer

classification system. Dietary risk

assessments for the pesticide were

conducted using the Reference Dose

(RfD) to assess chronic exposure and

risk.

The RfD is calculated at 0.057 mg/kg/

of body weight/day based on a NOEL of

5.7 mg/kg/day from the 2-year rat

feeding/carcinogenicity study and 100-

fold uncertainty factor. The theoretical

maximum residue contribution (TMRC)

from existing tolerances utilizes less

than 15 percent of the RfD for the

general population and less than 30

percent of the RfD for nonnursing

infants less than 1 year in age. The

proposed tolerance for cucurbit

vegetables would utilize less than 1

percent of the RfD for the general

population and all population

subgroups.

There is no reasonable expectation

that secondary residues will occur in

milk and eggs, or meat, fat, and meat

byproducts of livestock or poultry; there

are no livestock feed items associated

with the cucurbit vegetables.

The metabolism of imidacloprid in

plants and livestock is adequately

understood. The residues of concern are

combined residues of imidacloprid and

its metabolites containing the 6-

chloropyridinyl moiety, all calculated as

imidacloprid. The analytical method is

a common moiety method for

imidacloprid and its metabolites

containing the 6-chloropyridiyl moiety

using a permanganate oxidation, silyl

derivatization, and capillary GC-MS

selective ion monitoring.

There are currently no actions

pending against the continued

registration of this chemical.

Based on the information and data

considered, the Agency has determined

that the tolerance established by

amending 40 CFR 180 would protect the

public health. Therefore, it is proposed

that the tolerance be established as set

forth below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended, which

contains any of the ingredients listed

herein, may request within 30 days after

publication of this notice in the Federal

Register that this rulemaking proposal

be referred to an Advisory Committee in

accordance with section 408(e) of the

FFDCA.

A record has been established for this

rulemaking under docket number [PP

5E4598/P638] (including comments and

data submitted electronically as

described below). A public version of

this record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8 a.m. to 4:30 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

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

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer all comments received

electronically into printed, paper form

as they are received and will place the

paper copies in the official rulemaking

record which will also include all

comments submitted directly in writing.

The official rulemaking record is the

paper record maintained at the address

in ‘‘ADDRESSES’’ at the beginning of

this document.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

all the requirements of the Executive

Order (i.e., Regulatory Impact Analysis,

review by the Office of Management and

Budget (OMB)). Under section 3(f), the

order defines ‘‘significant’’ as those

actions likely to lead to a rule (1) having

an annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

known as ‘‘economically significant’’);

(2) creating serious inconsistency or

otherwise interfering with an action

taken or planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 30, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be 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.
Federal Register / Vol. 60, No. 239 / Wednesday, December 13, 1995 / Proposed Rules 64009

2. In § 180.472, by adding new

paragraph (f), to read as follows:

§ 180.472 1-[(6-Chloro-3-pyridinyl)methyl]-

N-nitro-2-imidazolidinimine; tolerances for

residues.

* * * *

*

(f) Time-limited indirect or

inadvertent tolerance: A time-limited

tolerance, to expire on December 31,

1996, is established for indirect or

inadvertent combined residues of the

insecticide 1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine and its metabolites

containing the 6-chloropyridinyl

moiety, all expressed as 1-[(6-chloro-3-

pyridinyl)methyl]-N-nitro-2-

imidazolidinimine, when present

therein as a result of the application of

the pesticide to growing crops listed in

this section and other nonfood crops as

follows:

Commmodity Parts per

million

Vegetables, cucurbit ................. 0.2

[FR Doc. 95–30372 Filed 12–12–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 721

[OPPTS–50601G; FRL–4976–3]

Ethane, 1,1,1,2,2-pentafluoro-;

Revocation of a Significant New Use

Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to revoke a

significant new use rule (SNUR)

promulgated under section 5(a)(2) of the

Toxic Substances Control Act (TSCA)

for ethane, 1,1,1,2,2-pentafluoro-, based

on receipt of new data. The data

indicate that for purposes of TSCA

section 5, the substance will not present

an unreasonable risk to human health.

DATES: Written comments must be

received by January 12, 1996.

ADDRESSES: All comments must be sent

in triplicate to: OPPT Document Control

Officer (7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M Street, SW.,

Room G–099, East Tower, Washington,

DC 20460.

Comments that are confidential must

be clearly marked confidential business

information (CBI). If CBI is claimed, an

additional sanitized copy must also be

submitted. Nonconfidential versions of

comments on this proposed rule will be

placed in the rulemaking record and

will be available for public inspection.

Comments should include the docket

control number. The docket control

number for the chemical substance in

this SNUR is OPPTS-50601G. Unit III of

this preamble contains additional

information on submitting comments

containing CBI.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to:

ncic@epamail.epa,gov. Electronic

comments must be submitted as ASCII

file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket number

(OPPTS–50601G). No CBI should be

submitted through e-mail. Electronic

comments on this proposed rule may be

filed online at many Federal Depository

Libraries. Additional information on

electronic submissions can be found in

Unit IV of this document.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, Rm. E–543A, 401 M St., SW.,

Washington, DC 20460, Telephone:

(202) 554-1404, TDD: (202) 554-0551; email: TSCA-Hotline @epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 23, 1992

(57 FR 44064), EPA issued a SNUR

(FRL–4001–2) establishing significant

new uses for ethane, 1,1,1,2,2-

pentafluoro-. Because of additional data

EPA has received for this substance,

EPA is proposing to revoke this SNUR.

I. Proposed Revocation

EPA is proposing to revoke the

significant new use and recordkeeping

requirements for ethane, 1,1,1,2,2-

pentafluoro- under 40 CFR part 721,

subpart E. In this unit, EPA provides a

brief description for the substance,

including its premanufacture notice

(PMN) number, chemical name (generic

name if the specific name is claimed as

CBI), CAS number (if assigned), basis for

the revocation of the section 5(e)

consent order for the substance, and the

CFR citation removed in the regulatory

text section of this proposed rule.

Further background information for the

substance is contained in the

rulemaking record referenced in Unit IV

of this preamble.

PMN Number: P–91–1392

Chemical name: Ethane, 1,1,1,2,2-

pentafluoro-.

CAS Registry Number: Not available.

Effective date of revocation of section

5(e) consent order: February 21, 1995.

Basis for revocation of section 5(e)

consent order: The order was revoked

based on test data submitted under the

terms of the consent order. Based on the

Agency’s analysis of the submitted data,

EPA can no longer support a finding

that the manufacture, processing,

distribution in commerce, use, or

disposal of the PMN substance may

present an unreasonable risk to human

health. Accordingly, EPA has

determined that further regulation

under section 5(e) is not warranted at

this time.

Toxicity testing results: The PMN

substance P–91–1392 was tested in a

cardiac sensitization study (epinephrine

challenge in dogs), a 90-day inhalation

toxicity study in rats, and a

developmental inhalation toxicity study

(rats and rabbits). The 90-day

subchronic study showed that there

were no observable adverse effects at

concentrations up to 50,000 parts per

million (ppm). There were no observed

developmental toxicity effects at

concentrations up to 50,000 ppm in the

developmental toxicity study. There

was evidence of maternal toxicity at

50,000 ppm but no maternal effects

noted at 15,000 ppm. The PMN

substance P–91–1392 was found to be a

cardiac sensitizer when exposures

occurred at a 10 percent concentration

in air (100,000 ppm) for 10 minutes.

Lower exposures did not elicit a

sensitization response.

CFR Number: 40 CFR 721.3240

II. Background and Rationale for

Proposed Revocation of the Rule

During review of the PMN submitted

for the chemical substance that is the

subject of this proposed revocation, EPA

concluded that regulation was

warranted under section 5(e) of TSCA

pending the development of information

sufficient to make a reasoned evaluation

of the environmental effects of the

substance, and that the substance is

expected to be produced in substantial

quantities and there may be significant

or substantial human exposure. EPA

identified the tests necessary to make a

reasoned evaluation of the risks posed

by the substance to the human health.

Based on these findings, a section 5(e)

consent order was negotiated with the

PMN submitter and a SNUR was

promulgated.

EPA reviewed testing conducted by

the PMN submitter pursuant to the