3394 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPPTS–50628; FRL–5720–3]

RIN 2070–AB27

Significant New Uses of Certain

Chemical Substances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating

significant new use rules (SNURs) under

section 5(a)(2) of the Toxic Substances

Control Act (TSCA) for 163 chemical

substances which were the subject of

premanufacture notices (PMNs) and

subject to TSCA section 5(e) consent

orders issued by EPA. Today’s action

requires persons who intend to

manufacture, import, or process these

substances for a significant new use to

notify EPA at least 90 days before

commencing the manufacturing or

processing of the substance for a use

designated by this SNUR as a significant

new use. The required notice will

provide EPA with the opportunity to

evaluate the intended use, and if

necessary, to prohibit or limit that

activity before it occurs. EPA is

promulgating this SNUR using direct

final procedures.

DATES: The effective date of this rule is

March 23, 1998. This rule shall be

promulgated for purposes of judicial

review at 1 p.m. (e.s.t.) on February 5,

1998.

If EPA receives notice before February

23, 1998 that someone wishes to submit

adverse or critical comments on EPA’s

action in establishing a SNUR for one or

more of the chemical substances subject

to this rule, EPA will withdraw the

SNUR for the substance for which the

notice of intent to comment is received

and will issue a proposed SNUR

providing a 30-day period for public

comment.

ADDRESSES: Each comment or notice of

intent to submit adverse or critical

comment must bear the docket control

number OPPTS–50628 and the name(s)

of the chemical substance(s) subject to

the comment. All comments should 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 and data may also be

submitted electronically to:

oppt.ncic@epamail.epa.gov. Follow the

instructions under Unit X of this

document. No Confidential Business

Information (CBI) should be submitted

through e-mail.

All comments which contain

information claimed as CBI must be

clearly marked as such. Three sanitized

copies of any comments containing

information claimed as CBI must also be

submitted and will be placed in the

public record for this rulemaking.

Persons submitting information on any

portion of which they believe is entitled

to treatment as CBI by EPA must assert

a business confidentiality claim in

accordance with 40 CFR 2.203(b) for

each portion. This claim must be made

at the time that the information is

submitted to EPA . If a submitter does

not assert a confidentiality claim at the

time of submission, EPA will consider

this as a waiver of any confidentiality

claim and the information may be made

available to the public by EPA without

further notice to the submitter.

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; e-mail:

TSCA-Hotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

Electronic Availability: Electronic

copies of this document are available

from the EPA Home Page at the Federal

Register-Environmental Documents

entry for this document under ‘‘Laws

and Regulations’’ (http://www.epa.gov/

fedrgstr/).

This SNUR will require persons to

notify EPA at least 90 days before

commencing manufacturing or

processing a substance for any activity

designated by this SNUR as a significant

new use. The supporting rationale and

background to this rule are more fully

set out in the preamble to EPA’s first

direct final SNURs published in the

Federal Register of April 24, 1990 (55

FR 17376). Consult that preamble for

further information on the objectives,

rationale, and procedures for the rules

and on the basis for significant new use

designations including provisions for

developing test data.

I. Authority

Section 5(a)(2) of TSCA (15 U.S.C.

2604(a)(2)) authorizes EPA to determine

that a use of a chemical substance is a

‘‘significant new use.’’ EPA must make

this determination by rule after

considering all relevant factors,

including those listed in TSCA section

5(a)(2). Once EPA determines that a use

of a chemical substance is a significant

new use, section 5(a)(1)(B) of TSCA

requires persons to submit a notice to

EPA at least 90 days before they

manufacture, import, or process the

substance for that use. The mechanism

for reporting under this requirement is

established under 40 CFR 721.10.

II. Applicability of General Provisions

General provisions for SNURs appear

under 40 CFR part 721, subpart A.

These provisions describe persons

subject to the rule, recordkeeping

requirements, exemptions to reporting

requirements, and applicability of the

rule to uses occurring before the

effective date of the final rule.

Provisions relating to user fees appear at

40 CFR part 700. Persons subject to this

SNUR must comply with the same

notice requirements and EPA regulatory

procedures as submitters of PMNs under

section 5(a)(1)(A) of TSCA. In particular,

these requirements include the

information submission requirements of

TSCA section 5(b) and 5(d)(1), the

exemptions authorized by section 5

(h)(1), (2), (3), and (5), and the

regulations at 40 CFR part 720. Once

EPA receives a SNUR notice, EPA may

take regulatory action under TSCA

section 5(e), 5(f), 6, or 7 to control the

activities on which it has received the

SNUR notice. If EPA does not take

action, EPA is required under TSCA

section 5(g) to explain in the Federal

Register its reasons for not taking

action.

Persons who intend to export a

substance identified in a proposed or

final SNUR are subject to the export

notification provisions of TSCA section

12(b). The regulations that interpret

section 12(b) appear at 40 CFR part 707.

Persons who intend to import a

chemical substance identified in a final

SNUR are subject to the TSCA section

13 import certification requirements,

which are codified at 19 CFR 12.118

through 12.127 and 127.28. Such

persons must certify that they are in

compliance with SNUR requirements.

The EPA policy in support of the import

certification appears at 40 CFR part 707.

III. Substances Subject to This Rule

EPA is establishing significant new

use and recordkeeping requirements for

the following chemical substances

under 40 CFR part 721, subpart E. In

this unit, EPA provides a brief

description for each substance,

including its PMN number, chemical

name (generic name if the specific name

is claimed as CBI), CAS number (if

assigned and and the specific chemical

identity is not claimed as CBI), basis for

the action taken by EPA in the TSCA

section 5(e) consent order or as a non-
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3395

section 5(e) SNUR for the substance

(including the statutory citation and

specific finding), toxicity concern, and

the CFR citation assigned in the

regulatory text section of this rule. The

specific uses which are designated as

significant new uses are cited in the

regulatory text section of this document

by reference to 40 CFR part 721, subpart

B where the significant new uses are

described in detail. Certain new uses,

including production limits and other

uses designated in the rule are claimed

as CBI. The procedure for obtaining

confidential information is set out in

Unit VII. of this preamble.

Where the underlying TSCA section

5(e) order prohibits the PMN submitter

from exceeding a specified production

limit without performing specific tests

to determine the health or

environmental effects of a substance, the

tests are described in this unit. As

explained further in Unit VI. of this

preamble, the SNUR for such substances

contains the same production limit, and

exceeding the production limit is

defined as a significant new use.

Persons who intend to exceed the

production limit must notify the Agency

by submitting a significant new use

notice (SNUN) at least 90 days in

advance. In addition, this unit describes

tests that are recommended by EPA to

provide sufficient information to

evaluate the substance, but for which no

production limit has been established in

the TSCA section 5(e) order.

Descriptions of recommended tests are

provided for informational purposes.

Data on potential exposures or

releases of the substances, testing other

than that specified in the TSCA section

5(e) order for the substances, or studies

on analogous substances, which may

demonstrate that the significant new

uses being reported do not present an

unreasonable risk, may be included

with significant new use notification.

Persons submitting a SNUN must

comply with the same notice

requirements and EPA regulatory

procedures as submitters of PMNs, as

stated in 40 CFR 721.1(c), including

submission of test data on health and

environmental effects as described in 40

CFR 720.50.

EPA is not publishing SNURs for

PMNs P–95–266, 95–615/616, P–95–

941, P–95–973, P–95–1046, P–95–1115,

P–95–1827, P–95–1854, P–95–2075, P–

96–262, P–96–291, P–96–317, P–96–576

through P–96–581, P–96–726 through

P–96–744, P–96–803/804, P–96–1277/

78, P–96–1482/1483, P–96–1708, P–96–

1509/1519, P–96–1548 through P–96–

1551, P–97–205 through P–97–208, and

P–97–276/277 which are subject to a

final TSCA section 5(e) consent order.

The TSCA section 5(e) consent orders

for these substances are derived from an

exposure finding based solely on

substantial production volume and

significant or substantial human

exposure and/or release to the

environment of substantial quantities.

For these cases there were limited or no

toxicity data available for the PMN

substances. In such cases, EPA regulates

the new chemical substances under

TSCA section 5(e) by requiring certain

toxicity tests. For instance, chemical

substances with potentially substantial

releases to surface waters would be

subject to toxicity testing of aquatic

organisms and chemicals with

potentially substantial human exposures

would be subject to health effects testing

for mutagenicity, acute effects, and

subchronic effects. However, for these

substances, the short-term toxicity

testing required by the TSCA section

5(e) order is usually completed within

1 to 2 years of notice of commencement

(NOC). EPA’s experience with exposurebased SNURs requiring short-term

testing is that the SNUR is often revoked

within 1 to 2 years when the test results

are received. Rather than issue and

revoke SNURs in such a short span of

time, EPA will defer publication of

exposure-based SNURs until either a

NOC or data demonstrating risk are

received unless the toxicity testing

required is long-term. EPA is issuing

this explanation and notification as

required in 40 CFR 721.160(a)(2) as it

has determined that SNURs are not

needed at this time for these substances

which are subject to a final TSCA

section 5(e) consent order under TSCA.

PMN Number P–87–323

Chemical name: (generic) Poly(oxy-1,2-

ethanediyl), alpha substituted-omegahydroxy-, C16-20 alkyl ethers.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on submitted fish, daphnia, and algae

tests on the PMN substance, EPA

expects toxicity to aquatic organisms at

surface water concentrations as low as

20 parts per billion (ppb). EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

did not exceed a concentration of 20

ppb when released to surface waters.

EPA has determined that other uses may

result in releases to surface waters above

20 ppb. Based on this information the

PMN substance meets the concern

criteria at § 721.170(b)(4)(i).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) and a 21-day daphnid chronic

toxicity test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) would help characterize the

environmental effects of the PMN

substance.

CFR citation: 40 CFR 721.3488.

PMN Number P–88–1108

Chemical name: (generic) Alcohols,

C6-12, ethoxylated, reaction product with

maleic anhydride.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a plastics additive.

Based on analogy to anionic surfactants,

EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 300 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters

in significant quantities. EPA has

determined that other uses of the

substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.524.

PMN Number P–90–581

Chemical name: (generic) Brominated

phthalate ester.

CAS number: Not available.

Effective date of section 5(e) consent

order: March 21, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to health and the environment.

Toxicity concern: Similar chemicals

have been shown to form

dibenzodioxins and dibenzofurans

when incinerated under combustion

conditions of municipal incinerators.
3396 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

Recommended testing: An incineration

simulation study is required to help

characterize the potential for the

formation of dibenzodioxins or

dibenzofurans when plastics or resins

containing the PMN substance are

incinerated. The PMN submitter has

agreed not to exceed the production

volume limit without performing this

study.

CFR citation: 40 CFR 721.3085.

PMN Numbers P–91–1131 and P–90–

564

Chemical name: (generic)

Imidazolethione.

CAS number: Not available.

Effective date of section 5(e) consent

order: October 25, 1995.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health.

Toxicity concern: Based on the

submitted 90-day subchronic study, the

PMN substance causes thyroid and

other systemic effects in test animals.

Based on the submitted developmental

toxicity study, the PMN substance

causes developmental toxicity in test

animals. Based on analogy to

structurally similar substances the PMN

substance may cause thyroid cancer.

Recommended testing: A 2-year, twospecies oral bioassay in rats (40 CFR

799.9420) (62 FR 43838, August 15,

1997) (FRL–5719–5) is recommended to

help characterize the human health

effects of the PMN substance.

CFR citation: 40 CFR 721.4469.

PMN Number P–92–314

Chemical name: (generic) Aryloxyarene.

CAS number: Not available.

Effective date of section 5(e) consent

order: March 11, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to the environment.

Toxicity concern: Based on test data on

this substance, there is concern for

toxicity to aquatic organisms,

particularly effects on daphnid

reproduction, at concentrations as low

as 1 ppb in surface waters.

Recommended testing: A 28-day

chironomid sediment toxicity study

(OPPTS 850.1790 test guideline (public

draft; 61 FR 16486, April 15, 1996))

(FRL–5363–1) is recommended to help

characterize the toxicity of the PMN

substance to benthic organisms.

CFR citation: 40 CFR 721.977.

PMN Numbers P–93–204 and P–94–

1870 through P–94–1874

Chemical name: (generic) Phenyl

substituted triazolinones.

CAS numbers: Not available.

Effective date of section 5(e) consent

order: July 23, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that these substances

may present an unreasonable risk of

injury to human health and the

environment.

Toxicity concern: Data on several of the

PMN substances and a chemical similar

to P–94–1870 have shown

developmental and reproductive effects,

blood and liver effects, and

neurotoxicity in test animals.

Recommended testing: An oral

developmental toxicity study in rats (40

CFR 799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) and a 90-day

subchronic oral study in rats (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help characterize the human health

effects. A semi-continuous activated

sludge (SCAS) study (OPPTS 835.3210

test guideline (public draft; 61 FR

16486, April 15, 1996)) (FRL–5363–1), a

ready biodegradability study (OPPTS

835.3110 test guideline (public draft; 61

FR 16486, April 15, 1996)) (FRL–5363–

1), and a soil sediment adsorption

isotherm (40 CFR 796.2750 or OPPTS

835.1220 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1) would help characterize the

environmental effects of the substance.

CFR citation: 40 CFR 721.9825.

PMN Number P–93–568

Chemical name: (generic)

Polysubstituted piperidine.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on submitted test data, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 30 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance would not be

released to surface waters above a level

of 30 ppb. EPA has determined that

other uses of the substance may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(i).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) and a 21-day daphnid chronic

toxicity test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) would help characterize the

environmental effects of the PMN

substance.

CFR citation: 40 CFR 721.6165.

PMN Number P–93–761

Chemical name: 2-Pyrrolidinone, 1,1′-

(2-methyl-1,5-pentanediyl)bis-.

CAS number: 146453–62–5.

Effective date of section 5(e) consent

order: September 6, 1995.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health.

Toxicity concern: Test data on the PMN

substance and similar chemicals have

shown that these types of chemicals

cause systemic toxicity and

neurotoxicity in test animals.

Recommended testing: A 90-day oral

subchronic study in rats (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) with

additional neurotoxicity endpoints

following NTIS–PB91–154617

(functional observation battery,

neurohistopathology and motor activity)

would help to characterize the systemic

and neurotoxicity effects. The PMN

submitter has agreed not to exceed the

production volume limit without

performing this test.

CFR citation: 40 CFR 721.9005.

PMN Number P–93–1369

Chemical name: (generic) N,N′-di(alkyl

heteromonocycle)amino chlorotriazine.

CAS number: Not available.

Effective date of section 5(e) consent

order: June 13, 1995.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to health and the environment.

Toxicity concern: Similar chemicals

have been shown to cause systemic

toxicity, developmental toxicity, and

cancer in test animals. In addition,

similar chemicals have been shown to

be toxic to aquatic organisms.

Recommended testing: EPA has

determined that a 90-day subchronic

toxicity test in rats via gavage (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3397

June 20, 1996) (FRL–5367–7)), a twospecies developmental study (rodent

and non-rodent) (40 CFR 799.9370) (62

FR 43832, August 15, 1997) (FRL–5719–

5) and a 2-year, one-species bioassay

(rats) (40 CFR 799.9420) (62 FR 43838,

August 15, 1997) (FRL–5719–5) would

help characterize the human health

effects of the PMN substance. The 90-

day subchronic toxicity test should

include special emphasis on

hematology; weight of the spleen and

thymus; cellularity of the bone marrow,

thymus, and spleen; and histopathology

of the liver, kidney, heart, and all

endocrine glands for which weight

changes are observed. In addition

natural killer cell activity should be

evaluated on the same population of test

animals, and IgM antibody plaqueforming cells should be enumerated in

two satellite groups of animals (10 in

the high-dose group and 10 in the

control group). EPA has determined that

a fish acute toxicity study (40 CFR

797.1400 or OPPTS 850.1075 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), a

daphnid acute toxicity study (40 CFR

797.1300 or OPPTS 850.1010 (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1)), and an algal acute

toxicity study (40 CFR 797.1050 or

OPPTS 850.5400 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1)) would help characterize

the environmental effects of the PMN

substance. The consent order contains

two production volume limits. The

PMN submitter has agreed not to exceed

the first production volume limit

without performing the 90-day

subchronic toxicity test. The PMN

submitter has also agreed not to exceed

the second higher production volume

limit without performing the twospecies developmental study and the 2-

year, one-species bioassay if the results

of the 90-day test indicate biological

activity at low levels (i.e., activity levels

comparable to those for triazines).

CFR citation: 40 CFR 721.2094.

PMN Number P–93–1631

Chemical name: (generic) Substituted

naphtholazo-substituted naphthalenylsubstituted azonaphthol chromium

complex.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a dye. Based on analogy

to structurally similar substances, EPA

is concerned that cancer will occur in

exposed workers. Based on submitted

test data, EPA is concerned that toxicity

to aquatic organisms may occur at a

concentration as low as 1 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance did

not present an unreasonable risk

because significant worker or

environmental exposure is not expected

because the substance was used as a

liquid and was not manufactured

domestically. EPA has determined that

domestic manufacture of the substance

and use as a solid may result in

significant worker or environmental

exposure. Based on this information the

PMN substance meets the concern

criteria at § 721.170 (b)(4)(i) and

(b)(1)(i)(D).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

would help characterize the health

effects of the PMN substance and a

chronic 60-day fish early life stage

toxicity test in rainbow trout (40 CFR

797.1600 or OPPTS 850.1400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) and a 21-

day daphnid chronic toxicity test (40

CFR 797.1330 or OPPTS 850.1300 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.981.

PMN Number P–93–1654

Chemical name: (generic) Substituted

polyoxyethylene.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an emulsifier for paint

and adhesives. Based on submitted test

data and analogy to nonionic

surfactants, EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 9 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters.

EPA has determined that other uses of

the substance may result in releases to

surface water at concentrations above 9

ppb. Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(i).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.7378.

PMN Number P–94–209

Chemical name: Phenol, 2,4-dimethyl-6-

(1-methylpentadecyl)-.

CAS number: 134701–20–5.

Basis for action: The PMN substance

will be used as an antioxidant. Based on

submitted test data, there is concern for

liver toxicity, kidney toxicity, adrenal

toxicity, and blood toxicity. Based on

submitted test data and analogy to

phenols, EPA is also concerned that

toxicity to aquatic organisms will occur

at concentrations as low as 1 ppb. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because workers

would not be subject to significant

dermal exposures and there were no

significant environmental releases. EPA

has determined that other uses of the

substance may result in significant

dermal exposures to workers and

significant environmental releases.

Based on this information the PMN

substance meet the concern criteria at

§ 721.170 (b)(3)(i) and (b)(4)(i).

Recommended testing: EPA has

determined that a dermal absorption

study, a 90-day subchronic oral study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–

7)), a chronic 60-day fish early life stage

toxicity test in rainbow trout (40 CFR

797.1600 or OPPTS 850.1400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and a

21-day daphnid chronic toxicity test (40

CFR 797.1330 or OPPTS 850.1300 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the health and

environmental effects of the PMN

substance.

CFR citation: 40 CFR 721.5725.

PMN Number P–94–921

Chemical name: Phenol, 4,4′-

methylenebis[2,6-dimethyl-.

CAS number: 5384–21–4.

Effective date of section 5(e) consent

order: July 5, 1995.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to health and the environment.

Toxicity concern: Similar phenols have

been shown to cause kidney and liver

toxicity, and blood effects in test

animals. In addition, chronic fish and

daphnid tests and a high

bioconcentration potential indicated a

concern concentration of 6 ppb.

Recommended testing: EPA has

determined that a 90-day subchronic
3398 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

oral toxicity test in rats (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help to characterize the human health

effects of the PMN substance. EPA has

also determined that a modified SCAS

test (OPPTS 835.3210 test guideline

(public draft; 61 FR 16486, April 15,

1996)) (FRL–5363–1), an aerobic aquatic

biodegradation test (40 CFR 796.3100 or

OPPTS 835.3100 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1), and an anaerobic

biodegradability of organic chemicals

(OPPTS 835.3400 test guideline (public

draft; 61 FR 16486, April 15, 1996))

(FRL–5363–1) would help to

charactarize the environmental effects.

The PMN submitter has agreed not to

exceed the production volume limit

without performing the 90-day

subchronic toxicity test.

CFR citation: 40 CFR 721.5730.

PMN Number P–94–1017

Chemical name: Urea, tetraethyl-.

CAS number: 1187–03–7.

Basis for action: The PMN substance

will be used as an intermediate. Based

on submitted test data EPA is concerned

that toxicity to aquatic organisms may

occur at a concentration as low as 1

ppm of the PMN substance in surface

waters. Based on analogy to similar

ureas and submitted test data EPA is

concerned that acute toxicity,

mutagenicity, developmental effects,

and reproductive effects could occur to

exposed workers. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance would not be

released to surface waters and exposed

workers would wear adequate protective

equipment to prevent dermal exposure.

EPA has determined that other uses of

the substance may result in releases to

surface waters which exceed the

concern concentration or dermal

exposure to workers. Based on this

information the PMN substance meets

the concern criteria at § 721.170 (b)(2),

(b)(3)(ii), and (b)(4)(i).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) and a 21-day daphnid chronic

toxicity test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) would help characterize the

environmental effects of the PMN

substance. EPA has determined that a

dermal developmental toxicity test in

rabbits and rats (40 CFR 799.9370) (62

FR 43832, August 15, 1997) (FRL–5719–

5) and a chromosome aberration assay

in mice (40 CFR 798.9538) (62 FR

43850, August 15, 1997) (FRL–5719–5)

or a micronucleus assay in mice (40 CFR

798.9539) (62 FR 43853, August 15,

1997) (FRL–5719–5) would help

characterize the health effects of the

PMN substance. The PMN submitter has

agreed to conduct the health tests before

reaching the production volume limit in

the SNUR.

CFR citation: 40 CFR 721.9928.

PMN Number P–94–1018

Chemical name: Guanidine, pentaethyl-

.

CAS number: 13439–89–9.

Basis for action: The PMN substance

will be used as an intermediate. Based

on submitted test data, EPA is

concerned that acute toxicity,

corrosivity, and neurotoxicity could

occur to exposed workers. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because exposed

workers would wear adequate protective

equipment to prevent dermal exposure.

EPA has determined that other uses of

the substance may result in exposure to

workers. Based on this information the

PMN substance meets the concern

criteria at § 721.170 (b)(2) and (b)(3)(i).

Recommended testing: None.

CFR citation: 40 CFR 721.4085.

PMN Number P–94–1019

Chemical name: Ethanaminium, N-

[bis(diethylamino)-methylene]-N-ethyl-,

bromide.

CAS number: 89610–32–2.

Basis for action: The PMN substance

will be used as a catalyst. Based on

submitted test data, EPA is concerned

that toxicity to aquatic organisms may

occur at a concentration as low as 10

ppb of the PMN substance in surface

waters. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance would not be

released to surface waters. EPA has

determined that other uses of the

substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at § 721.170(b)(4)(i).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) and a 21-day daphnid chronic

toxicity test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) would help characterize the

environmental effects of the PMN

substance.

CFR citation: 40 CFR 721.4090.

PMN Number P–94–1143

Chemical name: Butanoic acid,

antimony (3+) salt.

CAS number: 53856–17–0.

Effective date of section 5(e) consent

order: July 7, 1995.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to health.

Toxicity concern: Similar chemicals

have been shown to cause cancer,

dermal and ocular irritation,

cardiovascular effects, neurotoxic

effects, reproductive toxicity, and

developmental toxicity in test animals.

Recommended testing: A

pharmacokinetic test (OPPTS 870.8223

test guideline (public draft; 61 FR

31522, June 20, 1996) (FRL–5367–7)) is

recommended to help determine the

bioavailability of the PMN substance

after dermal administration. The PMN

submitter has agreed not to exceed the

production volume limit without

performing this test.

CFR citation: 40 CFR 721.1930.

PMN Number P–94–1743

Chemical name: (generic) Isophorone

diisocyanate neopentyl glycol adipate

polyurethane prepolymer.

CAS number: Not available.

Effective date of section 5(e) consent

order: December 8, 1995.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health.

Toxicity concern: Test data on the

substance and similar diisocyanates

have shown them to cause skin

sensitization and chronic lung toxicity

in test animals.

Recommended testing: EPA has

determined that the results of an acute

inhalation study (OPPTS 870.1300 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)), a 28-day

subchronic inhalation study in rats,

(Organization for Economic Cooperation

and Development (OECD) guideline no.

412), and a 90-day subchronic

inhalation toxicity study in rats (40 CFR

798.2450 or OPPT 870.3465 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help to characterize the health effects

caused by the substance. The PMN

submitter has agreed not to exceed the
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3399

production volume limit without

performing these tests.

CFR citation: 40 CFR 721.8079.

PMN Number P–94–2159

Chemical name: (generic)

Anthraquinone dye.

CAS number: Not available.

Basis for action: The PMN substance

will be used as described in the PMN.

Based on submitted test data and

analogy to aliphatic amines EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 2 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance would not be

released to surface waters. EPA has

determined that other uses of the

substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at § 721.170 (b)(4)(i).

Recommended testing: EPA has

determined that a fish acute toxicity

study modified with humic acid (40

CFR 797.1400 or OPPTS 850.1085 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.723.

PMN Number P–95–168

Chemical name: Phosphonic acid,

methylenebis-, tetrakis(1-methylethyl)

ester.

CAS number: 1660–95–3.

Effective date of section 5(e) consent

order: September 20, 1995.

Basis for section 5(e) consent order: The

Order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health.

Toxicity concern: Similar dimethyl

methyl phosphonate (DMMP) and

diisopropyl methylphosphonate (DIMP)

chemical substances have been shown

to cause oncogenicity in test animals. In

addition the PMN substance was

demonstrated to be a chromosome

mutagen in a mouse lymphoma study.

Recommended testing: The Agency has

determined that the results of a 2-year

bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

would help to characterize possible

human effects of the substance.

CFR citation: 40 CFR 721.6075.

PMN Number P–95–243

Chemical name: Phenol, 4-(1,1-

dimethylethyl)-, homopolymer.

CAS number: 30813–81–1.

Effective date of section 5(e) consent

order: October 5, 1995.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to the aquatic environment.

Toxicity concern: The PMN substance

has been shown to be toxic to aquatic

organisms. However, the substance also

has the advantages of eliminating or

reducing volatile organic solvents, and

reducing exposures to residual

monomers. EPA has evaluated two

processor/use sites where releases

sometimes exceed the concern level. In

light of the benefits of the substance,

EPA determined these releases did not

constitute an unreasonable risk and will

allow releases at these sites in the

section 5(e) consent order and SNUR.

Recommended testing: EPA has

determined that an activated sludge

adsorption isotherm study (OPPTS

835.1110 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1), a chronic 60-day fish early life stage

toxicity test in rainbow trout (40 CFR

797.1600 or OPPTS 850.1400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), a 21-day

daphnid chronic toxicity test (40 CFR

797.1330 or OPPTS 850.1300 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), or a

chironomid sediment toxicity test

(OPPTS 850.1790 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1)) would help characterize

possible effects of the PMN substance in

the aquatic environment. The consent

order contains two production limits.

The PMN submitter has agreed not to

exceed the first production limit

without performing the activated sludge

adsorption isotherm test. The PMN

submitter has also agreed not to exceed

the second higher production limit

without performing either the fish early

life stage with rainbow trout and the

daphnid chronic toxicity tests, or the

chironomid sediment toxicity test,

depending on the results of the

activated sludge adsorption isotherm

test.

CFR citation: 40 CFR 721.538.

PMN Number P–95–535

Chemical name: Reaction products of

formalin (37%) with amine C12.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an oilfield chemical.

Based on analogy to aliphatic amines,

EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 20 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters.

EPA has determined that other uses of

the substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.9285.

PMN Numbers P–95–605/606

Chemical name: (generic) Trifunctional

ketoximino silane.

CAS number: Not available.

Basis for action: The PMN substance

will be used as described in the PMN.

Based on analogy of the hydrolysis

product of the PMN substances to

similar compounds, EPA is concerned

that cancer and blood effects could

occur to exposed workers. EPA

determined that use of the substances as

described in the PMN did not present an

unreasonable risk because exposed

workers would wear adequate protective

equipment to prevent dermal exposure.

EPA has determined that other uses of

the substance may result in dermal

exposure to workers. Based on this

information the PMN substance meets

the concern criteria at § 721.170

(b)(1)(i)(D) and (b)(3)(iii).

Recommended testing: EPA has

determined that a 90-day subchronic

study in rats by the oral route (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) and a 2-

year, two-species bioassay (40 CFR

799.9420) (62 FR 43838, August 15,

1997) (FRL–5719–5) would help

characterize the health effects of the

PMN substance.

CFR citation: 40 CFR 721.9497.

PMN Number P–95–633

Chemical name: (generic) Sodium salt of

azo acid dye.

CAS number: Not available.

Basis for action: The PMN substance

will be used in a non-dispersive use.
3400 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

Based on analogy of the azo reduction

products to structurally similar

substances, EPA is concerned that

cancer and systemic toxicity will occur

in exposed workers. EPA determined

that use of the substance did not present

an unreasonable risk because significant

worker exposure is not expected

because the substance was not

manufactured, processed, or used as a

powder. EPA has determined that

manufacture, processing, and use of the

substance as a powder may result in

significant worker exposure. Based on

this information the PMN substance

meets the concern criteria at § 721.170

(b)(1)(i)(D) and (b)(3)(iii).

Recommended testing: EPA has

determined that a 90-day subchronic

study in rats by the oral route with

special attention to the liver, kidney,

spleen, and blood (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) would help characterize the

health effects of the substance.

CFR citation: 40 CFR 721.980.

PMN Number P–95–637

Chemical name: 2-Pentene,

1,1,1,2,3,4,4,5,5,5-decafluoro-.

CAS number: 72804–49–0.

Basis for action: The PMN substance

will be used as an intermediate. Based

on toxicity data submitted with the

PMN, EPA identified health concerns

for neurotoxicity. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because significant human exposure

is not expected. EPA has determined

that use of the substance other than as

described in the PMN may result in

significant human exposure. Based on

this information the PMN substance

meets the concern criteria at § 721.170

(b)(3)(i).

Recommended testing: None.

CFR citation: 40 CFR 721.5708.

PMN Number P–95–638

Chemical name: Pentane

1,1,1,2,2,3,4,5,5,5,-decafluoro.

CAS number: 138495–42–8.

Basis for action: The PMN substance

will be used as described in the PMN.

Based on toxicity data submitted with

the PMN, EPA identified health

concerns for neurotoxicity. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because significant

human exposure is not expected. EPA

has determined that use of the substance

other than as described in the PMN may

result in significant human exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(3)(i).

Recommended testing: None.

CFR citation: 40 CFR 721.5645.

PMN Number P–95–666

Chemical name: (generic) Polyether

acrylate.

CAS number: Not available.

Basis for action: The PMN substance

will be used in a radiation curing

formulation. Based on analogy to

acrylates, EPA identified concerns for

toxicity to aquatic organisms. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because significant

environmental exposure is not expected.

EPA has determined that other uses may

result in releases to water which are

significant environmental exposures.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.405.

PMN Numbers P–95–677/724

Chemical name: (generic) Antimony

double oxide.

CAS number: Not available.

Effective date of section 5(e) consent

order: March 12, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health and the

environment.

Toxicity concern: Similar chemicals

have been shown to cause cancer, lung

toxicity and ocular effects in test

animals. In addition to human health

concerns, an aquatic toxicity concern

has been identified if the substance is

released to surface waters. A concern

concentration of 5 ppb has been

established.

Recommended testing: EPA has

determined that a 2-year, one-species rat

inhalation bioassay, which has an

additional holding period, analyses of

lung burdens, and determination of

clearance rates of particles (as described

at (40 CFR 799.9420) (62 FR 43838,

August 15, 1997) (FRL–5719–5) would

help characterize the carcinogenicity,

lung toxicity and ocular effects of the

PMN substance. In addition, EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.5547.

PMN Numbers P–95–1103, P–95–1104,

and P–96–1235

Chemical name: (generic) Substituted

resorcinols.

CAS number: Not available.

Basis for action: The PMN substances

will be used as components of a

material for integrated circuit

fabrication. Based on submitted toxicity

data and analogy to phenols, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 9 ppb of P–95–1103/P–95–

1104 and 1 ppb of P–96–1235 in surface

waters. EPA determined that use of the

substances as described in the PMNs

did not present an unreasonable risk

because the substances would not be

released to surface waters in significant

quantities. EPA has determined that

other uses of the substances may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substances meet the concern criteria at

§ 721.170(b)(4)(i) and (b)(4)(ii).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) and a 21-day daphnid chronic

toxicity test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) would help characterize the

environmental effects of P–95–1103 and

P–95–1104. EPA has also determined

that a fish acute toxicity study (40 CFR

797.1400 or OPPTS 850.1075 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), a

daphnid acute toxicity study (40 CFR

797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3401

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of P–96–1235.

CFR citation: 40 CFR 721.9488.

PMN Number P–95–1128

Chemical name: (generic) Brominated

aromatic ester.

CAS number: Not available.

Effective date of section 5(e) consent

order: November 5, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and 5(e)(1)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health and the

environment.

Toxicity concern: Similar chemicals

have been shown to: (1) Degrade in the

environment resulting in substances

that may cause aquatic toxicity, and (2)

form dibenzodioxins and dibenzofurans

when incinerated under combustion

conditions of municipal incinerators.

EPA has determined that halogenated

dioxins and furans are probable human

carcinogens and may cause toxic effects

in aquatic and terrestrial organisms.

Recommended testing: The consent

order contains two production volume

limits. The PMN submitter has agreed

not to exceed the first production

volume limit without performing an

incineration simulation study

(guidelines available from EPA) to help

characterize the potential for the

formation of dibenzodioxins or

dibenzofurans when plastics or resins

containing the substance are

incinerated, and a porous pot test

(OPPTS 835.3220 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1) to determine the extent of

environmental degradation of the

substance. The PMN submitter has also

agreed not to exceed the second, higher

production volume limit without

performing a shake flask die-away test

(OPPTS 835.3170 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1), a fish bioconcentration

test (OPPTS 850.1730 test guideline

(public draft; 61 FR 16486, April 15,

1996) (FRL–5363–1)), a fish acute

toxicity study (40 CFR 797.1400 or

OPPTS 850.1075 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1)), a daphnid acute toxicity

study (40 CFR 797.1300 or OPPTS

850.1010 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), and an algal acute toxicity study (40

CFR 797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)).

CFR citation: 40 CFR 721.2925.

PMN Number P–95–1213

Chemical name: (generic) Hydroxy

terminated polyester.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to esters, EPA is concerned

that toxicity to aquatic organisms may

occur at a concentration as low as 200

ppb of the PMN substance in surface

waters. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance would not be

released to surface waters. EPA has

determined that other uses of the

substance may result in releases to

surface water at concentrations above

200 ppb. Based on this information the

PMN substance meets the concern

criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.6485.

PMN Number P–95–1235

Chemical name: 2-Naphthalenesulfonic

acid, 3-[[4-[(2,4-dimethyl-6-

sulfophenyl)azo]-2-methoxy-5-

methylphenyl]azo]-4-hydroxy-7-

(phenylamino)-, sodium salt, compd.

With 2,2′,2′′-nitrilotris [ethanol] (9CI).

CAS number: 94213–53–3.

Basis for action: The PMN substance

will be used in an open non-dispersive

use. Based on analogy of the azo

reduction products to similar

substances, EPA is concerned that

cancer, systemic toxicity,

developmental toxicity,

methemoglobinemia, and skin

sensitization will occur in exposed

workers. EPA determined that use of the

substance did not present an

unreasonable risk because significant

worker exposure is not expected

because the substance was not

manufactured, processed, or used as a

powder or manufactured domestically.

EPA has determined that manufacture,

processing, and use of the substance as

a powder or domestic manufacture may

result in significant worker exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(3)(iii).

Recommended testing: EPA has

determined that an Ames assay with the

Prival modification with a concurrent

positive control would help characterize

the health effects of the PMN substance.

CFR citation: 40 CFR 721.5281.

PMN Number P–95–1282

Chemical name: (generic) Reaction

product of dichlorobenzidine and

substituted alkylamide.

CAS number: Not available.

Effective date of section 5(e) consent

order: July 29, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and 5(e)(1)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to health.

Toxicity concern: 3,3′-dichlorobenzidine

(DCB) and possible reduction products

have been shown to cause oncogenicity

and mutagenicity in test animals.

Recommended testing: The following

studies would help characterize the

health effects of the PMN substance:

Monitoring data to detect the presence

of DCB under actual conditions of use

in polymer coloration or sheet metal

coating use (Az, R., Dewald B. and

Scnaitmann, D. 1991. Pigment

Decomposition in Polymers in

Applications at Elevated Temperatures

(Dyes and Pigments 15:1–14).

Monitoring data would include the

following elements: Extrusion or other

process), monitoring data to detect

airborne concentrations of DCB during

high-temperature coloration or sheet

metal coating use (see TSCA section 8(e)

data e.g., section 8(e)-962 supp.), radiolabeled pharmacokinetic study (oral) in

rats on the pigment (with the radio-label

on the DCB) (OPPTS 870.7485 test

guideline (public draft; 60 FR 45158,

August 30, 1995) (FRL–4973–2)) plus

radio-label), and a 2-year, two-species

bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5).

CFR citation: 40 CFR 721.9265.

PMN Number P–95–1288

Chemical name: 2-Naphthalenol, mono

and dioctyl derivs.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to phenols, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentrations

as low as 1 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance did not

exceed a concentration of 1 ppb when

released to surface waters. EPA has

determined that increased production
3402 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

volume may result in releases to surface

waters above 1 ppb. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.5255.

PMN Number P–95–1317

Chemical name: (generic)

Hydrochlorofluorocarbon.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on toxicity data submitted with the

PMN, EPA identified health concerns

for neurotoxicity. Based on analogy to

structurally similar chemicals, EPA

identified health concerns for cardiac

sensitization, liver toxicity, kidney

toxicity, and skin irritation. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because significant

human exposure is not expected. EPA

has determined that use of the substance

other than as described in the PMN may

result in significant human exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170 (b)(3)(i) and (b)(3)(ii).

Recommended testing: None.

CFR citation: 40 CFR 721.4462.

PMN Number P–95–1326

Chemical name: 3,8-Dioxa-4,7-

disiladecane, 4,4,7,7-tetraethoxy-.

CAS number: 16068–37–4.

Basis for action: The PMN substance

will be used in treatment of laminates

for printed circuit boards and sol-gel

ceramics. Based on analogy to

alkoxysilanes, EPA is concerned that a

significant risk of lung toxicity and

severe irritation to skin, eyes, and

mucous membranes could occur. EPA

determined that use of the substance did

not present an unreasonable risk

because the substance would not be

manufactured, processed, or used in a

manner that generated a vapor, mist, or

aerosol and significant worker

inhalation exposure is not expected.

EPA has determined that manufacture,

processing, or use of the substance in a

manner that generated a vapor, mist, or

aerosol may result in significant worker

inhalation exposure. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day subchronic

inhalation study in rats (40 CFR

798.2450 or OPPTS 870.3465 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help characterize the health effects of

the PMN substance.

CFR citation: 40 CFR 721.3155.

PMN Number P–95–1347

Chemical name: (generic) Aliphatic

polyisocyanate.

CAS number: Not available.

Basis for action: The PMN substance

will be used in an open non-dispersive

use. Based on analogy to diisocyanates,

there is concern for lung toxicity,

pulmonary sensitization, and irritation

to mucous membranes. EPA determined

that use of the substance as described in

the PMN did not present an

unreasonable risk because workers

would not be subject to significant

inhalation exposures. EPA has

determined that uses of the substance

that generate a mist, aerosol, or vapor

may result in significant inhalation

exposures to workers. Based on this

information the PMN substance meet

the concern criteria at

§ 721.170(b)(3)(ii).

Recommended testing: EPA has also

determined that a 90-day subchronic

inhalation study in rats (40 CFR

799.9346) (62 FR 43828, August 15,

1997) (FRL–5719–5) would help

characterize the health effects of the

PMN substance.

CFR citation: 40 CFR 721.6495.

PMN Number P–95–1356

Chemical name: (generic) Silylated

polyurethane.

CAS Number: Not available.

Basis for action: The PMN substance

will be used as a moisture curable

polymer. Based on analogy of the PMN

substance to alkoxysilanes, EPA expects

irritation to mucous membranes and

lung toxicity. EPA determined that use

of the substance as described in the

PMN did not present an unreasonable

risk because there were no significant

inhalation exposures. EPA has

determined that use of the substance

generating an aerosol or a mist may

result in significant inhalation

exposures. Based on this information

the PMN substance meets the concern

criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day subchronic

inhalation study (40 CFR 798.2450 or

OPPTS 870.3465 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) would help characterize the

health effects of the PMN substance.

CFR citation: 40 CFR 721.8095.

PMN Number P–95–1386

Chemical name: Benzene, 1,1′-

methylanebis[4-isocyanato-,

homopolymer, Bu alc.-blocked.

CAS number: 186321–98–2.

Basis for action: The PMN substance

will be used as described in the PMN.

Based on analogy to diisocyanates, EPA

is concerned that a significant risk of

oncogenicity, respiratory sensitization,

and chronic lung effects could occur.

EPA determined that use of the

substance did not present an

unreasonable risk because the substance

would not be manufactured, processed,

or used in a manner that generated a

vapor, mist, or aerosol and significant

worker inhalation exposure is not

expected. EPA has determined that

manufacture, processing, or use of the

substance in a manner that generated a

vapor, mist, or aerosol may result in

significant worker inhalation exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170 (b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day inhalation

study in rats (40 CFR 799.9346) (62 FR

43828, August 15, 1997) (FRL–5719–5)

would help characterize the health

effects of the PMN substance.

CFR citation: 40 CFR 721.2535.

PMN Number P–95–1411

Chemical name: Propanedioic acid, [(4-

methoxyphenyl)methylene]-,

bis(1,2,2,6,6-pentamethyl-4-piperidinyl)

ester (9CI).

CAS number: 147783–69–5.

Effective date of section 5(e) consent

order: November 22, 1995.

Basis for section 5(e) consent order: The

order was issued under section

5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health.

Toxicity concern: Similar chemicals

have been shown to cause toxicity to the

immune system, liver, blood, the male

reproductive system and the G.I. tract in

test animals.

Recommended testing: A 90-day

subchronic oral toxicity study in rats (40

CFR 798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help characterize the human health

effects. The PMN submitter has agreed

not to exceed the production volume

limit without performing this test.
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3403

CFR citation: 40 CFR 721.4589.

PMN Number P–95–1466

Chemical name: (generic) Substituted

aromatic aldehyde.

CAS number: Not available.

Basis for action: The PMN substance

will be used as described in the PMN.

Based on analogy to phenols and

aldehydes EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 3 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMNs did not present

an unreasonable risk because the

substance would not be released to

surface waters. EPA has determined that

other uses of the substance may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.526.

PMN Number P–95–1467

Chemical name: Benzaldehyde, 2-

hydroxy-5-nonyl-, oxime, branched.

CAS number: 174333–80–3.

Basis for action: The PMN substance

will be used as described in the PMN.

Based on analogy to phenols, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance would not be

released to surface waters. EPA has

determined that other uses of the

substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.528.

PMN Numbers P–95–1557/1558

Chemical name: (generic) Substituted

imines.

CAS number: Not available.

Basis for action: The PMN substances

will be used as intermediates. Based on

analogy to aliphatic amines EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substances

in surface waters. EPA determined that

use of the substances as described in the

PMNs did not present an unreasonable

risk because the substances would not

be released to surface waters. EPA has

determined that other uses of the

substances may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substances meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.4476.

PMN Numbers P–95–1575/1576/1577

Chemical name: Chromate(3-), bis[3-[[5-

(aminosulfonyl)-2-hydroxyphenyl]azo]-

4-hydroxy-7-[[2-oxo-1-

[(phenylamino)carbonyl] propyl]azo]-2-

naphthalenesulfonato(3-)]-, trisodium

(9CI) (P–95–1575), Chromate(3-), bis[7-

[(aminohydroxyphenyl)azo]-3-[[5-

(aminosulfonyl)-2-hydroxyphenyl]azo]-

4-hydroxy-2-naphthalene-sulfonato (3-

)]-, trisodium (9CI) (P–95–1576),

Chromate(3-), bis[7-

[(aminohydroxyphenyl)azo]-3-[[5-

(aminosulfonyl)-2-hydroxyphenyl] azo]-

4-hydroxy-2-naphthalenesulfonato (3-)]-

,-[[5-(aminosulfonyl) -2-

hydroxyphenyl]azo]-4-hydroxy-7-[[2-

hydroxy-1-[(phenylamino) carbonyl]-1-

propenyl]azo]-2-

naphthalenesulfonato(3-)]-, trisodium

(9CI) (P–95–1577).

CAS number: 119535–63–6 (P–95–

1575), 118716–62–4 (P–95–1576), and

118716–61–3 (P–95–1577).

Basis for action: The PMN substances

will be used as leather dyes. Based on

analogy to similar substances, EPA is

concerned that cancer, developmental,

kidney, and liver toxicity will occur in

exposed workers. EPA determined that

use of the substances did not present an

unreasonable risk because significant

worker exposure is not expected

because the substances were not

manufactured, processed, or used as a

powder. EPA has determined that

manufacture, processing, and use of the

substances as a powder may result in

significant worker exposure. Based on

this information the PMN substances

meet the concern criteria at § 721.170

(b)(1)(i)(B), (b)(1)(i)(C), (b)(3)(i), and

(b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5),

an oral 2-generation reproduction study

in rats (40 CFR 799.9380) (62 FR 43834,

August 15, 1997) (FRL–5719–5), and a

90-day subchronic inhalation study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–7))

would help characterize the health

effects of the PMN substances.

CFR citation: 40 CFR 721.9575 (P–95–

1575), 40 CFR 721.9576 (P–95–1576),

and 40 CFR 721.9577 (P–95–1577).

PMN Number P–95–1578

Chemical name: (generic)

Hydrofluorocarbon alkyl ether.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to similar substances, EPA

identified concerns for cancer,

cardiotoxicity, cardiosensitization,

respiratory failure, neurotoxicity, and

irritation to membranes. Based on

submitted test data EPA identified

concerns for acute toxicity. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because significant

human exposure is not expected. EPA

has determined that use of the substance

without the worker protection cited in

the PMN or if the substance is used

other than as an intermediate may result

in significant human exposure. Based

on this information the PMN substance

meets the concern criteria at § 721.170

(b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

bioassay (40 CFR 799.9420) (62 FR
3404 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

43838, August 15, 1997) (FRL–5719–5)

and a 90-day subchronic oral study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–7))

will address the potential health effects

of the PMN substance.

CFR citation: 40 CFR 721.3485.

PMN Numbers P–95–1650/1651/1652/

1653

Chemical name: (generic) Alkyl phenyl

polyetheramines.

CAS number: Not available.

Basis for action: The PMN substances

will be used as intermediates. Based on

analogy to aliphatic amines EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 3 ppb of the PMN substances

in surface waters. EPA determined that

use of the substances as described in the

PMNs did not present an unreasonable

risk because the substances would not

be released to surface waters. EPA has

determined that other uses of the

substances may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substances meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.6490.

PMN Number P–95–1750

Chemical name: (generic) Pentanediol

light residues.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a solvent. Based on

potential consumer exposures, EPA has

determined that the PMN substance may

cause significant or substantial human

exposure. EPA determined that use of

the substance as described in the PMN

did not cause significant or substantial

exposure from use as an industrial

solvent. EPA has determined that

exposures from consumer use may

result in significant or substantial

human exposures. Based on this

information activities other than those

described in the PMN may result in

significant changes in human exposure.

Recommended testing: EPA has

determined that a 28-day oral study in

rats (OECD guideline no. 407), an acute

rat oral study (OPPTS 870.1100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)), an ames

assay (40 CFR 798.5265 or OPPTS

870.5265 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–

7)), a mouse micronucleus assay by the

intraperitoneal route (40 CFR 799.9539)

(62 FR 43853, August 15, 1997) (FRL–

5719–5), and a developmental toxicity

study in one species by the oral route

(40 CFR 799.9370) (62 FR 43832, August

15, 1997) (FRL–5719–5) would help

characterize possible health effects of

the substance. EPA will require any

manufacturer importer, or processor

who distributes this substance for use in

a consumer product to perform this

testing.

CFR citation: 40 CFR 721.5650.

PMN Number P–95–1772

Chemical name: (generic) Polyalkyl

phosphate.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a specialty additive.

Based on analogy to neutral organic

substances, EPA expects toxicity to

aquatic organisms at surface water

concentrations as low as 1 ppb. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

did not exceed a concentration of 1 ppb

when released to surface waters. EPA

has determined that other uses may

result in releases to surface waters above

1 ppb. Based on this information the

PMN substance meets the concern

criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.5995.

PMN Number P–95–1806

Chemical name: (generic) Quaternary

ammonium hydroxide.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an additive. Based on

analogy to cationic surfactants, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 4 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance was not

released to surface waters. EPA has

determined that other uses may result in

releases to surface waters above the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.4467.

PMN Number P–95–1825

Chemical name: Thieno[3,4-b]-1,4-

dioxin, 2,3-dihydro- (9CI).

CAS number: 126213–50–1.

Basis for action: The PMN substance

will be used in an open non-dispersive

use. Based on analogy to structurally

similar substances, EPA identified

concerns for cancer and based on

submitted test data EPA identified

concerns for liver toxicity and

neurotoxicity. EPA determined that use

of the substance as described in the

PMN did not present an unreasonable

risk because significant human exposure

is not expected. EPA has determined

that use of the substance without the

worker protection cited in the PMN or

if the substance is manufactured

domestically may result in significant

human exposure. Based on this

information the PMN substance meets

the concern criteria at § 721.170

(b)(1)(i)(C) and (b)(3)(i).

Recommended testing: EPA has

determined that a 2-year, two-species

bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a 90-day subchronic oral study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–7))

will address the potential health effects

of the PMN substance.

CFR citation: 40 CFR 721.9662.

PMN Number P–95–1891

Chemical name: Siloxanes and

silicones, Me hydrogen, reaction
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3405

products with 2,2,6,6-tetramethyl-4-(2-

propenyloxy)piperdine.

CAS number: 182635–99–0.

Basis for action: The PMN substance

will be used as an ultraviolet light

stabilizer for polymers. Based on

analogy to hindered amines, there is

concern for toxicity to the immune

system and the G.I. tract, liver toxicity,

blood toxicity, and toxicity to the male

reproductive system. EPA determined

that use of the substance as described in

the PMN did not present an

unreasonable risk because workers

would not be exposed by inhalation.

EPA determined that use as a powder

may result in inhalation exposure to

workers. Based on this information the

PMN substance meets the concern

criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day subchronic

inhalation study in rats (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

characterize the human health effects of

the PMN substance.

CFR citation: 40 CFR 721.6170.

PMN Number P–95–1950

Chemical name: (generic) Substituted

ethoxyethylamine phosphonate.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a scale inhibitor. Based

on analogy to polyanionic monomers,

EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 30 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

was not released to surface waters. EPA

has determined that other uses may

result in releases to surface waters above

30 ppb. Based on this information the

PMN substance meets the concern

criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.6078.

PMN Number P–95–2101

Chemical name: Hydrazine, (2-

fluorophenyl).

CAS Number: 2368–80–1.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy of the PMN substance to

hydrazines EPA is concerned that

oncogenicity, liver and kidney effects,

lung effects, and blood effects will occur

to exposed workers and that toxicity

will occur to aquatic organisms. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because there were no

significant worker or environmental

exposures. EPA has determined that

domestic manufacture of the substance

may result in significant worker and

environmental exposures. Based on this

information the PMN substance meets

the concern criteria at § 721.170

(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a 90-day subchronic oral study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–7))

would help characterize the health

effects of the PMN substance. A fish

acute toxicity study (40 CFR 797.1400 or

OPPTS 850.1075 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1)), a daphnid acute toxicity

study (40 CFR 797.1300 or OPPTS

850.1010 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), and an algal acute toxicity study (40

CFR 797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.4257.

PMN Number P–96–19

Chemical name: Lithiated metal oxide

(LiNiO2).

CAS number: 12031–65–1.

Effective date of section 5(e) consent

order: June 26, 1996.

Basis for section 5(e) consent order: The

order was issued under section

5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health and the

environment.

Toxicity concern: Similar chemicals

have been shown to cause cancer and

systemic toxicity in test animals. In

addition, based on Structure Activity

Relationship (SAR) analysis derived

from test data on structurally similar

compounds, EPA expects toxicity to

aquatic organisms to occur at a

concentration of 30 ppb PMN substance

in surface waters.

Recommended testing: The results of a

90-day subchronic inhalation toxicity

study in rats (40 CFR 799.9346) (62 FR

43828, August 15, 1997) (FRL–5719–5)

and a 2-year, two-species bioassay via

inhalation (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

would help characterize the human

health concerns. The results of a fish

acute toxicity study (40 CFR 797.1400 or

OPPTS 850.1075 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1)), a daphnid acute toxicity

study (40 CFR 797.1300 or OPPTS

850.1010 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), and an algal acute toxicity study (40

CFR 797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1))

conducted using static method and

nominal concentrations, would help to

characterize the toxicity of the

substance. The consent order contains

two production volume limits. The

PMN submitter has agreed not to exceed

the first production volume limit

without performing the 90-day

subchronic toxicity test. The PMN

submitter has also agreed not to exceed

the second higher production volume

limit without performing the bioassay.

CFR citation: 40 CFR 721.5549.

PMN Number P–96–33

Chemical name:

Cyclopropanecarboxaldehyde.

CAS number: 1489–69–6.

Effective date of section 5(e) consent

order: November 27, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health.

Toxicity concern: Similar aldehydes

have been shown to cause lung

irritation, carcinogenicity, mutagenicity,

and liver toxicity in test animals.

Developmental effects are possible

based on the acid.

Recommended testing: EPA has

determined that an in vitro mouse

lymphoma assay (40 CFR 799.9530) (62

FR 43846, August 15, 1997) (FRL–5719–

5) and an in vivo mouse micronucleus

assay (40 CFR 799.9539) (62 FR 43853,

August 15, 1997) (FRL–5719–5), a 90-

day inhalation test in rats (OECD

guideline no. 413), a 2-year, one-species

bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

would help characterize the human

health effects. The consent order

contains two production volume limits.
3406 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

The PMN submitter has agreed not to

exceed the first production volume limit

without performing the in vitro mouse

lymphoma, in vivo mouse micronucleus

assays, and the 90-day inhalation test in

rats. The PMN submitter has also agreed

not to exceed the second production

volume limit without performing a 2-

year, one-species bioassay, which EPA

may elect not to require depending on

the results of the mutagenicity studies

and the 90-day test.

CFR citation: 40 CFR 721.2280.

PMN Number P–96–92

Chemical name: (generic) 1,4-

benzenediol, 2-(1,1,3,3-

tetramethylbutyl) and

Bis(dimethylamino substituted)

carbomonocycle.

CAS number: Not available.

Basis for action: The PMN substance

will be used in a consumer article.

Based on analogy to hydroquinones,

EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 1 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters

in significant quantities. EPA has

determined that other uses of the

substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.1155.

PMN Number P–96–93

Chemical name: Benzenamine, 4,4′-

methylenebis[2-methyl-6-(1-

methylethyl)]-.

CAS number: 16298–38–7.

Basis for action: The PMN substance

will be used in a non-dispersive use.

Based on submitted test data EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 20 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance would not be

released to surface waters. EPA has

determined that other uses of the

substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at § 721.170(b)(4)(i).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) and a 21-day daphnid chronic

toxicity test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)) would help characterize the

environmental effects of the PMN

substance.

CFR citation: 40 CFR 721.1105.

PMN Number P–96–236

Chemical name: 1-Tridecyn-3-ol, 3-

methyl.

CAS Number: 100912–15–0.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy of the PMN substance to 1-

hexyn-3-ol and other structurally

similar substances, EPA is concerned

that liver toxicity, kidney toxicity,

neurotoxicity, reproductive toxicity, and

cardiotoxicity will occur to exposed

workers. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because significant worker exposures

were not expected. EPA has determined

that domestic manufacture of the

substance or use of the substance

without dermal protective equipment

may result in significant worker

exposures. Based on this information

the PMN substance meets the concern

criteria at § 721.170(b)(3)(ii).

Recommended testing: EPA has

determined that an oral 2-generation

reproduction study in rats (40 CFR

799.9380) (62 FR 43834, August 15,

1997) (FRL–5719–5) and a 90-day

subchronic oral study in rats (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help characterize the health effects of

the PMN substance.

CFR citation: 40 CFR 721.9830.

PMN Number P–96–238

Chemical name: (generic) Azo

monochloro triazine reactive dye.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a dye. Based on analogy

to structurally similar substances and

submitted test data, EPA is concerned

that liver toxicity, blood toxicity,

oncogenicity, neurotoxicity, and

developmental toxicity will occur in

exposed workers. EPA determined that

use of the substance did not present an

unreasonable risk because significant

worker exposure is not expected

because the substance was

manufactured, processed, or used as

liquids. EPA has determined that

manufacture, processing, or use of the

substance as a solid may result in

significant worker exposure. Based on

this information the PMN substance

meets the concern criteria at § 721.170

(b)(3)(i), (b)(3)(ii), and (b)(3)(iii).

Recommended testing: EPA has

determined that an oral two-species

developmental toxicity test (40 CFR

799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) and a 90-day

subchronic oral study in rats (40 CFR

798.2650 or OPPT 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help characterize the health effects of

the PMN substance.

CFR citation: 40 CFR 721.9717.

PMN Number P–96–273

Chemical name: (generic) Chloroalkane.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on toxicity data submitted with the

PMN and by analogy to chlorinated

solvents, EPA identified health concerns

for liver toxicity, kidney toxicity,

neurotoxicity, and oncogenicity. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because significant

human exposure is not expected. EPA

has determined that use of the substance

other than as described in the PMN may

result in significant human exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170 (b)(1)(i)(C), (b)(3)(i), and

(b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a 90-day subchronic oral study in

rats (40 CFR 798.2650 or OPPT 870.3100

test guideline (public draft; 61 FR

31522, June 20, 1996) (FRL–5367–7))

would help characterize the health

effects of the PMN substance.

CFR citation: 40 CFR 721.2091.

PMN Number P–96–346

Chemical name: (generic)

Aminofunctional alkoxy alkyl siloxane.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an adhesion promoter.
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3407

Based on analogy to aliphatic amines

and ethoxysilanes, EPA is concerned

that toxicity to aquatic organisms may

occur at a concentration as low as 10

ppb of the PMN substance in surface

waters. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance was not released

to surface waters. EPA has determined

that other uses may result in releases to

surface waters above 10 ppb. Based on

this information the PMN substance

meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.9515.

PMN Numbers P–96–399/400/401/402/

403/404

Chemical name: (generic) Alkyl

polycarboxylic acids, esters with

ethoxylated fatty alcohols, reaction

products with maleic anhydride.

CAS number: Not available.

Basis for action: The PMN substances

will be used as site-limited production

intermediates. Based on analogy to

nonionic surfactants, EPA is concerned

that toxicity to aquatic organisms may

occur at a concentration as low as 9 ppb

of the PMN substances in surface

waters. EPA determined that use of the

substances as described in the PMNs

did not present an unreasonable risk

because the substances were not

released to surface waters. EPA has

determined that other uses may result in

releases to surface waters. Based on this

information the PMN substances meet

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.6477.

PMN Numbers P–96–406/407/408

Chemical name: (generic) Alkyltri, tetra,

and pentaamines.

CAS number: Not available.

Basis for action: The PMN substances

will be used as industrial lubricants and

fuel additives. Based on analogy to

aliphatic amines, EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 1 ppb of the

PMN substances in surface waters. EPA

determined that use of the substances as

described in the PMNs did not present

an unreasonable risk because the

substances were not released to surface

waters. EPA has determined that other

uses may result in releases to surface

waters. Based on this information the

PMN substances meet the concern

criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.2350.

PMN Numbers P–96–554/555/556/557/

558/559/560/561/564/565

Chemical name: (generic) Alkyl

polycarboxylic acids, esters with

ethoxylated fatty alcohols.

CAS number: Not available.

Basis for action: The PMN substances

will be used as intermediates. Based on

analogy to nonionic surfactants, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 20 ppb of the PMN substances

in surface waters. EPA determined that

use of the substances as described in the

PMN did not present an unreasonable

risk because the substances would not

be released to surface waters. EPA has

determined that other uses of the

substances may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substances meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.6475.

PMN Number P–96–573

Chemical name: (generic) Ethoxylated

alkyl quaternary ammonium compound.

CAS Number: Not available.

Basis for action: The PMN substance

will be used in an open dispersive use.

Based on analogy of the PMN substance

to cationic surfactants, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because there were no significant

environmental exposures. EPA has

determined that any use of the

substance other than for the specific use

described in the PMN may result in

significant environmental exposures.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.655.

PMN Number P–96–585

Chemical name: (generic) Salt of a

substituted polyalkylenepolyamine.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a processing aid. Based

on analogy to aliphatic amines, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance was not

released to surface waters. EPA has

determined that other uses may result in
3408 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

releases to surface waters. Based on this

information the PMN substance meet

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.6197.

PMN Number P–96–702

Chemical name: (generic) Substituted

phenyl azo substituted sulfo

carbopolycycle.

CAS number: Not available.

Basis for action: The PMN substance

will be used in an open nondispersive

use. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because it did not result in significant

human or environmental exposure. EPA

has determined that increased use of the

substance may result in significant

environmental and human exposure.

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

activated sludge adsorption isotherm

(OPPTS 835.1110 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1) would help characterize

the environmental effects of the PMN

substance. A murine immune allergic

response study (Toxicology and Applied

Pharmacology 112:190–197 (1992))

would help characterize the health

effects of the PMN substance.

CFR citation: 40 CFR 721.2122.

PMN Numbers P–96–767/773

Chemical name: (generic) Substituted

pyridine azo substituted phenyl.

CAS number: Not available.

Basis for action: The PMN substances

will be used as textile dyes. Based on

analogy to structurally similar

substances, EPA is concerned that liver

toxicity, kidney toxicity, oncogenicity,

blood toxicity, neurotoxicity, and

developmental toxicity will occur in

exposed workers. EPA determined that

use of the substances did not present an

unreasonable risk because significant

worker exposure is not expected

because the substances were not

manufactured domestically. EPA has

determined that domestic manufacture

of the substances may result in

significant worker exposure. Based on

this information the PMN substances

meet the concern criteria at § 721.170

(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5),

a two-species oral developmental

toxicity study (40 CFR 799.9370) (62 FR

43832, August 15, 1997) (FRL–5719–5),

and a subchronic oral study in rats (40

CFR 798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)) would

help characterize the health effects of

the PMN substances.

CFR citation: 40 CFR 721.8780.

PMN Number P–96–795

Chemical name: (generic) Mixed fatty

alkylamines, salt.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a processing aid. Based

on analogy to aliphatic amines, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance was not

released to surface waters. EPA has

determined that other uses may result in

releases to surface waters. Based on this

information the PMN substance meet

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.567.

PMN Number P–96–813

Chemical name: (generic) Phenothiazine

derivative.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a mediator in enzyme

catalyzed reactions. Based on analogy to

phenothiazines and submitted toxicity

data, EPA is concerned that blood

toxicity, liver toxicity, kidney effects,

adrenal toxicity, spleen toxicity,

reproductive toxicity, and neurotoxicity

will occur in exposed workers. Based on

submitted test data EPA is also

concerned that toxicity to aquatic

organisms will occur at concentrations

as low as 7 ppb. EPA determined that

use of the substance did not present an

unreasonable risk because the use as

described in the PMN would not result

in significant worker exposure or

environmental release. EPA has

determined that domestic manufacture

of the substance as a powder may result

in significant worker exposure or

environmental release. Based on this

information the PMN substance meets

the concern criteria at § 721.170 (b)(3)(i),

(b)(3)(ii), and (b)(4)(i).

Recommended testing: EPA has

determined that a 90-day subchronic

inhalation study in rats (40 CFR

798.2650 or OPPTS 870.3100 test

guideline (public draft; 61 FR 31522,

June 20, 1996) (FRL–5367–7)), a chronic

60-day fish early life stage toxicity test

in rainbow trout (40 CFR 797.1600 or

OPPTS 850.1400 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1)) and a 21-day daphnid

chronic toxicity test (40 CFR 797.1330

or OPPTS 850.1300 test guideline

(public draft; 61 FR 16486, April 15,

1996) (FRL–5363–1)) would help

characterize the health and

environmental effects of the PMN

substance.

CFR citation: 40 CFR 721.5913.

PMN Number P–96–824

Chemical name: (generic) Acrylate ester.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a monomer. Based on

analogy to acrylates, EPA identified

concerns for toxicity to aquatic

organisms at concentrations as low as 6

ppb. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because significant environmental

exposure is not expected. EPA has

determined that other uses may result in

releases to water which are significant

environmental exposures. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3409

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.2805.

PMN Number P–96–866

Chemical name: (generic) Derivative of

substituted carbomonocyclic carboxylic

acid-amine distillation stream

byproduct reaction product.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a processing aid. Based

on analogy to aliphatic amines, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance was not

released to surface waters. EPA has

determined that other uses may result in

releases to surface waters. Based on this

information the PMN substance meet

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.2082.

PMN Number P–96–897

Chemical name: (generic) Terpene

residue distillates.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an odor enhancer. Based

on analogy to neutral organic

substances, EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 10 ppb of

the PMN substance in surface waters.

EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance would not be

released to surface waters above a level

of 10 ppb. EPA has determined that

other uses of the substance may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.9635.

PMN Number P–96–941

Chemical name: (generic) Ceteareth-25

sorbate.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to nonionic surfactants, EPA

is concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as an intermediate

did not present an unreasonable risk

because the substance would not be

released to surface waters in significant

amounts. EPA has determined that other

uses of the substance may result in

releases to surface waters which

significantly exceed the concern

concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.2145.

PMN Number P–96–942

Chemical name: Methanone, [5-[[3-(2Hbenzotriazol-2-yl)-2-hydroxy-5-(1,1,3,3-

tetramethylbutyl)phenyl]methyl]-2-

hydroxy-4-(octyloxy)phenyl]phenyl-.

CAS number: 162245–07–0.

Effective date of section 5(e) consent

order: September 24, 1996.

Basis for section 5(e) consent order: The

order was issued under section 5

(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to human health. Toxicity

concern: Section 8(e) data and data on

analogous hindered phenol

benzotriazoles have shown similiar

substances to cause increased organ

weight (liver and kidney, with

associated histopathology at higher

doses); hematological effects (decreased

hemoglobin, packed cell volume, and

erythrocytes); and immune systems

effects(weight changes in thymus,

spleen, lymph nodes; decreased

leukocytes) in test animals.

Recommended testing: EPA has

determined that a 90-day gavage study

in rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–7))

with special attention to hematology

would help characterize systemic

toxicity and reproductive toxicity. The

PMN submitter has agreed not to exceed

the production volume limit without

performing this test.

CFR citation: 40 CFR 721.4885.

PMN Numbers P–96–945/946/947/948

Chemical name: (generic) Mixture of

hydrochlorofluoro alkanes and

hydrochlorofluoro alkene.

CAS number: Not available.

Basis for action: The PMN substances

will be used as intermediates. Based on

analogy to similar substances, EPA is

concerned that lung toxicity,

neurotoxicity, irritation, oncogenicity,

liver toxicity, kidney toxicity, and

cardiac sensitization will occur in

exposed workers. EPA determined that

use of the substance as an intermediate

did not present an unreasonable risk

because it did not result in significant

worker exposure. EPA has determined

that use other than an intermediate may

result in significant worker exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day subchronic

oral study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) and a 2-year, two-species oral

bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

would help characterize the health

effects of the PMN substance.

CFR citation: 40 CFR 721.4464.

PMN Numbers P–96–950/951

Chemical name: (generic) Polymers of

C13C15 oxoalcohol ethoxolate, ammonia,

and maleic anhydride.
3410 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

CAS number: Not available.

Basis for action: The PMN substances

will be used as described in the PMN.

Based on structure activity relationships

to nonionic surfactants-alkylethoxylates,

EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 9 ppb of the

PMN substances in surface waters. EPA

determined that use of the substances as

described in the PMNs did not present

an unreasonable risk because the

substances would not be released to

surface waters. EPA has determined that

other uses of the substances may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substances meet the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.6505.

PMN Number P–96–1176

Chemical name: Cyclohexanamine,

N,N-dimethyl-, compd. with alphaisotridecyl-omega-hydroxypoly(oxy-1,2-

ethanediyl) phosphate.

CAS Number: 164383–18–0.

Basis for action: The PMN substance

will be used as a pigment dispersant for

color dispersion. Based on analogy to

phosphate based anionic surfactants,

EPA expects toxicity to aquatic

organisms at surface water

concentrations as low as 20 ppb. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because there were no

significant environmental exposures.

EPA has determined that any use of the

substance other than for the specific use

described in the PMN may result in

significant exposures. Based on this

information the PMN substances meet

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance

CFR citation: 40 CFR 721.2222.

PMN Number P–96–1177

Chemical name: Tungstate

(W12(OH)2O386-) hexasodium (9CI).

CAS Number: 12141–67–2.

Basis for action: The PMN substance

will be used in an open non-dispersive

use. Based on submitted test data, EPA

is concerned that hepatotoxicity, kidney

toxicity, neurotoxicity, reproductive

toxicity, eye and skin irritation, and

toxicity to the GI tract, spleen, lungs,

pancreas, urinary bladder, and the

lymph system may occur. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because there were no

significant inhalation exposures. EPA

has determined that any use of the

substance other than for the specific use

described in the PMN may result in

significant inhalation exposures. Based

on this information the PMN substance

meets the concern criteria at

§ 721.170(b)(3)(i).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a 90-day subchronic inhalation

study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) would help characterize the

health effects of the PMN substance.

CFR citation: 40 CFR 721.9840.

PMN Number P–96–1216

Chemical name: Benzoic acid, 3-amino-

, diazotized, coupled with 6-amino-4-

hydroxy-2-naphthalenesulfonic acid,

diazotized, (3-aminophenyl)phosphonic

acid and diazotized 2,5-

diethoxybenzenamine.

CAS number: 163879–69–4.

Basis for action: The PMN substance

will be used as a coloring material.

Based on submitted toxicity data on the

PMN substance and analogy to the azo

reduction products, EPA is concerned

that eye irritation, skin sensitization,

reproductive toxicity in males, blood

toxicity, liver toxicity, kidney toxicity,

reproductive toxicity, spleen effects,

oncogenicity, neurotoxicity, and

developmental toxicity will occur in

workers exposed via inhalation. EPA

determined that use of the substance as

described in the PMN does not present

an unreasonable risk. Significant worker

inhalation exposure is not expected

because the substance will not be

manufactured, processed, or used as a

powder. EPA has determined that

manufacture, processing, and use of the

substance as a powder may result in

significant worker inhalation exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170 (b)(1)(i)(D), (b)(3)(i), and

(b)(3)(iii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a 2-generation reproductive toxicity

study (40 CFR 799.9380) (62 FR 43834,

August 15, 1997) (FRL–5719–5) would

help characterize the human health

effects of the PMN substance.

CFR citation: 40 CFR 721.1705.

PMN Number P–96–1233

Chemical name: (generic) Reaction

product of epoxy with anhydride and

glycerol and glycol.

CAS number: Not available.

Basis for action: The PMN substance

will be used as molding compound.

Based on analogy to diepoxides and

esters EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 30 ppb of the

PMN substance in surface waters. Based

on analogy to similar substances there is

concern for oncogenicity,

developmental toxicity, reproductive

toxicity, and neurotoxicity to exposed

workers. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance would not be

released to surface waters and workers

would not be exposed by inhalation.

EPA has determined that other uses or

uses as a powder may result in releases

to surface waters which exceed the

concern concentration or inhalation

exposure to workers. Based on this

information the PMN substance meets

the concern criteria at § 721.170

(b)(1)(i)(c), (b)(3)(ii), and (b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance. EPA has

also determined that a 2-year, twospecies oral bioassay (40 CFR 799.9420)

(62 FR 43838, August 15, 1997) (FRL–
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3411

5719–5), a 90-day subchronic inhalation

study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)), and a two-species oral

developmental toxicity test (40 CFR

799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) would characterize

the human health effects of the PMN

substance.

CFR citation: 40 CFR 721.9270.

PMN Number P–96–1239

Chemical name: (generic) Aliphatic

polyisocyanate homopolymer.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to structurally similar

substances, EPA is concerned that

pulmonary sensitization and irritation

will occur in exposed workers. EPA

determined that use of the substance did

not present an unreasonable risk

because significant worker exposure is

not expected because the substance was

used as an intermediate. EPA has

determined that use other than an

intermediate may result in significant

worker exposure. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day inhalation

study in rats (40 CFR 799.9346) (62 FR

43828, August 15, 1997) (FRL–5719–5)

would help characterize the health

effects of the PMN substance.

CFR citation: 40 CFR 721.4259.

PMN Number P–96–1240

Chemical name: Poly(oxy-1,2-

ethanediyl), α-sulfo-ω-[1-[(4-

nonylphenoxy)methyl]-2-(2-

propenyloxy)ethoxy]-, branched,

ammonium salts.

CAS number: 184719–88–8.

Basis for action: The PMN substance

will be used as an emulsifier. Based on

analogy to structurally similar

substances and submitted test data, EPA

is concerned that kidney toxicity,

reproductive toxicity, developmental

toxicity, and oncogenicity will occur in

exposed workers. EPA determined that

use of the substance did not present an

unreasonable risk because significant

worker exposure is not expected

because the substance was not

manufactured domestically. EPA has

determined that domestic manufacture

of the substance may result in

significant worker exposure. Based on

this information the PMN substance

meets the concern criteria at § 721.170

(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and

(b)(3)(iii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5),

a two-species oral developmental

toxicity test (40 CFR 799.9370) (62 FR

43832, August 15, 1997) (FRL–5719–5),

and a 90-day subchronic oral study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–7))

would help characterize the health

effects of the PMN substance.

CFR citation: 40 CFR 721.539.

PMN Number P–96–1263

Chemical name: (generic) Substituted

phenyl azo substituted

sulfocarbopolycle, sodium salt.

CAS number: Not available.

Basis for action: The PMN substance

will be used in a destructive use. Based

on analogy to structurally similar

substances, EPA is concerned that

oncogenicity, blood effects,

developmental toxicity, and

neurotoxicity will occur in workers

exposed via inhalation. EPA determined

that use of the substance as described in

the PMN does not present an

unreasonable risk. Significant worker

inhalation exposure is not expected

because the substance will not be

manufactured, processed, or used as a

powder. EPA has determined that

manufacture, processing, and use of the

substance as a solid may result in

significant worker inhalation exposure.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(3)(iii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5),

a 90-day subchronic inhalation study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–

7)), and a two-species oral

developmental toxicity test (40 CFR

799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) would characterize

the human health effects of the PMN

substance.

CFR citation: 40 CFR 721.9545.

PMN Numbers P–96–1280/1281/1504/

1505/1506/1507/1508

Chemical name: (generic) Quaternary

ammonium alkyletherpropyl

trialkylamine halides.

CAS number: Not available.

Basis for action: The PMN substances

will be used as industrial production

aids. Based on analogy to aliphatic

amines and cationic surfactants, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 2 ppb of the PMN substances

in surface waters. EPA determined that

use of the substances as described in the

PMN did not present an unreasonable

risk because the substances would not

be released to surface waters. EPA has

determined that other uses of the

substances may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substances meet

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.4095.

PMN Number P–96–1288

Chemical name: (generic)

Hydrofluoroalkene.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to structurally similar

substances, EPA is concerned that lung

toxicity, neurotoxicity, irritation,

oncogenicity, liver toxicity, kidney

toxicity, and cardiac sensitization will

occur in exposed workers. EPA

determined that use of the substance as

an intermediate did not present an

unreasonable risk because it did not

result in significant worker exposure.

EPA has determined that use other than

an intermediate may result in significant

worker exposure. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day subchronic

oral study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) and a 2-year, two-species oral

bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

would help characterize the health and

environmental effects of the PMN

substance.

CFR citation: 40 CFR 721.4465.

PMN Number P–96–1315

Chemical name: 9H-Thioxanthen-9-one,

2,4-diethyl.

CAS number: 82799–44–8.
3412 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

Basis for action: The PMN substance

will be used as a photopolymerization

initiator. Based on analogy to neutral

organic substances, EPA is concerned

that toxicity to aquatic organisms may

occur at a concentration as low as 1 ppb

of the PMN substance in surface waters.

EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance would not be

released to surface waters in significant

quantities. EPA has determined that

other uses of the substance may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a 21-day daphnid chronic toxicity

test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), and an algal acute toxicity study (40

CFR 797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.9664.

PMN Number P–96–1319

Chemical name: (generic) Nitro methyl

quinoline.

CAS number: Not available.

Basis for action: The PMN substance

will be used in a destructive use. Based

on analogy to structurally similar

substances, there is concern for

oncogenicity, mutagenicity, blood

toxicity, and neurotoxicity. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters

in significant amounts and workers

would not be exposed by inhalation.

EPA has determined that use without

appropriate respiratory protection may

result in significant inhalation exposure

to workers and disposal other than by

incineration may result in significant

drinking water exposures to exposed

populations. Based on this information

the PMN substance meets the concern

criteria at § 721.170 (b)(1)(i)(C) and

(b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a 90-day subchronic inhalation

study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) would characterize the human

health effects of the PMN substance.

CFR citation: 40 CFR 721.9080.

PMN Numbers P–96–1337/1338/1339

Chemical name: (generic) Amine

substituted metal salts.

CAS number: Not available.

Basis for action: The PMN substances

will be used as catalysts. Based on

analogy to structurally similar

compounds, EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 4 ppb of the

PMN substances in surface waters. EPA

determined that use of the substances as

described in the PMN did not present an

unreasonable risk because the

substances would not be released to

surface waters in significant quantities.

EPA has determined that other uses of

the substances may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substances meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.640.

PMN Number P–96–1410

Chemical name: (generic) Substituted

bisaniline.

CAS number: Not available.

Basis for action: The PMN substance

will be used as paper dye intermediate.

Based on analogy to neutral organics,

EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 4 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters

in significant quantities. EPA has

determined that other uses of the

substance may result in releases to

surface waters which exceed the

concern concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a 21-day daphnid chronic toxicity

test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), and an algal acute toxicity study (40

CFR 797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.1805.

PMN Number P–96–1427

Chemical name: (generic) Stilbene

diglycidyl ether.

CAS number: Not available.

Effective date of section 5(e) consent

order: March 14, 1997.

Basis for section 5(e) consent order: The

order was issued under section

5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA

based on a finding that this substance

may present an unreasonable risk of

injury to health.

Toxicity concern: Diglycidyl ether of

bisphenol A (DGEBA), other similar

chemicals, and epoxides have been

shown to cause mutagenicity,

oncogenicity, male reproductive toxicity

and mucous membrane irritation in test

animals.

Recommended testing: EPA has

determined that a 90-day subchronic

oral toxicity study with attention to the

male and female reproductive organs

(40 CFR 798.2650 or OPPTS 870.3100

test guideline (public draft; 61 FR

31522, June 20, 1996) (FRL–5367–7))

would help to characterize the

reproductive toxicity. The PMN

submitter has agreed not to exceed the

production volume limit without

performing this test. A 2-year bioassay

on bisphenol A-diglycidyl ether (40 CFR

799.9420) (62 FR 43838, August 15,

1997) (FRL–5719–5) would be required

to evaluate the carcinogenicity effects

which may be caused by the PMN

substance. This study will serve as a

surrogate for a carcinogenicity study on

the PMN substance. The order does not

require submission of the oncogenicity

study at any specified time or

production volume. However, the

order’s restrictions on manufacture,

import, processing, distribution in

commerce, use, and disposal of the

PMN substance will remain in effect

until the order is modified or revoked

by EPA based on submission of that

study or other relevant information.

CFR citation: 40 CFR 721.3465.
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3413

PMN Number P–96–1430

Chemical name: (generic)

Alkylpoly(oxyalkylene)amine.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to aliphatic amines EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 10 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as an intermediate

did not present an unreasonable risk

because it did not result in significant

environmental exposure. EPA has

determined that use other than an

intermediate may result in significant

environmental exposure. Based on this

information the PMN substance meets

the concern criteria at § 721.170(b)(4)

(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.641.

PMN Number P–96–1478

Chemical name: (generic) Ethoxylated

alcohol, phosphated, amine salt.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a polymer suspension

agent. Based on analogy to phosphate

ester surfactants EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 8 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because significant

releases of the substance is not expected

to surface waters. EPA has determined

that other uses of the substance may

result in releases to surface waters

which exceed the concern

concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.643.

PMN Numbers P–96–1510/1511/1512/

1513/1514

Chemical name: (generic)

Alkyletherpropyl dialkylamine.

CAS number: Not available.

Basis for action: The PMN substances

will be used as intermediates. Based on

analogy to aliphatic amines, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 1 ppb of the PMN substances

in surface waters. EPA determined that

use of the substances as described in the

PMN did not present an unreasonable

risk because there was not significant

releases of the substances to surface

waters. EPA has determined that uses

other than as an intermediate may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substances meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.2345.

PMN Number P–96–1536

Chemical name: 2-pyrrolidone, 1-

ethenyl-3-ethylidene-, (E)-.

CAS number: 153954–47–3.

Basis for action: The PMN substance

will be used as a crosslinker in a

polymerization reaction. Based on

analogy to structurally similar

chemicals, EPA identified health

concerns for oncogenicity, mutagenicity,

neurotoxicity, and developmental

toxicity. EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because significant human exposure is

not expected. EPA has determined that

use of the substance without impervious

gloves may result in significant human

exposure. Based on this information the

PMN substance meets the concern

criteria at § 721.170 (b)(1)(i)(C) and

(b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a two-species oral developmental

toxicity test (40 CFR 799.9370) (62 FR

43832, August 15, 1997) (FRL–5719–5)

will address the potential health effects

of the PMN substance as there is

concern and potential from all routes of

exposure.

CFR citation: 40 CFR 721.9010.

PMN Number P–96–1588

Chemical name: (generic)

Hydrochloride salt of a mixed fatty

amidoamine.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a processing aid. Based

on analogy to aliphatic amines, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 2 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance was not

released to surface waters. EPA has

determined that other uses may result in

releases to surface waters. Based on this

information the PMN substance meet

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.637.

PMN Number P–96–1649

Chemical name: (generic) Modified

silicone resin.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a polymerization

initiator. Based on analogy to neutral

organic chemicals, EPA is concerned

that toxicity to aquatic organisms may

occur at a concentration as low as 5 ppb

of the PMN substance in surface waters.

EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance would not be
3414 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

released to surface waters in significant

quantities. EPA has determined that

other uses of the substance may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substances meet the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a 21-day daphnid chronic toxicity

test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), and an algal acute toxicity study (40

CFR 797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.9499.

PMN Number P–96–1652

Chemical name: Phosphinothioic acid,

bis(2,4,4-trimethylpentyl)- (9Cl).

CAS number: 132767–86–3.

Basis for action: The PMN substance

will be used as a solvent extraction

reagent. Based on analogy to phosphatebased dialkyl anionic surfactants and

neutral organics, EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 10 ppb of

the PMN substance in surface waters.

EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because the substance would not be

released to surface waters in significant

quantities. EPA has determined that

other uses of the substance may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a chronic 60-day fish

early life stage toxicity test in rainbow

trout (40 CFR 797.1600 or OPPTS

850.1400 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a 21-day daphnid chronic toxicity

test (40 CFR 797.1330 or OPPTS

850.1300 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), and an algal acute toxicity study (40

CFR 797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.6045.

PMN Numbers P–96–1661/95–1654

Chemical name: (generic) Alkoxysilane

ester.

CAS number: Not available.

Basis for action: The PMN substance

will be used in coatings and as a filler.

EPA determined that use of the

substance as described in the PMN did

not present an unreasonable risk

because it did not result in significant

human exposure. EPA has determined

that increased use of the substance may

result in significant human exposure.

Recommended testing: EPA has

determined that a 90-day subchronic

inhalation toxicity study in rats (40 CFR

799.9346) (62 FR 43828, August 15,

1997) (FRL–5719–5) would help

characterize the health effects of the

PMN substance.

CFR citation: 40 CFR 721.537.

PMN Numbers P–97–57/58/59/60/61

Chemical name: (generic) Alkyl

substituted quaternary ammonium

chloride.

CAS number: Not available.

Basis for action: The PMN substances

will be used as surface active agents.

Based on submitted test data and

analogy to monoalkyl quaternary

surfactants EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 4 ppb of the

PMN substances in surface waters. EPA

determined that use of the substances as

described in the PMNs did not present

an unreasonable risk because the

substances would not be released to

surface waters during manufacturing

and processing. EPA has determined

that other uses of the substances may

result in releases to surface waters

which exceed the concern

concentration. Based on this

information the PMN substances meet

the concern criteria at § 721.170 (b)(4)(i)

and (b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substances.

CFR citation: 40 CFR 721.658.

PMN Number P–97–131

Chemical name: 2,7-

Naphthalenedisulfonic acid, 4-amino-3-

[[4′[[2-amino-4-[(3-butoxy-2-

hydroxypropyl)amino]phenyl]azo]-3,3′-

dimethyl[1,1′-biphenyl]-4-yl]azo]-5-

hydroxy-6-(phenylazo)-, disodium salt.

CAS number: 103580–64–9.

Basis for action: The PMN substance

will be used in ball point pen ink. Based

on potential dimethylbenzidine, aniline,

and triaminobenzene azo reduction

products there is concern for

oncogenicity, mutagenicity,

developmental toxicity, liver toxicity,

blood toxicity, and neurotoxicity. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters

in significant amounts and workers

would not be exposed by inhalation.

EPA has determined that domestic

manufacture, use as a powder, or

additional releases to surface water may

result in drinking water exposure or

inhalation exposure to workers. Based

on this information the PMN substance

meets the concern criteria at § 721.170

(b)(1)(i)(D) and (b)(3)(iii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5),

a 90-day subchronic inhalation study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–

7)), and a two-species oral

developmental toxicity test (40 CFR

799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) would characterize

the human health effects of the PMN

substance.

CFR citation: 40 CFR 721.5279.

PMN Number P–97–136

Chemical name: (generic) Alkoxylated

fatty acid amide alkylsulfate salt.

CAS number: Not available.

Basis for action: The PMN substance

will be used to soften cellulose. Based

on analogy to dialkyl cationic

surfactants EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 2 ppb of the

PMN substance in surface waters. EPA

determined that industrial uses of the

substance did not present an

unreasonable risk because it did not

result in significant environmental

exposure. EPA has determined that nonindustrial uses may result in significant

environmental exposure. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3415

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.720.

PMN Numbers P–97–143/144

Chemical name: (generic) Polymers of

styrene, cyclohexyl methacrylate and

substituted methacrylate.

CAS number: Not available.

Basis for action: The PMN substances

will be used as coating resins. Based on

analogy to structurally similar

substances, there is concern for

oncogenicity, mutagenicity,

reproductive toxicity in males,

developmental toxicity, lung and skin

sensitization, and membrane irritation.

EPA determined that use of the

substances as described in the PMN did

not present an unreasonable risk

because significant worker exposure is

not expected. EPA has determined that

domestic manufacture may result in

significant inhalation exposure to

workers. Based on this information the

PMN substances meets the concern

criteria at § 721.170(b)(1)(i)(C) and

(b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5),

a 90-day subchronic inhalation study in

rats (40 CFR 798.2650 or OPPTS

870.3100 test guideline (public draft; 61

FR 31522, June 20, 1996) (FRL–5367–

7)), and a two-species oral

developmental toxicity test (40 CFR

799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) would characterize

the human health effects of the PMN

substances.

CFR citation: 40 CFR 721.9492.

PMN Number P–97–193

Chemical name: 2,7-

Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-, coupled with diazotized 4-

butylbenzenamine, diazotized 4,4′-

cyclohexylidenebis[benzenamine] and

m-phenylenediamine, sodium salt.

CAS number: 182238–09–1.

Basis for action: The PMN substance

will be used in ink. Based on potential

aniline and triaminobenzene azo

reduction products and submitted test

data, there is concern for oncogenicity,

mutagenicity, and blood toxicity. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because workers

would not be exposed by inhalation.

EPA has determined that domestic

manufacture and use as a powder, may

result in inhalation exposure to workers.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170 (b)(1)(i)(D) and (b)(3)(iii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5)

and a 90-day subchronic inhalation

study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) would characterize the human

health effects of the PMN substance.

CFR citation: 40 CFR 721.5280.

PMN Number P–97–217

Chemical name: 1H-Imidazole, 2-ethyl4,5-dihydro-4-methyl-.

CAS number: 931–35–1.

Basis for action: The PMN substance

will be used as an epoxy catalyst. Based

on analogy to aliphatic amines, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 40 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because the substance would not be

released to surface waters in significant

quantities. EPA has determined that

other uses of the substance may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.4468.

PMN Number P–97–264

Chemical name: Silane,

(3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-

heptadecafluorodecyl)trimethoxy-.

CAS number: 83048–65–1.

Basis for action: The PMN substance

will be used in coatings, plastics, and

greases. Based on analogy to

alkoxysilanes, EPA is concerned that

toxicity to aquatic organisms may occur

at a concentration as low as 10 ppb of

the PMN substance in surface waters.

Based on analogy to alkoxysilanes and

perfluoro compounds, there is concern

for lung toxicity, irritation to mucuous

membranes, liver toxicity, blood

toxicity, immunosuppression, and

reproductive toxicity. EPA determined

that use of the substance as described in

the PMN did not present an

unreasonable risk because the substance

would not be released to surface waters

and workers would not be exposed by

inhalation. EPA has determined that

other uses of the substance may result

in inhalation exposures to workers and

releases to surface waters which exceed

the concern concentration. Based on

this information the PMN substance

meet the concern criteria at § 721.170

(b)(3)(ii) and (b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance. EPA has

also determined that a 2-year, twospecies oral bioassay (40 CFR 799.9420)

(62 FR 43838, August 15, 1997) (FRL–

5719–5), a 90-day subchronic inhalation

study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)), and an oral reproductive

toxicity test in rats (40 CFR 799.9380)

(62 FR 43834, August 15, 1997) (FRL–

5719–5) would help characterize the

health effects of the PMN substance.

CFR citation: 40 CFR 721.9503.

PMN Number P–97–302

Chemical name: Hexadecanoic acid,

ethenyl ester.

CAS number: 693–38–9.

Basis for action: The PMN substance

will be used as a component in adhesive

formulations. Based on analogy to vinyl

acetate and other similar substances,

there is concern for neurotoxicity,

mutagencity, oncogenicity, liver

toxicity, developmental toxicity and

reproductive toxicity. EPA determined

that use of the substance as described in

the PMN did not present an

unreasonable risk because workers

would not be subject to significant

exposures. EPA has determined that

other use of the substance may result in

significant exposures to workers. Based

on this information the PMN substance
3416 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

meets the concern criteria at § 721.170

(b)(1)(i)(C) and (b)(3)(ii).

Recommended testing: EPA has

determined that a 2-year, two-species

oral bioassay (40 CFR 799.9420) (62 FR

43838, August 15, 1997) (FRL–5719–5),

a 90-day subchronic oral study in rats

(40 CFR 798.2650 or OPPTS 870.3100

test guideline (public draft; 61 FR

31522, June 20, 1996) (FRL–5367–7)), an

oral two-species developmental toxicity

test (40 CFR 799.9370) (62 FR 43832,

August 15, 1997) (FRL–5719–5), and an

oral reproductive toxicity test in rats (40

CFR 799.9380) (62 FR 43834, August 15,

1997) (FRL–5719–5) would help

characterize the health effects of the

PMN substance.

CFR citation: 40 CFR 721.4158.

PMN Number P–97–304

Chemical name: (generic) Disubstituted

thiadiazolsulfone.

CAS number: Not available.

Basis for action: The PMN substance

will be used in an enclosed use. Based

on analogy to N-heterocycles there are

concerns for developmental toxicity.

Based on submitted toxicity data there

are concerns for neurotoxicity,

mutagenicity, and irritation to eyes,

lungs, and mucous membranes . EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because workers

would not be subject to significant

exposures. EPA has determined that

uses of the substance in a non-enclosed

process and other than for the specific

use designated in the PMN may result

in significant exposures to workers.

Based on this information the PMN

substance meet the concern criteria at

§ 721.170 (b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day subchronic

oral study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) and a two-species oral

developmental toxicity test (40 CFR

799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) would characterize

the human health effects of the PMN

substance.

CFR citation: 40 CFR 721.9659.

PMN Number P–97–314

Chemical name: (generic) Disubstituted

thiadiazole.

CAS number: Not available.

Basis for action: The PMN substance

will be used in an enclosed use. Based

on analogy to N-heterocycles there are

concerns for developmental toxicity.

Based on submitted toxicity data there

are concerns for neurotoxicity,

mutagenicity, and irritation to eyes,

lungs, and mucous membranes. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because workers

would not be subject to significant

exposures. EPA has determined that

uses of the substance in a non-enclosed

process and other than for the specific

use designated in the PMN may result

in significant exposures to workers.

Based on this information the PMN

substance meet the concern criteria at

§ 721.170 (b)(3)(i) and (b)(3)(ii).

Recommended testing: EPA has

determined that a 90-day subchronic

oral study in rats (40 CFR 798.2650 or

OPPTS 870.3100 test guideline (public

draft; 61 FR 31522, June 20, 1996) (FRL–

5367–7)) and a two-species oral

developmental toxicity test (40 CFR

799.9370) (62 FR 43832, August 15,

1997) (FRL–5719–5) would characterize

the human health effects of the PMN

substance.

CFR citation: 40 CFR 721.9657.

PMN Number P–97–328

Chemical name: (generic)

Ethylenediamine, substituted, sodium

salt.

CAS number: Not available.

Basis for action: The PMN substance

will be used as an intermediate. Based

on analogy to polyanionic monomers

and n-halo-nitro compounds, EPA is

concerned that toxicity to aquatic

organisms may occur at a concentration

as low as 30 ppb of the PMN substance

in surface waters. EPA determined that

use of the substance as described in the

PMN did not present an unreasonable

risk because significant releases of the

substance is not expected to surface

waters. EPA has determined that uses

other than as an intermediate may result

in releases to surface waters which

exceed the concern concentration.

Based on this information the PMN

substance meets the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.3565.

PMN Number P–97–417

Chemical name: (generic) Potassium salt

of polyolefin acid.

CAS number: Not available.

Basis for action: The PMN substance

will be used as a fuel additive. Based on

analogy to fatty acid anionic surfactants,

EPA is concerned that toxicity to

aquatic organisms may occur at a

concentration as low as 800 ppb of the

PMN substance in surface waters. EPA

determined that use of the substance as

described in the PMN did not present an

unreasonable risk because significant

releases of the substance is not expected

to surface waters. EPA has determined

that uses other than as a fuel additive

may result in releases to surface waters

which exceed the concern

concentration. Based on this

information the PMN substance meets

the concern criteria at

§ 721.170(b)(4)(ii).

Recommended testing: EPA has

determined that a fish acute toxicity

study (40 CFR 797.1400 or OPPTS

850.1075 test guideline (public draft; 61

FR 16486, April 15, 1996) (FRL–5363–

1)), a daphnid acute toxicity study (40

CFR 797.1300 or OPPTS 850.1010 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)), and an

algal acute toxicity study (40 CFR

797.1050 or OPPTS 850.5400 test

guideline (public draft; 61 FR 16486,

April 15, 1996) (FRL–5363–1)) would

help characterize the environmental

effects of the PMN substance.

CFR citation: 40 CFR 721.7375.

IV. Objectives and Rationale of the Rule

During review of the PMNs submitted

for the chemical substances that are

subject to this SNUR, EPA concluded

that for 25 of the 163 substances,

regulation was warranted under section

5(e) of TSCA, pending the development

of information sufficient to make

reasoned evaluations of the health or

environmental effects of the substances.

The basis for such findings is outlined

in Unit III. of this preamble. Based on

these findings, TSCA section 5(e)

consent orders requiring the use of

appropriate controls were negotiated

with the PMN submitters; the SNUR

provisions for these substances

designated herein are consistent with

the provisions of the TSCA section 5(e)

orders.

In the other 138 cases for which the

proposed uses are not regulated under a

TSCA section 5(e) order, EPA

determined that one or more of the

criteria of concern established at 40 CFR

721.170 were met.

EPA is issuing this SNUR for specific

chemical substances which have

undergone premanufacture review to

ensure that:

(1) EPA will receive notice of any

company’s intent to manufacture,
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3417

import, or process a listed chemical

substance for a significant new use

before that activity begins.

(2) EPA will have an opportunity to

review and evaluate data submitted in a

SNUR notice before the notice submitter

begins manufacturing, importing, or

processing a listed chemical substance

for a significant new use.

(3) When necessary to prevent

unreasonable risks EPA will be able to

regulate prospective manufacturers,

importers, or processors of a listed

chemical substance before a significant

new use of that substance occurs.

(4) All manufacturers, importers, and

processors of the same chemical

substance which is subject to a TSCA

section 5(e) order are subject to similar

requirements. Issuance of a SNUR for a

chemical substance does not signify that

the substance is listed on the TSCA

Inventory. Manufacturers, importers,

and processors are responsible for

ensuring that a new chemical substance

subject to a final SNUR is listed on the

TSCA Inventory.

V. Direct Final Procedures

EPA is issuing these SNURs as direct

final rules, as described in 40 CFR

721.160(c)(3) and 721.170(d)(4). In

accordance with 40 CFR

721.160(c)(3)(ii), this rule will be

effective March 23, 1998, unless EPA

receives a written notice by February 23,

1998 that someone wishes to make

adverse or critical comments on EPA’s

action. If EPA receives such a notice,

EPA will publish a notice to withdraw

the direct final SNUR for the specific

substance to which the adverse or

critical comments apply. EPA will then

propose a SNUR for the specific

substance providing a 30-day comment

period.

This action establishes SNURs for a

number of chemical substances. Any

person who submits a notice of intent to

submit adverse or critical comments

must identify the substance and the new

use to which it applies. EPA will not

withdraw a SNUR for a substance not

identified in a notice.

VI. Test Data and Other Information

EPA recognizes that section 5 of

TSCA does not require developing any

particular test data before submission of

a SNUN. Persons are required only to

submit test data in their possession or

control and to describe any other data

known to or reasonably ascertainable by

them. In cases where a TSCA section

5(e) order requires or recommends

certain testing, Unit III. of this preamble

lists those recommended tests.

However, EPA has established

production limits in the TSCA section

5(e) orders for several of the substances

regulated under this rule, in view of the

lack of data on the potential health and

environmental risks that may be posed

by the significant new uses or increased

exposure to the substances. These

production limits cannot be exceeded

unless the PMN submitter first submits

the results of toxicity tests that would

permit a reasoned evaluation of the

potential risks posed by these

substances. Under recent consent

orders, each PMN submitter is required

to submit each study at least 14 weeks

(earlier orders required submissions at

least 12 weeks) before reaching the

specified production limit. Listings of

the tests specified in the TSCA section

5(e) orders are included in Unit III. of

this preamble. The SNURs contain the

same production volume limits as the

consent orders. Exceeding these

production limits is defined as a

significant new use.

The recommended studies may not be

the only means of addressing the

potential risks of the substance.

However, SNUNs submitted for

significant new uses without any test

data may increase the likelihood that

EPA will take action under TSCA

section 5(e), particularly if satisfactory

test results have not been obtained from

a prior submitter. EPA recommends that

potential SNUN submitters contact EPA

early enough so that they will be able

to conduct the appropriate tests.

SNUN submitters should be aware

that EPA will be better able to evaluate

SNUNs which provide detailed

information on:

(1) Human exposure and

environmental release that may result

from the significant new use of the

chemical substances.

(2) Potential benefits of the

substances.

(3) Information on risks posed by the

substances compared to risks posed by

potential substitutes.

VII. Procedural Determinations

EPA is establishing through this rule

some significant new uses which have

been claimed as CBI subject to Agency

confidentiality regulations at 40 CFR

part 2. EPA is required to keep this

information confidential to protect the

CBI of the original PMN submitter. EPA

promulgated a procedure to deal with

the situation where a specific significant

new use is CBI. This procedure appears

in 40 CFR 721.1725(b)(1) and is similar

to that in § 721.11 for situations where

the chemical identity of the substance

subject to a SNUR is CBI. This

procedure is cross-referenced in each of

these SNURs.

A manufacturer or importer may

request EPA to determine whether a

proposed use would be a significant

new use under this rule. Under the

procedure incorporated from

§ 721.1725(b)(1), a manufacturer or

importer must show that it has a bona

fide intent to manufacture or import the

substance and must identify the specific

use for which it intends to manufacture

or import the substance. If EPA

concludes that the person has shown a

bona fide intent to manufacture or

import the substance, EPA will tell the

person whether the use identified in the

bona fide submission would be a

significant new use under the rule.

Since most of the chemical identities of

the substances subject to these SNURs

are also CBI, manufacturers and

processors can combine the bona fide

submission under the procedure in

§ 721.1725(b)(1) with that under

§ 721.11 into a single step.

If a manufacturer or importer is told that

the production volume identified in the bona

fide submission would not be a significant

new use, i.e. it is below the level that would

be a significant new use, that person can

manufacture or import the substance as long

as the aggregate amount does not exceed that

identified in the bona fide submission to

EPA. If the person later intends to exceed

that volume, a new bona fide submission

would be necessary to determine whether

that higher volume would be a significant

new use. EPA is considering whether to

adopt a special procedure for use when CBI

production volume is designated as a

significant new use. Under such a procedure,

a person showing a bona fide intent to

manufacture or import the substance, under

the procedure described in § 721.11, would

automatically be informed of the production

volume that would be a significant new use.

Thus the person would not have to make

multiple bona fide submissions to EPA for

the same substance to remain in compliance

with the SNUR, as could be the case under

the procedures in § 721.1725(b)(1).

VIII. Applicability of Rule to Uses

Occurring Before Effective Date of the

Final Rule

To establish a significant ‘‘new’’ use,

EPA must determine that the use is not

ongoing. The chemical substances

subject to this rule have recently

undergone premanufacture review.

TSCA section 5(e) orders have been

issued for 24 substances and notice

submitters are prohibited by the TSCA

section 5(e) orders from undertaking

activities which EPA is designating as

significant new uses. In cases where

EPA has not received a NOC and the

substance has not been added to the

TSCA Inventory, no other person may

commence such activities without first

submitting a PMN. For substances for

which an NOC has not been submitted
3418 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

at this time, EPA has concluded that the

uses are not ongoing. However, EPA

recognizes in cases when chemical

substances identified in this SNUR are

added to the TSCA Inventory prior to

the effective date of the rule, the

substances may be manufactured,

imported, or processed by other persons

for a significant new use as defined in

this rule before the effective date of the

rule. However, 123 of the 163

substances contained in this rule have

CBI chemical identities, and since EPA

has received a limited number of postPMN bona fide submissions, the Agency

believes that it is highly unlikely that

any of the significant new uses

described in the following regulatory

text are ongoing.

As discussed in the Federal Register

of April 24, 1990 (55 FR 17376), EPA

has decided that the intent of section

5(a)(1)(B) is best served by designating

a use as a significant new use as of the

date of publication rather than as of the

effective date of the rule. Thus, persons

who begin commercial manufacture,

import, or processing of the substances

regulated through this SNUR will have

to cease any such activity before the

effective date of this rule. To resume

their activities, these persons would

have to comply with all applicable

SNUR notice requirements and wait

until the notice review period,

including all extensions, expires.

EPA has promulgated provisions to allow

persons to comply with this SNUR before the

effective date. If a person were to meet the

conditions of advance compliance under

§ 721.45(h), the person would be considered

to have met the requirements of the final

SNUR for those activities. If persons who

begin commercial manufacture, import, or

processing of the substance between

publication and the effective date of the

SNUR do not meet the conditions of advance

compliance, they must cease that activity

before the effective date of the rule. To

resume their activities, these persons would

have to comply with all applicable SNUR

notice requirements and wait until the notice

review period, including all extensions,

expires.

IX. Economic Analysis

EPA has evaluated the potential costs

of establishing significant new use

notice requirements for potential

manufacturers, importers, and

processors of the chemical substance

subject to this rule. EPA’s complete

economic analysis is available in the

public record for this rule (OPPTS–

50628).

X. Public Record and Electronic

Submissions

The official record for this

rulemaking, as well as the public

version, has been established for this

rulemaking under docket control

number OPPTS–50628 (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 12 noon to 4 p.m.,

Monday through Friday, excluding legal

holidays. The official rulemaking record

is located in the TSCA Nonconfidential

Information Center, Rm. NE–B607, 401

M St., SW., Washington, DC.

Electronic comments can be sent

directly to EPA at:

oppt.ncic@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 in 5.1/6.1 or ASCII file

format. All comments and data in

electronic form must be identified by

the docket control number OPPTS–

50628. Electronic comments on this

proposed rule may be filed online at

many Federal Depository Libraries.

The OPPTS harmonized test

guidelines referenced in this document

are available on EPA’s World Wide Web

site under ‘‘Researchers and Scientists,’’

‘‘Environmental Test Methods &

Guidelines’’ (http://www.epa.gov/

epahome/research.htm).

XI. Regulatory Assessment

Requirements

Under Executive Order 12866,

entitled ‘‘Regulatory Planning and

Review’’ (58 FR 51735, October 4, 1993),

this action is not a ‘‘significant

regulatory action’’ subject to review by

the Office of Management and Budget

(OMB). In addition, this action does not

impose any enforceable duty or contain

any unfunded mandate as described in

the Unfunded Mandates Reform Act

(UMRA) of 1995 (Pub. L. 104–4), or

require prior consultation with State

officials as also specified in Executive

Order 12875, entitled ‘‘Enhancing the

Intergovernmental Partnership’’ (58 FR

58093, October 28, 1993). Nor does it

involve special considerations of

environmental justice related issues 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 additional 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).

According to the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., an agency may not conduct or

sponsor, and a person is not required to

respond to a collection of information

that requires OMB approval under the

PRA, unless it has been approved by

OMB and displays a currently valid

OMB control number. The OMB control

numbers for EPA’s regulations, after

initial display in the preamble of the

final rules, are listed in 40 CFR part 9.

The information collection requirements

related to this action have already been

approved by OMB pursuant to the PRA

under OMB control number 2070–0012

(EPA ICR No. 574). This action does not

impose any burden requiring additional

OMB approval.

If an entity were to submit a

significant new use notice to the

Agency, the annual burden is estimated

to average between 30 and 170 hours

per response. This burden estimate

includes the time needed to review

instructions, search existing data

sources, gather and maintain the data

needed, and complete, review and

submit the required significant new use

notice.

Send any comments about the

accuracy of the burden estimate, and

any suggested methods for minimizing

respondent burden, including through

the use of automated collection

techniques, to the Director, OPPE

Regulatory Information Division, U.S.

Environmental Protection Agency (Mail

Code 2137), 401 M Street, S.W.,

Washington, D.C. 20460, with a copy to

the Office of Information and Regulatory

Affairs, Office of Management and

Budget, 725 17th St., N.W., Washington,

DC 20503, marked ‘‘Attention: Desk

Officer for EPA.’’ Please remember to

include the OMB control number in any

correspondence, but do not submit any

completed forms to these addresses.

In addition, pursuant to section 605(b)

of the Regulatory Flexibility Act (RFA)

(5 U.S.C. 601 et seq.), the Agency has

previously certified, as a generic matter,

that the promulgation of a SNUR does

not have a significant adverse economic

impact on a substantial number of small

entities. The Agency’s generic

certification for promulgation of new

SNURs appears on June 2, 1997 (62 FR

29684) (FRL–5597–1), and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

XII. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3419

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a major rule as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements.

Dated: January 6, 1998.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

Therefore, 40 CFR part 721 is

amended as follows:

PART 721—[AMENDED]

1. The authority citation for part 721

continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and

2625(c).

2. By adding new § 721.405 to subpart

E to read as follows:

§ 721.405 Polyether acrylate.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a polyether acrylate (PMN

P–95–666) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

3. By adding new § 721.524 to subpart

E to read as follows:

§ 721.524 Alcohols, C6-12, ethoxylated,

reaction product with maleic anhydride.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as alcohols, C6-12,

ethoxylated, reaction product with

maleic anhydride (PMN P–88–1108) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 300).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

4. By adding new § 721.526 to subpart

E to read as follows:

§ 721.526 Substituted aromatic aldehyde.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a substituted aromatic

aldehyde (PMN P–95–1466) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

5. By adding new § 721.528 to subpart

E to read as follows:

§ 721.528 Benzaldehyde, 2-hydroxy-5-

nonyl-, oxime, branched.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

benzaldehyde, 2-hydroxy-5-nonyl-,

oxime, branched (PMN P–95–1467; CAS

No. 174333–80–3) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

6. By adding new § 721.537 to subpart

E to read as follows:

§ 721.537 Organosilane ester.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an organosilane ester

(PMN P–96–1661/P–95–1654) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(r) (370,000

kilogram (kg)) (90-day subchronic

inhalation study in rats-(40 CFR

799.9346) (62 FR 43828, August 15,

1997) (FRL–5719–5). A person may not

manufacture or import the substance

beyond the aggregate production

volume limit, unless that person

conducts this study on the substance

and submits all final reports and

underlying data in accordance with the

procedures and criteria specified in

paragraphs (a)(2)(i)(A), (a)(2)(i)(B),

(a)(2)(i)(C), and (a)(2)(i)(D) of this

section.

(A) Each study required to be

performed pursuant to this section must

be scientifically valid. Scientific valid

means that the study was conducted

according to:

(1) The test guidelines specified in

paragraph (a)(2)(i) of this section.

(2) An EPA-approved protocol.

(3) TSCA Good Laboratory Practice

Standards at 40 CFR part 792.

(4) Using methodologies generally

accepted at the time the study is

initiated.

(5) Any deviation from these

requirements must be approved in

writing by EPA.

(B) Before starting to conduct any of

the studies in paragraph (a)(2)(i) of this

section, the person must obtain

approval of test protocols from EPA by

submitting written protocols. EPA will

respond to the person within 4 weeks of

receiving the written protocols.

Published test guidelines specified in

paragraph (a)(2)(i) of this section (e.g.,

40 CFR part 797 or part 798) provide
3420 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

general guidance for development of test

protocols, but are not themselves

acceptable protocols.

(C) The person shall:

(1) Conduct each study in good faith

with due care.

(2) Promptly furnish to EPA the

results of any interim phase of each

study.

(3) Submit, in triplicate (with an

additional sanitized copy, if

confidential business information is

involved), the final report of each study

and all underlying data (‘‘the report and

data’’) to EPA no later than 14 weeks

prior to exceeding the applicable

production volume limit. The final

report shall contain the contents

specified in 40 CFR 792.185.

(D)(1) Except as described in

paragraph (a)(2)(i)(D)(2) of this section,

if, within 6 weeks of EPA’s receipt of a

test report and data, the person receives

written notice that EPA finds that the

data generated by a study are

scientifically invalid, the person is

prohibited from further manufacture

and import of the PMN substance

beyond the applicable production

volume limit.

(2) The person may continue to

manufacture and import the PMN

substance beyond the applicable

production limit only if so notified, in

writing, by EPA in response to the

person’s compliance with either of the

following paragraphs (a)(2)(i)(D)(2)(i) or

(a)(2)(i)(D)(2)(ii) of this section.

(i) The person may reconduct the

study. If there is sufficient time to

reconduct the study and submit the

report and data to EPA at least 14 weeks

before exceeding the production limit as

required by paragraph (a)(2)(i)(C)(3) of

this section, the person shall comply

with paragraph (a)(2)(i)(C)(3) of this

section. If there is insufficient time for

the person to comply with paragraph

(a)(2)(ii)(C)(3) of this section, the person

may exceed the production limit and

shall submit the report and data in

triplicate to EPA within a reasonable

period of time, all as specified by EPA

in the notice described in paragraph

(a)(2)(i)(D)(1) of this section. EPA will

respond to the person in writing, within

6 weeks of receiving the person’s report

and data.

(ii) The person may, within 4 weeks

of receiving from EPA the notice

described in paragraph (a)(2)(i)(D)(1) of

this section, submit to EPA a written

report refuting EPA’s finding. EPA will

respond to the person in writing, within

4 weeks of receiving the person’s report.

(E) The person is not required to

conduct a study specified in paragraph

(a)(2)(i) of this section if notified in

writing by EPA that it is unnecessary to

conduct that study.

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c) and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

7. By adding new § 721.538 to subpart

E to read as follows:

§ 721.538 Phenol, 4-(1,1-dimethylethyl)-,

homopolymer.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

phenol, 4-(1,1-dimethylethyl)-,

homopolymer (PMN P–95–243; CAS No.

30813–81–1) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(3)

of this section.

(2) High moleculation weight

exemption. A batch of the chemical

substance may be exempt from the

provisions of this rule if the average

number molecular weight of the

substance is greater than 1,000 and the

low molecular weight species below

1,000 and 500 are less than 25 percent

and 10 percent, respectively. To be

eligible for this exemption, the batch

must be individually measured.

(3) The significant new uses are:

(i) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (d), (f), (g)(3)(i), (g)(4)(i), and

(g)(5). The label and material safety data

sheet (MSDS) as required by this

paragraph shall also include the

following statement: This substance is

toxic to aquatic invertebrate.

(ii) Industrial, commercial, and

consumer activites. Requirements as

specified in § 721.80(q).

(iii) Release to water. Requirements as

specified in § 721.90 (a)(4) and (b)(4) (N

= 9). When calculating the surface water

concentrations according to the

instructions in § 721.91, the statement

that the amount of the substance that

will be released will be calculated

before the substance enters control

technology does not apply. Instead, if

the waste stream containing the

substance will be treated using primary

and secondary wastewater treatment

with control of suspended solids, before

release, then the amount of the

substance reasonably likely to be

removed from the waste stream by such

treatment may be subtracted in

calculating the number of kilograms

released. No more than 95 percent

removal efficiency may be attributed to

such treatment. These requirements do

not apply to the sites specifically

exempted in the TSCA section 5(e)

consent order for this substance.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (f), (g), (h), (i), and (k) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

8. By adding new § 721.539 to subpart

E to read as follows:

§ 721.539 Poly(oxy-1,2-ethanediyl), αsulfo-ω-[1-[(4-nonylphenoxy)methyl]-2-(2-

propenyloxy)ethoxy]-, branched,

ammonium salts.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

Poly(oxy-1,2-ethanediyl), α-sulfo-ω-[1-

[(4-nonylphenoxy)methyl]-2-(2-

propenyloxy)ethoxy]-, branched,

ammonium salts (PMN P–96–1240; CAS

No. 184719–88–8) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

9. By adding new § 721.567 to subpart

E to read as follows:

§ 721.567 Mixed fatty alkylamines, salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

mixed fatty alkylamines (PMN P–96–

795) is subject to reporting under this
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3421

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

10. By adding new § 721.637 to

subpart E to read as follows:

§ 721.637 Hydrochloride salt of a mixed

fatty amidoamine.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a hydrochloride salt of a

mixed fatty amidoamine (PMN P–96–

1588) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

11. By adding new § 721.640 to

subpart E to read as follows:

§ 721.640 Amine substituted metal salts.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as amine substituted metal

salts (PMNs P–96–1337/1338/1339) are

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 4).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

12. By adding new § 721.641 to

subpart E to read as follows:

§ 721.641 Alkylpoly(oxyalkylene)amine.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a

alkylpoly(oxyalkylene)amine (PMN P–

96–1430) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c) and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

13. By adding new § 721.643 to

subpart E to read as follows:

§ 721.643 Ethoxylated alcohol,

phosphated, amine salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

an ethoxylated alcohol, phosphated,

amine salt (PMN P–96–1478) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 8).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

14. By adding new § 721.655 to

subpart E to read as follows:

§ 721.655 Ethoxylated alkyl quaternary

ammonium compound.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an ethoxylated alkyl

quaternary ammonium compound (PMN

P–96–573) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial and

consumer activities. Requirements as

specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

15. By adding new § 721.658 to

subpart E to read as follows:

§ 721.658 Alkyl substituted quaternary

ammoniums.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as alkyl substituted

quaternary ammoniums (PMNs P–97–

57/58/59/60/61) are subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (b)(1) and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.
3422 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

16. By adding new § 721.720 to

subpart E to read as follows:

§ 721.720 Alkoxylated fatty acid amide,

alkylsulfate salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an alkoxylated fatty acid

amide, alkylsulfate salt (PMN P–97–136)

is subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(l).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c) and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

17. By adding new § 721.723 to

subpart E to read as follows:

§ 721.723 Anthraquinone dye.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an anthraquinone dye

(PMN P–94–2159) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

18. By adding new § 721.977 to

subpart E to read as follows:

§ 721.977 Aryloxyarene.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as aryloxyarene (PMN P–92–

314) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii),

and (g)(5). The label and MSDS as

required by this paragraph shall also

include the following statement: This

substance may be toxic to sediment

organisms.

(ii) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (f), (g), (h), (i), and (k) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

19. By adding new § 721.980 to

subpart E to read as follows:

§ 721.980 Sodium salt of azo acid dye.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a sodium salt of azo acid

dye (PMN P–95–633) is subject to

eporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(1), (w)(1), and

(x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

20. By adding new § 721.981 to

subpart E to read as follows:

§ 721.981 Substituted naphtholoazosubstituted naphthalenyl-substituted

azonaphthol chromium complex.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a substituted

naphtholoazo-substituted naphthalenylsubstituted azonaphthol chromium

complex (PMN P–93–1631) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (f), (v)(2), (w)(2),

and (x)(2).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

21. By adding new § 721.1105 to

subpart E to read as follows:

§ 721.1105 Benzenamine, 4,4′-

methylenebis[2-methyl-6-(1-methylethyl)]-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

benzenamine, 4,4′-methylenebis[2-

methyl-6-(1-methylethyl)]- (PMN P–96–

93; CAS No. 16298–38–7) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

22. By adding new § 721.1155 to

subpart E to read as follows:

§ 721.1155 1,4-benzenediol, 2-(1,1,3,3-

tetramethylbutyl)-and Bis(dimethylamino

substituted)carbomonocycle.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as 1,4-benzenediol, 2-

(1,1,3,3-tetramethylbutyl)- and Bis
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3423

(dimethylamino

substituted)carbomonocycle (PMN P–

96–92) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

23. By adding new § 721.1705 to

subpart E to read as follows:

§ 721.1705 Benzoic acid, 3-amino-,

diazotized, coupled with 6-amino-4-

hydroxy-2-naphthalenesulfonic acid,

diazotized, (3-aminophenyl)phosphonic

acid and diazotized 2,5-

diethoxybenzenamine.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance generically

identified as benzoic acid, 3-amino-,

diazotized, coupled with 6-amino-4-

hydroxy-2-naphthalenesulfonic acid,

diazotized, (3-aminophenyl)phosphonic acid and diazotized

2,5-diethoxybenzenamine (PMN P–96–

1216; CAS No. 163879–69–4) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(1), (w)(1), and

(x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

24. By adding new § 721.1805 to

subpart E to read as follows:

§ 721.1805 Substituted bisaniline.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a substituted bisaniline

(PMN P–96–1410) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 4).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

25. By adding new § 721.1930 to

subpart E to read as follows:

§ 721.1930 Butanoic acid, antimony (3+)

salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

butanoic acid, antimony (3+) salt (PMN

P–94–1143; CAS No. 53856–17–0) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), (a)(3), (b) (concentration

set at 0.1 percent), and (c).

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

0.1 percent), (g)(1)(i), (g)(1)(vi),

(g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(v),

and (g)(5). The label and MSDS as

required by this paragraph shall also

include the following statement: This

substance may cause neurologic effects.

This substance may cause

cardiovascular effects. This substance

may cause ocular irritation.

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(p) (675,000 kg).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (f), (g), (h), and (i)

are applicable to manufacturers,

importers, and processors of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

26. By adding new § 721.2082 to

subpart E to read as follows:

§ 721.2082 Derivative of substituted

carbomonocyclic carboxylic acid-amine

distillation stream byproduct reaction

product.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a derivative of substituted

carbomonocyclic carboxylic acid-amine

distillation stream byproduct reaction

product (PMN P–96–866) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

27. By adding new § 721.2091 to

subpart E to read as follows:

§ 721.2091 Chloroalkane.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a chloroalkane (PMN P–

96–273) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.
3424 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

28. By adding new § 721.2094 to

subpart E to read as follows:

§ 721.2094 N,N′-di(alkyl

heteromonocycle)amino chlorotriazine.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as N,N′-di(alkyl

heteromonocycle)amino chlorotriazine

(PMN P–93–1369) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(i) (this respirator meets the

minimum requirement for persons

exposed via inhalation during

manufacture), (a)(5)(ii), (a)(5)(iv),

(a)(5)(v) (these three respirators meet the

minimum requirements for persons

exposed via inhalation during

processing and use), (a)(6)(i), (a)(6)(ii),

(a)(6)(iii), (a)(6)(iv), (b) (concentration

set at 0.1 percent), and (c).

(ii) Hazard communication program.

Requirements as specified in

§ 721.72(a), (b), (c), (d), (e)

(concentration set at 0.1 percent), (f),

(g)(1)(iv), (g)(1)(vii), (g)(1)(viii),

(g)(1)(ix), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv),

(g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(q).

(iv) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (f), (g), (h), (i), and (k)

are applicable to manufacturers,

importers, and processors of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

29. By adding new § 721.2122 to

subpart E to read as follows:

§ 721.2122 Substituted phenyl azo

substituted sulfo carbopolycycle.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a substituted phenyl azo

substituted sulfo carbopolycycle (PMN

P–96–702) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(r) (204,000 kg)

(activated sludge adsorption isothermOPPTS 835.1110 test guideline (public

draft; 61 FR 16486, April 15, 1996)

(FRL–5363–1), daphnid acute toxicity-

§ 797.1300, fish acute toxicity-

§ 797.1400, murine immune allergic

response study (Toxicology and Applied

Pharmacology 112:190–197 (1992)). A

person may not manufacture or import

the substance beyond the following

aggregate production volume limits,

unless that person conducts the

following corresponding studies on the

substance and submits all final reports

and underlying data in accordance with

the procedures and criteria specified in

paragraphs (a)(2)(i)(A), (a)(2)(i)(B),

(a)(2)(i)(C), and (a)(2)(i)(D) of this

section.

(A) Each study required to be

performed pursuant to this section must

be scientifically valid. Scientifically

valid means that the study was

conducted according to:

(1) The test guidelines specified in

paragraph (a)(2)(i) of this section.

(2) An EPA-approved protocol.

(3) TSCA Good Laboratory Practice

Standards at 40 CFR part 792.

(4) Using methodologies generally

accepted at the time the study is

initiated.

(5) Any deviation from these

requirements must be approved in

writing by EPA.

(B) Before starting to conduct any of

the studies in paragraph (a)(2)(i) of this

section, the person must obtain

approval of test protocols from EPA by

submitting written protocols. EPA will

respond to the person within 4 weeks of

receiving the written protocols.

Published test guidelines specified in

paragraph (a)(2)(i) of this section (e.g.,

40 CFR part 797 or part 798) provide

general guidance for development of test

protocols, but are not themselves

acceptable protocols.

(C) The person shall:

(1) Conduct each study in good faith

with due care.

(2) Promptly furnish to EPA the

results of any interim phase of each

study.

(3) Submit, in triplicate (with an

additional sanitized copy, if

confidential business information is

involved), the final report of each study

and all underlying data (‘‘the report and

data’’) to EPA no later than 14 weeks

prior to exceeding the applicable

production volume limit. The final

report shall contain the contents

specified in 40 CFR 792.185.

(D)(1) Except as described in

paragraph (a)(2)(i)(D)(2) of this section,

if, within 6 weeks of EPA’s receipt of a

test report and data, the person receives

written notice that EPA finds that the

data generated by a study are

scientifically invalid, the person is

prohibited from further manufacture

and import of the PMN substance

beyond the applicable production

volume limit.

(2) The person may continue to

manufacture and import the PMN

substance beyond the applicable

production limit only if so notified, in

writing, by EPA in response to the

person’s compliance with either of the

following paragraph (a)(2)(i)(D)(2)(i) or

(a)(2)(i)(D)(2)(ii) of this section.

(i) The person may reconduct the

study. If there is sufficient time to

reconduct the study and submit the

report and data to EPA at least 14 weeks

before exceeding the production limit as

required by paragraph (a)(2)(i)(C)(3) of

this section, the person shall comply

with paragraph (a)(2)(i)(C)(3) of this

section. If there is insufficient time for

the person to comply with paragraph

(a)(2)(i)(C)(3) of this section, the person

may exceed the production limit and

shall submit the report and data in

triplicate to EPA within a reasonable

period of time, all as specified by EPA

in the notice described in paragraph

(a)(2)(i)(D)(1) of this section. EPA will

respond to the person in writing, within

6 weeks of receiving the person’s report

and data.

(ii) The person may, within 4 weeks

of receiving from EPA the notice

described in paragraph (a)(2)(i)(D)(1) of

this section, submit to EPA a written

report refuting EPA’s finding. EPA will

respond to the person in writing, within

4 weeks of receiving the person’s report.

(E) The person is not required to

conduct a study specified in paragraph

(a)(2)(i) of this section if notified in

writing by EPA that it is unnecessary to

conduct that study.

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

30. By adding new § 721.2145 to

subpart E to read as follows:
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3425

§ 721.2145 Ceteareth-25 sorbate.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as ceteareth-25 sorbate (PMN

P–96–941) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provision of subpart A of this part apply

to this section except as modified by

this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

31. By adding new § 721.2222 to

subpart E to read as follows:

§ 721.2222 Cyclohexanamine, N,Ndimethyl-, compd. with alpha-isotridecylomega-hydroxypoly(oxy-1,2-ethanediyl)

phosphate.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

cyclohexanamine, N,N-dimethyl-,

compd. with alpha-isotridecyl-omegahydroxypoly(oxy-1,2-ethanediyl)

phosphate (PMN P–96–1176; CAS No.

164383–18–0) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial and

consumer activities. Requirements as

specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

32. By adding new § 721.2280 to

subpart E to read as follows:

§ 721.2280 Cyclopropanecarboxaldehyde.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

cyclopropanecarboxaldehyde (PMN P–

96–33) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii),

(a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv),

(a)(6)(v), (b) (concentration set at 1.0

percent), and (c). Each person who is

reasonsonably likely to be exposed by

inhalation to the PMN substance in

vapor form during loading of rail cars is

provided with, and is required to wear,

at a minimum, a National Institute for

Occupational Safety and Health

(NIOSH) approved category 19C Type C

supplied-air respirator operated in

pressure demand or other positive

pressure mode and equipped with a full

facepiece with an assigned protection

factor (APF) of 200. As an alternative to

the respiratory requirements in this

section, manufacturers, importers, and

processors may use the new chemical

exposure limits provisions, including

sampling and analytical methods which

have previously been approved by EPA

for this substance, found in the TSCA

section 5(e) consent order for this

substance.

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

1.0 percent), (f), (g)(1)(i), (g)(1)(ii),

(g)(1)(iv), (g)(1)(ix), (g)(2)(ii), (g)(2)(iii),

(g)(2)(iv), and (g)(5).

(iii) Industrial, commercial, and

consumer activites. Requirements as

specified in § 721.80(q).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (f), (g), (h), and (i)

are applicable to manufacturers,

importers, and processors of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

33. By adding new § 721.2345 to

subpart E to read as follows:

§ 721.2345 Alkyletherpropyl dialkylamines.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

as alkyletherpropyl dialkylamines

(PMNs P–96–1510/1511/1512/1513/

1514) are subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

34. By adding new § 721.2350 to

subpart E to read as follows:

§ 721.2350 Alkyltri, tetra, and pentaamines.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as alkyltri, tetra, and

pentaamines (PMNs P–96–406/407/408)

are subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

35. By adding new § 721.2535 to

subpart E to read as follows:

§ 721.2535 Benzene, 1,1′-methylanebis[4-

isocyanato-, homopolymer, Bu alc.-blocked.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

benzene, 1,1′-methylanebis[4-

isocyanato-, homopolymer, Bu alc.-

blocked (PMN P–95–1386; CAS No.

186321–98–2) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:
3426 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(y)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

36. By adding new § 721.2805 to

subpart E to read as follows:

§ 721.2805 Acrylate ester.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an acrylate ester (PMN P–

96–824) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

37. By adding new § 721.2925 to

subpart E to read as follows:

§ 721.2925 Brominated aromatic ester.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a brominated aromatic

ester (PMN P–95–1128) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (f), (g)(3)(1), (g)(3)(ii),

(g)(4)(iii), and (g)(5).

(ii) [Reserved]

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(q).

(iv) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (f), (g), (h), (i), and (k) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

38. By adding new § 721.3085 to

subpart E to read as follows:

§ 721.3085 Brominated phthalate ester.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as brominated phthalate

ester (PMN P–90–581) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(q).

(ii) Hazard communication program.

A significant new use of this substance

is any manner or method of

manufacture, import, or processing

associated with any use of these

substances without providing risk

notification as follows.

(A) If as a result of the test data

required under the TSCA section 5(e)

consent order for this substance, the

employer becomes aware that this

substance may present a risk of injury

to human health or the environment the

employer must incorporate this new

information, and any information on

methods for protecting against such risk,

into a MSDS as described in § 721.72(c)

within 90 days from the time the

employer becomes aware of the new

information. If this substance is not

being manufactured, imported,

processed, or used in the employer’s

workplace, the employer must add the

new information to an MSDS before the

substances are reintroduced into the

workplace.

(B) The employer must ensure that

persons who will receive, or who have

received the substance from the

employer within 5 years from the date

the employer becomes aware of the new

information described in paragraph

(a)(2)(i)(A) of this section, are provided

an MSDS as described in § 721.72(c)

containing the information required

under paragraph (a)(2)(i)(A) of this

section within 90 days from the time the

employer becomes aware of the new

information.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

39. By adding new § 721.3155 to

subpart E to read as follows:

§ 721.3155 3,8-Dioxa-4,7-disiladecane,

4,4,7,7-tetraethoxy-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

3,8-dioxa-4,7-disiladecane, 4,4,7,7-

tetraethoxy- (PMN P–95–1326; CAS No.

16068–37–4) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(y)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

40. By adding new § 721.3465 to

subpart E to read as follows:

§ 721.3465 Stilbene diglycidyl ether.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

stilbene diglycidyl ether (PMN P–96–

1427) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii),
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3427

(a)(5)(iv), (a)(5)(v), (a)(6)(i), (b)

(concentration set at 0.1 percent), and

(c). As an alternative to the respiratory

protection requirements of this section,

manufacturers, importers, and

processors of this substance may follow

the terms of the new chemical exposure

limits section in the TSCA section 5(e)

consent order for this substance.

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

1.0 percent), (f), (g)(1)(ii), (g)(1)(vi),

(g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv),

(g)(2)(v), and (g)(5). The label and MSDS

as required by this paragraph shall also

include the following statement: When

using this substance use respiratory

protection or maintain workplace

airborne concentrations at or below an

8-hour time-weighted average of 0.5

milligram (mg)/meter (m3).

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(q).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (f), (g), (h), and (i)

are applicable to manufacturers,

importers, and processors of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

41. By adding new § 721.3485 to

subpart E to read as follows:

§ 721.3485 Hydrofluorocarbon alkyl ether.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a hydrofluorocarbon alkyl

ether (PMN P–95–1578) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section. Nonspray uses are exempt from the

provisions of this rule.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(iii), and (a)(6)(v).

(ii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

42. By adding new § 721.3488 to

subpart E to read as follows:

§ 721.3488 Poly(oxy-1,2-ethanediyl), alpha

substituted-omega-hydroxy-, C16-20 alkyl

ethers.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as poly(oxy-1,2-ethanediyl),

alpha substituted-omega-hydroxy-,

C16-20 alkyl ethers (PMN P–87–323) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 20).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

43. By adding new § 721.3565 to

subpart E to read as follows:

§ 721.3565 Ethylenediamine, substituted,

sodium salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as ethylenediamine,

substituted, sodium salt (PMN P–97–

328) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

44. By adding new § 721.4085 to

subpart E to read as follows:

§ 721.4085 Guanidine, pentaethyl-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

guanidine, pentaethyl- (PMN P–94–

1018; CAS No. 13439–89–9) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), and (a)(3).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), and (e) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

45. By adding new § 721.4090 to

subpart E to read as follows:

§ 721.4090 Ethanaminium, N-

[bis(diethylamino)-methylene]-N-ethyl-,

bromide.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

ethanaminium, N-[bis(diethylamino)-

methylene]-N-ethyl-, bromide (PMN P–

94–1019; CAS No. 89610–32–2) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

46. By adding new § 721.4095 to

subpart E to read as follows:
3428 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

§ 721.4095 Quaternary ammonium

alkyltherpropyl trialkylamine halides.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as quaternary ammonium

alkyltherpropyl trialkylamine halides

(PMNs P–96–1280/81/1504/1505/1506/

1507/1508) are subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

47. By adding new § 721.4158 to

subpart E to read as follows:

§ 721.4158 Hexadecanoic acid, ethenyl

ester.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

hexadecanoic acid, ethenyl ester (PMN

P–97–302; CAS No. 693–38–9) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(2)(i) and (a)(3).

(ii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (f) and (j).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), and (i) are applicable

to manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

48. By adding new § 721.4257 to

subpart E to read as follows:

§ 721.4257 Hydrazine, (2-fluorophenyl).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

hydrazine, (2-fluorophenyl) (PMN P–

95–2101; CAS No. 2368–80–1) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

49. By adding new § 721.4259 to

subpart E to read as follows:

§ 721.4259 Aliphatic polyisocyanate

homopolymer.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an aliphatic

polyisocyanate homopolymer (PMN P–

96–1239) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

50. By adding new § 721.4462 to

subpart E to read as follows:

§ 721.4462 Hydrochlorofluorocarbon.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a

hydrochlorofluorocarbon (PMN P–95–

1317) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

51. By adding new § 721.4464 to

subpart E to read as follows:

§ 721.4464 Mixture of hydrofluoro alkanes

and hydrofluoro alkene.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as a mixture of hydrofluoro

alkanes and hydrofluoro alkene (PMNs

P–96–945/946/947/948) are subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements specified as in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

52. By adding new § 721.4465 to

subpart E to read as follows:

§ 721.4465 Hydrofluoroalkane.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a hydrofluoroalkane

(PMN P–96–1288) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(h).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3429

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

53. By adding new § 721.4467 to

subpart E to read as follows:

§ 721.4467 Quaternary ammonium

hydroxide.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a quaternary ammonium

hydroxide (PMN P–95–1806) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

54. By adding new § 721.4468 to

subpart E to read as follows:

§ 721.4468 1H-Imidazole, 2-ethyl-4,5-

dihydro-4-methyl-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

1H-imidazole, 2-ethyl-4,5-dihydro-4-

methyl- (PMN P–97–217; CAS No. 931–

35–1) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 40).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

55. By adding new § 721.4469 to

subpart E to read as follows:

§ 721.4469 Imidazolethione.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an imidazolethione

(PMNs P–91–1131 and P–90–564) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

Formulations or mixtures containing the

PMN substance in concentrations at or

below 10 percent by weight or volume

are exempt from the provisions of this

rule.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(3), (b) (concentration set at 0.1

percent), and (c).

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

0.1 percent), (f), (g)(1)(ix), (g)(2)(i),

(g)(2)(v), and (g)(5). The label and MSDS

as required by this paragraph shall also

include the following statements: This

substance may cause thyroid cancer.

This substance may cause thyroid

effects.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (f), (g), and (h) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

56. By adding new § 721.4476 to

subpart E to read as follows:

§ 721.4476 Substituted imines.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as substituted imines (PMNs

P–95–1557/1558) are subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

57. By adding new § 721.4589 to

subpart E to read as follows:

§ 721.4589 Propanedioic acid, [(4-

methoxyphenyl)methylene]-, bis(1,2,2,6,6-

pentamethyl-4-piperidinyl) ester (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

propanedioic acid, [(4-

methoxyphenyl)methylene]-,

bis(1,2,2,6,6-pentamethyl-4-piperidinyl)

ester (9CI) (PMN P–95–1411; CAS No.

147783–69–5) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii),

(a)(6)(i), (b) (concentration set at 1.0

percent), and (c). As an alternative to

the respiratory protection requirements

of this section, manufacturers,

importers, and processors of this

substance may follow the terms of the

new chemical exposure limits section in

the TSCA section 5(e) consent order for

this substance.

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e), (f), (g)(1)(iv),

(g)(1)(vi), (g)(1)(viii), (g)(2)(ii), (g)(2)(iii),

(g)(2)(iv), and (g)(5).

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(q).

(iv) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (f), (g), (h), (i), and (k)

are applicable to manufacturers,

importers, and processors of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

58. By adding new § 721.4885 to

subpart E to read as follows:
3430 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

§ 721.4885 Methanone, [5-[[3-(2Hbenzotriazol-2-yl)-2-hydroxy-5-(1,1,3,3-

tetramethylbutyl)phenyl]methyl]-2-hydroxy4-(octyloxy) phenyl]phenyl-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

methanone, [5-[[3-(2H-benzotriazol-2-

yl)-2-hydroxy-5-(1,1,3,3-

tetramethylbutyl)phenyl]methyl]-2-

hydroxy-4-(octyloxy)phenyl]phenyl-

(PMN P–96–942; CAS No.162245–07–0)

is subject to the reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(ii), (a)(5)(iii), (a)(5)(iv),

(a)(5)(v), (a)(6)(i), (b) (concentration set

at 1.0 percent), and (c). As an alternative

to the respiratory protection

requirements of this section,

manufacturers, importers, and

processors of this substance may follow

the terms of the new chemical exposure

limits section in the TSCA section 5(e)

consent order for this substance.

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

1.0 percent), (f), (g)(1)(i), (g)(1)(iv),

(g)(1)(vi), (g)(1)(viii), (g)(2)(ii), (g)(2)(iv),

and (g)(5).

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(q).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (f), (g), (h), and (i) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

59. By adding new § 721.5255 to

subpart E to read as follows:

§ 721.5255 2-Naphthalenol, mono and

dioctyl derivs.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

2-naphthalenol, mono and dioctyl

derivs (PMN P–95–1288) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (where N = 1). When calculating

the surface water concentrations

according to the instructions in

§ 721.91, the statement that the amount

of the substance that will be released

will be calculated before the substance

enters control technology does not

apply. Instead, if the waste stream

containing the substance will be treated

before release, then the amount of the

substance reasonably likely to be

removed from the waste stream by such

treatment may be subtracted in

calculating the number of kilograms

released. No more than 90 percent

removal efficiency may be attributed to

such treatment.

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

60. By adding new § 721.5279 to

subpart E to read as follows:

§ 721.5279 2,7-Naphthalenedisulfonic acid,

4-amino-3-[[4′2-amino-4-[(3-butoxy-2-

hydroxypropyl)amino]phebyl]azo]-3,3′-

dimethyl[1,1′-biphenyl]-4-yl]azo]-5-hydroxy6-(phenylazo)-, disodium salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

2,7-naphthalenedisulfonic acid, 4-

amino-3-[[4′2-amino-4-[(3-butoxy-2-

hydroxypropyl)amino]phebyl]azo]-3,3′-

dimethyl[1,1′-biphenyl]-4-yl]azo]-5-

hydroxy-6-(phenylazo)-, disodium salt

(PMN P–97–131; CAS No. 103580–64–9)

is subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (f), (v)(1), (w)(1),

and (x)(1).

(ii) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 40).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (i), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

61. By adding new § 721.5280 to

subpart E to read as follows:

§ 721.5280 2,7-Naphthalenedisulfonic acid,

4-amino-5-hydroxy-, coupled with

diazotized 4-butylbenzenamine, diazotized

4,4′-cyclohexylidenebis[benzenamine] and

m-phenylenediamine, sodium salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

2,7-naphthalenedisulfonic acid, 4-

amino-5-hydroxy-, coupled with

diazotized 4-butylbenzenamine,

diazotized 4,4′-cyclohexylidenebis[benzenamine] and mphenylenediamine, sodium salt (PMN

P–97–193; CAS No. 182238–09–1) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (f), (v)(1), (w)(1),

and (x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

62. By adding new § 721.5281 to

subpart E to read as follows:

§ 721.5281 2-Naphthalenesulfonic acid, 3-

[[4-[(2,4-dimethyl-6-sulfophenyl)azo]-2-

methoxy-5-methylphenyl]azo]-4-hydroxy-7-

(phenylamino)-, sodium salt, compd. With

2,2′,2′′-nitrilotris [ethanol] (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

2-Naphthalenesulfonic acid, 3-[[4-[(2,4-

dimethyl-6-sulfophenyl)azo]-2-methoxy5-methylphenyl]azo]-4-hydroxy-7-

(phenylamino)-, sodium salt, compd.

With 2,2′,2′′-nitrilotris [ethanol] (9CI)

(PMN P–95–1235; CAS No. 94213–53–3)

is subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (f), (v)(1), (w)(1),

and (x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3431

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements specified in § 721.125 (a),

(b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

63. By adding new § 721.5547 to

subpart E to read as follows:

§ 721.5547 Antimony double oxide.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as antimony double oxide

(PMNs P–95–677 and P–95–724) are

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

0.1 percent), (f), (g)(1)(vii), (g)(2)(ii),

(g)(2)(iii), (g)(3)(ii), and (g)(5). The label

and MSDS as required by this paragraph

shall also include the following

statements: These substances may cause

lung toxicity. When using these

substances avoid any applications of

these substances which could cause

inhalation exposures. When using these

substances keep in liquid form only.

(ii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (f), (v)(1), (v)(2),

(w)(1), (w)(2), (x)(1), (x)(2), (y)(1), and

(y)(2). Manufacturing, processing or use

in any form which could cause

inhalation exposures.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements specified in § 721.125 (a),

(b), (c), (f), (g), (h), and (i) are applicable

to manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

64. By adding new § 721.5549 to

subpart E to read as follows:

§ 721.5549 Lithiated metal oxide.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as lithiated metal oxide

(LiNiO2) (PMN P–96–19; CAS No.

12031–65–1) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i),

(a)(6)(iv), (b) (concentration set at 0.1

percent), and (c). As an alternative to

the respiratory requirements listed here,

a manufacturer, importer, or processor

may choose to follow the new chemical

exposure limit (NCEL) provisions listed

in the TSCA section 5(e) consent order

for this substance.

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

0.1 percent), (f) (g)(1)(iv), (g)(1)(vii),

(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii),

(g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii),

(g)4)(i), and (g)(5).

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(q).

(iv) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 30).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in

§ 721.125(a), (b), (c), (d), (e), (f), (g), (h),

(i), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

65. By adding new § 721.5645 to

subpart E to read as follows:

§ 721.5645 Pentane 1,1,1,2,3,4,4,5,5,5,-

decafluoro.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro

(PMN P–95–638 and SNUN P–97–79;

CAS No. 138495–42–8) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(j) and uses other

than as described in the significant new

use notice.

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

66. By adding new § 721.5650 to

subpart E to read as follows:

§ 721.5650 Pentanediol light residues.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as pentanediol light residues

(PMN P–95–1750) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial and

consumer activities. Requirements as

specified in § 721.80(o).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

67. By adding new § 721.5708 to

subpart E to read as follows:

§ 721.5708 2-Pentene, 1,1,1,2,3,4,4,5,5,5-

decafluoro-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

2-Pentene, 1,1,1,2,3,4,4,5,5,5-

decafluoro- (PMN P–95–637; CAS

No.72804–49–0) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements specified in § 721.125 (a),

(b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.
3432 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

68. By adding new § 721.5725 to

subpart E to read as follows:

§ 721.5725 Phenol, 2,4-dimethyl-6-(1-

methylpentadecyl)-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

phenol, 2,4-dimethyl-6-(1-

methylpentadecyl)-) (PMN P–94–209;

CAS No. 134701–20–5) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(2)(i) and (a)(3).

(ii) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), and (k) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

69. By adding new § 721.5730 to

subpart E to read as follows:

§ 721.5730 Phenol, 4,4′′-methylenebis[2,6-

dimethyl-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

phenol, 4,4′′-methylenebis[2,6-

dimethyl- (PMN P–94–921) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv),

(a)(5)(v), (a)(6)(i), (b) (concentration set

at 1 percent), and (c).

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

1 percent), (f), (g)(1)(iv), (g)(2)(iv),

(g)(2)(v), (g)(3)(ii), (g)(4)(iii), and (g)(5).

The label and MSDS as required by this

paragraph shall also include the

following statements: This substance

may cause blood effects. This substance

may cause chronic effects.

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (g), (l), and (q).

(iv) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (f), (g), (h), (i), and

(k) are applicable to manufacturers,

importers, and processors of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

70. By adding new § 721.5913 to

subpart E to read as follows:

§ 721.5913 Phenothiazine derivative.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a phenothiazine

derivative (PMN P–96–813) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) and (i) are applicable to

manufacturers, and importers of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

71. By adding new § 721.5995 to

subpart E to read as follows:

§ 721.5995 Polyalkyl phosphate.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a polyalkyl phosphate

(PMN P–95–1772) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Releases to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 1 ppb).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

72. By adding new § 721.6045 to

subpart E to read as follows:

§ 721.6045 Phosphinothioic acid, bis(2,4,4-

trimethylpentyl)- (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

phosphinothioic acid, bis(2,4,4-

trimethylpentyl)- (9CI) (PMN P–96–

1652; CAS No. 132767–86–3) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 10). When calculating the

surface water concentrations according

to the instructions in § 721.91, the

statement that the amount of the

substance that will be released will be

calculated before the substance enters

control technology does not apply.

Instead, if the waste stream containing

the substance will be treated using

carbon adsorption treatment before

release, then the amount of the

substance reasonably likely to be

removed from the waste stream by such

treatment may be subtracted in

calculating the number of kilograms

released. No more than 99 percent

removal efficiency may be attributed to

such treatment.

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

73. By adding new § 721.6075 to

subpart E to read as follows:

§ 721.6075 Phosphonic acid, 1,1-

methylenebis-tetrakis(1-methylethyl) ester.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

phosphonic acid, 1,1-methylenebistetrakis(1-methylethyl) ester (PMN P–

95–168) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3433

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3),

(b) (concentration set at 0.1 percent),

and (c).

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

0.1 percent), (f), (g)(2)(i), (g)(2)(v), and

(g)(5). The label and MSDS required by

this paragraph shall also include the

following statement: This substance

may cause mutagenicity.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) through (h) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

74. By adding new § 721.6078 to

subpart E to read as follows:

§ 721.6078 Substituted ethoxyethylamine

phosphonate.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a substituted

ethoxyethylamine phosphonate (PMN

P–95–1950) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

75. By adding new § 721.6165 to

subpart E to read as follows:

§ 721.6165 Polysubstituted piperidine.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a polysubstituted

piperdine (PMN P–93–568) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 30).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

76. By adding new § 721.6170 to

subpart E to read as follows:

§ 721.6170 Siloxanes and silicones, Me

hydrogen, reaction products with 2,2,6,6-

tetramethyl-4-(2-propenyloxy)piperdine.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

siloxanes and silicones, Me hydrogen,

reaction products with 2,2,6,6-

tetramethyl-4-(2-propenyloxy)piperdine

(PMN P–95–1891; CAS No. 182635–99–

0) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(1), (w)(1), and

(x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

77. By adding new § 721.6197 to

subpart E to read as follows:

§ 721.6197 Salt of a substituted

polyalkylenepolyamine.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a salt of a substituted

polyalkylenepolyamine (PMN P–96–

585) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

78. By adding new § 721.6475 to

subpart E to read as follows:

§ 721.6475 Alkyl polycarboxylic acids,

esters with ethoxylated fatty alcohols.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as alkyl polycarboxylic

acids, esters with ethoxylated fatty

alcohols (PMNs P–96–554/555/556/557/

558/559) are subject to reporting under

this section for the significant new uses

described in paragraph (a)(1)(i) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial and

consumer activities. Requirements as

specified in § 721.80(g).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Chemical substance and

significant new uses subject to reporting.

The chemical substances identified

generically as alkyl polycarboxylic

acids, esters with ethoxylated fatty

alcohols (PMN P–96–560/561/564/565)

are subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(i) The significant new uses are:

(A) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(B) [Reserved]

(ii) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.
3434 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

(A) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(B) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

79. By adding new § 721.6477 to

subpart E to read as follows:

§ 721.6477 Alkyl polycarboxylic acids,

esters with ethoxylated fatty alcohols,

reaction products with maleic anhydride.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as alkyl polycarboxylic

acids, esters with ethoxylated fatty

alcohols, reaction products with maleic

anhydride (PMNs P–96–399/400/401/

402/403/404) are subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

80. By adding new § 721.6485 to

subpart E to read as follows:

§ 721.6485 Hydroxy terminated polyester.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a hydroxy terminated

polyester (PMN P–95–1213) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements specified in § 721.125 (a),

(b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

81. By adding new § 721.6490 to

subpart E to read as follows:

§ 721.6490 Alkyl phenyl polyetheramines.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as alkyl phenyl

polyetheramines (PMNs P–95–1650/

1651/1652/1653) are subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

82. By adding new § 721.6495 to

subpart E to read as follows:

§ 721.6495 Aliphatic polyisocyanate.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an aliphatic

polyisocyanate (PMN P–95–1347) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(y)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

83. By adding new § 721.6505 to

subpart E to read as follows:

§ 721.6505 Polymers of C13C15 oxoalcohol

ethoxolates.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as polymers of C13C15

oxoalcohol ethoxolates (PMNs P–96–

950/951) are subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

84. By adding new § 721.7375 to

subpart E to read as follows:

§ 721.7375 Potassium salt of polyolefin

acid.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a potassium salt of

polyolefin acid (PMN P–97–417) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

85. By adding new § 721.7378 to

subpart E to read as follows:

§ 721.7378 Substituted polyoxyethylene.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a substituted

polyoxyethylene (PMN P–93–1654) is
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3435

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(j) (use as an

emulsifier for paint and adhesives).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

86. By adding new § 721.8079 to

subpart E to read as follows:

§ 721.8079 Isophorone diisocyanate

neopentyl glycol adipate polyurethane

prepolymer.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as isophorone diisocyanate

neopentyl glycol adipate polyurethane

prepolymer (PMN P–94–1743) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section. Nonspray uses are exempt from the

provisions of this rule.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii),

(a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi),

(a)(6)(i), (a)(6)(ii), (a)(6)(iv), and (b)

(concentration set at 1.0 percent), and

(c).

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

1.0 percent), (f), (g)(1)(i), (g)(1)(ii),

(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv),

(g)(2)(v), and (g)(5). Manufacturers,

importers, and processors who

implement the product stewardship

provisions of the TSCA section 5(e)

consent order for these substances are

exempt from the requirements of

§ 721.63 and § 721.72.

(iii) Industrial, commercial and

consumer activities. Requirements as

specified in § 721.80(q).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) through (i) are applicable to

manufacturers, importers, and

processors of this substance.

Manufacturers, importers, and

processors who implement the product

stewardship provisions and keep

records as required by the TSCA section

5(e) consent order for these substances

are exempt from the requirements of

§ 721.125.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

(4) Applicability of § 721.5. The

provisions of § 721.5 do not apply to

manufacturers, importers, and

processors, implementing the product

stewardship provisions in the TSCA

section 5(e) consent order for this

substance.

87. By adding new § 721.8095 to

subpart E to read as follows:

§ 721.8095 Silylated polyurethane.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a silylated polyurethane

(PMN P–95–1356) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(y)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

88. By adding new § 721.8780 to

subpart E to read as follows:

§ 721.8780 Substituted pyridine azo

substituted phenyl.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as substituted pyridine azo

substituted phenyl (PMNs P–96–767

and P–96–773) are subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) and (i) are applicable to

manufacturers and importers of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

89. By adding new § 721.9005 to

subpart E to read as follows:

§ 721.9005 2-Pyrrolidinone, 1,1′-(2-methyl1,5-pentanediyl)bis-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

2-pyrrolidinone, 1,1′-(2-methyl-1,5-

pentanediyl)bis- (PMN P–93–761; CAS

No. 146453–62–5) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i) (There must be no

permeation of the PMN substance

greater than 0.08 grams (g)/minutes

(min) centimeter (cm2) after 8 hours of

testing in accordance with the most

current version of the American Society

for Testing and Materials (ASTM) F739

‘‘Standard Test Method for Resistance of

Protective Clothing Materials to

Permeation by Liquids or Gases.’’ The

results of all glove permeation testing

must be reported in accordance with the

most current version of (ASTM) F1194

‘‘Guide for Documenting the Results of

Chemical Permeation Testing of

Protective Clothing Materials.’’

Manufacturers, importers, and

processors must submit such glove test

data to the Agency and must receive

written Agency approval for each type

of glove tested prior to use of such

gloves. The following gloves have been

tested in accordance with the ASTM

F739 method and found to satisfy the

requirements for use by EPA: Ansell

Edmond/8–352/Neoprene rubber, 0.097

cm thick. Gloves may not be used for a

time period longer than they are

actually tested and must be replaced at

the end of each work shift), (a)(2)(ii),

(a)(2)(iii), (a)(3), (b) (concentration set at

1.0 percent), and (c).

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at
3436 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

1.0 percent), (f), (g)(l)(iii), (g)(l)(iv),

(g)(2)(i), (g)(2)(iii), (g)(2)(v), and (g)(5).

The label and MSDS as required by this

paragraph shall also include the

following statement: This substance is

expected to enhance the absorption of

other chemicals into skin or other

materials.

(iii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (o), (q), and (k) (use

other than as a heat transfer fluid).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (f), (g), (h), and (i)

are applicable to manufacturers,

importers, and processors of this

substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

(3) Determining whether a specific use

is subject to this section. The provisions

of § 721.1725(b)(1) apply to this section.

90. By adding new § 721.9010 to

subpart E to read as follows:

§ 721.9010 2-pyrrolidone, 1-ethenyl-3-

ethylidene-, (E)-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

2-pyrrolidone, 1-ethenyl-3-ethylidene-,

(E)- (PMN P–96–1536; CAS No. 153954–

47–3) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(2)(i) and (a)(3).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), and (e) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

91. By adding new § 721.9080 to

subpart E to read as follows:

§ 721.9080 Nitro methyl quinoline.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as nitro methyl quinoline

(PMN P–96–1319) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), and

(a)(6)(i).

(ii) Disposal. Requirements as

specified in § 721.85 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), and (j) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

92. By adding new § 721.9265 to

subpart E to read as follows:

§ 721.9265 Reaction product of

dichlorobenzidine and substituted

alkylamide.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a reaction product of

dichlorobenzidine and substituted

alkylamide (PMN P–95–1282) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e), (f), and (g)(5). The

label and MSDS as required by this

paragraph shall also include the

following statements: At temperatures

above 200 °C, this substance

decomposes to produce a suspect

human carcinogen, 3′,3′

dichlorobenzidine. Do not heat above

200 °C or 392 °F.

(ii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f) and processing

or use of the PMN substance at

temperatures above 200 °C.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (f), (g), (h), and (i) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

93. By adding new § 721.9270 to

subpart E to read as follows:

§ 721.9270 Reaction product of epoxy with

anhydride and glycerol and glycol.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as reaction product of epoxy

with anhydride and glycerol and glycol

(PMN P–96–1233) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(1), (w)(1), (x)(1)

and (y)(2).

(ii) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (i), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

94. By adding new § 721.9285 to

subpart E to read as follows:

§ 721.9285 Reaction products of formalin

(37%) with amine C12.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as reaction products of

formalin (37%) with amine C12 (PMN P–

95–535) is subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

95. By adding new § 721.9488 to

subpart E to read as follows:
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3437

§ 721.9488 Substituted resorcinols.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as substituted resorcinols

(PMNs P–95–1103, P–95–1104, and P–

96–1235) are subject to reporting under

this section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 9).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. The recordkeeping

requirements specified in § 721.125 (a),

(b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

96. By adding new § 721.9492 to

subpart E to read as follows:

§ 721.9492 Polymers of styrene,

cyclohexyl methacrylate and substituted

methacrylate.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as polymers of styrene,

cyclohexyl methacrylate and substituted

methacrylate (PMNs P–97–143/144) are

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a) and (i) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

97. By adding new § 721.9497 to

subpart E to read as follows:

§ 721.9497 Trifunctional ketoximino silane.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as trifunctional ketoximino

silane (PMNs P–95–605 and P–95–606)

are subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), and (a)(3).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), and (e) are applicable to

manufacturers, importers, and

processors of these substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

98. By adding new § 721.9499 to

subpart E to read as follows:

§ 721.9499 Modified silicone resin.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a modified silicone resin

(PMN P–96–1649) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 5).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

99. By adding new § 721.9503 to

subpart E to read as follows:

§ 721.9503 Silane,

(3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-

heptadecafluorodecyl)trimethoxy-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

silane,

(3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-

heptadecafluorodecyl) trimethoxy-

(PMN P–97–264; CAS No. 83048–65–1)

is subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii),

(a)(5)(xv), (a)(6)(ii), and (a)(6)(v).

(ii) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 10).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

100. By adding new § 721.9515 to

subpart E to read as follows:

§ 721.9515 Aminofunctional alkoxy alkyl

siloxane.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an aminofunctional

alkoxy alkyl siloxane (PMN P–96–346)

is subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

101. By adding new § 721.9545 to

subpart E to read as follows:

§ 721.9545 Substituted phenyl azo

substituted sulfocarbopolycle, sodium salt.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a substituted phenyl azo

substituted sulfocarbopolycle, sodium

salt (PMN P–96–1263) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as
3438 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

specified in § 721.80 (v)(1), (w)(1), and

(x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

102. By adding new § 721.9575 to

subpart E to read as follows:

§ 721.9575 Chromate(3-), bis[3-[[5-

(aminosulfonyl)-2-hydroxyphenyl]azo]-4-

hydroxy-7-[[2-oxo-1-

[(phenylamino)carbonyl] propyl]azo]-2-

naphthalenesulfonato(3-)]-, trisodium (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

chromate(3-), bis[3-[[5-(aminosulfonyl)-

2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-

oxo-1-[(phenylamino)carbonyl]

propyl]azo]-2-naphthalene sulfonato(3-

)]-, trisodium (9CI) (PMN P–95–1575;

CAS No. 119535–63–6) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(1), (w)(1), and

(x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

103. By adding new § 721.9576 to

subpart E to read as follows:

§ 721.9576 Chromate(3-), bis[7-

[(aminohydroxyphenyl)azo]-3-[[5-

(aminosulfonyl)-2-hydroxyphenyl]azo]-4-

hydroxy-2-naphthalene-sulfonato (3-)]-,

trisodium (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

chromate(3-), bis[7-

[(aminohydroxyphenyl)azo]-3-[[5-

(aminosulfonyl)-2-hydroxyphenyl]azo]-

4-hydroxy-2-naphthalene-sulfonato (3-

)]-, trisodium (9CI) (PMN P–95–1576;

CAS No. 118716–62–4) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(1), (w)(1), and

(x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

104. By adding new § 721.9577 to

subpart E to read as follows:

§ 721.9577 Chromate(3-), bis[7-

[(aminohydroxyphenyl)azo]-3-[[5-

(aminosulfonyl)-2-hydroxyphenyl] azo]-4-

hydroxy-2-naphthalene sulfonato (3-)]-,-[[5-

(aminosulfonyl) -2-hydroxyphenyl]azo]-4-

hydroxy-7-[[2-hydroxy-1-[(phenylamino)

carbonyl]-1-propenyl]azo]-2-

naphthalenesulfonato(3-)]-, trisodium (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

chromate(3-), bis[7-

[(aminohydroxyphenyl)azo]-3-[[5-

(aminosulfonyl)-2-hydroxy phenyl]

azo]-4-hydroxy-2-naphthalenesulfonato

(3-)]-,-[[5-(aminosulfonyl) -2-

hydroxyphenyl]azo]-4-hydroxy-7-[[2-

hydroxy-1-[(phenylamino) carbonyl]-1-

propenyl]azo]-2-naphthalene

sulfonato(3-)]-, trisodium (9CI) (PMN P–

95–1577; CAS No. 118716–61–3) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(1), (w)(1), and

(x)(1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

105. By adding new § 721.9635 to

subpart E to read as follows:

§ 721.9635 Terpene residue distillates.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as terpene residue distillates

(PMN P–96–897) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 10).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

106. By adding new § 721.9657 to

subpart E to read as follows:

§ 721.9657 Disubstituted thiadiazole.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a disubstituted

thiadiazole (PMN P–97–314) is subject

to reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (a),(b), (c), and (j).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

107. By adding new § 721.9659 to

subpart E to read as follows:

§ 721.9659 Disubstituted thiadiazosulfone.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as a disubstituted

thiadiazosulfone (PMN P–97–304) is
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3439

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (a),(b), (c), and (j).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

108. By adding new § 721.9662 to

subpart E to read as follows:

§ 721.9662 Thieno[3,4-b]-1,4-dioxin, 2,3-

dihydro- (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

thieno[3,4-b]-1,4-dioxin, 2,3-dihydro-

(9CI) (PMN P–95–1825; CAS No.

126213–50–1) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), (a)(4), (a)(5)(xii),

(a)(5)(xiii), (a)(5)(xiv), and (a)(6)(v).

(ii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), and (k) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

109. By adding new § 721.9664 to

subpart E to read as follows:

§ 721.9664 9H-Thioxanthen-9-one,2,4-

diethyl.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

9H-thioxanthen-9-one,2,4-diethyl (PMN

P–96–1315; CAS No. 82799–44–8) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 1).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (k) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

110. By adding new § 721.9717 to

subpart E to read as follows:

§ 721.9717 Azo monochloro triazine

reactive dye.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified

generically as an azo monochloro

triazine reactive dye (PMN P–96–238) is

subject to reporting under this section

for the significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80 (v)(2), (w)(2), and

(x)(2).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), and (i) are applicable to

manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

111. By adding new § 721.9825 to

subpart E to read as follows:

§ 721.9825 Phenyl substituted

triazolinones.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substances identified

generically as phenyl substituted

triazolinones (PMNs P–93–204, P–94–

1870, P–94–1871, P–94–1872, P–94–

1873, and P–94–1874) are subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(iii),

(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (b)

(concentration set at 1.0 percent), and

(c). The imperviousness of the gloves

selected pursuant to (a)(2)(i) of this

section must be demonstrated by actual

testing under (a)(3)(i) of this section and

not by manufacturer specifications. In

addition, there must be no permeation

of the chemical substance greater than

15 μg/day-cm2 as a daily cumulative

total when tested in accordance with the

most current version of the American

Society for Testing and Materials

(ASTM) F739 ‘‘Standard Test Method

for Resistance of Protective Clothing

Materials to Permeation by Liquids or

Gases’’ or ASTM F1383 ‘‘Standard Test

Method for Resistance of Protective

Clothing Materials to Permeation by

Liquids or Gases Under Conditions of

Intermittent Contact.’’

(A) For conditions of exposure which

are intermittent, gloves may be tested in

accordance with the most current

version of ASTM F1383 ‘‘Standard Test

Method for Resistance of Protective

Clothing Materials to Permeation by

Liquids or Gases Under Conditions of

Intermittent Contact,’’ provided the

contact time in testing is greater than or

equal to the expected duration of dermal

contact, and the purge time used in the

testing is less than or equal to the

expected duration of non-contact during

the intermittent cycle of dermal

exposure in the workplace. If ASTM

F1383 is used for testing, the company

must submit to the Agency a description

of worker activities involving the

chemical substance which includes

daily frequencies and durations of

potential worker exposures.

(B) The results of all glove permeation

testing must be reported in accordance

with the most current version of

(ASTM) F1194 ‘‘Guide for Documenting

the Results of Chemical Permeation

Testing of Protective Clothing

Materials.’’ The company must submit

all test data to the Agency and must

receive written Agency approval for

each type of glove tested prior to use of

such gloves. Gloves must be discarded

and replaced with such frequency as to

ensure that they will reliably provide an

impervious barrier to the chemical

substances under normal and expected

conditions of exposure within the work

area. Gloves that have been damaged or

are defective shall not be used. For

PMNs P–94–1871 through P–94–1874,

EPA has approved North Safety Butyl

Rubber gloves (32 mils thick). For P–93–

204 and P–94–1870, EPA has approved

North Safety Butyl Rubber gloves (32

mils thick) only if used in combination

with a chemical-resistant glove that has

been demonstrated (EPA review not

required) impermeable to the solvent,
3440 Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations

e.g., North Silvershield gloves and

North 4H gloves.

(ii) Hazard communication program.

Requirements as specified in § 721.72

(a), (b), (c), (d), (e) (concentration set at

1.0 percent), (f), (g)(1)(iv), (g)(1)(ix),

(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv),

(g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and

(g)(5).

(iii) Release to water. Requirements as

specified in § 721.90 (a)(4), (b)(4), and

(c)(4) (N = 5 for all the chemical

substances subject to the provisions of

this rule combined). However, contrary

to the requirements specified in

§ 721.91, if the waste stream containing

the chemical substances will be treated

using activated carbon adsorption, then

the amount of chemical substances

reasonably likely to be removed from

the waste stream by such treatment may

be subtracted in calculating the number

of kilograms released. No more than the

following percent removal efficiencies

may be attributed to such treatment for

each PMN: P–93–204, 99 percent; P–94–

1870, 98 percent; P–94–1871, 97

percent; P–94–1872, 92 percent; P–94–

1873, 90 percent; P–94–1874, 73

percent.

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (f), (g), (h), and (k)

are applicable to manufacturers,

importers, and processors of these

substances.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

112. By adding new § 721.9830 to

subpart E to read as follows:

§ 721.9830 1-Tridecyn-3-ol, 3-methyl.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

1-tridecyn-3-ol, 3-methyl (PMN P–96–

236; CAS No. 100912–15–0) is subject to

reporting under this section for the

significant new uses described in

paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Worker protection. Requirements

as specified in § 721.63 (a)(1), (a)(2)(i),

and (a)(3).

(ii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(f).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), and (i) are applicable

to manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

113. By adding new § 721.9840 to

subpart E to read as follows:

§ 721.9840 Tungstate (W12(OH)2O386-)

hexasodium (9CI).

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

tungstate (W12(OH)2O386-) hexasodium

(9CI) (PMN P–96–1177; CAS No. 12141–

67–2) is subject to reporting under this

section for the significant new uses

described in paragraph (a)(2) of this

section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(j).

(ii) [Reserved]

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), and (i) are applicable

to manufacturers, importers, and

processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

114. By adding new § 721.9928 to

subpart E to read as follows:

§ 721.9928 Urea, tetraethyl-.

(a) Chemical substance and

significant new uses subject to reporting.

(1) The chemical substance identified as

urea, tetraethyl- (PMN P–94–1017; CAS

No. 1187–03–7) is subject to reporting

under this section for the significant

new uses described in paragraph (a)(2)

of this section.

(2) The significant new uses are:

(i) Protection in the workplace.

Requirements as specified in § 721.63

(a)(1), (a)(2)(i), and (a)(3).

(ii) Industrial, commercial, and

consumer activities. Requirements as

specified in § 721.80(r) (445,000 kg) (a

dermal developmental toxicity study in

mice and rats and either a chromosome

aberration assay in mice (40 CFR

798.5385) or a micronucleus assay in

mice (40 CFR 798.5395)). A person may

not manufacture or import the substance

beyond the following aggregate

production volume limits, unless that

person conducts the following

corresponding studies on the substance

and submits all final reports and

underlying data in accordance with the

procedures and criteria specified in

paragraphs (a)(2)(i)(A), (a)(2)(i)(B),

(a)(2)(i)(C), and (a)(2)(i)(D) of this

section.

(A) Each study required to be

performed pursuant to this section must

be scientifically valid. Scientific valid

means that the study was conducted

according to:

(1) The test guidelines specified in

paragraph (a)(2)(i) of this section.

(2) An EPA-approved protocol.

(3) TSCA Good Laboratory Practice

Standards at 40 CFR part 792.

(4) Using methodologies generally

accepted at the time the study is

initiated.

(5) Any deviation from these

requirements must be approved in

writing by EPA.

(B) Before starting to conduct any of

the studies in paragraph (a)(2)(i) of this

section, the person must obtain

approval of test protocols from EPA by

submitting written protocols. EPA will

respond to the person within 4 weeks of

receiving the written protocols.

Published test guidelines specified in

paragraph (a)(2)(i) of this section (e.g.,

40 CFR part 797 or part 798) provide

general guidance for development of test

protocols, but are not themselves

acceptable protocols.

(C) The person shall:

(1) Conduct each study in good faith

with due care.

(2) Promptly furnish to EPA the

results of any interim phase of each

study.

(3) Submit, in triplicate (with an

additional sanitized copy, if

confidential business information is

involved), the final report of each study

and all underlying data (‘‘the report and

data’’) to EPA no later than 14 weeks

prior to exceeding the applicable

production volume limit. The final

report shall contain the contents

specified in 40 CFR 792.185.

(D)(1) Except as described in

paragraph (a)(2)(ii)(D)(2) of this section,

if, within 6 weeks of EPA’s receipt of a

test report and data, the person receives

written notice that EPA finds that the

data generated by a study are

scientifically invalid, the person is

prohibited from further manufacture

and import of the PMN substance

beyond the applicable production

volume limit.

(2) The person may continue to

manufacture and import the PMN

substance beyond the applicable

production limit only if so notified, in

writing, by EPA in response to the

person’s compliance with either of the

following paragraph (a)(2)(ii)(D)(2)(i) or

(a)(2)(ii)(D)(2)(ii) of this section.
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules and Regulations 3441

(i) The person may reconduct the

study. If there is sufficient time to

reconduct the study and submit the

report and data to EPA at least 14 weeks

before exceeding the production limit as

required by paragraph (a)(2)(ii)(C)(3) of

this section, the person shall comply

with paragraph (a)(2)(ii)(C)(3) of this

section. If there is insufficient time for

the person to comply with paragraph

(a)(2)(ii)(C)(3) of this section, the person

may exceed the production limit and

shall submit the report and data in

triplicate to EPA within a reasonable

period of time, all as specified by EPA

in the notice described in paragraph

(a)(2)(ii)(D)(1) of this section. EPA will

respond to the person in writing, within

6 weeks of receiving the person’s report

and data.

(ii) The person may, within 4 weeks

of receiving from EPA the notice

described in paragraph (a)(2)(ii)(D)(1) of

this section, submit to EPA a written

report refuting EPA’s finding. EPA will

respond to the person in writing, within

4 weeks of receiving the person’s report.

(E) The person is not required to

conduct a study specified in paragraph

(a)(2)(i) of this section if notified in

writing by EPA that it is unnecessary to

conduct that study.

(iii) Release to water. Requirements as

specified in § 721.90 (a)(1), (b)(1), and

(c)(1).

(b) Specific requirements. The

provisions of subpart A of this part

apply to this section except as modified

by this paragraph.

(1) Recordkeeping. Recordkeeping

requirements as specified in § 721.125

(a), (b), (c), (d), (e), (i), and (k) are

applicable to manufacturers, importers,

and processors of this substance.

(2) Limitations or revocation of

certain notification requirements. The

provisions of § 721.185 apply to this

section.

[FR Doc. 98–1074 Filed 1–21–98; 8:45 am]

BILLING CODE 6560–50–F