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Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

[OPTS-50575; FRL-3658--51

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 (SNUR) under

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

Control Act (TSCA) for several chemical

substances which were the subject of

premanufacture notices (PMNs), and are

now subject to TSCA section 5(e)

consent orders issued by EPA. Today's_

action requires certain 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 activity

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 these SNURs using direct

final procedures.

EFFECTIVE DATE: The effective date of

this rule is June 25, 1990.

Comment. If EPA receives notice

before May 24, 1990 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

each 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

comments must bear the docket control

number [OPTS-50575] and the specific

CFR section number for the substance

being addressed. Since some comments

may contain confidential business

information (CBI), all comments should

be sent in triplicate. to: TSCA Document

Receipt Office (TS-790), Office of Toxic

Substances, Environmental Protection

Agency, Rm. E-105, 401 M St., SW.,

Washington, DC 20460, Attn: Significant

New Use Rules.

Nonconfidential versions of comments

on this rule will be placed in the

rulemaking record and will be available

for public inspection. Unit X of this

preamble contains additional

information on submitting comments

containing CBI.

FOR FURTHER INFORMATION CONTACT.

Michael M. Stahl, Director,

Environmental Assistance Division (TS799), Office of Toxic Substances,

Environmental Protection Agency, Rm.

E-543B, 401 M St., SW., Washington, DC

20460, Telephone: (202) 554-1404, TDD:

(202] 554-0551.

SUPPLEMENTARY INFORMATION: This rule

describes significant new uses and

recordkeeping requirements for certain

persons who intend to manufacture,

import, or process certain chemical

substances designated in the rule. Each

of the following substances designated

in today's rule was the subject of a PMN

and a TSCA section 5(e) consent order

issued by EPA. The substances are

identified by generic chemical names

because the specific names have been

claimed as CBI (see Unit VII).

PMN Number Chemical Name

P--89-448 (generic) Alkanepolyol phosphate ester

P-89-650 (generic) Substituted ethylene

diamine, methyl sulfate quatemized

P-89-653 (generic) Adipic acid, polymer

with 1,4-cyclohexanedimethanol, dipropylene glycol, alkanepolyol, substituted alkanolamines, and carbomonocyclic dicarboxylic acid

P-89-703, P- (generic) Reaction products of

89-755, and secondary alkyl amines with a

P-89-756 substituted bonzenesuffonic

acid and sulfuric acid

This is the first rule EPA has issued

using the expedited procedures and

standard significant new use

designations established in EPA's recent

amendments to 40 CFR part 721. (See 54

FR 31308, July 27, 1989.) The preamble to

this rule explains in detail the

background and rationale supporting the

use of the new expedited process.

Where appropriate, future rules issued

using the expedited process will contain

an abbreviated version of this

background information but will cross- reference the more complete

explanation in the preamble of this rule.

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 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 720.10.

II. Objectives and Rationale for

Expedited SNUR Process

A. PMN Review and Use of Section 5(e)

Orders

A limited amount of toxicity data is

typically submitted with PMNs. Thus

EPA bases its review of new substances

primarily on structure-activity

relationships (SAR). During PMN

review, EPA may determine that "the

information available* **is insufficient

to permit a reasoned evaluation of the

health and environmental effects" of the

new chemical substance that is the

subject of the PMN. At the same time,

EPA may determine, under section

5(e)(1)(A)(ii)(I), based on SAR analysis

that activities involving the new

substance "may present an

unreasonable risk of injury to health or

the environment." When EPA makes

these two findings, it acts under section

5(e) to regulate the activities involving

the new substance which contribute to

the potential risk.

In most such circumstances, EPA

believes that it is appropriate to

negotiate an order (known as a "consent

order") under section 5(e) with the PMN

submitter to control human exposure

and/or environmental releases until test

data or other information sufficient to

assess adequately the potential hazard

become available. Section 5(e) consent

orders have specified a variety of

control measures, including protective

equipment, use limitations, process

restrictions, labeling requirements, and

limits on environmental release. Some

recent consent orders have included

testing requirements that are triggered

when specified levels of production

volume or other indices of increased

exposure are reached; under these

orders, the submitter may not exceed

the production volume limitation or

other restriction imposed by EPA until

test data specified by EPA have been

submitted to and reviewed by EPA.

In other instances, during PMN review

EPA may determine under section

5(e)(1)(A)(ii)[Il) that a new substance

will be produced in substantial

quantities and "may reasonably be

anticipated to enter the environment in

substantial quantities or there is or may

be significant or substantial human

exposure to the substance," and that the

available information is insufficient to

determine the effects of the substance.

17376
Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

Consent orders issued to address

concerns under section 5(e)(1)(A)(ii)(II)

may include recordkeeping provisions

and production volume limits.

B. Use of SNURS as a Follow-Up Tool

for Substances Subject to Section 5(e)

Consent Orders

Section 5(e) orders apply only to PMN

submitters. When a PMN submitter

commences commercial manufacture of

the substance and submits a Notice of

Commencement of Manufacture to EPA,

EPA adds the substance to the TSCA

Chemical Substance Inventory

maintained pursuant to section 8(b) of

TSCA. When a substance is listed on

the Inventory, it is no longer a "new

chemical substance" for which a PMN

would be required under section

5(a)(1)(A). Thus, under section 5(e) alone

other persons would be able to

manufacture, import, or process the

substance without EPA review and

without the restrictions imposed on the

•PMN submitter by the section 5(e) order.

EPA uses its SNUR authority to

extend limitations in section 5(e) orders

to other manufacturers, importers, and

processors. This ensures that the

original PMN submitters and subsequent

manufacturers, importers, and

processors are treated in an essentially

equivalent manner. These SNURs are

framed so that non-compliance with the

control measures or other restrictions in

the section 5(e) consent orders is,

defined as a "significant new use."

Thus, other manufacturers, importers,

and processors of the substances must

either observe the SNUR restrictions or

submit a significant new use notice to

'EPA at least 90 days before initiating

activities that deviate from these

restrictions. After receiving and

reviewing such a notice, EPA has the

option of either permitting the new use

or acting under section 5(e) or (f) to

regulate the new submitter's activities.

In addition to assuring that all

manufacturers, importers, and

processors are subject to similar

reporting requirements and restrictions,

SNURs for these substances have the

following objectives: That EPA will

receive notice of any company's intent

to manufacture, import, or process a

chemical substance listed on the TSCA

Inventory for a significant new use

before that activity begins; that 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; and that, 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.

C. Substances That May Raise

Concerns But Are Not Regulated Under

Section 5(e) -

EPA also reviews some new

substances that do not warrant action

under section 5(e) but merit other

follow-up monitoring and evaluation. On

the basis of test data or structureactivity relationships analysis, EPA may

identify potential health or

environmental effects that could create

a basis for concern if, because of

changes in use and related activities, the

substance's exposure or release

potential later changes or increases

beyond that described in the PMN.

In most such cases, EPA believes it is

appropriate to use SNUR authority to

monitor the commercial development of

these substances so that EPA can be

apprised of significant increases in

exposure potential, which may warrant

control measures or testing.

D. Rationale for Significant New Use

Designations

To determine what constitutes

significant new uses, EPA considers

relevant information about the toxicity

of the substance, likely exposures

associated with possible uses, and the

four factors listed in section 5(a)(2) of

TSCA. EPA designates the significant

new uses of each substance based on

these considerations.

In cases where significant new use

designations are based on provisions in

the section 5(e) order, EPA has already

made a determination either under

section 5(e)(1)(A)(ii)(I) (i.e., that

activities involving the substance may

present an unreasonable risk of injury to

health orthe environment), or under

section 5(e)(1)(A)(ii)(II) (i.e., that the

substance- may be produced in

substantial quantities and may enter the

environment in substantial quantities or

there may be significant or substantial

human exposure). While such a finding

is not necessary to promulgate a SNUR.

it strongly supports a determination that

the uses of the substance designated in

the rule would be significant new uses

of the substance. In this and future

SNURs, for each substance subject to a

section 5(e) order, EPA will specify the

findings that served as the basis of the

order.

For substances not subject to a

section 5(e) order or when EPA believes

that SNUR requirements should include

provisions which did not appear in a

section 5(e) order, the additional

provisions will conform to the criteria in

40 CFR 721.170, and the basis for these

additional provisions will be explained.

E. Conversion of Section 5(e) Orders

Into SNURS

The standard significant new use

designations in subparts B and C of 40

CFR part 721 are designed to be

consistent with standard provisions for

section 5(e) consent orders. Because

section 5(e) orders are framed to apply

only to PMN submitters, however, minor

wording changes may be needed to

convert the orders' provisions into

generally applicable requirements.

Under § 721.160(b), EPA may make such

wording changes provided that they do

not depart from the section 5(e) order's

substantive requirements. All of the

SNURs in today's rule are based on

recently issued section 5(e) orders, and

only minor wording changes are

necessary to convert the requirements

into SNURs.

Some earlier section 5(e) orders

contain provisions that require major

wording changes to be converted into

SNURs. Where a particular requirement

in a section 5(e) order is worded so

differently from the corresponding

SNUR provision that the basis for

selecting the SNUR provision would not

otherwise be evident, EPA will provide

an explanation for its choice of SNUR

provisions.

IIL. Applicability of General Provisions

General provisions for SNURs appear

under subpart A of 40 CFR part 721.

These provisions describe persons

subject to the rule, recordkeeping

requirements, exemptions to reporting

requirements, and conditions of advance

compliance for uses occurring before the

effective date of the final rule. See 53 FR

28358 (July 27, 1988).

EPA has recently amended 40 CFR

part 721 by establishing new subparts B,

C, and D. See 54 FR 31306 (July 27, 1989).

Subpart B establishes standard

significant new use designations.

Subpart C establishes recordkeeping

requirements. Each standard significant

new use and recordkeeping requirement

will apply to a specific substance only if

it is cited in the SNUR for that

substance. Subpart D contains

expedited procedures for establishing

significant new use requirements for

certain new substances that are

regulated under a section 5(e) consent

order. Subpart D also contains criteria

to determine whether uses not identified

in the PMN of non-section 5(e)

substances will be considered

candidates for a SNUR under expedited

procedures. SNURS for specific

substances are contained in subpart E.

17377
17378 Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

Rules on 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

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

authorized by section 5(h)(1), (2), (3),

and (5), and the rules in 40 CFR part 720.

Once EPA receives a SNUR notice, EPA

may take regulatory action under

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 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 rules 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 and must certify that they are

in compliance with the SNUR

requirements. The EPA policy in support

of the import certification appears at 40

CFR part 707.

IV. 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 applicable), basis for

the action taken by EPA in the section

5(e) consent order for the substance

(including the statutory citation and

specific finding), 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 the

rule by reference to 40 CFR part 721

subpart B where the significant new

uses are described in detail. Where the

underlying 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,

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 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 section 5(e) order. Descriptions of

recommended tests are provided for

informational purposes.

Each of these SNURs regulates a

chemical substance subject to a section

5(e) order where the finding under TSCA

is based solely on substantial

production volume and substantial

human or environmental exposure. In

each of these cases, there was limited or

no toxicity data available for the PMN

substance, a potentially substantial

production volume, and a potentially

substantial human or environmental

exposure. In such cases, EPA regulates

new chemicals under section 5(e) by

requiring certain toxicity tests. For

instance chemicals 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.

Each of these SNURs involves

information which has been claimed as

CBI. When a generic chemical name

appears in this Unit, the specific name is

claimed as CBI. In addition, each of the

SNURs identified in this Unit involves a

production limit as a significant new

use. Because the production volume

limit is contained in the section 5(e)

order and has been claimed as CBI, the

regulatory text incorporates the

production volume by reference to the

section 5(e) order. The procedures for

determining whether a specific

substance and/or a specific significant

new use which are CBI are covered by a

specific SNUR are described in Unit VII.

PMN Number P-89-448

Chemical name: (generic) Alkanepolyol

phosphate ester.

CAS number. Not applicable. Effective date of section 5(e) consent

order. October 12, 1989.

Basis for section 5(e) order. The Order

was issued under section 5(e)(1)(A)(i)

and (ii)(lI) of TSCA based on a finding

that this substance is expected to be

produced in substantial quantities and

there may be significant or substantial

human exposure.

Recommended testing: EPA has

determined that the results of a mouse

micronucleus assay (40 CFR 798.5395)

and a 28-day repeated dose oral study

in rats (OECD Guideline No. 407), with

the following modifications: (a) for all

test doses, a neurotoxicity functional

observational battery (40 CFR 798.6050),

and (b) for the highest test dose group

only, histopathologic examination

extended to include the testes/ovaries

and lungs, plus neuropathology (40 CFR

798.6400) would help characterize

possible effects of the substance. The

PMN submitter has agreed not to exceed

the production volume limit without

performing these tests.

CFR citation: 40 CFR 721.288.

PMN Number P-89-650

Chemical name: (generic) Substituted

ethylene diamine, methyl sulfate

quaternized.

CAS number. Not applicable.

Effective date of section 5(e) consent

order October 23, 1989.

Basis for section 5(e) order. The Order

was issued under section 5(e)(1)(A)(i)

and (ii)(II) of TSCA based on a finding

that this substance is expected to be

produced in substantial quantities and

there may be substantial environmental

releases and significant or substantial

human exposure

Recommended testing: EPA has

determined that the results of an acute

algal study (40 CFR 797.1050), acute

daphnid study (40 CFR 797.1300), and

acute fish study (40 CFR 797.1400) would

help characterize possible effects of the

substance. The PMN submitter has

agreed not to exceed the production

volume limit without performing these

tests.

CFR citation: 40 CFR 721.1082.

PMN Number P-89-653

Chemical name: (generic) Adipic acid,

polymer with 1,4-

cyclohexanedimethanol, dipropylene

glycol, alkanepolyol, substituted

alkanolamines, and carbomonocyclic

dicarboxylic acid.

CAS number. Not applicable.

Effective date of section 5(e) consent

order. October 31, 1989.

Basis for section 5(e) order. The Order

was issued under section 5(e)(1)(A)(i)

and (ii)(1I) of TSCA based on a finding

that this substance is expected to be

produced in substantial quantities and

there may be significant or substantial

human exposure.

Recommended testing: EPA has

determined that the results of 28-day

oral (OECD 407), acute oral (40 CFR

798.1175), Ames assay (40 CFR 798.5265),

and mouse micronucleus (40 CFR

798.5395) studies would help

characterize possible effects of the

substance. The PMN submitter has
Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 1 Rules and Regulations

agreed not to exceed the production

volume limit without performing these

tests.

CFR citation: 40 CFR 721.266.

PMN Numbers, P-89-703,. P-89-755,

and P491-756

Chemicalname: (generic) Reaction

products- of'secondary alkyl amines with

a substituted benzenesulfonic acid and

sulfuric acid.

CAS numbers: Not applicable.

Effective, date of section 5(e) consent

order: October, 12, 1989.

Basis for section 5(e) order: The Order

was issued under section 5(e)(1)(A)(il

and (ii)(II) of TSCA based on a finding

that each of. these substances is,

expected to, be produced in. substantial

quantities and there may be significant

or substantial human exposure..

Recommended testing: EPA. has

determined that the results of a 28-day

repeated dose oral study in rats (OECD

Guideline No. 407), with the following

modifications: (a) for all test doses, a

neurotoxicity functional. observationalbattery (40'CFR 798.6050), and (b) for the

highest test dose group only,

histopathologic examination extended

to include the testes/ovaries and lungs,

plus neuropathology (40 CFR 79&6400),

and a one-species oral developmental

toxicity test (40 CFR 79&4900) for each

of these three substances would help

characterize. their possible. effects. The

PMN submitter has. agreed not to exceed

the production volume. limits, without

performing these tests.

CFR citation: 40 CFR 721.295.

V. Direct Final Rule Procedure

EPA is issuing, today's SNURs as

direct final rules, as described in 40 CFR

721.160(c)(3) and 721.170(d)(4), This

approach reduces the time, relative to

notice and comment rulemaking, during

which a person may legally engage in a

significant new use before' the. SNUR

effective date and also conserves EPA

resources while providing an adequate

opportunity for public comment. For

further information on, this procedure,

refer to the. preamble to EPA's final rule

amending part 721 (54 FR 31298,, July 27,

1989).

• Direct final SNURS will go into effect

60 days after the date of publication in

the Federal. Register, unless; EPA

receives a written notice within 30 days.

after the date of publication. that

someone wishes to make adverse or

critical comments on a specific. SNUR. If

EPA receives, such a notice, EPA will

issue a. notice to withdraw the. direct

final SNUR(s) for the specific.

substance(s) to which the adverse or

critical comments apply..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. If EPA receives

such a notice, EPA will then propose. a

SNUR for the specific substance(s) with

a 30-day comment period.

VI. Test Data and Other-Information

EPA recognizes that section 5 of

TSCA does not require persons to

develop any particular test data before

submitting a SNUR notice. Persons are

only required to submit test data in their

possession or control and to describe

any other data known to or reasonably

ascertainable by them. However, EPA

suggests potential SNUR notice

submitters consider conducting tests

that would permit a reasoned evaluation

of the'potential risks posed by a

particular substance when utilized for

an intended use.

EPA has established production limits

in the, section, 5(e) consent orders for the

substances. that are, subject to this rule.

Under the consent orders, the

production limit- cannot, be exceeded

unless the PMN submitters first submit

the results. of tests that would permit a

reasoned evaluation of the potential

risks posed by these substances. Each

such order contains detailed procedures

for dealing, with situations where the

resulting data are invalid or equivocal,

or show that the substance will present

an unreasonable risk of injury under the

exposure limitations in the order.

SNURs contain' the same production.

limits as the consent orders; exceeding

these production limits is defined as a

significant new use.

Although SNURs in today's rule

contain the same production limits

established in the section 5(e): consent

orders,, the rule does, not set out

requirements for specific tests or

protocols. A listing of the tests specified

in the section 5(e) order for each,

substance subject to. today's rule is

included in Unit IV. The studies

specified in the section 5(e) order may

not be the only means of addressing the

potential risks. of the substance.

However, SNUR notices. submitted. for

significant new uses without any test

data may increase the likelihood that

EPA will take action under section 5[e),

particularly if satisfactory test results

have not been obtained from. a prior

submitter.

EPA believes it is likely that in most

cases the PMN submitter will conduct

the, tests identified in the section 5(e)

order. Accordingly, before beginning to

conduct a study, a person subject to the

SNUR should contact EPA to determine

whether the. study has already been

produced. EPA encourages persons to,

consult with EPA before selecting. a

protocol for testing, a substance. As part

of this pre-notice consultation, EPA will

discuss, the test data it believes

necessary to: evaluate. a significant new'

use of the substance. Test data should

be developed according to TSCA good

laboratory practice standards at 40 CFR

part 792.. Failure to do so may lead EPA

to find. such data- to- be insufficient to

evaluate reasonably the health or'

environmental effects of the: substance.

SNUR notice, submitters should be

aware that. EPA will be better able to

evaluate SNUR notices 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; and

(3) information on risks posed by, the

substances compared to risks. posed by

potential substitutes.

VII. Determining When a Substance or

Use Is Designated in. the. Rule

In some instances, EPA establishes a

significant new use set at production

volumes which have been: claimed as

CBI1. Other informationb, including the

specific chemical name of the substance,

may also be claimed CB. EPA has

decided it. is appropriate to keep this

information confidential to protect the

interest of the original PMN submitters

EPA will: reveal whether a specific

chemical substance is- subject to one of

these SNURs- only to a manufacturer or

importer who has shown, a' bona fide

intent to manufacture or' import the

substance. To establish a bona fide

intent, the person must submit the

information required under 40 CFR

721.11(b),. EPA will make a

determination as to whether the person

has established a bona fide intent to

manufacture. or import the substance. If

the person has. established a bona fide

intent, EPA will inform the person

whether the chemical substance is

included in the TSCA Inventory and

subject to a specific SNUR.

Each of these SNURs designates,

exceeding a specific aggregate

production volume as the significant

new use by reference to 40 CFR

721.80(q). Section 721.80(q) is used' when

the specific.volume is identified in the

section 5(e) consent order but has been

claimed as CBI. EPA promulgated a:

procedure to deal with the situation.

where a' specific significant new use. is

CBI. This procedure appears in 40 CFR

721.575(b)(1) and is similar to that in

§ 721.11 for situations where the

chemical identity of the. substance

17379v
17380 Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

subject to a SNUR is CBI. This

procedure is incorporated by reference

into each of these SNURs.

Under the procedure incorporated

from § 721.575(b)(1), a manufacturer or

importer (processors are not affected by

the production volume significant new

use unless they are also manufacturing

or importing the substance] 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. In the case of

these SNURs, the use would be the

specific aggregate manufacturing and

import volume intended by the person. 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 production

volume identified in the bona fide

submission would be a significant new

use under the rule. Since 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 § 721.575(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 manufacturer 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

are designated as significant new uses.

Under that procedure, if a person

showed a bona fide intent to

manufacture or import the substance,

under the procedure described in

§ 721.11, the person would automatically

be told any 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 § 721.575(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. In

those cases where a section 5(e) order

has been issued, the notice submitter is

prohibited by the section 5(e) order from

undertaking activities which EPA is

designating as a significant new use. If a

Notice of Commencement of

Manufacture (NOC) has not yet been

submitted to EPA for the substance and

the substance has not yet been added to

the TSCA Chemical Inventory, no other

person may commence such activities

without first submitting a PMN to EPA.

Therefore, EPA has concluded that in

cases where EPA has not received a

NOC, the uses designated in the SNUR

are not ongoing. Those who submitted

the PMNs covered by this rule have not

submitted NOCs for these substances.

However, EPA recognizes that if a

substance identified in a SNUR is added

to the Inventory prior to the effective

date of the rule, the substance 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.

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.

If the uses which had commenced

between the date of publication and the

effective date were considered ongoing,

rather than new, any person could

defeat the SNUR by initiating a

significant new use before the effective

date. This would make it difficult for

EPA to establish SNUR notice

requirements.

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 such persons to comply with this

SNUR before the effective date. If a

person were to meet the conditions of

advance compliance in 40 CFR 721.45(h),

the person will 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 substances

subject to this rule. EPA's complete

economic analysis is available in the

public record for this rule.

X. Rulemaking Record

EPA has established a record for this

rulemaking (docket control number

OPTS-50575). The record includes

information iconsidered by EPA in

developing this rule.

A public version of this record

containing nonconfidential materials is

available for reviewing and copying

from 8 a.m. to 4 p.m., Monday through

Friday, except legal holidays, in the

TSCA Public Docket Office, located at

Rm. NE-GO04, 401 M St., SW.,

Washington, DC.

Any person who submits comments

claimed as CBI must mark the comments

as "confidential," "trade secret," or

- other appropriate designation.

Comments not claimed as confidential

at the time of submission will be placed

in the public file. Any comments marked

as confidential will be treated in

accordance with the procedures in 40

CFR part 2. Any person submitting

comments claimed to be confidential

must prepare and submit a public

version of the comments that EPA can

place in the public file.

XI. Regulatory Assessment

Requirements

A. Executive Order 12291

Under Executive Order 12291, EPA

must judge whether a rule is "major"

and therefore requires a Regulatory

Impact Analysis. EPA has determined

that this rule will not be a "major" rule

because it will not have an effect on the

economy of $100 million or more, and it

will not have a significant effect on

competition, costs, or prices. While

there is no precise way to calculate the

total annual cost of compliance with this

rule, EPA estimates that the cost for

submitting a significant new use notice

would be approximately $4,500 to

$11,000, including a $2,500 user fee

payable to EPA to offset EPA costs in

processing the notice. EPA believes that,

because of the nature of the rule and the

substances involved, there will be few

SNUR notices submitted. Furthermore,

while the expense of a notice and the

uncertainty of possible EPA regulation

may discourage certain innovation, that

impact will be limited because such
Federal Register / Vol. 55. No. 79 / Tuesday, April 24, 1990 / Rules and Regulations3

factors! are unlikely to discourage: an

innovation that has high potential value.

This regulation was submitted to the

Office of Management and Budget

(OMB) for review as required by

Executive Order 12291.

A Regulatory Flexibility Act

Under the Regulatory Flexibility Act

(5 U.S.C. 605(b)), EPA has determined

that this; rule will not have a significant

impact on a substantial number of small

businesses. EPA has not determined

whether parties affected by this rule will

likely be small businesses. However,

EPA expects to receive few SNUR

notices for the substances. Therefore,

EPA believes that the number of small

businesses affected by this rule will not

be substantial, even if all of the SNUR

notice submitters were small firms.

C. Paperwork Reduction Act

The information collection

requirements contained in this rule have

been approved by OMB under the

provisions of the Paperwork Reduction

Act (44 U.S.C. 3501 et seq.), and have

been assigned OMB control number

2070-0012.

Public reporting burden for this

collection of information is estimated to

vary from 30 to 170 hours per response,

with an average of 100 hours per

response, including time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, 6nd completing and

reviewing the collection of information.

Send comments regarding the burden

estimate or any other aspect of this

collection of information, including

suggestions for reducing this burden, to

Chief, Information Policy Branch, PM223, U.S. Environmental Protection

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

20460; and to Office of Management and

Budget, Paperwork Reduction Project

(2070-0012), Washington, DC 20503.

List of Subjects in 40 CFR Part 721

Chemicals, Environmental protection,

Hazardous materials, Recordkeeping

and reporting requirements, Significant

new uses.

Dated: April 13, 1990.

Victor J. Kimm,

Acting Assistant Administrator for Pesticides

and Toxic Substances.

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 and 2607.

2. By adding new § 721.266 to subpart

E to read as follows:

§ 721.266 Adipic acid, polymerwith 1,4-

cyclohexane-dimethanol, dipropylene

glycol, alkanepolyol, substituted

alkanolamlnes, and carbomonocyclic

dicarboxylc' acid (generic! name)..

(a) Chemical'substance and

significant.new uses subject ta

reporting. (1) The chemical substance

identified- generically as adipic, acid.,

polymer with 1,4 -

cyclohexanedimethanol, dipropylene

glycol, alkanepolyol, substituted

alkanolamines, and carbomonocyclic

dicarboxylic acid (PMN P-89--653) 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. Uses as specified in

§ 721.80(q).

(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 following

recordkeeping requirements are

applicable to manufacturers, importers,

and processors of this substance:

recordkeeping requirements specified in

§ 721.125(a), (b), (c), and (i).

(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 § 721.575(b)(1) apply to

this section.

(Approved by the Office of Management and

Budget under OMB control number 2070-

0012)

3. By adding new § 721.288 to subpart

E to read as follows:

§ 721.288 Alkanepolyol phosphate ester

(generic name).

(a) Chemical substance and

significant new uses subject to

reporting. (1) The chemical substance

identified generically as alkanepolyol

phosphate ester (P-89-448) 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. Uses as specified in

§ 721.80(q).

(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 following

recordkeeping: requirements are!

applicable to manufacturers, importers,

and processors of this. substance:

Recordkeeping requirements specified in

§ 721.125(a), (b,. (c), and (i).

(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 § 721.575(b](1) apply to

this section.

(Approved by the Office of Management and

Budget under OMB control number 2070-

0012)

4. By adding new § 721.295 to subpart

E to read as follows:

§ 721.295 Reaction products of secondary

alkyl amines with a substituted

benzenesuifonic acid and sulfuric acid

(generic name).

(a) Chemical substances and

significant new uses subject to

reporting. (1) The chemical substances

identified generically as reaction

products of secondary alkyl amines with

a substituted benzenesulfonic acid and

sulfuric acid (PMNs P-89-703, P-89--755,

and P-89-756) are subject to reporting

under this section for significant new

uses described in paragraph (a)(2) of

this section.

(2) The significant new uses are:

(i) Industrial, commercial, and

consumer activities. Uses as specified in

§ 721.80(q).

(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 following

recordkeeping requirements are

applicable to manufacturers, importers,

and processors of these substances:

Recordkeeping requirements specified in

§ 721.125(a), (b), (c), and (i).

(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 § 721.575(b)(1) apply to

this section.

(Approved by the Office of Management and

Budget under OMB control number 2070-

0012)

5. By adding new § 721.1002 to subpart

E to read as follows:

§ 721.1082 Substituted ethylene diamine,

methyl sulfate quatemized (generic name).

(a) Chemical substance and

significant new uses subject to

II

17381
17382' Federal Register / Vol. 55, No. 79 / Tuesday, April 24, 1990 / Rules and Regulations

reporting. (1) The chemical substance

identified generically as ethylene

diamine, methyl sulfate quaternized (P89-650) 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. Uses as specified in

§ 721.80(q).

(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 following

recordkeeping requirements are

applicable to manufacturers, importers,

and processors of this substance:

Recordkeeping requirements specified in

§ 721.125(a), (b), (c), and (i).

(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 § 721.575(b)(1) apply to

this section.

(Approved by the Office of Management and

Budget under OMB control number 2070-

0012)

[FR Doc. 90-9466 Filed 4-23-90; 8:45 am.]

BILLING CODE 6560-50-D