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Federal Register / Vol. 49, No. 173 / Wednesday, September 5, 1984 / Rules and Regulations 3501

FOR FURTHER INFORMATION CONTACT:.

John A. Gwynn, Chief, Grants Policy

and Procedures Branch (PM-216),

Environmental Protection Agency,

Washington, D.C. 20460, (202) 382-5268.

SUPPLEMENTARY INFORMATION: EPA

implements the OMB Circulars and

Federal regulations which establish cost

principles for Federal assistance

agreements through the EPA's "General

Regulation for Assistance Programs" at

40 CFR 30.410. Section 30.410 lists the

Circulars and regulations applicable to

various types of recipient organizations.

Section 30.410(c) applies OMB Circular

A-122 to nonprofit recipient

organizations, except educational

institutions.

Section 30.410 does not list the dates

that 0MB Circulars and Federal

regulations are issued or revised. Unless

a circular or regulation indicates

otherwise, EPA applies the version of

the Circular or regulation that is m effect

on the date an assistance agreement is

awarded. The Federal Register preamble for the revised Circular A-122 issued on

April 27,1984 (49 FR 18620) specified that the revision would affect only

agreements awarded after May 29,1984,

the effective date of the revised Circular.

Accordingly, EPA will apply the revised

Circular to all assistance agreements

awarded after that date.

EPA's general regulation restricts

using assistance funds for advocacy

purposes at 40 CFR 30.601. Section

30.601 prohibits the use of assistance

funds for "lobbying or influencing

legislation before Congress" or "partisan

or political advocacy purposes." For

nonprofit recipient organizations other

than educational institutions, EPA will

implement this prohibition consistent

with § 30.410(c) and the requirements of

OMB Circular A-122 as revised.

Dated: August 22.1984.

Harvey G. Pippen, Jr.,

Director, Grants Administration Division.

JFR Doc. 84-23422 Filed 9-4-E 8:45 am]

BILUNG CODE 6560-50-M

40 CFR Part 721

[OPTS-50501A; FRL-2541-8]

Significant New Uses of Chemical

Substances;, Certain Chemicals

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is issuing a final

significant new use rule (SNUR) under

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

Control-Act (TSCA), 15 U.S.C. 2604(a)(2),

to require persons to notify EPA at least

g0 days before manufacturing,

importing, or processing potassium NNbis (hydroxyethyl) cocoamme oxide

phosphate and potassium N,N-bis

(hydroxyethyl) tallowamme oxide

phosphate for use in consumer product

formulations containing greater than

five percent by weight of these

substances. These chenucal substances

were the subject ofpremanufacture

notices (PMNs) P-82-400 and P-82-409

and a TSCA section 5(e) consent order

prohibiting use of the substances in

consumer products. Subpart A of the

rule contains general procedural

provisions applicable to all SNURs.

Subpart B contains provisions unique to

the two substances.

DATES. This rule shall be promulgated

for purposes of judicial review at 1:00

p.m. eastern time on September 19,1984.

Tis rule is effective October 19, 194.

FOR FURTHER INFORMATION CONTACT:.

Edward A. Klein, Director, TSCA

Assistance Office (TS-799), Office of

Toxic Substances, Environmental

Protection Agency, Rm. E--543, 401 M St..

SW.. Washington, D.C. 20460, Toll free:

(800-424-9065), In Washington, D.C..

(554-1404), Outside the USA: (Operator202-554-1404).

SUPPLEMENTARY INFORMATION: OMB

Control Number 2070-012.

I. Introduction

Section 5(a)(2) of TSCA 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) of TSCA. Once a use is

determined to be a significant new use,

persons must, under section 5(a)(1)(B),

submit a notice to EPA at least 90 days

before they manufacture, import, or

process the substance for that use. Such

a notice is generally subject to the same

statutory requirements and procedures

as a PMN submitted under section

5(a)(1)(A). In particular, these include

the information subission

requirements of section 5 (b) and (d)(1).

certain exemptions authorized by

section 5(h), and the regulatory

authorities of section 5 (e) and (f). If EPA

does not take regulatory action under

section 5, 6, or 7 to control activities on

which it has received a SNUR notice,

section 5(g) requires the Agency to

explain m the Federal Register its

reasons for not taking action.

Substances covered by proposed or

final SNURs are subject to the export reporting requirements of TSCA section

12(b). EPA regulations interpreting

section 12(b) requirements appear at 40

CFR Part 707 Substances covered by

final SNURs are subject to TSCA

section 13 import certification

requirements at 19 CFR 12.118 through

12.127 and 127.28 published in the

Federal Register of August 1, 1933 (48 FR

34734). The EPA policy in support of

these requirements appears at 40 CFR

Part 707 published m the Federal

Register of December 13,1983 (48 FR

55462).

IL Organization of This Rule

A. General

This rule establishes a new Part 721 in

Title 40 of the Code of Federal

Regulations (CFR) which is structured

into two major subparts. Subpart A

contains procedural provisions that

apply to this SNUR and will apply to all

SNURs. Since these provisions would

otherwise be repeated in each SNUR

applying to specific chemical

substances, the Agency decided to

promulgate Subpart A. In future SNURs

the provisions of Subpart A will apply

unless modified m the particular SNUR

at that time.

Subpart B will contain the specific

chemical substances and significant

new uses for those substances as each

SNUR is promulgated, including

modifications of the Subpart A

provisions for specific substances for

which the general provisions of Subpart

A are inappropriate. At tls time,

Subpart B consists of § 721.575 which

identifies two chemical substances and

the significant new use of those

substances discussed in Unit V of this

preamble.

The structure of Part 721 in two

subparts was originally proposed in the

Federal Register of November 26,1980

(45 FR 7970). Those sections which

appear in Subpart A of Part 721 have

been proposed either individually or

collectively and discussed in the Federal

Register as part of a number of

individual SNUR proposals. In adopting

Subpart A, EPA has considered public

comments submitted on the procedural

aspects of all SNURs proposed to date.

However, the Agency will consider any

further comments which are submitted

regarding the provisions of Subpart A.

B. Organization of Subpart A

Subpart A codifies the general

procedures for reporting on significant

new uses. The subpart contains nine

sections whlch are summarized below.

1. Section 721.1 describes the scope

and applicability of Part 721. This

section explains the interrelation of

Subparts A and B and the relationship

of Part 721 to the PMN rules m Part 720.

The section also states that. where the

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35012 Federal Register / Vol. 49, No. 173 / Wednesday, September 5, 1984 / Rules and Regulations

provisions of Parts 721 and 720 conflict,

Part 721 controls. Similarly, if Subparts

A and B conflict, Subpart B will govern. 2. Section 721.3 contains definitions

applicable to significant new use

reporting. Generally, the definitions in

section 3 of TSCA and those contained

in the PMN rules will apply to SNUR

reporting. Additional definitions have

been provided in § 721.3 where no PMN

definition exists or where the existing

PMN definitions are inappropriate for

SNUR reporting. As new definitions are considered for particular substances and

significant new uses, they will be

proposed as additions to Subpart A or B

as required.

3. Section 721.5 contains the general

scheme for determining who must report on significant new uses. EPA has chosen

the most inclusive requirements for

reporting consistent with section

5(a)(1)(B) of TSCA. There will be

occasions, such as with the rule being

codified here at § 721.575 m Subpart B,

where the Agency will not require

reporting from each of those persons

specified in § 721.5. In cases such as these, EPA will promulgate specific

language, such as is contained in

§ 721.575, to narrow the scope of the

Subpart A requirements.

Section 5(a)(1)(B) of TSCA requires

persons to submit a SNUR notice to EPA

90 days before they manufacture,

import, or process a substance for a significant new use. Therefore, the

language of § 721.5 makes clear that

manufacturers, importers, and

processors are subject to SNUR notice

requirements.

Section 721.5 is designed to cover a variety of situations. Paragraph (a)(1)

requires manufacturers, importers, and

processors who intend to engage in a designated significant new use to report.

Paragraph (a)(2) requires manufacturers,

importers, and processors who are

themselves not commencing a significant new use, but who intend to

distribute a substance subject to a SNUR in commerce, to submit a significant new use notice unless: (1)

They do not have a reasonable belief

that their customers intend to engage in

a significant new use without submitting

the required notice and (2) they can document that they have notified their

customers that the substance is subject

to a SNUR. EPA adopted this provision

because the Agency concluded that if a manufacturer, importer, or processor of a chemical substance subject to a SNUR

distributes the substance in commerce (unless the manufacturer, importer, or processor has complied with the two

provisionh specified above), that person

"intends" the significant new use to take

place, even if it does not know whether

its customers intend to engage in the

significant new use. Therefore, EPA has

provided, under § 721.5(a)(2), the means

by which persons who manufacture,

import, process, or distribute the

substance in commerce but who do not

intend to commence a significant new

use may demonstrate that they lack this

intent by compliance with the two

provisions specified above. The term "customer" is defined m § 721.3.

Section 721.5(b) provides that a

processor who engages in a significant

new use is not required to report if it can

document that it has a reasonable belief

that the substance intended to be

processed is not subject to a SNUR.

Examples of such documentation

include: (1) A letter from a supplier

assuring the purchaser that the

substance is not subject t. a SNUR, (2) a

written response from EPA to a bona

fide inquiry made under § 721.6

indicating that the substance in question

is not subject to a SNUR, and (3) written

eviaence (such as that which would be

submitted with a bona fide inquiry

under § 721.6) which demonstrates that

the chemical structure of the substance

in question would not be included in the

specific or generic chemical name

identified in Subpart B of Part 721. This

provision is consistent with paragraph (a)(2) to ensure that a significant new

use notice is submitted by a person who

actually intends to engage in a

significant new use before that use takes

place.

Section 721.5(c) provides that if a

manufacturer, importer, or processor later has a reasonable belief that a

customer is processing the substance for

a significant new use without submitting

a significant new use notice, the

manufacturer, importer, or processor

must submit a notice unless it ceases

supplying the substance to the

processor, notifies EPA enforcement

authorities, and does not resume

supplying the substance to the processor

until all required significant new use

notices have been submitted to-EPA and

the notice review periods have run

without regulatory action by EPA. This

section ensures that there will be no

intentional violations of SNURs after the

manufacture, import, or processing of a

substance identified in Subpart B of Part

721 has begun. EPA believes that this approach will

result in maximum compliance with

SNURs because it clearly sets out the

relative responsibilities of

manufacturers, importers, and

processors for reporting under section

5(a)(1)(B) of TSCA.

EPA has received comments on the

issues of who should be required to

submit a significant new use notice and

who should be liable for failure to

submit a notice. EPA believes section

5(a)(1)(B) of TSCA clearly provides that

manufacturers, importers, and

processors are liable for submission of

notices when they manufacture, import,

or process a substance for a significant

new use. Some comments stated that

manufacturers should not be held

responsible for the failure of a processor

to file a SNUR notice. Commenters also

stated that EPA could not require

manufacturers to inform their customers

that their products are subject to SNUR

reporting (or that they should be

required to so so only when the

chemical identity is confidential). Rather

than make a manufacturer, importer, or

processor liable when a customer

processes a substance for a significant

new use without submitting a significant

new use notice to EPA, EPA is

promulgating a scheme intended to

ensure good faith compliance with

SNURs by enabling those persons who

distribute a substance subject to a

SNUR in commerce (but who do not

themselves commence a significant new

use) either to submit a notice or to

inform their customers of the SNUR.

Section 721.5(d) provides that any

significant new use notice submitted by

an importer must be submitted by the

principal importer. The rationale for

doing so is the same as for the

requirement in the PMN rule, "Principal

Importer" is defined in § 721.3 and Is

very similar to the definition in the PMN

rule § 720.3(z). The definition has been

modified for this rule to apply to SNURs

rather than new chemical substances.

For a detailed explanation of the

principal importer concept and Its

application, see the preamble to the

PMN rule published in the Federal

Register of May 13, 1983 (48 FR 21726

and 21727).

4. Section 721.6 contains procedures

for determining whether a chemical

substance is subject to a SNUR when

the substance is identified by a generic

chemical name in Subpart B. This

section allows any person who intends

to manufacture, import, or process a

chenucal substance described by a

generic chemical name in Subpart B to

ask EPA whether their chemical

substance is subject to a SNUR. The

process for doing so is very similar to

the process required for manufacturers

and importers to show a bona fide intent

to manufacture or import under 40 CFR

710.7(g)(2) of the Inventory Reporting

Rules and 40 CFR 720.25(b)(2) of the

Premanufacture Notification Rules as

published in the Federal Register of May

13, 1983 (48 FR 21722). In instances such

as this SNUR, where the two chemical

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Federal Register / Vol. 49, No. 173 / Wednesday, September 5, 1984 / Rules and Regulations 35013

substances are specifically identified,

the provisions of § 721.6 will not apply.

Section 721.6 allows manufacturers,

importers, and processors to determine

whether they are subject to SNURs

while protecting confidential business

information (CBI) from unnecessary

disclosure. EPA proposed several

SNURs in winch the specific chemical

identities of the substances involved

were claimed as confidential by the

submitters of the PMNs for those

substances. In the proposals, EPA

identified the substances involved by

generic chemical names and PMN

numbers. After considering comments

on these proposals, EPA has concluded

that, in general, it will not be necessary

to reveal the specific chemical identities

of such substances during the

rulemaking or in the final rules.

However, in future SNURs, EPA will

continue to consider on a case-by-case

basis whether disclosure of specific

chemical identity is necessary.

5. Section 721.7 explains the

applicability of TSCA section 12 and

section 13 requirements for exports and

imports of substances subject to SNURs.

These requirements are summarized in

Unit I of tis preamble. 6. As discussed in previously

proposed SNURs, and as § 721.10

provides, SNUR notice submitters must

use the PMN form and follow the PMN

procedures which have been codified in

Part 720. In specific SNURs, such as this

one, EPA may modify the form

requirements to avoid collecting

information not relevant to review of the

significant new use. The Agency will

process the notice according to the

procedures in Part 720 except to the

extent these may be modified in specific

additions to Subpart B.

EPA will issue a summary of each

notice in the Federal Register under

section 5(d)(2). The review period for the

notice will run 90 days from EPA's

receipt of the notice. Under section 5(c),

this period may be extended up to an

additional 90 days for good cause. The

submitter may not manufacture, import,

or process the substance for the

significant new use until the review

period, including extensions, has

expired.

The Agency may regulate the

substance during the review period. If a

significant new use notice is submitted

for a chemical substance without

information sufficient to judge the

toxicity and exposure potential of the

substance, EPA may issue a section 5(e)

order limiting or prohibiting the use until

sufficient information is developed. In

addition, section 5ff) authorizes EPA to

prohibit a significant new use that

presents or will present an unreasonable

risk to health or the environment. EPA

may also refer information In a SNUR

notice to other EPA offices and other

Federal agencies. If EPA does not take

action under section 5, 6, or 7 to control

activities for which it has received a

significant new use notice, section 5(g)

requires the Agency to explain in the

Federal Register its reasons for not

taking action.

Section 721.10(b) allows two or more

persons who are required to submit a

notice for the same chemical substance

and significant new use to submit a joint

notice to EPA. EPA believes that in

many cases a manufacturer and a

processor may work together to develop

a significant new use and that each

would have information important to the

assessment of the use. However, EPA

does not want to receive duplicative

information and wishes to avoid the

burden on the submitters of such

duplication. Accordingly, § 721.10[b)

provides that a joint notice can be

submitted as long as it contains all

information that either person is

required to report. A joint notice may be

a single submission signed by both

parties or coordinated separate

submissions by both parties. Both

parties would remain liable individually

for failure to submit required

information in the joint notice, including

information which is known to or

reasonably ascertainable by them and

test data in their possession or controL

Section 721.10(d) makes clear that a

person submitting a significant new use

notice cannot manufacture, import, or

process the substance for the significant

new use until the notice review period,

including all extensions and

suspensions, has expired. As with

PMNs, EPA expects that significant new

use notice submitters may, on occasion.

suspend the notice review period, in

accordance with § 720.75[b) of the PMN

rule which applies to SNURs under

§ 721.10(c), to give the submitter

sufficient time to meet concerns raised

by EPA during review.

7 Section 721.13 establishes

enforcement and compliance provisions

for SNURs which have been discussed

in previous SNUR proposals.

It is unlawful for any person to fail or

refuse to comply with any provision of

section 5 of TSCA or any rule

promulgated under section 5.

Manufacture, import, or processing of a

chemical substance for a significant new

use without prior submission of a SNUR

notice is a violation of section 15 of

TSCA.

Section 15 also makes it unlawful for

any person to:

a. Use for commercial purposes a

chemical substance or mixture winch

such person knew or had reason to

know was manufactured, processed, or

distributed in commerce in violation of a

SNUR.

b. Fail or refuse to permit entry or

inspection as required by section 11 of

TSCA.

c. Fail or refuse to permit access to or

copying of records, as required by

TSCA.

Violators may be subject to vanous

penalties and to both crminal and civil

liability. Persons who submit materially

misleading or false information in

connection with the requirement of any

provision of a SNUR may be subject to

penalties calculated as if they never

filed their notices. Under the penalty

provision of section 16 of TSCA. any

person who violates sectiQn 15 could be

subject to a civil penalty of up to $25,000

for each violation. Each day of operation

in violation could constitute a separate

violation. Knowing or willful -violations

of a SNUR could lead to the unposition

of criminal penalties of up to one year of

imprisonment. Other remedies are

available to EPA under sections 7 and

17 of TSCA such as seeking an

injunction to restraniviolations of a

SNUR and the seizure of chencal

substances manufactured, imported, or

processed in violation of a SNUR.

Individuals, as well as corporations,

could be subject to enforcement actions.

Sections 15 and 16 of TSCA apply to "any person" who volates various

provisions of TSCA. EPA may, at its

'discretion, proceed against individuals

as well as companies. In particular, EPA

may proceed against individuals who

report false information or cause it to be

reported.

8. Section 721.17 establishes general

recordkeeping requirements for SNUR

notice submitters. These provisions

require the maintenance of

documentation of the information

contained m a SNUR notice for a period

of five years following the dateof the

notice submission. These provisions are

consistent with those required of PMN

submitters in § 720.78 in the P MN rule,

and the Agency believes they should

apply to SNUR notice submitters to

ensure compliance with the notice

requirements.

9. Section 721.19 establishes general

exemptions to significant new use

reporting requirements. Under this

approach, persons who manufacture,

import, or process chemical substances

identified in Subpart B will not be

subject to the reporting requirements for

significant new uses under the following

circumstances:

a. The person has applied for and has

been granted an exemption for test

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35014 Federal Register / Vol. 49, No. 173 / Wednesday, September 5, 1984 / Rules and Regulations

marketing the substance for the

significant new use in accordance with

section 5(h)(1) of the Act and § 720.38,of

the PMN rule.

b. The person manufactures, imports,

or processes the substance in small

quantities solely for research and

development in accordance with section

5(h)(3) of TSCA.

c. The person has applied for and

been granted an exemption under

section 5(h)(5) of TSCA.

d. The person manufactures, imports,

or processes the substance only-as an

impurity.

e. The person manufactures, imports,

or processes the substance only as a

byproduct which is used only by public

or private-orgamzations that: (1) Bum it

as a fuel, (2) dispose of it as a waste,

including m a landfill or for enriching soil, or (3) extract component chemical

substances from it for commercial

purposes. f. The person imports or processes the

substance as part of an article.

g. The person manufactures or

processes the substance solely for

export and, when distributed m

commerce, labels the substance in

accordance with sction 12(a)(1)(B) of

TSCA.

The first three exemptions come

directly from section 5(h) of TSCA. On

May 13, 1983, EPA issued its final

premanufacture notification rules (40 CFR Part 720), including § 720.36 which

contained detailed rules for the section

5(h)(3) exemption for chemical

substances manufactured or imported M"

small quantities solely for research and

development. In the Federal Register of

September 13, 1983 (48 FR 41132), EPA

stayed the effectiveness of § 720.36,

among other provisions of the PMN rule,

pending further rulemaking to revise the

provisions. Because § 720.36 is not m

effect,.EPA will rely on the general definition of "small quantities solely for

research and development" in

§ 720.3(cc) and section 5(h)(3) of TSCA

to determine whether a manufacturer,

importer, or processor qualifies under

this exemption. Upon promulgation of a

revised § 720.36, EPA intends to amend

§ 721.19(b) to adopt the provisions of the

revised § 720.36.

Section 721.19 also contains

exemptions from reporting when the

person manufactures, inports, or

processes the specific substances as

byproducts or impurities to conform to

similar exemptions m the PMN rule (see § 720.30 (g) and (h)(1), respectively, of

the PMN rule). Persons are also exempt

when they import or process the specific substances as part of an article because

EPA believes that people and the

environment will generally not be

exposed to substances in articles.

However, for specific significant new

uses of specific chemical substances,

EPA may decide to eliminate one or all

of these three exemptions if EPA

decides that review under a SNUR is

warranted for specific substances as

impurities or byproducts or in articles.

EPA has also exempted persons from

reporting when they manufacture or

process the specific substances solely for export from the United States. While

EPA might be concerned about worker

exposure or environmental release

during manufacture and processing of

substances solely for export, section

12(a) of TSCA exempts substances

manufactured, pro-cessed, or distributed

in commerce solely for export from

regulation under section 5(a)(2) unless

EPA finds that the activities will present

an unreasonable risk of injury to health

or the environment in the United States.

In most cases for SNURs, especially for

PMN substances which have not been

tested, EPA believes it will not have

made a "will present an unreasonable

risk" finding and, thus, could not

overcome the section 12(a) bar. In cases

where the significant new use of

concern would mvoive activities which

occur only outside the United States,

EPA would not have jurisdiction.

The PMN rule defines the term "manufacture solely for export" in

§ 720.3(s) ("manufacture" includes

import) which specifies that sucha

substance cannot be used in the United

States. Section 721.3 of this rule defines

the term "process solely for export" in a

similar fashion. Processing must be

performed at sites under the control of

the processor, distribution in commerce

is limited to purposes of export, and the

substance may not be used by the - processor other than m small quantities solely for research and development. In

addition, for both manufacture and

processing, the substance must be

labeled in accordance with section

12(a)(1)(B) of TSCA when distributed in

commerce. If a person manufactures or

processes a substance both for export and for use in the United States, such

manufacture or processing is not "solely for export" because the substance is

manufactured or processed for use in

the United States.

C. Organization of Subpart B

Subpart B of Part 721 will identify the

specific chemical substances and

significant new uses subject to

reporting. In addition, this subpart will

contain additional requirements or

modifications of Subpart A requirements and procedures necessary for specific substances. At this time, Subpart B

contains only § 721.575 which identifies

two chemical substances and significant

new uses which are the subject of this

rulemaking, as well as provisions

specifically applicable to the two

substances.

The Agency believes that there may

be circuitstances that will lead to the

modification of the significant new use

descriptions contained in Subpart B.

When a significant new use notice Is

submitted, EPA will review the use to

determine whether any regulatory action

is necessary. If following its review,

EPA allows the use to occur, the Agency

will consider amending the SNUR to

modify or eliminate the significant new

use description if it finds that a change

is warranted or that further notice of

that use under a SNUR is not warranted.

EPA may also amend Subpart B to

eliminate or modify other use

descriptions if it determines, based on

data available to EPA, that a substance

no longer presents health or

environmental concerns for those uses.

I. Background of Substances Subject to

Specific SNUR

The two chemical substances covered

by § 721.575 were the subject of PMNs,

They are potassium N,N-bis - (hydroxyethyl) cocamine oxide

phosphate, which was the subject of P82-400 and potassium N,N-bis

(hydroxyethyl) tallowamine oxide

phosphate, which was the subject of P82-409. For convenience, the chemical

substances will be referred to by their

PMN numbers in this preamble.

On June 1 and 2,1982, EPA received

two PMNs which the Agency designated

as P-82-400 and P-82-409. EPA

announced receipt of the two PMNs in

the Federal Register of June 11, 1982 (47

FR 25401). The notice submitter stated In

the PMNs that the substances, which are

amphoteric surfactants, will be used

primarily in industrial cleaning products

and could be used in general purpose

cleaners and in personal care products.

The PMN submissions included test data

for acute oral toxicity and eye and skin

irritation. The two substances were

tested for skin and eye irritation

potential at concentrations of 45 to 50

percent using rabbits. The reported

primary skin irritation scores were 6.05

for P-82-400 and 6.12 for P-82-409 (with

8 the maximum possible score). The

reported ocular irritation scores for the

substances ranged from 5.8 to 42.2 for P82-400 and 37.0 to 103.3 for P-82-409

(with 110 the maximum score). Based on

these results, EPA concluded that both

substances are severe primary skin and

eye irritants at concentrations of 45 to 50

percent. In addition, the substances may

be severe primary skin and eye irritants

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at lower concentrations. A more detailed analysis of the possible health

hazard posedby the substances appears

in the section 5(e) consent order for

these substances wich is included in

the record for this rulemaking.

The PMNs contained no data for eye and skin irritation at lower

concentrations that are likely to be

found in consumer products. Since

irritation effects of relatively low

concentrations were not known and

could not be reliably estimated from the

available data, EPA concluded that

information available to the Agency was

insufficient to permit a fully reasoned

evaluation of potential health effects of

the two substances at the lower

concentrations. EPA further determined

that, in the absence of sufficient

information to make such an evaluation,

the two substances may present an

unreasonable risk of injury to human

health.

Based on these findings, EPA

negotiated a section 5(e) consent order

with the notice submitter. The order

became effective on September 14,1982,

and prohibited the notice submitter from

manufacturing, processing, or

distributing either P-82-400 or P-82-409

for use as a "consumer chemical." The

order defined "consumer chemical" as "any chemical which is (1) sold or made

available directly to consumers for their

,use; or (2) present in a solution, mixture,

suspension, or gelatin which is sold or

made available to consumers for their

use." In addition, the order prohibited the notice submitter from manufacturing, processing, or distributing either P-82-

400 or P-82-409 unless a material safety

data sheet (MSDS) was distributed to

each vendee or other recipient of the

substances. The order required that the

MSDS state that the substances were

not to be manufactured, processed, or

distributed for use as consumer

chemicals. In addition, the notice

submitter stated that the MSDS would:

(1) Warn that preliminary screening

suggested that the substances may

cause severe skin and eye irritation and

(2) recommend the use of protective

gloves and eye protection by workers

who may be exposed to the substances.

IV. Reasons for Issuing Tis SNUR

As stated above, EPA issued a section

5(e) consent order to prohibit manufacture of the two substances for

use as consumer chemicals pending development of further information on

the substances' potential health effects;

however, the terms of the order apply

only to the notice submitter. Since the

notice submitter commenced

commercial manufacture of the

substances for industrial use and

submitted a notice of commencement of

manufacture to EPA, the Agency added

the substances to the TSCA Cheucal

Substance Inventory. Once a substance

has been added to the Inventory, any

person may manufacture, import, or

process the substance for any use. For

tlus reason, in the Federal Registcr of

February 17,1983 (48 FR 7142), EPA

proposed designating use of the

substances as consumer chemicals a

significant new use so that the Agency

could review such use before it occurs.

Since proposal of this SNUR, EPA

received a second set of data from tests

performed by the notice submitter on

these substances. These data indicate

that, when tested at concentrations of

five percent by weight, the substances

are minor eye irritants and not irritating

to the skin of rabbits. The results of

these studies have mitigated EPAs

concerns for use of these substances in

consumer products at concentrations

less than or equal to five percent by

weight. Accordingly, EPA is now

adjusting the definition of significant

new use to require reporting by

processors only when these substances

will be used in consumer products at

concentrations greater than five percent

by weight. These data submissions have

been added to the record of this

rilemaking.

EPA considered other possible approaches. One alternative approach

was not to place the substances on the

Inventory while the section 5(e) order

was in effect. One commenter disagreed

with this option. Under this approach,

because the substances would not be on

the Inventory, another person would

have to submit a PMN if that person

intended to manufacture the substances

for any use, even an industrial use about

which EPA has little concern. EPA

rejected this alternative as being overly

broad and inconsistent with its

Inventory policies.

Another alternative was to

promulgate a section 8(a) reporting rule

for the substances. Under such a rule,

EPA could have required any person to

report to EPA before manufacturing,

importing, or processing the substances

for use as a consumer chermcal. Because

the substances were subject to a section

5(e) order, the small business exemption of section 8(a) would not have applied.

However, if EPA received a report under

section 8(a) indicating that a person intended to manufacture, import, or

process the substances for use as a

consumer chemical, the Agency could

not take immediate action under section

5(e) as it can under a SNUR and thus

would not be able to regulate the

substances pending development of

information of effects of the substances

at concentrations being formulated. Tins

approach would have allowed

unnecessary risks to human health

during the time needed for data

development.

The Agency also considered

withdrawing the proposed rule after

receiving the data which indicated that

these substances would present little or

no risks to human health at

concentrations of five percent or less.

The Agency considered tus alternative

because the PMN submitter had

indicated that it had no forseeable plans

for use of these substances in consumer

products at concentrations greater than

five percent by weight. However, the

Agency cannot be confident that other

manufacturers or processors vll not

recommend the use of these substances

in consumer products at higher

concentrations. Therefore, the Agency

believes the approach it has selected is

more appropriate.

In response to the proposed SNUR,

some commenters stated that other

Federal agencies, namely the Food and

Drug Administration and the Consumer

Product Safety Commission. already

effectively control the risks of concern

in this instance. One commenter

suggested that section 9 of TSCA

needed to be invoked affirmatively to

retain EPA's jurisdiction of cases such

as these where a number of Federal

agencies may share jurisdiction. The

Agency disagrees with both of these

comments. EPA believes that Congress

intended TSCA to provide the Agency

with the necessary authority to prevent

or control risks posed by new chemical

substances which have many useful

applications not specifically excluded

from TSCA jurisdiction by Congress,

Including uses in consumer products. In

instances such as these, several Federal

agencies may have complementary, not

exclusive, roles. EPA believes this is

consistent with Congress' intent and will

continue to review new substances

wich may present unreasonable risks

and act to control those risks when

appropriate. In instances where EPA

believes another agency is more

properly suited to evaluate and control a

specific risk. it may then refer that case

to that Agency. Generally, section 9 of

TSCA does not apply to SNURs. A

referral under section 9 occurs only

when the Agency makes a finding that

an activity "presents or will present an

unreasonable risk." The Agency does

not make such a finding in a SNUR

rulemaking.

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V Significant New Uses Subject to

Reporting

To determine what would constitute a

significant new use of these chemical

substances, EPA considered relevant

information about the toxicity of the

substances and likely exposures

associated with possible uses as well as

the four factors listed m section 5(a)(2)

of TSCA. In particular, EPA considered

the extent to which potential uses may

affect human exposure. Based on these

considerations, EPA has decided to

define "use m a consumer product m

formulations contaimng greater than

five percent by weight" as a significant

new use of P-82-400 and P-82-409.

The Agency has defined "consumer

product" as "any chemical substance

wluch is directly, or as part of a mixture,

sold or made available to consumers for

their use in or around a permanent or

temporary household or residence, m or

around a school, or m recreation." This

definition of "consumer product" is

consistent with the definition of "consumer product" in the Consumer

Product Safety Act, 15 U.S.C. 2051.

Because this definition is unique to the

circumstances of these two substances,

the Agency has included it in § 721.575

as a supplement to the definitions in

§ 721.3 of Subpart A. Examples of

chemical substances present in a

mixture which is sold or made available

to consumers for their use include

substances used as surfactants in

household all-purpose cleaners, rug

shampoos, or laundry detergents which

are sold or made available to

consumers. In this rule EPA defines "6consumer" as a natural person who

uses products for personal rather than

business purposes.

In response to comments, the Agency

has made slight changes m the

significant new use description from the

proposed language. These changes are

not intended to alter the meaning or

spirit of the proposed language, only to

simplify the description. EPA's basis for

this significant new use determination is

explained below.

EPA believes that the use of P-82-400 or P-82-409 in a consumer product in

concentrations greater than five percent

by weight may change the duration and

type of exposure relative to the likely

exposures associated with the nonconsumer uses allowed under the

section 5(e) consent order. The largest

identified market for the substances for

which manufacture has been permitted

under the section 5(e) order is use in

industrial cleaners containing alkaline

materials such as caustic (sodium

hydroxide), ammonia, or metasilicates.

Industrial workers are believed to have

experience m the safe handling of

substances of this nature. Because of the

presence of alkaline material, these

products will generally carry labeling

which warns of potential skin and eye

irritation. This labeling will further

encourage the use of protective

equipment to limit potential exposure to

the substances during industrial use.

The PMN submitter indicated that P82-400 and P-82-409 could be used in

consumer products such as liquid soaps,

household all-purpose cleaners, rug

shampoos, scouring pads, oven and pot

and pan cleaners, and laundry

detergents. Use of may of these products

would involve direct contact with the

skin. Users of consumer products are not

likely to expect products such as liquid

soaps, household all-purpose cleaners,

rug shampoos, and laundry detergents to

cause severe eye or skin irritation. Thus,

the likelihood of eye and skin exposures

is greater since users of household

products are unlikely to take the same

precautions as do workers using

industrial cleaners. In addition, any use

of these substances in consumer

products could expose far more people

to the substances. Users of these

consumer products would constitute a

different, much larger segment of the

general population than the workers

potentially exposed to industrial

cleaners. Therefore, EPA believes that

use of the substances in a consumer

product at concentrations greater than

five percent by weight would increase

potential human exposure. Finally, EPA has already determined

in the section 5(e) consent order that use

of the substances as a consumer

chemical may present an unreasonable

risk. While such a finding is not

necessary to promulgate a SNUR, it

strongly supports the determination that

this use of the substances would be

significant.

VI. Persons Subject to SNUR Notice

Requirements Under § 721.575

Section 5(a)(1)(B) of TSCA requires

persons to submit a notice to EPA before

they manufacture or process a

substance subject to a SNUR for a

significant new use. As previously

explained, the language of TSCA and

§ 721.5 makes clear that manufacturers

(including importers) and processors are

subject to SNUR notice requirements.

Under § 721.5(a)(2) a manufacturer,

importer, or processornf a substance

subject to a SNUR who does not intend

to commence a significant new use but

who intends to distribute the substance

in commerce must submit a significant

new use notice unless the person: (1)

Has a reasonable belief at the time of

distribution that its customers do not

intend to engage in a significant new use

without first submitting a significant

new use notice and (2) can document

that the person has notified its

customers of the SNUR. As explained in

Unit II.B.3 of this preamble, this ensures

that EPAjwill receive a significant now

use notice from that distributor who

knows or has a reasonable belief that a

customer intends to engage in the

significant new use without submitting

the required notice or does not notify its

customers of the SNUR. For these

substances and this significant new use,

EPA believes that it will probably be

processors who actually formulate

consumer products containing either of

the two substances at greater than five

percent by weight and who most likely

will trigger the reporting requirements of

§ 721.5.

EPA considered allowing

manufacturers and processors to decide

which party should submit what

information to EPA so long as all

appropriate information was submitted.

Some commenters preferred this

alternative. However, EPA believes that,

in this case, the reporting scheme

contained in § 721.5 is more likely to

result in EPA receiving the most

complete and accurate information on

the particular substances and significant

new use.

EPA has also concluded that if these

two substances are distributed in

commerce as part of a mixture in Which

they occur at concentrations of five

percent or less by weight of the mixture,

no customer is likely to reformulate the

mixture in such a way that either P-82-

400 and P-82-409 could occur in a

comsumer product at greater than five

percent. Accordingly, § 721.575(b)(2)

provides that, in this instance,

§ 721.5(a)(2) does not apply and such a

distributor would not be required to

submit a significant new use notice or

notify customers of the SNUR,

VII. Uses Subject to SNUR Notice

Requirements

EPA recognizes that when chemical

substances identified in a proposed

SNUR are listed on the Inventory, they

may be manufactured, imported, or

processed for "significant new uses" as

defined in the proposal before

promulgation of the final rule. The

statute and its legislative history do not

make clear whether uses commenced

after proposal but before promulgation

may be considered significant new uses

subject to SNUR notification. However,

EPA believes that the intent of section

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

whether a use is a significant new use as

of the SNUR proposal date. If uses

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commenced during the proposal period

were not considered significant new

uses it would be almost impossible for

the Agency to establish SNUR notice

requirements since any person could

defeat the SNUR by mitiating the

proposed significant new use before the

rule becomes final. This is contrary to

the general intent of section 5(a)(1)(B).

One commenter supported EPA's

interpretation on this issue; another

disagreed. However, none of the

commenters indicated that the

significant new use established in ths

rule has occurred.

For the purposes of tlus rule, even if

these substances were manufactured,

imported, or processed between

proposal and promulgation for the

significant new use, such activities may

not continue after the effective date of

this rule. Any such person must cease

such activity'until the person has

complied with all SNUR notice

requirements. EPA recogmzes that this

interpretation could disrupt commercial

activities of persons who commenced

manufacture or processing for the

significant new use during the proposal

period; however, the Agency believes

that these persons were given adequate

notice of tis interpretation by the terms

of the proposal.

VIIL Procedures for Informing Persons

of the Existence of This Significant New

Use Rule

The rule will be codified in the CFR.

While tis Federal Register notice

provides legal notice of the nile, EPA

explored additional ways to inform

potential SNUR notice submitters of the

existence of the rule.

EPA will publish information

conceriung this and other final SNURs

in the TSCA Chemicals-m-Progress

Bulletin, published by the TSCA

Assistance Office of EPA's Office of

Toxic Substances. EPA will also use the

TSCA Chemical Substance Inventory to

inform persons of the existence of tis

and other final SNURs through footnotes

referring to the chencal identities of the

substances subject to SNURs. The

footnotes will refer to an Inventory

Appendix which will give a Federal

Register and CFR citation for the SNUR.

Commenters supported the use of all

available means of informing persons of

the existence of SNURs.

IX. Required Information

As discussed in the proposal, and

consistent with other proposed SNURs,

under § 721.10 the Agency will require

SNUR notice submifters to use the PMIN

form published in the Federal Register of

-May 13, 1983 (48 FR 21722). However, for

thepurposes of reviewing these two

substances, EPA is Interested only in

information concerning the formulation

and use of the substances in consumer

products. Because EPA does not wish to

collect information about worker

exposure during manufacture and

processing, § .721.575(b)(3) specifies that

submitters must complete only those

sections of the form dealing with the

chemcal identity, the submitter, and the

specific use. In addition, any health and

safety data relating to these substances

must be attached. Therefore, submitters

must complete only Parts I and M of the

form as it appears in Appendix A to 40

CFR Part 720.

X. Test Data

EPA recogmzes that under TSCA

section 5, a person is not required to

develop any particular test data before

submitting a significant new use notice.

Rather, a person is required only to

submit test data in his possession or

control and to describe any other data

known to or reasonable ascertainable

by that person. However, in view of the

potential health risk that may be posed

by the significant new use of P-82-400

and P-82-409, EPA encourages possible

SNUR notice submitters to test the

substances to evaluate the potential for

skin and eye irritation at the

concentrations the submitters propose to

use in consumer products. If a SNUR

notice is submitted for a significant new

use involving consumer exposure

without such test data. EPA would very

likely take action under section 5[e).

As part of an optional prenotice

consultation, EPA will discuss the test

data it believes necessary to evaluate a

significant new use of the substances.

Data should be developed and

submitted in accordance with the TSCA

good laboratory practices regulations

under 40 CFR Part 792 published in the

Federal Register of November 29,1983

(48 FR 53922). EPA encourages persons

to consult with the agency before

selecting a protocol for testing the

substances.

XI. Exemptions

Section 721.19 contains an exemption.

not in the proposal, for substances

manufactured, imported, or processed

only as an impurity or as a byproduct

for certain purposes. EPA has decided

not to modify tis general provision for

these particular substances. Therefore, if

the substances appear in a consumer

product only as an impurity, or are

produced as a byproduct, and meet the

requirements of § 721.19. they are not

subject to SNUR notice requirements.

The Agency is adopting tis policy

because identification of the presence of

the substances when used as an

impurity can be very difficult and

because the agency does not believe

that these substances would give rise to

significant exposures if they appear as

an impurity. The limited byproduct

exemption would not give rise to

consumer exposure. The Agency has

also decided to exempt these substances

from significant new use reporting if

they are imported or processed as part

of an article. This decision was made in

response to a comment received on this

Issue and because the identified risks

from uses of these substances in articles

are not likely to occur.

XUI Relationship of Section 5(e) Order

and SNUR

The original PMN submitter for P-82-

400 and P-82-409 is subject to a TSCA

section 5(e) consent order wich

prohibits it from manufacturing,

processing, or distributing these

substances in commerce for use as a

consumer chemical. Once this SNUR

goes into effect, the submitter will also

be subject to the SNUR. Since the SNUR

prevents any manufacturer, importer, or

processor from engaging in the

significant new use without notice to

EPA, EPA has determined that it is no

longer necessary to continue the section

5(e) consent order. Accordingly, once

the SNUR goes into effect. EPA will

revoke the section 5(e) consent order

thereby leaving the original submitter

subject to the same requirements as

other persons.

MII. Econonc Analysis

The Agency has evaluated the

potential costs of establishing

significant new use reporting

requirements for P-82-400 and P-82-409.

This evaluation is summarized below.

Persons who intend to manufacture,

import, or process the substances for the

significant new use, as defined in this

rule, would be required to submit a

SNTUR notice with the information

required by statute and this rule. The

cost of submitting a SNUR notice can be

estimated from the cost of submitting a

PMN, wich has been estimated to

range between $1.300 and $7,500 per

substance. However, because this rule

requires that only a portion of the PMN

form be completed. costs may actually

be lower.

Although the SNUR does not require

that persons submitting notices perform

additional testing. EPA expects that

some additional test data will be

developed. EPA recommends that the

substances be tested to evaluate the

potential for skin and eye irritation at

the concentrations at which they will be

found in consumer products. The direct

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costs of such tests would be about

$1,600 per substance. The dermal

irritation test would cost from $300 to

$1,000, with a most likely cost of $700.

The eye irritation test would cost from

$450 to $1,350, with a most likely cost of

$900.

The SNUR may also result m delay

costs. The delay caused by the

preparation of a SNUR notice and the

statutory notice review period could

reduce future profits. EPA estimates that

these delay costs could range from zero

to $6,128.

Total direct costs, including

notification, testing, and delay, would

range from $2,100 to $16,078 per

substance. It the original PMN submitter

also intends to undertake the significant new use, the direct costs could add from

less than 0.1 percent to 3.5 percent to the

estimated price of the substances.

EPA has not estimated any indirect

costs that may result from this SNUR.

Indirect costs may result from decisions

not to manufacture or process these

substances because of uncertainty about

possible Agency regulatory action or due to the magnitude of the direct costs.

The cost of this impact would be

whatever profits or benefits to consumers that use of the substances

would have generated. In addition, EPA

has not estimated the potential public

benefits gained through the avoidance of

potential health and environmental

problems. While the Agency

acknowledges that indirect costs and

benefits exist, it is impossible at this

time to precisely estimate their extent

A more complete economic analysis

of this SNUR and other regulatory

options is included in the rulemaking

record and is available for public

review.

XIV Judicial Reviewjudicial review of this final rule may

be available under section 19 of TSCA

in the United States Courts of Appeals

for the District of Columbia Circuit or

for the circuit m which the person

seeking review resides or has his/her

principal place of business. To provide

all'interested persons an equal

opportunity to file a thnely.petition for

judical review and to avoid so called "races to the courthouse," EPA has

decided to promulgate this rule for

purposes of judicial review two weeks

after publication in the Federal Register, as reflected in "DATES" in this

document. The effective date has, m turn, been calculated from the

promulgation date.

XV Rulemakmg Record

EPA has established a record for this

rulemaking (docket control number

OPTS-50501A). The complete record is

available to the public from 8:00 a.m. to

4:00 p.m., Monday through Friday,

except legal holidays in the OPTS

Reading Room, Rm..E-107, 401 M St.,

SW,, Washington, D.C.

The record includes basic information

considered by the Agency in developing

this rule. The record includes the

following:

1. The PMNs for these substances.

2. The Federal Register notice of

receipt of the PMNs.

3. A copy of the section 5(e) consent

order.

4. The economic analysis of the

proposed rule.

5. Test data received from the PMN

submitter.

6. Public comments.

7 OMB comments.

XV1. Regulatory Assessment

Requirements

A. Executive Order 12291

Under Executive Order 12291, EPA

must judge whether a regulation is

"Major" and therefore requires a Regulatory Impact Analysis. EPA has

determined that this rule is not a "Major

Rule" because it does 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

annual cost of this rule, EPA believes

the rest will be low. Even if EPA

receives 50 SNUR'notices, the direct

cost of the rule will be under $1 million.

In addition, because of the nature of the

rule and the substances subject to it,

EPA believes that there will be few

significant new use notices submitted.

Further, while the expense of a notice

and the uncertainty of possible EPA

regulation may discourage certain

innovation, that impact will be limited

because such factors are unlikely to

discourage an innovation which has

lhgh potential value. Finally, this SNUR

may encourage innovation in safe

chemical substances or highly beneficial uses.

This regulation was submitted to the

Office of Management and Budget

(OMB) for review as required by

Executive Order 12291.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act, 5

U.S.C. 605(b), EPA certifies that this rule

will not have a significant economic

impact on a substantial number of small

businesses. EPA recognizes that the

submitter of PMNs P-82-400 and P-82z409, who is also a possible submitter of a SNUR notice, is a small business. The

Agency cannot determine whether other

parties affected by this rule are likely to

be small businesses. However, EPA

believes that the number of small

businesses affected by this rule would

not be substantial, even if all the

potential significant new uses were

developed by small companies. EPA

expects to receive few SNUR notices for

the substances. The Agency hopes that

one of the first notice submitters will

test the substances to determine their

potential for skin and eye irritation at

concentrations greater than five percent

for which SNUR reporting is required.

With these data, EPA would be able to

evaluate the risks posed by the

substances used in consumer products

and, if necessary, take action to control

those risks. If test results indicate that

there are no risks at a certain

concentration, EPA will likely alter the

reporting triggers to reflect those results.

As more test data become available,

reporting triggers will continue to be

refined to identify those levels at which

acute effects are negligible. Because

uses m consumer products above levels

at which consumers wotld suffer effects

will be discouraged by responsible

manufacturers, fewer businesses will be

directly affected by this rule. In

addition, the cost of the testing that may

be encouraged by this rule should not

have a major impact on a small business

that may want to use these substances

as in consumer products.

C. Paperwork Reduction Act

The information reporting

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.

List of Subjects in 40 CFR Part 721

Intergovernmental relations,

Chemicals, Hazardous materials,

Recordkeeping and reporting

requirements, Significant new uses.

Dated: August 27,1984.

William D. Ruckolshaus,

Adminstrator.

Therefore, a new Part 721 is added to

40 CFR Chapter I, to read as follows:

PART 721-SIGNIFICANT NEW USES

OF CHEMICAL SUBSTANCES

Subpart A-General Provislons

Sec.

721.1 Scope and applicability.

721.3 Definitions.

721.5 Persons who must report.

721.6 Applicability determination when the

specific chemical identity is confidential.

721.7 Exports and imports.

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721.10 Notice requirements and procedures.

721.13 Compliance and enforcement.

721.17 Recordkeepmg.

721.19 Exemptions.

Subpart B-Significant New Uses of

Specific Chemical Substances

721.575 Potassium N,N-bis (hydroxyethyl)

cocoamme oxide phosphate and

potassium N,N-bis (hydroxyethyl)

tallowamne oxide phosphate.

Authority:. Sacs. 5. 8; Pub. L 94-469; 90 Stat.

2003. 2027 (15 U.S.C. 2601 -etseq.).

Subpart A-General Provisions

§ 721.1 Scope and applicability.

(a) This part identifies -uses of

chemical substances which EPA has

deternined are significant new uses

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

the Toxic Substances Control Act. In

addition, it specifies procedures for

manufacturers, importers, and

processors to report on those significant

new uses. This Subpart A contains

general provisions applicable to this

Part. The chemical substances and

significant new uses subject to this Part

are ideihtified in Subpart B.

(Ib) This Subpart A contains

provisions governing submission and

review of notices for the chemical

substances and significant new uses

identified in Subpart B of this Part. The

provisions of tiis Subpart A apply to the

chemical substances and significant

new uses identified in Subpart B of this

Part except to the extent they are

specifically modified or supplanted by

specific requirements in Subpart B. In

the event of a conflict between the

provisions of this Subpart A and the

provisions of Subpart B of this Part, the

provisions of SubpartB shall govern.

(c) The provisions of Part-720 of this

chapter apply to this Part 721. For

purposes of this Part 721, wherever the

phrase "new chemical substance"

appears in Part 720 of this Chapter, it

shall mean the chemical substance

subject to this Part 721. In the event of a

conflict between the provisions of Part

720 of this chapter and the provisions of

this Part 721, the provisions of this Part

721 shall govern.

§ 721.3 Definitions.

The definitions in section 3 of the Act,

15 U.S.C. 2602, and § 720.3 of this

chapter apply to this part. In addition,

the following definitions apply to this

Part-

"CAS Number" means Chemical

Abstracts Service Registry Number

assigned to a chemical substance on the

Inventory.

"Customer" means any person to

whom a manufacturer, importer, or

processor distributes any quantity of a

chemical substance, or of a mixture

containing the chemical substance,

whether or not a sale is involved.

"Principal importer" means the first

importer who, knowing that a chemical

substance will be imported for a

significant new use rather than

manufactured domestically, specifies

the chemical substance and the amount

to be imported. Only persons who are

incorporated, licensed, or doing

business in the United States may be

principal importers.

"Process for commercial purposes"

means the preparation of a chemical

substance or mixture containing the

chemical substance, after manufacture

of the substance, for distribution in

commerce with the purpose of obtaining

an immediate or eventual commercial

advantage for the processor. Processing

of any amount of a chemical substance

or mixture containing the chemical

substance is included in flus definition.

If a chemical substance or muxture

containing impurities is processed for

commercial purposes, then the

impurities also are processred for

commercial purposes.

"Process solely for export" means to

process for commercial purposes solely

for export from the United States under

the following restriction on domestic

activity:. Processing must be performed

at sites under the control of the

processor distribution in commerce is

limited to purposes of export; and the

processor may not use the chemical

substance except in small quantities

solely for research and development.

§ 721.5 Persons who must report

(a) The following persons must submit

a significant new use notice as specified

under the provisions of section 5(a)(1)(B]

of the Act, Part 720 of this chapter, and

§ 721.10.

(1) A person who intends to

manufacture, import, or process for

commercial purposes a chemical

substance identified in Subpart B of this

Part, and intends to engage in a

significant new use of the substance

identified in Subpart B.

(2) A person who intends to

manufacture, import. or process for

commercial purposes a chemical

substance identified in Subpart B of this

Part, and intends to distribute the

substance in commerce. A person

described in this paragraph is not

required to submit a significant new use

notice if that person (i) does not have a

reasonable belief, at the time of

commercial distribution of the chemical

substance, that hs/her customers intend

to engage in a significant new use of

that substance without submitting a

notice under tis Part, and (i} can

document that the person has notified

all customers, in writing, of the specific

section in Subpart B of this Part which

identifies the substance and the

significant new uses subject to this Part.

(b) A person who processes a

chemical substance identified in Subpart

B of this part for a significant new use of

that substance is not required to submit

a significant new use notice if that

person can document that it has

processed the chemical substance with

a reasonable belief that the substance is

not identified in Subpart B of this Part.

(c) If at any time after commencing

distribution in commerce of a chemical

substance identified in Subpart B of this

part a person described in paragraph

(a)(2) of this section has a reasonable

belief that a customer is engaging in a

significant new use of that substance

identified in Subpart B without

submitting a notice under this Part the

person is required to submit a

significant new use notice for that

chemical substance and significant new

use, unless the person is able to

document that it has done the following:

(1) Ceased supplying the chemical

substance to the customer when the

person has a reasonable belief that the

customer is processing the substance for

a significant new use without submitting

a notice under this Part,

(2] Notified EPA enforcement

authorities of the person's reasonable

belief that the customer is processing

the chemical substance for a significant

new use without submitting a notice

under this Part. promptly upon reaching

that belief, and

(3) Not resumed supplying the

chemical substance to the customer until

all notices required under this Part have

been submitted to EPA and the notice

review periods have ended without

regulatory action by EPA.

(d) Any notice of import must be

submitted by the principal importer.

§ 721.6 Applicability determination when

the specific chemical Identity Is

confidential.

(a) A person who intends to

manufacture, import, or process a

chemical substance which is described

by a generic chemical name in Subpart B

of this Part may ask EPA whether the

substance is subject to the requirements

of this Part. EPA will answer such an

inquiry only if EPA determines that the

person has a bonafide intent to

manufacture, import, or process the

chemical substance for commercial

purposes.

(b) To establish a bona fide intent to

manufacture, import, of process a

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chemical substance, the person who - intends to manufacture, import, or

process the chemical substance must

submit the following in writing to the

Office of Toxic Substances, TS-799, 401

M St. SW., Washington, D.C. 20460:

(1) The specific chemical identity of

the chemical substance that the person intends to manufacture, import, or

process.

(2) A signed statement that the person intends to manufacture, import, or

process the chemical substance for

commercial purposes.

(3) A description of the research and

development activities conducted to

date, and the purpose for which the

person will manufacture, import, or

process the chemical substance.

(4) An elemental analysis. (5) Either an X-ray diffraction pattern (for inorganic substances), a mass

spectrum (for most other substances), or

an infrared spectrum of the particular

chemical substance, or, if such data do

not resolve uncertainties with respect to

the identity of the chemical substance,

additional or alternative spectra or other

data to identify the substance.

(c) If an importer or processor cannot

provide all the information required in

paragraph (b) of this section because it

is claimed as confidential business

information by the importer's or

processor's manufacturer or supplier, the manufacturer or supplier may supply

the information directly to EPA.

(d) EPA will review the information

submitted by the manufacturer,

importer, or processor under paragraph (b) of this section to determine whether

that person has shown a bonafide intent to manufacture, import, or process the chemical substance. If necessary, EPA will compare this information

either to the information requested for

the confidential chemical substance

under § 710.7(e)(2)(v) of this chapter or

the information requested under

§ 720.85(b)(3)(iii] of this chapter.

(e) If the manufacturer, importer, or

processor has shown a bonafide intent

to manufacture, import, or process the

substance and has provided sufficient

unambiguous chemical identity information to enable EPA to make a

conclusive determination as to'the

identity of the substance, EPA will

inform the manufacturer, importer, or

processor whether the chemical

substance is subject to this Part and, if

so, which section in Subpart B of this

part applies.

(f) A disclosure to a person with a

bona fide intent to manufacture, import,

or process a particular chemical

substance that the substance is subject

to this Part will not be considered public

disclosure of confidential business

information under section 14 of the Act.

(g) EPA will answer an inquiry on

whether a particular chemical substance

is subject to this part within 30 days after receipt of a complete submission

under paragraph (b) of this section.

§ 721.7 Exports and imports.

The chemical substances identified in

Subpart B of this Part are subject to the

export notification requirements of

section 12(b) of the Act and Part 707 of

this chapter. The substances also are

subject to import certification

requirements in 19 CFR 12.118 through

12.127 and 127.28 under the authority of

section 13 of the Act. The EPA policy in

support of the import certification

requirements is set forth in Part 707 of

this chapter.

§ 721.10 Notice requirementi; and

procedures.

(a) Each person who is required to

submit a significant new use notice

under this part must submit the notice at

least 90 calendar days before

commencing manufacture, import, or

processing of a chemical substance

identified n Subpart B of this Part for a significant new use. The submitter must

comply with any applicable requirement

of section 5(b) of the Act, and the notice

must include the information and test

data specified in section 5(d)(1) of the

Act. The notice must be submitted on

the notice form m Appendix A to Part

720 of this chapter and must comply

with the requirements of Part 720,.

except to the extent that they are

inconsistent with this Part 721.

(b) If two or more persons are

required to submit a significant new use

notice for the same chemical substance

and significant new use identified in

Subpart B of this part, they may submit

a joint notice to EPA. Persons submitting

a joint notice must individually complete the certification section of Part I of the

required notification form. Persons who

are required to submit individually, but

elect to submit jointly, remain

individually liable for the failure to

submit required information which is

known to or reasonably ascertainable

by them and test data in their

possession or control.

(c) EPA will process the notice in

accordance with the procedures of Part

720- of this chapter, except to the extent

they are inconsistent with this Part 721.

(d) Any person submitting a

significant new use notice in response to

the requirements of this Part 721 shall

not commence manufacture, import, or

processing of a chemical substance

identified in Subpart B of this Part for a

significant new use until the notice

review period, including all'extensions

and suspensions, has expired.

§ 721.13 Compliance and enforcement.

(a) Failure to comply with any

provision of this Part is a violation of

section-15(1) of the Act (15 U.S.C. 2614),

(b) Using for commercial purposes a

chemical substance which a person

knew or had reason to know was

manufactured, imported, or processed In

violation of this part is a violation of

section 15(2) of the Act (15 U.S.C. 2014),

(c) Failure or refusal to permit access

to or copying of records, as required by

section -1 of the Act, Is a violation of

section 15(3) of the Act (15 U.S.C. 2614),

(d) Failure or refusal to.permit entry

or inspection, as required by section 11

of the Act, Is a violation of section 15(4)

of the Act (15 U.S.C. 2614).

(e) Violators of the Act or of this Part

may be subject to the civil and criminal

penalties in section 16 of the Act (15

U.S.C. 2615) for each violation. The

submission of false or misleading

information in connection with the

requirement of any provision of this Part

may subject persons to penalties /

calculated as if they never filed a notice.

(f) Under the authority of sections 7

and 17 of TSCA, EPA may:

(1) Seek to enjoin the manufacture,

import, or processing of a chemical

substance in violation of this part.

(2) Act to seize any chemical

substance which is being manufactured,

imported, or processed in violation of

this Part.

(3) Take any other appropriate action.

§ 721.17 Recordkeeping.

Any person subject to the

requirements of this part must retain

documentation of information contained

in that person's significant new use

notice. This documentation must be

maintained for a period of five years

from the date of the submission of the

significant new use notice.

§ 721.19 Exemptions.

The persons identified in § 721,5 are

not subject to the notification

requirements of § 721.10 for a chemical

substance identified in Subpart B of this

part if:

(a) The person has applied for and has

been granted an exemption for test

marketing the substance for a significant

new use identified in Subpart B in

accordance with section 5(h)(1) of the

Act and § 720.38 of this chapter.

(b) The person manufactures, imports,

or processes the substance in small

quantities solely for research and

development in accordance with section

5(h)(3) of the Act.

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Federal Register / Vol. 49, No. 173 / Wednesday, September 5, 1984 / Rules and Regulations 35021

(c) The person has applied for and

been granted an exemption under

section 5(h)(5) of the Act.

(d) The person manufactures, imports,

or processes the substance only as an

impurity.

(e) The person manufactures, imports,

or processes the substance only as a

byproduct which is used only by public

or private organizations that (1) burn it

as a fuel, [2) dispose of it as a waste,

including in a landfill or for enriching

soil, or (3) extract coniponent chemical

substances from it for commercial

purposes.

(f) The person imports or processes

the substance as part of an article.

(g) The person manufactures or

processes the substance solely for

export and, when distributing the

substance in commerce, labels the

substance in accordance with section

12(a)(1)(B) of the Act.

Subpart B-Significant New Uses for

Specific Chemical Substances

§721.575 Potassium N,N-bis

(hydroxyethyl) cocoamine oxide

phosphate, and potassium N,N-bis

-(hydroxyethyl) tallowamine oxide

phosphate.

(a) Chemical substances and

significant new use subject to reporting.

(1) The following chemical substances,

identified by their chemical names and

CAS Number are subject to reporting

under this Part for the significant new

use identified in paragraph (a](2) of this

section: Potassium N,N-bis

(hydroxyethyl) cocoamie oxide

phosphate (CAS Number 855712-26-1),

and potassium N,N-bis (hydroxyethyl)

tallowarmne oxide phosphate (CAS

Number 855712-27-2).

(2) The significant new use is: Use in a

consumer product at concentrations

greater than five percent by weight.

(b) Specific Requirements. The

provisions of Subpart A of this Part

apply to this section except as modified

by this paragraph.

(1) Definitions. In addition to the

definitions in § 721.3, the following

definitions apply to this section:

"Consumer" means any natural

person who uses products for personal

rather than business purposes.

"Consumer product" means any

chemical substance which is directly, or

as part'of a mixture, sold or made

available to consumers for their use in

or around a permanent or temporary

household or residence, in or around a

school, or in recreation.

(2) Persons who must report. The

provisions of § 721.5 apply to determine

persons who must report under this

section, except § 721.5(a)(2) does not

apply to a person who intends to

distribute either of the substances in

commerce as part of a mixture at

concentrations of five percent or less by

weight of the mixture.

(3) Notice requirements and

procedures. Section 721.10 applies to

this section, except a person bubmitting

a notice must complete only Parts I and

1 of the notice form.

BILUNG CODE essa-Zr.-M

DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric

Administration

50 CFR Part 652

[Docket No. 31220-245]

Atlantic Surf Clam and Ocean Quahog

Fisheries

AGENCY: National Marne Fisheries

Service (NMFS), NOAA. Commerce.

ACTION: Notice of Mid-Atlantic Area

closure.

SUMMARY. NOAA issues this notice

closing the mid-Atlantic surf clam

fishery. The action is necessarybecause

harvest from the fishery will exceed the

quarterly quota for the third calender

quarter. The intended effect of the

closure is to prevent harvests from

exceeding the annual quota for the

fishery.

EFFECTIVE DATES: 0001 hours Eastern

Daylight Time (EDT) September 16,1984.

through 2400 hours EDT September 29.

1984.

FOR FURTHER INFORMATION CONTACT:

Bruce Nicholls, Surf Clam Management

Coordinator, 617-281-2600, ext. 324.

SUPPLEMENTARY INFORMATION The

regulations implementing Amendment 3

to the Fishery Management Plan for

Atlantic Surf Clam and Ocean Quahog

Fisheries were published on January 29.

1982 (47 FR 4268). The regulations

contain at § 652.22(d) a provision

requiring that. if the Regional Director

determines the quota for surf clams for

any time period will be exceeded, the

Secretary of Commerce will publish a

notice in the Federal Register stating the

determination and setting a date and

time for closure of the fishery.

Harvest of surf clams in the MidAtlantic Area has been significantly

higher during 1934 than in previous

years. This is probably because

significant numbers of surf clams from

the strong 1976 and 1977 year classes

are now reaching the minmum. legal size

for harvest, thus elevating catch per

hour fished. On February 26.1934 (49 FR

6498, February 22,1934), the Regional

Director reduced allowable fishing time

from 24 to 12 hours per week in an

attempt to control harvest rates. Despite

this reduction, and a tvo-week closure

at the end of the second calendar

quarter (49 FR 23355, June 6,1934), rates

continue to exceed quarterly quota

guidelines. The Regional Director has

determined that the Mid-Atlantic Area

surf clam quota for the third calendar

quarter of 1934 will be reached on or

about August 31,1934. Fllowing

consultation with industry

spokespersons and the Mid-Atlantic

Fishery Management Council, the

regional Director has determined to

close the mid-Atlantic fishery for the

period from September 16,1934, through

September 29,1984.

Closure of the fishery .ill commence

at 0001 hours EDT on September 16,

1984. The fishery will remain closed

until 2400 hours EDT on September 29,

1984. This closure applies only to surf

clams taken in the fishery conservation

zone in the Mid-Atlantic Area.

The fishery will reopen at 0001 hours

EDT on September 30,1984, with 12

hours fishing time per week. At that

time, the Regional Director will evaluate

the status of the fishery and quotas. If

additional closure periods are required

to bring harvests down to the level

provided by the quotas, they will be

considered for later in the year.

Other Matters

This action is taken under the

authority of 50 CFR Part 652 and is taken

in compliance with Executive Order

12291.

(16 U.S.C. 1801 et seq.

List of Subjects in 50 CFR Part 652

Fisheries.

Dated: August 29,1934.

Carmen J. Blondin,

Deputy Azstant Admuustrator farFishernL

Rez-ourceMnaement National Mariae

Fisheries Service.

FRU COS-r4 9--1%4-8k 43amj

BUMLII ODE 35106-22-U

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