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Federal Register / Vol. 48, No. 94 / Friday, May 13, 1983 / Rules and Regulations

substance until information sufficient to

evaluate its health and environmental

effects is provided. EPA can take this

action if it determines that the available

information is insufficient for a reasoned

evaluation and either (1) the substance

may present an unreasonable risk of

injury to health or the environment, or

(2) the substance will be produced in

substantial quantities and there may be

significant or substantial human

exposure to the substance or substantial

release to the environment. Under

section 5(f), EPA may regulate a new

chemical substance if it finds that there

is a reasonable basis to conclude that

the manufacture, processing,

distribution in commerce, use, or

disposal of the substance will present an

unreasonable risk of injury to health or

the environment.

If EPA has not prohibited manufacture

or import of the chemical substance

during the review period, these activities

may begin as soon as the review period

expires, subject to restrictions or testing

requirements imposed during the review

period. When manufacture or import

begins and the notice submitter provides

a notice of commencement, EPA adds

the substance to the inventory.

Thereafter, any person may manufacture

or import the substance without

submitting a section 5 notice to EPA

(unless EPA has issued a significant new

use rule on the chemical under section

5(a)(2)).

Certain chemicals are exempt from

the section 5 notice requirements. They

include categories of substances

excluded from the TSCA definition of

chemical substance: tobacco and

tobacco products; nuclear materials;

firearms and ammunition; and

substances used solely as pesticides,

foods, food additives, drugs, or

cosmetics. In addition, section 5(h)

authorizes exemptions from section 5

notice requirements for new chemical

substances produced for test marketing

or research and development, and for

substances which exist temporarily as a

result of a chemical reaction in the

manufacture or processing of another

chemical substance to which there is no

human or environmental exposure. Also,

under section 5(h)(4) EPA may, upon

application and by rule, exempt the

manufacturer or importer of any new

chemical substance from all or part of

the section 5 requirements if the Agency

determines that the manufacture,

processing, distribution in commerce,

use, and disposal of the substance will

not present an unreasonable risk of

injury to health or the environment.

Section 5(d)(2) of the Act requires

EPA to publish certain information on

section 5 notices in the Federal Register,

including at the least: (1) information on

the identity and uses of the new

substance, (2) a description of test data

submitted under section 5(b), and (3) the

results of the tests. In addition, at the

beginning of every month, EPA must

publish a list of: (1) new chemical

substances undergoing section 5 review

and (2) new chemical substances for

which the notice review periods have

expired since the previous monthly

Federal Register notice.

Under section 14 of the Act, EPA is

prohibited from disclosing confidential

business information submitted under

TSCA, including section 5, except in

certain circumstances. Specifically, EPA

may disclose confidential business

information if it determines that

disclosure is necessary to protect human

health or the environment against an

unreasonable risk of injury to health or

the environment, and, to the extent

necessary, if the information is relevant

in any proceeding under the Act. Also,

EPA is not prohibited from disclosing

health and safety studies (including

underlying data) on chemical substances

for which a section 5 notice was

received. However, the Act does not

authorize EPA to reveal any such data

that would disclose confidential

processes or portions of a mixture.

B. Background

Section 5 notice requirements went

into effect on July 1, 1979, 30 days after

the publication of the Initial Inventory.

On that date, persons who intended to

manufacture new chemical substances,

or import them in bulk, became subject

to section 5 notice requirements. On July

30, 1980, EPA published a Cumulative

Supplement to the Initial Inventory,

which included chemical substances

reported by processors and users and

substances imported as part of mixtures

or articles. This supplement, together

with the Initial Inventory, make up the

Revised Inventory. Thirty days after

publication of the Revised Inventory, on

August 30, 1980, section 5 notice

requirements went into effect for

persons who imported new chemical

substances as part of a mixture. Under

the Interim Policy and this final section

5 notice rule, importers of new chemical

substances as part of an article are not

subject to the section 5 notification

requirements.

Since section 5 notice requirements

went into effect, EPA has operated the

notice review program under an Interim

Policy. In the preamble to the January

10, 1979, proposed section 5 notice rule,

EPA announced its Interim Policy for

handling notices submitted before the

publication of the Inventory. EPA

modified this policy in an Interim Policy

Statement published in the Federal

Register of May 15, 1979 (44 FR 28564).

This statement extended the Interim

Policy's coverage to all notices filed

before the effective date of the final

section 5 rule and notice form.

EPA issued a Revised Interim Policy

Statement in the Federal Register of

November 7, 1980 (45 FR 74378). This

statement clarified the May 15 statement

and discussed in more detail the type of

information EPA expected to receive in

notices, EPA's interim procedures for

handling confidential information, and

procedures for submitting and reviewing

test-marketing exemption applications.

The operation of the review program

under the Interim Policy is discussed

later in this preamble.

EPA proposed a rule to implement

section 5 notice requirements in the

Federal Register of January 10, 1979 (44

FR 2242). This proposal included a

description of the applicability of

section 5 requirements, the general

procedures for submitting notices,

information requirements in the notices,

and EPA's procedures for processing

information in notices, including

confidential business information. EPA

also proposed notice forms for

manufacturers, importers, foreign

manufacturers and suppliers, and

processors and customers.

In response to public comment on the

January 10 proposal, EPA reproposed

certain parts of the rule and forms in the

Federal Register of October 16, 1979 (44

FR 59764). In particular, the reproposal

shortened the notice form, reducing the

information required; itrevised

procedures for asserting and

substantiating claims of confidentiality;

and it revised the proposed

supplemental reporting requirement

under section 8(a) of TSCA. In addition,

EPA proposed in the Federal Register of

August 15, 1980 (45 FR 54642) that

persons notify EPA before they

processed for TSCA commercial

purposes substances that were

manufactured or imported for purposes

exempt from TSCA reporting. In the

Federal Register of September 23, 1980,

EPA proposed a clarification of

reporting responsibilities of importers in

the January proposal (45 FR 63806).

Finally, EFA issued a statement in the

Federal Register of July 2, 1982 (47 FR

28969) stating that, under the Interim

Policy, submitters were no longer

required to substantiate confidentiality

claims at the time a notice is submitted.

With this notice, EPA is now

promulgating final section 5 notice

requirements and review procedures.

This rule modifies the earlier proposals

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in light of EPA's experience under the

Interim Policy and public comments on

the rule. The rule will become effective

30 days after publication of this notice.

Until then, EPA will continue to operate

the notice review program under the

Interim and Revised Interim Policy

Statements.

II. General Approach to Notice Review

In conducting its review of a new

chemical substance, EPA assesses the

risks associated with all phases of the

life cycle of the substance, including its

manufacture, import, processing,

distribution in commerce, use, and

disposal. The review is based on

information provided by the submitter in

the notice and on information EPA may

obtain elsewhere, for example, in the

literature searches on new substances

and their structural analogues that EPA

conducts as part of its new chemical

review. However, it is ultimately the

notice submitter's responsibility to

provide enough information for an

adequate risk assessment.

In conducting its review, EPA

considers a number of different factors,

including the potential toxicity of the

substance which is determined from test

data submitted in the notice or obtained

elsewhere, data on structural analogues,

and structure-activity analyses. EPA

also reviews the potential for humans

and the environment to be exposed to

the substance during uses proposed by

the notice submitter. Also, because EPA

must assess the "reasonableness" of any risk, it considers such nonrisk factors as

the possible economic benefits of the

substance and the availability of

substitutes-or whether a substance is

intended as a substitute for a more toxic

substance.

Because the Act explicitly requires

EPA to assess risks associated with the

entire life cycle of new chemicals, EPA

evaluates both the new chemical

substance and related substances, such

as impurities, byproducts, degradation

products, unintended reaction products,

and other chemical substances

associated with the manufacture,

processing, distribution in commerce,

use, or disposal of the new chemical

substance, even if these related

substances are on the Inventory.

On the basis of its assessment, EPA

may take action during the review

period under section 5(e) to regulate the

substance while EPA obtains more data,

or under section 5(f) to regulate

manufacturing, processing, distribution

in commerce, use, or disposal, if EPA

determines that the substance will

present an unreasonable risk. EPA may

also issue a follow-up reporting

requirement under section 5(a)(2) or 8(a)

or regulate the chemical under section

5(b)(4) (risk list). EPA, however, can

regulate a substance only if it takes

positive action, either by order or by

rule. Without such action during the

review period, a substance can enter

commercial production unregulated

under TSCA. As a result, section 5 of the

Act does not establish a registration

program, and EPA has not in any sense "approved" substances that have

passed through review without

regulation.

From commencement of the notice

review program on July 1, 1979, to March

31, 1983, EPA received 2,201 valid

premanufacture notices. Of the total

number, the review period had expired

on 1,878 and 777 had entered

commercial production. In addition, EPA

reviewed 196 test-marketing exemption

applications under section 5(h)(1) of the

Act and granted 173 such exemptions.

During this period, EPA issued seven

section 5(e) orders regulating the

production of 18 new chemical

substances pending the development of

additional data, and entered into

voluntary control agreements with the

submitters of 49 notices. In addition,

submitters withdrew nine section 5

notices in the face of likely regulation.

Under the Interim Policy, EPA has

gained experience in reviewing notices,

which it has used in developing the final

section 5 notice rule, and it has

established review procedures that will

continue when this rule is effective. The

following sections outline our general review procedures for notices on new

chemicals.

A. Notice Review Process

The notice review process established

by EPA has six major phases: prenotice

communication, process start-up, initial

review, detailed review, regulatory

response, and process closeout. All new

chemicals are not subject to each phase. 1. Prenotice Communication. The EPA

Office of Toxic Substances, which is

responsible for the section 5 notice

review program, employs a Prenotice

Communications Coordinator to assist

persons preparing a notice or

considering the submission of a notice.

The Prenotice Communications

Coordinator provides guidance on a

wide variety of topics, and refers

persons to the appropriate EPA staff

members for guidance on other

questions. Topics for prenotice inquiries

include the scope of TSCA and this rule,

the contents of the TSCA Chemical

Substance Inventory, the notice form,

section 5 exemptions, premanufacture

testing, confidentiality and generic name

development, and notice review

procedures.

The Prenotice Communications

Coordinator can be reached by

telephone at 202-382-3745 or by writing

to the Prenotice Communications

Coordinator, Chemical Control Division

* (TS-794), Environmental Protection

Agency, 401 M Street, SW., Washington,

D.C. 20460.

2. Process Start-up. Process start-up

begins when EPA receives a notice. The

OTS Document Control Officer assigns a

premanufacture notice number to the

notice and acknowledges the receipt of

the notice to the submitter. The

acknowledgment includes the date when

the OTS Document Control Office

received the notice. The 90-day review

period begins on the date of receipt.

During process start-up, OTS staff

review the notice to determine whether

the substance and proposed uses are

subject to section 5 notice requirements

and whether all required information

has been submitted. In addition, the

Chemical Substance Inventory is

searched to ensure that a section 5

notice is required, and the Federal

Register notice required under section

5(d)(2) is prepared. This notice includes

the identity of the new chemical

substance; the premanufacture notice

number; the name of the submitter;

information on production, exposure,

and use; and test results. Information

claimed as confidential is omitted from

the notice or masked by generic

descriptions. At the same time, the OTS

Reading Room establishes a public file

containing a nonconfidential version of

the notice.

A Notice Manager is assigned to each

notice. The'Notice Manager coordinates

the review and serves as the EPA

contact on all matters concerning the

notice. Persons wishing to contact the

managers of particular notices can

obtain their names and telephone

numbers from the Prenotice

Communications Coordinator.

3. Initial Review. During the initial

review period, EPA identifies chemical

substances which require more detailed

review and which are candidates for

possible regulatory action. During this

phase, EPA conducts a preliminary

analysis of the chemical identity,

physical and chemical properties,

proposed uses, potential toxicity,

environmental effects, human exposure,

environmental release, and economic

benefits. EPA uses the information

contained in the notice, in certain cases

searches the scientific literature for data

on the substance and related

substances, and, when necessary, seeks

additional information from the

submitter. Initial review ends when the

staff reviews available risk data and

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nonrisk information and decides

whether more detailed review is

necessary, possibly in support of an

action under section 5(e) or 5(f), or

under other sections of the Act.

4. Detailed Review. During detailed

review, the Agency assesses the

concerns it identified during initial

review. EPA also examines the benefits

to society of the new chemical

substance and the availability of

substitutes. After assessing the risks and

certain nonrisk information, EPA

analyzes possible regulatory or other

control measures. If necessary, EPA

extends the notice review period under

section 5(c). 5. Regulatory Response. After

completion of its detailed review, EPA

may decide to regulate the substance

during the review period. It may issue

an order under section 5(e) if EPA finds

that the substance may present an

unreasonable risk of injury to health or

the environment, or that it may be

produced in substantial quantities,

pending the development of additional

data. EPA may control the substance

under section 5(f) if it finds that the

substance will present an unreasonable

risk. EPA may also identify the

substance as a candidate for regulation

under section 5(a)(2), 5(b)(4), or 8.

6. Process Closeout and Entry on the

Inventory. If EPA does not take action to

regulate a substance during the review

period, the submitter may manufacture

or import the new chemical substance

without restriction, as soon as the notice

review period expires. The submitter

must notify EPA by letter when

manufacture or import begins. This

letter must be sent to the Document

Control Officer (TS-793), Office of

Pesticides and Toxic Substances, 401 M

Street, SW., Washington, D.C. 20460.

This notice of commencement must

contain: the specific identity of the

chemical substance, its premanufacture notice number, and the date when

manufacture or import begins. When

EPA receives this letter, the substance is

added to the Inventory.

B. Test-Marketing Exemptionl

Applications

Under section 5(h)(1) of the Act,

persons may apply for an exemption from section 5(a) or 5(b) reporting

requirements to manufacture or import a

new chemical substance for testmarketing purposes. EPA may grant an

exemption if the applicant shows to

EPA's satisfaction that the testmarketing activities will not present any unreasonable risk of injury to health or

the environment. Therefore, EPA must

make an affirmative finding that the test

marketing will not present any

unreasonable risk, and manufacture or

import cannot begin until EPA grants the

exemption. This standard differs from

the finding EPA must make to take

regulatory action on a new chemical

under section 5(e); to act under section

5(e), EPA must conclude only that there

may be an unreasonable risk. Under

section 5(h)(6), EPA has only 45 days to

approve or deny an exemption

application. This limits the extent to

which EPA can gather information

beyond that contained in the testmarketing application.

To ensure an adequate review, testmarketing exemption applicants should

include in their applications, at a

minimum: (1) all existing data regarding

health and environmental effects of the

substance, including physical/chemical

properties or, in the absence of such

data, a discussion of toxicity based on

structure-activity relationships and

relevant data on chemical analogues; (2)

the maximum amount to be

manufactured or imported for test

marketing; (3) the maximum number of

persons who may-be provided the

substance during test maketing; (4) the

maximum number of persons who may be exposed to the substance as a result

of test marketing; (5) information on

estimated duration and routes of

exposure; and (6) a description of the

test-marketing activity, including the

length of time that will be required and

how the activity may be distinguished

from full-scale commercial production and from research and development.

These items are set out in § 720.38(b) of

the final rule.

C. Regulatory Actions

By March 31, 1983, EPA had issued

seven orders under section 5(e) to

control a total of 18 new chemical

substances. The first three orders would

have prohibited production of the new

substances pending the development of

further information. However, in each of

the three cases, the manufactuper or

importer withdrew its notice from

review, rather than allow the order to go into effect. EPA also issued four consent

5(e) orders. These consent orders allow

manufacture of the new chemical

substance under specific restrictions

pending the development of additional

information. In addition, nine section 5

notices have been withdrawn by submitters in the face of likely

regulation under section 5(e) or 5(f), but

before orders were actually issued.

EPA has also reached voluntary

agreements with a number of notice

submitters rather than taking formal

regulatory action. By March 31, 1983, the

submitters of 19 notices had agreed to

conduct testing in response to EPA

concerns. Measures to control exposure,

including labeling, Material Safety Data

Sheets, and worker protection devices,

where agreed to by the submitters of 30

notices, and the review periods for an

additional 43 notices were suspended in

response to EPA's concerns, to allow the

submitters time to develop additional

information voluntarily.

Ill. Provisions of the Rule

This unit discusses the provisions of

the rule and specifically points out

where these provisions differ from the

January 1979, October 1979, and August

1980 proposals. In a separate document,

Response to Comments on the

Premanufacture Notice Requirements

and Review Procedures, EPA discusses

in more detail its response to comments

on the earlier proposals. The Response

to Comments is available in the OTS

Public Reading Room.

A. Applicability

1. Who Must Report. Section 720.22 of

the rule specifies who is subject to the

section 5'notice requirements. These

provisions closely follow those proposed

in January 1979, which were based on the reporting requirements for the Initial

Inventory. A detailed discussion of who

must report follows.

a. US. manufacturers. Persons who

intend to produce or manufacture a new

chemical substance in the United States

for a commercial purpose must submit a

notice. Only manufacturers that are

incorporated, licensed, or doing

business in the United States may

submit a notice. Persons who extract a new chemical substance from a

previously existing substance, or a complex combination of substances, are

manufacturers of that new chemical

substance.

EPA has revised the definition of "manufacturer" in the final rule to

include certain persons who contract

with a manufacturer to make a chemical

substance (sometimes known as "toll

manufacture"). Under the definition in

the final rule, a person who contracts

with a manufacturer is also a

manufacturer if the substance is

manufactured or produced exclusively

for that person, and that person

specifies the identity of the substance

and controls the total amount produced

and the basic technology for the plant

process. In this situation, the person

who contracts with the actual

manufacturer must submit the notice.

This provision does not apply to the

person who simply orders a specific

chemical or a chemical with certain

properties from a manufacturer. Instead,

this provision only applies to the

.. . .. 21... .

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situation where the person not only

specifies the chemical identity, but

spells out the basic process for making

the chemical (althought the actual

manufacturer may make adjustments in

the specified process that are necessary

to adapt the process to the

manufacturer's own equipment.)

The rule further restricts this

provision to persons who have an

exclusive relationship with the

manufacturer (i.e., the manufacturer

does not sell the chemical to anyone

else). As a result, the person placing the

order also determines the total amount

to be manufactured. Therefore, if more

than one person orders the new

chemical, neither of them has specified

the total amount to be manufactured

and neither is responsible for submitting

the notice; instead, the person who

actually manufactures the chemical

must submit the notice.

EPA has added this provision to deal

with the situation in which one person

decides to manufacture a specified

amount of a certain chemical using a

certain process, but contracts with a

manufacturer to actually make the

chemical. In this case, EPA believes the

person contrhcting with the

manufacturer is the most knowledgeable

party and should be responsible for

submitting the notice. EPA recognizes,

however, that the actual manufacturer

will often have extensive information

that would be useful to EPA in its

review of the new chemical. Therefore,

EPA strongly encourages joint

submissions (see § 720.40(e)) in this

situation. Since both persons involved in

the transaction are manufacturers, both

are liable for the manufacture of the

new chemical if a notice has not been

submitted, or the review period has not

expired. EPA did not adopt the proposed

requirement that manufacturers of new

chemicals solely for export submit

notices under section 5(a) of the Act.

("Manufacture solely for export" is

defined in § 720.3(s) of the rule.) Instead,

EPA will soon propose that

manufacturers of chemicals solely for

export submit notices to EPA under

section 8(a) prior to manufacture. EPA

eliminated the requirement that

manufacturers of new chemical

substances solely for export submit a

section 5 notice in response to

comments that questioned EPA's legal

authority to require such reporting.

These comments will be addressed more

fully in the preamble to the proposed

section 8(a) reporting rule for exportonly chemicals.

The definition of "manufacture solely

for export" places certain restrictions on

domestic activity. The manufacturer of

an export-only chemical may process it

only at sites under the control of the

manufacturer. Distribution in commerce

is limited to the activities necessary to

export the chemical. Also, the

manufacturer of an export-only chemical

may not use the chemical for any

purpose, except in small quantities

solely for research and development.

b. Importers. Under § 720.22(b) of this

rule, persons who intend to import a

new chemical substance for a

commercial purpose are subject to

section 5 notice requirements. This

includes chemicals imported in bulk or

as part of a mixture. Because it would

be enormously difficult for an importer

to determine the identity and Inventory

status of each chemical substance in

imported articles (e.g., automobiles), the

rule does not require persons to submit

notices on new substances imported as

part of articles. However, new

chemicals imported in containers used

for transportation or for other purposes

are imported in bulk, not as part of an

article, and are subject to the notice

requirements.

EPA has eliminated the separate

importer notice forms; importers must

now complete the general notice form.

In their notices, however, importers are

required to provide information only on

exposure which occurs within the

United States.

In the January 1979 proposal and in

§ 720,3(1) of this rule, EPA defines.

importer to include the person primarily

liable for the payment of duties, the

consignee, the importer of record, the

actual owner, and any transferee. This

definition, which is adopted from the

definition of the U.S. Customs Service of

the Treasury Department, is consistent

with other definitions of importer issued

under the Act.

Several commenters on the January

1979 proposal suggested that EPA's

definition of importer did not adequately

indicate which party in an import

transaction was responsible for

submitting a section 5 notice. In

response to these comments, EPA

clarified importer reporting

responsibilities under section 5 in the

Federal Register of September 23, 1980

(45 FR 63806). This clarification has

been incorporated into the final rule in

§ 720.3(z) and § 720.22(b).

Under § 720.22(b), the "principal

importer" in any transaction leading to

the import of a new chemical substance

must submit a section 5 notice. The

principal importer is the first importer

who selects the new chemical substance

and determines the total amount to be

imported. The principal importer must

know that the substance will be

imported, and only a person

incorporated, licensed, or doing

business in the United States may

submit the notice. Occasionally, no one

person may fit this definition exactly. In

this case, the Prenotice Communications

Coordinator should be contacted to

determine the appropriate person to

submit the notice. Otherwise, the

incorrect party may submit the notice,

and the notice review period will not

begin to run until EPA determines who

should have submitted the notice and

that person actually submits it. Early

consultation with the Prenotice

Communication Coordinator will avoid

this delay. If import of a new chemical

substance occurs before the principal

importer submits a notice and the

review period expires, all importers

involved in the transaction are liable.

The following paragraphs further

explain the definition of principal

imported.

i. Selecting the chemical substance to

be importer. The principal importer

selects the new chemical substance for

import. Selecting the substance to be

imported includes selecting it by a trade

name or generic name as well as by its

specific chemical identity. Therefore, the

principal importer need not know the

specific chemical identity of the

imported substance. If the specific

chemical identity of the new chemical

substance is known only to the foreign

manufacturer or supplier, and the

manufacturer or supplier does not wish

to reveal the identity to the U.S.

importer, it can report the identity

directly to EPA. (See § 720.40(e) of the

rule.) In this way, foreign companies can

protect confidential business

information. In any case, however, EPA

must know the identity of the substance

before the review period can begin.

Importers, like manufacturers, are

responsible for determining whether

their substances are on the Inventory

and therefore whether they are new

chemical substances subject to section 5

notice requirements. A principal

importer that does not know the identity

of a chemical substance it intends to

import may have its foreign

manufacturer or supplier, or some other

person, report the chemical identity to

EPA using the bona fide procedures

described in § 720.25 of the rule. The

principal importer would provide the

evidence of a bona fide intent to import

the chemical. EPA will then search the

Inventory for the substance. If a notice

is required, EPA will inform the

importer. As a result, confidential

chemical identity will be protected, and

importers need not file unnecessary

notices.

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ii. Knowing that the substance will be

imported. A principal importer must

know that the new chemical substance

will be imported into the United States,

rather than manufactured domestically.

If a person orders a new chemical

substance directly from a foreign firm,

EPA will consider that person to know

that he or she is importing the

substance. If a person orders a chemical

from a U.S. firm and does not know and

has no reason to know that the U.S. firm

will fill the order by importing a new

chemical, the person would not be

subject to notification requirements or

liable under section 15 for failure to

submit a notice. In that case, the U.S.

firm filling the order would be required

to report.

iii. Specifying the total amount to be

imported. The principal importer

specifies the total amount of the

chemical substance to be imported. If

orders are collected from several

customers, the person who collects the

orders is the person who specifies the

total amount to be imported and is

subject to the notice requirements of this

rule. Individual customers of the

principal importer do not specify the

total amount, even though one might

have a disproportionately large order.

iv. Incorporated, licensed, or doing

business in the United States. A

principal importer must be incorporated,

licensed, or doing business under the

laws of the United States.

c. Processors. In August 1980, EPA

proposed that persons be required to

submit a section 5 notice to EPA before

they processed for TSCA commercial

purposes substances previously exempt

from reporting. Specifically, this applied

to byproducts; tobacco and tobacco

products; nuclear materials; substances

used solely as pesticides, firearms,

ammunition, foods, food additives,

drugs, and cosmetics; substances

manufactured before January 1, 1975,

and not processed and reported for the

Inventory after that date; research and

development (R and D) chemicals; and

substances granted test-marketing

exemptions.

EPA proposed processor notification

requirements to close a gap in section 5

rules. EPA recognized that not many

chemicals would be subject to

notification requirements under this

portion of the rule; however, EPA saw a

need to review the risks associated with

the processing and use of previously

exempt substances for TSCA purposes

before these activities occurred.

Persons who commented on the

proposal argued that the requirement

was unnecessary for R and D and testmarketed substances. They argued that

manufacturers of test-marketed

substances know how persons who buy

the substances are using them because

this information is necessary to make

sure they are in compliance with the

terms of the particular exemption. Also,

manufacturers of R and D chemicals

often know how their customers are

using these chemicals. Therefore, EPA

has eliminated the processor notification

requirement for R and D and testmarketed substances. Of course, if a

company that manufactures or imports a

chemical for R and D or test-marketing

purposes learns that its customer is

using the chemical substance for

nonexempt commercial purposes,

manufacture or import of the chemical

substance for sale to that customer for

that purpose must cease until a section 5

notice is submitted and the review

period expires.

EPA now also believes processor

notification is inappropriate for nuclear

materials, tobacco, and tobacco

products because these substances are

exempt from TSCA, regardless of how

they are used. In addition, EPA believes

that notification by processors of

pesticides for nonexempt commercial

uses is unnecessary because the uses of

registered pesticides are regulated under

the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA). Of course, if a

person intends to manufacture a

pesticide for nonpesticide uses, these

uses would not be subject to FIFRA.

However, in this case, the manufacturer

would be required by the statute to

notify EPA under section 5(a)(1)(A) if

the substance were not on the Inventory.

EPA also believes that notification for

the processing of food and food

additives for nonexempt purposes is

unnecessary. These substances will

already have been approved for human

ingestion by the Food and Drug

Administration (FDA). FDA also has

jurisdiction over cosmetics and devices,

as defined by the Federal Food, Drug,

and Cosmetic Act. Therefore, EPA

believes that notification by processors

of food, food additives, and cosmetics is

unnecessary, especially since persons

would still be required under section

5(a)(1)(A) to notify EPA before they

manufactured these substances for

nonexempt uses.

Finally, EPA believes that processor

notification requirements are

unnecessary for the nonexempt

processing of byproducts which have no

separate commercial purpose. As is true

of R and D and test-marketed

substances, the manufacturer of a

byproduct is expected to know of any

nonexempt uses planned by-its

customer. In such cases, the byproduct

would then be manufactured for a

commercial purpose and the

manufacturer would be required to

submit a notice. Notification

requirements are also unnecessary for

nonexempt processing of substances

which have not been manufactured

since January 1975, since such

processing rarely occurs.

Based on public comments and its

reevaluation of the proposal, EPA now

believes that processor notice

requirements are unnecessary.

Therefore, EPA has not included these

requirements in the final rule.

d. Agents and joint submitters. Under

§ 720.40(e) of the rule, persons required

to submit a section 5(a) notice may

designate an agent to submit the notice

for them. Both the person originally

subject to the notice requirements and

the agent must sign the certification on

the form. Therefore, both persons are

responsible for false or misleading

statements in the notice. The person

originally subject to the notice

requirements remains responsible for

the submission to EPA of all required

information known to or reasonably

ascertainable by him or her and all test

data in the person's possession or

control.

Persons may also submit joint section

5(a) notices to EPA. For example, a

principal importer may ask other parties

inthe U.S., such as customers, to

complete certain sections of the form if

they have relevant information. All

persons submitting the notice must sign

the certification on the form. They must

also assert all confidentiality claims

according to the procedures of this rule.

However, the person responsible for the

notice under section 5(a) is not absolved

of statutory notice requirements by

arranging a joint submission. This

person is required to complete all

mandatory sections of the form, to the

extent that he or she knows or can

reasonably ascertain the required

information, even if another person also

submits a certain section. If a joint

notice is submitted, the notice review

period will not begin until EPA has

received all required parts of the notice.

Therefore, the person subject to the

notice requirements should indicate to

EPA who else will be submitting parts of

the notice and identify those parts. EPA

will acknowledge receipt of the notice

when it has received submissions from

all of the joint submitters.

2. What chemical substances must be

reported. Section 5(a)(1)(A) of the Act

requires persons to notify EPA before

manufacturing or importing any new

chemical substance, except for

substances exempt under section 5(h).

New chemical substances are chemical

substances riot included in the TSCA

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Chemical Substance Inventory compiled

and updated under section 8(b).

Under section 3(2) of TSCA and

§ 720.3(e) of the rule, chemical

substances are defined as any organic

or inorganic substance of particular

molecular identity, including any

combination of such substances

occurring in whole or in part as a result

of a chemical reaction or occurring in

nature, and any element or uncombined

radical. However, the following

substances are excluded from the TSCA

definition of chemical substance:

mixtures; tobacco and tobacco products;

nuclear materials; firearms and

ammunition; and substances used solely

as pesticides, foods, food additives,

drugs, and cosmetics.

Manufacturers and importers are

responsible for determining whether a

substance is a new chemical substance

under TSCA and therefore whether they

are subject to section 5 notice

requirements. The published Inventory

will enable persons to determine

whether many specific chemical

substances have been entered on the list

and therefore are not new. However, in

difficult cases, EPA will assist persons

in ascertaining whether specific

substances are on the Inventory.

If a chemical substance is listed on

the public Inventory under a generic

name to mask its confidential identity,

persons will not be able to determine if

a specific substance falling into that

category is a new chemical substance.

Therefore, under § 720.25(b) of the rule,

EPA has established procedures for

informing persons whether a substance

they intend to manufacture or import is

a substance on the confidential

Inventory, or whether it is a new

substance subject to the section 5

notification requirements. Under these

procedures, persons requesting this

information from EPA first must

demonstrate a bona fide intent to

manufacture or import the substance by

submitting the items listed in

§ 720.25(b)(2). These items have not

changed from the proposed rule, except

that the person need not have a sample

of the substance available. EPA has

found that samples are unnecessary to

establish a person's intent to

manufacture or import the chemical or

to determine whether the chemical

substance is on the Inventory. If an

importer cannot provide certain

requested items related to chemical

identity because its foreign

manufacturer or supplier claims them

confidential, the importer can request

the foreign manufacturer or supplier to

send them directly to EPA.

EPA will respond to these inquiries

within 30 days of receipt of a complete

request. If the Agency determines that a

substance is not on the Inventory, it will

notify the person submitting the bona

fide inquiry that a section 5 notice must

be submitted before the substance is

manufactured or imported. If EPA

determines that the substance is on the

Inventory, it will inform the person that

a notice is not required. At the same

time, EPA will inform the person who

originally submitted the confidential

substance for the Inventory that another

person has demonstrated a bona fide

intent to manufacture or import the

substance and has been notified that the

substance is on the confidential

Inventory.

3. Exempt chemical substances.

Section 5(h) of the Act exempts, or

authorizes EPA to exempt, certain

chemical substances from section 5

notice requirements. In § § 720.36 and

720.38 of this rule, EPA clarifies several

of these exemptions. The sections have

not been substantively changed from the

corresponding sections of the January

1979 proposal. The most important of the

exemptions are discussed below.

a. Small quantities solely for research

and development. Chemical substances

manufactured or imported only in small

quantities solely for research and

development (R and D) are exempted

from section 5 notice requirements if the

submitter complies with § 720.36 of this

rule.

Like the Inventory reporting rules, this

rule defines "small quantities solely for

research and development" as

quantities that are not greater than

reasonably necessary for scientific.

experimentation, research, or analysis

(including activities associated with

product development). As the Inventory

rule and support documents indicate,

research and development activities

include tests of physical, chemical,

production and performance

characteristics. The chemical must be

used by, or directly under the

supervision of, a technically qualified

person. The manufacturer or importer

must evaluate information on the

chemical and inform all persons

engaged in experimentation, research, or

analysis on the new chemical substance

of any risk to health.

The section 5 notice rule deletes a

note included in the Inventory

definition. The note provided that, for

purposes of the Inventory, any

substance manufactured, imported, or

processed in quantities of less than 1,000

pounds a year would be presumed to be

manufactured solely in small quantities

for R and D, unless the submitter could

certify that the substance was used for

purposes unrelated to R and D.

This note was intended to provide

guidance for manufacturers in

evaluating low volume chemicals to

determine whether they were eligible for

the Inventory. If the note were included

in the section 5 notice rule, however, it

might be misconstrued to mean that

section 5 notices are not required for

any substance produced in quantities of

less than 1,000 pounds a year, or that

section 5 notices must be submitted for

all substances produced in quantities

greater than 1,000 pounds a year. This

deletion does not change the R and D

exemption of the Inventory reporting.

rule, but it eliminates a possible source

of misunderstanding about how

substances qualify for such exemptions.

In the future, the Agency may clarify the

R and D exemption by establishing a

more precise definition of "small

quantities" for specific substances or

groups of substances.

The final rule makes clear the

manufacturer's responsibility under

section 5(h)(3) to ensure that certain

persons are notified of any risk to health

that the manufacturer believes may be

associated with R and D activities on a

substance. This notification must go to

all persons engaged in experimentation,

research, or analysis on the substance,

including manufacture, processing, use,

transport, storage, or disposal of the

substance for research and development

purposes. The technically qualified

individual supervising the R and D

activities must ensure that the notice to

these persons is adequate. The rule does

not prescribe methods of notification.

Rather, it identifies certain acceptable

procedures, and leaves it to the

individual manufacturers or importers to

ensure that they adequately inform all

the persons who must be notified.

Section § 720.36(d) states that, upon

request, manufacturers and importers

must make available to EPA any

information evaluated by the

manufacturer or importer in determining

the need for notification. This provision

differs from § 720.38(d) of the proposed

rule which would have required the

manufacturer or importer to make this

information available to any person

exposed to the R and D substance, as

well as EPA. EPA has dropped this

requirement because it reduces the

burden on manufacturers or importers

since making this informatioD available

to persons exposed to the R and D

substance often would require

preparation of nonconfidential

summaries, and possible disclosure of

sensitive information such as medical

records. This change will not endanger

the health of exposed persons since they

will be notified of any risk by the

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manufacturer or importer. In addition,

EPA will have access to this

information, so it can ensure that the

notification of'exposed persons is

adequate.

The R and D provisions apply to all

substances manufactured or imported

after the effective date of the final rule,

including substances manufactured or

imported earlier under the R and D

exemption. Therefore, persons that have

been manufacturing or importing a

chemical under a R and D exemption

before the effective date of the final rule

cannot continue to manufacture, import,

process, distribute in commerce, use, or

dispose of this chemical under the

exemption until they have complied

with all the requirements described in

§ 720.36.

b. Test-marketing exemptions. Section

5(h)(1) of TSCA and § 720.38 of this rule

authorizes EPA, upon application, to

grant exemptions from any requirements

of section 5(a) or 5(b) of the Act for testmarketing purposes. To grant such an

exemption, the Agency must find that

the test marketing will not present any

unreasonable risk of injury to health or

the environment. Section 5(h)(6) and

§ 720.38(d) provide that EPA must either

approve or deny the application within

45 days of its receipt and must publish a

notice of its decision in the Federal

Register. If EPA grants an exemption, it

may impose restrictions on the testmarketing activities. The manufacturer

or importer must submit a section 5

notice for activities beyond those

permitted under the exemption.

In Unit II.B. of this preamble, EPA

provides guidance to persons submitting

test-marketing exemption applications

and describes the information these

applications should include.

c. Nonisolated intermediates. Under

§ 720.30(g)(8) of the rule, "any

nonisolated intermediate" is not subject

to the notice requirements.

Intermediates are defined in § 720.3(n)

as substances that are consumed in

whole or in part in chemical reactions

used for the intentional manufacture of

other substances or mixtures, or that are

intentionally present for the purpose of

altering the rate of such reactions.

Under § 720.3(w), a nonisolated

intermediate is an intermediate that is

not intentionally removed from the

equipment in which it is manufactured.

This definition modifies the definition

of intermediate in the Inventory

reporting rule (40 CFR Part 710). Under

the Inventory rule, substances that were

not intentionally removed from the

equipment in which they were

manufactured were not considered

intermediates and were not subject to

the reporting requirements of the

Inventory rule. In the section 5 notice

rule, EPA has defined these substances

as intermediates, but has exempted

them from reporting requirements as "nonisolated intermediates." The

change in definition is only for the sake

of clarity, and does not change the

status of these substances.

EPA is exempting nonisolated

intermediates for several reasons. First,

such substances are often extremely

difficult to identify; in developing the

reporting rule for the TSCA Inventory,

EPA received numerous comments on

this point. Second, because exposure to

such substances generally is limited,

they generally pose little risk to human

health and the environment. Third, in

excluding nonisolated intermediates

from the Inventory, the Inventory

reporting rule stated that these and

other excluded substances will not be

subject to the section 5 notice -

requirements. (See § 710.4(d).)

d. Byproducts. This rule expands the

definition of byproduct contained in the

Inventory rule to include substances

which are formed without a separate

commerical purpose during the

processing, use, and disposal of the new

chemical. Section 5(d)(1)(A) of the Act

authorizes EPA to require information

on such substances. This expanded

definition is consistent with the

definition of "byproduct" proposed in

January 1979. Under both the proposed

rule and the final rule, substances which

were not eligible for inclusion on the

Inventory are not subject to the section

5 notice requirements.

B. Information Submissions

1. Scope of information requirements.

On January 10, 1979, EPA proposed

notice requirements which included a

notice form requiring reporting of

detailed information on production,

processing, use, and exposure of a new

chemical substance. The mandatory

section of the form was designed to give

EPA enough information to conduct a

detailed review for possible regulatory

action under section 5(e) or 5(f). The

form included an optional section,

asking for information on industrial

hygiene, engineering safeguards, and

certain nonrisk factors. Based on public

comments on the January proposal and

EPA's early experience in reviewing

notices, EPA reproposed a shortened

form on October 16, 1979. This proposed

form was designed to require only

information needed for an initial

assessment of a new chemical

substance. Under both proposals, if EPA

determined that it needed more

information from the submitter or other

persons, it could ask those persons to

submit it voluntarily, or it could require

the information through mandatory

supplemental reporting under section 8

("letter-writing" authority) or action

under section 5(e).

In revising the information

requirements for the final rule, EPA has

considered the comments received on

the previous proposals and EPA's

information needs identified in its

review of over 2,200 notices under the

Interim Policy. The requirements are

limited to (1) information clearly

specified in the statute in sections

8(a)(2) (A) through (G) except (E), and

(2) other information that is essential to

the initial review of the potential health

and environmental risks presented by a

new substance and which reasonably

falls within the intent of section 5(d)(1).

This rule further reduces the

information requirements from those of

the October 1979 proposal. Several

commenters on the October 1979

proposal stated that EPA failed to

require information identified in the

January 1979 proposal as necessary for

review of the risks associated with new

chemicals. EPA agrees that much of this

information can be important in the

review of a new chemical substance.

However, the Agency does not believe it

is reasonable to require all such

information for every substance

reviewed under section 5 since EPA has

found that detailed information is

necessary only after it identifies a

specific risk concern. The information

required on the final notice form is

sufficient for EPA to identify substances

of potential concern and to determine

what additional information is needed

in those cases for which more detailed

review is necessary.

Under the Interim Policy, EPA has

contacted submitters during the review

period and requested that they supply

additionat1 information when this

information was important for its

review. Submitters have been generally

cooperative in providing the

information. In developing this rule, EPA

has assumed that such cooperation will

continue in the future. Failure to supply

such information when it is important to

the review may unnecessarily

complicate the review, and may result in

extension of the review period under

section 5(c). If EPA does not receive the

information it believes is necessary for

review, it will take action under section

5(e), when appropriate, to regulate the

substance pending submission of the

information.

Notice submitters must provide all

information requested in the form to the

extent that they know or can reasonably

ascertain it. Submitters are also required

to provide test data in their possession

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or control and descriptions of other data

known to or reasonably ascertainable

by them, if those data concern the

environmental or health effects of the

substance. These requirements are

described in more detail in the following

sections. In addition to required

information, submitters may provide

EPA with any other information they

believe should be considered in its

review of the substance. The notice is

incomplete, and the review period will

not begin, unless information in the

notice form and attachments is in

English, except that published scientific

literature submitted with the notice need

not be translated.

The Importer Form proposed in

October 1979 has been incorporated into

the general notice form resulting in a

single form that will be used by all

submitters reporting under section

5{a)(1)(A). This change will simplify

notification for submitters since they

will have to become familiar with only

one form and there will be no confusion

as to which form should be submitted.

EPA recognizes that some importers

may not have the same amount of

information available to them as

domestic manufacturers. Importers, just

as domestic manufacturers, need only

submit information specified on the form

to the extent that they know or can

reasonably ascertain it. Importer

notices, however, will be held to the

same standard as domestic notices in

determining whether the notice is

complete or whether action under

section 5(e) is necessary to obtain

additional information.

The units below discuss the level of

detail required in completing the form,

and other general issues.

a. Known to or reasonably

ascertainable by. Section 5(d)(1)A) of

the Act requires that notices contain

certain information on chemical identity,

use, and exposure insofar as it is

"known to the person submitting the

notice or insofar as reasonably

ascertainable." This rule defines known

or reasonably ascertainable information

as "all information in a person's

possession or control, plus all

information that a reasonable person

similarly situated might be expected to

possess, control, or know," In response

to commenters who believed that the

phrase "or could obtain without

unreasonable burden or cost" is unclear,

EPA has dropped this phrase from the

definition. This is not a subslantive

change, however, since such information

is included in "information that a

reasonable person. . . might be

expected to possess, control or know."

Therefore under the new definition, just

as it is in the proposed definition, cost

and burden are factors in determining

whether information is known to or

reasonably ascertainable by the

submitter.

Many commenters on the January and

October proposals expressed difficulty

in determining what information EPA

considers to be "reasonably

ascertainable." Specifically, they were

uncertain about the effort that EPA

expects them to make in obtaining

certain types of information, and what

would constitute an "unreasonable

burden or cost." In two parts below-"

Information From Other Persons" and

"Test Data"-EPA discusses in more

detail its interpretation of "reasonably

ascertainable" in specific contexts.

Also, in Unit C.1.c. below, "Incomplete

Submissions," EPA briefly describes

notices received under the Interim

Policy that did not contain "reasonably

ascertainable" information. However,

EPA believes that it is not possible to

define "know to or reasonably

ascertainable" more explicitly.

Also, as discussed in the preamble to

the October 1979 proposal, a detailed

definition of "reasonably ascertainable"

may result in inequitable treatment of

notice submitters. What would be a

reasonable effort for one company under

certain circumstances might be

extremely burdensome for the same

company under different circumstances,

or for another company in the same

situation. The meaning of this phrase

will depend on the specific

circumstances surrounding the

development of the new chemical. The

nature of the substance, the projected

sales volume and profit, and the size of

the company are factors in determining

what information can reasonably be

obtained. Therefore, EPA believes that "reasonably ascertainable" can be

defined only on a case-by-case basis

and that notice submitters must be

responsible for deciding when and how

to obtain required data, and when

required information is not reasonably

ascertainable. Certainly, in most

instances, data-gathering that is so

costly as to preclude commercialization

is not reasonable.

To minimize the burden on submitters,

EPA has dropped the provision in the

proposed rule that would have required

submitters to provide a brief description

of their procedures for identifying data

that are known to or reasonably

ascertainable by them. EPA believes

this provision is unnecessary; EPA

generaiiy can judge from the notice itself

whether it includes information that is

known to or reasonably ascertainable

by the submitter. EPA will also check

this as part of its compliance

inspections.

b. Information from other persons. In

many cases, persons other than the

notice submitter may have information

necessary or useful for EPA's review.

For example, processors and other

customers may have information on

exposure associated with use or release,

and foreign manufacturers and suppliers

may have information on chemical

identity, impurities, and health and

safety data. Some of this information

must be submitted because it is

considered to be in the submitter's

possession or control, for example,

information that the submitter's parent

company or subsidiary has if the related

company was involved with R and D,

test marketing, or commercial

development of the new chemical. Other

information may be reasonably

ascertainable by the submitter, if not

already known, and therefore also must

be included in the notice.

EPA, however, has not adopted the

requirement proposed in January 1979,

that submitters contact customers and

ask them to submit a Processing and

Consumer Use Form. EPA also has

eliminated the request in the October

1979 form that submitters report the

number of customers intending to use

the new chemical substance in ways not

known to the submitter and to report the

percentage of production volume

allocated to those customers during the

first three years of production. The form

does, however, ask submitters to

estimate how much of the substance will

be manufactured or imported for each

known category of use.

EPA has eliminated mandatory

customer contact because information

from processors and other customers

often is not necessary for substances

that do not undergo detailed review.

EPA has found that when this

information is necessary. EPA reviewers

can generally obtain it either informally

from the submitter or from the published

literature. Submitters, however, are still

encouraged to obtain use and exposure

data from potential customers for

inclusion in the notice. The more

complete the information in a notice, the

less likely it is that EPA will need to

seek more information later, possibly

requiring an extension of the review

period under section 5(c), or regulatory

action to obtain information under

section 5(e).

The elimination of mandatory

customer contact will reduce the burden

on submitters and their customers

without significantly reducing the

effectiveness of EPA's review. By

requiring the submitter to estimate how

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much of a substance will be

manufactured for known uses, EPA will

be able to determine whether processing

and use are likely to cause a problem, or

wh-ther more information is needed.

In the final rule, EPA has also

eliminated the requirement that

importers contact foreign manufacturers

and suppliers, since much of the

information they could provide (e.g.,

exposure to workers and release to the

environment outside the U.S.) is not

subject to EPA's review, and EPA

generally does not have the authority to

require foreign companies to report.

More importantly, EPA believes that

under the notice requirements in the

final rule, the principal importer will

contact its foreign manufacturer or

supplier when necessary to obtain

required information. For instance, if the

principal importer does not know the

specific identity of the new substance, it

will contact the foreign manufacturer to

obtain it; otherwise, the submission will

be incomplete and EPA will not review

it. Of course, the principal importer is

encouraged to have its foreign

manufacturer or supplier submit any

other information useful for review to

the importer or directly to EPA.

c. Test data and other data. Section

720.50 of the rule describes notice

requirements for test data and other

data related to the health and

environmental effects of a new chemical

substance. Under section 5(d)(1)(B) of

the Act, submitters must report all test

data related to health and

environmental effects which is in their

possession or control. Under section

5(d)(1)(C), they must provide a

description of "any other" health and

environmental effects data which they

know of or can reasonably ascertain.

Health and environmental effects data

on both the new chemical substance and

related substances are necessary for an

effective evaluation of risks that may be

presented by a new substance.

Therefore, the requirements to submit

data apply to both the new chemical

substance and related chemicals.

Related chemicals include impurities,

byproducts, degradation products,

unintended reaction products, and other

chemical substances related to the

manufacture, processing, distribution in

commerce, use, or disposal of the new

substance.

To eliminate unnecessary reporting,

§ 720.50(c) imposes lesser requirements

for data on related chemicals than are

imposed for data on the new substance

itself. Unlike the October 1979 proposed

rule, the final rule does not limit the

reduced requirements to related

chemicals on the Inventory. Instead,

they apply to all related chemicals,

regardless of their Inventory status. The

submitter is not required to provide

published data on these substances

because EPA can obtain the data

elsewhere, regardless of whether or not

they are on the Inventory. Therefore,

submitters need only describe

unpublished data on related chemicals.

i. Definition of test data. Section

720.3(gg) defines "test data." Tests, in

EPA's definition, include both formal

and informal tests and experiments.

However, EPA no longer includes

recorded observations, monitoring, or

measurements as "tests"; instead, these

would be "test data" if they were

obtained in the course of a test or

experiment. EPA believes this change

more closely reflects the general

understanding of these terms. Test data

also include objectives, experimental

methods and materials, protocols,

results, and data analyses of tests and

experiments, as well as raw data and

other information relevant to the

development and analysis of the data.

In the January 1979 proposal, the

definition of "test data" included risk

assessments. The final rule eliminates

this provision, since EPA no longer

believes that an analysis of the risk

presented by the combined effects of

hazard and exposure is described by the

word "test." EPA has also eliminated

the word "study" from the final

definition of "test data" for the same

reasons. Risk assessments are more

appropriately included within the term

"health and safety study," which is

defined in § 720.3(k). EPA has added

risk assessments to the examples of

health and safety studies listed in

§ 720.3(k)(2).

In addition to reflecting more

adequately the use of the term "test

data" in the Act, the new definition will

reduce the burden on submitters. Since

risk assessments are now "other data"

under the final rule, not "test data,"

submitters need only describe risk

assessments which are known or

reasonably ascertainable. Under the

proposal, submitters were required to ,

provide copies of all risk assessments

which were' in their possession or

control.

The new definition of "test data," and

the reduced reporting requirements

which result, will not significantly affect

EPA's ability to review the risk

presented by new substances. If a risk

assessment described by the submitter

is needed for review, EPA will ask the

submitter to provide it voluntarily. If the

submitter does not provide it, EPA may

'extend the review period or take action

to obtain it under section 5(e) of the Act.

ii. Notice requirements for test data.

Section 720.50(a)(2) of the rule requires

submitters to provide full reports on test

data in their possession or control that

are relevant to the health and

environmental effects of the

manufacture, processing, distribution in

commerce, use, or disposal of the new

chemical substance. These include data

on the new chemical substance in pure

form, technical grade, and formulated

form. The rule requires a full report to be

submitted for data on health effects,

ecological effects, environmental fate

characteristics, monitoring data, and

physical and chemical properties related

to health and environmental effects.

A full report must include

experimental methods and materials,

results, discussion and data analyses,

conclusions, references, and the name

and address of the laboratory that

developed the data. EPA has dropped

the requirement that the submitter

provide data in a specified "full report

format"; any format is acceptable if it

includes the items listed. If the test data

have been published in the open

scientific literature, § 720.50(a)(3)(ii)

authorizes submitters to provide only a

standard literature citation. This

provision reduces the requirements of

the January 1979 proposal, which

allowed submitters to cite articles

containing test data only if the

periodical in which the articles

appeared was listed in Appendix I of the

proposed form. Any other test data in

the submitter's possession or control

may be submitted in summary form.

However, the submitter must provide a

full report upon request by EPA.

Sections 720.50 (a)(4)(i) and (b)(4) of

the rule exempt incomplete reports (e.g.,

from ongoing studies) from the full

report requirements. However,

submitters must describe the nature and

objective of any incomplete study,

report, or test; name and address of the

laboratory developing the data; progress

to date; types of data collected;

significant preliminary results; and

anticipated completion date. In addition,

if the study or report yields significant

preliminary or final results before the

end of the notice review period, and if

the results were not submitted with the

notice, the submitter must provide the

relevant study, report, or test results to

the OTS Document Control Officer

within 10 days of receipt; but in no event

later than 5 days before the end of the

notice review period. If the information

becomes available during the last 5 days

of the review period, the submitter must

immediately inform its EPA contact for

that notice by telephone. (See "New

Information" below.)

iii. Possession or controL In the final

rule, EPA haii retained the definition of

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"possession or control" proposed on

January 10, 1979. Several commenters on

the January proposal suggested that this

definition would impose an undue

burden on notice submitters, while

others believed that EPA's definition did

not go far enough. EPA, however,

believes that its proposed definition is

appropriate. Under this definition, the

Agency is likely to obtain all relevant

data without imposing an unreasonable

burden. In particular, by limiting the

definition to affiliated companies

associated with the development of the

new chemical substance, EPA has

focused the information requirement on

the companies most likely to have

relevant data and to profit from the new

substance. Comments on "possession or

control" are addressed more specifically

in EPA's Response to Comments, which

is available in the Public Reading Room.

iv. Other data known to or reasonably

ascertainable by the submitter. Section

5[d)(1)(C) requires submitters to

describe "any other data," including

data from health and safety studies; on

health and environmental effects that

they know or can reasonably ascertain.

In § 720.50(b) of the rule, EPA interprets "any other data" to be (1) test data not

in the submitter's possession or control

but known to or reasonably

ascertainable by the submitter, and (2)

any data, other than test data, that the

submitter possesses, controls, knows, or

can reasonably ascertain. For example,

if the submitter knows of toxicity or

environmental fate data in the

possession or control of another person,

the submitter is required under section

5(d)(1)(C) and § 720.50(b) to describe

those data to EPA. If the data have been

published in the open literature, the

submitter need only provide a standard

citation. If the data have not been

published, or the study is incomplete,

the submitter need only describe the

data and provide a summary of the

results (if available), or provide the

names and addresses of persons who

have the data.

The final rule requires less

information to describe data from

incomplete studies than was required by

the January 1979 proposal. EPA

recognizes that information such as a

study's nature and purpose, progress to

date, and significantly preliminary

results on another persons's ongoing

study will seldom be available to the

submitter. Also, as a result of the

revised definition of "test data,"

discussed in Unit B.l.c.i. above, risk

assessments are "other data" under the

final rule, and must be described to EPA

as required by § 720.50[b).

Section 720.50(b)(1)(ii) clarifies EPA's

interpretation of "known to or

reasonably ascertainable" as it applies

to data submitted under section

5(b)(1)(C). In this context, known to or

reasonably ascertainable includes data

known to employees or other agents

associated with research and

development test marketing, or

commercial marketing of a new

chemical substance. These data include

data learned by employees as a result of

discussions, symposia, and scientific

articles.

v. Data that need not be submitted.

Efficacy data and monitoring data on

exposure of human or ecological

populations outside the United States

need not be submitted. In addition,

persons are not required to resubmit any

data previously submitted to EPA, as

long as they were not claimed

confidential. Submitters should identify

the data previously submitted, the date

it was submitted, and the EPA office

which received it. However, it is

sometimes difficult or time-consuming

for the Office of Toxic Substances to

obtain such information from other EPA

offices in time to complete its review.

Therefore. EPA encourages submitters

to include all relevant information with

the notice.

Relevant data previously submitted to

another Federal agency must be

included with the section 5 notice. This

represents a change from the proposed

rules which would not have required

notices to include information already

submitted to other agencies. EPA made

this change because experience under

the Interim Policy indicates that it is

difficult to obtain information from other

agencies in time to analyze and use it

during the 90-day review period. EPA

does not believe this change will be

burdensome to submitters, since

relatively few data described or

submitted as part of section 5 notices

have been previously submitted to other

Federal agencies.

d. New information or data. During

the notice review period, submitten

may obtain additional information that

may be relevant to EPA's review.

Section 720.40ff) of the rule requires

submitters to provide EPA with this

information if it materially adds to.

changes, or makes significantly more

complete the information contained in

the original notice. Examples of

information that must be submitted

under this provision include: preliminary

or final results of health and

environmental effects tests not

previously known to the submitter, or

not complete at the time of notice

submission; new uses not described in

,the notice; significant increases in

estimated production volume; new

information significantly adding to

information on chemical identity (e.g.,

significant changes in impurity levels,

new information characterizing complex

reaction products or polymers); and

similar information.

The proposed rule would have

required this information to be

submitted to EPA "immediately."

Commenters asked for more specific

guidance on how long they would have

to submit new information. The final

rule now specifies that the information

must be submitted within 10 days of

receipt, but no later then 5 days before

the end of the review period. If the

information becomes available during

the last 5 days of the review period, the

submitter must telephone its EPA

contact for the notice "immediately."

EPA interprets this to mean as soon as

possible, generally within 24 hours.

2. Section-by-Section Review of the

Notice Form. The following paragraphs

describe the major differences between

the form proposed on October 16, 1979,

and the final form issued with this rule.

a. Submitter identification. This

section remains generally the same as in

the October form. However, submitters

are now asked to provide prenotice

communication, bona fide request, and

test-marketing exemption numbers to

help coordinate the Agency's review.

The parent company no longer must be

identifed because the Agency believes

that it can be obtain this information

from the submitter during the review

period in the few instances it is needed.

The form also eliminates the

requirement that submitters state the

intended date of commencement of

manufacture or import and submit

evidence of intent to manufacture if the

intended date is more than 3 years after

the date of the notice. EPA agrees with

commenters that the submitter's

certification on the form is sufficient

evidence of intent to manufacture or

import. However, EPA generally

encourages manufacturers and

importers to submit notices as close as

is feasible to 180 days before

manufacture or import is expected to

begin, since early notices are more

likely to have more complete

information.

b. Chemical identity. For the most

part, the requirements'for information

on the new substance's identity remain

the same as in the October 1979

proposal. However, manufacturers and

importers of new polymers must provide

'slightly different information than that

specified in October. Instead of

providing the range of composition of

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each monomer in the polymer,

manufacturers need only estimate the

typical composition of the monomers

and other reactants, e.g., catalysts and

initiators. This information is necessary

to evaluate fully the composition of the

polymer. Submitters also must provide a

representative structural diagram. The

Agency has found that the majority of

submitters have been able to develop

such diagrams. To define further the

composition of the new polymer,

submitters must provide an estimate of

the percent of the polymer composition

below 500 and 1,000 molecular weight

and describe how the estimates were

made. The Agency believes that such

information is essential to characterize

fully the unique identity of the new

polymer and its associated risks.

The rule requires that manufacturers

provide at least one generic name for

the substance, when chemical identity

has been claimed confidential. EPA

agrees with commenters that the

requirement to provide three names,

contained in the October proposal, is

unnecessary, since the three names

generally mask the identity of the

substance to a similar degree. EPA

encourages submitters to consult with

EPA to develop a useful generic name

before submitting the notice. If EPA

determines that the generic name

provided with the notice is inadequate,

submitters will be required to develop a

new name when the identity is added to

the Inventory upon commencement of

manufacture.

In general, the specific chemical

identity of a substance is a critical

element of the notice. If a submission

does not adequately provide this

information, EPA will determine that it

is incomplete. If the submitter does not

know the identity of a new chemical

substance-for example, because it

imports the substance under a

trademark or makes it from unknown

reactants-the submitter may authorize

another person to report the specific

identity or information that allows EPA

to determine the identity. The

submission, however, will be considered

incomplete and the review period will

not begin until EPA receives this

information. For a discussion of

incomplete submissions, see Unit

III.C.1.e. below.

c. Production and use information.

This rule requires reasonable estimates

of the maximum production volume

during the first year of production and

the maximum 1?-month production

volume during the first 3 years of

production. EPA believes that these

projections provide sufficient

information to perform its exposure

assessment and economic analysis. The

proposed rule would have required

submitters to report both maximum and

minimum projections for eabh of the first

3 years of manufacture. Since EPA's

review of notices under the Interim

Policy has typically focused on the first

year production volume and anticipated

maximum volume, more detailed

requirements are not justified.

The final rule requires information on

the intended categories of use of the

new substance in a level of detail

similar to that contained in the January

proposal. However, it does not require

that the submitter consult the standard

use classification system developed by

EPA for providing its use description.

EPA believes that the general concepts

of "function" and "application" provide

an appropriate method of categorizing

uses. A description of use in terms of the

substance's chemical function and the

general application of that function will

provide EPA with sufficient information

to identify the populations exposed to

the new substance and the nature of

that exposure. The submitter also must

provide the estimated percent of

production volume devoted to each

category of use.

Many commenters stated that EPA

does not have the authority to require

information beyond the broadest

category of use (e.g., surfactant,

photographic chemical) or that use

information, at the level of detail

required, is not typically known by the

manufacturer. EPA disagrees. The

category of use description required

under these rules is consistent with the

general intent under section 5(d)(1) to

provide EPA with the information

necessary for review. Adequate

information on the use of a substance is

critical in the evaluation of the potential

risks associated with human exposure to

and environmental release of the new

substance in that use. EPA has found

that the information required in this

section is the minimum necessary to

conduct a review of such risks. In

addition, EPA has found that such

information is available to the great

majority of notice submitters because

substances are typically manufactured

for a particular use.

Under section 5(d)(2) of the Act, EPA

must issue the uses or intended uses of a

new substance for publication in the

Federal Register. EPA will publish the

use as reported in the notice unless it is

claimed confidential. Consistent with

the Act's requirements and the October

proposal, this rule requires

manufacturers who claim use to be

confidential to provide a

nonconfidential (generic) use

description which EPA can issue for

publication in the Federal Register.

d. Hazard information. This rule

retains the requirement to submit a copy

or reasonable facsimile of any hazard

information which will be provided to

workers or customers, e.g., a Material

Safety Data Sheet. Several commenters

stated that hazard information is not

required under section 8(a)(2). EPA

believes that such information falls

clearly within the requirements of

section 5(d)(1)(C) of the Act since it

provides data on the potential exposure

and health effects of the new substance.

Such information has been an important

factor in EPA's evaluation of new

substances under the Interim Policy.

e. Transportation and detection

methods. EPA has eliminated proposed

questions on transport and detection

methods. Again, experience indicates

that data in response to these questions

is not especially useful in notice review.

f. Human exposure and environmental

release information. EPA has retained

the requirement that submitters describe

the manufacture and processing

operations involving the new chemical

substance at sites they control.

Commenters on the October proposal

stated that providing this informatioh

would be unduly burdensome and might

jeopardize the confidentiality of process

information. However, in its review of

notices under the Interim Policy, EPA

has found the process description

necessary to make qualitative estimates

of potential workplace exposure, to

estimate the amounts of the new

substance and byproducts released, and

to evaluate estimates provided in other

parts of the form. EPA has also found

that process descriptions based on

known or reasonably ascertainable

information may be developed by

submitters in less time than was

originally anticipated, and that OTS

procedures adequately protect any

confidential business information

contained in the notice.

In response to these comments,

however, the Agency has reduced the

amount of information it will require in

the process description from the

requirement proposed in October. EPA

does not require that a mass balance of

materials entering and leaving majorunit operations and chemical

conversions beprovided, nor must

submitters report the methods of

transfer of materials and whether the

operations are open or closed to the

workplace. Based on its experience

under the Interim Policy, EPA has found

that identification of major unit

operations and chemical conversions,

identity and mass of materials entering

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the process, and points of release of the

new substance is sufficient for its initial

review and is information known to or

reasonably ascertainable by submitters.

The sections of the form on

occupational exposure to and

environmental release of the new

substance are largely unchanged from

the October form. Instead of requiring

the specific routes by which workers

will be exposed, submitters need only

identify the activities of workers. This more generic approach will still provide

EPA with a more accurate indication of

exposure potential. Submitters also are not required to provide estimates of the

concentration of the new substance in

the workplace because EPA can make

such estimates from the process

description to the extent necessary for

its initial review. Submitters are now

required to identify the type of control

technology used to control

environmental release since control

equipment is frequently used and since

manufacturers typically have identified

the equipment that will be used by the

time the notice is submitted. The final

rule does not require estimates of the

duration of release for each point of

release. EPA will instead use reasonable

estimates based on the duration of the

process in its release analysis.

g. Sites controlled by others. The

section on industrial sites controlied by

others has been modified to require

general information on the activities of

customers who process and use the new

chemical substance. Submitters must

provide a narrative description of

processing and activities focusing on

those aspects which relate to the

potential for human exposure and

environmental release of the new chemical substance to the extent that

they know or can ascertain this

information.

The October proposal would have

required submitters to provide the same

quantitative estimates for sites

controlled by others as for the sites

which they controlled themselves.

However, manufacturers typically do

not have such detailed quantitative

information on activities not under their

control. Furthermore, the specific

circumstances of customers' operations

may vary, and all customers may not yet

be known, so that it may be difficult to

make quantitative estimates. The

narrative description required in the

form will provide sufficient information

for EPA to evaluate potential worker

exposure and environmental release at

customers' sites for EPA's initial review,

and allow identification of additional

information needs where the Agency

has identified a specific concern. In this

case, EPA may contact the submitter or

possible customers to obtain additional

information.

h. Consumer and commercial user

exposure. EPA has eliminated this

section from the final form. Thus,

manufacturer estimates of exposure that

would result from commercial and

consumer use of the new chemical

substances or final products containing

the new substance are not required. EPA

intends to use the information provided

in the "use" section of the form and

other information, such as production

volume, physical/chemical properties,

and its nwn knowledge of typical

commercial and consumer exposure

scenarios, to evaluate commercial and

consumer exposure. EPA's experience "under the Interim Policy indicates that it

can conduct such an evaluation where

the submitter provides the information

required in other sections of the form.

i. List of attachments. The list of

attachments is generally the same as it

was in the October form. For a

discussion of test data requirements, see

Unit III.B.1.c. of this preamble.

j. Optional information. The final form

does not contain a detailed optional

information section as was proposed in

the January 1979 form. EPA believes

such a detailed section may limit the

information that might be submitted

and, by identifying specific questions,

may make optional information seem

mandatory. The Instructions Manual

describes generally those items in which

additional information would be most

helpful in EPA's review. For example,

submitters may wish to provide

information on relative risk, process

chemistry, efficacy, additional exposure

and environmental release information,

industrial hygiene, engineering

safeguards, use restrictions, and

economic and other benefits of the new

substance. Information in these areas

may eliminate the need for extensive

communication between EPA and the

submitter during the review period and

may reduce the possibility of an

extension of the notice review period

under section 5(c) or regulation under

section 5(e) or 5(f). Although submitters are encouraged to submit optional

information, they are in no way required

to do so.

k. Federal Register notice. EPA has

eliminated the section of the October

form which requested information for

the section 5(d)(2) Federal Register

notice. Sections for generic descriptions

of confidential chemical identity and

category of use have been moved to

other parts of the form. In compiling the

section 5(d)(2) notice, the Agency will

assemble the necessary information

from the various parts of the notice. For

a further discussion of generic

descriptions, see Unit III.D. of this

preamble.

I. Confidentiality claims. Submitters

may assert claims of confidentiality for

any information on the notice form and

any attachments to the form, although

they should note that under section

14(b), claims for information in health

and safety studies will be denied unless

disclosure would reveal process

information, proportions of a mixture, or

information unnecessary to interpret the

study. (See Unit III.D.4) Instructions for

making claims are given on the form. If

chemical identity or use is claimed

confidential, the submitter must provide

a generic chemical name or generic use

that is as specific as possible.

EPA no longer requires substantiation

of confidentiality claims when the notice

is submitted. However, any submitter

that claims information confidential

must supply two copies of the notice:

One complete copy, and one "sanitized"

copy with all confidential information

deleted. EPA will put the sanitized copy

in the public record. The notice is

incomplete, and the review period does

not begin, until EPA has received both

the complete notice and the sanitized

notice. EPA explains its confidentiality

policy in more detail in Unit III.D. of this

preamble.

C. Notice and Review Procedures

1. Submission and Processing of

Notices.

a. Acknowledgement of receipt. Under

§ 720.65(a), EPA will acknowledge

receipt ofeach notice by letter to the

submitter. The 90-day notice review

period begins on the date of receipt

indicated on the letter of

acknowledgement.

b. Consolidated notices. In the course

of reviewing section 5 notices under the

Interim Policy, groups of notices were

often submitted for substances which

were similar in structure and use.These

notices contained a large amount of

duplicative information, such as

exposure, release, or use data. In

response to requests for relief from

submitters, EPA has developed

procedures for submission of a "consolidated" notice. Persons who

intend to manufacture or import two or

more structurally related new chemical

substances may contact the Prenotice

* Communications Coordinator to obtain

approval to submit a single "consolidated" section 5 notice for the

related substances. The submitter must

identify each new chemical substance

individually; a consolidated notice

cannot be submitted for an open-ended

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category of chemicals. A consolidated

section 5 notice is suitable for chemical

substances with the same or similar

uses and for which there are similar test

data or other information.

Manufacturers may not submit a

consolidated notice on a series of

intermediates and a final product in a

given process because these chemicals

do not sufficiently share common test

data or other information.

EPA will not accept a consolidated

notice unless the submitter has

contacted the Prenotice

Communications Coordinator to

determine whether the group of

chemicals are sufficiently similar that

they are suitable for review in a

consolidated notice. EPA encourages

submitters to submit consolidated

notices when appropriate; such notices

will reduce the burden on the submitter

of preparing multiple section 5 notices

sharing common information.

Consolidated notices also will improve

the efficiency and consistency of EPA's

review by allowing the staff to review

structurally related chemicals, and the

data and other information that are

common to them, at the same time.

c. Incomplete submissions. Under

§ 720.65(c) of this rule, EPA may

determine that a submission is

incomplete, and therefore does not

constitute a notice under section 5 of the

Act. For example, failure to provide

chemical identity or otherwise to supply

information required in the notice form,

if that information is known to or

reasonably ascertainable by the

submitter, will result in a submission

that does not constitute a notice. A

submission is incomplete if all

information (except information

published in the scientific literature) is

not in English or test data and other

data are not complete. A submission is

also incomplete if the submitter claims

information confidential and does not

submit a second copy of the notice from

which all confidential information has

been deleted. The review period will not

begin until the submission is complete.

If a submission is incomplete, EPA

may first request the missing

information from the submitter by

telephone. If the submitter does not

provide it quickly, EPA will inform the

submitter in writing within 30 days of

receiving the submission that it is

incomplete. However, if EPA obtains

additional information during the notice

review period, from the submitter or

elsewhere, that indicates the original

submission was incomplete, EPA may

declare the notice incomplete within 30

days of receiving the new information.

Under § 720.65(c) (4) and (5),

submitters may file objections to an EPA

finding that a submission is incomplete

with the Director of the Office of Toxic

Substances ("the Director"). The

Director, or his or her delegate, will

determine whether the original

submission was complete or incomplete,

or will modify the requirements for

completing the submission. If the

Director affirms that the original

submission was incomplete, the notice

period will not begin to run until EPA

receives the missing information. If the

Director finds that the original

submission was complete, the 90-day

review period will resume on the date

that EPA notifies the submitter that the

notice is complete. Therefore, if EPA

informed the submitter that the notice

was incomplete on the 15th day, the day

after EPA finds the notice was complete

would be the 16th day. However, if EPA

can complete its review by the date 90

days from the date of the original

submission, the Director may inform the

submitter that the review period began

when EPA received the original notice

and has run without interruption. EPA

recognizes that resuming the review

period on the date EPA notified the

submitter that the submission was

incomplete may conceivably delay the

start of manufacture or importation in

some cases; however, EPA has an

overriding responsibility to conduct an

adequate review which ensures against

a potential risk to human health or the

environment. EPA will avoid delaying

the starting date whenever possible.

If EPA identifies a minor problem in

the submission, such as failure to date it

or a typographical error that renders an

entry ambiguous, it may, under

§ 720.65(b), ask the submitter to correct

the notice. The submitter is under no

obligation to make the correction, but

failure to do so may cause EPA to

extend the review period under section

5(c) of the Act. Of course, if the

submitter corrects the minor problem,

EPA may still extend the period under

section 5(c) if good cause otherwise

exists.

The final rule modifies the procedures

for incomplete submissions proposed in

January 1979. Under the proposed

procedures, submitters had no formal

appeal procedures if EPA determined

that a submission did not meet the

standards for review, and the review

period for submissions with minor errors

could be stopped until the errors were

corrected. EPA has changed these

requirements in response to comments

and because of its experience under the

Interim Policy.

EPA, however, disagrees with

commenters who argued that EPA has

no authority to determine that a

submission is incomplete, and that

EPA's only remedy is section 5(e). The

Act explicitly requires the submitter to

provide certain information in a section

5(a) notice that is known to or

reasonably ascertainable by the

submitter. A submission that fails to

meet the minimum statutory

requirements, therefore, is not a

complete notice under the Act, and EPA

is justified in refusing to review it.

Section 5(e) is not an appropriate

remedy for this situation. The purpose of

section 5(e] is to allow EPA to regulate

new chemical substances "pending the

development of information" necessary

for a reasoned evaluation of health and

environmental effects. Its purpose is not

to gather information that the submitter

already knows or can reasonably

ascertain and that is required by the Act

to be submitted in the initial notice.

Under the Interim Policy, EPA has

received several submissions that, it

believed, did not include required

information that was known or

reasonably ascertainable by the

submitter and which therefore did not

meet the statutory requirements. For

example, one submission did not include

the molecular structure of the new

chemical substance. EPA scientists

determined that representative

molecular structures for the substance

were in fact known to or reasonably

ascertainable by the submitter, because

a knowledgeable chemist would be able

to derive the structure from process

information. Therefore" the notice

review period did not begin until this

information was provided to EPA.

In another case, the submitter

described the category of use of a new

chemical substance only as "photographic chemical" without

specifying its end use in terms of its

function and application (e.g., reducing

agent in developer solution). The term

"photographic chemical" was

inadequate for EPA's assessment of

potential human exposure and

environmental release. In a third type of

problem, submitters often have

described the chemistry of the

manufacturing operation without

indicating the order and type (e.g.,

distillation, mixing) of the manufacturing

steps. For example, manufacturers of

coatings for manufactured parts have

sometimes failed to provide information

on coating operations at sites they do

not control. In such cases, if EPA staff

cannot quickly obtain the information

from the submitter in response to a

telephone request, EPA will declare the

notice incomplete and the review period

will not begin until EPA receives the

information.

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d. Extension of review period. Section

5(c] of the Act provides that EPA may

extend the 90-day review period for up

to an additional 90 days for good cause.

Section 720.75(c) of this rule provides

that EPA will notify the submitter if EPA

extends the period and gives examples

of circumstances that EPA believes

could constitute good cause for

extension. EPA will also issue for

publication a Federal Register notice

when it extends a review period under

section 5(c). The notice will describe the

extension and give the reasons for it.

e. Suspension of review period.

Section 720.75(b) of thjs rule provides

that a notice submitter may voluntarily

suspend the running of the review

period at any time, but only if the

Director, or his or her delegate, agrees. If

the Director does not agree, EPA will

notify the submitter and the review

period will continue to run. The

suspension must be for a specified

period of time. If the notice submitter

makes the request orally, the Director

may grant a suspension for 15 days. EPA

will send the submitter a written

confirmation of the suspension if it is

granted orally. The Director will extend

the suspension if the OTS Document

Control Officer receives a written

confirmation of the request within 15

days of the approved oral request. In

this case, the running of the review

period is suspended as of the date of the

confirmed oral request. The notice

submitter also may request a suspension

in writing. In this case, the suspension

begins the date the Document Control

Officer receives the request, if EPA

approves the request.

Under the Interim Policy, EPA has

found suspension of the review period

may be beneficial when questions

concerning anew chemical substance

that arise during the notice review

period can be adequately addressed by

the notice submitter. Suspension of the

review period is often helpful in these

cases because a submitter may not be

able to respond to EPA's concerns

within the review period, even if EPA

extends the period to 180 days under

section 5(c). For example, in one

instance the Agency needed more

detailed use and exposure information

which the submitter was able to obtain

from potential customers. In other cases,

the notice review period was suspended

to allow time for voluntary health

effects testing, and for chemical analysis

to determine the levels of certain

impurities. Voluntary suspensions

benefit both EPA and notice submitters

because they save EPA resources and

often eliminate the need for regulatory

action.

f. Closeout and commencement of

manufacture. Under § 720.75(d), EPA

will notify submitters when the notice

review period has ended, if EPA has not

taken action under section 5(e) or 5(f) of

the Act. EPA will inform submitters that

they can begin manufacture or import

for commercial purposes. This action

does not constitute EPA approval or

certification of the substance and does

not preclude later regulatory action by

EPA. Submitters may begin to

manufacture or import a new chemical

substance after the close of the review

period, even if they have not been

notified by EPA that the review period

has ended. In the final rule, EPA has

dropped the notice of continuing review

proposed in January 1979, since the

closeout notification can serve the same

purpose, i.e., informing the submitter of

any concerns EPA may have about the

new chemical substance, and any

regulatory actionsbeing considered.

Also, there is no obligation that EPA

inform a submitter that it is

contemplating regulation of the new

chemical substance.

Section 720.102 requires that

submitters notify EPA when they begin

to manufacture or import the new

chemical substance, so EPA may add

the substance to the Inventory. The

submitter must provide chemical

identity, premanufacture notice number,

and the date that manufacture or import

for commercial purposes begins. EPA

proposed this requirement in January

1979 and believes that most notice

submitters to date have notified EPA

when they began manufacture or import.

However, any persons who already

have begun to manufacture or import a

chemical substance after undergoing

notice review, but who have not yet

submitted a notice of commencement or

manufacture, must submit the notice by

the effective date of this rule to allow

EPA to update the Inventory.

2. Supplemental Reporting. In January

1979, EPA proposed supplemental

reporting ("letter-writing") authority

which would have enabled EPA to

obtain additional written information on

a new chemical substance or related

chemicals during the notice review

period. EPA also proposed an analogous

provision for requesting health and

safety studies. EPA based its authority

to obtain certain information known to

or reasonably ascertainable by the

submitter and others on section 8 of the

Act. Even after the scope of reporting

was narrowed in the October 1979

reproposal, many commenters objected

to the supplemental reporting

provisions, arguing that EPA does not

have authority to require such reporting.

Since the reporting requirements in

the final rules are reduced from those in

the proposed rules, the ability of EPA to

obtain additional information during the

review period is especially important.

While EPA still believes it has the

authority under section 8 to obtain

additional information from the

submitter and others who may have

information about the new chemical

substance during the notice review

period, EPA has not adopted

supplemental reporting authority

because it has proved unnecessary to an

effective section 5 notice review

program. EPA also has eliminated the

provision for requesting health and

safety studies on the new chemical

substances or related chemicals. EPA

has found that telephone calls to

submitters are generally adequate to

obtain additional information during the

notice review period. In the occasional

case where a submitter is unwilling to

provide the information, EPA has the

option of taking action under section

5(e) (regulation of a new chemical

substance pending development of new

information) or sectiqn 11 (subpoena

authority). Although these actions are

more resource-intensive and timeconsuming than a supplemental

reporting request, such formal actions

will rarely be necessary. However, EPA

is prepared to act under these

authorities when submitters do not

provide the necessary information.

3. Actions Under Sections 5(e) and

5(f). In the final rule, EPA has deleted

§ § 720.36 and 720.37 of the January 1979

proposal, which described EPA's

procedures for taking action under

sections 5(e) and 5(f). It is not necessary

to include these provisions in the rule,

because many of the procedures are

already set out in the statute, and

because submitters will be notified of

the remaining procedures when EPA

takes action against a specific

substance. In dropping these sections,

EPA has deleted the provision that

would allow it to notify persons other

than the notice submitter, who would be

affected by the order, of the basis of a

proposed section 5(d) or 5(f) action.

Many commenters objected to this

provision, arguing that only the notice

submitter couldbe subject to a section

5(e) or 5(f) order. EPA will notify only

those persons subject to a section 5(e) or

5(f) order, and it will allow only those

persons to file objections to the order.

Of course, any person who uses a new

chemical substance that the person

knows or has reason to know was

manufactured, imported, processed, or

distributed in commerce in violation of a

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section 5(e) or 5(f) order is in violation

of section 15 of TSCA.

EPA has also eliminated § 720.37(b)(6)

of the January 1979 proposal, which

provided that EPA would consider

subsequent notice submissions for

substances subject to a section 5(f)

order to be applications for modification

or revocation of the order, rather than

section 5 notices. This section was

eliminated because EPA recognizes that

a subsequent submission for a chemical

substance subject to a section 5(f) order

might describe different conditions of

exposure which might not present an

unreasonable risk. Therefore, EPA will

consider these submissions to be section

5 notices, and they will undergo review.

4. Recordkeeping. The final rule

retains the provision in the proposed

rule that requires notice submitters to

retain documentation of information in

the notice. This would include the

sources of information provided in the

notice, e.g., production volume estimates

in marketing plans. Submitters also must

keep records of production volume for

the first three years of production and

the date of commencement of

manufacture or import, and

documentation of this information. In

addition, submitters must keep copies of "other data," which they were required

to describe in § 720.50(b), if they are in

the submitter's possession or control.

This information must be retained for 5

years from the date of commencement of

manufacture.

EPA has dropped the provision that

the submitter retain health and safety

data referenced in the notice for 30

years. EPA believes this provision is

unnecessary because the submitter must

include these data, or a standard

literature citation to these data, with its

notice. Therefore, EPA will already have

the data in its own files.

Persons who manufacture or import a

chemical substance under the terms of

an R and D exemption must retain

documentation of compliance with the

exemption requirements, including

copies of the information they used to

determine the heed to make any

notification of risk to health or to

persons exposed to the chemicals. This

information must be retained for 5 years

from the final date of manufacture or

import under the exemption.

Persons who are granted a testmarketing exemption application must

retain documentation of information

submitted in the notice. They also must

document compliance with any

restrictions EPA imposes when it grants

the exemption. This information must be

retained for five years from the final

date of manufacture or import under the

exemption.

5. Compliance and Inspections. It is

unlawful for any person to fail or refuse

to comply with any provision of section

5 or any rule promulgated under section

5. Manufacture or processing of new

chemical substances without complying

with section 5 and this rule is a violation

of section 15. When more than one

manufacturer or importer is involved in

a transaction, each one is liable for

manufacture or import of a new

chemical substance if a notice has not

been submitted or the review period has

not expired, even though only one

person involved in each transaction

(e.g., the principal importer) may submit

the notice.

Section 15 of TSCA makes it unlawful

for any person to: (i) Use for commercial

purposes a chemical substance or

mixture which such person knew or had

reason to know was manufactured,

processed, or distributed in commerce in

violation of this rule.

(ii) Fail or refuse to establish and

maintain records or to permit access to

or copying of records as required by the

Act or a rule promulgated under the Act.

(iii) Fail or refuse to permit entry or

inspection as required by section 11.

Violators may be subject to criminal

and civil liability. Persons who submit

materially misleading or false

information in connection with the

requirement of any provision of this rule

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

section 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 this rule could lead to the imposition

of criminal penalties of up to $25,000 for

each day of violation and imprisonment

for up to one year. Other remedies are

available to EPA under sections 7 and

17 of TSCA such as seeking an

injunction to restrain violations of the

rule and the seizure of chemical

substances manufactured or processed

in violation of the rule.

Individuals as well as corporations

could be subject to enforcement actions.

Sections 15 and 16 apply to "any

person" who violates various provisions

of TSCA. Thus, in actions under section

16, EPA may, at its discretion, proceed

against individuals, such as corporate

officials, as well as the companies

themselves. In particular, this includes

individuals who report false information

or who cause it to be reported.

EPA will also direct its resources to

detecting violations of other aspects of

the section 5 notice rule, particularly the

terms of exemptions for research and

development and for test marketing.

EPA will conduct inspections under

section 11 of TSCA to assess

compliance with the requirements of

section 5 and this final rule. Inspectors

will compare the information in the

submitter's notice with the actual

conditions of manufacture or import to

verify that the information was correct,

estimates were reasonable, and any

exposure controls described in the

notice are in place.

D. Confidentiality

The Act recognizes the importance to

industry of maintaining the

confidentiality of certain business

information; section 14 allows a

submitter to claim confidentiality for

any information submitted to EPA under

the Act.-However, the Act also makes

clear that the public interest in chemical

regulation must also be considered, and

in certain cases, outweighs the

protection of confidential business

information. Thus, section 14 also

provides that health and safety studies

may be revealed and that any

confidential information may be

revealed if necessary to protect health

or the environment from an

unreasonable risk of injury.

Certain provisions of section 5 also

highlight EPA's responsibility to provide

meaningful information to the public

concerning new chemical substances.

Section 5(d)(1) states explicitly that a

section 5 notice must be made available

for "examination by interested persons,"

subject to the confidentiality provisions

of section 14. Further, section 5(d)(2)

requires EPA to issue for publication a

Federal Register notice upon receipt of

each section 5 notice, that identifies the

chemical substance, lists the intended

uses, and describes test data, also

subject to the confidentiality provisions

of section 14. More generally, the Act

includes a variety of provisions under

which citizens can petition EPA to take

particular actions on section 5 notices.

These provisions indicate that Congress

intended informed citizen involvement

in review of new chemical substances,

although EPA is to be the primary

decisio.nmaker. Public participation

cannot be effective unless meaningful

information is made available to

interested persons.

In addition to these responsibilities

which are related directly to the Act,

EPA has general responsibilities under

the Freedom of Information Act (FOIA).

Under the FOIA, persons may request

disclosure of any information submitted

in a notice. When such a request is

made, EPA, in accordance with the

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procedures of 40 CFR Part 2, Subpart B,

must review information which is

claimed confidential to determine

whether it is entitled to confidential

treatment. If EPA determines that the

information is confidential and therefore

does not disclose it, the FOIA requester

may bring an action in Federal court to

review EPA's decision.

The confidentiality provisions in the

final rule take into account various

requirements under the Act, including

the need: (1) to provide nonconfidential

information to the public, (2) to give EPA

information it needs to respond to FOIA

requests, (3) to allow pqrsons to assert

claims of confidentiality with the

minimum burden, and (4) to reduce

uncertainty about the criteria EPA will

use in making its confidentiality

determinations. In determining the final

confidentiality provisions, EPA also

considered its experience with section 5

notices under the Interim Policy as well

as comments received on the January

1979 and October 1979 proposals. EPA

believes these provisions represent a

balance between the industry's need for

confidentiality of business information

and the public interest in having access

to information about new chemicals.

1. Assertion of Confidentiality Claims.

A person may assert a claim of

confidentiality for any information

submitted to EPA. Submitters must

assert the claim when they submit the

confidential information. If the -

information to be claimed confidential is

contained on the notice form, submitters

must assert their claims by marking the

box on the form adjacent to the item. To

assert a claim for information in an

attachment to the form, submitters must

clearly mark all confidential items in the

attachment.

Any submitter that claims information

confidential must provide two copies of

its submission: a complete copy of the

notice including all confidential

information and a "sanitizied" copy in

which all confidential information has

been deleted. EPA will assume that the

submitter has prepared a sanitized copy

that accurately deletes any information

claimed confidential. EPA will place the

submitter's sanitized copy in the public

file. If the submitter does not provide a

sanitized copy, the submission is

incomplete and the notice period will

not begin. EPA believes this provision is

in the best interest of the submitter, the

public, and EPA.

Alternatively, if the submitter does

not provide the sanitized copy with the

notice, EPA could consider the

submission complete and allow the

submitter to provide the sanitized

version early in the notice review

period. However, this would deprive the

public of access to the notice

information for a significant portion of

the review period. EPA could also

prepare the sanitized copy itself.

However, this would require substantial

EPA resources and there is a chance

that EPA inadvertently would not delete

all of the information claimed

confidential. In addition, EPA believes It

is more efficient for the submitter, which

is more familiar than EPA with the

nature, extent, and rationale for the

claims, to prepare the sanitized copy.

EPA also considered the alternative of

putting the entire notice, including

information claimed confidential, in the

public file if the submitter did not

provide a sanitized version. However,

EPA believes this would be

unnecessarily harsh. Therefore, EPA

believes that treating the notice as

incomplete until it receives the sanitized

version is the most equitable policy.

2. Generic Information. A submitter

that claims chemical identity or use

confidential must provide generic

information for release to the public. By

requiring generic chemical names and

uses, EPA can meet its obligation to

provide the public with important

information on the risks of new

substances without revealing

confidential business information. EPA

requires that the generic information be

provided on the notice form so it can

include this information in the section

5(d)(2) Federal Register. notice. If EPA

had to request the generic information

after it received the notice, or develop

the generic information itself, EPA could

not meet the requirement that the

Federal Register notice be published 5

days after EPA receives the notice form.

Unlike the proposed rule, the final rule

does not state that the generic chemical

name must disclose "toxicologically

significant information to the maximum

extent possible"; instead, the generic

name should reveal the substance's

chemcial identity to the maximum

extent possible. EPA has found that,

prior to a.substantive review of the

hazard potential of a new substance, it

is often difficult to identify

toxicologically significant portions of

the molecule. Therefore, at the beginning

of the notice review period, it is more

useful to require instead that the

chemical identity be revealed as fully as

possible. The generic use should also be

as specific as possible. EPA encourages

submitters to contact the EPA Prenotice

Communications Coordinator to discuss

appropriate generic names and uses

before actually submitting the notice.

The proposed rule would have

required that submitters provide three

generic chemical names with the section

5 notice; however, the final rule requires

only one. EPA's experience in the

section 5 program has shown that three

names are not necessary since,

generally, all three names provided are

similar in specificity. EPA will publish

the generic name given in the notice in

the section 5(d)(2) Federal Register

notice. However, when the manufacturer

or importer submits a notice of

commencement of manufacture using

the same generic name, EPA may

determine that the generic name is more

generic than necessary to protect

confidential chemical identity EPA will

then propose a more specific name. If

that name is unacceptable, the submitter

must explain why EPA's name would

disclose confidential business

information and propose an alternative.

EPA will publish the submitter's

alternative name if it is acceptable.

Otherwise, EPA will put the generic

name it devised on the public Inventory,

30 days after giving notice to the

submitter.

EPA has not adopted the proposed

requirement that submitters provide

generic information on physical/

chemical properties (in terms of ranges)

and submitter's identity (in terms of

geographic location, annual sales, and

type of company) if they are claimed

confidential. EPA made this change in

response to commenters who stated that

it is difficult to develop generic

descriptions of physical/chemical

properties and submitter's identity

which provide useful information

without disclosing confidential business

information. Also, unlike chemical

identity and category of use, EPA is not

required to issue any information

concerning physical/chemical properties

or the submitter's identity for

publication in the Federal Register.

Therefore, generic information on these

categories is not necessary.

3. Substantiation of Claims. The final

rule does not require substantiation of

any confidentiality claims when a

section 5 notice is submitted. However,

a confidentiality claim for chemical

identity must be substantiated when the

notice of commencement of manufacture

is submitted.

This approach reflects a substantial

modification of the confidentiality

procedures proposed in January 1979

and October 1979. The January proposal

would have required submitters to

substantiate confidentiality claims at

the time of submission only for chemical

identity and health and safety data,

while the October proposal would have

required substantiation of all

confidentiality claims at the time of

submission (though it allowed assertion

and substantiation by category.) EPA

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believed that this "up-front"

substantiation would be necessary to

allow EPA to respond to FOIA requests

in a timely manner.

Under the Interim Policy, submitters

were encouraged to substantiate all

confidentiality claims when the notice

was submitted; if they did not

substantiate their claims, EPA sent a

letter requesting substantiation. EPA

changed this policy in a notice published

in the Federal Register of July 3, 1982 (47

FR 28969). In-that notice, EPA explained

that because EPA had not received large

numbers of FOIA requests, "up-front"

substantiation of claims was not

necessary to make timely responses to

FOIA requests. Also, the substantiation

requirement had not reduced the

number of confidentiality claims as

expected. The final rule adopts the same

policy. EPA will request substantiation

for information submitted in section 5

notices only when it receives an FOIA

request for the information claimed

confidential, or when EPA has its own

reasons for making a final

confidentiality determination, for

example, when EPA is contemplating

regulatory action. By not requiring "upfront" substantiation of all claims,

submitters will not have to incur the

burden of substantiation unnecessarily.

The final rule requires submitters to

substantiate claims of confidentiality for

chemical identity at the time a notice of

commencement of manufacture or

import is submitted, and provides that

EPA may disclose a chemical identity

claimed as confidential but not

accompanied by adequate

substantiation. As EPA stated in the

Interim Policy of May 15, 1979, all

information submitted to EPA under the

section 5 notice program before the

effective date of the final rule will

become subject to the confidentiality

policies of this rule (45 FR 28567). The

Interim Policy does not require

submitters to substantiate claims of

confidentiality when the notice of

commencement is submitted, although

EPA encourages them to do ao. As a

result, EPA has received notices of

commencement in which chemical

identity was claimed confidential

without any accompanying

substantiation. Under the final rule,

these chemical identities could be

disclosed when it goes into effect.

In the May 1979 Interim Policy EPA

stated that it would give submitters

"ample opportunity to update or modify

confidentiality claims prior to becoming

subject to any new requirements." EPA

believes that 45 days after the effective

date of this rule is an ample period for

submitters with unsubstantiated claims

of confidentiality of chemical identity in

notices of commencement of

manufacture or import to substantiate

those claims. EPA will notify each

affected person by letter. If EPA has not

received substantiation for the claim

within 45 days after the effective date of

this rule, it may place the specific

chemical identity on the public

Inventory consistent with EPA's general

procedures for handling confidential

information in 40 CFR Part 2.

4. Health and Safety Studies. Section

14(a) of TSCA prohibits EPA from

disclosing confidential. business

information reported under the Act

except in certain specific circumstances.

Section 14(b), however, states that EPA

is not prohibited from disclosing health

and safety studies of substances for

which section 5 notification is required,

unless disclosure reveals confidential

processes or portions of a mixture.

Therefore, EPA cannot refuse to disclose

such information in response to an FOIA

request, and EPA will deny any claim of

confidentiality for the protocol, data,

analysis, and results in a health and

safety study if the submitter does not

establish that disclosure would reveal

the following confidential information:

(1) process information, (2) portions of a

mixture, or (3) information unrelated to

the effects of the substance on human

health and the environment.

In some submissions, chemical

identity may be claimed confidential

and attachments to the notice form may

contain health and safety studies on the

new chemical. EPA will disclose the

specific chemical identity that is the

subject of those studies if disclosure of

chemical identity: (1) is necessary to

interpret the health and safety study,

and (2) would not reveal confidential

process or mixture information.

Disclosure of chemical identity is

discussed in more detail below.

5. Specific Chemical Identity. A major

issue in this rulemaking has been the

confidentiality of the specific chemical

identity that is the subject of a section 5

notice. This issue is of particular

concern when health and safety studies

are submitted for the substance. Under

section 14(b) of TSCA, EPA may not

withhold from the public data from

health and safety studies unless the data

would disclose confidential

manufacturing or processing processes

or the proportions of specific chemical

substances in a mixture. The disclosure

requirement applies to data in the study

and data underlying the study.

As EPA stated in the January 1979

proposal, the Agency considers the

specific chemical identity always to be

part of a health and safety study even

when it does not appear in the study.

Consequently, the chemical identity

would be subject to the disclosure

requirements of section 14(b). However,

in many cases the chemical identity is

one of the most commercially sensitive

pieces of information in the section 5

notice. Because of the substantial

concern expressed by industry about the

harm of disclosing confidential chemical

identities, EPA explored ways of

limiting the commercial harm of such

disclosure while still meeting the

requirements of section 14(b) of TSCA

and providing the public with adequate

information about health and safety

studies.

In January 1979, EPA proposed that

confidential chemical identities would

not be released prior to commencement

of manufacture or import, even when

health and safety studies had been

submitted in the notice. After

commencement of manufacture,

chemical identity would be disclosed if

health and safety studies had been

submitted and the identity was not

exempt under section 14(b) by virtue of

revealing a confidential process or

confidential proportions of substances

in a mixture. Because of the sensitivity

of this issue, under its Interim Policy,

EPA has honored claims of

confidentiality for specific chemical

identity, even when health and safety

studies have been submitted, reserving a

final decision on the issue for this final

rule.

This issue generated a great deal of

comment. Industry has expressed its

concerns about disclosure of

confidential chemical identities at any

time, while public interest groups and

others are concerned that health and

safety studies would be meaningless

without knowledge of the specific

chemical identity involved. In an

attempt to meet both these concerns,

EPA has chosen an approach that

balances the need for confidentiality,

the need to understand health and

safety studies, and the provisions of

TSCA.

Under § 720.85 of the rule, in the

absence of any hqalth and safety

studies, chemical identity will be held

confidential as long as it meets the

general tests for confidentiality in 40

CFR Part 2. This is true both before and

after commencement of manufacture or

import. Under § 720.90(c) of the rule, if

any health and safety studies have been

submitted for the chemical substance in

question, the specific chemical identity

will be held confidential only if

disclosure would reveal confidential

manufacturing or processing processes

or the confidential proportions of

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substances in a mixture, or if the

specific chemical identity is not

necessary to interpret any of the studies.

This solution will result in disclosure

of a confidential chemical identity only

when it is necessary to interpret a

health and safety study, unless

disclosure would reveal confidential

process or mixture information that is

protected under section 14(b). This

meets concerns expressed by both

industry and public interest gtioups.

Industry was concerned that a rule

mandating disclosure even when

disclosure would not serve any public

interest would unnecessarily penalize

companies conducting health and safety

studies. One the other hand, public

interest groups were concerned that

disclosure of health and safety studies

without the identity of the substance

involved would be meaningless if

knowledge of the specific identity were

necessary to understand the study.

Under this approach, companies will be

able to present arguments that

disclosure of the specific chemical

identity is not necessary to interpret a

study and, at the same time, members of

the public requesting access to studies

will be able to argue why disclosure of

the specific identity is necessary.

This solution to the issue of

confidential chemical identities'also has

an impact on development of generic

chemical names. Companies that claim

specific chemical identity confidential in

their notices who wish to argue that

knowledge of the specific identity is not

necessary to interpret their health and

safety studies are encouraged to choose

generic names which are sufficiently

specific to interpret their health and

safety studies. Sufficiently specificgeneric names will tend to support

arguments that disclosure of the specific

chemical identity is not necessary to

understand the study.

IV. Related Rulemaking and Other

Actions

A. Section 5(h)(4) Exemptions

Under section 5(h)(4), EPA may, upon

application and by rule, exempt

manufacturers or importers from all or

part of the requirements of section 5 if it

determines that the manufacture, import,

processing, distribution in commerce,

use, or disposal of a new chemical

substance will not present an

unreasonable risk of injury to health or

the environment. Based on its

experience in the section 5 review

program to date, EPA has promulgated

one section 5(h)(4) exemption rule and

proposed two others.

EPA promulgated an exemption for

new chemicals used in certain'instant

photographic and peel-apart film

articles, published in the Federal

Register of June 4, 1982 (47 FR 24308).

Persons may manufacture these

chemicals without undergoing the full

90-day section 5 review, as long as the

manufacturer uses certain exposure

controls.

EPA also proposed rules to exempt

certain site-limited intermediates, low

volume chemicals, and polymers, which

were published in the Federal Register

of August 4, 1982 (47 FR-33896). The

proposed exemption for site-limited

intermediates and chemicals

manufactured at 10,000 kg or less per

year would exempt these chemicals if

they do not have certain adverse health

or environmentaleffects and the

manufacturer or importer submits a

short notice to EPA 14 days before

manufacture begins. A qualified expert

would assess the new chemical (unless

it was manufactured at 1,000 kg or less

per year) to ensure that it met the

exemption criteria. The polymer

exemption would allow manufacture or

import of certain new polymers as long

as EPA is notified when manufacture

begins. Other new polymers would

undergo an abbreviated 14-day section 5

notice review.

EPA is reviewing the comments on

these proposed exemptions and intends

to issue final exemption rules in mid1983. If the provisions of the final rules

are similar to the provisions in the

proposed rules, EPA expects that

approximately 60 percent of all new

chemicals will qualify for one or more of

these exemptions.

B. New Chemical Follow-Up Rules

EPA will promulgate follow-up

reporting rules on certain new chemical

substances under section 5(a)(2) and

8(a) of TSCA. Such rules will allow EPA

to obtain information on selected new

chemical substances after they have

entered commercial production, and to

reassess certain new chemical

substances before they are produced for

new uses that may significantly increase

their risk to human health or the

environment.

EPA has proposed significant new use

rules (SNURs) and section 8(a) rules for

chemical substances in the Federal

Register and will continue to do so. A

SNUR requires persons to notify EPA 90

days before they manufacture, import, or

process the substances subject to the

rules for a significant new use, as

defined by the rule. The same reporting

requirements, review procedures, and

authorities that apply to notices for new

substances apply to SNUR notices.

However, if after receipt of a SNUR

notice, EPA does not act to regulate the

chemical, it must state its reasons in the

Federal Register. Section 8(a) rules

require limited reporting of information;

these rules will be used primarily to

monitor changes in exposures to

chemicals of concern.

Follow-up is an important complement

to the section 5 notice review program,

which is necessarily limited by the

nature of notices on new substances and

the section 5 review process. Notices

describe the specific uses for which the

submitter intends to manufacture or

import a new chemical substance and

the exposures associated with the

intended methods of manufacture,

processing. uses, and disposal. EPA will

generally base its review and any

regulation under section 5(e) or 5(f] on

these uses and exposures. In some

cases, a substance may raise concern,

but the exposure predicted from the

information in the notice may not

present a significant risk. In these cases,

EPA might not take action against the

substance during the review period.

However, once such a substance has

completed section 5 review and has

entered commerce, anyone may

manufacture, import, or process it for

any use without EPA review, even a use

likely to result in high levels of exposure

that would significantly increase risk. In

such a case, EPA might require reporting

under a SNUR or section 8(a) rule to

ensure review and the opportunity to

control these risks before they occur.

C. Testing Guidelines

EPA issued premanufacture testing

guidelines which were published in the

Federal Register of January 27, 1981 (46

FR 8985). In these guidelines, EPA

recommends that notice submitters use

the Organization for Economic

Cooperation and Development (OECD)

Minimum Premarket Data set as a

starting point in setting up a testing

program for new chemicals. EPA is not

requiring these data, and a submission

that does not contain them would be

complete if it otherwise meets the

requirements of the Act. Instead, EPA

intends that submitters use the testing

guidelines flexibly, tailoring their

evaluations of new chemicals to the

specific new chemicals in question. EPA

also encourages submitters to follow

any Good Laboratory Practides issued

under TSCA.

V. Related Documents

A. Response to Comments

During this rulemaking, EPA has

solicited public comment on several

proposals and other public documents.

These include the January 10, 1979,

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proposed rule (44 FR 2242); the October

16, 1979, proposed rule (44 FR 59764); the

methodology for the Economic Impact

Analysis (44 FR 39450); the proposed

processor reporting requirement (45 FR

54642); the clarification of the importer

definition (45 FR 63806); the draft

Regulatory Analysis and the proposed

Economic Impact Analysis (45 FR

74945); and the notice on substantiation

of confidentiality claims (47 FR 28969).

EPA received numerous comments from

individual companies, trade

associations, labor unions, public

interest organizations, and other groups.

and individuals. These comments were

carefully considered in developing the

final rule.

EPA has prepared a detailed

Response to Comments on the

Premanufacture Notice Requirements

and Review Procedures for New

Chemical Substances. In this document,

EPA has summarized the major

comments that it received on the

documents listed above and gives its

response to each. The Response to

Comments is available in the Public

Reading Room.

B. Instructions Manual

EPA is also distributing an

Instructions Manual for Premanufacture

Notification of New Chemical

Substances. All persons subject to

section 5 notice requirements, or who

believe that these requirements may

apply to them, should obtain a copy of

this manual from the OTS Industry

Assistance Office. In the manual, EPA

describes: (1) EPA's statutory authority

under section 5 of the Act; (2) section 5

reporting requirements; (3) EPA notice

review procedures; (4) procedures for

asserting and substantiating

confidentiality claims; and (5)

instructions for completing the notice

form.

VI. Regulatory Impact Analysis

Under Executive Order 12291, EPA

must determine whether a rule is

"major" and therefore subject to the

Regulatory Impact Analysis

requirement. EPA considers this rule to

be major. Although the rule will not

have an annual effect on the economy of

$100 million or more, the costs of

complying with the rule will result in an

increase in costs for chemical

manufacturers and photographic

companies, and there may be some

effects on innovation. Also, EPA will

incur certain costs to conduct the notice

review program. EPA based its

classification of this rule as "major" on

various studies conducted on the cost of

compliance with section 5 notice

requirements and the effect of these

requirements on new chemical

innovation. EPA has prepared a

Regulatory Impact Analysis to

accompany this rule which summarizes

these studies.

EPA included brief regulatory

analyses of the January 1979 and

October 1979 proposed rules in the

preambles to those rules. In November

1980, EPA issued an extensive draft

Regulatory Analysis. The Regulatory

Impact Analysis that accompanies this

rule compares the notice form proposed

by EPA in October 1979, a form

proposed by the Chemical

Manufacturers Association (CMA] in

1979, an in-house draft form comparable

to the form required in this rule, and the

final form. The Regulatory Impact

Analysis concludes that the primary

economic effect of the final form is that

industry's cost is between $5 million and

$12 million annually to complete the

notices. These costs are similar to the

costs of the CMA form and considerably

less than the costs of EPA's October

1979 form.

The Analysis also concludes that

while the October 1979 form makes it

easier for EPA to identify problem

chemicals and take action, the

probability of EPA identifying these

problem chemical is not significantly

lower with the other forms. Thus the

incremental benefits of the lengthier

October 1979 form are small.

The third major finding of the

Regulatory Impact Analysis concerns

the distributional effect of the existing

notice review program. Based on data

from several industry-commissioned

surveys and on data in confidential

section 5 notice files, it appears that

there has been no significant reduction

in the number of new chemical

innovations since 1979 among the

largest companies, but limited data

suggest that there probably has been a

decline in innovation activity by smaller

companies, which tend to produce low

volume chemicals. To help reduce this

effect on small companies, EPA employs

consultants to assist them in preparing

notices, at no expense to the submitters.

The fourth major finding of the

Analysis is that promulgation of the

proposed section 5(h)(4) exemptions to

the section 5 notification program would

reduce the annual cost to industry of

complying with section 5 notification

requirements by 19 to 30 percent, to

between $4.2 and $9.1 million annually.

In addition, the proposed exemptions

will significantly' reduce the burden of

the nqw chemical review requirements

on small firms. If EPA promulgates the

provisions in the proposed exemption

rules, there will be cost savings of 11 to

35 percent of total notification costs for

firms with sales less than $100 million

annually.

These findings on cost to submitters

were reached by calculating the cost of

filing the notice form, the cost of delay

(the present value of profits delayed

because of the notice review process),

the cost of maintaining confidentiality,

and the cost of implementing voluntary

controls on the ntenufacturing,

processing or marketing of a particular

new substance when requested by EPA.

The benefit findings were based on

EPA's analysis of each case in which it

took action on a new chemical

substance, to determine what types of

information were critical to the decision

to seek controls and whether that

information would be required on all

four forms. If the information would not

have been in the submission and if EPA

would not have identified the problem

through telephone contact or other

means, the potential for adverse health

effects occasioned by not identifying the

problem were determined. The

Regulatory Impact Analysis is available

for review in the Public Document

Room.

This regulation was submitted to the

Office of Management and Budget for

review as required by Executive Order

12291.

VII. Applicability of Paperwork

Reduction Act an Regulatory

Flexibility Act

Under the Paperwork Reduction Act

of 1980, 44 U.S.C. 3501 et seq., the

information provisions in this rule must

be submitted for approval to the Office

of Management and Budget (OMB). The

Agency previously submitted

information collection requirements to

OMB under the Premanufacture

Notification (PMN) Interim Policy which

were assigned OMB control number

2000-0054. The information collection

requirements in this final rule were

approved by OMB and assigned OMB

control number 2070-0012.

As required by the Regulatory

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

assessed the impact of this rule on small

businesses. In various analyses of the

chemical industry, small business has

been defined in numerous ways,

particularly in terms of annual sales

levels. To account for different

interpretations of the term "small

business" within the chemical industry,

the Agency analyzed the effect of this

rule using two annual sales levels to

define small, $30 million and $100

million.

EPA estimates that firms with sales

less than $30 million per year will

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absorb about 7 percent of total industryrelated costs to comply with this rule, or

about $0.36 to $0.91 million annually.

Firms with sales less than $100 million

per year will incur about 13 percent of

total industry costs, or about $0.67 to

$1.69 million annually. The proposed

exemptions will substantially reduce the

reporting burden for small companies,

however. Taken together, the proposed

exemption rules would reduce total

program costs for firms with sales less

than $30 million and $100 million per

year by 11 to 33 percent and 11 to 35

percent, respectively.

VIII. Public Record

EPA has established a public record

for this rulemaking (docket number

OTS-50002), which is available for

inspection in Rm. E-107, 401 M St. SW.,

Washington, D.C. 20460 from 8:00 a.m. to

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

except legal holidays. This record

includes all the information considered

by EPA in developing this rule except for confidential business information

which has been segregated. While part

of the record, such information is not

available to the public.

The list below describes the

information in the record. This list, in

accordance with section 19(a)(13) of the

Act, identifies the complete rulemaking

record:

1. USEPA-OTS. Premanufacture

Notification Requirements and Review

Procedures. Notice of Proposed

Rulemaking.

2. USEPA-OTS. Premanufacture

Notification Requirements and Review

Procedures: Support Document.

3. USEPA-OTS. Impact of TSCA

Premanufacturing Review Requirements

(EPA 230/2-12/76-005).

4. Seven working drafts of proposed

40 CFR Part 720 dated from June 20, 1978

to December 3, 1978; three working

drafts of the preamble to proposed 40

CFR Part 720 dated from October 28,

1978, to December 3, 1978; eight working

drafts of the proposed Premanufacture

Notice Form dated from July 30, 1978, to

December 3, 1978; two working drafts of

the Premanufacture Notice Form for

Importers dated from October 5, 1978, to

December 3, 1978; three working drafts

of the Premanufacture Notice Form for

Foreign Manufacturers/Suppliers dated

from October 5, 1978, to December 3,

1978; and one draft of the Processing

and Consumer Use Form dated

December 3, 1978.

5. USEPA-OTS. Reproposal of

Premanufacture Notice Forms and

Provisions of Rules; Notice of Proposed

Rulemaking.

6. USEPA-OTS. Impact of TSCA

Proposed Premanufacturing Notification

Requirements; contract No. 68-014717.

7. Working drafts of the proposed

Premanufacture Notice Forms dated

June 28, 1979, July 13, 1979, and August

7, 1979.

8. EPA Documents distributed at the

meetings of the Administrator's Toxic

Substances Advisory Committee

(ATSAC), August 14, 1979, and

September 25, 1979.

9. EPA materials on the planned

reproposal of the Premanufacture Notice

Forms distributed at the Embassy

Officials Briefing, September 11, 1979.

10. USEPA-OTS. Premanufacture

Notification and Review: Economic

Impact.

11. USEPA-OTS. Proposed Processor

Reporting Requirements. Notice of

Proposed Rulemaking.

12. USEPA-OTS. Cost Estimations of

Alternative Processor Notification

Requirements; contract no. 68-01-5878.

13. USEPA-OTS. Premanufacture

Notification and Review Procedures:

Clarification of Importer Reporting

Responsibilities.

14. USEPA-OTS. Draft Regulatory

Analysis. Premanufacture Notification

and Review Procedures.

15. USEPA-OTS. Proposed Economic

Impact Analysis of Proposed Section 5

Notice Requirements; contract no. 68-

01-5878.

46. USEPA-OTS. Regulatory Impact

Analysis of Section 5 Notice

Requirements; contract no. 68-01-5878.

17. USEPA-OTS. Response to

Comments on New Chemical Notice

Requirements & Review Procedures.

18. All factual information and raw

data of any sort considered during the

rulemaking.

19. EPA correspondence to persons

outside EPA concerning this rule.

20 Correspondence (including

comments on the proposed rule)

received from persons outside EPA

before the close of the comment periods,

and correspondence received after the

close of the comment periods if

considered.

21. EPA memoranda summarizing

meetings and telephone conversations

with outside persons relevant to the

development of this rulemaking.

The docket of the record detailing its

specific contents is available in the OTS

Reading Room.

List of Subjects in 40 CFR Part 720

Chemicals, Environmental protection,

Premanufacture notification, Hazardous

materials, Recordkeeping and reporting

requirements.

Dated: April 26, 1983.

Lee L. Verstandig,

Acting Administrator.

Therefore, 40 CFR Chapter I is

amended by adding Part 720 to read as

follows:

PART 720-PREMANUFACTURE

NOTIFICATION

Subpart A-General Provisions

Sec.

720.1 Scope.

720.3 Definitions.

Subpart B-Applicability

720.22 Persons who must report.

720.25 Determining whether a chemical

substance is on the Inventory.

720.30 Chemicals not subject to notification

requirements.

720.36 Exemptions for research and

development.

720.38 Exemptions for test marketing.

Subpart C-Notice Form

720.40 General.

720.45 Informiation that must be included in

the notice form.

720.50 Submission of test data and other

data concerning the health and

environmental effects of a substance.

720.57 Imports.

Subpart D-Disposition of Notices

720.60 General.

720.62 Notice that notification is not

required.

720.65 Acknowledgement of receipt of a

notice; errors in the notice; incomplete

submissions; false and misleading

statements.

720.70 Notice in the Federal Register.

720.75 Notice review period.

720.78 Recordkeeping.

Subpart E-Confidentiality and Public

Access to Information

720.80 General provisions.

720.85 Chemical identity.

720.87 Categories or proposed categories of

uses of a new chemical substance.

720.90 Data from health and safety studies.

720.95 Public file.

Subpart F-Commencement of

Manufacture or Import

720.102 Notice of commencement of

manufacture or import.

Subpart G-Compllance and Inspections

720.120 Compliance.

720.122 Inspections.

Appendix A-Premanufacture Notice for

New Chemical Substances

Authority: Toxic Substances Control Act,

15 U.S.C. 2604, 2607, 2613.

Subpart A--General Provisions

§ 720.1 Scope.

This Part establishes procedures for

the reporting of new chemical

substances by manufacturers and

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importers under section 5 of the Toxic

Substances Control Act, 15 U.S.C. 2604.

The rule defines the persons and

chemical substances subject to the

reporting requirements, prescribes the

contents of section 5 notices, and

establishes procedures for submitting

notices. The rule also establishes EPA

policy regarding claims of

confidentiality for, and public disclosure

of, various categories of information

submitted in connection with section 5

notices (OMB Control No. 2070-0012).

§ 720.3 Definitions.

(a)(1) For the purposes of this Part. the

terms "cosmetic," "device," "drug,"

"food," and "food additive" have the

meanings contained in the Federal Food,

Drug, and Cosmetic Act, 21 U.S.C. 321 et

seq., and the regulations issued.under it,

In addition, the term "food" includes

poultry and poultry products, as defined

in the Poultry Products Inspection Act,

21 U.S.C. 453 et seq.; meats and meat

food products, as defined in the Federal

Meat Inspection Act, 21 U.S.C. 60 et seq.;

and eggs and egg products, as defined in

the Egg Products Inspection Act, 21

U.S.C. 1033 et seq.

(2) The term "pesticide" has the

meaning contained in the Federal

Insecticide, Fungicide, and Rodenticide

Act, 7 U.S.C. 136 et seq. and the

regulations issued under it.

(3) The terms "byproduct material."

"source material," and "special nuclear

material" have the meanings contained

in the Atomic Energy Act of 1954, 42

U.S.C 2014 et seq. and the regulations

issued under it.

(b) "Act" means the Toxic Substances

Control Act, 15 U.S.C. 2601 et seq.

(c) "Article" means a manufactured

item (1) which is formed to a specific

shape or design during manufacture, (2)

which has end use function(s)

dependent in whole or in part upon its

shape or design during end use, and (3)

which has either no change of chemical

composition during its end use or only

those changes of composition which

have no commercial purpose separate

from that of the article and that may

occur as described in § 720.36(g)(5),

except that fluids and particles are not

considered articles regardless of shape

or design.

(d) "Byproduct" means a chemical

substance produced without a separate

commercial intent during the

manufacture, processing, use, or

disposal of another chemical substance

or mixture.

(e) "Chemical substance" means any

organic or inorganic substance of a

particular molecular identity, including

any combination of such substances

occurring in whole or in part as a result

of a chemical reaction or occurring in

nature, and any chemical element or

uncombined radical, except that

"chemical substance" does not include:

(1) Any mixture.

(2) Any pesticide when manufactured,

processed, or distributed in commerce

for use as a pesticide.

(3) Tobacco or any tobacco product.

(4) Any source material, special

nuclear material, or byproduct material.

(5) Any pistol, firearm, revolver,

shells, or cartridges.

(6) Any food, food additive, drug,

cosmetic, or device, when manufactured,

processed, or distributed in commerce

for use as a food, food additive, drug,

cosmetic, or device.

(f) "Commerce" means trade, traffic,

transportation, or other commerce (1)

between a place in a State and any

place outside of such State, or (2) which

affects trade, traffic, transportation, or

commerce between a place in a State

and any place outside of such State.

(g) "Customs territory of the United

States" means the 50 States, Puerto

Rico, and the District of Columbia.

(h) "Director" means the Director of

the EPA Office of Toxic Substances.

(i) "Distribute in commerce" means to

sell in commerce, to introduce or deliver

for introduction into commerce, or to

hold after introduction into commerce.

(j) "EPA" means the U.S.

Environmental Protection Agency.

(k) "Health and safety study" or "study" means any study of any effect

of a chemical substance or mixture on

health or the environment or on both,

including underlying data and

epidemiological studies, studies of

occupational exposure to a chemical

substance or mixture, toxicological,

clinical, and ecological, or other studies

of a chemical substance or mixture, and

any test performed under the Act.

Chemical identity is always part of a

health and safety study.

(1) Not only is information which

arises as a result of a formal, disciplined

study included, but other information

relating to the effects of a chemical

substance or mixture on health or the

environment is also included. Any data

that bear on the effects of a chemical

substance on health or the environment

would be included.

(2) Examples include:

(i) Long- and short-term tests of

mutagenicity, carcinogenicity, or

teratogenicity; data on behavioral

disorders; dermatoxicity;

pharmacological effects; mammalian

absorption, distribution, metabolism,

and excretion; cumulative, additive, and

synergistic effects; acute, subchronic,

and chronic effects; and structure/

activity analyses.

(ii) Tests for ecological or other

environmental effects on invertebrates,

fish, or other animals, and plants,

including: acute toxicity tests, chronic

toxicity tests, critical life stage tests,

behavioral tests, algal growth tests, seed

germination tests, plant growth or

damage tests, microbial function tests,

bioconcentration orbioaccumulation

tests, and model ecosystem (microcosm)

studies.

(iii) Assessments of human and

environmental exposure, including

workplace exposure, and impacts of a

particular chemical substance or

mixture on the environment, including

surveys, tests, and studies of: biological,

photochemical, and chemical

degradation; air, water, and soil

transport; biomagnification and

bioconcentration; and chemical and

physical properties, e.g., boiling point,

vapor pressure, evaporation rates from

soil and water, octanol/water partition

coefficient, and water solubility.

(iv) Monitoring data, when they have

been aggregated and analyzed to

measure the exposure of humans or the

environment to a chemical substance or

mixture.

(v) Any assessments of risk to health

and the environment resulting from the

manufacture, processing, distribution in

commerce, use, or disposal of the

chemical substance.

(1) "Importer" means any person who

imports a chemical substance, including

a chemical substance as part of a

mixture or article, into the customs

territory of the United States. "Importer"

includes the person primarily liable for

the payment of any duties on the

merchandise or an authorized agent

acting on his or her behalf. The term

also includes, as appropriate:

(1) The consignee.

(2) The importer of record.

(3) The actual owner if an actual

owner's declaration and superseding

bond has been filed in accordance with

19 CFR 141.20; or

(4) The transferee, if the right to draw

merchandise in a bonded warehouse has

been transferred in accordance with

Subpart C of 19 CFR 144. (See "principal

importer.")

(m) "Impurity" means a chemical

substance which is unintentionally

present with another chemical

substance.

(n) "Intermediate" means any

chemical substance that is ensumed, in

whole or in part, in chemical reactions

used for the intentional manufacture of

another chemical substance(s) or

mixture(s), or that is intentionally

present for the purpose of altering the

rates of such chemical reactions.

Federal Reuister / Vol. 48 No. 94 / Friday, May 13, 1983 / Rules and Regulations

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(o) "Inventory" means the list of

chemical substances manufactured or

processed in the United States that EPA

compiled and keeps current under

section 8(b) of the Act.

(p) "Known to or reasonably

ascertainable by" means all information

in a person's possession or control, plus

all information that a reasonable person

similarly situated might be expected to

possess, control, or know.

(q) "Manufacture" means to produce

or manufacture in the United Stateg-or

import into the customs territory of the

United States.

(r) "Manufacture or import for

commercial purposes" means:

(1) To import, produce, or manufacture

with the purpose of obtaining an

immediate or eventual commercial

advantage for the manufacturer or

importer, and includes, among other

things, "manufacture" of any amount of

a chemical substance or mixture:

(i) For commercial distribution,

including for test marketing.

(ii) For use by the manufacturer,

including use for product research and

development or as an intermediate.

(2) The term also applies to

substances that are produced

coincidentally during the manufacture,

processing, use, or disposal of another

substance or mixture, including

byproducts that are separated from that

other substance or mixture and

impurities that remain in that substance

or mixture. Byproducts and impurities

without separate commercial value are

nonetheless produced for the purpose of

obtaining a commercial advantage, since

they are part of the manufacture of a

chemical substance for commercial

purposes. (s) "Manufacture solely for export"

means: to manufacture for a commercial

purpose solely for export from the

United States under the following

restrictions on domestic activity:

(1) Processing is limited solely to sites

under the control of the manufacturer.

(2) Distribution in commerce is limited

to purposes of export.

(3) The manufacturer may not use the

substance except in small quantities

solely for research and development.

(t) "Manufacturer" means a person who imports, produces, or manufactures

a chemical substance. A person who

extracts a component chemical

substance from a previously existing

chemical substance or a complex

combination of substances is a

manufacturer of that component

chemical substance. A person who

contracts with a manufacturer to

manufacture or produce a chemical

substance is also a manufacturer if (1)

the manufacturer manufactures or

produces the substance exclusively for

that person, and (2) that person specifies

the identity of the substance and

controls the total amount produced and

the basic technology for the plant

process.

(u) "Mixture" means any combination

of two or more chemical substances if

the combination does not occur in

nature and is not, in whole or in part,

the result of a chemical reaction; except "mixture" does include (1) any

combination which occurs, in whole or

in part, as a result of a chemical reaction

if the combination could have been

manufactured for commercial purposes

without a chemical reaction at the time

the chemical substances comprising the

combination were combined, and if all

of the chemical substances comprising

the combination are not new chemical

substances, and (2) hydrates of a

chemical substance or hydrated ions

formed by association of a chemical

substance with water, so long as the

nonhydrated form is itself not a new

chemical substance.

(v) "New chemical substance" means

any chemical substance which is not

included on the Inventory.

(w) "Nonisolated intermediate" means

any intermediate that is not

intentionally removed from the

equipment in which it is manufactured,

including the reaction vessel in which it

is manufactured, equipment which is

ancillary to the reaction vessel, and any

equipment through which the chemical

substance passes during a continuous

flow process, but not including tanks or

other vessels in which the substance is

stored after its manufacture.

(x) "Person" means any natural

person, firm, company, corporation,

joint-venture, partnership, sole

proprietorship, association, or any other

business entity, any State or political

subdivision thereof, any municipality,

any interstate body, and any

department, agency or instrumentality of

the Federal Government.

(y) "Possession or control" means in

possession or control of the submitter,

or of any subsidiary, partnership in

which the submitter is a general partner,

parent company, or any company or

partnership which the parent company

owns or controls, if the subsidiary,

parent company, or other company or

partnership is associated with the

submitter in the research, deveiopment,

test marketing, or commercial marketing of the chemical substance in question.

(A parent company owns or controls

another company if the parent owns or

controls 50 percent or more of the other

company's voting stock. A parent

company owns or controls any

partnership in which it is a general

partner.) Information is included within

this definition if it is:

(1) In the submitter's own files

including files maintained by employees

in the course of their employment.

(2) In commercially available data

bases to which the submitter has

purchased access.

(3) Maintained in the files in the

course of employment by other agents of

the submitter who are associated with

research, development, test marketing,

or commercial marketing of the chemical

substance in question.

(z) "Principal importer" means the

first importer who, knowing that a new

chemical substance will be imported

rather than manufactured domestically,

specifies the identity of the chemical

substance and the total amount to be

imported. Only persons who are

incorporated, licensed, or doing

business in the United States may be

principal importers.

(aa) "Process" means the preparation

of a chemical substance or mixture, after

its manufacture, for distribution in

commerce (1) in the same form or

physical state as, or in a different form

or physical state from, that in which it

was received by the person so preparing

such substance or mixture, or (2) as part

of a mixture or article containing the

chemical substance or mixture.

(bb) "Processor" means any person

who processes a chemical substance or

mixture.

(cc) "Small quantities solely for

research and development" (or "small

quantities solely for purposes of

scientific experimentation or analysis or

chemical research on, or analysis of,

such substance or another substance,

including such research or analysis for

the development of a product") means

quantities of a chemical substance

manufactured, imported, or processed or

proposed to be manufactured, imported,

or processed solely for research and

development that are not greater than

reasonably necessary for such purposes.

(dd) "State" means any State of the

United States and the District of

Columbia, the Commonwealth of Puerto

Rico, the Virgin Islands, Guam, the

Canal Zone, American Samoa, the

Northern Mariana Islands, and any

other territory or possession of the

United States.

(ee) "Technically qualified individual"

means a person or persons (1) who,

because of education, training, or

experience, or a combination of these

factors, is capable of understanding the

health and environmental risks

associated with the chemical substance

which is used under his or her

supervision, (2) who is responsible for

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enforcing appropriate methods of

conducting scientific experimentation,

analysis, or chemical research to

minimize such risks, and (3) who is

responsible for. the safety assessments

and clearances related to the

procurement, storage, use, and disposal

of the chemical substance as may be

appropriate or required within the scope

of conducting a research and

development activity.

(ff) "Test data" means data from a

formal or informal test or experiment,

including information concerning the

objectives, experimental methods and

materials, protocols, results, data

analyses, recorded observations,

monitoring data, measurements, and

conclusions from a test or experiment.

(gg) "Test marketing" means the

distribution in commerce of no more

than a predetermined amount of a

chemical substance, mixture, or article

containing that chemical substance or

mixture, by a manufacturer or processor,

to no more than a defined number of

potential customers to explore market

capability in a competitive situation

during a predetermined testing period

prior to the broader distribution of that

chemical substance, mixture, or article

in commerce.

(hh) "United States," when used in the

geographic sense, means all of the

States.

Subpart B-Applicability

§ 720.22 Persons who must report.

(a) (1) Any person who intends to

manufacture a new chemical substance

in the United States for commercial

purposes must submit a notice unless

the substance is excluded under

§ 720.30.

(2) If a person contracts with a

manufacturer to manufacture or produce

a new chemical substance, and (i) the

manufacturer manufactures or produces

the substance exclusively for that

person, and (ii) that person specifies the

identity of the substance, and controls

the total amount produced and the basic

technology for the plant process, that

person must submit the notice. If it is

unclear who must report, EPA should be

contacted to determine who must submit

the notice.

(3) Only manufacturers that are

incorporated, licensed, or doing

business in the United States may

submit a notice.

(b)(1) Any person who intends to

import a new chemical substance into

the United States for commercial

purposes must submit a notice, unless

the substance is excluded under § 720.30

or unless the substance is imported as

part of an article.

(2) When several persons are involved

in an import transaction, the notice must

be submitted by the principal importer.

If no one person fits the principal

importer definition in a particular

transaction, the importer should contact

EPA to determine who must submit the

notice for that transaction.

§ 720.25 Determining whether a chemical

substance Is on the Inventory.

(a) A new chemical substance is a

chemical that is not on the Inventory.

(b)(1) A chemical substance is listed

on the Inventory by specific chemical

name if its identity is not confidential. If

its identity is confidential, it is listed by

specific name in the confidential portion

of the Inventory. The confidential

chemical substance is also listed on the

public Inventory by a generic name

which masks the specific identity. A

person who intends to manufacture or

import a chemical substance not listed

on the Inventory by specific chemical

name may ask EPA whether the

substance is included on the

confidential Inventory. EPA will answer

such an inquiry only if EPA determines

that the person has a bona fide intent to

manufacture or import the chemical

substance for commercial purposes.

(2) To establish a bona fide intent to

manufacture or import a chemical

substance, the person who proposes to

manufacture or import the substance

must submit to EPA:

(i) The specific chemical identity of

the substance that the person intends to

manufacture or import.

(ii) A signed statement that the person

intends to manufacture or import that

chemical substance for commercial

purposes.

(iii) A description of the research and

development activities conducted to

date, and the purpose for which the

person will manufacture or import the

chemical substance.

(iv) An elemental analysis.

(v) 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.

(3) If an importer cannot provide all

the information required by paragraph

(b)(2) of this section because it is

claimed confidential business

information by its foreign manufacturer

or supplier, the foreign manufacturer or

supplier may supply the information

directly to EPA.

(4) EPA will review the information

submitted by the proposed manufacturer

or importer under this paragraph to

determine whether it has a bona fide

intent to manufacture or import 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).

(5) If the proposed manufacturer or

importer has shown a bona fide intent to

manufacture or import the substance,

and provide sufficient unambiguous

chemical identity information so EPA

can make a conclusive determination of

the chemical substance's Inventory

status, EPA will search the confidential

Inventory and inform the proposed

manufacturer or importer whether the

chemical substance is on the

confidential Inventory.

(6) If the chemical substance is found

on the confidential Inventory, EPA will

notify the person(s) who originally

reported the chemical substance that

another person has demonstrated a

bona fide intent to manufacture or

import the substance and therefore was

told that the chemical substance is on

the Inventory.

(7) A disclosure of a confidential

chemical identity to a person with a

bona fide.intent to manufacture or

import the particular chemical

substance will not be considered a

public disclosure of confidential

business information under section 14 of

the Act.

(8) EPA will answer an inquiry on

whether a particular chemical substance

is on the confidential Inventory within

30 days after receipt of a complete

submission under paragraph (b)(2) of

this section (OMB Control No. 2070-

0012).

§ 720.30 Chemicals not subject to

notification requirements.

The following substances are not

subject to the notification requirements

of this Part:

(a) Any substance which is not a "chemical substance" as defined in

§ 720.3(e).

(b) Any mixture as defined in

§ 720.3(u).'

(c) Any new chemical substance

which will be manufactured or imported

in small quantities solely for research

and development under § 720.36.

(d) Any new chemical substance

which will be manufactured or imported

'A new chemical substance that is manufactured or imported as part of a mixture is subject to the

requirements of this Part. This exclusion applies

only to a mixture as a whole and not to any

chemical substances which are part of the mixture.

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solely for test-marketing purposes under

an exemption granted under § 720.38.

(e) Any new chemical substance

manufactured solely for export.

(f) Any new chemical substance

which is manufactured or imported

under the terms of a rule promulgated

under section 5(h)(4) of the Act.

(g) Any byproduct if its only

commercial purpose is for use 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 component chemical

substances from it for commercial

purposes. (This exclusion only applies to

the byproduct; it does not apply to the

component substances extracted from

the byproduct.)

(h) The chemical substances

described below: (Although they are manufactured for commercial purposes

under the Act, they are not

manufactured for distribution in

commerce as chemical substances per se and have no commercial purpose

separate from the substance, mixture, or article of which they are a part.)

(1) Any impurity.

(2) Any byproduct which is not used

for commercial purposes.

(3) Any chemical substance which

results from a chemical reaction that occurs incidental to exposure of another

chemical substance, mixture, or article

to environmental factors such as air,

moisture, microbial organisms, or

sunlight.

(4) Any chemical substance which

results from a chemical reaction that

occurs incidental to storage or disposal

of another chemical substance, mixture,

or article.

(5) Any chemical substance which

results from a chemical reaction that

occurs upon end use of another chemical

substance, mixture, or article such as an adhesive, paint, miscellaneous cleanser or other housekeeping product, fuel

additive, water softening and treatment

agent, photographic film, battery, match,

or safety flare, and which is not itself

manufactured or imported for

distribution in commerce or for use as

an intermediate.

(6) Any chemical substance which

results from a chemical reaction that

occurs upon use of curable plastic or rubber molding compounds, inks, drying

oils, metal finishing compounds,

adhesives, or paints, or any other

chemical substance formed during the

manufacture of an article destined for

the marketplace without further

chemical change of the chemical

substance except for those chemical

changes that occur as described

elsewhere in this paragraph.

(7) Any chemical substance which

results from a chemical reaction that

occurs when (i) a stabilizer, colorant,

odorant, antioxidant, filler, solvent,

carrier, surfactant, plasticizer, corrosion

inhibitor, antifoamer or defoamer,

dispersant, precipitation inhibitor,

binder, emulsifier, deemulsifier,

dewatering agent, agglomerating agent,

adhesion promoter, flow modifier, pH

neutralizer, sequesterant, coagulant,

flocculant, fire retardant, lubricant,

chelating agent, or quality control

reagent functions as intented, or (ii) a

chemical substance, which is intended

solely to impart a specific

physiochemical characteristic, functions

as intended.

(8) Any nonisolated intermediate.

§ 720.36 Exemptions for research and

development.

(a) This Part does not apply to a

chemical substance if:

(1) The chemical substance is

manufactured or imported only in small

quantities solely for research' and

development.

(2) The manufacturer or importer (i)

evaluates the chemical substance in

accordance with paragraph (b) of this

section, and (ii) notifies all persons

engaged in experimentation, research, or

analysis on the new chemical substance,

including the manufacture, processing,

use, transport, storage, and disposal of

the substance associated with research

and development activities, of any risk

to health, identified under paragraph (b)

of this section, which may be associated

with the substance, in accordance with

paragraph (c) of this section. A

technically qualified individual must

ensure the adequacy of the notification.

(3) The chemical substance is used by,

or directly under the supervision of, a

technically qualified individual.

(b)(1) The manufacturer or importer

must evaluate any information or test

data in its possession or control to

determine whether there is reason to

believe there is any risk to health

associated with the chemical substance.

This information must include:

(i) Any information concerning any

significant adverse reaction by persons exposed to the substance which may

reasonably be associated with such

exposure.

(ii) Any information provided to the

manufacturer or importer by a supplier

or any other person concerning a health

risk believed to be associated with the

substance.

(2) In addition, the manufacturer or

importer must determine whether the

substance is subject to any rule or order

proposed or promulgated under section

4, 5, or 6 of the Act; or the notice

requirements of section 8(e) of the Act.

In addition, the manufacturer or

importer must ascertain whether EPA,

under section 5(h)(3) of the Act, has

determined that any risk to health may

be associated with the substance.

(c) The manufacturer or importer must

assure that persons are notified by

means of a container labeling system,

conspicuous placement of notices in

areas where exposure may occur,

written notification to each person, or

any other method of notification which

adequately informs persons of risks

which the manufacturer or importer has

reason to believe may be associated

with the substance, as determined under

paragraph (b) of this section. The

adequacy of the notification is the

responsibility of the manufacturer or

importer. If the importer is not the

manufacturer, it is the importer's

responsibility to make the necessary

evaluation and notification of any risks

to health which may be associated with

the substance. In making such

evaluations, the importer must obtain

that information described in paragraph

(b) of this section which is reasonably

ascertainable.

(d) Upon request, the manufacturer or

importer must make available to EPA

any information evaluated by the

manufacturer or importer in determining

the need for notification under

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

(e) The requirements for this

exemption apply to all new chemical

substances, including chemical

substances manufactured or imported

under such an exemption before the

effective date of this rule.

§ 720.38 Exemptions for test marketing.

(a) Any person may apply for an

exemption to manufacture or import a

new chemical substance for test

marketing. EPA may grant the

exemption if the person demonstrates

that the chemical substance will not

present an unreasonable risk to injury to

health or the environment as a result of

the test marketing.

(b) Persons applying for a testmarketing exemption should provide the

following information:

(1) All existing data regarding health

and environmental effects of the

chemical substance, including physical/

chemical properties or, in the absence of

such data, a discussion of toxicity based on structure-activity relationships (SAR)

and relevant data on chemical

analogues.

(2) The maximum quantity of the

chemical substance which the applicant

will manufacture or import for test.

marketing.

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(3) The maximum number of persons

who may be provided the chemical

substance during test marketing.

(4) The maximum number of persons

who may be exposed to the chemical

substance as a result of test marketing,

including information regarding duration

and route of such exposures.

(5) A description of the test-marketing

activity, including its length and how it

can be distinguished from full-scale

commercial production and research

and development.

(c) In accordance with section 5(h)(6)

of the Act, after EPA receives an

application for exemption under this

section, the Agency will file with the

Office of the Federal Register a notice

containing a summary of the information

provided in the application, to the extent

it has not been claimed confidential.

(d) No later than 45 days after EPA

receives an application, the Agency will

either approve or deny the application.

Thereafter, EPA will publish a notice in

the Federal Register explaining the

reasons for approval or denial.

(e) In approving an application for

exemption, EPA may impose any

restrictions necessary to ensure that the

substance will not present an

unreasonable risk of injury to health and

the environment as a result of test

marketing (OMB Control No. 2070-0012).

Subpart C-Notice Form

§ 720.40 General.

(a) Use of the notice form. Each

person who is required by Subpart B to

submit a notice must complete, sign, and

submit a notice containing the

information in the form and manner set

forth in EPA Form No. 7710-25 2 under

Appendix A of this part. Except as

otherwise provided in Subpart C, each

notice must be submitted with all

referenced attachments. The information

on the form and all attachments (unless

the attachment appears in the open

scientific literature) must be in English.

All information submitted must be true

and correct.

(b) When to submit a notice. Each

person who is required to submit a

notice must submit the notice at least 90

calendar days before manufacture or

import of the new chemical substance

for commercial purposes begins.

(c) Where to submit a notice. Each

person who submits a notice must

submit it to the address listed on the

notice form.

(d) General notice requirements. Each

person who submits a notice must

2 Copies may be obtained from: Industry

Assistance Office (TS-799), Office of Toxic

Substances, Environmental Protection Agency, 401

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

provide the information described in

§ 720.45 and specified on the notice

form, to the extent such information is

known to or reasonably ascertainable

by the submitter. In accordance with

§ 720.50, the notice must also include

any test data in the su5mitter's

possession or control and descriptions

of other data which are known to or

reasonably ascertainable by the

submitter and which concern the health

and environmental effects of the new

chemical substance.

(e) Agency or joint submissions. (1) A

manufacturer or importer may designate

an agent to submit the notice. Both the

manufacturer or importer and the agent

must sign the certification on the form.

(2) A manufacturer or importer mIay

authorize another person, (e.g., a foreign

manufacturer or supplier, or a toll

manufacturer) to report some of the

information required in the notice to

EPA on its behalf. If separate portions of

a joint notice are not submitted together,

the submitter should indicate which

information will be supplied by another

person and identify that person. The

other person must submit the

information on the appropriate part of

the notice form. The manufacturer or

importer and any other person supplying

the information must sign the

certification provided on their respective

notice forms.

(3) If EPA receives a submission

which does not include information

required by this rule, which the

submitter indicates that it has

authorized another person to provide,

the notice review period will not begin

until EPA receives that information.

(f) New information. During the notice

review period, if the submitter

possesses, controls, or knows of new

information that materially adds to,

changes, or otherwise makes

significantly more complete the

information included in the notice, the

submitter must that information to the

address listed on the notice form within

ten days of receiving the new

information, but no later than five days

before the end of the notice review

period. The new submission must

clearly identify the submitter and the

notice to which the new information is

related. If the new information becomes

available during the last five days of the

notice review period, the submitter must

immediately inform its EPA contract for

that notice by telephone.

(g) Chemical substances subject to a

section 4 test rule.

(1) Except as provided in paragraph

(g)(3) of this section, if (i) A person

intends to manufacture or import a new

chemical substance which is subject to

the notification requirements of this

Part, and (ii) The chemical substance is

subject to a test rule promulgated under

section 4 of the Act before the notice is

submitted, section 5(b)(1) of the Act

requires the person to submit the test

data required by the testing rule with

the notice. The person must submit the

data in the form and manner specified in

the test rile and in accordance with

§ 720.50. If the person does not submit

the test data, the submission is

incomplete and EPA will follow the

procedures in § 720.65.

(2) If EPA has granted the submitter

an exemption under section 4(c) of the

Act from the requirement to conduct

tests and submit data, the submitter may

not submit a notice until EPA receives

the test data.

(3) If EPA has granted the submitter

an exemption under section 4(c) of the

Act and if another person previously has

submitted the test data to EPA, the

exempted person may either submit the

test data or provide the following

information as part of the notice:

(i) The name, title, and address of the

person who submitted the test data to

EPA.

(ii) The date the test data were

submitted to EPA.

(iii) A citation for the test rule.

(iv) A description of the exemption

and a reference identifying it.

(h) Chemical substances subject to a

section 5(b)(4) rule. (1) If a person (i)

intends to manufacture or import a new

chemical substance which is subject to

the notification requirements of this part

and which is subject to a rule issued

under section 5 (b)(4) of the Act; and (ii)

is not required by a rule issued under

section 4 of the Act to submit test data

for the substance before the submission

of a notice, the person must submit to

EPA data described in paragraph (h)(2)

of this section at the time the notice is

submitted.

(2) Data submitted under paragraph

(h)(1) of this section.must be data which

the person submitting the notice

believes show that the manufacture,

processing, distribution in commerce,

use and disposal of the substance, or

any combination of such activities, will

not present an unreasonable risk of

injury to health or the environment

(OMB Control No. 2070-0012).

§ 720.45 Information that must be

Included In the notice form.

Each person who submits a notice

must include the information specified

in the notice form to the extent it is

known to or reasonably ascertainable

by the submitter. However, no person is

required to include information which

relates solely to exposure of human or

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ecological populations outside of the

United States. The notice form requires

the following information relating to the

manufacture, processing, distribution in

commerce, use, and disposal of the new

chemical substance:

(a)(1) For substances whose

composition can be represented by a

definite structural diagram (class 1

substances), the notice must provide the

chemical name (preferably Chemical

Abstracts Service (CAS) or International

Union of Pure and Applied Chemistry

(IUPAC) homenclature), the molecular

formula, CAS Registry Number (if

available), and a structural diagram.

(2) For chemical substances that

cannot be fully represented by a structural diagram (class 2 substances),

the notice must provide the chemical

name, the CAS Registry Number (if

available), and molecular formula. The

notice must identify the immediate

precursors and reactants by name and

CAS Registry Number (if the number is

available). The notice must include a partial or incomplete structural diagram

if possible. Chemical names for such

substances should be developed

according to the guidelines in the TSCA

Chemical Substance Inventory, Initial

Inventory, Volume 1.

(3) For polymers, the notice must

identify monomers and other reactants

used in the manufacture of the polymer

by chemical name and CAS Registry

Number (if available). The notice must

indicate the typical percent of each monomer and other reactant in the

polymer (by weight percent of total

polymer); the maximum residual of each monomer present in the polymer; and a partial or incomplete structural diagram,

if possible. The notice must provide

estimates of the minimum numberaverage molecular weight of the polymer

and the amount of low weight species

below 500 and below 1,000 molecular

weight and describe how the estimates

were obtained.

(b) The impurities anticipated to be

present in the substance by name, CAS

Registry number, and weight percent of

the total substance.

(c) Known synonyms or trade names of the new chemical substance.

(d) A description of the byproducts

resulting from the manufacture,

processing, use, and disposal of the new

chemical substance.

(e) The estimated maximum amount to

be manufactured or imported during the

first year of production and the

estimated maximum amount to be

manufactured or imported during any

12-month period during the first three

years of production.

(f) A description of intended

categories of use by function and

application, the estimated percent of

production volume devoted to each

category of use, and the percent of the

new substance in the formulation for

each commercial or consumer use.

(g) For sites controlled by the

submitter:

(1) The identity of sites where the new

substance will be manufactured,

processed, or used.

(2) A process description of each

manufacture, processing, and use

operation which includes a diagram of

the major unit operations and chemical

conversions, the identity and entry point

of all feedstocks, and the points of

release of the new chemical substance.

(3) Worker exposure information,

including worker activities, physical

form of the new substance to which

workers may be exposed, the number of

workers, and the duration of activities.

(4) Information on release of the new

substance to the environment, including

the quantity and media of release and

type of control technology used.

(h) For sites not controlled by the

submitter, a description of each type of

processing and use operation involving

the new chemical substance, including

identification of the estimated number of

processing or use sites, situations in

which worker exposure to and/or

environmental release of the new chemical substance will occur, the

number of workers exposed and the

duration of exposure, and controls

which limit worker exposure and

environmental release.

§ 720.50 Submission of test data and

other data concerning the health and

environmental effects of a substance.

(a) Test data on the new chemical

substance in the possession or control of

the submitter. (1) Except as provided in

paragraph (d) of this section, each notice

must contain all test data in the

submitter's possession or control which

are related to the effects on health or the

environment of any manufacture,

processing, distribution in commerce,

use, or disposal of the new chemical

substance or any mixture or article

containing the new chemical substance,

or any combination of such activities.

This includes test data concerning the new chemical substance in a pure,

technical grade, or formulated form.

12) A full report or standard literature

citation must be submitted for the

following types of test data:

(i) Health effects data.

(ii) Ecological effects data.

(iii) Physical and chemical properties

data.

(iv) Environmental fate

characteristics.

(v) Monitoring data and other test

data related to human exposure to or

environmental release of the chemical

substance.

(3)(i) If the data do no appear in the

open scientific literature, the submitter

must provide a full report. A full report

includes the experimental methods and

materials, results, discussion and data

analysis, conclusions, references, and

the name and address of the laboratory

that developed the data.

(ii) If the data appear in the open

scientific literature, the submitter need

only provide a standard literature

citation. A standard literature citation

includes author, title, periodical name,

date of publication, volume, and page

numbers.

(4) (i) If a study, report, or test is

incomplete when a person submits a

notice, the submitter must identify the

nature and purpose of the study; name

and address of the laboratory

developing the data; progress to date;

types of data collected; significant

preliminary results; and anticipated

completion date.

(ii) If a test or experiment is

completed before the notice review

period ends, the person must submit the

study, report, or test to the address

listed on the notice form, as specified in

paragraph (a)(3)(i) of this section, within

ten days of receiving it, but no later than

five days before the end of the review

period. If the test or experiment is

completed during the last five days of

the review period, the submitter must

immediately inform its EPA contact for

that notice by telephone.

(5) For test data in the submitter's

possession or control which are not

listed in paragraph (a)(2) of this section,

a person is not required to submit a

complete report. The person must

submit a summary of the data. If EPA so

requests, the person must submit a full

report within ten days of the request,

but no later than five days before the

end of the review period.

(6) All test data described by

paragraph (a) are subject to these

requirements, regardless of their age,

quality, or results.

(b] Other data concerning the health

and environmental effects of the new

chemical substance that are known to

or reasonably ascertainable by the

submitter. (1] Except as provided in

paragraph (d) of this section, any person who submits a notice must describe the

following data, including any data from

a health and safety study, if the data are

related to the effects on health or the

environment of any manufacture,

processing, distribution in commerce,

use, or disposal of the new chemical

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substance, of any mixture or article

containing the new chemical substance.

or of any combination of such activities:

(i) Any data, other than test data, in

the submitter's possession or control.

(ii) Any data, including test data.

which are not in the submitter's

possession or control, but which are known to or reasonably ascertainable

by the submitter. For the purposes of

this section, data are known to or

reasonably ascertainable by the

submitter if the data are known to any

of its employees or other agents who are

associated with the research and

development, test marketing, or

commercial marketing of the substance.

(2) Data that must be described

include data concerning the new

chemical substance in a pure, technical

grade, or formulated form.

(3) The description of data reported

under this paragraph must include:

(i) If the data appear in the open

scientific literature, a standard literature

citation, which includes the author, title,

periodical name, date of publication.

volume, and pages.

(ii) If the data are not contained in the

open scientific literature, a description

of the type of data and summary of the

results, if available, and the names and

addresses of persons the submitter

believes may have possession or control

of the data.

(4) All data described by this

paragraph are subject to these

requirements, regardless of their age,

quality, or results; and regardless of

whether they are complete at the time

the notice is submitted.

(c) Data concerning related

chemicals. A person must submit test

data or descriptions of other data

concerning impurities, byproducts,

degradation products, unintended

reaction products, or other chemical

substances or mixtures related to" the

manufacture, processing, distribution in

commerce, use, or disposal of the new

chemical substance only if the data have

not been published in the open scientific

literature. The submitter may either

submit these data with the notice or

describe them in accordance with

§ 720.50(b)(3)(ii), rather than providing a

full report.

(d) Data that need not be submitted-

(1) Data previously submitted to EPA. (i)

A person need not submit any data

previously submitted to EPA with no

claims of confidentiality if the notice

includes the office or person to whom

the data were submitted, the date of

submission, and, if appropriate, a

standard literature citation as specified

in paragraph (a)(3)(ii) of this section.

(ii) For data previously submitted to

EPA with a claim of confidentiality, the

person must resubmit the data with the

notice and any claim of confidentiality,

under § 720.80.

(2) Efficacy data. This Part does not

require submission of any data related

solely to product dfficacy. This does not

exempt a person from submitting any of

the data specified in paragraph (a), (b),

.or (c) of this section.

.(3) Non-U.S. exposure data. This Part

does not require submission of any data

which relates only to exposure of

humans or the environment outside the

United States. This does not exclude

nonexposure data such as data on

health effects (including epidemiological

studies), ecological effects, physical and

chemical properties, or environmental

fate characteristics.

§ 720.57 Imports.

(a) Except as otherwise provided in

this section, the provisions of this

Subpart C apply to each person who

submits a notice for a new chemcial

substance which he or she intends to

import for a commercial purpose. In

addition, each importer must comply

with this section.

(b) EPA will hold the principal

importer, or the importer that EPA

determines must submit the notice when

there is no principal importer under

§ 720.22[b) (2), liable for complying with

this Part, for completing the notice form

and for the completeness and

truthfulness of all information which it

submits.

Subpart 0-Disposition of Notices

§ 720.60 GeneraL

This subpart establishes procedures

that EPA will follow in reviewing

notices.

§ 720.62 Notice that notification Is not

required.

When EPA receives a notice, EPA will

review it to determine whether the

chemical substance is subject to the

requirements of this Part. If EPA

determines that the chemical substance

is not subject to these requirements,

EPA will notify the submitter that

section 5 of the Act does not prevent the

manufacture or import of the substance

and that the submission is not a notice

under this Part (0MB Control No. 2070-

0012).

§ 720.65 Acknowledgment of receipt of a notice; errors in the notice; Incomplete

submissions; false and misleading

statements.

(a) Notification to submitter. EPA will

acknowledge receipt of each notice by

sending the submitter a letter that

identifies the premanufacture notice

number assigned to the new chemical

substance and the date on which the

review period begins. The review period

will begin on the date the notice is

received by the Office of Toxic

Substances Document Control Officer.

The acknowledgment does not

constitute a finding by EPA that the

notice, as submitted, is in compliance

with this Part.

(b) Errors in the notice. (1) Within 30

days of receipt of the notice, EPA may

request that the submitter remedy errors

in the notice. The following are

examples of such errors:

(i) Failure to date the notice form.

(ii) Typographical errors that cause

data to be misleading or answers to any

questions to be unclear.

(iii) Contradictory information.

(iv) Ambiguous statements or

information.

(2) In the request to correct the notice,

EPA will explain the action which the

submitter must take to correct the

notice.

(3) If the submitter fails to correct the

notice within 15 days of receipt of the

request. EPA may extend the notice

period under section (5)(c) of the Act, in

accordance with § 720.75(c).

(c) Incomplete submissions. (1) A

submission is not complete, and the

notification period does not begin, if:

(i) The wrong person submits the

notice form.

(ii) The submitter does not sign the

notice form.

(iii) Some or all of the information in

the notice or the attachments are not in

English, except for published scientific

literature.

(iv) The submitter does not use the

notice form.

(v) The submitter does not provide

information that is required by section

5(d)(1) (B) and (C) of the Act and

§ 720.50.

(vi) The submitter does not provide

information required on the notice form

and by § 720.45 or indicate that it is not

known to or reasonably ascertainable

by the submitter.

(vii) The submitter does not submit a

second copy of the submission with all

confidential information deleted for the

public file. as required by § 720.80(b)(2).

(viii) The submitter does not include

any information required by section

5(b)(1) of the Act and pursuant to a rule

promulgated under section 4 of the Act,

as required by § 720.40(g).

(ix) The submitter does not submit

data which the submitter believes show

that the chemical substance will not

present an unreasonable risk of injury to

health or the environment, if EPA has

listed the chemical substance under

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section 5(b)(4) of the Act, as required in

§ 720.40(h).

(2)(i) If EPA receives an incomplete

submission, the Director, or his or her

delegate, will notify the submitter within

30 days of receipt that the submission is

incomplete and that the notice review

period will not begin until EPA receives

a complete notice.

(ii) If EPA obtains additional

information during the notice review

period that indicates the original

submission was incomplete, the

Director, or his or her delegate, may

declare the submission incomplete

within 30 days after EPA obtains the

additional information and so notify the

submitter.

(3] The notification that a submission

is incomplete under paragraph (c)(2) (i)

or (ii) of this section will include:

(i) A statement of the basis of EPA's

determination that the submission is

incomplete.

(ii) The requirements for correcting

the incomplete submission.

(iii) Information on procedures under

paragraph (c)(4) of this section for filing

objections to the determination or

requesting modification of the

requirements for completing the

submission.

(4) Within ten days after receipt of

notification by EPA that a submission is

incomplete, the submitter may file

written objections requesting that EPA

accept the submission as a complete

notice or modify the requirements

necessary to complete the submission.

(5)(i) EPA will consider the objections

filed by the submitter. The Director, or

his or her delegate, will determine

whether the submission was complete or

incomplete, or whether to modify the

requirements for completing the

submission. EPA will notify the

submitter in writing of EPA's response

within ten days of receiving the

objections.

(ii) If the Director, or his or her

delegate, determines, in response to the

objection, that the submission was complete, the notice review period will

be deemed suspended on the date EPA

declared the notice incomplete, and will

resume on the date that the notice is

declared complete. The submitter need

not correct the notice as EPA originally

requested. If EPA can complete its

review within 90 days from the date of

the original submission, the Director, or

his or her delegate, may inform the

submitter that the running of the review

period will resume on the date EPA

originally declared it incomplete.

(iii) If the Director, or his or her

delegate, modifies the requirements for *completing the submission or concurs

with EPA's original determination, the

notice review period will begin when

EPA receives a complete notice.

(d) Materially false or misleading

statements. If EPA discovers at any time

that person submitted materially false or

misleading statements in the notice, EPA

may find that the notice was incomplete

from the date it was submitted, and take

any other appropriate action.

§ 720.70 Notice In the Federal Register.

(a) Filing of Federal Register notice. In

accordance with section 5(d)(2) of the

Act, after EPA receives a notice, EPA

will file with the Office of the Federal

Register a riotice including the

information specified in paragraph (b) of

this section.

(b) Contents of notice. (1) In the public

interest, the specific chemical identity

listed in the notice will be published in

the Federal Register unless the submitter

has claimed chemical identity

confidential. If the submitter claims

confidentiality, a generic name will be

published in accordance with

§ 720.85(a)(3).

(2) The categories of use of the new

chemical substance will be published as

reported in the notice unless this

information is claimed confidential. If

confidentiality is claimed, the generic

information which is submitted under

§ 720.87(b) will be published.

(3) A list of data submitted in

accordance with § 720.50(a) will be

published. In addition, for test data

submitted in accordance with

§ 720.40(g), a summary of the data will

be published.

(4) The submitter's identity will be

published, unless the submitter has

claimed it confidential.

§ 720.75 Notice review period.

(a) Length of notice review period.

The notice review period specified in

section 5(a) of the Act runs for 90 days

from the date the Document Control

Officer for the Office of Toxic

Substances receives a complete notice,

or the date EPA determines the notice is

complete under § 720.65(c), unless the

Agency extends the period under

section 5(c) of TSCA and paragraph (c)

of this section.

(b) Suspension of the running of the

notice review period (1) A submitter

may voluntarily suspend the running of

the notice review period if the Director

or his or her delegate agrees. If the

Director does not agree, the review

period will continue to run, and EPA

will notify the submitter. A submitter

may request a suspension at any time

during the notice review period. The

suspension must be for a specified

period of time.

(2) A request for suspension may be

made in writing to the Document

Control Officer (TS-793), Office of

Pesticides and Toxic Substances, 401 M

Street SW., Washington, D.C. 20460. The

suspension also may be made orally,

including by telephone, to the

submitter's EPA contact for that notice.

EPA will send the submitter a written

confirmation that the suspension has

been granted (OMB Control No. 2070-

0012).

(i) An oral request may be granted for

15 days only. To obtain a longer

suspension, the Document Control

Officer for the Office of Toxic

Substances must receive written

confirmation of the oral request. The

notice review period is suspended as of

the date of the oral request.

(ii) If the submitter has not made a

previous oral request, the running of the

notice review period is suspended as of

the date of receipt of the written request

by the Document Control Officer for the

Office of Toxic Substances.

(c) Extension of notice review period.

(1) At any time during the notice review

period, EPA may determine that good

cause exists to extend the notice review

period specified in paragraph (a) of this

section.

(2) If EPA makes such a

determination, EPA will:

(i) Notify the submitter that EPA is

extending the notice review period for a

specified length of time, and state the

reasons for the extension.

(ii) Issue a notice for publication in

the Federal Register which states that

EPA is extending the notice review

period and gives the reasons for the

extension.

(3) The initial extension may be for a

period of up to 90 days. If the initial

extension is for less than 90 days, EPA

may make additional extensions.

However, the total period of extensions

may not exceed 90 days for any notice.

(4) The following are examples of

situations in which EPA may find that

good cause exists for extending the

notice review period:

(i) EPA has reviewed the notice and

determined that there is a significant

possibility that the chemical substance

will be regulated under section 5(e) or

section 5(f) of the Act, but EPA is unable

to initiate regulatory action within the

initial 90-day period.

(ii) EPA has reviewed the submission

and is seeking additional information.

(iii) EPA has received significant

additional information during the notice

review period.

(iv) The submitter has failed to correct

a notice after receiving EPA's request

under § 720.65(b).

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(d) Notice of expiration of notice

review period. EPA will notify the

submitter that the notice review period

has expired or that EPA has completed

its review of the notice. Expiration of the

review period does not constitute EPA

approval or certification of the new

chemical substance, and does not mean

that EPA may not take regulatory action

against the substance in the future. After

expiration of the statutory notice review

period, in the absence of regulatory

action by EPA under section 5(e), 5(f), or

6(a) of the Act, the submitter may

manufacture or import the chemical

substance even if the submitter has not

received notice of expiration.

(e) Withdrawal of a notice by the

submitter. (1) A submitter may

withdraw a notice during the notice

review period. A statement of

withdrawal must be made in writing to

the Document Control Officer (TS-793).

Office of Pesticides and Toxic

Substances, 401 M St. SW., Washington,

D.C. 20460. The withdrawal is effective

upon receipt of the statement by the

Document Control Officer (OMB Control

No. 2070-0012).

(2) If a manufacturer or importer

which withdrew a notice later resubmits

a notice for the same chemical

substance, a new notice review period

begins.

§ 270.78 Recordkeeping

(a) Any person who submits a notice

under this Part must retain

documentation of information in the

notice, including (1) other data, as

defined in § 720.50(b), in the submitter's

possession or control; and (2) records of

production volume for the first three

years of production or import, the date

of commencement of manufacture or

import, and documentation of this

information. This information must be

retained for five years from the date of

commencement of manufacture of

import.

(b) Persons who manufacture or

import a chemical substance under the

terms of a research and development

exemption must retain documentation of

compliance with the exemption,

including copies of the information they

used to determine the need to make any

notification of risk to health under

§ 720.36 for five years from the final

date of manufacture or import under the

exemption.

(c) Any person who obtains a testmarketing exemption under this Part

must retain documentation of

information in the application and

documentation of compliance with any

restrictions imposed by EPA when it

granted the application. This

information must be retained for five

years from the final date of manufacture

or import under the exemption (OMB

Contrbl No. 2070-0012).

Subpart E-Confidentiality and Public

Access to Information

§ 720.80 General provisions.

(a) A person may assert a claim of

confidentiality for any information

which he or she submits to EPA under

this Part.

(b) Any claim of confidentiality must

accompany the information when it is

submitted to EPA.

(1)(i) For information submitted on the

notice form, the claim(s) must be

asserted on the form in the manner

prescribed on the notice form.

(ii) When a person submits

information in an attachment, the

claim(s) must be asserted in the

attachment as described on the notice

form.

(2) The person must submit two copies

of each notice form and any

attachments if any information is

claimed confidential.

(i) One copy of the form and

attachments must be complete. In that

copy, the submitter must mark the

information which is claimed

confidential in the manner prescribed on

the notice form.

(ii) The second copy must be complete

except that all information claimed as

confidential in the first copy must be

deleted. EPA will place the second copy

in the public file.

(iii) If the submitter does not provide

the second copy, the submission is

incomplete and the notice review period

does not begin to run until EPA receives

the second copy, in accordance with

§ 720.65(c)(vi). I

(c) EPA will disclose information that

is subject to a claim of confidentiality

asserted under this section only to the

extent permitted by the Act, this

Subpart, and Part 2 of this Title.

(d) If a notice submitter does not

assert a claim of confidentiality for

information at the time it is submitted to

EPA, EPA may make the information

public and place it in the public file

without further notice to the submitter

(OMB Control No. 2070-0012).

§ 720.85 Chemical Identity.

(a) Claims applicable to the period

prior to commencement of manufacture

or import. (1)(i) A person who submits

information to EPA under this Part may

assert a claim of confidentiality for the

chemical identity of the new chemical

substance. This claim will apply only to

the period prior to the commencement of

manufacture or import for commercial

purposes. A submitter may assert this

claim only if the submitter believes that

public disclosure prior to

commencement of manufacture or

import of the fact that anyone intends to

manufacture or import the specific

chemical substance for commercial

purposes would reveal confidential

business information.

(ii) If the notice includes a health and

safety study concerning the new

chemical substance and if the claim for

confidentiality with respect to the

chemical identity is denied in

accordance with § 720.90(c), EPA will

deny a claim asserted under this

paragraph.

(2) Any person who asserts a claim of

confidentiality for chemical identity

under this paragraph must provide one

of the following items at the time the

notice is submitted:

(i) The generic name which was

accepted by EPA in the prenotice

consultation conducted under paragraph

(a)(3) of this section.

(ii) One generic name that is only as

generic as necessary to protect the

confidential chemical identity of the

particular chemical substance. The

name should reveal the specific

chemical identity to the maximum

extent possible. The generic name will

be subject to EPA review and approval

at the time a notice of commencement is

submitted.

(3)(i) Any person who intends to

assert a claim of confidentiality for the

chemical identity of a new chemical

substance may seek a determination by

EPA of an appropriate generic name for

the substance before submitting a

notice. For this purpose, the person

should submit to EPA:

(A) The chemical identity of the

substance.

(B) A proposed generic name(s) which

in only as generic as necessary to

protect the confidential chemical

identity of the new chemical substance.

The name(s) should reveal the chemical

identity of the substance to the

maximum extent possible.

(ii) Within 30 days, EPA will inform

the submitter either that one of the

proposed generic names is adequate or

that none is adequate and further

consultation is necessary.

(4) If a submitter claims chemical

identity to be confidential under this

paragraph, and if the submitter complies

with paragraph (a)(2) of this section,

EPA will issue for publication in the

Federal Register notice described in

§ 720.70 the generic name proposed by

the submitter or one agreed upon by

EPA and the submitter.

(b) Claims applicable to the period

after commencement of manufacture or

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import. (1) Any claim of confidentiality

under paragraph (a) of this section is

applicable only until the substance is

manufactured or imported for

commercial purposes and becomes

eligible for inclusion on the Inventory.

To maintain the confidential status of

the chemical identity when the

substance is added to the Inventory, a

submitter must reassert the

confidentiality claim and substantiate

the claim in the notice of

commencement of manufacture required

uner § 720.102. A submitter may not

claim the chemical indentity

confidential for the period after

commencement of manufacture or

import unless the submitter claimed the

chemical identity confidential for the

period prior to commencement of

manufacture or import under paragraph

(a) of this section.

(2)(i) A person who believes that

public disclosure of the fact that anyone

manfactures or imports the new

chemical substance for commercial

purposes would reveal confidential

business information may assert a claim

of confidentiality under this paragraph.

(ii) If the notice includes a health and

safety study concerning the new

chemical substance, and if the claim for

confidentiality with respect to the

chemical identity is denied in

accordance with § 720.90(c), EPA will

deny a claim asserted under this

paragraph.

(3) Any person who asserts a

confidentiality claim for chemical

identity must:

(i) Comply with the requirements of

paragraph (a)(3) of this section regarding

submission of a generic name.

(ii) Agree that EPA may disclose to a

person with a bona fide intent to

manufacture or import the chemical

substance the fact that the particular

chemical substance is included on the

confidential Inventory for purposes of

notification under section 5(a)(1)(A) of

the Act.

(iii) Have available for the particular

chemical substance, and agree to furnish

to EPA upon request:

(A) An elemental analysis.

(B) 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 chemical substance.

(iv) Provide a detailed written

substantiation of the claim, by

answering the following questions:

(A) What harmful effects to your

competitive position, if any, do you

think would result if EPA publishes on

the Inventory the identity of the

chemical substance? How could a

competitor use such information given

the fact that the identity of the

substance otherWise would appear on

the Inventory of chemical substances

with no link between the substance and

your company or industry? How

substantial would the harmful effects of

disclosure be? What is the casual

relationship between the disclosure and

the harmful effects?

(B) For what period of time should

confidential treatment be given? Until a

specific date, the occurrence of a

specific event, or permanently? Why?

(C) Has the chemical substance been

patented? If so, have you granted

licenses to others with respect to the

patent as it applies to the chemical

substance? If the chemical substance

has been patented and therefore

disclosed through the patent, why

should it be treated as confidential for

purposes of the Inventory?

(D) Has the identity of the chemical

substance been kept confidential to the

extent that your competitors do not

know it is being manufactured on

imported for a commercial purpose by

anyone?

(E) Is the fact that someone is

manufacturing or importing this

chemical substance for commercial

purposes available to the public, e.g., in

technical journals or other publications;

in libraries; or in State, local, or Federal

agency public files?

(F) What measures have you taken to

prevent undesired disclosure of the fact

that you are manufacturing or importing

this substance for a commercial

purpose?

(G) To what extent has the fact that

you are manufacturing or importing this

chemical substance for a commercial

purpose been disclosed to others? What

precautions have you taken in regard to

these disclosures? Has this information

been disclosed to the public or to

competitors?

(H) In what form does this particular

chemical substance leave the site of

manufacture, e.g., as part of a product;

in an effluent or emission stream? If so,

what measures have you taken to guard

against discovery of its identity?

(I) If the chemical substance leaves

the site of manufacture in a product that

is available to either the public or your

competitors, can they identify the

substance by analyzing the product?

(J) For what purpose do you

manufacture or import the substance?

(K) Has EPA, another Federal agency,

or any Federal court made any pertinent

confidentiality determinations regarding

this chemical substance? If so, copies of

such determinations must be included in

the substantiation.

(L) If the notice includes a health and

safety study concerning the new

chemical substance, the submitter must

also answer the questions in § 720.90 (b)

(2).

(4) If the submitter does not meet the

requirements of this paragraph, EPA will

deny the claim of confidentiality.

(5) (i) EPA will publish a generic name

on the public Inventory if:

(A) The submitter asserts a claim of

confidentiality in accordance with this

pargraph.

(B) No claim for confidentiality of the

specific chemical identity as part of a

health and safety study has been denied

in accordance with Part 2 of this Title or

§ 720.90.

(ii) Publication of a generic name on

the public Inventory does not create a

category for purposes of the Inventory.

Any person who has a bona fide intent

to manufacture or import a chemical

substance which is described by a

generic name on the public Inventory

may submit an inquiry to EPA under

§ 720.25 (b) to determine whether the

particular chemical substance is

included on the confidential Inventory.

(iii) Upon receipt of a request

described in § 720.25 (b), EPA may

require 'the submitter which originally

asserted confidentiality for a chemical

substance to submit to EPA the

information listed in paragraph (b) (3)

(iii) of this section.

(iv) Failure to submit any of the

information required under paragraph

(b) (3) (iii) of this section within ten days

of a request by EPA under this

paragraph is a waiver of the original

submitter's confidentiality claim. In this

event, EPA may place the specific

chemical identity on the public

Inventory without further notice to the

original submitter.

(6) If a submitter asserts a claim of

confidentiality, under this paragraph,

EPA will examine the generic chemical

name proposed by the submitter.

(i) If EPA determines that the generic

name proposed by the submitter is only

as generic as necessary to protect the

confidential identity of the particular

chemical substance, EPA will place that

generic name on the public Inventory.

(ii) If EPA determines that the generic

name proposed by the submitter is more

generic than necessary to protect the

confidential identity, EPA will propose

in writing, for review by the submitter,

an alternative generic name that will

reveal the chemical identity of the

chemical substance to the maximum

extent possible.

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(iii) If the generio name proposed by

EPA is acceptable to the submitter, EPA

will place that generic name on the

public Inventory.

(iv) If the generic name proposed by

EPA is not acceptable to the submitter,

the submitter must explain in detail why

disclosure of that generic name would

reveal confidential business information

and propose another generic name

which is only as generic as necessary to

protect the confidential identity. If EPA

does not receive a response from the

submitter within 30 days after the

submitter receives the proposed name,

EPA will place EPA's chosen generic

name on the public Inventory. If the

submitter does provide the information

requested, EPA will review the

response. If the submitter's proposed

generic name is acceptable, EPA will

publish that generic name on the public

Inventory. If the submitter's proposed

generic name is not acceptable, EPA will

notify the submitter of EPA's choice of a

generic name. Thirty days after this

notification, EPA will place the chosen

generic name on the public Inventory.

§ 720.87 Categories or proposed

categories of uses of a new chemical

substance.

(a) A person who submits information

to EPA under this Part on the categories

or proposed categories of use of a new

chemical substance may assert a claim

of confidentiality for this information.

(b] A submitter that asserts such a

claim must:

(1) Report the categories or proposed

categories of use of the chemical

substance.

(2) Provide, in nonconfidential form, a

description of the uses that is only as

generic as necessary to protect the

confidential business information. The

generic use description will be included

in the Federal Register notice described

in § 720.70.

(c) The person must submit the

information required by paragraph (b) of

this section in the manner specified in

the notice form.

§ 720.90 Data from health and safety

studies.

(a) Information other than specific

chemical identity. Except as provided in

paragraph (b) of this section, EPA will

deny any claim of confidentiality with

respect to information included in a

health and safety study, unless the

information would disclose confidential

business information concerning:

(1) Processes used in the manufacture

or processing of a chemical substance or

mixture.

(2) In the case of a mixture, the

portion of the mixture comprised by any

of the chemical substances in the

mixture.

(3) Informaton which is not in any

way related to the effects of a substance

on human health or the environment,

such as the name of the submitting

company, cost or other financial data,

product development or marketing

plans, and advertising plans, for which

the person submits a claim of

confidentiality in accordance with

§ 720.80.

(b) Specific chemical identity. (1)

Claims applicable to period prior to

commencement of manufacture. A claim

of confidentiality for the period prior to

commencement of manufacture or

import for the chemical identity of a

chemical substance for which a health

and safety study was submitted must be

asserted in conjunction with a claim

asserted under § 720.85(a).

(2) Claims applicable to period after

commencement of manufacture or

import for commercialpurposes. To

maintain the confidential status of the

chemical identity of a chemical

substance for which a health and safety

study was submitted after

commencement of manufacture or

import, the claim must be reasserted and

substantiated in conjunction with a

claim under § 720.85(b). In addition to

the questions set forth in

§ 720.85(b)(3)(iv) of this Part, the

submitter must answer the following

questions:

(i) Would disclosure of the chemical

identity disclose processes used in the

manufacture or processing of a chemical

substance or mixture? Describe how this

would occur. In responding to the

q uestion in § 720.85(b)(3)(iv)(A), explain

at harmful competitive effects would

occur from disclosure of this process

information.

(ii) Would disclosure of the chemical

identity disclose the portion of a mixture

comprised by any of the substances in

the mixture? Describe how this would

occur. In responding to the question in

§ 720.85(b)(3)(iv)(A), explain what

harmful competitive effects would occur

from disclosure of this information.

(iii) Do you assert that disclosure of

the chemical identity is not necessary to

interpret any of the health and safety

studies you have submitted? If so,

explain how a less specific identity

would be sufficient to interpret the

studies.

(c) Denial of confidentiality claim.

EPA will deny a claim of confidentiality

for chemical identity under paragraph

(b) of this section, unless:

(1) The information would disclose

processes used in the manufacture or

processing of a chemical substance or

mixture.

(2) In the case of a mixture, the

information would disclose the portion

of the mixture comprised by any of the

substances in the mixture.

(3) The specific chemical identity is

not necessary to interpret a health and

safety study.

(d) Use of generic names. When EPA

discloses a health and safety study

containing a specific chemical identity,

which the submitter has claimed

confidential, and if the Agency has not

denied the claim under paragraph (c) of

this section, EPA will identify the

chemical substance by the generic name

selected under § 720.85. (OMB Control

No. 2070-0012)

§ 720.95 Public file.

All information submitted with a

notice, including any health and safety

study and other supporting

documentation, will become part of the

public file for that notice, unless such

materials are claimed confidential. In

addition, EPA may add materials to the

public file, subject to Subpart E of this

Part. Any of the nonconfidential

material described above will be

available for public inspection in the

Office of Toxic Substances Public

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

SW., Washington, DC 20460, during

normal business hours.

Subpart F-Commencement of

Manufacture or Import

§ 720.102 Notice of commencement of

manufacture or Import.

(a) Applicability. Any person who

commences to manufacture or import a

new chemical substance for a

commercial purpose for which that

person previously submitted a section 5

notice under this Part must submit a

notice of commencement of manufacture

or import.

(b) When to report. (1) If manufacture

or import for commercial purposes

begins on or after the effective date of

this rule, the submitter must submit the

notice to EPA on the first day of such

manufacture or import.

(2) If manufacture or import for

commercial purposes began or will

begin before the effective date of this

rule, the submitter must submit the

notice by the effective date of this rule.

(c) Information to be reported. The

notice must contain the following

information: specific chemical identity,

premanufacture notice number, and the

date when manufacture or import

commences. If the person claimed

chemical identity confidential in the

commencement notice, and wants the

identity to be listed on the confidenial

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Inventory, the claim must be reasserted

and substantiated in accordance with

§ 720.85(b). Otherwise, EPA will list the

specific chemical identity on the public

Inventory (OMB Control No. 2070-0012).

Subpart G-Compliance and

Inspections

§ 720.120 Compliance.

(a) Failure to comply with any

provision of this Part is a violation of

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

(b) A person who manufactures or

imports a new chemical substance

before a notice is submitted and the

notice review period expires is in

violation of section 15 of the Act even if

that person was not requied to submit

the notice under § 720.22 of this Part.

(c) Using for commercial purposes a

chemical substance or mixture which a

person knew or had reason to know was

manufactured, processed, or distributed

in commerce in violation of section 5 of

this rule is a violation of section 15 of

the Act (15 U.S.C. 2614].

(d) Failure or refusal to establish and

maintain records or to permit access to

or copying of records, as required by the

Act, is a violation of section 15 of the

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

(e) Failure or refusal to permit entry or

inspection as required by section 11 is a

violation of section 15 of the Act (15

U.S.C. 2614).

(f) Violators may be subject to the

civil and criminal penalties in section 16

of the Act (15 U.S.C. 2615) for each

violation. Persons who submit

materially misleading or false

information in connection with the

requirements of any provision of this

rule may be subject to penalties

calculated as if they never filed their

notices.

(g) EPA may seek to enjoin the

manufacture or processing of a chemical

substance in violation of this rule or act

to seize any chemical substance

manufactured or processed in violation

of this rule or take other actions under

the authority of section 7 of this Act (15

U.S.C. 2606) or section 17 or this Act (15

U.S.C. 2616).

§ 720.122 Inspections.

EPA will conduct inspections under

section 11 of the Act to assure

compliance with section 5 of the Act and

this rule, to verify that information

submitted to EPA under this rule is true

and correct, and to audit data submitted

to EPA under this rule.

BILLING CODE 6560-50-M

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