16298 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 704, 720 and 721

[OPPTS–50593B; FRL–4921–8]

RIN 2070–AC14

Premanufacture Notification;

Revisions of Premanufacture

Notification Regulations; Final Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: Pursuant to section 5 of the

Toxic Substances Control Act (TSCA),

EPA is promulgating procedural

amendments to the premanufacture

notification (PMN) rule to incorporate a

number of regulatory initiatives

designed to streamline and reduce the

administrative costs and burdens of the

section 5 new chemicals program. These

actions will allow EPA to concentrate its

limited resources on identifying and

controlling those new chemical

substances most likely to present an

unreasonable risk of injury to human

health and the environment.

DATES: This rule will become effective

May 30, 1995. In accordance with 40

CFR 23.5, this rule shall be promulgated

for purposes of judicial review at 1:00

p.m. eastern savings time on April 12,

1995.

FOR FURTHER INFORMATION CONTACT:

James B. Willis, Acting Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

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

DC 20460, Telephone: (202) 554–1404,

TDD: (202) 554–0551.

SUPPLEMENTARY INFORMATION: EPA

published its final PMN rule (40 CFR

part 720) on May 13, 1983 (48 FR 21722)

and subsequently amended certain parts

of the rule on September 13, 1983 (48

FR 41132) and April 22, 1986 (51 FR

15096). On February 8, 1993, EPA

proposed additional amendments to the

PMN rule (58 FR 7661). Please consult

those documents for further information

on the PMN rule and the proposed

amendments. The docket control

number for this action is OPPTS–

50593B.

I. Background

A. Statutory Authority

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

persons notify EPA at least 90 days

before they manufacture or import a

new chemical substance for commercial

purposes. For the purposes of TSCA, a

new chemical substance is one that is

not listed in the Master File of the TSCA

Chemical Substance Inventory (‘‘the

Inventory’’) compiled under TSCA

section 8(b), which consists of

substances originally reported under the

Inventory reporting regulations (40 CFR

part 710) and substances added via

notices of commencement of

manufacture or import (NOCs)(40 CFR

720.102) from submitters of PMNs.

B. History

Since 1979, EPA has reviewed over

25,000 section 5 notices for new

chemical substances. During the

intervening years, EPA has

implemented a number of initiatives

which have enabled the Agency to

review a growing number of new

chemical substances more efficiently.

As discussed in the February 8, 1993

proposed rule (58 FR 7661), EPA is

amending the PMN rule at 40 CFR part

720 to further reduce the costs of

administering the Agency’s new

chemicals program and to implement

other efficiencies for EPA and

submitters. Please consult the proposed

rule for a more detailed discussion of

the objectives and rationale for these

amendments.

II. Discussion of Final Amendments

and Response to Comments

The final rule adopts the proposed

amendments with minor revisions. The

Agency reviewed and considered all

comments received on the proposed

amendments. A complete copy of all

comments received is available in the

public docket for this rulemaking, along

with EPA’s response to comments not

addressed in this document. A

discussion of the final amendments

including a summary of significant

comments and the Agency’s response

follows:

A. Correct Chemical Identity

EPA is amending §720.45(a) of the

PMN rule to require that submitters of

section 5 notices provide the currently

correct Chemical Abstracts (CA) Index

Name or CA Preferred Name for each

chemical substance included in the

notice (‘‘reported substance’’) that is

consistent with TSCA Inventory listings

for similar substances. Persons who

request a search of the confidential

Inventory by demonstrating a bona fide

intent to manufacture or import a

chemical substance for commercial

purposes (‘‘bona fide’’) will also be

required to provide CA nomenclature

and chemical identity information in

accordance with amended §720.25, as

discussed later in this document. The

rule also requires that a currently valid

Chemical Abstracts Service (CAS)

Registry Number (CASRN) consistent

with the CA name be reported for the

substance if a CASRN already exists for

that substance. Until now, the PMN rule

has indicated that CA nomenclature is

the preferred, but not required chemical

nomenclature system for PMN

reporting. Therefore, submitters were

able in the past to identify the PMN

substance using alternative

nomenclature. Having the currently

correct CA identification for a substance

is important to EPA because the

reporting of incorrect, inconsistent,

ambiguous, or obsolete chemical names,

molecular formulae, or chemical

structure information, or names that are

not CA Index or CA Preferred Names,

causes extra resources to be spent by

EPA in establishing the best

descriptions for substances under TSCA

for searching the Inventory.

Although a CASRN has not been

routinely required for a reported

substance if a CASRN is not already

available and the amendment only

requires that CASRNs be reported for

substances that already have them, EPA

strongly recommends that submitters

provide CASRNs for all reported

substances, especially when the

chemical identity is not being claimed

as confidential business information

(CBI). The fact that a CASRN exists does

not prohibit a submitter from claiming

this information as confidential. Having

more substances reported with CASRNs

will save EPA resources involved with

chemical review and Inventory

searching.

Submitters must provide a CA Index

Name or CA Preferred Name that is

consistent with the application of the

Ninth Collective Index (9CI) of CA

nomenclature rules and conventions.

(This definitive guide to CA

nomenclature has been used since

1972.) Whether to report a CA Index

Name or Preferred Name for a substance

depends on whether the chemical

identity of the substance is well-defined

or poorly defined.

For well-defined substances

appropriately named using CA Index

nomenclature, the specific chemical

name chosen as most accurately

describing the substance should be

based on all information that the

submitter can reasonably ascertain

about its chemical structure, including,

where applicable, the degree of

structural specificity of the substance

(e.g., whether specific isomers are

intended to be manufactured in the

reaction that produces the substance).

For poorly defined substances properly

named using CA Preferred

nomenclature, the specific name of

choice should be based on the
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16299

submitter’s knowledge of the identities

of the chemical precursors used, the

sources of the reactants (synthetic,

isolated by processing from certain

naturally occurring materials, etc.), the

nature of the reaction, and the types of

chemical substances constituting the

product combination, etc. For naming

any kind of substance, the submitter’s

knowledge of impurities or byproducts

is also a consideration.

When more than one substance

results from a reaction, one should

determine whether the product

combination can be viewed for TSCA

purposes as a mixture of separately

reportable substances. For example,

when the intended product combination

is known to always be completely

composed of a specific number of

identified substances that do not react

with one another, the combination can

be represented as a mixture of

individual components. If this is not the

case, a single chemical name must be

used to collectively describe the product

combination as one substance. Where

the chemical components can be

represented as a mixture, they may be

reported in a single PMN as long as the

components are not intended to be

separated. Otherwise, multiple PMNs or

a consolidated PMN (requiring preapproval by EPA) must be submitted.

The PMN rule retains all of the other

chemical identity information required

at §720.45(a), including molecular

formula and chemical structure

information. However, for substances

not able to be characterized by a single

chemical structure, the amendments

require the submitted representative or

partial structural diagram to be as

complete as known to or reasonably

ascertainable by the submitter. Failure

to fully comply with the chemical

identification elements of this

requirement will result in the notice

being declared incomplete by EPA

pursuant to §720.65(c)(1). Such

incomplete notices will not be

processed or reviewed by the Agency

until the chemical identification

requirement is satisfied.

Concerning the degree of chemical

structure information that can be

reasonably ascertained for a given

substance, submitters should

understand that, for TSCA Inventory

purposes, all substances are categorized

by EPA into two groups according to the

degree of certainty about the chemical

structure of a substance: Class 1 and

Class 2. Class 1 substances are those of

precisely known chemical composition

for which a single, complete structural

diagram can be drawn. Class 2

substances are those having chemical

compositions not completely definite or

known; therefore, they cannot be

characterized by definite, complete

chemical structure diagrams. This rule

amendment requires complete structural

diagrams to be provided for Class 1

substances; for Class 2 substances,

partial structure diagrams are required

that are as complete as can be

reasonably ascertained from the Class 2

chemical identity.

All of the chemical identification

requirements described above should be

satisfied if the submitter uses the CAS

Registry Services Inventory Expert

Service, which is a special extension of

CAS for identifying substances to be

submitted under TSCA. Submitters may

also choose to use the services of

another chemical information service or

consultant that the submitter considers

capable of generating correct CA names,

chemical structure diagrams or

molecular formulae where appropriate,

and obtaining existing CASRNs.

Alternatively, the submitter can search

publicly available databases to retrieve

this information, if available, or attempt

to generate a name without assistance

from another person or organization, if

the submitter has sufficient knowledge

about the Ninth Collective (9CI) Index of

CA nomenclature rules and conventions

and about how similar substances are

named for the Inventory.

Information describing CA

nomenclature rules and conventions can

be obtained from CAS. In addition, the

Agency is preparing a series of

Inventory nomenclature papers that are

intended to generate better

understanding of how various classes of

substances or types of complex product

combinations are identified for TSCA

purposes. The Inventory papers provide

informal technical guidance that is

intended solely to illustrate how various

types of substances are represented on

the TSCA Inventory based on the

information provided by the submitters.

The papers are not intended to be used

for identifying substances for reporting

purposes or for determining the need to

report. Generally, EPA has attempted to

maintain a consistent Inventory by

closely following the guidance

contained in the papers. However, EPA

cannot guarantee that the guidance

discussed in these papers has been

applied to all substances listed on the

Inventory. The initial Inventory

reporting utilized four types of reporting

forms with very different format and

data requirements, making it difficult to

ensure complete consistency. The

Inventory papers will be available from

the TSCA Assistance Information

Service at (202) 554–1404; TTD (202)

554–0551; on line service modem (202)

554–5603.

An information sheet on the CAS

Registry Services is also available from

the TSCA Assistance Information

Service. Printed copies of the nonconfidential Inventory can be purchased

from the Government Printing Office;

computer tapes, CD ROM, and PC

diskettes, (up-dated semi-annually)

containing this Inventory information

can be purchased from the National

Technical Information Service (NTIS).

Regardless of how submitters

determine correct CA chemical

nomenclature, submitters should

provide the party generating the CA

nomenclature with the same chemical

identity information that the submitter

would have to send to EPA if reporting

the substance in a PMN: the same types

of information, levels of detail, degrees

of specificity, byproduct and impurity

information, etc. The party assigning a

chemical identity should ensure that the

name choice reflects the current CA

nomenclature rules and conventions, as

well as how similar substances are

named for the Inventory, or the

chemical name will be incorrect and the

notice may be declared incomplete by

the Agency.

The final rule at §720.45(a)(3)(i) and

(ii) sets forth the required mechanism

for obtaining CA nomenclature directly

from CAS or alternative sources, as

follows:

Method 1. A submitter using this

method obtains the correct chemical

identification directly from the CAS

Registry Services Inventory Expert

Service prior to submitting a notice to

EPA. CAS will provide such services

pursuant to arrangements between CAS

and persons informing CAS that their

substances will be reported to EPA in a

notice. Submitters should call or write

to the CAS Registry Services for

information. Submitters must provide

EPA with a copy of the chemical

identification report obtained from CAS

along with the completed notice, to

verify that they obtained the

information directly from CAS.

EPA believes that most submitters

will find it advantageous to utilize the

services of CAS to meet this

requirement. As discussed in the

proposed rule, due to CAS’ authoritative

position in the field of chemical

identification and its familiarity with

TSCA Inventory and nomenclature

policies, EPA believes that chemical

names and other chemical identity

information assigned by CAS according

to this method should be acceptable to

the Agency. For these reasons, EPA

strongly recommends that submitters

use the services of CAS to satisfy the

amended provisions.
16300 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

Submitters should note, however, that

if EPA disagrees with the identification

assigned by CAS to a given substance,

the Agency reserves the final authority

to designate how a reported substance

should be named and represented for

the Inventory. This will not delay

processing of the PMN by EPA. In the

event EPA does not agree with a

chemical name, CASRN, chemical

structure or molecular formula provided

to a submitter by CAS for TSCA

purposes according to Method 1, EPA

will work with CAS to either modify the

submitted chemical identity when

necessary or confirm that CAS’

identification is most appropriate, to

ensure that a correct TSCA description

is assigned. Using Method 1, there will

be no delay in EPA review or additional

cost to the submitter resulting from an

identification error by CAS or an

identity verification request by EPA

provided that the submitter has given

complete chemical information to CAS

that is identical to the chemical identity

information contained in the section 5

notice to EPA. EPA will assume

responsibility for resolving chemical

identity problems occurring when

Method 1 is used. However, if EPA

determines that the chemical identity

information submitted to EPA is not

identical to that provided CAS, the

notice may be deemed incomplete in

accordance with §720.65(c)(1).

Method 2. Using this method, a

submitter may obtain the required

chemical identity information from any

chemical information service or

consultant, or can retrieve or develop

the proper CA identifications without

assistance. EPA emphasizes that with

this method submitters will need to

provide for each substance a correct CA

Index or Preferred Name and other

chemical identity information, as

required under §720.45(a)(1) and (2),

that is consistent with Inventory listings

for similar substances. It will be the

submitter’s responsibility under Method

2 to seek the required information from

a source the submitter believes to be

sufficiently knowledgeable about CA

nomenclature conventions and TSCA

Inventory listings.

In contrast to Method 1, if a submitter

uses Method 2 and reports any chemical

identity information that is considered

incorrect by EPA, the submitter, not the

Agency, will be considered responsible

for correcting the chemical

identification. EPA will declare such a

notice incomplete under §720.65(c)(1)

and will not further process or review

it until the submitter provides the fully

correct chemical identity information

specified in this amendment.

Concerning the task of generating

correct CA nomenclature, it should be

noted that there are many chemical

names on the CAS Registry File,

particularly CA names for indefinitely

described substances, that are not

appropriate for uniquely identifying

substances on the Inventory. Thus, the

application of just the CA nomenclature

rules to name a new substance may not

necessarily guarantee an acceptable

chemical name for TSCA purposes. One

must also be familiar with the ways in

which similar substances are listed in

the Inventory. As stated above, EPA is

developing papers on specific Inventory

nomenclature issues for public

distribution.

Whether a submitter uses CAS or

another method to obtain CA

nomenclature, EPA will assume that

upon sending a notice to the Agency,

the submitter agrees with the chemical

identity information provided by the

source. Regardless of which method is

chosen by a submitter for properly

identifying a reported substance, EPA

remains the final authority for naming

new substances for the TSCA Inventory.

For submitters to have ample time to

become familiar with the process of

obtaining chemical identity information

from CAS, another chemical

information service, or a consulting

party for obtaining chemical

identifications, submitters should

contact their chosen source at least 1 or

2 months before the intended

submission date of a notice. This is

especially important the first time one

would have to report under this

amendment.

EPA anticipates that many submitters

would consider chemical identity

information and/or submitter identity

information given to CAS (by Method 1)

or another third party (by Method 2) to

be CBI. Until submitted to EPA under a

provision of TSCA, CBI is not subject to

EPA’s procedural and security

protections under TSCA. Therefore,

provisions for handling any CBI first

submitted to CAS or another outside

party must be arranged directly with

that party. Submitters should not

assume that CAS or another outside

party is required to adhere to EPA’s

TSCA-CBI procedures regarding the

possession, handling, labelling, storage,

tracking, auditing, or other processing of

this information.

However, based on currently available

information, it is EPA’s understanding

that any confidential, proprietary, or

trade secret information that CAS would

receive according to Method 1 of this

rule amendment prior to the

information being reported to EPA

would be handled in accordance with

the long-established security procedures

and policies that CAS has implemented

to safeguard any confidential

information provided by its customers.

When submitting chemical substance

identity information to CAS or any other

information service, a submitter who

indicates that the substance identity is

CBI should be aware that a CASRN for

that substance may already exist due to

CAS’s prior knowledge of the existence

of that substance from another source.

In such a case, the chemical identity

would already have been assigned a

CASRN and placed by CAS in its

publicly accessible files.

Based on its knowledge of CAS’s

procedures, EPA believes that CAS

currently does not place the substance

identity into the publicly available CAS

Registry File, if not already present

there, when a submitter has requested

confidential treatment of the

information. However, EPA cannot

ensure that CAS will continue this

practice in the future, nor can EPA

ensure how other services handle this

type of information. As always, it is the

submitter’s responsibility to ensure that

the information service it uses properly

protects the confidentiality of its data.

Submitters choosing to use either

Method 1 or Method 2 should inquire

how the information service, consultant,

or party receiving their confidential

information will handle, protect, and

use such information.

The final rule at §720.45(a)(4) and (5)

sets forth procedures for importers and

manufacturers who do not possess the

complete chemical identity information

required to submit a notice to EPA about

a substance they intend to import or

manufacture because of proprietary

claims by the U.S. or foreign supplier of

the new chemical substance or a

reactant used to manufacture the new

chemical substance. Section 720.45(a)(4)

requires that the importer of a

proprietary new chemical substance

have the foreign supplier follow the

procedures for obtaining CAS

nomenclature for the new chemical

substance from CAS or alternative

sources as specified in §720.45(a)(3).

The foreign supplier would provide the

chemical identity information on the

new chemical substance specified in

§§720.45 (a)(1) and (2) directly to EPA

as part of a joint submission or letter of

support clearly referencing the

importer’s notice and in the case of

PMNs, the user fee identification

number of the PMN submission

established by the U.S. submitter (see 40

CFR 700.45(e)(3)).

Section 720.45(a)(5) contains

provisions for manufacturers who

cannot provide complete chemical
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16301

identity information because the new

chemical substance is manufactured

using a reactant whose identity is

claimed confidential by its supplier. In

this situation, however, due to logistical

obstacles to generating correct CA

nomenclature and other chemical

identity information for a substance

based on multiple submissions from

different sources, each containing part

of the overall chemical identity, EPA

will not require the submitter to first

develop or obtain a correct CA chemical

identification for the given substance

before submitting a section 5 notice.

Instead, the final rule requires that the

manufacturer provide all the

information known by the manufacturer

about the chemical identity of the

reported substance and the proprietary

reactant. This would typically include

tradename, generic chemical name, or

partial composition information about

the confidential reactant such as that

listed in a Material Safety Data Sheet

(MSDS) or in other product literature

and any other chemical identity

information the submitter may know or

reasonably ascertain about the

confidential reactant or reported

substance. In addition, the manufacturer

must ensure that the supplier of the

proprietary reactant sends a letter of

support directly to EPA providing the

specific chemical identity of the

confidential reactant, including the CAS

number, if available, and the

appropriate PMN or exemption number,

if applicable. This should be

information known to or reasonably

ascertainable by the supplier since that

person is responsible for determining

that the proprietary reactant is either on

the Inventory or being manufactured

under terms of an applicable section 5

exemption.

As indicated above, §§720.45(a)(4)

and (5) require that persons providing

information as part of a joint submission

or letter of support clearly reference the

importer or manufacturer’s notice and

user fee identification number (See 40

CFR 700.45(c)(3)), if appropriate so that

EPA can be sure of properly linking the

two submissions. In addition, any CBI

claims must be clearly marked in the

notice or letter of support along with a

statement that this information must not

be shared with the notice submitter. The

statutory review period for a section 5

notice will not begin until EPA receives

all parts of a joint notice, or all

necessary supporting documents

providing chemical identity information

for a notice.

Comment. EPA should resolve

nomenclature issues leading to

inconsistency (1) within the TSCA

Inventory, (2) between CAS and TSCA

nomenclature and (3) between how a

substance is named for TSCA purposes

and how it is named by the chemical

industry for marketing purposes.

Response. Basically, there is only one

set of nomenclature rules used for the

TSCA Inventory; the CA nomenclature

system has always been utilized by EPA

to represent and name substances for

Inventory purposes. However,

recognizing the complexity of the

various types of commercial chemical

substances that would be reported

under TSCA and the need for accurately

representing these substances on the

Inventory, EPA held numerous meetings

with trade associations at the time the

Initial Inventory was compiled to

develop guidelines for identifying these

substances. Before the Inventory was

initially compiled, EPA worked with

CAS to refine some of the nomenclature

policies for certain categories of

chemical substances, such as (1)

substances of variable composition, (2)

natural fats, and (3) polymers.

The TSCA Inventory was initially

compiled from information submitted

by chemical manufacturers, importers,

and processors. Perceived Inventory

inconsistencies reflect the different

ways in which similar substances were

described and reported by submitters.

Differences in commercial intent, author

emphasis, and level of detail or

knowledge of composition resulted in

some variation in names. This flexibility

in nomenclature was considered

necessary by the chemical industry at

the time of the Initial Inventory

reporting. The Agency checked the

original 160,000 reports for the Initial

Inventory using a computer program

that was designed to identify obvious

discrepancies; the Agency then worked

with the submitters of problem

substances to correct the Inventory

reports. If there were no obvious

discrepancies, the Agency was not able

to identify substances that were

identified incorrectly by the submitters,

and consequently, some incorrectly

identified substances might have been

added to the Inventory. However, when

the Agency adds substances to the

Inventory through the PMN program, it

works with the submitters and CAS to

attempt to ensure that consistent

nomenclature is used.

The Agency will continue using its

current nomenclature system, striving to

maintain consistency. As discussed

above, a series of Inventory

nomenclature guidance papers (that will

be available through TSCA’s Assistance

Information Service) is under

development at the Agency to publicly

articulate Agency nomenclature

practices used for Inventory

representation of various types of

chemical substances.

Comment. CA nomenclature should

not be required for TSCA submissions;

CAS should not have an exclusive

interest.

Response. EPA developed the TSCA

Inventory using CA nomenclature and

numbers; CAS has been assisting EPA in

compiling, maintaining and updating

the Inventory since 1977. CA

nomenclature and numbers are used by

all major industrial countries for their

chemical inventories. This form of

international harmonization enhances

international trade and conserves the

resources of chemical industries and

governments. Many major chemical

manufacturers now utilize CA

nomenclature, too. The use of one

nomenclature system minimizes

confusion in regulatory matters and

trade, and facilitates compliance

monitoring. Moreover, the Agency has

the authority to specify the form of

nomenclature for TSCA purposes.

Therefore, the Agency believes that the

use of CA nomenclature is appropriate.

Submitters have the choice of which

nomenclature service to use, as long as

names are consistent with TSCA

nomenclature requirements.

Comment. Problems with

nomenclature not provided by CAS

should not delay Agency review.

Response. Chemical identification

errors by submitters result in wasted

resources and significant delays for both

EPA and submitters. For this reason, the

Agency has determined that it will

consider submissions incomplete and

thus delay their review if the incorrect

nomenclature is received from a source

other than CAS. The Agency believes, as

a result of its years of experience using

CAS nomenclature, that chemical

substance identities provided by CAS

specifically for TSCA purposes will

rarely be in error and that any errors

would be relatively minor. EPA has

insufficient experience with other

chemical nomenclature services to

allow EPA to assume that the

nomenclature provided by such services

would normally be consistent with

Inventory nomenclature requirements.

Comment. The burden of supplying

CA nomenclature is significant, both in

terms of time and financial resources.

Response. The Agency disagrees with

this comment. The Agency recognizes

that the time and cost of submitting a

notice will increase to some extent

because of the requirement to use CAS

nomenclature. This will be true for

those who utilize the TSCA

nomenclature services of CAS or other

providers or choose to develop CAS

nomenclature on their own. EPA does
16302 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

not believe that this requirement will

present significant problems because, in

EPA’s experience under the section 5

program, some submitters already use

CAS private registry services, despite

the absence of a requirement to do so

under the previous PMN regulations,

apparently with minimal added cost or

delay.

The Agency recognizes that the lead

time required to prepare a PMN may

increase. In most cases, submitters can

be preparing other sections of their

notices pending nomenclature

assignments. The added up-front time in

compiling a PMN should not be a major

factor. According to EPA records many

PMN substances are not manufactured

until a month or more after the PMN

review period ends. The Agency

believes that submitters should always

take the time necessary to ensure that

their chemical substance is correctly

identified upfront. The practice of

relying on EPA to correct submitter

errors, after the fact, has over the years

consumed significant Agency resources.

The Agency believes that this change in

the procedural rule will place this

responsibility where it legitimately

belongs.

Comment. The burden imposed on

small manufacturers and importers is

too large.

Response. EPA does not consider this

burden to be unreasonable, especially

because small companies already save

$2,400 on each of their PMN

submissions compared with larger

companies. Small companies have

historically been responsible for a

disproportionately large number of

errors in chemical identities. The

burden of generating CA nomenclature

will be offset, in many cases, because

with the inclusion of proper chemical

names in the initial section 5 notice the

review period will not be suspended for

problems with chemical identity. Small

companies may also benefit

significantly from an early knowledge of

the correct chemical identity, which

may enhance their customer service,

Inventory search efforts, and regulatory

compliance.

Comment. Requirements to generate

CA nomenclature will create problems

in protecting confidentiality.

Response. The Agency does not

believe that the requirement for CA

nomenclature will create undue

problems with confidentiality for

submitters. All submitters must be

responsible for the confidentiality of

their information prior to submission to

the Agency.

Comment. EPA should not require CA

nomenclature for polymers and for bona

fide inquiries (bona fides).

Response. While submitters must

report all monomers and other reactants

used to manufacture reported polymers,

CA nomenclature is required for

polymers, in part, because in certain

cases the appropriate CA name for the

polymer is based on more than just the

names of the monomers and other

reactants. CA nomenclature for certain

polymeric substances may be based on

structural repeating units or other

important structural features of the

polymeric material. Examples include

certain block polymers, certain posttreated or functionalized polymers, and

siloxanes and silicones. The Agency has

chosen to maintain a consistent policy

for nomenclature using CA names for all

substances, avoiding the potential

confusion and compliance problems

which could occur if only some

substances required CA names.

In a separate rulemaking published

concurrently with this document, the

Agency has decided not to require CAS

nomenclature for polymers that are

manufactured under terms of the

polymer exemption in accordance with

40 CFR 723.250, since the Agency will

no longer review exemption notices for

exempted polymers. However, since

chemical identity information is

required as part of the recordkeeping

requirements, persons who are

manufacturing polymers under terms of

the polymer exemption are encouraged

to use standard CA nomenclature in

their records.

The Inventory search process is the

same for both PMNs and for bona fides.

In the case of bona fides, chemical

identity issues frequently have

interfered with the Agency’s ability to

give an accurate response to submitters

within the 30–day period to which the

Agency has committed itself. In general,

there have been more problems with

chemical identity for bona fides than for

PMNs, in part because much less

chemical information has been required

for bona fides than for PMN

submissions. Once a correct chemical

name is developed for purposes of a

bona fide, the same name can be used

for a subsequent PMN submission

without further expense.

B. Revised Requirements for Bona Fides

The Agency is amending §720.25 by

revising certain provisions of the

procedures to establish a bona fide

intent to manufacture or import a

substance. This amendment reduces or

simplifies existing analytical

information requirements, modifies

and/or clarifies other existing

information requirements, and requires

some additional types of information in

bona fides.

The amendments eliminate the need

for elemental analysis data [former

§720.25(b)(2)(iv)] as well as reduce and

simplify other analytical information

requirements [former §720.25(b)(2)(v)]

by identifying an infrared spectrum as

the usual practice for characterizing the

new chemical substance. Two other

parts of this section, regarding chemical

identity information, and the

description of research and

development (R&D) activities and use

[former §720.25(b)(2)(i) and (iii),

respectively] were modified and/or

clarified. There are three new

information requirements regarding the

most probable manufacturing site and

process to be used, as well as an

approximate date when the submitter

would be likely to submit a section 5

notice for the substance if it is not found

in the Inventory. EPA believes that the

amendments represent a balanced tradeoff of requirements between the former

and amended provisions. The

amendments will enable submitters to

better demonstrate a bona fide intent

while the Agency will be better able to

protect the CBI of the original

submitters of Inventory substances. The

additional information or data required

in the amendment is considered

reasonably ascertainable by the

submitter, and generally would have

been determined already by the time the

submitter has developed a bona fide

intent to manufacture or import a

substance for a commercial purpose.

Under the amended §720.25(b)(2)(i),

submitters of a bona fide must provide,

as described in the amended provisions

of §720.45(a) discussed in unit II.A

above, a currently correct CA Index

Name or CA Preferred Name, whichever

is appropriate, and a currently correct

CASRN (if the substance already has a

CASRN assigned to it). In addition, the

Agency requires a molecular formula

and a complete or partial chemical

structure diagram if these are known or

reasonably ascertainable. Failure to fully

comply with the chemical identification

elements of this requirement will result

in the bona fide being declared

incomplete by EPA and returned to the

submitter.

The amendments modify the

requirement for a description of R&D

activities conducted to date on the

substance and the purpose for

manufacture or import [former

§720.25(b)(2)(iii)]. Since in the past

many submitters have inadvertently

omitted one of these two different

pieces of information in their notices,

EPA is making the requirements clearer

by separating the requests for the

description of R&D activities and the
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16303

purpose for which the submitter will

manufacture or import the substance

into different subparagraphs of the

amended rule [amended

§720.25(b)(2)(iii) and (iv), respectively].

In addition, in the amended

§720.25(b)(2)(iii)(A), EPA elaborates on

the information required by listing some

of the general types of R&D activities to

be reported. Also, the year in which

R&D was started by the submitter on the

substance is required. EPA believes that

these modifications will enable the

submitter to indicate the scope and

length of its commitment towards

developing the substance for

commercial use. EPA expects that this

information be briefly stated.

In the amended §720.25(b)(2)(iii)(B),

EPA provides an alternative reporting

requirement for importers who do not

perform R&D activities on the substance

and have no knowledge of R&D

activities that may have been conducted

outside of the United States. Such

importers will be allowed, in lieu of

presenting R&D information, to indicate

for how long, and in which country a

given substance has been in commerce

outside the United States, as well as to

state whether they believe that the

substance has already been used outside

of the United States for the same

commercial applications intended by

the submitter. This alternative

requirement is similar to the informal

EPA practice in the past of allowing

such a prospective importer to satisfy

the former §720.25(b)(2)(iii) by

providing certain information on foreign

commercial activity of the substance.

In the amended §720.25(b)(2)(iv), for

clarity, the term ‘‘purpose’’ used in the

former §720.25(b)(iii) has been replaced

by the phrase ‘‘major intended

application or use’’ because some

submitters have misunderstood the type

of information required and have not

provided a description of the intended

end use.

EPA has simplified the analytical data

requirements in the amended

§720.25(b)(2)(v) to reflect the usual

practice of submitters providing an

infrared spectrum to characterize the

chemical substance. An infrared

spectrum is required, unless infrared

analysis is not suitable for the substance

or does not yield good structural

information about the substance. In

such cases, the amendment requires a

spectrum or instrumental readout from

another method of spectral or

instrumental analysis that yields better

structural or compositional information.

Amended §720.25(b)(2)(vi) consists of

a minor but new information

requirement to estimate the month and

year in which the person would intend

to submit a section 5 notice for the

substance if it is not found in the

Inventory. EPA believes that submitters

with a bona fide interest in a substance

would have already considered a future

timeframe for reporting the substance

under section 5 if in fact it is a new

chemical substance. The intent of this

requirement is not to legally bind the

submitter to a certain date for

submission of a PMN. In addition to

using this information to determine a

demonstration of a bona fide intent to

manufacture or import the substance, if

EPA can anticipate how many bona fide

submitters may report their substances

in PMNs in a given year, the Agency

may be able to better allocate resources

for reviewing the expected PMNs.

Amended §720.25(b)(2)(vii) requires

the address of the facility under the

submitter’s control where the substance

is most likely be manufactured or

processed in the future for a commercial

purpose. For imported substances it

requires the facility at which processing

is most likely to occur, if any.

Amended §720.25(b)(2)(viii) requires

a manufacturer to briefly describe either

in words or with a process flow diagram

the manufacturing process that the

submitter would most likely use to

produce commercial quantities of the

substance. The process description does

not have to be detailed or

comprehensive. Importers are required

to briefly describe how the substance

would most likely be processed or used

at a site controlled by them, or, if no

processing or use of the substance is

anticipated to occur at a submittercontrolled facility, an importer may

state that such commercial activity is

not expected to occur. This information

is not intended to be legally binding, but

rather to assist EPA in determining

whether the submitter appears to have

serious intentions for commercializing

the substance in question.

The Agency has also clarified the

procedure for a foreign manufacturer or

supplier to provide confidential

chemical identity information directly

to EPA, to complete a notice when the

chemical identity is considered

proprietary information by the foreign

party and will not be disclosed to the

bona fide submitter. As amended, it is

the importer’s responsibility at

§720.25(b)(3)(i) to ensure that the

foreign supplier provides the required

chemical identity information in

accordance with §§720.45(a)(1), (2), and

(3) to EPA in a timely manner so that

EPA can easily link the information to

the importer’s bona fide.

The amendments at §720.25(b)(3)(ii)

indicate how to meet chemical

identification requirements when

submitters of substances to be

manufactured or imported do not

possess full knowledge of the chemical

identity of the substance to be reported

because a purchased reactant or

component used in the reported

material has a confidential chemical

identity that is the proprietary

information of the supplier. Similar to

the procedures specified at §720.45(a)(5)

for section 5 notices involving

confidential (often trademarked or

tradenamed products) reactants or

starting materials, the bona fide

submitter reports all the information

known by the submitter about the

substance identity. In addition, the

supplier must submit a letter of support

to EPA providing the specific chemical

identity of the proprietary reactant,

including the CAS number, if available,

and referencing the submitter’s bona

fide. As previously discussed in this

Unit under Correct Chemical Identity,

correct CA nomenclature is not required

when a reported substance involves the

use of a purchased proprietary reactant.

This is due to logistical obstacles

involved in generating correct CA

identifications for substances based on

multiple submissions of parts of the

overall identity from different sources.

However, the submitter must coordinate

with the supplier to ensure that the

remaining specific chemical identity

information is sent by the chemical

supplier directly to EPA in a timely

manner, to complete the bona fide

request and initiate review by EPA. If

the appropriate supporting document

from the supplier is not received within

30 days after EPA receives the

submitter’s bona fide, the bona fide will

be considered incomplete.

Further, EPA has included language

in amended §720.25(b)(9) to describe

what constitutes an incomplete bona

fide, and how EPA will handle

incomplete ones. When an incomplete

bona fide is received and identified as

such, EPA will immediately return the

bona fide (minus any supplierconfidential portions) directly to the

submitter. The submitter will then have

to resubmit the completed bona fide, in

its entirety, to have EPA perform the

Inventory search and respond to the

inquiry.

Comment. Appropriate bona fide

intent exists even though many bona

fide substances are never submitted as

PMNs.

Response. Each bona fide request

requires a certification statement about

commercial intent. As a result, the

Agency believes it is reasonable to

expect that most bona fide submissions

involving substances not found to be on

the Inventory would result in
16304 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

subsequent PMNs. This judgment takes

into account the types of factors that

could legitimately cause submitters to

change their minds. The Agency expects

that once the new requirements are in

place, a larger percentage of bona fides

will eventually result in submission of

PMNs.

Comment. The proposed bona fide

requirements are burdensome and the

existing requirements need not be

changed; EPA should not require

process information, specific

manufacturing site, the year that

research and development started (or

the length of foreign use), or the

estimated date of PMN submission in

order to establish bona fide intent.

Response. EPA believes that the

information requested does not cause a

significant burden because it should be

known to or reasonably ascertainable by

the submitter without developing or

collecting additional data. EPA believes

that submitters who have not yet

considered these topics or developed

this information are not at a commercial

development stage consistent with

showing bona fide intent.

Comment. EPA should focus on

abusers of the bona fide process rather

than increasing the reporting burdens

on all submitters.

Response. The Agency believes that

the perceived problem of submitter

abuse of the bona fide process involves

more than a few submitters. EPA

believes that the best solution is to

improve the integrity of the entire

process through the new requirements

so that all submitters will demonstrate

a serious bona fide intent prior to

receiving confidential Inventory

information.

Comment. Greatly increased

requirements for bona fide intent may

lead to more PMN submissions.

Response. Rather than increasing the

number of PMNs, EPA believes that the

revised procedures will reduce the

number of bona fides from persons who

do not have a bona fide intent to

manufacture the substance. In any

event, persons who intend to

manufacture or import a new chemical

substance for a commercial purpose are

free to submit a PMN without

submitting a prior bona fide.

C. ‘‘Two percent rule’’ for Polymers

Section 720.45(a)(2)(iii) allows

submitters to indicate on the PMN form

which monomers and other reactants

used at 2 weight percent or less (based

on the dry weight of the polymer)

should be included as part of the

polymer description on the Inventory.

This gives a manufacturer the flexibility

of increasing the weight percent above

the 2 percent level without submitting

another PMN, but also requires that the

monomer or reactant always be present

at some level in the polymer. In

practice, many polymer manufacturers

currently request Agency pre-approval

of a consolidated PMN to allow the

manufacture of a new polymer with

levels of monomers above and below the

two percent level (i.e., with and without

the monomer in the polymer’s chemical

identity). As a general rule, if the weight

of monomer or reactant charged to the

reaction vessel is 2 percent or less, the

monomer or reactant is not considered

part of the chemical identity of the

polymer, unless indicated by the

submitter on the PMN form. The 2

percent limit for polymers, referred to as

the ‘‘two percent rule’’, has been in

place since the Inventory reporting

regulations were published on

December 23, 1977 (see 40 CFR 710.5(c))

and was adopted because the Agency

and the regulated community believed it

would be difficult to identify the exact

amount of monomers or other reactants

actually incorporated in the final

polymer. Accordingly, polymer

manufacturers can use other monomers

or reactants at 2 percent or less without

changing the chemical identity of an

Inventory-listed polymer.

Under the final rule, persons may

continue to determine the weight

percentage of monomer or other reactant

based on the weight of monomer or

other reactant actually ‘‘charged’’ to the

reaction vessel. However,

§720.45(a)(iii)(B) now allows persons

the flexibility, where technically

feasible, to determine the minimum

weight of monomer or other reactant

required in theory to account for the

actual weight of monomer or other

reactant molecules or fragments

chemically ‘‘incorporated’’ (chemically

combined) in the polymeric substance

manufactured. Consequently, a PMN

submitter or a person relying on existing

polymer Inventory listings may

determine which monomers or other

reactants constitute the polymer identity

on the basis of either method.

During the compilation of the

Inventory, the method of reporting the

percent composition of monomers and

other reactants ‘‘as charged’’ was viewed

as a reasonable approach by chemical

and polymer industries. However, due

to advanced analytical capabilities

developed over the intervening years,

certain polymer manufacturers asked

EPA to revise the ‘‘two percent rule’’ to

allow manufacturers the option of

determining the amounts of monomers

and other reactants that are present ‘‘in

chemically combined form’’

(incorporated) in a polymer as an

alternative to the practice of requiring

reporting based on the amounts added

(charged) to the reaction vessel. The

final rule allows this option. The

Agency believes that allowing

submitters to report on the basis of

amounts incorporated in the polymer

will provide a better indicator of

physical, chemical, and toxicological

properties of polymers. At the same

time, this action will allow

manufacturers greater flexibility in

commercial innovation, reduce the

number of unnecessary PMNs

representing slight variations in

polymer composition, and provide

greater consistency with international

reporting policies. However, the Agency

believes that manufacturers should be

aware that there may be certain

drawbacks and burdens involved in

using the method of computation based

on incorporated amounts of monomers

and other reactants. For example, use of

the ‘‘incorporated’’ method may have

regulatory consequences if process

modifications (such as a change in

catalyst or solvent used or method and/

or order of charging the reactants) affect

the degree of chemical incorporation

such that the 2 percent level is exceeded

for a monomer or other reactant not

specified as part of the chemical

identity for the polymer, as discussed in

the proposed rule (58 FR 7664).

If a person determines those

monomers or other reactants used at 2

percent or less on the basis of the

amount incorporated in the polymer,

EPA believes that it is reasonable to

require that such manufacturers

maintain in their records analytical data

or appropriate theoretical calculations

(if it can be documented that an

analytical determination is not feasible

or not necessary) to demonstrate that the

amounts of monomers and other

reactants incorporated in the

manufactured polymer have been

accurately determined

[§720.45(a)(2)(iv)]. Additional guidance

on appropriate measurements or

theoretical calculations is available in

EPA’s Draft Technical Guidance

Document on the Polymer Exemption

Rule. That document is in the docket for

that rulemaking (OPPTS 50594B) and is

available through the TSCA Assistance

Information Service.

EPA recognizes that it was a matter of

convenience, rather than one of science,

to have thus far required reporting of the

amounts of polymer reactants charged

rather than the amounts incorporated;

the former method requires only

‘‘bookkeeping’’, while the latter may

require extensive and expensive

analytical work. After 16 years of

experience with the Inventory and PMN
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16305

reporting rules, however, EPA has come

to realize that the ‘‘amount charged’’

approach has drawbacks. In particular,

this approach of identifying many

polymers based on monomers and other

reactants charged to the reactor in

quantities significantly larger than the

amounts found to be incorporated in the

polymer may not adequately represent

the physical, chemical, and

toxicological properties of the polymer.

Until now under the PMN rule,

inefficiently incorporated reactants,

reactants charged in large excess, and

reactants with other functions besides

their reactant ones were often likely to

produce reportable polymers, even

though the degree of chemical

incorporation may have been less than

or equal to two percent. For example,

free-radical initiators are often charged

in quantities greater than two percent to

start many polymer chains

simultaneously and limit the amount of

high-molecular-weight polymer

produced. Chemical incorporation of

these initiators is inefficient, since many

processes other than chain initiation can

consume the initiator. The weight of the

final polymer that can be attributed to

fragments originating from the initiator

is often less than 2 percent by weight.

In the past, a manufacturer may have

used many different initiators, all

charged at greater than 2 percent, to

produce what would be the same

polymer if the ‘‘incorporated’’ method

of computation was used. The result

represented what many manufacturers

believed to be excess reporting. Similar

problems arose with solvents that have

reactive functions, and with

neutralizing agents used in excess of

their salt-forming capacities. Technical

details concerning the ‘‘two percent

rule’’ are contained in EPA’s Draft

Technical Guidance Document on the

Polymer Exemption Rule, which is

available in the public docket for this

rulemaking [OPPTS–50593B].

The Agency has always believed the

actual content of a polymer is a better

indicator of its physical, chemical, and

toxicological properties, but adopted the

‘‘amount charged’’ method of

computation as a matter of convenience

to industry. The Agency believes that, in

light of advanced analytical capabilities,

it is now reasonable to also allow the

submitter to optionally use the amounts

of monomers and other reactants

incorporated, as an alternative to the

‘‘amounts-charged’’ method.

Comment. Several comments

supported EPA’s proposal to modify the

‘‘two percent rule’’ by allowing polymer

manufacturers to determine the amounts

of monomers and other reactants that

are ‘‘incorporated’’ in the polymer, as an

alternative to the current practice of

reporting based on the ‘‘amounts

charged’’ to the reaction vessel. One

comment stated that the use of the

incorporation method, where the

technology is available and feasible,

more accurately represents the actual

properties of the polymer. Commenters

also stated that PMN submitters and/or

manufacturers relying on existing

listings of polymers on the Inventory

should be able to use either method as

long as they are in compliance with the

‘‘two percent rule.’’

Response. The proposed amendment

was intended to allow this flexibility.

Persons relying on existing Inventory

listings of polymers or persons

submitting PMNs may use either

method as long as they can demonstrate

the percentage of monomers or other

reactants either charged to the reaction

vessel or incorporated in the polymer.

Comment. The amendment to the

‘‘two percent rule’’ should be clearly

stated to be an option rather than a

regulatory requirement. EPA should

abandon the proposed rule’s arbitrary

distinction and clarify that, for purposes

of TSCA compliance, a polymer should

be described either by analysis or by

calculation.

Response. EPA has clearly indicated

in this preamble and in the regulatory

text that a manufacturer may use either

method to determine which monomers

or other reactants constitute the polymer

identity.

Comment. EPA should establish a

‘‘five percent rule’’ for non-monomer

reactants such as free radical initiators,

chain transfer reagents, and pH

neutralizing agents. These reactants are

known to correlate poorly with the

amounts charged and incorporated.

Routine analytical testing would be

inconclusive.

Response. EPA continues to believe,

as stated in the preamble to the

proposed rule (58 FR 7672), that a 5

percent rule would create a larger

potential variation in those physical and

chemical properties of a polymer that

may have toxicological implications.

Further, adopting a ‘‘five percent rule’’

would not be consistent with the

Agency’s goal of harmonizing, to the

extent possible, the reporting of

polymers with other international

reporting practices that use a 2 percent

standard.

In the past, industry has asserted that

free radical initiators were not expected

to be incorporated, so allowing a

company to use the ‘‘incorporated’’

method should already provide a greater

measure of flexibility. Manufacturers

who are unable to develop reliable

analytical data or reasonable theoretical

calculations to support their use of the

‘‘incorporated’’ method should continue

to follow the current practice of

calculating 2 percent based on the

monomers and other reactants

‘‘charged’’ to the reaction vessel.

Comment. EPA should allow use of

any scientifically sound and technically

appropriate incorporation measurement

or theoretical calculation method. The

proposal should be modified so that

analytical and recordkeeping

requirements for the incorporation

method are not so onerous as to

virtually negate the advantage of its use.

A company that uses the ‘‘incorporated’’

method would be required to maintain

analytical data to support this

determination at the site of

manufacture.

Response. The rule does not specify

any particular analytical methodology

for the ‘‘incorporated’’ method. The

Agency would also allow theoretical

calculations if it can be documented

that an analytical determination is not

technically feasible or not necessary as

discussed above. Further, EPA believes

that it is reasonable to require that

manufacturers who use the

‘‘incorporated’’ method maintain

records of analytical data or appropriate

theoretical calculations that

demonstrate compliance with the ‘‘two

percent rule’’ at the site of manufacture

to verify compliance in a

straightforward manner.

D. Multiple photocopies of section 5

submissions

The Agency is amending

§720.40(d)(2) to require submitters to

provide EPA with one original and two

complete copies of section 5 notices, in

addition to a sanitized copy in which

CBI has been deleted under §720.80.

Submitters are also required to provide

one original and two additional copies

of any test data.

Comment. EPA should not require the

submission of copies of test data. Test

reports range from hundreds to

thousands of pages and submitting extra

copies would result in excessive

volumes of material for EPA to handle.

Response The two extra copies of test

data will reduce the Agency’s

administrative burden and will facilitate

scientific reviews of the data submitted.

The Agency’s request for these test

results falls clearly within the General

Information Collection Guidelines, 5

CFR 1320.6 of the rules on the

Paperwork Reduction Act of May 10,

1988 promulgated by the Office of

Management and Budget. Under these

guidelines, the Agency is allowed to

request an original and two copies of
16306 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

any document that satisfies its statutory

requirements.

E. Electronic Transmission of Section 5

Notices; Removal of PMN from the CFR

EPA is amending the PMN rule at

§720.40(a) to allow for future reporting

via magnetic or other electronic media.

This amendment is designed to promote

the use of electronic media for data

submission. EPA is investigating the use

of magnetic tape, floppy diskettes, and

electronic data interchange as means to

submit information, and is participating

in a nation-wide trend toward reducing

reliance on paper for information

transfer. EPA has already taken steps in

TSCA and other program areas to

encourage electronic submission, and

intends to expand this effort to the PMN

review program.

Information may be submitted

electronically (on magnetic or other

media) once EPA publishes a format for

electronic submissions. Pilot projects

using electronic submissions for the

Inventory Update Rule (40 CFR part

710) and Toxic Release Inventory Rule

(40 CFR part 372) will be used as a

baseline for enhancements to

developing a standard Agency-wide

format. Such submissions will have to

meet this format and all other media

specifications published by EPA.

EPA is taking this opportunity to

remove the full text of EPA form 7710–

25 (PMN form) from the Code of Federal

Regulations (CFR)(40 CFR part 720,

Appendix A) and also correct the

address for availability (40 CFR 720.40).

The PMN form, which has been printed

each year in the CFR, requires

approximately 10 pages of publication

and does not represent the most current

document in use by PMN submitters.

Removing the form from the CFR

reflects standard Agency policy of not

printing the full text of final forms in

the CFR and will result in a significant

cost savings for the Agency. In general,

EPA has determined that it is not legally

obligated to publish forms in full text.

Under the Administrative Procedure Act

(APA), 5 U.S.C. 552(a)(1)(c), EPA is

obligated to describe forms and give a

source of availability. In addition to

removing the form, EPA is making

conforming amendments to those

sections that reference part 720,

Appendix A to remove reference to

Appendix A.

In addition, the PMN form that

appears in the CFR has been photo

reduced and cannot be used in a

practical sense by those who must

comply with the reporting requirements.

More importantly, the Agency has

continued to implement editorial

revisions to the form since it was first

published as part of the final rule in

1983. These revisions are intended to

reflect PMN regulations and the policy

initiatives implemented during the

intervening years. Any substantive

removal or addition of reporting

requirements is accomplished by notice

and comment rulemaking.

Comment. Comments were generally

supportive of developing an electronic

data interchange (EDI) with the Agency,

although some reservations and

concerns were expressed. Comments

questioned (1) how practical it might be

to submit some information, such as

toxicity studies, electronically, (2)

signature certification and (3) the

security of CBI submissions. One

comment suggested holding a workshop

to address CBI concerns.

Response. EPA will not implement an

EDI application for TSCA section 5

submissions until an Agency policy is

developed for EDI standard practices.

Thus, submitters would not have to

develop unique interchange devices for

section 5.

Electronic authentification technology

is commercially available to address

signature certification concerns and

general security concerns. The Agency

is required to protect CBI, and any EDI

practices will ensure the confidentiality

of data transmissions. The Agency is

receptive to working with industry and

other concerned parties to develop an

EDI application for the New Chemicals

Program, including CBI procedures. In

the interim, the Agency encourages the

use of PMN software developed by

industry and approved for use by the

Agency for generating hardcopy section

5 notices.

In addition to EDI, the Agency is

analyzing other electronic reporting

media to determine which is most

appropriate for these submissions, given

the variety of documents and materials

involved. All comments on electronic

reporting are welcome.

F. Mandatory Form for Notice of

Commencement of Manufacture or

Import (NOC)

Under this amendment, all PMN

submitters are required to use a

standard one-page form to submit a

NOC. In addition, the NOC information

requirements at §720.102(c) have been

slightly expanded; however, all

information can be provided on the onepage standard form (EPA Form 7710–

56).

Every NOC received at EPA on or after

the effective date of these final rule

amendments must contain the required

information on the new standard NOC

reporting form. This form will

automatically be provided to each PMN

submitter as an attachment to EPA’s

letter acknowledging PMN receipt letter

sent to submitters shortly after each

PMN is received. Persons who have not

submitted NOCs for PMNs that have

been previously submitted to EPA can

obtain copies of the NOC form from the

TSCA Assistance Information Office.

Many submitters are already reporting

voluntarily using a similar form.

Previous NOC information reporting

requirements, which are unaffected by

these amendments, include specific

chemical identity of the PMN substance,

PMN number, the date manufacture or

import commenced, and substantiation

of CBI claims for chemical identity,

which is required at the time a NOC is

submitted. The amendment at

§720.102(c)(ix) requests a clear

indication of whether the submitter

identity and/or other information on the

form are also claimed as confidential.

Confidentiality claims can only be

asserted by the submitter if

corresponding claims were made in the

PMN.

EPA is amending NOC reporting to

require that complete submitter identity

information be provided on the form.

This would include the name and

address of the submitter, the name and

dated signature of the authorized

official, and the name and telephone

number of a technical contact in the

United States.

The amended NOC provisions also

require a generic chemical name for a

substance whose chemical identity is

claimed as CBI. This name could either

be (1) the same generic name provided

in the PMN, (2) a generic name as

revised by the submitter, as long as it

masks no more of the chemical identity

than the original generic name

provided, or (3) an improved or

corrected generic name agreed to via

negotiation with EPA.

Because the initial intention to

manufacture or import a substance

sometimes changes between the time of

PMN submission and the NOC,

submitters are required to specify in the

NOC whether commencement occurred

via manufacture or import and the

address of the site(s) at which

manufacture commenced.

All of the above amendments to

information requirements for NOCs

involve information that the submitter

will already know by the time

manufacture or importation of the

substance has commenced.

Consequently, providing this

information in the NOC will not

constitute a significant reporting

burden. EPA will not process a NOC

that does not contain the chemical
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16307

identity, the date of commencement,

and the PMN number.

Comment. EPA needs to define in the

regulations or form the ‘‘date of

commencement.’’ Is this the first date

that a chemical reaction occurs in the

manufacturing operation; the date that

the last amount of final product is

produced in a batch operation; the first

date that the PMN chemical is drummed

off; or another date?

Response. The Agency considers the

date of commencement to mean the date

of completion of manufacture for nonexempt commercial purposes of the first

amount (e.g., batch, drum, etc.) of the

chemical substance identified in the

PMN. The Agency chose not to use the

date on which the manufacturing

process is started because that particular

process may in some instances not

result in the successful manufacture of

the PMN substance. For importers, the

date of commencement is the date the

new chemical substance clears United

States Customs. The final rule contains

this definition.

Comment. The information required

for an NOC duplicates that already

submitted in the PMN: site of

manufacture, name and telephone

number of technical contact. This

information should not be required,

since a manufacturer is free to change

any of these items after the PMN review

period has expired. The Inventory

Update Rule is the appropriate vehicle

for the Agency to gather this

information.

Response. An NOC may be filed years

after the PMN was submitted. In the

interim, the information provided in the

original PMN may have changed due to

change of location, change in

ownership, etc. Up-to-date telephone

numbers are important when problems

need to be resolved. The Agency

believes that the site of first

manufacture or import is an important

compliance monitoring tool. Although

the Agency recognizes that a company

may switch from import to domestic

manufacture (or vice versa) after the

PMN review period has expired, the

Agency may find cause to investigate

such changes that occur shortly after the

expiration of the PMN review period.

Comment. The NOC form should be

made available for public comment

prior to finalization.

Response Although the form was not

published in the Federal Register as

part of the proposed rulemaking, it was

available in the public docket and at the

public hearings for this rulemaking held

on April 26–27, 1993. Draft copies of the

form have been available through the

TSCA Assistance Information Office.

The form has also been routinely

distributed to all PMN submitters for

use on a voluntary basis during the past

year.

Comment. EPA should clarify its

statement that an NOC will be declared

incomplete if any required information

is missing. It is possible that EPA could

declare an NOC incomplete past the 30–

day period, potentially resulting in a

compliance problem. EPA should

provide that the original NOC filing date

will be considered the effective date for

determining compliance with the

requirement that the NOC be filed

within 30 days after the first day of

commercial manufacture or importation.

For example, if EPA determines that

responses to CBI claims are inadequate,

the NOC should not be declared

untimely because it is considered

incomplete.

Response. EPA will continue its

practice of adding a PMN substance to

the Inventory as of the date the Agency

receives the NOC from the PMN

submitter with the correct chemical

identity, date of commencement and

PMN number. Further, EPA does not

believe it is a significant burden for

companies to submit a completed

standard one-page NOC form that

requests information that should be

known to the submitter when

manufacture or importation commences.

Comment. The NOC form should be

computer compatible or the submitter

should be allowed to use a computer

facsimile as long as it has the same

format as the NOC form. Companies

should not be required to receive

advance approval of computer

facsimiles.

Response. The Agency will allow

submitters to use a computer generated

form, as long as the form is readable by

Agency staff.

Comment. EPA should allow an

‘‘authorized official or designated

representative’’ to sign the NOC form.

The term ‘‘authorized official’’ might be

construed to mean a corporate vice

president. This type of form should not

require a corporate vice president’s

signature.

Response. The ‘‘authorized official’’

has always been designated by the

submitting company and should be a

person that the submitting company

deems responsible for the truth and

accuracy of each statement in the

certification.

Comment. The NOC form and/or

accompanying instructions should

indicate clearly that a sanitized version

must be submitted if any information is

claimed confidential and that all

submitter identification information

will be treated as CBI. Furthermore, the

submitter must be permitted to claim

the signature of the authorized official

as CBI.

Response. EPA does not require

submission of a sanitized copy of the

NOC form because NOC submissions are

not placed in the public files.

Information on the NOC form that was

claimed confidential in the original

PMN submission may also be claimed

confidential on the NOC form, although

new confidentiality claims cannot be

made in an NOC for information not

claimed as confidential in the original

PMN submission.

G. Comments on Other Issues

The Agency also discussed certain

issues relating to CBI claims in the

proposed rule (58 FR 7665) but did not

propose any additional PMN rule

amendments at that time. The Public

Docket for this rulemaking contains a

complete set of comments on this issue,

as well as comments received in

response to a discussion on use of

geographic locators by section 5

reporting facilities. Several industry

commenters expressed concern about

the discussion in the proposal regarding

enhanced review of all confidential

claims. Specifically, some commenters

were concerned that the discussion

signalled a change of rules on making

CBI claims in the PMN process. As

stated in the proposal, the purpose

behind the discussion of CBI claims

filed in PMNs was to remind the

regulated community of its obligations

concerning CBI claims. As noted at that

time, there are no changes to the CBI

procedures included in the PMN rule

amendments.

Industry submitters have an

obligation to insure that only that

information which needs to be kept

confidential is claimed as CBI. Further,

CBI claims are routinely reviewed and

submitters who make broad,

indiscriminate CBI claims will be

contacted and requested to substantiate

their claims pursuant to 40 CFR part 2.

III. Economic Analysis

EPA has evaluated the potential costs

of the amendments for potential

submitters of section 5 notices. The

Agency’s complete economic analysis is

available in the public record for this

rule (OPPTS–50593B).

The regulatory impact analysis

estimates the costs and benefits

attributable to the regulation. In this

case, the analysis also contains

estimates for the three additional

amendments to section 5 regulations

that are published elsewhere in this

Federal Register. These new provisions

amend the PMN Exemptions for

Polymers, Chemical Substances
16308 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

Manufactured in Quantities of 1,000

Kilograms or Less per Year (40 CFR part

723), and the Expedited Process for

Issuing Significant New Use Rules (40

CFR part 721). Because these regulations

are amendments to current regulations,

their costs and benefits are incremental

as compared to the current regulations.

The costs and benefits associated with

these amendments are partially

quantified; many of the benefits are

unquantified but are of significant

importance. Considering only the

quantified costs and benefits, there is a

slight cost increase for industry and a

slight cost savings for EPA. Assuming

either 1,000, 2,000, or 3,000 annual

section 5 submissions, the savings as

compared to the current regulation are

estimated to be:

Annual Number

of Submissions

Annual Cost Savings

($ Million)

Industry Government

1,000 ................. -0.1 0.1

2,000 ................. -0.3 0.2

3,000 ................. -0.4 0.2 – 0.3

The aspects of the amendments that

have the greatest quantified cost impact

on industry are the change in

requirements for a bona fide TSCA

Inventory search request and the

requirement to provide correct chemical

identification. Both requirements are

expected to enable the Agency to utilize

resources more effectively, thereby

providing better service to industry. One

of the major unquantified benefits of

this amendment is increased flexibility

under the ‘‘two percent rule,’’ allowing

industry to make minor compositional

changes, providing more manufacturing

latitude to the submitter and possibly

reducing the number of section 5

submissions. Another unquantified

change is the requirement to use a

standardized form for NOCs, the impact

of which is expected to be minimal as

many submitters are already using a

similar form.

IV. Rulemaking Record

EPA has established a record for this

rulemaking (docket control number

OPPTS–50593B). The record includes

basic information including public

comments considered by the Agency in

developing this rule amendment. A

public version of the record without any

confidential information is available in

the TSCA Public Docket Office from 12

noon to 4 p.m., Monday through Friday,

except legal holidays. The TSCA Public

Docket Office is located in Rm. NE–

G307 (Northeast Mall), 401 M St., SW.,

Washington, DC.

V. Other Regulatory Requirements

A. Executive Order 12866

Under Executive Order 12866 (58 FR

51835, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to review by the Office of

Management and Budget (OMB) and the

requirements of the Executive Order.

Under section 3(f), the Order defines a

‘‘significant regulatory action’’ as an

action that is likely to (1) have an

annual effect on the economy of $100

million or more, or adversely and

materially affect a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

referred to as ‘‘economically

significant’’) (2) create serious

inconsistency or otherwise interfere

with an action taken or planned by

another agency; (3) materially alter the

budgetary impacts of entitlement,

grants, user fees, or loan programs or the

rights and obligations of recipients

thereof; or (4) raise novel legal or policy

issues arising out of legal mandates, the

President’s priorities, or the principles

set forth in this Executive Order.

Pursuant to Executive Order 12866, it

has been determined that this rule is not

a ‘‘significant regulatory action’’ under

section 3 (f) of the Order. This action is

therefore not subject to OMB review.

B. Regulatory Flexibility Act

Pursuant to the Regulatory Flexibility

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

has determined that this regulatory

action will not impose any adverse

economic impacts on small entities.

EPA believes that, even if all of the

section 5 notice submitters were small

firms, the number of small businesses

affected by this action will not be

substantial.

C. Paperwork Reduction Act

The information collection

requirements in this rule have been

approved by the OMB under the

provisions of the Paperwork Reduction

Act, 44 U.S.C. 3502 et seq and have

been assigned OMB control number

2070–0012. The public reporting burden

for this collection of information is

estimated to vary from 18 to 21 hours

per response, with an average of 20

hours per response, including time for

reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing the collection

of information.

List of Subjects

40 CFR Part 704

Chemicals, Confidential business

information, Environmental protection,

Hazardous substances, Imports,

Reporting and recordkeeping

requirements.

40 CFR Part 720

Chemicals, Environmental protection,

Premanufacture notification, Hazardous

materials, Reporting and recordkeeping

requirements.

40 CFR Part 721

Administrative practice and

procedure, Chemicals, Environmental

protection, Hazardous substances,

Imports, Labeling, Occupational Safety

and Health, Reporting and

Recordkeeping requirements.

Dated: March 21, 1995.

Carol M. Browner,

Administrator.

Therefore, 40 CFR chapter I,

subchapter R, parts 704, 720 and 721 are

amended as follows:

1. In part 704:

PART 704—[AMENDED]

a. The authority citation for part 704

continues to read as follows:

Authority: 15 U.S.C. 2607(a).

b. Section 704.25 is amended by

revising paragraph (d) to read as

follows:

§704.25 11-Aminoundecanoic acid.

* * * * *

(d) What information to report.

Persons identified in paragraph (b) of

this section must submit a

Premanufacture Notice Form (EPA Form

7710–25).

* * * * *

c. Section 704.104 is amended by

revising paragraph (d) to read as

follows:

§704.104 Hexafluoropropylene oxide.

* * * * *

(d) What information to report.

Persons identified in paragraph (b) of

this section must submit a

Premanufacture Notice Form (EPA Form

7710–25).

* * * * *

2. In part 720:

PART 720 — [AMENDED]

a. The authority citation for part 720

continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2613.

b. Section 720.25 is amended by

revising paragraphs (a), (b)(1), (2)(i),
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16309

(2)(iii), (2)(iv), (2)(v), (3), and by adding

paragraphs (b)(2)(vi), (2)(vii), (2)(viii),

and (b)(9) to read as follows:

§720.25 Determining whether a chemical

substance is on the Inventory.

(a) A new chemical substance is any

chemical substance that is not currently

listed on the Inventory.

(b)(1) A chemical substance is listed

in the public portion of the Inventory by

a specific chemical name (either a

Chemical Abstracts (CA) Index Name or

a CA Preferred Name) and a Chemical

Abstracts Service (CAS) Registry

Number if its identity is not

confidential. If its identity is

confidential, it is listed in the public

portion of the Inventory by a TSCA

Accession Number and a generic

chemical name that masks the specific

substance identity. The confidential

substance is listed by its specific

chemical name only in the confidential

portion of the Inventory, which is not

available to the public. A person who

intends to manufacture or import a

chemical substance not listed by

specific chemical name in the public

portion of the Inventory may ask EPA

whether the substance is included in 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) * * *

(i) Except as provided in paragraphs

(b)((3)(i) and (ii) of this section, the

specific chemical identity of the

substance that the person intends to

manufacture or import, using the

currently, correct CA name for the

substance and the other correct

chemical identity information in

accordance with §§720.45(a)(1), (2)),

and (3).

* * * * *

(iii)(A) A brief description of the

research and development activities

conducted to date related to the

substance, including the year in which

the person first started to conduct

research or development activity on the

substance, and the general types of

research and development activities

conducted thus far (e.g., synthesis,

substance isolation/purification,

formulating, product development,

process development, end-use

application, toxicity testing, etc.). The

person must also indicate whether any

pilot plant or production-scale plant

evaluations have been conducted

involving the manufacture or processing

of the substance.

(B) If an importer is unable to provide

the information requested in paragraph

(b)(2)(iii)(A) of this section from the

foreign manufacturer or supplier, the

following information shall be

submitted:

(1) A brief statement indicating how

long the substance has been in

commercial use outside of the United

States.

(2) The name of a country in which

it has been commercially used.

(3) Whether the importer believes that

the substance has already been used

commercially, in any country, for the

same purpose or application that the

importer is intending.

(iv) A specific description of the

major intended application or use of the

substance.

(v) An infrared spectrum of the

substance, or alternative spectra or other

data which identify the substance if

infrared analysis is not suitable for the

substance or does not yield a reasonable

amount of structural information. When

using alternative spectra or instrumental

analysis, the person must submit a

spectrum or instrumental readout for

the substance.

(vi) The estimated date (month/year)

in which the person intends to submit

a Premanufacture Notice (PMN) for this

substance if EPA informs the notice

submitter that the substance is not on

the Inventory.

(vii) The address of the facility under

the control of the submitter at which the

manufacture or processing of the

substance would most likely occur. For

an imported substance, the facility

under the control of the importer at

which processing of the substance

would likely occur, if any.

(viii)(A) For substances intended to be

manufactured in the United States, a

description of the most probable

manufacturing process that would be

used by the submitter to produce the

substance for non-exempt commercial

purposes.

(B) For substances intended to be

imported, a brief description of how the

submitter is most likely to process or

use the substance for a commercial

purpose. If the substance is not expected

to be processed or used at any facility

under the importer’s control, a

statement to this effect must be included

along with a description of how the

substance will be processed or used at

sites controlled by others, if this

information is known or reasonably

ascertainable.

(3)(i) If an importer cannot provide

the chemical identity information

required by paragraph (b)(2)(i) and (v) of

this section because it is claimed

confidential by its foreign manufacturer

or supplier, the foreign manufacturer or

supplier must supply the required

information directly to EPA in

accordance with §720.45(a)(1), (2), and

(3) and reference the importer’s notice.

If the appropriate supporting document

from the foreign party is not received

within 30 days after EPA receives the

importer’s notice, the notice will be

considered incomplete.

(ii) If a manufacturer cannot provide

all of the required information in

accordance with §720.45(a)(1), (2), and

(3) because the new chemical substance

is manufactured using a reactant that

has a specific chemical identity claimed

as confidential by its supplier, the

notice must contain chemical identity

information that is as complete as

known by the manufacturer. In addition,

a letter of support for the notice must

then be sent to EPA by the chemical

supplier of the confidential reactant,

providing the specific chemical identity

of the proprietary reactant. The letter of

support must reference the

manufacturer’s notice. If the appropriate

supporting document from the supplier

is not received within 30 days after EPA

receives the manufacturer’s notice, the

notice will be considered incomplete.

* * * * *

(9) If the required chemical identity

information has not been reported

correctly or completely in the notice

(except as provided under paragraph

(b)(3)(ii) of this section) or if any other

required data or information has been

omitted or is incomplete, EPA will

consider the whole notice to be

incomplete. As soon as an incomplete

notice is identified as such by EPA, the

Agency will immediately return the

notice directly to the submitter. The

submitter must then resubmit the

whole, completed bona fide notice to

EPA in order to have the Agency

perform the desired Inventory search

and respond to the notice.

c. Section 720.40 is amended by

revising paragraphs (a) and (d) to read

as follows:

§720.40 General.

(a) Use of the notice form; electronic

submissions. (1) Each person who is

required by subpart B of this part to

submit a notice must complete, sign,

and submit a notice containing the

information in the form and manner

specified in this paragraph. The

information submitted and all

attachments (unless the attachment

appears in the open scientific literature)

must be in English. All information

submitted must be true and correct.

(2) Information may be submitted on

paper, or electronically, as follows:

(i) Information submitted on paper

must be submitted in the form and

manner set forth in EPA Form No.

7710–25, which is available from the
16310 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

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

DC 20460. Information which is not

submitted on the EPA Form No. 7710-

25 or a photocopy thereof (e.g., on a

form created by commercial formmaking software) must be in a format

pre-approved by the Agency.

(ii) Information may be submitted

electronically (on magnetic or other

media) pursuant to an EPA published

format for electronic submissions. Such

submissions must comply with this

format and all other media

specifications published by EPA.

Persons submitting electronically must

still complete and submit on paper the

Certification and Submitter

Identification sections of Form 7710–25.

* * * * *

(d) General notice requirements. (1)

Each person who submits a notice must

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 person. In accordance with §720.50,

the notice must also include any test

data in the person’s possession or

control, and descriptions of other data

which are known to or reasonably

ascertainable by the person and which

concern the health and environmental

effects of the new chemical substance.

(2) A person who submits a notice to

EPA under this part must provide EPA

with an original and two complete

copies of the notice, including all test

data and any other information attached

to the notice form. If information is

claimed as confidential pursuant to

§720.80, a sanitized copy must also be

provided.

* * * * *

d. Section 720.45 is amended by

revising paragraph (a) to read as follows:

§720.45 Information that must be included

in the notice form.

* * * * *

(a)(1) The specific chemical identity

of the substance that the person intends

to manufacture or import, which

includes the following:

(i) The currently correct Chemical

Abstracts (CA) name for the substance,

based on the Ninth Collective Index

(9CI) of CA nomenclature rules and

conventions, and consistent with

listings for similar substances in the

Inventory. For each substance having a

chemical composition that can be

represented by a specific, complete

chemical structure diagram (a Class 1

substance), a CA Index Name must be

provided. For each chemical substance

that cannot be fully represented by a

complete, specific chemical structure

diagram (a Class 2 substance), or if the

substance is a polymer, a CA Index

Name or CA Preferred Name must be

provided (whichever is appropriate

based on CA 9CI nomenclature rules

and conventions). In addition, for a

Class 2 substance, the notice must

identify the immediate chemical

precursors and reactants by specific

chemical name and Chemical Abstracts

Service Registry Number (CASRN), if

the number is available. Tradenames or

generic names of chemical precursors or

reactants are not acceptable as

substitutes for specific chemical names.

(ii) The currently correct CASRN for

the substance if a CASRN already exists

for the substance.

(iii) For a Class 1 substance and for

any Class 2 substance for which a

definite molecular formula is known or

reasonably ascertainable, the correct

molecular formula.

(iv) For a Class 1 substance, a

complete, correct chemical structure

diagram; for a Class 2 substance or

polymer, a correct representative or

partial chemical structure diagram, as

complete as can be known, if one can be

reasonably ascertained.

(2) For a polymer, the submitter must

also report the following:

(i) The specific chemical name and

CASRN, if the number is available, of

each monomer and other reactant used,

at any weight percent, to manufacture

the polymer. Tradenames or generic

names of chemical reactants or

monomers are not acceptable as

substitutes for specific chemical names.

(ii) The typical percent by weight of

each monomer and other reactant in the

polymer (weight of the monomer or

other reactant expressed as a percentage

of the weight of the polymeric chemical

substance manufactured), and the

maximum residual amount of each

monomer present in the polymer.

(iii) For monomers and other reactants

used at 2 weight percent or less (based

on the dry weight of the polymer

manufactured), indicate on the PMN

form any such monomers and other

reactants that should be included as part

of the polymer description on the

Inventory, where the weight percent is

based on either (A) the weight of

monomer or other reactant actually

charged to the reaction vessel, or (B) the

minimum weight of monomer or other

reactant required in theory to account

for the actual weight of monomer or

other reactant molecules or fragments

chemically incorporated (chemically

combined) in the polymeric substance

manufactured.

(iv) For a determination that 2 weight

percent or less of a monomer or other

reactant is incorporated (chemically

combined) in a polymeric substance

manufactured, as specified in

paragraphs (a)(2)(iii)(B) of this section,

analytical data or appropriate

theoretical calculations (if it can be

documented that analytical

measurement is not feasible or not

necessary) to support this determination

must be maintained at the site of

manufacture or import of the polymer.

(v) Measured or estimated values of

the minimum number-average

molecular weight of the polymer and

the amount of low molecular weight

species below 500 and below 1,000

molecular weight, with a description of

how the measured or estimated values

were obtained.

(3) The person must use one of the

following two methods to develop or

obtain the specified chemical identity

information reported under paragraphs

(a)(1) and (2) of this section and must

identify the method used in the notice:

(i) Method 1. Obtain the correct

chemical identity information required

by paragraphs (a)(1) and (2) of this

section directly from the Chemical

Abstracts Service (CAS), specifically

from the CAS Registry Services

Inventory Expert Service, prior to

submitting a notice to EPA. A copy of

the chemical identification report

obtained from CAS must be submitted

with the notice.

(ii) Method 2. Obtain the correct

chemical identity information required

by paragraphs (a)(1) and (2) from any

source. The notice will be incomplete

according to §720.65(c)(1)(vi) if the

person uses Method 2 and any chemical

identity information is determined to be

incorrect by EPA.

(4) If an importer submitting the

notice cannot provide all the

information specified in paragraphs

(a)(1) and (2) of this section because it

is claimed as confidential by the foreign

supplier of the substance, the importer

must have the foreign supplier follow

the procedures in paragraph (a)(3) of

this section and provide the correct

chemical identity information specified

in paragraphs (a)(1) and (2) of this

section directly to EPA in a joint

submission or as a letter of support to

the notice, which clearly references the

importer’s notice and PMN User Fee

Identification Number. The statutory

review process will commence upon

receipt of both the notice and the

complete, correct information.

(5) If a manufacturer cannot provide

all the information specified in

paragraphs (a)(1) and (2) of this section

because the new chemical substance is
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16311

manufactured using a reactant having a

specific chemical identity claimed as

confidential by its supplier, the

manufacturer must submit a notice

directly to EPA containing all the

information known by the manufacturer

about the chemical identity of the

reported substance and its proprietary

reactant. In addition, the manufacturer

must ensure that the supplier of the

confidential reactant submit a letter of

support directly to EPA providing the

specific chemical identity of the

confidential reactant, including the CAS

number, if available, and the

appropriate PMN or exemption number,

if applicable. The letter of support must

reference the manufacturer’s name and

PMN User Fee Identification Number

under §700.45(c)(3) of this chapter. The

statutory review period will commence

upon receipt of both the notice and the

letter of support.

* * * * *

e. Section 720.80 is amended by

revising paragraph (b)(2) to read as

follows:

§720.80 General provisions.

* * * * *

(b) * * *

(2) If any information is claimed as

confidential, the person must submit, in

addition to the copies specified by

§720.40, a sanitized copy of the notice

form (or electronic submission) and any

attachments.

(i) The original and two copies of the

notice, specified at §720.40 (or

electronic submission) and attachments

must be complete. The submitter must

designate that information which is

claimed as confidential in the manner

prescribed on the notice form (or in

EPA’s electronic submission

instructions).

(ii) The sanitized copy must be

complete except that all information

claimed as confidential in the original

must be deleted. EPA will place this

sanitized copy in the public file.

(iii) If the person does not provide the

sanitized copy, or information in a

health and safety study (except

information claimed as confidential in

accordance with §720.90), the

submission will be deemed incomplete

and the notice review period will not

begin until EPA receives the sanitized

copy or the health and safety study

information is included, in accordance

with §720.65(c)(1)(vii).

* * * * *

f. Section 720.95 is amended by

revising the third sentence to read as

follows:

§720.95 Public file.

* * * Any of the nonconfidential

material described in this subpart will

be available for public inspection in the

TSCA Nonconfidential Information

Center, Room B607, Northeast Mall, 401

M St., SW., Washington, DC between

the hours of 1 p.m. and 4 p.m.,

weekdays, excluding legal holidays.

g. Section 720.102 is amended by

revising paragraphs (c) and (d) to read

as follows:

§720.102 Notice of commencement of

manufacture or import.

* * * * *

(c) Information to be reported on

form. (1) The notice must be submitted

on EPA (Form 7710–56), which is

available from the Environmental

Assistance Division (7408), Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. The

form must be signed and dated by an

authorized official. All information

specified on the form must be provided.

The notice must contain the following

information:

(i) The specific chemical identity of

the PMN substance.

(ii) A generic chemical name (if the

chemical identity is claimed as

confidential by the submitter).

(iii) The premanufacture notice (PMN)

number assigned by EPA.

(iv) The date of commencement for

the submitter’s manufacture or import

for a non-exempt commercial purpose

(indicating whether the substance was

initially manufactured in the United

States or imported). The date of

commencement is the date of

completion of non-exempt manufacture

of the first amount (batch, drum, etc.) of

new chemical substance identified in

the submitter’s PMN. For importers, the

date of commencement is the date the

new chemical substance clears United

States customs.

(v) The name and address of the

submitter.

(vi) The name of the authorized

official.

(vii) The name and telephone number

of a technical contact in the United

States.

(viii) The address of the site where

commencement of manufacture

occurred.

(ix) Clear indications of whether the

chemical identity, submitter identity,

and/or other information are claimed as

confidential by the submitter.

(2) If the submitter claims the

chemical identity confidential, and

wants the identity to be listed on the

confidential portion of the 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. Submitters who did not

claim the chemical identity, submitter

identity, or other information to be

confidential in the PMN cannot claim

this information as confidential in the

notice of commencement.

(d) Where to submit. Notices of

commencement of manufacture or

import should be submitted to:

TSCA Document Control Office (7407),

Office of Pollution Prevention and Toxics,

Environmental Protection Agency, 401 M St.,

SW., Washington, DC 20460.

* * * * *

Appendix A [Removed]

h. Appendix A to part 720 is removed.

3. In part 721:

PART 721—[AMENDED]

a. The authority citation for part 721

continues to read as follows:

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

2652(c).

b. Section 721.25 is amended by

revising the last sentence of paragraph

(a) to read as follows:

§721.25 Notice requirements and

procedures.

(a)* * * The notice must be

submitted on EPA Form 7710–25, and

must comply with the requirements of

part 720 of this chapter, except to the

extent that they are inconsistent with

this part 721.

* * * * *

[FR Doc. 95–7709 Filed 3–24–95; 3:32 pm]

BILLING CODE 6560–50–F

40 CFR Part 721

[OPPTS–50595B; FRL–4921–9]

RIN 2070–AC14

Amendment for Expedited Process To

Issue Significant New Use Rules for

Selected New Chemical Substances;

Final Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating an

amendment to the regulations governing

significant new uses of chemical

substances. The amendment authorizes

EPA to impose any of the ‘‘significant

new use’’ designations in 40 CFR part

721 subpart B using expedited

rulemaking procedures to promulgate

‘‘significant new use’’ rules (SNURs) for