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
16312 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

certain new chemical substances not

subject to the Toxic Substances Control

Act (TSCA) section 5(e) Orders (referred

to as ‘‘non-5(e) SNURs’’). Currently, the

significant new use regulations limit the

type of activities which EPA can

designate as a significant new use by

expedited rulemaking without first

issuing a section 5(e) Order. This

amendment allows EPA to promulgate

expedited SNURs for certain new

chemical substances without issuing a

section 5(e) Order for the substance, and

thereby facilitates EPA’s ability to

efficiently and expeditiously regulate

new chemical substances.

DATES: This rule will become effective

on May 30, 1995. In accordance with 40

CFR 23.5, this rule shall be promulgated

for purposes of judicial review at 1 p.m.

eastern 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: Under

section 5 of TSCA, when EPA regulates

activities associated with a new

chemical substance described in a

premanufacture notice (PMN), EPA

generally issues an Order under section

5(e) of TSCA regulating the PMN

submitter and/or promulgates a SNUR

under section 5(a)(2) regulating all

manufacturers and processors of the

PMN substance. EPA promulgated a

procedural ‘‘Generic SNUR’’ (or

‘‘Expedited Follow-Up Rule’’) in 40 CFR

part 721 on July 27, 1989 (54 FR 31298).

On February 8, 1993, EPA proposed

amending the SNUR regulations in 40

CFR 721.170(c)(1) to authorize EPA to

impose any of the ‘‘significant new use’’

designations in 40 CFR part 721 subpart

B using expedited rulemaking

procedures to promulgate non-5(e)

SNURs. 58 FR 7676. (Public hearings

were held in April 1993.) Previously,

significant new use designations

available for expedited non-5(e) SNURs

were limited to environmental release

activities and certain industrial,

commercial, or consumer activities.

This amendment authorizes EPA to

include other important designations,

such as protection in the workplace and

hazard communication, in non-5(e)

SNURs promulgated via expedited

rulemaking procedures.

As explained in the rule proposal:

‘‘Whereas a section 5(e) Order applies

only to the original PMN submitter who

signs the Order, a SNUR applies to all

manufacturers and processors of the

chemical substance. The reporting

requirements of a non-5(e) SNUR apply

also to the original PMN submitter

(because, without a section 5(e) Order,

the PMN submitter is not exempted by

40 CFR 721.45(i)). Since only one

Agency action is required instead of

two, and fewer EPA resources are

necessary to obtain similar regulatory

results, a non-5(e) SNUR is more

efficient than a combination of section

5(e) Order and ‘5(e)-SNUR’ (under 40

CFR 721.160) to regulate new chemical

substances.’’ 58 FR 7677. The rule

proposal also stated that promulgation

of a non-5(e) SNUR would allow the

PMN submitter to commence

commercial manufacture of the PMN

substance sooner than would issuance

of a section 5(e) Order followed by

promulgation of a 5(e)-SNUR.

I. Authority

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

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

that a use of a chemical substance is a

‘‘significant new use.’’ EPA must make

this determination by rule after

considering all relevant factors,

including those listed in section 5(a)(2).

The enumerated factors pertain to the

potential for increased manufacturing

and processing volume, increased

exposure, and changes in anticipated

methods of manufacture, processing,

distribution and disposal. Once EPA

has, by rule, determined that a use of a

chemical substance is a significant new

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

persons to submit a notice to EPA at

least 90 days before commencing any

manufacturing, importing, or processing

activities designated by the SNUR as a

‘‘significant new use.’’ The mechanism

for reporting under this requirement is

set out in 40 CFR 721.10.

The supporting rationale and

background for SNURs are more fully

set out in the preamble to EPA’s first

SNURs issued under the Expedited

Follow-Up Rule and published on April

24, 1990 at 55 FR 17376. Consult that

preamble for further information on the

objectives, rationale, and procedures for

the rules and on the basis for significant

new use designations.

II. Applicability of General Provisions

General provisions for SNURs appear

in subpart A of 40 CFR part 721. These

provisions describe persons subject to

SNURs, recordkeeping requirements,

exemptions to reporting requirements,

and applicability of SNURs to uses

occurring before the effective date of a

SNUR. Rules on user fees appear in 40

CFR part 700. Persons subject to a SNUR

must comply with the same notice

requirements and EPA regulatory

procedures as submitters of PMNs under

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

these requirements include the

information submission requirements of

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

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

and (5), and the regulations at 40 CFR

part 720. Once EPA receives a SNUR

notice, EPA may take regulatory action,

if appropriate, under sections 5(e), 5(f),

6, or 7 to control the activities on which

it has received the SNUR notice. If EPA

does not take action, EPA is required

under section 5(g) to explain in the

Federal Register its reasons for not

taking action.

Persons who intend to export a

substance identified in a proposed or

final SNUR are subject to the export

notification provisions of TSCA section

12(b). The regulations that interpret

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

III. Discussion of Comments and Final

Rule

The public comments submitted to

EPA on the proposed rule indicated a

need for clarification regarding EPA’s

goals underlying this rule amendment.

The goals that EPA believes are

promoted by this amendment are: (1) to

regulate new chemical substance risks

using fewer EPA resources, and (2) to

allow PMN submitters proposing to

produce such substances to commence

commercial manufacture sooner (subject

to appropriate limitations that reduce

risk). The amendment will achieve these

goals by eliminating language in 40 CFR

§721.170(c)(1) that previously prevented

EPA from promulgating expedited non5(e) SNURs containing worker

protection or hazard communication

requirements. In cases where those

types of requirements are appropriate,

this amendment will enable EPA and

the PMN submitter to bypass

development of a section 5(e) Order and

proceed directly to promulgation of a

SNUR. The PMN submitter and other

interested parties will generally have a

similar opportunity for dialogue with

EPA and input into development of the

specific regulatory terms as they do in

the development of a section 5(e) Order/

5(e)-SNUR combination.

1. Comment. Many comments

indicated concern that EPA would use

the amendment to promulgate more

SNURs with less input from the PMN

submitter.

EPA Response. To the contrary, EPA’s

intentions are to: (1) issue fewer section

5(e) Orders, not more SNURs; and (2)

where appropriate, develop non-5(e)

SNURs based on voluntary amendments

of PMNs that accomplish the same end

as section 5(e) Order/5(e)-SNUR

combinations but without the extra step.
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16313

In particular, EPA intends a process

involving the active participation of the

original PMN submitter for the

substance that may be subject to a

SNUR; this process will be less formal

than negotiating a section 5(e) Consent

Order.

As explained in the preamble to the

proposed rule (58 FR 7678, February 8,

1993), the non-5(e) SNUR process

provides interested persons several

opportunities for comment. Section

721.170(d)(2) requires EPA to notify the

PMN submitter at least 7 days before

expiration of the 90–day PMN review

period regarding the Agency’s risk

concerns and the activities under

consideration for designation as a

significant new use. In most cases, EPA

actually expects to provide this notice

many days before the ‘‘Day-83’’ deadline

required by section 721.170(d)(2). Of

course, once a PMN submitter receives

this notice, the submitter may respond

to EPA with comments regarding both

the risk concerns and the potential

regulatory terms or ‘‘significant new

use’’ designations. Furthermore, the

expedited ‘‘direct final’’ non-5(e) SNUR

rulemaking procedure does provide a

comment opportunity, which was

described in the preamble to the

proposed rule (58 FR 7678) as well as

in the preamble to the Generic SNUR

(54 FR 31305, July 27, 1989). Thus, this

expanded non-5(e) SNUR process will

in fact provide individual notice to the

PMN submitter before the non-5(e)

SNUR is published, followed by notice

and opportunity for comment to all

persons when the non-5(e) SNUR is

published in the Federal Register.

Also as stated in the rule proposal: ‘‘A

non-5(e) SNUR is typically appropriate

for PMNs on chemical substances

expected to be toxic but where the PMN

indicates the submitter’s intention to

limit activities, implement control

measures, or otherwise adequately

mitigate human exposures and

environmental releases. Activities

described in such PMNs may not

present an unreasonable risk of injury to

human health or the environment so as

to warrant the issuance of an Order

under section 5(e) of TSCA [followed by

promulgation of a 5(e)–SNUR], but

deviations from the described activities

may present an unreasonable risk

warranting the imposition of regulatory

controls via a section 5(e) Order. In

those cases, a non-5(e) SNUR may be the

least burdensome regulatory alternative

for the Agency to pursue, as it will

allow the PMN submitter to proceed

with planned activities while requiring

notification to, and review by, EPA for

activities which have not been

reviewed.’’ 58 FR 7677.

Additionally, using this non-5(e)

SNUR process, where EPA perceives

that use of a new chemical substance as

described in the PMN may present

unreasonable risk, then, instead of

suggesting a section 5(e) Consent Order/

5(e)-SNUR combination, EPA may

informally request the submitter to

amend its PMN to include appropriate

exposure controls. If the submitter

agrees to amend its PMN accordingly,

EPA can then allow the submitter to

commence manufacture immediately

upon expiration of the 90–day PMN

review period. Because the amended

PMN would reflect the same controls

that will be in the non-5(e) SNUR, EPA

will not require the submitter to wait

until the non-5(e) SNUR is published to

commence commercial manufacture.

If, instead, the PMN submitter cannot

reach agreement with EPA regarding the

need or appropriateness of the modified

terms for the PMN, and/or prefers to

negotiate a formal section 5(e) Consent

Order, EPA may then issue a section

5(e) Order. However, experience shows

that additional time and resources will

very probably need to be expended

before the section 5(e) Order can be

finalized, which must occur before EPA

will allow the PMN review period to

expire, which in turn must precede

commencement of commercial

manufacture of the PMN substance.

Section 5(e)(1)(B)(ii) of TSCA prohibits

EPA from issuing a section 5(e) Order

after expiration of the 90–day statutory

review period. Therefore, EPA will not

allow the review period to expire until

the section 5(e) Order is finalized, and

‘‘extension’’ (pursuant to TSCA section

5(c)) or ‘‘suspension’’ (pursuant to 40

CFR 720.75(b)) of the review period is

usually necessary to allow sufficient

time for development of the section 5(e)

Order. TSCA section 5(a) prohibits

commencement of commercial

manufacture of the PMN substance

before the 90–day statutory PMN review

period expires. Furthermore, if EPA and

the submitter cannot agree on the terms

for a section 5(e) Consent Order, EPA

can issue a section 5(e) Order

unilaterally.

Thus, this rule amendment is

intended to eliminate unnecessary

section 5(e) Orders and should not itself

increase the number of new chemical

substances regulated by EPA via SNURs

under section 5 of TSCA. Rather,

substances that would formerly have

been regulated by 5(e)-SNURs may now

be regulated by non-5(e) SNURs. The

amendment still requires EPA to

provide notice allowing the PMN

submitter (or others) to respond to EPA

with comments regarding the perceived

risks and the proposed regulatory

requirements for a given new chemical

substance.

2. Comment. Some comments

indicated a desire for criteria to restrict

EPA’s discretion as to when it would

use the non-5(e) SNUR procedure. The

Chemical Manufacturers’ Association

(CMA) suggested that EPA should

commit to promulgating expedited non5(e) SNURs only when EPA finds that

the chemical substance ‘‘may present an

unreasonable risk,’’ i.e., the standard

articulated in TSCA section 5(e) for the

issuance of administrative orders.

EPA Response. EPA has stated many

times that TSCA authorizes EPA to

promulgate a SNUR without finding that

a chemical substance ‘‘may present

unreasonable risk.’’ Rather, section

5(a)(2) of TSCA and 40 CFR 721.170(b),

which is not being amended in this

rulemaking, set forth the criteria EPA

has used and will continue to use for

non-5(e) SNURs.

As discussed above, where EPA

perceives that the scenario described in

a PMN may present an unreasonable

risk, EPA may request the submitter to

amend the PMN to include appropriate

exposure controls. If the submitter

refuses, EPA would not promulgate a

non-5(e) SNUR, but would likely

attempt to negotiate a section 5(e)

Consent Order. Unlike promulgation of

a non-5(e) SNUR, to issue a section 5(e)

Consent Order, EPA must determine

that activities associated with the PMN

substance ‘‘may present an

unreasonable risk’’ of injury to human

health or the environment. Again,

however, extension or suspension of the

review period would be necessary to

allow sufficient time for development of

the section 5(e) Order, and, if EPA and

the submitter cannot agree on the need

or terms for a section 5(e) Consent

Order, EPA can issue a section 5(e)

Order unilaterally.

Nevertheless, as elaborated elsewhere,

EPA believes that non-5(e) SNURs will

save time and resources for both EPA

and industry without unduly sacrificing

the ability to negotiate the regulatory

terms. EPA expects that PMN submitters

will recognize this and will generally

prefer a non-5(e) SNUR over a section

5(e) Order/5(e)–SNUR combination.

3. Comment. Many commenters

disapproved of EPA’s ability to use the

expedited non-5(e) SNUR procedure to

impose regulatory requirements not

listed in subpart B of 40 CFR part 721.

EPA Response. The final rule limits

‘‘significant new use’’ designations for

non-5(e) SNURs to subpart B provisions

only. EPA expects that limiting

expedited non-5(e) SNURs to the

standard ‘‘significant new use’’

designations published in subpart B of
16314 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

40 CFR part 721 will help provide PMN

submitters with a clear understanding

when notified by EPA of the regulatory

terms that EPA intends to apply to their

PMN substance via a non-5(e) SNUR.

If, in the future, EPA decides that

additional ‘‘significant new use’’

designations are needed for non-5(e)

SNURs, EPA can add those designations

to subpart B via notice and comment

rulemaking or promulgate individual

SNURs containing those designations

through notice and comment

rulemaking.

4. Comment. Several commenters

disagreed with EPA’s assertion that,

since suspensions to issue section 5(e)

Orders would be eliminated, the

proposed amendment would allow

commercial manufacture to commence

sooner. They stated the amendment

would actually cause greater delay

because EPA could declare any use

inconsistent with the PMN to be a

significant new use. They claim that the

PMN submitter will need more time to

identify all potential uses and

associated information before

submitting a PMN, so that EPA will not

promulgate a SNUR requiring further

notices for those uses of the substance.

EPA Response. The comment

indicates a need to clarify how EPA

regulates new chemical substances and

particularly how the word ‘‘use’’ is

employed in the context of new

chemical substance SNURs and section

5(e) Consent Orders. The SNURs

promulgated by EPA to date for new

chemical substances show that EPA

rarely, if ever, designates as a

‘‘significant new use’’ every activity not

expressly contemplated in the PMN.

Rather, EPA generally defines a

‘‘significant new use’’ for new chemical

substances as activities lacking specific

exposure controls (such as gloves,

goggles, respirators and waste disposal)

which therefore may present an

unreasonable health or environmental

risk. EPA will define as ‘‘significant’’

any use not identified in the PMN only

where the substance is expected to be

toxic and EPA cannot be certain that

specific exposure controls will

adequately mitigate all concerns. In

sum, the amendment is not intended to

change the substantive content or terms

that EPA has used to regulate new

chemical substances or to write SNURs

in the past; rather, it is a procedural

change enabling EPA to establish those

same terms in an expedited SNUR

without first issuing a section 5(e)

Consent Order. This amendment should

not change the amount of time and

effort a PMN submitter must invest to

identify potential uses of the new

chemical substance. PMN submitters

will continue to be required to provide

information that is known to or

reasonably ascertainable by the

submitter when the PMN is submitted

and throughout the PMN review period.

(15 U.S.C. 2604(d)(1)(A), 40 CFR

720.45).

5. Comment. One commenter stated

that certain designations in subpart B

are ‘‘by their nature’’ not appropriate for

non-5(e) SNURs (quoting the preambles

to the proposed and final Generic

SNUR, see e.g., 54 FR 31304). The

commenter also stated ‘‘EPA should not

designate the failure to use personal

protective equipment as a significant

new use of a chemical substance that

has completed premanufacture review

and is not subject to an Order under

Section 5(e). If such protection is

required, it should be imposed on the

initial manufacturer who submitted the

PMN pursuant to a Section 5(e) Consent

Order .... EPA should not shortcut this

process simply because ‘a non-5(e)

SNUR is more efficient than a

combination of Section 5(e) order and a

5(e) SNUR ... to regulate new chemical

substances.’’’ 58 FR 7677.

EPA Response. Several provisions in

subpart B (i.e., 40 CFR 721.80(k), (q),

and (t)) expressly refer to terms of the

section 5(e) Consent Order and are thus

inapplicable to non-5(e) SNURs. There

is no need to specifically exclude these

provisions from §721.170.

Based on over 4 years of experience

with 5(e)–SNURs and non-5(e) SNURs

under §§721.160 and 721.170, EPA now

believes that provisions for worker

protection and hazard communication

should be available if EPA and the PMN

submitter prefer to bypass the

cumbersome section 5(e) Order/5(e)–

SNUR process and go directly to a non5(e) SNUR. Under the revised non-5(e)

SNUR process, allowing designation of

any of the ‘‘significant new use’’

provisions in subpart B, risks to workers

can be controlled via SNURs without

the need to also issue Consent Orders.

EPA believes the imposition of worker

protection requirements in a non-5(e)

SNUR is appropriate where the new

chemical substance is expected to be

toxic to humans and the PMN indicates

that the submitter will implement

worker protection measures. Again, this

non-5(e) SNUR will not only save EPA

resources, but will also allow the PMN

submitter to commence manufacture

sooner (i.e., immediately upon

expiration of the 90–day review period,

rather than suspending or extending the

review period to negotiate a section 5(e)

Order), provided that the submitter does

in fact implement the stated protective

measures so that the submitter is not

required by the SNUR to submit another

notice to EPA. The non-5(e) SNUR will

bind the PMN submitter as effectively as

a section 5(e) Order while saving the

submitter the costs of delayed marketing

of the new chemical substance.

6. Comment. EPA should not disrupt

business by defining as a ‘‘significant

new use’’ an activity which the original

PMN submitter or another company

commences between the filing of the

notice of commencement (NOC) of

manufacture (per 40 CFR 720.102) and

the publication of the SNUR.

EPA Response. EPA generally does

not consider those activities that

commenced prior to publication of a

proposed SNUR to be ‘‘significant new

uses.’’ In SNUR preambles for

individual chemicals, EPA routinely

states that a ‘‘new’’ use is one that is not

ongoing when the proposed SNUR is

published in the Federal Register. If

EPA is informed that a use which it

proposes to define as ‘‘new’’ was

already ongoing before the proposal was

published, EPA will generally

determine that use is not ‘‘new.’’ See,

e.g., 57 FR 31326, July 15, 1992. (One

exception would be if the original PMN

submitter engaged in an activity

prohibited by a section 5(e) Order.)

7. Comment. Employers have hazard

communication and worker protection

obligations under the Occupational

Safety and Health Act without regard to

the existence of TSCA section 5(e)

Orders and SNURs. EPA should not

over extend itself into the area of

occupational safety and health.

EPA Response. TSCA section 5

authorizes EPA to review and regulate

new chemical substances to prevent

unreasonable risks to human health and

the environment. A senate report

discussion of TSCA section 5 expressly

notes that the Federal statutes existing

when TSCA was enacted, including

specifically the Occupational Safety and

Health Act, ‘‘do not provide for this type

of premarket scrutiny.’’ S. Rept. No. 698,

94th Cong. 2d Sess. 1 (1976).

Requirements imposed by the

Occupational Safety and Health

Administration (OSHA) may not always

apply to new chemical substances

governed by TSCA section 5. For

example, OSHA hazard communication

requirements only apply to a substance

for which there is at least one positive

study (29 CFR 1910.1200(d)(2)), whereas

many new chemical substances have not

been tested at all. Furthermore, OSHA

permissible exposure limits (PELs) (29

CFR Part 1910) generally apply only to

specific chemical substances, and very

few new chemical substances subject to

section 5 of TSCA are subject to OSHA

PELs. Lastly, the requirements of EPA’s

worker protection and hazard
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16315

communication provisions in section

5(e) Consent Orders and SNURs are

consistent with OSHA’s requirements.

8. Comment. One commenter stated

that the increased incidence of non-5(e)

SNURs would subject more chemicals to

TSCA section 12(b) export notification

requirements, increasing the burden on

industry and EPA to report such

activity. The commenter suggested a

mechanism so that substances subject to

a SNUR but contained in finished

products or a small percentage of a

mixture were not subject to TSCA 12(b)

notification.

EPA Response. As stated previously

in response to other comments, the

intent of this rule amendment is not to

increase the number of new chemical

substances regulated by EPA. Rather

EPA expects to offer PMN submitters

the option of a non-5(e) SNUR, instead

of a section 5(e) Consent Order. In either

instance, EPA has determined that

exposure controls are needed and will

regulate the substance through one of

those procedural mechanisms. This rule

will not increase the section 12(b)

reporting burden on industry or EPA.

The same comment suggesting a de

minimis exemption for section 12(b)

reporting was recently submitted on a

proposed amendment to the section

12(b) rule at 40 CFR part 707, subpart

D. EPA considered this comment in that

rulemaking and stated in the preamble

to the final rule amending the section

12(b) rule: ‘‘While de minimis–type

regulatory exemptions may be

appropriate in many circumstances, at

the present time, EPA believes it is

preferable to provide foreign countries

12(b) notifications so they have the

opportunity to make their own

determinations regarding what level of a

chemical in mixtures is deemed

important. However, if further

experience with the 12(b) or PIC [Prior

Informed Consent joint program of the

United Nations Environment

Programme and the Food and

Agriculture Organization] programs

indicate that a de minimis regulatory

exemption is warranted, EPA will

reexamine this option at a later time.’’

58 FR 40240–41; July 27, 1993.

Therefore, under the current rules

implementing section 12(b) of TSCA (40

CFR part 707, subpart D), if a substance

or mixture is subject to a section 5(e)

Order or rule, then export notification is

required, except for substances

contained in ‘‘articles’’ (as defined in 40

CFR 720.3(c)).

9. Comment. The original Generic

SNUR, including the restriction on non5(e) SNUR designations, was negotiated

by a multi-interest dialogue group and

should not be changed unilaterally by

EPA.

EPA Response. EPA has followed the

notice and comment rulemaking

procedures required by the

Administrative Procedure Act, and

believes it has improved the final rule

amendment in direct response to the

valuable comments that were submitted.

Given the elimination of non-subpart B

provisions, the benefits to PMN

submitters from this rulemaking, and

the potential delays of procedural

approaches other than promulgating this

final rule at this time, EPA has decided

that it is in the public interest to go

forward with this final rule. EPA

expects this final rule to satisfy all

statutory requirements and most, if not

all, interested parties.

IV. Economic Analysis

The Agency’s complete economic

analysis is available in the public record

for this rulemaking (OPPTS–50595B).

The regulatory impact analysis

estimates the costs and benefits

attributable to the final regulation. In

this case, the analysis also contains

estimates for three amendments to other

regulations, namely the Revisions of

Premanufacture Notification

Regulations, the Revision of Exemption

for Chemical Substances Manufactured

in Quantities of 1,000 Kilograms or Less

Per Year, and the Revisions of

Exemption for Polymers. As these

regulations are amendments to current

regulations, the costs and benefits are

incremental and estimate the effect of

the amendment with respect to the old

regulation.

This non-5(e) SNUR amendment will

eliminate the need to develop a section

5(e) Consent Order before promulgating

an expedited SNUR in those cases

where EPA determines that activities

described in the PMN submission will

not present unreasonable risk. The

major industry benefit is the avoidance

of the delay and costs associated with

negotiating a Consent Order; generally,

the submitter will be able to commence

commercial manufacture immediately

after the 90–day PMN review period

without suspending or extending it. The

submitter, along with other

manufacturers and processors, will be

bound by the expedited SNUR.

Industry savings from this

amendment are based on avoidance of

delay costs and are estimated to range

from $65,000 to $330,000 per year.

Annual government savings are

estimated to range from $240,000 to

$960,000. These estimates are based on

the following assumptions: (1) 1,000 to

3,000 PMNs will be submitted annually;

(2) in the absence of this amendment,

5% of these PMNs will be subject to

section 5(e) Orders; and (3) with this

amendment, 40% of these section 5(e)

Orders will be avoided and replaced by

non-5(e) SNURs.

V. Rulemaking Record

EPA has established a record for this

rulemaking (docket control number

OPPTS–50595B). The record includes

basic information and comments

considered by the Agency in developing

this rule. A public version of the record

is available in the TSCA

Nonconfidential Information Center,

from 12 noon to 4 p.m., Monday

through Friday, except legal holidays.

The TSCA Nonconfidential Information

Center is located in Rm. NE–B607,

Northeast Mall, 401 M St., SW.,

Washington, DC.

VI. Regulatory Assessment

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

(58 FR 51735, October 4, ‘993) 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
16316 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

SNUR notice submitters were small

firms, the number of small businesses

affected by this rule will not be

substantial.

C. Paperwork Reduction Act

There is no additional reporting

burden associated with this amendment.

The information collection requirements

in this rule have been approved by the

Office of Management and Budget

(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.

List of Subjects in 40 CFR Part 721

Chemicals, Environmental protection,

Hazardous materials, Recordkeeping

and reporting requirements, Significant

new uses.

Dated: March 21, 1995.

Carol M. Browner,

Administrator.

Therefore, 40 CFR Chapter I, part 721

is amended as follows:

PART 721 — [AMENDED]

1. The authority citation for part 721

continues to read as follows:

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

2625(c).

2. By revising §721.170(c)(1) to read

as follows:

§721.170 Notification requirements for

selected new chemical substances that

have completed premanufacture review.

* * * * *

(c) * * *

(1) When EPA decides to establish

significant new use reporting

requirements under this section, EPA

may designate as a significant new use

any one or more of the activities set

forth in subpart B of this part. In

addition, EPA may designate specific

recordkeeping requirements described

under subpart C of this part that are

applicable to the substance.

* * * * *

[FR Doc. 95–7710 Filed 3–24–95; 3:32 pm]

BILLING CODE 6560–50–F

40 CFR Part 723

[OPPTS–50594B; FRL–4929–8]

RIN 2070–AC14

Premanufacture Notification

Exemptions; Revisions of Exemptions

for Polymers; Final Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating

amendments to the polymer exemption

rule to expand the exemption criteria

and exempt manufacturers of eligible

polymers from certain section 5

premanufacture notification (PMN)

requirements. EPA has determined that

the manufacture, processing,

distribution in commerce, use, and

disposal of new chemical substances

meeting the revised polymer exemption

criteria will not present an unreasonable

risk of injury to human health or the

environment under terms of the

exemption. These final amendments

reflect criteria developed and used by

EPA to assess the hazards associated

with new polymeric substances over the

past 15 years the New Chemicals

Program has been in place. EPA believes

that these amendments will encourage

the manufacture of safer polymers by

reducing industry’s reporting burden for

this category of chemical substances.

DATES: This rule will become effective

May 30, 1995. In accordance with 40

CFR 23.5 (50 FR 7271), this rule shall

be promulgated for purposes of judicial

review at 1 p.m. eastern 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: The

polymer exemption rule was originally

promulgated on November 21, 1984.

The supporting rationale and

background for that exemption was

published at 49 FR 46066 on November

21, 1984 and 46 FR 54688 on November

3, 1981. On February 8, 1993, EPA

proposed amendments to the 1984

polymer exemption rule (58 FR 7679).

Consult those documents for further

information on the objectives, rationale,

and procedures for the rule and the

basis for the finding that polymers

eligible for exemption will not present

an unreasonable risk of injury to human

health and the environment under terms

of the exemption. The docket control

number for this document is OPPTS–

50594B.

The amended rule allows

manufacture and distribution of

polymers meeting the exemption criteria

without submission of a PMN or an

exemption notice prior to

commencement of manufacture for a

commercial purpose under terms of the

exemption. However, manufacturers of

exempted polymers are required to

submit an annual report on exempted

polymers for which manufacture or

importation commenced for the first

time under terms of the exemption

during the preceding calendar year.

Recordkeeping requirements are

retained as part of the rule to document

compliance with the exemption criteria.

Overall, these amendments constitute a

substantial revision of the existing

polymer exemption rule.

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. A ‘‘new chemical substance’’

is any substance that is not on the

Inventory of Chemical Substances

compiled by EPA under section 8(b) of

TSCA. Section 5(h)(4) of TSCA

authorizes EPA, upon application and

by rule, to exempt the manufacturer or

importer of any new chemical substance

from part or all of the provisions of

section 5 if the Agency determines that

the manufacture, processing,

distribution in commerce, use, or

disposal of the new chemical substance

will not present an unreasonable risk of

injury to human health or the

environment. In this preamble and

under the rule, references to

‘‘manufacture’’ and ‘‘manufacturer’’

include ‘‘import’’ and ‘‘importer’’,

respectively, as defined in TSCA section

3 and the PMN rule.

B. History/Rationale

In 1984, the Agency published a

TSCA section 5(h)(4) rule granting an

exemption for persons who manufacture

or import certain polymers, set forth at

40 CFR 723.250. Since promulgation of

the 1984 polymer exemption rule (the

‘‘1984 exemption’’), the Agency has

reviewed over 2,000 polymers

submitted as polymer exemption notices

in the 21–day review process in

addition to over 10,000 polymers

submitted as PMNs since the initiation

of the 90–day PMN review process in

1979. In the course of performing hazard

and risk assessments for these polymers,

the Agency has developed internal

guidelines for identifying polymeric

substances that do not present an

unreasonable risk of injury to human

health or the environment. These

guidelines are based on (1) EPA’s

ongoing review of the available

literature on the toxicity of polymers, (2)

EPA’s analyses of various samples of the

PMN polymer data base, (3) information

provided to EPA by outside groups