Protection of Stratospheric Ozone

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-6301-7]

RIN 2060-AG12

Protection of Stratospheric Ozone

AGENCY: Environmental Protection Agency.

ACTION: Notice of proposed rulemaking.

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[[Page 8039]]

SUMMARY: This action proposes to list as acceptable with restrictions

two substitutes for ozone depleting substances (ODSs) under the U.S.

Environmental Protection Agency's (EPA) Significant New Alternatives

Policy (SNAP) program. SNAP implements section 612 of the amended Clean

Air Act of 1990, which requires EPA to evaluate substitutes for the

ODSs to reduce overall risk to human health and the environment.

Through these evaluations, SNAP generates lists of acceptable and

unacceptable substitutes for each of the major industrial use sectors.

The intended effect of the SNAP program is to expedite movement away

from ozone depleting compounds while avoiding a shift into substitutes

posing other environmental problems.

On March 18, 1994, EPA promulgated a final rulemaking setting forth

its plan for administering the SNAP program (59 FR 13044), and issued

decisions on the acceptability and unacceptability of a number of

substitutes. In this Notice of Proposed Rulemaking (NPRM), EPA is

issuing its preliminary decisions on the acceptability of halon

substitutes in the fire suppression and explosion protection sector

which have not previously been reviewed by the Agency. To arrive at

determinations on the acceptability of substitutes, the Agency

completed a cross-media evaluation of risks to human health and the

environment by sector end-use.

DATES: Written comments or data provided in response to this document

must be submitted by April 19, 1999. A public hearing will be held if

requested in writing. If a public hearing is requested, EPA will

provide notice of the date, time and location of the hearing in a

subsequent Federal Register notice. For further information, please

contact the SNAP Coordinator at the address listed below under For

Further Information.

ADDRESSES: Written comments and data should be sent to Docket A-91-42,

U.S. Environmental Protection Agency, OAR Docket and Information

Center, Room M-1500, 401 M Street, S.W., Washington, D.C. 20460. The

docket may be inspected between 8 a.m. and 5:30 p.m. on weekdays.

Telephone (202) 260-7548; fax (202) 260-4400. As provided in 40 CFR,

Part 2, a reasonable fee may be charged for photocopying. To expedite

review, a second copy of the comments should be sent to Kelly Davis at

the address listed below under For Further Information. Information

designated as Confidential Business Information (CBI) under 40 CFR,

Part 2, Subpart B, must be sent directly to the contact person for this

notice. However, the Agency is requesting that all respondents submit a

non-confidential version of their comments to the docket as well.

FOR FURTHER INFORMATION CONTACT: Kelly Davis at (202) 564-2303 or fax

(202) 565-2096, U.S. Environmental Protection Agency, Mail Code 6205-J,

401 M Street, SW, Washington, D.C. 20460. Overnight or courier

deliveries should be sent to our 501-3rd Street, NW, Washington, DC,

20001 location.

SUPPLEMENTARY INFORMATION:

Overview of This Action

This action is divided into four sections:

I. Section 612 Program

A. Statutory Requirements

B. Regulatory History

II. Proposed Listing of Substitutes

III. Administrative Requirements

A. Executive Order 12866

B. Unfunded Mandates Reform Act

C. Regulatory Flexibility Act

D. Paperwork Reduction Act

E. Applicability of Executive Order 13045: Children's Health

Protection

F. Executive Order 12875: Enhancing Intergovernmental

Partnerships

G. The National Technology Transfer and Advancement Act

H. Executive Order 13084: Consultation and Coordination With

Indian Tribal Governments

IV. Additional Information

I. Section 612 Program

A. Statutory Requirements

Section 612 of the Clean Air Act authorizes EPA to develop a

program for evaluating alternatives to ozone-depleting substances. EPA

is referring to this program as the Significant New Alternatives Policy

(SNAP) program. The major provisions of section 612 are:

Rulemaking--Section 612(c) requires EPA to promulgate rules making

it unlawful to replace any class I (chlorofluorocarbon, halon, carbon

tetrachloride, methyl chloroform, methyl bromide, and

hydrobromofluorocarbon) or class II (hydrochlorofluorocarbon) substance

with any substitute that the Administrator determines may present

adverse effects to human health or the environment where the

Administrator has identified an alternative that (1) reduces the

overall risk to human health and the environment, and (2) is currently

or potentially available.

Listing of Unacceptable/Acceptable Substitutes--Section 612(c) also

requires EPA to publish a list of the substitutes unacceptable for

specific uses. EPA must publish a corresponding list of acceptable

alternatives for specific uses.

Petition Process--Section 612(d) grants the right to any person to

petition EPA to add a substitute to or delete a substitute from the

lists published in accordance with section 612(c). The Agency has 90

days to grant or deny a petition. Where the Agency grants the petition,

EPA must publish the revised lists within an additional six months.

90-day Notification--Section 612(e) requires EPA to require any

person who produces a chemical substitute for a class I substance to

notify the Agency not less than 90 days before new or existing

chemicals are introduced into interstate commerce for significant new

uses as substitutes for a class I substance. The producer must also

provide the Agency with the producer's unpublished health and safety

studies on such substitutes.

Outreach--Section 612(b)(1) states that the Administrator shall

seek to maximize the use of federal research facilities and resources

to assist users of class I and II substances in identifying and

developing alternatives to the use of such substances in key commercial

applications.

Clearinghouse--Section 612(b)(4) requires the Agency to set up a

public clearinghouse of alternative chemicals, product substitutes, and

alternative manufacturing processes that are available for products and

manufacturing processes which use class I and II substances.

B. Regulatory History

On March 18, 1994, EPA published the Final Rulemaking (FRM) (59 FR

13044) which described the process for administering the SNAP program

and issued EPA's first acceptability lists for substitutes in the major

industrial use sectors. These sectors include: refrigeration and air

conditioning; foam blowing; solvent cleaning; fire suppression and

explosion protection; sterilants; aerosols; adhesives, coatings and

inks; and tobacco expansion. These sectors comprise the principal

industrial sectors that historically consume large volumes of ozone-

depleting compounds.

The Agency defines a ``substitute'' as any chemical, product

substitute, or alternative manufacturing process, whether existing or

new, that could replace a class I or class II substance. Anyone who

produces a substitute must provide the Agency with health and safety

studies on the substitute at least 90 days before introducing it into

interstate commerce for significant new use as an alternative. This

requirement applies to chemical manufacturers, but may include

importers, formulators or end-users when they are responsible for

introducing a substitute into commerce.

[[Page 8040]]

II. Proposed Listing of Substitutes

To develop the lists of unacceptable and acceptable substitutes,

EPA conducts screens of health and environmental risks posed by various

substitutes for ozone-depleting compounds in each use sector. The

outcome of these risk screens can be found in the public docket, as

described above in the Addresses portion of this notice.

Under section 612, the Agency has considerable discretion in the

risk management decisions it can make in SNAP. The Agency has

identified five possible decision categories: acceptable; acceptable

subject to use conditions; acceptable subject to narrowed use limits;

unacceptable; and pending. Fully acceptable substitutes (i.e., no

restrictions) can be used for all applications within the relevant

sector end-use. Conversely, it is illegal to replace an ODS with a

substitute listed by SNAP as unacceptable. A pending listing represents

substitutes for which the Agency has not received complete data or has

not completed its review of the data.

After reviewing a substitute, the Agency may make a determination

that a substitute is acceptable only if certain conditions of use are

met to minimize risks to human health and the environment. Use of such

substitutes in ways that are inconsistent with such use conditions

renders these substitutes unacceptable.

Even though the Agency can restrict the use of a substitute based

on the potential for adverse effects, it may be necessary to permit a

narrowed range of use within a sector end-use because of the lack of

alternatives for specialized applications. Users intending to adopt a

substitute acceptable within narrowed use limits must ascertain that

other acceptable alternatives are not technically feasible. Companies

must document the results of their evaluation, and retain the results

on file for the purpose of demonstrating compliance. This documentation

shall include descriptions of substitutes examined and rejected,

processes or products in which the substitute is needed, reason for

rejection of other alternatives, e.g., performance, technical or safety

standards, and the anticipated date other substitutes will be available

and projected time for switching to other available substitutes. Use of

such substitutes in applications and end-uses which are not specified

as acceptable in the narrowed use limit renders these substitutes

unacceptable.

In this NPRM, EPA is issuing its preliminary decision on the

acceptability of certain substitutes not previously reviewed by the

Agency. As described in the March 1994 rulemaking for the SNAP program

(59 FR 13044), EPA believes that, as a general matter, notice-and-

comment rulemaking is required to place any alternative on the list of

prohibited substitutes, to list a substitute as acceptable only under

certain use conditions or narrowed use limits, or to remove an

alternative from either the list of prohibited or acceptable

substitutes.

EPA does not believe that notice and comment rulemaking procedures

are required to list alternatives as acceptable with no limitations.

Such listings do not impose any sanction, nor do they remove any prior

license to use a substitute. Consequently, EPA adds substitutes to the

list of acceptable alternatives without first requesting comment on new

listings. Updates to the acceptable and pending lists are published as

separate Notices of Acceptability in the Federal Register.

The sections below present a detailed discussion of the proposed

substitute listing determinations by major use sector. Tables

summarizing listing decisions in this Notice of Proposed Rulemaking are

in Appendix G. The comments contained in Appendix G provide additional

information on a substitute. These comments are not part of the

regulatory decision, and therefore they are not mandatory for use of a

substitute. Nor should the comments listed in Appendix G be considered

comprehensive with respect to other legal obligations pertaining to the

use of the substitute. However, EPA encourages users to apply all

comments listed in the application of these substitutes. In many

instances, the comments simply allude to sound operating practices that

have already been identified in existing industry and/or building-code

standards. Thus, many of the comments, if adopted, would not require

significant changes, if any, in existing operating practices for the

affected industry.

A. Fire Suppression and Explosion Protection

EPA is proposing to list IG-100 and HCFC Blend E as acceptable

halon substitutes subject to certain use conditions. In implementing

its application of conditions to limit the use of alternatives under

the SNAP program, EPA has sought to avoid overlap with other existing

regulatory authorities. EPA believes that section 612 clearly

authorizes imposition of use conditions to ensure safe use of replacing

agents. EPA's mandate is to list agents that ``reduce overall risk to

human health and the environment'' for ``specific uses.'' In light of

this authorization, EPA only intends to set conditions for the safe use

of halon substitutes in the workplace until OSHA incorporates specific

language addressing gaseous agents in OSHA regulation. Under Public Law

91-596, section 4(b)(1), OSHA is precluded from regulating working

conditions currently being regulated by another federal agency. EPA is

specifically deferring to OSHA and has no intention to assume the

responsibility for regulating workplace safety, especially with respect

to fire protection. EPA's workplace use conditions will not bar OSHA

from regulating under its P.L. 91-596 authority.

Additionally, EPA understands that, under the National Technology

Transfer and Advancement Act of 1995, Section 12(d), Pub. L. 104-113,

federal agencies are required to use technical standards that are

developed or adopted by voluntary consensus standards bodies, using

such technical standards as a means to carry out policy objectives or

activities. EPA will consider adopting such technical standards as they

become available.

1. Proposed Acceptable Subject to Use Conditions

Total Flooding Agents. IG-100 is proposed acceptable as a Halon

1301 substitute for total flooding applications. IG-100, which is

composed of 100% nitrogen, is designed to lower the oxygen level in a

protected area to a level that does not support combustion. The

toxicological issues of concern with inert gas systems differ from

those of halocarbon agent systems, since the endpoint for hypoxic (low

oxygen) atmospheres associated with inert gas systems is asphyxiation,

while the endpoint for halocarbon agents is cardiosensitization leading

to cardiac arrhythmia. Peer reviews by medical specialists considering

specific questions regarding exposure of a typical working population

to inert gas fire suppression systems have provided sufficient

information to support use conditions previously listed for IG-541, IG-

55, and IG-01; EPA has determined these use conditions are appropriate

for IG-100 as well.

Specifically, because the terms No Observed Adverse Effect Level

(NOAEL) and Lowest Observed Adverse Effect Level (LOAEL) are not

appropriate when considering the continuum of health effects associated

with hypoxic atmospheres, EPA proposes a ``no effect level'' for inert

gas systems at 12% oxygen, and a ``lowest effect level'' at 10% oxygen.

Thus, consistent with the

[[Page 8041]]

OSHA conditions used by EPA for all total flooding agents, EPA proposes

that an IG-100 system could be designed to an oxygen level of 10% if

employees can egress the area within one minute, but may be designed

only to the 12% level if it takes longer than one minute to egress the

area. If the possibility exists for the oxygen to drop below 10%,

employees must be evacuated prior to such oxygen depletion. A design

concentration of less than 10% oxygen may only be used in normally

unoccupied areas, provided that any employee who could possibly be

exposed can egress within 30 seconds.

EPA does not encourage any employee to intentionally remain in an

area following discharge of IG-100 (or any other total flooding agent),

even in the event of accidental discharge. In addition, the system must

include alarms and warning mechanisms as specified by OSHA.

EPA intends that all personnel be evacuated from an area prior to,

or quickly after, discharge. An inert gas system may not be designed

with the intention of personnel remaining in the area unless

appropriate protection is provided, such as self-contained breathing

apparatuses.

2. Proposed Acceptable Subject to Narrowed Use Limits

Streaming Agents. HCFC Blend E is proposed acceptable as a Halon

1211 substitute for streaming agent uses in nonresidential

applications. This agent is a blend of an HCFC, an HFC, and an

additive. The primary constituent, an HCFC, is currently listed as

acceptable for use in non-residential streaming applications. The

secondary constituent, an HFC, is listed acceptable as a flooding agent

subject to use conditions. Upon combustion, the synergistic effect of

these two compounds can result in the formulation of hydrochloric and

other acids at levels potentially harmful to human health. The

formulation of such byproducts of combustion is similar for many

halocarbon fire extinguishing agents. The manufacturer claims the

presence of the additive might help mitigate these potential effects.

This potential risk of human health effects, although it does not

outweigh the risks associated with fire, necessitate limiting the use

of this blend to non-residential applications only. EPA recommends that

the potential risks associated with the use of this blend, as well as

handling procedures to reduce such risk, be clearly labeled on each

extinguisher containing this blend. Additionally, section 610(d) of the

Clean Air Act and its implementing regulations prohibit the sale and

distribution of HCFCs in fire extinguishers for residential

applications. (See 61 FR 69671, December 4, 1996, and 58 FR 69637,

December 30, 1993.)

EPA has reviewed the environmental impacts of this blend and has

concluded that, by comparison to Halon 1211, it reduces overall risk to

the environment. The ozone-depletion potential of the HCFC is 0.02; no

other constituent in the blend has ozone-depleting characteristics.

EPA's review of environmental and human health impacts of this blend is

contained in the public docket for this rulemaking.

III. Administrative Requirements

A. Executive Order 12866

Under Executive Order 12866, (58 FR 51735; October 4, 1993) the

Agency must determine whether the regulatory action is ``significant''

and therefore subject to OMB review and the requirements of the

Executive Order. The Order defines ``significant regulatory action'' as

one that is likely to result in a rule that may: (1) Have an annual

effect on the economy of $100 million or more or adversely affect in a

material way the economy, a sector of the economy, productivity,

competition, jobs, the environment, public health or safety, or State,

local, or tribal governments or communities; (2) create a serious

inconsistency or otherwise interfere with an action taken or planned by

another agency; (3) materially alter the budgetary impact 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 the Executive Order.

Pursuant to the terms of Executive Order 12866, OMB notified EPA

that it considers this a ``significant regulatory action'' within the

meaning of the Executive Order and EPA submitted this action to OMB for

review. Changes made in response to OMB suggestions or recommendations

have been documented in the public record.

B. Unfunded Mandates Reform Act

Section 202 of the Unfunded Mandates Reform Act of 1995 requires

EPA to prepare a budgetary impact statement before promulgating a rule

that includes a Federal mandate that may result in expenditure of $100

million or more in any one year by state, local, and tribal

governments, in aggregate, or by the private sector. Section 203

requires the Agency to establish a plan for obtaining input from and

informing any small governments that may be significantly or uniquely

affected by the rule. Section 205 requires that regulatory alternatives

be considered before promulgating a rule for which a budgetary impact

statement is prepared. The Agency must select the least costly, most

cost-effective, or least burdensome alternative that achieves the

rule's objectives, unless there is an explanation why this alternative

is not selected or this alternative is inconsistent with law.

Because this proposed rule is estimated to result in the

expenditure by State, local, and tribal governments or the private

sector of less than $100 million in any one year, the Agency has not

prepared a budgetary impact statement or specifically addressed the

selection of the least costly, most cost-effective, or least burdensome

alternative. Because small governments will not be significantly or

uniquely affected by this rule, the Agency is not required to develop a

plan with regard to small governments. However, this proposed rule has

the net effect of reducing burden from part 82, Stratospheric

Protection regulations, on regulated entities.

C. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA) generally requires an agency

to conduct a regulatory flexibility analysis of any rule subject to

notice and comment rulemaking requirements unless the agency certifies

that the rule will not have a significant economic impact on a

substantial number of small entities. Small entities include small

businesses, small not-for-profit enterprises, and small governmental

jurisdictions. This proposed rule would not have a significant impact

on a substantial number of small entities because costs of the SNAP

requirements as a whole are expected to be minor. In fact, this

proposed rule offers regulatory relief to small businesses by providing

acceptable alternatives to phased-out ozone-depleting substances. The

actions proposed herein may well provide benefits for small businesses

anxious to examine potential substitutes to any ozone-depleting class I

and class II substances they may be using, by requiring manufacturers

to make information on such substitutes available. Therefore, I certify

that this action will not have a significant economic impact on a

substantial number of small entities.

D. Paperwork Reduction Act

EPA has determined that this proposed rule contains no information

[[Page 8042]]

requirements subject to the Paperwork Reduction Act, 44 U.S.C. 3501 et

seq., that are not already approved by the Office of Management and

Budget (OMB). OMB has reviewed and approved an Information Collection

Request by EPA described in the March 18, 1994 rulemaking (59 FR 13044,

at 13121, 13146-13147); its OMB Control Number is 2060-0226.

E. Applicability of Executive Order 13045: Children's Health Protection

This rule is not subject to E.O. 13045, entitled Protection of

Children from Environmental Health Risks and Safety Risks (62 FR 19885,

April 23, 1997), because it does not involve decisions on environmental

health risks or safety risks that may disproportionately affect

children.

F. Executive Order 12875: Enhancing Intergovernmental Partnerships

Under Executive Order 12875, EPA may not issue a regulation that is

not required by statute and that creates a mandate upon a State, local

or tribal government, unless the Federal government provides the funds

necessary to pay the direct compliance costs incurred by those

governments, or EPA consults with those governments. If EPA complies by

consulting, Executive Order 12875 requires EPA to provide to the Office

of Management and Budget a description of the extent of EPA's prior

consultation with representatives of affected State, local and tribal

governments, the nature of their concerns, copies of any written

communications from the governments, and a statement supporting the

need to issue the regulation. In addition, Executive Order 12875

requires EPA to develop an effective process permitting elected

officials and other representatives of State, local and tribal

governments ``to provide meaningful and timely input in the development

of regulatory proposals containing significant unfunded mandates.''

Today's rule does not create a mandate on State, local or tribal

governments. The rule does not impose any enforceable duties on these

entities. Accordingly, the requirements of section 1(a) of Executive

Order 12875 do not apply to this rule.

G. The National Technology Transfer and Advancement Act

The National Technology Transfer and Advancement Act of 1995

(NTTAA), Section 12(d), Pub. L. 104-113, requires federal agencies and

departments to use technical standards that are developed or adopted by

voluntary consensus standards bodies, using such technical standards as

a means to carry out policy objectives or activities determined by the

agencies and departments. If use of such technical standards is

inconsistent with applicable law or otherwise impractical, a federal

agency or department may elect to use technical standards that are not

developed or adopted by voluntary consensus standards bodies if the

head of the agency or department transmits to the Office of Management

and Budget an explanation of the reasons for using such standards.

Although this proposed rule includes technical standards for

exposure limits, there are no applicable voluntary consensus standards

on this subject. EPA will consider adopting such technical standards as

they become available.

H. Executive Order 13084: Consultation and Coordination with Indian

Tribal Governments

Under Executive Order 13084, EPA may not issue a regulation that is

not required by statute, that significantly or uniquely affects the

communities of Indian tribal governments, and that imposes substantial

direct compliance costs on those communities, unless the Federal

government provides the funds necessary to pay the direct compliance

costs incurred by the tribal governments, or EPA consults with those

governments. If EPA complies by consulting Executive Order 13084

requires EPA to provide to the Office of Management and Budget, in a

separately identified section of the preamble to the rule, a

description of the extent of EPA's prior consultation with

representatives of affected tribal governments, a summary of the nature

of their concerns, and a statement supporting the need to issue the

regulation. In addition, Executive Order 13084 requires EPA to develop

an effective process permitting elected and other representatives of

Indian tribal governments ``to provide meaningful and timely input in

the development of regulatory policies on matters that significantly or

uniquely affect their communities.'' Today's rule does not

significantly or uniquely affect the communities of Indian tribal

governments, because this regulation applies directly to facilities

that use these substances and not to governmental entities.

Accordingly, the requirements of section 3(b) of Executive Order 13084

do not apply to this rule.

IV. Additional Information

For copies of the comprehensive SNAP lists or additional

information on SNAP, contact the Stratospheric Protection Hotline at 1-

800-296-1996, Monday-Friday, between the hours of 10:00 a.m. and 4:00

p.m. (EST).

For more information on the Agency's process for administering the

SNAP program or criteria for evaluation of substitutes, refer to the

SNAP final rulemaking published in the Federal Register on March 18,

1994 (59 FR 13044). Notices and rulemakings under the SNAP program, as

well as EPA publications on protection of stratospheric ozone, are

available from EPA's Ozone World Wide Web site at (http://www.epa.gov/

ozone/title6) and from the Stratospheric Protection Hotline, whose

number is listed above.

List of Subjects in 40 CFR Part 82

Environmental protection, Administrative practice and procedure,

Air pollution control, Reporting and recordkeeping requirements.

Dated: February 10, 1999.

Carol M. Browner,

Administrator.

For the reasons set out in the preamble, 40 CFR part 82 is proposed

to be amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

1. The authority citation for Part 82 continues to read as follows:

Authority: 42 U.S.C. Sec. 7414, 7601, 7671-7671q.

2. Subpart G is amended by adding the following Appendix G to read

as follows:

Subpart G--Significant New Alternatives Policy Program

* * * * *

Appendix G to Subpart G--Substitutes Subject to Use Restrictions

and Unacceptable Substitutes Listed in the [FR publication date]

final rule, effective [30 days after FR publication date].

Summary of Proposed Decisions

[[Page 8043]]

Fire Suppression and Explosion Protection Total Flooding Agents

[Substitutes Acceptable Subject to Use Conditions]

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End Use Substitute Decision Conditions Comments

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Halon 1301, Total Flooding IG-100.......... Acceptable...... Until OSHA EPA does not

Agents. establishes contemplate

applicable workplace personnel remaining

requirements: in the space after

system discharge

during a fire

without Self-

Contained Breathing

Apparatus (SCBA) as

required by OSHA.

IG-100 systems may be EPA does not

designed to an encourage any

oxygen level of 10% employee to

if employees can intentionally remain

egress the area in the area after

within one minute, system discharge,

but may be designed even in the event of

only to the 12% accidental

oxygen level if it discharge. In

takes longer than addition, the system

one minute to egress must include alarms

the area. and warning

mechanisms as

specified by OSHA.

If the possibility See additional

exists for the comments 1, 2.

oxygen level to drop

below 10%, employees

must be evacuated

prior to such oxygen

depletion.

A design

concentration of

less than 10% many

only be used in

normally occupied

areas, as long as an

employee who could

possibly be exposed

can egress within 30

seconds.

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Additional Comments

1. Must conform with OSHA 29 CFR 1910, Subpart L, Section

1910.160.

2. Per OSHA requirements, protective gear (SCBA) must be

available in the event personnel must re-enter the area.

Fire Suppression and Explosion Protection Streaming Agents

[Substitutes Acceptable Subject to Narrowed Use Limits]

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End use Substitute Decision Limitations Comments

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Halon 1211, Streaming Agents.... HCFC Blend E...... Acceptable........ Nonresidential

uses only.

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[FR Doc. 99-3992 Filed 2-17-99; 8:45 am]

BILLING CODE 6560-50-P