Protection of Stratospheric Ozone: Listing Hexafluoropropylene (HFP) and HFP-Containing Blends as Unacceptable Refrigerants Under EPA's Significant New Alternatives Policy (SNAP) Program

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-6224-7]

RIN 2060-AG12

Protection of Stratospheric Ozone: Listing Hexafluoropropylene

(HFP) and HFP-Containing Blends as Unacceptable Refrigerants Under

EPA's Significant New Alternatives Policy (SNAP) Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule.

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SUMMARY: With this action, EPA's Significant New Alternatives Policy

(SNAP) program lists as unacceptable for all refrigeration and air-

conditioning end-uses hexafluoropropylene (HFP) and any blend

containing HFP. Today's action responds to EPA's recent discovery of

toxicity data concerning HFP, which present significant concerns about

risks to human health that may arise as a result of exposure to HFP,

either as a single chemical or in a blend, in the refrigeration and

air-conditioning sector. Therefore, EPA is listing HFP and all HFP-

containing blends as unacceptable substitutes for CFC-12 and HCFC-22 in

this sector.

DATES: Effective Date: This action is effective January 26, 1999.

Comments: EPA will consider all written comments received by February

25, 1999 to determine if any change to this action is necessary.

ADDRESSES: Information relevant to this notice is contained in Air

Docket A-91-42, Central Docket Section, South Conference Room 4, U.S.

Environmental Protection Agency, 401 M Street, S.W., Washington, D.C.

20460, telephone: (202) 260-7548. The docket may be inspected between

8:00 a.m. and 5:30 p.m. weekdays. As provided in 40 CFR Part 2, a

reasonable fee may be charged for photocopying. Those wishing to notify

EPA of their intent to submit adverse comments on this action should

contact Kelly Davis, U.S. EPA, Stratospheric Protection Division,

Office of Atmospheric Programs, Office of Air and Radiation (6205-J),

401 M Street, S.W., Washington, DC 20460, (Docket # A-91-42), (202)-

564-2303.

FOR FURTHER INFORMATION CONTACT: Kelly Davis, U.S. EPA, Stratospheric

Protection Division, Office of Atmospheric Programs, Office of Air and

Radiation (6205-J), 401 M Street, S.W., Washington, DC, 20460, (202)-

564-2303 or electronically at [email protected]. General information

about EPA's SNAP program can be found by calling EPA's Stratospheric

Ozone Protection Hotline at (800) 296-1996 or by viewing EPA's SNAP

Program world wide web site at www.epa.gov/ozone/title6/snap/snap.html.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Section 612 Program

A. Statutory Requirements

B. Regulatory History Background

C. Listing of Substitutes

D. Necessity for Interim Final Rule

II. Listing of HFP and HFP-Containing Blends as Unacceptable

III. Summary of Supporting Analyses

A. Unfunded Mandates Reform Act and Regulatory Flexibility Act

B. Executive Order 12866: Review of Significant Regulatory

Actions by OMB

C. Paperwork Reduction Act

D. Executive Order 12875: Enhancing Intergovernmental

Partnerships

E. Submission to Congress and the General Accounting Office

F. Executive Order 13045: Children's Health Protection

G. 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

refers 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.

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

person to petition EPA to add a substance to or delete a substance 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 Background

On March 18, 1994, EPA published the Final SNAP Rule (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 compose the principal

industrial sectors that historically consumed the largest 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.

C. 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.

Under section 612, the Agency has considerable discretion in the

risk management decisions it can make under the SNAP program. The

Agency has identified five possible decision categories: acceptable,

acceptable subject to use conditions; acceptable subject to narrowed

use limits; unacceptable; and pending. Acceptable substitutes can be

used for all applications within the relevant sector end-use.

Conversely, it is illegal to replace an ozone-depleting substitute with

a substitute listed by SNAP as unacceptable for that end-use. 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. Such

substitutes are described as ``acceptable subject to use conditions.''

Use of such substitutes without meeting associated use conditions

renders these substitutes unacceptable and subjects the user to

enforcement for violation of section 612 of the Clean Air Act.

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 with 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.

As described in the Final SNAP Rule, EPA does not believe that

rulemaking procedures are required to list alternatives that are

determined to be acceptable with no limitations. Such listings do not

impose any sanction, nor do they remove any prior license to use a

substitute. Consequently, EPA periodically adds substitutes to the list

of acceptable alternatives without first requesting comment on new

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

separate Notices in the Federal Register.

Also as described in the Final SNAP Rule, EPA believes that 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. In this interim final rule, however, EPA is listing HFP

and HFP-containing blends as unacceptable in all refrigeration and air-

conditioning end-uses, without prior notice and comment. The reasons

for the Agency's decision to do so in an interim final rule rather than

in a notice-and-comment rulemaking are discussed in section D below.

D. Necessity for Interim Final Rule

Section 307(d)(3) of the Clean Air Act (CAA or the Act) states that

in the case of any rule to which section 307(d) applies, notice of

proposed rulemaking must be published in the Federal Register. The

promulgation or revision of regulations under Title VI of the CAA

(relating to stratospheric ozone protection) is generally subject to

section 307(d). However, section 307(d) does not apply to any rule

referred to in subparagraph (A) or (B) of section 553(b) of the

Administrative Procedure Act (APA), 5 U.S.C. 551 et seq.

APA section 553(b) requires that any rule to which it applies be

issued only after the public has received notice of, and an opportunity

to comment on, the rule. However, APA section 553(b)(B) exempts from

those requirements any rule for which the issuing agency for good cause

finds that providing prior notice-and-comment would be impracticable,

unnecessary or contrary to the public interest. Thus, any rule for

which EPA makes such a finding is exempt from the notice-and-comment

requirements of both APA section 553(b) and CAA section 307(d).

EPA believes that the circumstances presented here provide good

cause to

[[Page 3867]]

take the actions set forth in this final rule without prior notice and

comment, since providing prior notice and comment would be

impracticable and contrary to the public interest. Specifically, EPA is

concerned about health risks to workers associated with the use of HFP

in replacement refrigerant formulations, in light of recently reviewed

toxicity data concerning HFP. The data indicate that typical worker

exposure levels for HFP are above minimal levels of concern for

noncancer risks. Exposures to HFP have been shown to lead to kidney

damage. As a result, when HFP is used as a refrigerant or as a

component in a refrigerant blend, there is a significant chance that

persons who manufacture, service or dispose of refrigeration and air-

conditioning equipment that contains HFP or an HFP blend may be exposed

to levels that put them at risk of kidney damage, particularly if they

have not been specifically trained in the handling of HFP or of blends

containing HFP. Moreover, since HFP has not historically been used in

refrigeration equipment, refrigerant technicians generally are not

trained to handle HFP or HFP blends. Thus, any persons servicing or

disposing of refrigeration and air-conditioning units that use an HFP-

containing blend would be subject to an actual and immediate health

risk. The Agency believes that there is a real threat of exposure.

Several parties have made submissions of HFP-containing

refrigerants under the SNAP program and the 90-day prohibition on

marketing has expired. Thus, EPA is concerned that refrigerant blends

that contain HFP may currently be commercially available and in actual

use around the nation. As a consequence, the Agency believes that good

cause exists to take the actions set forth in this final rule without

prior notice and comment in order to mitigate the risk of exposure to

this toxic substance.

As stated in section 612 of the Act, one of the Agency's objectives

in implementing the SNAP program is to promulgate rules making it

unlawful to replace any class I or class II substance with any

substitute that EPA determines may present adverse effects to human

health or the environment. The Agency believes that HFP and HFP-

containing blends present an unacceptable risk to human health, and

that immediate action by EPA is necessary in order to mitigate any

resulting harm. The use of HFP in the refrigeration and air-

conditioning sector will come to a halt most quickly through the

publication of this interim final rule. In addition, this action,

combined with Agency outreach and communication efforts, should provide

any current or potential users of HFP or HFP-containing blends with

immediate notice that EPA does not consider HFP to be an appropriate

compound to use in the refrigeration and air-conditioning sector and

that potential health risks are associated with exposure to HFP during

the manufacture and servicing of any refrigeration and air-conditioning

equipment that contains HFP. A full notice-and-comment rulemaking would

defeat the regulatory objective of the SNAP program to fully ensure

protection of human health.

Nonetheless, EPA is providing 30 days for submission of public

comments following today's action. EPA will consider all written

comments submitted in the allotted time period to determine if any

change to this action is necessary.

Section 553(d) of the APA generally provides that rules may not

take effect earlier than 30 days after they are published in the

Federal Register. However, if an Agency identifies a good cause, APA

section 553(d)(3) allows a rule to take effect earlier, provided that

the Agency publishes its reasoning in the final rule. Since EPA has

determined that good cause exists to list HFP and HFP-containing blends

as unacceptable as a replacement refrigerant, EPA is making this action

immediately effective in order to ensure the fullest protection of

human health.

II. Listing of HFP and HFP-Containing Blends as Unacceptable

As noted above, in light of information recently reviewed by EPA

concerning the toxicity of HFP, EPA is greatly concerned about the use

of HFP in replacement refrigerant formulations. EPA has completed an

HFP risk screen, a copy of which is available in the docket, which

indicates that its use as a refrigerant or in refrigerant blends will

pose an unacceptable risk to anyone exposed to HFP during the

manufacture or servicing of refrigeration or air-conditioning equipment

that contains HFP or an HFP-containing blend. Because of the extremely

low occupational exposure limit for HFP, and the fact that worker

exposure levels for HFP were predicted to be above levels of concern

for noncancer risks, HFP should not be used in the refrigeration and

air conditioning sector. It should be noted that today's determination

has no bearing on the use of HFP or any blend that contains HFP, other

than as a replacement for a class I or class II substance in the

refrigeration and air-conditioning sector. Other industrial sectors may

have safeguards in place to protect against worker exposure to HFP.

Based on the review of the available toxicity information related to

HFP, and the results of the EPA risk screen, EPA is today listing HFP

and all HFP-containing blends as unacceptable for all refrigeration and

air-conditioning end-uses, whether as substitutes for a class I

substance such as CFC-12, or as substitutes for a class II substance

such as HCFC-22.

III. Summary of Supporting Analyses

A. Unfunded Mandates Reform Act and Regulatory Flexibility Act

Since this action is not subject to notice-and-comment rulemaking

requirements under the APA or any other law, it is also not subject to

sections 202, 204 or 205 of the Unfunded Mandates Reform Act (UMRA). In

addition, since this action does not impose annual costs of $100

million or more on small governments or uniquely affect small

governments, the Agency has no obligations under section 203 of UMRA.

Moreover, since this action is not subject to notice-and-comment

requirements under the APA or any other statute as stated above, it is

not subject to section 603 or 604 of the Regulatory Flexibility Act.

B. Executive Order 12866: Review of Significant Regulatory Actions by

OMB

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

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

and therefore subject to Office of Management and Budget (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 entitlements, 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.

OMB has determined that this rule is not a ``significant regulatory

action'' within the meaning of the Executive Order.

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C. Paperwork Reduction Act

EPA has determined that this final rule contains no information

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 two Information Collection

Requests by EPA which are described in the March 18, 1994 rulemaking

(59 FR 13044, at 13121, 13146-13147) and in the October 16, 1996

rulemaking (61 FR 54030, at 54038-54039). The OMB Control Numbers are

2060-0226 and 2060-0350.

D. 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 upon any 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.

E. Submission to Congress and the General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business

Regulatory Enforcement Fairness Act of 1996, EPA submitted a report

containing this rule and other required information to the U.S. Senate,

the U.S. House of Representatives, and the Comptroller General of the

General Accounting Office prior to publication of the rule in today's

Federal Register. This rule is not a ``major rule'' as defined by 5

U.S.C. 804(2).

F. Executive Order 13045: Children's Health Protection

This final 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.

G. 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 officials 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. The rule does not impose any

enforceable duties on these entities. Accordingly, the requirements of

section 3(b) of Executive Order 13084 do not apply to this rule.

H. National Technology Transfer and Advancement Act

The National Technology Transfer and Advancement Act of 1995

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

departments to use the 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.

This proposed rule does not mandate the use of any technical

standards; accordingly, the NTTAA does 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., Eastern Time.

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

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

SNAP final rule published in the Federal Register on March 18, 1994 (59

FR 13044). Notices and rules published under the SNAP program, as well

as EPA publications on protection of atmospheric ozone, are available

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

title6/snap, and from the Stratospheric Protection Hotline number

listed above.

List of Subjects in 40 CFR Part 82

Environmental protection, Administrative practice and procedure,

Air pollution control, Reporting and recordkeeping requirements.

Dated: January 19, 1999.

Carol M. Browner,

Administrator.

40 CFR Part 82 is 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 Appendix F to read as follows:

Subpart G--Significant New Alternatives Policy Program

* * * * *

Appendix F to Subpart G--Unacceptable Substitutes Listed in the

Janaury 26, 1999 Final Rule, Effective Janaury 26, 1999

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Refrigeration and Air-Conditioning Sector UnacceptabLe Substitutes

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End-use Substitute Decision Comments

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All refrigeration and air- Hexafluoropropylene Unacceptable........ Presents unacceptable toxicity

conditioning end uses. (HFP) and all HFP- risk.

containing blends.

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[FR Doc. 99-1765 Filed 1-25-99; 8:45 am]

BILLING CODE 6560-50-P