Protection of Stratospheric Ozone: Reconsideration of the 610 Nonessential Products Ban

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-6358-4]

RIN 2060-AH99

Protection of Stratospheric Ozone: Reconsideration of the 610

Nonessential Products Ban

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This proposed rulemaking proposes changes to the current

regulations that implement the statutory ban on nonessential products

that release class I ozone-depleting substances under section 610 of

the Clean Air Act, as amended. This proposed rulemaking was developed

by EPA based on new and compelling information that has been gathered

and indicates that some sectors continue to use class I substances in

products where the use of those substances today should be considered a

``nonessential use of class I substances in a product.'' The products

affected by this rulemaking are aerosol products, pressurized

dispensers, plastic foam products, and air-conditioning and

refrigeration products that contain or are manufactured with

chlorofluorocarbons.

DATES: Comments must be received by August 13, 1999 unless a public

hearing is held. A public hearing, if requested, will be held in

Washington, D.C. If such a hearing is requested, it will be held on

June 29, 1999. Anyone who wishes to request a hearing should call Cindy

Newberg at 202/564-9729 by 5 pm Eastern Time June 21, 1999. Ater that

time, interested parties may contact the Stratospheric Protection

hotline regarding if a hearing will be held as well as the time and

place of such a hearing. If a public hearing is held, the comment

period will be extended until August 30, 1999.

ADDRESSES: Comments on this action should be addressed to Public Docket

No, A-98-31 at the address below. Comments and materials supporting

this rulemaking are contained in Public Docket No. A-98-31 Waterside

Mall (Ground Floor) Environmental Protection Agency, 401 M Street, SW.,

Washington, D.C. 20460 in room M-1500. Dockets may be inspected from

8:00 a.m. until 5:30 p.m., Monday through Friday. A reasonable fee may

be charged for copying docket materials.

FOR FURTHER INFORMATION CONTACT: Cindy Newberg, Program Implementation

Branch, Stratospheric

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

Radiation (6205-J), 401 M Street, SW., Washington, D.C. 20460,

(202)564-9729. The Stratospheric Ozone Information Hotline at 1-800-

296-1996 can also be contacted for further information. Interested

persons may contact the Stratospheric Protection Hotline to learn if a

hearing will be held and to obtain the date and location of any

hearing. Any hearing will be strictly limited to the subject matter of

this proposal.

SUPPLEMENTARY INFORMATION: The contents of this preamble are listed in

the following outline:

I. Regulated Entities

II. Background

A. Class I Ban

1. Reconsideration

2. Determinations Under 610

3. The Purpose or Intended Use of the Product

4. The Technological Availability of Substitutes

5. Safety and Health

6. Medical Devices

7. Other Products

8. Reconsidering Nonessential Determinations

B. Class II Ban

1. Reconsideration

2. Determinations Under Section 610(d)

3. Future Notice of Proposed Rulemaking

III. Today's Action

A. Foam Products

B. Aerosol Products and Pressurized Dispensers

C. Air-conditioning and Refrigeration Appliances

IV. Proposed Effective Dates and Grandfathering

V. Summary of Supporting Analysis

A. Executive Order 12866

B. Regulatory Flexibility

C. Unfunded Mandates Act

D. Paperwork Reduction Act

E. Executive Order 12875: Enhancing the Intergovernmental

Partnership

F. National Technology Transfer and Advancement Act

G. Applicability of Executive Order 13045

H. Executive Order 13084: Consultation and Coordination With

Indian Tribal Governments

I. Regulated Entities

Entities potentially regulated by this action are those that wish

to sell

and/or distribute in interstate commerce aerosols, pressurized

dispensers, plastic foam products, refrigerators and air-conditioning

equipment that contain chlorofluorocarbons (CFCs). Regulated categories

and entities include:

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Example of regulated

Category entities

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Industry.................................. Aerosol packagers.

Aerosol manufacturers.

Air-conditioning and

refrigeration equipment

manufacturers.

Specialty chemical

manufacturers.

Foam manufacturers.

Air conditioning and

refrigeration distributors.

Air conditioning and

refrigeration retailers.

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This table is not intended to be exhaustive, but rather provides a

guide for readers regarding entities likely to be regulated by this

action. This table lists the types of entities that EPA is now aware

could potentially be affected by this action. Other types of entities

not listed in the table could also be affected. To determine whether

your company is regulated by this action, you should carefully examine

the applicability criteria contained in Section 610 of the Clean Air

Amendments of 1990, discussed in regulations codified at 40 CFR Part

82, subpart C and published on January 15, 1993 (58 FR 4768); December

30, 1993 (58 FR 69672) and discussed below. If you have questions

regarding the applicability of this action to a particular entity,

consult the person listed in the preceding FOR FURTHER INFORMATION

CONTACT section.

II. Background

Title VI of the Act divides ozone-depleting chemicals into two

distinct classes. Class I is comprised of chlorofluorocarbons (CFCs),

halons, carbon tetrachloride and methyl chloroform, methyl bromide and

hydrobromofluorocarbons. Class II is comprised of

hydrochlorofluorocarbons (HCFCs). (See listing notice January 22, 1991;

56 FR 2420.) Section 610(b) of the Act, as amended, requires EPA to

promulgate regulations banning nonessential products releasing class I

substances. EPA published a final rule for the Class I Nonessential

Products Ban on January 15, 1993 (58 FR 4768). A final rule

establishing regulations that implemented the statutory ban on

nonessential products containing or manufactured with class II ozone-

depleting substances under section 610(d) of the Clean Air Act, as

amended, was issued December 30, 1993 (58 FR 69637). That final rule

was developed to clarify definitions and provide exemptions, as

authorized under section 610(d). All of the regulations are codified at

40 CFR Part 82 subpart C. Comments and materials supporting those

rulemakings are contained in Public Dockets A-91-39 and in A-93-20.

A. Class I Ban

Section 610(b) of the Act directs EPA to identify nonessential

products that ``release Class I substances into the environment

(including any release during manufacture, use, storage, or disposal)''

and to ``prohibit any person from selling or distributing any such

product, or offering any such product for sale or distribution, in

interstate commerce.''

Section 610(b)(1) and (2) specify products to be prohibited under

this requirement, including ``chlorofluorocarbon-propelled plastic

party streamers and noise horns'' and ``chlorofluorocarbon-containing

cleaning fluids for noncommercial electronic and photographic

equipment.''

Section 610(b)(3) extends the prohibition to other products

determined by EPA to release class I substances and to be nonessential.

In determining whether a product is nonessential, EPA is to consider

the following criteria: ``the purpose or intended use of the product,

the technological availability of substitutes for such product and for

such Class I substance, safety, health, and other relevant factors.''

The regulatory Class I Ban currently identifies as nonessential,

and therefore subject to the prohibitions:

(A) plastic party streamers and noise horns propelled by

chlorofluorocarbons;

(B) cleaning fluids for electronic and photographic equipment which

contain a chlorofluorocarbon, including but not limited to liquid

packaging, solvent wipes, solvent sprays, and gas sprays, except for

those sold or distributed to a commercial purchaser;

(C) plastic flexible or packaging foam product which is

manufactured with or contains a chlorofluorocarbon, including but not

limited to,

Open cell polyurethane flexible slabstock foam,

Open cell polyurethane flexible molded foam,

Open cell rigid polyurethane poured foam,

Closed cell extruded polystyrene sheet foam,

Closed cell polyethylene foam, and

Closed cell polypropylene foam, except flexible or

packaging foam used in coaxial cable; and

(D) any aerosol product or other pressurized dispenser which

contains a chlorofluorocarbon, except:

Medical devices listed in 21 CFR 2.125(e),

Lubricants for pharmaceutical and tablet manufacture,

Gauze bandage adhesives and adhesive removers,

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Topical anesthetic and vapocoolant products,

Lubricants, coatings or cleaning fluids for electrical or

electronic equipment, which contain CFC-11, CFC-12, or CFC-113 for

solvent purposes, but which contain no other CFCs,

Lubricants, coatings or cleaning fluids used for aircraft

maintenance, which contain CFC-11 or CFC-113, but which contain no

other CFCs,

Mold release agents used in the production of plastic and

elastomeric materials, which contain CFC-11 or CFC-113, but which

contain no other CFCs,

Spinnerette lubricant/cleaning sprays used in the

production of synthetic fibers, which contain CFC-114, but which

contain no other CFCs,

Containers of CFCs used as halogen ion sources in plasma

etching,

Document preservation sprays which contain CFC-113, but

which contain no other CFCs, and

Red pepper bear repellent sprays which contain CFC-113,

but which contain no other CFCs.

Verification and public notice requirements have been established

for distributors of certain products intended exclusively for

commercial use.

The preamble to the 1993 rulemaking established that EPA should in

the future reconsider exceptions granted and limitations of the ban

under that rulemaking based on new and compelling information regarding

the availability of substitutes for class I substances. In 1993 EPA

limited consideration of banned products to aerosols, pressurized

dispensers, and foams. These sectors traditionally used ozone-depleting

substances and were subject to the Class I Ban. Since that rulemaking

was issued, the phaseout of production and consumption of class I

substances has become effective and the Significant New Alternatives

Policy (SNAP) program established under Section 612 of the Act has been

promulgated. The phaseout of newly manufactured class I substances and

the identification of acceptable substitutes provide compelling reasons

to reconsider the initial decisions regarding both product-specific

exemptions and the decision to limit the ban's effect to major sectors

that traditionally used ozone-depleting substances. Therefore, it is

appropriate now to reconsider the applicability of the Class I Ban to

both specific products and product categories.

1. Reconsideration

The regulations implementing the Class I Ban provide for EPA to

reconsider decisions that were made regarding specific products and

product categories. EPA indicated in 1993 that the Agency would

reconsider decisions in the future based on developments of product

substitutes not containing class I substances. EPA has previously

reconsidered specific decisions. In December 1993 (58 FR 69672), EPA

reconsidered the application of the Class I Ban to replacement parts

that were previously manufactured and stored for future use, such as

car seats designed and manufactured for a particular model vehicle.

Based on development of new substitutes and the characterization of

the criteria for nonessentiality discussed below, particularly as

applied to the use of class I substances in products that are

themselves not nonessential, EPA believes that it is now appropriate

for EPA to reconsider previous determinations. Specifically, it is

appropriate to reconsider the determinations for the air-conditioning

and refrigeration, solvents, and foam-blowing sectors.

2. Determinations Under 610

As stated above, Section 610(b)(3) extends the prohibition to other

products determined by EPA to release class I substances and to be

nonessential. In determining whether a product is nonessential, EPA is

to consider the following criteria: ``the purpose or intended use of

the product, the technological availability of substitutes for such

product and for such class I substance, safety, health, and other

relevant factors.'' The statute requires EPA to consider each criterion

but did not outline either a ranking or a methodology for comparing

their relative importance, nor does it require that any minimum

standard within each criterion be met. To develop the initial

rulemaking, EPA considered all of these criteria in determining whether

a product was nonessential. In addition, EPA reviewed the criteria used

in the development of its 1978 ban on aerosol propellant uses of CFCs

under the Toxic Substances Control Act (TSCA). Today's action follows

the same methodology of that rulemaking.

3. The Purpose or Intended Use of the Product

This criterion relates to the importance of the product,

specifically whether the product is sufficiently important that the

benefits of its continued production outweigh the associated danger

from the continued use of a class I ozone-depleting substance in it, or

alternatively, whether the product is so unimportant that even a lack

of available substitutes might not prevent the product from being

considered nonessential. The initial class I final rulemaking includes

a discussion about the contributions of a product to the quality of

life.

The distinction between a ``nonessential product'' and a

``nonessential use of class I substances in a product'' is a relevant

criterion. For example, while foam cushioning products for beds and

furniture are not ``frivolous,'' the use of a class I substance in the

manufacturing process for foam cushioning where substitutes are readily

available is considered nonessential. The ability of manufacturers to

switch from using a class I substance is a relevant indicator for this

criterion. The class I final rule states that ``the Agency believes

that in sectors where the great majority of manufacturers had already

shifted to substitutes, the use of a class I substance in that product

may very well be nonessential.'' Consequently, EPA believes it is

appropriate under this criteria to examine sectors where most of the

market has previously switched out of CFCs.

4. The Technological Availability of Substitutes

EPA has previously interpreted this criterion to mean the existence

and accessibility of alternative products or alternative chemicals for

use in, or in place of, products releasing class I substances. EPA

believes that the phrase ``technological availability'' includes both

currently available substitutes (i.e., presently produced and sold in

commercial quantities) and potentially available substitutes (i.e.,

determined to be technologically feasible, environmentally acceptable

and economically viable, but not yet produced and sold in commercial

quantities). However, EPA considered the current availability of

substitutes more compelling than the potential availability of

substitutes in determining whether a product was nonessential.

The corresponding criterion from the 1978 aerosol ban is the

``nonavailability of alternative products.'' In its supporting

documentation, EPA stated that this was the primary criterion for

determining if a product had an ``essential use'' under the 1978 rule.

EPA emphasized, however, that the absence of an available alternative

did not alone disqualify a product from being banned as nonessential.

The availability of substitutes is clearly a critical criterion for

determining if a product containing a class I substance is

nonessential. In certain cases, a substitute that is

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technologically feasible, environmentally acceptable and economically

viable, but not yet produced and sold in commercial quantities, may

meet this criterion with respect to certain products. However, EPA

believes that, where substitutes are readily available, the use of

controlled substances could be considered nonessential even in a

product that is extremely important. It should be noted, however, that

EPA does not necessarily advocate all substitutes that are currently

being used in place of CFCs in the products EPA identifies as

nonessential. In many cases potential substitutes are subject to other

regulatory programs. For example, the SNAP program promulgated under

CAA 612 carefully considers the relative risks and merits of different

substitutes for ozone-depleting substances. Substitutes are listed

under that regulatory program as acceptable, unacceptable, or

acceptable subject to use restrictions for specific uses. Within the

limited purposes of the nonessential products bans, EPA considers the

existence and accessibility of alternative products or alternative

chemicals for use in, or in place of, products releasing class I

substances. Any future use of such substitutes must comport with any

conditions of the SNAP program, if applicable.

5. Safety and Health

EPA interprets these two criteria to mean the effects on human

health and the environment of the products releasing class I substances

or their substitutes. In evaluating these criteria, EPA considered the

direct and indirect effects of product use, and the direct and indirect

effects of alternatives, such as ozone depletion potential,

flammability, toxicity, corrosiveness, energy efficiency, ground level

air hazards, and other environmental factors.

If any safety or health issues prevented a substitute from being

used in a given product, EPA then considered that substitute to be

``unavailable'' at the time for that specific product or use. EPA noted

in the initial rulemaking that as new information becomes available on

the health and safety effects of possible substitutes, EPA could

reevaluate determinations made regarding the nonessentiality of

products.

6. Medical Devices

Section 610(e) states that ``nothing in this section shall apply to

any medical devices as defined in section 601(8).'' Section 601(8)

defines ``medical device'' as ``any device (as defined in the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, drug

(as defined in the Federal Food, Drug, and Cosmetic Act), and drug

delivery system--(A) if such device, product, drug, or drug delivery

system utilizes a Class I or Class II substance for which no safe and

effective alternative has been developed and, where necessary, approved

by the Commissioner of the Food and Drug Administration (FDA); and (B)

if such device, product, drug, or drug delivery system, has, after

notice and opportunity for public comment, been approved and determined

to be essential by the Commissioner in consultation with the

Administrator.''

The FDA currently is reviewing its determinations under 21 CFR

2.125(e). At this time, the FDA lists 12 medical devices for human use

as essential uses of CFCs in 21 CFR 2.125(e). These devices consist of

certain metered dose inhalers (MDIs), contraceptive vaginal foams,

intra-rectal hydrocortisone acetate, polymyxin B sulfate-bacitracin-

zinc-neomycin sulfate soluble antibiotic powder without excipient for

topical use, and anesthetic drugs for topical use on accessible mucous

membranes where a cannula is used for application. For additional

information regarding FDA determinations and plans for potential

regulatory changes, see 62 FR 10242 (March 6, 1997).

Medical products as determined by FDA and listed as essential at 21

CFR 2.125(e) are exempt from the Class I Ban at 40 CFR part 82, subpart

C. This notice does not propose any changes to this current exemption.

However, other medical related products not contained in the FDA's list

of essential uses (21 CFR 2.125(e)), and therefore not subject to

610(e), that were considered in the initial Class I Ban rulemaking, and

given exemptions, under 610(b) are reconsidered in this action. Those

products are gauze bandage adhesives and adhesive removers, lubricants

for pharmaceutical and tablet manufacture, and topical anesthetic and

vapocoolant products.

7. Other Products

In drafting the initial rulemaking to prohibit certain products

under section 610(b)(3), the Agency considered every major use sector

that used class I substances including: refrigeration and air-

conditioning, solvent use, fire extinguishing, foam blowing, and

aerosol use. Based on that review, EPA identified three broadly defined

product categories for further evaluation: aerosol products and

pressurized dispensers containing CFCs or halons, plastic flexible and

packaging foams, and halon fire extinguishers for residential use.

EPA believed that in each of these sectors two important conditions

existed: substitutes were already available for the product or the

class I substance used or contained in that product; and, either the

affected industry had, for the most part, moved out of the use of class

I substances or the market share of products using or containing class

I substances was small and shrinking. In addition, in the case of

aerosols and plastic flexible and packaging foams, section 610(d)

imposed a self-effectuating ban on the sale or distribution of such

products containing or produced with class II substances after January

1, 1994.

The 1993 rulemaking specifically discussed the other sectors and

provided information regarding the Agency's determinations.

Refrigeration and air-conditioning, including mobile air-conditioning,

represented the largest total use of class I substances in the United

States in 1993. At the time the initial rulemaking was promulgated,

substitutes were available for some refrigeration and air-conditioning

products. For example, the automotive manufacturers were in the process

of switching to HFC-134a for new models rather than CFC-12 in their

air-conditioning systems. However, potential substitutes for other

refrigeration and air-conditioning uses were still being evaluated.

EPA did not include prohibitions on the use of class I substances

in refrigeration or air-conditioning in the 1993 rulemaking because

determinations regarding substitutes for all such uses were not

anticipated to be available within the time-frame of that rulemaking.

Accordingly, EPA could not conclude that the use of class I

refrigerants in any refrigeration or air-conditioning uses were

nonessential at the time of that rulemaking. Furthermore, at that time,

EPA had not yet issued final regulations that specifically addressed

non-automotive refrigeration and air-conditioning uses of class I

substances (subsequently promulgated under CAA Section 608 and codified

at 40 CFR part 82, subpart F). These regulations addressed standards

for the recovery and reuse of refrigerants.

Solvent uses of class I substances, including commercial

electronics de-fluxing, precision cleaning, metal cleaning and dry

cleaning also represented a significant use in 1993. Industry had

already identified potentially available substitutes for nearly all of

the thousands of products then manufactured with class I solvents,

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and many companies had already phased out the use of CFCs in certain

products. EPA did not address solvent use in that rulemaking (accept

where the solvent application was within an aerosol or pressurized

dispenser) because the sheer number of products and the range of

potential substitutes made it impossible for EPA to conclude

definitively that substitutes were available for any of these specific

uses, and thus that such uses were nonessential, within the short

statutory time-frame for the Class I Ban rulemaking. However, EPA

believed a ban on such uses would be unnecessary as most manufacturers

were phasing out use as particular substitutes became available, in

anticipation of the impending production phaseout.

EPA considered the use of class I substances in fire extinguishing

applications in its initial review as well. Halons were widely used in

fire extinguishing systems. These fire extinguishing systems include

both total flooding systems (such as stationary fire suppression

systems in large computer facilities) and streaming systems (such as

hand-held fire extinguishers). In evaluating possible nonessential uses

of halons in fire fighting, the Agency divided the fire protection

sector into six broad end uses: (1) Residential/Consumer Streaming

Agents, (2) Commercial/Industrial Streaming Agents, (3) Military

Streaming Agents, (4) Total Flooding Agents for Occupied Areas, (5)

Total Flooding Agents for Unoccupied Areas, and (6) Explosion Inertion.

Substitutes for halons, whether other halocarbons or alternatives such

as water, should meet four general criteria to provide a basis for

determining that the use of halon in residential fire extinguishers is

nonessential. They must be effective fire protection agents, they must

have an acceptable environmental impact, they must have a low toxicity,

and they must be relatively clean or volatile. In addition, they must

be commercially available as a halon replacement in the near future.

EPA concluded that while satisfactory substitutes were not yet

available in most commercial and military applications within the short

statutory time-frame of the rulemaking, certain substitutes were

already commercially available for hand-held halon fire extinguishers

in residential settings. Consequently, the Agency decided to evaluate

this application more closely in order to determine whether residential

fire extinguishers containing halon should be designated nonessential

products, or whether the continued use of halons, despite the

imposition of the excise tax and the impending production phaseout,

indicated that this application did not meet the criteria for

nonessentiality. Ultimately, after reviewing the issue and soliciting

comment, the final rulemaking did establish a ban on the use of halon

in residential streaming applications. Furthermore, the use of CFCs in

fire extinguishing equipment was also restricted.

EPA considered aerosols and pressurized dispensers likely

candidates for designation as nonessential products in 1993 because a

great deal of information on substitutes for CFCs in these applications

already existed. Research on substitutes for CFCs in aerosol

applications began in the 1970s in response to the early studies on

stratospheric ozone depletion and the 1978 ban on the use of CFCs as

aerosol propellants. Consequently, extensive data already existed on

possible substitutes for most remaining aerosol uses.

The 1978 aerosol ban prohibited the manufacture of aerosol products

using CFCs as propellants. Other uses of CFCs in aerosols (such as

solvents, active ingredients, or sole ingredients) were not included in

the ban. In addition, certain ``essential uses'' of CFCs as aerosol

propellants were exempted from the ban because no adequate substitutes

were available at the time. Consequently, although the use of CFCs in

aerosols was reduced dramatically by the 1978 ban, the production of a

number of specific aerosol products containing CFCs were still legal

including: metered dose inhalant drugs; medical solvents such as

bandage adhesives and adhesive removers; skin chillers for medical

purposes; aerosol tire inflators; mold release agents; lubricants,

coatings, and cleaning fluids for industrial/institutional applications

to electronic or electrical equipment; special-use pesticides; aerosols

for the maintenance and operation of aircraft; diamond grit spray;

single-ingredient dusters and freeze sprays; noise horns; mercaptan

stench warning devices; pressurized drain openers; aerosol polyurethane

foam dispensers; and whipped topping stabilizers. In 1993, EPA

concluded that satisfactory substitutes were available for most uses of

CFCs in aerosols and pressurized dispensers. As a result, the Agency

banned all uses of CFCs in aerosols and pressurized dispensers except

for certain products, such as medical devices, that it specifically

exempted. EPA further concluded that the implementation of the

production phaseout of CFCs on January 1, 1996, would serve to

eliminate the continued use of CFCs in all but the most essential

applications, such as the permitted production for metered dose

inhalant drugs.

8. Reconsidering Nonessential Determinations

New and compelling information has been gathered recently by EPA

that indicates that some sectors continue to use class I substances in

products where the use of the substance today should be considered a

``nonessential use of class I substances in a product.'' Since the

promulgation of the initial regulations under Section 610, the SNAP

program has been established and now provides information regarding

acceptable substitutes for various applications. While the SNAP program

does not consider the efficacy of the substitute substance as a

replacement for the ozone-depleting substances, for most applications

there are sources of information regarding the effectiveness of the

substitutes, such as laboratory testing and information provided by

major users and trade associations. For example, many substitutes have

been listed by SNAP as acceptable for various refrigeration

applications. Domestically, newly manufactured refrigerators for

residential use are employing these available substitutes. Therefore,

it is reasonable for the Agency at this time to reconsider applying the

610 Class I ban to include refrigeration applications by determining if

the use of a class I substance in refrigeration applications now meets

the definition of nonessentiality, as described in this notice.

Today's action proposes to amend the class I ban to meet the

Agency's obligations to eliminate the nonessential uses of class I

substances. Specifically, EPA has determined that it is appropriate to

reconsider the determinations for the air-conditioning and

refrigeration, foam-blowing, aerosols, and pressurized dispensers

product categories. Today's action proposes amending the class I ban to

include additional nonessential uses of CFCs for these end-use

applications.

B. Class II Ban

On December 30, 1993, EPA published a final rulemaking (58 FR

69637) addressing issues related to the statutory prohibition against

the sale or distribution, or offer for sale or distribution in

interstate commerce of nonessential products containing or manufactured

with a class II substance, imposed by Section 610(d) of the Act.

Section 610(d)(1) states that after January 1, 1994, ``it shall be

unlawful for any person to sell or distribute, or

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offer for sale or distribution, in interstate commerce--(A) any aerosol

product or other pressurized dispenser which contains a class II

substance; or (B) any plastic foam product which contains, or is

manufactured with, a class II substance.'' Section 610(d)(2) authorizes

EPA to grant certain exceptions and Section 610(d)(3) creates

exclusions from the Class II Ban in certain circumstances.

Section 610(d)(2) authorizes the Administrator to grant exceptions

from the Class II Ban for aerosols and other pressurized dispensers

where ``the use of the aerosol product or pressurized dispenser is

determined by the Administrator to be essential as a result of

flammability or worker safety concerns,'' and where ``the only

available alternative to use of a class II substance is use of a class

I substance which legally could be substituted for such class II

substance.''

Section 610(d)(3) states that the ban of class II substances in

plastic foam products shall not apply to ``foam insulation products''

or ``an integral skin, rigid, or semi-rigid foam utilized to provide

for motor vehicle safety in accordance with Federal Motor Vehicle

Safety Standards where no adequate substitute substance (other than a

class I or class II substance) is practicable for effectively meeting

such standards.'' Unlike the Class I Ban, the Class II Ban was self-

executing. Section 610(d) bans the sale of the specified class II

products by its own terms, without any reference to required EPA

regulations. However, EPA did issue regulations implementing the Class

II Ban in order to better define the products banned under Section

610(d) and to grant authorized exceptions under Section 610(d)(2).

Section 301(a) of the Act gives EPA the authority to promulgate such

regulations as are necessary to carry out its functions under the Act,

and EPA determined that it was necessary to issue the Class II Ban

regulations for those purposes.

1. Reconsideration

Since the issuance of the final rule providing exemptions from the

statutory Class II Ban, EPA amended the final rule with regards to fire

suppression based on compelling information that the Agency received.

That amended regulation was issued in the Federal Register on December

4, 1996 (61 FR 64424) and subsequently codified at 40 CFR Part 82,

subpart C.

EPA has received information indicating that it may be appropriate

to reconsider the continued relevance of the current list of exemptions

for specific aerosol products and pressurized dispensers. The Agency is

aware that since the issuance of that initial final rulemaking, there

has been further substitution away from ozone-depleting substances for

a variety of aerosol products and pressurized dispensers.

2. Determinations Under Section 610(d)

The statutory criteria for providing an exemption from the Class II

Ban are explicit. For any potential exemption the use of the aerosol

product or pressurized dispenser must be found to be essential based on

flammability or worker safety concerns and EPA must find that the only

available alternative to use of a class II substance is use of a class

I substance which could legally be substituted for such class II

substance.

The initial final rulemaking regarding the Class II Ban provided

exemptions for:

Lubricants, coatings, or cleaning fluids for aircraft

maintenance containing HCFCs as solvents;

Lubricants, coatings, or cleaning fluids for electrical,

electronic or photographic equipment containing HCFCs as solvents;

Aircraft pesticides; Mold release agents

containing HCFCs as solvents;

Mold release agents containing HCFC-22 as a propellant,

for use where no alternative, including an alternative formulation, is

available and where the seller must notify purchaser about the

restriction;

Spinnerette lubricant/cleaning sprays containing HCFCs as

solvents and/or propellants;

Document preservation sprays containing HCFCs as solvents;

Document preservation sprays containing HCFCs as

propellants, for use on thick books, books with coated or dense paper,

and tightly bound documents, only;

Portable fire extinguishing equipment containing HCFCs as

fire extinguishants, for use in non-residential applications only; and

Wasp and hornet sprays, for use near high-tension power

lines only and where the seller must notify purchaser about

restrictions.

3. Future Notice of Proposed Rulemaking

EPA is currently reviewing information concerning the above aerosol

products and pressurized dispensers given exemptions in the December

1993 rulemaking. In particular, the Agency is evaluating whether there

are technologically available substitutes for the HCFCs used in these

products. Since the implementation of the Class II Ban on January 1,

1994, progress has been made to further identify substitutes for

various applications. In addition, as stated above, the SNAP program

has been established and provides lists of acceptable substitutes for

various applications, including applications affected by the Class II

Ban. When EPA completes its evaluation of the existing exemptions for

HCFCs in pressurized dispensers and aerosol products, the Agency plans

to issue a notice of proposed rulemaking and request comments, should

the Agency determine that any rule revisions are appropriate.

III. Today's Action

Today, EPA is proposing to revise the Class I Ban to include

additional products and to eliminate exemptions. EPA is proposing to

expand the scope of the Class I Ban to include additional categories of

products.

A. Foam Products

Today, EPA is proposing to ban the sale and distribution and offer

of sale or distribution in interstate commerce of all foam products

(both insulating and non-insulating) that release class I substances

into the environment (including any release during manufacture, use,

storage, or disposal). EPA believes there are acceptable substitutes

available for replacing any continued use of class I substances as

blowing agents for foam products. For example, the SNAP program lists

exemptions for various foam applications by providing lists that are

specific to the type of foam for which the particular substitute has

been listed as acceptable. These categories are rigid polyurethane used

in appliances and commercial applications, flexible polyurethane,

integral skin polyurethane, polyurethane extruded sheet foam,

polyolefin, rigid polyurethane slabstock, polystyrene, extruded

boardstock & billet, rigid polyurethane and polyisocyanurate laminated

boardstock, and phenolic insulation board and bunstock. The SNAP

program does not consider the efficacy of the substitute substance as a

replacement for the ozone-depleting substances in each application.

However, given the phaseout of production for the class I substances

previously used in these products, and the information gathered through

trade associations, newsletters, media articles, technical

publications, and United Nations Environmental Programme (UNEP)

Technical Options Committee reports, it appears that for all foam

products, there are currently sufficient

[[Page 31778]]

technically available substitutes for the use of a class I substance.

EPA requests comments on revising the Class I Ban to ban the sale and

distribution or offer of sale and distribution in interstate commerce

of any foam plastic product or plastic foam product that releases class

I substances into the environment (including any release during

manufacture, use, storage, or disposal). EPA will consider any specific

data indicating that substitutes are not available for certain foam

products.

B. Aerosol Products and Pressurized Dispensers

As stated above, EPA initially provided exemptions for a narrow

list of aerosol products and pressurized dispensers that release class

I substances into the environment. EPA today, is proposing to eliminate

exemptions for: gauze bandage adhesives & adhesive removers, topical

anesthetic and vapocoolant products, lubricants for pharmaceutical

tablet manufacture, containers of CFCs used as halogen ion sources in

plasma etching, and red pepper bear repellent sprays containing CFC-113

as a solvent. EPA believes that substitutes are available for such uses

of class I products and therefore that such use is no longer essential.

EPA is not proposing any changes to the exemption for medical devices

that are determined to be essential by the Food and Drug Administration

and are listed at 21 CFR 2.125(e). Products such as metered dose

inhalers (MDIs) are listed at 21 CFR 2.125(e). The Class I Ban will

continue to provide an exemption for the sale and distribution or offer

of sale or distribution in interstate commerce of MDIs that release

class I substances into the environment, as well as any other essential

medical device listed at 21 CFR 2.125(e).

Given the statutory links established between the Class I and Class

II Bans for aerosol products and pressurized dispensers, namely the

criterion in 610(d) that states that the alternative to the use of a

class II substance is the legal use of a class I substance, at this

time EPA is not proposing to eliminate exemptions for aerosol products

or pressurized dispensers from the Class I Ban that are also exempted

from the Class II Ban. However, if and when EPA subsequently issues a

proposed rulemaking reconsidering those exemptions from the Class II

Ban, that notice will also include the reconsideration for the

remaining aerosol products and pressurized dispensers under the Class I

Ban as well.

EPA requests comments on the proposed changes to the list of

exemptions for aerosol and pressurized dispensers that release class I

substances into the environment, and specifically any data indicating

that such uses are still essential.

C. Air-Conditioning and Refrigeration Appliances

The initial rulemaking implementing the Class I Ban specifically

considered refrigeration and air-conditioning. As noted above, at the

time the initial rulemaking was promulgated, substitutes were available

for some refrigeration and air-conditioning products; however,

potential substitutes for other refrigeration and air-conditioning

applications were still under development and evaluation. Thus EPA did

not include prohibitions on the use of class I substances in

refrigeration or air-conditioning in that rulemaking.

Currently there are substitutes identified for a variety of

refrigeration and air-conditioning applications. While substitutes

continue to be developed and evaluated for these applications, the

Agency is confident that there are sufficient technologically available

substitutes for the use of class I substances in all refrigeration and

air-conditioning applications as documented in the docket for this

rulemaking. The SNAP program also provides lists of acceptable

substitutes for various applications.

Since the production and importation of CFCs ceased January 1,

1996, EPA believes it is highly unlikely that there would be continued

domestically manufactured air-conditioning and refrigeration appliances

with CFCs. EPA has raised this question at industry stakeholder

meetings and other forums with representatives from the air-

conditioning and refrigeration manufacturing community, as well as with

the refrigerant suppliers for these manufacturers. EPA recognizes that

there may be a limited number of products manufactured abroad and

imported into the United States as well as some potential domestic

manufacturing of refrigeration and air-conditioning products containing

class I substances that EPA is not aware of; however, given the

criteria for nonessentiality discussed above, EPA believes that air-

conditioning and refrigeration appliances that contain CFCs meet the

criteria for nonessential uses of a class I substance. Therefore, it is

reasonable for the Agency to consider broadening the applicability of

the Class I Ban to include refrigeration applications. EPA is today

proposing to amend Sec. 82.66 to add a provision banning the sale and

distribution or offer for sale or distribution of air-conditioning and/

or refrigeration appliances that contain class I substances.

EPA heard from two manufacturers regarding potential economic

impacts of this proposal. A manufacturer has stated that well over 90%

of the compact refrigerators are sold by large retailers and very small

quantities are sold by small dealers. Another manufacturer reported

that several foreign manufacturers have exported compact refrigerators

containing CFCs and non-CFC containing compact refrigerators into the

U.S. during 1998. Since they are able to produce both types of

refrigerators, the use of CFCs should be considered a ``nonessential

use of class I substances in a product.'' One manufacturer believed

that the differential in manufacturing costs is between $2.00 and $3.00

per unit, which might translate into a $5.00 price differential if the

costs are passed on to the consumer. EPA requests comments regarding

the costs and sales of these refrigerators.

EPA would like to clarify that consistent with all other products

subject to the nonessential products bans, this proposed addition of

air-conditioning and refrigeration appliances covers the sale and

distribution of new products, not used products. Furthermore, this

proposal would not affect the servicing of existing products with class

I refrigerants.

EPA requests comments on expanding the Class I Ban to include air-

conditioning and refrigeration appliances. In particular, EPA requests

comments regarding whether there are sufficient technologically

available substitutes for the use of class I substances in all new air-

conditioning and refrigeration appliances.

IV. Proposed Effective Dates and Grandfathering

EPA is proposing that the effective date for the proposed changes

to this rulemaking 60 days from the date of publication of a final rule

in the Federal Register. Given the potential harm releases of class I

substances represent and given that most products affected by these

proposed changes to the ban no longer use class I substances, EPA

believes this is an appropriate effective date. The Agency also

considered the potential for a longer implementation date for these

proposed regulatory changes, such as 6 months from the date of

publication of the final rule in the Federal Register; however, as

stated

[[Page 31779]]

above, this additional time did not seem necessary and thus is not the

Agency's lead option. However, EPA requests comments and rationale

regarding both the proposed 60-day effective date and alternative

effective dates for the proposed changes discussed in this notice.

V. Summary of Supporting Analysis

A. Executive Order 12866

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

Agency must determine whether this proposed 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.

It has been determined by OMB and EPA that this action is not a

``significant regulatory action'' under the terms of Executive Order

12866 and is therefore not subject to OMB review under the Executive

Order.

B. Regulatory Flexibility

EPA has determined that it is not necessary to prepare a regulatory

flexibility analysis for this proposed rule. EPA believes that this

proposed rule will not have a significant economic impact on a

substantial number of small entities. EPA has received a letter from a

manufacturer citing market research from import reports by the

Department of Commerce. This manufacturer stated that well over 90% of

the compact refrigerators are sold by large retailers and very small

quantities are sold by small dealers. Another manufacturer reported

that several foreign manufacturers have exported compact refrigerators

containing CFCs and non-CFC containing compact refrigerators into the

U.S. during 1998. Since they are able to produce both types of

refrigerators, the use of CFCs should be considered a ``nonessential

use of class I substances in a product.'' Our assessment indicates that

replacing the CFC portion of the import market with more non-CFC

refrigerators is economically and technically feasible. One

manufacturer believes that the differential in manufacturing costs is

between $2.00 and $3.00 per unit, which might translate into a $5.00

price differential if the costs are passed on to the consumer.

In light of the ready supply, coupled with a low price

differential, EPA certifies that very little if any negative impact

would be felt by the small distributors.

C. Unfunded Mandates Act

Section 202 of the Unfunded Mandates Reform Act of 1995 (``Unfunded

Mandates Act'') (signed into law on March 22, 1995) requires that the

Agency prepare a budgetary impact statement before promulgating a rule

that includes a Federal mandate that may result in expenditure by

State, local, and tribal governments, in aggregate, or by the private

sector, of $100 million or more in any one year. Section 203 requires

the Agency to establish a plan for obtaining input from and informing,

educating, and advising any small governments that may be significantly

or uniquely affected by the rule. Section 204 requires the Agency to

develop a process to allow elected state, local, and tribal government

officials to provide input in the development of any action containing

a significant Federal intergovernmental mandate. Under section 205 of

the Unfunded Mandates Act, the Agency must identify and consider a

reasonable number of regulatory alternatives before promulgating a rule

for which a budgetary impact statement must be prepared. The Agency

must select from those alternatives the least costly, most cost-

effective, or least burdensome alternative that achieves the objectives

of the rule, unless the Agency explains why this alternative is not

selected or the selection of 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 proposed rule, the Agency is not required to

develop a plan with regard to small governments. Finally, because this

NPRM does not contain a significant intergovernmental mandate, the

Agency is not required to develop a process to obtain input from

elected state, local, and tribal officials.

D. Paperwork Reduction Act

This action requires no information collection subject to the

Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and therefore no

information collection request will be submitted to OMB for review.

E. Executive Order 12875: Enhancing the Intergovernmental Partnership

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.

F. National Technology Transfer and Advancement Act

The National Technology Transfer and Advancement Act of 1995

(NTTAA), section 12(d), Public Law 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

[[Page 31780]]

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.

G. Applicability of Executive Order 13045

This proposed 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 is not an

economically significant regulatory action as defined in E.O. 12866 and

because it does not involve decisions on environmental health risks or

safety risks that may disproportionately affect children.

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 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, 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.

List of Subjects in 40 CFR Part 82

Administrative practice and procedure, Air pollution control,

Chemicals, Chlorofluorocarbons, Exports, Hydrochlorofluorocarbons,

Imports, Interstate commerce.

Dated: June 4, 1999.

Carol M. Browner,

Administrator.

For the reasons set out in the preamble title 40, chapter I of the

Code of Federal Regulations, is proposed to be amended to read 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. 7414, 7601, 7671-7671q.

Subpart C--[Amended]

2. Section 82.66 is amened by removing paragraphs (d)(2)(ii),

(iii), (iv),(ix), and (xi); by redesignating (d)(2)(v) through

(d)(2)(viii) as (d)(2)(ii) through (d)(2)(v); by redesignating

(d)(2)(x) as (d)(2)(vi); by revising paragraph (c); and by adding

paragraph (e) to read as follows:

Sec. 82.66 Nonessential Class I Products and Exceptions.

* * * * *

(c) Any plastic foam product which is manufactured with or contains

a class I substance.

* * * * *

(e) Any air-conditioning or refrigeration appliance which contains

a class I substance used as a refrigerant.

[FR Doc. 99-15014 Filed 6-11-99; 8:45 am]

BILLING CODE 6560-50-P