[Federal Register Volume 66, Number 221 (Thursday, November 15, 2001)]
[Rules and Regulations]
[Pages 57512-57523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28191]



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Part II





Environmental Protection Agency





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40 CFR Part 82



Protection of Stratospheric Ozone: Reconsideration of the 610 
Nonessential Products Ban; Final Rule

  Federal Register / Vol. 66, No. 221 / Thursday, November 15, 2001 / 
Rules and Regulations  

[[Page 57512]]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-7101-1]
RIN 2060-AH99


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rulemaking amends 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 final rule does not affect the use of Class II ozone-
depleting substances. This rulemaking was developed by EPA based on new 
and compelling information that was gathered and indicates limited 
continued use by some sectors of 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'' based on the availability and 
widespread use of alternatives. 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 Class I substances (e.g., 
chlorofluorocarbons). Through this action, an additional category of 
products will be added and some products will be removed from the list 
of banned products (i.e., products that cannot be introduced into 
interstate commerce).

EFFECTIVE DATE: January 14, 2002.

ADDRESSES: 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, DC 
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, Stratospheric Program 
Implementation Branch, Global Programs Division, Office of Atmospheric 
Programs, Office of Air and Radiation (6205-J), 1200 Pennsylvania 
Avenue, NW, Washington, DC 20460, (202) 564-9729. The Stratospheric 
Ozone Information Hotline at 1-800-296-1996 can also be contacted for 
further information.

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 Products
    7. Other Products
    8. Reconsidering Nonessential Determinations
    B. Class II Ban
    1. Determinations under Section 610(d)
    2. Reconsideration
    3. Potential Future Notice of Proposed Rulemaking
III. Summary and Response to Comments
    A. Foam Products
    B. Aerosol Products and Pressurized Dispensers
    C. Air-Conditioning and Refrigeration Appliances
    D. Metered Dose Inhalers
IV. Effective Dates and Grandfathering
V. Summary of Today's Action
VI. Summary of Supporting Analysis
    A. Executive Order 12866
    B. Regulatory Flexibility
    C. Unfunded Mandates Act
    D. Paperwork Reduction Act
    E. Executive Order 13132: Federalism
    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. Congressional Review Act
    J. Executive Order 13211: Energy Effects
VII. Judicial Review

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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               Category                  Example of regulated  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.
------------------------------------------------------------------------

    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 Clean Air Act (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.
    On June 14, 1999, EPA proposed changes to the Class I Nonessential 
Products Ban (64 FR 31772). Today's action is based on those proposed 
changes and comments the Agency received in response to that NPRM.
    In a separate action, EPA's Significant New Alternatives Policy 
(SNAP) program, recently made available for public comment new 
information concerning the use of Class II substances and non-ozone 
depleting alternatives in

[[Page 57513]]

the production of plastic foam products. That information includes: 
sector description and size, non-ozone depleting alternatives currently 
used in each sector and technically viable alternatives. That document, 
Protection of Stratospheric Ozone: Notice of Data Availability; New 
Information Concerning SNAP Program Proposal on HCFC Use in Foams (May 
23, 2001, 66 FR 28408) does not pertain directly to today's action. 
However, in gathering information for that document, the Agency did not 
uncover any additional information that indicated significant continued 
use of CFCs in foam manufacturing.

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 promulgated by EPA under these statutory 
provisions currently identifies as nonessential, and therefore subjects 
to the prohibitions, the following:
    (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:

I. open cell polyurethane flexible slabstock foam,
II. open cell polyurethane flexible molded foam,
III. open cell rigid polyurethane poured foam,
IV. closed cell extruded polystyrene sheet foam,
V. closed cell polyethylene foam, and
VI. 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,
--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.
    Through this action, an additional category of banned products will 
be added and some products will be removed from the exempted list. The 
preamble to the 1993 rulemaking implementing the Class I Ban 
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 
statutory Class II 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 
mandated under section 612 of the Act has been established. 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.
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 products 
using substitutes to 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 vehicle model.
    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, on June 14, 1999, (64 FR 31774) EPA 
proposed that it was appropriate to reconsider previous determinations. 
Specifically, EPA proposed 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 on sale 
of nonessential products 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

[[Page 57514]]

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 similar 
methodology.
3. The Purpose or Intended Use of the Product
    This criterion relates to the importance of the product, in terms 
of benefits to society, 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 
has little benefit, such that even a lack of available substitutes 
might not prevent the product from being considered nonessential. The 
initial Class I final rulemaking included 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 initial 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 criterion 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 considers the current availability of 
substitutes more compelling than the potential availability of 
substitutes in determining whether a product is 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 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 Class I substances could 
be considered nonessential even in a product that is extremely 
important.
    EPA does not necessarily advocate the use of 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 health and 
environmental 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. However, 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 Products
    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 is currently 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 document 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

[[Page 57515]]

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 all 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 or stationary 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, 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. Moreover, 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. 
EPA concluded that 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. 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 was 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;

[[Page 57516]]

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.
8. Reconsidering Nonessential Determinations
    New and compelling information has been gathered by EPA that 
indicates that in some sectors there is limited continued use of 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 determine the efficacy of substitute substances 
as potential replacements for 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. Newly manufactured refrigerators in 
the United States for residential use are employing these available 
substitutes. As described in this notice, the Agency has determined 
that the use of a Class I substance in refrigeration applications now 
meets the definition of nonessentiality and that it is, therefore, 
reasonable now to promulgate revisions to the regulations that extend 
the Class I Ban to refrigeration applications. Similarly, substitutes 
now appear to be available for certain foam, aerosol, and pressurized 
dispenser uses.
    Today's action amends 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 of nonessentiality for the air-conditioning and 
refrigeration, foam-blowing, aerosols, and pressurized dispensers 
product categories. Today's action amends 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 (580 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 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. 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;
--Wasp and hornet sprays, for use near high-tension power lines only 
and where the seller must notify purchaser about restrictions; and
--the definition of foam insulation product.
2. Reconsideration
    Since the issuance of the final rule providing exemptions from the 
statutory Class II Ban, EPA amended the final rule with regard 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

[[Page 57517]]

reconsider the continued relevance of the current list of exemptions 
for specific aerosol products and pressurized dispensers; and 
potentially the definition of foam insulation product. 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 insulating foam, aerosol products and pressurized 
dispensers.
3. Potential Future Notice of Proposed Rulemaking
    EPA is currently reviewing information concerning the above aerosol 
and foam products and pressurized dispensers, as well as the exemptions 
from the Class II Ban provided in the December 1993 rulemaking. 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, as well as the definition of foam 
insulation product, the Agency may proceed with a notice of proposed 
rulemaking if the Agency determines that any rule revisions are 
appropriate.

III. Summary and Response to Comments

    On June 14, 1999, EPA issued an NPRM proposing changes to the Class 
I Ban (64 FR 31772). EPA received ten comments regarding this 
rulemaking. These comments are contained in Air Docket A-98-31. While 
most of the comments suggested minor changes or clarifications with 
regard to the proposal, nine of the ten comments generally supported 
EPA in acting to revise the Class I Ban.

A. Foam Products

    EPA proposed 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 stated in the NPRM its belief that there are acceptable 
substitutes available for replacing any continued use of Class I 
substances as blowing agents for foam products. EPA requested 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 stated that it would consider any specific 
data indicating that substitutes are not available for certain foam 
products.
    EPA received two comments that specifically addressed plastic foam 
products. Both comments address specific types of foam. The first 
comment, from a manufacturer, stated that they currently have a 
stockpile of CFC-11 for producing integral skin foam. According to the 
comment, the company has continued to use small quantities of CFC-11 
while conducting research and development of alternative foam systems. 
The company stated that ``it is the only producer of CO2 
blown systems for integral skin foams that has developed foam systems 
meeting FAA requirements for commercial aircraft.'' The company further 
stated that it has ``manufactured a large number of molded articles 
with the new non-CFC blown systems over the last several years'' and 
that ``this accomplishment has required a considerable research and 
development work for several different foam systems.'' The company 
stated that the change to the new molds and tooling was underway and 
would be complete within a few months. The commenter believes that they 
should be permitted to produce some integral skin with the remaining 
CFC-11 that they have on hand, particularly if they ``encounter any 
unforeseen problems.'' The commenter further questioned why EPA is 
pursuing this rulemaking since the commenter believes there will only 
be a ``very minor impact on ozone depletion.''
    EPA applauds the efforts of this manufacturer in replacing CFCs in 
its processes. EPA recognizes that foam blowing companies have invested 
significant time and effort in developing substitute products. However, 
EPA does not agree with the commenter's reasons to exempt the use of 
the CFCs that remain on hand. Since the commenter indicates there are 
alternatives already available for the products that it manufactures, 
EPA believes this indicates that the continued use of CFC-11 in this 
plastic foam product meets the definition of nonessential. Therefore, 
EPA does not believe that the final rule should be modified to exempt 
the continued production of integral skin foam products with CFC-11. 
However, EPA recognizes the concerns with existing inventories of 
manufactured products containing Class I substances that have already 
been completely manufactured and placed into inventory. Therefore, 
existing inventories of previously manufactured products are considered 
below at section IV: Effective Dates.
    With regard to the general comment regarding the benefits from this 
rulemaking, EPA believes that it is obligated under the criteria 
established by section 610 of the Act to list products that are 
nonessential. The recovery of the ozone layer and its resulting 
benefits are based on the cumulative implementation of all the programs 
established under Title VI of the Act, not one individual rule.
    EPA received a comment from the National Aeronautics and Space 
Administration (NASA) regarding the use of specific plastic foam 
products for the space shuttle. NASA identified one particular product, 
BX-250, a foam which is part of the thermal protection system of the 
Space Shuttle External Tank and which uses CFC-11 as a blowing agent. 
NASA stated that ``although extensive efforts have been made and 
continue to be made to replace this material, no viable alternative has 
been identified.'' NASA requested that EPA revise the proposed rule to 
provide an exemption for CFC-blown foam products in applications that 
are associated with space vehicles. NASA suggested that EPA consider 
using the same language that EPA has previously adopted under 40 CFR 
part 63, subpart GG (40 CFR 63.742) for the National Emissions 
Standards for Hazardous Air Pollutants (NESHAPs) program. NASA provided 
EPA with additional information concerning its proactive pursuit of 
potential alternative blowing agents.
    Since human space flight safety is of paramount importance to NASA, 
prior to implementing any new material, that material must undergo a 
rigorous development and qualification program for which no suitable 
substitute has yet been identified. NASA requested that EPA consider 
using the language at 40 CFR 63.742:

    Space vehicle means a man-made device, either manned or unmanned, 
designed for operation beyond earth's atmosphere. This definition 
includes integral equipment such as models, mock-ups, prototypes, 
molds, jigs, tooling, hardware jackets, and test coupons. Also included 
is auxiliary equipment associated with test, transport, and storage, 
which through contamination can compromise the space vehicle 
performance.


[[Page 57518]]


EPA agrees that an exception is necessary, but EPA disagrees with 
NASA's proposed language. This language is far broader than what EPA 
concludes is actually necessary based on an evaluation of the 
information NASA presented. If EPA were to simply exempt all foams used 
for any applications associated with space vehicles EPA could be 
exempting products where there are already suitable substitutes. NASA 
only provided information concerning one particular type of foam used 
in applications associated with the Space Shuttle External Tank. 
Therefore, based on that information, through this action, EPA will 
modify Sec. 82.66(c) to provide an exemption for foam products 
manufactured with or containing Class I substances that are used as 
part of the thermal protection system of external tanks for space 
vehicles and will add the definition of space vehicles found at 
Sec. 63.742 to Sec. 82.62. The exemption will be limited to the use of 
CFC-11 as a blowing agent and where no other CFCs are contained in the 
foam product. Although EPA did not propose this exemption or the 
additional definition, they are logical outgrowths of the comment 
submitted by NASA and thus it is appropriate to proceed to final action 
without providing any additional proposal or opportunity for further 
comment.

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 proposed 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 stated in the NPRM that the Agency believes there are 
substitutes available for these uses of Class I products and therefore 
these exemptions should be eliminated. Additionally, EPA did not 
propose 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). Also, 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 
exemptions are available only where the alternative to the use of a 
Class II substance is the legal use of a Class I substance, EPA did not 
propose to eliminate exemptions for aerosol products or pressurized 
dispensers from the Class I Ban that are also exempted from the Class 
II Ban. However, EPA stated that if the Agency subsequently issues a 
proposed rulemaking reconsidering 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 requested 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.
    EPA received three comments that directly concern the proposed 
changes to the aerosol and pressurized dispensers. All three comments 
generally support the proposed changes to the Class I Ban. The first 
comment stated that the proposed changes to the ban were reasonable and 
agreed that for all of the listed products there are suitable 
substitutes for the Class I components. The comment stated that the 
market impact of these regulatory changes would be small.
    The second comment, from a trade association, approved of EPA's 
decision to delay any proposed changes to the exemptions that are 
linked to the Class II Ban by the statutory language in 610(d). The 
commenter provided additional information regarding the Class II Ban 
and its exemptions. The third comment, from a manufacturer of aerosol 
products and pressurized dispensers, provided information concerning 
products with exemptions linked to both the Class I and Class II Bans. 
EPA will consider the information provided by these commenters in the 
future when the Agency addresses the Class II Ban and the linked Class 
I and Class II exemptions. Regarding the commenters' statements on the 
impact of today's action, EPA agrees with the comments and the 
assessment of the limited impacts of this action.
    Therefore, EPA is taking final action to eliminate the Class I 
exemptions, as proposed; and will consider Class II exemptions at a 
later date.

C. Air-Conditioning and Refrigeration Appliances

    Today, 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 stated in the June 14, 1999, NPRM that it was 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. EPA 
further stated that while 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 and given the designated criteria for nonessentiality, EPA 
believed that air-conditioning and refrigeration appliances that 
contain CFCs meet the criteria for nonessential uses of a Class I 
substance. Therefore, EPA stated that it now was reasonable to consider 
broadening the applicability of the Class I Ban to include air-
conditioning and refrigeration applications. EPA proposed 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 requested comments on 
expanding the Class I Ban to include air-conditioning and refrigeration 
appliances. In particular, EPA requested comments regarding whether 
there are sufficient technologically available substitutes for the use 
of Class I substances in all new air-conditioning and refrigeration 
appliances.
    EPA received three comments on air-conditioning and refrigeration 
applications. The first commenter, a trade association, stated that it 
generally supported the proposal but noted that it had recommendations 
regarding implementation. Their support, according to the comment, is 
based on the knowledge that non-CFC technology for domestic 
refrigeration is widely disseminated.
    The second commenter, a manufacturer, generally supports the 
efforts of EPA to restrict the manufacture of refrigerators and room 
air conditioners containing CFCs. The manufacturer stated that this is 
``a positive move that will hasten the day when CFCs (for which 
substitutes are available) can be eliminated completely from 
commerce.'' Both these commenters stated that they did not believe that 
the ban would in any way unfairly treat foreign manufacturers or 
importers. The association noted that ``most, perhaps all, of the firms 
that are importing these products are also producing and/or selling 
non-CFC units.'' EPA agrees that replacement technology is widely 
available and

[[Page 57519]]

therefore the use of CFCs in this category of products now meets the 
criteria for nonessentiality. Furthermore, EPA agrees that the effects 
of this rule will be consistent for both domestic and imported goods.
    Comments from the manufacturer applauded EPA for not including the 
servicing of existing products with Class I refrigerants in this 
rulemaking and stated that banning use of CFCs for servicing would be 
unfair to consumers who opt for repairing older appliances. EPA agrees 
with the commenters' statements about not including servicing of 
existing products, and has not done so in this rulemaking. Under 
section 608 of the Act, EPA has issued requirements pertaining to the 
service, maintenance, repair, and disposal of these appliances.
    Another commenter noted that while EPA clearly states that this 
proposed addition of air-conditioning and refrigeration appliances 
covers the sale and distribution of new products, it is unclear with 
regards to used products (64 FR 31778). The commenter believes this is 
so since regulatory language at Sec. 82.66 did not provide specific 
reference to new products but rather bans classes of products. The 
commenter alleges that the language ``any air-conditioning or 
refrigeration appliance which contains a Class I substance used as a 
refrigerant'' could imply that all are banned, not just new. EPA 
disagrees with this commenter's interpretation. The Agency stated 
previously, and with regard to all products covered under the Class I 
and Class II Bans, that the effectiveness of these regulations is 
limited to all sales and distribution in interstate commerce up to and 
including the sale to the ultimate end user, but that the ban does not 
extend to a resale of the products after a period of use. EPA 
previously stated on December 30, 1993, that the resale of used 
products means a sale, by a person after a period of use other than 
demonstration use. The Agency recognizes that more than one consumer 
often derives utility from owning and using certain durable goods and 
therefore stated (58 FR 69643) that:

while EPA's interpretation of ``interstate commerce'' is such that 
interstate commerce includes the entire chain of sale and 
distribution from the manufacturer of a new product to its ultimate 
consumer, the Agency recognizes in the NPRM that in the case of 
durable consumer goods such as boats and motor vehicles, resale of 
the product to additional consumers may occur after the original 
sale of the new product to the ultimate consumer after some period 
of use by the original ultimate consumer.

    Therefore, EPA believes that the language at Sec. 82.66 has been 
properly constructed and is consistent with EPA's past approach under 
the 610 ban. EPA believes that the interpretation of interstate 
commerce remains as including the entire chain of sale and distribution 
from the manufacturer of a new product to its ultimate consumer but 
does not extend to any resale by that initial ultimate consumer to 
additional consumers after some period of use has occurred.
    EPA received a comment from the Department of the Navy on behalf of 
the Department of Defense (DoD) that generally supported the proposed 
regulations as drafted. However, the Navy asked to clarify whether 
their interpretation of the term ``appliance,'' consistent with section 
601 of the Act and previously promulgated at 40 CFR part 82, subpart F 
was also the definition used with regard to this action. Section 601 of 
the Act states that an appliance is used for ``household or commercial 
purposes.'' Therefore, EPA has previously stated in regulations 
implementing Section 608 of the Act that the definition of 
``appliance'' includes ``all air-conditioning and refrigeration 
equipment except that designed and used exclusively for military 
applications' (58 FR 28660). EPA continues to agree with this 
interpretation.
    DoD stated that while it has aggressively sought to eliminate Class 
I ozone-depleting substances from military equipment, in some cases 
equipment using Class I ozone-depleting substances is still being 
procured until suitable substitutes are fully qualified and new 
equipment or equipment modifications are available. For example, the 
Department of the Navy was scheduled to take delivery of its final CFC-
114 shipboard chillers in early 2000. Additional chillers using non-
ozone-depleting refrigerants are in the final qualification process and 
according to the comment, were scheduled for delivery late in 2000. The 
comment further stated that the existing chillers that use CFC-114 are 
to be converted to a non-ozone-depleting substance within the next few 
years. EPA applauds the efforts of DoD to replace the uses of all ODSs. 
EPA reminds DoD that the section 608 codified language limits the 
exemption of military appliances to those that are designed and used 
``exclusively'' for military applications. EPA believes DoD will be 
able to find suitable substitutes for all ODS use in a timely manner.

D. Metered Dose Inhalers

    EPA received two comments regarding metered dose inhalers (MDIs). 
EPA specifically noted in the preamble to the proposed rule (64 FR 
31778) that:

    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).

    The first commenter stated that EPA should not permit the marketing 
and sales of CFC-containing MDIs that ``do not themselves qualify under 
the Act for essential use allowances under section 604.'' The commenter 
believes that ``while the agency has consistently urged the FDA not to 
approve new CFC-MDIs, the EPA fails to prohibit marketing of new CFC-
containing MDIs under section 610 even though it is well within the 
authority, if not the mandate, of the agency to do so.'' EPA notes that 
the proposed changes in the June 14, 1999, NPRM did not contemplate any 
changes with regard to the FDA linked exemptions. EPA disagrees with 
this commenter's interpretations. EPA regularly consults with the FDA 
to authorize production of limited quantities of Class I substances for 
use in medical devices, including MDIs, as specified under section 
604(d) of the Act. However, EPA defers to FDA on all medical judgments 
pertaining to approval of new medical products, including MDIs. EPA has 
neither the authority nor the medical expertise, to consult with FDA on 
such matters and has never urged the FDA to not approve new CFC-MDIs. 
EPA continues to believe that the most appropriate means for linking 
these rules is through cross reference to 21 CFR 2.125(e) where any 
medical device, including but not limited to MDIs, is listed as 
essential.
    EPA received a second comment regarding MDIs. This commenter stated 
that to be a medical device under section 601(8) of the Act, a product 
must be approved and determined to be essential by the FDA 
Commissioner. The commenter stated that FDA may move the list of 
essential uses to another section and suggested that EPA ``take this 
opportunity now to amend its section 610 implementing regulations so as 
to except products deemed essential by FDA under the CAA--rather than 
refer to 21 CFR 2.125(e).'' The commenter recommended that 
Sec. 82.66(d)(2)(i) should be amended to read: ``medical devices 
determined to be essential by the Food and Drug

[[Page 57520]]

Administration.'' EPA disagrees with this commenter. EPA does not 
believe it is necessary to take any action regarding the reference to 
21 CFR 2.125(e) at this time. If the FDA were to move the list of 
exempted products, EPA would undertake any necessary regulatory actions 
at that time only if such steps were necessary. Moreover, EPA would 
likely not consider language that is as broadly constructed as the 
language suggested by the commenter. EPA believes that because FDA now 
lists all essential medical devices in 21 CFR 2.125(e), it is 
appropriate to retain the reference to that rule in the 610 ban.

IV. Effective Dates and Grandfathering

    EPA proposed a 60-day effective date for this rulemaking, but 
discussed the possibility of a longer time frame if necessary. EPA 
received two comments supporting the proposed effective date for the 
amendments. However, these two comments, as well as an additional 
comment, raised concerns regarding products that were already 
manufactured and placed into inventory prior to the effective date. One 
commenter stated that the effective date for the provisions on air-
conditioning and refrigeration products should be based on the date of 
import for goods that are imported, and based on date of manufacture 
for goods that are produced domestically. The commenter stated that 
this was necessary to allow for goods already in inventory to be sold 
or distributed. However, the commenter states that the general 
effective date for the rulemaking should be 60 days from the date of 
publication of the final rule in the Federal Register because the 
industry has been aware of the action for several years.
    EPA recognizes the concerns with products that have already been 
manufactured and placed into initial inventory. Given that the ban is 
on all sales and distribution of all products until the sale to the 
ultimate end user, EPA has in previous rulemakings promulgated under 
section 610 of the Act, permitted products that are manufactured and 
placed into initial inventory by a specific date to be 
``grandfathered'' and thus sold and distributed in interstate 
inventory. Through this rulemaking, EPA is establishing a provision to 
permit air-conditioning and refrigeration appliances containing a Class 
I substance as a refrigerant that are placed into initial inventory by 
January 14, 2002 to continue to be sold and distributed through sale to 
the ultimate consumer. As with all provisions of the ban, this 
provision includes both products manufactured in the United States and 
those manufactured abroad and subsequently imported into the United 
States, as well as products manufactured domestically for export.
    EPA received a comment raising concerns about existing inventories 
regarding a specific type of integral skin foam used in commercial 
aviation that will now be covered by the ban based on today's action. 
EPA agrees with this commenter's concerns about such previously 
manufactured products and is adding a similar provision to also 
grandfather existing inventories of completely manufactured products. 
These products must be manufactured and placed into initial inventory 
by January 14, 2002 to qualify for the grandfathering provision.
    To ensure consistent interpretation regarding what is meant by 
initial inventory, EPA is restating in this FRM the interpretation 
provided in the preamble to the December 30, 1993 FRM. EPA stated that 
initial inventory means ``that the original product has completed all 
of its manufacturing processes and is ready for sale by the 
manufacturer (e.g., the foam is manufactured).'' The Agency further 
clarified that ``that product may be subsequently incorporated into 
another product by a different manufacturer after purchase.'' To 
continue selling products after the effective date of the provisions, 
the manufacturer or distributor ``must be able to show, upon request by 
EPA, that the product was in fact manufactured, and thus placed into 
initial inventory.'' EPA stated that shipping forms, lot numbers, 
manufacturer date stamps or codes, invoices, or the like are normally 
kept records that could be maintained from the time the product was put 
into initial inventory as proof of the date a product was placed into 
initial inventory (58 FR 69661).
    To facilitate consistent understanding, through this action, EPA is 
adding to its list of definitions, a definition of ``initial 
inventories'' as defined above. Products that are manufactured and 
placed into initial inventories by January 14, 2002 may continue to be 
sold and distributed in interstate commerce, not withstanding the 610 
ban.

V. Summary of Today's Action

    Through this action, EPA is today amending the current regulations 
that implement the statutory ban on nonessential products. EPA is 
replacing the previous list of banned plastic foam products with a more 
encompassing prohibition that exempts only one particular foam product 
used to provide thermal protection to external tanks for space 
vehicles. EPA is also amending the list of banned products to include 
any air-conditioning or refrigeration appliances that contain a Class I 
substance used as a refrigerant. In addition, EPA is adding definitions 
of space vehicles and initial inventories to the definitions section of 
the regulation and is exempting air-conditioning and refrigeration 
products, as well as integral skin foam used in the commercial aviation 
industry, when such products are fully manufactured and placed into 
initial inventory by a specific date.

VI. Summary of Supporting Analysis

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether this 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

    After considering the economic impacts of today's final rule on 
small entities, EPA has concluded that this action will not have a 
significant economic impact on a substantial number of small entities, 
and that it is therefore not necessary to prepare a regulatory 
flexibility analysis for this final rule. In determining whether a rule 
has a significant economic impact on a substantial number of small 
entities, the impact of concern is any significant adverse economic 
impact on small entities, since the primary purpose of the regulatory 
flexibility analyses is to

[[Page 57521]]

identify and address regulatory alternatives ``which minimize any 
significant economic impact of the proposed rule on small entities.'' 5 
U.S.C. 603 and 604.
    This final rule will not have a significant economic impact on a 
substantial number of small entities for the following reasons. First, 
as discussed elsewhere in this preamble, acceptable substitutes for 
CFCs are widely available and currently used by domestic manufacturers 
for the applications covered by this rule. Second, the rule affects the 
use of CFCs only. Except for a limited number of essential uses (e.g., 
Metered Dose Inhalers), production and importation of CFCs has been 
prohibited in the United States since January 1, 1996. Since production 
ceased, inventories have been dwindling. The information the Agency has 
reviewed, indicates that CFCs are primarily being used to service 
existing equipment such as older automobile air conditioners. EPA 
believes it very unlikely that there is any significant use of CFCs in 
manufacturing new products affected by this rulemaking by any 
businesses, large or small. In addition, EPA's contacts with 
manufacturers and organizations representing these manufacturers 
supports the view that there is little if any ongoing manufacturing of 
products using Class I substance. In developing information for this 
and other rulemakings, except where noted in the response to comments 
in today's action, EPA did not encounter any manufacturers large or 
small that are continuing to use Class I substances in their products. 
Moreover, in the few exception cases (see preamble III. Summary and 
Response to Comments), EPA was able to accommodate most of the 
commenters' concerns, notably by including provisions to 
``grandfather'' existing inventories of products already manufactured 
and placed in initial inventories, allowing these existing inventories 
to be sold. The findings in the development of this rulemaking and 
others are in keeping with EPA's view that non-Class-I substitutes are 
widely used and available, and that the transition away from Class I 
substances for the affected products is essentially complete.

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 final 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. Finally, because this FRM 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 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    Under section 6 of Executive Order 13132, EPA may not issue a 
regulation that has federalism implications, that imposes substantial 
direct compliance costs, and that is not required by statute, unless 
the Federal government provides the funds necessary to pay the direct 
compliance costs incurred by State and local governments, or EPA 
consults with State and local officials early in the process of 
developing the proposed regulation. EPA also may not issue a regulation 
that has federalism implications and that preempts State law, unless 
the Agency consults with State and local officials early in the process 
of developing the proposed regulation.
    This final rule does not have federalism implications within the 
meaning of Executive Order 13132. It will not have substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132. This rule alters the applicability of the 
Class I Ban to certain ozone depleting substances but does not impose 
any enforceable duties on the states or local governments. Thus, the 
requirements of section 6 of the Executive Order 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 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 final rule does not mandate the use of any technical 
standards; accordingly, the NTTAA does not apply to this rule.

[[Page 57522]]

G. Applicability of Executive Order 13045

    This final rule is not subject to Executive Order 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 Executive 
Order 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

    On January 1, 2001, Executive Order 13084 superseded by Executive 
Order 13175. However, this rule was developed during the period when 
Executive Order 13084 was still in force, and so tribal considerations 
were addressed under Executive Order 13084. 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. Accordingly, the requirements 
of section 3(b) of Executive Order 13084 do not apply to this rule.

I. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. A Major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective January 14, 2002.

J. Executive Order 13211: Energy Effects

    This rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355 (May 22, 2001)) because it is not a 
significant regulatory action under Executive Order 12866.

VII. Judicial Review

    Under section 307(b)(1) of the Clean Air Act, EPA hereby finds that 
these regulations are of national applicability. Accordingly, judicial 
review of this action is available only by the filing of a petition for 
review of this action in the United States Circuit Court of Appeals for 
the District of Columbia Circuit within 60 days of publication. Under 
section 307(b)(2) of the Act, the requirements that are the subject of 
today's rule may not be challenged later in judicial proceedings 
brought to enforce these requirements.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Chemicals, Exports, Government procurement, 
Imports, Labeling, Reporting and recordkeeping requirements.

    Dated: November 1, 2001.
Christine Todd Whitman,
Administrator.

    Title 40, Code of Federal Regulations, part 82, is 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.


    2. Section 82.62 is amended by removing paragraph designations (a) 
through (i), placing the existing definitions in alphabetical order, 
and adding new definitions for ``Initial Inventory'' and ``Space 
Vehicles'' to read as follows:


Sec. 82.62  Definitions.

* * * * *
    Initial Inventory means that the original product has completed all 
of its manufacturing processes and is ready for sale by the 
manufacturer. Products in initial inventory may be subsequently 
incorporated into another product by a different manufacturer after 
purchase. To continue selling products after the effective date of the 
provisions, the manufacturer or distributor must be able to show, upon 
request by EPA, that the product was in fact manufactured, and thus 
placed into initial inventory prior to the effective date. Shipping 
forms, lot numbers, manufacturer date stamps or codes, invoices, or the 
like are normally kept records that could be maintained from the time 
the product was put into initial inventory and may be used to 
demonstrate when a product was placed in initial inventory.
* * * * *
    Space Vehicles means a man-made device, either manned or unmanned, 
designed for operation beyond earth's atmosphere. This definition 
includes integral equipment such as models, mock-ups, prototypes, 
molds, jigs, tooling, hardware jackets, and test coupons. Also included 
is auxiliary equipment associated with test, transport, and storage, 
which through contamination can compromise the space vehicle 
performance.

    3. Section 82.65 is amended by adding paragraphs (h) and (i) to 
read as follows:


Sec. 82.65  Temporary exemptions.

* * * * *
    (h) Any person may sell or distribute, or offer to sell or 
distribute, in interstate commerce, at any time, any air-conditioning 
or refrigeration products specified as nonessential in Sec. 82.66(e) 
that are manufactured and placed into initial inventory by January 14, 
2002.
    (i) Any person may sell or distribute, or offer to sell or 
distribute, in interstate commerce, at any time, any integral skin foam 
products manufactured with a Class I substance for use in commercial 
aviation and specified as nonessential in Sec. 82.66(c) that are 
manufactured and placed into initial inventory by January 14, 2002.

    4. Section 82.66 is amended by:
    a. Revising paragraph (c);
    b. Removing paragraphs (d)(2)(ii) through (iv), (ix), and (xi);
    c. Redesignating paragraphs (d)(2)(v) through (viii) as paragraphs 
(d)(2)(ii) through (v) respectively;

[[Page 57523]]

    d. Redesignating paragraphs (d)(2)(x) as paragraph (d)(2)(vi); and
    e. Adding a new paragraph (e).
    The additions and revisions 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; except any plastic foam product blown with CFC-11, 
but which contains no other Class I substances and where this product 
is used to provide thermal protection to external tanks for space 
vehicles;
    (d) * * *
    (e) Any air-conditioning or refrigeration appliance as defined in 
CAA 601(l) that contains a Class I substance used as a refrigerant.

[FR Doc. 01-28191 Filed 11-14-01; 8:45 am]
BILLING CODE 6560-50-P