[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]
[[Page 57511]]
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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.
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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 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
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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