[Federal Register Volume 64, Number 113 (Monday, June 14, 1999)]
[Proposed Rules]
[Pages 31772-31780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15014]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6358-4]
RIN 2060-AH99
Protection of Stratospheric Ozone: Reconsideration of the 610
Nonessential Products Ban
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This proposed rulemaking proposes changes to the current
regulations that implement the statutory ban on nonessential products
that release class I ozone-depleting substances under section 610 of
the Clean Air Act, as amended. This proposed rulemaking was developed
by EPA based on new and compelling information that has been gathered
and indicates that some sectors continue to use class I substances in
products where the use of those substances today should be considered a
``nonessential use of class I substances in a product.'' The products
affected by this rulemaking are aerosol products, pressurized
dispensers, plastic foam products, and air-conditioning and
refrigeration products that contain or are manufactured with
chlorofluorocarbons.
DATES: Comments must be received by August 13, 1999 unless a public
hearing is held. A public hearing, if requested, will be held in
Washington, D.C. If such a hearing is requested, it will be held on
June 29, 1999. Anyone who wishes to request a hearing should call Cindy
Newberg at 202/564-9729 by 5 pm Eastern Time June 21, 1999. Ater that
time, interested parties may contact the Stratospheric Protection
hotline regarding if a hearing will be held as well as the time and
place of such a hearing. If a public hearing is held, the comment
period will be extended until August 30, 1999.
ADDRESSES: Comments on this action should be addressed to Public Docket
No, A-98-31 at the address below. Comments and materials supporting
this rulemaking are contained in Public Docket No. A-98-31 Waterside
Mall (Ground Floor) Environmental Protection Agency, 401 M Street, SW.,
Washington, D.C. 20460 in room M-1500. Dockets may be inspected from
8:00 a.m. until 5:30 p.m., Monday through Friday. A reasonable fee may
be charged for copying docket materials.
FOR FURTHER INFORMATION CONTACT: Cindy Newberg, Program Implementation
Branch, Stratospheric
[[Page 31773]]
Protection Division, Office of Atmospheric Programs, Office of Air and
Radiation (6205-J), 401 M Street, SW., Washington, D.C. 20460,
(202)564-9729. The Stratospheric Ozone Information Hotline at 1-800-
296-1996 can also be contacted for further information. Interested
persons may contact the Stratospheric Protection Hotline to learn if a
hearing will be held and to obtain the date and location of any
hearing. Any hearing will be strictly limited to the subject matter of
this proposal.
SUPPLEMENTARY INFORMATION: The contents of this preamble are listed in
the following outline:
I. Regulated Entities
II. Background
A. Class I Ban
1. Reconsideration
2. Determinations Under 610
3. The Purpose or Intended Use of the Product
4. The Technological Availability of Substitutes
5. Safety and Health
6. Medical Devices
7. Other Products
8. Reconsidering Nonessential Determinations
B. Class II Ban
1. Reconsideration
2. Determinations Under Section 610(d)
3. Future Notice of Proposed Rulemaking
III. Today's Action
A. Foam Products
B. Aerosol Products and Pressurized Dispensers
C. Air-conditioning and Refrigeration Appliances
IV. Proposed Effective Dates and Grandfathering
V. Summary of Supporting Analysis
A. Executive Order 12866
B. Regulatory Flexibility
C. Unfunded Mandates Act
D. Paperwork Reduction Act
E. Executive Order 12875: Enhancing the Intergovernmental
Partnership
F. National Technology Transfer and Advancement Act
G. Applicability of Executive Order 13045
H. Executive Order 13084: Consultation and Coordination With
Indian Tribal Governments
I. Regulated Entities
Entities potentially regulated by this action are those that wish
to sell
and/or distribute in interstate commerce aerosols, pressurized
dispensers, plastic foam products, refrigerators and air-conditioning
equipment that contain chlorofluorocarbons (CFCs). Regulated categories
and entities include:
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Example of regulated
Category entities
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Industry.................................. Aerosol packagers.
Aerosol manufacturers.
Air-conditioning and
refrigeration equipment
manufacturers.
Specialty chemical
manufacturers.
Foam manufacturers.
Air conditioning and
refrigeration distributors.
Air conditioning and
refrigeration retailers.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be affected by this action. Other types of entities
not listed in the table could also be affected. To determine whether
your company is regulated by this action, you should carefully examine
the applicability criteria contained in Section 610 of the Clean Air
Amendments of 1990, discussed in regulations codified at 40 CFR Part
82, subpart C and published on January 15, 1993 (58 FR 4768); December
30, 1993 (58 FR 69672) and discussed below. If you have questions
regarding the applicability of this action to a particular entity,
consult the person listed in the preceding FOR FURTHER INFORMATION
CONTACT section.
II. Background
Title VI of the Act divides ozone-depleting chemicals into two
distinct classes. Class I is comprised of chlorofluorocarbons (CFCs),
halons, carbon tetrachloride and methyl chloroform, methyl bromide and
hydrobromofluorocarbons. Class II is comprised of
hydrochlorofluorocarbons (HCFCs). (See listing notice January 22, 1991;
56 FR 2420.) Section 610(b) of the Act, as amended, requires EPA to
promulgate regulations banning nonessential products releasing class I
substances. EPA published a final rule for the Class I Nonessential
Products Ban on January 15, 1993 (58 FR 4768). A final rule
establishing regulations that implemented the statutory ban on
nonessential products containing or manufactured with class II ozone-
depleting substances under section 610(d) of the Clean Air Act, as
amended, was issued December 30, 1993 (58 FR 69637). That final rule
was developed to clarify definitions and provide exemptions, as
authorized under section 610(d). All of the regulations are codified at
40 CFR Part 82 subpart C. Comments and materials supporting those
rulemakings are contained in Public Dockets A-91-39 and in A-93-20.
A. Class I Ban
Section 610(b) of the Act directs EPA to identify nonessential
products that ``release Class I substances into the environment
(including any release during manufacture, use, storage, or disposal)''
and to ``prohibit any person from selling or distributing any such
product, or offering any such product for sale or distribution, in
interstate commerce.''
Section 610(b)(1) and (2) specify products to be prohibited under
this requirement, including ``chlorofluorocarbon-propelled plastic
party streamers and noise horns'' and ``chlorofluorocarbon-containing
cleaning fluids for noncommercial electronic and photographic
equipment.''
Section 610(b)(3) extends the prohibition to other products
determined by EPA to release class I substances and to be nonessential.
In determining whether a product is nonessential, EPA is to consider
the following criteria: ``the purpose or intended use of the product,
the technological availability of substitutes for such product and for
such Class I substance, safety, health, and other relevant factors.''
The regulatory Class I Ban currently identifies as nonessential,
and therefore subject to the prohibitions:
(A) plastic party streamers and noise horns propelled by
chlorofluorocarbons;
(B) cleaning fluids for electronic and photographic equipment which
contain a chlorofluorocarbon, including but not limited to liquid
packaging, solvent wipes, solvent sprays, and gas sprays, except for
those sold or distributed to a commercial purchaser;
(C) plastic flexible or packaging foam product which is
manufactured with or contains a chlorofluorocarbon, including but not
limited to,
Open cell polyurethane flexible slabstock foam,
Open cell polyurethane flexible molded foam,
Open cell rigid polyurethane poured foam,
Closed cell extruded polystyrene sheet foam,
Closed cell polyethylene foam, and
Closed cell polypropylene foam, except flexible or
packaging foam used in coaxial cable; and
(D) any aerosol product or other pressurized dispenser which
contains a chlorofluorocarbon, except:
Medical devices listed in 21 CFR 2.125(e),
Lubricants for pharmaceutical and tablet manufacture,
Gauze bandage adhesives and adhesive removers,
[[Page 31774]]
Topical anesthetic and vapocoolant products,
Lubricants, coatings or cleaning fluids for electrical or
electronic equipment, which contain CFC-11, CFC-12, or CFC-113 for
solvent purposes, but which contain no other CFCs,
Lubricants, coatings or cleaning fluids used for aircraft
maintenance, which contain CFC-11 or CFC-113, but which contain no
other CFCs,
Mold release agents used in the production of plastic and
elastomeric materials, which contain CFC-11 or CFC-113, but which
contain no other CFCs,
Spinnerette lubricant/cleaning sprays used in the
production of synthetic fibers, which contain CFC-114, but which
contain no other CFCs,
Containers of CFCs used as halogen ion sources in plasma
etching,
Document preservation sprays which contain CFC-113, but
which contain no other CFCs, and
Red pepper bear repellent sprays which contain CFC-113,
but which contain no other CFCs.
Verification and public notice requirements have been established
for distributors of certain products intended exclusively for
commercial use.
The preamble to the 1993 rulemaking established that EPA should in
the future reconsider exceptions granted and limitations of the ban
under that rulemaking based on new and compelling information regarding
the availability of substitutes for class I substances. In 1993 EPA
limited consideration of banned products to aerosols, pressurized
dispensers, and foams. These sectors traditionally used ozone-depleting
substances and were subject to the Class I Ban. Since that rulemaking
was issued, the phaseout of production and consumption of class I
substances has become effective and the Significant New Alternatives
Policy (SNAP) program established under Section 612 of the Act has been
promulgated. The phaseout of newly manufactured class I substances and
the identification of acceptable substitutes provide compelling reasons
to reconsider the initial decisions regarding both product-specific
exemptions and the decision to limit the ban's effect to major sectors
that traditionally used ozone-depleting substances. Therefore, it is
appropriate now to reconsider the applicability of the Class I Ban to
both specific products and product categories.
1. Reconsideration
The regulations implementing the Class I Ban provide for EPA to
reconsider decisions that were made regarding specific products and
product categories. EPA indicated in 1993 that the Agency would
reconsider decisions in the future based on developments of product
substitutes not containing class I substances. EPA has previously
reconsidered specific decisions. In December 1993 (58 FR 69672), EPA
reconsidered the application of the Class I Ban to replacement parts
that were previously manufactured and stored for future use, such as
car seats designed and manufactured for a particular model vehicle.
Based on development of new substitutes and the characterization of
the criteria for nonessentiality discussed below, particularly as
applied to the use of class I substances in products that are
themselves not nonessential, EPA believes that it is now appropriate
for EPA to reconsider previous determinations. Specifically, it is
appropriate to reconsider the determinations for the air-conditioning
and refrigeration, solvents, and foam-blowing sectors.
2. Determinations Under 610
As stated above, Section 610(b)(3) extends the prohibition to other
products determined by EPA to release class I substances and to be
nonessential. In determining whether a product is nonessential, EPA is
to consider the following criteria: ``the purpose or intended use of
the product, the technological availability of substitutes for such
product and for such class I substance, safety, health, and other
relevant factors.'' The statute requires EPA to consider each criterion
but did not outline either a ranking or a methodology for comparing
their relative importance, nor does it require that any minimum
standard within each criterion be met. To develop the initial
rulemaking, EPA considered all of these criteria in determining whether
a product was nonessential. In addition, EPA reviewed the criteria used
in the development of its 1978 ban on aerosol propellant uses of CFCs
under the Toxic Substances Control Act (TSCA). Today's action follows
the same methodology of that rulemaking.
3. The Purpose or Intended Use of the Product
This criterion relates to the importance of the product,
specifically whether the product is sufficiently important that the
benefits of its continued production outweigh the associated danger
from the continued use of a class I ozone-depleting substance in it, or
alternatively, whether the product is so unimportant that even a lack
of available substitutes might not prevent the product from being
considered nonessential. The initial class I final rulemaking includes
a discussion about the contributions of a product to the quality of
life.
The distinction between a ``nonessential product'' and a
``nonessential use of class I substances in a product'' is a relevant
criterion. For example, while foam cushioning products for beds and
furniture are not ``frivolous,'' the use of a class I substance in the
manufacturing process for foam cushioning where substitutes are readily
available is considered nonessential. The ability of manufacturers to
switch from using a class I substance is a relevant indicator for this
criterion. The class I final rule states that ``the Agency believes
that in sectors where the great majority of manufacturers had already
shifted to substitutes, the use of a class I substance in that product
may very well be nonessential.'' Consequently, EPA believes it is
appropriate under this criteria to examine sectors where most of the
market has previously switched out of CFCs.
4. The Technological Availability of Substitutes
EPA has previously interpreted this criterion to mean the existence
and accessibility of alternative products or alternative chemicals for
use in, or in place of, products releasing class I substances. EPA
believes that the phrase ``technological availability'' includes both
currently available substitutes (i.e., presently produced and sold in
commercial quantities) and potentially available substitutes (i.e.,
determined to be technologically feasible, environmentally acceptable
and economically viable, but not yet produced and sold in commercial
quantities). However, EPA considered the current availability of
substitutes more compelling than the potential availability of
substitutes in determining whether a product was nonessential.
The corresponding criterion from the 1978 aerosol ban is the
``nonavailability of alternative products.'' In its supporting
documentation, EPA stated that this was the primary criterion for
determining if a product had an ``essential use'' under the 1978 rule.
EPA emphasized, however, that the absence of an available alternative
did not alone disqualify a product from being banned as nonessential.
The availability of substitutes is clearly a critical criterion for
determining if a product containing a class I substance is
nonessential. In certain cases, a substitute that is
[[Page 31775]]
technologically feasible, environmentally acceptable and economically
viable, but not yet produced and sold in commercial quantities, may
meet this criterion with respect to certain products. However, EPA
believes that, where substitutes are readily available, the use of
controlled substances could be considered nonessential even in a
product that is extremely important. It should be noted, however, that
EPA does not necessarily advocate all substitutes that are currently
being used in place of CFCs in the products EPA identifies as
nonessential. In many cases potential substitutes are subject to other
regulatory programs. For example, the SNAP program promulgated under
CAA 612 carefully considers the relative risks and merits of different
substitutes for ozone-depleting substances. Substitutes are listed
under that regulatory program as acceptable, unacceptable, or
acceptable subject to use restrictions for specific uses. Within the
limited purposes of the nonessential products bans, EPA considers the
existence and accessibility of alternative products or alternative
chemicals for use in, or in place of, products releasing class I
substances. Any future use of such substitutes must comport with any
conditions of the SNAP program, if applicable.
5. Safety and Health
EPA interprets these two criteria to mean the effects on human
health and the environment of the products releasing class I substances
or their substitutes. In evaluating these criteria, EPA considered the
direct and indirect effects of product use, and the direct and indirect
effects of alternatives, such as ozone depletion potential,
flammability, toxicity, corrosiveness, energy efficiency, ground level
air hazards, and other environmental factors.
If any safety or health issues prevented a substitute from being
used in a given product, EPA then considered that substitute to be
``unavailable'' at the time for that specific product or use. EPA noted
in the initial rulemaking that as new information becomes available on
the health and safety effects of possible substitutes, EPA could
reevaluate determinations made regarding the nonessentiality of
products.
6. Medical Devices
Section 610(e) states that ``nothing in this section shall apply to
any medical devices as defined in section 601(8).'' Section 601(8)
defines ``medical device'' as ``any device (as defined in the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, drug
(as defined in the Federal Food, Drug, and Cosmetic Act), and drug
delivery system--(A) if such device, product, drug, or drug delivery
system utilizes a Class I or Class II substance for which no safe and
effective alternative has been developed and, where necessary, approved
by the Commissioner of the Food and Drug Administration (FDA); and (B)
if such device, product, drug, or drug delivery system, has, after
notice and opportunity for public comment, been approved and determined
to be essential by the Commissioner in consultation with the
Administrator.''
The FDA currently is reviewing its determinations under 21 CFR
2.125(e). At this time, the FDA lists 12 medical devices for human use
as essential uses of CFCs in 21 CFR 2.125(e). These devices consist of
certain metered dose inhalers (MDIs), contraceptive vaginal foams,
intra-rectal hydrocortisone acetate, polymyxin B sulfate-bacitracin-
zinc-neomycin sulfate soluble antibiotic powder without excipient for
topical use, and anesthetic drugs for topical use on accessible mucous
membranes where a cannula is used for application. For additional
information regarding FDA determinations and plans for potential
regulatory changes, see 62 FR 10242 (March 6, 1997).
Medical products as determined by FDA and listed as essential at 21
CFR 2.125(e) are exempt from the Class I Ban at 40 CFR part 82, subpart
C. This notice does not propose any changes to this current exemption.
However, other medical related products not contained in the FDA's list
of essential uses (21 CFR 2.125(e)), and therefore not subject to
610(e), that were considered in the initial Class I Ban rulemaking, and
given exemptions, under 610(b) are reconsidered in this action. Those
products are gauze bandage adhesives and adhesive removers, lubricants
for pharmaceutical and tablet manufacture, and topical anesthetic and
vapocoolant products.
7. Other Products
In drafting the initial rulemaking to prohibit certain products
under section 610(b)(3), the Agency considered every major use sector
that used class I substances including: refrigeration and air-
conditioning, solvent use, fire extinguishing, foam blowing, and
aerosol use. Based on that review, EPA identified three broadly defined
product categories for further evaluation: aerosol products and
pressurized dispensers containing CFCs or halons, plastic flexible and
packaging foams, and halon fire extinguishers for residential use.
EPA believed that in each of these sectors two important conditions
existed: substitutes were already available for the product or the
class I substance used or contained in that product; and, either the
affected industry had, for the most part, moved out of the use of class
I substances or the market share of products using or containing class
I substances was small and shrinking. In addition, in the case of
aerosols and plastic flexible and packaging foams, section 610(d)
imposed a self-effectuating ban on the sale or distribution of such
products containing or produced with class II substances after January
1, 1994.
The 1993 rulemaking specifically discussed the other sectors and
provided information regarding the Agency's determinations.
Refrigeration and air-conditioning, including mobile air-conditioning,
represented the largest total use of class I substances in the United
States in 1993. At the time the initial rulemaking was promulgated,
substitutes were available for some refrigeration and air-conditioning
products. For example, the automotive manufacturers were in the process
of switching to HFC-134a for new models rather than CFC-12 in their
air-conditioning systems. However, potential substitutes for other
refrigeration and air-conditioning uses were still being evaluated.
EPA did not include prohibitions on the use of class I substances
in refrigeration or air-conditioning in the 1993 rulemaking because
determinations regarding substitutes for all such uses were not
anticipated to be available within the time-frame of that rulemaking.
Accordingly, EPA could not conclude that the use of class I
refrigerants in any refrigeration or air-conditioning uses were
nonessential at the time of that rulemaking. Furthermore, at that time,
EPA had not yet issued final regulations that specifically addressed
non-automotive refrigeration and air-conditioning uses of class I
substances (subsequently promulgated under CAA Section 608 and codified
at 40 CFR part 82, subpart F). These regulations addressed standards
for the recovery and reuse of refrigerants.
Solvent uses of class I substances, including commercial
electronics de-fluxing, precision cleaning, metal cleaning and dry
cleaning also represented a significant use in 1993. Industry had
already identified potentially available substitutes for nearly all of
the thousands of products then manufactured with class I solvents,
[[Page 31776]]
and many companies had already phased out the use of CFCs in certain
products. EPA did not address solvent use in that rulemaking (accept
where the solvent application was within an aerosol or pressurized
dispenser) because the sheer number of products and the range of
potential substitutes made it impossible for EPA to conclude
definitively that substitutes were available for any of these specific
uses, and thus that such uses were nonessential, within the short
statutory time-frame for the Class I Ban rulemaking. However, EPA
believed a ban on such uses would be unnecessary as most manufacturers
were phasing out use as particular substitutes became available, in
anticipation of the impending production phaseout.
EPA considered the use of class I substances in fire extinguishing
applications in its initial review as well. Halons were widely used in
fire extinguishing systems. These fire extinguishing systems include
both total flooding systems (such as stationary fire suppression
systems in large computer facilities) and streaming systems (such as
hand-held fire extinguishers). In evaluating possible nonessential uses
of halons in fire fighting, the Agency divided the fire protection
sector into six broad end uses: (1) Residential/Consumer Streaming
Agents, (2) Commercial/Industrial Streaming Agents, (3) Military
Streaming Agents, (4) Total Flooding Agents for Occupied Areas, (5)
Total Flooding Agents for Unoccupied Areas, and (6) Explosion Inertion.
Substitutes for halons, whether other halocarbons or alternatives such
as water, should meet four general criteria to provide a basis for
determining that the use of halon in residential fire extinguishers is
nonessential. They must be effective fire protection agents, they must
have an acceptable environmental impact, they must have a low toxicity,
and they must be relatively clean or volatile. In addition, they must
be commercially available as a halon replacement in the near future.
EPA concluded that while satisfactory substitutes were not yet
available in most commercial and military applications within the short
statutory time-frame of the rulemaking, certain substitutes were
already commercially available for hand-held halon fire extinguishers
in residential settings. Consequently, the Agency decided to evaluate
this application more closely in order to determine whether residential
fire extinguishers containing halon should be designated nonessential
products, or whether the continued use of halons, despite the
imposition of the excise tax and the impending production phaseout,
indicated that this application did not meet the criteria for
nonessentiality. Ultimately, after reviewing the issue and soliciting
comment, the final rulemaking did establish a ban on the use of halon
in residential streaming applications. Furthermore, the use of CFCs in
fire extinguishing equipment was also restricted.
EPA considered aerosols and pressurized dispensers likely
candidates for designation as nonessential products in 1993 because a
great deal of information on substitutes for CFCs in these applications
already existed. Research on substitutes for CFCs in aerosol
applications began in the 1970s in response to the early studies on
stratospheric ozone depletion and the 1978 ban on the use of CFCs as
aerosol propellants. Consequently, extensive data already existed on
possible substitutes for most remaining aerosol uses.
The 1978 aerosol ban prohibited the manufacture of aerosol products
using CFCs as propellants. Other uses of CFCs in aerosols (such as
solvents, active ingredients, or sole ingredients) were not included in
the ban. In addition, certain ``essential uses'' of CFCs as aerosol
propellants were exempted from the ban because no adequate substitutes
were available at the time. Consequently, although the use of CFCs in
aerosols was reduced dramatically by the 1978 ban, the production of a
number of specific aerosol products containing CFCs were still legal
including: metered dose inhalant drugs; medical solvents such as
bandage adhesives and adhesive removers; skin chillers for medical
purposes; aerosol tire inflators; mold release agents; lubricants,
coatings, and cleaning fluids for industrial/institutional applications
to electronic or electrical equipment; special-use pesticides; aerosols
for the maintenance and operation of aircraft; diamond grit spray;
single-ingredient dusters and freeze sprays; noise horns; mercaptan
stench warning devices; pressurized drain openers; aerosol polyurethane
foam dispensers; and whipped topping stabilizers. In 1993, EPA
concluded that satisfactory substitutes were available for most uses of
CFCs in aerosols and pressurized dispensers. As a result, the Agency
banned all uses of CFCs in aerosols and pressurized dispensers except
for certain products, such as medical devices, that it specifically
exempted. EPA further concluded that the implementation of the
production phaseout of CFCs on January 1, 1996, would serve to
eliminate the continued use of CFCs in all but the most essential
applications, such as the permitted production for metered dose
inhalant drugs.
8. Reconsidering Nonessential Determinations
New and compelling information has been gathered recently by EPA
that indicates that some sectors continue to use class I substances in
products where the use of the substance today should be considered a
``nonessential use of class I substances in a product.'' Since the
promulgation of the initial regulations under Section 610, the SNAP
program has been established and now provides information regarding
acceptable substitutes for various applications. While the SNAP program
does not consider the efficacy of the substitute substance as a
replacement for the ozone-depleting substances, for most applications
there are sources of information regarding the effectiveness of the
substitutes, such as laboratory testing and information provided by
major users and trade associations. For example, many substitutes have
been listed by SNAP as acceptable for various refrigeration
applications. Domestically, newly manufactured refrigerators for
residential use are employing these available substitutes. Therefore,
it is reasonable for the Agency at this time to reconsider applying the
610 Class I ban to include refrigeration applications by determining if
the use of a class I substance in refrigeration applications now meets
the definition of nonessentiality, as described in this notice.
Today's action proposes to amend the class I ban to meet the
Agency's obligations to eliminate the nonessential uses of class I
substances. Specifically, EPA has determined that it is appropriate to
reconsider the determinations for the air-conditioning and
refrigeration, foam-blowing, aerosols, and pressurized dispensers
product categories. Today's action proposes amending the class I ban to
include additional nonessential uses of CFCs for these end-use
applications.
B. Class II Ban
On December 30, 1993, EPA published a final rulemaking (58 FR
69637) addressing issues related to the statutory prohibition against
the sale or distribution, or offer for sale or distribution in
interstate commerce of nonessential products containing or manufactured
with a class II substance, imposed by Section 610(d) of the Act.
Section 610(d)(1) states that after January 1, 1994, ``it shall be
unlawful for any person to sell or distribute, or
[[Page 31777]]
offer for sale or distribution, in interstate commerce--(A) any aerosol
product or other pressurized dispenser which contains a class II
substance; or (B) any plastic foam product which contains, or is
manufactured with, a class II substance.'' Section 610(d)(2) authorizes
EPA to grant certain exceptions and Section 610(d)(3) creates
exclusions from the Class II Ban in certain circumstances.
Section 610(d)(2) authorizes the Administrator to grant exceptions
from the Class II Ban for aerosols and other pressurized dispensers
where ``the use of the aerosol product or pressurized dispenser is
determined by the Administrator to be essential as a result of
flammability or worker safety concerns,'' and where ``the only
available alternative to use of a class II substance is use of a class
I substance which legally could be substituted for such class II
substance.''
Section 610(d)(3) states that the ban of class II substances in
plastic foam products shall not apply to ``foam insulation products''
or ``an integral skin, rigid, or semi-rigid foam utilized to provide
for motor vehicle safety in accordance with Federal Motor Vehicle
Safety Standards where no adequate substitute substance (other than a
class I or class II substance) is practicable for effectively meeting
such standards.'' Unlike the Class I Ban, the Class II Ban was self-
executing. Section 610(d) bans the sale of the specified class II
products by its own terms, without any reference to required EPA
regulations. However, EPA did issue regulations implementing the Class
II Ban in order to better define the products banned under Section
610(d) and to grant authorized exceptions under Section 610(d)(2).
Section 301(a) of the Act gives EPA the authority to promulgate such
regulations as are necessary to carry out its functions under the Act,
and EPA determined that it was necessary to issue the Class II Ban
regulations for those purposes.
1. Reconsideration
Since the issuance of the final rule providing exemptions from the
statutory Class II Ban, EPA amended the final rule with regards to fire
suppression based on compelling information that the Agency received.
That amended regulation was issued in the Federal Register on December
4, 1996 (61 FR 64424) and subsequently codified at 40 CFR Part 82,
subpart C.
EPA has received information indicating that it may be appropriate
to reconsider the continued relevance of the current list of exemptions
for specific aerosol products and pressurized dispensers. The Agency is
aware that since the issuance of that initial final rulemaking, there
has been further substitution away from ozone-depleting substances for
a variety of aerosol products and pressurized dispensers.
2. Determinations Under Section 610(d)
The statutory criteria for providing an exemption from the Class II
Ban are explicit. For any potential exemption the use of the aerosol
product or pressurized dispenser must be found to be essential based on
flammability or worker safety concerns and EPA must find that the only
available alternative to use of a class II substance is use of a class
I substance which could legally be substituted for such class II
substance.
The initial final rulemaking regarding the Class II Ban provided
exemptions for:
Lubricants, coatings, or cleaning fluids for aircraft
maintenance containing HCFCs as solvents;
Lubricants, coatings, or cleaning fluids for electrical,
electronic or photographic equipment containing HCFCs as solvents;
Aircraft pesticides; Mold release agents
containing HCFCs as solvents;
Mold release agents containing HCFC-22 as a propellant,
for use where no alternative, including an alternative formulation, is
available and where the seller must notify purchaser about the
restriction;
Spinnerette lubricant/cleaning sprays containing HCFCs as
solvents and/or propellants;
Document preservation sprays containing HCFCs as solvents;
Document preservation sprays containing HCFCs as
propellants, for use on thick books, books with coated or dense paper,
and tightly bound documents, only;
Portable fire extinguishing equipment containing HCFCs as
fire extinguishants, for use in non-residential applications only; and
Wasp and hornet sprays, for use near high-tension power
lines only and where the seller must notify purchaser about
restrictions.
3. Future Notice of Proposed Rulemaking
EPA is currently reviewing information concerning the above aerosol
products and pressurized dispensers given exemptions in the December
1993 rulemaking. In particular, the Agency is evaluating whether there
are technologically available substitutes for the HCFCs used in these
products. Since the implementation of the Class II Ban on January 1,
1994, progress has been made to further identify substitutes for
various applications. In addition, as stated above, the SNAP program
has been established and provides lists of acceptable substitutes for
various applications, including applications affected by the Class II
Ban. When EPA completes its evaluation of the existing exemptions for
HCFCs in pressurized dispensers and aerosol products, the Agency plans
to issue a notice of proposed rulemaking and request comments, should
the Agency determine that any rule revisions are appropriate.
III. Today's Action
Today, EPA is proposing to revise the Class I Ban to include
additional products and to eliminate exemptions. EPA is proposing to
expand the scope of the Class I Ban to include additional categories of
products.
A. Foam Products
Today, EPA is proposing to ban the sale and distribution and offer
of sale or distribution in interstate commerce of all foam products
(both insulating and non-insulating) that release class I substances
into the environment (including any release during manufacture, use,
storage, or disposal). EPA believes there are acceptable substitutes
available for replacing any continued use of class I substances as
blowing agents for foam products. For example, the SNAP program lists
exemptions for various foam applications by providing lists that are
specific to the type of foam for which the particular substitute has
been listed as acceptable. These categories are rigid polyurethane used
in appliances and commercial applications, flexible polyurethane,
integral skin polyurethane, polyurethane extruded sheet foam,
polyolefin, rigid polyurethane slabstock, polystyrene, extruded
boardstock & billet, rigid polyurethane and polyisocyanurate laminated
boardstock, and phenolic insulation board and bunstock. The SNAP
program does not consider the efficacy of the substitute substance as a
replacement for the ozone-depleting substances in each application.
However, given the phaseout of production for the class I substances
previously used in these products, and the information gathered through
trade associations, newsletters, media articles, technical
publications, and United Nations Environmental Programme (UNEP)
Technical Options Committee reports, it appears that for all foam
products, there are currently sufficient
[[Page 31778]]
technically available substitutes for the use of a class I substance.
EPA requests comments on revising the Class I Ban to ban the sale and
distribution or offer of sale and distribution in interstate commerce
of any foam plastic product or plastic foam product that releases class
I substances into the environment (including any release during
manufacture, use, storage, or disposal). EPA will consider any specific
data indicating that substitutes are not available for certain foam
products.
B. Aerosol Products and Pressurized Dispensers
As stated above, EPA initially provided exemptions for a narrow
list of aerosol products and pressurized dispensers that release class
I substances into the environment. EPA today, is proposing to eliminate
exemptions for: gauze bandage adhesives & adhesive removers, topical
anesthetic and vapocoolant products, lubricants for pharmaceutical
tablet manufacture, containers of CFCs used as halogen ion sources in
plasma etching, and red pepper bear repellent sprays containing CFC-113
as a solvent. EPA believes that substitutes are available for such uses
of class I products and therefore that such use is no longer essential.
EPA is not proposing any changes to the exemption for medical devices
that are determined to be essential by the Food and Drug Administration
and are listed at 21 CFR 2.125(e). Products such as metered dose
inhalers (MDIs) are listed at 21 CFR 2.125(e). The Class I Ban will
continue to provide an exemption for the sale and distribution or offer
of sale or distribution in interstate commerce of MDIs that release
class I substances into the environment, as well as any other essential
medical device listed at 21 CFR 2.125(e).
Given the statutory links established between the Class I and Class
II Bans for aerosol products and pressurized dispensers, namely the
criterion in 610(d) that states that the alternative to the use of a
class II substance is the legal use of a class I substance, at this
time EPA is not proposing to eliminate exemptions for aerosol products
or pressurized dispensers from the Class I Ban that are also exempted
from the Class II Ban. However, if and when EPA subsequently issues a
proposed rulemaking reconsidering those exemptions from the Class II
Ban, that notice will also include the reconsideration for the
remaining aerosol products and pressurized dispensers under the Class I
Ban as well.
EPA requests comments on the proposed changes to the list of
exemptions for aerosol and pressurized dispensers that release class I
substances into the environment, and specifically any data indicating
that such uses are still essential.
C. Air-Conditioning and Refrigeration Appliances
The initial rulemaking implementing the Class I Ban specifically
considered refrigeration and air-conditioning. As noted above, at the
time the initial rulemaking was promulgated, substitutes were available
for some refrigeration and air-conditioning products; however,
potential substitutes for other refrigeration and air-conditioning
applications were still under development and evaluation. Thus EPA did
not include prohibitions on the use of class I substances in
refrigeration or air-conditioning in that rulemaking.
Currently there are substitutes identified for a variety of
refrigeration and air-conditioning applications. While substitutes
continue to be developed and evaluated for these applications, the
Agency is confident that there are sufficient technologically available
substitutes for the use of class I substances in all refrigeration and
air-conditioning applications as documented in the docket for this
rulemaking. The SNAP program also provides lists of acceptable
substitutes for various applications.
Since the production and importation of CFCs ceased January 1,
1996, EPA believes it is highly unlikely that there would be continued
domestically manufactured air-conditioning and refrigeration appliances
with CFCs. EPA has raised this question at industry stakeholder
meetings and other forums with representatives from the air-
conditioning and refrigeration manufacturing community, as well as with
the refrigerant suppliers for these manufacturers. EPA recognizes that
there may be a limited number of products manufactured abroad and
imported into the United States as well as some potential domestic
manufacturing of refrigeration and air-conditioning products containing
class I substances that EPA is not aware of; however, given the
criteria for nonessentiality discussed above, EPA believes that air-
conditioning and refrigeration appliances that contain CFCs meet the
criteria for nonessential uses of a class I substance. Therefore, it is
reasonable for the Agency to consider broadening the applicability of
the Class I Ban to include refrigeration applications. EPA is today
proposing to amend Sec. 82.66 to add a provision banning the sale and
distribution or offer for sale or distribution of air-conditioning and/
or refrigeration appliances that contain class I substances.
EPA heard from two manufacturers regarding potential economic
impacts of this proposal. A manufacturer has stated that well over 90%
of the compact refrigerators are sold by large retailers and very small
quantities are sold by small dealers. Another manufacturer reported
that several foreign manufacturers have exported compact refrigerators
containing CFCs and non-CFC containing compact refrigerators into the
U.S. during 1998. Since they are able to produce both types of
refrigerators, the use of CFCs should be considered a ``nonessential
use of class I substances in a product.'' One manufacturer believed
that the differential in manufacturing costs is between $2.00 and $3.00
per unit, which might translate into a $5.00 price differential if the
costs are passed on to the consumer. EPA requests comments regarding
the costs and sales of these refrigerators.
EPA would like to clarify that consistent with all other products
subject to the nonessential products bans, this proposed addition of
air-conditioning and refrigeration appliances covers the sale and
distribution of new products, not used products. Furthermore, this
proposal would not affect the servicing of existing products with class
I refrigerants.
EPA requests comments on expanding the Class I Ban to include air-
conditioning and refrigeration appliances. In particular, EPA requests
comments regarding whether there are sufficient technologically
available substitutes for the use of class I substances in all new air-
conditioning and refrigeration appliances.
IV. Proposed Effective Dates and Grandfathering
EPA is proposing that the effective date for the proposed changes
to this rulemaking 60 days from the date of publication of a final rule
in the Federal Register. Given the potential harm releases of class I
substances represent and given that most products affected by these
proposed changes to the ban no longer use class I substances, EPA
believes this is an appropriate effective date. The Agency also
considered the potential for a longer implementation date for these
proposed regulatory changes, such as 6 months from the date of
publication of the final rule in the Federal Register; however, as
stated
[[Page 31779]]
above, this additional time did not seem necessary and thus is not the
Agency's lead option. However, EPA requests comments and rationale
regarding both the proposed 60-day effective date and alternative
effective dates for the proposed changes discussed in this notice.
V. Summary of Supporting Analysis
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether this proposed regulatory action is
``significant'' and therefore subject to OMB review and the
requirements of the Executive Order. The Order defines ``significant
regulatory action'' as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlement, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
It has been determined by OMB and EPA that this action is not a
``significant regulatory action'' under the terms of Executive Order
12866 and is therefore not subject to OMB review under the Executive
Order.
B. Regulatory Flexibility
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis for this proposed rule. EPA believes that this
proposed rule will not have a significant economic impact on a
substantial number of small entities. EPA has received a letter from a
manufacturer citing market research from import reports by the
Department of Commerce. This manufacturer stated that well over 90% of
the compact refrigerators are sold by large retailers and very small
quantities are sold by small dealers. Another manufacturer reported
that several foreign manufacturers have exported compact refrigerators
containing CFCs and non-CFC containing compact refrigerators into the
U.S. during 1998. Since they are able to produce both types of
refrigerators, the use of CFCs should be considered a ``nonessential
use of class I substances in a product.'' Our assessment indicates that
replacing the CFC portion of the import market with more non-CFC
refrigerators is economically and technically feasible. One
manufacturer believes that the differential in manufacturing costs is
between $2.00 and $3.00 per unit, which might translate into a $5.00
price differential if the costs are passed on to the consumer.
In light of the ready supply, coupled with a low price
differential, EPA certifies that very little if any negative impact
would be felt by the small distributors.
C. Unfunded Mandates Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (``Unfunded
Mandates Act'') (signed into law on March 22, 1995) requires that the
Agency prepare a budgetary impact statement before promulgating a rule
that includes a Federal mandate that may result in expenditure by
State, local, and tribal governments, in aggregate, or by the private
sector, of $100 million or more in any one year. Section 203 requires
the Agency to establish a plan for obtaining input from and informing,
educating, and advising any small governments that may be significantly
or uniquely affected by the rule. Section 204 requires the Agency to
develop a process to allow elected state, local, and tribal government
officials to provide input in the development of any action containing
a significant Federal intergovernmental mandate. Under section 205 of
the Unfunded Mandates Act, the Agency must identify and consider a
reasonable number of regulatory alternatives before promulgating a rule
for which a budgetary impact statement must be prepared. The Agency
must select from those alternatives the least costly, most cost-
effective, or least burdensome alternative that achieves the objectives
of the rule, unless the Agency explains why this alternative is not
selected or the selection of this alternative is inconsistent with law.
Because this proposed rule is estimated to result in the
expenditure by State, local, and tribal governments or the private
sector of less than $100 million in any one year, the Agency has not
prepared a budgetary impact statement or specifically addressed the
selection of the least costly, most cost-effective, or least burdensome
alternative. Because small governments will not be significantly or
uniquely affected by this proposed rule, the Agency is not required to
develop a plan with regard to small governments. Finally, because this
NPRM does not contain a significant intergovernmental mandate, the
Agency is not required to develop a process to obtain input from
elected state, local, and tribal officials.
D. Paperwork Reduction Act
This action requires no information collection subject to the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and therefore no
information collection request will be submitted to OMB for review.
E. Executive Order 12875: Enhancing the Intergovernmental Partnership
Under Executive Order 12875, EPA may not issue a regulation that is
not required by statute and that creates a mandate upon a State, local
or tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments, or EPA consults with those governments. If EPA complies by
consulting, Executive Order 12875 requires EPA to provide to the Office
of Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create a mandate on State, local or tribal
governments. The rule does not impose any enforceable duties on these
entities. Accordingly, the requirements of section 1(a) of Executive
Order 12875 do not apply to this rule.
F. National Technology Transfer and Advancement Act
The National Technology Transfer and Advancement Act of 1995
(NTTAA), section 12(d), Public Law 104-113, requires federal agencies
and departments to use technical standards that are developed or
adopted by voluntary consensus standards bodies, using such technical
standards as a means to carry out policy objectives or activities
determined by the agencies and departments. If use of such technical
standards is inconsistent with applicable law or otherwise impractical,
a federal agency or department may
[[Page 31780]]
elect to use technical standards that are not developed or adopted by
voluntary consensus standards bodies if the head of the agency or
department transmits to the Office of Management and Budget an
explanation of the reasons for using such standards.
This proposed rule does not mandate the use of any technical
standards; accordingly, the NTTAA does not apply to this rule.
G. Applicability of Executive Order 13045
This proposed rule is not subject to E.O. 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not an
economically significant regulatory action as defined in E.O. 12866 and
because it does not involve decisions on environmental health risks or
safety risks that may disproportionately affect children.
H. Executive Order 13084: Consultation and Coordination With Indian
Tribal Governments
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments ``to provide meaningful
and timely input in the development of regulatory policies on matters
that significantly or uniquely affect their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments, because this regulation
applies directly to facilities that use these substances and not to
governmental entities. Accordingly, the requirements of section 3(b) of
Executive Order 13084 do not apply to this rule.
List of Subjects in 40 CFR Part 82
Administrative practice and procedure, Air pollution control,
Chemicals, Chlorofluorocarbons, Exports, Hydrochlorofluorocarbons,
Imports, Interstate commerce.
Dated: June 4, 1999.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble title 40, chapter I of the
Code of Federal Regulations, is proposed to be amended to read as
follows:
PART 82--PROTECTION OF STRATOSPHERIC OZONE
1. The authority citation for Part 82 continues to read as follows:
Authority: 42 U.S.C. 7414, 7601, 7671-7671q.
Subpart C--[Amended]
2. Section 82.66 is amened by removing paragraphs (d)(2)(ii),
(iii), (iv),(ix), and (xi); by redesignating (d)(2)(v) through
(d)(2)(viii) as (d)(2)(ii) through (d)(2)(v); by redesignating
(d)(2)(x) as (d)(2)(vi); by revising paragraph (c); and by adding
paragraph (e) to read as follows:
Sec. 82.66 Nonessential Class I Products and Exceptions.
* * * * *
(c) Any plastic foam product which is manufactured with or contains
a class I substance.
* * * * *
(e) Any air-conditioning or refrigeration appliance which contains
a class I substance used as a refrigerant.
[FR Doc. 99-15014 Filed 6-11-99; 8:45 am]
BILLING CODE 6560-50-P
