United States
Environmental Protection
Agency
Air and Energy Engineering
Research Laboratory
Research Triangle Park, NC 27711
Research and Development
EPA/600/S2-89/061 Feb. 1990
4*EPA Project Summary
Alternative Formulations to
Reduce CFC Use in U.S.
Exempted and Excluded Aerosol
Products
Thomas P. Nelson and Sharon L. Wevill
Chlorofluorocarbons (CFCs) were
banned from use as aerosol
propellants In the U.S. in 1978.
However, the ban allowed for certain
exemptions if it could be
demonstrated that no acceptable
alternative propellants were available
and that the products were essential.
Essentiality was based on three
criteria: 1) the economic significance
of the product; 2) the environmental
and health impacts of the product and
its substitutes; and 3) the effects on
the quality of life resulting from no
longer having the product or a
reasonable substitute available. If a
CFC served some purpose other than
as the propellant, that product was
excluded from the regulation. This
report examines the products
exempted and excluded from the 1978
ban,the present consumption of CFCs
still utilized for these products in the
U.S., and alternative formulations
which may be used to reduce or
eliminate the CFC content of these
products. The study shows that about
40% of the CFC usage in these
products can be immediately replaced
by available substitutes. Seven
categories of products were identified
for which immediate replacement of
all of the CFC content is not
technically feasible. Complete CFC
replacement in these products must
await the commercialization of newer
substitutes currently being developed
by industry. However, some reform-
ulation is possible in the interim for
some of these seven categories,
allowing for reduction of CFC usage.
The product category requiring the
longest time to reformulate appears to
be metered-dose inhalant drug
products which will require the newer
chemicals and which must also be
subjected to regulatory approval by
the U.S. Food and Drug
Administration.
This Project Summary was
developed by EPA's Air and Energy
Engineering Research Laboratory,
Research Triangle Park, NC,, to
announce key findings of the research
project that is fully documented in a
separate report of the same title (see
Project Report ordering information at
back).
Introduction
The use of Chlorofluorocarbons (CFCs)
in categories of aerosol propellant use
considered "nonessential" was banned in
the U.S. by regulations promulgated in
1978. An aerosol was defined as a
package consisting of a self-pressurized,
non-returnable container constructed of
metal, glass, or plastic that contains a
fluid product and that is fitted with a valve
for expelling the product as a spray,
liquid, gas, foam, powder, or paste. The
banned CFC propellants were the fully
halogenated types: CFC-11, CFC-12,
CFC-113, CFC-114, and CFC-115.
New EPA regulations were pro-
mulgated in 1988 to implement the
Montreal Protocol of 1987. Under the
1988 regulations, the entire supply of
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fully halogenated chlorofluorocarbons will
be reduced.
tn view of the recent renewed interest
in reducing worldwide production and
consumption of CFCs and other
chemicals implicated in the depletion of
the Earth's stratospheric ozone layer, the
U.S. Environmental Protection Agency
(EPA) undertook a study of currently
exempted and excluded CFG aerosol
applications and their alternatives. The
report of that study is summarized in this
document.
The EPA report lists CFG aerosol
applications exempted and excluded by
the 1978 regulations and provides the
rationale for those cases. Technically
feasible methods for reducing CFCs in
these aerosol products are suggested.
Formulation options for a number of
products that currently use regulated
CFCs are presented, as are the factors
considered in developing the alternative
formulations. Formulation options are
presented in the context of flammability
(on© of the most important
considerations), manufacturing difficulty,
cost, and end-use acceptability.
Conclusions are presented for seven
categories of aerosol uses in which CFCs
are most difficult to eliminate, and partial
or interim reformulations of some
categories to decrease CFG use are
noted. Possible CFC reductions, based
on several scenarios, are shown.
Elements of the proposed CFC
reduction plan are compared with the
scheduled reductions called for by the
1987 Montreal Protocol, and additional
studies on aerosol formulation are
recommended.
Exempted/Excluded CFC Aerosol
Applications
Table 1 lists CFC aerosol applications
exempted from EPA's 1978 regulation.
Tho 14 applications shown in Table 1
were exempted because they required a
CFC propellant for reasons of safety,
health, or national security.Some CFC
aerosol applications were excluded from
the 1978 regulation because they contain
propellant only; that is, the propellant is
the sole ingredient and may be
considered the product itself. If the CFC
serves any purpose other than as the
propelling agent, the CFC is deemed an
active ingredient and the product is also
excluded from regulation. Table 2 lists
such excluded CFC aerosol applications.
Rationale for Exempting,
Excluding, or Not Regulating
The rationale applied in 1978 and 1979
by EPA and the Food and Drug
Administration (FDA) when considering
proposed exemptions included:
The need for a nonflammable
product;
The 5 years often taken by the Drug
Division of the FDA to approve an
Amended New Drug Application
(applies to bronchodilators and other
inhalants);
Required solvency and purity
profiles;
Doctrine of equivalency-that highly
similar products cannot reasonably
be treated differently
Limited availability of substitute
propellents or products;
Stratospheric ozone impact (e.g.,
production tonnage per year) and
Life-saving potential of the proposed
exempted product (e.g., medical,
military, flammable gas alarm
systems).
The rationale for exempting specific
essential uses of CFC aerosols is
examined. The 14 specific applications
listed in Table 1 are discussed, as are
specific excluded applications (such as
skin chillers used for medical purposes)
and nonregulated applications.
Approximately 28 product types and
groups have been or are being produced
in aerosol formulas that contain CFCs.
Background data on each product or
product group are provided, including
how the CFC component functions.
Industry's interest in preserving the CFC
ingredient(s) is explained. The primary
reasons for requesting exempted status
were the unavailability of substitutes, the
long delays while obtaining approval from
the FDA, solvency and purity profiles
(especially for CFC-113 uses), life-saving
potential of the product, and regulations
in hospitals, aircraft organizations, etc.
against the use of flammable propellents
in aerosols.
During the 1977 to 1978 transition
period, no nonflammable liquid propellant
alternatives to CFCs were lexicologically
approved and commercially available for
use. Today the situation has changed,
with the clearance of HCFC-22 and
certain blends of HCFC-22/142b, and the
forthcoming availability of HFC-134a,
HCFC-123, HCFC-141b, and HCFC-124.
As may be anticipated, some
exempted, or excluded, products are no
longer in use or have been replaced with
ones that contain alternative propellants.
However, inhalant and solvent type
products are steadily growing in sales
volume.
Factors Considered When
Developing Alternative
Formulations
Two or more formulation options are
presented for a number of products that
currently use regulated CFCs. Some
have a relatively greater potential than
others for stratospheric ozone depletion.
The following factors were considered
when developing the alternative
formulations:
Production of sprays with desired
particle size distribution;
Control of flammability;
Precautionary use of questionable
solvents, such as methylene chloride;
Miinimum changes in anticipated use
patterns;
Maintenance of dispenser and
organoleptic stabilities;
Cost of alternative formulations;
Availability of the alternative, including
Toxic Substance Control Act (TSCA)
considerations;
Pressure limitations;
Product utility or efficacy for intended
uses;
Toxicological factors; and
Spray rate and use-up rate
optimization.
Aerosol Reformulation Options
(1989-1993)
When substituting alternative aerosol
formulas for CFC-based aerosol
products, one of the most important
considerations is flammability. De-
pending on circumstances, one or more
of three main formulation routes (shown
in Figure 1 will be taken.
For companies producing CFC
aerosols, the transition to non-CFC
formulations will increase in difficulty and
cost (and often decrease in acceptability)
as the replacement formulas go from
Type 1A to 3B (shown in Figure 1).
Costs of Converting Filling
Lines
Many of the current fillers and
marketers of non-pharmaceutical CFC-
type aerosol products are not equipped
to handle flammable propellants. To
handle Type 3 products, most would
either have to 1) commit capital, time,
and training resources to convert, while
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Table 1. Exempted Aerosol Propellent Applications-1978
1. Release agents for molds used to produce plastic and elastomeric materials.
2. Lubricants for rotary-type press-punches for the production of pharmaceutical tablets.
3. Lubricants, cleaner-solvents, de-dusters or coatings for industrial/institutional applications to electronic or
electrical equipment.
4. Mercaptan stench warning devices for mines.
5. Other warning devices, such as intruder alarms; boat horns, bicycle horns.
6 Flying insect pesticides for use in commercial food handling areas, except when applied by total release or
metered valve aerosol devices.
7. Propellants for flying insect pesticides for the fumigation of aircraft.
8. Flying insect spray for tobacco barns.
9. Metered dose inhalant drugs, as follows:
steroid drugs for humans, (oral and nasal),
Ergotamine tartrate drugs, and
Adrenergic bronchodilator drugs (oral).
10. Contraceptive vaginal foams for human use.
11. Aerosols for the maintenance and operation of aircraft.
12. Aerosols necessary for the military preparedness of the U.S.
13. Diamond grit sprays.
14. CFC-II5 (CCIF2-CF3 for the aeration of puffed food product.
Table 2. Nonregulated CFC Aerosol Applications (Propellant as Active Ingredient)
1. CFC-12 used as a polyurethane blowing agent (insulation foams).
2. CFC-12 and CFC-114 mixtures used in tire inflators.
3. Certain specialty foams, whips, and puffs.
4. Medical solvents such as silicone-based bandage adhesive (CFC-113) and bandage adhesive
remover (CFC-113, with 5% CO2.
5. CFC-12 and CFC-114 refrigeration and air-conditioning system refill units.
6. Drain openers.
7. Microscope slide cleaners.
8. Computer cleaners and dusters (equivalent to No. 3 in Table 1).
9. Boat horns.
10. Halon fire extinguishers (4 and 15 oz. containers)
11. Intruder alarm sonic devices for homes and cars.
12. Skin chillers (medical).
still accepting a statistical risk of fire or 2)
use a contract filler equipped to handle
flammable propellents.
The conversion cost for a medium-
speed Type 3 aerosol line would average
$900,000. Smaller operators would
probably use contract fillers rather than
convert. Some of the larger operators
would be expected to convert only one
line, while the remaining larger operators
would probably convert only to Type 1
and Type 2 products or use a contract
filler.
Table 3 shows estimates of the total
industry costs of in-house filler
conversions from CFCs to the Type 1, 2,
and 3 products defined in Figure 1.
Conclusions
Seven categories of aerosol uses
involving CFCs have been judged most
difficult to eliminate:
1. Certain mold releases.
2. Lubricants for electrical and electronic
applications;
3. Lubricants for pharmaceutical pill and
tablet presses;
4. Solvent cleaners and dusters for
electronic and electrical equipment;
5. Metered-dose inhalant drugs;
6. Contraceptives for human use;and
7. Solvents for medical use.
Partial or interim reformulations for some
of the products in these categories are
noted, as are possible reductions, based
on several scenarios, for CFC
consumption in the U. S.
The perceived need for CFCs in these
seven product categories is based on the
lack of available alternatives that can
completely replace the CFCs at the
present time; however, approximately 40
percent of the CFCs now used in
exempted, or excluded U.S. aerosol
products can be replaced immediately.
Further, alternative non-CFC formulations
for some of the seven remaining CFC-
dependent categories are judged,
technically feasible, pending the
commercial availability of four "future1"
HCFCs and HFCs. Longer-range CFG
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7". Nelson and S. Wevilf are with Radian Corp., Austin, TX 78720
N. Dean Smith is the EPA Project Officer (see below).
The complete report, entitled "Alternative Formulations to Reduce CFG Use in
U.S. Exempted and Excluded Aerosol Products," (Order No. PB90
149972IAS;Cost: $23.00, subject to change) will be available only from:
National Technical Information Service
5285 Port Royal Road
Springfield, VA 22161
Telephone: 703-487-4650
The EPA Project Officer can be contacted at:
Air and Energy Engineering Research Laboratory
U.S. Environmental Protection Agency
Research Triangle Park, NC 27711
United States
Environmental Protection
Agency
Center for Environmental Research
Information
Cincinnati OH 45268
Official Business
Penalty for Private Use $300
EPA/600/S2-89/061
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