United States
Environmental
Protection Agency
Office of Air and Radiation
Stratospheric Protection Division
6205J
Mav 1995
Final Rule Summary
MEETING LABELING REGULATION REQUIREMENTS
This guidance offers manufacturers, distributors, wholesalers,
and retailers instruction on how to comply with the final
labeling regulation. Examples illustrate many of the key
regulatory features and clarifies the issues that have been
raised since the rule's publication in February 11, 1993 (58
FR8136). - -, '
KEY FEATURES ON THE FINAL REQUIREMENTS
On November 15, 1990; Congress amended the Clean
Air Act (CAA). Section 611 of the Act, as amended,
requires labeling of products made with or containing
class I and class II ozone-depleting substances. It also
requires that containers containing class I or class II
substances be labeled. The final regulation includes
the following key requirements:
1) Treatment of Products and Imports
Manufactured Prior to May 15, 1993
All products made before May 15, 1993 are exempt
from labeling requirements if the manufacturer is able
to show within 24 hours, upon request, that its prod-
ucts were made before that date.
If an importer imports products made prior to May 15,
1993 he/she rnust show, upon request by EPA, that
such products were made before the deadline. The
date of manufacture may appear in supplemental
printed material such as shipping papers, bills of
lading, and invoices, or may be made available
through index code references, or any other means by
which a company tracks its products.
2) Products Manufactured with Class I Substances
Label Pass-Through Requirement
Manufacturers of products that use a class I substance
must label their products. Such products manufac-
tured, with class I substances may be electronic parts
washed in class I solvents, such as electrical compo-
nents and metal products, plumbing fixtures, and
products using class I adhesives, such as some packag-
ing, books, and sporting goods. If. a manufacturer
purchases a product from a supplier that labels its
product "manufactured with," the manufacturer does
not need to incorporate that information into a label on
its final product. In other words, manufacturers need
only label their products according to their own direct
manufacturing process. Labels on products containing
class I substances and containers of class I or class II
substances, however, must be passed through the
stream of commerce to the ultimate consumer, since
the ozone-depleting substance is contained at the time
of purchase. In the case of adhesive or solvent
products, the. purchaser is likely to release the sub-
stance upon application of the product.
For example, a product containing, such as an adhe-
sive, must be labeled as "containingn. When that
product is applied by a subsequent manufacturer in
affixing a cushion to a seat, the seat must be labeled as
a "product manufactured with" because the class I
substance in the adhesive has been released. The
subsequent sale of the seat to an automobile manufac-
turer would not result hi labeling of a car based on
that product. .
Subsidiaries and the Label Pass-Through Requirement
The rule states that wholly-owned subsidiaries are part
of a parent company and are required to pass the
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warning statement between subsidiaries. If a subsid-
iary is not 100 percent wholly-owned, the label is not
required to be passed through from one subsidiary to
another.
If a parent company owns 100 percent of another
company and sells a small portion following the
effective date of this regulation, EPA may look
unfavorably upon the parent company if it appears that
the company made the change with, intention of
avoiding the label pass-through requirement by selling
a small share of its subsidiary company.
A Reduction in Use ofCFC-113 and/or Methyl Chloro-
form Over 1990 Use (Applicable Only Until 5/15/94)
If a company (including its divisions, branches, or
facilities) achieved a total use reduction of methyl
chloroform (MCF) and/or CFC-113 used as solvents
in its manufacturing processes by 95 percent or greater
over its 1990 use, its products manufactured with
MCF and/or CFC-113 could have been exempted
from the labeling requirements. It must have achieved
the above reduction either over the most recent calen-
dar year, or for a 12-month period ending within 60
days of its certification to EPA.
Companies were to have submitted certifications to
EPA under this provision until May 15, 1994.
Incidental, Uses of Class I Substances
Labeling is not required for non-contact incidental
uses of class I substances, including:
•A process in which a class I substance, such as a
solvent, is used to clean or maintain manufacturing
equipment, where the surface area being cleaned has
no direct contact with the product.
•A process in which a class I substance is used in
refrigerated equipment to keep food products cold; the
refrigerant does not come into direct contact with the
food products.
Labeling is not required for some contact incidental
uses that are:
•A process in which a class I substance is used inter-
mittently, not routinely, as part of the direct manufac-
turing process, such as spot cleaning textiles, cleaning
ink plates, or testing for leaks in a cooling system and
condenser.
•A process in which there is an initial contact between
the substance and the product, that occurs infrequently
(typically as part of a maintenance process), and
perhaps unintentionally. An example-is the use of
methyl chloroform as a spot remover in the textile
industry; it is used infrequently and is not routine part
of the manufacturing process.
Labeling is required for uses that are not considered to
be incidental. These include:
•Most mold release agents that are applied systemically
throughout a manufacturing process.
•Defluxing of printed circuit boards during a continu-
ous production process. . • *•
•Food processing, such as the manufacturing of some
spices.
3) Products Containing Class I Substances and
Containers of Class I or Class n Substances
*
The Distinction Between Containers and Products
Containing
Containers of class I or class II substances or mixtures
containing one of these substances must be labeled as
of the effective date of the regulation. Products
containing class I substances must also be labeled on
May 15, 1993.
Products containing class II substances will be re-
quired to be labeled before January 2015 should the
Administrator make the determination that substitutes
are available for those products.
A container contains a class I substance if the sub-
stance must be transferred into another container or
into another product in order to realize its intended
use.
•Examples are a 5-gallon can of CFC-12, or an isotank.
of MCF, which would eventually be transferred into
other vessels, such as refrigeration equipment or
degreasing units, for their intended use.
A product contains a class I substance if the substance
is used in the container or equipment without having
to be transferred. Examples include some aerosols,
solvents, adhesives, inks, coatings, and closed-cell
foams.
Upon subsequent use of these products, however, a
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company-would label its products ." manufactured with"
(see example above in #2).
"Products containing" also include some air-condition-
ing and refrigeration equipment. When they are
installed in other products, such as automobiles, their
labels would remain the same, because the refrigerant
is intact at the point of purchase.
Treatment of Containers of Recaptured Substances and
Waste ' . , '
Companies are exempt from labeling waste that is to
be discarded, i.e., landfilled or incinerated. Waste
that is to be recycled or reclamed still requires a
label. .' -• ---•.,•••
Destruction Exemption .
Companies that destroy controlled substances used in
their manufacturing processes to a 98 percent destruc-
tion efficiency are exempt from the labeling require-
ments, provided they use any of the following five
destruction technologies: liquid injection incineration,
reactor cracking, gaseous/fume oxidation, rotary kiln
incineration, and cement kiln.
Trace Quantities of Impurities Resulting from Inadver-
tent .Production, Unreacted Feedstocks, and Process
Ag?nts
Inadvertent Production: EPA realizes there are cir-
cumstances in which an ozone-depleting substance is
formed from a chemical reaction that takes place in a
manufacturing process, such as the formation of
carbon tetrachloride in the chlorination of drinking
water. Such production is unintentional, resulting in
trace quantities of a class I substance remaining in the
final product, and therefore does not-trigger the
labeling requirements. Exemptions for trace quantities
are exemptions only for products "containing." and not
for products "manufactured with." Only products
"containing" can actually "contain" trace quantities.
t
Process Agents: In addition, when manufacturers use
an ozone-depleting substance as a feedback or a
process agent in their manufacturing processes and
insignificant or trace quantities of the substance
remain in the final product, the product is exempt
from the labeling requirements for a "product contain-
ing." .
For example, carbon tetrachloride is used as a catalyst
in producing chlorinated rubber; the remaining trace
amounts in final product would not trigger the labeling
requirements for a "product containing." This intro-
duction of the substance is essential to the process and
is neither consumed nor inadvertently produced, thus
the final product would be labeled as a "product
manufactured with."
In the case where a process agent is introduced, then
removed from a product-such as in the case of many
explosion suppressants—the product would still require
a label indicating it was "manufactured with a class I
substance," unless the removed substance is subse-
quently transformed.
Treatment of the Use of Class I Substances for Re-
pairs, Used Products and Spare Parts
If a company sells solvent-cleaning products that do
not contain ozone-depleting substances, and those
products are used by manufacturers who may use
ozone-depleting substances in their processes and then
return the used solvent product for recycling, any
contamination of those used non-class I solvents
resulting in trace amounts of class I substances in the
recycled product, would not trigger labeling.
If a company recycles solvents or other chemical
products that contain class I substances necessary as
part of their composition, it must label the new (recy-
cled) product as a "product containing" a class I
substance, since the
class I substance contained therein is necessary to the
functioning of the product.
If a company sells used products, it is not required to
relabel them, because they have already been intro-
duced into interstate commerce.
If a company performs repairs or upgrades on prod-
ucts using class I substances, it is not required to label
them; however, if it purchases components made with
class I substances, those components should be la-
beled, but the label is not required to be passed
through wirn the product. Products being upgraded,
for example, would not require a new label on the
final product, because they are not being introduced
into interstate commerce.
A company is exempt from the labeling pass-through
requirement for spare parts that are purchased from
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another manufacturer and intended solely for repair
purposes. Spare parts manufactured with a class I
substance would require a label; however, once these
parts are sold to a distributor who is to sell them to
repair persons, such distributor would not be required
to pass the label through, as long as the spare parts are
sold to persons using diem for repair purposes only.
4) Label Appearance and Placement
How the Labels Must Look
Format the labels so that they are in a square or
rectangular area widi or without a border. The word
"WARNING" must be in capital letters. See rule for
type size requirements.
The warning statement must be hi strong contrast
against its background. For example, black on white
or red on white present strong contrasts; however,
yellow on white or dark blue on green do not. The
key is that the warning statement be "clearly legible
and conspicuous."
The warning statement may be printed directly on a
product or its outer packaging, or on alternative
labeling; actual adhesive labels, although an option,
are not required.
Wfure the Labels Should Appear
Principal Display Panel (POP) or a Display Panel
Area. Placing the warning statement on any of these
display panels clearly meets die mandate that die
statement be clearly legible and conspicuous.
Alternative Labels. These may be used, as long as die
statement is clearly legible and conspicuous. Exam-
ples are hang tags, tape, cards, stickers, and orner
similar types of overlabeling.
Outer Packaging. The warning statement may be
placed in die product's outer packaging if the product
is sold in its packaging, or if the consumer is able to
read and understand the warning statement on such
packaging at the tune of purchase.
Supplemental Printed Materials. Placing the warning
statement conspicuously in supplemental printed
information that accompanies the product or container,
such as invoices, bills of lading, package inserts, and
Material Safety Data Sheets (MSDS) at the time of
purchase meets die requirements as long as the pur-
chaser can read the warning statement upon purchase.
Regardless of size, all containers may be labeled .using
supplemental printed material, provided die material
is readily available to die consumer and die warning is
legible and conspicuous.
Promotional Materials. For products purchased
dirough telephone or mail orders, print die warning
statement in a conspicuous place in sales promotional
literature, journals, newspapers, or displays so me
warning statement is available before die time of
purchase. -A company could include an insert in such
printed material bearing die warning statement.
Anodier option would be die use of supplemental
printed materials diat accompany die product at die
time of delivery. Widi diis option, die consumer must
be able to return die product if, at die time of delivery
or payment, diey choose not to make die purchase
based on die warning statement.
Products diat are labeled on any one of die above
mediods do not require additional labeling.
5) Treatment of Products Manufactured for Export
Products manufactured for export are not required to
be labeled, but diere must be sound evidence diat such
products are intended for export. This could include:
•Clear identification of an export area in a warehouse.
•Destination papers, shipping papers, or otiier docu-
mentation indicating diat die products are intended for
export. This information must be readily available on
site upon request by EPA.
6) Treatment of Products Manufactured for Import
The importer will be held liable for all products
subject to die labeling requirements imported into die
United States. These products are introduced into
interstate commerce at die site of U.S. Customs
clearance and include products manufactured widi
controlled substances.
Importers must have a reasonable belief diat products
introduced into interstate commerce are accurately
labeled. In order to have a reasonable belief, import-
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ers may investigate at least one step back into the
manufacturing process or develop a contractual/
agreement with its supplier indicating whether the
products have been made with ozone-depleting sub-
stances. An MSDS would be another option for
establishing- a reasonable belief.
An importer planning to incorporate its imported
product made with class I substances into a new
product must label the import; however, it is not
required to label its final product if no class I sub-
stance is used in the manufacture of the final product.
If the product contains a class I substance, such as an
air conditioner to be installed into an automobile, the
importer must label the final product (the vehicle) as
a product containing upon its introduction into inter-
state commerce.
Imports and products introduced "in bond" at the
U.S./Mexico border are considered imports and
subject to the labeling rule, regardless of
"Maquiladora" status.
7) Labeling of Packaging Materials
Manufacturing of Packaging Materials Made With
Class I Substances Must Label
If a company makes packaging materials using class I
substances, it must label its products as "manufactured
with a class I substance." The.company's customer,
however, is not required to pass the label on the
packaging materials through with its product. Exam-
ples of these products include some corrugated pack-
aging or open-cell foam-blown materials.
Manufacturers of Packaging Materials Used to Pack-
age Other Products Made by That Company
If a company makes its own packaging materials using
a class I substance and it also makes a product using
no ozone-depleting substances to be sold in those
packaging materials, its final package must be labeled
based on its use of class I substances in the packaging
materials.
For example, a candy company may use a class I
adhesive to affix a wrapper. The final product would
be labeled "manufactured with."
8) Products and Processes Under Research &
Development
The use of class I or class II substances in the research
and development of a product or process does not
require labeling, since neither one has been introduced
into interstate commerce. Upon a new product's
introduction into interstate commerce, labeling would
be required.
9) EPA Petition Processes ,
A manufacturer may petition EPA to add a class II
substance or process using such a substance to the
labeling regulation if EPA determines that substitute
products or processes: do not rely on class II sub-
stances; reduce the overall, risk to human health and
the environment; and, are currently or potentially
available. •
For products made with class I substances, a manufac-
turer may petition EPA to temporarily exempt a
product or process using a class I substance from the
labeling requirements if EPA determines that no
substitute products or processes exist that: do not rely
on class I substances; reduce the overall risk to human
health and the environment; and are currently or
potentially available. -
10) Introduction Into Interstate Commerce
There are three entry points into interstate commerce
for purposes of labeling requirements:
• Site of U.S. Customs (Customs) clearance.
Labeling may occur: (1) at the foreign production
facility per agreement between manufacturer and
importer, while in transit, or another location before
U.S. Customs inspects goods; (2) in supplemental
printed material prior to the products' entering the
location in which Customs inspection occurs.
• Introduction into manufacturer's, distributor's,
wholesaler's or retailer's warehouse. Labeling may
occur at manufacturer's production facility, or upon
entry into manufacturer's warehouse.
Distributors, wholesalers, and retailers must pass
labeling information through to the customer.
Labeling information received from a manufacturer
must remain with products in the warehouse until
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the distributor, wholesaler, or retailer distributes or
sells them. If the labeled products are repackaged
or requke new labels, such labeling must be secured
prior to the release of the products from the ware-
house.
For example, a distributor purchases a bulk ship-
ment of nuts and bolts that are labeled on supple-
mental printed material as products manufactured
CFCs. The supplemental printed material must
remain with the products in inventory until the
distributor is ready to sell them. Prior to the sale,
the distributor may repackage the products into
smaller boxes and label the individual boxes. The
labeling must be secured prior to the release of the
products.
Release from manufacturer's production facility
where manufacturer has no warehouse. Labeling
may occur during production on production .line, at
end of production line, or any time prior to release
of products from production facility.
EFFECTIVE DATES
• Regulation effective May 15, 1993 pursuant to
section 611,.
• The grandfather provision, discussed above, only
applies to those products made prior to May 15,
1993.
FOR ADDITIONAL INFORMATION
Contact the Stratospheric Ozone Information Hotline
at 800 296-1996, Monday-Friday, between the hours
of 10:00 a.m.-4:00 p.m. (Eastern). International
callers must dial 202 783-1100.
To receive copies of the final rule and any follow-up
activity regarding the labeling rule, such as notices on
petitions, see the Federal Register in a local university
or in government libraries, or call the hotline.
Labeling Charged Containers
A container charged with a class I substance must be
labeled either when it leaves the place of charging
activity, whea it enters storage for further sale, or
when it enters a site of U.S. customs clearance.
Containers kept within a facility for a company's own
manufacturing purposes need not be labeled because
they are not being introduced into interstate com-
merce.
Recharging "Products Containing"
A halon manufacturer or distributor refills a fire
extinguisher for use in a customer's facility. The
container discharging the halon would be labeled as a
"container containing;" however, the fire extinguisher,
already purchased, would not require additional
labeling. Fire extinguishers would be labeled as
"products containing" when they are sold. Subsequent
labeling upon refilling activity would not be required.
Servicing of "products containing" such as degreasers,
fire extinguisher, and air conditioners would not
require relabeling by distributors or manufacturers.
EPA cannot hold servicers liable for removal of labels
by customers.
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