Labeling of Products Containing or Made With ODS

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 clarify the issues that have been raised since the rule's original publication on February 11, 1993.

Key Features of 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 (ODS) . It also requires that containers containing class I or class II substances be labeled. The final regulation includes the following key requirements:

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 products were made before that date.

If an importer imports products made prior to May 15, 1993, he/she must 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.

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 manufactured with class I substances may be electronic parts washed in class I solvents, such as electrical components and metal products, plumbing fixtures, and products using class I adhesives, such as some packaging, 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 substance upon application of the product.

For example, a product containing, such as an adhesive, must be labeled as "containing". When that product is applied by a subsequent manufacturer in affixing s cushion to a seat, the seat must be labeled as a "product manufactured with" because the CFCs have been released. The subsequent sale of the seat to an automobile manufacturer would not result in 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 warning statement between subsidiaries. If a subsidiary 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 of CFC-113 and/or Methyl Chloroform 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 calendar 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 intermittently, not routinely, as part of the direct manufacturing 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 continuous production process.
Food processing, such as the manufacturing of some spices.

Products Containing Class I Substances and Containers of Class I or Class II 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 required 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 substance 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 company would label its products "manufactured with" (see the example above).

"Products containing" also include some air conditioning 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 reclaimed still requires a label.

Destruction Exemption

Companies that destroy controlled substances used in their manufacturing processes to a 98 percent destruction efficiency are exempt from the labeling requirements, 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 Inadvertent Production, Unreacted Feedstocks, and Process Agents

Inadvertent Production

EPA realizes there are circumstances in which an ozone-depleting substance is formed from a chemical reaction that takes place in a manufacture 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.

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 containing".

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 introduction 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 subsequently transformed.

Treatment of the Use of Class I Substances for Repairs, 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 (recycled) 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 introduced into interstate commerce.

If a company performs repairs or upgrades on products 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 labeled, but the label is not required to be passed through with the product. Products being upgraded, for example, would not require a new label on the final product, because they are not being introduced in the interstate commerce.

A company is exempt from the labeling pass-through requirement for spare parts that are purchased from 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 them for repair purposes only.

Label Appearance and Placement

How the Labels Must Look

Format the labels so that they are in a square or rectangular area with or without a border. The word "WARNING" must be in capital letters. See rule for type size requirements.

The warning statement must be in 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.

Where the Labels Should Appear

Principal Display Panel (PDP) or a Display Panel Area

Placing the warning statement on any of these display panels clearly meets the mandate that the statement be clearly legible and conspicuous.

Alternative Labels

These may be used, as long as the statement is clearly legible and conspicuous. Examples are hang tags, tape, cards, stickers, and other similar types of overlabeling.

Outer Packaging

The warning statement may be placed in the 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 time 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 the requirements as long as the purchaser can read the warning statement upon purchase.

Promotional Materials

For products purchased through telephone or mail orders, print the warning statement in a conspicuous place in sales promotional literature, journals, newspapers, or displays so the warning statement is available before the time of purchase. A company could include an insert in such printed material bearing the warning statement. Another option would be the use of supplemental printed materials that accompany the product at the time of delivery. With this option, the consumer must be able to return the product if, at the time of delivery or payment, they choose not to make the purchase based on the warning statement.

Products that are labeled in any one of the above methods do not require additional labeling.

Treatment of Products Manufactured for Export

Products manufactured for export are not required to be labeled, but there must be sound evidence that such products are intended for export. This could include:

Clear identification of an export area in a warehouse.
Destination papers, shipping papers, or other documentation indicating that the products are intended for export. This information must be readily available on site upon request by EPA.

Treatment of Products Manufactured for Import

The importer will be held liable for all products subject to the labeling requirements imported into the United States. These products are introduced into interstate commerce at the site of U.S. Customs clearance and include products manufactured with controlled substances.

Importers must have a reasonable belief that products introduced into interstate commerce are accurately labeled. In order to have a reasonable belief, importers 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 substances. 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 substance 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 interstate 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.

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. Examples of these products include some corrugated packaging or open- cell foam-blown materials.

Manufacturers of Packaging Materials Used to Package 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."

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.

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 substances; reduce the overall risk to human health and the environment; and, are currently or potentially available.

For products made with class I substances, a manufacturer 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.

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 the distributor, wholesaler, or retailer distributes or sells them. If the labeled products are repackaged or require new labels, such labeling must be secured prior to the release of the products from the warehouse.
For example, a distributor purchases a bulk shipment of nuts and bolts that are labeled on supplemental 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.

Labeling Charged Containers

A container charged with a class I substance must be labeled either when it leaves the place of charging activity, when 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 commerce.

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.

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.

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