Essential Use Exemptions

I. The Montreal Protocol

In the early 1970s, researchers began to investigate the effects of various chemicals on the ozone layer. At that time it was determined that certain industrial chemicals, particularly chlorofluorocarbons (CFCs), were depleting stratospheric ozone, leading to increased biologically active ultraviolet light (called UVB) reaching the earth. Increased UVB reaching the earth can result in serious health effects such as skin cancer, cataracts and suppression of the immune system as well as harm crops, plastics and other materials and certain types of marine life.

Throughout the 1980s, as scientific evidence demonstrated a need for action, international negotiations to protect the ozone layer eventually led to an agreement signed in 1987 called the Montreal Protocol on Substances that Deplete the Ozone Layer. To date, over 161 countries, including the United States, have signed the Protocol and in so doing have committed to taking:

"appropriate measures to protect human health and the environment against adverse effects likely to result from human activities which modify or are likely to modify the ozone layer;"

As a legally-binding international agreement, the Montreal Protocol obliges its signatories (called Parties) to reduce and eventually eliminate their production and consumption of ozone depleting substances. This is accomplished through adherence to phaseout schedules for the production and consumption of specific ozone-depleting substances (ODS) including CFCs, halons, carbon tetrachloride, methyl chloroform, hydrochlorofluorocarbons (HCFCs) and methyl bromide (MBr). Phaseout dates under the Protocol are different for developed and developing countries. Developing countries are provided a longer time frame for phasing out the production and consumption of these chemicals.

II. Essential Use Exemptions Under the Montreal Protocol

Under the terms of the Protocol, as of January 1, 1996, developed countries, including the United States, were required to eliminate the production and importation of CFCs and other ODS for nearly all uses. However, in recognition that alternatives might not be available by that date for certain important products, the Parties established a process for exempting certain "essential uses" from the Protocol’s production and import bans. Essential uses granted to the United States allow continued import and production of the class I ODSs for the following uses:

CFC-11, -12, and -114 as propellants in metered dose inhalers (MDIs) used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).
Methyl Chloroform for use in the Space Shuttle and Titan Rockets
A general exemption for Class I ODSs used in essential laboratory uses (Defined in 40 CFR Subpart A, Appendix G )

Approval of essential use exemptions is based upon substantive criteria established under Decision IV/25 of the Montreal Protocol. Under these criteria, a use of a controlled substance should qualify as "essential" only if:

It is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects);
There are no available technical and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health;
Steps have been taken to minimize emissions; and
ODSs of sufficient quantity and quality are not available from existing stocks.

Once alternatives have been developed which are technically and economically feasible, and acceptable from the standpoint of health and the environment, essential use exemptions will be phased out. It is important to note that the Parties did not intend to establish a permanent essential use exemption. Rather, the Parties anticipated that substitutes for the ozone depleting chemicals used in exempted products such as MDIs would be developed, as they have been for other uses such as fire suppression, refrigeration, and air conditioning.

III. The Essential Use Process in the United States

Through Title VI (Stratospheric Ozone Protection) of the 1990 Clean Air Act Amendments (CAAA), the requirements of the Montreal Protocol are implemented in the United States. Section 614 (b) of the Act states that

"this title, (Title VI), as added by the Clean Air Act Amendments of 1990 shall be construed, interpreted, and applied as a supplement to the terms and conditions of the Montreal Protocol, as provided in Article 2, paragraph 11 thereof, and shall not be construed, interpreted, or applied to abrogate the responsibilities or obligations of the United States to implement fully the provisions of the Montreal Protocol."

Consistent with the Montreal Protocol, the Environmental Protection Agency (EPA) both phased out the production and consumption of most ozone depleting substances (beginning on January 1, 1996), and accepts yearly nominations for essential use exemptions to permit the production and consumption of certain ODS deemed essential, such as CFCs for use in MDIs.

EPA’s annual essential use process begins in late summer when EPA publishes a Federal Register Notice requesting applications for essential use exemptions for consideration by the Parties in the following year. Exemption requests are for two years into the future. For example, at their 2002 meeting the Parties will consider essential use exemption requests for the year 2004.

The first step in the process to qualify a use as essential under the Protocol is for applicants to ascertain whether the use of the controlled substance meets the Protocol Parties Decision IV/25 criteria (determining when a use is essential, discussed above), before submitting an application. Users should then notify EPA of the candidate use and provide information so that U.S. government agencies and Protocol Parties can evaluate that use according to the criteria under Decision IV/25. The United Nations Environment Programme (UNEP) Technology and Economic Assessment Panel ( TEAP ) has issued a handbook entitled "Handbook on Essential Use Nominations" which was updated in 2001. Applicants should follow the guidelines in the handbook when preparing their exemption requests. All requests for exemptions submitted to EPA must present the information prescribed in the TEAP handbook, since the U.S. government does not forward incomplete nominations to the UNEP Ozone Secretariat .

Applicants requesting exemptions to produce medical devices must first ensure that their medical use is listed as essential under the Food and Drug Administration’s(FDA's) essential use list (21 CFR 2.125 (e)). The Food and Drug Administration is responsible, under the CAA, for determining, in consultation with the Administrator of EPA, which medical devices containing CFCs are an essential use. Applicants may petition FDA to have their medical devices listed on 2.125 (e). For further information, contact FDA at 1 (301)594-2041.

Upon receipt of an essential use exemption request, EPA reviews the application and works with other Federal Agencies and the US Department of State to determine if the applicant has supplied information demonstrating that it meets the Protocol’s essential use criteria and consequently warrants being nominated for an exemption. Nominations deemed to meet the criteria are consolidated and submitted to the UNEP Ozone Secretariat. The Ozone Secretariat forwards all Parties’ nominations to the UNEP TEAP and its Technical Options Committee (TOC). These panels are made up of international experts, who review the submissions and make recommendations to the Parties for exemptions. Recommendations are then considered by the Parties at their annual meeting, where a final decision is taken.

To date, the Parties to the Montreal Protocol have only granted essential use exemptions for CFCs to be used in MDIs for the treatment of asthma and COPD, for methyl chloroform for use in the Space Shuttle and Titan Rockets, and a general laboratory exemption for class I ODSs.

After essential use decisions are made by the parties, EPA publishes the amounts in the Federal Register and notifies applicants in writing of the specific amount of their essential use allowance. With this exemption, recipients may produce or import the amount of ozone depleting substance allocated by the EPA. For more information on the essential use exemption process, please call EPA’s Stratospheric Protection Division Hotline at 1-800-296-1996.

IV. Laboratory Essential Uses

The laboratory exemption is a general exemption that allows the continued production and import of small amounts of class I ozone depleting substances (ODSs) for use in essential laboratory and analytical methods (defined by 40 CFR Subpart A, Appendix G). For practical purposes, this exemption provides a means for laboratories to procure small amounts of high purity class I ODS for research and testing purposes. Companies or individuals do not have to apply for the exemption, and there is no quantity associated with this exemption. Parties to the Protocol have approved this exemption through the year 2007. For more information about the general laboratory exemption please read our fact sheet on the topic.

Beginning January 1, 2002, the following methods are no longer included in the general laboratory and analytical use exemption:

Testing of oil, grease, and total petroleum hydrocarbons (TPH) in water
Testing of tar in road-paving materials
Forensic finger-printing.

EPA announced this change in a final rule published February 11, 2002 (67 FR 6352), in response to Decision XI/15 by the Parties of the Protocol. As a consequence, class I substances produced or imported after January 1, 2002, may not be used for the methods listed above. If you are required to test for oil, grease, or TPH in water, you may continue to comply by using an alternative (non-CFC) method that has been approved by EPA's Office of Water. You may also use CFCs that were produced or imported before January 1, 2002, for as long as the Office of Water accepts the test method.

More information on EPA's approved methods for testing of oil, grease, and TPH is available from EPA's Office of Water.

V. Essential Use Allowances for Metered Dose Inhalers (MDIs)

CFCs for use in MDIs are the only exemption where EPA continues to receive essential use applications each year. EPA recognizes the vital importance of MDIs in the treatment of asthma and chronic obstructive pulmonary disease and is committed to protecting the health of patients who require these medications. To this end, EPA in consultation with the Food and Drug Administration (FDA), work to ensure the continued availability of CFCs for use in MDIs through our allocation of essential use allowances each year. EPA will continue to work with FDA and the pharmaceutical industry to ensure that CFCs remain available for use in essential MDIs until adequate CFC-free alternatives are available to all who need them.

VI. Metered Dose Inhalers and the Transition to CFC-free MDIs

First introduced in the 1950s, metered dose inhalers were a revolutionary way to deliver medication to respiratory patients. MDIs contain an active drug dissolved or suspended in a propellant. As originally designed and currently made, the majority of MDIs use CFCs to propel the medication out of the canister. MDI allow precisely measured doses of drug and propellant to be delivered into the patients lung. Since CFCs are so stable, they are not metabolized and are rapidly re-emitted when the patient exhales.

MDIs are the only significant commercial product for which CFCs are still produced today. Knowledge concerning the effects of ozone depleting chemicals on the stratosphere, the Montreal Protocol and the Clean Air Act have prompted elimination of the use of ozone depleting chemicals in non-essential applications. These same forces -- scientific knowledge, the Protocol and the CAA-- have spurred the development of non ozone-depleting substitutes for use in MDIs. All major US pharmaceutical companies are reformulating their MDIs to be CFC-free. Three CFC-free MDIs are approved by FDA at this time, and we anticipate that more will be coming into the market over the next few years. In addition, US manufacturers have introduced CFC-free MDIs in more than 45 countries worldwide.

The Parties to the Protocol anticipated that CFC-free MDIs would be developed and that their availability would eventually eliminate the need for MDI essential use exemptions from the Protocol. Although the Parties have not established a firm date for eliminating the essential use exemption, they have urged signatory countries to develop transition strategies which advance and complete the transition to CFC-free MDIs.

To accomplish the transition to CFC-free medical devices in the United States, the FDA has published criteria to determine when CFC medical devices should no longer be deemed essential because safe, effective, CFC-free alternatives are available. FDA announced the criteria in a final rule published July 24, 2002 (67 FR 48370). For more information about the criteria, please visit FDA's MDI website .

Over the last few years, EPA has worked with other public health agencies, industry, and patient groups to educate patients and health care providers about the serious health consequences of ozone depletion and the transition to CFC-free MDIs. This work has culminated in the development of a brochure entitled "Your Metered Dose Inhaler Will be Changing...Here Are the Facts." One of the most important outcomes of this effort is that patient groups, such as the Allergy and Asthma Network/Mothers of Asthmatics, the American Lung Association , and the Asthma and Allergy Foundation of America , together with industry, EPA, the FDA, and the National Institutes of Health (NIH), have agreed on the important and consistent messages that patients need about the transition to CFC-free MDIs, to help them manage their own transitions in an informed way. You can access or download the brochure in its entirety through NIH's National Heart, Lung, and Blood Institute's website .