CFC Use Continues to Dwindle Under Montreal Protocol Guidance
By Gregory Dutton, Law Clerk, Office of Enforcement and Compliance Assurance, US EPA; Law Student, Pace Law School, gdutton at law.pace.edu.

The U.S. Environmental Protection Agency recently published a final rule and a proposed rule relating to allotments of chlorofluorocarbons (CFCs) to be used in producing inhalers. CFCs, while stable in the troposphere, break down in the stratosphere. Within the stratosphere is a highly concentrated area of ozone known as our ozone layer. CFCs break down the stratospheric ozone layer allowing more ultraviolet-B radiation to reach Earth’s surface, causing damage such as increased skin cancer rates and harm to marine ecosystems. In 1978, armed with this knowledge and public support, the U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) published rules banning the use of CFCs as propellants in aerosol containers. Language within the rule exempted certain “essential uses” for CFCs from the ban, including metered-dose inhalers (MDIs). The 1987 Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol), an international agreement to phase out the use of CFCs, has similar language exempting MDIs.

Albuterol, also known as Salbutarnol to the international community, is a drug frequently used in MDIs to treat asthma attacks. In 2005 the FDA published a rule removing the “essential use” designation from Albuterol MDIs, effective December 31, 2008 . At the time, there were two Albuterol MDIs on the market which did not use ozone depleting substances (ODSs), such as CFCs. Based on the FDA’s conclusion that the non-ODS MDIs are satisfactory replacements for those Albuterol MDIs using CFCs, it published the rule effectively banning use of CFCs in Albuterol MDIs after December 31, 2008 . In 2006 CFC MDIs made up 60% of Albuterol MDIs. By the end of 2007, fewer than 40% of Albuterol MDIs will be CFC MDIs.

The phase-out of CFCs in Albuterol MDIs, the most popular kind of inhaler that uses CFCs, has a clear effect on the overall requirement for CFCs in total MDIs. On June 12, 2007 , EPA authorized 167 Metric Tons of CFCs to be distributed in 2007 for MDIs, and proposed that a mere 27 metric tons be allotted in 2008. This demonstrates a significant decrease in need for CFCs in MDIs. The precipitous drop in need is caused by a number of factors, namely the phase-out of CFC use in Albuterol MDIs and stockpiling of unused CFCs from previous years’ allotments. Though the allotted amount of CFCs may increase in 2009, currently the trend suggests effective cooperation between government agencies and the MDI manufacturing industry to continue producing effective, essential medical products in an environmentally responsible manner.

Albuterol MDIs are certain to be only the first in a series of inhalers to successfully eliminate the need for ODSs. However, non- CFC Albuterol MDIs may be difficult to initially obtain at comparable prices. Albuterol inhalers containing CFCs currently offer relatively inexpensive generic brands. The new CFC free Albuterol MDIs are still under patent, so no inexpensive generic brand is available. In many places the price is as much as $20 higher, which is particularly burdensome to low income asthmatics. Especially since low income communities report higher rates of asthma attributed to poor environmental conditions near their communities. Prices for the non- CFC Albuterol MDIs will drop once generic brands are produced, but that will not occur until 2010 at the earliest. The hope is that healthcare plans will provide a stop-gap between current pricing and the release of more affordable non-ODS generic brands.

Despite the short-term drawbacks, the reduction of CFC usage, even for essential use purposes, will offer long-term health benefits to people and the environment. The ozone layer is currently experiencing depletion at an average of 4.5 percent at mid-latitudes. Considering that the depletion rate would have eventually reached 20 percent or more had treaties like the Montreal Protocol not been enacted, this is a real accomplishment. If current international agreements are adhered to, the ozone layer should recover to pre-1980 levels in the year 2050.

Different government agencies are working under the guidance of international agreements in conjunction with private industries and it is making a difference.  These efforts have led to improving public health, improving environmental conditions, and curbing global warming. Now and in the near future, we should be using the Montreal Protocol’s success as an example in fostering new agreements with the international community in order to build relations with other countries, attack global problems with global solutions, and curb the potential damages resulting from global climate change.