CONGRESSWOMAN ELISE STEFANIK
On Wednesday, December 12, 2012, the House is scheduled to consider H.R. 6190, a bill to direct the Administrator of the Environmental Protection Agency (EPA) to allow for the distribution, sale and consumption in the United States of remaining inventories of over-the-counter CFC epinephrine inhalers, under a suspension of the rules requiring a two-thirds majority vote for passage. The bill was introduced by Rep. Michael Burgess (R-TX) on July 25, 2012, and referred to the Committee on Energy and Commerce, which held a mark-up and reported the bill by voice vote on August 1, 2012.
H.R. 6190 would direct the EPA to allow the distribution of remaining inventories of the asthma inhaler known as Primatene Mist. Under current EPA regulations, epinephrine’s inhalers containing chlorofluorocarbons (CFCs) have been banned since December 31, 2011. The bill would direct the EPA to refrain from taking any enforcement action against any distributor or seller on the basis of any federal law implementing the Montreal Protocol. The bill would also direct the EPA to issue a “No Action Assurance Letter” to any requesting distributor or seller stating the agency will not initiate such an enforcement action. H.R. 6190 would sunset on August 1, 2013.
The bill would not amend the Clean Air Act or change the environmental protections in the Montreal Protocol. Additionally, it would not limit the FDA’s authority to ensure the safety and effectiveness of the remaining inventory of inhalers. It would not authorize the manufacturing of new CFC inhalers.
According to House Report 112-673, epinephrine inhalers containing chlorofluorocarbons (CFCs), most commonly marketed as Primatene Mist, have been sold in the U.S. without physician's prescription as an over-the-counter (OTC) medicine to provide relief of asthma symptoms for over 40 years. As of December 31, 2011, the manufacture and sale of these inhalers has been banned for the purpose of reducing emissions of ozone depleting substances into the air pursuant to the “Montreal Protocol on Substances that Deplete the Ozone Layer” and Title VI of the Clean Air Act. The shift to CFC-free inhalers is part of a larger transition that has affected many consumer and industrial products over the last several decades. According to a fact sheet on H.R. 6190 provided by the House Committee on Energy and Commerce, to date, no over-the-counter replacement is available. An estimated 1.7 to 2.3 million asthma sufferers in the United States relied on this medication before the ban went into effect.
There is currently a remaining inventory of approximately 1.2 million OTC epinephrine inhalers. According to the FDA, epinephrine users can use the product after December 31, 2011 because the product phase-out only applies to the manufacture and sale of the product after December 31, 2011, as long as the product has not expired. This legislation would direct the EPA to allow for the distribution and sale of the remaining inventories of the inhaler without threat of EPA enforcement actions.
House Energy and Commerce Myth vs. Fact on H.R. 6190 is available here.
EPA fact sheet on the transition to Ozone-Safe Propellants is available here.
According to the Congressional Budget Office (CBO), “implementing this legislation would have no significant impact on the federal budget because of the limited amount of EPA resources dedicated to these activities. Pay-as-you go procedures do not apply to H.R 6190 because the bill would not affect direct spending or revenues."