I 
112TH CONGRESS 
2D SESSION 
H. R. 6190 
To direct the Administrator of the Environmental Protection Agency to allow 
for the distribution, sale, and consumption in the United States of 
remaining inventories of over-the-counter CFC epinephrine inhalers. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 25, 2012 
Mr. BURGESS (for himself, Mr. ROSS of Arkansas, Mr. BARTON of Texas, Mr. 
PITTS, Mr. CARTER, and Mr. MATHESON) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To direct the Administrator of the Environmental Protection 
Agency to allow for the distribution, sale, and consump-
tion in the United States of remaining inventories of 
over-the-counter CFC epinephrine inhalers. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Asthma Inhalers Relief 
Act of 2012’’. 
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SEC. 2. DISTRIBUTION, SALE, AND CONSUMPTION OF RE-
MAINING 
INVENTORIES 
OF 
OVER-THE- 
COUNTER CFC EPINEPHRINE INHALERS. 
(a) IN GENERAL.—The Administrator of the Envi-
ronmental Protection Agency— 
(1) shall allow for the distribution, sale, and 
consumption in the United States of remaining in-
ventories of CFC epinephrine inhalers manufactured 
pursuant to the exception for medical devices under 
section 604(d)(2) of the Clean Air Act (42 U.S.C. 
7671c(d)(2)); 
(2) shall not take any enforcement action or 
otherwise seek to restrict the distribution, sale, or 
consumption of such inhalers on the basis of any 
Federal law implementing the Montreal Protocol; 
and 
(3) shall, in response to any request of any dis-
tributor or seller of such inhalers, including any 
such request pending on the date of the enactment 
of this Act, issue a No Action Assurance Letter to 
the requesting party stating that the Environmental 
Protection Agency will not initiate an enforcement 
action relating to the distribution or sale of any such 
inhaler occurring prior to August 1, 2013. 
(b) RULE OF CONSTRUCTION.—Nothing in this Act 
shall be construed to limit or otherwise affect the authority 
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of the Food and Drug Administration under the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
to ensure the safety and effectiveness of CFC epinephrine 
inhalers to be distributed, sold, or consumed pursuant to 
this Act. 
(c) DEFINITIONS.—In this Act: 
(1) The term ‘‘CFC epinephrine inhaler’’ means 
any epinephrine inhaler containing chlorofluorocar-
bons that was manufactured and classified as over- 
the-counter before January 1, 2012. 
(2) The phrase ‘‘Federal law implementing the 
Montreal Protocol’’— 
(A) means any provision of title VI of the 
Clean Air Act (42 U.S.C. 7671 et seq.) or other 
Federal law implementing the Montreal Pro-
tocol; and 
(B) includes the final rule published by the 
Food and Drug Administration entitled ‘‘Use of 
Ozone-Depleting Substances; Removal of Essen-
tial-Use Designation (Epinephrine)’’ published 
in the Federal Register at 73 Federal Register 
69532 (November 19, 2008). 
(3) The term ‘‘Montreal Protocol’’ has the 
meaning given such term in section 601 of the Clean 
Air Act (42 U.S.C. 7671). 
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(4) The term ‘‘over-the-counter’’ means not 
subject to section 503(b)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)) or 
otherwise required pursuant to Federal law to be 
dispensed only upon issuance of a prescription. 
(d) SUNSET.—This section ceases to be effective Au-
gust 1, 2013. 
Æ 
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