I 

113TH CONGRESS 

1ST SESSION H. R. 1220 

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 

MARCH 15, 2013 

Mr. BURGESS (for himself, Mr. DINGELL, 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 consumption in the United States of remaining inventories of 

over-the-counter CFC epinephrine inhalers. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Asthma Inhalers Relief 

5 Act of 2013’’. 


srobinson on DSK4SPTVN1PROD with BILLS
2 

•HR 1220 IH

1 SEC. 2. DISTRIBUTION, SALE, AND CONSUMPTION OF RE2 MAINING INVENTORIES OF OVER-THE3 COUNTER CFC EPINEPHRINE INHALERS. 

4 (a) IN GENERAL.—The Administrator of the Envi5 ronmental Protection Agency— 

6 (1) shall allow for the distribution, sale, and 

7 consumption in the United States of remaining in8 ventories of CFC epinephrine inhalers manufactured 

9 pursuant to the exception for medical devices under 

10 section 604(d)(2) of the Clean Air Act (42 U.S.C. 

11 7671c(d)(2)); 

12 (2) shall not take any enforcement action or 

13 otherwise seek to restrict the distribution, sale, or 

14 consumption of such inhalers on the basis of any 

15 Federal law implementing the Montreal Protocol; 

16 and 

17 (3) shall, in response to any request of any dis18 tributor or seller of such inhalers, including any 

19 such request pending on the date of the enactment 

20 of this Act, issue a No Action Assurance Letter to 

21 the requesting party stating that the Environmental 

22 Protection Agency will not initiate an enforcement 

23 action relating to the distribution or sale of any such 

24 inhaler occurring prior to August 1, 2013. 

25 (b) RULE OF CONSTRUCTION.—Nothing in this Act 

26 shall be construed to limit or otherwise affect the authority 


srobinson on DSK4SPTVN1PROD with BILLS
3 

•HR 1220 IH

1 of the Food and Drug Administration under the Federal 

2 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 

3 to ensure the safety and effectiveness of CFC epinephrine 

4 inhalers to be distributed, sold, or consumed pursuant to 

5 this Act. 

6 (c) DEFINITIONS.—In this Act: 

7 (1) The term ‘‘CFC epinephrine inhaler’’ means 

8 any epinephrine inhaler containing chlorofluorocar9 bons that was manufactured and classified as over10 the-counter before January 1, 2012. 

11 (2) The phrase ‘‘Federal law implementing the 

12 Montreal Protocol’’— 

13 (A) means any provision of title VI of the 

14 Clean Air Act (42 U.S.C. 7671 et seq.) or other 

15 Federal law implementing the Montreal Pro16 tocol; and 

17 (B) includes the final rule published by the 

18 Food and Drug Administration entitled ‘‘Use of 

19 Ozone-Depleting Substances; Removal of Essen20 tial-Use Designation (Epinephrine)’’ published 

21 in the Federal Register at 73 Federal Register 

22 69532 (November 19, 2008). 

23 (3) The term ‘‘Montreal Protocol’’ has the 

24 meaning given such term in section 601 of the Clean 

25 Air Act (42 U.S.C. 7671). 


srobinson on DSK4SPTVN1PROD with BILLS
4 

•HR 1220 IH

1 (4) The term ‘‘over-the-counter’’ means not 

2 subject to section 503(b)(1) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)) or 

4 otherwise required pursuant to Federal law to be 

5 dispensed only upon issuance of a prescription. 

6 (d) SUNSET.—This section ceases to be effective Au7 gust 1, 2013. 

Æ 


srobinson on DSK4SPTVN1PROD with BILLS