I 

109TH CONGRESS 

1ST SESSION H. R. 2357 

To protect American workers and responders by ensuring the continued commercial availability of respirators and to establish rules governing product 

liability actions against manufacturers and sellers of respirators. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 12, 2005 

Mr. SHUSTER (for himself, Mr. HOLDEN, Ms. HART, and Mr. SMITH of 

Texas) introduced the following bill; which was referred to the Committee 

on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in 

each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To protect American workers and responders by ensuring 

the continued commercial availability of respirators and 

to establish rules governing product liability actions 

against manufacturers and sellers of respirators. 

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 ‘‘Respirator Access As5 surance Act of 2005’’. 
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1 SEC. 2. FINDINGS. 

2 The Congress finds the following: 

3 (1) Each year millions of workers, responders 

4 and citizens in the United States and around the 

5 world depend on the availability of respirators made 

6 in the United States for protection against exposure 

7 to hazardous materials and in the event of terrorist 

8 incidents, airborne disease epidemics, and other dis9 asters. 

10 (2) Respirators are tested, and the design and 

11 labeling of respirators is regulated by an inde12 pendent federal agency, the National Institute for 

13 Occupational Safety and Health (NIOSH), which is 

14 part of the federal Centers for Disease Control and 

15 Prevention. NIOSH establishes the performance 

16 standards for respirators, independently tests and 

17 certifies respirators to its standards, and performs 

18 follow-up field audits of respirators to ensure contin19 ued compliance with NIOSH performance standards. 

20 Prior to the establishment of NIOSH, respirators 

21 were approved by the United States Bureau of 

22 Mines. 

23 (3) Respirator manufacturers and sellers do not 

24 and cannot control or determine the manner in 

25 which their products are used. 
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1 (4) Manufacturers and sellers of respirators de2 signed and labeled in compliance with NIOSH re3 quirements have been named as defendants in a sub4 stantial number of product liability claims alleging 

5 that these NIOSH-approved designs and warnings 

6 are defective. 

7 (5) Respirators are sold in and have an effect 

8 on interstate commerce. 

9 (6) Manufacturers of respirators may cease 

10 making such products, in principal part because of 

11 the costs of litigation. 

12 (7) A continued United States capacity to man13 ufacture and distribute respirators is necessary to 

14 assure that these products remain available. Lack of 

15 availability of respirators will increase risks to the 

16 health of millions of American workers and emer17 gency responders. 

18 (8) The protections set forth in this Act are 

19 needed to assure the continued commercial avail20 ability of lifesaving respirators. 

21 SEC. 3. DEFINITIONS. 

22 In this Act: 

23 (1) ‘‘Manufacturer’’ means any person who, in 

24 the course of a business conducted for that purpose, 

25 designs, makes, produces, packages, or labels any 
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1 respirator or component part of a respirator, or en2 gages another to do so. 

3 (2) ‘‘NIOSH’’ means the National Institute for 

4 Occupational Safety and Health. 

5 (3) ‘‘NIOSH approval’’ means a certificate or 

6 formal document issued by NIOSH stating that an 

7 individual respirator or combination of respirators 

8 has met the minimum requirements of part 84 of 

9 title 42, Code of Federal Regulations, or part 11 of 

10 title 30, Code of Federal Regulations, and that the 

11 manufacturer is authorized to use and attach an ap12 proval label to any respirator manufactured in con13 formance with the plans and specifications upon 

14 which the approval was based. For purposes of this 

15 Act, NIOSH approval shall also mean certification 

16 and/or approval by any Federal Government agency 

17 with authority to approve respirators, including the 

18 United States Bureau of Mines and the Mine Safety 

19 and Health Administration. 

20 (4) ‘‘Respirator’’ means any device designed to 

21 provide the wearer with respiratory protection 

22 against inhalation of hazardous materials. 

23 (5) ‘‘Seller’’ means a person or entity, including 

24 a retailer, distributor, or wholesaler, that is regularly 

25 engaged in selling respirators. 
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1 SEC. 4. EFFECT OF NIOSH APPROVAL OF DESIGN AND LA2 BELING. 

3 A manufacturer or seller of a respirator shall not be 

4 subject to any claim for defective design or warning or 

5 any claim which is based on such an allegation if such 

6 respirator has received a NIOSH approval, and such res7 pirator is manufactured in compliance with the NIOSH8 approved design and labeling. This provision shall not 

9 apply to a respirator that fails to comply with the NIOSH10 approved design and labeling standards. 

11 SEC. 5. PREEMPTION AND STATUTORY CONSTRUCTION. 

12 (a) PREEMPTION.—The provisions of this Act shall 

13 supersede any and all State or local laws insofar as they 

14 may now or hereafter relate to any claim for defective de15 sign or warning or any claim which is based on such an 

16 allegation if such respirator has received a NIOSH ap17 proval. 

18 (b) STATUTORY CONSTRUCTION.—Nothing in this 

19 Act may be construed to affect any defense available to 

20 a defendant under any other provision of state or federal 

21 law, or to create a cause of action or federal court jurisdic22 tion pursuant to section 1331 or 1332 of title 28, United 

23 States Code, that otherwise would not exist under applica24 ble law. 
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1 SEC. 6. APPLICABILITY. 

2 This Act applies to any civil action in a Federal or 

3 State court, on the basis of any legal theory, for harm 

4 allegedly caused, directly or indirectly, by a respirator, a 

5 respirator manufacturer, or a respirator seller. 

6 SEC. 7. EFFECTIVE DATE. 

7 This Act shall become effective upon enactment and 

8 shall apply to any action that has not proceeded to trial 

9 as of the date of enactment, regardless of when the res10 pirator was manufactured or sold. 

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