II 

109TH CONGRESS 

1ST SESSION S. 1406 

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 SENATE OF THE UNITED STATES 

JULY 14, 2005 

Mr. CORNYN introduced the following bill; which was read twice and referred 

to the Committee on the Judiciary 

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’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 
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1 (1) Each year millions of workers, responders, 

2 and citizens in the United States and around the 

3 world depend on the availability of respirators made 

4 in the United States for protection against exposure 

5 to hazardous materials and in the event of terrorist 

6 incidents, airborne disease epidemics, and other dis7 asters. 

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

9 labeling of respirators is regulated by an inde10 pendent Federal agency, the National Institute for 

11 Occupational Safety and Health, which is part of the 

12 Centers for Disease Control and Prevention. NIOSH 

13 establishes the performance standards for res14 pirators, independently tests and certifies that res15 pirators meet its standards, and performs follow-up 

16 field audits of respirators to ensure continued com17 pliance with NIOSH performance standards. Prior 

18 to the establishment of NIOSH, respirators were ap19 proved by the United States Bureau of Mines. 

20 (3) Respirator manufacturers and sellers do not 

21 and cannot control or determine the manner in 

22 which their products are used. 

23 (4) Manufacturers and sellers of respirators de24 signed and labeled in compliance with NIOSH re25 quirements have been named as defendants in a sub-
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1 stantial number of product liability claims alleging 

2 that these NIOSH-approved designs and warnings 

3 are defective. 

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

5 on interstate commerce. 

6 (6) Manufacturers of respirators may cease 

7 making such products, in principal part because of 

8 the costs of litigation. 

9 (7) A continued United States capacity to man10 ufacture and distribute respirators is necessary to 

11 assure that these products remain available. Lack of 

12 availability of respirators will increase risks to the 

13 health of millions of American workers and emer14 gency responders. 

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

16 needed to assure the continued commercial avail17 ability of lifesaving respirators. 

18 SEC. 3. DEFINITIONS. 

19 In this Act: 

20 (1) MANUFACTURER.—The term ‘‘Manufac21 turer’’ means any person who, in the course of a 

22 business conducted for that purpose, designs, makes, 

23 produces, packages, or labels any respirator or com24 ponent part of a respirator, or engages another to 

25 do so. 
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1 (2) NIOSH.—The term ‘‘NIOSH’’ means the 

2 National Institute for Occupational Safety and 

3 Health. 

4 (3) NIOSH APPROVAL.—The term ‘‘NIOSH 

5 approval’’ means a certificate or formal document 

6 issued by NIOSH stating that an individual res7 pirator or combination of respirators has met the 

8 minimum requirements of part 84 of title 42, Code 

9 of Federal Regulations, or part 11 of title 30, Code 

10 of Federal Regulations, and that the manufacturer 

11 is authorized to use and attach an approval label to 

12 any respirator manufactured in conformance with 

13 the plans and specifications upon which the approval 

14 was based. For purposes of this Act, NIOSH ap15 proval shall also mean certification or approval by 

16 any Federal Government agency with authority to 

17 approve respirators, including the United States Bu18 reau of Mines and the Mine Safety and Health Ad19 ministration. 

20 (4) RESPIRATOR.—The term ‘‘Respirator’’ 

21 means any device, including component or replace22 ment parts for a device, designed to provide the 

23 wearer with respiratory protection against inhalation 

24 of a hazardous atmosphere. 
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1 (5) SELLER.—The term ‘‘Seller’’ means a per2 son or entity, including a retailer, distributor, or 

3 wholesaler, that is regularly engaged in selling res4 pirators. 

5 SEC. 4. EFFECT OF NIOSH APPROVAL OF DESIGN AND LA6 BELING. 

7 (a) IN GENERAL.—A manufacturer or seller of a res8 pirator shall not be subject to any claim for defective de9 sign or warning relating to a respirator or any claim which 

10 is based on such an allegation if such respirator has re11 ceived a NIOSH approval, and such respirator is manufac12 tured in compliance with the NIOSH-approved design and 

13 labeling in effect on the date of manufacture. This provi14 sion shall not apply to a respirator that fails to comply 

15 with the NIOSH-approved design and labeling standards 

16 in effect on the date of manufacture. 

17 (b) WITHDRAWAL OF APPROVAL.—Subsection (a) 

18 shall not apply to a manufacturer or seller of a respirator 

19 if NIOSH withdraws its approval for the respirator that 

20 is the subject of the claim involved based on a finding by 

21 NIOSH that the manufacturer or seller— 

22 (1) withheld from or misrepresented to NIOSH 

23 material information about the respirator’s design or 

24 labeling and the respirator otherwise would not have 

25 been approved; or 
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1 (2) made an illegal payment to a NIOSH offi2 cial or employee for the purpose of securing or main3 taining approval of the respirator’s design or label4 ing. 

5 (c) STATUTE OF LIMITATIONS.—A statute of limita6 tions that would otherwise apply to claims to which sub7 section (b) applies shall not begin to run until the date 

8 on which NIOSH withdraws its approval for the respirator 

9 involved. 

10 SEC. 5. PREEMPTION AND STATUTORY CONSTRUCTION. 

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

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

13 may now or hereafter relate to any claim for defective de14 sign or warning relating to a respirator or any claim which 

15 is based on such an allegation if such respirator complied 

16 with the NIOSH-approved design and labeling in effect 

17 on the date of manufacture. 

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 juris22 diction pursuant to section 1331 or 1332 of title 28, 

23 United States Code, that otherwise would not exist under 

24 applicable 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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