(1) Each year millions of workers, responders 
and citizens in the United States and around the 
world depend on the availability of respirators made 
in the United States for protection against exposure 
to hazardous materials and in the event of terrorist 
incidents, airborne disease epidemics, and other dis-
asters. 
(2) Respirators are tested, and the design and 
labeling of respirators is regulated by an inde-
pendent Federal agency, the National Institute for 
Occupational Safety and Health (NIOSH), which is 
part of the Centers for Disease Control and Preven-
tion. NIOSH establishes the performance standards 
for respirators, independently tests and certifies res-
pirators to its standards, and performs follow-up 
field audits of respirators to ensure continued com-
pliance with NIOSH performance standards. Prior 
to the establishment of NIOSH, respirators were ap-
proved by the United States Bureau of Mines. 
(3) Respirator manufacturers and sellers do not 
and cannot control or determine the manner in 
which their products are used. 
(4) Manufacturers and sellers of respirators de-
signed and labeled in compliance with NIOSH re-
quirements have been named as defendants in a sub-
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stantial number of product liability claims alleging 
that these NIOSH-approved designs and warnings 
are defective. 
(5) Respirators are sold in and have an effect 
on interstate commerce. 
(6) Manufacturers of respirators may cease 
making such products, in principal part because of 
the costs of litigation. 
(7) A continued United States capacity to man-
ufacture and distribute respirators is necessary to 
assure that these products remain available. Lack of 
availability of respirators will increase risks to the 
health of millions of American workers and emer-
gency responders. 
(8) The protections set forth in this Act are 
needed to assure the continued commercial avail-
ability of lifesaving respirators. 
SEC. 3. DEFINITIONS. 
In this Act: 
(1) ‘‘Manufacturer’’ means any person who, in 
the course of a business conducted for that purpose, 
designs, makes, produces, packages, or labels any 
respirator or component part of a respirator, or en-
gages another to do so. 
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(2) ‘‘NIOSH’’ means the National Institute for 
Occupational Safety and Health. 
(3) ‘‘NIOSH approval’’ means a certificate or 
formal document issued by NIOSH stating that an 
individual respirator or combination of respirators 
has met the minimum requirements of part 84 of 
title 42, Code of Federal Regulations, or part 11 of 
title 30, Code of Federal Regulations, and that the 
manufacturer is authorized to use and attach an ap-
proval label to any respirator manufactured in con-
formance with the plans and specifications upon 
which the approval was based. For purposes of this 
Act, NIOSH approval shall also mean certification 
and/or approval by any Federal Government agency 
with authority to approve respirators, including the 
United States Bureau of Mines and the Mine Safety 
and Health Administration. 
(4) ‘‘Respirator’’ means any device designed to 
provide the wearer with respiratory protection 
against inhalation of hazardous materials. 
(5) ‘‘Seller’’ means a person or entity, including 
a retailer, distributor, or wholesaler, that is regularly 
engaged in selling respirators. 
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SEC. 4. EFFECT OF NIOSH APPROVAL OF DESIGN AND LA-
BELING. 
A manufacturer or seller of a respirator shall not be 
subject to any claim for defective design or warning or 
any claim which is based on such an allegation if such 
respirator has received a NIOSH approval, and such res-
pirator is manufactured in compliance with the NIOSH- 
approved design and labeling. This provision shall not 
apply to a respirator that fails to comply with the NIOSH- 
approved design and labeling standards. 
SEC. 5. PREEMPTION AND STATUTORY CONSTRUCTION. 
(a) PREEMPTION.—The provisions of this Act shall 
supersede any and all State or local laws insofar as they 
may now or hereafter relate to any claim for defective de-
sign or warning or any claim which is based on such an 
allegation if such respirator has received a NIOSH ap-
proval. 
(b) STATUTORY CONSTRUCTION.—Nothing in this 
Act may be construed to affect any defense available to 
a defendant under any other provision of state or federal 
law, or to create a cause of action or Federal court juris-
diction pursuant to section 1331 or 1332 of title 28, 
United States Code, that otherwise would not exist under 
applicable law. 
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SEC. 6. APPLICABILITY. 
This Act applies to any civil action in a Federal or 
State court, on the basis of any legal theory, for harm 
allegedly caused, directly or indirectly, by a respirator, a 
respirator manufacturer, or a respirator seller. 
SEC. 7. EFFECTIVE DATE. 
This Act shall become effective upon enactment and 
shall apply to any action that has not proceeded to trial 
as of the date of enactment, regardless of when the res-
pirator was manufactured or sold. 
Æ 
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