February 3, 2010

Mr. Les Weisbrod, President
American Association for Justice
777 6th St. NW
Washington, DC 20001

Dear Mr. Weisbrod:

Thank you for your letter of March 24, 2009, asking the Department to reconsider the position taken in a December 31, 2008, posted on OSHA's website on January 9, 2009, letter from then-Acting Assistant Secretary of Labor for Occupational Safety and Health Thomas M. Stohler to Daniel K. Shipp, President of the International Safety Equipment Association.  In that letter, Mr. Stohler expressed the belief that a standard promulgated by the Occupational Safety and Health Administration (OSHA) that requires employers to provide only respirators certified by the National Institute of Occupational Safety and Health (NIOSH), in circumstances where respirators are required, preempts the application of state tort laws and precludes state court juries from imposing tort liability on respirator manufacturers for harm caused by use of such respirators.  The purpose of this letter is to inform you that neither the Office of the Solicitor nor OSHA's current Assistant Secretary agrees with that position and to explain why it is not consistent with sound principles of preemption law.

First, the position taken in Mr. Stohler's letter did not take full account of relevant jurisprudence regarding preemption principles at the time it was written.  Second, as noted in your letter, the Supreme Court's subsequent decision in Wyeth v. Levine, 129 S.Ct. 1187 (March 4, 2009) is directly to the contrary.  Finally, the position taken in the December 2008 letter is inconsistent with the "general policy" announced by President Obama in a Memorandum to the Heads of Executive Departments and Agencies, issued on May 20, 2009, "that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption." (http://www.whitehouse.gov/the_press_office/Presidential-Memorandum-Regarding-Preemption/);74 Fed. Reg. 24693.

Statutory Framework

Both NIOSH and OSHA were created by the Occupational Safety and Health Act of 1970 (OSH Act), 29 U.S.C. 651 et seq., giving NIOSH authority for research into occupational safety and health matters, and OSHA authority for promulgating and enforcing occupational safety and health standards.  The Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 801 et seq., created MSHA and gave it authority for certain activities previously carried out by agencies at the Department of the Interior.  The Mine Act and regulations issued under the OSH Act require use of NIOSH-certified respirators. 30 U.S.C. 842(h) (Mine Act); 29 C.F.R. 1910.134(d)(1)(ii) (OSHA Respiratory Protection standard).

Neither the OSH Act nor the Mine Act contains any language indicating that Congress meant the statutes or regulations promulgated under them to preempt state tort actions.  To the contrary, Section 4(b)(4) of the OSH Act, 29 U.S.C. 653(b)(4), provides "[n]othing in this Act shall ... enlarge or diminish or affect in any other manner the common law or statutory rights, duties, or liabilities of employers and employees under any law with respect to injuries, diseases, or death arising out of, or in the course of, employment."  This provision is the Act's sole reference to state tort law, and it is, significantly, a savings clause.  See Lindsey v. Caterpillar, 480 F.3d 202 (3rd Cir. 2007) (allowing product liability action against tractor manufacturer); Pedraza v. Shell Oil Co., 942 F.2d 48, 53-54 (1st Cir. 1991) (holding that 4(b)(4) saves suits by employees seeking compensation for injuries, whether brought against employers or third-party suppliers such as Shell, the defendant in that case); United Steelworkers of America, AFL-CIO v. Marshall, 647 F.2d 1189, 1235-1236 (D.C. Cir.1980) ("when a worker actually asserts a claim under workmen's compensation law or some other state law, neither the worker nor the party against whom the claim is made can assert that any OSHA regulation or the OSH Act itself preempts any element of the state law") (emphasis supplied).  Both the Pedraza and Lindsey decisions also pointed out that this result is consistent with the provision's legislative history, citing a statement by then-Solicitor of Labor Lawrence Silberman during consideration of the legislation that it "would in no way affect the present status of the law with regard to workmen's compensation legislation or private tort actions."  Pedraza, supra at 54 (emphasis by court); Lindsey, supra at 207-208.¹

The Mine Act contains an even more comprehensive savings clause.  Section 506 of that statute, 30 U.S.C. §955, provides that state laws or regulations imposing more stringent requirements than those imposed by the Act are not to be construed or held to be in conflict with the Mine Act.  Accordingly, the Mine Act does not preempt actions against mine equipment manufacturers for allegedly inadequate warnings about the limitations of MSHA-approved mine equipment.  See Davis v. Eagle Coal and Dock Co., 220 W.Va. 18, 640 S.E.2d 81 (W.Va. 2006), cert. denied sub nom J.H. Fletcher & Co. v. Davis, 551 U.S. 1113 (2007) (allowing a miner's suit alleging inadequate warning on a dust collection device).

In short, the OSH Act's and the Mine Act's terms do not show a "clear and manifest purpose of Congress" that regulations promulgated pursuant to the statutes preempt related tort actions under state law.  Wyeth, supra, at 1194 (internal quotes and citations omitted).  All indications are to the contrary.

Respirator Regulations

In 1995, NIOSH issued regulations that included procedures under which manufacturers could submit respirators to NIOSH for certification, and established the minimum criteria these respirators must meet.  42 C.F.R. Part 84; 60 Fed. Reg. 30366 (June 8, 1995).  In 1998, OSHA issued a new respiratory protection standard, requiring that employers relying on respirators to comply with OSHA requirements provide only NIOSH-approved respirators to their employees.  29. C.F.R. 1910.134; 63 Fed. Reg. 1152 (1998).²  Neither NIOSH's 1995 regulation nor OSHA's 1998 standard contains any language explicitly preempting state tort remedies or other state requirements.  Nor do the preambles to those rules express any preemptive intent.  The issue of preemption of state tort law was never even addressed during either rulemaking, as far as can be determined from the responses to comments provided by the agencies when the final rules were issued.

The structure and language of these rules also do not provide any basis for inferring intent to preempt state tort law.  Instead, the most logical reading of both rules is that they are intended to establish minimum requirements for respirator manufacture or use.  In this respect, the NIOSH criteria are completely different from the DOT requirements considered by the Supreme Court in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), on which the December 2008 letter relied.  In Geier, the Court found that the agency had carefully assessed the risks and benefits of various alternatives and intended its rule to promote the "gradual phase-in" of "alternative [passive restraint] protection systems" rather than to mandate immediate installation of a single type of system.  529 U.S. at 879, 881 (emphasis in original).  State-imposed tort liability for failure to install a single type of passive restraint system would have conflicted with objectives underlying the agency's choice of regulatory solutions, including the gradual phase-in of alternative types of systems, the need to overcome safety problems associated with airbags, and the necessity of building public confidence.  By contrast, the NIOSH rules repeatedly characterize the safety requirements listed throughout the regulation as "minimum" requirements.  See, e.g. 42 C.F.R. 84.72 ("Breathing tubes; minimum requirements"); 42 C.F.R. 84.73 ("Harnesses; installation and construction; minimum requirements"); 42 C.F.R. 84.74 ("Apparatus containers; minimum requirements").  Moreover, the NIOSH certification standards address only a limited number of respirator characteristics, qualities, and traits; they do not contain any specifications or tests governing other critical aspects of respirator safety (e.g., performance of straps, method of strap attachment, respirator durability).  Again, state tort awards for failure to meet appropriate standards in these areas would not conflict with any NIOSH determination.

Similarly, NIOSH labeling requirements also impose only minimum requirements that each respirator be marked to identify the manufacturer, the NIOSH approval number, and any use restrictions imposed by NIOSH.  42 C.F.R. 84.33.  Indeed, the standard application package NIOSH provides to manufacturers specifically advises that label approval does not restrict a respirator manufacturer from providing additional, up-to-date warnings, use instructions or hazard information through package inserts, customer mailings, or other media, so long as the information does not conflict with the approved labeling.  Even with respect to respirator characteristics that NIOSH has certified, the NIOSH regulations, at 42 C.F.R. 84.35, provide specific procedures for manufacturers to submit new and more effective respirator models at any time improvements become advisable, for example because of newly-discovered respiratory risks in the workplace or expanded technical knowledge.  Because NIOSH itself does not prohibit respirator manufacturers from developing respirators that are more protective or that provide more comprehensive warning information than the minimum criteria require, OSHA also does not prohibit use of such respirators.

Preemptive Effect of OSHA and NIOSH regulations

As shown above, neither the OSH Act nor the respirator regulations themselves expressly preempt state tort actions.  Nor do they indicate Congressional or agency intent to preempt such actions.  This conclusion does not mean that a state tort suit could never be preempted on conflict grounds.  If OSHA or MSHA rules require (or prohibit) a specific action that must be specifically performed (or avoided), a state could not make that action (or omission) a tort.  The conclusion does mean, however, that state tort suits are not preempted merely because respirators meet the minimum requirements for federal certification.

The conclusion that neither the OSH Act nor the respirator regulations prevent a state from imposing tort liability on a manufacturer of a certified respirator is further supported by the Supreme Court's decision in Wyeth, holding that FDA approval of a drug's label does not preempt state tort remedies for failure to provide adequate warnings in the label.  The Wyeth court reemphasized the long-established principle that in preemption cases, courts must "start with the assumption that the historic police powers of the states are not to be superseded by the Federal act unless that was the clear and manifest purpose of Congress." Id. at 1194-1195.  The Court first examined the Federal statute on which the defendant relied.  It found that nothing in either the statute or the regulations promulgated under it required preemption of state tort remedies.  The Court also found no actual conflict between the FDA approval of a drug and package insert and the plaintiff's claim that the manufacturer should have provided a stronger warning.  As in Wyeth, there is no conflict between the OSHA/NIOSH regulatory system and tort suits alleging that respirator manufacturers should provide additional safeguards.  Similarly, the ability of a respirator manufacturer to provide supplemental label information without federal approval weighs heavily against finding that the federal scheme is intended to be preemptive. 129 S.Ct. at 1196-1199.

As you point out, some of the assumptions in the December 31 letter are questionable.  For example, it is far from clear, as that letter asserted, that the threat of state tort litigation may induce manufacturers to withdraw needed respirators from the market or decline to produce new ones.  It appears at least equally possible that eliminating potential tort liability would be a disincentive for manufacturers to conduct the research, testing, and product improvement necessary to keep pace with emerging hazards and improved technical knowledge and would actually discourage continuous product improvement.  See Wyeth at 1199-1200 (Congress "may also have recognized that state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.")  Categorically eliminating tort liability would also not promote the OSH Act's objective of stimulating business efforts to "perfect existing programs for providing safe and healthful working conditions" and encouraging businesses to "build [] upon advances already made ... for providing safe and healthful working conditions."  29 U.S.C. 651(b)(1), (b)(4).

Finally, asserting that the OSH Act or the respirator regulations precludes a state court judgment imposing tort liability on manufacturers of NIOSH-certified respirators is contrary to the President's May 20 Memorandum, which directed that Federal preemptive authority be exercised only where "justified under legal principles governing preemption, including the principles outlined in Executive Order 13132."  Section 4(a) of Executive Order 13132 provides:

Agencies shall construe, in regulations and otherwise, a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.

The assertion that the OSH Act or the respirator regulation preempts state tort liability for the manufacture of certified respirators is not justified under that principle.

For all of these reasons, we believe that the December 31 letter, particularly when viewed through the prism of the recent Wyeth decision, substantially overstated the case for preemption.  Although we recognize that courts ultimately will decide whether tort suits are preempted, we are concerned that the letter has been introduced by defendants in recent tort actions in support of their arguments against liability.  For this reason as well, we believe it is important that the Department state its position clearly:  we do not interpret the Federal respiratory protection standards to preempt state tort actions involving respirators on the ground that the respirators meet Federal requirements.

  Based on the foregoing analysis, the Assistant Secretary for OSHA is withdrawing the December 31, 2008, letter.

Sincerely,



Deborah Greenfield
Acting Deputy Solicitor

   cc:        David Michaels, Assistant Secretary for
  Occupational Safety and Health

¹ It is significant that Congress did not include in the Act any private right of action or other remedy for workplaces injuries, disease, or death.  United Steelworkers, supra, at 1236; Pedraza, supra, at 54.  It is unlikely that Congress, having found occupational safety and health legislation necessary because "personal injuries and illnesses rising out of work situations impose a substantial burden ... in terms of lost production, wage loss, medical expenses, and disability compensation payments," 29 U.S.C. 651(a), would in that same legislation remove the means of judicial recourse for those injuries.  Instead, the lack of any private remedy under the federal OSH Act strongly suggests Congress believed that "widely available state rights of action provided appropriate relief" for workplace injuries. Wyeth, supra, at 1199.  [Return to Text]

² These procedures replaced an earlier respirator evaluation program originally developed by the Interior Department's Bureau of Mines in the 1930s and, after passage of the Mine Act in 1977, administered by NIOSH and MSHA.  OSHA and MSHA standards already included requirements that respirators be certified under the old program, and MSHA amended its standards to require approval under the new NIOSH program shortly after NIOSH implemented it.  30 C.F.R. 56.5005, 57.5005, 57.5044, 58.610, 70.300, 72.610 (1994).  OSHA's pre-1998 respiratory protection standard, 29 C.F.R. 1910.134(b)(11) (1997), was adopted without notice and comment pursuant to section 6(a) of the OSH Act, 29 U.S.C. 651(a), and was based on national consensus standards developed by the American National Standards Institute (ANSI).  The ANSI standards, as voluntary codes, had no preemptive effect, and there is no indication that OSHA's adoption of them as mandatory standards was meant to change that.  [Return to Text]