Defending Cases Involving Hazardous Substances: Preemption Under the Federal Hazardous Substances Act
Defending the manufacture, distribution, or sale of a chemical or other hazardous substance may appear to be an insurmountable task. Many household cleaners and chemicals are extremely flammable, and if used incorrectly, have potentially grave consequences. However, given that such products are necessary to everyday life and given concerns over the undue restriction interstate commerce, Congress struck a balance between the interests of safety and the interests of commerce when it enacted, and subsequently revised, the Federal Hazardous Substances Act (FHSA).
The FHSA was enacted in 1960. The purpose of the law was to "provide nationally uniform requirements for adequate cautionary labeling of packages of hazardous substances which are sold in interstate commerce and are intended or suitable for household use." House Comm. on Interstate and Foreign Commerce, Federal Hazardous Substances Labeling Act, H.R. Rep. No. 86-1861 (1960). As enacted, the FHSA did not contain a preemption provision. However, when the Act was amended in 1966, the legislative history addressed the impracticality of having the states potentially producing fifty different labels for a particular hazardous substance. Comm. on Interstate and Foreign Commerce, Child Protection Act of 1966, H.R. Rep. No. 89-2166 (1966). Thus, the Act was amended to provide that "no State or political subdivision of a State may establish or continue in effect a cautionary labeling requirement" applicable to the product governed by the Act "unless such cautionary labeling requirement is identical to the labeling requirement" under the Act. 15 U.S.C. sec. 1261, note (b)(1)(A).
In 1976, when Congress decided to expand upon the preemption provision of the FHSA, the Senate Committee on Commerce noted that the FHSA's preemption scheme "is designed to meet the competing interests of those who view Federal requirements as merely minimum standards and those who would opt for uniform national requirements." Senate Committee on Commerce, Consumer Product Safety Commission Improvements Act of 1976, S. Rep. No. 94-251 (1976). For that reason, Congress permitted states to impose additional labeling requirements, via the exemption process, if they were able to convince the CPSC that (1) such requirements provide "a significantly higher degree of protection from such risk of illness or injury" than do the requirements of the FHSA, and (2) such requirements do not unduly burden interstate commerce. 15 U.S.C. sec. 1261, note (b)(3)(A)(ii); Lee, 792 F. Supp. at 1008. As explained by the District Court in Lee, "[p]ermitting the assertion of state common law causes of action which would have the same effect but would not undergo the review mandated by the FHSA would frustrate this scheme." Lee, 792 F. Supp. at 1008. To permit a state common law action, other than a misbranding action, to proceed would impermissibly take from the federal agency the decision as to the proper balance between the costs and burdens to manufacturers and the safety of consumers.
For the FHSA and its preemption clause to apply, the substance involved must be a "hazardous substance" as defined by the Act, and the product must be labeled in accordance with the Act.
The FHSA applies to "hazardous substances" defined by the Act as substances or mixtures of substances which are flammable or combustible if such substance or mixture of substances may cause substantial injury as a proximate cause of a foreseeable use. 16 C.F.R. sec. 1261(f). The terms "flammable" or "combustible" refer to substances with a flashpoint at or below 20 degrees. 15 C.F.R. 1500.3(c)(6)(i). The FHSA requires that the label include:
(A) the name of the manufacturer, packer, distributor, or seller
(B) the common name or the chemical name of the hazardous substance or of each component which contributes substantially to its hazard
(C) the word "DANGER" on substances which are extremely flammable, corrosive or highly toxic
(D) the word "WARNING" or "CAUTION" on all other hazardous substances
(E) the principal hazard or hazards, such as "Flammable," "Combustible," "Vapor Harmful," "Causes Burns," "Absorbed Through Skin," or similar wording descriptive of the hazard
(F) precautionary measures describing the action to be followed or avoided
(G) instruction, when necessary or appropriate, for first-aid treatment
(H) the word "poison" for any hazardous substance defined as "highly toxic" by 15 U.S.C. sec. 1261(h)
(I) instructions for handling and storage
(J) the statement "Keep out of the reach of children"
15 U.S.C. sec. 1261(p)(1)(A-J). The Code has additional labeling requirements specific to the particular composition of the substance. For example, for products containing 10% or more of toluene or petroleum distillates, the label must state "danger," "harmful or fatal if swallowed," and "call physician immediately." 16 C.F.R. sec. 1500.14(b)(3)(ii). Products containing 10% or more of toluene must contain the statement "vapor harmful" as well. 16 C.F.R. sec. 1500.14(b)(3)(iii).
The FHSA applies regardless of whether the product label states that it is for "professional" or "industrial" use. Canty v. Ever-Last Supply Co., 296 N.J. Super. 68, 685 A.2d 1365 (1996). It is true that the Code provides that industrial supplies are not covered by the Act simply because a serviceman may bring them into the home, or an industrial worker may take a supply for his own use. 16 C.F.R. sec. 1500.3(c)(10)(i). For this reason, Courts have held that products which are not in the steam of commerce available to ordinary consumers were not subject to the Act. Christenson v. St. Mary's Hospital, 835 F. Supp. 498 (D.C. Minn. 1993)(Hospital supply product not in the stream of commerce available to ordinary consumers which was brought home was not a product to which the FHSA applied); Barnes v. Litton Industrial Products, Inc., 555 F.2d 1184 (4th Cir. 1977)(Burning alcohol, supplied to prison for use in dental procedures, which was marketed to dentists and professional dental laboratories, was not subject to the FHSA's labeling requirements). However, the test is not whether the product says it is for industrial use. The test is, under 16 C.F.R. sec. 1500.3(c)(10)(i), "whether under any reasonably foreseeable condition of purchase, storage, or use the article may be found in or around a dwelling."
If the product is a "hazardous substance" as defined by the Act, and the product is labeled in accordance with the Act, then subsequent tort claims are generally barred. However, claimants continue in their efforts to defeat the preemption clause of the FHSA. Defenses raised include the claims that (1) the FHSA is not applicable to false advertising and fraud claims; (2) the FHSA is not applicable to "instructions for use," but are only applicable to "warnings;" and (3) federal law does not preempt state law claims.
False Advertising and Fraud Claims
Absent further amendment, intentional fraud claims survive the preemption provisions of the FHSA. The United States Supreme Court in Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992), held that not all of the petitioner's claims were barred by the preemption provisions of the Federal Cigarette Labeling and Advertising Act. In Cipollone, the petitioner claimed that the respondent-cigarette manufacturers concealed material facts regarding the health risks of cigarettes. The Supreme Court held that the fraudulent misrepresentation claims were not preempted because Congress did not indicate in the Act a desire to insulate cigarette manufacturers from making fraudulent statements regarding their products. Cipollone, 505 U.S. at 528-529. There are no provisions in the FHSA which would indicate Congress's intention to insulate the manufacturers of hazardous substances from liability related to fraudulent representations on their part.
"Instructions for Use" versus "Warnings"
Although the terms "warning" and "instruction" may have different meanings generally, there is no distinction under the FHSA. Section 16 C.F.R. 1500.121 addresses what is meant by the FHSA when it requires cautionary statements on product labels. Such cautionary statements include:
...signal words; affirmative statements of the principal hazard(s) associated with a hazardous substance; the common or usual name, or chemical name, of the hazardous substance, the name and place of business of the manufacturer, packer, distributor, or seller; statements of precautionary measures to follow; instructions, when appropriate, for special handling and storage; the statement "Keep Out of the Reach of Children" or its practical equivalent; and, when appropriate, first-aid instructions.
16 C.F.R. sec. 1500.121(a)(1). There is no difference under the FHSA between the term "instruction" and the term "warning."
Preemption of State Law Claims
The vast majority of courts interpreting the preemptive effect of the FHSA have held that the FHSA preempts state law claims for defective or inadequate labeling on hazardous substances, excepting claims for noncompliance with the labeling requirements of the Act. Moss v. Parks Corporation, 985 F.2d 736, 740 (4th Cir. 1993), cert. denied, 509 U.S. 9061 (1993); Busch v. Graphic Color Corp., 268 Ill. App. 3d 763, 644 N.E.2d 839, 844 (1995); Salazar v. Whink Products Co., 881 P. 2d 431, 433-434 (Colo. App.), cert. denied, 115 S. Ct. 1315 (1994); State v. Seier, 871 S.W.2d 611, 613 (Mo. App. 1994); Lee v. Boyle-Midway Household Products, Inc., 792 F. Supp. 1001 (W.D. Pa. 1992); Pennsylvania General Ins. Co. v. Landis, 96 F. Supp. 2d 408 (D. N.J. 2000); Milanese v. Rust-Oleum Corp, 244 F. 3d 104 (2nd Cir. 2001); Kirstein v. W.M. Barr & Co., Inc., 983 F. Supp. 753 (N.D. Ill. 1997), aff'd 159 F. 3d 1065 (7th Cir. 1998), cert. denied, 526 U.S. 1065 (1999). However, claimants may take the position that state common law tort claims are not preempted under the FHSA, claiming that the U.S. Supreme Court in Medtronic, Inc. v. Lohr, 116 S.Ct. 2240 (1996), a case addressing a defective pacemaker lead, overruled the Court's previous decision in Cipollone. However, there are significant differences between the Medical Device Amendments of 1976 (MDA) at issue in Medtronic and the FHSA with respect to the preemption issue.
Unlike the MDA, the FHSA does not have a grandfather clause or equivalent to the MDA's 510(k) process which permits products onto the market without meeting specific federal safety requirements. Products in compliance with the FHSA are required to meet the labeling standards as set forth in the Act. It was the MDA's sec. 510(k) process, which was primarily administrative as opposed to substantive, and which was designed to simply preserve the status quo, which led the Medtronic Court to conclude that the legal remedies of the status quo were likewise preserved. See Mitchell v. Collagen Corporation, 126 F. 3d 902 (7th Cir. 1997). Further, in the MDA and related regulations, there were no federal requirements with respect to the subject pacemaker lead. The Medtronic Court found only generic federal concerns about the safety of medical devices generally, and thus, in the absence of specific federal guidelines, refused to find preemption. In contrast, the FHSA contains very specific labeling requirements for hazardous substances which are specific to the quantity of certain ingredients used. In addition to the requirements being very specific to the chemical composition of a particular product, the labeling requirements themselves are very specific as to the language to be used and the placement and appearance of the warning.
Thus, the task of defending the manufacturer, distributor or seller of a hazardous substance is not an overwhelming task as the doctrine of preemption continues to provide relief where the product is properly labeled in compliance with federal law