Consumer Product Safety Commission

The Consumer Product Safety Commission is an independent agency charged with regulatory responsibility over the safety of consumer products (which are defined by law to exclude foods, drugs and pesticides, regulated under FFDCA, as well as tobacco and certain other products regulated elsewhere). The commission was established by the Consumer Product Safety Act (CPSA) of 1972. The regulatory authority over hazardous substances in consumer products derives from the CPSA and the Federal Hazardous Substances Act (FHSA), which has existed since 1960. The FHSA was formerly administered by the Food and Drug Administration, but authority was transferred to the commission by §30(a) of the CPSA.

The CPSA establishes the Consumer Product Safety Commission with the mandate "to protect the public against unreasonable risks of injury associated with consumer products" and "to develop uniform safety standards" [§2(b)]. The agency is run by a five member commission appointed by the president (with the consent of the Senate) for seven-year terms. (In recent years, only three commissioners have been appointed, and in this circumstance, two constitute a quorum.) Decision-making by the commission is by majority vote among commissioners who may have been appointed by different administrations. This makes the development of analyses to support decisions somewhat different at CPSC than at agencies answering to a single administration appointee. Staff develop positions and options for the commission's consideration, laying information out for a final, publicly held, sometimes contentious debate.

The impetus is on the commission to promulgate consumer product safety standards when it is deemed necessary to protect the public against unreasonable risks of injury. That is, its task is to identify and act against hazards as opposed to endorsing products as "safe." Although much of the focus of the CPSA is on acute hazards, there are specially mentioned provisions for chronic toxicity, as discussed below. The commission has a wide variety of regulatory options that can be applied as deemed necessary, including labeling, mandating other provision of information, endorsement of voluntary standards, manufacturing standards, product performance standards, bans, and recalls [CPSA §§7,8,15].

The FHSA defines a hazardous substance (or mixture) as one that is corrosive, an irritant, a strong sensitizer, or flammable, or one that "may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children" [FHSA §2(f)(1)(A)]. Section 3 of this act gives authority to "declare by regulation any substance or mixture of substances which...meets the requirements" of this definition to be a hazardous substance. (Section 3 specifies a series of procedures which includes the right to petition for hearings; it is these more extensive procedural requirements, in addition to the focus on chemical hazards, that chiefly distinguishes regulation under the FHSA from that under the CPSA.) Labeling of substances declared to be hazardous is mandated. However, if "notwithstanding such cautionary labeling...the degree or nature of the hazard...is such that the objective of the protection of the public health and safety can be adequately served only by keeping such substance...out of the channels of interstate commerce," the substance can be declared a "banned hazardous substance" [§2(q)(1)].

Many of the provisions of the CPSA and the FHSA apply to both acute and chronic hazards. There is a particular provision in the CPSA regarding chronic hazards, however. Before any rule "relating to a risk of cancer, birth defects, or gene mutations" can be proposed, the commission must appointment a Chronic Hazard Advisory Panel of independent scientific experts [§28] from nominations by the president of the National Academy of Sciences; "the Commission shall request the Panel to review the scientific data and other relevant information...to determine if any substance in the product is a carcinogen, mutagen, or a teratogen." If so, "the Panel shall include in its report an estimate, if such an estimate is feasible, of the probable harm to human health that will result from exposure to the substance" [CPSA §31(b)].

In promulgating a rule, the commission must make findings regarding "the degree and nature of risk...; the need of the public for the consumer products subject to such rule, and the probable effect...upon the utility, cost, or availability of such products...; and...any means of achieving the objective of the order while minimizing adverse effects on competition or disruption or dislocation of manufacturing and other commercial practices consistent with the public health and safety" [CPSA §9(f)(1)]. The final regulatory analysis of the rule must contain "A description of the potential benefits and potential costs of the rule, including... [those] that cannot be quantified in monetary terms, and the identification of those likely to receive the benefits and bear the costs" [§9(f)(2)]. Such analysis must also be included for "alternatives to the final rule which were considered, together with...a brief explanation of the reason why these alternatives were not chosen." The commission is prohibited from promulgating a rule unless it finds "that the rule...is reasonably necessary to eliminate or reduce an unreasonable risk of injury; that promulgation of the rule is in the public interest;...that the benefits expected from the rule bear a reasonable relationship to its costs; and...that the rule imposes the least burdensome requirement which prevents or adequately reduces the risk of injury" [§9(3)]. It must also find that no currently implemented voluntary standard will suffice and that, if the rule is a ban, no other reasonable rule would protect the public. (As with most risk analyses, these findings are protected from judicial review unless the final rule itself is challenged.)

The requirements of the CPSA for rulemaking to include a statement on "the degree and nature of risk" [CPSA §9(f)(1)] and for each Chronic Hazard Advisory Panel to "include in its report an estimate, if such estimate is feasible, of the probable harm to human health" [§31(b)] constitute a fairly clear statutory call for the conduct of risk assessment. In addition, however, perhaps more than any other agency, the CPSC is explicitly required to justify its regulation in terms of costs and benefits. Whereas other cost-benefit balancing laws (e.g., FIFRA) merely make brief mention taking costs and feasibility into account, the consumer product laws lay out a series of specific findings that must be made.

The extensive need under the existing consumer protection statutes to cast regulatory risk analyses in terms of costs, benefits, impact on consumers, and the least burdensome regulatory approach among many options focuses attention of CPSC analyses on typical uses at typical levels under various regulatory options. The mandate for protection against "unreasonable risk" has an element of protecting individuals, but the mandated consideration of the costs and benefits of options means that the main concern is for how the number of users and the typical exposure during use will be affected by the various control options. That is, once the product has been determined to be toxic, the main focus is on population rather than on individual risk.

The statutes make no mention of protection of sensitive subpopulations from injury, although the CPSA [§9(e)] does mandate that the special needs of the handicapped and elderly be taken into account regarding the disruption to consumer convenience resulting from a potential rule.