The U.S. Consumer Product Safety Commission (CPSC) has published a notice of proposed rulemaking in the Federal Register proposing to make more stringent a federal prohibition on phthalates in many children’s products.[1] Phthalates are used as a plasticizing agent and have been linked by some studies to endocrine disruption. CPSC’s proposal implements nearly every restriction proposed by a Chronic Hazard Advisory Panel (CHAP) in a July 2014 report.[2] The proposed rule would expand on a statutory ban on phthalates in certain children’s products that became effective when Congress enacted the Consumer Product Safety Improvement Act of 2008 (CPSIA).[3] Comments on CPSC’s proposed rule are due March 16, 2015.

If finalized, CPSC’s proposed phthalates rule would be one of the first federal actions regulating the use of a chemical on the basis of cumulative risk. The Environmental Protection Agency (EPA) and Congress could follow the Commission’s lead and take actions of their own to regulate the use of certain compounds on the basis of cumulative risk assessments. For the last several years, EPA has been considering how to regulate phthalates on the basis of cumulative risk. The U.S. Senate also considered legislation that would give EPA a mandate to consider cumulative risks posed by exposure to certain chemicals. As a result, CPSC’s proposed rule could mark the beginning of an era in which federal regulators impose restrictions on the use of chemicals, and phthalates in particular, on the basis of risks posed by cumulative exposure.

Background of the Proposed Rule

Congress enacted section 108 of CPSIA based primarily on concerns that phthalates can act as endocrine disrupters. Section 108 permanently banned three phthalates (DEHP, DBP and BBP) in concentrations greater than 0.1% in children’s toys and child care articles. The CPSIA defines “children’s toys” as consumer products intended for use by children 12 years old or younger when playing, and “child care articles” as consumer products intended for children 3 years old or younger to facilitate sleeping or feeding, or to help such a child who is sucking or teething. Section 108 also imposed an interim ban, which will terminate when the rule proposed by CPSC becomes final, on three phthalates (DINP, DDP and DNOP) in children’s toys that can be placed in a child’s mouth and child care products. Pursuant to section 108, CPSC convened the CHAP to study the health effects of phthalates and phthalate alternatives in children’s products. Section 108 required the CHAP to complete a report recommending whether CPSC should ban any phthalates or phthalate alternatives in addition to the three phthalates permanently banned by the CPSIA. It then required CPSC to promulgate a rule that determines whether to (1) continue any of the three interim bans, and (2) designate additional phthalates or phthalate alternatives to be banned from children’s products.

The CHAP’s July 2014 report[4] recommended that CPSC take three actions: (1) make permanent the interim ban on one phthalate (DINP); (2) impose a permanent ban on four phthalates (DIBP, DPENP, DHEXP and DCHP); and (3) impose an interim ban on one phthalate (DIOP). The CHAP evaluated the effects of phthalate and phthalate alternative exposure on human health, noting that the greatest sources of exposure are food and personal care products rather than children’s products. The CHAP found that several phthalates studied, as well as all of the phthalate alternatives considered, posed low, acceptable health risks. By contrast, the report concluded that exposure to five phthalates cumulatively contribute to the risk of disruption to male reproductive development. The CHAP proposed a permanent ban for these five phthalates. The report proposed an interim ban for DIOP because its chemical structure indicated that the phthalate would contribute to cumulative risks to male reproductive development, but the studies available offered evidence insufficient for the CHAP to recommend a permanent ban.

The Proposed Rule

CPSC’s proposed rule adopts, with one notable exception, every recommendation contained in the CHAP report. CPSC proposes to implement the permanent ban on five phthalates (DINP, plus DIBP, DPENP, DHEXP and DCHP), but it has declined to ban DIOP on an interim basis. The proposal would ban these phthalates in children’s toys and child care products at concentrations greater than 0.1%. CPSC intends to make its rule effective 180 days after publication of a final rule in the Federal Register.

The proposed rule would lift the interim ban on DIDP and DNOP, while imposing a permanent ban on DINP, DIBP, DPENP, DHEXP and DCHP. CPSC found that, considered individually, the risks posed by each of the phthalate and phthalate alternatives examined were within acceptable limits. Thus, contribution to cumulative risk of disruption to male reproductive development was the decisive factor in the Commission’s decision whether or not to ban a phthalate. Those phthalates that CPSC does not propose banning were found not to contribute to this cumulative risk, while the five phthalates included in the proposed ban were found to cumulatively contribute to the risk of disruption to male reproductive development. The Commission’s decision not to ban DIOP on an interim basis was based on its finding that the it had insufficient evidence to ban the phthalate permanently and that section 108 did not give CPSC the authority to impose interim bans by rule.

The proposal would also apply only to children’s toys and child care products, rather than a broader class of children’s products. The proposed rule notes that section 108 gives CPSC the authority to restrict phthalates in all children’s products, not merely children’s toys and child care products. Nonetheless, CPSC concluded that the CHAP’s findings provide an insufficient basis for extending a ban beyond children’s toys and child care products. Further, the proposal notes that the sparse information available to the Commission suggests that exposures from children’s products not covered by the proposed rule “would be negligible.” The proposal will also make the permanent ban on DINP more stringent than the interim ban imposed by section 108; the interim ban on children’s toys covered only those that can be placed in a child’s mouth.

The proposed rule would also ban these five phthalates at concentrations greater than 0.1%. The CPSC intends this threshold to strike a balance between prohibiting “intentional phthalate use while allowing trace levels.” The proposal also explains that CPSC rejected the alternative of setting risk-based limits for each phthalate on the grounds of impracticality. According to the preamble, it would be difficult to set risk-based limits because phthalate exposure “is not necessarily proportional to the phthalate concentration in the product.” As a result, CPSC proposes to ban these phthalates at the same concentration as those permanently banned by the enactment of section 108.

EPA and Cumulative Risk

CPSC’s proposal to restrict five phthalates in children’s products may be just the first of several federal actions regulating chemical compounds on the basis of risk posed by cumulative exposure. EPA has for several years been considering restricting the use of phthalates pursuant to its authority under the Toxic Substances Control Act (TSCA).[5] In a 2008 report commissioned by EPA, a committee of the National Research Council concluded that sufficient data existed for EPA to consider regulating phthalates on the basis of cumulative risks.[6] The report found that phthalate exposure cumulatively contributes to the disruption of male reproductive development—the same cumulative risk on which CPSC has based its proposal—thereby making a full risk assessment of phthalates appropriate. 

EPA’s action plan for regulating phthalates even provides that the CPSC’s approach to regulating phthalates will factor into how EPA decides to regulate these compounds under section 6(a) of TSCA.[7] The action plan, last revised in 2012, stated EPA’s intention to develop a rule in coordination with both CPSC and the Food and Drug Administration.[8] The plan provides that CPSC’s approach to phthalates regulation would inform “EPA’s determination of the extent of any future TSCA section 6 action addressing these chemicals.” The restrictions proposed by the CPSC may, therefore, influence EPA’s approach to phthalates under TSCA.

Apart from EPA’s own efforts, the U.S. Senate considered, during the 113th Congress, a bill that would have amended TSCA to require that EPA consider cumulative risks in its decisions to restrict chemicals.[9] The bill, proposed by the late Sen. Frank Lautenberg (D-NJ), would have required EPA to determine whether chemicals meet a safety standard based on, to the extent practicable, “information relating to the effect of cumulative exposure to that chemical substance….” The bill would have defined “cumulative exposure” to mean “the sum of aggregate exposure to each of the chemical substances that are known or suspected to contribute appreciably to the risk of the same or similar health effects.” It is unclear whether CPSC’s proposed rule may prompt renewed consideration of similar legislation during the 114th Congress.