Despite a clear directive from Congress, the Consumer Product Safety Commission (CPSC) says it may continue to allow the sale of children's products containing a controversial plastics chemical.

Effective Feb. 10, 2009, the Consumer Product Safety Improvement Act of 2008 bans the sale of children's products containing phthalates, a class of chemicals used to make plastics soft and pliable. Congress passed the bill in July, and President Bush signed it into law on Aug. 14.

Congress banned the substance in response to growing public concern over the health effects of exposure to phthalates. Scientists have linked phthalates to reproductive and developmental abnormalities in fetuses and infants.

However, a legal opinion from CPSC raises new questions on how the agency will implement the ban. CPSC General Counsel Cheryl A. Falvey says that although children's products containing phthalates cannot be manufactured after Feb. 10, 2009, those manufactured before Feb. 10 can continue to be sold indefinitely.

Sen. Barbara Boxer (D-CA), a lead proponent of the phthalate ban, criticized Falvey's legal interpretation in a Nov. 21 letter. Boxer said the law's intent is to ban the sale of children's products containing phthalates regardless of their manufacture date. She called the opinion "a pathetic and transparent attempt to avoid enforcing this law."

Boxer cited the operative provision in the law, which reads, "Beginning on the date that is 180 days after the date of enactment of this Act, it shall be unlawful for any person to manufacture for sale, offer for sale, distribute in commerce, or import into the United States any children's toy or child care article that contains" any of the phthalates identified in the law.

In her legal opinion, Falvey cited a different law, the Consumer Product Safety Act, which sets the framework for consumer product regulation and governs CPSC's regulatory process. "The Consumer Product Safety Act expressly states that consumer product safety standards apply only to product manufactured after the effective date of a new standard," Falvey writes.

Language in the Consumer Product Safety Act should supersede language in the phthalate ban, according to Falvey. The provision in the Consumer Product Safety Improvement Act of 2008 regarding phthalates says new rules "shall be considered consumer product safety standards under the Consumer Product Safety Act." However, that clause appears in a section of the act concerning "effect on state laws" and is aimed at preventing CPSC from using the phthalate ban to preempt stricter laws and regulations at the state level.

In her letter, Boxer called on Falvey to immediately withdraw her opinion. The views expressed in Falvey's opinion "have not been reviewed or approved" by the CPSC.

If CPSC backs away from Falvey's opinion and enforces the letter of the law, the economic impact will be significant. Making it illegal to "manufacture for sale, offer for sale, distribute in commerce, or import" children's products containing phthalates beginning in February 2009 will likely leave companies at each link in the supply chain with excess inventory.

Industry lobbying groups, such as the U.S. Chamber of Commerce, opposed a ban on phthalates when Congress was debating the Consumer Product Safety Improvement Act. Consumer safety advocates, long concerned with the health effects of phthalates, pushed for the ban.

The European Union and the state of California have already enacted restrictions on phthalates in consumer products. Other states are also considering restrictions.

The federal ban on phthalates was one of the final sticking points for Congress during the debate on the Consumer Product Safety Improvement Act. The provision bans three types of phthalates outright. Three other phthalates will be banned temporarily pending further study.

The new policy on phthalates represents a dramatic shift in the federal government's approach toward regulating toxic substances. Usually, chemicals enter and stay on the market without regulation and are only pulled if scientists prove a definitive health risk. In this case, the banned substances will only be allowed back on the market if their safety is proven.

In an August statement, OMB Watch Executive Director Gary D. Bass said, "The bill turns our usual system of chemical regulation on its head by requiring proof of safety, not proof of harm, an approach we strongly support."