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A coming federal ban on toys and child-care products containing phthalates could signal the beginning of a shift in how chemicals are regulated in the United States.
It also means manufacturers of vinyl toys and products intended to help infants eat, sleep or teethe will need to switch to different materials or use nonphthalate plasticizers for the vinyl products they sell into the U.S. market.
Some believe the decision represents a shift toward banning products believed to cause harm despite the absence of scientific certainty a precautionary approach like the one used in the European Union. Typically in the U.S., chemicals are regulated after studies indicate potential harm exists and a regulatory review is conducted.
``I believe this legislation is important as the first national effort to begin to exercise a precautionary principle in the use of chemicals as additives to products that affect human health,'' said Sen. Dianne Feinstein, D-Calif., in a statement. ``Chemical additives should not be placed in products that can impact health adversely until they are tested and found to be benign.''
The passage of a nationwide ban on phthalates with an establishment of national standards for the level of lead in toys means there will be national standards, not a patchwork of state laws.
``Our principle concern that the toy industry would end up with a confusing patchwork of individual state limits on chemicals seems to have been avoided,'' said a spokesman for the New York-based Toy Industry Association Inc.
A joint Senate-House conference committee approved the ban July 28 on six types of phthalates three are banned permanently and three temporarily as part of a bill that increased the funding and authority of the Consumer Product Safety Commission. It passed the House and Senate in late July, and comes on the heels of phthalate bans passed in California, Washington and Vermont in the past nine months.
The federal ban goes into effect 180 days after the bill is signed. The law permanently bans the sale of toys intended for children 12 or younger or child-care articles for children 3 and under that contain more than 0.1 percent of three phthalates: di(2-ethylhexyl) phthalate, dibutyl phthalate and butyl benzyl phthalate.
Child-care articles are defined as products intended to facilitate sleep or the feeding of children 3 or younger, or to help them with sucking or teething. The bill further defines mouthing toys as those that can be chewed and sucked and are smaller than 5 centimeters or contain a part smaller than 5 centimeters.
The bill also places a temporary ban on any toy or child-care article that contains more than 0.1 percent of three other phthalates diisononyl phthalate (DINP), diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DNOP) until a scientific advisory panel review is completed, at which time the ban could be made permanent or lifted. DINP is the phthalate most commonly used as a plasticizer for toys.
``The short-term impact is that downstream manufacturers will have to seek alternative materials or products, or [use] alternative plasticizers,'' said Chris Bryant, managing director of chemical products and technology for the American Chemistry Council in Arlington, Va.
``If you need the vinyl for your product, you will find an alternative plasticizer,'' said Allen Blakey, vice president of industry and government affairs for the Vinyl Institute, also in Arlington. ``If you don't feel the vinyl is important, you will switch materials.''
U.S. firms manufacture $1.4 billion of phthalates annually, with less than 5 percent used in children's products. Major retailers Wal-Mart and Toys ``R'' Us previously had said they would stop carrying toys and child-care products that contain phthalates, beginning Jan. 1.
ACC said it supports the increased funding and a stronger CPSC but is disappointed Congress chose to ban phthalates in the products.
``Restricting phthalates from children's products, when they have been deemed safe for use in those products by the CPSC, will do nothing to protect children's health,'' said ACC products director Sharon Kneiss. ``There is no scientific basis for Congress to restrict phthalates from toys and children's products.''
There is no provision in the bill to revisit the three phthalates permanently banned. But the industry will have an opportunity to prove the safety of the three temporarily banned phthalates under a review process scheduled to take three years.
Under the bill, CPSC must set up a Chronic Hazard Advisory Panel 180 days after the law goes into effect to study the health effects of phthalates and phthalate alternatives on women and young children.
The panel must complete its report within 18 months, submit it to the CPSC, which would have to lift the temporary ban on DINP, DIDP and DNOP or promulgate a rule to ban the chemicals permanently.
Bryant said ACC is ``confident that the panel will come to the conclusion that those phthalates are safe.''
However, even if CPSC rules three years from now that those three phthalates are safe, reintroducing them into the marketplace will be challenging because it is likely alternate plasticizers or materials will have taken their place, as they have in the European Union, where all six plasticizers have been banned since 1999.
The EU ban is narrower, however, restricted to mouthing toys that are about 2 inches or less on each side.
Some animal studies have shown that certain phthalates interfere with hormonal systems, disrupt testosterone production and cause malformed sex organs. However, a 2003 CPSC study concluded few children are at risk from phthalates because the amount they ingest does not reach a harmful level.