A chemical used to make plastic for baby bottles and food-can liners that has been linked to possible cancer risks is safe at current exposure levels, U.S. health regulators said.
The Food and Drug Administration ``has concluded that an adequate margin of safety exists'' for the chemical, bisphenol A, when used in products coming into contact with food, agency staff said in a draft report dated yesterday and available on the FDA's Web site.
While the FDA has approved bisphenol A as safe for people, a report in April from the U.S. National Toxicology Program said animal studies suggested its use may pose a cancer risk and lead to early or delayed puberty. The FDA said that study lacked sufficient information on different exposure levels to warrant changing current safety recommendations.
``FDA's thorough analysis confirms that food contact products made from polycarbonate plastic, including products for infants and children, can continue to be used safely,'' Steven G. Hentges, managing director of the American Chemistry Council, which represents the chemical industry, said in an e-mailed statement.
The FDA assessment recommended more detailed testing, specifically in adult, pregnant and newborn monkeys, to look for effects on nervous system development and behavior.
Panel Review
A subcommittee of the FDA's Science Board, an advisory panel, plans to review the agency's draft report at a Sept. 16 meeting in Rockville, Maryland. U.S. lawmakers have considered banning products that contain bisphenol A following questions regarding its safety. In April, Canada became the first country to label bisphenol A as ``toxic'' and is considering banning the use of baby bottles containing the chemical.
Several companies that produce plastic bottles, such as Energizer Holding Inc.'s Playtex Infant Care unit and Thermo Fisher Inc., the maker of Nalgene sports bottles, have stopped using the chemical in their new products due to the concerns.
Average infant exposures are about 2,000 times below FDA's safety level, and exposures among adults are 27,000 times lower, the draft report said.
For each kilogram of their body weight, infants are exposed to about 2.42 micrograms of bisphenol A each day, according to the report. On the same basis, adults are exposed to about 0.185 micrograms daily. The FDA has found that a daily 5,000 micrograms per kilogram of body weight is a safe level of exposure, the draft said. A microgram is a millionth of a gram.
The National Toxicology Program plans in early September to report its analysis of studies conducted on bisphenol A, said Robin Mackar, a spokeswoman for the program, in a telephone interview today. The report will focus on the risk to reproduction, she said.
The Food and Drug Administration ``has concluded that an adequate margin of safety exists'' for the chemical, bisphenol A, when used in products coming into contact with food, agency staff said in a draft report dated yesterday and available on the FDA's Web site.
While the FDA has approved bisphenol A as safe for people, a report in April from the U.S. National Toxicology Program said animal studies suggested its use may pose a cancer risk and lead to early or delayed puberty. The FDA said that study lacked sufficient information on different exposure levels to warrant changing current safety recommendations.
``FDA's thorough analysis confirms that food contact products made from polycarbonate plastic, including products for infants and children, can continue to be used safely,'' Steven G. Hentges, managing director of the American Chemistry Council, which represents the chemical industry, said in an e-mailed statement.
The FDA assessment recommended more detailed testing, specifically in adult, pregnant and newborn monkeys, to look for effects on nervous system development and behavior.
Panel Review
A subcommittee of the FDA's Science Board, an advisory panel, plans to review the agency's draft report at a Sept. 16 meeting in Rockville, Maryland. U.S. lawmakers have considered banning products that contain bisphenol A following questions regarding its safety. In April, Canada became the first country to label bisphenol A as ``toxic'' and is considering banning the use of baby bottles containing the chemical.
Several companies that produce plastic bottles, such as Energizer Holding Inc.'s Playtex Infant Care unit and Thermo Fisher Inc., the maker of Nalgene sports bottles, have stopped using the chemical in their new products due to the concerns.
Average infant exposures are about 2,000 times below FDA's safety level, and exposures among adults are 27,000 times lower, the draft report said.
For each kilogram of their body weight, infants are exposed to about 2.42 micrograms of bisphenol A each day, according to the report. On the same basis, adults are exposed to about 0.185 micrograms daily. The FDA has found that a daily 5,000 micrograms per kilogram of body weight is a safe level of exposure, the draft said. A microgram is a millionth of a gram.
The National Toxicology Program plans in early September to report its analysis of studies conducted on bisphenol A, said Robin Mackar, a spokeswoman for the program, in a telephone interview today. The report will focus on the risk to reproduction, she said.