It will be at least 18 months before new federal rules require substances regulated under the Food and Drug Act to undergo an environmental assessment. Health Canada is concerned because certain chemicals in drugs and some foods are now at detectable levels in the environment.
Some of this is due to the disposal of unused prescription drugs in hospitals and homes (see letter, page 1252). “We are concerned about it,” says Elizabeth Nielsen, director general of Health Canada's Office of Regulatory and International Affairs. “But we can't regulate how a consumer disposes of something. We can only provide advice.”
In conjunction with the new regulations, they plan to issue “Best Practices” documents aimed at consumers, manufacturers and water-monitoring agencies, and perhaps hospitals. They will also urge physicians to reduce the number of prescriptions they write.
“We're very much at the developmental stage,” says Nielsen. An international workshop of scientists has identified gaps in the research that need to be addressed (www.hc-sc.gc .ca /ear-ree). Meanwhile, Nielsen's office is meeting with nongovernmental and other groups in preparing the regulations for publication in the Canada Gazette in September 2003.
In the interim, new products submitted for approval under the Food and Drugs Act will have to undergo an environmental assessment under the New Substances Notification Regulations of the Canadian Environmental Protection Act.
The US Food and Drug Administration is also considering requiring more tests to determine the effect of drugs on the environment. A survey of 100 waterways in 30 states found minute amounts of dozens of antibiotics, hormones, pain relievers, cough suppressants, disinfectants and other products (toxics .usgs .gov). — Barbara Sibbald, CMAJ