Chemical name: 1,1'-Biphenyl, 2,2',3,3',4,4',5,5',6,6'-decabromo-

Final regulatory action has been taken for the category: Industrial

Final regulatory action: The chemical is Banned

Use or uses prohibited by the final regulatory action:

The Regulations prohibit the manufacture, use, sale, offer for sale or import of PBB, or a mixture of product containing PBB, unless the substance is incidentally present.

Use or uses that remain allowed:

The Regulations do not apply to PBBs substances that are:

contained in a hazardous waste, hazardous recyclable material or non-hazardous waste

contained in a control product (eg pesticide)

present as a contaminant in a chemical feedstock used in a process from which there are no releases of the substance and provided that the substance is destroyed or completely converted in that process to a substance that is not listed in Schedule 1 or 2 of the Regulations; or

that are used:

in a laboratory for analysis

in scientific research

as a laboratory analytical standard.

The Regulations also establish a permit system that provides a mechanism for temporarily exempting certain applications of a prohibited substance listed in the Regulations. Each permit lasts for 12 months, and can be renewed only twice. However, since PBBs are not currently used in Canada, it is unlikely that a permit will be required.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

History of the Regulatory Action

All commercial manufacturing and processing uses were first prohibited effective May 1, 1979 pursuant to the Polybrominated Biphenyl Regulations (SOR/79-351) under the Environmental Contaminants Act.

The Polybrominated Biphenyl Regulations were revoked when the Polybrominated Biphenyl Regulations, 1989 (SOR/90-129) were rolled over into the Canadian Environmental Protection Act (CEPA), which consolidated various pieces of 1970s environmental legislation, including the Environmental Contamination Act.

The Polybrominated Biphenyls Regulation, 1989 were replaced in 1996 by the Prohibition of Certain Toxic Substances Regulations (SOR-96-237) under CEPA. These Regulations consolidated the existing Regulations for all toxic substances for which it had been determined that their use in Canada should be totally banned for environmental or health protection.

The Prohibition of Certain Toxic Substances Regulations were replaced by the Prohibition of Certain Toxic Substances Regulations 2003 (SOR/2003-99) under CEPA 1999, which have since been amended to the Prohibition of Certain Toxic Substances Regulations, 2005 (SOR/2005-40).

The Prohibition of Certain Toxic Substances Regulations, 2005 (hereafter referred to as "Regulations") prohibit the manufacture, use, sale, offer for sale and import of toxic substances listed in Schedules 1 and 2 to the Regulations. PBB is found on Schedule 1, which lists substances subject to total prohibition, with the exception of incidental presence. Schedule 2 lists substances that are subject to prohibitions relates to concentration or use.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

PBBs acumulate in food chains. They are excreted in the milk of PBB-contaminated cows. Hens contaminated with PBBs lay eggs containing PBBs. Bioaccumulation of PBBs has frequently been observed, especially in hepatic and adipose tissue, in various species including fish such as carp, fathead minnows, and Atlantic salmon, birds and mammals, including humans. Debromination of higher PBBs and bioaccumulation of PBBs having fewer than seven bromine atoms occur in young Atlantic salmon.

Expected effect of the final regulatory action in relation to human health:

The Regulations protect the health of Canadians and ecosystems by ensuring that future production, importation and use of PBB is prohibited with very limited exemptions.

Summary of known hazards and risks to the environment:

Industrial discharges and solid wastes from a PBB manufacturing plant in Michigan have caused widespread environmental contamination. High concentrations of PBBs have been found in river water, in river sediments, in certain species of fish, and in ducks. More recently, PBBs have been found in deer, rabbits, coyote and raven, from contaminated sites, and in herring gull eggs from different Michigan locations on the Great Lakes. In Canada, PBBs have been found in wastewater from the only plant which had used commercial quantities of PBBs.

For many animals, except mink and guinea pigs, the acute toxicity of PBBs is low. There is, however, much evidence of chronic toxicity to various species, including rats, chickens, cattle and sheep. The reproduction of birds and mammals is adversely affected by PBBs. There is evidence that PBBs are embryotoxic and teratogenic. PBBs are potent and long-lasting inducers of the mixed function oxidase (MFO) enzymes. Liver nodules have been found in mice which had been fed PBBs.

PBBs accumulate in food chains. They are excreted in the milk of PBB-contaminated cows. Hens contaminated with PBBs lay eggs containing PBBs. Bioaccumulation of PBBs has frequently been observed, especially in hepatic and adipose tissue, in various species including fish such as carp, fathead minnows, and Atlantic salmon, birds and mammals, including humans. Debromination of higher PBBs and bioaccumulation of PBBs having fewer than seven bromine atoms occur in young Atlantic salmon.

Expected effect of the final regulatory action in relation to the environment:

The Regulations protect the health of Canadians and ecosystems by ensuring that future production, importation and use of PBB is prohibited with very limited exemptions

Date of entry into force of the final regulatory action: 15/05/2005