Chemical name: Asbestos, amosite

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:

All uses are prohibited, except as stated in the exemptions following.

Use or uses that remain allowed:

If the intended use is subject to the provisions and exemptions of Annex 3.3 of the Ordinance relating to Environmentally Hazardous Substances.

Exemptions:

1. On reasoned request, the Federal Agency for the Environment, Forests and Landscapes my permit a manufacturer or trader to continue to supply certain products or articles or to import them as commercial goods after the dates laid down in Annex 3.3, Number 31 if:

1. according to the state of the art, there is no replacement substance for the asbestos and provided that no more than the minimum amount of asbestos for the desired purpose is employed, or

b. due to particular design conditions, only spare parts containing asbestos can be used.

Labeling:

Manufacturers may only supply packing drums and packaging for asbestos, product or articles containing asbestos, and unpackaged products containing asbestos if they carry a label giving the information laid out in Annex 3.3, Numbe 33 of the Ordinance relating to Environmentally Hazardous Substances.

All other provisions stated in Annex 3.3 apply equally.

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

Summary of the final regulatory action:

Asbestos shall no longer be used, except to manufacture products or articles which may be supplied or imported as commercial goods in accordance with Annex 3.3 of the Ordinance relating to Environmentally Hazardous Substances (SR 814.013)

The specified conditions are:

If the intended use is subject to the provisions and exemptions of Annex 3.3 of the Ordinance relating to Environmentally Hazardous Substances.

Exemptions:

1. On reasoned request, the Federal Agency for the Environment, Forests and Landscapes my permit a manufacturer or trader to continue to supply certain products or articles or to import them as commercial goods after the dates laid down in Annex 3.3, Number 31 if:

1. according to the state of the art, there is no replacement substance for the asbestos and provided that no more than the minimum amount of asbestos for the desired purpose is employed, or

b. due to particular design conditions, only spare parts containing asbestos can be used.

Labeling:

Manufacturers may only supply packing drums and packaging for asbestos, product or articles containing asbestos, and unpackaged products containing asbestos if they carry a label giving the information laid out in Annex 3.3, Numbe 33 of the Ordinance relating to Environmentally Hazardous Substances.

All other provisions stated in Annex 3.3 apply equally.

The reasons for the final regulatory action were relevant to:

Summary of known hazards and risks to human health:

Actinolite is an amphibole form of asbestos

Fibrosis in many animal species, and bronchial carcinomas and pleural mesotheliomas in the rat, have been observed following inhalation of both chrysotile and amphibole asbestos. In these studies, there were no consistent increases in tumour incidence at other sites, and there is no convincing evidence that ingested asbestos is carcinogenic in animals. Data from the inhalation studies have shown that shorter asbestos fibres are less fibrogenic and carcinogenic. The length, diameter and chemical composition of fibres are important determinants of their deposition, clearance and translocation within the body. Available data also indicate that the potential of fibres to induce mesotheliomas following intrapleural or intraperitoneal injection in animal species is mainly a function of fibre length and diameter; in general, fibres with maximum carcinogenic potency have been reported to be longer than 8 µm and less that 1.5 µm in diameter.

Effects on man: There is general consensus amongst the scientific community that all types of asbestos fibres are carcinogenic and can cause asbestosis, lung cancer and mesothelioma when inhaled. The evidence for carcinogenicity to humans is sufficient (Group 1). Numerous reports from several countries have described cases or series of pleural and peritoneal mesotheliomas in relation to occupational exposure to various types and mixtures of asbestos (including talc containing asbestos) although occupational exposures have not been identified in all cases. Mesotheliomas of the tunica vaginalis testis and of the pericardium have been reported in persons occupationally exposed to asbestos.

Epidemiological studies, mainly on occupational groups, have established that all types of asbestos fibres are associated with diffuse pulmonary fibrosis (asbestosis), bronchial carcinoma and primary malignant tumours of the pleura and peritoneum (mesothelioma). That asbestos causes cancers at other sites is less well established. Cancers other than of the lung or mesothelioma have been considered in many studies. Some indicated an approximately two-fold risk with regard to gastrointestinal cancer in connection with shipyard work, and some increased risk was also seen in association with exposure to both chrysotile and crocidolite, to crocidolite or to chrysotile. Cancer of the colon and rectum was associated with asbestos exposure during chrysotile production, with an approximately two-fold risk; a similar excess was found for unspecified asbestos exposure. Some excess of ovary cancer has been reported in two studies but not in another; exposure to crocidolite was probably more predominant in the studies that showed excesses. Bile-duct cancer appeared in excess in one study based on record-linking, and large-cell lymphomas of the gastrointestinal trace and oral cavity appeared to be strongly related to asbestos exposure in one small study covering 28 cases and 28 controls, giving a risk ratio of 8; however ten cases and one control also had a history of malaria. An excess of lymphopoietic and haematopoietic malignancies has been reported in plumbers, pipe-fitters, sheet-metal workers and others with asbestos exposure.

Generally cases of malignant mesothelioma are rapidly fatal. The observed incidence of these tumours, which was low until about 30 years ago has been increasing rapidly in males in industrial countries. The long latency required for mesothelioma to develop after asbestos exposure has been documented in a number of publications. An increasing proportion of cases has been seen with increasing duration of exposure. As asbestos-related mesothelioma became more widely accepted and known to pathologists in western countries, reports of mesothelioma increased. The incidence of mesothelioma prior to, eg 1960, is not known. Mesotheliomas have seldom followed exposure to chrysotile asbestos only. Most, but not all, cases of mesothleioma have a history of occupational exposure to amphibole asbestos, principally crocidolite either alone or in amphibole-chrysotile mixtures. Mesotheliomas related to shipyard work and other exposures, including household contact with asbestos workers, have also been subject to epidemiological studies, resulting in risk ratios of about 3 to 15 in comparison with background rates not clearly referable to asbestos exposure. Exposure to crocidolite has been studies with regard to risk of lung cancer, and risk ratios of about 2 to 3 have been reported. Three lung cancers and two mesothleiomas occurred in 20 individuals after one year of high exposure to crocidolite; at least 17 of the cases had asbestos induced lung changes on X-ray films.

Evidence for carcinogenicity to animals (sufficient) Asbestos has been tested for carcinogenicity by inhalation in rats, by intrapleural administration in rats and hamster, by intraperitoneal injection in mice, rats and hamsters and by oral administration in rats and hamsters. Chrysotile, crocidolite, amosite, anthophyllite and tremolite produced mesotheliomas and lung carcinomas in rats after inhalation exposure and mesotheliomas following intrapleural administration. Chrysotile, crocidolite, amosite and anthophyllite induced mesotheliomas in hamsters following intrapleural administration. Intraperitoneal administration of chrysotile, crocidolite and amosite induced peritoneal tumours, including mesotheliomas, in mice and rats. Given by the same route, crocidolite produced abdominal tumours in hamsters, and trmolite and actinolite produced abdominal tumours in rats. A statistically significant increase in the incidence of malignant tumours was observed in rats given filter material containing chrysotile orally. In more recent studies, tumour incidence was not increased by oral administration of amosite or tremolite in rats, of amosite in hamsters or of chrysotile in hamsters. In two studies in rats, oral administration of chrysotile produced a low incidence of benign adenomatous polyps of the large intestine in males (9/250 versus 3/524 pooled controls) and of mesenteric haemangiomas (4/22 versis 0/47 controls). Synergistic effects were observed following intratracheal administration of chrysotile and benzo[a] pyrene to rats and hamster and of intratracheal administration of chrysotile and subcutaneous or oral administration of N-nitrosodiethylamine to hamsters.

Other relevant data: Insulation workers exposed to asbestos 'displayed a marginal increase' in the incidence of sister chromatid exchange in lymphocytes in one study. Chrysotile did not induce micronuclei in bone marrow cells of mice or chromosomal aberrations in bone-marrow cells of rhesus monkeys treated in vivo. In cultured human cells, conflicting results were reported for the induction of chromosomal aberrations and negative results for the induction of sister chromatid exchanges by chrysotile and crocidolite; amosite and crocidolite did not induce DNA strand breaks, and crocidolite was not mutagenic. Amosite, anthophyllite, chrysotiel and crocidolite induced transformation of Syrian hamster embryo cells, chrysotile and crocidolite transformed BALB/c3T3 mouse cells, and chrysotile transformed rat mesothelial cells. Neither amosite nor crocidolite transformed CH3 10T1/2 cells. In cultured rodent cells, amosite, anthophyllite, chrysotile and crocidolite induced sister chromatid exchanges; chrysotile and crocidolite induced aneuploidy and micronuclei. Chrysotile did not induce unscheduled DNA synthesis in rat hepatocytes. Amosite, chrysotile and crocidolite were inactive or weakly active in induc ing mutation in rodent cells in vitro; none were mutagenic to bacteria.

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

A reduction of exposure to asbestos for workers.

Date of entry into force of the final regulatory action: 09/06/1986