Declaration
The chemical formaldehyde (CAS No 50-00-0) was declared a Priority Existing Chemical for full assessment under the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) on 5 March 2002. It was nominated by the public, unions and non-government organisations for assessment due to its adverse effects and widespread use. In addition, there were indications of a need to review the occupational exposure standard and develop a National Environmental Protection Measure (NEPM) for formaldehyde.
Objectives
The objectives of this assessment were to:
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characterise the properties of formaldehyde;
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determine the uses of formaldehyde in Australia;
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determine the extent of environmental, public and occupational exposure to formaldehyde;
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characterise the risk to humans and the environment resulting from exposure to formaldehyde; and
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determine the extent to which any risk can be minimised.
Sources of information
Information for the assessment was obtained from various sources including industry, literature searches, site visits, all levels of governments, and other organizations, such as research institutes and overseas regulatory authorities.
Industry
In accordance with the Act, manufacturers and importers of formaldehyde were required to apply for assessment and supply relevant information. Data supplied by applicants included:
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quantity of the chemical and/or products containing the chemical manufactured and/or imported;
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quantity of the chemical formulated into products;
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uses of the chemical and products containing the chemical;
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methods used in handling, storing, manufacturing and disposal of the chemical and products containing the chemical;
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information on human and environmental exposure to the chemical;
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Material Safety Data Sheet (MSDS) and labels; and
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contact details of their customers.
The National Industrial Chemical Notification and Assessment Scheme (NICNAS) conducted a questionnaire survey (the NICNAS survey) in October 2002 to investigate the use patterns, occupational exposure levels, control technologies and environmental exposure to formaldehyde. Randomly selected formulators and end users of formaldehyde products participated in the NICNAS survey. Further details are provided in Section 7.3.
A number of industry associations were also contacted and provided relevant information. A list of all companies, associations and individuals consulted during this assessment is provided in Appendix 1.
Literature review
A number of overseas peer-reviewed assessment reports on formaldehyde are available (see Section 2.4). The major source of information on the health effects of formaldehyde for this assessment was the Concise International Chemical Assessment Document (CICAD) for formaldehyde, published under the International Programme on Chemical Safety (IPCS, 2002). To enhance the efficiency of the NICNAS assessment and provide transparency, not all primary sources of data in the CICAD were evaluated. However, relevant studies published since the cited reviews were identified (up to July 2004) and assessed on an individual basis.
Site visits
Information on methods of use and potential for workers’ exposure was also obtained through a number of site visits. The site visits included formaldehyde and formaldehyde resin manufacturers, a wood panel plant, funeral homes, pathological laboratories and film processing plants.
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During all stages of preparation, the report has been subject to internal peer review by NICNAS and the Australian Government Department of the Environment and Heritage (DEH). Selected parts of the report were also externally peer reviewed by independent experts from Australia and overseas.
Background
Introduction
Formaldehyde is a naturally occurring, volatile organic compound which is ubiquitous in the environment. It is formed primarily by the combustion of organic materials and by a variety of natural and anthropogenic activities.
Formaldehyde is the product of many natural processes, such as forest and bush fires, animal wastes, microbial products of biological systems, and plant volatiles. In water, it is also formed by the irradiation of humic substances by sunlight. As a metabolic intermediate, formaldehyde is present at low levels in most living organisms. It is emitted by bacteria, algae, plankton, and vegetation as well.
Anthropogenic sources of formaldehyde from combustion processes account directly or indirectly for most of the formaldehyde entering the environment. Direct combustion sources include power plants, incinerators, refineries, wood stoves, kerosene heaters, and cigarettes. Formaldehyde is also produced indirectly by photochemical oxidation of hydrocarbons or other formaldehyde precursors that are released from combustion processes. Other anthropogenic sources of formaldehyde in the environment include industrial on-site uses and off-gassing from building materials and consumer products.
Secondary formation of formaldehyde occurs in the atmosphere through the photochemical oxidation of natural and anthropogenic volatile organic compounds in the air, such as methane, isoprene, and pollutants from mobile and stationary sources, such as alkanes, alkenes, aldehydes and alcohols.
Global production
Since 1889 in Germany, formaldehyde has been produced commercially by the catalytic oxidation of methanol. Various manufacturing methods were used in the past, but only two are widely used today: the silver catalyst and metal oxide catalyst processes (IARC, 1995). Formaldehyde is used predominately in the production of resins, followed by fertilizer production, and for various other purposes, such as preservatives and disinfectants. Formaldehyde can be used in a variety of industries, including the medical, detergent, cosmetics, food, rubber, metal, wood, leather, petroleum, and agricultural industries, and as a hydrogen sulfide scavenger in oil operations.
Because of its low cost and high purity, formaldehyde has become one of the most important industrial and research chemicals in the world. The global production of formaldehyde in 1999 (the most recent figure) was estimated 5 to 6 million tonnes (Asia: 1 to 1.5 million tonnes, North America: 1 to 1.5 million tonnes, Western Europe: 2 to 2.5 million tonnes) (OECD, 2002). A global production figure of 12 million tonnes in 1992 was reported by IARC (1995). Formaldehyde is listed on the Organisation for Economic Cooperation and Development’s (OECD) List of High Production Volume (HPV) chemicals, i.e. production volume of 1000 tonnes or more in at least one OECD country (OECD, 2004).
Australian perspective
In Australia, consistent with overseas use, formaldehyde is mainly used in the manufacture of formaldehyde-based resins, which are widely used in a variety of industries, predominately the wood industry. Formaldehyde is on the 2003 Australian High Volume Industrial Chemical List (HVICL) compiled by NICNAS (NICNAS, 2002), which means it is an industrial chemical that had a combined annual import and manufacturing quantity of 1000 tonnes or more during 2001-2002. The total quantity of formaldehyde manufactured and imported is detailed in Sections 7.1 and 7.2.
Concerns have been expressed by the public and several organisations over its widespread use and adverse health effects, including its sensitisation potential and carcinogenicity.
Formaldehyde is listed in the OASCC’s Hazardous Substances Information System (DEWR, 2004) and in Schedules 2 and 6 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) (NDPSC, 2005). It is also listed in the Australian Code for the Transport of Dangerous Goods by Road and Rail (FORS, 1998) as a dangerous good. An Australian occupational exposure standard for formaldehyde has been established (DEWR, 2004).
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Formaldehyde has been assessed by several national and international bodies, who have reviewed and evaluated data pertaining to the health and/or environmental hazards posed by the chemical. Of these, the most noteworthy are:
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International Agency for Research on Cancer examined a number of recent epidemiology studies on carcinogenicity (IARC, 2004a). It concluded that the carcinogen classification for formaldehyde be upgraded from probable human carcinogen (Category 2A) to known human carcinogen (Category 1) based on evidence that exposure to formaldehyde may cause nasopharyngeal cancer in humans (more details in Section 11.6). IARC has also reviewed formaldehyde on a number of previous occasions (IARC, 1987, 1995);
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Concise International Chemical Assessment Document (CICAD) No. 40: Formaldehyde, published by the International Programme on Chemical Safety (IPCS, 2002);
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A Screening Information Data Set (SIDS) Initial Assessment Report (SIAR) prepared by the German BMU (Bundesministerium für Umwelt, Naturschutzund Reaktorsicherheit) was agreed at the Organization for Economic Cooperation and Development (OECD) 14th SIDS Initial Assessment Meeting (SIAM) in March 2002 (OECD, 2002). It concluded that further work on the environmental exposure assessment was needed;
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US Agency for Toxic Substances and Disease Registry (ATSDR) report (ATSDR, 1999); and
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Environmental Health Criteria (EHC) Number 89: Formaldehyde, published by the IPCS (IPCS, 1989).
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