Jump to top navigation | Jump to main navigation | Jump to content
Therapeutic Goods Administration logo

TGA News Issue 38 (July 2002) - Chemicals

Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.

Increase surveillance of worker exposure to acrylamide, report says

Revision of the hazard classification for acrylamide has been recommended by NICNAS in its latest priority existing chemical assessment report published on 7 May 2002. The possible risk of impaired fertility and the designation of the chemical as being harmful in contact with the skin are among the changes.

"Airborne levels of acrylamide are greater in processes using the crystal form of the chemical as opposed to liquid or gel forms. NICNAS recommends the use of liquid or gel forms instead of crystalline acrylamide where possible," said the Director of NICNAS, Dr Margaret Hartley.

"There is cause for concern about the risk of nerve damage in workers with repeated occupational exposure to acrylamide. Routine air monitoring by industry would help reduce this exposure. Establishment of formal health surveillance guidelines and setting of a biological exposure standard by NOHSC would assist in early identification of symptoms and help in prevention of acrylamide-induced nerve damage," Dr Hartley said.

Acrylamide is not manufactured in Australia, but is imported in large volumes and used to make polyacrylamides which have a wide spectrum of use in a number of diverse applications, including water and sewerage treatment, paper manufacture, surface coatings, textile processing, cosmetics and oil exploration. The chemical may be released to the environment, with ninety nine per cent finding its way into water. It is slightly toxic to aquatic plants and organisms and to terrestrial plants and micro-organisms.

Publication of the PEC report revokes the declaration of acrylamide as a priority existing chemical under section 62 of the Act.

The report is available from the NICNAS website: PEC Assessment Reports <http://www.nicnas.gov.au/publications/car/pec/default.asp>. Hard copies are also available (free) on request to:

NICNAS
GPO Box 58
Sydney NSW 2001
Australia

Freecall: 1800 638 528

Widely used citrus solvent reviewed

On 7 May 2002, NICNAS released a final report on the chemical limonene. The report assessed the health, safety and environmental risks of limonene and made a number of recommendations for safe use.

Limonene is manufactured in Australia from orange oils by extraction through distillation. It is also imported both as raw material and as an ingredient in products.

Limonene is used widely as a fragrance additive in household and cosmetic products. It is also present in most of the essential oils that are commonly used in Australia, particularly citrus oils. Most limonene-containing consumer products contain less than one per cent limonene. In the workplace, it is used mainly in hand cleaners, industrial cleaning and degreasing products, removers and strippers.

The report finds that limonene causes skin irritation and that contact with oxidised products of limonene (formed by exposure of limonene to light and air) can cause skin sensitisation.

The report recommends limonene be classified as a skin sensitiser and further recommends a number of measures to prevent the formation of oxidation products.

The publication of this report revokes the declaration of limonene as a priority existing chemical under section 62 of the Act.

The report is available from the NICNAS website: PEC Assessment Reports <http://www.nicnas.gov.au/publications/car/pec/default.asp> Hard copies are also available (free) on request to:

NICNAS
GPO Box 58
Sydney NSW 2001
Australia

Freecall: 1800 638 528

Top of page

Health intake standards for acutely toxic pesticides

TGA's Chemicals Unit develops methods for establishing health intake standards for acutely toxic pesticides

The TGA's Chemicals Unit provides toxicology and public health advice on agricultural and veterinary (agvet) chemicals to the National Registration Authority for Agricultural and Veterinary Chemicals (NRA). Part of this advice includes recommending an Acceptable Daily Intake (or ADI1) for each chemical, a health standard with which to compare the long-term (or chronic) dietary intake of agvet chemical residues in food.

Recent agricultural studies carried out in the United Kingdom have shown that, despite median residue levels in bulked food commodities being very low, the variability between residues in individual commodity units (for example, apples, carrots etc) can be higher than expected and a few individual "hot" units may contain quite high levels of residues. There have also been a few reported cases in which people have experienced short-term adverse health effects following the acute ingestion of produce which contained high levels of pesticides, albeit from an illegal use (for example, aldicarb on watermelons in the USA). For these reasons, moves have been made, both internationally and nationally, to establish a health standard for short-term exposures to those pesticides which can cause adverse effects after a single dose.

The concept of a health standard to cover acute exposure scenarios in the occupational health setting has existed for a number of years. In 1990, the WHO International Programme on Chemical Safety (IPCS) noted that "consideration should be given to the potentially acute toxic effects [of residues] that are not normally considered in the assessment of the ADI". Since then, a number of national regulatory agencies as well as the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) have worked to develop technical procedures and guidance for conducting such acute dietary risk assessments.

There are two key processes in conducting an acute dietary risk assessment for pesticides, that is the establishment of a health guideline value (the so-called acute reference dose, or ARfD2) and the measurement or estimation of the actual acute dietary intake of the pesticide residue. The estimated consumption of chemical residues during a single meal or during a single day (based on an Australia New Zealand Food Authority (ANZFA) database on dietary consumption habits in Australia) is then compared with the health guideline value, to determine whether it is safe to use the particular pesticide on a particular commodity crop.

Methodologies are being developed for establishing Acute Reference Dose (ARfD) values from the available toxicology database and for estimating the acute intake of pesticides residues. At its 2001 meeting, the JMPR decided to establish an international Working Group to coordinate all of the different national agency approaches to setting ARfDs; staff of the TGA's Chemicals Unit are actively participating in this Working Group.

  1. The ADI or 'Acceptable Daily Intake' may be compared with the TDI ('Tolerable Daily Intake'). Because pesticides are deliberately applied to crops to improve food production, low residues which may result can be considered 'acceptable' if they are not of toxicological concern. In contrast, the TDI is a health limit for food contaminants which should not be present but which may be unavoidable eg. aflatoxins.
  2. The ARfD is defined as the estimate of the amount of a substance in food or drinking water, expressed on a milligram per kilogram body weight basis, that can be ingested in one meal or during one day, without appreciable health risk to the consumer, on the basis of all known facts at the time of the evaluation.

Top of page

Information wanted - formaldehyde

Formaldehyde was declared a priority existing chemical (PEC) for full assessment by a notice published in the Chemical Gazette of March 2002.

The assessment will determine the risk of adverse effects to the environment, workers and the public in Australia, by identifying the health and environmental hazards of formaldehyde and the potential for exposure in Australia. Recommendations on ways to reduce any identified risks will be made.

Formaldehyde is widely used in Australia, mainly in resins during furniture and textile manufacturing and to a lesser extent as a preservative in cleaning and cosmetic products. It is also emitted as a result of industrial processes.

NICNAS is seeking information relevant to the assessment of formaldehyde, such as uses of formaldehyde and products containing formaldehyde, concentrations of formaldehyde in mixtures and information on human and environmental exposure.

Companies who wish to manufacture or import formaldehyde during the period of the PEC review are required to apply to NICNAS. No application fee applies. Data requirements for importers/manufacturers and formulators of formaldehyde and formaldehyde products are stipulated in the Gazette notice (Chemicals Gazette <http://www.nicnas.gov.au/Publications/Chemical_Gazette.asp>, March 2002).

NICNAS asks end users of formaldehyde and formaldehyde products to contact them to discuss the assessment and the information they are seeking.

For further information or assistance, please contact NICNAS:

Fax: 02 8577 8888
Freecall: 1800 638 528

For information on the NICNAS PEC program, please visit the NICNAS website <http://www.nicnas.gov.au>.

Top of page

Information wanted - sodium cyanide

Sodium cyanide was recently declared a priority existing chemical (PEC) for full environmental assessment (see the Chemicals Gazette, 7 May 2002).

The assessment will focus on determining the risk of adverse effects to the environment in Australia, by identifying the environmental hazards of sodium cyanide and the potential for such exposures. Recommendations on ways to reduce any identified risks will be made.

Sodium cyanide is widely used in the mining industry in Australia for extraction of gold. Escape of the chemical into the environment can result in high acute toxicity to aquatic life, birds and animals. Consumption of contaminated tailings by birds has resulted in mass poisonings.

NICNAS is seeking assistance from anyone who may have information relevant to this assessment of sodium cyanide, such as uses of sodium cyanide and products containing sodium cyanide, concentrations of sodium cyanide in mixtures, and information on environmental exposure.

Companies who wish to manufacture or import sodium cyanide during the period of the PEC review are required to apply to NICNAS for assessment. No application fee applies. Data requirements for importers/manufacturers and formulators of sodium cyanide and sodium cyanide products are stipulated in the Gazette notice (Chemicals Gazette <http://www.nicnas.gov.au/Publications/Chemical_Gazette.asp>, May 2002).

For further information or assistance, please contact NICNAS

Fax: 02 8577 8888
Freecall: 1800 638 528

For information on the NICNAS PEC program, please visit the NICNAS website <http://www.nicnas.gov.au>.

Top of page

NICNAS news

NICNAS Relocation to the Department of Health and Ageing

The Government announced on 26 November 2001, as part of its machinery of government changes, that the responsibility for the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) would move to the Health and Ageing portfolio.

The Therapeutic Goods and Other Legislation Amendment Bill 2002 was introduced into Parliament on 21 March 2002 to give effect to this administrative order.

The Hon Trish Worth, MP, Parliamentary Secretary to the Minister for Health and Ageing, has executive responsibility for the Therapeutic Goods Administration, which now includes NICNAS.

The placement of NICNAS within the TGA group provides for an ongoing, consistent approach to the protection of human health from industrial chemicals.

NICNAS will continue to service all its stakeholders with the provision of high quality independent chemical assessment advice. It will continue its strong links with the range of relevant Commonwealth and State/Territory regulatory bodies, as this is necessary for the achievement of objectives.

Commitments have been given that NICNAS will maintain its service standards and that the NICNAS Industry Government Consultative Committee (IGCC) will continue to be the primary consultative body for industry on NICNAS matters.

NICNAS contact details

NICNAS has settled into its new Marrickville office and contact details are:

  • Street address: 334-336 Illawarra Road, Marrickville NSW 2204
  • Postal address: GPO Box 58, Sydney NSW 2001, Australia
  • Telephone: +61 2 8577 8800
  • Fax: +61 2 8577 8888
  • Freecall: 1800 638 528
  • Email:
  • Website: www.nicnas.gov.au

Top of page