National Industrial Chemicals Notification and Assessment Scheme

R46 MAY CAUSE HERITABLE GENETIC DAMAGE

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R46 MAY CAUSE HERITABLE GENETIC DAMAGE

4.96 A substance is included in Category 2 if there is sufficient

evidence to provide a strong presumption that human exposure to the substance may result in the development of heritable genetic damage, generally on the basis of appropriate animal studies and other relevant information.

To place a substance in Category 2, positive results are needed from assays showing

mutagenic effects, or

(b) other cellular interactions relevant to mutagenicity, in germ cells of mammals in vivo, or

(c) mutagenic effects in somatic cells of mammals in vivo in combination with clear evidence that the substance or a relevant metabolite reaches the germ cells.

With respect to placement in Category 2, at present the following methods are appropriate:

in vivo germ cell mutagenicity assays:

specific locus mutation test,
heritable translocation test,
dominant lethal mutation test.

These assays actually demonstrate the appearance of affected progeny or a defect in the developing embryo.

in vivo assays showing relevant interaction with germ cells (usually DNA):

assays for chromosomal abnormalities, as detected by cytogenetic analysis, including aneuploidy caused by malsegregation of chromosomes,
test for sister chromatid exchanges (SCEs),
test for unscheduled DNA synthesis (UDS),
assay of (covalent) binding of mutagen to germ cell
DNA,
assaying other kinds of DNA damage.

These assays provide evidence of a more or less indirect nature. Positive results in these assays would normally be supported by positive results from in vivo somatic cell mutagenicity assays, in mammals or in humans (see under Category 3).

(c) in vivo assays showing mutagenic effects in somatic cells of mammals (see sub section 4.98(a)), in combination with toxicokinetic methods, or other methodologies capable of demonstrating that the compound or a relevant metabolite reaches the germ cells.

For paragraphs 4.98(b) and 4.98 (c), positive results from host- mediated assays or the demonstration of unequivocal effects in in vitro assays can be considered as supporting evidence.

CATEGORY 3

Substances are determined to be hazardous and classified as Harmful (Xn) and assigned risk phrase R40 in accordance with the criteria given below.

R40 POSSIBLE RISK OF IRREVERSIBLE EFFECTS

A substance is included in Category 3 if there is evidence from appropriate mutagenicity studies, of concern that human exposure can result in the development of heritable genetic damage, but that this evidence is insufficient to place the substance in Category 2.

4.101 To place a substance in Category 3, positive results are needed in assays showing

mutagenic effects, or
other cellular interaction relevant to mutagenicity, in somatic cells in mammals in vivo.

The latter especially would normally be supported by positive results from in vitro mutagenicity assays.

4.102 For effects in somatic cells in vivo at present the following methods are appropriate:
(a) in vivo somatic cell mutagenicity assays:

bone marrow micronucleus test or metaphase analysis,

metaphase analysis of peripheral lymphocytes,

mouse coat colour spot test.

(b) in vivo somatic cell DNA interaction assays:

test for SCEs in somatic cells,

test for UDS in somatic cells,

assay for the (covalent) binding of mutagen to somatic cell DNA,

assay for DNA damage, for example, by alkaline elution, in somatic cells.

4.103 Substances showing positive results only in one or more in vitro mutagenicity assays should normally not be classified. Their further investigation using in vivo assays, however, is strongly indicated. In exceptional cases, for example, for a substance showing pronounced responses in several in vitro assays, for which no relevant in vivo data are available, and which shows resemblance to known mutagens/carcinogens, classification in Category 3 could be considered.

APPENDIX 5
Additional material considered by the Administrative Appeals Tribunal: Unpublished studies and published articles available after preparation of the draft report.
Blair A, Hartge P, Stewart PA, et al (1998) Mortality and cancer incidence of aircraft maintenance workers exposed to trichloroethylene and other organic solvents and chemicals: extended follow up. Occup Environ Medicine, 55: 161-171
Boice JD, Marano DE et al. (1999) Mortality among aircraft manufacturing workers. Occup Environ Med, 56: 581-597.
Brauch H, Weirich G et al. (1999) Trichloroethylene exposure and specific somatic mutations inpatients with renal cell carcinoma. Journal of the National Cancer Institute, 9(10): 954-961.
Bruning T, Sundberg, AGM et al (1999) Glutathione transferase alpha as a marker for tubular damage after trichloroethylene exposure. Arch Toxicol, 73:246-254.
Clay P (1999) Trichloroethylene and S-(1,2-dichlorovinylcysteine): in vivo COMET and UDS assays in the rat kidney. Zeneca Central Toxicology Laboratory Report No. CTL/R/2976. First supplement to CTL/T/2976.
Clay P (1998) Trichloroethylene and S-(1,2-dichlorovinylcysteine): in vivo COMET and UDS assays in the rat kidney. Zeneca Central Toxicology Laboratory Report No. CTL/R/2976.
Dekant W and Henschler D (1999) Organ-specific carcinogenicity of haloalkenes mediated by glutathione conjugation. J Cancer Res Clin Oncol, 125: 174-181.
Green T, Dow J, Ellis M.K. et al (1997) The role of glutathione conjugation in the development of kidney tumours in rats exposed to trichloroethylene. Chemico-Biolgical Interactions 105: 99-117
Green T. (1997) Formic acid excretion in rats and mice exposed to trichloroethylene. Report No: CTL/R/1312, Central Toxicology Laboratory, Cheshire UK.
Green and Dow (1999) Trichloroethylene induced vitamin B12 and folate deficiency leads to increased formic acid excretion in the rat. Report No: CTL/R/1431, Central Toxicology Laboratory, Cheshire, UK.
Green T, Dow J, Foster JR et al (1999) Trichloroethanol: Long-term drinking water study in the Fischer rat. Interim report at one year. Report No: CTL/R/1312, Central Toxicology Laboratory, Cheshire UK.
Green LC and Lash TL (1999) Re: “Renal cell cancer correlated with occupational exposure to trichloroethylene”. J Cancer Res Clin Oncol, 125: 430-432.
Green T (1998) Analysis of urine samples from humans occupationally exposed to trichloroethylene. Zeneca Central Toxicology Laboratory Report No. CTL/R/1364.
Griffin JM, Lipscomb JC et al. (1998) Covalent binding of trichloroethylene to proteins in human and rat hepatocytes. Toxicology Letters, 95: 173-181.
Halmes NC, Samokyszyn VM et al. (1997) Covalent binding and inhibition of cytochrome P4502E1 by trichloroethylene. Xenobiotica 27(1): 101-110.
Hayashi M, Ueda T et al. (1998) Development of genotoxicity assay system that use aquatic organisms. Mutagen Research, 399: 125-133.
Kautianen A, Vogel JS et al. (1997) Dose-dependent binding of trichloroethylene to hepatic DNA and protein at low doses in mice. Chemico-Biological Interactions, 106: 109-121.
Lash LH, Lipscomb JC (1999) Glutathione conjugation of trichloroethylene in human liver and kidney: kinetics and individual variation. Drug Metabolism and Disposition, 27(3): 351-359.
Lash LH, Putt DA et al. (1999) Identification of S-(1,2-dichlorovinyl) glutathione in the blood of human volunteers exposed to trichloroethylene. Journal of Toxicology and Environmental Health, Part A, 56: 1-21.
McLaughlin JK & Blot WJ (1997) A critical review of epidemiology studies of trichloroethylene and perchloroethylene and risk of renal-cell cancer. Int. Arch. Occup. Environ. Health, 70: 222-231.
Morgan RW, Kelsh MA et al. (1998) Mortality of aerospace workers exposed to trichloroethylene. Epidemiology, 9(4): 424-431.
Ritz B (1999) Cancer mortality among workers exposed to chemicals during uranium processing. J Occup. Med., 41;14:556-566.
Robbiano L, Mereto E et al. (1998) Increased frequency of micronucleated kidney cells in rats exposed to halogenated anaesthetics. Mutation Research, 413: 1-6.
Sujatha TV and Hegde MJ (1998) C-mitotic effects of trichloroethylene (TCE) on bone marrow cells of mice. Mutation Research, 413: 151-158.
Terracini B and Parker VH (1965) A pathological study on the toxicity of S-dichlorovinyl-L-cystine. Food Cosmet Toxicol 3: 67-74.
Vamvakas S, Bruning, T et al. (1998) Renal cell cancer correlated with occupational exposure to trichloroethylene. J Cancer Res Clin Oncol, 124: 374-382.
APPENDIX 6

DECISION_AND_REASONS_FOR_DECISION_[1999]_AATA_1023__ADMINISTRATIVE_APPEALS_TRIBUNAL_)___)_No_V1998/955__General_ADMINISTRATIVE_DIVISION'>DECISION AND REASONS FOR DECISION [1999] AATA 1023

ADMINISTRATIVE APPEALS TRIBUNAL )

) No V1998/955

General ADMINISTRATIVE DIVISION ) )

Re Dow Chemical (Australia) Limited

Applicant

And Director, Chemicals Notification and Assessment

Respondent
DECISION
Tribunal Deputy President A M Blow OAM, QC.,

Professor G A R Johnston AM, FRACI, FTSE

Miss E A Shanahan
Date 31 December 1999

Place Melbourne

Decision The decisions under review are affirmed.

[Sgd A M Blow]

Deputy President

CATCHWORDS

Health Law – industrial chemicals – classification of a "priority existing chemical" – trichloroethylene –carcinogenicity and mutagenicity.

Industrial Chemicals (Notofication and Assessment) Act 1989 – ss.60E(5), 102(1)(b)

Melbourne Pathology Pty Limited v Minister for Human Services and Health (1996) 40 ALD 565

Friends of Hinchinbrook Society Inc v Minister for Environment (1997) 69FCR 28.

REASONS FOR DECISION
31 December 1999 Deputy President A M Blow OAM, QC.,

Professsor G A R Johnston AM, FRACI, FTSE

Miss E A Shanahan

This is an application pursuant to s.102(1)(b) of the Industrial Chemicals (Notification and Assessment) Act 1989 ("the Act"). The applicant is seeking the review of a series of decisions made by the respondent on 14 July 1998 under s.60E(5) of the Act whereby she refused to vary a draft report in a number of respects. The draft report relates to a chemical called trichloroethylene. The decisions under review relate to passages in the draft report concerning the carcinogenicity and mutagenicity of trichloroethylene.

2. The objects of the Act are set out in s.3 thereof, which reads as follows:-

"(3) The object of this Act is to provide for a national system of notification and assessment of industrial chemicals for the purposes of:

(a) aiding in the protection of the Australian people and the environment by finding out the risks to occupational health and safety, to public health and to the environment that could be associated with the importation, manufacture or use of the chemicals; and

(b) providing information, and making recommendations, about the chemicals to Commonwealth, State and Territory bodies with responsibilities for the regulation of industrial chemicals; and

(c) giving effect to Australia's obligations under international agreements relating to the regulation of chemicals; and

(d) collecting statistics in relation to the chemicals;

being a system under which information about the properties and effects of the chemicals is obtained from importers and manufacturers of the chemicals."
3. On 4 April 1995 the Minister for Industrial Relations published a notice in the Chemical Gazette under s.51 of the Act declaring trichloroethylene a priority existing chemical. On 16 June 1995 ICI Australia Operations Pty Limited applied under s.55(2) of the Act for the assessment of trichloroethylene. On 19 June 1995 the applicant made a similar application. When such an application is made, s.57(1) of the Act obliges the respondent to cause the relevant chemical to be assessed, and to cause a report to be prepared. That sub-section reads as follows:-

"Where the Director receives an application or applications for the assessment of a priority existing chemical, he or she must cause the chemical to be assessed in accordance with section 60A and a report of the assessment to be prepared."
4. The Act makes provision for the assessment process and the preparation of a draft assessment report in ss.60A, 60B and 60C, which read as follows:-

"60A Nature of assessment

(1) The officer preparing the report of the preliminary assessment of a priority existing chemical must determine the significance, for the making of a determination described in subsection (2) in relation to that chemical, of each of the matters required to be taken into account by the notice declaring the chemical as a priority existing chemical.

(2) The officer preparing the report of the full assessment of a priority existing chemical must determine the risk (if any) of adverse health effects, safety effects or adverse environmental effects that could be caused by:

(a) importation of the chemical (if it is proposed to import the chemical); or

(b) manufacture of the chemical (if it is proposed to manufacture the chemical in Australia); or

(c) the use, storage, handling or disposal of the chemical.

(3) In making a determination under subsection (1) or (2), the officer must take into account the matters required to be taken into account by the notice declaring the chemical as a priority existing chemical.
60B Contents of assessment reports

(1) An assessment report (whether it is a draft assessment report made under section 60C or a final assessment report made under section 60F) must include a summary of health, safety and environmental matters considered in the assessment and such recommendations as may reasonably be made in relation to each of the following matters:

(a) the content of a Material Safety Data Sheet in respect of the chemical;

(b) the precautions and restrictions to be observed during the importation, manufacture, handling, storage, use of disposal of the chemical to protect persons exposed to the chemical;

(c) controls to limit emissions of the chemical into the environment, including permissible concentrations in emissions of the chemical into the air or water from a manufacturing plant or other facility;

(d) the packaging, labelling, handling or storage of the chemical;

(e) the measures to be employed in emergencies involving the chemical to minimise hazard to persons and damage to the environment;

(f) the uses of the chemical;

(g) the means of disposal of the chemical;

(h) the circumstances (if any) in which secondary notification of the chemical is required;

(i) any prescribed matter.

(2) The assessment report (whether draft or final) must not contain exempt information.
60C Draft assessment report

On completing an assessment of a priority existing chemical, the Director must cause a draft report of the assessment to be prepared."
5. The draft report was completed by 13 March 1998. On that day a copy of the draft report was sent to the applicant with a notice under s.60D(1)(b) of the Act asking the applicant to notify the respondent of any errors in it. Some non-controversial corrections were made as a result. Once that stage is reached, s.60E of the Act provides for interested parties to request the respondent to make variations to the draft report. The relevant provisions in that section read as follows:-

"60E Variation of draft assessment report

(1) Within 56 days of giving the draft assessment report to each applicant, the Director must:

(a) give a copy of the draft report with any corrections to each applicant and to any person who has provided information for the assessment in response to a notice under section 58; and

(b) publish a notice in the Chemical Gazette:

(i) describing the matters contained in the draft report; and

(ii) stating that the draft report has been given to each applicant and person who provided information under section 58; and

(iii) describing how a person may obtain a copy of the draft report; and

(iv) describing how a person may ask the Director to vary the draft report.

(2) Within 28 days of the publication of the notice under subsection (1), a person may request the Director, in the approved form, to vary the draft report.

(3) The Director must make a decision about the variation within 56 days after the publication of the notice under subsection (1).

(4) The Director must decide to vary the draft report as requested if he or she is satisfied that the report, varied as requested, would be correct.

(5) The Director must decide to refuse to vary the draft report as requested if he or she is not satisfied that the report, varied as requested, would be correct."
6. A notice was published in the Chemical Gazette on 5 May 1998 pursuant to s.60E(1)(b). The applicant faxed to the respondent a request dated 1 June 1998 seeking a number of variations to the draft report. Three other requests under s.60E were also sent to the respondent. On 24 July 1998 the respondent made a series of decisions in relation to each of the four requests she had received. She made a separate decision in relation to each variation that had been requested to the draft report – either a decision under s.60E(4) making a requested variation, or a decision under s.60E(5) refusing to make a requested variation. Some of the variations requested by the other parties were made under s.60E(4). The applicant has applied to this Tribunal in respect of the requests made by it all of which were refused by respondent under s.60E(5).

7. In March 1994 the National Occupational Health and Safety Commission published a booklet entitled "Approved Criteria for Classifying Hazardous Substances [NOHSC:1008 (1994)]". Although she was under no legal obligation to do so, the respondent in her draft report assessed trichloroethylene by reference to the Approved Criteria as published in March 1994. A fresh edition of the Approved Criteria has been published in 1999. That document constitutes a standard declared by the Commission under s.38(1) of the National Occupational Health and Safety Commission Act 1985. It is common ground that, in reviewing the respondent's decisions as to the draft report, we should apply the 1999 edition of the Approved Criteria. The relevant passages in the 1999 edition do not vary significantly from those in the March 1994 edition.

8. Generally speaking the Approved Criteria are intended to be the same in substance as the criteria used by the European Communities in their legislation for classifying dangerous substances. Appendix 3 to the Approved Criteria lists a series of "risk phrases" relevant to different types of health effects. These have been taken from an EEC Council Directive. The following risk phrases are relevant in this case:

"R40 Possible risk of irreversible effects."

"R45 May cause cancer."`

"R46 May cause heritable genetic damage"

"R49 May cause cancer by inhalation."

9. Chapter 3 of the Approved Criteria sets out how those criteria are to be applied. It contains the following paragraphs that are relevant to this case:

"3.4 Classifying the substance will involve finding and putting together all the available information on the substance and assessing this information against the criteria. This process will identify the health hazards of the substances and appropriate risk phrases to be used.

…

3.10 If evidence is available to show that in practice the toxic effect of a substance on humans is, or is likely to be, different from that suggested by the results of animal testing, then the substance should be classified according to its toxicity in humans.

3.11 If only some information is available for the substance, then the health effects criteria and other suitable information should be applied as far as possible to classify the substance. …

3.12 The classification for a substance may need to be revised periodically as new information about that substance becomes available."
10. Chapter 4 of the Approved Criteria, entitled "Health Effects Criteria", contains the following provisions relevant to this case:

"4.1 The criteria in this chapter are those used by the European Communities in EC Council Directive 67/548/EC³for classifying dangerous substances based on their hazards to health. These criteria take into account both short and long term health effects, and are applicable to both pure substances and mixtures.

…

4.4 For the purposes of classification, health effects are subdivided into:

…

carcinogenic effects (R40, R45, R49);
mutagenic effects (R40, R46);

…

A substance may have more than one health effect.

Criteria for classification and choice of risk phrases for ingredients and mixtures.

…

4.9 For specific effects on health (carcinogenicity, mutagenicity and reproductive toxicity) the criteria in paragraphs 4.76 to 4.133 are to be used.

…

CARCINOGENIC SUBSTANCES

4.76 Substances are determined to be hazardous due to carcinogenic effects if they fall into one of the following categories:
Category 1 Substances known to be carcinogenic to humans.

Category 2 Substances which should be regarded as if they are carcinogenic to humans.

Category 3 Substances which cause concern for humans owing to possible carcinogenic effects but in respect of which the available information is not adequate for making a satisfactory assessment.
EXPLANATORY NOTES REGARDING THE CATEGORISATION OF CARCINOGENIC SUBSTANCES

4.77 The placing of a substance into Category 1 is done on the basis of epidemiological data; placing into Categories 2 and 3 is based primarily on animal experiments.

…
CATEGORY 2

4.80 Substances are determined to be hazardous and classified as Toxic (T) and assigned risk phrase R45 or R49 in accordance with the criteria given below.

R45 MAY CAUSE CANCER

R49 MAY CAUSE CANCER BY INHALATION²

²For substances which present a carcinogenic risk only when inhaled, for example, dust, vapour or fumes (and where other routes of exposure, for example, by swallowing or in contact with the skin do not present any carcinogenic risk) the specific risk phrase R49 should be used.

4.81 A substance is included in Category 2 if there is sufficient evidence, on the basis of appropriate long term animal studies or other relevant information, to provide a strong presumption that human exposure to that substance may result in the development of cancer.

4.82 For classification as a Category 2 carcinogen either positive results in two animal species should be available or clear positive evidence in one species, together with supporting evidence such as genotoxicity data, metabolic or biochemical studies, induction of benign tumours, structural relationship with other known carcinogens, or data from epidemiological studies suggesting an association.

4.83 Human data providing suspicions of carcinogenic potential may warrant a Category 2 classification irrespective of the nature of any animal data. Increased confidence in the credibility of a causal relationship would be provided by evidence of carcinogenicity in animals and/or of genotoxic potential in short term screening tests.

CATEGORY 3

4.84 Substances are determined to be hazardous and classified as Harmful (Xn) and assigned risk phrase R40 in accordance with the criteria given below.
R40 POSSIBLE RISK OF IRREVERSIBLE EFFECTS

4.85 A substance is included in Category 3 if there is some evidence from appropriate animal studies that human exposure can result in the development of cancer, but this evidence is insufficient to place the substance in Category 2.
Category 3 actually comprises 2 sub-categories

(a) substances which are well investigated but for which the evidence of a tumour-inducing effect is insufficient for classification in Category 2. Additional experiments would not be expected to yield further relevant information with respect to classification;

(b) substances which are insufficiently investigated. The available data are inadequate, but they raise concern for humans. This classification is provisional; further experiments are necessary before a final decision can be made.

4.86 For a distinction between Categories 2 and 3 the arguments listed below are relevant which reduce the significance of experimental tumour induction in view of possible human exposure. These arguments especially in combination, would lead in most cases to classification in Category 3, even though tumours have been induced in animals:

carcinogenic effect only at very high dose levels exceeding the `maximal tolerated dose'. The maximal tolerated does is characterised by toxic effects which, although not yet reducing lifespan, go along with physical changes such as about 10% retardation in weight gain,
appearance of tumours, especially at high dose levels, only in particular organs of certain species known to be susceptible to a high spontaneous tumour formation,
appearance of tumours, only at the site of application, in very sensitive test systems (eg intraperitoneal, or subcutaneous application of certain locally active compounds), if the particular target is not relevant to humans,
lack of genotoxicity in short-term tests in vivo and in vitro,
existence of a secondary mechanism of action with the implication of a practical threshold above a certain dose level (eg hormonal effects on target organs or on mechanisms of physiological regulation, chronic stimulation of cell proliferation),
existence of a species-specific mechanism of tumour formation (eg by specific metabolic pathways) irrelevant for humans.

…

MUTAGENIC SUBSTANCES
4.88 Substances are determined to be hazardous due to mutagenic effects if they fall into one of the following categories:

Category 1 Substances known to be mutagenic to humans.

Category 2 Substances which should be regarded as if they are mutagenic to humans.

Category 3 Substances which cause concern for humans owing to possible mutagenic effects, but in respect of which available information does not satisfactorily demonstrate heritable genetic damage.
EXPLANATORY NOTES REGARDING THE CATEGORISATION OF MUTAGENIC SUBSTANCES

4.89 A mutation is a permanent change in the amount or structure of the genetic material in an organism, resulting in a change of the phenotypic characteristics of the organism. The alterations, may involve a single gene, a block of DNA, or a whole chromosome. Effects involving single genes may be a consequence of effects on single DNA bases (point mutations) or of large changes, including deletions, within the gene. Effects on whole chromosomes may involve structural or numerical changes. A mutation in the germ cells in sexually reproducing organisms may be transmitted to the offspring. A mutagen is an agent that gives rise to an enhanced occurrence of mutations.

4.90 It should be noted that substances are classified as mutagens with specific reference to inherited genetic damage. However, the type of results leading to classification of chemicals in Category 3: 'induction of genetically relevant events in somatic cells', is generally also regarded as an alert for possible carcinogenic activity.

4.91 Method development for mutagenicity testing is an ongoing process. For many new tests no standardised protocols and evaluation criteria are presently available. For the evaluation of mutagenicity data the quality of the test performance and the degree of validation of the test method have to be considered.

…

CATEGORY 3

4.99 Substances are determined to be hazardous and classified as Harmful (Xn) and assigned risk phrase R40 in accordance with the criteria given below.

R40 POSSIBLE RISK OF IRREVERSIBLE EFFECTS

4.100 A substance is included in Category 3 if there is evidence from appropriate mutagenicity studies, of concern that human exposure can result in the development of heritable genetic damage, but that this evidence is insufficient to place the substance in Category 2.

4.101 To place a substance in Category 3, positive results are needed in assays showing

(a) mutagenic effects, or

(b) other cellular interaction relevant to mutagenicity, in somatic cells in mammals in vivo.

The latter especially would normally be supported by positive results from in vitro mutagenicity assays.

4.102 For effects in somatic cells in vivo at present the following methods are appropriate:

(a) in vivo somatic cell mutagenicity assays:

bone marrow micronucleus test or metaphase analysis,
metaphase analysis of peripheral lymphocytes,
mouse coat colour spot test.

(b) in vivo somatic cell DNA interaction assays:

test for SCEs in somatic cells,
test for UDS in somatic cells,
assay for the (covalent) binding of mutagen to somatic cell DNA,
assay for DNA damage, for example, by alkaline elution, in somatic cells.

4.103 Substances showing positive results only in one or more in vitro mutagenicity assays should normally not be classified. Their further investigation using in vivo assays, however, is strongly indicated. In exceptional cases, for example, for a substance showing pronounced responses in several in vitro assays, for which no relevant in vivo data are available, and which shows resemblance to known mutagens/carcinogens, classification in Category 3 could be considered.
11. In the draft report, the respondent concluded that trichloroethylene should be classified as a "mutagen category 3 (R40(M3) Possible risk of irreversible effects, mutagen category 3) and carcinogen category 2 (R45-May cause cancer)". The applicant contends that trichloroethylene should have been categorised as a category 3 carcinogen (not category 2), and that it should not have been classified as a mutagen at all.
12. In reviewing the respondent's decisions in relation to the draft report by reference to the Approved Criteria, we are bearing in mind that, whilst those criteria do not have the force of law for our purposes, they are intended to be adopted by State and Territory occupational health and safety legislation, and thus have been drafted with the intention that for certain purposes they should have the force of law. However the criteria are addressed to practical people skilled in their particular trades and industries, and should be construed in the light of practical considerations, rather than being treated like an Act of Parliament: Melbourne Pathology Pty Limited v Minister for Human Services and Health (1996) 40 ALD 565 at 580-581.

13. Counsel for the respondent submitted that we should take into account the "precautionary principle" that was discussed by Sackville J in Friends of Hinchinbrook Society Inc v Minister for Environment (1997) 69 FCR 28 at 78-80. In simplistic terms, that principle requires that a cautious approach be taken when there is a threat of harm and scientific uncertainty. That is a principle of common sense, rather than a rule of law. It is a very relevant principle in this case. But it would be a mistake if, out of an abundance of caution, we were to give trichloroethylene a carcinogenicity classification or a mutangenicity classification otherwise than in accordance with the Approved Criteria.

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