National Industrial Chemicals Notification and Assessment Scheme

137. The applicant sought four changes to the draft report in its letter of 1 June 1988 (T5, pp 215-217). The first requested change related to page 130 of the draft report, which dealt with the classification of trichloroethylene in relation to genotoxicity. The applicant wished the draft report to say that trichloroethylene did not meet the Approved Criteria for classification as a Category 3 (R40-M3) substance. We have decided that it did meet the Approved Criteria for such a classification after reviewing the evidence as to mutagenicity above. The decision under review in relation to that requested change must be affirmed.

138. The second requested change related to page 131 of the draft report, which dealt with the classification of trichloroethylene as a Category 2 carcinogen. The applicant sought the substitution of a paragraph saying that trichloroethylene met the approved criteria for classification as Category 3 carcinogen, and shortly stating the basis for such a conclusion. For the reasons we have stated, we believe that the paragraph which the applicant wanted changed was entirely appropriate, and that the respondent's decision as to the second requested change should be affirmed. The challenged paragraph read as follows:-

"Trichloroethylene meets the Approved Criteria for classification as a Carcinogen Category 2 (National Occupational Health and Safety Commission (NOHSC), 1994), that is, a substance regarded as if it is carcinogenic to humans, on the basis of the occurrence of tumours in experimental animals and limited evidence in workers. Thus the available data provides suspicions of carcinogenic potential in humans (R45)."
139. The third requested change concerned the last paragraph of section 17.1 on page 184 of the draft report. The original version reads as follows:

"The European Union is currently considering the classification of trichloroethylene. Any new information that becomes available as a result of this consideration should be considered in order to determine whether the above classification remains valid."
The applicant requested that it be changed to read as follows:

"The European Union is currently considering the classification of trichloroethylene with respect to carcinogenicity and mutagenicity. Until the results of research studies clearly indicate a different classification is appropriate it is recommended that the current hazard classification Carcinogen: Category 3 R40(3) be maintained."
140. We have rejected the applicant's contentions as to the carcinogenicity classification of trichloroethylene. We think there is a significant chance that the European Union's consideration of the classification of the chemical may reveal or highlight new information in relation to carcinogenicity, and that the challenged paragraph in the draft report is therefore quite appropriate. We have therefore decided to affirm the third decision under review.

141. The fourth request by the applicant for a change to the draft report sought the inclusion in the abstract on page 2 thereof of a paragraph in the same terms as the last one we have quoted. As we have reached a contrary conclusion as to the appropriate carcinogenicity category, and see no need to refer to the European Union's current consideration of the appropriate classification of trichloroethylene as to carcinogenicity and mutagenicity in the abstract, we have decided to affirm the fourth decision under review, namely the decision not to include such a paragraph in the abstract.

142. Thus we have decided to affirm all four of the decisions under review. We considered whether it would be more appropriate to set aside the decisions under review and remit the matter to the respondent with recommendations that the draft report be changed to incorporate references to material we have referred to that was published after the draft report was written, and to the studies referred to in paragraph 52 above. Whilst the inclusion of such references in the draft report would have been desirable, we think it preferable to do all we can to ensure that this litigation is brought to an end, and that the process of reclassifying trichloroethylene is completed as soon as possible. We have therefore decided that it is preferable simply to affirm the decisions under review.
I certify that the 142 preceding paragraphs are a true copy of the reasons for the decision herein of Deputy President A M Blow OAM, QC., Professor G A R Johnston AM, FRACI, FTSE, Miss E A Shanahan
Signed: .....................................................................................

Personal Assistant

Date/s of Hearing 3,4,5,8,9, November 1999

Date of Decision 31 December 1999

Counsel for the Applicant Mr J Beach

Solicitors for Applicant Arthur Robinson & Hedderwicks

Counsel for the Respondent Mr S Gageler

Solicitor for the Respondent Australian Government Solicitor

Axelson O,Anderson K, et al. (1978) A cohort study on trichloroethylene exposure and cancer mortality. Journal of Occupational Medicine, 20: 194-196

CEFIC (1986) The occurrence of chlorinated solvents in the environment. Chemistry and Industry, 24: 861-869.

99-117.
Green T, Mainwaring GW & Foster JR (1997b) Trichloroethylene-induced moude lung tumours: Studies of the mode of action and comparisons between tissues. Fundamental and Applied Toxicology,