Explicit Recognition of the Precautionary Principle
in the Gene Technology Act 2000

Keir Bristow
Solicitor - Corrs Chambers Westgarth
Intellectual Property and Public Law practice groups
Keir_Bristow@corrs.com.au Tel 02 92106100

The Gene Technology Act 2000 (Commonwealth) (“the Act”) was enacted on 21 December 2000.  It sets up a regulatory regime in relation to dealings with genetically modified organisms in Australia, which regime will come into force on 22 June 2001.  Broadly speaking, the Act prohibits dealings with genetically modified organisms unless a licence to conduct the dealing has been granted by the Gene Technology Regulator (“the Regulator”) or the dealing is specifically permitted by the Act or by regulations made under the Act.

Section 4 of the Act provides as follows:

The object of this Act is to be achieved through a regulatory framework which:

(aa)         provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation; …

This paragraph contains one possible formulation of the broad regulatory concept known as “the precautionary principle”.

The Gene Technology Bill (“the Bill”), as originally drafted, did not contain any specific mention of the precautionary principle.  Section 4(aa) was included as the result of an amendment made to the Bill in the Senate.  This amendment was initially proposed by the Australian Labor Party (“the ALP”).

This article examines how the above statement of the precautionary principle came to be included in the Act, and briefly discusses the consequences of its inclusion.

The Senate Committee Report

The specific inclusion of the precautionary principle in the Act was recommended in a report (“the Report”) by the Senate Community Affairs References Committee (“the Committee”) on the Gene Technology Bill.  The Report was delivered on 1 November 2000 and is entitled A Cautionary Tale: Fish Don't Lay Tomatoes. [1]   The Committee was dominated by Senators from the ALP and the Australian Democrats. Senators from the Coalition were in the minority.

The Report recommended that the precautionary principle be specifically included in the objects clause of the Bill (section 4).  (The inclusion of the principle as a test in the licensing provisions was specifically not supported.)  The recommendation in the Report was that the formulation of the precautionary principle that should be included be that contained in the Environment Protection and Biodiversity Conservation Act 1999 (“the EPBC Act”).  The ALP proposal to include the precautionary principle in the Bill reflected this recommendation.

The EPBC Act formulation of the precautionary principle

Sub-section 391(2) of the EPBC Act reads as follows:

The precautionary principle is that lack of full scientific certainty should not be used as a reason for postponing a measure to prevent degradation of the environment where there are threats of serious or irreversible environmental damage.

It should be noted that this formulation is different from that the formulation in the United Nations Framework Convention on Climate Change (“the UN Convention”) and the formulation in the Rio Declaration on Environment and Development (“the Rio Declaration”), in that it does not specifically restrict the application of the principle to "cost-effective measures". [2]   The formulation in the EPBC Act is referred to below as “the EPBCA formulation”. [3]   A formulation of the principle which is restricted to cost-effective measures is referred to below as “the Cost-Effective formulation”.

The fundamental legal difference between the EPBCA formulation and the Cost-Effective formulation is that, under the latter, it is permitted to avoid taking a measure aimed at the protection of the environment which is considered not to be “cost-effective” (whatever that term may mean exactly, and however it may be defined and applied), provided that there is a “lack of full scientific certainty” that any threat of serious or irreversible environmental damage exists.  In addition, there is a clear political difference in that the Cost-Effective formulation explicitly accepts that a balance must be struck between environmental and practical commercial interests, which the EPBCA formulation alone does not.

The Report did not specifically state why the inclusion of the EPBCA formulation in the Act was recommended, rather than inclusion of the Cost-Effective formulation. The reason appears to be that the Committee was simply keen that, to the extent that the Act applies to environmental protection, the Act should incorporate a principle that is identical to the principle in the EPBC Act, for the sake of consistency in the field of Federal environmental protection legislation.

The Parliamentary debate - November

Section 4(aa) of the Act differs slightly from the EPBCA formulation recommended in the Report.  To examine the reasons behind this, it is necessary to consider the Senate debate regarding the amendment.

On the day the Report was delivered, the Senate debate on the Bill, which had been adjourned after its second reading speech on 30 August 2000, was recommenced.

The ALP hinted very early in the recommenced debate that it would be proposing to amend section 4 of the Bill to include a reference to the precautionary principle.

On 1 November 2000, one ALP senator stated that the precautionary principle which the ALP would be seeking to have inserted in the Bill would be consistent with the EPBCA formulation.  In addition, she made the following statement:

“The precautionary principle actually states that, even if there is not absolute scientific evidence that there will be a health threat or an environmental threat, the person approving the licence must require that there be conditions set so that people behave as though there will be a threat to the environment.” [4] (emphasis added)

On 6 November 2000, a different ALP senator stated unambiguously that the formulation of the precautionary principle which the ALP would propose would apply to both threats of harm to human health and threats of damage to the environment.  He went on to say that the proposed wording was “similar” to that in the EPBC Act.  This same formulation was repeated by a third ALP senator on 7 November 2000, who also said the wording was “quite similar” to that in the EPBC Act.

In early November, it therefore seems that the ALP was prepared to extend the EPBCA formulation recommended in the Report to apply also to threats of harm to human health.  However, the ALP did not formally table its proposed amendment at that time.  In the debate a month later, the extended formulation of the precautionary principle (to include threats of harm to human health) was proposed by the minor parties and opposed by the ALP. [5]

Further substantial debate on the issue of the inclusion of the precautionary principle in the Bill was something which the minor parties, namely the Democrats, Greens and One Nation, hoped and claimed to expect would be “one of the first areas for debate and amendment”.  However, the substantive Senate debate on the precautionary principle did not take place until the very early hours of 8 December 2000.  This was the continuation of the parliamentary business of 7 December 2000, the last sitting day of the Spring session before the two month summer recess.

The Parliamentary debate - December

The ALP formally proposed its amendment at 12.59 am on 8 December 2000. [6]   Unlike the wording of the proposed amendment that it had foreshadowed in the brief Senate debate on the Bill a month earlier, this proposal was to include the EPBCA formulation in section 4 of the Bill.  No mention was made of extending its application to threats of harm to human health.

The Democrats, Greens and One Nation opposed the ALP proposal on the basis that it was a “watered-down” precautionary principle, in comparison with their proposals that extended its application to threats of harm to human health.

The ALP supported its proposal by saying the wording it proposed was “essentially the same” as, and consistent with, the wording in both the EPBC Act and the Rio Declaration. In response to opposition by the Australian Democrats, the ALP noted that the EPBCA formulation appeared to be acceptable to the Democrats when the EPBC Act was legislated in 1999.

The Government noted the difference between the EPBCA formulation and the Cost-Effective formulation.  Although the Government indicated that it was willing to accept the ALP proposal, [7] this was subject to the inclusion of the word “cost-effective” between the words “postponing” and “measures”.  The claimed purpose of including the word “cost-effective” was to make the formulation consistent with the Rio Declaration, “a declaration that the Australian government has endorsed”.  The ALP indicated that it was prepared to accept this change to its proposal.  The ALP senator who made the initial ALP proposal himself moved the inclusion of the word “cost-effective” in that proposal. [8]

The Greens responded as follows:

… [P]utting in the term “cost-effective” is a weasel word to simply give the Monsantos' of the world an avenue for copping out of the precautionary principle.  We all know that.

To this comment, the ALP responded simply that the words reflected those in the Rio Declaration, a document to which the Greens themselves had often cited approvingly in Senate debate. [9]

The Democrats commented that the amended wording would make the statement of the precautionary principle in the Act weaker than the statement in the EPBC Act.  This, argued the Democrats, may have an impact on public confidence in the whole area of gene technology and should therefore be a cause of great concern.

The ALP proposal, with the amendment suggested by the Government and moved by the ALP itself, was passed at 1.09 am.  The Bill, as amended, was agreed to at 2.36 am.  On 21 December 2000, the Bill received royal assent and became the Gene Technology Act.

The significance of the precautionary principle in the Act

The inclusion of the Cost-Effective formulation of the precautionary principle in section 4 of the Act appears to have resulted from a deal between the two major political parties.  The Government was only prepared to accept the inclusion of the precautionary principle if it was restricted to that contained in the Rio Declaration, namely the Cost-Effective formulation, and made no mention of threats of harm to human health.

In practice, the significance of the statement of the precautionary principle in section 4 will depend primarily on how the Regulator will interpret the information before him or her when making a decision under section 56(1) of the Act.  That section prohibits the Regulator from granting a licence unless and until he or she is satisfied that any risks posed by dealings with genetically modified organisms for which he or she has received a licence application are able to be managed in such a way as to protect the health and safety of people and the environment.  Clearly, section 4 will technically only apply to such a decision to the extent that the risks that may exist are alleged threats of damage to the environment.  One immediate consequence of this restriction could be expected to be that opponents of gene technology generally or of a specific licence application will attempt always to portray alleged risks as threats of harm to the environment. 

It will, however, be very interesting to see whether, as a result of the precautionary principle applying to environmental threats, in practice the Regulator will take a more risk-averse approach when presented with evidence of alleged threats to human health and safety, even though section 4 does not apply to such alleged risks.  Even though taking such an approach in relation to such risks is not specifically mandated by the Act, the Regulator may take the view that the subjective weighing up of the strength of the evidence on the one hand and the magnitude of a potential risk on the other hand falls squarely within the legitimate discretion of the Regulator, when he or she is deciding what risks are posed by the activity to which a licence application relates, and whether or not they are manageable.  Failing to take this more “precautionary” approach when it comes to risks of human health and safety, and allegations that greater protection is therefore accorded to the environment than to people, could expose the Regulator to serious public criticism and a loss of public confidence which he or she could not attribute solely to the limitations imposed upon him or her by the Act.

The scope for appeal from decisions of the Regulator is therefore substantial.  Licence applicants may perceive that an appeal is justified if, in relation to potential risks to the environment, the Regulator takes measures (such as refusing a licence or imposing onerous licence conditions) which in their view are not “cost-effective”, or if the information on which the Regulator based his or her decision displays in their view not only a “lack of full scientific certainty” (whatever that means) but a fundamental lack of scientific significance or relevance whatsoever. Licence applicants may also perceive that an appeal is justified if, in relation to potential risks to human health or safety, the Regulator applies (implicitly or explicitly) the precautionary principle or a precautionary approach which they see as going beyond that specifically required by the Act. 

Opponents of gene technology generally or of the licence application in question specifically may perceive that an appeal is justified if there is, in their view, evidence indicating that a threat of “serious or irreversible environmental damage” may exist, if the Regulator has not accepted the potential risk and imposed all measures that in their view are cost-effective to prevent that risk. [10]

Whether or not such appeals are ultimately successful, they are likely in many cases to be lengthy and expensive proceedings involving substantial scientific evidence, before judges who in many cases have relatively limited understanding of the evidence or the underlying scientific fields involved.  The consequences are likely to be a substantial delay in the approval of licences to conduct dealings with genetically modified organisms in contentious fields (such as genetically modified crops), and a “siege mentality” in the Office of the Gene Technology Regulator, where a major factor in decision-making may become the best way to avoid provoking an appeal.

In reality, in some cases the licence applicant and the opponents of gene technology may be so committed to doing (or being seen to be doing) everything they can to further their respective interests, that the Regulator may be unable to avoid an appeal of his or her decision no matter how proper and sound that decision may be.

Keir Bristow

23 February 2001

Footnotes

[1] The Report can be found at http://www.aph.gov.au/senate/committee/clac_ctte/index.htm

[2] Article 3(1) of the UN Convention on Climate Change states: "Where there are threats of serious or irreversible damage, lack of full scientific certainty should not be used as a reason for postponing such measures, taking into account that policies and measures to deal with climate change should be cost-effective so as to ensure global benefits at the lowest possible cost." (emphasis added)  Article 15 of the Rio Declaration states: "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation." (emphasis added)

[3] Although the EPBCA formulation itself does not make reference to the issue of cost-effectiveness, it is included in another section of the EPBC Act.  In section 134(4), which sets out certain factors to be considered by the Minister when deciding whether to impose conditions on the approval of certain types of actions (“controlled actions”, being those otherwise prohibited by Part 3 of the EPBC Act), the Minister must consider “the desirability of ensuring as far as practicable that the condition is a cost-effective means for the Commonwealth and the person taking the action to achieve the object of the condition.”

[4] In light of the statements of other ALP senators on 6 and 7 November 2000, the failure to mention threats to human health in the last part of this statement would appear to be simply a mistake.

[5] It seems likely that the “about face” by the ALP resulted from discussions between the ALP and the Government in which the Government indicated that it would never accept extension of the precautionary principle in the Bill to threats of harm to human health.  The Government’s response on 8 November 2000 to the ALP’s foreshadowed proposal of an extended precautionary principle was to state that “Australia strongly opposed the use of the precautionary principle in relation to human health in international forums.”  In the Senate debate on 8 December 2000, the Government provided further detail of its opposition to the extended formulations proposed by the minor parties on the grounds that such proposals (a) were inconsistent with the Rio Declaration, (b) required further consideration in the international arena, and (c) may commit Australia to a path that “may have difficulties and be inconsistent with international best practice”.

[6] By that time of the morning, the issue of the precautionary principle had already been discussed for approximately half an hour in the context of proposals by the Australian Democrats, Greens and One Nation.

[7] The Government was originally opposed to the ALP proposal. In the Senate debate on 8 November 2000, the Parliamentary Secretary to the Minister for Health and Aged Care said that the Government’s opposition was on the grounds that it predicted that 85% of the work of the Gene Technology Regulator would relate to research, that the precautionary principle was “inappropriate for application to research” and that such application would “stymie” research and development and “create confusion and uncertainty and have the potential to affect adversely our R&D base in Australia.”

[8] Throughout the debate, the Democrats referred to negotiations between the Government and the ALP and a “deal” they alleged had been made between the Government and the ALP in relation to the Bill.  In light of the substantial turn-around by both the Government and the ALP in relation to the form of the precautionary principle to be included in the Act, these statements by the Democrats cannot be lightly dismissed.  The Democrats also noted that it was unfortunate that this issue had apparently been left to be discussed at the latest possible time on the last sitting day of 2000.

[9] In the early Senate debate on 1 November 2000, the Greens senator in fact said that the Report of the Committee should be commended because it adopts the precautionary principle, “a basic outcome of the 1992 Rio conference … If there is one great breakthrough in this report it is that it sensibly says – eight years after Rio – that the precautionary principle is the fundamental if we are going to apply genetic technology.”  The ALP proposal merely reflected the precautionary principle adopted by that Report and the “cost-effective” amendment merely reflected the Rio Declaration, both of which the same senator subsequently criticised.

[10] The question of who, other than the licence applicant, would have the right to appeal decisions of the Regulator is itself a substantial question, doing justice to which would require a further article.