18 November 2004
Dr J.B. Jaftha
The Senior Manager: Genetic Resources Management
National Department of Agriculture
Private Bag X250
By fax: (021) 319 6329
e-mail SMGRM@nda.agric.za
Dear Dr Jaftha,
COMMENTS ON THE AMENDMENTS TO THE GMO ACT
Please receive the
comments submitted by Biowatch
Civil society has been calling for a review of this Act since 1999, because we are concerned that at best it does not fulfil the requirements of good biosafety legislation or implement the Biosafety Protocol. At worse, the GMO Act is unlawful and unconstitutional. The proposed amendments does not address our concerns nor does it give effect to our Constitution or the Biosafety Protocol, because it does not implement the following principles:
§ The Right to a Safe and Healthy Environment;
§ The Right to Safe and Healthy Food;
§ The Right to Administrative Justice;
§ The Right of Access to Information; and
§ The Precautionary Principle.
In our submission
we explain why this is so. We hope you will take our carefully considered
comments into account and thereby acknowledge the important role civil society
plays in balancing the very powerful short term interests of multinational
companies with that of
Civil society urges our government to
initiate a new process that will:
§ Include public participation in the widest sense;
§ Develop a national policy on GMOs;
§ Initiate a public process to develop a new GMO Act;
§ Publish the GMO Act, Regulations and Amendments simultaneously for public
input;
§ Ensure presentation in Parliament, including hearings and debates on
GMO policy and legislation;
§ Broaden representation on the Advisory Committee of the GMO Act.
We look forward to further discussion and debate on this very critical issue.
Sincerely yours
Elfrieda Pschorn-Strauss
COMMENTS
ON GENETICALLY MODIFIED ORGANISMS AMENDMENT BILL
1. EXECUTIVE SUMMARY
This document contains the comments of the Biowatch Trust (“Biowatch”) on the Genetically Modified Organisms Amendment Bill[1] (“the Bill”). The substance of Biowatch’s comments are set out under separate headings below and essentially deal with the following broad areas of concern.
§
The
narrow, non-consultative approach adopted by the Department of Agriculture in
preparing the Bill has resulted in a poorly drafted and wholly inadequate Bill
that fails to address the central problems with the Genetically Modified
Organisms Act[2]
(“GMO Act”), and in some cases, exacerbates them. If passed, the Bill is likely to give rise to
on-going litigation and create more administrative difficulties for the
Department.
§
The
Bill is inconsistent with the Constitution as well as
other legislation highlighted below.
§
The Bill does not address a
number of significant shortcomings in the GMO Act. These include the Act’s failure to adopt a
sufficiently risk averse approach to environmental protection in the widest
sense, and the lack of an adequate public participation process with access to
information required to make such a process meaningful. In both of these aspects, the Act falls foul
of constitutionally entrenched rights that have been given effect to in
subsequent legislation.
§
Because of these concerns,
Biowatch does not wish to comment extensively on the draft Bill at this stage
as it is of the view that the GMO Act requires far more substantial amendments
than those effected by the draft Bill.
Accordingly, it asks that the procedure for adopting amendments be
re-initiated with the formulation and distribution of a guiding policy in
relation to the proposed amendments, as a starting point, and full consultation,
involving civil society as well as public sector stakeholders, prior to the
circulation of draft amendments.
§
Proposed amendments to the
Regulations under the GMO Act should be published for comment simultaneously
with the publication of a revised draft Bill in order to enable effective
public participation.
§
In order to demonstrate the
substance of its concerns, Biowatch has set out the reasons for the view
expressed above in the rest of this document.
It also highlights some of the key concerns that it has in relation to a
number of provisions including those addressing access to information and
administrative appeals.
2. introduction
The Genetically Modified Organisms Amendment Bill was published in Government Notice R2166 of 8 October 2004.[3] In terms of that notice, the general public was invited to submit comments in writing within 30 days of publication of the notice. An employee of Biowatch, Ms Elfrieda Pshorn-Strauss, was advised by the Registrar of Genetically Modified Organisms, Ms Michelle Vosges,[4] that the 30 day period referred to 30 working day. Accordingly, the period for submission of comments expires on 19 November 2004 and Biowatch’s comments have been submitted timeously.
Further, while Biowatch is not a natural or juristic person, it acts in the interests and on behalf of members of the public concerned about the widespread commercialisation of genetically modified organisms (“GMOs”) in South African and the determination of policy and law regulating their use, control and release. It follows that Biowatch is entitled to submit these comments on the draft Bill.
Biowatch’s comments follow under the headings set out below.
3. flawed approach to legislative amendment PROCESS
The whole issue of genetic modification is
a matter of great public concern in
The National Department of Agriculture (“The Department”) is well aware of public concerns in relation to GMOs and the fact that many people regard the GMO Act to be wholly inadequate. It is also aware of at least some of the deficiencies in the GMO Act and regulations that have been exposed in the course of recent litigation and appeals to the GMO Appeals Board, instituted by Biowatch, and of the fact that the GMO Act is not consistent with other later legislation. Unfortunately, the Department has chosen not to consult widely to identify all the deficiencies in the GMO Act before drafting the Bill. This means that many of the most serious concerns about the GMO Act have not been addressed, and even the attempts to bring it into conformity with the Cartagena Protocol to the Convention on Biological Diversity are wholly inadequate.[6]
Biowatch’s overriding comment is that the narrow, non-consultative approach adopted by the Department in preparing the Bill has resulted in a poorly drafted and wholly inadequate Bill that fails to address the central problems with the GMO Act, and in some cases, exacerbates them. If passed, the Bill is likely to give rise to on-going litigation and create more administrative difficulties for the Department.
Biowatch’s reasons for this view are explained in more detail below.
3.1 Absence of guiding policy
The adoption of new legislation such as the GMO Act, which puts in place a new regulatory system, is ordinarily preceded by the formulation of a policy framework that will guide the drafting of the relevant legislation. The policy process itself would be shaped and influenced by an appropriate public participation process to ensure that the rights, interests and concerns of all interested and affected parties are considered in the policy document and, ultimately, the regulatory system flowing out of that policy. The importance of policy as a tool in guiding the legislative process becomes even more evident in the context of seeking to regulate an industry such as the biotechnology industry, which raises a range of serious concerns noted above.
The hasty circumstances in which the GMO
Act was adopted meant that it was not preceded by the policy-making process
referred to above. Undoubtedly, this has
contributed to the current shortcomings in the Act. Accordingly, Biowatch submits that any
attempt to amend the GMO Act should be preceded by the formulation of a guiding
Departmental policy, drawn up in terms of a process that includes wide
consultation with relevant stakeholders (including other interested and
affected government departments) and a comprehensive public participation
process.
3.2 Inadequate public participation and scope of amendments
As mentioned above, the range and scope of the issues dealt with in the Bill is far too narrow. Biowatch believes that the amendment of legislation as important as the GMO Act, merits a consultative process that solicits comments from the public and interested and affected parties before the drafting process begins (particularly because the public participation at the time the GMO Act was first passed was wholly inadequate).
Inviting comments on amendments that are far too limited in scope cannot correct this deficiency and the Department should immediately initiate a process of wide consultation to ensure that all issues of concern are considered, and where appropriate, addressed in the Bill.
As importantly, Biowatch's view is supported by the environmental management principles set out in Chapter 1 of the National Environmental Management Act[7] ("NEMA"). These principles apply to the actions of all organs of state which may significantly affect the environment: this would naturally include the formulation and adoption of the Bill. Of particular relevance are the following principles contained in section 2(4) of NEMA:
(f) …The participation of all interested and affected parties in
environmental governance must be
promoted…,. and
(g)
Decisions must take into account the interests, needs and values of
all interested and affected parties, and this includes recognising all forms of
knowledge, including traditional and ordinary knowledge… and
(k)
Decisions must be taken in an open and transparent manner, and
access to information must be provided in accordance with the law.
These principles indicate that a participatory approach with all interested and affected parties is required to ensure that comments and recommendations are considered prior to the preparation of first draft amendments.
3.3 Inconsistencies with the Constitution and other legislation
The GMO Act is, in several respects, inconsistent with the Constitution and with other legislation enacted to give effect to constitutional rights, such as the Promotion of Administrative Justice Act[8] (“PAJA”), yet these issues are not addressed in the Bill. In addition, the GMO Act is not aligned with other important, and relevant, legislation such as NEMA and the National Environmental Management: Biodiversity Act[9] (“Biodiversity Act”). (Specific examples of these inconsistencies are discussed under separate headings below).
The approach adopted to the amendment of the GMO Act is fundamentally flawed because it does not take adequate, or any, account of these laws.
3.4 Non-alignment with the regulations
The manner in which the GMO Act was initially drafted led to most of the regulatory framework for the permitting system being contained in regulations to the Act[10] (“the GMO Regulations”). Accordingly, any effort to revise the Act must include a revision of these Regulations due to the inherent flaws in the latter as well as the need to create consistency between the two pieces of legislation. By way of example, the Bill introduces certain clear inconsistencies between the GMO Act and the Regulations. These include a proposed provision for the issue of "extension permits" in the Act without any explanation of how this would align with the fast tracking process provided for in regulation 5(12) of the Regulations. Further, the Bill introduces a reference to "public input" in terms of amendments to section 5(1)(g) of the GMO Act without in any way expanding on this concept or explaining how it links to the notice and comment procedure outlined in regulation 6 of the Regulations.
3.5 Extensive consultations must precede preparation of completely revised Bill
Biowatch’s primary comment is that the amendments that the Bill seeks to make are wholly inadequate and fail to take into account legitimate concerns regarding the regulation of GMOs. These deficiencies can only be cured by means of a wide process of consultation to ensure that all relevant considerations are taken into account before the next draft of the Bill is prepared. Furthermore, in preparing a revised draft, the Bill must be aligned with other relevant laws and new draft GMO regulations should be published for comment simultaneously in order to enable effective public participation.
In light of this submission, Biowatch believes that the draft Bill will require substantial revision and does not consider it constructive to provide detailed comments on the current amendments. Should the proposal for a revision of the process be implemented, Biowatch would like to, and believes that it is entitled to, submit further comments. The focus of these comments would be to identify the areas in which the GMO Act, as it currently stands, is fundamentally flawed. In addition, Biowatch would be very willing to provide draft wording for amendments to the GMO Act although it has not done so at this stage, due to its view that this would be premature in light of its preliminary comments.
In the interests of demonstrating the substance for the views set out above, certain of Biowatch’s key concerns with the current draft are highlighted below.
4. Inconsistency with environmental legislation
4.1 Section 24 of the Constitution
Section 24 of the Constitution provides as follows:
“Everyone
has the right-
(a) to an environment that is not harmful to their health
or well-being; and
(b) to have the environment protected, for the benefit of present
and future generations, through reasonable legislative and other
measures that-
(i) prevent pollution and ecological
degradation;
(ii) promote conservation; and
(iii) secure ecologically sustainable development and use of natural resources while promoting justifiable economic and social development.” (emphasis added)
All legislation is subordinate to the Constitution and must be consistent with it. The following observations can be made with reference to the section quoted above.
·
Section
24(a) entrenches the rights of individuals to object to laws (or other conduct)
that are harmful to the environment.[11] The GMO Act opens itself up to this objection
by failing to provide adequate, or any safeguards, against the consequences
of issuing permits for activities involving GMOs. It does this in a number of ways that
include, significantly, the failure to stipulate the circumstances in which a
risk assessment (“RA”) or environmental impact assessment (“EIA”) is required
or the minimum requirements with which such assessments must comply. In this regard, section 5 of the GMO Act
makes it clear that even an RA is optional and “may” be required by the
Executive Council. Further, the
definition of "contained use" in section 1 of the GMO Act includes
the transportation and disposal of GMOs (in the context of contained use). Given the fact that no permit is required in
terms of the Regulations for contained use, this definition is too wide and
fails to ensure adequate, or any, regulation of these activities despite the
fact that they may well occur outside of contained use facilities. The draft Bill does not address these
shortcomings in any way. In addition, the
draft Bill introduces new difficulties by providing for the issue of an
extension permit without providing any indication of the circumstances in which
this would be done or the requirements that would need to be satisfied by
an applicant for such a permit.
·
The
environment referred to in section 24(a) includes social and economic aspects
of the environment.[12] The potential social and economic impacts of
activities involving GMOs are extensive, particularly in a country such as
·
Section
24(b) requires the State to provide legislation that protects the environment
and that, among other things, is ecologically sustainable. In other words, the relevant regulatory
framework provided by the GMO Act should ensure the careful consideration of
the advantages and disadvantages of activities involving GMOs, which should
include a consideration of both their long-term impacts on the environment and
on the sustainability of other non-GM practices that take place in reliance on
the environment. Provision for the impact on the environment is not
currently provided for adequately or at all.
·
In
addition, the inclusion of an obligation to protect future generations requires
a precautionary approach that takes into account scientific uncertainty and
controversy in relation to GMOs. Neither
the GMO Act nor the draft Bill currently adopts a precautionary approach.
·
Lastly,
section 24(b) entitles South Africans to legislation that is reasonable. Reasonableness should be judged in the
context of the constitutional rights that the section seeks to give effect to. For the reasons articulated above, both the
GMO Act and the draft Bill fall short of this standard. In addition, the reasonableness of
legislative measures can be judged with reference to other legislation already
enacted. Certain provisions of NEMA,
discussed below, are relevant in this regard.
Section 24 places an onus on the
State to give effect to the constitutional rights articulated in relation to
the environment. The inadequacies of the
current regulatory system in place for GMO activities mean that the State
cannot fulfil this obligation without substantially revising the GMO Act in a
way that far exceeds the approach adopted in the draft Bill.
4.2 Section 2 of the National Environmental Management Act
Section 2 of NEMA sets out principles that apply to the actions of all organs of state that may significantly affect the environment.[13] Given the range of activities regulated by the GMO Act, it is clear that the decision to amend the GMO Act is an action that may significantly affect the environment and accordingly, the NEMA principles should be seen as relevant guiding considerations in relation to the amendment process.
Certain principles in section 2 are highlighted below.
“(3)
Development must be socially, environmentally and economically sustainable.
(4) (a) Sustainable development
requires the consideration of all relevant factors including the following:
(vii)
that a risk-averse and cautious approach is applied, which takes into
account the limits of current knowledge about the consequences of decisions and
actions; and
(viii)
that negative impacts on the environment and on people's
environmental rights be anticipated and prevented, and where they cannot
be altogether prevented, are minimised and remedied.” (emphasis added)
These principles expressly apply to the regulation of “development” which is not defined but would include development of the nature initiated by the biotechnology industry. In determining the appropriate means of regulating this industry, it is Biowatch’s submission, that the NEMA principles require the legislators to ensure that the development of biotechnology is sustainable. Among other things, this requires the adoption of a risk averse approach, which is not provided for in the GMO Act or the draft Bill, despite wording in the preamble to the current Act that suggests an intention to take this approach. In addition, the NEMA principles provide a useful indication of considerations that should be applied in determining whether legislation constitutes reasonable measures, within the meaning of section 24 of the Constitution.
Furthermore, the failure of the GMO Act to identify clearly when environmental impacts assessments are mandatory, is in our view a very serious omission that must be addressed if further litigation is to be avoided. As the recent appeal by Biowatch to the Appeal Board under the GMO Act against the decision to grant Syngenta permits in relation to Event Bt11 maize (“the Syngenta Appeal”) has shown, there is a complete lack of clarity on this issue and the Appeal Board apparently does not believe that section 24(1) of NEMA is decisive on this issue. Even if it is lawful to give an official the power to decide whether or not an EIA should be done (which is arguable), it is essential that the legislature establish the criteria on which such a decision should be made. This is not apparent from the GMO Act nor is it addressed by the Bill.
4.3 Section 78 of the Biodiversity Act
Section 78(1) of the Biodiversity Act stipulates that no permit for release of a GMO should be issued in circumstances where the Minister of Environmental Affairs and Tourism believes that it may pose a threat to the environment or any indigenous species unless a prior EIA has been conducted. The Minister is required to convey his belief to the relevant authority issuing permits under the GMO Act before the application for a permit is decided.[14]
In order to give effect to this, the GMO Act must be amended to include a requirement of notification to be given to the Minister in relation to applications for release. It may be that notification of every application is not required and that criteria are determined for the circumstances in which notification would be required. If this approach is adopted, it should be set out clearly in the GMO Act and should be measured against the risk averse and protective standards required in terms of the Constitution read with NEMA.
5. inconsistency with administrative justice requirements
Section 33 of the Constitution
entrenches the right of all South Africans to administrative action that is
lawful, reasonable and procedurally fair.
This right has been expanded upon in PAJA as well as in the regulations
made under PAJA[15]
("the PAJA Regulations").
5.1 Procedural fairness in relation to public participation
Section 3 of PAJA sets out the
requirements for procedural fairness in relation to administrative action that
materially and adversely affects the rights or legitimate expectations of any
person. Section 4 of PAJA provides
similar requirements in relation to administrative action that affects the
rights of the public (as opposed to any person). The reference to the public includes a sector
of the public, in circumstances where the effect of the administrative action
is narrower than the public at large.[16] The requirements contained in section 4 of
PAJA are expanded upon in the PAJA Regulations, particularly Chapter 2 thereof,
which sets out a notice and comment procedure.
For present purposes, administrative
actions to which these requirements apply would include the authorising of permits
by the Executive Council and the issue of permits by the Registrar. This is due to the fact that these activities
detrimentally impact on the rights and/or expectations of a broad range of
members of the public, whose environments, lives or livelihoods are directly or
indirectly affected by the authorisation issued in terms of the GMO Act. This is particularly so in light of the broad
rights afforded to all South Africans under section 24 of the Constitution.
In addition, these requirements
would apply to the administrative actions associated with the lodging and
hearing of an appeal, with regard to the rights and legitimate expectations of
the appellant.
However the procedures set out in
the GMO Act and the GMO Regulations that apply to these actions fall short of
the requirements of sections 3 and 4 of PAJA (read with Chapter 2 of the PAJA
Regulations) in a number of ways, none of which are remedied by the draft
Bill. Some examples of these
deficiencies are set out below.
5.1.1 Adequate notice of administrative action
The imperative to ensure procedurally fair administrative action includes adequate public participation. In turn, adequate public participation requires the disclosure of sufficient information. In this regard, PAJA requires that adequate notice of the nature and purpose of a proposed administrative action be given.[17] No procedure is set out in the GMO Act for notification to the public, in relation to application for permits. <