Analysis of Public
Submissions
Analysis of
Public Submissions
3.
section 3.3 |
appendix 3
Outcomes of Consultation: Submissions
from the Public
Section contents
3.
Analysis of Public Submissions
22
3.3
Statutory and regulatory system
44
Background
44
Outline of this section
45
Adequacy of current statutory and regulatory system
45
Problems with current system
46
Suggested improvements
48
Royal Commission on Genetic Modification | Report Appendix 3
3.3 Statutory and regulatory
system
Background
The Warrant contains two items that relate to the statutory and regulatory
framework and processes that are currently in place in New Zealand, namely
Warrant item (2) and, under "Relevant matters", item (n).
Warrant item (2) called for information and comment on:
any changes considered desirable to the current legislative, regulatory, policy or
institutional arrangements for addressing, in New Zealand, genetic modification, genetically
modified organisms, and products
and Warrant item (n) called for information and comment on:
whether the statutory and regulatory processes controlling genetic modification,
genetically modified organisms, and products in New Zealand are adequate to address the
strategic outcomes that, in your opinion, are desirable, and whether any legislative,
regulatory, policy or other changes are needed to enable New Zealand to achieve these
outcomes
Both Warrant items invited submitters' comments on the current legislative,
regulatory, policy and institutional arrangements. The first, item (2), invited
comment on desirable changes and item (n) on their adequacy and, also, changes
needed to achieve strategic outcomes (discussed in the previous section). Given
the similarity of these Warrant items and the ways in which submitters raised
issues around regulatory and legislative processes, their responses to these two
Warrant items are combined into a single section of the report.
The few public submitters who commented on legislation and regulations tended
to make general comments about the adequacy or inadequacy of current regulatory
and legislative processes rather than link suggested changes to the strategic
outcomes they identified as desirable. Thus, their comments generally related to
how they perceived the current processes as operating and how they might be
improved.
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Outline of this section
This section of the report presents submitters' views about:
*
the adequacy of the current legislative and regulatory system
*
problems with the legislative and regulatory framework
*
suggested improvements.
Adequacy of current statutory and
regulatory system
As Table 3.4 shows, only 113 public submitters made any comment about the
overall adequacy of the current legislative and regulatory framework, and most of
their comments were of a general nature. When specific comments were made
they were almost always with regard to food, referring to either labelling
requirements or production controls. To some extent, their less specific comments
may have reflected their general lack of familiarity with, or detailed knowledge of,
current legislation and regulations and the decision-making processes. The most
significant features of the current legislative and regulatory framework are the
Hazardous Substances and New Organisms (HSNO) Act, which is the principal
legislation affecting the use of genetic modification in New Zealand, and the
Environmental Risk Management Authority (ERMA).
Adequacy of current framework/process
Number
%
Inadequate ­ complete renewal required
61
54.0
Needs major improvement to be made adequate
29
25.7
Adequate ­ no improvement required
10
8.8
Needs minor improvement to be made adequate
7
6.2
Adequate but could be improved
6
5.3
Table 3.4
Adequacy of current statutory framework and regulatory
process (n = 113)
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It needs to be noted that many submitters may not have felt a need to address the
current legislative and regulatory framework as they were recommending a total
ban on genetic modification, precluding the need for more detailed comment.
Submitters were more likely to comment on general issues such as the perceived
lack of attention given to ethical and cultural issues; the lack of independence of
individuals and organisations responsible for administering regulations and
approving applications; and the lack of guiding principles to inform these
processes and ensure better decision-making.
Problems with current system
Some 292 public submitters commented on perceived problems with the current
statutory framework and regulatory process. Few public submissions contained
specific references to the current legislation (rarely was the HSNO Act referred to
and submitters were more likely to refer to ANZFA than ERMA). Their greatest
concerns related to insufficient regulation of genetic modification activity and
little recognition of public views, including ethical, spiritual and cultural
considerations. See Table 3.5. Some also expressed concern about lack of clarity
around definitions used. Other than in submissions presented by Maori interests,
Treaty of Waitangi and other Maori-related concerns were seldom raised.
In general, public submitters made no comment about characteristics of the
legislation, such as its prescriptive rather than principles or outcomes basis and the
absence of discretionary powers. Similarly, they made no comment about
compliance costs and impacts on research investment. In fact, they were more
likely to suggest that current legislation and low compliance costs enable or
promote research rather than limit it.
Public submitters addressing the current regulatory framework were intent on
freeing ERMA and ANZFA from what they saw as excessive levels of corporate
control. They expressed a desire for regulatory bodies and decisions to be totally
transparent and above suspicion. Most of these submitters felt that ANZFA and
ERMA were currently biased towards corporations, and politicians overseeing the
process could not be trusted to work on behalf of the general public instead of big
business. The example most frequently cited was that of a recent court case in the
United States in which it was shown that the FDA declared genetically modified
foods to be safe against the recommendation of many of its own scientists. This
perceived bias in the regulatory system was also felt to be rife in the political
system as well, with politicians more concerned about big business than public
safety. Given this lack of trust, a number of submitters felt that "... a referendum is
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essential if our present leaders still proclaim themselves to be governing for the
good of all the people of New Zealand."
Public submitters also raised issues around consistency with respect to the
legislative frameworks of New Zealand and its international trading and other
partners. They typically expressed a view that any inconsistency with international
partners could be a virtue. They thought that New Zealand should take an
independent stance, as with the case of nuclear power. Such independence, they
argued, could give New Zealand moral, ethical and economic advantage.
Problems with framework/process
Number
%
Under-regulates GM
154
52.7
Potential to allow patenting of genetic material
76
26.0
Too little recognition of those opposed
39
13.4
GM inappropriate for ethical/spiritual/cultural reasons
34
11.6
Over-regulates GM
10
3.4
Fails to protect information and intellectual property
8
2.7
Barrier to GM research investment
5
1.7
Too high transaction costs for applicants
5
1.7
Includes irrelevant social/economic and ethical criteria
1
0.3
Inconsistent with international agreements
1
0.3
Inconsistent with trading partners
1
0.3
Other
6
2.1
Multiple response
Table 3.5
Problems with current statutory framework and
regulatory process (n = 292)
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Other identified problems with the regulatory process (but mentioned only once
or twice) included:
*
too much secrecy in the application process
*
overly low transactions costs for applicants
*
limits on consumer choice
*
unnecessary bureaucracy
*
no viable risk assessment strategy
*
need for the debate on genetic modification to be separated into research,
medical uses and field releases.
Suggested improvements
The public submitters who commented on legislative improvements (4259 in
total) tended to focus on what the legislation should do. Few commented on what
needed to be changed to make it more effective. This lack of specificity probably
reflected the majority's lack of familiarity with the legislation. One of the strongest
messages given by public submitters who commented on legislative improvements
was their desire for the legislation to bar all genetic modification, genetically
modified food or specific genetic modification uses (57.9%). Most of these wanted
all genetic modification activities barred. The next strongest message, as Table 3.6
shows, was for more stringent food labelling requirements (46.3% of those who
commented).
Most submitters demanding a stricter food-labelling regime were insistent that it
be comprehensive, detailing any use of genetic modification anywhere in the
production of that food. Many expressed dissatisfaction with the labelling regime
proposed by ANZFA, one individual, for instance, writing that "... the new
labelling laws announced by ANZFA (an organisation who has no non-industry
consumer representation) have favoured the Biotech Industry and Grocery
Manufacturers over the concerns and fears of the people who have to eat the food."
Public submitters wondered why New Zealand has delayed the implementation of
a labelling regime when other countries have had one in place for years.
Many submitters who preferred a total ban on genetically modified products also
expressed resignation that they could not keep genetic modification out of New
Zealand. They, therefore, insisted that, at the very least, a comprehensive labelling
regime must be installed.
The improvements to decision-making processes around genetic modification
suggested by public submitters were usually of a generic nature. Only 109
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Table 3.6
Improvements to legislation (n = 4259)
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Improvements to legislation
Number
%
Bar all GM or GM food/crops or specific uses
2469
57.9
More stringent labelling, particularly for GM food
1974
46.3
Increase prescription of procedures (fines, penalties and enforcement) 467
11.0
New organisational/institutional mechanisms required
192
4.5
Expand to include social, economic, and ethical considerations
153
3.6
Clarify principles, concepts and definitions
52
1.2
Improved protection of information and intellectual property
31
0.7
Allow greater procedural discretion
21
0.5
Provide appeal and review mechanisms, institutions and processes
21
0.5
Ban specific aspects of GM
19
0.4
Define liability
10
0.2
Increase consistency with key trading partners
7
0.2
Increase compatibility with international obligations
2
0.0
Other
94
2.2
The "Other" category included suggested improvements to HSNO Act and other legislation:
*
amending to increase restrictions
*
amending to decrease restrictions
*
repealing the new organism sections
*
retrospective application (re. Application A363 ­ Monsanto) after amendments
*
introducing strictest labelling requirements, covering any amount of genetic modification
*
removing any requirement for GM-labelling
*
withdrawing from ANZFA and replacing it with a New Zealand body
*
reviewing ANZFA assessment methods
*
gaining independence from international organisations and free trade agreements
*
repealing the Plant Variety Rights Act
*
amending the Biosecurity Act to exclude GM-biotechnology
*
following the EU stance on genetic modification.
Multiple response
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submitters commented on ERMA. However, most of these argued for more
attention to social and ethical considerations and increased independence. See
Table 3.7 for details of suggested improvements to ERMA, Table 3.8 for
improvements to decision-making processes.
For 310 submitters commenting on processes in general, their comments seemed
to be directed at ideal types rather than responding to known shortcomings of
current arrangements. The suggested establishment of an independent body was a
case in point. A small number of submitters suggested the setting up of an
independent, trustworthy organisation (defined as free from profit motive) that
would monitor, assess, and audit genetic modification experiments, trials and
genetically modified products to ensure their ethical, environmental and health
safety. However, there were also specific suggestions for changes to, or extensions
of, current legislation. For instance, in suggesting changes to the legislation to ban
specific aspects of genetic modification, submitters variously identified terminator
technology, antibiotic resistance marker genes, viable genetically modified
organisms, genetic modification of animals, patenting, experiments, commercial
uses and military uses as requiring total bans. Others suggested embedding liability
clauses in legislation to:
*
provide protection for non-genetic modification producers
*
establish an indemnity scheme for health risks
*
establish central (rather than regional) government responsibility for impacts
*
require public liability insurance and/or bonds for environmental protection
*
set a tax on genetically modified products.
Public submitters expressly asked for more principle-based processes. In particular,
given their concerns about the shortcomings of risk assessment, the potential
enormity of risks and the general lack of information about risks, they argued for a
precautionary approach to any decision-making.
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Improvements to ERMA
Number
%
Expand capacity on social, economic and ethical considerations
50
45.9
Increased independence
30
27.5
Clarify assessment criteria and/or method
24
22.0
Separating process from corporate control
20
18.3
Increase enforcement ­ heavier fines, penalties for non-compliance
19
17.4
Increase discretion over procedures
13
11.9
Increase Maori representation
1 1
1 0 . 1
Reduce costs
6
5.5
Other
16
14.7
The "Other" category included the following specific suggestions about ERMA:
*
legislating consideration of health, ecosystems, ethics, biodiversity, and public education, not only
economic matters in risk assessment
*
renewing, renaming, reorganising ERMA to focus on risk management
*
more diverse membership on ERMA
*
reduce time needed for approval.
Multiple response
Table 3.7
Improvements to ERMA (n = 109)
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Improvements to process
Number
%
Increase public consultation and participation
154
48.1
New organisational/instruction mechanisms required
113
35.3
Establish controls commensurate with risk
62
19.4
Case-by-case assessment
29
9.1
Increase consultation and participation of Maori
27
8.4
Provide appeal and review mechanisms
19
5.9
Establish an independent body
15
4.7
Delegate oversight of contained laboratory experiments
11
3.4
Improved protection of information and intellectual property
4
1.3
Industry undertakes regulation
3
0.9
Decrease public consultation and participation
3
0.9
Allow self-regulation through peer review processes
2
0.6
Delegate oversight of low-risk contained laboratory experiments
1
0.3
Other
12
3.8
The "Other" category included the following suggestions:
*
adopting the Precautionary Principle
*
directing government research funds to organic research and development
*
introducing a Genetic Bill of Rights / Protection from Genetic Discrimination
*
introducing a Code of Conduct
*
establishing a Ministry of Organic Production
*
establishing a Ministry for Genetic Modification.
Multiple response
Table 3.8
Improvements to process (n = 320)
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