ENVIRONMENTAL RISK MANAGEMENT AUTHORITY
DECISION
Date signed:
4 May 2004
Application code
REA04001
Application category
Grounds for reassessment of an organism under section 62 of the
Hazardous Substances and New Organisms (HSNO) Act 1996
Applicant
GE Free New Zealand in Food and Environment
Contact
Claire Bleakley
Purpose
Date request received
To request that the Authority decide whether there are grounds for
reassessment of the approval to field test onion (Allium cepa L.)
genetically modified by the CP4 EPSPS gene conferring tolerance to
the herbicide glyphosate (Application GMF03001)
17 February 2004
Consideration date
31 March-19 April 2004
Considered by
A Committee of the Genetically Modified Organism (GMO) Standing
Committee of the Environmental Risk Management Authority (the
Authority)
Decision
The Committee1 decided that there are no grounds for a reassessment of the approval to field
test in containment genetically modified onion (Approval GMF000040).
Purpose of the Request & Relevant Legislative Criteria
The Authority was requested to decide whether or not grounds exist for reassessing the
approval to field test in containment onion (Allium cepa L.) genetically modified by the CP4
EPSPS gene conferring tolerance to the herbicide glyphosate2 (the field test). The approval
was granted to Crop and Food Research Limited by a Special Committee of the Authority
(the Special Committee) on 18 December 2003 following a public hearing of the application
(GMF03001) on 3-5 November 2003.
1
A Committee of the Genetically Modified Organism (GMO) Standing Committee of the Environmental Risk
Management Authority, appointed to consider this application for Grounds for Reassessment.
2
The approval (GMF000040) relates to application code GMF03001.
The applicant3 proposed that grounds exist for reassessment of the decision to approve the
field test and, in support of this proposition, provided the information listed in the ERMA
New Zealand Evaluation and Review Report for REA04001 (E&R Report)4.
In accordance with section 62(2) of the HSNO Act, the Authority may decide that grounds
exist to reassess the approved organism if significant new information relating to the effects
of the organism has become available5, or information showing a significant change of use, or
a significant change in the quantity manufactured, imported, or developed has become
available.6
Application Process
Application receipt
The request for a decision that grounds exist for a reassessment of the field test (application
GMF03001) was formally received on 17 February 2004 under section 62 of the HSNO Act
1996. The receipt of a request for grounds for reassessment of an approval is not required to
be publicly notified.
Information available for consideration
The documents available to the Committee for the consideration of the request included:
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Application (Form 6) and supporting information7 from the applicant (received 17
February 2004).
Letter from the applicant containing further information received on 1 March 2004.
E&R Report for REA04001 prepared by ERMA New Zealand staff (the Agency) to
assist and support the Committee's decision-making.
Decision on application GMF03001 to field test in containment onion (Allium cepa
L.) genetically modified by the CP4 EPSPS gene conferring tolerance to the herbicide
glyphosate.
Decision path for determining grounds for reassessment for new organisms under
section 62 of the HSNO Act (source: ERMA New Zealand Protocol; Decision Paths).
Decision-Making Committee
The request was considered by a Committee of the GMO Standing Committee of the
Environmental Risk Management Authority (the Authority) appointed in accordance with
section 19(2)(b) of the HSNO Act (the Committee). The Committee comprised the following
3
GE Free New Zealand in Food and Environment.
4
Section 3 of the E&R Report pp3-4.
5
Section 62(2)(a) of the HSNO Act.
6
Section 62(2)(c) of the HSNO Act.
7
The full list of supporting papers is in the E&R Report at pages 3-4.
Environmental Risk Management Authority Decision: Application REA04001
Page 2 of 7
members: Professor Colin Mantell (Chair), Dr Lin Roberts, Dr Manuka Henare and Mr Neil
Walter.
Consideration
Consideration meetings were held on 31 March and 28 April 2004. The E&R Report was
provided to the Committee and to the applicant prior to the consideration. The Committee
extended to Claire Bleakley (for the applicant) a ten working day period in which to comment
on the content of the E&R Report. The Committee directed that this opportunity to comment
did not extend to the introduction of further supporting information. In response, the
applicant requested that the application be held at this stage pending the receipt of further
relevant information from various sources.
The Committee considered this request. However, it determined to proceed with the
consideration of this application for the reasons that further information supporting the
grounds alleged was not required in order to allow it to assess this application and to bring
resolution to these potential grounds. Where new information relevant to the approval
becomes available in the future the applicant may lodge another request for that new
information to be looked at notwithstanding the outcome of this request.
Evaluation
In considering the request for grounds for reassessment, the Committee took into account the
information provided (as listed above). Having read the application, the Committee identified
eleven potential grounds sought to be established by the applicant as listed in the E&R
Report8. These grounds were assessed individually against the criteria in section 62(2) of the
HSNO Act. The Committee adopted a wide interpretation of section 62 in reviewing the
information provided by the applicant and accordingly considered whether the information
was significant new information relating to the effects of the organism in terms of s62(2)(a)
of the HSNO Act and also whether the information disclosed any other grounds for
reassessment.
Ground 1:
The applicant asserts that the only benefit on which the Authority based their decision to
approve the field test GMF03001 was for a reduction in overall pesticide use. The applicant
has submitted information which it claims disputes the estimates of pesticide usage provided
during the assessment of GMF03001 and disputes benefits associated with a reduction in
pesticide usage.
The Committee considers that the evidence submitted by the applicant in support of ground 1
for reassessment does not meet the criteria set out in section 62(2)(a) of the Act on the basis
that the information does not represent significant new information relating to the effects of
the onion field test. The Committee notes that while the paper by the author Benbrook,
supplied by the applicant, was not directly considered in making the decision to approve the
field test, an earlier publication by the same author was taken into account during that
consideration. The decision to approve the application was not based on an expectation of
8
Section 4 of the E&R Report, pp 4-14.
Environmental Risk Management Authority Decision: Application REA04001
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reduced herbicide use. In its decision on application GMF03001, the Special Committee
identified considerable uncertainty attaching to the claim that genetically modified onions
would reduce herbicide use. This finding was based in part on the earlier work by Benbrook,
however, this more recent paper does not increase the available information about potential
herbicide reduction.
Ground 2:
The applicant asserts that all other scientific knowledge that could be obtained from the field
test could be obtained from other methods.
The Committee notes that the Special Committee did consider alternative methods of
achieving the research objectives in accordance with section 44A(2)(b) of the HSNO Act.
The Committee considers that the evidence submitted by the applicant in support of ground 2
for reassessment does not meet the criteria set out in section 62(2)(a) of the Act on the basis
that no significant new information relating to the effects of the onion field test were
submitted by the applicant, and further endorses the view stated in the decision on application
GMF03001 that potential New Zealand cultivars need to be field tested in New Zealand
conditions9.
Ground 3:
The applicant submitted a number of publications in support of its claim that there is
significant new information relating to the health effects of ingestion of genetically modified
foods by animals and humans associated with this field test of GM onions.
The Committee considers that the evidence submitted by the applicant in support of ground 3
for reassessment does not meet the criteria set out in section 62(2)(a) of the Act on the basis
that no significant new information relating to the health effects of the onion field test was
submitted by the applicant. The approval given for GMF03001 prohibits the commercial sale
and human consumption of the genetically modified onions10 and the supplied references did
not raise new information specifically on potential health effects of the EPSPS transgene in
any other food11, therefore the Committee does not consider the information to be relevant to
the approval of the field test. The Committee also noted that appropriate studies of potential
health effects of GM onions would be required for a future conditional release application.
Ground 4:
The applicant cited the recent scientific results from the United Kingdom Farm Scale
Evaluations of GM canola, maize and sugar beet as new information relating to the
environmental effects of the GM onion field test.
The Committee considers that the evidence submitted by the applicant in support of ground 4
for reassessment does not meet the criteria set out in section 62(2)(a) of the Act on the basis
9
Section 2.8.1.3 of the Decision for GMF03001 p37.
10
Control 5.4 of Decision for GMF03001 p48.
11
Section 4.24 of E&R Report on GMF03001 refers.
Environmental Risk Management Authority Decision: Application REA04001
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that no new information on the effects of the field test of GM onions on wildlife and the
environment has been presented. The Committee stresses that these papers (published prior to
the hearing of application GMF03001) were taken into account in the decision to approve the
field test and are specifically cited in the decision12.
Ground 5:
The applicant submitted a reference from Hartzler (2003) to support its claim that there is
new information relating to weed resistance and the number of weeds showing tolerance to
glyphosate.
The Committee considers that the evidence submitted by the applicant in support of ground 5
for reassessment does not meet the criteria set out in section 62(2)(a) of the Act on the basis
that no new information relating to the effects of the field test of GM onions has been
presented. It is noted that this information was presented in the public submissions on
application GMF03001.
Ground 6:
The applicant has presented internet news articles to support its claim that there is new
information suggesting that there are alternative methods of achieving the research objective
that have fewer adverse effects on human health and the environment than the field test.
The Committee considered that the internet news article from BioScience News & Advocate
(relating to concerns that conventional onion breeding programmes may be destroyed by
activists opposed to the field test) was new information but was not significant. The
information on alternative methods of growing onions was also relevant to some of the
original objectives of doing the research stated by Crop and Food Research Limited in their
application. However, the Committee find that this information is not significant in relation to
the effects of the approved onion field test because the objective is not simply to grow onions
with low or reduced herbicide usage, rather it is to assess the agronomic performance in New
Zealand field conditions of particular lines of genetically modified onions.
The Committee endorsed the view stated in the decision on application GMF03001 that there
were no alternative methods available to assess the performance of the GM onions in natural
weather and soil conditions other than by field testing. The Committee also considered that
the second field test objective, which is to provide a platform for environmental impact
research on GM crops, could not be done by methods other than field testing.
Ground 7:
The applicant questions the adequacy of containment for insects used to pollinate GM onions
and provided a report from Greenpeace Germany that mentions a study by Dr. Kaatz of HGT
occurring from GM canola pollen to microorganisms in the gut of honey bees.
The Committee considers that the evidence submitted by the applicant in support of ground 7
for reassessment does not meet the criteria set out in section 62(2)(a) of the Act on the basis
that no new information has been presented that is relevant to the onion field test approval.
12
Decision for GMF03001 p23.
Environmental Risk Management Authority Decision: Application REA04001
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This information is not relevant because no flowering (and no pollen) is involved in this field
test.
Ground 8:
The applicant would like to challenge the use of potatoes to follow the planting of GM onions
in the field test crop rotation on the basis of evidence provided in submission 5800 on
GMF03001, presented during the hearing for GMF03001, and that contained in a publication
from Meier & Wackernagel (2003). The essence of the claim is that gene flow from potatoes
could spread transgenic material from the onions outside of the field test site.
The Committee considers that while new, the information contained in the Meier &
Wackernagel (2003) publication is not significant to the effects of the onion field test. The
issue with which it deals (potential for gene flow) was exhaustively dealt with in the original
Evaluation and Review Report on application GMF03001 and adequately addressed in the
consideration of the field test. That consideration also took into account submission 5800 and
all of the evidence presented to the hearing, therefore there is no other new information
relating to this ground.
Ground 9:
The applicant has submitted a number of publications relating to the human health and
environmental effects of the herbicide glyphosate.
The Committee considers that the evidence submitted by the applicant in support of ground 9
for reassessment does not meet the criteria set out in section 62(2)(a) of the Act. This
information relates to the registration and use of glyphosate which may be relevant to a
release application. However, due to the small scale of the GM onion field test, the use of
glyphosate on the site of this field test will be insignificant in the context of overall current
glyphosate use in the New Zealand environment. Therefore, the Committee find no ground
for reassessment in this information.
Ground 10:
The applicant has submitted two publications relating to the evolution of new viruses by
recombination or by the use of viral promoter sequences.
The Committee considered that there had been extensive assessment of the issue which this
information raises in the original Evaluation and Review Report on application GMF03001
and that no significant information additional to that previously considered had been
presented. The Committee find no ground for reassessment in this information.
Ground 11:
The applicant submitted an excerpt which it attributes to the New Zealand Green Party which
criticises the Environmental Risk Management Authority.
The Committee considers that the evidence submitted by the applicant in support of ground
11 for reassessment is irrelevant to the effects of the onion field test and does not provide any
grounds for a reassessment in accordance with section 62 of the Act.
Environmental Risk Management Authority Decision: Application REA04001
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Overall evaluation
In accordance with section 62(2) of the HSNO Act the Committee has considered whether or
not grounds exist for a reassessment of the field test approval. Applying a wide interpretation
of the section, grounds other than those specified in paragraphs (a), (b) and (c) of the section
may be considered in addition to the specified grounds. Therefore, the Committee has
reviewed all of the information provided by the applicant, evaluated the request in relation to
all the statutory criteria in section 62(2) of the Act and considered whether other grounds may
exist, similar in character to those specified in that section, by discussing the relevance of the
matters raised to the effects of the field test.
In considering all of the information provided by the applicant, the Committee did not limit
itself to determining whether the grounds specified in section 62(2) of the HSNO Act could
be established but also considered whether the information disclosed any other grounds for
reassessment of the field test approval. None were found.
On the basis of the information presented by the applicant and the Evaluation and Review
Report prepared by the Agency, the Committee considers that no grounds have been shown
to exist for a reassessment of the approval to field test in containment onion (Allium cepa L.)
genetically modified by the CP4 EPSPS gene conferring tolerance to the herbicide
glyphosate. The Committee have found no significant new information relating to the effects
of the onion field test. While some new information has been provided, this was of little
relevance to the effects of the onion field test and was far from significant enough to be
material to the decision to approve the field test.
The Committee wish to make it clear that these matters, put forward by the applicant as
grounds for a reassessment of the approval, have been dealt with. While acknowledging that
the applicant has requested that action be held on the application pending receipt of further
information, the Committee holds the view that in light of the insubstantial nature of the
grounds claimed it seemed worthwhile to conclude this proceeding and to bring resolution to
these potential grounds. It is open for future requests for consideration of potential grounds
for reassessment to be made but these should be on the basis of significant new relevant
information becoming available.
The Committee note that most of the information supplied with this request was not new
information (i.e. the information had been available at, or prior to, the GMF03001 hearing).
The Committee’s view is that the grounds for reassessment provision in section 62 of the
HSNO Act should not be seen as an avenue for re-litigating ground that has been
exhaustively covered in the two months of consideration that was devoted to the GM onion
application.
It was unanimously decided that the request for establishing grounds for reassessment
(REA04001) under section 62 of the HSNO Act be declined.
_____________________
_______________
Professor Colin Mantell,
Date
Chair of Decision-Making Committee of the Authority
Environmental Risk Management Authority Decision: Application REA04001
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