Dir 128 Full Risk Assessment and Risk Management Plan (rarmp)


Summary of submissions from the public



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  1. Summary of submissions from the public

The Regulator received 13 submissions from the public on the consultation RARMP. The issues raised in these submissions are summarised in the table below. All issues raised in the submissions that related to risks to the health and safety of people and the environment were considered in the context of currently available scientific evidence in finalising the RARMP that formed the basis of the Regulator’s decision to issue the licence.

Issues raised: AT: Alternative technology; C: containment, E: Environment; EC: Economic issues; GT: gene transfer; F: food; FL: food labelling; H: Health; L: liability; LC: Licence condition; M: Marketing; P: Pesticides; R: Research; RA: Risk analysis; S: Segregation.

Other abbreviations: Act: the Gene Technology Act 2000; APVMA: Australian Pesticides and Veterinary Medicines Authority; FSANZ: Food Standards Australia New Zealand; GM: Genetically modified; GMO: Genetically modified organism.

Sub. No:

Issue

Summary of issues raised


Comment

1

GT

When a similar "Trial" of GE Canola was undertaken, the researchers seemed to have no knowledge of "The Birds And The Bees". Cross-pollination occurred with 10,000Acres of normal canola.


GM crop field trials (‘limited and controlled releases’) licenced by the Regulator are subject to strict conditions to restrict the spread and persistence of the GMOs and their genetic material in the environment. Conditions imposed on this field trial include measures to minimise pollen transfer to non-GM wheat and barley crops by isolating the field trial by 200m from sexually compatible species. These measures have been effective in previous GM wheat and barley trials.

H

We have no idea about how ingestion of such abnormal proteins may induce aberrant immune responses, possibly inducing CJD-like human disease. What precautions are in place?

All the introduced genes are derived from plants and bacteria that are widespread and prevalent in the environment. Most of them are commonly consumed by people or people are naturally exposed to them. None of the introduced proteins are members of protein classes that are known to have members with toxic or allergenic properties. No GM material from the trial will enter the human food supply or be used for animal feed.

2

E, M, RA

The public does not want GMO crops or food grown in SA and hence that is why there is a moratorium in SA. However, the trials will go ahead due to corporate agribusiness pressure being applied to our governments and regulators, who are supposed to be there to protect people’s health and the environment. OGTR appears to be ‘a rubber stamp’, doing no independent testing of its own. Other countries have banned GMOs. We do not want our natural biodiversity contaminated with GM organisms.

States have the ability to introduce moratoria on growing GM crops for marketing and trade purposes, not for health and safety reasons. The Regulator is required to assess GMO applications in accordance with the Act, the object of which is to the protect the health and safety of people and the environment. Comprehensive RARMPs include a thorough and critical assessment of data supplied by the applicant, together with a review of other relevant national and international scientific literature. The RARMP concluded that risks to human health and safety of people, and to the environment, from this limited and controlled release of GM wheat and barley are negligible. Nevertheless, strict conditions have been imposed to restrict the spread and persistence of the GMOs and their genetic material in the environment.

AT

GM wheat and barley are not needed as there are excellent traditional varieties from which seed can be saved. If there was better food distribution, instead of mega profits for giant agribusiness then gene technology would not be needed.

These matters do not relate to risks to human health and safety and the environment and are outside the scope of assessments conducted by the Regulator.

3

GT

Concerned about wind mediated dispersal of GM pollen to any nearby wheat and barley crops and whether this could end up being a legal minefield for both the University and the federal government.

Licence conditions impose strict controls that minimise the potential for pollen transfer to non-GM wheat and barley crops due to wind by requiring an isolation distance of at least 200 metres. These measures have been effective in previous GM wheat and barley trials.

4

E, R

Objects to trials for yield before trials for ecological impact are exhaustively pursued.

The RARMP concluded that risks to human health and safety of people, and to the environment, from this limited and controlled release of GM wheat and barley are negligible. Data relating to ecological impacts would be required for a future application for a commercial release of any of these GMOs. Relevant data may be collected during this field trial.

5

GT

Controls should include not planting in area where organic wheat or barley is the surrounding crop even if outside 200m buffer zone.

Wheat and barley plants are predominately self-pollinating and most pollen falls within the first few metres. Review of the literature indicates that isolating the GM wheat and barley by at least 200m will effectively minimise the likelihood of pollen transfer to any nearby wheat and barley crops, including organic crops. These measures have been effective in previous GM wheat and barley trials.

6

F, AT, EC

Wants food to stay free from GMO. Other means of farming produce food just as nutritious. Wants open air trials and commercial cultivation banned and research on sustainable farming systems supported. GM crops are not accepted worldwide and countries buy Australian wheat because it is GM free.

These matters do relate to risk to human health and safety and the environment and are outside the scope of assessments conducted by the Regulator. Marketing and trade issues are the responsibility of States and industry.

GT

Because so many crops are wind-pollinated, it is almost impossible to keep areas GM free.

Licence conditions impose strict controls that minimise the potential for pollen transfer via wind to sexual compatible plants by requiring an isolation distance of at least 200 metres.

7

EC, AT

Australian governments must create a secure future for Australian wheat by adopting and implementing policies to: ban open air GM wheat field trials; reject commercial cultivation of GM wheat; and support research on sustainable farming systems.

Alternative agricultural practices and marketing and trade issues are outside the scope of assessments conducted by the Regulator. Marketing and trade issues are the responsibility of States and industry.

C, S

The GM wheat trials and commercialisation may contaminate conventional and organic wheat. This could occur at any point from seed to spoon via cross-pollination, misreading of labels, mistakes in handling, illegal planting, poor machinery cleaning, spillages and ineffective segregation.

The application is for a limited and controlled release (field trial). Strict licence conditions have been imposed to minimise spread and persistence of the GM wheat and barley. These include conditions to isolate trial sites from other wheat and barley crops, cleaning of equipment used with GM plant materials, secure transport and storage of GM plant materials, and post-harvest monitoring at trial sites to ensure all GM plants are destroyed.

EC

A GrainGrowers’ report [What the World Wants From Australian Wheat, 2011] states that wheat importers in SE Asia, north Asia, Middle East and Europe (which accounts to about 80% of exported Australian wheat) will not buy GM wheat now or in the foreseeable future. The report also states the domestic and feed millers do not believe Australian consumers would accept GM wheat. International food companies also reject foods with GM. GM commercialisation poses an unacceptable risk to the industry.

Marketing and trade issues are outside the scope of assessments conducted by the Regulator. These issues are the responsibility of States and industry.

8

-

Wants DIR 128 open air trial of GM wheat and barley in WA (and SA) rejected.




R, H, F

GM wheat is not grown anywhere in the world, and we in Australia do not want to be used for risky experimentation. GM products should be tested for safety and health impacts by an independent panel of experts before being put on the market. Findings should be made public.

The Regulator uses information provided by applicants as well as published scientific literature to assess GMO applications. The detailed RARMPs are publicly available on the OGTR website. This trial has limits on scale and duration, and has strict controls to minimise spread and persistence of the GM wheat and barley. The RARMP concluded that this trial poses negligible risks to the health and safety of people and the environment. Further information related to the potential for toxicity, allergenicity or weediness has been identified that may be required to assess an application for larger scale trials or commercial release of any of these GMOs. If any of the GMOs were proposed to be used in human food, FSANZ would conduct a pre-market safety assessment, which would also be subject to public consultation and made available on their website.

EC

There is a ban on the commercial growing of GM crops in WA and SA and this needs to be respected.

States have the ability to introduce moratoria on growing GM crops for marketing and trade purposes, not for health and safety reasons. The Regulator is required to assess GMO applications in accordance with the Act, the object of which is to protect the health and safety of people and the environment. People dealing with GMOs must comply with State requirements as well as conditions imposed by the Regulator.

FL

Consumers need the right to be able to choose GM free food. The current labelling laws are full of loopholes making it impossible to eat GM free, unless eating organic.

Labelling of GM foods is the responsibility of FSANZ.

P

GM crops are increasingly found to need more (not less) chemicals to grow. This has severe negative impacts on soil and water, our environment, human health and animal health.

Glyphosate resistant crops lead to glyphosate resistant weeds.



The regulation of agricultural chemicals, including herbicide resistance management, in Australia is the responsibility of APVMA. The APVMA will not register a chemical product unless satisfied that its approved use would not be likely to have an effect that is harmful to people or the environment.

S

Evidence from around the world shows there is a high risk that GM crops will contaminate conventional and organic varieties.

Cites recent case from WA Supreme Court (Marsh vs Baxter) case, and suspended imports due to unapproved GM wheat in Oregon, USA.



Marketing and trade issues, including matters relating to segregation and coexistence of different farming systems, are the responsibility of the States and industry, not the Regulator.

Note that the Marsh vs Baxter case, in which an organic farmer claimed damages from a neighbouring GM grower for loss of organic certification, related to commercially approved GM canola, not to GM material from any limited and controlled release authorised by the Regulator.

The current application is a limited and controlled release (field trial) of GM wheat and barley. Strict licence conditions have been imposed to restrict and spread and persistence of the GMOs. There has been no documented loss of containment from any field trial authorised by the Regulator.


EC

Raises similar issues as submission number 7 in relation to the GrainGrowers’ report.

See response to submission 7.

9

S, EC

Raises the same issues regarding the GrainGrowers report as in submission 7, and regarding GM crops contaminating conventional and organic varieties as in submission 8.

See relevant elements of responses to submissions 7 and 8.

10

C, S, EC

Wants DIR 128 open air trial of GM wheat and barley rejected.

The ban on the commercial growing of GM crops in WA and SA needs to be respected. No one gains anything from the GM crops, except for the GMO producing companies.

Concerned about the damage to organic wheat suppliers due to the possibility of contamination from GM crops. As there are only a handful of organic grain suppliers in WA, it is imperative that these trials are aborted as our industry cannot afford to lose any more suppliers as per the Steve Marsh case.


Marketing and trade issues, including matters relating to segregation and coexistence of different farming systems, are the responsibility of the States and industry, not the Regulator. States have the ability to introduce moratoria on growing GM crops for marketing and trade purposes. People dealing with GMOs must comply with State requirements as well as conditions imposed by the Regulator.

As noted in response to submission 8, the Marsh vs Baxter case related to commercially approved GM canola, not to GM material from any limited and controlled release authorised by the Regulator.



The current application is a limited and controlled release (field trial) of GM wheat and barley. Strict licence conditions have been imposed to restrict and spread and persistence of the GMOs.

M, L

Raises the same issues regarding the, GrianGrowers’ report as submission 7.

See responses to submission 7.




RA, E, H

GM products should be tested for safety and health impacts by an independent panel of experts before being put on the market. Findings should be made public.

The Regulator uses information provided by applicants as well as published scientific literature to assess GMO applications. The detailed RARMPs are publicly available on the OGTR website. This trial has limits on scale and duration, and has strict controls to minimise spread and persistence of the GM wheat and barley. The RARMP concluded that this trial poses negligible risks to the health and safety of people and the environment. Further information related to the potential for toxicity, allergenicity or weediness has been identified that may be required to assess an application for larger scale trials or commercial release of any of these GMOs. If any of the GMOs were proposed to be used in human food, FSANZ would conduct a pre-market safety assessment, which would also be subject to public consultation and made available on their website.

11

-

Objects to the approval of DIR 128 GM wheat and barley trial.




C, S

There have been documented examples of so-called ‘trials’ of GM crops contaminating the environment. Cites 3 examples: unapproved GM wheat in Oregon, USA (2013), GM rice in US (2006) and GM canola Topas 19/2 in Australia (2005).

Strict licence conditions have been imposed to restrict the spread and persistence of the GMOs in the environment, including isolation from sexually compatible species, and cleaning and post-harvest monitoring of trial sites. Similar conditions have been effective for other GM wheat and barley trials conducted in Australia.


EC

GM wheat and barley is not grown commercially anywhere in the world. Market rejection of GM wheat and barley means that no country wants to import it. Wheat is Australia’s most important agricultural commodity. Two thirds of our wheat is exported. Australia’s clean paddocks are being used for a GM experiment for which there is no market.

Marketing and trade issues are outside the scope of assessments conducted by the Regulator. These issues are the responsibility of States and industry.

RA

Given the past record of the OGTR in approving GM "trials", we have no expectation that the precautionary principle will prevail or that you will take our arguments into consideration.

As required by the Gene Technology Act, the Regulator has prepared a comprehensive RARMP, including a thorough and critical assessment of data supplied by the applicant, together with a review of other relevant national and international scientific literature. The risk assessment process, outlined in the OGTRs Risk Analysis Framework (April 2013. All comments received on the consultation RARMP that were relevant to health and safety of people and the environment were taken into consideration in finalising the RARMP and making a decision on issuing a licence. Information on how submissions have been considered is presented in the appendix. Strict licence conditions have been imposed on this field trial to restrict the spread and persistence of the GMOs and their genetic material in the environment.

H, E

The health and safety of people or the environment are not served by approval of experimental GM wheat and barley constructs into the open paddocks of Australia.

The RARMP concluded that this limited and controlled field trial poses negligible risks to the health and safety of people and the environment. Strict licence conditions have been imposed on this field trial to restrict the spread and persistence of the GMOs and their genetic material in the environment.

12

S, EC

There are many unresolved issues of liability and unacceptable risks associated with GM contamination worldwide. Current laws and regulations, surveillance and monitoring are inadequate to deal with segregation demands of different markets and public concerns over health and environmental safety. Cites Marsh vs Baxter case in WA. Calls for a freeze of new approvals of GM crops, including open-air trials until thorough testing.

Marketing and trade issues, including matters relating to segregation and coexistence of different farming systems, are the responsibility of the States and industry, not the Regulator. The RARMP concluded that this limited and controlled field trial poses negligible risks to the health and safety of people and the environment.

C

Who is responsible to the control and cleanup of the spread and spill of GM seed and crops as the GM industry is turning their backs on these problems? Escapes for GM trials have occurred and attempts to eradicate the resulting GM weeds post-trial is likely to continue for many years. Cites 2013 examples: unapproved GM wheat in Oregon, China intercepting and destroying shipments of GM corn and seed that attempted to bypass Chinese environmental and food safety tests, GM canola failing to germinate in WA and harm to pigs fed GM soy and GM corn. Also mentions trial sites in Tasmania that still have GM canola weeds after 10 years.

As this application is for a limited and controlled release (field trial), strict licence conditions have been imposed to restrict the spread and persistence of the GMOs and their genetic material in the environment. These include conditions to isolate trial sites from other wheat and barley crops, cleaning of equipment used with GM plant materials, secure transport and storage of GM plant materials, and post-harvest monitoring at trial sites to ensure all GM plants are destroyed. Similar conditions have been effective for other GM wheat and barley trials conducted in Australia.

M

The world has already rejected GM wheat from earlier attempts in the US and Canada in 2004 to commercialise it. People do not want to eat GM wheat & barley and Australia’s established markets must not be placed at avoidable risk.

Marketing and trade issues are outside the scope of assessments conducted by the Regulator. These issues are the responsibility of States and industry.

13

S, AT

Objects to the GM wheat and barley trials taking place in WA. Despite buffer zones around GM canola, even their property has been affected. Believes that GM is not the solution and that farming for children’s future and health is of great priority.

The RARMP concluded that this limited and controlled field trial poses negligible risks to the health and safety of people and the environment. Strict licence conditions have been imposed to restrict the spread and persistence of the GMOs and their genetic material in the environment.

Marketing and trade issues, including matters relating to segregation and coexistence of different farming systems, are the responsibility of the States and industry. They are not the responsibility of the Regulator.






2 The identities of some of the genes have been declared as Confidential Commercial Information (CCI) under section 185 of the Act.

3The term ‘line’ is used to denote plants derived from a single plant containing a specific genetic modification resulting from a single transformation event.

4< http://www.aphis.usda.gov/brs/status/relday.html>, accessed January 2014.

5 More detail on potential for unintended effects as a result of the process of genetic modification can be found in the document Methods of plant genetic modification available from the Risk Assessment References page on the OGTR website.

6 A more detailed discussion of uncertainty is contained in the Regulator’s Risk Analysis Framework available from the Risk Assessment References page on the OGTR website or via Free call 1800 181 030.

7 Prescribed agencies include GTTAC, State and Territory Governments, relevant local governments, Australian Government agencies and the Minister for the Environment.

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