Dear all,

I am circulating this very widely.  Please find attached our response to ACRE's consultation on guidance for the design of post-market monitoring plans for GM crops, which are a requirement of the new EC Deliberate Release Directive.  Feel free to send on.  We are very concerned at the explicit intention not to require monitoring of health effects or gene flow, though monitoring for environmental effects will be required.  Despite the importance of the issue, the reasons given for the first are utterly incredible (eg. that anecdotal reports of any health effects from workers involved in GM trials will suffice; no procedure is suggested even for this).  This will not meet the objectives of the Directive and clearly undermines Government's claims to a science based and responsible approach, and must be opposed.  To support monitoring and deal with any unexpected effects it is also important that a register of all GM crop locations is established and maintained.

Background and summary of the proposals
  - the replacement of Directive 90/220 by Directive 2001/18 in October 2002 introduced a new requirement for post-release monitoring plans to be submitted with all applications for commercial release of a GMO (Part C consent)
 - the objectives and general principles for monitoring are described in Annex VII to EC Directive 2001/18: to "confirm that any assumptions regarding the occurence and impact of potential adverse effects of the GMO or its use ... are correct,and identify the occurance of adverse effects ... on human health or that environment which were not anticipated".
- ACRE (Advisory Committee on Releases to the Environment) has developed these draft guidelines for companies.  It propose four categories of risk (I-IV).  It suggests that effects not identified in the risk assessment (IV) and effects arising from interractions between different GM crop releases (III) should be covered by 'general surveillance', rather than 'case-specific' monitoring, which seems reasonable.  However, risks identified in the risk assessment as worthy of monitoring (I) or having an extremely low liklihood of causing harm and for which there is a high degree of confidence (II) should be surveyed by 'case-specific monitoring'.
 - the company monitoring plans will have to identify which category of risk each part of the plan is addressing, the monitoring mechanism and frequency of reporting.  They should include mechanisms for responding to emergency situations.  The monitoring reports should be made public.

I hope you are able to influence these proposals.

Kind regards
Gundula Azeez
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Guidance on Post-market Monitoring
Soil Association Response to ACRE Consultation, August 2003

Summary

The draft guidance is inadequate in many ways.  In particular, there needs to be: monitoring of health effects.  The proposal to not require such monitoring and the reasons given are completely unacceptable the levels of gene flow to non-GM crops should be monitored in all cases. statements of the assumptions of the all potential effects of GM crops, quantified where possible, should be the foundation for the design of the plans and reports.
the plans should not be implemented by the companies but by DEFRA approved independent agents/organisations, and paid for by the consent holders.
a statutory, map-based, field-specific, public register of all GM crop locations must be introduced and maintained for a minimum of 5 years.

Comments on the proposals

1. Introduction
Thank you for the opportunity to comment on this guidance.  The Soil Association is the main certifier and promoter of organic food and farming in the UK.  Organic farming is based on natural processes and designed to avoid potential risk factors; it has a range of proven environmental benefits.  GMOs are prohibited as they contradict the organic movementís principles for safe and sustainable agriculture. Organic farming now accounts for c. 4.5% of UK farmland and purchases of some organic food are made by about 80% of UK consumers. The Soil Association also opposes the general introduction of GM crops as it is concerned about the potential negative impacts that they could have on the environment, health, the viability of non-GM food and consumer choice. 

2.  Scope of post-release monitoring ñ health effects and gene flow We are astonished that there no proposals to monitor health effects. The reasons given in paragraph 1.5 are completely unacceptable and such a proposition is probably illegal. There is absolutely no reason to take environmental effects seriously, but disregard health effects especially as they have been one of the central concerns in the public opposition to GM foods. 

As the objective of post-release monitoring, according to EC Directive 2001/18, is to test assumptions, it is ridiculous to refer back to the assessments made at the approval stage, especially as these been heavily criticised.  By suggesting that the Government can rely on anecdotal reports from workers exposed to GM crops rather than any systematic monitoring is to trivialise this important issue, and completely undermines the Governmentís claims of taking a science-based approach to GMOs.  It is also ridiculous and ignorant to refer to the lack of reported adverse effects elsewhere, as there has been no monitoring of the health effects in North America or elsewhere, no establishment of the cause of the L-tryptophan GM food supplement disaster, or any investigation of the negative effects uncovered in the few animals feeding trials (Flavr Savr tomato, Puzstaiís work on GM potatoes etc.), and the Government should know this.  The Government must introduce strict health monitoring requirements or it will be making a major political mistake.

( strict monitoring requirements for health effects must be introduced

Another category of effects which must be monitored in all cases are the levels of gene flow to other crops.  This is another surprising omission.   Although, we would hope that gene flow would be monitored in most cases anyway for direct environmental and health reasons, the guidance does not require that gene flow must always be monitored.  In fact para 3.9 suggests that monitoring gene flow is only necessary to investigate particular effects from gene flow which does not allow for the fact that these plans are about testing assumptions.

Information on gene flow to non-GM crops will be very important if unexpected problems emerge.  In addition, monitoring gene flow is important for supporting the maintenance of non-GM food supplies to ensure valid comparisons can be made with the effects of GM crops; to ensure the protection from contamination of organic farming which has proven public benefits and would be undermined if contamination occurred; and to ensure alternative food sources remain should problems emerge.  To support the monitoring of gene flow it is very important that a statutory register of all GM crop locations is maintained and that the GM event data and samples are available for testing  - see comments on practicalities.

( the guidance must make it clear that the levels of gene flow to non-GM crops should be monitored in all cases.

 Principles for extent of the monitoring
We are concerned about the statement in para. 2.3 that the plans should be ìproportionate to the perceived risks identified in the environmental risk assessmentî.  This conflicts with the objective that the plans should be testing the assumptions, ie. test the perceived safety.  The risks are presumably perceived as none or very limited, otherwise the GMOs would not have been approved.

( in para 2.3, the statement that plans must be proportionate to the perceived risks should be changed.

We are concerned about the suggestion in para 3.7 that ìevents which are considered to be extremely unlikely, or to have minimal impact should they occur are thus not prime candidates for monitoringî.  This should be amended to make it clear that companies cannot make their own judgements on this; effects should only fall into this category where they have been so identified by the regulatory bodies and where there is good scientific proof which is accepted by public interest organisations.  Otherwise, as the objective of the plans is that the assumptions should be tested, such effects should be properly monitored.

( para 3.7 should be amended to ensure that only those effects assessed as unlikely/of minimal impact by regulatory bodies and on the basis of scientific proof which is accepted by public interest organisations are considered low priorities for monitoring

To address the concerns of environmental and health organisations such as the Soil Association which have been opposing GM crops, we would like the Government to specifically ensure that the main concerns raised in the past or in the future by such organisations are specifically addressed and as a matter of priority (even if they have been assessed as low priorities by the regulatory bodies and companies).

(  a new requirement should be added to ensure that there is monitoring of effects which have been raised as key concerns by groups concerned about GM crops

 Division between case-specific and general surveillance monitoring The proposal that category I and II risks be covered by case-specific monitoring and that category III and IV risks by general surveillance, seems too rigid.  This may be inappropriate for certain cases and is likely to work out as very inefficient. Some category II risks, for example, may be common to many GM crops, such as (?) the possibility of new allergies or animal/plant/human viruses.  It would appear to be more appropriate and efficient to use a general surveillance mechanism to cover common or similar effects in several crops than require separate monitoring of the effects each GM variety.  We agree that general surveillance is needed to monitor for the effects of interactions between releases and also for unanticipated effects.

( the statement in 2.6 that category I and II risks can be considered case-specific needs reconsidering.

5.  Assumptions being tested
It is very important that every single assumption about the effects on the environment, safety and gene flow are clearly stated and that the plan is designed to test all of these.  Although this is referred to in 3.1 and 3.11, this point needs to be made distinctly and much more strongly, and repeated in the section on general surveillance. Statements of the assumptions of the effects, quantified where possible, should be the foundation for the design of the monitoring and reports. For example, we would want to see the assumptions on the distances pollen travels by wind and insects, the precise positional effects of the inserted gene, and the actual/presumed level and fate of horizontal gene transfer to gut bacteria to be stated, among others.

( statements of the assumptions of the all potential effects, quantified where possible, should be central to the plans and reports.

Case-specific monitoring - side-effects
It is very important that case-specific monitoring is not limited to the effects of the introduced trait, as suggested by the guidance, but also covers the positional effects of the inserted gene, ie. the effects on other genes, and also the side-effects of the new gene on other biochemical pathways.  No mention is made of these very important points in the current draft.

( the guidance must require statements and testing of the assumptions on positional effects and side-effects of the gene on other biochemical pathways.

7.  Provision for anecdotal reporting
It is important that in addition to the planned systematic reporting the plans contain provisions for including information from anecdotal reports, and regular reports are followed up.  This could prove to be an important source of information, and it is important that a system is in place to follow up concerns, which has not been the case in North America.  This will require the companies to release GM event data and samples for testing which we understand many are not doing at the moment.

( there must be provision for responding to anecdotal reports of effects

 General comment on the draft guidance
The draft is much more general and vague in tone than we expected and we feel this is a weakness.  As the companies will have no incentive to undertake monitoring on a level that the public would wish and will seek to do the minimum possible, the Government should dictate much more clearly the extent and level of monitoring it expects.  This would also ensure consistency between the plans from different companies. (The guidance should provide a list of all the effects that that the companies should be monitoring such as: gene flow, allergies, new viruses, horizontal gene transfer in all cases; resistant volunteers with all herbicide resistant GM crops. etc.)  There should be more guidance on the appropriate mechanisms for different effects.  There also needs to be more information on existing general surveillance mechanisms, such as those for human and animal health effects.  It is not clear at the moment how trends in these will be monitored.

( the various effects that should be monitored should be listed
( there should be guidance on suitable monitoring mechanisms  for different effects
( there should be information on general surveillance mechanisms covering human and animal health effects

Practical implementation of the plans
There are a number of important practical issues that need addressing or strengthening.  It is inappropriate to leave the appointment of the researchers to the companies.  Post-release monitoring will have a very important health, environmental, economic and political role and the information gathered must be independent, reliable and credible.  All monitoring should be carried out by DEFRA approved organisations, not the companies, but paid for by the consent holders.

( the plans should not be implemented by the companies but by DEFRA approved independent agents/organisations, and paid for by the consent holders.

There needs to be greater public involvement in the plans.  The draft plans should be made available for public comment before they are accepted, and the final information must be easily accessiable to the public, such as on the internet.

( the draft plans must be made available for public comment before being accepted, and the final plans put on the internet.

To support the monitoring of gene flow for environmental/health reasons, to support the anecdotal reporting of effects, and to tie-in with the need to control contamination for co-existence reasons, it is very important that a map-based, field-specific, statutory register of GM crops locations is introduced and maintained for at least 5 years (we recommend 30 years to cover the long viability of oilseed rape in the seed bank).  This must be publicly accessible.

( a statutory, map-based, field-specific, public register of all GM crop locations must be introduced and maintained for a minimum of 5 years.