Is glyphosate safe? We have the right to know!

Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes made this Freedom of Information request to European Food Safety Authority

Response to this request is delayed. By law, European Food Safety Authority should normally have responded promptly and by (details)

From: Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

Dear Bernhard Url, Executive Director of the European Food Safety Authority,

Under the right of access to documents in the EU treaties, as enshrined in Regulation 1049/2001 and in the Aarhus Regulation, we are requesting documents which contain the following information:

There is an alarming scientific controversy between the European Food Safety Agency (EFSA) and the International Agency for Research on Cancer of the World Health Organisation (IARC) with regard to the carcinogenicity of glyphosate. In March 2015, IARC concluded that glyphosate is a probable human carcinogen (category 2A) . However, later that same year, in November 2015, EFSA concluded that glyphosate is "unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential" .

Proper classification of glyphosate is crucial because it potentially affects public health and entails important regulatory consequences. It is therefore vital to investigate why there are contradictory results in the EFSA and IARC assessments. To date EFSA has explained that its "evaluation considered a large body of evidence, including a number of studies not assessed by the IARC which is one of the reasons for reaching different conclusions" (EFSA news story, 12 November 2015 - http://www.efsa.europa.eu/en/efsajournal...). This means that the EFSA peer review is based on unpublished studies whose findings cannot yet be verified and subjected to independent scrutiny.

The need to achieve clarity in this regard is both urgent and evident. Glyphosate is used in around 750 pesticides commercialised by 91 companies across the globe. According to data published by IARC, glyphosate is registered in "over 130 countries as of 2010 and is probably the most heavily used herbicide in the world." (https://monographs.iarc.fr/ENG/Monograph...)

The European Union is obliged to take decisions as openly as possible so that it contributes to strengthening the principles of democracy and respect for fundamental rights, and to ensure the protection of human health, which the EU is committed to ensure in all of its policies and activities.

Therefore we, members of the European Parliament, on the basis of regulation (EC) No 1049/2001 on public access to documents and regulation (EC) No 1367/2006 on the application of the provisions of the Århus Convention, request access to all documents that have been used during the EFSA peer review. Our request covers complete documents and not only their summaries, and extends also to the names of the authors and their declarations of conflicts of interests.

Respectfully,

Heidi Hautala
Member of the European Parliament
Greens/EFA

Benedek Jávor
Member of the European Parliament
Greens/EFA

Michèle Rivasi
Member of the European Parliament
Greens/EFA

Bart Staes
Member of the European Parliament
Greens/EFA

Postal address:
European Parliament
Rue Wiertz 60
B-1047 Brussels

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Sent request to European Food Safety Authority again.

From: EFSA.public.access.to.documents
European Food Safety Authority


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Attachment EFSA Ref.15451073 PAD 2016 034 Acknowledgement Your request of 15 March 2016.pdf
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Dear Honourable Members of the European Parliament, Mrs Rivasi, Mrs
Hautala and Mr Jávor,  

 

Please find attached the acknowledgement letter referenced 15451073 from
Mr Dirk Detken, the Head of the Legal and Regulatory Affairs Unit of EFSA.

 

Yours sincerely,

 

 

Mariama Mesnaoui

Public Access to document Team

Legal and Regulatory Affairs Unit

 

[1]Description: Description: Description:
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Via Carlo Magno 1A

I-43126 Parma
Italy

Tel. +39 0521036264  Fax: +39 05210360264
[2][email address
[3]www.efsa.europa.eu

[4]twitter.com/EFSA_EU [5]Description: Description: Description:
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[6]youtube.com/EFSAchannel [7]Description: Description: Description:
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This e-mail, including its attachments, is intended only for the use of
the recipient(s) named above. Unless you are a named recipient (or
authorised by a recipient), access to this e-mail message or any
disclosure or copying of its content, or any action taken in reliance on
it is unauthorised and may be unlawful.  If you are not the intended
recipient, please let the sender know immediately.

 

References

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7. http://www.google.it/url?q=http://common...

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From: Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

Dear Mr Dirk Detken,

Thank you for your acknowledgement of our request for access to documents. I would like to clarify two matters:
1. The request was sent under the access to documents Regulation 1049/2001 and the Aarhus Regulation whereas in your response you refer only to the former. Could you please confirm that you will apply both regulations?
2. The request is signed by 4 MEPs, Benedek Javor, Heidi Hautala and Bart Staes.

Many thanks in advance, best regards
Heidi Hautala, Benedek Jávor, Michèle Rivasi and Bart Staes

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From: EFSA.public.access.to.documents
European Food Safety Authority


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Dear Honourable Members of the European Parliament, Mrs Hautala, Mr Jávor,
Mrs Rivasi and Mr Staes,
 
Thank you for your e-mail of 17 March 2016, by means of which you
clarified your access request, registered with EFSA as PAD 2016/034.
Regarding your first point, we would like to ensure you that we fully
consider it in the process of assessing the accessibility of the requested
documents.
We hereby also acknowledge that your request was “signed by four Members
of the European Parliament, Heidi Hautala, Benedek Jávor, Michèle Rivasi
and Bart Staes”.
 
You will receive a reply to your request for access by 11 April 2016 at
the latest.
 
Yours sincerely,
 
Mariama Mesnaoui
Public Access to document Team
Legal and Regulatory Affairs Unit
 
 
Via Carlo Magno 1A
I-43126 Parma
Italy
Tel. +39 0521036264  Fax: +39 05210360264
[1][email address
[2]www.efsa.europa.eu
[3]twitter.com/EFSA_EU [4][IMG]
[5]youtube.com/EFSAchannel [6][IMG]
This e-mail, including its attachments, is intended only for the use of
the recipient(s) named above. Unless you are a named recipient (or
authorised by a recipient), access to this e-mail message or any
disclosure or copying of its content, or any action taken in reliance on
it is unauthorised and may be unlawful.  If you are not the intended
recipient, please let the sender know immediately.
 

References

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1. mailto:[email address]
2. http://www.efsa.europa.eu/
3. http://twitter.com/EFSA_EU
4. http://www.google.it/url?q=https://about...
5. http://youtube.com/EFSAchannel
6. http://www.google.it/url?q=http://common...

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From: EFSA.public.access.to.documents
European Food Safety Authority


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Attachment EFSA Ref.15557826 PAD 2016 034 Reply Your request of public access to documents of 15 March 2016.pdf
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Attachment Annex I.pdf
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Dear Honourable Members of the European Parliament, Mrs Hautala, Mr Jávor,
Mrs Rivasi and Mr Staes,

 

Please find attached the letter referenced 15557826 from Mr Dirk Detken,
the Head of the Legal and Regulatory Affairs Unit of EFSA.

 

Yours sincerely,

 

Mariama Mesnaoui

Public Access to document Team

Legal and Regulatory Affairs Unit

 

 

Via Carlo Magno 1A

I-43126 Parma
Italy

Tel. +39 0521036264  Fax: +39 05210360264
[1][email address
[2]www.efsa.europa.eu

[3]twitter.com/EFSA_EU [4][IMG]

[5]youtube.com/EFSAchannel [6][IMG]

This e-mail, including its attachments, is intended only for the use of
the recipient(s) named above. Unless you are a named recipient (or
authorised by a recipient), access to this e-mail message or any
disclosure or copying of its content, or any action taken in reliance on
it is unauthorised and may be unlawful.  If you are not the intended
recipient, please let the sender know immediately.

References

Visible links
1. mailto:[email address]
2. http://www.efsa.europa.eu/
3. http://twitter.com/EFSA_EU
4. http://www.google.it/url?q=https://about...
5. http://youtube.com/EFSAchannel
6. http://www.google.it/url?q=http://common...

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From: Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

Dear Mr Detken,

Many thanks for your response, dated 11 April 2016, to our access to documents request number PAD 2016/034 submitted originally on 15 March 2016.

In your response you ask us to narrow down the scope of the request in order for you to process it. You also make some points about data protection and provide some information in relation to that part of our request. Please consider this response a clarification of our request. We reserve the right to later make a confirmatory application in response to your official answer once our request has been narrowed, clarified and officially responded to following this clarification.

Narrowing the scope of our request with regard to the studies

We are prepared to limit the scope of our request. We would like to request access to all studies used by EFSA to assess carcinogenicity of glyphosate and its representative formulation in their entirety. This should include in particular the fourteen studies in rodents included in the joint submission dossier, including the raw data. Moreover, we would like to request access to all the historical control data used in that context, and in particular the historical control incidences for renal tumours and for haemangiosarcoma from the laboratories that performed the mouse carcinogenicity studies cited by EFSA. Finally, we would also like to request access to all studies that you assessed concerning mechanisms of carcinogenicity such as genotoxicity and oxidative stress in relation to glyphosate and its representative formulation in their entirety.

Clarifying the need to access personal data

We understand that our request for the names of the Member State representatives who were involved in the assessment of glyphosate needs to comply with the provisions of Regulation (EC) No 45/2001 on the protection of personal data. In the absence of a specific approval from the persons concerned, we would like to clarify in what way our request meets the other criteria for accessing personal data.

On the necessity of the transfer, we would like to clarify that having access to the names of the experts that are involved in the assessment of glyphosate, and to their declarations of interest, is essential if we are to be able to ensure their independence and impartiality. Indeed, some very serious questions have been raised about the accuracy of the assessment made by EFSA; particularly since the WHO's assessment resulted in the opposite conclusion: that glyphosate was a "probably carcinogenic to humans".

As regards the legitimate interests of the data subject, on this point the CJEU has ruled that if the necessity of data transfer is established, as we hope to have achieved above, then it would be "for the institution concerned to determine that there is no reason to assume that that transfer might prejudice the legitimate interests of the data subject".

We therefore await your response on this point, now that we have made the necessary clarifications.

Yours sincerely,

Heidi Hautala, Benedek Jávor, Michele Rivasi and Bart Staes
Members of the European Parliament

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From: Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

Dear Mariama Mesnaoui,

I am writing to ask when you plan to respond to this request? By our calculations the deadline for your response has already passed.

We look forward to receiving an update from you in a timely manner.

Many thanks, yours sincerely,

Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

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From: EFSA.public.access.to.documents
European Food Safety Authority

Dear Honourable Members of the European Parliament Mrs Hautala, Mr Jávor, Mrs Rivasi and Mr Staes,

Thank you very much for your reminder. To let you know that we are working on the matter in view of providing you with an update next Tuesday 31th May 2016 at the latest.

Yours sincerely,

Claus Reunis on behalf of Dirk Detken
Public Access to document Team
Legal and Regulatory Affairs Unit - EFSA

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Things to do with this request

Anyone:
Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes only:
European Food Safety Authority only: