Is glyphosate safe? We have the right to know!

Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes made this access to documents request to European Food Safety Authority

Response to this request is long overdue. By law, under all circumstances, European Food Safety Authority should have responded by now (details). You can complain by requesting an internal review.

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

Delivered

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 This means that the EFSA peer review is based on unpublished studies whose findings cannot yet be verified and subjected to independent scrutiny.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

Link to this

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

Delivered

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.
 

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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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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.

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

Delivered

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

Delivered

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


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Attachment EFSA Ref 15652304 PAD 2016 034 Your request of 15 March 2016.pdf
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Attachment PAD 2016 034 Enclosure.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 15652304 from Mr Dirk Detken,
the Head of the Legal and Regulatory Affairs Unit of EFSA.

 

Yours sincerely,

 

Lisa Margini

 

Public Access to document Team

Legal and Regulatory Affairs Unit

 

European Food Safety Authority (EFSA) 

Seat 08/B06

Via Carlo Magno 1/A
I-43126 Parma
Tel: +39 0521 036 823
Fax: +39 0521 036 0823

E-mail: [1][email address]

[2]Description: Description: cid:image001.png@01CA2FC5.DF65E460

 

The information in this email and any attachments is confidential and
intended solely for the use of the individual(s) to whom it is addressed
or otherwise directed.

If you are not a named addressee or otherwise an intended recipient, you
are requested to immediately notify the sender and to delete the email and
all attachments from your system. This communication does not constitute
any formal commitment on behalf of the European Food Safety Authority.

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

Delivered

Dear Mr Detken,

Thank you for your response dated 31 May 2016 to our clarification mail of 25 April 2016. You have now indicated that our request covers 82 studies with a total of approximately 100 000 to 300 000 pages. We can confirm that we seek full access to those 82 studies .

Unfortunately, it remains unclear to us whether we shall have access to these studies or not.

In addition, you did not respond to our request for access to the names of the Member State representatives that were involved in the assessment of glyphosate, despite the fact that we provided additional reasons to explain the necessity of the transfer of the personal data requested.

Please be aware that we cannot accept the “potential voluntary solution” of a physical reading room. Regulation (EC) No 1049/2001 does not foresee such an approach and we do not see how this could be a solution to a public access to documents request. Only public access will be adequate to allow for proper independent scientific review of those studies. Moreover, it would indicate that any decisions regarding commercial confidentiality in those studies would be left to the owners of the studies alone, which is not in line with the access to documents regulation, and which could create an inappropriate precedent.

We would therefore kindly like to request that you clarify within ten days whether or not we are entitled to have access to the requested documents and names of Member State representatives. Please also indicate how much time you consider that it might take you to process these studies with regard to checking whether they contain any issues referred to in the exceptions in the public access to documents and environmental information regulations or in Article 63 of Regulation (EC) No 1107/2009. As indicated by the public access to documents regulation, you only need to consult with the authors if it is not clear whether or not an exception actually applies.

If we do not hear from you within 10 days, we reserve the right to proceed to a confirmatory application in line with Article 7(4) of Regulation (EC) No 1049/2001.

Yours sincerely,
Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

PS. We fail to understand your calculation as to the numbers of pages concerned. You had indicated in your first response of 11 April that studies count from 500 to 1000 pages, and that the total of 1500 studies initially requested would amount to 700 000 to one million pages. We therefore fail to understand how the 6% to which we have reduced our request in terms of the number of studies should amount to 15-30% of the total volume of pages (100 000 - 300 000 pages).

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


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Attachment EFSA Ref.15872910 PAD 2016 034 Reply to your e mail of 10 June 2016.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 15872910 from Mr Dirk Detken,
the Head of the Legal and Regulatory Affairs Unit of EFSA.

 

Yours sincerely,

 

Lisa Margini

 

Public Access to document Team

Legal and Regulatory Affairs Unit

 

European Food Safety Authority (EFSA) 

Seat 08/B06

Via Carlo Magno 1/A
I-43126 Parma
Tel: +39 0521 036 823
Fax: +39 0521 036 0823

E-mail: [1][email address]

[2]Description: Description: cid:image001.png@01CA2FC5.DF65E460

 

The information in this email and any attachments is confidential and
intended solely for the use of the individual(s) to whom it is addressed
or otherwise directed.

If you are not a named addressee or otherwise an intended recipient, you
are requested to immediately notify the sender and to delete the email and
all attachments from your system. This communication does not constitute
any formal commitment on behalf of the European Food Safety Authority.

 

 

 

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

 

Further to my previous letter of 20 June 2016 related to your request for
the 82 studies submitted during the renewal assessment of the active
substance of glyphosate, I take the occasion to provide you with an update
on the consultation EFSA has launched in application of Article 4(4) of
Regulation (EC) No 1049/2001 and which was addressed to the Glyphosate
Task Force, representing the 24 companies who submitted the studies to
EFSA.

 

This is to inform you that we are still receiving replies by the
Glyphosate Task Force and individual companies which are members of the
Task Force. We started the screening of the incoming replies, in order to
provide you with a realistic time plan on the way forward with regard to
your pending request for the disclosure of the studies. With reference to
Article 6(3) of the PAD Regulation, you will receive a follow-up letter on
the status of your request by next Friday 15 July 2016.

 

As announced in my letter of 20 June 2016 we will provide you in the
meantime with the exchanges with the companies that submitted the studies
to EFSA by 12 July 2016.

 

Yours sincerely,

 

On behalf of Dirk Detken,

 

EFSA Public Access Team

Legal and Regulatory Affairs Unit

 

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Via Carlo Magno 1A

43126 Parma (Italy)

[2]www.efsa.europa.eu

[3]twitter.com/EFSA_EU [4]Description: Twitter_logo_blue

[5]youtube.com/EFSAchannel [6]Description: YouTube-logo-full_color

 

 

This e-mail and its attachments is intended for the recipient(s) named in
the message.  If you are not an intended recipient, please let the sender
know immediately. Any disclosure or copying of the message content is
unauthorised and may be unlawful if you are not the intended recipient.

 

 

 

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From: EFSA.public.access.to.documents
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Attachment EFSA Ref.15951962 PAD 2016 034 Disclosure Correspondence with companies owners of studies.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 15951962 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: cid:image001.jpg@01CF4F1E.E87FB350

 

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:
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[6]youtube.com/EFSAchannel [7]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
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Attachment EFSA Ref.15968079 Letter on the status of the consultations Your request of 15 March 2016.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 15968079 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:
cid:image001.jpg@01CF4F1E.E87FB350

 

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:
cid:image002.jpg@01CF4F1E.E87FB350

[6]youtube.com/EFSAchannel [7]Description: Description: Description:
cid:image003.jpg@01CF4F1E.E87FB350

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

Delivered

Dear Mariama Mesnaoui,

Thank you for your letter dated 15 July in which you provide an update of the status of our access to documents request filed on 15 March 2016. We look forward to receiving copies of the correspondence maintained so far with the authors of the studies by 3rd August, and also to receiving a final response to our request by 16 September 2016, once you have assessed the respective confidentiality claims.

We would like to take this opportunity to remind you that under Regulation 1049/2001 there is an overriding public interest test that would need to be conducted on the companies' confidentiality claims. This should be taken in conjunction with Regulation 1367/2006 on access to environmental information, which states that "an overriding public interest in disclosure shall be deemed to exist where the information requested relates to emissions into the environment."

We look forward to your final response in September.

Thank you in advance.

Yours sincerely,
Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

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

Delivered

Dear Mr Detken,

We have compared the list that you sent us on 31 May 2016 of the 182 studies that fall within the scope of our narrowed request with your correspondence with GTF Members that you shared with us on 12 July 2016, based on the confirmatory application by the NGO Corporate Europe Observatory.

In the list with the 182 studies, you have indicated that no data protection was claimed inter alia for studies 121, 134 and 154, and that these studies would thus be publicly available.

However, according to the correspondence with GTF Members that we have seen, the study owners claim confidentiality for the study 121 (Cheminova) and for the study 154 (Monsanto), respectively.

In addition, we could not find study 134 in the open literature – instead the JMPR in 2004 referred to it as "unpublished report" (see page 162).
http://apps.who.int/iris/bitstream/10665...

We are therefore writing to ask if you could please clarify the status of these three studies? If there is no data protection claimed for them as indicated in your list of 31 May, please let us know where we can have access to these studies.

Should data protection be claimed by the owners of these studies, as is manifest at least for studies 121 and 154 from your correspondence with Cheminova and Monsanto, we would like to ask you to carefully review your entire table with regard to the data protection claims of the 182 studies.

Many thanks in advance.

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 for your e-mail of 20 July 2016 by means of which you ask clarification on the information in the list of studies.
Please note that we will provide you with a complete answer together with our reply of 16 September 2016 at the latest.

Yours sincerely,

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

Public Access to document Team
Legal and Regulatory Affairs Unit

Via Carlo Magno 1A
I-43126 Parma
Italy
Tel. +39 0521036264 Fax: +39 05210360264
[email address]
www.efsa.europa.eu
twitter.com/EFSA_EU
youtube.com/EFSAchannel
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.

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


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Attachment EFSA Ref.16019503 PAD 2016 034 Disclosure Replies to EFSA consultation by study owners.pdf
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Attachment EFSA Ref.16019503 PAD 2016 034 Disclosure Enclosure 1.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 16019503 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:
cid:image001.jpg@01CF4F1E.E87FB350

 

Via Carlo Magno 1A

I-43126 Parma
Italy

Tel. +39 0521036264  Fax: +39 05210360264
[2][email address
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Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes left an annotation ()

EFSA promised to provide the four Greens/EFA MEPs with an update on this access to documents request by 16 September. Instead, they called one of our advisors (before the deadline) and asked for a meeting to explain to us their decision in person. Because our MEPs have a busy schedule, we only managed to find a date on 29 September, hence the delay. In theory, after the meeting on 29/09, we should expect a decision from EFSA on this request.

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


Attachment image001.png
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Attachment Out 16212018 PAD 2016 034 Letter to the MEPs 20.09.2016.pdf
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Attachment Enclosure to letter ref.1612018 letter from Monsanto and Helm AG.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 disclosure letter referenced 16212018 and its
enclosure from Mr Dirk Detken, the Head of the Legal and Regulatory
Affairs Unit of EFSA.

The original letter will follow by express courier.

Yours sincerely,

 

Lisa Margini

 

Public Access to document Team

Legal and Regulatory Affairs Unit

 

European Food Safety Authority (EFSA) 

Seat 08/B06

Via Carlo Magno 1/A
I-43126 Parma
Tel: +39 0521 036 823
Fax: +39 0521 036 0823

E-mail: [1][email address]

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

Delivered

Subject: Clarification letter on access to documents request, registered under number PAD 2016/034, filed on 15 March 2016

Dear Mr. Detken,

Many thanks for your letter, dated 7 October 2016, which we received on 12 October via email due to a delivery error caused by the fact that your response was initially sent to the wrong email address. We would like to thank you for updating the list of studies that fall under the scope of our request (subtracting eight due to publication, adding two), as well as clarifying our request of 20 July 2016.

In your letter you state that you will provide us partial access to the documents requested under Regulations 1049/2001 and 1367/2006 within 2 months, or by 9 December 2016. You also state that we have 15 working days from receipt of your letter to exercise our right to a confirmatory application. Since we received the letter on 12 October and Tuesday 1st and Wednesday 2nd November are not working days for the European Parliament, this means that the deadline contained in your letter would be Thursday 3rd November.

However, we are writing to respectfully request, in the spirit of Article 6(3) of the regulation on access to documents and with a view to finding a fair solution, that you clarify and confirm to us - in writing - that our right to file a confirmatory application will start running as of 9 December 2016, which is the deadline you have set for sending us the redacted documents, in application of Article 6(3).

We trust that you appreciate our inability to send a thorough and detailed confirmatory application until we have had the opportunity to see the redacted documents and to consult with the scientific community on the extent to which the partial access provided would allow for independent scientific scrutiny of those studies and the conclusions from the assessment process. Indeed, without seeing the redacted documents we cannot be sure of the extent to which our access to documents request has been satisfied, or not.

Of course, should the redacted documents be sent to us prior to 9 December 2016, the deadline would begin to run once we receive the documents requested, as is stipulated in the Regulation 1049/2001.

Pending your written confirmation of the deadlines which apply to our right to file a confirmatory application, we would like to make the following preliminary observations. We reserve the right to develop these comments further and/or modify them in our formal confirmatory application, which we hope you agree that we would send once we have received the redacted documents.

-----------------------------------------------------------
Preliminary Observations

We welcome your decision to grant us access to the raw data and findings (aggregated in tables and figures). However, we strongly believe that access to at least the following sections of the studies is crucial for a proper assessment of the raw data and findings:
1. “material, experimental conditions and methods” sections
2. “results and discussion” sections

We do not consider that these sections fall under Article 4(2) first indent of Regulation 1049/2001. Without prejudice to this consideration, in light of the high-level and yet unresolved controversy between EFSA and the International Agency for Research on Cancer of the World Health Organisation (IARC), we are convinced that there is clearly an overriding public interest in disclosure of studies that have been key for the assessment of glyphosate. Such disclosure is necessary to ensure public accountability of EFSA and to allow independent scrutiny of those studies and the conclusions from the assessment process.

In addition, we would like to let you know that we will be seeking further access to the declarations of interest of the Member State representatives, and to their names.
--------------------------------------------------------

We would like to kindly request you to provide us with a response to this clarification letter at your earliest convenience (please no later than 31 October at noon in light of the deadline you have set for a confirmatory application in your letter of 7 October).

We would like to thank you in advance for your cooperation.

With best regards,

Heidi Hautala, MEP,
Benedek Jávor, MEP,
Michèle Rivasi, MEP,
Bart Staes, MEP

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

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

Thank you for your message.
I confirm that it is also our understanding that you will be able to submit a confirmatory application against the EFSA decision taken in PAD 2016/034 in line with the applicable deadlines of Regulation 1049/2001 as of the 9th December 2016.

We also take note of your preliminary observations which, as you indicate, do not qualify as a confirmatory application at this stage.

Kind regards,

Public Access to Documents Team, on behalf of Mr Dirk Detken, the Head of the Legal and Regulatory Affairs Unit of EFSA

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