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

Waiting for an internal review by European Food Safety Authority of their handling of this request.

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 This means that the EFSA peer review is based on unpublished studies whose findings cannot yet be verified and subjected to independent scrutiny.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

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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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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:
cid:image002.jpg@01CF4F1E.E87FB350

[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
authorised by a recipient), access to this e-mail message or any
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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
[3]www.efsa.europa.eu

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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


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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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If you are not a named addressee or otherwise an intended recipient, you
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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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From: Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

Delivered

Dear EFSA,

Many thanks for your letter dated 9 December, and for the CD containing partially redacted documents which we received on Tuesday 13th December. Whilst we review the documents received, we wanted to clarify the deadline for filing a confirmatory application with you.

By our calculations, given that the European Parliament is closed from 23/12 to 02/01/17 inclusive, a 15 working day deadline would mean that we have until Thursday 12/01/17 if we were to send you a confirmatory application.

Could you kindly confirm this deadline in writing?

Many thanks in advance.

Yours sincerely,

Heidi Hautala, Benedek Jávor, Michele 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, Ms Hautala, Ms Rivasi,
Mr Jávor, Mr Staes,

 

Thank you for your message. We hereby confirm your calculations.

 

Yours sincerely,

 

EFSA Public Access to Documents

Legal and Regulatory Affairs Unit

 

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the message.  If you are not an intended recipient, please let the sender
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From: Andreas Pavlou


Attachment Out 16421634 PAD 2016 034 Disclosure Your request of of 15 03 2016.pdf
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[SENT ON 9 DECEMBER 2016 – UPLOADED ONTO ASKTHEEU.ORG ON 21 DECEMBER 2016]

--------------------------------------------------------------------------

Van: EFSA.public.access.to.documents
[[1][email address]]
Verzonden: vrijdag 9 december 2016 18:17
Aan: HAUTALA Heidi; JÁVOR Benedek; RIVASI Michèle; STAES Bart
Onderwerp: PAD 2016/034_Disclosure_ Your request of 15 March 2016

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

 

Please find attached the disclosure letter referenced 16421634 from Mr
Dirk Detken, the Head of the Legal and Regulatory Affairs Unit of EFSA.

The enclosure will follow by express courier.
I wish you a good reception of these documents.

Yours sincerely,

 

 

 

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: [2][email address]

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AsktheEU Admin left an annotation ()

The CD with the scientific reports was sent to the requesters directly with the above letter, but has yet to be uploaded to the AsktheEU.org website.

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

Delivered

Dear EFSA,

Please find bellow our confirmatory application as sent to you my email on 10th January.
We would also like to thank Mr Dirk for his written acknowledgement of the receipt of our confirmatory application.

Yours sincerely,

Heidi Hautala, Benedek Javor, Michele Rivasi and Bart Staes

Brussels, 10 January 2017

Re: Our request for public access to documents of 15 March 2016 (Ref.: PAD 2016/034) – confirmatory application

Dear Mr. Detken,

We thank you for your letter of 7 October 2016, which we received on 11 October 2016, in which you inform us of your decision concerning our request for public access to unpublished studies on the genotoxicity and carcinogenicity of glyphosate, the herbicide. We received your letter dated 9th December and later received CDs with the documents on Tuesday 13th December. You have decided to grant us partial access to 75 unpublished studies used for the glyphosate review.

Herewith, we would like to submit a confirmatory application in accordance with Article 7(2) of Regulation (EC) No 1049/2001 (hereafter referred to as “PAD Regulation”). While we welcome your decision to grant us access to the raw data and findings (aggregated in tables and figures), and while we welcome that you recognize the motivation behind our request, namely to allow for independent scrutiny of key studies used by EFSA and Member States in their assessment of glyphosate, you continue to withhold sections of the studies that in our view are crucial for an independent assessment.

1. Access to “material, experimental conditions and methods” as well as “results and discussion”

Concretely, we request that you also release the following sections of the 75 unpublished studies: “material, experimental conditions and methods” as well as “results and discussion”, as these sections contain elements that are at the core of the controversy around whether or not glyphosate should be classified as a probable carcinogen. A proper independent scrutiny is not possible without these sections.

Access to these parts is necessary to be able, inter alia:
to know about the chemical purity of the tested substance,
to assess whether the statistical method most appropriate for the analysis of the results was established before commencing the study (included in the materials and methods section),
to assess the origin of the animals used, as this relates to the controversial issue of historical controls (included in the materials and methods section),
to have access to the pathology report, so as to be able to verify potentially speculative claims with regard to viral infections, to check whether the evaluation of observed tumour incidences was done correctly, and to see whether a peer review was done by a second pathologist (pathology report included in the results section)
to check the validity of dismissals based on "excessive toxic effects" (included in the discussion section).

For more details, please see the Annex.

You argued in your decision that these sections should not be disclosed in order to protect the economic investment of the study owners. However, we consider that any valid economic interests by the study owners would already be sufficiently protected by the non-disclosure of the appendixes and other administrative data, which you refer to in your letter of 7 October 2016 as “the credentials that give the raw data its specific value in the context of regulatory market authorisation”.

We would like to clarify that the parts of the studies bearing the regulatory certification by dedicated laboratories and including the statement of Good Laboratory Practice (GLP) compliance should also be made available. Indeed, under Article 4(4) of Directive 2004/9/EC on GLP, "The names of laboratories subject to inspection by a designated authority, their GLP compliance status and the dates upon which laboratory inspections or study audits have been conducted shall not be considered to be confidential."

We can accept that you will not grant access to information related to the “methods” sections insofar as it is demonstrated to be covered by Article 63(2) of Regulation (EC) No 1107/2009. However, that Article only refers to “the method of manufacture” (point a) and “methods of analysis for impurities in the active substances as manufactures except for methods for impurities that are considered to be toxicologically, ecotoxicologically or environmentally relevant” (point d).

In other words, the legislator explicitly excluded methods for analysis of toxicologically relevant impurities from the methods for analysis of impurities that are normally deemed to undermine the protection of the commercial interests. By analogy, it is clear that methods for the analysis of the active substance itself, which undoubtedly is toxicologically relevant, are also not normally deemed to undermine the protection of the commercial interests.

We would like to remind you that, according to the case-law of the ECJ, the exceptions in Article 4 of the Regulation must be interpreted strictly. It is also settled in the case-law that if an institution refuses access it must explain how disclosure of the document could specifically and actually undermine the interest protected by the exception. Moreover, the risk of that interest being undermined must be reasonably foreseeable and must not be purely hypothetical. It should also be noted that the requested documents contain “environmental information” within the meaning of Regulation No 1367/2006 (the “Aarhus Regulation”). Article 6(1) of the Aarhus Regulation states that the exceptions in Article 4 must be interpreted strictly, and that the application of these exceptions must take into account the public interest served by disclosure.

Therefore, we do not agree with your claim that “the PAD Regulation has an erga omnes effect, which means that it is presumed competitors will obtain and exploit the studies for their own commercial advantage, particularly with a view of producing that substance and obtaining authorisations to market that substance on different markets within or outside the EU.” On the contrary, except for the information contained in Article 63(2) of Regulation 1107/2009/EC, there is no presumption that the commercial interests of the study owners will be undermined by disclosure. EFSA must carry out an individual examination of each document and demonstrate a serious risk that is reasonably foreseeable and not purely hypothetical. EFSA has not discharged its duty in this regard, particularly in relation to the information in the “material, experimental conditions and methods” and “results and discussion” sections.

2. Access to names of the Member State experts and their declarations of conflicts of interests

The PAD Regulation contains an exception specifically to protect the “privacy and the integrity of the individual, in particular in accordance with Community legislation regarding the protection of personal data”. The jurisprudence developed by the European Court of Justice has established that the conditions of Regulation 45/2001 on the protection of personal data need to be fulfilled.

Article 8 of Regulation 45/2001 states that, in the absence of specific consent from the data subject, personal data shall only be transferred “if the recipient establishes the necessity of having the data transferred and if there is no reason to assume that the data subject’s legitimate interests might be prejudiced.”

In accordance with the jurisprudence of the European Court of Justice, summarized in paragraph 47 of Case C-615/13 P, whoever requests such a transfer must first establish that it is necessary. If it is demonstrated to be necessary, it is then for the institution concerned to determine whether there is a compelling reason to assume that that transfer might prejudice the legitimate interests of the data subject. If there is no such reason, the transfer requested must be made. If, to the contrary, EFSA determines that there is such as reason, then the various competing interests must be weighed against each other.

When it comes to the necessity of transfer, the EU Food Safety Authority has been accused of partiality in its assessment process due not only to the reliance on non-published studies produced by the same actors that have an interest in getting their products approved, but due to the potential that the experts involved in the assessment have links with industry lobbies that can lead to potential conflicts of interest.

Whilst the experts are nominated by the Member States concerned, the necessity of establishing that there is no potential for a conflict of interest is essential if citizens, EU decision-makers, elected Members of the European Parliament and NGOs and companies alike are able to be sure that the decision-making process is impartial. This was held to be the case in Case C-615/13 P Client Earth v EFSA, where the Court of Justice held that disclosure of the names of the experts who commented on an EFSA draft guidance document was necessary “so that the impartiality of each of those experts in carrying out their tasks as scientists in the service of EFSA could be specifically ascertained.”

Indeed, as the court has already held in, inter alia, Sweden and Turco v Council (C-39/05 P and C-52/05 P), Sweden v MyTravel and Commission (C-506/08 P), Council v Access Info Europe (C-280/11 P), and Council v in 't Veld (C-350/12 P), the transparency of the decision-making process followed by public authorities contributes to that authority acquiring greater legitimacy and leads to an increase in confidence in that authority due to the fact that the authority then becomes more accountable to citizens in a democratic system.

Transparency of the names and declarations of interest of these experts is therefore essential to specifically ascertain their independence and impartiality and so we can be sure that they are thoroughly assessing each of the studies submitted to them.

To date, you have not established reasoning as to why the legitimate interests of the data subjects might be prejudiced by the publication of their names.

Nevertheless, in the event that you decide that the names of the Member State experts should not be provided to us, we believe that the declarations of interest should still be made available (or partially available), but with the personal data removed in line with the regulation so that they are no longer identifiable “directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his or her physical, physiological, mental, economic, cultural or social identity”.

3. Overriding public interest with regard to the exception of Article 4(2), first indent, of the PAD Regulation concerning the “commercial interests of natural and legal person, including intellectual property”

In case you decide to maintain your decision despite our arguments under Point 1 above, we consider that there is a clear overriding public interest in disclosure of the information on material, experimental conditions and methods, as well as results and discussion.

a) The need to disclose the scientific evidence related to a far-reaching regulatory decision
Glyphosate is the world’s most widely used herbicide. The global use of glyphosate has increased dramatically, by a factor of 260, in the last 40 years (from 3 200 tonnes in 1974 to 825 000 tonnes in 2014)1. Whether or not this substance is carcinogenic is therefore of very high public interest.
Proper classification of glyphosate is of paramount importance, as a classification as carcinogenic category 1A or 1B would lead to concrete regulatory consequences under EU legislation, namely that glyphosate could no longer be approved (unless two very specific and narrow derogations apply).
According to Article 4(1) of Regulation (EC) No 1107/2009, “An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.
The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied.”
Point 3.6.3. of Annex II of that Regulation sets out the following:

“An active substance, safener or synergist shall only be approved, if, on the basis of assessment of carcinogenicity testing carried out in accordance with the data requirements for the active substances, safener or synergist and other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not or has not to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with Article 18(1)(b) of Regulation (EC) No 396/2005.”
The EFSA conclusion on the peer review is a key basis for the Commission decision on the renewal of the approval of glyphosate. According to Article 14(2) of Regulation (EC) No 1107/2009, a renewal may be granted for up to 15 years. As indicated in the Annex, EFSA has stated publicly that “unpublished studies that were the core basis of the peer review evaluation were not available to the IARC experts”.
We are deeply concerned that a far-reaching decision such as the renewal of the approval of the world’s most widely used herbicide for 15 years should be based on unpublished studies, particularly in light of the diverging conclusion by IARC with regard to the classification of glyphosate.
Several provisions of the EU Treaties, namely Article 11 TEU and 15 TFEU, require the European Union 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 and the environment, which the EU is committed to ensure in all of its policies and activities.
The formal classification process is ongoing at the European Chemicals Agency. To ensure public accountability and credibility of this process, in addition to the peer review by EFSA, it is vital to allow for full public scrutiny of unpublished studies on carcinogenicity and genotoxicity. This requires not only the release of raw data and aggregated findings, but also access to the sections on material, experimental conditions and methods, as well as on results and discussion.

b) The application of possible risk mitigation measures and of toxicological reference values cannot compensate for a controversial classification

You argue that the public interest cannot be presumed overriding over the reasons justifying the refusal of the parts of the documents not disclosed as EFSA concluded that the high level of protection required under Regulation (EC) No 1107/2009 could be achieved through the application of available risk mitigation measures, and that the toxicological reference values proposed by EFSA would offer a sufficient margin of exposure. However, this is based on the controversial conclusion by EFSA that “glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008”. If however glyphosate was to be classified as carcinogenic category 1A or 1B, your argument would no longer be valid, as the regulatory consequences would be triggered irrespective of possible risk mitigation measures.

c) Assessment by JMPR not a valid contradictory assessment

You also argue that an additional contradictory assessment of EFSA’s peer review was already done by other bodies such as the Joint FAO/WHO meeting on pesticides (JMPR), implying that another assessment would not really be necessary, all the more that according to you, the JMPR “reached a conclusion in line with the EFSA assessment on glyphosate carcinogenicity”. We shall refrain from any comments with regard to possible conflicts of interest of key members of the JMPR2. The JMPR adopted the conclusion “that glyphosate is unlikely to pose a carcinogenic risk to humans from exposure through the diet”. However, in the context of Regulation (EC) No 1107/2009, it is the classification of an active substance, safener or synergist as carcinogenic that a priori triggers non-approval. And classification according to Regulation (EC) No 1272/2008 is hazard-based, and not risk-based. In other words, a conclusion on the specific likeliness of the carcinogenic risk of glyphosate to humans from exposure specifically through the diet, valid or not, is not relevant for the general assessment that needs to be done pursuant to Article 4(1) and Annex II, point 3.6.3. of Regulation (EC) No 1107/2009 with regard to the classification of glyphosate.

d) Key public actors and public institutions call for publication of the studies and/or refer to an overriding public
To further illustrate why we consider that there is an overriding public interest, we would like to refer to:
the letter of Commissioner Andriukaitis of 4 April 2016 to Richard Garnett, Chairman of the Glyphosate Task Force, in which he wrote the following3: “This is a particularly sensitive and complex case and there is consequently a strong public request for full transparency on the studies used by EFSA for the assessment of the carcinogenicity of the substance. For this reason, I believe that the proactive publication by the Glyphosate Task Force of the full studies including the underlying raw data would be beneficiai [sic] for the society as a whole and would facilitate the ongoing discussions and the decision-making process.”
the resolution of the European Parliament of 13 April 2016 on the “Renewal of the approval of the active substance glyphosate”, which includes the following call on the Commission4: “Calls on the Commission and on EFSA to disclose immediately all the scientific evidence that has been the basis for the positive classification of glyphosate and the proposed re-authorisation, given the overriding public interest in disclosure”;
the Special Rapporteur of the Human Rights Council on the implications for human rights of the environmentally sound management and disposal of hazardous substances and wastes, stated the following on 14 September 2016 in the context of his mission to Germany5: “The Special Rapporteur notes that, under international law, health and safety information about toxic chemicals should never be confidential.”
e) Aarhus Convention and the overriding public interest where information relates to emissions into the environment

Article 6(1) of the Aarhus Regulation lays down a legal presumption that an overriding public interest in disclosure exists where the information requested relates to emissions into the environment.

In its letter, EFSA states that “[t]he protected sections of the studies neither contain information on emissions, discharges or other released nor information on the impact of actual emissions or discharges of glyphosate on the environment.” It also refers to case C-673/13 P which was pending at the time of the decision, and states that it “will adapt its approach to the final ruling once available.”

The Court of Justice’s judgment in this case was handed down on 23 November 2016 and it clarifies that the information requested, particularly the “material, experimental conditions and methods” as well as “results and discussion”, meets the definition of “information related to emissions into the environment”.

Glyphosate is clearly released to the environment when used as intended. In contrast to the interpretation adopted by EFSA in its decision, the Court has now clarified that the concept of information related to emissions into the environment “cannot be limited to information concerning emissions actually released into the environment when the plant protection product or other active substance in question is used on plants or soil, where those emissions depend, inter alia, on the quantities of product actually used by farmers and the exact composition of the final product marketed”6.

The Court went on to state that “Consequently, that concept also covers information on foreseeable emissions into the environment from the plant protection product or active substance in question, under normal or realistic conditions of use of that product or substance, namely the conditions under which the authorisation to place that product or substance on the market was granted and which prevail in the area where that product or substance is intended to be used.”7

The Court concluded that “Although the placing on the market of a product or substance is not sufficient in general for it to be concluded that that product or substance will necessarily be released into the environment and that information concerning the product or substance related to ‘emissions into the environment’, the situation is different as regards a product such as a plant protection product, and the substances which that product contains, which, in the course of normal use, are intended to be released into the environment by virtue of their very function. In that case, foreseeable emissions, under normal or realistic conditions of use, from the product in question, or from the substances which that product contains, into the environment are not hypothetical and are covered by the concept of ‘emissions into the environment’ within the meaning of the first sentence of Article 6(1) of Regulation No 1367/2006”.8

The requested studies are intended to evaluate the hazards posed by glyphosate emissions under normal and realistic conditions of use, including chronic and long-term exposure of the type experienced by workers, rather than waiting for the long-term effects of exposure to the emissions to manifest themselves. Animal tests often use a dose that is higher than average exposure to avoid the use of an excessive number of animals for the testing. However, the results are extrapolated to be able to draw conclusions regarding normal use over a longer term. Therefore, the studies are on foreseeable emissions; they are not hypothetical.

The Court went on to hold that “it is also necessary to include in the concept of ‘information which relates to emissions into the environment’ information enabling the public to check whether the assessment of actual or foreseeable emissions, on the basis of which the competent authority authorised the product or substance in question, is correct, and the data relating to the effects of those emissions on the environment. It is apparent, in essence from recital 2 of Regulation No 1367/2006 that the purpose of access to environmental information provided by that regulation is, inter alia, to promote more effective public participation in the decision-making process, thereby increasing, on the part of the competent bodies, the accountability of decision-making and contributing to public awareness and support for the decisions taken. In order to be able to ensure that the decisions taken by the competent authorities in environmental matters are justified and in order to participate effectively in decision-making in environmental matters, the public must have access to information enabling it to ascertain whether the emissions were correctly assessed and must be given the opportunity reasonably to understand how the environment could be affected by those emissions.”9

The sections on material, experimental conditions and methods as well as those on results and discussion contain elements, which are essential to be able to assess whether the evaluation carried out by EFSA regarding the foreseeable emissions from the use of glyphosate and their possible effects on human health and on the environment was correct.

In these circumstances, EFSA is precluded by Article 6 of Regulation No 1367/2006 from refusing disclosure on the basis of the protection of the commercial interests of natural or legal persons.

In conclusion, we, Members of the European Parliament, request that
on the basis of Directive 2004/9/EC on good laboratory practice, EFSA provides access to the GLP statements,
on the basis of Regulation (EC) No 1049/2001 on public access to documents, and Regulation No 1367/2006 on the Aarhus Convention, EFSA also provides access to the sections on material, experimental conditions and methods as well as results and discussion of all 75 unpublished studies, as these are essential to allow for an independent scrutiny and do not fall under Article 4(2), first indent of the PAD Regulation, given that legitimate commercial interests of the study owners are already sufficiently protected by the non-disclosure of the information related to the introductory and administrative pages, the introduction, background and summary of the studies. In case you disagree with this, we argue that there is clearly an overriding public interest in the release of those sections to allow for an independent scrutiny.

Yours sincerely,

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

Annex

In 2015, EFSA provided detailed answers to an Open letter by MEPs and German MPs on the EFSA peer review dated 20/10/201510. In that letter, EFSA wrote:

“Based on a comprehensive genotoxicity data package on the active substance glyphosate, and considering a weight of evidence approach on all available data, it is concluded that glyphosate is unlikely to be genotoxic in vivo and does not require hazard classification regarding mutagenicity according to the CLP Regulation. It is noted that unpublished studies that were the core basis of the peer review evaluation were not available to the IARC experts as reported in the IARC monograph 112 on glyphosate (IARC, 2015)” (own emphasis added).

Most prominent amongst those pivotal unpublished studies are studies on which Greim et al. (2015) have published a review11 as well as a supplemental material12. IARC did consider these studies in its monograph on glyphosate13, but found the following: "The Working Group was unable to evaluate these studies... because the information provided in the review article and its supplement was insufficient (e.g. information was lacking on statistical methods, choice of doses, body-weight gain, survival data, details of histopathological examination, and/or stability of dosed feed mixture).”

This highlights the crucial importance and need to provide access to the information on material, experimental conditions and methods (which comprises statistical methods, choice of doses) as well as of the sections on results and discussion (which comprises body-weight gain, survival data, details of histopathological examination, and/or stability of dosed feed mixture). In contrast to EFSA, lack of access to this information made it impossible for IARC to consider these studies as part of their assessment on glyphosate.

The importance of statistical analysis as well as historical control data is further supported by the following statement in EFSA’s conclusion on the peer review of the active substance glyphosate in relation to the diverging assessment as compared to IARC14: “The assessment of the few epidemiological studies included in the IARC monograph, which were not reported in the original RAR (three out of ten cohort studies, six out of 19 case-control studies) was presented in the addendum of August 2015 to the RAR (Germany, 2015). With regard to the studies on experimental animals, three of the five mice studies used by the EU peer review and three of the nine studies in rats were not assessed by IARC. Importantly, there is a different interpretation of the statistical analysis used to assess the carcinogenic findings in the animal studies and on the use of historical control data; the EU peer review considered relevant historical control data from the performing laboratory” (own emphasis added).

Indeed, many different scientists have raised strong concerns about the statistical analysis used by EFSA as well as the use of historical control data (see Commentary by Portier et al.15, Report by Clausing16).

In a response17 to an Open letter by Portier et al 18, the Executive Director of EFSA wrote the following: “EFSA is of the opinion that the planning of a study before the initiation of the experimentation as established in the respective protocol – which includes the planned statistical analysis – is a key element in assessing the quality of a study; therefore deviations from the statistical analysis used by the study authors should be limited and properly justified. This is in line with OECD recommendations: “The central concept of this document is that the experimental design represents the strategy for answering the question of interest and that the specific statistical analyses are tactical methods used to help answer the questions. Therefore, the statistical methods most appropriate for the analysis of the data collected should be established at the time of designing the experiment and before the study starts.”

It is clear from this exchange that application of the right statistical methods is one key issue that is at the heart of the controversy. It will not be possible to resolve this without full public access to the section on material, experimental conditions and methods, which contains the statistical analysis.

To illustrate the need to have access to the results, we would like to refer to the example of the diverging information about the validity of the unpublished study by Kumar et al. 2001 (listed as Number 155 in the Annex to your letter of 31 May 2016). EFSA wrote the following in its conclusion on the peer review: “Out of five mice studies considered, one study with Swiss albino mice showed a statistically significant increased incidence of malignant lymphomas at the top dose of 1460 mg/kg bw per day. This study was discussed at length during the first Pesticides Peer Review Experts’ Meeting (PPR 125). ... The study was re-considered during the second experts’ teleconference (TC 117) as not acceptable due to viral infections that could influence survival as well as tumour incidence – especially lymphomas” (own emphasis added).
However, one can find the following in the proposal of the German authorities for the harmonised classification of glyphosate19:
"During a teleconference (TC 117) on carcinogenicity of glyphosate hold by EFSA (EFSA, 2015, ASB2015-12200), it was mentioned by an U.S. EPA observer that the Kumar (2001, ASB2012-11491) study had been excluded from U.S. EPA evaluation due to the occurrence of viral infection that could influence survival as well as tumour incidences, especially those of lymphomas. However, in the study report itself, there was no evidence of health deterioration due to suspected viral infection and, thus, the actual basis of EPA’s decision is not known" (own emphasis added).
It would be unacceptable to dismiss positive studies based on unfounded speculations. This example highlights the need to have access to the results and discussion, so as to inter alia have access to the description by the pathologist.

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From: Andreas Pavlou


Attachment EFSA Ref.16801099 PAD 2017 005 CA Extension Your confirmatory application of 10 01 2017.pdf
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