2015 Challenge to EFSA decision on carcinogenicity of glyphosate 20 November 2015

A challenge by independent academic and governmental scientists from around the world over the European Food Safety Agency (EFSA) decision that the widely used herbicide, glyphosate “is unlikely to pose a carcinogenic hazard to humans.”

They challenge that the EFSA decision runs counter to the finding earlier in 2015 by the International Agency for Research on Cancer (IARC), the highly respected cancer arm of the World Health Organization that glyphosate is a probable human carcinogen.

The full Open Letter is on http://www.zeit.de/wissen/umwelt/2015-11/glyphosat-offener-brief.pdf.

November 27, 2015

Mr. Vytenis Andriukaitis

Commissioner Health & Food Safety

European Commission

Rue de la Loi / Wetstraat 200

1049 Brussels

Belgium

Cc: (email only)

Mr. Phil Hogan, European Commissioner for Agriculture and Human

Development

Dr. Ladislav Miko, Deputy Director-General, DG Health & Food Safety

Dr. Bernhard Url, Executive Director, EFSA

Dr. Giovanni La Via, Chair, ENVI Committee EFSA Panel on Plant Protection Products and their Residues

Mr. Christian Schmidt, Minister of Food and Agriculture

Dr. Helmut Tschiersky, President of the Federal Office of Consumer Protection

and Food Safety (BVL)

Professor Dr. Dr. Andreas Hensel, President, BFR

Dr. Christopher Wild, Director, IARC

Mr. Jim Jones, Assistant Administrator, USEPA

Open letter: Review of the Carcinogenicity of Glyphosate by EFSA and BfR

Dear Commissioner Andriukaitis,

We are a group of independent academic and governmental scientists from around the world who have dedicated our professional lives to understanding the role of environmental hazards on cancer risks and human health. We have banded together and write to you at this time to express our deep concern over

the recent European Food Safety Agency (EFSA) decision[1] that the widely used herbicide, glyphosate “is unlikely to pose a carcinogenic hazard to humans.” We ask that you forward the letter to the representatives of all EU member states before the next meeting of the Standing Committee on Plants, Animals, Food and Feed (December 10/11). The EFSA decision, based upon the Renewal Assessment Report[2] provided by the German Federal Institute for Risk Assessment (BfR), runs counter to the finding earlier this year by the International Agency for Research on Cancer (IARC), the highly respected cancer arm of the World Health Organization that glyphosate is a probable human carcinogen. This IARC classification is based on a comprehensive assessment of the peer-reviewed toxicologic and epidemiologic literature undertaken over a 12-month period by a Working Group of

17 independent expert scientists. The IARC review linked glyphosate to dose-related increases in malignant tumors at multiple anatomical sites in experimental animals and to an increased incidence of non-Hodgkin lymphoma in exposed humans.2

We reviewed these two differing decisions on the human carcinogenicity of glyphosate and conclude that the IARC WG decision is by far the more credible. The IARC WG decision was reached relying on open and transparent procedures by independent scientists who completed thorough conflict-of-interest statements and were not affiliated or financially supported in any way by the chemical manufacturing industry. It is fully referenced and depends entirely on reports published in the open, peer-reviewed biomedical literature. It is part of a long tradition of deeply researched and highly credible reports on the

carcinogenicity of hundreds of chemicals issued over the past four decades by IARC and used today by international agencies and regulatory bodies around the world as a basis for risk assessment, regulation and public health policy. In contrast, the BfR decision is not credible because it is not supported by the evidence and it was not reached in an open and transparent manner.

Accordingly, we urge you and the European Commission to disregard the flawed EFSA finding on glyphosate in your formulation of glyphosate health and environmental policy for Europe and to call for a transparent, open and credible review of the scientific literature.

The IARC Working Group Decision

The International Agency for Research on Cancer (IARC) Monographs Programme identifies environmental causes of cancer in humans and has evaluated more than 950 agents since 1971. The Monographs Programme evaluates chemicals, drugs, mixtures, occupational exposures, lifestyles and personal habits, physical agents and biological agents. Monographs are written by an ad hoc Working Group (WG) of international scientific experts over a period of about 12 months ending in an eight-day meeting. The WG evaluates all of the publically-available scientific literature on a given substance and, through a transparent and rigorous process[3], reaches a decision on the degree to which the scientific evidence supports that substance’s ability to cause or not cause cancer.

For Monograph 112[4], 17 expert scientists evaluated the carcinogenic hazard for 4 insecticides and the herbicide glyphosate[5]. The WG concluded that the data for glyphosate meets the criteria to be identified as a probable human carcinogen. This finding stirred great debate globally on the safety of glyphosate and led to a careful evaluation by numerous agencies of the IARC monograph results when they became available on July 29, 2015.

The BfR Addendum

In October, 2015, the EFSA reported[1] on their evaluation of the Renewal Assessment Report[2] (RAR) for glyphosate. 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”. Addendum 1 (the BfR Addendum) of the RAR[2] discusses the scientific rationale for differing from the IARC WG conclusion.

We have serious concerns with regard to the scientific evaluation of the BfR Addendum and feel that it is misleading regarding the potential for a dose-dependent carcinogenic hazard from exposure to glyphosate. Since the BfR Addendum is the basis for the European Food Safety Agency (EFSA) conclusion[1], it is critical that we express these concerns. We are also concerned about some of the implications of the BfR Addendum regarding the use of human data in identifying carcinogenic hazards. Our comments to the BfR Addendum will focus on the human evidence, the animal laboratory evident and the mechanistic evidence.

Information