ECPA member companies are among the world’s leading developers of crop protection solutions which enable farmers to produce food for a growing world in a safe and environmentally sustainable way.
While the product authorisation process is the essential assurance to farmers and consumers that crop protection products meet the highest standards for safety, efficacy and quality, the effective transparency of safety data submitted to regulatory agencies can further enhance public confidence and strengthen the understanding of the stringent safety standards of crop protection products, as well as enhance trust in the product authorization process.
ECPA member companies are committed to increased transparency of safety data in order to better engage in dialog with society to increase understanding and build trust. As a first step, ECPA and CropLife International and its member companies are developing straightforward ways to enable non-commercial access to safety-relevant information.
In addition, CropLife International is developing an industry website to provide additional context and background information, as well as links to transparency initiatives of its member companies.
The crop protection product authorisation process:
- Before any crop protection product can be approved for use, all safety data related to human health and the environment must be submitted to regulatory authorities for their review.
- All safety studies generated must be in accordance with demanding international standards such as the Good Laboratory Practice (GLP) and must be performed by certified third-party laboratories.
- Highly skilled independent experts in the regulatory authorities undertake one of the most stringent product approval processes for any industry in the world.
- Most of the data submitted to the regulatory authorities is already available to the public. In addition, ECPA and CropLife International and their member companies are making a global commitment to enable more public access to safety data related to its crop protection products.
- Certain parts of the data submitted to approve new products is considered Confidential Business Information (CBI). The protection of CBI ensures continued investment in innovations to help farmers grow safe, nutritious and affordable food for our world’s increasing population.
Global Transparency Initiative Q&A:
When was the commitment launched?
On the 26th March 2018, ECPA, CropLife International and their member companies launched their transparency commitment. With the initiative the crop protection industry is making a global commitment to make more safety-related data of its products publicly available. The initiative stems from the industry’s commitment to transparency, responsibility and sustainability.
What is the commitment about?
The initiative is a voluntary and non-binding commitment of the world’s leading manufacturers of crop protection products. Through this commitment companies recognize that they play an important role in making crop protection safety data more easily accessible to the public to provide greater transparency. Access to safety data for non-commercial purposes will be accommodated by the individual member companies. Member companies are further committed to continue to proactively engage in conversations with all stakeholders to explain the existing regulatory process and the safety, efficacy and benefits of crop protection products.
What information is already available?
All relevant health and environmental safety information is already made public through various channels, such as the product label, product brochures or company websites, peer reviewed scientific literature and regulatory summaries by competent authorities. In the EU, for example, the regulatory risk assessment and study summaries for all active ingredients, and sometimes also for the crop protection products, is online with links to review reports and decisions. Further, the active substance registration reports (done by a rapporteur member state and containing the study summaries and risk assessment, as well as summaries on scientific literature) are published on the EFSA website. EFSA also peer-reviews the registration reports and publishes their peer review. Note that each registration report contains a confidential section, containing information such as on composition and manufacturing that is not public.
So why is the crop protection industry doing this now?
Proactively engaging with stakeholders to explain safety measures, efficacy and benefits of our products is key to responsible and transparent industry behaviour. ECPA, CropLife International and their members want to make a concerted effort in showing all the already available data and facilitate public access to regulatory safety data from each company. We listen to diverse points of view and we hope that through this commitment we can start a constructive dialogue with stakeholders to help broaden our understanding of issues and concerns.
What information will this initiative make available?
With this initiative, the industry takes its responsibility and goes one step further in making safety data more easily accessible. We believe that enhanced transparency of regulatory crop protection safety data can help maintain public confidence in the regulatory review process and thereby address the questions consumers may have about crop protection products. As a first step, ECPA and CropLife International member companies are developing straightforward ways to enable non-commercial access to safety information – see here an example from Bayer. In addition, CropLife International has launched an industry website to provide additional context and background information, as well as links to transparency initiatives of its member companies.
What information will not be available?
Confidential Business Information (CBI) is not disclosed. Disclosing regulatory data which qualifies as CBI could significantly harm innovation by reducing competition and undermining the policy balance between the public’s interest in relevant health and environmental safety information, and competitive commercial interests achieved through the protection of regulatory data. In order to protect the privacy and safety of researchers no names, addresses or personal information of scientists will be disclosed. These parts will be blackened in the documents.
What is confidential business information and why is this important?
The crop protection industry is research intensive - investing around $3 billion every year in innovation to ensure sustainable products are continuously being created. CBI is information that, if disclosed, could cause harm to the developer’s commercial interests. Regulatory data are submitted to regulatory authorities with the understanding that CBI will be protected by confidentiality rules and will not be disclosed at any time. If disclosed without permission, it could be detrimental to a developer’s business interests or to the safety and privacy of researchers. Similar to the violation of patents and trademarks, disclosure of CBI can lead to the significant loss of potential revenue, and failure to adequately protect CBI discourages the research and development of innovative plant protection products. Protection of CBI is therefore a crucial incentive for innovators to create new technologies.
Are the data requirements for crop protection product approvals in low income countries different to those in in OECD members, such as the EU and US?
The high cost, level of expertise and human resource required to evaluate crop protection product dossiers among OECD members is often hard for low income countries to match. This is why CropLife International members try to ensure their products are evaluated and registered in an OECD country before an application for commercial access in a low income country. However, local use conditions must still be taken into consideration by the applicant in support of local registration.
What is ECI and how is it connected to data transparency?
European citizens' initiative is a tool given to European citizen to come up with legislative proposals. Last year an ECI was launched asking the European Commission to “"Ban glyphosate and protect people and the environment from toxic pesticides". While the European Commission renewed glyphosates license it looked into ways of further increasing the transparency and quality of studies used in the scientific assessment of substances.
Our industry agrees that citizens must be able to understand how pesticides are approved and in this context companies have agreed to facilitate public access to regulatory safety data.
What will the European Commission propose?
The proposal from the Commission will include making all studies in the application dossier accessible to the public, insofar as it does not threaten business secrets or confidential information, in line with existing legislation. The Commission believes that this will reinforce the trust of EU citizens in the EU system of approval for plant protection products.
The proposal will be made in spring of 2018. The likely launch date is 11th April 2018.
What would this proposal specifically include?
At this stage the Commission has not clearly defined what the proposal will contain, but it has set a high level of ambition. The Commission has stated that it would be looking to make the studies publicly accessible, and that it would seek to make an absolute maximum of industry studies subject to disclosure.
This means keeping a strict definition of commercial confidentiality, in line with existing case law, and making the studies accessible and understandable by those who will want to request them.
It remains unclear at this stage how all this information would be disclosed: The format of the disclosure will be key to ensuring adequate democratic scrutiny: the studies themselves are technical, lengthy documents, but they should be accompanied by relevant summaries for all to understand. It is unclear as well which platform the Commission intends to use to make the studies available, and whether there will be different levels of access depending on stakeholders.
Are there other measures being considered to reinforce the transparency of the evaluation system?
We expect the proposal from the European Commission to contain additional measures to strengthen the governance of scientific studies by involving public authorities in the process, enhancing the auditing of studies and exceptionally allowing public authorities to commission ad hoc studies in case of serious doubts on the safety of a substance. This will ensure that public money is used only in cases where scientific sources, both independent and from industry, cannot concur on the safety of the substance.
The role of EFSA will also be adapted to strengthen its management board with representatives of civil society, improve its cooperation with Member States scientific agencies, and increase public participation into the process.
Is the EU approval process really independent?
We are confident that the easier access of industries studies will show that we conduct our scientific assessments in line with the highest standards of scientific practice. As far as the independence of EFSA is concerned, the reform of EFSA’s management board which will be included in the proposal will ensure adequate control by civil society, the European Parliament, and Member States. We are confident that these are sufficient safeguards which will reaffirm that the process is fully independent.