Foro Global sobre Seguridad Alimentaria y Nutrición (Foro FSN)

The following comments are provided by the Bayer Crop Science Regulatory Scientific Affairs (RSA) team. RSA is made of nearly 50 scientists with combined expertise in environmental science, chemistry, biology, biotechnology, microbiology, cell biology, microbial genomics, biodiversity, water quality, microplastics, soil carbon, entomology, pollinators, animal science, epidemiology, medical toxicology, public health, nutrition, digital agriculture, social and behavioural science. The RSA team is spread across the globe, in North and Latin America, Europe, Africa, and Asia.

RSA promotes food, feed, and environmental safety and sustainability, both, inside and outside the company. Internally, it guides the company’s R&D process based on external scientific, policy, and regulatory developments; it contributes to the development and implementation of Bayer’s biodiversity and habitat strategy; and it promotes employees’ education and awareness through newsletters, online portals, and trainings.

Externally, RSA drives the company’s transparency initiatives. It engages in dialogues and partnerships with policymakers, regulators, universities, medical and scientific societies to develop, disseminate, and promote sound science through joint research, academic publications, conferences, workshops, education programs, capacity building, and a regulatory visitors program. The team prepares and provides science-based background information to support policy and regulatory processes enabling the delivery of current and future products that bring value to farmers, the environment, and society. The team constantly address academic and regulatory concerns and publications, ensuring timely communications and appropriate documentation.

Since 2017, Bayer has been disclosing safety-relevant study summaries and granting non-commercial access to full study reports for our marketed crop protection products and genetically modified (GM) crops. https://www.cropscience.bayer.com/transparency-crop-science

Companies in the private sector are generally well-informed about the development or revision of policies that are relevant to their business. However, they face barriers that hinder their ability to access and contribute to such processes with scientific inputs, mainly due to perceived conflicts of interest, lack of transparent mechanisms, and communication issues. Such barriers can lead to governmental policies that are not informed by the best available scientific evidence, or that fail to address important issues.

1. Perceived conflicts of interest – Often, policymakers tend to be reluctant to engage with and accept inputs from private companies' scientists. This is all in all due to their concerns about the impartiality and accountability of private sector’s scientists.

Since private companies have a vested economic interest in the outcomes of policies that relate to their business, the intellectual independence and scientific impartiality of private company’s scientists are often deemed undermined by a “conflict of interest”, and their scientific research (even when published in peer-review journals) is preventively disregarded by many as biased and incomplete, designed to demonstrate the safety and efficacy of a product, rather than to fully investigate any potential risks or downsides.

Such general suspicion is based on the unsubstantiated idea that private interest (e.g. profit) is inherently incompatible with and antithetical to public interest (e.g. human health and environmental sustainability). Such idea applies particularly to companies that develop agricultural technologies (e.g. agrochemicals, fertilizers) that, despite their extreme utility, can have negative impacts on people’s health or the environmental, if not properly managed.

This rationale does not consider that companies that sell agricultural inputs have not only a heightened responsibility and a unique potential, but also a rational business interest in championing sustainable agriculture: indeed, if farmers thrive, the whole value chain thrives, up- and down-stream; and for farmers to thrive, they must: (a) be healthy and rely on healthy soil, pristine water, functional biodiversity, predictable weather, hence their need to mindfully select and manage safe inputs and preserve their natural assets; (b) have access to markets, hence their need to deliver food that meets the local and international safety standards (e.g. Maximum Residue Limits – MRLs) required for food to be traded and sold to consumers.

For these reasons, to ensure their own business success, input companies are well aware that they need to deliver solutions that are, at the same time, highly performing (e.g. high-yielding, resistant to abiotic and biotic stresses) and safe for farmers, consumers, and the environment. Private companies’ scientists are motivated to make this happen, by developing better and better solutions, and in turn compensated for their efforts.

Science is evolving, and technologies with it. But it takes time and resources. In order to develop and register continuously more sustainable alternative technologies and always provide the most effective and appropriate solutions to protect people and the environment, a sufficient transition period is critical for the agricultural input industry. It takes 11 years on average between the discovery, development, research tests and the final registration and marketing of a new active substance (16 years for GM crops). For every active substance that is registered for use, there are about 160,000 potential candidates in private companies’ pipelines that do not make it past the research stage. This huge endeavor needs large investments (it takes nearly €250 million to deliver a single new active substance), which are only possible if input companies keep thriving by making farmers and others in the food value chain thrive.

For the safety assessments of active substances, Bayer applies criteria that reflect the standards of reference authorities who represent different agronomic realities and whose programs for regulating pesticides are generally well developed (e.g. in the US, Canada, Brazil, the EU, Australia, New Zealand, Japan, and China). In 2012, Bayer stopped selling any World Health Organization (WHO) acute tox class 1 pesticides (formulated products), regardless of regulatory approval status. Additionally, since 2016, the company has committed to only selling products with active ingredients that have a registration for use in at least one OECD country or, for new active ingredients, have a complete OECD safety data package. The company continues to build on international standards as laid out in the FAO/WHO International Code of Conduct on Pesticide Management and support the work of the Organization for Economic Cooperation and Development (OECD) to improve and harmonize testing and risk assessment methodologies as well as pesticide registration processes across countries and regions.

Before they are put on the market, Bayer’s genetically modified (GM) crops undergo more food and environmental safety testing and oversight than any other agricultural product – including conventional (or non-GM) crops. The guidelines for establishing safety of GM crops that are followed by Bayer (and all other GM crop developers in the public and private sectors) and recognized by regulatory authorities globally were developed over many years by international scientific bodies like the FAO/WHO Codex Alimentarius Commission and the Organization for Economic Development (OECD). Only after Bayer has met internal safety testing requirements is the GM crop submitted to global regulatory authorities for their review to demonstrate that they are safe to eat, safe to grow, and safe for the environment.

The contribution that private companies’ scientists can provide to policy making processes is not limited to “hard science”. Socio-economic and behavioral studies are carried out by companies to understand farmers’ motivations for (not) applying safe and sustainable products and practices (e.g. uptake of personal protective equipment by smallholder farmers in low-income countries). These studies drive companies’ trainings and stewardship services and can help shape more effective policies.

So, yes, private companies do have their own interests (just like any other stakeholder who engages in policy processes), and such interests are not in “conflict” but rather fully supportive of more efficient, inclusive, resilient, and sustainable agrifood systems.

“Implementation science” is the scientific study of methods to promote the uptake of research findings and evidence-based practices into regular use by practitioners and policymakers. Industry can provide private scientists, academics, and policymakers neutral tools and methods to build and unbiased collaboration.

2. Lack of transparent mechanisms - Private sector’s scientists are proactive in seeking out opportunities to provide inputs to policymakers by building relationships (mostly through industry associations) and attending policy-related events and conferences. However, more formal channels/mechanisms enabling private scientists to provide inputs to policymakers are not always there (e.g. in some countries, private companies’ scientists are not allowed on scientific panels of policy and regulatory bodies, even after they have left the company), and it is not always clear which information, data, evidence is requested, and in what format; and the degree to which inputs can or will be incorporated in the policies.

We highlight the need to mainstream in all policy processes at international, regional, and national level formal channels/mechanisms enabling private companies to clearly know what scientific inputs are needed, when, how they must be submitted, and to who. Such mechanism would enable private entities, as well as those in the public sector, to most efficiently and effectively invest resources to generate and share the most relevant inputs. Such mechanisms should be open to continuous submissions of updated scientific knowledge as it becomes available. This would enable policymakers to (re)shape their decisions in more timely and effective ways.

3. Communication issues - When developing and designing policies and regulatory systems, an understanding of both the theoretical scientific principles and practical and application-related aspects in agriculture is essential. Yet, even when regulators and policymakers are PhD scientists (more frequently the former ones, less the latter ones) and have deep theoretical knowledge within a certain scientific area, they may not be aware or have a deep practical understanding of the latest related technologies that industry (applied) scientists are more likely to be familiar with. When policymakers have a low level of scientific expertise, the specialist technical jargon of scientists may be difficult for them to translate into relevant policies and guidelines.

Publishing in peer-review journals jointly with academics and scientists from public institutions is a common practice and a good way for private sector scientists to contribute to policy topics, but it may not always be the most effective way to reach policymakers. Rather, to fill this gap in communication between scientists and policymakers – which is likely expanding as the pace of scientific discovery and technological development is accelerating thanks to digital tools – there is the need for more science communicators trained to translate science and innovation to audiences with different degrees of scientific proficiency. More education programs at university level to train science communicators should be funded.

 

In full alignment with the core principles of the first-ever FAO Science and Innovation Strategy, our company puts science and evidence-based knowledge at the basis of all its decisions, and we emphasise the need for science and innovation to be rights-based and people-centered, gender-equal, evidence-based, needs-driven, sustainability-aligned, risk-informed, and ethics-based.

We recognize the importance of the FAO Strategy to guide the development of more inclusive science-policy interfaces, in support of science-based policy making for greater policy coherence, shared ownership and collective action.

We praise the Strategy’s promotion of partnerships with the private sector to enhance FAO’s access to relevant knowledge networks and support knowledge dissemination, harness private sector-led innovations to achieve improved production, nutrition, environmental sustainability, and human welfare, and promote incentive mechanisms to make appropriate new technologies accessible in low- and middle-income countries.

From our side, we are willing to work with FAO to support its technical work and normative guidance by providing the most credible, relevant and legitimate evidence, knowing that it will be assessed in a rigorous, transparent, and neutral manner.