Developing an Inclusive and Impactful Approach to Transparency for
Biotechnology in Food & Agriculture
May 2020
Innovation flourishes when science and consumer values are aligned andcomplement one another. The U.S. government’s regulatory approach towards
innovative products cannot exist in isolation. It should be supported by credible
transparency measures. A proactive approach to transparency stands to build trustand foster an inclusive environment to address our most pressing societal,
nutritional, and environmental concerns.
BIO understands that consumers want more information about innovative
biotechnologies like gene editing, what is in their food and whether their food issafe. Our members will be a driver of that endeavor. “Transparency” is interpreted
broadly by both industry and stakeholders. Therefore, for the purposes of our work,
we use “transparency” as an umbrella term under which we define specific focus
areas (see description of focus areas below).
Within the broader agri-food ecosystem, diverse stakeholder priorities are driving
an interest in transparency and assurances provided by government agencies.
Examples include: the assurance by independent verifiers of stewarded use of thetechnology; timely notification of what is coming to the marketplace; how safetymeasures were applied in product development; and how potential risk is managed
and mitigated across a supply chain.
From these key insights, we believe that an effective approach for transparency
includes: Defined roles for all participants, including government, public and private
developers, civil society, the food value chain, and the public Clear principles and goals for building trust and answering questions
 A mechanism for independent verification and the use of best managementpractices in the development and introduction of new products Diversity of perspectives represented in governance systems
 Resources that enable small and emerging company participation
 A publicly available repository of information about plant, animal andmicrobial biotechnologies and breeding methods and A comprehensive and connected communications approach.
Roles for the U.S. Government
BIO is advocating that the U.S. government play a role in driving an inclusive andimpactful approach to transparency. We encourage agencies to ensure thatregulatory policies are durable and legally defensible, based on science and theactual risk of biotechnologies and plant, animal, and microbial products. Further, we
encourage agencies to articulate to the public the rationale for their approach,including how they approach their safety assessment for innovative technologies.

The U.S. government should establish a biotechnology clearinghouse that is geared
toward consumers and builds off the Food and Drug Administration’s Agricultural
Biotechnology Education and Outreach Initiative. This clearinghouse should provide
information about common uses of biotechnology, like gene editing, and the safetyof innovations commonly used in the food and agricultural system.
We look forward to working with agency experts to evaluate mechanisms to affirm
and communicate the safety and benefits of biotechnology.
Finally, we urge the U.S. government to align global regulatory approaches, as best
as possible, to smooth global trade and promote domestic market access.
Assurances by Focus Area•

Stewardship and Safety
Government regulations are in place to provide for the safety of products andensure that stewardship programs advance the responsible management ofproducts and technology. Under appropriate science-based government
regulations and strong industry stewardship, biotechnology will continue toimprove our planet, our health and our food.
Maintaining quality control and responsible management of biotechnology
products is central to developing and commercializing food and farminnovations. Product stewardship is the management of a product from its
inception through its lifecycle.
Establishment and implementation of quality management systems that
include processes and best practices related to regulatory compliance andadditional market requirements are beneficial. Stakeholder engagement indevelopment of a stewardship program is important so stakeholder questions
and needs are addressed. BIO will advocate for appropriate policies in any
stewardship plan that account for potential impacts on downstream markets.
Further, transparency about the structural governance and operational
details of the approach (e.g., funding, verification methods and estimatedcosts) are important to building trust.

•Information Available to the Marketplace
Food companies and retailers are embracing the information economy andincreasingly making their own transparency commitments to consumers.
Public advocacy groups maintain a sharp focus on the agriculture industry as
technology changes our perception of the food system. Ultimately, for any ofthese important stakeholder groups to embrace biotechnology in themarketplace, they will ask for information about what is beingcommercialized and where it is in the food supply.
BIO and its member companies encourage and will prioritize increased
openness about products entering the marketplace and best practices

developers use in advancing beneficial products to the commercialmarketplace. To address the general demand for increased information, we
support the development of a website to complement transparencyinitiatives. The U.S. government, BIO and other stakeholders will work
cooperatively so information about a myriad of topics will be proactively
posted, including topics like: notification of products or classes of products
entering the market, peer-reviewed papers examining innovation in food andagriculture, the international regulatory landscape, and best breedingpractices in plants and animals and the use of beneficial microbialinnovations.
•Stakeholder Engagement & Social Considerations
No single company or association can accomplish the goal of societal trustthat enables innovation acceptance. The entire value chain needs to beengaged, and the full breadth of innovative solutions will come out of atrusted ecosystem.
BIO and its member companies will listen to the questions and needs ofstakeholders. As the stakeholder and influencer landscape evolves alongsidetechnology development, we will engage more diverse and representativeparties. Working together, we will provide mechanisms for consumers to ask
questions and highlight curiosities about biotechnology and its impact on thefood system, health, and the environment.
The process to validate the benefits of innovation - either real or anticipated- should be a collaborative effort among developers and stakeholders.
Through sharing these benefits, stakeholders, especially those in the foodvalue chain, should be able to convey the value of these innovations toconsumers and build trust in and seek to promote the agri-food ecosystem.

•Independent Verification
Stakeholders value independent verification of the use of best management
practices in the development and introduction of new products. A processthat examines meaningful criteria in an objective, predictable and consistent
way is important for technology developers, as well as stakeholders looking
to endorse innovation in product development.
To further support transparency, an independent verifier should have apublic-facing role to share processes and governance with interested
stakeholders. In addition, an independent verifier should have the ability tosupport small and emerging companies in developing robust programs.
We recognize that others have a history of developing and improving
verification programs. We look forward to working with stakeholders to better
understand the universe of verification programs and how independent
verifiers and their programs could complement an inclusive and impactful
approach to transparency.

•Communications
BIO and its member companies will continue to highlight progress in foodand farm innovation through public-facing communications tools. Ourcommunications platforms and social media channels, including Innovature,
will focus on fostering inclusive and diverse social dialogue around theimportance of technology in food and agriculture.
We believe it is critical to partner with a broad and diverse range ofstakeholders and the U.S. government to amplify important research about
scientific innovation, as well as consumer perceptions of biotechnology andthe messages that resonate with value chains and the public.
BIO will continue to work with food companies and retailers to better
understand how disclosure mechanisms, including digital disclosure, could
provide access to more information about innovation in food and agriculture.