Regulatory Harmonization

The plant science industry is driven by its purpose of advancing innovation in agriculture for a sustainable future. GM crops offer a range of benefits to farmers, consumers, and the environment by expressing traits such as herbicide tolerance, insect resistance or enhanced product quality.

Since the commercial introduction of GM crops over 25 years ago, technology developers and regulatory authorities all over the world have gained significant experience in evaluating their safety for humans, animals, and the environment. In fact, over 3,500 independent regulatory agency reviews have deemed these crops safe for food and feed, and GM crops have been consumed for decades by people and animals without a single confirmed health or safety issue. Yet, despite their proven safety record these crops have face increased regulatory requirements that have delayed and restricted access to innovative products for farmers and consumers.

It's time for a new approach

Given our experience with GM crops as developers and regulators, it is time to re-evaluate the current approaches to the regulation of GM crops. This would provide value for:

  • Regulators:
    • Leverage extensive experience of existing safety assessments and data submissions.
    • Free governmental resources to focus on other areas (e.g. training, knowledge sharing and inter/intra agency collaborations).
    • Provide a framework for emerging regulatory systems in countries beginning to adopt GM crops.
    • Help achieve the UN Sustainable Development Goals (SDGs).
  • Consumers:
    • Enjoy national and local economic growth and stability from reductions in production costs and increased yields.
    • Benefit from global food and nutrition security through lower food prices and a safe, stable, food supply.
    • Purchase value-added products, such as biofortified foods and crops with extended shelf life, which can reduce food waste.
    • Help to protect the environment by choosing products that are sustainably grown.
  • Farmers:
    • Expedite farmer adoption of sustainable farming practices that benefit the environment and preserve natural resources, and help farmers adapt to and mitigate climate change.
    • Increase in income for rural economies resulting from yield increases.
    • Result in a larger variety of traits and/or crops being commercially available to farmers.
  • Developers:
    • Reduce product development costs and timelines, which can enable smaller and public sector developers to bring diverse agricultural innovations to the marketplace.
    • Lower cost barriers to working on new crops and traits.
    • Make product launch timelines more predictable, enabling resource streamlining, patent protection, and better deployment/ allocation of resources.

What is regulatory harmonization?

Today, there is little alignment between governments and their regulatory requirements for GM crops. Instead, individual governments often have their own safety data and testing requirements for GMOs before they will be approved for cultivation or import. This means farmers may not have access to all the important tools needed to farm sustainably — and farmers in some regions may have an advantage over farmers in other regions in being able to adapt to and mitigate climate change and protect biodiversity, as well as socio-economic benefits.

However, if regulatory requirements across countries or regions became more similar or aligned, then important innovations could move to the market in a more predictable and efficient way — as well as be more equally accessible. This approach is known as regulatory harmonization.

Regulatory harmonization includes a spectrum of different types of alignment between national regulatory frameworks and requirements. Alignment could be anything from governments having consistent requirements for the regulatory review process, to internationally recognized technical guidance documents, standards and principles, to sharing data and assessments, to approving a product if it has already received approval from another regulatory agency.

Aligning on data requirements that industry must submit

Despite Codex Guidelines and resources from the Organisation for Economic Cooperation and Development (OECD) providing the scientific/technical foundation for a common approach to GM food and feed safety assessment, regulatory data requirements vary widely between countries. Familiarity and History of Safe Use (HOSU) achieved over the last 25 years should also enable streamlined approaches. CropLife International has taken on a harmonization project that provides recommendations for studies and data requirements that could modernize and align regulatory regimes for GM crops internationally. This is not a new concept. The International Medical Device Regulators Forum (IMDRF) launched a pilot program to enable a single audit for medical device safety and efficacy that has been accepted by participating countries, including Canada and the US.

Why we need harmonized regulations

Regulatory harmonization not only helps to make innovations available to farmers in a more timely and predictable manner, but it can increase efficiencies in regulatory agencies worldwide and reduce duplication of effort. Regulatory harmonization does not mean that national autonomy needs to be compromised, there are many ways that countries can cooperate without compromising national autonomy from synchronizing on data requirements to sharing safety assessment conclusions.

The CropLife International recommendations

In a series of papers, published in a special issue of the Journal of Regulatory Science in January 2021, CropLife International has outlined, in their view, what a truly risk-based safety assessment for GM crops could look like given their 25+ years of experience cultivating and reviewing GM crops. This includes a series of core and hypothesis-driven studies that would comprise the safety assessment. You can download the papers below:

CropLife International has also produced a series of fact sheets and infographics that summarize the paper. You can download these at the links below: