WHAT IS REGULATORY HARMONIZATION?

For the last 25 years, geneticallymodified (GM) crops have been safely
grown and consumed worldwide.
Farmers planting genetically modified
organisms (GMOs) have enjoyedlivelihood improvements, as well as
environmental and biodiversity benefits,
while also mitigating climate change byadopting no-till methods.
Despite scientific consensus around the safety ofbiotech crops, and the myriad of benefits, many
promising new biotech crops still don’t reachthose who need them. This is partially because
global regulations for GMOs are not aligned. Somecountries demand extra studies that often don’tadd value for the assessment of their safety, whileothers ask for studies to be repeated year afteryear; even when neighboring countries with thesame growing conditions have already completedthem.
If different governments had more consistent orsimilar regulatory frameworks and requirements,
agricultural innovations could move more
quickly to farmers, which could result in more
safe and nutritious foods and the adoption of
more sustainable farming practices that benefit
biodiversity and the environment.

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 beapproved 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 overfarmers 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 acrosscountries or regions became more similar oraligned, then important innovations could moveto the market in a more predictable and efficient
way — as well as be more equally accessible. Thisapproach is known as regulatory harmonization.
Regulatory harmonization includes a spectrumof 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 recognizedtechnical guidance documents, standards andprinciples, to sharing data and assessments, toapproving a product if it has already received
approval from another regulatory agency.

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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 25years should also enable streamlined approaches.
The CropLife International harmonization project 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 andefficacy that has been accepted by participating countries, including Canada and the USA.

Consistent criteria from governments
More data at higher cost does not result in a higher level of safety. The alignment onrequirements for the evaluation of GM crops between governments, even on a small scale,would provide valuable consistency for developers facilitating simultaneous submissions in
multiple geographies and reducing asynchronous approvals.

Data Transportability
Laboratory and field data generated on GM plants in one country can inform support
regulatory decision-making for GM plants in another country. Using this concept of datatransportability data across regions has been successfully used by multiple countries toeliminate redundancy, create regulatory efficiencies, and enable timely regulatory approvals.

Safety assessment sharing
Safety assessment sharing refers to the concept of two or more countries sharing their risk
assessment conclusions and utilizing those assessment conclusions to inform their own
sovereign decision making. Although the scope depends on the agreement, this can be used
to share regulatory resources, improve efficiency and synchronization of GM food safetyassessments. A good example of how this works in practice is illustrated through the work
agreement between Health Canada and Food Standards Australia New Zealand (FSANZ).

Regulatory Cooperation through trade agreements
There are also regulatory cooperation agreements that have been facilitated through trading
partners. For example, there is a proposal in place for any GM event that is approved by amember state of the Common Market of Eastern and Southern Africa (COMESA) - that willbe traded within COMESA - the original country of approval will share its decision documentswith receiving countries to facilitate decision-making. For a GM event that has yet to beapproved, an application is made through the COMESA Secretariat for an independent risk
assessment and subsequent scientific opinion, which is binding on all states. Although thishas yet to be implemented, it is a good example of the potential for regulatory cooperation
within trading groups.

Mutual recognition
Mutual recognition refers to a single decision authority that will be binding in all memberstates. A good example of mutual recognition is the European Union where an European
Food Safety Authority approval is valid in all member states.

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Why do we need harmonized regulations?
Regulatory harmonization not only helps to make innovations available to farmers in a more timelyand 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 becompromised, there are many ways that countries can cooperate without compromising national
autonomy from synchronizing on data requirements to sharing safety assessment conclusions.

Core Set of Studies: Studies necessary for a science-based risk assessment of a GM plant.
Supplementary Studies: Studies to be conducted upon identification of information and/or hypothesisthat indicates increased risk to the environment or human or animal health. The conduct of these studies
depend on the nature of the introduced trait, intended use and data obtained from core studies.
*These are suggested core studies for typical GM plants. There may also be alternative newly expressed
substances (e.g. RNAi).

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