Sound regulation and proper stewardship are essential to ensure the responsible and sustainable use of plant biotechnology. CropLife International supports a global, innovation-friendly regulatory environment – one that is predictable, transparent, and guided by state-of-the-art science.
Regulation of GM Crops
Plant biotechnology refers to the use of genetic engineering to modify plants to produce desired traits. Genetically modified (GM or GMO) plants are created by using biotechnology to insert a gene from a different organism into a recipient plant to give that plant a new, desired trait. For example, many GM plants contain a gene from a soil bacterium that protects the plant against insect pests.
In the countries where they are available, farmers have widely adopted GM crops due to the many benefits that they provide, including insect resistance, herbicide tolerance, and 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. 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.
Time & Cost to Market
Getting these innovative new genetically modified traits from the lab to their fields requires a tremendous investment from product developers and seed companies.
The good news is that the cost of discovery, development, and authorization of a new GM trait has declined by $21 million over the past 10 years. However, the time to bring these new innovations to market has increased from 13.1 years to 16.5 years.
Despite product developers improving parts of the research and development process, longer regulatory timelines mean that it is taking them longer to realize a return on their investment. And just as important, it is taking longer to get these new innovations into the hands of farmers.
As a solution, there are many ways that governments can modernize their regulatory systems to address this timeline issue and ensure that farmers have access to the tools that they need to farm sustainably.
Regulatory agencies need to first adopt science-based data requirements taking into account the many years of experience with this technology. Countries can also work to align their regulatory requirements among themselves so that the same data package can be submitted in many different countries. Collaboration could include anything from sharing data and assessments, to conducting joint assessments, to approving a product if it has already received approval from another regulatory agency – all of which reduce the burden on developers of all types to bring a product to farmers.
Journal of Regulatory Science
In a series of papers, published in a special issue of the Journal of Regulatory Science in January 2021, CropLife International outlined 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.
- Journal of Regulatory Science Special Issue January 2021
- Journal of Regulatory Science Editorial January 2021
- Recommendations for Science-Based Safety Assessment of Genetically Modified (GM) Plants for Food and Feed Uses (Waters et al.)
- Stacked Trait Products Are As Safe As Non-Genetically Modified (GM Products Developed by Conventional Breeding Practices (Goodwin et al).
- Streamlining Data Requirements for the Environmental Risk Assessment of Genetically Modified (GM) Crops for Cultivation Approvals (Anderson et al.)
- Data Transportability for Studies Performed to Support and Environmental Risk Assessment for Genetically Modified (GM) Crops (Bachman et al.)
- Core and Supplementary Studies to Assess the Safety of Genetically Modified (GM) Plants Used for Food and Feed (Brune et al)
- Toxicological Assessment of Newly Expressed Proteins (NEPs) in Genetically Modified (GM) Plants (Roper et al)
- Allergy Risk Assessment for Newly Expressed Proteins (NEPs) in Genetically Modified (GM) Plants (McClain et al)
- Recommendations for Assessing Human Dietary Exposure to Newly Expressed Proteins in Genetically Modified Crops
Celiac Peptide Database
Consistent with guidance published by the European Food Safety Authority (Naegeli et al., 2017), CropLife International members have created the linked document which describes the process used to identify and add new peptides, should they exist, to a list of peptides implicated in celiac disease published by Sollid et al., 2020 and expanded in 2021 by CropLife International members. Potential peptides were identified through a comprehensive targeted literature search and publication review to determine if the publications contained novel peptides of interest, and if so, whether those peptides conformed to criteria described in Sollid et al., 2012 or were contained in crystal structure data. Through publication review, it was concluded that a total of 10 peptides, five amidated and five deamidated, met the criteria for inclusion in the 2024 database.
- A detailed description of the publication search and review process, including the list of publications, can be found here.
- A complete selection of 2024 celiac peptides, including transamidations, can be found here.
Prior versions of the CropLife Celiac Peptide Database and all relevant information are available in our Resource Library.
Related Resources
Infographic
Benefits of Regulatory Harmonization
Document
Benefits of Regulatory Harmonization of GM Crops Fact Sheet
Document
Literature Review for 2024 Celiac Peptide Table
Document
Celiac Peptide Table 2024
Document
Compositional Assessment of Genetically Modified Plants Used for Food and Feed Fact Sheet
Infographic
Environmental Risk Assessments
Document
Environmental Risk Assessments Fact Sheet
Infographic
Food and Feed Safety Assessment
Document