# One risk assessment for genetically modified plants

**Authors:** Muffy Koch, Jaylee DeMond, Matthew G. Pence, Elena A. Schaefer, Gary Rudgers

PMC · DOI: 10.3389/fbioe.2025.1619857 · Frontiers in Bioengineering and Biotechnology · 2025-07-18

## TL;DR

The paper suggests a single global risk assessment for genetically modified plants to avoid redundant reviews and streamline regulatory processes.

## Contribution

The paper proposes a unified global risk assessment model for GM plants to reduce regulatory burdens and promote harmonization.

## Key findings

- Repeated country-by-country risk assessments for GM plants are unnecessary and inefficient.
- A global risk assessment model can streamline approvals and reduce redundant regulatory work.
- Harmonizing risk assessments can accelerate access to GM plant benefits worldwide.

## Abstract

With over 30 years’ experience conducting risk assessments for genetically modified (GM) plants, regulatory agencies that review the safety of GM plants understand the potential food, feed, and environmental risks associated with these products. This vast regulatory experience is underutilized when risk assessments for GM plants are repeated on a per-country basis. The redundancy in country-by-country reviews of the same GM plants places a disproportionate regulatory burden on developers and strains limited government resources for conducting safety reviews. Requiring repeated, multi-country risk assessments to obtain food and feed import permits or cultivation permits for GM plants is unnecessary as repeated assessments do not change the safety and associated risks of already approved products. To avoid redundancies in the regulation of GM plants, we propose adoption of one, global risk assessment for food, feed, and environmental release carried out to international standards. Our proposed model for one global risk assessment encourages the sharing of food, feed and environmental risk assessment summaries between countries while maintaining national approvals for GM plants. Steps towards a streamlined and efficient review process for GM plants are discussed, including implementing a global, forward-looking approval process that eliminates repetitive risk assessments and re-reviews of low-risk traits. Harmonization of risk assessment is an achievable goal that would accelerate regulatory approvals and enable broader access to the benefits of GM plants which are currently only available to some countries.

## Full-text entities

- **Diseases:** toxicity (MESH:D064420), ES (MESH:D012512), late blight (MESH:D000067562)
- **Chemicals:** GM (-)
- **Species:** Solanum lycopersicum (tomato, species) [taxon 4081], Manihot esculenta (cassava, species) [taxon 3983], Homo sapiens (human, species) [taxon 9606], Solanum tuberosum (potatoes, species) [taxon 4113], Prunus domestica (plum, species) [taxon 3758], Oryza sativa (Asian cultivated rice, species) [taxon 4530], Medicago sativa (alfalfa, species) [taxon 3879], Malus domestica (apple, species) [taxon 3750], Glycine max (soybean, species) [taxon 3847], Fragaria x ananassa (strawberry, species) [taxon 3747], Musa acuminata (banana, species) [taxon 4641], Solanum bulbocastanum (ornamental nightshade, species) [taxon 147425], Citrus (genus) [taxon 2706], Carica papaya (mamon, species) [taxon 3649]

## Full text

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## Figures

1 figure with captions in the complete paper: https://tomesphere.com/paper/PMC12313703/full.md

## References

60 references — full list in the complete paper: https://tomesphere.com/paper/PMC12313703/full.md

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Source: https://tomesphere.com/paper/PMC12313703