Table 1 Comparison of some GMO regulatory steps
From: Engineering biology applications for environmental solutions: potential and challenges
Regulatory steps | Explanation | UK | EU | USA |
|---|---|---|---|---|
Pre-development risk assessment | Assessment of potential risks of R&D to human health and the environment | Conducted by developers, sometimes with assessment by SACGM, ACRE, HSE or other bodies; includes human health and environmental risks, containment measures etc. | Conducted by developers, member states and EFSA; includes human health and environmental risks, containment measures etc. | Conducted by developers, sometimes with assessment by USDA (e.g., APHIS), FDA, EPA; includes ecological and human health risks, containment measures etc. |
R&D and/or trials | Research and development phase, including any necessary trials | Must comply with HSE regulations and legal conditions for trials | Must comply with local regulations and conditions, overseen by member states and EFSA | Must comply with federal regulations and may require Experimental Use Permits |
Regulated product application | Application for product approval, assessing risks to human health and environment | Application includes detailed scientific data and risk assessments, reviewed by various committees depending on application | Application includes detailed scientific data and risk assessments, reviewed by member state competent authorities and EFSA | Application to USDA, FDA, or EPA, includes risk assessments and may involve GRAS determination |
Scientific advisory committee review | Review by scientific advisory committees | May be reviewed by committees at DEFRA, FSA, HSE etc.; potentially assessed by reference laboratories; may request additional tests or information from developers | Reviewed by EFSA; potentially assessed by reference laboratories; may request additional tests or information from developers | Reviewed by relevant competent authority (USDA, FDA, EPA); may involve public consultation and scientific review |
Public consultation and feedback | Period for public comments and feedback on the application | Consultation may take place during legislative process; | Public comments invited for 30–60 days; Member states develop emergency plans which can be consulted upon; compliance with transparency regulations | Public objections or complaints can be submitted within 30 days of an application’s publication |
Decision to approve or request further info | Decision-making stage where approval is granted or further information requested | Decision to approve taken by ministers; may request further information before approval. | Vote by Standing Committee on Plants, Animals, Food and Feed (PAFF) | Decision by competent authority (USDA, FDA, EPA); may request further data or approve with conditions |
Approval and conditions | Notification of approval and any associated legislative processes | Public notification of approval with or without conditions for distribution, sale, and use; compliance with inspections and other requirements | Public notification of approval with or without conditions for distribution, sale, and use; comply with inspections, reporting, and transparency requirements | Approval and registration with conditions for distribution, sale, and use; comply with inspections and reporting of adverse effects |
Renewal of Authorisation | Process for renewing the authorisation after the initial approval period | Renew authorisation every 10 years | Renew GMO authorisation every 10 years | Renew permits and licences as required; comply with conditions and annual maintenance fees |
