1. Model Act: Proposed Provisions for a Transparent, Effective and Workable Biosafety Regulatory Framework Stanley H. Abramson, Esq. Arent Fox Kintner Plotkin & Kahn, PLLC Laura van der Meer, Esq. International Environmental Resources SPRL

2. 2 Current Situation Parties to the Convention on Biological Diversity must ensure that they have appropriate biosafety measures in place. Countries that ratify the Cartagena Protocol on Biosafety without appropriate means for implementation may find themselves in non- compliance.

3. 3 Purpose of the Model Act To assist developing countries by providing legal provisions that may be considered in connection with the development of national biosafety frameworks and systems. To assist countries that wish to join the Biosafety Protocol to comply with its requirements. Model Act is the only reference currently available that is compliant with the Biosafety Protocol.

4. 4 The Model Act is an independent resource that: Provides a structure to assist with initial efforts to prepare new national biosafety frameworks or to consider what amendments might be required to existing laws; Helps governments to review and test concepts and provisions under consideration in existing national drafts; Can be readily adapted to suit local needs and utilized, in whole or in part, to meet national needs.

5. 5 Authorship and Peer Review Produced by two legal experts as a result of extensive review of the requirements of the Biosafety Protocol and existing national and regional laws and approaches to biosafety. Subject to an independent peer review process in which extensive comments from two internationally renowned legal experts were considered and addressed in the final version.

6. 6 Model Act Structure Part I. General Provisions Part II. Institutional Arrangements Part III. Notification and Authorization Requirements Part IV. Review Mechanisms Part V. Safeguards Part VI. Public Information, Awareness and Participation Part VII.Identification and Documentation Part VIII.Enforcement Part IX.Implementation Measures Annexes I: Information Required in Applications II: Risk Assessment III: Information Requirements for Notices to the Biosafety Clearing House

7. 7 General Provisions: Scope Applies to contained use, intentional introduction, and import/export of LMOs (GMOs) “that may have an adverse effect on the conservation and sustainable use of biological diversity, taking also into account risks to human health.” Does not apply to: LMOs that are pharmaceuticals for human use; LMOs in transit through but not destined for use in the adopting country; or Any other LMOs or categories of LMOs exempted under the Protocol or by the Competent Authority

8. 8 General Provisions: Definitions Track the Protocol to greatest extent possible: –Critical definitions of contained use, LMO, living organism and modern biotechnology maintained; –“intentional introduction into the environment” means any deliberate introduction that is not contained use, but does not include LMOs imported for direct use for food or feed or for processing. Interpretation of certain key concepts provided: –Clarifies that “risks to human health” focuses on potential adverse effects on human health that result from adverse impacts on the conservation and sustainable use of biodiversity.

9. 9 Institutional Arrangements Competent Authority (CA) –Responsible for administering the Act and promoting public awareness and education –Serves as National Focal Point Scientific Advisory Committee (SAC) –Scientific experts appointed by Competent Authority –Conducts and audits risk assessments –Reviews applications and notifications –Recommends risk management measures –Provides other expert advice and assistance as the Competent Authority may request

10. 10 Procedures for Contained Use Notification required 60 days before activity commences. Activity may only take place in facilities with adequate containment requirements and in conformity with regulations. Activity may commence if no response from CA. Decision must be made within 60 days where additional information is requested or a risk assessment is undertaken.

11. 11 Procedure for Intentional Introduction Application (Annex I) submitted to CA. CA reviews for completeness and acknowledges receipt within 30 days, stating whether application is complete or deficient. CA forwards application to SAC for review and audit of risk assessment and proposed risk management measures. CA provides SAC with RA Report. RA Report is provided to applicant for comment within 30 days.

12. 12 Distinctions in Decisionmaking for Intentional Introduction Intentional Introduction for purposes other than Placing on Market Decision within 120 days of receipt of application. Final decision to be published. Placing on the Market Public notice of proposed decision. Relevant comments submitted within 60 days taken into account. Decision within 270 days of receipt of application. Final decision to be published.

13. 13 Basis for Decision Final decisions must be based on: –Information submitted by Applicant; –Risk assessment report from SAC; –Applicant’s comments on SAC report; and –For placing on the market, any relevant public comments submitted within 60-day comment period. All final decisions must be recorded in a written decision document including: –Applicant and request; –Summary of review process undertaken; –Summary of risk assessment by SAC; –Decision and justifications.

14. 14 Exemptions and Simplified Procedures Competent Authority can act on its own initiative or in response to a petition. Options include: –Exemption of LMOs or activities that do not pose significant risk; and –Designation of categories of LMOs or activities that can proceed under notification rather than application process.

15. 15 Review Mechanisms CA may review any authorization or exemption based on significant new scientific evidence. Applicant may request review of prior decision based on: –Change in circumstance or –Additional scientific information. Independent entity must be designated to consider administrative appeals by applicants. Appeal to court of law permitted following conclusion of administrative process.

16. 16Safeguards Monitoring required for all regulated activities: –Must notify CA of new scientific information; and –Must provide additional information to CA on request. Unintentional Introduction –Notification required where significant adverse effects are likely. Cessation Orders can be issued in cases of: –imminent danger based on validated scientific evidence –failure to demonstrate substantial compliance with prior authorization or order of CA that results in material infringement of any provision of the Act or implementing regulations.

17. 17 Enforcement and Liability Enforcement –Authorizes appointment of inspectors with authority to enter and inspect and seize goods. –Violation of material provisions of the Act may result in fines consistent with those established for violations of similar laws. –Repeated, knowing violations may result in prohibition from activities involving LMOs. Liability and Redress –Liability and redress for any damage that occurs as a result of activities subject to the Act shall be addressed by applicable laws.

18. 18Summary Model Act intended to assist countries by providing one possible structure and some options for operationalizing Biosafety Protocol requirements based on workable regulatory systems already in existence. Act can help countries better evaluate draft laws or identify additional areas that need work. Individual country legal, cultural and environmental characteristics and needs are fundamental. Consistency with the Biosafety Protocol is critical.

19. 19Publication The full text of the Model Act may be downloaded at: www.arentfox.com/modelbiosafetyact.pdf Any questions or concerns as well as requests for additional information on the Peer Review process may be addressed to: ModelBiosafetyAct@arentfox.com