Transcript No Slide Title

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
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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 noncompliance.
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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.
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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.
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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.
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Model Act Structure
Part I.
Part II.
Part III.
Part IV.
Part V.
Part VI.
Part VII.
Part VIII.
Part IX.
Annexes
I:
II:
III:
General Provisions
Institutional Arrangements
Notification and Authorization Requirements
Review Mechanisms
Safeguards
Public Information, Awareness and Participation
Identification and Documentation
Enforcement
Implementation Measures
Information Required in Applications
Risk Assessment
Information Requirements for Notices to the Biosafety Clearing House
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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
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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.
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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
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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.
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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.
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Distinctions in Decisionmaking
for Intentional Introduction
•Decision within 120
days of receipt of
application.
•Final decision to be
published.
Intentional
Introduction
for purposes
other than
Placing on
Market
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.
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Basis for Decision
• Final decisions must be based on:
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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:
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–
–
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Applicant and request;
Summary of review process undertaken;
Summary of risk assessment by SAC;
Decision and justifications.
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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.
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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.
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Safeguards
• 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.
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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.
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Summary
• 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.
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Publication
• 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:
[email protected]