POLST 362.3 The IPE of Biotechnology

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POLST 362.3 The IPE of Biotechnology

• Lecture 7
• Regulation

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POLST 362.3

• Introduction
• Remember, IPE involves two broad areas of
  inquiry
• Gains/losses for a state from International
  Integration
• Governance of International Integration
• Next two lectures focus on related policy issues
  
• Promotion
• Regulation

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• Regulation has multiple goals
• public good failures health and safety
  environmental safety
• common pool goods property rights
• market failures competition law
• social reasons income distribution, ethics,
  social impact

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• The risk analysis challenge
• Health and safety and environmental
  sustainability
• Conventional Risk Hazard x Exposure
• New Risk Hazard x Exposure x Outrage
• Hazard assessment challenge
• Exposure management challenge
• Outrage communication challenge
• RA complicated by probabilistic, hypothetical and
  speculative science

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• Domestic regulatory systems
• Uneven/incomplete regulatory systems
• Health assessments international scientific
  consensus but limited capacity to assess re diet
• Environmental control 88 signed CBD 75 have
  quarantine 48 seed certification and 20 seed
  quality 72 have research base (13 basic 38
  developing 21 advanced)
• Many in Africa/Asia have limited technical
  capacity

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Dueling regulatory models
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• Canadas regulatory system
• reflects NA model
• highly integrated sometimes hard to identify
  where public oversight ends and private action
  takes over
• takes 2-7 years to satisfy

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Fuzzy line between public and private regulation
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• EU making efforts to open system
• ban since October 1998
• scientific studies released in 2001
• 2001/18/EC prosecutions of 7 states
• measures to extend labeling/traceability
• EU FSA
• 2010 vision for life sciences/biotech

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• Possible WTO challenge of EU
• EU suspended approvals since 1998 some approvals
  in abeyance against EU decisions
• EU requires labeling above 0.9 but moving to
  traceability some countries ban GMOs
• EU has not conducted risk assessment recent
  studies do not support bans/labels no basis for
  the 0.9 tolerance based on science

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• Potential outcome of WTO challenge
• EU at risk for all three points
• Absence of international consensus through Codex
  or IPPC could weaken US case
• If EU loses, it could try to implement interim
  ban/labeling as precautionary measure and do RA
• EU might ignore decision (hormones case precedent)

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• Biotechnology and trade
• 40 modifications involving 13 crops approved
• 130 million acres in 13 countries in 2001
• GM production concentrated (99 in US, Argentina,
  Canada and China) in exporting countries (up to
  88 of trade from GM producers)
• Up to 177 countries could be importing GMOs
• Most of exports for food, feed and processing and
  not for propagation

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Global GM production and trade
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• GMO presence in foods
• Some say up to 70-80 of foods has GMOs
• recent work in Canada shows
• 38 of all foods GM free due to categories (dry
  pasta, flours not containing corn or flax, most
  fruits and vegetables, TOFU)
• 62 could have GM elements but only 11 likely to
  have detectable proteins--either proteins
  removed, altered or never there

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Domestic labeling systems
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• Some consensus on labeling
• all currently require detection (EU proposing
  traceability)
• some products exempt (e.g. additives, active
  ingredients, highly processed foods)
• Tolerances range from 0-5
• Widely differing enforcement systems
• Codex having terrible time finding consensus

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• International regulatory response
• Seven institutions attempting to develop rules
  for international trade
• developing standards
• developing testing protocols
• developing rules and DSMs
• Problem is there is no common view on the goal of
  international regulation

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• IPPC/OIE/Codex Alimentarius
• Establish mostly science-based standards for
  plants, animals and foods
• Takes time to develop standards (6 years in
  Codex)
• Provide non-binding dispute avoidance system
• Provide technical expertise to WTO in SPS and TBT
  cases
• Nominate experts for WTO dispute panels

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• World Trade Organization
• SPS standards allowed if and only if
• fit with MFN and national treatment
• conform to international standards (e.g. IPPC) or
  use scientific principles and risk assessment
• not act as disguised barrier
• TBT impact uncertain
• Binding dispute settlement no precaution
• Risk that WTO handling of GM questions will spill
  over to other issues first GM food case

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• Regional Initiatives/OECD
• Harmonization projects to make regulatory
  processes more transparent and efficient
• Focus on creating common science base for review
• RIs EU-US, US-Canada, EU-Japan, EU-Canada
• OECD 14 consensus documents related to biology
  food safety conference procedural efforts
• Limited by regional/developed country focus

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• BioSafety Protocol
• Requires advanced informed consent for first
  movement of LMOs for propagation, based on
  scientific risk assessment
• Commodity trade must be notified
• Uncertain impact with socioeconomic and
  precautionary elements no DSM
• Capacity building in LDCs vital

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• Possible regulatory approaches
• Broad-based issues seldom negotiated in narrow
  institutions rather consensus can be base for
  regulation in institutions
• All use scientific risk assessment
• All make decisions by consensus
• All but BSP regulate products not processes
• Patchwork arrangements may be only option

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• Other regulations
• markets administered domestically but some
  extraterritoriality
• intellectual property rights domestic but
  extended to WTO via TRIPS
• competition law in patent laws and anti-trust
  legislation nationally but no international
  effect
• social objectives distribution of benefits,
  ethical or social conformity domestically
  handled but some effort to extend internationally
  through
• BSP
• UNDP

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• Conclusions
• Regulation has become highly complex, integrated
  and laden with multiple expectations
• significant potential for regulation to appear to
  be promotion or strategic