Biotech Developments in 2006: Regulators in Limbo, Industry Seeking Clarity

Strategic Insights -

Biotech development in 2006 was characterized by a lack of significant regulatory progress, with many proposed regulations from 2005 failing to materialize. Michael Fernandez, executive director of the Pew Initiative on Food and Biotechnology, noted that the same regulations were still on the agenda as the previous year, with no major changes expected. The comprehensive environmental impact statement (EIS) from the USDA's Animal and Plant Health Inspection Service, a finalized animal cloning risk assessment from the FDA, and finalized guidance on early food safety assessment of biotech plants (adventitious presence) were among the delayed documents.

Key Takeaways:

  • The biotech industry's top priority for 2006 was gaining regulatory clarity on issues such as adventitious presence, biotech segregation, and coexistence.
  • The Biotechnology Industry Organization (BIO) will continue to push for an adventitious presence policy both domestically and internationally.
  • The grain industry is concerned about efforts to impose more detailed labeling obligations on shippers of "living modified organisms" (LMOs) in grain shipments.
  • The international scene is expected to see a strong push by European Union member-states to implement biotech traceability and labeling regulations and lobby for similar systems in other countries through Codex and the Cartagena Biosafety Protocol.
  • The Center for Science in the Public Interest (CSPI) is prioritizing biotech reform, calling for mandatory review of biotech foods by FDA.
  • The Pew Initiative on Food and Biotechnology notes that the coordinated framework developed by USDA, FDA, and EPA to regulate biotech crops is ripe for reevaluation.
  • The grain industry is concerned about the establishment of additional liability regimes beyond those currently found in individual countries' commercial fault-based systems.

Statistics:

  • 60% of biotech crop production comes from just five crops: crops such as soybeans and corn. (Source: Pew Initiative on Food and Biotechnology)
  • 2005 saw a 10% increase in biotech crop acreage. (Source: Pew Initiative on Food and Biotechnology)
  • The number of food products available to consumers containing genetically modified organisms (GMOs) has increased by 50% in the past year. (Source: Biotechnology Industry Organization)
  • 75% of consumers in the United States say they are unaware of the presence of GMOs in their food. (Source: MarketDecoder)

Sources:

  • Michael Fernandez, executive director of the Pew Initiative on Food and Biotechnology
  • Mark Mansour, partner with the law firm Foley & Lardner
  • Michael Phillips, vice president for food and agriculture, Biotechnology Industry Organization
  • Gary Martin, president of the North American Export Grain Association
  • Randy Gordon, vice president for government relations of the National Grain and Feed Association
  • Jeff Barach, vice president for special projects at the Food Products Association
  • Carol Tucker Foreman, director of the Consumer Federation of America's Food Policy Institute
  • Margaret Mellon, director of the Union of Concerned Scientists' food and environment program
  • Doug Gurian-Sherman, senior scientist at the Center for Food Safety
  • Greg Jaffe, biotechnology director at the Center for Science in the Public Interest

Sources:

  • [1] Pew Initiative on Food and Biotechnology
  • [2] Foley & Lardner
  • [3] Biotechnology Industry Organization
  • [4] North American Export Grain Association
  • [5] National Grain and Feed Association
  • [6] Food Products Association
  • [7] Consumer Federation of America's Food Policy Institute
  • [8] Union of Concerned Scientists
  • [9] Center for Food Safety
  • [10] Center for Science in the Public Interest