Bio-Safety Protocols - HCIA

1. 1 Bio-Safety Protocols - HCIA Governor's Temporary Advisory Commission on Bioprospecting Office of Hawaiian Affairs Adolph Helm and Paul Koehler Hawaii Crop Improvement Association

2. 2 Presentation Agenda HCIA and crop biotechnology Bioprospecting and Biotechnology Safety protocols re: Field testing Review evolution of the current regulatory process Coordinated Framework of federal and state agencies Question and answer

3. 3 HCIA � brief perspective Seed industry established in Hawaii during the late 60s Five companies on four islands Dow/Mycogen, Syngenta, Pioneer, Monsanto, HARC Utilize ~8,000 ac, and harvest ~4,000 ac annually Seed corn accounts for ~95% of the total value $144 M of economic activity annually through direct and indirect (multiplier) inputs 16.6% average annual growth over the past 10 years Employing 1,000 employees plus ~1,000 indirect Second largest agricultural commodity statewide (NASS/HDOA) Pineapple ($79.3M), Seed crops ($70.4M), Sugarcane ($58.8M) Source: Tom Loudat, May 2006 http://www.nass.usda.gov/hi

4. 4 Corn planted across the US

5. 5 Impact of biotech crops: US

6. 6 Growth of biotech crops: Worldwide

7. 7 Scientific groups endorse GM crop safety �To date, no adverse health effects attributed to genetic engineering have been documented in the human population.� US NAS http://nap.edu/catalog/10977.html �Thus far, in those countries where transgenic crops have been grown, there have been no verifiable reports of them causing any significant health or environmental harm.� FAO, United Nations http://www.fao.org/es/esa/en/pubs_sofa.htm �The BMA shares the view of the Royal Society that there is no robust evidence to prove that GM foods are unsafe. However, we endorse the call for further research and surveillance to provide convincing evidence of safety and benefit.� BMA http://www.bma.org.uk/nsf/Content/GMFoods/$file/GM.pdf

8. 8 Bioprospecting and Biotechnology Bioprospecting does not equal biotechnology Both involve the use of advanced technology Concerns & fear about unnatural, perhaps being unwise Must weigh the risks and benefits associated with each Bioprospecting does frequently use advanced biotechnological processes and techniques, eg; Searching for desirable characteristics (hits) in a plant or animal genome and cloning the gene(s) Sequencing the gene(s) to help determine and understand gene(s) function Introducing the gene(s) into a plant or animal cell Source: Bioprospecting: Issues and Policy Considerations, Jan. 2006 Legislative Reference Bureau; Peter Pan, Researcher http://www.state.hi.us/lrb/rpts06/biocon.pdf

9. 9 Evolution of US Regulatory Oversight 1970s & early 80s, transgenic plant technology began to emerge & need for guiding principles 1986: Office of Science & Technology Policy (OSTP) published �Coordinated Framework for the Regulation of Biotechnology� Involves one or several groups; USDA, EPA & FDA USDA � ensure new plant varieties are safe to introduce Administered through APHIS and BRS EPA � ensure new pest resistant varieties are safe to grow FDA � ensure new plant varieties are safe to consume Source: http://www.aphis.usda.gov/biotechnology/brs_main.shtml

10. 10 Evolution Regulatory Oversight, cont�d USDA/APHIS/BRS/HDOA further responsibilities; BRS biotechnologists consider and consult with the HDOA in reviewing all proposed field trials Consider the State�s unique ecology, and environment HDOA can require additional recordkeeping and reviews each application from BRS and can require additional planting requirements and restrictions on a case by case basis Depending on the field trial, sites can be inspected many times to insure requirements are being followed 2004; APHIS conducted 79 inspections of permitted field tests and 148 inspections of field trials approved through notification process During 10-year period, overall compliance rates exceeded 98% Source: http://www.aphis.usda.gov/biotechnology/brs_main.shtml

11. 11 Notifications and Permits - defined Notification Most GE plants are regulated under this process May be used for plants and traits that meet certain low risk safety-based criteria Developer must test in a way that meets specific requirements from APHIS/BRS and HDOA Permit Generally more restrictive, used for specialized GE traits Used when GE plant could pose an elevated level of risk Number of field tests in Hawaii 1988 to 2005; 1,855 field tests; 1,767 notifications; 88 permits Source: http://www.aphis.usda.gov/biotechnology/brs_main.shtml

12. 12 Reviewing applications for field trials Team of BRS biotechnologists and other experts check application and data for completeness If more information is needed, it is requested Confinement measures are reviewed and established Can include; distance isolation, time isolation, washing and cleaning of equipment, windbreaks, removal of tassels, tilling and irrigation of harvested fields to remove viable plant material multiple times and more�. HDOA also requires added recordkeeping In addition to plant, pollinate and harvest dates & the above Any changes to field test site including thefts & vandalism Presence of endangered or threatened species Source: http://www.aphis.usda.gov/biotechnology/brs_main.shtml

13. 13 Keeping pace with advances in biotech USDA/APHIS/BRS revised regulations in 1993, 1997, 2003 and 2006 Stricter confinement measures and greater oversight BRS established Office of Science to ensure that APHIS biotech related regulations are grounded in the latest science Office of Science helps BRS remain informed about the latest scientific knowledge useful for the development of regulatory policies One primary responsibility is to oversee the peer-reviewed process for the scientific information used as the basis of APHIS� regulatory policies and decisions Source: http://www.aphis.usda.gov/biotechnology/brs_main.shtml

14. 14 Summary Seed industry is a major part of Hawaii�s diversified Ag sector Coordinated Framework in place USDA, EPA, FDA and HDOA Covered by laws and regulatory systems of federal & state govnm�t Rigorous and evolving with time Changes have been made to strengthen the process 98% compliance record for the past 10 years Mechanism in place (Office of Science) to keep BRS informed of the latest advancements in science