Impact of Biosafety Regulations: Alternative Communication Angle

1. Impact of Biosafety Regulations: Alternative Communication Angle Margarita Escaler PhD National Institute of Education, Nanyang Technological University, Singapore

2. Overview of Presentation • Relevant facts about APEC (plus India and Pakistan) • visàvis biotech/biosafety • Biotechnology regulatory systems in APEC + 2 • Differences in biosafety regulations across countries • Impacts of biosafety regulations • Current situation regarding biotech commercialization • Future outlook • Key communication messages

3. APEC + India/Pakistan • Varied group of countries which includes: • Large traders of agricultural commodities • GM producers and non-GM producers • Major importers and major exporters • CPB members and non-members • Developed and developing countries

4. APEC = 21 Economies • Accounts for half of the world’s grain production and over • half of the world’s GDP • Intra-APEC trade extremely important for member • economies which absorb over 72% of the bloc’s exports and • imports • Accounts for 54% of GM crops planted globally (80.4 • million hectares out of 148 million hectares in 2010) • 7 member economies currently growing GM crops; • 16 have food/feed or environment approvals • Public acceptance of biotech crops varies across economies

5. Biosafety Regulations in APEC + 2 • Most have regulations/laws in place that enable use of GM • crops to some degree (i.e. R&D, importation, cultivation) • Member economies are at different stages of development • and implementation • Most of them are being developed in line with the CPB • Varying regulatory capacities across economies • National regulatory systems address issues differently and • contain different components and characteristics • Large differences in import approval & marketing policies

6. Where the differences lie… • Biosafety Protocol parties and non-parties • Number of GM crops authorized in different countries • Product-based vs process-based regulations • Labeling regulations and tolerance levels • Policy on low-level presence (LLP) of unapproved events • Treatment of stacked events • Socio-economic considerations • Public participation

7. Biosafety Protocol Members • 1: GM producers; not members of CPB • (e.g. Australia, Canada, Chile, USA) • 2: Non GM producers; members of the CPB • (e.g. Indonesia, Japan, Malaysia, New Zealand, PNG, • Peru, ROK, Thailand, Viet Nam, Kenya) • 3: GM producers; members of the CPB (e.g. China, Mexico, • Philippines, India, Pakistan, Egypt) • 4: Not GM producers; not members of the CPB (e.g. Brunei • Darussalam, Hong Kong, Russian Federation, Singapore, • Chinese Taipei) Sources: Biosafety Clearing House; Gruere, G.P. and Rosegrant, M.W., 2008

8. Number of GM crops authorized in APEC +2 Source: James, 2010

9. Product/Process-based Regulations • Majority of APEC economies have adopted process-based • regulations • Exceptions are: e.g. Canada, Chinese Taipei, USA • Almost all are mandatory Sources: Ramessar et al., 2008; Gruere, G.P. 2006

10. Labeling Regulations & Thresholds • Mandatory and includes derived products • (e.g. China, Russian Federation 0.9%) • Mandatory labeling based on product content (e.g. Australia • 1%, New Zealand 1%, Japan 5%, ROK 3%, Chinese Taipei • 5%, Thailand 5%) • Voluntary for substantial equivalence (e.g. Canada 5%, Hong • Kong 5%, Philippines 5%, USA) • Mandatory but not yet implemented (e.g. Chile, Indonesia, • Malaysia, Viet Nam) • No labeling policy in place yet or pending legislation • (e.g. Singapore, Peru, Pakistan, India) Sources: Ramessar et al., 2008; Gruere, G.P. 2006; USDA GAIN Reports; Individual country websites

11. Policy on Low Level Presence (LLP) • Zero tolerance for unapproved products (e.g. China, Japan) • One country (Philippines) has adopted LLP policy and is • consistent with Codex (not yet implemented) • Majority of the economies have no dedicated LLP in place • (default zero tolerance?)

12. Major Corn Importing Countries in APEC In Bold: Major GM producing countries Sources: USDA and UN Commodity Trade Statistics Database

13. Major Soybean Importing Countries in APEC In Bold: Major GM producing countries Sources: UN Commodity Trade Statistics Database and USDA

14. Treatment of Stacked Events • No requirement for separate approval if traits being • combined were already approved individually (e.g. Australia, • New Zealand, Canada, ROK, Chinese Taipei, Mexico) • Treated as a single/new/unique event (e.g. Chile, Japan) • No articulated/written policy for risk assessment (e.g. Singapore, • Indonesia, Malaysia, Peru)

15. Socio-economic Considerations EXAMPLES Source: Falck-Zepeda, 2010 • USA and Canada - not part of the formal or informal • regulatory process; voluntary/additional information • Mexico - Biosafety Law and other related law instruments, • make specific references to the need of considering socio- • economic issues • Peru – Andean Community Regional Biosafety Strategy • considers socio-economic considerations that may be • adopted by member countries that are developing their • own laws and regulations • China – final commercial approval lies in central gov’t • which may consider socio-economic impacts (e.g. on foreign • trade) • Philippines – EO514 includes as one of its principles taking into • account social, economic, cultural and ethical considerations

16. Public Participation • Most regulatory systems include the ability for public to • comment before a decision is made on a GMO application • Differences: length of time, the degree of participation, at • what stage of the decision-making process (R&D, • environmental release or importation) • Examples: • Philippines – all stages of the decision-making process • Australia/New Zealand – two rounds of public comment • (6 weeks) • USA – only during commercialization decision (60 days)

17. Characteristics of a functional/protective biosafetysystem • Comprehensive • Adequate legal authority • Clear safety standard • Proportionate risk-based reviews • Transparent and understandable • Participatory • Post approval oversight • Flexible and adaptable • Efficient, workable and fair Source: Jaffe, G. 2006.

18. Impacts of Biosafety Regulations • Over-regulation can result in any of the following: • Time delay (asynchronous approvals) • High cost of regulatory compliance • Regulatory uncertainty and unpredictability • Significant impact on public sector R&D particularly in • developing countries Biotechnology Innovation Trade Potential Benefits Sources: Bayer, Norton and Falck-Zepeda, 2008, 2010

19. Current Situation re GM crops • Global adoption of GM crops expanding since 1996 • In 2010, 148 Mha; 29 countries; >15M farmers • Record 87-fold increase in area between 1996 • and 2010 • 30 commercial events at present • 4 most important crops: soybean, maize, cotton • and canola • 2 most dominant traits: HT and IR Source: James, 2010; JRC Report, 2009

20. Future Outlook Source: JRC Report, 2009

21. Source: JRC Report, 2009

22. Theoretical combinations to produce new GM maize by stacking Source: JRC Report, 2009

23. Emergence of New Biotech Players Source: JRC Report, 2009 • By 2015, 44% of commercial events will come from Asia, particularly from China and India • Isolated Foreign Approvals (IFA’s) will become more common and therefore increase potential for more LLP issues

24. Key Communication Messages • Widespread use of GM crops is a reality – No turning back! • Introduction of new GM events is accelerating – 90 by 2015 • Regulatory systems will be subject to an increasingly large and • unmanageable workload based on today’s systems • Biosafety delays can have a negative impact on trade, biotech • development/innovation = foregone potential benefits • Calls have been made for simpler, workable and fair regulatory • processes, mutual recognition of other country’s decisions, • regional harmonization, practical polices on LLP, etc. • WITHOUT • compromising health and safety (and well-being) of humans and the environment

25. THANK YOU!