Impact of Biosafety Regulations:Alternative Communication Angle

Margarita Escaler PhDNational Institute of Education,

Nanyang Technological University, Singapore

Margarita Escaler PhDNational Institute of Education,

Nanyang Technological University, Singapore

Overview of Presentation

- Relevant facts about APEC (plus India and Pakistan) vis à vis 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

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

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

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

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

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

Number of GM crops authorized in APEC +2

Source: James, 2010

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

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

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?)

Major Corn Importing Countries in APEC

Sources: USDA and UN Commodity Trade Statistics Database In Bold: Major GM producing countries

Major Soybean Importing Countries in APEC

Sources: UN Commodity Trade Statistics Database and USDA

In Bold: Major GM producing countries

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)

Socio-economic Considerations

• 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

Source: Falck-Zepeda, 2010EXAMPLES

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)

Characteristics of a functional/protective biosafety system

• 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.

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

Trade Biotechnology Innovation

Potential Benefits

Sources: Bayer, Norton and Falck-Zepeda, 2008, 2010

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

Source: JRC Report, 2009

Future Outlook

Source: JRC Report, 2009

Theoretical combinations to produce new GM maize by stacking

Source: JRC Report, 2009

Source: JRC Report, 2009

Emergence of New Biotech Players

• 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

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

THANK YOU!