Recommendations

At the day long consultation organized on March 1, 2006 by RIS in collaboration with Ministry of Environment and Forest (MoEF) and All India Crop Biotechnology Association (AICBA) following points emerged during the discussions.

Liability and Redress
The Cartagena Protocol on Biosafety (CPB) provided an opportunity to address environmental and other concerns. The Protocol enables to address even minimum risk from the potential harm of Living Modified Organisms (LMOs) to the environment and human health. The issue of liability and redress arises from LMOs and its products where damage results through transboundary movement, is possible. So, in the context of the Protocol concerns damage from the transboundary movement of LMOs.

Points emerged during discussion

Drawing attention to the balancing act of benefits that are likely to develop, one thing became clear in the whole discussion, that although developing the national position in implementation of legislation should have short-term and long-term questions to be answered but the imports particularly illegal or disguised that will take place is something for which really need to be done on an urgent basis. It is also important here to realize the gaps in the national legislation viz. a viz CPB.


Damage
• In the presentation on these issues, it was suggested to confine assessment to biodiversity only. However, there was also an emphatic suggestion to include socio-economic aspects in the damage assessment as one of the key criteria.

Standard of Liability
• There was an elaborate discussion on the potential or actual damage scenarios and application of international rules and procedures on liability and redress to the damage scenarios.

• The elements of rules and procedures on liability and redress, including definition and nature of damage, valuation of damage to biodiversity and to human health and plant, threshold of damage, roles of Parties of import and export and standard of liability need to be considered.

• There was detailed discussion on whether a strong national legislation is sufficient or an effective international regime may also be required to support the national initiatives.

Standards of liability

• There was an opinion expressed that fault based liability may be opted as standard for the liability regime. However, this position should be backed with good case studies having short term and long-term experiences in perceptive but meanwhile India may opt for case by case approach for approval.

• Similarly, more studies are needed to draw distinction between strict and absolute liability along with the instances enumerated.

• Agronomic; biodiversity; health and food safety as standards for liability assessment.

Issues in Handling and Transboundary Movement

The Protocol aims to ‘ensure an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, taking into account the risks to human health, and specifically focusing on transboundary movements’.

Points emerged during discussion

Issues for CoP- MoP- 3 for LMO- FFPs

• Threshold for adventitious or intended presence of LMOs to trigger identification requirement

• Threshold for unapproved LMOs

• Harmonization of sampling and detection technique

Type of Document Accompanying LMOs

• Stand alone
• Commercial in-voice
• Existing documentation

Stand-alone Document
• Column 14, Type of intended use:

- Commercial:
Need to specify whether it is for consumption/ industrial purpose ((LMOs – FFP)

- Research :
Need to specify whether it is for lab work or glasshouse/ limited field trials

Compliance Mechanism: Issues and Options
Section VI of the procedures and mechanisms on compliance provide for measures to promote compliance and address cases of non-compliance. The Conference of the Parties serving as the meeting of the Parties to the Protocol identified and adopted various measures that the Compliance Committee, which was established by the same decision, may take with a view to promoting compliance and in response to cases of non-compliance. In taking such measures the Committee is required to take into account the capacity of the Party concerned and such other factors as the cause, type, degree and frequency of non-compliance (section VI, paragraph 1).

Points emerged during discussion

• Biosafety rules are at divergent level of implementation. Therefore the compliance mechanism in different country would be so divergent that uniform compliance regime may not work.

• Issues of non-Parties at compliance mechanism.

• Need to linkage and conflict in international rule and regulation among different MEAs.

• Establish Technical Benchmarks at national level and CPB compliance be judged against them.

• Time frame should given for the Party to implement the Protocol.

• Compliance mechanism through multilateral process with the participation of NGO and stakeholders.

• Three approaches for non-compliance mechanisms in different MEAs: rigid, moderate and soft approach. Accordingly a strategy for CPB be worked out.

• Multilateral effort for capacity building.

Other Points
• EPAPQ OrderFood Safety Bill
Biotech Develop Strategy (DBT)
Harmonisation of domestic legislations.

• Codex and WTO: conflicts:- Mandatory & Voluntary Labelling

• Do we have GM trade policy and focus preferences we require notified labs for international standards.

• Multiple LMO events used in some crops.
18.2 (a): BCH; “May contain”

- Terminology
- Risk Assessment Methods
- Traceability
- Documentation and standards

• System of continuous dialogue and research