Stewardship and liability
Best practice and options to consider
- “Stewardship” has many different meanings. This guide defines it as the responsible management of an agricultural input from its initial creation, through its use and commercialization to eventual withdrawal from the market.
- Focuses on safety for researchers, the environment, and the food chain for humans and animals
- Seeks to achieve and maintain plant product integrity
- Works to prevent trade disruptions and improve the flow of goods
- Ensures full compliance with national and international legislation, and with contractual arrangements with other parties
- Operates a governance system and processes covering research, development, and commercialization
- Requires a “continuous improvement” approach
Stewardship and liability are of major importance to the private sector when considering potential PPPs and technology donations. They are a primary reason why in recent years industry has made only a few true technology donations for humanitarian use. This has been especially true in the case of GM technology.
Biosafety legislation and liability
Biosafety legislation and liability laws always require national government authorization for research testing and commercial use of crops produced using genetic engineering. This means that until a country issues a registration approval for cultivation and/or food and/or feed consumption, there is a clear legal responsibility and liability, even if the government scientific assessments show that there are no safety or environmental issues. In some cases the reach of these laws means that technology providers as part of the “chain of custody” can still be legally liable for damage, even if they are not involved with the research program or distribution of final products.
Best practice and options to consider
Private companies typically conduct a formal benefits-risk analysis when considering technology provision for humanitarian use in the public sector. Companies have often decided that lack of incentives, know-how and processes (for example in many African countries), combined with risks to future private sector business, fiscal liability, and reputation damage greatly outweigh the donation benefits. There are exceptions, but in these cases the private sector is usually providing capacity-building to enable and sometimes enforce stewardship within the research and development programs and their outputs. The SFSA recommends that prospective PPP parties review together the primary components of the benefits–risk case for both institutions, and seek risk-reducing and benefit-increasing solutions that enable technology access.
Reputation and financial damage.
The possibility of financial damage through fines, cost-recovery, and remediation is a very important consideration. Reputation damage is sometimes underestimated, but can be at least as, if not more, important when it results in loss of business. There have been cases in which private companies gave genetically modified seeds to poor populations as a donation. This looked to be a laudable humanitarian measure. However, media criticized the companies, arguing that poor populations granted free seeds become dependent on the donors. Although there were no financial consequences, this criticism clearly discouraged some private sector participation in PPPs. Another example is when genuine humanitarian gestures are reported to be “just another means of opening up new commercial markets”. Partners should review the potential for reputation damage, and identify risks in the business plan, so that these are fully taken into account as part of the terms of the PPP. Opportunities for the private sector to also improve their reputation through involvement in PPPs and by dedicated publications outlining their contributions and support should also be considered as part of the benefits and risk case.
Liability, biodiversity, and GMOs.
A new consideration for parties is the recently agreed international treaty on liability and redress. The Kuala Lumpur-Nagoya Supplementary Protocol to the Cartagena Biosafety Protocol establishes an internationally binding claim for countries importing GMOs to make the responsible producer in the exporting country liable for any possible damage caused by the imported GMOs. If cultivation of imported genetically modified plants is proved to have negative consequences for a country’s biodiversity and limits economic exploitability, the affected country is entitled to demand redress payments or reparations for the damage. The affected importing country is responsible for proving that its biodiversity was, in fact, harmed and that a specific imported GMO caused the damage. The Protocol comes into force when at least 40 states have ratified it. It will be open for signature at the United Nations Headquarters in New York from March 2011.
An important consideration for all parties is the closeness of involvement with work programs which could have liability questions. If problems do occur, typically the closer the parties’ involvement the more likely there will be demonstrable liability for claims. Parties need to review the amount of authorization and control that is appropriate and realistically possible, and how this influences legal liability. In any event, reputations will be affected. This may be a key incentive for involvement in capacity-building or product sign-off procedures.
SFSA encourages the public sector to be responsive to private partner concerns, and for both parties to agree to a stewardship strategy for the PPP maximize benefits and mitigate risks. Understanding the scope, implications, financial commitment, and actual implementation of stewardship best practice are required to enable more PPPs to be undertaken, particularly those involving agricultural biotechnology. The strategy needs to review both parties’ operational practices and contain the following components:
- Stewardship policy, processes, and procedures for research and development, responsible commercialization, launch, and discontinuation of biotechnology-derived plant products,
- Leadership roles and responsibilities assigned to individuals,
- Stewardship training and awareness programs for employees, contractors, cooperators, licensees, and growers,
- Communication networks for dissemination of information,
- Plant product or technology integrity. A clear process and standards defined to maintain integrity,
- Stewardship verification processes for internal and external operations,
- Third party contracts. Stewardship is included and applicable for subsequent licensing agreements,
- Incident management. Policy and process to manage any potential incidents involving biotechnology-derived plant products,
- Management reviews at milestones along the output product life-cycle,
- Regular updating of the stewardship strategy and activities so as to always reflect best industry practice.
Each PPP should establish an action-orientated program that will deliver the stewardship strategy. Best practice procedures use Critical Control Point Analysis to identify and minimize risks and loss of product integrity . Scientists, technical staff, or contractors doing the actual research work should write and follow the Standard Operating Procedures (SOPs). Each party should have stewardship policies, processes, and procedures in operation before seeking a PPP. However, if this is not the case, or funding is an issue, then it is recommended to include these in the PPP terms. Public sector funders, foundations, and non-governmental organizations (NGOs) need to be made aware of the essential importance and costs of institutional training for change management on stewardship. They also need to realize that these should be required as part of research proposals. Partners must embrace “stewardship thinking” as an integral part of running quality science programs in PPP.
Public and private sector parties should agree on a common set of standards for themselves and third-party contractors, integrate these into their policies and procedures, and implement them in practice.
SFSA is committed to supporting capacity-building on stewardship and product identity preservation. More information is available on best practice through the SABIMA project with FARA. For further queries, please contact Dr. Viv Anthony (SFSA) or Professor Walter Alhassan (FARA).
1 Excellence through stewardship: advancing best practices in agricultural biotechnology www.excellencethroughstewardship.org
3 ILSI (2004) A simple guide to understanding and applying th Hazard Analysis Critical Control Point concept by M. van Schothorst. ILSI Europ Concise Monograph Series. Third edition.