Prior to receiving an LMO notification, risk assessors may need familiarise themselves with issues such as environmental protection goals, regulatory requirements and compliance of a national framework with the Protocol to gain an understanding of the general framework within which the risk assessment must be carried out to comply with international obligations, national laws and administrative procedures.
The biosafety framework of each country may address administrative matters by establishing mechanisms for (i) the selection of risk assessors and/or establishment of advisory bodies; (ii) handling confidential information (Article 21); (iii) public awareness and participation (Article 23); and (iv) if and how socio-economic considerations should be taken into account in the decision-making process (Article 26), amongst other things. The following sections of this module provide an overview on how some issues might be considered by risk assessors prior to undertaking a risk assessment.
2. The broad national context
Most countries have overarching environmental and public health strategies as well as national and international obligations that provide the broad context within which the risk assessment of LMOs is carried out.
2.1 National protection goals and assessment endpoints
Countries are sovereign in setting their own goals such as the protection of the environment, biodiversity or the health of their citizens. In so doing, they often adopt environmental and public health strategies as part of their national policy and legislation. These strategies, in turn, are often derived from, or compliant with, broader internationally agreed instruments.
Environmental and health policies and laws often define sets of “protection goals” or values to be protected. Some protection goals are defined broadly (e.g. conservation of biodiversity) while others are more specific (e.g. protection of a threatened or endangered species). Regardless of whether they are broad or specific, protection goals set the context for all (environmental) risk assessments.
|Example 1 – Biodiversity protection goal in the European Union
“To halt the loss of biodiversity and the degradation of ecosystem services in the EU by 2020, restore them in so far as feasible, while stepping up the EU contribution to averting global biodiversity loss.”
Council of the European Union (2010).
In addition to the protection goals, national legislations sometimes also define “assessment endpoints”. Assessment endpoints are valued biological or ecological entities that need to be protected and have some attribute that is measurable.
Ecological assessment endpoints, for instance, are most easily expressed in terms of impacts on a valued species (e.g. survival and reproduction of the yellow fin tuna). Any component, from virtually any level of biological organization or structural form that is recognized as an entity that needs to be protected, can be considered an assessment endpoint.
|Example 2 – Assessment endpoints
“An assessment endpoint is an explicit expression of the environmental value to be protected, operationally defined as an ecological entity and its attributes.”
US Environmental Protection Agency (1998).
Once a risk assessment has been triggered, the risk assessor(s) will need to identify the relevant protection goals and assessment endpoints when these are available. The risk assessor(s) then determines which assessment endpoints are meaningful to the specific case at hand to ensure that the protection goals will be adequately covered. For example, the regulatory framework of a country may identify “agricultural biodiversity” as one of its protection goals and the risk assessor(s) may be asked to consider, as an assessment endpoint, the abundance of a valued species, for example an insect pollinator, in the environment where the LMO may be released.
Selecting endpoints is among the most critical aspects when preparing a conceptual model for the risk assessment as it contributes to setting the stage for the risk assessment and the remaining steps of the process (see Module 3).
In conclusion, before undertaking a risk assessment of an LMO, risk assessors and other biosafety officers must understand national protection goals and the importance of deciding upon relevant assessment endpoints in order to plan a risk assessment.
2.2 Other national and international obligations
A country may have national laws and international obligations, such as trade agreements, that are not directly related to biosafety or to the environment but may influence how the risk assessor(s) will proceed once a risk assessment of an LMO is triggered. Such obligations may, for instance, affect establishing the scope of the risk assessment (see Module 3).
For examples of relevant international treaties and agreements see Module 1.
3. National biosafety context
3.1 National biosafety framework
Many countries address biosafety related issues through a large process that includes the development and implementation of a National Biosafety Framework (NBF). An NBF consists of a combination of policy, legal, administrative and technical instruments that are set in place to address safety for the environment and human health in relation to modern biotechnology.
In most cases, the administration of biosafety responsibilities is either shared by several government departments (e.g. environment, agriculture, health, science) or centralized and managed by one office which is responsible for the coordination of biosafety issues over a number of government departments.
The choice of framework most often reflects existing regulatory structures and the resources available at the national level for implementing the biosafety regulations.
There has been a significant increase in the number of countries that possess NBFs. A global initiative funded by the Global Environment Facility (GEF) and its implementing agencies helped this process by providing administrative and technical assistance to countries for developing and implementing their NBFs in accordance with their obligations under the Cartagena Protocol.
Countries’ requirements and priorities resulted in the development of national biosafety policies in a variety of forms. Some choose to develop a standalone policy on biosafety, whilst others formulated combined policies on biotechnology and biosafety. Some policies are part of wider policies on biodiversity conservation and environmental protection, trade related issues, biosecurity and quarantine, or established within the overall context of sustainable development or Agenda 21 (UNCED, 1992).
As of July 2009, through the GEF funded initiatives, 111 developing countries have completed the development phase of their National Biosafety Frameworks and made them available online.
3.2 Competent national authorities
While the NBFs consist of policy, legal, administrative and technical instruments, the institutional responsibility for decision-making and for risk assessments of LMOs usually falls to Competent National Authorities (CNAs). According to the Cartagena Protocol, each Party is to designate one or more CNAs to perform the administrative functions required by the Protocol.
Additionally, according to the Protocol, it is a Party’s obligation to clearly indicate, though the Biosafety Clearing-House (BCH), any existing laws, regulations or guidelines for implementation of the Protocol, as well as the names and addresses of its CNA(s).
The NBFs usually set out competencies and procedures depending on the LMO (e.g. the type of LMO or its intended use). As such, risk assessments may be assigned to different CNAs within the same country.
|Example 3 – Competent National Authorities in Mexico
In Mexico, for instance, depending on the LMO and its intended use, one or more of its CNAs (Ministry of Health, Ministry of Agriculture, Livestock, Rural Development, Fisheries and Food, and Ministry of Environment and Natural Resources) may be responsible for the risk assessment.
The options chosen by countries for the institutional setup of CNAs in each NBF include (i) a single CNA receiving and processing all requests regarding LMOs, or (ii) more than one CNA, each with different responsibilities and with either a single or multiple routes for the submission of applications regarding LMOs.
In cases when a Party designates more than one CNA, information on their respective responsibilities should be clearly stated and made available to the BCH. This information may include, for instance, which CNA is responsible for which type of LMO.
In most of the draft NBFs, developed by countries assisted by the UN Environment Programme (UNEP) as a GEF implementing agency, the responsibility of risk assessment has been assigned to the CNA(s) or the overall biosafety body, with or without advice from either an ad hoc scientific advisory body, or an established advisory committee.
|Example 4 – Competent National Authorities and National Biosafety Frameworks
While the competent national authority (or authorities) is responsible for carrying out administrative functions under the Protocol vis-à-vis other Parties, the decision-making process under a Party’s national biosafety framework for reaching a decision on the proposed import of an LMO is likely to involve a wide range of national authorities. The national biosafety framework should set out the domestic level procedure, including any necessary consultations, by which any decision on a proposed import will be taken.
IUCN (2003) An Explanatory Guide to the Cartagena Protocol on Biosafety.
National Biosafety Frameworks, when established, define the conditions that trigger the need for a risk assessment. Without prejudice to any right of a country to subject all living modified organisms to a risk assessment, under the Cartagena Protocol two specific cases require mandatory risk assessments prior to making a decision: a) the first intentional transboundary movement of a living modified organism for intentional introduction into the environment of the Party of import, and b) a final decision regarding the domestic use of a living modified organism, including its placement on the market, that may be subject to transboundary movement for direct use as food or feed, or for processing.
Upon receiving a request that triggers a risk assessment, the CNA takes several actions as part of a process to ensure that a scientifically sound risk assessment is carried out by risk assessors. These may include the following:
- Reviewing the LMO notification for completeness against a pre-determined list of information;
- Specifying the terms of reference of the risk assessment and the information expected in the final report;
- Identifying one or more risk assessors who will conduct and manage the risk assessment.
|Example 5 – Institutional responsibilities for risk assessment
– the National Biosafety Committee makes decisions, being advised by the Scientific Commission of the National Biosafety Committee. The scientific committee shall consist of seven members. The members of the scientific committee will be experts from the field of microbiology, genetics, medicine, biochemistry and molecular biology, pharmacy, agriculture, veterinary science, biotechnology and safety at work.
– The CNA is assisted in its work by a Scientific Advisory Committee, which is responsible for conducting risk assessment. In Grenada and the Bahamas, risk assessment is done by the national biosafety coordinating body. In addition to the Scientific Advisory Committee, St. Lucia’s CNA is supported in its work by a legislated entity called the Biosafety Unit. Staffing of the unit is also legally constituted and is comprised of the following: biosafety coordinator, information technology specialist, biosafety appraisal officer, public education specialist, administrative secretary and inspectors.
– An inter-sectoral National Biosafety Technical Working Group will be established with primary responsibility for risk assessment; decision making will be through the National Biosafety Technical Committee.
– Risk assessment will be the responsibility of an Expert Board under the National Biodiversity and Biosafety Center (NBBC). It will consist of experts from research institutions of the Academy of Science, Tajik Academy of Agricultural Science and Ministry for Healthcare. All these subdivisions have the relevant capacity, technical equipment and work experience.
– The Director for Department of Environment (the CNA) can specify the means by which scientifically-based risk assessments are to be carried out and appoint appropriate bodies to undertake risk assessments.
: UNEP (2006).
3.3 Risk assessment practices and principles
The risk assessment process includes practices and principles that may differ between countries.
As seen in Module 1, Annex III of the Protocol lists the general principles for risk assessment. Individual Parties use these general principles to guide the development and implementation of their own national risk assessment process. As such, the general principles for risk assessment may be incorporated into the country’s laws, or be included in guidelines adopted by the country.
|Example 6 – Risk assessment practices in various countries
, once an LM plant has been sufficiently field-tested, the applicant may request that the crop be ‘flexibilized’ that is, be approved for unconfined (usually large-scale) planting for certain specified uses. These are: (i) for regulatory purposes — to provide material for analytical, toxicological and other required tests; (ii) for export; (iii) for off-season seed increase — not to be sold in the country; (iv) for tests to be later presented (after approval for commercialization is granted) in support of new variety registration; or (v) for pre-commercial multiplication pending variety registration.
, the risk assessment audits for plants with novel traits (PNTs, which includes LMOs) are undertaken in offices of the Plant Biosafety Office of the Canadian Food Inspection Agency (CFIA; http://www.inspection.gc.ca/english/plaveg/bio/pbobbve.shtml
, a group of scientists, together with authorities from the Ministry of Agriculture, analyse the applicant’s risk assessment on the basis of national legislation. This group may request help from other experts to decide on an application. When the Ministry of Agriculture has become familiar with an LM crop, it may allow the applicant to increase the area planted for the crop but the applicant will have to continue to present the risk assessment as was done for the first application. Any biosafety measures for a semi-commercial release would also have to be maintained.
In New Zealand
, responsibility for risk assessment lies with the applicant based on the criteria in the legislation. Forms and guides assist applicants understand the intent of the legislative criteria. The Environmental Risk Management Authority (ERMA) evaluates the information provided and if required can seek further expert information or reports as appropriate. Low risk activities that conform to the requirements of the regulatory regime are not publicly notified. Some activities are discretionary for public notification while there are others for which there is a mandatory requirement for public notification (see ERMA’s website: http://www.epa.govt.nz
In the Philippines
, the National Committee on Biosafety for the Philippines audits the risk assessment on LMO activities and calls on the expertise of the Scientific and Technical Review Panel to provide an independent safety audit and recommendations.
In South Africa
, as a general guideline, if scientific reviewers consider a repeat activity of assessed risk to be one that does not differ from an earlier approved activity in terms of the nature of the LMO (host and modified DNA), the applicant, the release environment, the size of the release and the confinement conditions, they will consider a fast track procedure for approval.
In the United Kingdom
, the United Kingdom Advisory Committee on Releases to the Environment (ACRE) reviews the safety of LMO activities at the request of Ministers and makes recommendations on whether activities should proceed and what minimum risk management conditions are needed to minimize harm to the environment and human health (http://www.defra.gov.uk/acre/
In the United States of America
, the US Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS; http://www.aphis.usda.gov
) identifies specific activities where notification only is needed before an activity commences. The regulators review all of these notifications and can request full risk assessment review if they believe the activity differs sufficiently from the familiar to warrant this additional regulation. Risk assessments are audited within APHIS, the Environmental Protection Agency (EPA; http://www.epa.gov
) and the Food and Drug Administration (FDA; http://www.fda.gov
) depending on the nature of the LMO and its use.
: UNEP-GEF (2005).
4. Expert advice and the role of the risk assessor(s)
4.1 Scientific advisory body
In some countries the necessary expertise required to carry out risk assessments of LMOs resides in the regulatory agencies and the risk assessments are carried out internally. In such cases, these agencies typically have the option of requesting additional expert input if deemed necessary.
On the other hand, the regulatory frameworks of many other countries call for the establishment of scientific expert panels on an ad hoc basis once a risk assessment has been triggered. In such cases, a CNA assesses what expertise is needed for each specific case and pools together an external team of risk assessors consisting of experts in the relevant scientific fields. Such an advisory body may contain a pool of experts at the national, regional or international levels, who can be called upon to assist the mandated risk assessor(s) when a need arises. A scientific advisory body allows the CNA to quickly engage the appropriate expertise for a particular risk assessment. In cases when a CNA establishes a team or panel of risk assessors, it typically designates one of the risk assessors to coordinate the risk assessment process.
|Example 7 – How scientists are involved in the risk assessment process
National institutions responsible for a biosafety framework may include, for instance, a scientific advisory body that carries out or reviews a risk assessment and recommends what, if any, risk management measures may be needed to protect the environment and human health.
, experts who will conduct risk assessment will be chosen from a roster of experts that will be adopted by Government. In every case, experts will be selected separately.
, the Ministry of Agriculture, one of the CNAs for Biosafety, consults a group of scientists for advice on each request. The Inter-Secretarial Commission on Biosafety of Genetically Modified Organisms (CIBIOGEM; http://www.cibiogem.gob.mx
) also has a database of 350 experts in different disciplines from whom they can seek advice.
In New Zealand
, in addition to the in-house expertise of ERMA, an expert science panel of eminent researchers has been established and a roster of experts including overseas experts is maintained and is used as appropriate.
In South Africa
, the regulatory office has a database of over 60 scientists and experts used in risk assessment. However, not all of these experts are needed for every review. The reviewers all sign a confidentiality agreement with the regulators.
: UNEP-GEF (2005).
4.2 Responsibilities of the risk assessor(s)
National frameworks establish different types of responsibilities for the risk assessors. These responsibilities are usually specified in the terms of reference for the risk assessment and may include, for example:
- Review of the information provided in the LMO dossier, and in particular the information in the risk assessment provided by the applicant, if available;
- Identify any other relevant scientific information on the subject at hand, including previous risk assessments or new information that has come to light;
- Consider information gaps and scientific uncertainties and possible ways to address them;
- Conduct the risk assessment and prepare a report.
These actions are performed in a process that can be iterative. For example, it is possible that while the risk assessment is being conducted, a new piece of scientific information comes to light and reveals some information gaps that had not been previously identified. In such a case, it may be necessary to identify and engage additional sources of scientific expertise that should be included in the initial risk assessment panel or scientific advisory body.
In reviewing the LMO dossier or at any subsequent steps of the risk assessment, the CNA(s) or the risk assessor(s) may decide that further documentation is needed and may choose to request it from the applicant or to conduct or commission their own testing.
The risk assessor(s) in charge of leading the process is often responsible for the coordination of the expert panel or risk assessment team. Additionally they report the findings and disseminate relevant documents among other parties involved, including other stakeholders (see below), as appropriate, to ensure that information is shared properly and in a timely manner.
Parties to the Protocol shall ensure that they have procedures to protect confidential information as per Article 21 of the Protocol and in accordance with national legislation. As such, the risk assessor(s) is also required to respect any confidential business information indicated by the CNA taking into account that, according to the Protocol, the following information cannot be considered confidential: a) the name and address of the notifier; b) a general description of the living modified organism(s); c) a summary of the risk assessment highlighting the effects of the LMO on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and d) any methods and plans for an emergency response.
Once a scientific risk assessment is completed, the risk assessor(s) prepares a risk assessment report in accordance with the terms of reference established by the CNA. The report should be sufficiently detailed to provide the necessary scientific information to the decision makers (see Module 4).
4.3 Roster of Experts on Biosafety
To facilitate countries’ access to relevant expertise when needed, the Parties to the Cartagena Protocol on Biosafety established the “Roster of Experts on Biosafety”. The aim of this Roster is to "provide advice and other support, as appropriate and upon request, to developing country Parties and Parties with economies in transition, to conduct risk assessment, make informed decisions, develop national human resources and promote institutional strengthening, associated with the transboundary movements of living modified organisms".
Information on individuals listed in the Roster of Experts on Biosafety is accessible through the BCH at http://bch.cbd.int/database/experts
. As of August 2012, the Roster of Experts on Biosafety contained 130 experts from 41 countries.
4.4 Stakeholder participation
In the context of risk assessments of LMOs, stakeholders are all those with an interest or stake in biosafety, i.e. in the safe transfer, handling and use of LMOs in the country (UNEP-GEF, 2003).
While there is no direct mention to stakeholder participation in article 15 on Risk Assessment of the Protocol, article 23 requires that Parties consult the public in the decision-making process regarding an LMO.
Determining the extent to which the public and other stakeholders may be involved in the decision-making process is a prerogative of each regulatory framework.
Some countries have a mechanism that enables public participation during the risk assessment and/or decision-making process. For example, one of the CNAs in New Zealand- the Environmental Risk Management Authority (ERMA, http://www.epa.govt.nz
)- opens LMO notifications to public consultation on its website.
- Council of the European Union (2010) Press release: 3002nd Council meeting – Environment. Brussels, 15 March 2010. Available at http://www.consilium.europa.eu/ueDocs/cms_Data/docs/pressData/en/envir/113373.pdf (access June 2010).
- IUCN (2003) An Explanatory Guide to the Cartagena Protocol on Biosafety. Available at http://bch.cbd.int/database/record-v4.shtml?documentid=41476 (access June 2010).
- UNCED (1992) Agenda 21. Rio Declaration on Environment and Development, United Nations Conference on Environment and Development (UNCED), Rio de Janerio, Brazil, 3-14 June 1992. Available at http://www.un.org/esa/dsd/agenda21 (access June 2010).
- UNEP (2006) A Comparative Analysis of Experiences and Lessons from the UNEP-GEF Biosafety Projects. Available at: http://www.unep.org/biosafety/Documents/UNEPGEFBiosafety_comp_analysisDec2006.pdf (access May 2010).
- UNEP-GEF (2003) A Biosafety Framework Development Toolkit - Phase 0: Starting the Project. Available at: http://www.unep.ch/biosafety/old_site/development/devdocuments/TOOLKIT%202006%20Phase0.pdf (access May 2010).
- UNEP-GEF (2005) A Biosafety Framework Development Toolkit - Phase 3: Drafting the NBF - Designing the Administrative Systems for Handling Applications and Notification. Available at: http://www.unep.ch/biosafety/old_site/development/devdocuments/TOOLKIT%202006%20Phase3b.pdf (access May 2010).
- US Environmental Protection Agency (1998) Guidelines for Ecological Risk Assessment. EPA/630/R-95/002F. Available at http://www.epa.gov/raf/publications/pdfs/ECOTXTBX.PDF (access August 2012).