Handling applications

Applicants are required to submit applications to regulators for permission to carry out certain activities with GMOs. The administrative process is designed to enable efficient handling of the applications so that decision making is undertaken with due consideration and the necessary information. The administration process is distinct from the decision-making process.

  1. Setting up an administration system
    Before receiving applications, a biosafety administration office needs to establish processes which could include those to:

    • implement the institutional structures established by the NBF
    • appoint and train staff for identified positions
    • draft more detailed guidance, where this is needed
    • set up internal procedures
    • publicise the system and
    • provide for pre-submission consultations, if required by applicants.

    Not all countries have a single biosafety administration office. Some countries have biosafety administration responsibilities in several government departments. Others have centralised their national biosafety administration into one office responsible for co-ordinated governance of biosafety issues over a number of government departments. The choice of framework reflects existing regulatory structures and the resources available for sustaining biosafety regulation. Regardless of which institutions are involved, most biosafety frameworks include some or all of the following bodies:

    • A national decision making body that reviews data on proposed GM activities and approves or rejects them on the basis of the regulatory policy.
    • A biosafety administration office that receives and processes applications for GM activities; carries out daily biosafety administration; and coordinates public input, risk assessment and decision making activities of the NBF. This office is usually responsible for issuing biosafety communication (information about biosafety) and for coordinating consultation with stakeholders about biosafety processes.
    • A scientific advisory body that carries out, reviews or audits risk assessments on GM activities and recommends what, if any, terms and conditions (risk management measures) may be needed to protect the environment and human health. This body may also advise on general biosafety issues.
    • An inspectorate that is responsible for inspections to ensure compliance with the regulations and which functions with, or in collaboration with, an enforcement authority.
    • A mechanism for public participation in policy development and/or decision-making.

    The location, composition, responsibilities and inter-relationships between these bodies will vary from country to country and will reflect the different legal systems used by individual countries.

    While the legislative instruments (acts, laws, orders, regulations) will have specified the institutions that form the NBF, establishing these new institutions may require submissions to ministers or permanent secretaries, calls for nominations, and official appointment of people to committees or boards for the institutions. The selection of staff may require advertisements for new posts; interviews for applicants, and the preparation of job offers and contracts when posts are fulfilled. These staff members may need office space, office equipment and training. Much of this can be incorporated within the responsible ministry, department or existing agency, but the process may need to be driven by a designated officer or individual who is officially allocated this responsibility

  2. Administrative steps in processing GMO applications
    When applications for GMO activities are received at the biosafety administrative office, they should be processed in a manner that is efficient and meets the needs and expectations of applicants and the general public, as well as any obligations under national legislation and international agreements. The administrative processes vary depending on the type of activity. To ensure an efficient review process, governments should provide clear guidance on the process and the information they require for each type of activity. Laboratory research, field development and testing, general (commercial) release and commodity imports frequently have different administrative requirements because they have different levels of risk. The available knowledge on specific GMOs is accumulated as the research and development progresses, meaning that there are different levels of information available at different stages in the GMO development.

    To deal with this variability the following basic steps follow the receipt of an application for GMO activity in many biosafety administrative systems:

    • Record receipt of the application
      • Use a document tracking system
    • Assess whether approval for the proposed activity is required, and whether the application meets the requirements of the regulations
      • Acknowledge receipt of the application or issue a letter requesting missing information needed to fulfil the requirements for review and decision making
      • Give the application a record number and enter its details into an administrative database linked to a document tracking system
    • Publicise the receipt of an application, if required
    • Call for public input, if required
      • Ensure that a public copy of the application that does not contain any confidential business information (CBI) is available for public review
      • Receive and document public input before directing this to the scientific review committee and/or the decision making body, as required
    • Arrange for a risk assessment review
      • Liaise with the scientific advisory body to convene a review committee with the correct scientific expertise to carry out the risk assessment
      • Where an application contains CBI ensure that confidentiality forms are signed and returned by the review committee before release of the application
      • Ensure that the risk assessment addresses safety issues raised by the public consultation process
    • Ensure that the appropriate experts assess socio-economic issues
      • Include review of socio-economic issues raised by the public consultation process
    • Where information is found to be missing or clarification is needed during the risk assessment process, or the socio-economic review process, request the information from the applicant
      • If necessary, schedule a meeting between the applicant and the scientific review body, or the socio-economic review body
    • Receive the safety recommendations from the scientific advisory body and forward these to the national decision-making body
    • Receive the socio-economic recommendations from the socio-economic experts and forward these to the national decision-making body
    • Call a decision-making meeting when the review recommendations are available
      • Be sure scientific and socio-economic experts are available should the decision-making body require clarification
      • Request additional information from the applicant, or ensure that the applicant is available to meet with the decision-making body to provide clarification, when needed
    • Receive the decision and prepare the decision document
    • Notify the applicant
    • Make decisions (risk assessments and decision documents) publicly available, on the national and international BCH
    • Schedule any necessary inspection(s) of release sites during and after the activity
      • Review the inspection reports and follow up as needed
    • Ensure that activity reports are received
      • Review the monitoring data to determine whether the terms and conditions need to be revised or the monitoring requirement can be removed
    • Manage any new information that is submitted on applications in the system
    • Manage applications for appeals and the appeal process
    • Manage unintended releases and other non-compliance issues
    • Arrange for decisions to be reviewed in response to new information
    • Monitor the BCH for GMO decisions that will impact on imports of food and feed, or may result in unintended transboundary movement
      • Alert the national competent authority when decisions in other countries are likely to impact on national food and feed imports, or unintended transboundary movement of unapproved GMOs in to the country

    How countries deal with administrative activities is determined by their national biosafety framework. Some countries have chosen a system that centralises receipt of GMO applications at a single office. Other countries have chosen to use existing regulatory agencies for plants, animals, medicines, etc., as entry points for applications and to harmonise risk assessment through a centralised biosafety review process.

    Even within these two major approaches there are numerous variations. In fact, almost every national biosafety framework is different in order to accommodate local regulatory structures and processes, and there is no ‘perfect fit’ model for administration of biosafety. All administrative systems have the potential to function efficiently if they meet the objectives of the regulatory framework, are cost effective, and are harmonised with existing regulatory process.

    Before an application for an approval is formally submitted to a national biosafety regulatory office, there can be pre-submission consultations between the applicant and the regulatory authority, to ensure that the application contains the required information and that the applicant clearly understands the processes for biosafety review and decision making. Pre-submission meetings have helped to streamline the administration of applications in many countries.

    Countries may use different terms for biosafety submissions, such as “request”, “application”, “dossier”, “submission” or “notification”. The format of the application may also vary. In many cases it will consist of a letter signed by the legal entity, together with an accompanying document containing the risk assessment information requested by the regulatory authority. The information in the application should be of publication quality, with all claims substantiated by references. Copies of these references are usually provided in electronic format on a DVD in the cover of the application. In most countries the applications are provided in electronic format for easy of storage, movement and reading. However, some regulatory offices require one hardcopy of each application for public access in the office. This copy does not contain any CBI and is prepared by the applicant. The references are usually provided electronically, even for the hard copy.

  3. Timeframes

    It is important to clarify the time period within which a decision has to be made and when the procedure for handling requests starts. The guidelines may establish time limits within which certain steps and decisions have to be taken. The CPB stipulates timeframes for specific decisions and these are provided below (Table 1). The timelines generally start at the receipt of an application.

    The time needed for various biosafety activities usually shortens as biosafety officers become familiar with the procedures and risks associated with specific GMOs and as they gain confidence in the effectiveness of the biosafety process.

    Table 1. Procedural timeframes obligated by the Cartagena Protocol on Biosafety.

    Regulatory activity

    Timeframe

    Reference

    Acknowledgement of receipt of notification and how to proceed with the first intentional transboundary movement of a LMO

    90 days

    Article 9(1)

    Communicate a decision on an AIA import notification

    270 days from date of acknowledgement

    Article 10(3)

    Take a decision on a GMO import for food, feed or processing (applicable to developing country Party or a Party with an economy in transition, in the absence of a domestic regulatory framework)

    270 days

    Article 11(6)

    Inform the BCH of a decision to approve a LMO for domestic use as food, feed or processing, including placing on the market

    15 days

    Article 11(1)

    Notify an applicant of a change in decision regarding a transboundary movement

    30 days

    Article 12(1)

    Party response to changed decision on transboundary movement

    90 days

    Article 12(3)

    Notification of unintentional transboundary movement likely to have significant adverse effect

    Immediate

    Article 17(1)

  4. Other administrative duties

    In addition to handling applications for activities with GMOs, biosafety administration offices carry out a range of other biosafety administrative duties that need to be factored into the time allocations and staffing of the office. These include:

    • Providing secretarial services to the national biosafety bodies, such as decision making committees and scientific review and other advisory committees
    • Having a procedure for dealing with accidents, emergencies and unintentional releases, which generally get priority over daily administration
    • Having procedures to handle new information that is submitted to the biosafety office about the safety of a previously approved GM activity
    • Administrating appeals against decisions made by the national authority.
    • Review the regulations and guidelines with respect to how they are working and whether changes are recommended.
    • Modifications or additions to guidance documents as new GMOs and related activities raise new biosafety issues that need to be addressed.
    • Ongoing liaison with stakeholders such as parliament, ministers, ministries, applicants, the public and regional and international biosafety meetings and conventions
    • Running the biosafety website and ensuring adequate communication
    • Ongoing training of the human resources used in the biosafety review process.      

    All of these activities can take up considerable administrative time and effort and need to be considered in the planning of national biosafety administration offices.

  5. Resource requirements for national biosafety

    Scientifically sound safety assessments and measures for safe handling of GMOs require human, financial, and information resources as well as an adequate infrastructure. Initially, when the biosafety office is dealing with the setting up of the biosafety structures and handling of one or two applications a year, the full quota of staff are not needed. However, once the biosafety office is fully functional and is assessing applications, resources would be required.

    Officials with formal responsibility for biosafety and who take decisions on proposed releases are, in essence, the gatekeepers who determine what biotechnology products, if any, will be allowed, and when. Those who have regulatory authority set the standard for testing and commercial release. The capacity and experience of these people may be the most important resource of all. Efforts to empower them and keep them well informed are worthwhile.

    The scope of scientific disciplines relevant to biosafety review is extensive. Expertise needs to be matched to each application taking into account the GMO, its use and the release environment. An administrator assesses the required expertise for each application and pulls together a team that has the expertise needed for the risk assessment. Whether these experts are voluntary or are paid will be determined by the policy in each country. Bearing in mind that a risk assessment review can take many hours or even days, especially for a new GMO, administrators need to spread the load across the available scientific community to prevent overloading specific individuals and to expedite the process.

    To be effective, the biosafety reviewers will need skills in risk assessment and risk management procedures in addition to their biological expertise. They will also need a broad understanding of the principles of inspections and monitoring. Training programmes, organised regularly by the biosafety administration office, help provide biosafety skills for existing and new reviewers. Past applications provide case studies to build experience and confidence in the risk assessment process. International training manuals and programs are available to assist with risk assessment and biosafety training.

    Scientific biosafety review teams require a significant amount of information and data on which to base their recommendations. Information to support safety assessments and recommendations is available from many sources and in a variety of formats: peer reviewed scientific publications, experts in relevant professional fields (e.g., breeders, agronomists, seed suppliers), conference proceedings, review articles, and colleagues working in local institutions. Decision documents from other national biosafety committees are a particularly rich source of information on identified risks and management options for particular GMOs and products.

    Feedback is a useful and often essential component for GMO trials and general releases. Trials are carried out to collect data of commercial and biosafety importance. Regulators can implement feedback mechanisms to ensure that findings and experiences from field trials are tabled for consideration by review teams. This keeps the reviewers informed of issues that arise during the trials and helps them to determine management procedures for future trials. This feedback also provides regulators with information to address concerns that may arise during or after the trials. It is essential for the regulatory authorities to be very precise about the data that they want collected and the acceptable methodology for doing this monitoring. Collecting data after general release approval can be requested as a condition of the approval.

    Ultimately the sustainability of any national biosafety system will be determined by its recurrent funding. To this end, developers of regulatory frameworks and administrative systems need to balance efficiency and effectiveness to ensure an affordable system that maintains high safety standards.

    Biosafety systems require implementation and running costs for effective compliance. The costs of establishing and operating a biosafety system include:

    • Education of policy makers and stakeholders
    • Development of regulations and guidance documents
    • Development and distribution of procedural information
    • Technical training for reviewers
    • Managing information and documentation
    • Administrative expenses of risk assessment and decision making reviews and meetings
    • Salary and support for employees
    • Pre-release site visits (if required)
    • Inspections of activities
    • Review of inspection reports for compliance
    • Training for inspectors
    • Review of processes and recording mechanisms, and
    • Training customs personnel on cross border movement of regulated materials.

    In some countries, applicants are charged fees to cover some of these costs. While this approach may be suitable for applicants from the private sector, where such costs are viewed as a normal part of product development, applicants from national research institutes, universities and other public sector organisations may find these regulatory costs prohibitive. Thus, in setting fees, regulators need to consider the constraints this will have on stakeholders and on access to new technology.

    Compliance costs refer to expenses incurred by the applicant in meeting regulatory requirements. Included are expenses for:

    • Generating data needed for the application
    • Financial losses resulting from delays in reguatory decision making
    • Implementation of risk management measures
    • Post-release monitoring prescribed as a condition of approval, and
    • Reporting and documentation.

    Part of achieving sustainability and effectiveness in biosafety requires balancing risk management measures with the level of risk. Similarly, the risk assessment and public consultation efforts should also reflect the level of risk. Initially public consultation costs may be high, but with time and a good regulatory track record, these costs are likely to decrease as confidence in the regulatory system and the technology grows. Some regulatory agencies with mandatory public consultation requirements have struggled to engage the general public on applications for activities that no longer raise safety concerns.

    [1] Adapted from Traynor, PL, Frederick, R and M Koch. 2002. A Workbook for technical training. Biosafety and risk assessment in agricultural biotechnology. ABSP. Institute of International Agriculture. Michigan State University. http://www.iia.msu.edu/absp/biosafety_workbook.html