Guideline for the administration of biosafety applications by X973L5E

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									               AFRICAN BIOSAFETY NETWORK OF EXPERTISE
        AFRICAN UNION - NEPAD PLANNING AND COORDINATING AGENCY




         GUIDELINE FOR THE ADMINISTRATION OF
               BIOSAFETY APPLICATIONS




October 2010
      African Biosafety Network of Expertise (ABNE)
      Guideline for the Administration of Biosafety Applications




                                                         Contents
ACKNOWLEDGMENTS ........................................................................................ 4
1 INTRODUCTION ................................................................................................. 4
1.1 Purpose of this guideline ............................................................................................... 4
1.2. Using this guideline....................................................................................................... 4
   1.2.2. Terminology used in this guideline ......................................................................... 5
1.3. Administration and national regulatory policies ....................................................... 6
2. QUALITY MANAGEMENT SYSTEMS............................................................... 6
2.1. Guidance ........................................................................................................................ 7
2.2. Documentation .............................................................................................................. 7
2.3. Training ......................................................................................................................... 7
2.4. QMS inspection and audit ........................................................................................... 8
2.5. QMS review ................................................................................................................... 8
3. HANDLING APPLICATIONS ............................................................................. 8
3.1. Setting up an administration system........................................................................... 8
3.2. Administrative steps in processing GMO applications ........................................... 10
   3.2.1. Receipt of an application ....................................................................................... 12
   3.2.2. Screening for completeness ................................................................................... 13
   3.2.3. Public participation ................................................................................................ 16
   2.2.4. Risk assessment ..................................................................................................... 17
   3.2.5. Confidential business information ......................................................................... 18
   3.2.6. Dissemination of documents ................................................................................. 19
   3.2.7. Risk assessment ..................................................................................................... 19
   3.2.8. Decisions ............................................................................................................... 20
3.3. Timeframes ................................................................................................................. 21
   Table 1. Procedural timeframes obligated by the Cartagena Protocol on Biosafety. ...... 21
3.4. Other administrative duties ....................................................................................... 21
3.5 Resource requirements for national biosafety .......................................................... 22
   3.5.1. Managers ............................................................................................................... 22
   3.5.2. Government officials and decision makers ........................................................... 23
   3.5.3. Scientists ................................................................................................................ 23
   3.5.4. Information access ................................................................................................. 24
   3.5.5. Feedback mechanisms ........................................................................................... 24
   3.5.6. Financial support ................................................................................................... 25
4. DECISION MAKING ........................................................................................ 26
4.1. Factors considered in national decisions .................................................................. 27
   4.1.1. Applications for contained use .............................................................................. 27
   4.1.2. Applications for confined field and clinical trails ................................................. 28
   4.1.3. Applications for general release ............................................................................ 28
   4.1.4. Applications for import of GM commodities ........................................................ 30
4.2 Decision documents ..................................................................................................... 31
4.3. Biosafety Clearing House ........................................................................................... 31
5. MONITORING .................................................................................................. 31
6. INSPECTIONS AND ENFORCEMENT ............................................................ 32
6.1. Applicant reporting requirements ............................................................................ 33



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      Guideline for the Administration of Biosafety Applications



6.2. Inspection reports ....................................................................................................... 34
6.3. Training inspectors ..................................................................................................... 34
6.4. Skills required for biosafety inspection .................................................................... 34
6.5. Enforcement ................................................................................................................ 35
   6.5.1. Legal authority for enforcement ............................................................................ 35
   6.5.2. Administrative tasks for enforcement.................................................................... 35
   6.5.3. Roles and responsibilities ...................................................................................... 35
7. CONCLUSION ................................................................................................. 36
7.1. Continuous improvement .......................................................................................... 36
7.2. Qualities of biosafety administrative systems .......................................................... 37
7.3. Reviewing biosafety administration .......................................................................... 38
8. SOURCES FOR BACKGROUND INFORMATION .......................................... 39
APPENDIX 1 ........................................................................................................ 40
Guidance for Document Tracking Codes ........................................................................ 40
APPENDIX 2 ........................................................................................................ 43
Sample SOP for Handling Applications .......................................................................... 43




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Acknowledgments
This manual was derived from many excellent sources, some of them no longer
available on project websites. The sources that are still available are provided at the
end of the manual. Special mention is made of two other sources, the Implementation
Manual from Central and Eastern European Biosafety Project and the first draft of the
Administrative Toolkit from the UNEP-GEF Project on Development of National
Biosafety Frameworks.

1 Introduction
1.1 Purpose of this guideline

National biosafety offices have a wide range of responsibilities. These include the
general administration of biosafety processes in the country, development of biosafety
policy, staff training, outreach and training for stakeholders and the public, interaction
with regional and international stakeholders, and keeping politicians informed about
national biosafety.
The biosafety review process involves a large volume of documentation, movement of
documents and tracking of input and responses from many stakeholders. Add to this the
requirement for securing confidential business information and the legal nature of the
decisions that will derive from the biosafety reviews, and it becomes clear that the
national biosafety office needs to be well managed and functional in all aspects of its
administration.
This guideline has been developed to assist national biosafety offices with the
implementation of their national biosafety frameworks (NBF). The guidance should be
adapted to national requirements. It also could be adapted to facilitate the handling of
applications for regional reviews. This guidance document introduces quality
management systems (QMS), how they relate to biosafety administration and how to
structure a QMS for the administration of applications in a national biosafety office.


1.2. Using this guideline
The aim of this guidance document is to provide practical advice for countries as they set
up and implement an administrative system for national biosafety. Administrative
systems for handling applications, decision-making on GMOs, monitoring, inspections
and enforcement of biosafety decisions form a central pillar of any NBF. Countries
wishing to enable access to genetically modified biotechnology tools will need to set up
an appropriate administrative system that builds on existing systems, and is able to
implement the regulatory system required by the national biosafety regulations and
policy.

This guideline covers the following aspects of an administrative system for biosafety:
          Quality management systems (Section 2)
          Handling applications (Section 3)
          Decision making (Section 4)


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          Monitoring (Section 5)
          Inspection (Section 6).
This module does not provide detailed guidance on risk assessment and risk management
as these functions are addressed by specific guidance materials.
The guideline is designed to be used by many countries and so it is general in nature and
recognises that different countries will use approaches, legal instruments, and
terminology that are best suited to their own situation. For this reason, the guideline
illustrates key activities and does not take into account the individual circumstances of
every country. Countries are encouraged to adapt the materials to reflect their national
policies and to add aspects and approaches that will meet their particular needs, priorities
and situation.

1.2.2. Terminology used in this guideline
An attempt has been made to use general terminology so as not to prejudge what
approach a country may decide to take.

      Application is used to cover all forms of notification or submission to the
       regulatory authority for permission to carry out activities with genetically
       modified organisms (GMOs).
      Applicant is used to describe an individual or institution that will notify or apply
       to regulatory authorities in the country when a particular GMO, or an activity
       involving a GMO requires notification or prior authorisation under the national
       regulatory policy.
      Confined use describes the research and development of GMOs in short term
       field or clinical trials that are managed to minimise impact on or persistence in
       the environment.
      Contained use describes the research and use of GMOs inside a facility that is
       designed to minimise the release of living organisms into the environment.
      GM activities is used to describe activities that could be carried out with GMOs
       in the course of their development, testing and use. Not all countries will require
       permission for all activities.
      General release describes the approved, general use of a GMO with no or
       minimal regulation. Also termed ‘unconfined release’, and approvals may
       have some conditions.
      Genetically modified organism (GMO) describes a plant, animal or microbe
       derived through recombinant-DNA techniques. The term, living modified
       organism (LMO) has been used where discussion focuses on the Cartagena
       Protocol on Biosafety.
      GM product is used to describe non-living products that are derived from
       GMOs.
      Inspection describes the check for compliance with regulatory conditions for
       activities with GMOs. This may include the review and investigation of facilities,
       materials and documents related to GMOs.


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      Monitoring describes the scientific collection of biosafety data to support
       biosafety decisions. It also describes the systematic measurement of the effects of
       GMOs over time.
      National biosafety framework (NBF) describes the national structures
       established by legislation to implement a biosafety regulatory process in a
       country.
      Unconfined release describes the approval for the general use of a GMO with no
       or minimal regulation. This is also termed ‘general release’, and may have some
       conditions for use appended to the approval.

1.3. Administration and national regulatory policies

 The components of an NBF are interdependent. The national policy on biosafety
 provides the rationale for the development of a regulatory system for biotechnology
 and guides how decisions will be made regarding the development, testing and use of
 GMOs. The regulatory system forms the basis for the administrative systems for
 handling applications and decision-making, systems for follow up and compliance, and
 mechanisms for public awareness, education, participation and access to information.
 In developing a regulatory system to suit the requirements of a country, the relevant
 government bodies must develop and implement administrative systems that will
 enable them to carry out the day-to-day activities required by the legislation. In many
 cases, these can build on the current systems rather than creating new, stand alone
 entities.
 In developing a biosafety administrative system, countries need to analyse their
 biosafety policies and to understand how administrative systems function in existing
 regulatory agencies. Countries may find it more effective, to build onto an existing
 administrative system rather than to create something new. However, the choice of
 how to develop the administrative system will depend on each country’s particular
 situation, needs and priorities.

2. QUALITY MANAGEMENT SYSTEMS
Quality management systems (QMS) are widely adopted in business and the public
sector to help ensure timely, accurate and consistent implementation of day-to-day
functions. The QMS are specific to each function in an organisation and are
comprised of the following components that keep them current and useful where they
are deployed:
      Guidance
      Documentation
      Training
      Inspection
      Auditing
      Review.


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One of the biggest benefits of QMS for the public sector is the institutional memory
that the systems establish. The public sector is plagued in many countries by a highly
mobile workforce, which leaves critical positions unmanned from time to time.
Establishing a QMS for biosafety administration will enable a biosafety framework to
keep functioning with minimal disruptions when key personnel move to new
positions.

2.1. Guidance

The guidance for QMS generally comes in the form of manuals, such as this one, and
includes standard operating procedures (SOPs) that detail the work processes that are
to be conducted or followed within the organisation. The SOPs document the way
activities are to be performed and should be made available to all personnel to
facilitate consistent performance and institutional memory to cope with the movement
of staff. This documentation helps to maintain quality control and can provide quality
assurance processes for all of the important actions in the national biosafety office.
While general guidance documents are available, it is important that they are adapted
to be specific to the organisation or facility where the functions are performed.
Importantly the guidance should reflect the national biosafety policy and the
authorisation under which the activities are being implemented. This helps to ensure
compliance with governmental regulations and policies.

2.2. Documentation

Documentation of specific actions is important for maintaining adequate records of all
activities in the national biosafety office. This documentation is most often formatted
as a set of forms that are completed as activities progress. These forms can be used to
demonstrate that the national biosafety process is being managed in compliance with
the regulations and the documentation can be examined by regulatory personnel and
auditors to help investigate and understand problems should these arise. Importantly,
to ensure that the documentation system remains viable and is implemented readily by
biosafety personnel, it should be reviewed annually to see where improvements can be
made.
In most countries regulatory documentation is handled electronically. Thus the basic
electronic backup and disaster recovery systems are important, as is the security to
ensure that the files and records are only accessed by authorised personnel.

2.3. Training

All personnel involved with biosafety administration should be properly trained to
ensure that they understand their responsibilities and are able to:
      Handle applications and administrative activities properly
      Keep records that are accurate and correct, and
      Take appropriate actions in the event of problems arising.




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The training should review all the QMS that will be used by personnel and they
should have access to copies of all the relevant guidance documents and standard
operating procedures. However, this documentation should not be considered a
replacement for face-to-face training of personnel and all training should be recorded
to ensure that staff members are updated regularly on the latest processes. It can be
useful to combine training with the review of current systems, so that problems can be
identified and addressed and improvements can be implemented.

2.4. QMS inspection and audit

Inspection and audit systems are valuable where regulatory compliance is essential or
where quality assurance levels affect the functioning and economics of a process. In
the public sector, maintaining a high level of service and keeping within appropriate
timelines may require regular inspection during the implementation stages of a
biosafety administrative process and QMS development.
Auditing involves the appointment of an external expert to review the QMS in an
organisation and to recommend where improvements are needed and where changes
could facilitate the functionality of specific activities. Many governments have
existing public sector auditing processes that could provide this review process for
biosafety regulation.

2.5. QMS review

It is recommended that SOPs, forms and training curricula are reviewed annually to
ensure that they are updated and functional. Outdated documentation and reporting
systems for QMS can become obsolete and cumbersome. This leads to non-
compliance with the measures and can result in a breakdown of the processes. Annual
reviews are usually undertaken by the personnel who use the QMS and are
coordinated by management to ensure that the recommendations for renewal are
implemented in a timely manner.

3. HANDLING APPLICATIONS

3.1. Setting up an administration system

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.
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


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      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.
Once the administrative office is established, a review of the regulatory
documentation would help to determine where more detailed guidance is needed. For
example, it may be useful to create standard formats (forms) for easy submission of


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applications for the different types of activities that are regulated. It may be necessary
to discuss and allocate internal administrative responsibilities, and establish internal,
written SOPs for the various activities that will form part of the daily tasks of the
biosafety office. Establishing a website which allows access to all the documentation,
and an explanation of the purpose and functioning of the biosafety office, is a valuable
output of the setting up process.
Finally, it will be necessary to publicise the existence of the office to related ministries
and decision makers, as well as applicants, stakeholders and the general public. It is
likely that even before these activities have been completed, the office will have to
deal with applications. This may mean that the development of the system runs
parallel to its implementation.

3.2. 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
           o Use a document tracking system
       Assess whether approval for the proposed activity is required, and whether the
        application meets the requirements of the regulations
            o Acknowledge receipt of the application or issue a letter requesting missing
              information needed to fulfil the requirements for review and decision
              making
            o 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
            o Ensure that a public copy of the application that does not contain any
              confidential business information (CBI) is available for public review




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       o 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
       o Liaise with the scientific advisory body to convene a review committee
         with the correct scientific expertise to carry out the risk assessment
       o Where an application contains CBI ensure that confidentiality forms are
         signed and returned by the review committee before release of the
         application
       o Ensure that the risk assessment addresses safety issues raised by the public
         consultation process
   Ensure that the appropriate experts assess socio-economic issues
       o 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
       o 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
       o Be sure scientific and socio-economic experts are available should the
         decision-making body require clarification
       o 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
       o Review the inspection reports and follow up as needed
   Ensure that activity reports are received
       o 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



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      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
           o 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.

3.2.1. Receipt of an application

When an application is formally submitted to a national biosafety office, it is recorded and
assigned an identifying or tracking number that will be used to distinguish this application
from all others. Assigning a tracking number is the responsibility of the biosafety
administration office and is useful for systematically keeping track of requests, and of the
status of their administrative and technical progress through the national system. All


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records relating to the applications are stored under the tracking number, which is used to
make information readily available to interested parties. At this time it is useful to open a
tracking record for the application to time and track its movement through the various
stages of the review process. Additional guidance on tracking numbers is given in
Appendix 1.
Using a searchable electronic database enables easy location and sharing of specific
information. The format for the database is determined by the country authority. The
design of this database should facilitate easy information sharing of risk assessment reports
and decision documents with the interested public and with the international Biosafety
Clearing House. The biosafety office needs to ensure that access to the full database is
restricted to only authorised personnel.
Having recorded the application, an acknowledgement of receipt can be issued to the
applicant. However, some regulatory processes first require that the application is checked
for compliance with the information requirements of the regulations before sending the
acknowledgement. In this case, the acknowledgement is sent out only after the next step is
completed, i.e., screening for completeness to ensure that the application meets the
information and legal requirements for submissions (Section 3.2.2).
For countries that are parties to the CPB, the obligations for Advance Informed Agreement
(AIA) notifications require that acknowledgement of receipt is issued within 90 days of
receipt of the application. This acknowledgement of receipt must state whether the
notification fulfils the information requirements, or whether more information or review
time is being requested. In cases where these timeframes are being followed, the
acknowledgement of receipt can state when the application review process officially
begins and when it is likely to be completed.

3.2.2. Screening for completeness

Where regulations stipulate the information that needs to be submitted with an application,
it saves time to assess whether the application meets these requirements before proceeding
with the review and decision making. This is usually the responsibility of an
administration officer and can be facilitated by an information checklist. The checklist can
be part of internal procedure documents. Information requirements for applications vary
according to the proposed activity, the level of risk and the regulatory regime, so the
checklist will need to distinguish between activities.
Screening an application for completeness requires answering a number of questions:
   1. Is it clear who the applicant is and what the request is for, i.e. who wants to do
      what, why, when and where?
   2. Do the proposed activities require an approval under national biosafety law?
   3. Does the application comply with the information requirements laid down in the
      national regulatory system for this type of activity?
Typically information requirements can include the following:
      Administrative data, such as name and contact information of the applicant;
         whether the organism will be imported and what, if any, regulation has covered
         the development of the organism to date.



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         Biology Document, that describes the growth, characteristics and uses of the
          plant, microbe or animal in the release environment. Some regulatory authorities
          make country-specific biology documents available on the regulatory website.
          Mostly, these biology documents are developed by the applicant and the draft is
          submitted with the application. The biosafety office has new biology documents
          reviewed and approved by the regulators before they are posted on the website.
          The OECD provides consensus biology documents1 that are a useful start to
          developing country-specific documents that relate to the release environment and
          local uses.
         Core Characterization, which describes the GMO, the type of activity and the
          receiving environment. This information should be sufficient to initiate the risk
          assessment and be relevant to the planned activity (contained, confined,
          unconfined use, import, export, transit, etc.). Information requirements are
          frequently detailed in guidelines or regulations, and will vary from one GMO to
          the next. This requires that the detailed information requirements are provided in
          ‘living documents’, that can be changed to include new information needs as and
          when the need arises without having to wait for Ministerial or parliamentary
          approval. Thus, guidelines are often used to outline information requirements.
          In addition, while conducting the risk assessment review, it may be necessary to
          request additional information or clarification of information provided with the
          original application.
         Environmental Characterization, which describes the interaction of the GMO
          with the receiving environment and can include sections on how the comparator
          was chosen for the safety assessment studies; the phenotype of the GMO; its
          cultivation or use in the country; interactions with sexually compatible relatives;
          residual effects and impact on non-target organisms; and any other environmental
          interactions that may be relevant. The number of seasons of trials and number of
          trial environments will depend on the GMO and its biology and use in each
          country. These are important requirements that should be clarified by the
          regulators and the regulatory scientific advisors and can be discussed at pre-
          submission or planning meetings with the applicant.
         Detection and identification information provides a detection method capable of
          distinguishing the GMO from other organisms of the same species. This is not
          needed for contained or confined research, but may be a requirement for confined
          commercial production or unconfined activities such as general release
          (commercial or public sector) to farmers or industry.
         Food and feed use approval information is often requested for general release
          and information will be required on biosafety components reviewed for this
          usaage of the GMO. If the national biosafety office has a single entry point for
          all aspects of the biosafety review then the requirements for food and feed safety
          review will need to be included in the available guidance documents.
         Special management considerations, which may be necessary for specific
          GMOs, such as insect resistance management plans, integrated weed

1
 OECD consensus biology documents:
http://www.oecd.org/document/51/0,3343,en_2649_34387_1889395_1_1_1_1,00.html


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             management plans and stewardship plans to address market segregation,
             transboundary movement and/or prevention of trade disruption.
            Post-release monitoring plan, if this is needed for assessing specific
             environmental uncertainties raised by the risk assessment for a general release
             application.
            Payment of the application fee, where this is a requirement.

Guidelines may contain ‘checklists’ that can assist both the applicant and the biosafety
officers in the evaluation for completeness of both administrative and technical
information. A sample checklist for administrative completeness is given in Table 1.
Table 1. A checklist for assessing administrative completeness of applications.
NN= not needed
(This is an example that should be adapted to reflect the requirements of the national regulation for GMOs)
Information category      Activity
                          Contained    Confined    General     Food &       Export      Export     Export
                             use         use       release      feed          for      for food      for
                                                               import      research     & feed    planting
Applicant details and
signature
Description of activity                                                       NN
and GMO
Molecular                    NN         Vector;                               NN
characterisation                        Method
Environmental risk           NN           NN                                  NN         NN
assessment
Food & feed risk             NN           NN                                  NN
assessment
Proposed risk                                                               Packag-
management conditions                                                         ing
Site map and                                         NN          NN           NN         NN         NN
infrastructure details
Stewardship plan             NN           NN                                  NN         NN         NN
Detection and                NN           NN                                  NN
identification method
Recipient details for        NN           NN         NN
shipping
Socio-economic               NN           NN                                  NN         NN         NN
assessment
Advanced informed            NN                                               NN
agreement

When an application does not fulfil the information requirements, additional information
should be requested from the applicant. In such situations, the procedural ‘time clock’ may
not start until the information is received, or may be stopped until the information is
received.
The conclusion that a certain application complies with the information requirements, does
not mean that additional information may not be requested by the reviewers or decision
makers through the national biosafety office. Requests for additional information can be


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made during the screening for completeness stage as well as during the risk assessment,
socio-economic analysis and decision making processes. Reasons for ‘stopping the review
clock’ need to be stated in the guidelines and it may be useful to include provisions for
applicants to ask for a ‘pause’ in order to collect new information or to verify existing
information.
There can be an overlap in information requested during “screening for completeness” and
technical information requested during the risk assessment review. Technical information
requirements depend on the nature of the GMO and the development stage of the activity.
An application for a new GMO will have less2 biosafety data than an application for a
GMO already approved in other countries. Similarly, an application to place a GMO on
the market usually contains more biosafety information than a request to move a newly
developed GMO from a laboratory to a greenhouse for further testing. Regulators need to
ensure additional information requests are realistic in terms of being available and being
relevant to the assessment requirements for the activity and the level of risk posed by the
GMO.
As soon as it has been established that an application complies with the information
requirements, and acknowledgement of receipt should be sent, if not already done, and the
application can be processed for review and decision-making.

3.2.3. Public participation

Many regulatory systems allow for public consultation during their GMO decision making
process. In those countries where public participation is a requirement for policy making,
but not for decision making on specific applications, this section need not be included in
administrative guidelines for handling applications.
Where public participation and/or notification is required, it is necessary to ensure that the
public has been informed and invited to comment when an application is entered into the
review and decision making process. Mechanisms for obtaining public input vary from
country to country and the national legislation and regulations should form the basis for
how this is carried out. Importantly, a standard operating procedure for obtaining and
processing public input, should be established to ensure that the mechanisms and end
points are well defined.
In preparing guidelines for public input, it is valuable to note that some applications will
trigger a wide range of comments and input, while others may trigger a few general
objections to the technology, with no specific comments about the proposed activity. As
regulatory systems adopt electronic handling of applications and public consultation, there
is a danger that communities may missed out on opportunities to respond to activities
planned in their neighbourhood. In some countries, regulators establish mailing lists of
interested and affected parties to ensure more focused outreach for public input. In all
cases, it is important to style public communication in an easily assessable format,
including the use of local languages and non-technical wording.
The sustainability of the public participation in decision making on GMOs is dependent on
the cost-effectiveness of the consultation, and it is important to consider who will be

2
  Newly developed GMOs are first tested for efficacy before the complex task of biosafety data collection
is undertaken. As such, early trials have less biosafety information on the GMO than trials approaching
general approval.


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required to fund the process of information output and feedback from the public. It may be
difficult for many developing country governments to fund public consultation on
applications. While some private sector applicants may be able to fund these activities,
many government research institutes in developing countries may find it difficult to cover
the costs of pubic participation. Some government institutes in developing countries
already have programmes that consult the public on new technology, and these may be a
cost-effective option for consultation on biosafety applications.
Having ensured that the interested and affected public are informed of the proposed
activity, the biosafety administrator needs to collate public feedback for the decision
makers. Where public concerns include safety issues, the administrator may wish to
forward these to the scientific advisory body for risk assessment and recommendations
before the final decision is made. Socio-economic concerns raised by the public should be
reviewed by socio-economic advisors to the decision making body. These are frequently
experts in the ministries that are represented on the NBF.

2.2.4. Risk assessment

National policy and legislation determines which activities need to have a risk assessment.
The types of activities with GMOs that may have risk assessment requirements include:
      Import and export of GMOs including for food and feed use
      Transit
      Contained use (e.g., for research and teaching, development, scale up or
       production and use)
      Confined use (e.g., for field or clinical testing and development, or for
       production and use)
      General release (e.g., for unconfined commercial or non-commercial
       production and use)
The types of activities that are regulated is determined by the NBF in each country.
During the implementation of a national biosafety process, many applications will require
an initial risk assessment, as they will be new to regulators and to scientific reviewers.
Some countries exclude contained use for research and teaching from a risk assessment
review procedure, but ensure that the facility is registered and inspected Many countries
require that a written risk assessment is available for inspection to ensure that risk
assessments are carried out for all new GMO activities within a registered facility.
As regulators gain familiarity with specific GMOs and the level of risk they pose, this
leads to a situation where repeated reviews of the risks are unnecessary unless some
significant change has occurred in the activity or the GMO since it was previously
reviewed. While the regulators will still need to be notified that the activity is continuing,
they may be comfortable with issuing a permit without repeating a full risk assessment.
This permit would have the same terms and conditions for safety as were used with the
earlier permits. This leads to what is called a ‘fast track’ process where the decision
makers may decide to apply simplified procedures for familiar activities that have a low
risk.




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In the case of fast tracking, the applicant is required to notify the regulator that an activity
will be carried out and provide sufficient information about any changes to protocols of
GMOs to enable the regulator to trigger inspections or a risk assessment as required.
Where an activity is deemed to require a risk assessment review under the national
legislation, the administrators must ensure that this happens. In many countries the
biosafety administration office determines what scientific expertise is needed to review the
application and assess the risks and risk management conditions needed. The
administrators establish a review team for each application. This team may consist of two
to four experts who, together, can understand and critically assess all aspects of the
activity. Applications for general release may have review teams of more experts, as food
and feed safety must be assessed for these decisions. In some countries the necessary
expertise resides in the biosafety regulatory bodies and risk assessments are carried out
internally. These biosafety review bodies generally have the mandate to request additional
expert input as they deem necessary.
There should be requirements that scientific reviewers declare any conflict of interest if
they are asked to review an application in which they have a personal, professional or
economic interest. This is necessary to maintain the independence and credibility of the
review process.
Having identified the scientific review committee for each application, the administration
office is responsible for meeting the requirements of confidential business information, the
dissemination of documents to all the reviewers and the organisation of meetings for
review groups, if these are necessary.

3.2.5. Confidential business information

As a result of the innovative nature of modern biotechnology, some of the business and
research applications have technical, business and efficacy data that applicants may wish
to keep confidential, in order to maintain a competitive advantage in the market place or to
protect their right to patent the technology if the GMO or procedures prove effective.
Therefore, many NBFs make allowance for applicants to identify business information that
they wish to keep confidential and they have mechanisms in place to protect such
information. The type of information that may be kept confidential is sometimes specified
in the national regulatory regime. The accepted criteria for confidential business
information should be stated clearly in guidance documents. Regulators may require
applicants to substantiate why certain information needs to be kept confidential.
In most cases the applicant is allowed to mark information that they wish to keep
confidential and the regulator assesses whether this meets the requirements of the
regulations. If the confidential information is acceptable, the administrators, reviewers and
decision makers are bound not to release the information. All people with access to
confidential business information should be required to sign confidentiality agreements
when they accept biosafety regulatory responsibilities.
If the regulators do not accept that the identified information should be kept confidential,
they should have a consultation with the applicant to review the request for confidentiality.
If, after the consultation, the applicant wishes to withdraw the application rather than
reveal confidential information, they should be given the option to do so.
In general, the following information is not kept confidential:


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      The name and address of the notifier
      A general description of the LMO
      A summary of the risk assessment; and any risk management requirements.
When confidential business information is accepted in an application, it is marked as such
in all documents distributed to reviewers and decision makers. In this way the information
is not withheld from regulators and should not affect their ability to regulate the activity.
When a regulatory system makes applications available for public review, the applicant is
usually asked to provide a copy of the application with the confidential business
information removed, but marked. This copy is usually provided in electronic and hard
copy and the administration office needs to ensure that it is the only copy that can be
accessed by the public. By indicating where confidential information was deleted, it keeps
the public informed and upholds the rights of the applicant.

3.2.6. Dissemination of documents

The dissemination of copies of applications for review can be one of the most time
consuming and costly activities of a biosafety administration office. Many regulatory
offices now deal with the application documents in an electronic form, which greatly
minimises the time and resources needed for this activity. However, the distribution of
electronic documents is difficult to control and regulators need to ensure that confidential
copies are deleted from the computers of the reviewers and decision makers at the end of
the review period. This requirement can be stipulated in the confidentiality agreement that
is signed and returned to the biosafety office before reviewers and decision makers receive
the applications.
Regulatory offices in many countries function under very tight resource constraints.
Where electronic document dissemination is not feasible, regulators sometimes ask
applicants to provide the required hard copies for the reviewers and the decision makers in
order to facilitate the distribution of documents. The confidentiality agreements requiring
the return or destruction of applications also apply to hard copies. The regulatory officers
need to follow up with reviewers and decision makers to confirm that the deletion and/or
destruction of copies of applications has happened after the review.

3.2.7. Risk assessment

From an administrative point of view the responsibility for ensuring that the risk
assessment takes place usually rests with the biosafety administration office. The
procedures and minimum requirements for risk assessment and risk management are laid
out in national regulatory legislation, regulation and guidelines.
When applications are for new GMOs or activities, it may be necessary to schedule a
meeting for the scientific reviewers to discuss the application, carry out a risk assessment,
and identify acceptable risk management procedures.
During the risk assessment, scientists may identify gaps in the data or questions that they
wish the applicant to address. Mechanisms for this are usually outlined in national
biosafety guidelines. Some systems allow the reviewers to hold transparent meetings with



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applicants to address these issues. Others require the reviewers to address these questions
and data needs in writing to the applicant through the biosafety administrative office.
When additional information is requested the regulator usually stops the procedure clock
and gives the applicant a reasonable amount of time to submit the information before
resuming the review and restarting the clock, or considering the application as withdrawn.
This clock stopping is important where timeframes are established for specific regulatory
activities (see section 3.3). For reasons of efficiency and transparency, requests for
additional information are best made in writing and should be specific and scientifically
justified.
The outcome of the risk assessment consists of recommendations or advice for the
decision-making body. The administration officer needs to receive the risk
assessment recommendations, including a summary of the risk assessment and send
these to the decision making body within the timeframe for decision making.
Once reviewers are familiar with certain GM activities and GMOs, e.g., when the
same GMO is being repeatedly assessed for the same use and released in the same
location, then the risk assessment procedures may be simplified and attention can
focus on the risks posed by any new traits or changes to the methodology of the
activities. The decision to simplify risk assessment reviews for specific GMOs is
usually taken on a case-by-case basis with the approval of the competent authority and
in accordance with the requirements of the regulatory policies.

3.2.8. Decisions

The regulatory policies determine how decisions are made. Decision makers take the
risk assessment recommendations into consideration and they may also consider socio
economic impact and other issues allowed by the regulations, such as national
imperatives and benefits. Some regulations require the consideration of alternative
technologies that may address the same issue, or a comparison with existing practices.
The decision should include the risk management measures that are needed to carry
out the activity and should contain the summary of the risk assessment that was
prepared by the review team.
Once the decision-makers have made a decision about a specific application it is
usually the responsibility of the administration officer to
      compile a decision document
      notify the applicant
      issue a rejection letter, permit or other form of approval, with or without terms
       and conditions
      make the decision public
      make the decision available to the Biosafety Clearing House
      confirm that distributed copies of the application have been returned, deleted
       or destroyed
      schedule inspections



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          review inspection reports, and
          review activity reports.
The requirements and formats for these activities are usually detailed in national
guidelines and vary from country to country to reflect national regulatory processes.
The requirements for decisions that are logged on the Biosafety Clearing House are
provided in guidance and can vary according to the type of GM activity3.

3.3. 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    90 days               Article 9(1)
    with the first intentional transboundary movement of a LMO
    Communicate a decision on an AIA import notification             270 days from date    Article 10(3)
                                                                     of
                                                                     acknowledgement
    Take a decision on a GMO import for food, feed or processing     270 days              Article 11(6)
    (applicable to developing country Party or a Party with an
    economy in transition, in the absence of a domestic regulatory
    framework)
    Inform the BCH of a decision to approve a LMO for domestic use   15 days               Article 11(1)
    as food, feed or processing, including placing on the market
    Notify an applicant of a change in decision regarding a          30 days               Article 12(1)
    transboundary movement
    Party response to changed decision on transboundary movement     90 days               Article 12(3)
    Notification of unintentional transboundary movement likely to   Immediate             Article 17(1)
    have significant adverse effect


3.4. 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


3
    http://bch.biodiv.org/decisions/


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           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.

3.5 Resource requirements for national biosafety4

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 ten or more applications a year, the following resource requirements are
usually required:

3.5.1. Managers

In the course of implementing biosafety regulations, management responsibilities may
be placed on individuals who have little or no prior experience in this area. Biosafety
managers will need skills in:
            Priority setting
            Resource acquisition and allocation


    4
      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




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         Coordination with multiple agencies
         Meeting management
         Communication across many sectors
         Information access and management
         Handling of confidential or proprietary information.

3.5.2. Government officials and decision makers

The impact of biotechnology and GMOs on many sectors (health, agriculture,
environment, development, industry, trade) generally requires the involvement of a
number of ministries in biosafety regulation. A coordinated approach, with strong
political support, is essential to ensure that the biosafety system functions effectively.
In addition, it is important that officials from relevant ministry, and their science
advisors, are kept well informed on the role of biosafety systems in ensuring safe
development and testing and leading to informed decisions on applications.
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.

3.5.3. Scientists

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. Scientists will need to adhere to the confidentially protection on
some information in applications.
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.
Some countries have a large pool of qualified life scientists with the knowledge and
experience needed to review the safety of GMO activities, while others do not. Where
countries lack sufficient scientific capacity they will find it difficult not to overtax the
available experts. Careful delegation of review responsibilities can also assist scientist
to use their time effectively. For example, using the same set of reviewers for similar
GMOs allows them to use their knowledge of earlier applications to speed up the
review of repeat activities. Similarly, using allergenicity and human health experts to
review only those applications that have a potential impact on human health, and only
those sections of the applications that apply to human health, makes the best use of
their time.


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It is important that the required scientific expertise is available. Often a
multidisciplinary approach with the participation of ecologists, entomologists, soil
biologists etc, is necessary in addition to molecular biology and biochemistry
expertise. 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.

3.5.4. Information access

Scientific biosafety review teams require a significant amount of information and data
on which to base their recommendations. Information increases the confidence with
which decisions are made and reduces the chance of errors. Most of the necessary
information is supplied with the application. However, a predetermined set of
questions may not elicit all the information that is necessary and sufficient to complete
an informed risk assessment. Where gaps exist, or if supporting or confirming
information is needed, review teams can go back to the applicant or can access other
sources of information.
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.

3.5.5. Feedback mechanisms

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. Many regulatory authorities request field trial reports that record compliance
with the regulatory terms and conditions for the trial and summarise the data collected
during the season and during post-harvest monitoring.
While some data on environmental impact can be collected during trials, large
commercial plantings of GM crops provide unique conditions that may result in new
data. When the general release of a GMO is authorised, it is sometimes necessary to
require the applicant to collect specific data after the initiation of commercial
production. The exact data and the reasons for collecting the data must be based on


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the scientific findings of the review body. Feeding this information back to regulators
enables ongoing monitoring of the impact of the crop on the environment.
Many countries obtain this feedback by requiring a post-commercial production report
to be submitted on the specific aspects of environmental impact at the end of a certain
time period. 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.

3.5.6. Financial support

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


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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.

Often food safety data can be used across many countries, but additional
environmental data may need to be collected locally to supplement existing
environmental information on specific events. There are instances where local
regulators may require additional food safety data to evaluate impact on communities
where foods are used differently or in greater quantities, or where there may be a
genetic disposition in local populations that requires additional risk assessment. For
GMOs that have undergone prior review in another country, requiring a complete
replication of the data, particularly food safety data, can be a costly process and is
rarely scientifically justified. The financial outlay for collecting a new set of data may
prevent some applicants from making the technology available to local citizens.
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.

4. Decision making
There are two clear aims in decision making on GM activities and GMOs:
          Accountability, determined by compliance to the regulatory regime, and

          Transparency, provided through decision documents.

The decision making criteria are defined in national regulations and policy. In
countries where the biosafety system is based strongly on safety the risk assessment is
often the primary focus for decision making. In countries that base their biosafety
systems more closely on impact assessments, issues such as benefits, socio-economic
impact, public input and national imperatives are also taken into account before
decisions are made. Many national biosafety frameworks make a clear distinction



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between the safety recommendations from scientific advisory bodies and decision-
making.
The types of decisions made by regulators differ according to the activity that is
regulated and the requirements of the national legislation. Contained research,
confined field testing and clinical trials very rarely have an environmental risk
assessment because the organisms are not released permanently and do not persist in
the environment. Measures are established to deal with unintended release. The
safety assessments for research therefore focus on the measures needed to contain and
confine the organisms and on personnel safety. For low risk categories of GMO
research and development and for facilities with high levels of containment,
regulatory offices introduce notification systems for specific activities with specific
categories of GMOs to streamline their regulatory process. These systems often
require facility registration that stipulates the need for an internal risk assessment and
notification procedure for all new GMOs. This requires minimal regulatory action
unless the internal risk assessment for a specific GMO triggers more extensive
containment, confinement and/or regulation, at which point the regulators need to
determine the terms and conditions for this higher risk research.
Initially, however, development and testing of GMOs may require regulatory review
up until the risks are better understood, the risk management conditions have proved
effective and the applicant has a record of compliance with safety requirements. Once
this level of experience has been established the regulatory input may diminish for
familiar activities known to be of low risk, but will be required again when the GMOs
are moved out of containment for further evaluation and selection in field or clinical
trails.
The level of regulation of field and clinical trials is also determined relative to the risk
of the activity. Once the risk assessment has clearly defined the potential risks and
feasible risk management measures, the decision is given with terms and conditions
under which the activity must be carried out.
Some level of regulation may continue after general use approval depending on the
nature of the GMO and its use. Regulatory terms and conditions may sometimes be
included in general use permits, e.g., the implementation of insect resistance
management systems applicable to some insect resistant GM crops. Other GMOs can
be approved for commercial use without the need for any post-approval biosafety
regulation.

4.1. Factors considered in national decisions

Countries make sovereign decisions about the development, import, or deployment of
GMOs and their products.

4.1.1. Applications for contained use

Activities carried out during the development of a new GMO are undertaken in
contained facilities and may or may not require application and approval under the
NBF. Many countries use international management standards for contained facilities,




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such as the guidelines from the U.S. National Institutes of Health5. In addition to
requiring compliance with these containment measures, countries may require
contained facilities that work with GMOs to be registered with the national biosafety
office. This would require a facility registration form, but does not require a decision,
as such.
Some countries require a written risk assessment for projects that develop and test
GMOs in containment and others require that registered facilities keep written records
of the GMOs stored and used in the facility. Bearing in mind that a single
transformation experiment can produce thousands of GMOs, there is minimal
information needed about individual GMOs. However, information about
transformation vectors and recipient organisms is usually recorded. It is expected that
contained research facilities will be inspected from time to time to ensure that the
containment guidelines are being implemented.

4.1.2. Applications for confined field and clinical trails

The testing and selection phases of GMO development are used by the applicant to
select the best GMOs for general release and to assess the environmental safety of the
new GMOs and their food and feed safety. This testing entails releases into the
environment in a confined space for a short period of time, after which the GMOs are
completely removed from the release site.
The factors considered in decisions on field and clinical trials focus on the ability of
the applicant to confine the GMO to the test site and to maintain control over the
regulated material while it is transported, stored, used and removed from the site. The
regulator will also be interested in the post-use monitoring of the site to ensure that no
viable GMOs remain after testing.
Field and clinical trials do not have a socio-economic impact on the release
environment and so these issues are not considered in decisions on applications for
confined testing. Similarly, the material from the trials does not enter the food and
feed chain and so food and feed safety information is not needed for decisions on
confined testing. Because of the transient nature of confined trials many countries do
not require public comment for these applications. However, if the confinement
measures extend to land adjacent to the trial sites, then the regulators frequently
require that the applicant has discussed the consequences of this with neighbours who
could be affected by the inspections and follow-up procedures in the case of an
unintentional release.
Once applicants move toward general use and commercial release, they need to be
confident that their products are safe for consumption and will not impact adversely
on the environment, or on human health. These data are collected during confined
testing to be presented in the application for general release approval.

4.1.3. Applications for general release

For general release applications the safety of the food, feed, fibre and any other
products derived from the GMO is included in the risk assessment and in decision

5
    http://oba.od.nih.gov/oba/rac/guidelines_02/NIH_Gdlines_2002prn.pdf


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making. For example, in reviewing the safety of insect tolerant cotton, the impact of
the new protein on animal feed containing cotton seed cake is part of the risk
assessment. Similarly, in reviewing the safety of insect resistant maize, the impact of
the glucose syrup and starch processing steps on the integrity and activity of the new
proteins forms an integral part of the food safety assessment.
Because of the amount of safety information needed on each GM event, applicants
usually bring only one event forward for general release approval and then use this to
breed the new traits into conventional varieties after approval has been received. (An
important exception to this is with vegetatively propagated plants such as bananas,
potatoes and cassava, which are not suited to efficient breeding.) The data on this
event include a detailed molecular characterisation of the genetic changes; information
of the potential impact of this event on the environment and the food and feed safety
data for the event.
Safety data provide just one of the sets of data that national decision makers take into
account when reviewing an application for general release. Other considerations may
include national policies on technology, research and sustainable development; the
potential benefits and role of the technology in meeting national goals and objectives
in food production, food security, wealth creation, job creation, trade and related
areas. Regulators may compare the product of the new technology to existing
products and consider what impact deployment may have on indigenous knowledge,
heritage and culture. Some regulators will be required to consider the socio-economic
impact if the technology is not approved. In all cases the considerations that must be
included in biosafety decision making are clearly defined in national regulations.
Table 3 summarises issues that have been factored into decision making on the
general release and use of GMOs.

     Table 3. Some decision-making considerations for general release of GMOs6 (Case-by-case
     assessments may be needed, but not all considerations are needed for every GMO and not all are
     taken into account by every country.)

    Molecular           Human & animal           Environmental             Other issues
 characterisation           safety                   safety
Insert effects        Food safety              Impact on:              National imperatives
Copy number           Toxicity                 Living organisms          Food security
Expression levels     Pathogenicity             Biodiversity             Wealth creation
Stability, etc.       Allergenicity/            Outcrossing              Sustainable development
                         Digestibility          Weediness              Economics
                      Nutrition                 Invasiveness             Access and cost
                      Workers safety            Non-target organisms     Labour
                      Unexpected products      Gene flow                 Trade,
                      Gene stability           Gene stability            Product stewardship, etc.
                      Other                    Air, soil, water        Social
                                               Other                      Ethics or religion,
                                                                          Indigenous knowledge
                                                                          Traditional technology
                                                                          Gender impacts
                                                                          Equity issues, etc.




     6
       Adapted from Kitch L, M Koch and I Sithole-Niang, 2002. Crop Biotechnology: A working paper
     for administrators and policy makers in sub-Saharan Africa. FAO, Harare.



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Of necessity, decisions on GMOs need to be made on a case-by-case basis, as each
GMO may have a different level of risk and different impact on the release
environment. GMOs may also differ in the benefits offered and the way in which they
impact on local communities.
In considering the social impact of new technology it may be necessary to consult
with a wide range of stakeholders before making a final decision on local utilization.
Bear in mind, however, that these impacts are only relevant to general release
applications, not to research and testing activities. Public acceptance or concerns will
help to indicate the degree of acceptance of the GMO in a particular locality and will
provide an opportunity to address the concerns that are raised.
For general release applications the decision-makers may want to consider the
potential impact on trade, labour, food security, gender, small business development,
sustainable development and poverty alleviation. These are just some of the socio-
economic factors that may be important in the final decision. For general release
applications some countries use socio-economic experts to provide recommendation
on socio-economic impact of the new GMO. These considerations are provided
separately and in addition to the risk assessments and recommendations provided by
the scientific advisory body. Some countries with concerns about the potential impact
on trade, require a stewardship plan that outlines how the applicant will ensure that the
approved GMO will not impact negatively on trade and markets for conventional or
organic production.

4.1.4. Applications for import of GM commodities

Applications for food and feed imports do not require a full environmental risk
assessment as they are not intended for planting or production in the country. In
addition, they have been approved for production in the exporting country and so the
food and feed safety assessment has been completed. These commodity imports
therefore require a shorter review process where the scientific advisors ensure that the
food and feed review in the country of origin was sufficient and appropriate for local
use and consumption and that the conditions for transport and storage are sufficient to
ensure that the regulated materials are not available for planting or production in the
country.
To facilitate trade it is important for the regulatory office to be proactive in approving
events for commodity import. These safety reviews and import conditions can be
undertaken prior to receiving an application, so that the biosafety administration office
has the approvals and conditions of import immediately on hand when traders request
permission for imports from specific countries. From a safety perspective it is not
necessary to know the exact amount of GM material or the exact events in the
shipment, only that there may be GM material and that the GM events approved in the
exporting country are also approved for import in this country.
For all applications, the factors that are considered and those that lead to the final
decision should be carefully laid out in a decision document that is freely available to
the public.




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4.2 Decision documents

Communicating national decisions on GMOs is seen as an important contribution to
transparency. The format and contents of a decision document will depend on the
regulations in each country as these will determine what was considered in reaching the
decision. Common forms of decision documents are letters or permits and the applicant
usually receives the decision before it is made public. This enables clarifications and
minor edits to the content before it is made public. In the interests of public disclosure,
decision documents are usually posted on the national biosafety website.
In general, a decision document records the decision on a specific application, outlines the
authority under which the decision was made, and summarises what was taken into
consideration when the decision was made. Some decision documents include a summary
of the risk assessment and a list of the people involved in the review process. Some
decision documents summarise the input received from the public. If the document is a
rejection of an application, then the reasons for rejection should be clearly stated so that
the applicant knows what these issues are. If the decision document is the approval
notification it will need to list any terms and conditions deemed essential for the safe
implementation of the activity.
In addition, if the risk assessors or decision makers have highlighted any essential
inspections or monitoring requirements, these should be stated in the decision document.
This will alert the biosafety administrators so that inspections can be scheduled and, when
required, a monitoring plan can be established with the applicant.
Decision documents should provide details of what is approved as the decision may not
necessarily grant exactly what the applicant is requesting, but may apply conditions such
as time limits, geographical location limits, and other specific restrictions or requirements.

4.3. Biosafety Clearing House

Countries that are parties to the CPB have specific obligations regarding information
sharing. The Biosafety Clearing House (BCH)7 is a repository for biosafety information
and parties have to register national decisions on GMOs on the BCH within certain time
frames (see Table 1). According to the CPB a failure to communicate a decision on the
import of a GMO does not imply consent or refusal. It is a task also for the biosafety
administrative office to dissemination to relevant agencies the decisions communicated
through the BCH by other countries.
As such, the administrative officers of any NBF will be responsible for keeping the
country’s information on the BCH up-to-date and accurate. Most countries have
completed capacity building projects to enable this to happen.

5. Monitoring
The term “monitoring” describes the collection of scientific biosafety data to support the
scientific basis for biosafety decisions. It also describes the systematic measurement of
the effects of GMOs over time. The aim of GMO monitoring is to identify direct,
indirect, immediate, delayed, or unintended harmful effects that GMOs and their use
7
    www.biodiv.org/bch/


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might cause to the environment or human health. Because risk assessment is undertaken
with an incomplete but sufficient understanding of the GMO, some potential risks may
cause the decision makers to add monitoring requirements to an approval so that specific
uncertainties can be studied and addressed with real data that is collected during the first
years of the use of the GMO. These data obtained by monitoring are used to impose new
risk management conditions on approvals or to maintain, renew, or withdraw an approval
for general release of a GMO.
Monitoring is an expensive process that needs clear goals and careful planning. Not all
activities will require monitoring plans. If the regulatory authorities require monitoring
as a condition of an approval, they must define clearly what information is needed, what
the outputs and end points of the monitoring are and how the information will be used.
Specific requirements for monitoring should be laid out clearly in the decision documents
for each approved application.
The regulators need to work with the applicant to design methodology that is practical,
affordable and will address the information gaps. It is also recommended that the data
are analysed as they are received so that the applicant, regulators and scientific advisors
can assess whether the methodology is working or whether it needs to be modified. If the
data are not useful and the methodology cannot be improved, then the monitoring should
be stopped as soon as possible.
Monitoring may be carried out by a competent agency identified in the NBF or by the
applicant, who analyses the data and submits both the data and the analysis to the
regulator for review.
Monitoring activities require regular reporting and the administration office needs to
ensure that these reports are submitted on time and that they are reviewed by the
scientific advisory body, or a sub-committee of this body. Recommendations for the
reviewers may need to be forwarded to the decision makers and/or to the applicant.
Some reports may initiate meetings with the applicant that will need to be scheduled
by the biosafety office. If the monitoring data result in a revision of the authorisation,
the biosafety office will need to prepare the revision and send it to the applicant. The
applicant should be given a short period of time to respond to the revised decision
document. Once clarifications and small edits are completed the revised decision
should be posted on the website and the BCH for public access.

6. Inspections and Enforcement
The term “inspection”’ describes the check for compliance with biosafety regulations
and with the terms and conditions for activities with GMOs. Countries need to establish
sustainable mechanisms for inspecting GMO activities. Inspections are usually carried
out by the biosafety regulators and will involve site visits. These may be to facilities,
field trial sites, clinical trial sites or storage areas. Inspectors may also visit ports and
processing facilities. In the course of an inspection, the inspectors may review physical
containment measures, confinement procedures, materials and documentation related to
the movement, storage, planting and destruction of GMOs. Sites of unintended release
are also likely to be inspected. It is the responsibility of the biosafety administrators to
schedule inspections in accordance with the regulatory requirements.




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Initially when the biosafety administration is handling only a very few applications
and registered research facilities, it will be possible for inspectors to visit all the sites
at key times in the project timelines. However, as the biosafety office gets busier and
personnel are fully occupied it is seldom possible to inspect all stages of each
approved activity. Prioritising inspections becomes important when the demand for
inspections rises to a point where not all activities can be inspected at every stage.
To assist with inspection scheduling, any specific requirements for inspections should
be clearly set out in the decision documents for each GM application. The scientific
advisors may identify key activities that should be inspected and the regulatory office
needs to set priorities for inspections based on these recommendations. The
inspection priorities usually reflect the level of risk posed by a specific activity as a
whole, or at a specific time during the activity. Development of an inspection check
list or form helps to keep the inspection on track and focused. Biosafety offices
quickly become aware of applicants that take special care to fulfil the regulatory
requirements of approvals and those that are less reliable in this regard.
Enforcement follows identification of non-compliance. Most correction of non-
compliance is initiated by the regulators, but for more serious violations law
enforcement officers may be needed. How countries deal with enforcement is detailed
in their regulatory regime.
In many countries warnings are issued when non-compliance is identified and the
applicant is inspected again after a short period of time to see whether the compliance
levels have improved. Persistent non-compliance will trigger the corrective actions
allowed for in the national regulations and these applicants may have their approval
for certain GM activities revoked.
Most countries use existing inspectorates, such as plant and quality control officers, to
handle biosafety inspections. These officers have authority to carry out inspections,
but need to be trained in the priorities and procedures for biosafety inspections. One
of the functions of the biosafety administration office is to provide and update
guidance manuals for biosafety inspection and to ensure that inspectors are well
trained to carry out biosafety inspections.
The day-to-day activities of an inspector could include inspection of facilities,
imports, shipments, field trials, commercial field releases, as well as the follow up of
reports of non-compliance and the ongoing review of planned GM activities in the
country. Inspections of imports and facilities are greatly assisted by proper planning
and preparation. Pre-visit preparation includes an understanding of the facility, its
GM activities and the staff arrangements. This requires a review of the literature and
reports related to each facility and notification to the applicant of the inspection date,
except in exceptional circumstances.

6.1. Applicant reporting requirements
Many biosafety systems require applicants to keep documentation of the biosafety
components of their research, development and monitoring programmes. These
documents include biosafety guidance documents, regulatory containment and
confinement requirements, standard operating procedures and records of transport,
storage, planting, reproductive isolation, harvest, post-harvest monitoring, monitoring



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and destruction. These reports are kept in files for facility registration, greenhouse,
clinical trials and field trials and are reviewed by inspectors during inspections.

6.2. Inspection reports

The inspection should include a discussion with the biosafety office both at the outset
and at the end to clarify issues and address minor problems. An inspection report
should be submitted within a specified time after the inspection to both the regulators
and the facility. The report should clearly indicate actions that need to be taken at the
facility and timeframes within which these are to be done.
Biosafety inspectors submit inspection reports that are reviewed by the administrators
who initiate follow up actions as needed. Some agencies provide standard formats for
reporting that ensure that all aspects are covered in the inspection, to minimise the
time needed to prepare the inspection reports, and to provide a consistent inspection
reporting format that is easy to analyse and that clearly identifies non-compliance and
issues that need to be resolved.

6.3. Training inspectors

Most countries identify and train inspectors from existing regulatory agencies to
undertake biosafety inspections. Regulatory agencies in departments of agriculture,
customs, health and environment often have inspectorates with inspectors who already
have legal training and inspection rights. These inspectors need training in biosafety
and basic biotechnology to equip them for inspection of GM activities. Some
countries train biosafety officers as legal inspectors and other countries use scientists
to undertake biosafety inspections of contained facilities and field trials.

6.4. Skills required for biosafety inspection

Biosafety inspectors need four types of skills: legal, technical, organisational, and
personal.
Legal skills usually come through legal training and qualification as officers of law in
the country. Technical skills include a good understanding of ecology, general
biology, molecular biotechnology and gene transfer, a willingness to read scientific
literature critically and a good understanding of what is needed to run a biotechnology
laboratory and testing facilities.
Organisational skills are the most critical for effective performance. The biosafety
inspectors must develop processes and systems that enable them to cope with
increasing numbers of approvals. A slow increase in numbers of applications and
approvals will give inspectors an opportunity to understand their role and to
streamline and prioritise their time and procedures. In addition, inspectors require
personal qualities that give them credibility to do their job. These qualities include
trustworthiness, non-corruptibility, good conduct, a willingness to take oaths of duty,
a high work ethic, and good interpersonal skills. The regulatory authority should also
require a disclosure of possible conflict of interests.




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On-the-job training for biosafety inspectors means that regulators and scientific
advisors may need to work closely with new biosafety inspectors until the process and
procedures are well understood by them. The biosafety administrators should develop
inspection guidelines so that the inspectors can proceed without accompaniment.
Bearing in mind that the number of GMO trials is usually small at the start, and grows
relatively slowly, it is seldom necessary to have a large inspectorate for the
implementation of the NBF.

6.5. Enforcement

The biosafety inspections may be carried out under several legal instruments. These
are usually outlined in the regulations and may or may not make specific mention of
GMOs, or of how they are regulated and how compliance is checked and enforced.
Many countries have an existing administrative law that sets regulations for carrying
out inspections and dealing with non-compliance. Existing criminal law establishes
how evidence and statements of non-compliance are taken and how legal actions
proceed once non-compliance has been identified.

6.5.1. Legal authority for enforcement

The legal authority for enforcement is determined by the national laws. These may be
existing laws, or the laws may be amended to deal specifically with GMOs. Some
biosafety frameworks may include additional or specific enforcement clauses for
GMO activities.

6.5.2. Administrative tasks for enforcement

When the inspectors or regulators become aware of an infringement they need to take
action immediately. In some instances this means contacting the biosafety office to
plan and approve corrective action. However, many infringements are unintended and
easily corrected. The corrections need to be implemented quickly to maintain safety
levels and the credibility of the system. The corrective action should be recorded and
kept in the applicant’s documentation file and also submitted to the regulatory office if
this is required in the regulations.
Where an infringement cannot be quickly or easily corrected, the activity may need to
be stopped until the corrections can be implemented to the satisfaction of the
regulators. Most regulatory systems provide for this and the process must follow the
legal requirements. In extreme cases where the infringement may have resulted in
harm, or the negligence is deemed unacceptable, the enforcement agency may wish to
prosecute the applicant. Prosecution is usually carried out under the country’s
existing legal system.

6.5.3. Roles and responsibilities

The responsibility for enforcement falls primarily on the enforcement agency.
However, these officers rely on the biosafety administrators and inspectors for
evidence to support any legal action that is taken. The biosafety administrators need



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to provide documentation to support an infringement claim. These documents may
include:
      the approval document with the conditions clearly stated
      the inspection reports identifying the infringement
      an assessment of the impact of the infringement with respect to safety, and
      any evidence seized or collected to support the claim, such as soil or plant
       analyses, photographs, signed statements, etc.
Administrative officers and inspectors may be called as witnesses during the
prosecution proceedings.

7. CONCLUSION


7.1. Continuous improvement

Countries preparing their NBFs need to be aware that the development of an
administrative system for biosafety is a work in continuous progress. Biotechnology is a
rapidly evolving field in which new issues and activities are constantly emerging, and
governments have to be able to deal with changes in their national priorities and in public
concerns. An administrative system is best designed to evolve according to changing
circumstances or demand. For example, in many countries, it may take many
applications per year to justify a stand-alone biosafety administration office, as in most
instances the submission of applications starts slowly, and builds up to a point where
more staff and resources are needed.
The development of an administrative system is an ongoing, iterative exercise, and
feedback during the implementation of the NBF gives a country an opportunity to ensure
that the NBF is able to respond to changing needs, priorities and circumstances. In
developing and implementing NBFs, countries need to make sure that there is a
mechanism for gathering information on how the NBF systems work in practice, what
problems are arising, and how the NBF responds to changing circumstances. This
feedback could come from the biosafety bodies established to carry out certain functions,
the applicants who use the biosafety administration system, the interested public who
accesses information from the system, or an auditor general’s office that is responsible
for reviewing the operations of government. All of this feedback will indicate how well
the administration is working in practice.
In this regard, it is important to get some of the basic aspects of the regulatory policy
and administrative system clearly defined from the start. These include:
      a clear definition of the objective of the legislation
      the importance of definitions which in turn prescribe the scope and the
       applicability of the regulations and will be central to any legal interpretation of
       the legislation, and
      the authority under which the biosafety process is implemented. This is
       particularly important when dealing with multiple centres of responsibility.



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7.2. Qualities of biosafety administrative systems

The following questions are useful for determining the most useful qualities of an
administrative system:
         Clarity
              o Is it clear what processes and procedures apply to GMOs, GM
                derived products and activities involving GMOs?
              o Will users of the system – be they government, the public, or
                applicants – understand how the administrative system works?
              o Is a clear message or are consistent instructions being
                communicated through the country’s policy, laws, websites,
                employees, messages to the media, etc.?
         Transparency
              o Is the system transparent?
              o Can applicants and others stakeholders find out and understand
                how the administrative system works?
              o Is it possible to follow the decision making process from the initial
                filing of an application through to the final decision?
         Consistency
              o Are terms and definitions used throughout the administrative
                system in a consistent manner?
         Practicality
              o Is the process workable?
              o Can the process work in practice as well as on paper?
              o Are the resources available to implement this process?
              o Do the stakeholders understand the process?
              o Are they willing to comply with it or will it create enforcement
                problems?
         Authority
              o What sorts of authority are required to implement the
                administrative system procedures? For example, the authority to
                inspect private property or the authority to request test data from
                an applicant.
              o Does the institution that is being charged with implementing this
                process actually have the authority to implement?
         Participation
              o Is the system participatory?
              o Are there mechanisms for all interested stakeholders to participate
                in the decision process?


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             o Is public participation allowed at various stages in the decision-
               making process?
        Effectiveness
             o Does the administrative system achieve its objective?
        Predictability
             o How predictable is the administrative system?
             o Has it been designed in such a way that applicants and other
               stakeholders can expect the administrative system to work in a
               predictable manner?
             o Is it clear to applicants and other stakeholders who is responsible
               for taking decisions and on what basis?
             o Are the time frames, for example, clear and definite?
        Enforceability
             o Do the resources exist to carry out this enforcement?
             o Is enforcement likely to be a problem or will there be willing
               compliance?
             o Can there be non-governmental enforcement through the help of
               industry and/or the public?
             o What sort of training will be needed if existing enforcement
               mechanisms are to be used?
        Adaptability
             o How adaptable does the system need to be?
             o How adaptable is it?
             o Will changes be difficult, costly, or confusing?
             o Are the elements that will most likely need changing relatively
               easy to change?

7.3. Reviewing biosafety administration

  Once a country has developed its NBF it needs to ensure that the component
  systems work well in practice, and are responsive to changing needs, priorities
  and circumstances.
  Review of biosafety processes, guidelines, regulations and even laws is a
  necessary component of any regulatory system. Processes should be reviewed
  annually to understand where they are not efficient and what changes are needed
  to improve functionality. These changes should be made immediately and should
  be reflected in all the guidance documentation, standard operating procedures and
  other checklists.




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8. Sources for background information
Cohen J., Quemada H. and Frederick R.J. 2003. Food safety and GM crops:
Implications for developing-country research. 2020 Vision, Focus 10, Brief 16.
Connor, A.J., Glare T.R. and Nap J.P. 2003. The release of genetically modified crops
into the environment. The Plant Journal. 33:19-46.
FAO. 2004. International standards for phytosanitary measures. Pest risk analysis for
quarantine pests, including analysis of environmental risk and living modified
organisms. ISPM No.11. http://www.fao.org/newsroom/en/news/2004/43684/index.html
Mackenzie R., Burhenne-Guilmin F., La Vina, A.G.M. and Werksman J.D., in
cooperation with Ascencio A., Kinderlerer J., Kummer K., and Tapper R. 2003. An
Explanatory Guide to the Cartagena Protocol on Biosafety. IUCN Environmental
Policy and Law Paper No. 46, 2003, available at http://www.cbd.int/doc/books/2003/B-
01669.pdf
Kitch, L, Koch, M and I Sithole-Niang. 2002. Crop biotechnology. A working paper
for administrators and policy makers in sub-Saharan Africa. FAO Regional Office,
Box 3730, Harare, Zimbabwe.
Kuiper, H.A., Kleter G.A., Noteborn H.P., Kok E.J. 2001. Assessment of the food
safety issues related to genetically modified foods. Plant Journal. Special issue: Plant
GM technology. 27(6):503-528
McLean MA, Frederick RJ, Traynor, PL, Cohen JI, and Komen J. 2002. A Conceptual
Framework for Implementing Biosafety: Linking Policy, Capacity and Regulation,
ISNAR Briefing Paper No. 47, available at http://www.eldis.org/assets/Docs/30039.html
McLean MA, Frederick RJ, Traynor, PL, Cohen JI, and Komen J. 2003. J, A Framework
for Biosafety Implementation: Report of a Meeting. The Hague: International Service for
National Agricultural Research (ISNAR).
Mugoya C. and Bananuka J. 2004. Resource book for implementation of biosafety in
East Africa. BIOEARN. Kampala, Uganda. http://www.bio-earn.org/biosafety-manual.html
Paarlberg, R.L. 2000.Governing the GM crop revolution: Policy choices for developing
countries. 2020 Brief 68.
Traynor, P.L., Frederick R. and Koch M. 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
SCBD/UNEP, Biosafety and the Environment: An Introduction to the Cartagena
Protocol on Biosafety, 2003, available at http://www.biodiv.org/biosafety
UNEP/GEF. 2008. Guide for the implementation of national biosafety frameworks.
http://www.unep.org/biosafety/files/Final%20National%20Biosafety%20Frameworks.pdf




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   African Biosafety Network of Expertise (ABNE)
   Guideline for the Administration of Biosafety Applications




APPENDIX 1
   Guidance for Document Tracking Codes

  Document tracking codes are used for the administration of biosafety submissions
  by most regulatory agencies that receive and process applications for biosafety
  work. They use a code that is generally made up of one or more the following
  pieces of information:
       Date received
       Submitter
       Number of application from that submitter in that year
       Activity code
Date
   The date is commonly the year followed by the day, using the ordinal (Julian)
   date (see list at the end).
   3 June 2011 is written as: 2011-155 (i.e., the 154th day in 2011)
   1 January 2001 is written as: 2011-001, etc.
Submitter
   The submitter is commonly a letter code that can be recognised.
       For example: University of the Cape Coast might be UCC.
   In time there may be applications from different departments at the university so
   it may be wise to add a digital count for different submitting entities within one
   institution, e.g. UCC01 for the first submitter and UCC02, etc., for each
   additional submitter from that institution.
Submission number
   The submission number is commonly the number of submissions from that
   submitter in the year:
       For example, UCC01-001 for the first submission from the "01" department at
       Univ. of Cape Coast in that year.
  Some agencies use the submission number to mean the number of submissions
  received by the agency in that year regardless of the submitter.
       For example, South Africa used 00 format for many years until they had to
       expand it to include 100 or more applications in a year.
       The U.S. is already using 5 digits, e.g., 10000, because of the thousands of
       notifications they get for field trials in each state, in each year.
Activity code
  The Activity code is arbitrary and is not used by all agencies, but is useful to
  quickly identify applications for specific types of activities. A common code is:
       A = facility registration
       B = contain use (lab research; greenhouse work; microorganism production)


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    African Biosafety Network of Expertise (ABNE)
    Guideline for the Administration of Biosafety Applications



       C = confined trials (field trials and clinical trials)
       D= unconfined release (growing, using)
       E = food and feed import
       F = other
As such, using the second option for the submission number, a document tracking
code for the first application from the Univ. of Cape Coast (first department to submit)
for confined field trials, received at the agency on 24th May 2011, would look like
this:
       2001-144-UCC01-001-C
This code would appear on the front page of all regulatory documents related to the
trial application (risk assessment recommendations; public notice copy; decision
document; activity reports from the submitter; inspection reports, etc.) and it would be
used as a reference in all correspondence.




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     African Biosafety Network of Expertise (ABNE)
     Guideline for the Administration of Biosafety Applications



Table of ordinal day number for various calendar dates

   Day       Jan     Feb    Mar        Apr   May   Jun    Jul   Aug   Sep   Oct   Nov   Dec
     1         1     32     61          92   122   153    183   214   245   275   306   336
     2         2     33     62          93   123   154    184   215   246   276   307   337
     3         3     34     63          94   124   155    185   216   247   277   308   338
     4         4     35     64          95   125   156    186   217   248   278   309   339
     5         5     36     65          96   126   157    187   218   249   279   310   340
     6         6     37     66          97   127   158    188   219   250   280   311   341
     7         7     38     67          98   128   159    189   220   251   281   312   342
     8         8     39     68          99   129   160    190   221   252   282   313   343
     9         9     40     69         100   130   161    191   222   253   283   314   344
    10        10     41     70         101   131   162    192   223   254   284   315   345
    11        11     42     71         102   132   163    193   224   255   285   316   346
    12        12     43     72         103   133   164    194   225   256   286   317   347
    13        13     44     73         104   134   165    195   226   257   287   318   348
    14        14     45     74         105   135   166    196   227   258   288   319   349
    15        15     46     75         106   136   167    197   228   259   289   320   350
    16        16     47     76         107   137   168    198   229   260   290   321   351
    17        17     48     77         108   138   169    199   230   261   291   322   352
    18        18     49     78         109   139   170    200   231   262   292   323   353
    19        19     50     79         110   140   171    201   232   263   293   324   354
    20        20     51     80         111   141   172    202   233   264   294   325   355
    21        21     52     81         112   142   173    203   234   265   295   326   356
    22        22     53     82         113   143   174    204   235   266   296   327   357
    23        23     54     83         114   144   175    205   236   267   297   328   358
    24        24     55     84         115   145   176    206   237   268   298   329   359
    25        25     56     85         116   146   177    207   238   269   299   330   360
    26        26     57     86         117   147   178    208   239   270   300   331   361
    27        27     58     87         118   148   179    209   240   271   301   332   362
    28        28     59     88         119   149   180    210   241   272   302   333   363
    29        29     60     89         120   150   181    211   242   273   303   334   364
    30        30            90         121   151   182    212   243   274   304   335   365
    31        31            91               152          213   244         305         366

* Feb 29 exists only on a leap year.




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  African Biosafety Network of Expertise (ABNE)
  Guideline for the Administration of Biosafety Applications




APPENDIX 2
  Sample SOP for Handling Applications


  STANDARD OPERATING PROCEDURE (SOP) FOR THE HANDLING OF
  BIOSAFETY APPLICATIONS WITHIN [COUNTRY]

  Note: This Standard Operating Procedure (SOP) is intended solely as an example
  that may be used as an educational resource by regulatory offices that are
  developing or revising their own quality management programs for handling
  applications for approval of activities with genetically modified organisms
  (GMOs). This example should be adapted for compliance with national
  regulations that govern the handling of applications.

   A. DESCRIPTION OF THE ACTIVITY
  A.1. To ensure compliance with requirements for handling biosafety applications
  in [country].

   B. SCOPE
  B.1. This SOP applies to the handling of applications for approval of activities
  with GMOs in [country] and covers applications for import, export, transit,
  contained use, confined use, food and feed commodity imports and general use.

   C. SOP AUTHORISATION
  Name of Authorised Party:
  Title:
  Signature:
  Date:
  Implementation Date:
  In Effect Until:

   D. DEFINITIONS
  D.1. Administration office: An office within a national biosafety framework that
  is responsible for receiving biosafety applications for approval of GM activities.
  D.2. Applicant: A permanent resident of [country] or designated agent to whom
  all correspondence with respect to the application including the notification of
  authorisation shall be addressed.
  D.3. Confidential business information (CBI): Information in applications that
  will be kept confidential.
  D.4. Confined use: The research and development of GMOs in short term clinical or
  field trials that are managed to minimise impact on or persistence in the environment.
  D.5. Contained use: The research and use of GMOs within a facility that is designed
  to minimise GMO release into the environment.
  D.6. Event: Each individual GMO produced during the modification of a single
  plant species using a specific genetic construct.




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D.7. General release: The approved, general use of a GMO with no or minimal
regulation. Also termed ‘unconfined release’, and may have some conditions
appended to the approval for use.
D.8. Genetically modified organism (GMO): A plant, animal or microbe
derived through recombinant-DNA techniques.
D.9. Genetically modified product: A non-living product that is derived from a
GMO.
D.10. Inspection: A check for compliance with regulatory conditions for
activities with GMOs. This may include the review and investigation of facilities,
materials and documents related to approved activities with a GMO.
D.11. Monitoring: The scientific collection of biosafety data to support biosafety
decisions, including the systematic measurement of the effects of GMOs over
time.
D.12. National biosafety framework (NBF): The national structures established
by legislation to implement a biosafety regulatory process in a country.
D.13. Unconfined release: The approval use of a GMO with no or minimal
regulation. This is also termed ‘general release’, and may have some conditions
for use appended to the approval.

 E. GENERAL REQUIREMENTS FOR THE HANDLING OF BIOSAFETY
 APPLICATIONS
E.1. The biosafety administration officers shall comply with this SOP.
E.2. All biosafety applications shall be handled in an efficient manner, honouring
timeframes and communication requirements.
E.3. All biosafety applications shall be securely transported between regulatory
bodies and individuals.
E.4. All biosafety applications shall be clearly documented and labelled.
E.5. The confidential information in biosafety applications shall be access only by
persons who have signed confidentiality agreements with the biosafety
administration office.
E.6. Only public information shall be released in public communication from the
biosafety administration office.

 F. SPECIFIC REQUIREMENTS FOR THE HANDLING OF BIOSAFETY
 APPLICATIONS
F.1. The biosafety application shall be given a processing number and a tracking
sheet shall be opened on the day it is received at the biosafety administration
office.
F.2. The administrative completeness of the application shall be assessed within [ ]
days of receipt.
    F.2.1. Receipt of the application shall be acknowledged in written
    communication with the applicant within [ ] days of determination of
    administrative completeness or administrative deficiency.
F.3. Confidential business information shall be identified and secured.
F.4. Applications that do not require risk assessment or public comment shall be
forwarded within [ ] days to the decision making committee.
F.5. An appropriate risk assessment review team shall be established within [ ]
days for applications that require risk assessment prior to decision making and are
deemed to be administratively complete.


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African Biosafety Network of Expertise (ABNE)
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    F.5.1. Applications shall be forwarded for risk assessment review within [ ]
    days of acknowledgement for administrative completeness.
    F.5.2. Applicants shall be notified within [ ] days if additional information is
    required for the risk assessment review process.
F.6. An appropriate socio-economic review team shall be established for
applications that require socio-economic review prior to decision making.
    F.6.1. Applications will be forwarded for socio-economic review within [ ]
    days of acknowledgement for administrative completeness
    F.6.2. Applicants shall be notified within [ ] days if additional information is
    required for the socio-economic review process.
F.7. Public comment shall be invited for applications that require public comment
prior to decision making.
F.8. Applications for which risk assessment recommendations, and/or socio-
economic assessment recommendations, and/or pubic comments have been
received shall be forwarded to the decision making committee within [ ] days of
receipt of the required reviews and comments.
    F.8.1 Applicants shall be notified within [ ] days if additional information is
    required for decision making.
F.10. Decisions shall be forwarded to the applicant within [ ] days from the start of
the decision making process.
F.11. A decision document shall be made public within [ ] day of notification to
the applicant of the decision.
F.12. Appropriate inspections shall be scheduled within [ ] days following
notification to an applicant of a decision to approve an application.
F.13. Reporting requirements for applications shall be monitored and documented
within the timeframes stipulated in the decision document.

 G. ASSESSING ADMINISTRATIVE COMPLETENESS
G.1. The application shall be assessed to confirm that it contains all the
components required in the national regulations for an application of that type.
G.2. Applicants shall be notified in writing within [ ] days when the application
meets the administrative requirements for submission and the application shall
enter the review process immediately.
G.3. The applicant shall be notified in writing within [ ] days if information
sections or other components are missing from the application.
    G.2.1. The review clock shall be stopped until the missing information is
    received.
G.2.2. The applications shall be considered withdrawn if the information is not
received within the allotted timeframe, unless the applicant has applied for
extended time to meet the submission requirements for the application.
G.4. The administration officer shall notify the applicant in writing when the
application meets the administrative requirements within [ ] days of receiving the
additional information requested for completeness and the application shall enter
the review process immediately.

 H. CONFIDENTIAL BUSINESS INFORMATION (CBI)
H.1. The administration officer shall review information that is marked as
confidential and determine whether this meets the national regulatory
requirements for CBI.


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African Biosafety Network of Expertise (ABNE)
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    H.1.2. Where clarity is needed the administration officer shall consult with the
    national biosafety committee to clarify whether CBI is allowed.
H.2. The applicant shall be consulted if changes are needed to the information that
can be considered CBI.
    H.2.1. The applicant shall have the opportunity to withdraw the application if
    agreement on CIB is not reached.
H.3. Copies of the application that contain CBI shall be secured within the
biosafety system and only distributed to authorised persons who have signed
confidentiality agreements.
H.4. Only a copy of the application that has had the CBI deleted shall be made
available for public access.
H.5. All persons who have access to applications that contain CBI shall have
signed confidentiality agreements prior to receiving applications with CBI.
H.6. The confidentiality agreement that allows access to CBI shall contain
measures to ensure that all distributed applications containing CBI, with the
exception of the official copy held at the administration office, shall be deleted
and/or destroyed after the decision on the application has been made.
H.7. Confidential business information will remain confidential in applications
that have been withdrawn.

 I. RISK ASSESSMENT REVIEW
I.1. The administration officer shall establish a scientific review team for an
application that requires risk assessment review.
1.2. The risk assessment review team shall be established within [ ] days of
acknowledging in writing to the applicant that the application fulfils administrative
requirements.
I.2. The risk assessment review team shall have the expertise needed to evaluate
the safety of the specific GMO activity.
I.3. All members of the risk assessment review team shall sign and return
confidentiality agreements prior to receiving applications that contain confidential
business information.
I.4. The administration officer shall stipulate a return date for the risk assessment
recommendations.
I.5. The applicant shall be notified in writing within [ ] days if the risk assessment
team require additional information.
     I.5.1. The review clock shall be stopped until the additional information is
     received.
     I.5.2. The applications shall be considered withdrawn if the information is not
     received within the allotted timeframe, unless the applicant has applied for
     extended time to submit the additional information.
I.5. The risk assessment reviewers shall be reminded of the deadline one week
prior to its date.
I.6. The risk assessment recommendations shall be drafted and dated by the review
team. The recommendations shall state clearly the risks that were assessed, the risk
management measures that are recommended for the activity, any specific
inspections or monitoring that is recommended, and shall be signed by all the
reviewers.




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African Biosafety Network of Expertise (ABNE)
Guideline for the Administration of Biosafety Applications



I.7. Reviewers who disagree with the final recommendations shall send a written
explanation of their objections and findings. These objection shall be submitted to
the administration office by the deadline set for the risk assessment.

 J. PUBLIC COMMENT
J.1. The administration office shall enable public comment on the applications that
require this input under the national regulations.
J.2. The public comment period shall occur [at the time stipulated in the
regulations].
J.3. The public shall be notified of the comment period and the deadline in the
manner stipulated in the regulations.
J.4. Public comments shall be received by the responsibly body stipulated in the
regulations.
J.5. The public comments shall be assessed and summarised within [ ] days of the
deadline, by the responsible regulatory body.
J.6. Public comments requiring response by the applicant or the scientific or socio-
economic advisory bodies shall be forwarded to these bodies within [ ] day of the
deadline for written response.
     J.6.1. The applicant and the advisory bodies shall submit their response in
     writing to the administration office within [ ] days of receiving the public
     comments.
J.7. The summary of the public comments shall be sent to the decision making
body as stipulated in the regulations.
J.8. The summary of the public comments shall be made public in the manner
stipulated in the regulations, where this is a requirement of the regulations.

 K. DECISION MAKING
K.1. The administration office shall forward the application to the decision making
body, within [ ] days of compiling the required documentation.
    K.1.1 The documentation may include one or more of the following,
    depending on the activity for which approval is being requested: risk
    assessment recommendations; socio-economic assessment; public comments
    and applicant and/or advisory body responses to public comments.
K.2. The decision making body shall request additional information, if required,
from the applicant or the advisory bodies within [ ] days of receiving the
application.
    K.2.1. The applicant and the advisory bodies shall submit the information
    within [ ] days of receiving the request.
K.3. The decision making body shall submit their decision to the administrative
office within [ ] days of receiving the application or the additional information that
they requested.
K.4. The administrative office shall inform the applicant of the decision within [ ]
days of receiving it from the decision making body.
K.5. The administration office shall issue the permission for the activity within [ ]
days of receiving it from the decision making body.
    K.5.1. The permission document shall contain the risk management terms and
    conditions for the activity, when these are needed.

L. CORRECTIVE ACTION


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African Biosafety Network of Expertise (ABNE)
Guideline for the Administration of Biosafety Applications



L.1. If the handling of a biosafety application does not comply with the regulatory
requirements, the administration office shall immediately notify the senior officer
in the office who will initiate appropriate reporting and corrective actions.
    L.1.1. The senior officer shall notify the applicant within [ ] hours of
    confirmation that the regulatory requirements have not been complied with.
L.2. In the event of an application, or documentation relating to an application,
being released to an unauthorised person all attempts shall be made to recover the
documents as quickly as possible.
    L.2.1. The senior officer shall notify the applicant within [ ] hours of
    confirmation that documentation has been misdirected to an unauthorised
    source.
L.3. If the timeframes allocated for aspects of the handling of an application are
not adhered to, the senior officer in the administration office shall be notified.
    L.3.1. The senior officer shall notify the applicant within [ ] hours of the new
    timeframes for handling of the application.
L.4. The corrective action shall be documented by the administration office as a
Record of Corrective Action.

 M. RECORD KEEPING
M.1. Copies of the Record of Application Receipt and Handling, including the
record of timeframes for review, shall be retained by the administration office for
[ ] years from the decision on the application.
M.2. All records associated with the handling of the application shall be available
for inspection by the Auditor General upon request.

 N. RELATED SOPS
M.1. The following SOPs shall also be consulted:
[List any related SOPs]

 O. REVIEW AND DISTRIBUTION
O.1. This SOP shall be reviewed by the senior officer in the administration office
no less than annually.
O.2. Revised SOPs shall be distributed to all personnel involved with the handling
of applications, who shall then destroy their older copy.
O.3. Archival copies of this SOP shall be maintained by the senior officer in the
administration office for no less than [X] years.

 P. ASSURANCE
P.1. I have read this document and approve of its contents. I certify that this
document will be made available to all personnel to which it applies.

P.2. Name of Responsible Party (please print):

   Signature of Responsible Party:

   Date:

Attachments
Sample checklist of administrative completeness for different types of applications.


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African Biosafety Network of Expertise (ABNE)
Guideline for the Administration of Biosafety Applications



Record of application receipt and handling
Record of corrective action




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