NIGERIA NATIONAL BIOSAFETY COMMUNICATION STRATEGY
August 27, 2018
NATIONAL BIOSAFETY EMERGENCY RESPONSE STRATEGY
August 27, 2018
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FEDERAL REPUBLIC OF NIGERIA

 

 

 

NATIONAL BIOSAFETY ADMINISTRATIVE MANUAL

 

 

 

August 2018

 

 

Contents

1.0      Introduction. 2

2.0      Procedure for decision-making on Biosafety Applications. 2

3.0      Confidential Business Information. 3

4.0      FEES FOR VARIOUS BIOSAFETY APPLICATIONS FOR PERMITS: 4

5.0      Application Reference Codes. 5

Checklist for completeness of application dossier. 7

Supplementary Completeness of Biosafety Application Checklist. 14

 


 


 

1.0              Introduction

This manual serves as a step-by-step guide for Biosafety personnel with regard to handling applications for various biosafety services. It specifies the processes involved from the receipt of an application right through to when decision(s) is taken and communicated to the applicant. The manual shall be a working tool for personnel of the National Biosafety Management Agency (NBMA) as well as serve as a guide for prospective applicants.

2.0            Procedure for decision-making on Biosafety Applications

  1. Receipt of application,
  2. Documentation(Filing of Application and assigning appropriate Ref. Code),
  3. Acknowledgement of application within 21 days(which includes communication of fees to be paid by applicant),
  4. Confirmation of Payment of processing fee,
  5. Review of application dossier for completeness,
  6. Correspondence to applicant for incomplete dossier,
  7. Summary of application and brief information on the place, duration and time for the display of application dossier,
  8. Stopping the clock if dossier is not complete until response is received from Applicant,
  9. Constitution of National Biosafety Committee (NBC) and National Biosafety Technical Sub-Committee (NBTS)and referral of Application dossiers to the committees for review and recommendation.

NOTE: Not all applications require referral to NBC and NBTS.

  1. NBMA inspects site(s) of intended release prior to first NBC review meeting,
  2. Display of copies of application and relevant information at strategic places to enable the general public and relevant government ministries and agencies study and make comments on the application and provide relevant information within 21 days to the Agency,
  3. The Agency may, prior to the display, make announcement in at least two national and one local Newspapers or other news media.
  4. The Agency may, in addition to the comments received, hold public hearings or consultations to obtain further comments and inputs that will assist in the review or processing of the application,
  5. NBC second meeting holds for one or two days and reviews application within seven working days after the expiration of the period of the display of the application dossier, taking into account the recommendation of the NBTS,
  6. NBC submits recommendation to Director General/CEO of NBMA after  meeting,
  7. DG/CEO takes decision on application,
  8. Decision document is prepared,
  9. Decision document(Permission/rejection)is communicated to Applicant ,
  10. Decision is made available in the Biosafety Clearing House (BCH), NBMA website and other news media and
  11. Inspection of site(s)/facility by NBMA for compliance to terms, conditions and safety measures based on the final decision on application.

 

 

 

 

3.0             Confidential Business Information

  1. The Agency shall not disclose any confidential business information submitted by any Applicant.
  2. To determine if any information identified by an applicant qualifies as confidential business information that cannot be disclosed to the public, the Agency shall ascertain that:

 

  1. the information has not previously been released to the public anywhere in the world;
  2. the applicant has shown that steps have been taken to prevent the release of such information;
  3. release of the information would be detrimental to the applicant.

 

  • The following information shall not be considered confidential business information and can be disclosed to the public:

 

  1. the name and address of the applicant;
  2. a general description of the Genetically Modified Organism (GMO);
  3. a summary of the risks assessment for the GMO;
  4. any scientific data that specifically addresses potential environmental or food risk from GMOs and any method; and
  5. plans for emergency response.

 

4.0            FEES FOR VARIOUS BIOSAFETY APPLICATIONS FOR PERMITS:

 

These fees cover expenses for servicing various Committees’ meetings, Inspections and permit.

 

 

S/No.

 

Activity/Application

 

Charge (N)

 

 Charge ($)

1. Accreditation of institution and certification of Biosafety facilities, Confined Fields(Green House/Laboratory) Processing 500,000.00
Permit 50,000.00
2. Certification of new Biosafety facility

(Green House/Laboratory)

Processing 300,000.00
Permit

 

30,000.00
3. Confined Field Trial (CFT) Processing 2,500,000.00
Permit

 

100,000.00
4. Renewal of trials Processing 1,000,000.00
Permit

 

50,000.00
5. General/Commercial Release Processing 3,500,000.00
Permit

 

150,000.00
6. Appeals Processing 300,000.00
7. Transit Processing 100,000.00
Permit

 

50,000.00
8. Multi-locational Trials  

Processing

3,500,000.00
Permit

 

50,000.00
9. Fast – Track Processing[1]  
i. Accreditation of institution and certification of Biosafety facility

(Green House/Laboratory)

650,000.00
ii. Certification of new Biosafety facility

(Green House/Laboratory)

400,000.00
iii. CFT 4,500,000.00
iv. Renewal of trials 1,500,000.00
v. General/Commercial Release 4,500,000.00
vi. Appeals 400,000.00
vii. Transit 150,000.00
viii Multi-locational Trials 4,500,000.00

5.0            Application Reference Codes

Application Code
GMO import for Food, feed and processing for commercialization NBMA/CM/FFP/IM/00——
GMO export for food, feed and processing for commercialization NBMA/CM/FFP/EX/00——
Locally  commercialized GM for food, feed and processing NBMA/CM/FFP/D/00——
GMO import for general release for planting NBMA/CM/P/IM /00——–
Locally  commercialized GMO for planting NBMA/P/D/00—————-
GM imported for contained use NBMA/CT/00—————–
GMO for single location confined field trial NBMA/CFT/00—————
GMO for multi-location confined field trial NBMA/CFT/MLT/00——–
GMOS for on Field Trial NBMA/OFT/ 00——–
Accreditation of Institution NBMA/AI/ 00——–
Certification of Containment Facility NBMA/CCF/ 00——–

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


A

Checklist for completeness of application dossier

 

                                                                           Application Ref. Code———————–

 

S/N Information to look out for  while checking for completeness of application dossier Available (Yes ) Not available (No.) Remarks
1.        1. Name of Applicant
2. Address, telephone, e-mail, fax, website of applicant

 

A.      Type of Application
3. Name of the GMO. Purpose of release (i.e. contained use, CFT, General Release)
4. Scientific name, taxonomy and species of the GMO

 

5. Method of modification

 

6. Location/area of intendedresearch
7. Biological and biochemical difference from related living species

 

8.  Trait removed from the donor
9. Phenotypic and genetic markers of interest

 

10. Degree of relatedness between donor and recipient or between parental organisms
11. Description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, preys, parasites and competitors, symbionts and hosts

 

12. Description of genetic trait or phenotypic characteristics and, in particular, any new traits and characteristics which may be expressed or no longer expressed
13. Nature and source of the vectors

 

14. Purpose of modification  and benefits
15. Description of the proposed general/experimental release, including the purposes and foreseen products
16. Foreseen date of the release and duration of release(s)
17. Preparation of the site prior  to the release
18. Location and size of the site

 

19. Quantity of GMO(s) to be released either in number or weight

 

20. When and where the GMO has been approved previously and grown or consumed
21. Method of  land cultivation or other activities
22. Worker protection measures to be taken during the release
23. Post release treatment of the site of release
24. Techniques for incineration or inactivation of the GMOs or products at the end of the experiment/release
25. Likelihood of gene transfer to other organisms
B.        RISK MANAGEMENT/ POTENTIAL IMPACT
26. Is there a potential risk?

 

27. Measures for mitigating adverse impacts
28. Type of environment or the geographical areas of the country for which the product is suited
29. Proposed packaging which must be appropriate so as to avoid unintended release of the Genetically Modified (GM) products
30. Is the risk assessment report indicating the potential risk(s) available?

 

31. Control of the Release (Methods and procedures to avoid or minimize the spread of the GMOs or GM products beyond their site of release or the designated area for use)
32. Methods and procedures to protect the site from intrusion by unauthorized individuals
33.  Methods and procedures to prevent other organisms from entering the site
34. Type of waste to be generated and expected amount of waste
35. Description of waste treatment envisaged
36. Methods and procedures for controlling the GMOs or GM products in case of unexpected spread

 

37. Methods for the isolation of the area affected by the spread

 

C.        EMERGENCY PLAN
38. Plans for protecting human health, animals, plants and the environment in case of the occurrence of an undesirable effect
39. Measures to take in case of unintended release of misused GM materials
40. Methods for tracing the GMOs or GM products and for monitoring their effects
41. Specificity (to identify the GMOs or GM products and to distinguish them from the donor, recipient or where appropriate, the parental organism), sensitivity and reliability of the monitoring techniques
42. Methods for disposal or incineration of plants, animals, packaging materials, soil etc. that were exposed during or after the spread

 

43. Techniques for detecting transfer of the donated genetic material to other organisms
44. Methods to detect aberrant gene expression
45. Specific instructions or recommendations for storage and handling
46. Proposed isolation distance from related species and human habitation
47. Proposed labelling
D.       INFORMATION ON PERSONNEL
48. Information on personnel and training which shall include qualifications and training of persons who shall be responsible for planning and carrying out the implementation of the project, including those responsible for supervision, monitoring and evaluation of the safety measures. (This applies to Trials and Containment Facilities )

 

 

 

 

 

¨Complete                   oProceed with application review

 

 

 

 

 

 

 

Reviewed by:

 

Name: ——————————————————————————————

 

Signature: ————————————————- Date: —————————-

 

 

Counter signed by:

 

Name: —————————————————————————————–

 

Signature: ——————————————- Date: ———————————

 

 

 

 

 


B

Supplementary Completeness of Biosafety Application Checklist

 

                                                                           Application Ref. Code———————–

 

S/N Information missing in the initial review of application dossier. This Check list would be used to assess further information provided by the Applicant after the first assessment. Now available (Yes ) Not still available (No.) Remarks
1. Name of Applicant
2 Address, telephone, e-mail, fax, website of applicant

 

A.        Type of Application
3. Information on personnel and training which shall include qualifications and training of persons who shall be responsible for planning and carrying out the implementation of the project, including those responsible for supervision, monitoring and evaluation of the safety measures. (This applies to Trials and Containment Facilities)
4. Name of the Genetically Modified Organism (GMO)

 

5. Scientific name, taxonomy and species of the GMO

 

6 Method of modification

 

7 Location/area of intended release
8 Biological and biochemical difference from related living species

 

9  Trait removed from the donor
10 Phenotypic and genetic markers of interest

 

11 Degree of relatedness between donor and recipient or between parental organisms
12 Description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, preys, parasites and competitors, symbionts and hosts

 

13 Description of genetic trait or phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed
14 Nature and source of the vectors

 

15 Purpose of modification  and benefits
16 Description of the proposed deliberate release, including the purposes and foreseen products
17 Foreseen date of the release and duration of release(s) applied for
18 Preparation of the site prior  to the release
19 Location and Size of the site

 

20 Purpose of release (i.e. contained use, Confined Field Trial, commercialization)
21 Quantity of genetically modified organisms to be released either in number or weight

 

21 When and where the GMO has been approved previously and grown or consumed
22 Method of  land cultivation or other activities
23 Worker protection measures to be taken during the release
24 Post release treatment of the site of release
25 Techniques for incineration or inactivation of the genetically modified organisms or products at the end of the experiment/release
26 Likelihood of gene transfer to other organisms
27 Impacts on human and animal health and the environment.

 

28 Measures for mitigating adverse impacts
29 Type of environment or of the geographical areas of the country for which the product is suited
30 Proposed packaging which must be appropriate so as to avoid unintended release of the genetically modified products
31 Is the risk assessment report indicating the potential risk(s) available?

 

32 Control of the Release (Methods and procedures to avoid or minimize the spread of the genetically modified organisms or products beyond their site of release or the designated area for use)
33 Methods and procedures to protect the site from intrusion by unauthorized individuals
34  Methods and procedures to prevent other organisms from entering the site
35 Type of waste to be generated and expected amount of waste
36 Description of waste treatment envisaged
37 Methods and procedures for controlling the genetically modified organisms or products in case of unexpected spread

 

38 Methods for the isolation of the area affected by the spread

 

39 Plans for protecting human health, animals, plants and the environment in case of the occurrence of an undesirable effect
40 Measures to take in case of unintended release of misused GM materials
41 Methods for tracing the genetically modified organisms or products and of monitoring their effects
42 Specificity (to identify the genetically modified organism or product and to distinguish them from the donor, recipient or where appropriate, the parental organism), sensitivity and reliability of the monitoring techniques
43 Methods for disposal or incineration of plants, animals, packaging materials, soil etc. that were exposed during or after the spread.

 

44 Techniques for detecting transfer of the donated genetic material to other organisms
45 Methods to detect aberrant gene expression
46 Specific instructions or recommendations for storage and handling
47 Proposed isolation distance from related species and human habitation
48 Proposed labelling

 

 

 

 

 

 

 

Information now complete     o         Proceed with application review

 

¨

 

 

 

 

Reviewed by:

 

Name: ——————————————————————————————

 

Signature: ————————————————- Date: —————————-

 

 

Counter signed by:

 

Name: —————————————————————————————–

 

Signature: ——————————————- Date: ———————————

 

[1] For the fast-track, the charges indicated above are just for processing, fees for permits are same as for the applications under normal processing.

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