AFDC 1 1(6525) P3                                                                  
                              DRAFT TANZANIA STANDARD                                                                          
 
 
 
 
Biotechnology - Genetical ly modified organisms and their derived 
products - Requirements  for surveillance  
 
 
 
 
 
 
 
 
 
  
 
                            TANZANIA BUREAU OF STANDARDS  
 
 
 
 0 Foreword  
Genetically modified organisms (GMOs) or their derived products  are well regulated in our country 
through biosafety laws, standards and regulations. GMOs and/or derived products shall be  released in 
the environment or placing in the market after authorization by National Biosafety Focal Point (NBFP).  
Upon authorization specific conditions may be prescribed by the NBFP such as  the geographical areas 
where such GMOs can be released or place d on the market. Moreover, there could be cases when 
members of the community suspect and alert on spread or presence of GMOs or GMOs ingredients on 
markets or in the environment. One way this can be confirmed is through surveillance. Released GMOs 
may hav e adverse impact on the environment and should be monitored. Thus, there are must be in place 
the means of tracking and surveillance for movement and spread of both authorized and non -authorized 
GMOs on the markets and in the environment.  
This Tanzania sta ndard has been developed to provide guidance to researchers, technology developers, 
industry, consumers and regulators on a common approach to monitoring and surveillance of genetically 
modified organisms (GMOs) or thei r derived products for the purposes o f detection; statistical distribution; 
approval status; compliance to standards and regulations; availability of new informatio n for use in risk 
assessments; and in generation of new scientific information.  
During the preparation of this standard, referenc e was made to the following documents:  
 The Environmental M anagement ( Biosafety) Regulations , 2009 .  
 ISPM NO.6 ( 2018) International Standards for phytosanitary measures, guidelines for 
surveillance.  
 KS 2570: 2015 Genetically modified organisms or their derived products - Guidelines for 
surveillance  published by Kenya Bureau of Standards (KEBS).  
 Manual for detection of GMO and crops in Tanzania  2010  Published by Vise President Office 
(VPO).  
1 Scope  
This Tanzania  Standard describes the requirements  for surveil lance of GMOs and their  derived products. 
It is also applicable to surveillance of GMO s and derived therapeutics products . This, is applicable to 
delimiting surveillance , detection surveillance , monitoring surveillance   
2 Normative references  
The following referenced documents are indispensable for the application of this standard. For dated 
references, only the edition cited applies. For undated references, the latest edition of the referenced 
document (including any amendments) applies;  
AFDC 11(6 530) P1 Foodstuffs - Methods of analysis for the detection of genetically modified organisms 
and derived products - Sampling strategies   
AFDC11 (5382) P1/ISO 21569 , Foodstuffs  - Methods of analysis for the detection of genetically modified 
organisms and de rived products - Qualitative nucleic acid -based methods   
AFDC11 (5383) P1/ISO 21570 , Foodstuffs  - Methods of analysis for the detection of genetically modified 
organisms and derived products - Quantitative nucleic acid -based methods    
 AFDC11 (5384)  P1/ISO 2 1572:20 19, Foodstuffs - Molecular biomarker analysis - Immunochemical 
methods for the detection and quantification of proteins  
3 Terms and d efinitions  
For purposes of this standard, the following definitions shall apply:  
3.1 alerts  
are notifications on non -complying products circulating in the market  
3.2 event  
any unique variant of a genetic modification  
3.3 delimiting surveillance   
a surveillance  conducted to establish the boundaries of an area considered to be having or free from  a 
GMO or its derived product  
3.4 detection surveillance   
a surveillance  conducted in an area to determine if a GMO or its derived product is present  
3.5 monitoring surveillance   
a routine surveillance  to verify the presence and characteristics of a GMO or its derived product  
3.6 Genetically modified organism  
means any organism that possesses a novel combination of genetic material obtained through the use of 
modern biotechnology  
4 Requirements  
Surveillance  of GMOs or their derived products involves colle ction, recording, analysis and interpretation 
and dissemination of information. Surveillance can be general or specific. Case specific monitoring may 
be required to verify the environmental risk assessment while general surveillance aims at identifying 
unanticipated adverse effects. General surveillance makes use of existing surveillance systems in 
addition to developing more focused monitoring systems such as questionnaires.  
4.1 General surveilla nce  
 General surveillance is a process whereby information on a GMO concerned or its derived products 
are gathered from available sources and provided for use in detection; distribution; approval status; 
compliance with existing standards and Biosafety regulations;  and in generation of new scientific 
information.  
 General surveillance should be designed to detect unanticipated consequences of release of GMOs 
into environment. Such consequences may include: emergence of super weeds and invasive 
organisms,  change in biodiversity etc, that can be associated with a GMO under question.   
 Data quality, management and statistical analysis are important when developing general 
surveillance plans   
  In general surveillance, comparisons should be made with appropriate  baseline data.  
4.1.1 Sources of information  
The sources of information on GMOs or their derived products may include:  
 a) regulators;  
 b) international, national and count ry government institutions ;  
 c) academic and research institutions;  
 d) scient ific societies;  
 e) developer, producers, farmers and processors;  
 f) consumers;  
 g) museums;  and gene banks  
 h) scientific and trade journals;  
 i) reports;  
 j) contemporary observations;  
 k) non-governmental organizations; and  
 I) general public  
            m) traders  
4.1.2  Collection, storage and retrieval of information  
4.1.2.1  For purposes of general surveillance, information may be obtained as follows:  
 a) desk review;  
 b) questionnaire and interviews;  
 c) field visits;  
 d) data base sear ches;  
 e) tracking of alerts;  
 f) random checks;  
 g) consumer feedback; and  
            h) experimental research.  
4.1.2.2  Data from sources in 4.1.1 shall be made available to the Nat ional Biosafety Clearing House 
(NBCH) and updated as new information becomes available.   
 4.1.2.3  Means of enhancing information gathering for general surveillance include:  
a) legislative obligations (for the general public or specific agencies);  
b) cooperative agreements (between institutions and spec ific agencies); and  
c) Public  education/awareness programmes.  
4.1.3 Use of information   
Information gathered through general surveillance will most often be used:  
a) To map  presence of GMOs and derived products;  
b) To guide regulatory instruments  development on  GMOs and derived products;  
c) To support declarations of GMO status;  
d) To aid early detection of unauthorized GMOs and derived products;  
e) To compile  lists of GMO events, and ingredients in GMO derived products, and  
f) To create general public awareness  
4.2 Specific surve illance   
Specific surveillances  are procedures for obtaining information on GMOs or their derived products 
released into the environment or market over a defined period.  
4.2.1 Surveillance  plan  
Specific surveillance s may include detection, delimiting or monitoring surveillance s.  
The surveillance  plan should include:  
a) Definition of the purpose (e.g. early detection, assurances for GMO free status); information for a 
commodity event and product ingredient list and the  specification of the biosafety or food safety 
requirements to be met;  
b) Identification of the target GMO;  
c) Identification of scope (e.g. geographical area, market, production system, product, season);  
d) Identification of timing (dates, frequency, d uration);  
e) The commodity, event and product ingredient list as appropriate;  
f) Indication of the statistical basis (e.g. threshold for labeling, presenc e of GMO, level of confidence, 
number and size of samples, selection of sites, number of sites frequ ency of sampling, assumptions); 
and  
g) Description of surveillance  methodology and quality management including an explanation of:  
i. Sampling procedures as per AFDC 11(6530) P1 ; 
ii. purpose of surveillance , type of GMO, or ingredient in the product;  
iii. Testing procedures e.g. AFDC11 (5382) P1/ISO 21569, AFDC11 (5383) P1/ISO 21570, 
AFDC11 (5384) P1/ISO 21572 ; and  
iv. Surveillance  data reporting procedures.  
  
 4.2.2 GMO event or ingredient surveillance s  
a) Surveillance s for specific GMO event or ingredients w ill provide information to be used mainly:  
 i) In declaration and verification of  the status of GMO or their derived  
 ii) Early detection of unauthorized GMO events or ingredients  and  
 iii) For reporting to other organizations such as international BCH and trading partners.  
b)  The selection of suitable surveillance  areas may be determined by the:  
 i) Previously reported presence (including alerts) and distribution of GMOs or their derived 
products;  
 ii) Type of GMO event and ingredient in the product; and  
 iii) Distribution of target GMO or their derived product and especiall y of their areas of marketing, 
commercial use or production.  
c) The timing of surveillance  may be determined by:  
i. The use, movement, dispersal or production/life cycle of  GMOs or their derived products;  
ii. The timing of important phases in handling of GMOs or their derived products (e.g. imports, 
harvesting, supplies to markets, release to the environment);  
iii. Whether the  event or ingredient is best detected on the GMO or their derived product  
iv. Availability of new information  
v. Upon a request by a client ; and  
vi. Directives of the regulatory authorities . 
d) The selection of surveillance  procedures may be determined by the type of identifier by which the GMO 
or derived product can be recognized, and by the accuracy and sensitivity of t echniques used to test for 
the GMO or ingredient.  
4.2.3  Commodity specific surveillance s  
Commodity specific surveillance s can provide useful information for GMO event s contained in the 
commodities especially where data from general surveillance is lacking.  
a) The selection of suitable surveillance  sites may be determined by:  
 i) geographical distribution of production areas and/or their size;   
 ii) production systems;  
 iii) cultivars , variety  or breeds present; and  
 iv) supply and value addition chain.  
b) Surveillance s should be timed in relation to season and stage of commodity, and import regimes.  
 
  
 4.2.4  Targeted and random sampling   
Surveillance s should normally be designed to favour detection of specific G MOs or their derived products. 
However, the surveillance  plan should also include random sampling to detect un expected occurrence. It 
should be noted that if information on the prevale nce of a GMO or their derived produc ts in an area is 
required, the results from targeted surveillance s may not provide an accurate assessment.  
5. Creation of public awareness using surveillance information  
In Tanzania, the Biosafety regulations require the National Biosafety Focal Point to promote and facilitate 
public awareness, education, and participation concerning the safe transfer , handling and use of GMOs 
and products thereof. Thus, the information obtained in GMOs monitoring surveillance s will be  used to 
inform the NBFP, which will in turn create awareness on presence or absence of GMOs, extent of spread 
in the environment and potential risks if any, mitigation measures and regulatory  requirements for the 
same.  
5.1 Public awareness and participat ion are important:  
a) For consensus -building on issues that affect people directly or indirectly;  
b) To build a sense of ownership and collective responsibility;  
c) To promote sustainable development;  
d) To promote smooth implementation of the decisions;  
e) To build transparency and accountability;  
f) To provide balanced information in terms of pros and cons ; and 
g) To harmonize institutions that provide awareness activities  
h) To build transparence and thus confidence on GMOs handling  
5.2 The NBFP shall endeavor to make avail able to the public:  
a) Information on all GMOs or their products which have received, or have been denied, 
authorization, as the case may be, for import, deliberate release (including the location of the 
release), placing on the market or contained use;  
b) The r isk assessment report in respect of the GMOs or products thereof; and  
c) The report on the evaluation of the outcome of the risk assessment.  
d) The general and specific surveillance reports  
6 Good surveillance practices   
Accurate surveillance data depends on expertise in sampling methods, pres ervation and transportation of 
samples for identification and record keeping associated with samples, technical validity and regular 
maintenance of equipment and supplies.  
a) GMO developer or researchers shall have  in place  GMOs monitoring systems  
b) Sampling methods for surveillance data will be in accordance with the  AFDC 11 (6530) P1 
Monitoring methods should be appropriate  and proportional   
c) Preservation of the samples will depend on the type of sample being handled and the method of 
analysis  to be used; samples will be handled according to peer reviewed protocols.  
d) Samples shall be handled in a manner that eliminates possibilities of contaminations  
e) All GMO samples, unless  contradicts preservation protocols, shall be packaged  and transported 
according to the laws   
 f) All records associated with sampling, preservations, transportation, nucleic acid and proteins 
extraction, number of samples, questionnaires, experts involved  etc. will be kept for a reasonable 
period of time  
g) Where th e main purpose is to monitor spread into the environment, geographical coordinates of 
surveillances  areas will be recorded and the affected environment (plant species, type of food, 
affected species etc) clearly  described  
7 Technical requirements for analy tical services  
7.1 Appropriate analytical services should be available, either internally or  contracted to support general 
surveillance and specific surveillance  activities. Characteristics of the analytical services include:  
i. Expertise in GMO identification;  
ii. Necessary facilities and equipment;  
iii. Access to specialists for verification where necessary;  
iv. Infrastructure for record keeping;  
v. Facilities for processing and storing of voucher specimens; and  
vi. Use of standard operating pr ocedures  
 
7.2 To increase confidence in the surveillance , the results should be replicable.  
8 Record keeping  
8.1 Each entity undertaking surveillance should keep appropriate records derived from general and 
specific surveillance s. Information kept should be appropriate for the intended purpose. Information in the 
records should include to the extent possible:  
 i) scientific name or unique identifier of the GMO;  
 ii) nomenclature such as family/order;  
 iii) GMO product;  
 iv) collection site;  
 v) date of collection and name of collector;  
 vi) date of identification and name of the person identifying;  
 vii) date of verification and name of person verifying;  
            viii) tissue(s) affected by gene expression; and  
 ix) references, if any.  
8.2 Reports of new occurrences of GMOs should include information on any measures taken, and such 
reports made available on request.  
 
  
 9 Transparency  
Each institution/person undertaking surveillance according to this draft Tanzania standard  should, when 
required, avail data or reports on presence, distribution, or absence of a GMO or its derived prod ucts to 
interested or affected parties while respecting confidentiality and existing laws.  
10 Response to alerts  
10.1 Alerts arise in circumstances where there is knowledge of a non -confo rming product in the market as 
notified by a regulatory authority  on the likelihood of it entering or circulating in the country.  
10.2 Alerts should contain information that generally indicates:  
 i) Potential risk to human health, animal health and environment;  
 ii) Whether the product is on the market; and  
 iii) If immediate action is required.  
10.3 Alerts originating from trading partners should be channeled to regulatory institutions .  
10.4 The regulatory authority  should disseminate the information  to the NBFP  while taking the necessary 
immediate measures.  
10.5 Alerts should be treate d with confidentiality.  
10. Surveillance report  
10.1 The surveillance report shall i nclud e the following:  
a) Date of surveillance  
b) Surveillance or  names and signatures  
c) Type of surve illance (specific or general surveillance)  
d) Methods used (questionnaire, sampling, preservation  method  etc.)  
e) Reasons for surveillance  (response to alert, implementing existing monitoring plans etc .) 
f) Geographical areas covered  (coordinates be provided, district names etc) . For confidentiality, 
names of shops, shopping malls, etc. shall not be exposed  but such names shall be made known 
to regulatory authorities   
g) Event(s) of GMOs t argeted  
h) Transportation of the sample  
i) Findings of the surveillance   
1) Adherence to existing monitoring plan (for authorized GMOs only)  
2) Adverse effect on environment,  
3) GMO presence and  event,  
4) dispersal,  
5) gene flow,  
6) mitigation measures in place,  
7) environmental exposure,  
8) Any other observations worth reporting  
j) Recommendations to regulatory authorities  
k) Information worth sharing with  general  public   
 10.2 report submission  
The GMO surveillance report may be submitted to the competent authority  when applicable . However, a 
copy shall be made available to the NBFP.  
Any report of surveillance shall be accepted and shared with general public if:  
a) Data  were collected based on AFDC 11 (6530)  
b) Does not violate Tanzania laws