First schedule (Section 4)
Part I – Administration of Authority
1. Composition of Authority
(1)The Authority shall consist of thirteen part-time members appointed by the Minister.(2)The members referred to in subparagraph (1) shall include the following:(a)one representative each from the ministries responsible for—(i) science and technology;(ii) environment and natural resources;(iii) agriculture;(iv) health;(v) commerce, trade and industry;(vi) information; and(vii) justice(b)one person each from the following groups:(i) consumers;(ii) religious;(iii) farmers; and(iv) traditional authorities and;(3)The Chairperson and Vice-Chairperson shall be appointed by the Minister from amongst the members.(4)A person shall not be appointed as a member of the Authority if the person—(a)is an undischarged bankrupt;(b)has been convicted of an offence under any law in force or this Act;(c)has been convicted of any other offence and sentenced to a term of imprisonment of not less than six months; or(d)has any financial, contractual or other interest in any biotechnology enterprise likely to benefit directly or indirectly from biotechnology or its products.2. Seal of Authority
(1)The seal of the Authority shall be such device as may be determined by the Authority and shall be kept by the Secretary.(2)The affixing of the seal shall be authenticated by the Chairperson or the Vice-Chairperson and the Secretary or one other person authorised in that behalf by a resolution of the Authority.(3)Any contract or instrument which, if entered into or executed by a person not being a body corporate, would not be required to be under seal, may be entered into or executed without seal on behalf of the Secretary by the Secretary or any other person generally or specifically authorised by the Authority in that behalf.(4)Any document purporting to be a document under the seal of the Authority or issued on behalf of the Authority shall be received in evidence and shall be executed or issued, as the case may be, without any further proof, unless the contrary is proved.3. Tenure of office of member and vacancy
(1)Subject to the other provisions of this Act, a member of the Authority shall hold office for a period of three years from the date of appointment and may be re-appointed for a further like period.(2)The office of a member becomes vacant—(a)upon the member’s death;(b)if the member is adjudged bankrupt;(c)if the member is absent from three consecutive meetings of the Authority of which the member has had notice, without the prior approval of the Authority;(d)upon the expiry or one month’s notice of the member’s intention to resign from office, given by the member in writing to the Authority;(e)if the member becomes mentally or physically incapable of performing the duties of a member of the Authority;(f)if the member is convicted of an offence under this Act;(g)if the member is convicted of an offence under any other written law and sentenced therefor to imprisonment for a term of six months or more; or(h)if a member acquires any interest in a biotechnology enterprise or any commercial enterprise likely to benefit directly from biotechnology or its products.4. Proceedings of Authority
(1)Subject to the other provisions of this Act, the Authority may regulate its own procedure.(2)The Authority shall meet for the transaction of business as often as is necessary or expedient for the conduct of its business at such places and times as the Authority may determine.(3)Upon giving notice of not less than fourteen days, a meeting of the Authority may be called by the Chairperson and shall be called if not less than one third of the members so request in writing:Provided that if the urgency of any particular matter does not permit the giving of such notice, a special meeting may be called upon a shorter notice given by three members of the Authority.(4)The quorum at any meeting of the Authority shall be five of the members.(5)There shall preside at any meeting of the Authority—(b)in the absence of the chairperson, the vice-chairperson; and(c)in the absence of both the chairperson and the vice-chairperson, such member as the members present may elect from amongst themselves for the purpose of that meeting.(6)A decision of the Authority on any question shall be by a majority of votes of the members present and voting at the meeting and, in the event of an equality of votes, the person presiding at the meeting shall have, in addition to a deliberative vote, a casting vote.(7)Where a member is for any reasonable cause unable to attend any meeting of the Authority, the member may, in writing, nominate another person from the same organisation to attend such meeting in that member's stead and such person shall be deemed to be a member for the purpose of such meeting.(8)The Authority may invite any person whose presence in its opinion is desirable to attend and to participate in the deliberations of a meeting of the Authority but such person shall have no vote.(9)The validity of any proceedings, act or decision of the Authority shall not be affected by any vacancy in the membership of the Authority or by any defect in the appointment of any member or by reason that any person not entitled so to do, took part in the proceedings.(10)The Authority shall cause minutes to be kept of the proceedings of every meeting of the Authority and every meeting of any committee established by the Authority.5. Committees of Authority
(1)The Authority may, for the purpose of performing its functions under this Act, constitute any committee and may delegate to any such committee such of its functions as it thinks fit.(2)The Authority may appoint as members of a committee constituted under sub-paragraph (1), persons who are or are not members of the Authority and such persons shall hold office for such period as the Authority may determine.6. Allowances of members
There shall be paid to members of the Authority or any committee of the Authority such allowances as the Authority may, with the approval of the Minister, determine.7. Disclosure of interest
(1)A person who is present at a meeting of the Authority or any committee of the Authority and who is directly or indirectly interested in a matter that is the subject of consideration at the meeting shall, as soon as is practicable after the commencement of the meeting, disclose the interest and shall not, unless the Authority or the committee otherwise directs, take part in any consideration or discussion of, or vote on, any question relating to the matter.(2)A disclosure of interest made under this paragraph shall be recorded in the minutes of the meeting at which it is made.8. Registrar and staff of Authority
(1)The Authority shall appoint a suitably qualified and experienced person as Registrar of the Authority who shall be the chief executive officer of the Authority and who, subject to the general or special direction of the Authority, shall be responsible for the carrying out of the provisions of this Act, and shall be responsible for the administration of the Act.(2)The Authority shall, with the approval of the Minister, determine the terms and conditions of service of the Registrar.(3)The Registrar shall be an ex-officio member and Secretary of the Authority.(4)Where the Registrar is for any reason absent or unable to perform the functions of office, or wheve a vacancy occurs in the office of Registrar, the Authority shall designate a member of staff to act in that capacity for the duration of the absence until the Registrar resumes functions of office or until another Registrar is appointed in terms of sub-paragraph (1), and that person has, while so acting, such powers and shall perform such duties as may be delegated or assigned by the Authority.(5)The Authority may appoint, on such terms and conditions as the Authority may with the approval of the Minister determine, such other staff as it considers necessary for the performance of its functions under this Act.9. Prohibitation of publication of, or disclosure of information to unauthorised persons
(1)A person shall not, without the consent in writing given by or on behalf of the Authority, publish or disclose to any unauthorized person, otherwise than in the course of duties of that person, the contents of any document, communication or information whatsoever, which relates to or which has come to the knowledge of that person in the course of that person’s duties under this Act.(2)Any person who contravenes the provisions of sub-paragraph (1) commits an offence and is liable, upon conviction, to a fine not exceeding ten thousand penalty units or to imprisonment for a term not exceeding two years, or to both.(3)If any person, having any information which to the knowledge of that person has been published or disclosed in contravention of sub-paragraph (1), unlawfully publishes or communicates any such information to any other person, the person commits an offence and is liable, upon conviction, to a fine nor exceeding ten thousand penalty units or to imprisonment for a term not exceeding two years or to both.10. Immunity of members of Authority and staff
No action or other proceeding shall lie or be instituted against any member of the Authority or a committee of the Authority, or any member of the staff of the Authority, for or in respect of any act or thing done or omitted to be done in good faith in the exercise or performance, or purported exercise or performance, of any of the powers or functions conferred under this Act.Part II – Financial provisions
11.
(1)The funds of the Authority shall consist of such moneys as may—(a)be appropriated by Parliament for the purpose of the Authority;(b)paid to the Authority by way of fees, levy, grants or donations; and(c)vest in or accrue to the Authority.(2)The Authority may—(a)accept moneys by way of grants or donations from any source in Zambia and subject to the approval of the Minister, from any source outside Zambia;(b)subject to the approval ot the Minister, raise by way of loans or otherwise, such moneys as it may require for the discharge of its functions; and(c)in accordance with the regulations made under this Act, charge and collect fees for services provided by the Authority.(3)There shall be paid from the funds of the Authority—(a)such monies as may be necessary for the performance of its functions under the Act;(b)salaries, allowances and loans of the staff of the Authority;(c)such reasonable travelling, transport and subsistence al1 owances for members or the members of any committee of the Authority when engaged in the business of the Authority, at such rates as the Minister may determine; and(d)any other expenses incurred by the Authority in the performance of its function.(4)The Authority may, subject to the approval of the Minister, invest in such manner as it thinks fit such of its funds as it does not immediately require for the performance of its functions.12. Financial year
The financial year of the Authority shall be the period of twelve months ending on 31st December, in each year.13. Accounts
The Authority shall cause to be kept proper books of accounts and other records relating to its accounts.14. Annual report
(1)As soon as practicable, but not later than six months after the expiry of each financial year, the Authority shall submit to the Minister a report concerning its activities during the financial year.(2)The report referred to in sub-paragraph (1) shall include information on the financial affairs of the Authority and there shall be appended thereto—(a)an audited balance sheet;(b)an audited statement of income and expenditure; and(c)such other information as the Minister may require.(3)The Minister shall, not later than thirty days after the first sitting of the National Assembly next after the receipt of the report referred to in sub-paragraph (1), lay it before the National Assembly.Second Schedule (Section 13)
Information required for the application
I – General Information
A.Name and address of the applicantB.Information on personnel and training1.Name ot person(s) responsible for the planning and carrying out the release, including those responsible for supervision, monitoring and safety, in particular, name and qualificalion(s) of the responsible scientist.2.Information on training and qualification(s) of personnel involved in carrying out the release.II – Information relating to the genetically modified organism(s) or products thereof
A.Characteristics of—(c)(where appropriate) parental organism(s)3.Other names (usual name, strain name, cultivars name, local name etc.).4.Phenotypic and genetic markers.5.Degree of relatedness between donor and recipient or parental organisms.6.Description of identification and detection techniques.7.Sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques.8.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.9.Potential for genetic transfer and exchange with other organisms.10.Verification of the genetic stability of the organisms rind factors affecting it, taking into account the relevance of the laboratory experiments undertaken for the authentic ecological conditions under which the organisms live or are used.11.Pathological, ecological and physiological traits:(a)classification of hazard according to existing national rules concerning the protection of human and animal health and/or the environment;(b)generation time in natural ecosystem, sexual and asexual reproductive cycle;(c)information on survival, including seasonability and the ability to form survival structures e.g.: seeds, spores or sclerotia;(d)pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organisms. Possible activation of latent viruses (proviruses). Ability to colonize other organisms;(e)antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for therapy and prophylaxis;(f)involvemen in environmental processes: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.12.Nature of indigenous vectors:(b)Frequency of mobilisation;(d)Presence of genes, which confer resistance.13.History of previous modifications.B.Characteristics of the Vector1.Natute and source of the vector.2.Sequence of transposons, vectors and other non-coding genetic segments used to construct the genetically modified organism (s) and products thereof and to make the introduced vector and insert function in the genetically modified organism (s) and products thereof.3.Frequency of mobilisation of inserted vector and/or genetic transfer capabilities and methods of determination.4.Information on the degree to which the vector is limited to the DNA required to perform the intended function.5.Factors (chemical, biological, climatic, etc.) influencing the functional level of the promoter/enhancer, and how the functional level is changed.C.Characteristics of the genetically modified organism(s) and products thereof1.Information relating to the genetic modification:(a)method used for the modification;(b)methods used to construct and introduce the insert(s) into the recipient or to delete a sequence;(c)description of the insert and/or vector construction;(d)purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function;(e)number of intact and truncated vector inserts. Sequence, functions identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known sequence; and(f)sequence and methylation pattern of the recipient DNA as far as 100 kbp up and down stream from all DNA inserts.2.Information on the final genetically modified organism (s) and products thereof:(a)description of the genetic trait(s) of phenotypic characteristics and in particular any new traits and characteristics which may be expressed or no longer expressed;(b)structure and amount of any vector and/or donor nucleic acid remaining in the final construction of the genetically modified organism (s) and products thereof;(c)stability of the organism in terms of genetic traits;(d)rate and level of expression of the new genetic material. Methods and sensitivity of measurement;(e)activity of the expressed protein(s);(f)expression levels for the recipient’s genes situated as far as 100 kbp up and down stream from all DNA inserts;(g)sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques;(h)history of previous releases or uses of the genetically modified organism (s) or products thereof;(i)health considerations:(i)toxic or allergenic effects of the viable or non-viable genetically modified organism or product thereof or their metabollic products;(iii)comparison of the genetically modified organism (s) or products thereof to the donor; recipient or (where appropriate) parental organism regarding pathogenicity;(iv)capacity for colonisation;(v)if the organisms is pathogenic to humans who are immuno competent:(a)disease caused and mechanism of path pathogenicity including invasiveness and virulence;(d)host range, possibility of alteration;(e)possibility of survival outside human;(f)presence of vectors or means of dissemination;(h)antibiotic resistance patterns;(j)availability of appropriate therapies.III – Information relating to the conditions of release and the receiving environment
A.Information on the release1.Description of the proposed deliberate release, including the purpose(s) and foreseen products;2.Foreseen dates of the release and time planning of the experiment including frequency and duration of releases;3.Preparation of site prior to the release;5.Method(s) to be used for the release;6.Quantities of genetically modified organism(s) or products thereof to be released;7.Disturbance on the site (type and method of cultivation, mining, irrigation or other activities);8.Workers protection measures taken during the release;9.Post-release treatment of the site;10.Techniques foreseen for elimination or inactivation of the genetically modified organism (s) or products thereof at the end of the experiment;11.Information on, and results of, previous releases of the genetically modified organism (s) or products thereof, especially at different scales and in different ecosystems.B.Information of the environment (both on site and in the wider environment)1.Geographical location and grid reference of the site(s) (in case of notification the site(s) of release will be the foreseen areas of use of the product).2.Physical and biological proximity to humans and other significant biota.3.Proximity to significant biotopes or protected areas.4.Size of local population.5.Economic activities of local populations which are based on the natural resources of the area.6.Distance to closest areas protected for drinking water and/ or environmental purposes.7.Climatic characteristics of the region(s) likely to be affected.8.Geographical, geological and pedoiogical characteristics.9.Flora and fauna, including crops, livestock and migratory species.10.Description of target and non-target ecosystems likely to be affected.11.A comparison of the natural habitat of the recipient organism with the proposed site(s) of release.12.Any known planned developments or changes in land use in the region, which could influence the environmental impact of the release.IV – Information relating to the interactions between the genetically modified organism(s) or products thereof and the environment
A.Characteristics and factors affecting the survival, multiplication, gene expression and dissemination1.Biological features which affect survival, multiplication and dispersal.2.Known or predicted environmental conditions which may affect survival, multiplication and dissemination (wind, water, soil, temperature, pH, pollutants such as pesticides, heavy metals and others, etc.).3.Sensitivity to specific agents.B.Interactions with the environment1.Predicted habitat of the genetically modified organism (s) or products thereof.2.Studies of the behaviour and characteristics of the genetically modified organism (s) or products thereof and their ecological impact carried out in simulated natural environments, such as microorganisms, growth rooms, green houses.3.Genetic transfer capability:(a)post-release transfer of genetic material from genetically modified organism (s) or products thereof into organisms in affected ecosystems;(b)post-release transfer of genetic material from indigenous organisms to the genetically modified organism (s) or products thereof;4.Likelihood of post-release selection leading to the expression of unexpected and/or undesirable traits in the genetically modified organism (s) or products thereof.5.Measures employed to ensure and verify genetic stability. Description of genetic traits, which may prevent or minimise dispersal or genetic material. Methods to verify stability.6.Routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc.7.Description of ecosystems to which the genetically modified organism(s) or products thereof could be disseminated.C.Potential environmental impact1.Potentials for excessive population increase in the environment.2.Competitive advantage of the genetically modified organism (s) or products thereof in relation to the unmodified recipient or parental organism(s).3.Identification and description of the target organisms.4.Anticipated mechanism and result of interaction between the released genetically modified organism(s) or products thereof and the target organism.5.Identification and description on non-target organisms which may be affected unwittingly.6.Likelihood of post release shifts in biological, or in host range.7.Known or predicted effects on non-target organisms in the environment, impact on population levels of competitors, preys, hosts, symbionts, predators, parasites and pathogens.8.Known or predicted involvement in biogeochemical processes.9.Other potentially significant interactions with the environment.V. Information on monitoring, control, waste treatment and emergency respose plans
A.Monitoring techniques1.Methods for tracing the genetically modified organism (s) or products thereof, and for monitoring their effects.2.Specificity (to identify the genetically modified organism(s) or products thereof, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques.3.Techniques for detecting transfer of the donated genetic material to other organisms.4.Methods to detect aberrant gene expression.B.Control of the release1.Methods and procedures to avoid and/or minimise the spread of the genetically modified organism (s) or products thereof beyond the site of release or the designated area for use.2.Methods and procedures to protect the site from intrusion by unauthorised individuals.3.Methods and procedures to prevent other organisms from entering the site.C.Waste treatment1.Type of waste generated;2.Expected amount of waste;4.Description of treatment envisaged.D.Emmegency response plan1.Methods and procedures for controlling the genetically modified organism (s) or products thereof in case of unexpected spread.2.Methods for decontamination of the areas affected, e.g. eradication of the genetically modified organism (s) or products thereof.3.Methods for disposal or sanitation of plants, animals, soils, etc. that was exposed during or after the spread.4.Methods for the isolation of the area affected by the spread.5.Plans for protecting human Health and the environment in case ot the occurrence of an undesirable effect.Third Schedule (Section 29)
Additional information required in the case of notification for placing on the market
A.The following information shall he provided in the notification for placing on market products in addition to that of Annex I:1.Name of the product and name(s) of genetically modified organism(s) contained therein.2.Name of the manufacturer or distributor and his address, including address in the country;3.Specificity of the product, exact conditions of use including, when appropriate, the type of environment and/ or the geographical areas(s) of the country for which the product is suited.4.Type of expected use: industry, agriculture and skilled trades, consumers use by public at large.B.The following additional information shall be provided when required/relevant:1.Measures to take in case or unintended release or misuse.2.Specific instructions or recommendations for storage and handling.3.Estimated production in and/or imports to the country.4.Proposed packaging. This must be appropriate so as to avoid unintended release of the genetically modified organism (s) during storage, or at a later stage proposed labelling. This must include, at lease in summarised form, the information referred to in points A.1, A.2, A.3, B.1 and B.2.C.The following information concerning labelling of products thereof shall be provided on a label and/or in accompaning documents:1.The words “This product contains genetically modified organism (s)” whenever there is evidence of the presence of genetically modified organism (s) in the product.2.The words “This product may contain genetically modified organism (s)” where the presence of genetically modified organism (s) in a product cannot be excluded but there is no evidence of any presence of genetically modified organism (s).3.The words “This product may cause [specify the particular reactions, allergies or other side effects]” where it is known that a particular reaction, allergy or other side effect may be caused by the product.4.Where applicable, further or as a qualification to C.1 or C.2, the words “This product contains genetic material (nucleic acids) from genetically modified organism (s)” or this product is based on raw materials from genetically modified organism”.5.The identification and labelling shall specify the relevant traits and characteristics in sufficient detail for purposes of traceability and to facilitate verification by both importing and transiting countries.Fourth Schedule (Section 24)
Risk assessment
The risk assessment shall take the following parameters into consideration:A.General Principles1.The guiding principle of risk assessment is the precautionary approach. Where the transboundary movement, or use or handling of genetically modified organism(s) or products thereof may cause, or has a proven or theoretical potential (or based or reasonable scientific theory of hazards based on deductive, circumstantial as well as inductive evidence) to cause harm to biodivesity, ecosystems, human or animal health, the lack of full scientific certainty or consensus regarding the level of risk should not be interpreted as the lack of risk, or as acceptable risk.2.The risk assessment should take into account, inter alia, all relevant scientific theory, evidence and experience, including previous risk assessments. This enables the risk acsessment to evolve in the light of new evidence and knowledge; a genetically modified organism or product thereof previously considered acceptable may no longer be acceptable, and vice versa.3.It shall be accepted as a principle underlying the risk assessment that every transgenic line is different because of random insertion, even if they are made with the same vector system, the same gene constructs and the same variety, and that it has to be well characterised to be stable for at least five generations under a reasonable range of environmental conditions that it may encounter.4.The risk assessment should take into account, inter alia:(a)all relevant scientific theory, evidence and experience;(b)The general characteristics of both the genetically modified organism or product thereof and the parent organisms, the vector(s) used, the genetic modifications and the novel trait(s), including marker traits(s) and other sequences even when not expressed;(c)the naive environments or host range of the recipient organism and donor organisms;(d)the intended use(s) of the genetically modified organism or product thereof and the nature of the receiving and surrounding environments;(e)potential impact of the genetically modified organism or product thereof on the environment, including long-term direct and indirect ecological impacts, particularly on centres of origin and areas with high genetic diversity of taxa related to the genetically modified organism or product thereof;(f)effects, long term and direct or indirect, of the genetically modified organism or product thereof on human, plant and animal health;(g)socio-economic impacts;(h)conformity with ethical norms;(i)details of risk assessments completed elsewhere.B.Specific information requirementsThe information required for risk assessment should include the following:1.Characteristics of donor and recipient organisms or parental organisms:(a)scientific name and taxonomy;(b)strain, cultivar or other name:(c)species it is related to and degree or relatedness;(d)the degree of relatedness between the donor and recipient organisms, or between the parental organisms;(e)all sites from where the donor and recipient organisms or parental organisms were collected, if known;(f)information on the type of reproduction (sexual/asexual) and the length of reproductive cycle or generation time, as appropriate, as well as the formation of resting and survival stages;(g)history of prior genetic manipulation, whether the donor or recipient organisms are already genetically modified;(h)phenotypic and genetic markers of interest;(i)description of identification and detection techniques for the organisms, and the sensitivities of these techniques;(j)geographic distribution and natural predators, prey, parasites, competitors, symbionts and hosts;(k)climatic characteristics of original habitats;(l)ability of the organisms to survive and colonise the environment to which release is intended or otherwise;(m)genetic stability of the organisms, and factors affecting the stability;(n)the presence of endogenous mobile genetic elements of viruses likely to affect the genetic stability;(o)the potential of the organisms to transfer or exchange genes with other organisms, either vertically or horizontally;(p)pathogenicity to humans or animals, if any;(q)if pathogenic, their virulence, infectivity, toxicity and modes of transmission;(r)known allergeneicity and/or toxicity of biochemical and metabolic products;(s)availability of appropriate therapies for pathogenicity, allergeneicity and toxicity.2.Characteristics of the Vector(s):(a)nature and source of the vector(s);(b)genetic map of the vecto(s), position of the gene(s) inserted for the transfer, other coding and non coding sequences affecting the expression of the introduced gene(s), and marker gene(s);(c)ability of the vector(s) to mobilise and transfer genes by integration and methods for determining the presence of the vector(s);(d)complete nucleotide sequence of the vector(s);(e)history of prior genetic manipulation, whether the donor or recipient organisms are already genetically modified;(f)potential for pathogenicity and virulence;(g)natural and host range of vectors;(h)natural habitat and geographic distribution of natural and potential hosts;(i)potential impacts on human and animal health and the environment(j)measures for counteracting adverse impacts;(k)potential to survive and multiply in the environment, or to from genetic recombinants; and(l)genetic stability of vectort(s), such as hypermutability.3.Characteristics of the genetically modified organism or product thereof:(a)the description of the modifications made using gene technology;(b)the function of the genetic modifications and/or the new insert, including any mrker gene(s);(c)purpose of the modification and intended use in relation to need or benefit;(d)method of modification and, in case of transgenic organisms, the methods for constructing inserts and to introduce them into the recipient organism;(e)whether introduced gene(s) are integrated or extra chromosomal;(f)number of insert(s) and its/their structure(s), for example, the copy number, the number of truncated or fragmented inserts, whether in tandem or other types of repeats and the position of each insert;(g)nucleotide sequence of each insert, including at least 100 kbp up and down stream form the insetrt;(h)products of the transferred gene(s), levels of expression and integration;(i)stability of the introduced gene(s) in terms of expression and integration;(j)biochemical and metabolic differences of the genetically modified organism or product thereof compared with unmodified organism;(k)probability of vertical or horizontal gene transfer to other species;(l)probability of inserts or transferred gene(s) to generate pathogenic recombinants with endogenous viruses, plasmids and bacteria:(m)allergeneicities, toxicities, pathogenicities and unintended effects;(n)autecology of the genetically modified organism or product thereof compared with that of the unmodified organism(o)susceptibility of the genetically modified organism or product thereof to diseases and pests compared with the unmodified organism;(p)detailed information on past used including results on all experiments leading to previous releases4.Characteristics of resuscitated organisms and gene(s) and fossil DNA sequences:Resuscitated Organism(a)scientific name and taxonomy;(b)identify of nearest species and their characteristics which are of relevance to the intended use;(c)site at which it was found;(d)method used for resuscitation;(e)purpose of introducing the organism and benefits, if any;(f)impacts on human and animal health and the environment;(g)measures for counteracting adverse impacts;(h)length of time the organisms has been in use;(j)likelihood of gene transfer to other organisms;(k)fossil and living nearest relative species;(l)biological and biochemical differences from related living species;(m)information on previous uses since resuscitation.DNA sequences from fossils or from resuscitated organism(a)scientific name and taxonomy of the species whether resuscitated or a fossil;(b)site of origin of the fossil;(c)site of the gene in the resuscitated genome, if known;(d)base sequence of the extracted gene;(e)method used in extracting the gene;(f)function of gene, if known;(g)purpose of use and benefits, if any;(h)environment in which it lived before fossilisation;(i)fossil species related to the species from which the gene was taken;(j)living species related to the species from which the gene was taken;5.Safety Considerations for Human and Animal Health:Information on the genetically modified organism or product and informationon the donor and recipient organisms as well as the vector before it was disarmed or disabled in cases where it has been disarmed or disabled, regarding:(a)capacity for colonisation(b)if the genetically modified organism or product thereof is pathogenic to humans or animals the following information is required:(i)disease caused and mechanisms of pathogenicity, including invasiveness and virulence, and property of virulence;(iv)host range and possibilities of alteration;(v)ability to survive outside of the human or animal host;(vi)the existence of vectors or other means of transmission;(vii)biological stability;(ix)availability of appropriate therapies.6.Environmental Considerations:Information on the genetically modified organism or product thereof and information on the donor and recipient organism as well as the vector before it was disarmed or disabled where it has been disarmed or disabled, regarding:(a)factors affecting the survival, reproduction and spread of the genetically modified organism or product thereof in the environment;(b)available techniques for detection, identification and monitoring of the genetically modified organism or product thereof;(c)available techniques for detecting transmission of genes from the genetically modified organism or product thereof to other organisms;(d)known and predicated habitats of the genetically modified organism or product thereof;(e)description of the ecosystems which could be affected by accidental release of the genetically modified organism or product thereof;(f)possible interaction between the genetically modified organism or product thereof and other organisms in the ecosystem which might be affected by accidental release;(g)known or predicted effect on plants and animals such as pathogeneity, infectibity, toxicity, virulence, being a vector of pathogens, allergeneicity, and colonisation;(h)possible involvement in biogeochemical processes;(i)availability of methods for decontamination of the area in case of accidental releases;(j)effects of agricultural practices with possible undesirable impacts on the environment.7.Socio-economic Considerations:(a)anticipated changes in the existing social and economic patterns resulting from the introduction of the genetically modified organism or product thereof;(b)possible threats to biological diversity, traditional crops or other products and, in particular, farmer’s varieties and sustainable agriculture;(c)impacts likely to be posed by the possibility of substituting traditional crops, products and indigenous technologies through modern biotechnology outside of their agro-climatic zones;(d)anticipated social and economic costs due to loss of genetic diversity, employment, market opportunities and, in general, means of livelihood of the communities likely to be affected by the introduction of the genetically modified organism or product thereof;(e)possible countries and/or communities to be affected in terms of disruptions to their social and economic welfare;(f)possible effects, which are contrary to the social, cultural, ethical and religious values of communities arising from the use or release of the genetically moditied organism or product thereof.Fifth Schedule (Section 27)
Risk Managment Schemes
The user shall employ the following risk management schemes and procedures from the development, through all stages of testing of the genetically modified organism or the product of a genetically modified organism, to its intended use or commercialisation.1.Imported products of genetically modified organisms used for human or animal health (for example, antibodies, drugs and hormones):(a)observation to ensure that changes in food habits, nutrition and other factors that could conceivably modify the expected impacts are insignificant;(b)such observation can be limited in scope when it is shown that adequate trials on the specific products have been made on humans or animals, as appropriate, in areas other than the State of import.2.Imported microbial genetically modified organisms for human and animal health:Besides the limited observation specified in 1, experiments shall be carried out to evaluate viability and risks of reacquiring virulence or lending virulence to other micro-organisms when in the body and in the environment, since some spilling is inevitable.3.Imported genetically modified organisms for contained use:(a)the products of genetically modified organisms will be treated as in 1 above.(b)experiments will be made in complete laboratory containment to determine:(i)longevity of the genetical1y modified organism in cases of unintended release in the premises and in the surrounding environment; and(ii)genetic transfer into other micro-organisms and implications thereof on human and animal health and the environment; and(d)methods for counteracting adverse impacts resulting from unintended releases should be specified.4.Products of genetically modified organism made locally:(a)trial on experimental animals will be made when the product of the genetically modified organisms is intended to be used on humans;(b)in all other cases, trials will be made on species for which the product of the genetically modified organism has been designed.5.Genetically modified organisms made locally for use as human or animal vaccines:(a)initial molecular, tissue culture, serological and other related studies in the laboratory in complete containment;(b)trials with experimental animals under strict containment;(c)experiments in complete containment to evaluate the extent of transfer of the genes of the vector introduced or of other genes through the agency of the vector to the genetically modified organism or to other species which will be found in association with the genetically modified organism to ensure that virulence is not acquired by the genetically modified organism in question or by other micro-organisms;(d)trials on animals completely contained from their species and from related species and species known to be susceptible to the gene recipient micro-organism from which the genetically modified organism has been made; and(e)statistically valid trials in conditions in which the vaccinated individuals live in their communities.6.Imported plant or microbial genetically modified organism for release:(a)the reports from releases in areas other than the State of Import shall be thoroughly evaluated by the Authority. Particular emphasis shall be given to whether the applicable regulations in the previous release have been adequate to ensure safety;(b)if the regulations mentioned in (a) have not been found adequate, the Authority shall decide at which step in item 8 the observations should begin;(c)if it is decided that the previous release mechanisms have been rigorous enough, observations shall be made in experimental conditions completely contained from the outside environment, but otherwise kept at the same soil community, moisture, air temperature and plant and animal community conditions as the intended area of release;(d)the observations will include the health of the genetically modified organism, the health of the organism within the area of limited release, and the biological diversity and the ecology of the area; and(e)nationally approved limited field releases will be carried out with appropriate emergency procedures in place to deal with possible cases of escape.7.Imported animal genetically modified organism for lease:(a)the reports from releases in areas other than Zambia shall be thoroughly evaluated by the Authority. Particular emphasis shall be given to whether the applicable regulations in the previous release have been adequate to ensure safety;(b)if the regulations mentioned in (a) have not been found adequate, the Authority shall decide at which step in item 9 the observations should begin;(c)if it is decided that the regulations used in the previous release have been rigorous enough, then observations will be made in complete containment in the expected ambient climatic, nutritional and other environmental conditions to monitor physiological functions, adaptations and gene transfers;(d)when the results have met the stated requirements, then a trial release may be authorised with adequate emergency plans put in place to deal with cases of escape.8.Plant or microbial genetically modified organisms produced locally for eventual release:(a)laboratory biomolecular experiments on trans formation or resuscitation and other phenomena will be carried out in complete containment;(b)tissue culture experiments to develop the genetically modified organism, when required, will be carried out in complete containment;(c)observations aimed at understanding the nature of the genetically modified organism shall be carried out in complete containment;(d)experiments with the soil, soil micro-organisms, plant and animal species, under the environmental conditions of the area of intended release, will be carried out in complete containment;(e)complete observations of the interactions of the genetically modified organism with the environment (soil including micro-organisms and terrestrial communities) will be made in enclosed fields but not fully contained. At the end of the expetiment, the products of the genetically modified micro-organisms may be use on an experimental basis, other wise they shall be destroyed;(f)the product from the genetically modified organism shall be subjected to the procedure in 4;(g)the monitoring of the spread and behaviour of any released plant or micro-organism, genetically modified organism shall continue for at least 150 years in the case of trees, and for at least 30 years in the case of annuals and micro-organisms, the duration for perennials which live shorter than trees being in between. The user who is responsible for releasing the genetically modified organisms or its successor shall provide annual reports to the Authority.9.Animal genetically modified organism produced locally for eventual release:(a)laboratory biomolecular experiments on transformation (or resuscitation if it is possible) and other phenomena will be carried out in complete containment;(b)methods of incubating the transformed generative cell or the resuscitated animal will be carried out in complete containment;(c)the rearing of and observations on the genetically modified organism will be carried out under complete containment;(d)the genetically modified organism shall be observed under complete containment in an experimental environment which simulates the intended area of release in climatic, microbial, animal and plant communities. The observations shall include the condition of the transgenic animal and those of its micro-organisms especially in the context of gene transfer and those of the microbial, plant and animal communities in the experiment, again including gene transfer;(e)a limited release will be carried out in an area with appropriate enclosure and emergency measures put in place to prevent escape. Observations will include the condition of the genetically modified organism, its micro-organism focusing on gene transfer, and the ecology of the microbial, plant and animal communities in the area, again including gene transfer;(f)if the animal is intended to yield a product, the regulation of the product will follow the procedure in item 4;(g)the monitoring of the spread and behaviour of any released animal genetically modified organism will continue for at least 30 years.10.General Requirements:(a)all trials, experiments or observations specified in all the above eases (1-9) are put in their logical sequence and shall be subjected to the hierarchical procedures of approval by the lower institutional and higher national level bodies, namely the institution at biosafety committees or the subcommittees or the Scientific Advisory Committee and the Authority;(b)experiments starting from transformation of living organisms or resuscitation of fossil organisms carried out under completely contained laboratory conditions and continuing in the development of genetically modified organisms or products thereof shall be subject to approval by the institutional biosafety committee or by the Authority as the case may be. All experiments outside of strict laboratory isolation and initial experiments involving imported genetically modified organisms or products thereof shall be subject to approval by the Authority. All final approval for the use of genetically modified organisms or products thereof shall be made by the Authority;(c)once approval from the Authority is obtained at the completion of the final stage of trials, experiments or observations, the genetically modified organism in question or the product thereof can be employed for its intended use. The Authority shall notify its decision in writing to the competent authority.(d)whenever there is need to dispose of the genetically modified organism or the product thereof upon the completion of every trial or experiment, it shall be made through complete incineration or other approved means of complete destruction.(e)the release of genetically modified organisms or products therefo shall be monitored appropriately and emergency plans to prevent escape and accident shall always be in place.