National Policy on Biosafety

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The Need for a National Policy on Biosafety 34 in Sri Lanka 2. Policy Framework 36 2.1 Policy Objectives 36 2.2 Policy Principles 37 2.3 Policy Statements 38 3. Definitions 40 4. Annex! : Proposed Regulatory Mechanism 42 30 31 PREFACE As a signatory to the Convention on Biological Diversity (CBD) and Cartagena Protocol on Biosafety (CPB) Sri Lanka is obliged to implement the articles of the CPB and develop its own national regulatory framework for the safe transfer, banding, use and release of genetically modified organisms and products resulting from modern biotechnology. The National Biosafety Framework, a system of legal, technical and administrative mechanisms established under the Ministry of Environment and Natural resources has been set in place to address these issues. A National Policy on Biosafcty is an important element of this framework and provides for safe application of modem biotechnology, and ensure that no adverse effects would result on conservation and sustainable use of biological diversity in the country as well as human health and environment. When developing the National Biosafety Policy for Sri Lanka the Ministry of Environment and Natural Resources appointed a National Sub-Committee comprising of representatives from government departments, universities and institutions involved in research and development, national policy, environmental, legal and safety issues and industrial aspects of biotechnology. The mandate of the sub-committee was to examine and review policy instruments on Biosafety in other countries and prepare a policy suitable for the Sri Lankan situation. The National Sub-Committee comprised of the following persons. Dr. M.C.N. Jayasuriya (National Science and Technology Commission) Chairman Prof. A.LT. Perera (Project Coordinator, National Biosafety Framework Development Project, Ministry ofEnvironmentand Natural Resources) 32 Prof. G. Widanapathirana (University ofKelaniya) Ms. S.P.D. Rukshanthi (Agriculture Biotech Centre, Univers ity of Pcradcniya) Prof. Sirimalcc Fernando (University of Sri Jayawardcncpura) Dr. Evcrad Jayamannc (Coconut Research Institute) Ms. Gayatbri Gunaruwan (The Ceylon Chamber of Commerce) Dr. C.K. Shanmugarajah (Ministry ofHealth, Nutrition and Welfare) Dr. Kumu d~1 Fernando (Department of Agriculture) Mr. Gamm, Gamage (Director Biodiversity, Ministry of Environment and Natural Resources) Mr. Jagath Gunewardcnc (Attorney-at-Law) Mr. D.M?.P. de Silva (MinistryofEnvironmentandNatural Resources) Wu. G. P1yasena (Department of Fisheries, Ministry of Fisheries and Aquatic Resources) The draft document prepared by the National Sub Committee was discussed at se~eral forums,. d'.scussion sessions, seminars and workshops, and having c~nsidered the opinions of various individuals, scientific bodies involved in b1otc~l111~logy research and development and non-governmental organ1zat1ons, has been finalized. The National Policy on Biosafcty covers, the need for a national policy for Sri ~anka, policy objectives, policy principles and policy statements. It docs not include policy strategies; which needs to be developed. The policy was approved by Cabinet of Ministers in 2005. 33 1. NATIONAL POLICY ON BlOSAFETY TUE NEED FOR A NATIONAL POLICY ON BLOSAFETY IN SRl LANKA Biotechnology refers to any technological application that use~ biological systems, living organisms, or derivatives thereof, to make or mo~1 fy pro <luct~ or processes for a specific use. Biotechnology ts not a nc~v p1occss in S11 Lanka. Traditional animal and plant breeding tcchmquc~ (such . as h b "dization and the selection o[ plants and animals with sp~c1fic Y n ~ I h oher characteristics) have for centuries been used lo create, or examp e, i., yielding or drought and disease-resistant plant varieties. Over recent years, however, modern biotechnology has :evo\utioniz~d our ability to alter life-forms through applying in vitro nucleic ~c1d ~e~hm ques, including recombinant deoxyribonucleic acid (DNA) and direct mJect1on ~f nucleic acid into cells or organelles, or fusion of cells beyond the tax~no1:11c family, that overcome natural physiological r~~roductive ?r recomb111a~10n barriers and that arc not techniques used in trad1t10nal breeding and selection. Modem biotechnology may have the potential to lead to co~sidcrable advances in medicine, agriculture, and other fields. At the same time, many of the risks of modem biotechnology (such as potential adverse effects on biological diversity, and risks to hwnan health) are not yet known. The concept ofbiosafety refers to the need to protect human health and the environment from the possible adverse effects of the products of '.no~crn biotechnology. It describes cffo1ts to reduce and eliminate the potential nsks that may result from modern biotechnology and its products. 34 There is an urgent need to establish biosafcty measures for Sri Lanka, not only for genetically modified organisms (GMOs) and Food, Feed and Processed Products (FFP) that may be produced locally in the future, but also for those that may be imported into the country. There remains considerable uncertainty about potential risks associated with modem biotechnology. The possible costs of mitigating or reversing any ham1 that may occur as a result of the use of modem biotechnology may also prove to be immense, and far-reaching, especially to the government which is ultimately responsible for assuring the health status and food security of the Sri Lankan population. It is therefore of prime importance to establish a National Policy on Biosafety, which will set the overall framework in which adequate safety measures will be developed and put into force, so that Sri Lanka can minimize possible risks to hwnan health and the environment while extracting maximum benefit from any potential that modem biotechnology may offer. The National Policy on Biosafety is also an important tool to ensure that the knowledge, practices and benefits of Sri Lanka's traditional biotechnology techniques arc safeguarded. The National Policy on Biosafety is guided by the principle that any perceived threat of serious or irreversible damage or lack of scientific certainty shall not be used as a reason for postponing measures to prevent environmental degradation and health impacts. It thus implies shifting the burden of proof, requiring that modem biotechnology applications used in Sri Lanka are first proved to be harmless, instead of waiting to take action once they have been proven harmful. The establishment of a National Policy on Biosafety is an important step in meeting the obligations of the Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafcty (CP), both of which Sri Lanka has ratified. As a Party to these International Conventions, Sri Lanka has thereby 35 committed to take action to support the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources; as well as to ensure an adequate level of protection in the field of the safe transfer, handling and use ofliving modified organisms resulting from modern biotechnology. 2. POLICY FRAMEWORK The national policy on biosafcty shall conform to National Development Objectives of the GovcrnmcntofSri Lanka 2.1 Policy Objectives The Biosafety Policy renews the commitment of the government, in ensuring adequate levels of protection in the safe use of modern biotechnology based on the precautionary principle, within the framework of sustainable development for the benefit of present and future generations. This policy supports other related policies and is intended to be complementary and not to replace or undermine them. The major policy objectives arc as follows: 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 Implementation of biosafety measures in order to ensure that there will be no adverse effects on human health, the environment and biodiversity. Ensure effective regulation and management of GMO/FFP that might be imported to Sri Lanka, based on the Advanced Informed Agreement and the signing of which should be guided by the Precautionary Principle. Regulate and manage any locally produced GMO/FFP. Promote dissemination of knowledge in the safe use and probable hazards of modem biotechnology. Ensure biosafcty and biocthical considerations in the development and application of modern biotechnology 36 r 2.1.6 Provide a • • • net 1c· n msti~t1~nal framework for national decision makino 2.2 2.2. l 2.2.2 2.2.3 2.2.4 2.2.5 wor mg, momtonng Research & Devel . o, cooperation in all matt I . . opmcnt, and mternational ers re atmg to b1osafety. Policy Principles Sri Lanka reco!!n • l "' izcs t lat although modern biotcchnoloo d . pr~ducts could be beneficial, their safety in rcoar oY an its animal health and their effects on b. d. . o d to human and d to ivcrs1ty and the environm t an the economy arc not established en :~:~;~~~d:~;c~,~~:~• shall cnsu:c •,~~1~;::::o~::;;~~~~:~:~ infonned agreement. precautionary pnnc1plc and the advanced Sri L~~k a shall place utmost importance on c b l · developing its own apa J it1es in all aspects ofbiosafcty The manufacture use • ' ' rn1port, export, sale or trans-bounda movements of modem biotcchnolo . . ry products shall conform fully to all I gy applt catwns, practices and re evant national legislations. Public awareness, education and partici ati . . . processes shall be d . p on m the dec1s1on-making ma c cssenttal for cnsurino the j d .. ::~::cb~~~:~ol~g~~:\ applications, practi~e s an~ ;;~~~c~:\~~ opment, without Jeopa d. • h environment, biodiversity and human health. r iz1ng t e Risk assessment and management of GMO/FFP sh II b . according to national biosafety rcouJation a e car ned ~ut evaluation of a biotechnology prod"' t / Where sc1ent1fic nsk rise to a neoa( . . uc 'app !Cation or procedure oivcs o ive iccommendat1on, this shall not be overruled. o 37 ~ ----------------c.......:..-=~ 2.2.6 2.2.7 2.3. • • • • 2.3. l As a matter of public health protection and democratic governance, the industries involved in the use of modem biotechnology shall reveal information on organisms used and all other relevant data in order that consumers arc aware of the substances they arc exposed to. Safety test data, especially for agricultural biotechnology and human genetic testing, manipulations and applications, shall be fu lly disclosed and made pub) ic. Some international fora arc structurally biased to favour commercial considerations over public health, environmental and safety interests. Decisions on biosafcty issues shall be made in fora that do not suffer from this structural orientation. Policy Statements Recognizing the importance of protecting its people, environment and biodiversity while promoting a sustainable social and economic development through the implementation ofbiosafety measures, Recognizing the human health, environmental and socio-economic risks that may be incurred by careless or unscrupulous development of modem biotechnology and the use of its products, Realizing the need for developing our own capabilities in biosafety through research & development and training and Reaffirming the commitment to the obligations of the CBD and CP, There shall be a National Focal Point for Biosafcty at the Ministry of Environment and Natural Resources. It shall be the controlling authority for all issues relating to biosafety in Sri Lanka, including R&D, development of industry linkages, establishment of relevant legislations, protocols and guidelines. 38 [ 2.3.2. Labeling of genetically modi ficd mandatory. Once appro d products shall be made ve compulsory I b r · for all products resultino fJ d . a e 111g will be required 0 rom mo ern brotechnolo II of the production proces I: . . gy, at a stages d s, rom iaw material to final d . or er that the consumer may k . r pro uct, 111 ' ma e an 1111ormcd choice. 2.3.3. National safety guidelines and . 1 . adopted by industries us. d1mp e~entat1on practices shall be mg mo ern brntechnoJo Th . shall cover all related . . gy. e guidelines . aspects, mcludmo material handlino equipment, storage, waste disposal, Jaboratory~afcty, etc. o , 2.3.4. ?M detection and analytical laboratories d . 2.3.5. 2.3.6. 2.3.7. 2.3.8. identified, established and su . . uly accredited shall be things, proper assessment o/~;~tc~ II~ ord;r that, amongst other labeling requirements can be ensured. oo sa ety and adherence to Priorities in Human Resource Dev 1 . . assessed identified and developed. e opment m B1osafcty shall be Public awareness of modern biotechnoloo . . assessment of potential risk oY 111 relation to shall be enhanced . l . s/bcnefits and management techniques , mvo vmo the co • polic mak . o mmun1ty at large, includin . y ers, legislators, administrators the .· g biotechnology industries S . I ' . p11vate sector and • pecia courses 111 tu 1 • technology and ethics shall be offered to na ra s~1ences, professional activities come . t personnel, who tn their mo contact w·th b. fi · their ethical applications. J iosa ety issues and Research into the risks to th . can be caused b d e e nv1ronment and human health that Y mo cm biotechnology sh 11 b Adequate funds shall be allocated t . 1 a e supported. o imp ement such programmes. Safety standards shall be reviewed and upd t d basis. a c on a regular 39 2.3.9. Appropriate knowledge bases and infrastructure for information exchange on biosafcty shall be established and developed. 2.3 .10. A Master Plan for Biosafety shall be established and used to implement the strategics and to develop the infrastrncture and instruments outlined in this policy. 2.3.11 In the interim period leading up to the establishment of the infrastructure necessary to enable full implementation of the National Policy on Biosafcty, appropriate regulations shall be drafted and enforced as a matter urgency under the laws in existence at present, pa1ticularly in the case of GMO/FFP. 3. DEFINITIONS Modern biotechnology - The Cartagena Protocol on Biosafcty defines modem biotechnology as the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family, that overcome natural physiological, reproductive or recombination barriers and that arc not techniques used in traditional breeding and selection. The Precautionary Principle - A lack of scientific certainty of the potential adverse effects of Living Modifcd Organisms on the conservation and sustainable use of biological diversity, on the environment and human health may be due to insufficient relevant scientific information and knowledge. This shall not prevent a count1y from taking appropriate steps/precautions with regard to the import of Living Modifcd Organisms, in order to avoid or minimize such potential adverse effects. 40 I Genetically Modif d O . . . ie rgan1sm (Living Modified Oro . livmg organism or part the f I . I . banism) - any ' rco w 11c 1 is capable of r o · · own or in the body/cell ofa tl . . cbcncratmg itself on its no 1c1 oroanism a 1d h . been modified by modern b. t h b . ' , w ose genetic material has 10 cc nolooy 111 a way t . mating or natural recombination. o no occurring naturally by Advanced Informed Agreement - a fonnal ao or between a state and a g o f orccment between two states . r up o states belonging t • mtegration oroanizatio11 to t "' o a regional economic 0 , ransrer any GMO d information supplied by th . . pro ucts thereof, based on that the information is c elexportmg state, with the explicit understandino omp ete and accurate b Risk assessment - the use of scienffi identify and characterize the nature l~k1ccl~hnd dothfer appropriate methods to • ' 1 00 o occurrence d • magnitude of any hazards w·th d 'an potential ' J ue regard to the precautionary principle Transboundary m ovement - any movement of GM . products, intentional or unintentional d b Os or b10technology transfer, across one or more 11at· I b ' an . y any means mcluding gene 1ona oundanes 41 ANNEX 1 PROPOSED REGULATORY MECHANISM APPLICATION & REVIEW PROCEDURES Feasibility or Applicability of project lo counlry Environmental Impact Assessment (EIA) Cosl-bcnefil-risk analysis APPLICANT Proposal froml t apphcanl I NATIONAL FOCAL POINT (eg. NATIONAL COUNCIL FOR BIOSAFETY (NCB) Proposal forwarded Competent Authorilics in relevant fi elds of application (e.g. line Ministries) I \ Legislalion Public consuhalion 42 Approved fo r initialion