Cartagena Protocol and Capacity Building. Dr. Vibha Ahuja Biotech Consortium India Limited, New Delhi

Transcription

1 Cartagena Protocol and Capacity Building Dr. Vibha Ahuja Biotech Consortium India Limited, New Delhi

2 NEED FOR BIOSAFETY REGULATIONS NATIONAL BIOSAFETY FRAMEWORK ESSENTIAL TO REGULATE PRODUCTION AND RELEASE OF GMOs IN ANY COUNTRY WITH A BIOTECHNOLOGY PROGRAMME ENSURES SAFE ACCESS TO NEW PRODUCTS AND TECHNOLOGIES DEVELOPED IN THE COUNTRY OR ELSEWHERE. PROVIDES A LEVEL OF PUBLIC CONFIDENCE THAT PRODUCTS PLACED ON THE MARKET HAVE BEEN ASSESSED AS SAFE

3 EARLY INITIATIVES FIRST SET OF RECOMMENDATIONS FORMULATED AT ASILOMAR IN 1975 THESE FORMED THE BASIS OF SUBSEQUENT REGULATIONS IN USA AND OTHER COUNTRIES INITIALLY THE FOCUS WAS MORE ON USE OF TECHNOLOGY AND THUS SAFETY WITHIN THE LABORATORY AND HUMAN HEALTH IN GENERAL THE FOCUS SHIFTED TO THE END PRODUCTS IN ADDITION TO THE TECHNOLOGY WITH RELEASE OF COMMERCIAL PRODUCTS

4 REGULATORY FRAMEWORK IN USA COORDINATED FRAMEWORK INVOLVING THREE GOVERNMENT AGENCIES I.E. USDA, FDA AND EPA USDA LEAD AGENCY FOR GENETICALLY ENGINEERED PLANTS, FDA FOR FOODS AND DRUGS AND EPA FOR PESTICIDAL SUBSTANCES ENGINEERED INTO PLANTS PRODUCTS REGULATED ACCORDING TO THEIR INTENDED USE WITH SOME PRODUCTS BEING REGULATED UNDER MORE THAN ONE AGENCY NO NEW LAWS HAVE BEEN ENACTED AND PROVISIONS MADE IN EXISTING LAWS GUIDELINES FOR RESEARCH AND DEVELOPMENT ACTIVITIES BY NATIONAL INSTITUTE OF HEALTH

5 REGULATORY FRAMEWORK IN EUROPEAN UNION HARMONIZED APPROACH TO ADDRESS ISSUES OF GMOs AND GMMs SINCE 1990 NEW FRAMEWORK IN PLACE SINCE 2001 STEP BY STEP APPROVAL PROCESS ON A CASE-BY- CASE ASSESSMENT FOR ANY GMO OR PRODUCT CONSISTING OF OR CONTAINING GMOs BEFORE RELEASE INTO ENVIORNMENT OR PLACING IN THE MARKET APPROVAL PROCESS STARTS WITH SUBMISSION TO COMPETENT AUTHORITY IN MEMBER STATE

6 REGULATORY FRAMEWORK IN EUROPEAN UNION SUMMARY/ASSESSMENT REPORT IS FORWARDED TO THE COMMISSION AND ALL MEMBER STATES PUBLIC COMMENTS ARE SOUGHT TO REACH AGREEMENT WRITTEN CONSENT FOR MARKETING FOR A PERIOD OF NO MORE THAN 10 YEARS OTHER KEY FEATURES INCLUDE USE OF PRECAUTIONARY PRINCIPLE, INSPECTION AND COMPLIANCE MEASURES, REQUIREMENT OF TRACIBILITY AND ABILITY OF A MEMBER STATE TO RESTRICT OR PROHIBIT THE USE OF IMPROVED GMO IF DETAILED GROUNDS ARE JUSTIFIED

7 REGULATORY FRAMEWORK IN CANADA REGULATIONS COORDINATED BY CANADIAN FOOD INSPECTION AGENCY (CFIA), HEALTH CANADA AND ENVIRONMENT CANADA CFIA REGULATES PLANTS AND SEEDS WITH NOVEL TRAITS, ANIMAL VACCINES AND BIOLOGICS, LIVESTOCK FEED AND FERTILIZERS ENVIRONMENT CANADA REGULATES PRODUCTS TO BE USED IN ENVIRONMENTAL PROTECTION HEALTH CANADA REGULATES FOODS, DRUGS, COSMETICS, MEDICAL DEVICES AND PEST CONTROL PRODUCTS. TEN PIECES OF EXISTING REGULATIONS ARE USED AND NO NEW LAWS ENACTED ONLY COUNTRY WHICH REFERS TO PLANTS WITH NOVEL TRAIT AND NOVEL FOOD IN PLACE OF GM PLANTS OR GM FOODS

8 REGULATORY FRAMEWORK IN AUSTRALIA GENE TECHNOLOGY ACT NOTIFIED IN 2000 MAIN AUTHORITY IS GENE TECHNOLOGY REGULATOR THREE GENE TECHNOLOGY ADVISORY COMMITTEES ARE TECHNICAL ADVISORY COMMITTEE, COMMUNITY CONSULTATIVE COMMITTEE AND ETHICS COMMITTEE REGULATIONS ALSO INVOLVE AGENCIES FOR SPECIFIC PRODUCTS AND FUNCTIONS SUCH AS AGRICULTURAL AND VETERINARY CHEMICALS, INDUSTRIAL CHEMICALS, FOODS INTENDED FOR HUMAN CONSUMPTION, THERAPEUTIC GOODS, IMPORT.

9 REGULATORY FRAMEWORK IN SOUTH AFRICA GENETICALLY MODIFIED ORGANISMS ACT CAME INTO FORCE IN 1999 ALL GMOs ARE REGULATED PROVISIONS IMPLEMENTED BY AN EXECUTIVE COUNCIL, SCIENTIFIC ADVISORY COMMITTEE AND INSPECTORATE OTHER ACTS ALSO USED FOR AGRICULTURAL AND FOOD CROPS

10 REGULATORY FRAMEWORK IN ASIAN REGION JAPAN USES A SERIES OF VOLUNTARY GUIDELINES ADMINISTERED THROUGH FOUR GOVERNMENT AGENCIES CHINA PRODUCED BIOSAFETY GUIDELINES IN 1993 AND RULES FOR SAFETY AND MANAGEMENT OF GMO PRODUCTS IN KEY FEATURE IS THE REQUIREMENT OF LABELING OF ALL GM PRODUCTS PHILLIPINES, MALAYSIA, THAILAND ETC. HAVE BIOSAFETY GUIDELINES INDIA NOTIFIED RULES IN 1989 UNDER EPA, 1986 AND GUIDELINES ISSUED IN 1990 WITH MORE SPECIFIC GUIDELINES IN 1998 AND REGULATORY REFORMS ARE UNDER PROCESS

11 INTERNATIONAL AGREEMENTS 1. CONVENTION ON BIOLOGICAL DIVERSITY 2. CARTAGENA PROTOCOL ON BIOSAFETY 3. THE INTERNATIONAL PLANT PROTECTION CONVENTION 4. THE WORLD TRADE ORGANIZATION

12 AGENCIES ISSUING INTERNATIONAL GUIDELNIES 1. OECD: GUIDELINES FOR RECOMBINANT RESEARCH (1986), GMMs AND LARGE SCALE INDUSTRIAL USE (1992), TRANSGENIC CROPS AND FOODS (1993), SPECIFIC BIOLOGY DOCUMENTS ON VARIOUS CROPS 2. UNEP: INTERNATIONAL TECHNICAL GUIDELINES FOR SAFETY IN BIOTECHNOLOGY, WHO: LABORATORY BIOSAFETY MANUAL 2003, GUIDELINES FOR MANUFACTURE OF BIOLOGICS (GENERAL AND FOR SPECIFIC PRODUCTS) 4. FAO: CODEX ALIMENTARIUS STANDARDS 5. ICH: GUIDELINES FOR PHARMA PRODUCTS

13 ARTICLE 19(3) OF THE CBD The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any LMO resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.

14 CARTAGENA PROTOCOL The Cartagena Protocol is a protocol of the Convention on Biological Diversity (CBD) Entered into force September countries have ratified

15 ROAD TO CPB CBD 1 st CoP Expert Panel meeting Cairo Open-ended Ad Hoc group of Experts, Madrid CBD 2 nd CoP Six meetings of Ad Hoc Biosafety Working Group Ex CoP Informal consultations Resumed Ex Cop

16 ELEMENTS OF THE PROTOCOL Objectives: To ensure an adequate level of protection for safe transfer,handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity. The Protocol also takes into account risks to human health. The protocol specifically focuses on transboundary movement of LMOs.

17 LMOs subject to the provisions of the Protocol o All LMOs which may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health (Article 4) (except as excluded) LMOs subject to AIA provisions o SCOPE LMOs intended for intentional introduction into the environment (Article 7(1))

18 Contd/- LMOs excluded from the Protocol s AIA provisions o LMOs in transit (Article 6(1)) o o o LMOs destined for contained use in the Party of import (Article 6(2)). LMOs intended for direct use for food, feed or for processing (LMO-FFPs) (Article 7(2)). LMOs identified by the meeting of the Parties to the Protocol as being note likely to have adverse impacts (Article 7(4)). LMOs excluded from the Protocol provisions on transboundary movements o LMOs that are pharmaceuticals for humans that are addressed by other international organization or agreements (Article 5)

19 PRECAUTIONARY PRINCIPLE Lack of scientific certainty regarding potential adverse effects of LMOs will not prevent a Party to take a decision with regard to the import of LMOs. Precautionary principle has been incorporated in certain Articles of the protocol, namely Article 10 on Decision procedure, Article 11 on Procedure for LMOs intended for direct use as food, feed or for processing and Annexure III.

20 ADVANCED INFORMED AGREEMENT PROCEDURE (ARTICLE 7) The AIA procedure applies on the first occasion that a LMO covered under Protocol is intentionally brought from a Party into another Party. The elements of the procedure include: o Competent authority o Notification and information o Decision of a Party of import o Risk assessment

21 SIMPLIFIED SYSTEM FOR AGRICULTURE COMMODITIES I.E. LMO/FFPs The Protocol s specific AIA procedure does not apply to LMO-FFPs. Parties making a final decision about the domestic use of an LMO must notify the other Parties through Biosafety Clearing House. Parties to the Protocol may require prior consent of LMO-FFPs under their relevant domestic regulatory framework. Countries which do not have domestic regulatory framework will take a decision on the first import of LMO-FFPs in accordance with risk assessment.

22 EXPORT DOCUMENTATION Under Article 18 LMO-FFPs must be accompanied by documentation specifying that they may contain LMOs and they are not intended for intentional introduction into the environment. The details of the procedure still remain to be worked out and are supposed to be settled within two years after the Protocol enters into force.

23 RELATIONSHIP WITH OTHER AGREEMENTS Three preambular paragraphs: Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development. Emphasising that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements. Understanding that the above recital is not intended to subordinate this Protocol to other international agreements.

24 BIOSAFETY CLEARING HOUSE The Protocol established a Biosafety Clearing House. BCH is to facilitate the exchange of scientific, technical, environmental and legal information on, and experience with LMOs and to assist Parties to implement the Protocol. Parties have to provide the BCH the following: o Laws, regulations and guidelines for implementation of the Protocol o Bilateral, regional and multilateral arrangements under Article 14 o Decisions on import or release of LMOs o Summaries of risk assessment or environmental reviews of LMOs generated by regulatory processes of Parties.

25 LIABILITY AND REDRESS A system for liability and redress where the transboundary movement of LMOs may cause damage or harm to biodiversity and human health is provided. For this purpose, the Parties to the Protocol at its first meeting will adopt a process for elaboration of rules and procedures for liability and redress, and complete the process within a period of four years.

26 CAPACITY BUILDING Many developing countries do not have adequate human resources and infrastructure. Article 22 provides for capacity building in biosafety for effective implementation of the Protocol in developing country Parties. It further provides that for this purpose, the needs for developing countries for financial resources and access to and transfer of technology and know-how shall be taken fully into account.

27 Obligation under the Cartagena Biosafety Protocol Setting up a regulatory Framework. Notify the Focal Point for the Protocol. Notify the BCH Focal Point and post decisions on the BCH Notify the Point of Contact for import of LMOs. Advanced Informed Agreement (Article 7) Decision Procedure (Article 10 ) Unintentional transboundary movement & emergency measures (Article 17) Handling Transport, Packaging & Identification (Article 18) - LMOs for FFP - LMOs for contained use - LMOs for intentional release Liability & Redress (Article 27)

28 Harmonizing the Domestic Regulatory Framework with the Biosafety Protocol Protocol is specific to LMOs whereas the Domestic law applies to all GMOs and products derived therefrom. The domestic law does not address issues related to adventitious presence of LMOs or documentation to accompany any shipment containing LMOs. No mechanism for verification in the absence of self declaration. No threshold established in India for labeling or for seeking approval of GEAC. Adequate testing technologies to be developed for verification to comply with national laws. Development for food safety assessment guidelines. The domestic law does not address issues related to unintentional transboundary movement & emergency measures & liability and redress.

29 SETTING UP OF INDIA BIOSAFETY CLEARING HOUSE (BCH) BCH comprises a Central Portal and a distributed network of national components to assist Parties to fulfill obligation under the protocol. The Central Portal may be seen at

30 OBJECTIVES OF BCH 1. Facilitate the exchange of scientific technical environment and legal information on, and experience with Living Modified Organisms (LMOs). 2. Assist parties to implement the protocol taking into account the special needs of developing country parties, in particular the least developed and small island developing states among them, and countries with economies in transition as well as countries that are centre of origins and centre of genetic diversity.

31 BCH: INFORMATION SHARING Providing access to information regarding domestic laws and regulations Housing summaries of risk assessment conducted under the protocol and links to more details of those assessments Providing access to information on capacity building initiatives and opportunities for participation in such initiatives Providing access to a search mechanism for experts on biosafety on a roster.

32 OPTIONS FOR PARTICIPATION IN BCH 1. Register data in the central portal using the Management Centre 2. Register data locally using database templates and send data to the Central portal 3. Make data available through a local website and allow the central portal to crawl to retrieve metadata 4. Store data on national BCH databases, and actively make those data available through the central portal using BCH interoperability protocols.

33 FORMATS FOR INFORMATION IN BCH formats identified by CBD Secretariat NATIONAL CONTACTS National Focal Points (NFPs) Competent National Authorities (CNAs) National Biosafety Websites and Databases LAWS AND REGULATIONS National Laws, Regulations and Guidelines Bilateral, Regional and Multilateral Agreements DECISIONS AND DECLARATIONS Decisions on LMOs under AIA Procedure Decisions on LMOs on Food/Feed/Processing (FFP) Other Decisions and Declarations Risk Assessments Unique Identification Contd/-

34 CAPACITY- BUILDING Capacity Building- Needs and Priorities Capacity- Building Opportunities Capacity-Building Projects ROSTER OF EXPERTS Guidelines for using roster Procedures for nominating experts Updating information on experts OTHER RESOURCES Bibliographic information Relevant Websites

35 BCH HOME PAGE(indbch.nic.in)

36 HOME PAGE OF BIOSAFETY PROJECT WEBSITE

37 NATIONAL INITIATIVES Eight training cum awareness workshops organized by MoEF & DBT in after the first release of Bt cotton. Six training cum awareness workshops organized by MoEF in the cotton growing states during Six training cum awareness workshops organized by DBT for the members of IBSC Six training cum awareness workshop on biosafety concerns organized by MoEF during Workshop on Liability and Redressal Article 27 of CBP on March Workshop to address the Identification requirement under Article 18 of the CBP in April 2005.

38 TRAINING NEEDS ASSESSMENT OBJECTIVE: SURVEY To identify the training needs of agricultural biotechnology stakeholders in the public and private sectors as regards genetically engineered crops, livestock, and the products derived from these (including foods).

39 AREAS FOR TRAINING Development of LMOs/GMOs; Risk assessment (impact on human health and environment); Risk management; Identification of LMOs/GMOs; Regulatory capacity building; Human resource development and training; Public awareness, education and participation; Information exchange and data management; Scientific and institutional collaborations; Technology transfer; Socio-economic considerations; Sustainable use and conservation of biodiversity

40 STAKEHOLDERS Senior government officials (policy/decision makers); Regulators (e.g. application reviewers/assessors, advisors, administrators); Enforcement officials (e.g. field inspectors health, food and agriculture departments, custom and plant quarantine officers); Scientists/technical personnel who review or prepare applications (public and private sector); Legal experts; Economists; Information managers including IT specialists; Graduate and undergraduate students; Interest groups (e.g. consumer groups, farmer associations, professional associations, NGOs); Mass media and outreach/extension workers (e.g. journalists and agricultural extensionists) and General public and political leadership

41 PROPOSED TRAINING MODULES PUBLIC AWARENESS ACTIVITIES: USE OF PRINT AND ELECTRONIC MEDIA USE OF EXISTING NETWORKS AND CHANNELS SUCH AS AGRICULTURAL EXTENSION OFFICES AND DEPARTMENTS, NUTRITION EDUCATION DEPARTMENTS, HEALTH EDUCATION PROGRAMMES ETC. NETWORK OF SCIENTIFIC COMMUNICATORS RISK COMMUNICATION STRATEGIES FOR REGULATORS DEVELOPMENT OF TV/RADIO EDUCATIONAL PROGRAMMES PRIMERS/BROCHURES/BOOKLETS/FAQS/GLOSSARY OF TERMS USE OF LOCAL LANGUAGES INTERACTION WITH MEDIA Contd../-

42 NATIONAL WORKSHOPS: SERIES OF EVENTS FOR BORDER CONTROL AUTHORITIES, SCIENTISTS OF SAUs, RESEARCH INSTITUTIONS, SCIENTISTS OF HEALTH AND NUTRITION ORGANIZATIONS, HEALTH AND FOOD INSPECTORS CONSULTATIONS/WORKSHOPS ON POST RELEASE MONITORING PROCEDURES NATIONAL CONSULTATIONS ON VARIOUS ARTICLES OF CARTAGENA PROTOCOL WORKSHOPS ON VARIOUS CROPS UNDER DEVELOPMENT SUGGESTED APPROACH TO HAVE COORDINATING AGENCIES AT THE CENTRAL LEVEL WHICH CAN INTERACT WITH THE LOCAL/REGIONAL ORGANIZATIONS TO HAVE UNIFORMITY AND COMPLIMENTARITY WITH THE NATIONAL APPROACH. Contd../-

43 LABORATORY TRAINING: TRAINING PROGRAMMES ON GOOD LABORATORY PRACTICES FOR RESEARCHERS SERIES OF SEMINARS ON SPECIFIC AREAS PERTINENT TO GMO BIOSAFETY IN BOTH FOOD AND FEED SAFETY EVALUATION AND ENVIRONMENTAL RISK ASSESSMENTS SHORT TERM TRAINING ON DETECTION METHODS Contd../-

44 UPDATION OF RULES/GUIDELINES: REVIEW AND UPDATE THE PROVISIONS OF NATIONAL RULES AND GUIDELINES AS WELL AS NOTIFY ADDITIONAL POLICIES/RULES/ GUIDELINES GUIDELINES TO BE DEVELOPED FOR HANDLING, PACKAGING AND TRANSPORT OF GMOS GUIDELINES TO BE DEVELOPED FOR NEW GMOS AND PRODUCTS AND NEWER APPLICATIONS OF EXISTING GMOS E.G. TRANSGENIC ANIMALS INCLUDING LIVESTOCK AND FISH, USE OF PLANTS AND ANIMALS FOR PRODUCTION OF PHARMACEUTICALS/ BIOCHEMICALS Contd../-

45 STUDIES AND SURVEYS: REVIEW OF GUIDELINES FOR TRANSPORT OF LMOS IN VARIOUS COUNTRIES STUDY ON GLOBAL STATUS, IMPACT AND COST IMPLICATIONS OF LABELING BASELINE SURVEYS FOR DEVELOPING PROTOCOLS FOR RISK ASSESSMENT PARTICULARLY ECOLOGICAL ISSUES BASELINE SURVEYS FOR ASSESSMENT OF AWARENESS AMONG THE USER SEGMENTS Contd../-

46 PUBLICATION/DOCUMENTS/WEBSITES/ VIDEO FILMS: HANDBOOKS FOR VARIOUS REGULATORY BODIES. RESOURCE MATERIAL ON BIOSAFETY ISSUES FOR SPECIFIC STAKEHOLDERS. MANUALS ON RISK ASSESSMENT AND MANAGEMENT PROCEDURES, AIA PROCEDURE, METHODS AND APPROACHES FOR LMO DETECTION. NEWSLETTERS/BULLETINS VIDEO FILMS ON SUCCESSFUL CASE STUDIES CDS/VIDEOS ON REGULATORY REQUIREMENTS DEDICATED BIOSAFETY WEBSITE ETC. Contd../-

47 INTERNATIONAL CONFERENCES FOR CAPACITY BUILDING REQUIREMENTS: LMOs TESTING METHODS, FACILITIES AND EQUIPMENTS INCLUDING BOTH PRIVATE AND PUBLIC SECTOR RISK ASSESSMENT AND MANAGEMENT PROCEDURES INCLUDING CASE STUDIES BY DIFFERENT COUNTRIES REGIONAL CONFERENCE (ASIA OR ASIA PACIFIC) ON UNDERSTANDING AND HARMONIZATION OF BIOSAFETY RULES, GUIDELINES AND PRIORITIES/APPROACH FOR EFFECTIVE IMPLEMENTATION OF CARTAGENA PROTOCOL.

48 STUDY TOURS: PARTICIPATION IN THE INTERNATIONAL CONFERENCES BY LEADING SCIENTISTS FROM BOTH PUBLIC AND PRIVATE SECTOR. STUDY TOURS/EXCHANGE PROGRAMMES DIRECTORY OF RESOURCE PERSONS COMPENDIUM OF BIOSAFETY TRAINING PROGRAMMES LONG-TERM TRAINING PROGRAMMES

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