CamBioTec, a Canadian-Latin American Networkpromoting the safe and effective use of agricultural andenvironmental biotechnology, undertook an analysis ofthe current capacities of Argentina, Chile and Canadawith respect to the management of information relatedto assessment and approval of products of modernbiotechnology/genetically engineering. This report isbased on data obtained during a number of interviewsand institutional visits conducted during August 1998and includes: an overview of current regulatory policy,identification of key human resources and authorities,analysis of information management capacity,recommendations for capacity building, anddescriptions of relevant international initiatives. Canadahas a regulatory system in place that is respectedthroughout the world for its ability to insure high-quality agricultural biotechnology products that meetinternational human and environmental health andsafety standards. Argentina is recognized as leaderamong Latin American countries in the regulation of
*Corresponding author
biotechnology products. Chile is a well-known center ofgenetic diversity for a number of plant species but withvery little in the way of biosafety regulation. Togetherthese countries represent a broad spectrum of technicalexperience, regulatory policy, and agricultural interests.
In 1998, over 40 million acres of transgenic crops weregrown around the globe. As these products are traded andpass from one country to the next, it is important to ensurethat domestic regulator regimes are in place around theglobe to ensure the safe use of these products. This reportoutlines the current capacities of Argentina, Chile andCanada with respect to the management of informationrelated to assessment and approval of product of modernbiotechnology/ genetically engineering. The data in thisreport is based on a number of interviews and institutionalvisits conducted during August 1998.
The regulatory systems of Canada, Argentina, and Chile are
Biosafety information management systems. A comparative analysis of the regulatory systems in Canada, Argentina, and Chile.
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all at different stages of development. Canada has a systemin place that is respected throughout the world for its abilityto insure high-quality agricultural biotechnology productsthat meet international human and environmental health andsafety standards. Argentina is recognized as leader amongLatin American countries in the regulation of biotechnologyproducts. And finally, Chile is a well-known center ofgenetic diversity for a number of plant species but withvery little in the way of biosafety regulation. Together thesecountries represent a broad spectrum of technicalexperience, regulatory policy, and agricultural interests.
As with any information system, the key to success isalways the people that use the system. In the case of abiosafety system these people are the regulatory authoritiesof the various government apartments involved inregulation of biotechnology products. Whether through inspecific designation in their job description or through anevolution of their duties, each regulatory group tends tohave one or two people that deal with biotechnologyproducts on behalf of the group. This report identifies thekey biotechnology contacts within these regulatorydepartments.
As the volumes of information required to process and trackthe development of biotechnology products increases, agreater need is placed on information management systemsrather than on traditional paper files. Regulatory departmentin all three countries have relatively modern computer
systems often networked through LANs and access, thoughsometimes limited, to the Internet as a resource.
Recommendations for information systemcapacity building:
The key to successful technology transfer is based ontechnology pull rather than push. Canada has much to offerSouthern cone partners in the development andimplementation of domestic biosafety regulatory systems.Based on the analysis of the current capacity of all threecountries, the following recommendation are made:
• Begin trilateral discussion of the Canadian andArgentine models to gain a better understanding ofthe regulatory development process in all threecountries
• Develop an electronic network [email list serve] toconnect regulators brought together through thistechnology transfer initiative.
• Develop a formal database of experts in the areasof biotechnology products and risk assessment forthe benefit of both Canadian regulators and thosein Latin America.
• Link information dissemination about productapprovals and field trials with the currentUNEP/OECD/UNIDO initiatives.
Table of Contents1. Overview of current Regulatory Policy
1.1. Canada
1.1.1. Technical Exertise1.1.2. Regulations and Procedures
1.2. Argentina
1.2.1. Regulations and Procedures
1.3. Chile
1.3.1. Technical Exertise1.3.2. Regulations and Procedures
2. Identification of Key Human Resources andAuthorities
2.1. Canada2.2. Argentina2.3. Chile
3. Analysis of Information Management Capacity
3.1. Canada3.2. Argentina3.3. Chile
4. Recommendations for Capacity Building
4.1. Argentina4.2. Chile4.3. Interaction with Canada
5. Relevant International Initiatives
5.1. OECD
5.1.1 Programme on the Harmonization ofRegulatory Oversight in Biotechnology
5.2. UNIDO
5.2.1. Biosafety Information Network andAdvisory Service (BINAS)5.2.2. Genetically Modified Organisms: A Guideto Biosafety
5.3. UNEP
5.3.1. Convention on Biological Diversity5.3.2. Biosafety Protocol5.3.3. Global Environment Facility pilotbiosafety enabling project
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1. Overview of Current Regulatory Policy
In 1998, over 40 million acres of transgenic crops weregrown around the globe. As these products are traded andpass from one country to the next it is important to ensurethat domestic regulator regimes are in place around theglobe to ensure the safe use of these products. Theregulatory systems of Canada, Argentina, and Chile are allat different stages of development. Canada has a system inplace that is respected throughout the world for its ability toensure high-quality agricultural biotechnology products thatmeet international human and environmental health andsafety standards. Argentina is recognized as leader amongLatin American countries in the regulation of biotechnologyproducts. And finally, Chile is a well-known center ofgenetic diversity for a number of plant species, but withvery little in the way of biosafety regulation. Together thesecountries represent a broad spectrum of technicalexperience, regulatory policy, and agricultural interests.
The regulatory systems of Canada and Argentina whiledeveloped independently are remarkably similar instructure. In developing biosafety regulations andestablishing experienced regulators, Argentina should beconsidered to be about three years behind Canada. Chile, onthe other hand, should be considered to be about whereCanada was in 1988. Chilean departments have not reallycome together yet to address the need for a regulatoryframework, the first step in regulatory development. Thegrowing numbers of transgenic plant products incommercial use throughout the world make it crucial for allcountries to have sufficient knowledge, experience andinfrastructure to determine and implement assessmentcriteria appropriate for their environment.
1.1 Canada
The Canadian regulatory system for products ofbiotechnology is based on a product rather than processphilosophy of regulation. The rationale for this approach isto provide for the assessment of all "novel" productsintroduced into Canada which may have a negative impacton human health, the environment, or the agriculturalindustry. As result, Canada has adopted a very broaddefinition of biotechnology, and focused regulations onnovel traits rather than "genetic engineering".
"Biotechnology" means the application of science andengineering in the direct or indirect use of livingorganisms or parts or products of living organisms intheir natural or modified forms;
Government of Canada, 1986
In December 1992, the federal Cabinet approved aframework for the regulation of products of biotechnologyin Canada. This framework, produced by the WorkingGroup on Safety & Regulations, provided federal
departments with 6 principles to guide them in thedevelopment of a regulatory system which:
1. maintains Canada's high standards forthe protection of the health of workers, thegeneral public and the environment;
2. uses existing legislation and regulatoryinstitutions to clarify responsibilities and avoidduplication;
3. continues to develop clear guidelinesfor evaluating products of biotechnology whichare in harmony with national priorities andinternational standards;
4. provides for a sound scientificdatabase on which to assess risk and evaluateproducts;
5. ensures both the development andenforcement of Canadian biotechnologyregulations are open and include consultation;and
6. contributes to the prosperity and wellbeing of Canadians by fostering a favourableclimate for investment, development, innovationand adoption of sustainable Canadianbiotechnology products and processes.
Government of Canada, 1992
Point two of this framework is particularly important withrespect to the authority and responsibility for biotechnologyproducts within the federal government. Unlike countriessuch as Australia that have a "gene law", Canada chose toamend existing legislation and regulatory departments toaccommodate these new products. The result is a number ofdifferent regulations with varying styles that have beendeveloped based on specific product and usagerequirements but ensure an equivalent level of safety fromdepartment to department. The only department to take onnew responsibilities due to the introduction ofbiotechnology products is Environment Canada. Unlike,pharmaceuticals or plants, products such as industrialenzymes or organisms for bioremediation did not fall undertraditional regulatory structures, so they are now capturedunder the Canadian Environmental Protection Act.
1.1.1 Technical Exertise
The first source of Canadian technical expertise for theassessment of a "novel" product lies within the regulatorydepartments. Evaluators within Federal departments take onsignificant technical responsibilities in the assessmentprocess and in some cases are the only sources of technicalexpertise used in an approval. Not surprisingly, regulatorypersonnel are a vital repository of technical information onbiosafety and risk assessment of biotechnology products. Asecond level of technical knowledge comes from otherexperts within the government that specialize in either riskassessment or biological research. Some evaluators usegovernment laboratories and researchers to verify test data
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provided in company submissions. These in-houseexpertsmay at times be asked to provide their scientificopinion on the evaluation of certain submissions.
The third level of technical expertise comes from externalexperts such as academic researchers. These individuals arerecognized as leading authorities on specific organisms aregenerally contacted on an "as needed" basis. Rather thanestablish a formal external advisory body to processapplications, as is the case in some countries, the role ofexternal advisors remains informal and case specific.
1.1.2 Regulations and Procedure
As indicated in the framework above, all new products ofbiotechnology are regulated under existing federallegislation. There were however, a number of amendmentswere made to these acts to highlight the specificrequirements for novel products of biotechnology. Inaddition, a number of guideline documents were producedto clarify what additional information may be required for abiotechnology product to comply with these regulations.
i. statutory instruments amended to accommodatenovel biotechnology products:• JUS-96-001-01 (SOR/DORS): Amendments to the
Feeds Act -- Novel Feeds• JUS-96-002-01 (SOR/DORS): Amendments to the
Fertilizers Act -- Novel Supplements• JUS-96-003-01 (SOR/DORS): Amendments to the
Health of Animals Regulations -- Permits toRelease Veterinary Biologics
• JUS-96-004-01 (SOR/DORS): Amendments to theSeeds Regulations -- Release of Seed
• JUS-97-022-01 (SOR/DORS): RegulationsAmending The New Substances NotificationRegulations
• Novel Food Regulatory Proposal as Published inCanada Gazette Part I (August 26th 1995)
ii. Regulatory directives, trade memorandums, andguidelines specific for novel biotechnology products:• Regulatory Directive Dir94-08: Assessment
Criteria for Determining Environmental Safety ofPlants With Novel Traits
• Regulatory Directive Dir95-01: Field TestingPlants with Novel Traits in Canada
• Regulatory Directive Dir95-03: Guidelines for theAssessment of Livestock Feed from Plants withNovel Traits
• Trade Memorandum T-4-118: Guidelines to SafetyAssessments of Microorganisms in Fertilizers andSupplements Regulated under the Fertilizers Act
• Trade Memorandum T-4-119: Explanatory Noteson the Information to be Submitted for SafetyAssessments of Microbial Supplements
• Canadian Food Inspection Agency - VeterinaryBiologics - Biotechnology Guidelines
• Guidelines for the Notification and Testing of NewSubstances: Organisms - Pursuant to The NewSubstances Notification Regulations of theCanadian Environmental Protection Act
• Information Note: Reporting Substances that areProducts of Microorganisms under the NewSubstances Notification Regulations
• Information Note 08-96: Notification of Post-transitional Biotechnology Products under theNew Substances Notification Regulations
• Guidelines for the safety Assessment of NovelFoods (Sept 1994)
The procedures for the introduction of a new biotechnologyproduct in Canada could best be explained by walkingthrough the regulatory procedures for a specific type ofproduct as below:
Sample: Regulatory steps in the Risk Assessment ofPlants with Novel Traits
Step 1: Contained
Contained use of a plant is defined as use within alaboratory, growth chamber, or greenhouse. No oversightby Canadian Food Inspection Agency (CFIA) orenvironmental assessment is required for plants incontained use as they are expected to remain within thesefacilities and therefore pose no hazard to the environment.Similarly, no food/feed use for these product would beallowed without Health Canada/ CFIA approval. [Note:Food and/or feed must be obtained prior tocommercialization, but may be sought at any stage ofprocess.]. Import permits may be required if plant materialfor confined use is brought from outside the country.
Prior to Step 2:
Before a confined field trial can take place, the CFIA mustundertake an environmental assessment. Details onevaluation criteria and data formats can be found in thereference document:
Field Testing Plants with Novel Traits in Canada
If authorized, continue to step 2.
Step 2: Confined Field Trials
Confined Field Trial refers to a small test plot of plants thatare grow in an open field with measures taken to ensure:reproductive isolation, restrictions on post-harvest land use,site monitoring, and control and disposition of seed, plantsand progeny. As above, no food/feed use for these productwould be allowed without Health Canada/ CFIA approval.[Note: Food and/or feed use must be obtained prior tocommercialization, but may be sought at any stage of thisprocess.] Again, an import permit may be required if plant
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material for confined use is brought from outside thecountry.
Prior to Step 3:
Before an unconfined field trial can take place, the CFIAmust undertake an environmental assessment. This is amore detailed assessment than would be required for aconfined use permit. Details on evaluation criteria and dataformats can be found in the reference documents:
Assessment Criteria for Determining Environmental Safetyof PNTs and subsequent guidelines
If authorized, continue to step 3.
Step 3: Unconfined Release
Plants that have received an unconfined release permit canthen be grown in large quantities for variety registrationtrials or seed multiplication. There is no requirement forreproductive isolation or restrictions on post-harvest landuse, however, monitoring for adverse effects continues.Once again, no food/feed use for these product would beallowed without Health Canada/ CFIA approval. [Note:Food and/or feed must be obtained prior tocommercialization, but may be sought at any stage ofprocess.]. Import permits may be required if plant materialfor unconfined use is brought from outside the country.
Prior to Step 4:
At this step Health Canada or CFIA must undertake a Foodor feed safety assessment. Details on evaluation criteria anddata formats can be found in the reference documents:
Health Canada - Novel Food Guidelines or Feeds Act(CFIA)
If authorized, continue to step 4.
Step 4: Commercialization
The final step, where applicable, is variety registrationsignifying permission for commercial release of theproduct. Food/Feed or industrial use permits are issued atthis step. Even after commercial approval adverse effectmonitoring continues.
1.2 Argentina
The Argentine regulatory system for products ofbiotechnology is philosophically different than the systemestablished in Canada. Rather than focussing on novelproducts, Argentine regulations focus on the biosafety ofproducts developed through the process of geneticengineering. As a result the regulatory system is based onthe following definition of "genetically modifiedorganisms".
"Genetically Modified Organisms" means organisms in which any of the genes or other genetic material have beenmodified by means of the following techniques:
• the insertion by any method into a virus, bacterial plasmid or other vector system of a nucleic acid molecule,which has been produced by any method outside that virus, bacterial plasmid or other vector system, as toproduce a new combination of genetic material which is capable of being inserted into an organism in which thatcombination does not occur naturally and within which it will be heritable genetic material;
• the insertion into an organism, by micro-injection, macro-injection, micro-encapsulation or other direct means, ofheritable genetic material prepared outside that organism;
• where they involve the use of recombinant DNA molecules in in vitro fertilization that implies the genetictransformation of an eukaryotic cell.
Government of Argentina, 1992
In 1991 the Secretary of Agriculture, Livestock and Fisheries created the Comisión Nacional Asesora de BiotecnologíaAgropecuaria (CONABIA) (The National Advisory Committee on Agricultural Biosafety) as a mechanism for consultationand technical support on the design and management of regulations concerning the biosafety of the introduction andenvironmental release of transgenic material. The CONABIA is made up of representatives of both public and privatesectors engaged in agricultural biotechnology.
Public Sector Representation Private Sector Representation
• SENASA- (National Service of Health andQuality of Agri-foods [Animal and Plantbranches])
• INASE- (National Institute of Seeds)
• ASA- (Association of Argentine Seeders)• Foro Argentino de Biotecnología (Argentina Forum of
Biotechnology)• CAPROVE- (Argentine Chamber of Veterinary
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• Secretariat of Public Health• Secretariat of Natural Resources and
Sustainable Development• National institutes of research
• INTA- (National Institute ofAgricultural Technology)
• CONICET- (National Council ofScientific and Technical Research)
• University of Buenos Aires
Products)• CASAFE (Chamber of Agricultural Health and
Fertilizers)• Argentine Society of Ecology.
The Department of Agricultural Production under the National Department of Agriculture and Forestry Production andEconomics from the Undersecretariat of Agriculture, Livestock and Forest Production acts as secretariat to the CONABIA.
1.2.1 Regulations and Procedures
While the philosophy underlying the Argentine regulationsfor assessments of GMOs is fundamentally different thanCanadian regulations, the product approval procedures areremarkably similar to those outlined in the "Regulatorysteps in the Risk Assessment of Plants with Novel Traits"are utilized for GMOs in Argentina. The main differencesin the two systems are:
• Argentina exerts regulatory oversight on productsfor contained use (same data required forcontained or confined trial) where Canada does notexert oversight until Confined use is requested.
• Canada asks for more detailed information in thefield trial applications
• Unconfined release requirements in both countiesare remarkable similar. (Note: Unconfined statusin Argentina is called flexibilization)
Apart from these differences the systems are remarkablysimilar. The same types of approvals (environmentalassessment, feeds, human health, and variety registration)are required in both countries and are based on very similarinformation requirements. CONABIA provides thebiosafety element for each of the approvals. The specificregulations involved in the approval process are as follows.
i. New statutory instruments, specific for GMOs:
• Creation of the CONABIA, Resolutions # 124/91,669/93 and 328/97 of the SAGYP.
• Requirements for the environmental releases ofGMOs, Resolutions # 656/92, 837/93 and289/97of the SAGYP.
ii. Statutory instruments, non specific for GMOs:
• Decree-Law regulating the Health Defense ofAgricultural Production, # 6704/66 and itsamendments.
• Law regulating Seeds and PhytogeneticConstructions, # 20247/73 and its regulatory order.
• Law regulating Veterinary Products,Manufacturing and Commercialization Inspection# 13636/49.
1.3 Chile
The Chilean regulatory system for products ofbiotechnology is still in its infancy. The regulatory systemfor field trials is operating under sanitary and phyto-sanitary regulations for importation of plant material. Thus,the law requires field trials of imported transgenic productsonly. There's no system in place for the regulation oftransgenic products developed domestically and no systemfor approval of products for commercial use. This meansthat there are no commercial approved transgenic productsavailable to the Chilean consumer. A few plant productshave received approval for large scale growing, but arerestricted to multiplication of seed and re-export for useelsewhere; none of these products are available to Chileanconsumers.
1.3.1 Technical Exertise
In November 1993 the "Advisory Committee on theRelease of Transgenic Organisms (CALT)" was created toprovide technical support to the Agricultural and LivestockService (SAG) with regard to the introduction andenvironmental release of transgenic material. The CALTmembers are specialists appointed by the Minister ofAgriculture as permanent officials representing the Ministryof Agriculture, Ministry of Health, agricultural researchcentres and Universities. The Advisory board does not haveany private sector representation.
CALT Representation
• Ministry of Agriculture, Agricultural andLivestock Service (SAG)
• INIA- (National Agricultural ResearchInstitute)
• CONICYT- (National Commission onScientific and Technical Research)
• University of Chile• Catholic University• Austral University• Institute of Public Health
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The Department of Plant Protection under the NationalAgricultural and Livestock Service acts as secretariat to theCALT.
1.3.2 Regulations and Procedures
The procedures for control of agricultural products in Chileare somewhat different than those in Canada. Chileanregulators are very focused on preserving the uniqueindigenous species found in the distinct ecosystem zonesthat divide the country. The primary role of the Agriculturaland Livestock Service (SAG) is the protection of the zonesthrough quarantine procedures. As a result, the regulatorysystem is very focused on the threat of invasive foreignspecies. The regulations under which Chile is currentlyregulating GMOs are limited in their authority to productsof import. Transgenic plants produced at INIA, agovernment research facility, have been voluntarilysubmitted to CALT for review. Chilean regulators seem tobe taking "a wait and see approach" before developingdomestic regulations hoping to benefit from internationalinitiatives such as the UN Biosafety Protocol. Theseregulations currently in place are as follows:
i. statutory instruments, specific for GMOs:
• Resolution of exemption 1927/93 of the SAG
ii. statutory instruments, non specific for GMOs:
• Decree-Law 3554/81
2. Identification of Key Human Resources andAuthorities
As with any information system, the key to success isalways the people that use the system. In the case of abiosafety information system, users of the system are theregulatory authorities of the various governmentdepartments involved in regulation of biotechnologyproducts. Whether through specific designation in their jobdescription or through an evolution of their duties, eachregulatory group in all of the countries studied tend to haveone or two people that deal with biotechnology products onbehalf of the group. The following is a breakdown of thedifferent regulatory departments and the key biotechnologycontacts within those departments.
2.1 Canada
Governmental agencies involved in the regulation ofagricultural biotechnology products
Agricultural and LivestockBiosafety
• Canadian Food Inspection Agency (CFIA). Animal Health• Health Canada, Health Protection Branch, Office of Food Biotechnology
Human Health • Health Canada, Health Protection Branch, Office of Food Biotechnology.
Seeds Certification • Canadian Food Inspection Agency (CFIA). Animal HealthAgrochemical • Pest Management Regulatory Agency (PMRA)
National coordinating bodies for biotechnology regulations
• National Biotechnology Strategy, BiotechnologyCoordinating Group, Subgroup on Safety andRegulation
Within the Canadian Food Inspection Agency there arefour groups responsible for evaluations: Seeds, Feeds,Fertilizers, Health of Animals. Coordinated interaction witheach of these groups of evaluators can be achieved throughthe Biotechnology Strategies and Coordination Office,Associate Director, Margaret Kenny
Ms. Margaret KennyAssociate DirectorCanadian Food Inspection Agency59 Camelot DriveNepean, ON KIA OY9Tel: 952-8000Fax: 228-6604Email: [email protected]
The primary biotechnology contact for each group in CFIAis listed below (next page).
Within Environment Canada regulatory authority overbiotechnology products falls New Substances NotificationDivision:
Import and Manufacture of New BiotechnologySubstances - CEPA
Dr. Nigel A. SkipperHead, Biotechnology SectionEnvironment CanadaCommercial Chemicals Evaluation Branch14th Floor, Place Vincent MasseyOttawa, ON K1A 0H3CanadaTel: 953-1678Fax: 819-953-7155Email: [email protected]
Within Health Canada there are two groups that haveresponsibility for Biotechnology products; each authorized
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under separate acts of parliament. The first if the Office ofFood Biotechnology, under the Food and Drugs Act, thatcoordinated evaluations of novel food products with othergroups in Health Canada responsible for nutritional andtoxicological assessments. The second group deals withhealth related aspects of environmental releases under theCanadian Environmental Protection Act (primarilymicroorganisms).
Novel Foods
Ms. Karen E. McIntyreHead, Office of Food BiotechnologyHealth Canada, Research CentreHealth Protection BranchEvaluation DivisionSir Frederick Banting Res.Centre, 4th FTunney's PastureOttawa, ON K1A 0L2CanadaTel: 952-7322Fax: 952-6400Email: [email protected]
Import and Manufacture of New BiotechnologySubstances - CEPA
Allan GodfreyHealth CanadaBiotechnology SectionEnvironmental Health Centre Tunney's PastureOttawa, OntarioCanadaK1A 0L2
Within the Pest Management Regulatory Agency there areagain multiple groups each of which evaluate differentaspects of a submission. These activities are coordinatedthrough the Alternatives Strategies and Regulatory Affairsgroup:
Pest Control Products
Mr. John D. SmithSenior Project ManagerPest Management Regulatory AgencyAlternatives Strategies and Regulatory AffairsSir Charles Tupper Building2250 Riverside DriveOttawa, ON K1A 0K9CanadaTel: 736-3670Fax: 736-3659Email: [email protected]
2.2 Argentina
Governmental agencies involved in the regulation ofagricultural biotechnology products:
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Agricultural and LivestockBiosafety
• Secretariat of Agriculture, Livestock and Fisheries (SAGPyA )• Argentine Institute of Plant Health and Quality (IASCAV)• National Agri-food Health and Quality Service (SENASA).
Human Health • Secretariat of Health, National Committee on Biotechnology andHealth (CONBySA), Subcommittee on Food.
Seeds Certification • National Institute of Seeds (INASE).Agrochemical • Argentine Institute of Plant Health and Quality (IASCAV).
National coordinating bodies for biotechnology regulations• National Advisory Committee on Agricultural and
Livestock Biotechnology (CONABIA)• National Committee on Biotechnology and Health
(CONBySA), Subcommittee on Food.Coordination of CONABIA within SAGPyA, and thereforeprimary assessment of GMOs, is the responsibility of theAgricultural Production Directorate headed by CarmenVicien. The staff within this directorate can coordinate theevaluators within the various agencies under the secretaryof agriculture (SENSA, INASE...)
Carmen VicienDirectora de Produccíon Agrícola, SAGPYAAvenida Paseo Colón 982 – 2o Piso Officina 220CP 1063 – Buenos Aries – ArgentinaTel: 54-1-349-2222Fax: 54-1-349-2224E-mail: [email protected] various evaluator contacts are listed below.
2.3 Chile
Governmental agencies involved in the regulation ofagricultural biotechnology products
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Agricultural and Livestock Biosafety • Ministry of Agriculture, Agricultural andLivestock Service (SAG), Department ofAgricultural Protection, Subdepartment ofAgricultural Defense
Human Health • Ministry of Health, Subdepartment ofBromatology, Institute of Public Health.
Seeds Certification • SAG, Technical Department of Seeds.Agrochemical • SAG, Department of Agricultural Protection,
Subdepartment of Agricultural Defense.• Ministry of Health.
National coordinating body for biotechnology regulations
• Advisory Committee on the Release of TransgenicOrganisms (CALT)
Within the Agricultural and Livestock Service (SAG) thekey Biotechnology contacts would be:
At this time, the international affairs department hasvolunteered to coordination the various groups in SAG withrespect to biosafety capacity building.Julio LopezInternational AffairsTel: 56-2-6883811Fax: 56-2-6717419E-mail: [email protected] the Ministry of Health initial contacts should bemade through:Luis Navarrete MuñozDirectorPublic Health InstituteMinistry of HealthMarathon 1000Santiago, ChileTel: 56-2-2391105
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3. Analysis of Information Management Capacity
In analyzing the information management capacity of thevarious government departments it is important to keep inmind that the volumes and urgency of information dictatesystem requirements. The key to developing an appropriatesystem for each situation is to thoroughly understand thecurrent information needs and hopefully anticipate near-term and long-term information requirements.
As the volumes of information required to process and trackthe development of biotechnology products increase, agreater need is placed on information management systemsrather than on traditional paper files. In this regard, Canadais at a significant advantage relative to many othercountries, in that we have an advanced and well-usedtelecommunications and computer infrastructure. Toolssuch as high-speed Internet connections are readilyavailable and used almost universally throughout bothgovernment and businesses. Canadians also enjoy thebenefit of seamless integration into the U.S. network.
Countries such as Argentina and Chile have relativelymodern computer systems often networked through LANs.External linkages and tend to be slow due to limitedbandwidth for telecommunications connections such as tothe Internet. For example, a Latin American researchInstitute of 300 people would typically share a 64 KBPSconnection, where a Canadian office of 12 people sharingthat same bandwidth would likely be considering anupgrade. As well, Latin American countries tend not tohave developed a sufficient number of domestic networknodes and as a result Internet service providers (ISPs) oftenhave only a single high-speed connection to the Internetthrough a provider in the United States. This means that amessage being sent across the street in Chile to a computerthat is using a different ISP must be routed through theUnited States. Similarly, when that single connection fails,those users are isolated from the rest of the Internet untilrepairs are made.
Within the regulatory agencies studied, Internet access isoften restricted to only a few machines within eachorganization. Often people are required to log onto specificworkstation in order to check their e-mail [often not routedthrough the LAN to the computer on their desk]. As aresult, communications via Internet do not tend to have thesame immediate response rate as is generally found here inCanada. The basic hardware and software tools areavailable to ensure effective information management withthe regulatory groups of both Argentina and Chile. Whatare lacking are applications designed to specifically handlethese products.
3.1 Canada
Canada’s various regulatory departments differ in the typesof information they need as well as in the volume ofinformation they wish to process. In the regulation of
transgenic plants the Plant Protection Branch of theCanadian Food Inspection Agency (CFIA) deals with thebulk of this information. This reason for this is simply thatthey are the first department to look at regulatorysubmissions for new products (i.e. field trials are usuallyconducted before food or feed assessments) and they oftenreceive multiple field trial submissions before a finalenvironmental assessment is done. Thus while HealthCanada had rendered about 40 Novel Food decision, CFIAhas approved about 4000 field trials. Not surprisingly, thePlant Protect Branch has had to develop a fairly advancedinformation tracking and retrieval system. An in-housedatabase was developed to track field trial submissions,field inspections, environmental assessment submissions,and approvals. This database is currently running on aFileMaker pro platform and is available within CFIA viatheir LAN. The Plant Protection Branch has alreadyreceived budget approval to develop in Internet interface totheir database for both publicly accessible information aswell as a secure system for field personnel to access thedatabase via the World Wide Web.
Other regulatory groups such as Health Canada's FoodBiotechnology Office and Environment Canada's NewSubstances Notifications group are not currently dealingwith significant enough volumes of information to haveforced them to create such an elaborate tracking andmonitoring system. Beyond tracking and monitoring, allregulatory departments utilize databases of one form oranother for classification and retrieval of scientific reportsrelevant to the assessment procedure. As well, wideavailability of the Internet has provided a valuable tool toregulators searching scientific literature. One regulatorygroup commissioned the development of a pathogendatabase, but in hindsight felt the use of "off-the-shelf"databases was more cost-effective. When questioned, mostregulators felt that the most useful source for searchingscientific literature was still the Commonwealth AgricultureBureau Database on CD-ROM (now available online) orpersonal contact with known experts.
Use of the World Wide Web as a tool for providinginformation has been use by all federal departments
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involved in biosafety regulation. The amounts and types ofinformation posted by these groups vary based on theinformation generated by the department and the need topresent the public with information. All of the sites listedbelow provide links to regulations and guidelines producedby the department. The CFIA site is particularly useful inthat it also provides lists of approved products, decisiondocuments, and regulatory directives on the biology ofcommonly studies organisms.CFIA – (http://www.cfia-acia.agr.ca/english/ppc/biotech/bsco.html)Environment Canada –(http://www2.ec.gc.ca/cceb1/eng/biohome.html)Health Canada [Novel Food] – (http://www.hc-sc.gc.ca/main/hc/web/datahpb/datafood/english/)For the most part, Canadian regulatory agencies have donean excellent job of managing the information related toproducts of biotechnology. The one area in which there isroom for improvement is the tracking of personal contacts.Every regulatory uses personal contact with experts toassist in their assessments, and when a regulator leaves thedepartment, the contact with those experts also leaves. Infuture, attempts should be made to prevent this loss ofcorporate memory during staff changes by developing adatabase of experts.
3.2 Argentina
Secretariat of Agriculture, Livestock and Fisheries(SAGPyA) has done a very good job developinginformation systems to suit their current needs. The numberof field trials in Argentina has been steadily growing since1991. In 1997, SAGPyA processed 78 field trialsubmissions up from 40 the year before, prompting thedepartment to begin development on a database to trackapplications and field trials. The database was developedin-house to run on a stand-alone PC using a FoxPro [xbase] platform. Thus far, the system is not yet been thetested due to a lack of human resources to enter and test thedata.
SAGPyA has also produced a WebSite that prominentlydisplays information on CONABIA including informationon regulations, field releases, and agricultural biosafetyissues.
(http://www.sagyp.mecon.ar/HOME/English.htm).
All information is provided in both English and Spanishand is presented in a clear and well-organized format. Nowthat Argentina has five biotechnology products approvedfor commercial use, it would be useful to list these productson the WebSite.
Internet access is somewhat restricted in that it is onlyavailable from certain machines, bandwidth is shared acrossthe organization providing slower access times, and thefirewalls can create up to 24-hour delays in downloading ofsome information. Thus, Internet searches are more timeconsuming and less efficient for collecting biosafetyinformation from countries such as Argentina. Traditionallibrary database searches and personal contacts tend to be abetter use of time. With regard to personal contacts, e-mailis available to all regulators in Argentina though often notat the workstation that they regularly use. This could resultin some delays in response to e-mail requests form Canada.
During site visits regulators in Argentina were found to bewell informed about biosafety issues should be commendedon their efforts to keep up to date on scientific researchrelated to their regulatory duties. While Canada may haveprocessed a large volume of field trial applications, thevariety of products examined by Argentina is comparable.
3.3 Chile
Tracking and monitoring of information in Chile is not animmediate concern because of the small volume ofinformation. CALT the national advisory body onenvironmental releases of transgenic organisms currentlyreviews 15 to 20 applications annually. Since there is nosystem for approving these products for "commercial use"field trials are limited to products for multiplication and re-export. It is expected that once a regulatory system is put inplace, information volumes will increase and a trackingsystem will have to be implemented.
The ministry of agriculture has established a WebSiteproviding information on all different groups within thisministry including SAG (regulatory agency) and INIA(research agency).
(http://www.minagri.gob.cl/)
The WebSite is available in Spanish only and informationon SAG is limited to a basic organizational overview.There's no information currently available about regulationof any products. INIA on the other hand, has what appearsto be a fairly well managed network including an Intranetinformation system. Both INIA and CONICYT haveoffered to provide resources to upgrade and train SAGpersonnel to help develop their WebSite.
As in Argentina, Internet access is somewhat restricted. InSAG for example, e-mail is assigned to groups within theagency and rather than individuals. As well, not allmachines have access to the Internet, and limited bandwidth
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is shared across the organization. Thus, for the personnel atSAG internet does not appear to be widely used forgathering or disseminating information, but this maychange once the regulatory demands on the agencyincrease.
4. Recommendations for Capacity Building
The experience of Canadian regulators in the developmentof regulations, assessment of products, and management ofinformation, can greatly assist Southern Cone regulators inincreasing their capacity to deal with these new products.Based on interactions with the regulatory departmentsdiscussed in this document, the following recommendationsare made:
4.1 Argentina
The Argentine regulatory system for products ofbiotechnology is already fairly well developed and wellsuited to the current volume of products being processed bythis country. The regulators have done an excellent job ofsetting up a system that protects human health and theenvironment, while assuring that approval andcommercialization of new products occur in a timely andefficient manner. The primary role for Canadians in theevolution of regulatory system will be to
1. help the Argentines modify their system toaccommodate the growing number of applicationsthey are asked to handle; and
2. provide personal contacts with relevant experts topromote an exchange of technical information.
Last year CONABIA, the national advisory body, reviewed78 applications for field trials. This is up almost onehundred percent from the year before. As a result, SAGPyAwas forced to increase their staff and start preliminaryscreening of applications in-house. It is clear that this trendwill continue over the next few years and SAGPyA will beexpected to rely more and more on decisions from theirregulators rather than CONABIA. During site visits, theSAGPyA staff displayed good technical knowledge andexperience could handle greater responsibility in theapproval process. These staff members will benefit greatlyfrom interactions with Canadian regulators in seeing howlarge volumes information are handle. It is expected thatover the next few years the role of CONABIA will beforced to change as the demands on committee membersincreases and experience with the products and in-houseexpertise grows. It may eventually be decided that certaintypes of approvals or combinations of organisms andtransformation could be handled competently by SAGPyAstaff rather than requiring a decision from CONABIA.
4.2 Chile
The Chilean regulatory system for products ofbiotechnology is still in its infancy. The regulatory systemfor field trials is operating under sanitary and phyto-
sanitary regulations for importation of plant material.There's no system in place for the approval of products forcommercial use. At present, products can be grown only formultiplication of seed and re-export. In addition, theregulators do not yet have the experience or familiarity withthe products they are asked to evaluate. The role forCanadians in the evolution of the Chilean regulatory systemis twofold. Primarily, the Chileans need to establish thepolicy and regulatory framework for the assessment ofthese products. In addition, access to technical expertise isrequired. With respect to the development of a regulatoryand policy framework, the Chileans should be exposed to asmany approaches to regulation as possible. Meeting withChilean regulators revealed that they are more concerned atthis time with environmental protection and conservation ofgenetic resources than using biotechnology to increaseagricultural production. The philosophical approach toregulation by SAG appears to be closer to the approach ofEnvironment Canada rather than that of CFIA. Therefore, itis recommended recommend that any Chilean regulators beexposed to both regulatory groups.
The technical needs of the Chileans are very different fromthose of the Argentines. In fact, the need for an expandedtechnical advisory body is significant. The lack of in-houseexperts should be augmented, at least in the short-term, by agreater use of the advisory body (CALT). This groupshould be expanded to include individuals with industrialexpertise and formalized procedures for review ofapplications should be established. The Chileans maybenefit greatly from interactions with the Argentineregulators to discuss their development and use ofCONABIA and how they dealt with issues such asrepresentation and confidential business information. Ifpossible, the Chilean visits to Canada should be coordinatedto coincide with those of their Argentine counterparts.
4.3 Interactions with Canada
The key to successful technology, knowledge or resourcetransfer is based on "information pull" rather than "push". IfCanada is to have a significant impact on the way countriessuch as Argentina and Chile regulate products ofbiotechnology, there must exist the right attitude and desirefor collaboration. Partners must first recognize that there isa need for what Canada can offer to them, and secondengage champions to integrate this knowledge intodomestic regulatory systems. In the case of Argentina, bothof these requirements have been satisfied. The case ofChile, the attitude towards products of biotechnology is oneof suspicion. To date, commercial products ofbiotechnology have not focused on priority areas for theChilean agricultural industry or consumers and thus areseen to be forced on them by foreign multinationals.Domestic development of products of biotechnology hasalready begun and once this is recognized, attitudes willlikely change.
Insofar as policy development is concerned, there is value
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in providing models for countries such as Chile to use asreference. But ultimately, policy and regulatorydevelopment is a domestic issue. It is hoped to that throughdiscussion of the Canadian and Argentine models andparticularly in sharing how and why these models havebeen developed to their current form, a better understandingof the regulatory process will be achieved in all threecountries and open the doors to regulatory harmonization.
With regard to technical cooperation, both Chile andArgentina have advisory bodies designed to augment thetechnical knowledge of their regulators. It is expected thatthese advisory bodies will continue to play a vital role inthe regulatory process for the next several years,particularly with regard to their understanding of uniquedomestic situations that cannot be provided from Canada.However, as regulators gain more experience with theseproducts and conduct more of the assessments in-house,networks of personal contacts will become more important.It is recommended that an electronic network [email listserve] be established to connect regulators brought togetherthrough this technology transfer initiative. In addition, aneffort should be made to develop a formal database ofexperts in the areas of biotechnology products and riskassessment for the benefit of both Canadian regulators andthose in Latin America. This database should be madeavailable to as many regulators as possible, and includeexperts from all over the world.
Finally, an effort should be made to link informationdissemination about product approvals and field trials withcurrent OECD / UNEP initiatives such as BioTrack and theGlobal Environment Facility Biosafety Enabling PilotProject. At this time, information about product approvalsis still not available in any sort of regularly updatedclearinghouse mechanism. However, should theseinternational organizations decided to establish and/ormaintain a global database or internet based search system,Canada, Argentina and Chile should be prepared toparticipate and possibly prototype such an initiative.
5. Relevant International Initiatives
Since biotechnology products are being rapidly adoptedaround the world there is an increasing need to ensureconsistent safety standards are put in place to protect humanhealth and the environment from any potential adverseeffects of these products. To date, there are only threeinternational organizations (OECD, UNIDO, and UNEP)that have, or plan to, invest significant resources intobiosafety information systems. Recent pressures due toincreasing global trade in these products and the UNBiosafety protocol negotiations have encouragedcooperation between these organizations.
5.1 OECD
5.1.1 Programme on the Harmonization ofRegulatory Oversight in Biotechnology
The OECD Programme on the Harmonization ofRegulatory Oversight in Biotechnology is an initiativedesigned to ensure that environmental health and safetyaspects are properly evaluated, while avoiding non-tarifftrade barriers to products of biotechnology. The majority ofOECD member countries have (or are developing) a systemof regulatory oversight for the products of modernbiotechnology which are intended for release into theenvironment. The Programme is expected to play acoordinating role for regulatory department in membercountries.
There are three main areas of work:1. The development of Consensus Documents, onspecific scientific issues related to biotechnology,2. Outreach activities, including the developmentand maintenance of Biotrack Online, that makesinformation on the Harmonization programmeavailable to anyone interested, and3. General Issues associated with harmonization ofbiotechnology regulation.
Outreach Activities - InformationDissemination
BioTrack is an online database used to track regulatordevelopments and field trials of transgenic plant products inOECD member counties. BioTrack Online currentlyincludes:
• information related to major legislativedevelopments in OECD Member countries(including details of the relevant regulatoryauthorities);
• an online database (including a search facility) offield trials of transgenic organisms in OECDMember countries; and
• links to other related World Wide Web sites.
Further development of BioTrack Online is planning tofocus on information related to the regulatory oversight ofproducts of biotechnology which is used by governmentsand industry in preparing notifications/assessments.
There will be co-operative development of OECD’sBioTrack Online with UNIDO’s Biosafety InformationNetwork and Advisory Service (BINAS). The first step in1996 was the construction of a joint BioTrack/Binas page(BIOBIN) on the World Wide Web. Currently, this is an aidto users to navigate between the two sites. However, during1997-1999, BIOBIN will be developed further in an effortto contribute towards a global information system related toregulatory issues and harmonization.
A second project is a joint global survey with UNEP onRegulatory Oversight on the Commercialization ofAgricultural Products Derived through ModernBiotechnology. Questionnaires have been forwarded toapproximately 180 countries. The national responses will
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be documented and used to compare current regulatorysystems. This information will also be used by UNEP forthe implementation of the UNEP International TechnicalGuidelines on Biotechnology.
Contact for OECD’s Secretariat
OECD Environment Directorate, Environmental Health andSafety Division
5.2.1 Biosafety Information Network andAdvisory Service (BINAS)
In 1992, UNIDO decided to develop an in-house capabilityto foster biosafety by providing developing countries withthe science-based and informational tools needed to attainan adequate oversight capability in biotechnology. Thisresulted in the establishment of the Biosafety InformationNetwork and Advisory Service (BINAS), a bioinformaticsresource drawing largely upon the expertise and experienceof the International Centre for Genetic Engineering andBiotechnology. Today the stated objective of BINAS is toassist member States in developing regulations forbiotechnology.
Available on the Internet since December 1994, BINASdatabases have provided biosafety data from sourcesworldwide. The database spectrum will soon be expandedto include technology-impact assessments and intellectualproperty rights. At the request of Governments in EasternEurope, BINAS convened an expert group meeting toconsider the feasibility of establishing a regionalbiotechnology forum mandated to work towards theharmonization of biotechnology oversight in the region.The meeting led to further requests for assistance to BINASby Government authorities in the participating countries
and a BINAS expert has already visited Bulgaria to adviseofficials involved in developing biotechnology regulations.A similar regional initiative, involving the ASEANcountries, is currently being considered.
5.2.2 Genetically Modified Organisms: AGuide to Biosafety
This book Jointly produced by UNIDO and theCommonwealth Agriculture Bureau International is aimedat scientists and administrators with the intention offocusing on the major issues underlying the safety ofbiotechnology and how these affect policies for itsregulation. Large arrays of biotechnology applications arereviewed with emphasis on risk assessment procedures. Inthis context, the book analyses potential adverse effects onhealth and the environment, and pays due attention tomitigation procedures.
The UN Convention on Biological Diversity is the firstUNEP initiative to focus on the issue of biotechnology andmore specifically biosafety. The Convention signed in 1992laid out provision for the development of a biosafetyprotocol.
Article 19. Handling of Biotechnology and Distribution of its Benefits
3. 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 anyliving modified organism resulting from biotechnology that may have adverse effect on the conservation andsustainable use of biological diversity.
4. Each Contracting Party shall, directly or by requiring any natural or legal person under its jurisdictionproviding the organisms referred to in paragraph 3 above, provide any available information about the use andsafety regulations required by that Contracting Party in handling such organisms, as well as any availableinformation on the potential adverse impact of the specific organisms concerned to the Contracting Party intowhich those organisms are to be introduced.
Article 8. In-situ Conservation
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Each Contracting Party shall, as far as possible and as appropriate:
(g) Establish or maintain means to regulate, manage or control the risks associated with the use and release ofliving modified organisms resulting from biotechnology which are likely to have adverse environmental impactsthat could affect the conservation and sustainable use of biological diversity, taking also into account the risks tohuman health;
Convention on Biological Diversity, 1992
5.3.2 Biosafety Protocol
The protocol, which is currently under negotiation, isintended to, along with other complementary regional andinternational instruments, hopes to offer an effectiveframework for regional and international cooperation aimed
at enhancing the transfer of, and ensuring safety in,biotechnology. Unfortunately this has not been evident thusfar. The protocol has included an article specifically on theexchange of information related to biosafety and movementof products of biotechnology.
ARTICLE 19 - INFORMATION SHARING/BIOSAFETY CLEARING-HOUSE/ [BIOSAFETY DATABASE]
The Parties shall facilitate the collection and exchange of [publicly available] [scientific, technical, environmentaland legal] information on, and experience with, LMOs to enable Parties to make informed decisions related tobiosafety, taking into account the special needs of developing countries and the countries with economies intransition, through a [Biosafety Clearing-house] [Biosafety Database]. …
Consolidated Text: Fifth meeting of the Protocol Working Group, Aug. 1998
5.3.3 Global Environment Facility pilotbiosafety enabling project
In November 1997, the Council of the Global EnvironmentFacility (GEF) approved a $2.744 million UNEP/GEF pilotbiosafety enabling project. The aim of the project was toprovide assistance to developing countries and countrieswith economies in transition in formulating nationalbiosafety frameworks for the implementation of the UNEPInternational Technical Guidelines for Safety inBiotechnology, and the future implementation of anyagreements on biosafety. Given that it was not yet possibleto have a full understanding of the kinds of assistance thatcountries might need in addressing biosafety issues and thefuture implementation of biosafety agreements, theusefulness of the project lies in assisting Governments toundertake an initial assessment of the state-of-play in theircountries on matters of biosafety.
This effort is to be accompanied by a global awareness-raising initiative on biotechnology-related biosafetyaspects, given the central importance of those issues for theConvention on Biological Diversity and the potentiallonger-term operational implications for the GlobalEnvironment Facility. In implementing the project, UNEPhas agreed work closely with, and seek advice from,relevant United Nations bodies, governmental and non-governmental organizations, the biotechnology industry, theSecretariat of the Convention and regional institutions. Theproject mangers have planned a series of regionalworkshops for this.
Contacts
Convetion on Biological Diversity Secretariat:World Trade Centre393 St Jacques Street, Office 300Montréal, QuébecCanada H2Y 1N9(Montreal Metro Stop is "Square Victoria")Tel: +1-514-288-2220Fax: +1-514-288-6588Email: [email protected]
The ideas and the content of this report belong to the authorand are not responsibility of CIDA.
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Web Sites related with Biosafety
Compiled and edited by:
Jason FlintPresident
BIOINTEL
Javier VerasteguiCoordinator,
CamBioTec-CanadaBIOTECanada
Argentina
• Comité Nacional Asesor en Biotecnología Agropecuaria- CONABIA
