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SELECTED NATIONAL AND REGIONAL INSTRUMENTS RELATED TO MODERN BIOTECHNOLOGY


AFRICA

African Union

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

OAU Draft Model National Legislation on Safety in Biotechnology (revised) (2001)

Y

Y

Y

Y

Y

Y


Y

Y

Y

Y

Y

Y

Selected Legal Annotations and Comments

The draft OAU Model Law was developed over the course of two years. The latest revision, when finished, will be tabled for adoption at the next OAU Council of Ministers meeting. It follows in the footsteps of an earlier OAU model law on access to genetic resources and community knowledge. The draft law on biosafety could be developed into an African-wide framework for the development of biosafety laws. It could also provide the basis for a harmonized legislative approach. The extent to which African countries will use the model is unknown, but its inclusion here is illustrative of its many innovative features.

The model law applies to the import, contained use, release or placement on the market of any GMO or products from GMOs (art.2). Governments are to designate or establish a competent national authority (CA) (art.3(1)) and establish a national biosafety committee (NBC) to provide the competent national authority with policy recommendations and guidelines (art.3(2)). The NBC will include representatives from governmental and non-governmental institutions and the private sector (art.3(2)(a)). The CA shall take account of the recommendations and guidelines in its decision-making process (art.2(1)). In addition, institutions undertaking the activities within the scope of the law are to create institutional biosafety committees (IBC) (art.2(3)).

No person shall import, make contained use, release or place on the market a GMO or product of GMOs (art.4(1)). An application for approval must be submitted to the CA (art.4(2)). It will include inter alia (a) a report on risks to the environment, biodiversity and health, including the consequences of unintentional releases, (b) information on previous approvals or rejections, (c) the place and purpose of the activities, (d) statement asserting that the information provided is correct (art.4(3)(b), (d), (e) and (f)).

When the application is received, the information included is to be made available to the public and other governmental agencies by the CA (art.5(1)). The information provided is subject to confidentiality restrictions for business purposes, after the applicant makes a claim for confidentiality to the CA (art.11(1)). Information that cannot be kept confidential includes (1) a description of the GMO or the product; (2) methods and plans for monitoring and emergency plans (3) evaluation of foreseeable effects (pathogenic or ecological) (art.5(2)(a-c)). The CA may make the confidential information available if it decides that it is in the public interest to do so (art.12(3)). The public may make comments within a period specified by the CA (art.5(2)). Where the CA arranges for a public consultation it is to be announced in the media with national coverage for a given period of time (art.5(3)). The CA is to take into consideration when it is making or reviewing its decisions the public’s views and concerns (art.5(4)). The CA is to make available to the public information on consents and denials as well as the risk assessment for the GMO or product of a GMO at issue (art.5(5)).

Criteria are provided for the CA’s decision-making. Decisions must be in writing (art.6(2)). Approvals are to state that the activity approved is to be carried out on a “step-by-step” basis and that risk assessment should be carried out at each step (art 6(4)), though the CA may waive this where there is no risk to environment, biodiversity or health.

Approvals must require subsequent monitoring and evaluation of risks (art.6(5)). Approval cannot be issued unless the CA considers and duly determines that the GMO or product of GMOs poses “no risks to the environment, biological diversity or health” (art.6(6)). The precautionary principle is reflected in article 6(7): where a threat of serious damage exists, lack of scientific evidence should not be used as a basis for not taking preventative measures. In addition, no approval is to be given unless the activity will (a) benefit the country, (b) contribute to sustainable development, (c) not have adverse socio-economic effects and (d) “accord with ethical values and concerns of communities and does not undermine traditional knowledge and technologies” (art.6(8)). Approvals may be revoked or subjected to conditions when new information arises or review of existing information indicates risks to the environment, biodiversity or health (art.7(1)). Applicants are to notify the CA when information on possible risks becomes available after approval (art.7(2)).

Decisions shall not be made without an assessment of risks to the environment, biodiversity and health, including socio-economic conditions (art.8(2)). Risk assessments are to be carried out on a case-by-case basis according to guidelines that will be annexed to the model law (art.8(3)). The CA may undertake the risk assessment or cause it to be undertaken (art.8(6)). Either the CA evaluates the assessment or causes it to be evaluated (art.8(4)). The applicant may be required to bear the cost of assessment and/or evaluation (art.8(7)). Where the assessment indicates that the risks cannot be avoided, the CA must refuse approval (art.8(5)).

The CA may impose a variety of risk management measures including prohibiting the activity, ordering cessation, ordering the limitation of damage and requiring restoration and taking measures in emergency situations at the cost of the person responsible and require periodic monitoring reports (art.9). Information on safety measures is to be made available to persons likely to be affected by an accident (art.10(1)). Applicants are to notify accidents immediately to the CA along with other information (art.10(2)).

Any GMO or product of a GMO is to be clearly identified and labelled as such (art.11(1)). Identification is to specify the relevant traits and characteristics in sufficient detail for purposes of traceability. In addition, any product of a GMO is to be clearly labelled and packaged using words that will be specified in a subsequent annex to the model law that is unavailable. The CA may require additional information in particular whether the product may cause reactions, allergies or other risks (art.11(2)).

The draft model law includes provisions on export in article 13. It implicitly requires authorization from the exporting country’s CA prior to export. An exporter must provide to the CA of the exporting country written advanced informed agreement from the importing country’s CA (art.13(1)). No authorization for export will be given if the exporting country bans the GMO or the product of GMOs (art.13(4)).

Liability and redress provisions are provided in article 14. Strict liability applies for any harm caused by a GMO or product of a GMO and harm is to be fully compensated (art.14(1)). Liability attaches to the person responsible for the activity as well as the GMO provider, supplier or developer (art.14(2)). Harm to the environment or biological diversity is to be compensated including costs of reinstatement, rehabilitation, clean-up measures, which are actually incurred, and the costs of preventive measures (art.14(4)). Liability shall also extend to direct or indirect harm or damage caused to “the economy or social or cultural practices or the livelihood or indigenous knowledge systems or technologies of a community or communities” (art.14(5)). Harm includes disruption or damage to production systems, agricultural systems, reduction in yields, soil contamination, damage to biological mass and damage to the economy of an area or community. Any person or group is entitled to bring a claim and seek redress in respect of any breach or threatened breach of the act, including damage to the environment, biodiversity and socio-economics (art.14(7)). No costs are to be awarded against any person entitled to bring a claim if it was instituted “reasonably out of concern for the public interest or in the interesting in protecting the environment or biodiversity (art.14(8)).

Existing activities need to reapply for authorization (art.17(1)).

South Africa

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Genetically Modified Organisms Act (1997)

Y





Y


Y

Y

Y

Y



Selected Legal Annotations and Comments

This act applies to (1) GMOs; (2) development, production, release, use and application of GMOs; and (3) use of gene therapy (though not gene therapy techniques) (sect.2(1)). The Ministry of Agriculture oversees the Act’s implementation. The Act is only enabling in nature and does not specify outright, for example, that a release must have a permit. The Act will be further elaborated upon via regulations. The Minister may make regulations inter alia on the application and issue of permits, procedures for risk assessment and environmental impact assessment, requirements for general release and marketing of GMOs and the importation/exportation of GMOs (sect.20(1)).

The Minister of Agriculture shall appoint an interagency Executive Council for GMOs composed of representatives from various governmental agencies (sect.3). The Council is to advise the Minister on all aspects concerning activities within the law’s scope of application and ensure that all activities are performed according to the Act (sect.4). The Council has the power to inter alia (1) require a permit for the use of facilities to develop, produce, use or apply GMOs or to release GMOs into the environment, to submit through a registrar a risk assessment and where required an environmental impact assessment of these activities (sect.5(a)); (2) require a registrar to examine an application’s conformity with the Act (sect.5(b)); and (3) approve the use of facilities or a release (sect.5(g)). The Council may also inform any other country of an accident that may have an impact on that country’s environment (sect.5(i)) and approve and publish guidelines for all GMO uses (sect.5(l)).

The Minister shall appoint a qualified person to act as registrar, in consultation with the Council (sect.8(1)). The registrar administers the Act (sect.8(2)(a)). The registrar, subject to the instructions of the Council, inter alia (1) issues, amends and withdraws permits issued under the Act and (2) enforces the Act (sect.9(a and b)). The registrar may appoint inspectors (sect.15(1)) who are empowered to enter facilities or places with a warrant when there is a reason to believe the Act has been contravened (sect.15(4)) and who undertake routine inspections (without a warrant) (sect.16).

The Act establishes an Advisory Committee whose members are appointed by the Minister after recommendation by the Council (sect.10(1)). The Committee’s membership is to reflect representation from all fields of expertise involved with GMOs (sect.10(2)). The Committee is to act as the national advisory body on all matters related to genetic modification of organisms (sect.11). Advice may include that related to GMO introductions into the environment, proposals for specific activities or projects, contained use, importation and exportation and proposed regulations and guidelines (sect.11(1)(b)). The Committee may advise upon request (or upon its own initiative) the Minister, the Council, other Ministries and bodies. It may also invite written comments from knowledgeable persons on any aspect of genetic modification of organisms (sect.11(1)(d)). Committee members are to recuse themselves when the Committee considers subjects in which they have direct or indirect interest (sect.13).

Users are to ensure that appropriate measures are taken to avoid adverse environmental impacts that may arise from the use of GMOs (sect.17(1)). Liability for damage is borne by the user.

The Act does not have public participation provisions, though these may exist in other South African laws. There are confidentiality provisions that apply (sect.18(1)). The Council decides after consultation with the applicant which information is to be kept confidential (sect.18(2)). Information that cannot be kept confidential includes the GMO description, methods and plans for monitoring GMOs and emergency plans and an evaluation of foreseeable impacts, particularly pathogenic or ecologically disruptive impacts (sect.18(2)).

Tunisia

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Draft Law on the Contained Use, Voluntary Release and Commercialization of GMOs

Y


Y

Y


Y



Y

Y


Y


Selected Legal Annotations and Comments

The Law regulates the contained use, deliberate release and commercialization of GMOs. Such activities can be carried out upon authorization. The applicant requesting the authorization must hold a degree in, inter alia, agronomy, biology, medicine, veterinary, or have a specialization recognized by the Biosafety National Commission. A decree by the Minister of the Environment would set up modalities for the granting of authorization (art.3). Any import, utilization, release and commercialization of GMOs is to be controlled by competent agencies of the Ministries of Finance, Agriculture, Trade, Environment and Health (art.4). Following international scientific standards, GMOs are classified into two different groups according to the level of risk they may pose to the conservation and sustainable use of biodiversity, environment and human health (art.6). Criteria for the classification are contained in Annex II to the Law. Public information requirements are reflected in art.7. A dossier containing all the information concerning the utilization of GMOs in public or private laboratories is to be made available to the public. The dossier is to contain, with the exception of information protected by trade and industrial secretsand by the present Law, general information on: (1) the activities of laboratories and the purposes of research; (2) GMOs to be used; (3) containment measures; (4) emergency plans in case of accidents which have to be approved by the biosafety national commission; (5) traceability of GMOs; (6) consumers’ information on the presence of GMOs in certain products; (7) a summary on the opinion of the Biosafety National Commission; and (8) the address of the Biosafety National Commission for any comment the public may wish to send (art.7).

The Biosafety National Commission is tasked with inter alia: (1) providing technical opinions on any application for import, contained use, deliberate release and commercialization of GMOs; (2) verifying and analysing documents prepared for risk assessment; (3) supervising the risk assessment for the release and commercialization of GMOs; (4) setting limits for the presence of GMOs food products, seeds and plants; (5) establishing and updating the list of GMOs to be regularly controlled; (6) preparing a list of experts in the field of GMOs; (7) setting up the conditions and modalities for transport of GMOs within the national territory; (8) controlling any GMO imported or locally produced; (9) giving advice on establishing national policy and (10) assisting the competent organizations in establishing regulations in the field of biotechnology and the competent institutions in implementing such regulations (art.9).

Research or industrial productions are to be contained through physical, chemical or biological barriers to avoid the spread of such organisms into the environment (art.13).

GMOs used for the first time for research and development purposes need to be authorized by the Minister of the Environment after risk analysis carried out by a specialized organization proposed by the Biosafety National Commission (art.14). A register referencing all activities carried out with GMOs is to be established by users. A report on such activities has to be transmitted annually to the Minister of Environment (art.18).

In case of accident users are to ensure that appropriate measures are taken. The Minister of the Environment is to be provided with all the information concerning the accident (art.19).

Authorization by the Minister of the Environment is needed prior to any deliberate release of GMOs for other than commercial purposes. Authorization is no longer needed if a risk assessment has been carried out by a competent body that is to be previously authorized by the Biosafety National Commission (art.20).

Any person has the right to have information on possible impact on the environment, biodiversity and human health caused by a deliberate release of GMOs. Notwithstanding this, access to information is subject to confidentiality provisions. Information considered confidential, whether protected by this law or patented, is not accessible (art.21).

Authorization by the Minister of the Environment is also needed prior to the commercialization of products containing GMOs. In this case, approval for such authorization is to be given by the competent authority for sanitary and environmental control of such products (art.23).

Chapter V focuses on crimes and sanctions. Experts responsible for controlling procedures are appointed by the Minister of the Agriculture, Trade, Environment, Public Health (art.28).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Draft Law Concerning the Import and Transfer of GMOs

Y




Y

Y

Y

Y

Y

Y




Selected Legal Annotations and Comments

The import of GMOs is covered by an existing law on external trade and by the provisions of the draft law concerning the import and transfer of GMOs (art.1).

Any import of GMOs requires prior authorization. Applicants, in order to be able to request authorizations, must hold a degree in agronomy, medicine, chemistry, biology, etc. A decree will set forth standards for import. All import provisions established by international agreements, prior informed consent and notification provisions apply (art.3, 4). Any product imported or transiting in the national territory is to be packed in a safe manner. Labels specifying the presence of GMOs are to be visible on the package. Informative notification facilitating control procedures is to accompany the package (art.5).

Before it can be authorized by the Ministry of Environment, an import must be first approved by the competent authority for sanitary and environmental control of the products (art.7).

Once physically present in the national territory and while waiting for final authorization, GMOs are to be kept in special places, separated by type and under the responsibility of custom officers (art.11). When authorization is refused, the importer is responsible for taking, within 15 days, all measures to destroy the GMOs (art.12).

Authorization is also needed prior to the transit of GMOs through the national territory. The applicant is to provide Information on the type of product (art.13). Any voluntary or involuntary accident resulting in the dissemination of GMOs into the environment is regulated by the Tunisian law. Both the author of the accident and the exporter are considered liable (arts.14-21).

NEAR EAST

Egypt

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Biosafety Regulation and Guidelines (1994)[3]

Y

Y




Y



Y

Y

Y



Selected Legal Annotations and Comments

The Ministry of Agriculture and Land Reclamation (MALR) through two decrees created the Egyptian Biosafety System. Ministerial Decree 85 (1995) establishes a National Biosafety Committee (NBC) and Ministerial Decree 136 (1995) adopted biosafety regulations and guidelines. It is unclear the extent to which the guidelines are legally binding. Procedures for commercialising GMO crops are established by Ministerial Decree 1648 (1998). It establishes the responsibilities of the Central Administration for Seeds (CAS) for the release of GM and conventional seeds; procedures for small scale release permits, registration and requirements for commercial release. Decree 242 (1997) applies to GM foods. Foodstuffs produced through GMOs may not be imported until safety is confirmed. A certificate should accompany any imported seeds from the country of origin confirming that the seeds were not produced from untested GM plants.

The Egyptian biosafety system has been expanded in stepwise fashion (as the need arises). This may explain the lack of clarity in the system described by commentators in secondary literature. It also appears that the primary focus of the system, at the moment, is on GM crops.

Institutionally, a number of organizations are involved in the system. New plant varieties are controlled, tested and registered by the Central Administration for Seed Testing and Certification (CASC). CASC is within the Ministry of Agriculture. Food safety and food import permitting is handled by the Supreme Committee for Food Safety within the Ministry of Health. The Ministry of Industry within the Organization undertakes standard setting for food and industrial products imported or locally produced for Standardization and Quality Control. The Ministry of Trade and Supply oversees the control of product imports and exports. The Ministry of Environment oversees the implementation of the Environmental Protection Law.

The Biosafety Guidelines have an aspirational tone. Words such as “would” and “should” are used throughout the document. Key principles are proposed. For example, regulatory review should focus on the characteristics and identified risks of the biotechnology products, not mainly on the process that created it. Also, the degree of familiarity with the behaviour of similar organisms when released into the environment should determine the level of regulation required depending on the hazard identified.

The guidelines propose creating a National Biosafety Committee (NBC) comprising policy makers and designers, governmental and academic scientific experts in agriculture, health, industry and environment, the private sector and non-technical members representing the interest of the surrounding community with respect to health and environmental protection (para. 1.2). The NBC is to inter alia: (1) establish policies and procedures to govern the use of modern biotechnology in Egypt (para. 1.1); (2) formulate national biosafety guidelines for contained and uncontained use for laboratory practices, greenhouse facilities, small scale field trails and commercial release (para. 1.3(a)); (3) review new initiatives to evaluate the benefits and potential risks of research with GMOs and periodically review containment measures if a licence is issued (para. 1.3(b)); and (4) provide technical advice to regulatory authorities and institutions (para. 1.3(d)).

The NBC is to request that all institutions conducting recombinant DNA research create Institutional Biosafety Committees (IBC) (para. 2.0). The IBC is to be responsible for ensuring that r-DNA research is carried in conformity with the NBC Guidelines (para. 2.1). Recommendations are made on the expertise that should be reflected in the IBC. An institutional biosafety officer is to be appointed. IBCs are to inter alia assemble a comprehensive set of research and containment oriented guidelines tailored to the institution’s research activities, establish a programme to inspect the physical containment facility and report annually to the NBC (para. 2.3).

The Biosafety Guidelines provide risk assessment recommendations. They suggest that any risk identified has to be balanced against the benefits in order to determine what is an “acceptable risk”. Other guidelines are provided for laboratory practices, greenhouses and small scale field-testing.

While the guidelines appear to indicate that the NBC has only an advisory role in decision-making, secondary literature reviewed in the absence of primary legislation indicates that the NBC actually issues permits. NBC is involved in research and field-testing, as well as commercial release of GM crop plants.

Field test approval does not require the applicant to submit a report at its conclusion. The purpose of the field trials is to evaluate variety performance. Monitoring takes place to ensure compliance with biosafety requirements and not to collect biosafety information. According to commentators it is rare for a field test to generate valid biosafety data unless a risk assessment component is built into the tests.

Applications for research or first release of GM crop plants are made to the NBC. A principal investigator, who is an NBC member, is tasked with reviewing the application. The NBC serves as lead agency and co-ordinates with secondary agencies for review; discusses the application; and decides whether or not to issue a permit. Risk management measures are determined prior to authorization. NBC members who are applicants don’t take part in the vote. Where genetically modified plant material is imported, an import permit must be obtained in advance from the Supreme Committee for Food Safety (SCFS) prior to importation.

Applications for commercialization are made to NBC. Applications for plant varieties produced within Egypt must provide various types of information including data from food and feed safety studies and evidence to support a determination of low or negligible environmental risk. Upon approval the NBC forwards the application to a “Seed Registration Committee” (it is unclear from the literature whether the committee is within the CASC or is one of the three NBC subcommittees) for its approval to conduct field trials. The SRC assigns a team to supervise cultivation, ensure compliance with biosafety requirements, confirm new phenotypes and evaluate agronomic performance. With successful field trails and the submission of a report, NBC authorizes the applicant to apply to the SRC for final approval to commercially release the variety. For imported plant materials, the applicant must first obtain an import license from the SCFS.

NORTH AMERICA

Canada

In Canada, the regulatory approval process for biotechnology products is based around at least ten different pieces of legislation (MacKenzie, 2000). Distinctions are not made between organisms and products made from recombinant DNA techniques and more traditional techniques such as plant breeding. Instead, the regulatory trigger is whether a new organism or product has a novel trait or characteristic that sets it apart from other similar, but non-modified organisms or products, regardless of the process used. This is most apparent for plants.

Plants with novel traits (PNTs) are varieties or genotypes regulated because they or their characteristics are not considered to be “familiar” or “substantially equivalent” to those in a distinct, stable population of cultivated species of seed in Canada and have been intentionally selected, created or introduced through a genetic change (CFIA, 1994). “Familiarity” is “the knowledge of the characteristics of a plant species and experience with the use of that plant species in Canada” (CFIA, 1994). “Substantial equivalence” is the equivalence of a novel trait within a particular plant species, as it relates to the novel plant’s use and safety for humans, the environment, compared to plants of the same species that are used and generally considered safe in Canada (CFIA, 1994).

An environmental safety assessment for PNTs generally takes into consideration (1) weediness potential, (2) gene flow, (3) plant pest potential, (4) impact on non-target organisms and (5) impacts on biodiversity. Safety assessments are undertaken on a “case by case basis” as a part of a “continuum of research, development, evaluation and commercialization” (CFIA, 1994). In general, each new application needs an assessment. Safety assessments are undertaken by the applicant and reviewed by the government regulator prior to authorization (MacKenzie, 2000). Any subsequent authorization must take into consideration potential risks and an applicant as specified in the authorization must take risk management measures. Information from previous authorizations can be used to satisfy subsequent regulatory requirements for additional authorizations. The extent to which provincial regulatory requirements differ from those at the federal level is unclear, however a single window approach and harmonization is sought (CFIA, 1994).

At the federal level, the Canadian Food Inspection Agency (CFIA) has the primary responsibility for regulating PNTs. Within CFIA, the Plant Biosafety Office takes the lead responsibility. Co-ordination with other internal offices takes place depending on the future use of the product or organism regulated. In addition, Health Canada has the primary responsibility for assessing novel human foods prior to marketing.

Food labelling responsibilities are split between CFIA and Health Canada. CFIA handles general food labelling policies and regulations not related to health and safety such as misrepresentation and fraud along with basic food labelling requirements (CBAC, 2001). Health Canada’s responsibilities relate to health and safety issues related to for example allergenicity.

Environment Canada regulates organisms that are not PNTs and uses not otherwise regulated pursuant to the Canadian Environmental Protection Act and the New Substances Notification Regulations (1999) (CBAC, 2001). All new substances, including products from biotechnology, are notified to Environment Canada and assessed for their potential to adversely effect the environment and human health. This is to take place prior to import or manufacture. Environment Canada assesses the environmental risk of new organisms derived from biotechnology. Until the Department of Fisheries and Oceans adopts new regulations, transgenic, aquatic organisms will be regulated under CEPA (CBAC, 2001).

What follows are brief descriptions of some of the applicable legislation and regulations with regard to PNTs.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Plant Protection Act (1990) and Regulations (1995)

Y








Y

Y




Selected Legal Annotations and Comments

The CFIA’s Plant Health and Production Division issues permits to import PNTs and derived products pursuant to section 43 of the Plant Protection Regulations (CFIA, 1998). PNTs or products derived from them that have been subject to plant risk assessment (PRA), and that do not pose a plant pest risk, do not require an import permit (CFIA, 1998). Conversely, PNTs that do present a plant pest risk require a permit to import. Importers that are unclear about the status of a PNT are to submit an application to the Division (CFIA, 1998). The application’s contents are kept confidential (CFIA, 1998). A permit shall be issued when the Division determines that the thing is imported for purposes of scientific research, educational, processing, industrial or exhibition purposes (sect.43(1)(a)). The person must be able and willing to comply with permit conditions and “will take every precaution to prevent the spread of any pest or biological obstacle to the control of the pest” (sect.43(1)(b)). Apparently, where these criteria cannot be met the permit is not to be issued. Packaging, transport, handling and control are to ensure that the pest is not introduced into Canada (sect.43(2)).

It appears that a PRA is conducted by the CFIA. PRAs determine whether the organism is a pest, could be infested or constitutes or could constitute a biological obstacle to control the pest (sect.2). They also provide the basis for recommended actions to prevent introduction or control a pest; whether the thing assessed could have a significant adverse effect on the environment; and how to minimize degradation to Canadian flora (sect.2).

There does not appear to be any public participation process established by either instrument.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Seed Act (1985) and Regulations (1996)

Y





Y



Y

Y




Selected Legal Annotations and Comments

The Seed Act and regulations (Part V) provide CFIA with the authority to regulate the release of seeds with novel traits (NT seed) into the environment, either for confined field trials or unconfined field trials. The CFIA Plant Biosafety Office administers the regulatory process. Two regulatory directives supplement the Act and regulations: 2000-07 (confined field trials) and 94-08 (unconfined field trials).

According to the Seed Act, unless otherwise provided, no person shall sell, import or export any seed unless the seed conforms to prescribed standards and is marked and packed and the package is labelled (sect.3(a)) and sell or import seed that is not registered properly (sect.3(b)). A novel trait of a seed has two aspects. First, it is a characteristic that “has been intentionally selected, created or introduced into a distinct, stable population of cultivated seed of the same species through a specific genetic change” (reg. sect.107(1)). Second, “based on a valid scientific rationale, it is not substantially equivalent, in terms of its specific use and safety...for the environment and for human health, to any characteristic of a distinct, stable population of cultivated seed of the same species in Canada. This is determined based on weediness potential, gene flow, plant pest potential, impact on non-target organisms and impacts on biodiversity (reg. sect.107(1)). Essentially, seed that is substantially equivalent is exempt from regulation (reg. sect.108(c)).

A notification to CFIA and an authorization is needed prior to any confined or unconfined release. (reg. sect.109(1)(a and b)), though this is not necessary for registered seeds (reg. sect.109(2)). Information to accompany the notification includes that on the novel trait and information and test data relevant to identifying the risk to the environment, including risk to human health (reg. sect.110(1)(d and e)). Additional information requirements depend on the whether the release is confined or unconfined. For example, for confined releases, information on the confinement measures to mitigate establishment and spread (reg. sect.110(2)(b)(i)) and for unconfined releases data describing the potential interaction of the seed or derived plants with other life forms, and an evaluation of the potential risk of harm posed to the environment, including the risk to human health (reg. sect.110(3)). Where seed is intended for future commercialization, the applicant for confined release is encouraged to undertake experiments designed to meet additional regulatory requirements for confined releases under the Directive 94-08. Information has been generated by CFIA on the biology of several agriculture plant species is available to the applicant for comparison purposes for use in the determination of substantial equivalence.

The Minister evaluates the notification information, including the potential impact and risk to the environment (including human health) and either authorizes the release (subject to conditions) or denies it (reg. sect.111). Criteria are provided to guide the Minister’s evaluation of the risks to the environment (reg. sect.111(2)). For example, he is to consider the effects of the release on the environment and the magnitude of the environment’s exposure to the seed and the seed’s toxicity (reg. sect.111(2)). When a person becomes aware of any new information regarding environmental/ human health risks any time after the notification, the information is to be provided to the Minister (reg. sect.112(1)). The information can be used by the Minister to re-evaluate the potential impact on and risk to the environment to subsequently change the conditions of the authorization (reg. sect.112(2)).

No provisions for public participation are apparent. Confidential information is to be indicated by the applicant. The Plant Biosafety Office sends non-confidential information about each new field trial to designated provincial government contacts. Non-confidential information (decision documents) is also sent to the OECD and posted on the Plant Biosafety Offices WWW site.

Where the NT seeds are intended for use in livestock feed or have pesticidal properties additional approvals may be required from CFIA’s Feeds Section or from Health Canada’s Pest Management Regulatory Agency. In addition, prior to commercialization, the PNT may need to be evaluated as a novel food by Health Canada. Finally, the NT needs to fulfil the criteria for registration under the Seeds Act and Seeds Regulations (Part III). No variety may be registered if the variety or its progeny may be detrimental to human or animal health and safety or the environment when grown and used as intended (sect.72(e)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Feeds Act and Regulations (1983)

Y

Y




Y



Y

Y




Selected Legal Annotations and Comments

The Feed Regulations in part address the release of novel livestock feeds into environment. The implementation of the regulations is overseen by the CFIA, Feeds Section. The regulations are supplemented by a regulatory directive on the assessment of livestock feed from plants with novel traits. In short, where a PNT may be fed to livestock its safety and efficacy of the product as a novel feed. Novel feed means a feed made of an organism or organisms, or parts or products thereof that, inter alia, has a novel trait. There are two descriptors of “novel trait”. First, the feed characteristic must have been intentionally selected, created or introduced into the feed through a specific genetic change (sect.2). Second, the feed characteristic, based on a valid scientific rationale, is not substantially equivalent in terms of its specific use and safety both to the environment, human and animal health, to any characteristic of a similar feed (sect.2). A novel livestock feed cannot be released without (1) notification, (2) a written undertaking by the developer taking responsibility for and assuming the costs of safe disposal and (3) and subsequent authorization (sect.4.1(1)(a)-(c)). Application information for a novel feed is to include inter alia identification and characterization of the novel feed and all information and test data on the novel feed relevant to identifying environmental risks (sect.4.2(1)(d) and (f)). The Minister makes a decision to authorize the release in particular after evaluating the potential impact on and risk to the environment, including potential impacts to human and animal health (sect.4.3(1)). To guide decision-making, the same criteria for evaluating the risk to the environment from PNTs are used for novel livestock feeds (sect.4.3(2)). Likewise as with PNTs requirements are placed on the notifier to provide new information to the Minister when it arises (sect.4.4).

All feeds are to be registered (sect.5). Some of the registration requirements include providing the CFIA with satisfactory evidence to permit an assessment or evaluation of the safety and efficacy of the feed in respect of livestock and its potential effect on humans and on the environment (sect.8(1)).

Labelling requirements for all feeds are specified (sect.26), however there does not appear to be a specific requirement for novel feeds.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Food and Drugs Act (1985) and Regulations

Y

Y

Y


Y

Y



Y

Y




Selected Legal Annotations and Comments

Division 28 of the Food and Drugs Act apply to sale and advertisement of novel foods in Canada. The Canadian Food Inspection Agency will likely review the environmental and human health safety of confined and unconfined releases into the environment of, for example, a PNT to be used as a food pursuant to the Seeds Act. Health Canada oversees the assessment of novel food pursuant to the Food and Drug Act and Regulations.

A novel food is “(a) a substance, including a micro-organism, that does not have a history of safe use as a food”; (b) a food “manufactured, prepared, preserved or packaged by a process that (i) has not been previously applied to that food, and (ii) causes the food to undergo a major change”; and (c) “a food derived from a plant, animal or micro-organism that has been genetically modified such that” (i) the organism exhibits characteristics that have not previously been observed in that organism; (ii) the organism no longer exhibits characteristics that have been previously observed in that organism; or (iii) one or more characteristics of the organism no longer fall within the anticipated range for that organism (sect.B.28.001). In general, no novel food can be sold or advertised in Canada without (i) notifying Health Canada and (ii) receiving authorization (sect.B.28.002(1)). Notifications are to include inter alia a description of the novel food, details of the major change in the food, information relied on to establish the novel food’s safety and the text of all labels (sect.B.28.002(2)(c and e)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

National Standard for Voluntary Claims About Foods That Are and Are Not Products of Gene Technology (July 2001 draft).














Selected Legal Annotations and Comments

The Food and Drug Act sets out the general requirements for food labelling. No person can label, package, treat, process, sell or advertise any food in a false, misleading, or deceptive manner or that is likely to create an erroneous impression regarding the food’s character, value, quantity, composition, merit or safety (sect.4). According to the CFIA Guide to Food Labelling and Advertising (CFIA, 1996), since 1993, there have been three major consultations on foods derived from genetic modification. Guidelines have been developed. Mandatory labelling is required if there is a health or safety change or a signification change in nutrition or composition. In addition, any labelling must be understandable, truthful and not misleading. Finally, voluntary positive labelling (“does contain products from biotechnology”) and negative labelling (“does not contain products from biotechnology”) is permitted provided it is truthful and not misleading (CFIA, 1996). There are no federal obligations to indicate that a food is a product of gene technology (Canadian General Standards Board, 2001). Because of the lack of federal regulations on this specific aspect of food labelling, an initiative is under way to create a voluntary national standard for labelling of foods derived from biotechnology. The Canadian General Standards Board oversees the standards development process. The process is open to the public and transparent (CFIA, a).

A first draft standard has been circulated in 2001 for public comment. The standard would apply to voluntary labelling and advertising of food in order to distinguish whether or not the food is a product of gene technology or contains or does not contain ingredients that are products of gene technology (sect.1.1). It would not apply to the labelling of foods produced using processing aids, veterinary biologics or livestock feeds that are products of gene technology (sect.1.2). Distinctions are made between claims for single ingredient and multi-ingredient food (sect.4). In general, it is proposed that claims that a single ingredient food is a product of gene technology can only be made for that food when it is obtained from sources of which more than 5 percent are products of gene technology (sect.5.2). Similarly, a 5 percent threshold is proposes for multi-ingredient foods claimed to be produced from gene technology (sect.5.3). Conversely, a threshold of less than 5 percent is proposed for single and multi-ingredient foods claimed not to be a product of gene technology (sect.6). Verification provisions are established. No claim is permitted if it cannot be verified (sect.7.1). The person making the claim is responsible for providing the data necessary to verify the claim (sect.7.2.2). Provisions on confidential information are proposed. The claimant must have in place a verification system (sect.7.3). In addition, the claimant must have a plan that includes a detailed description of sources of food/ingredients and a description of the management system used to maintain integrity of the food/ingredient (sect.7.3.2). The standard is equivocal on testing and detection methods (sect.7.4).


[3] With the exception of the Guidelines, only secondary source material was available. The information and annotations provided are taken directly from Madkour M., El Nawawy A. and Traynor P. 2000. Analysis of a National Biosafety System: Regulatory Policies and Procedures in Egypt. International Service for National Agricultural Research, The Hague.

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