Regulation of Biotechnology in the Americas Drew L. Kershen Earl Sneed Centennial Professor Univ. of...
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Transcript of Regulation of Biotechnology in the Americas Drew L. Kershen Earl Sneed Centennial Professor Univ. of...
Regulation of Biotechnologyin the Americas
Drew L. KershenEarl Sneed Centennial Professor
Univ. of Oklahoma, College of LawCopyright 2007, all rights reserved
In the Beginning (1987):US National Academy of Science
• Point 1: There is no evidence that unique hazards exist either in the use of rDNA techniques or in the movement of genes between unrelated organisms.
• Point 2: The risks associated with the introduction of rDNA-engineered organisms are the same in kind as those associated with the introduction of unmodified organisms and organisms modified by other methods.
• Point 3: Assessment of the risks of introducing rDNA-engineered organisms into the environment should be based on the nature of the organism and the environment into which it is introduced, not on the method by which it is produced.
In the Beginning (1992):Agenda 21 of Rio de Janiero
• Ch. 16 – Environmentally Sound Management of Biotechnology– “16.1. … By itself, biotechnology cannot resolve all
the fundamental problems of environment and development, so expectations need to be tempered by realism. Nevertheless, it promises to make a significant contribution in enabling the development of, for example, better health care, enhanced food security through sustainable agricultural practices, improved supplies of potable water, more efficient industrial development processes for transforming raw materials, support for sustainable methods of afforestation and reforestation, and detoxification of hazardous wastes. …”
United States of America:Coordinated Framework for Regulation of
Biotechnology (1986)• “Biotechnology also includes recently developed and
newly emerging genetic manipulation technologies … While the recently developed methods are an extension of traditional manipulations that can produce similar or identical products, they enable more precise genetic modifications and therefore hold the promise for exciting innovation and new areas of commercial opportunity.”
• “Upon examination of the existing laws available for the regulation of products developed by traditional genetic manipulation techniques, the working group concluded that, for the most part, these laws as currently implemented would address regulatory needs adequately.”
United States of America:Regulatory Structure
• United States Department of Agriculture– Evaluation: is the plant is safe to grow?– Plant Protection Act – regulated article (1986)
• Field test permits and notification• Interstate movement permits• Petitions for Non-regulated status
– National Environmental Policy Act• Three recent federal district court decisions
– www.aphis.usda.gov/biotechnology
United States of America:Regulatory Structure
• Environmental Protection Agency (EPA)– Evaluation: Is the plant safe for the environment?– Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA)• Plant-incorporated Protectants (PIPs) from modern
biotechnology
– Federal Food, Drug & Cosmetic Act (FFDCA)• Residues of PIPs in raw agricultural products
– Plant-Pesticides Subject to FIFRA and FFDCA, 59 Fed. Reg. 60,496 (Nov. 23, 1994) – statement of policy never formally adopted but applied in fact
United States of America:Regulatory Structure
• Food and Drug Administration (FDA)– Evaluation: Is the food/feed safe to eat?– Federal Food, Drug & Cosmetic Act (FFDCA)
• Substantial equivalence for safety (1992)• Voluntary consultation – proposed mandatory
consultation (2001), not adopted – all companies do consult on every transgenic food/feed
• Voluntary labeling – no “material” differences; if so, label for nutrition and safety (1992)
– www.cfsan.fda.gov
El marco coordinado regulatorio
USDA Todo producto agropecuario
FDA
Todo producto que se usa de alimento
EPA
Todo producto al cual se le haya incorporado una resistencia
USDAEstatus
No-regulado
EPA•Registro•Tolerancias•Exenciones
FDA• Completa la
consulta• Archiva los
resultados
Aplicante entrega datos las agencias
Decisión publicada en Reg. Fed. &
sitio web
Decisión publicada en Reg. Fed. &
sitio web
Publicada en sitio web
Mercado
United States of America:Regulatory Structure Evaluation
• Modern biotechnology is the trigger for scrutiny• “The CAST panel [of five members of the NAS] agrees
with the position of the eleven professional scientific societies, as well as several governmental panels: regulating the inherited traits of plans for pest resistance because these traits were introduced by genetic engineering and not through conventional breeding is scientifically invalid.”
• NRC (NAS) (2000): “There is currently no formal environmental regulation of most conventionally improved crops, so it is clear that the standards being set for transgenic crops are much higher than for their conventional counterpoints.”
Canada:Federal Regulatory Framework
for Biotechnology (1993)
• Principles adopted by agreement between regulatory agencies include (among others)– Use existing law and regulatory departments– Follow sound, scientific knowledge base for
risk assessment– Foster a favorable climate for investment,
development, innovation and adoption– Establish clear guidelines in harmony with
national priorities and international standards
Canada:A Unique Regulatory Structure
• Plant with Novel Traits (PNT)– “means a characteristic of the seed that
• (a) has been intentionally selected, created or introduced into a distinct, stable population of cultivated seed of the same species through a specific genetic change, and
• (b) based on valid scientific rationale, is not substantially equivalent, in terms of its specific use and safety both for the environment and for human health, to any characteristic of a distinct, stable population of cultivated seed of the same species in Canada, having regard to weediness potential, gene flow, plant pest potential, impact on non-target organisms and impact on biodiversity”
– Plant with novel traits, Seed Regulations under the Seeds Act
Canada:A Unique Regulatory Structure
• Novel Food means (among others)– “a food that is derived from a plant, animal, or
microorganism (p,a,m) that has been genetically modified such that:
• (i) the p,a,m. exhibits characteristics that were previously not observed in the p,a,m;
• (ii) the p,a,m no longer exhibits characteristics that were previously observed in that p,a,m; or
• (iii) one or more characteristics of the p,a,m no longer fall within the anticipated range for that p,a,m.
– Novel Food Regulations under the Food & Drug Act
Canada:Regulatory Structure
• Canadian Food Inspection Agency (CFIA)– PNT evaluation: is the plant safe to grow? Is the
plant safe for the environment? Is the feed safe to eat by animals?
– Seeds Act• Voluntary guidelines for laboratory work (1977)• Confined field trial permits – Directive 2000-07 (2000)• Environmental safety assessment – Dir. 94-08 (1994)
– Feeds Act• Assessment of Livestock Feeds from PNTs – Dir. 95-03
(1995)– Seeds Act
• Registration as a variety for commercial sale – only if the above requirements have been satisfied
Canada:Regulatory Structure
• Health Canada (HC)– Novel food evaluation: is the food safe for humans?– Food and Drug Act
• Notification to HC to gain approval – data and consultation• Notification for “major change”, i.e. the modified food is
outside the accepted limits of natural variations for composition, structure, nutritional quality, physiological effects, metabolization, or other safe use of the food
• HC can approve in 45 days or request additional information; upon receipt of additional information, HC has 90 days to take a decision.
• Labeling only for health and safety, not for novelty per se– Seeds Act:
• Registration as a variety for commercial sale – only if the above requirement has been satisfied
Canada:Regulatory Structure Evaluation
• Novelty is the trigger for scrutiny– Modern biotechnology is novel at the trait introduction stage of
plant breeding – all transgenic crops– Accelerated Mutagenesis is novel at the trait modification stage
for seed registration• Herbicide-tolerate imidazolinone (BASF Clearfield crops)
– Conventional Breeding is novel at the incremental increase stage for seed registration
• Low-phytate barley for better utilization of phosphorus
• Canadian and U.S. regulatory systems for transgenic crops are quite similar– Canadian regulatory system applies more often to crops and
foods developed through other breeding techniques
Brazil:Regulatory Structure
• Presidential Decree No. 5,591 of Nov. 22, 2005, implementing Law No. 11.105 of 24 March 2005– GMOs and derivatives (products thereof)– Broad scope: construction, cultivation,
production, manipulation, transport, transfer, import, export, storage, research, marketing, consumption, disposal and discarding
– Principle of precaution to secure environmental protection
Brazil:Regulatory Structure
• National Biosafety Technical Commission (CTNBio)– Evaluation – all aspects related to GMOs and
derivatives (GMOs & D)– Special law and system for GMOs &D– 27 members
• 12 technical and scientific specialists from human health, animal, plant, and environmental sciences
• 9 ministerial representatives • 6 civil society representatives for consumer rights, health,
environment, biotechnology, family farms, and occupational health that specified Ministries appoint
– Renders technical decisions granting or denying approval
Brazil:Regulatory Structure
• National Biosafety Council (CNBS)– Higher Advisory Body to President on policy
• Ministers of eleven different ministries
– When requested by CTNBio, takes decision related to socioeconomic matters and national interest relating to GMOs & D
– Power to avocate to itself analysis and decision on commercial use of GMOs & D
– Decision on appeals by agencies and entities of CTNBio decisions
Brazil:Regulatory Structure
• Registration and Monitoring Agencies– Ministries of Agriculture, Health, Environment, and
Aquaculture & Fisheries– Receive decisions from CTNBio and CNBS approving
GMOs & D for registration and licensure– Monitor the registration and licensure– Enforce administrative sanctions for administrative
infringements• Civil and Administrative Liability for “damages to
the environment and third parties … jointly for indemnification or full redress, independently of guilt.”
Brazil:Regulatory Structure Evaluation
• Biosafety Regulatory Structure that is very similar to the UNEP-GEF model– Special laws; GMOs and D trigger the laws– Precautionary principle – Broader in scope that the Cartagena Protocol– Technical science decision but with significant overlay of public
participation and political decisions
• Labeling Laws – Decree No. 4680 of 24 Apr 2003 as implemented by Ordinance No. 2,658 of 22 Dec 2003 – above 0.9% transgenic
• Judicial Interventions – e.g. suspension of June transgenic corn authorization; immediately overruled by a higher court
Regulatory Structures:Conclusion
• After 20 years+ research experience and 10 years+ commercial experience – The beginning evaluations were correct– Today even more reason to adopt the beginning evaluations
• Regulatory developments: consequences– Cost with special impact on public research– Time, effort, and delay – misuse of resources– Unscientific in policy and societal education
• Transgenic crops are being approved– Canada and United States promote, but slowly– Brazil permits, but excessive precaution– No regulatory system promotes scientifically and appropriately
for the benefit of society, particularly the poor resource farmer
References:In the Beginning
• US National Academy of Science, Introduction of Recombinant DNA-Engineered Organisms into the Environment: Key Issues (1987)
• Report of the United Nations Conference on Environment and Development, A/Conf.151/26 (Vol. II) 13 August 1992
References:United States of America
• Coordinated Framework for Regulation of Biotechnology, 51 Fed. Reg. 23,302 (June 26, 1986)
• Council for Agricultural Science & Technology (CAST), Issue Paper No. 10, The Proposed EPA Plant Pesticide Rule (Oct. 1998)
• Nat’l Research Council, Genetically Modified Pest-Protected Plants: Science and Regulation (2000)
• U.S. regulatory agencies unified biotechnology website: www.usbiotechreg.nbii.gov
References:Canada
• Agbios website– Clear, short discussion of the Canadian Regulatory System– Documents include many Canadian regulations for PNTs and
Novel Foods– www.agbios.com/main.php
• On the left column. Click on “The Regulation of Agricultural Biotechnology Products”
• http://www.inspection.gc.ca/english/plaveg/bio/pntchae.shtml -- Canadian Food Inspection Agency (CFIA)
• http://www.hc-sc.gc.ca/sr-sr/biotech/food-aliment/index_e.html -- Health Canada (HC)
References:Brazil
• CTNBio website:– Has the relevant laws, decrees, regulations,
and ordinances– Has other information about the activities of
CTNBio– http://www.ctnbio.gov.br
País miembro donde el producto se venderá primero
Comisión Europea
Otros países miembros
Nadie se opone
Mercado
Nadie se opone
La Unión Europea
http://gmoinfo.jrc.it