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

Canada:Regulatory Structure

• Novel, traditional • Novel, transgenic

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

Annex: European Union Flowcharts

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

Otros países miembros

País donde el producto se venderá primero

COMISIÓN EUROPEA

oposiciónPanel científico

Comité Regulatorio

favorable

Mercado

No favorable

Consejo de MinistrosAdoptan 2/3

partes, o no toman, decisión dentro de 3 meses

http://gmoinfo.jrc.it