Governmental and International Control of Genetic
Engineering
(including patents, genetic testing, cloning and embryo manipulation)
Warning: The information on this page could be very out of date.
Ifgene's glossary and key to abbreviations
Contents
OECD's list of links to national biotechnology web sites:
http://www.oecd.org/document/17/0,2340,en_2649_34385_1890001_1_1_1_1,00.html
Ethical norms or codes and safety guidelines embodied in international declarations, protocols or conventions are not necessarily recognised by all countries.
Genetically Modified Organisms (GMOs)
Under the Convention on Biological Diversity, a global treaty was adopted on genetically modified organisms at Montreal on 29 January 2000. After five years of talks, ministers and senior officials from over 130 governments finalized a legally binding agreement for protecting the environment from risks posed by the transboundary transport of living modified organisms (LMOs [also called GMOs]) created by modern biotechnology. Under the 'Cartagena Protocol on Biosafety', governments will signal whether or not they are willing to accept imports of agricultural commodities that include LMOs by communicating their decision to the world community via an Internet-based Biosafety Clearing House. In addition, shipments of these commodities that may contain LMOs are to be clearly labeled. The Convention on Biological Diversity's secretariat's web site is at http://www.cbd.int/default.shtml .
The United Nations Environment Programme (UNEP) is developing International Technical Guidelines on Safety in Biotechnology. Following a global consultation at Cairo in 1995, UNEP adopted a consolidated text on risk assessment and risk management of GMOs. United Nations Environment Programme International Register on Biosafety web site offers information from many sources on biosafety. It focuses on information useful in establishing a regulatory framework for the safe development, transfer, and application of biotechnology. It also provides links to other Web sites concerning biosafety, biotechnology, and biodiversity. http://www.chem.unep.ch/biodiv/default.html
Organization for Economic Cooperation and Development (OECD) Biotrack Online BioTrack Online is part of OECD's Programme on the Harmonization of Regulatory Oversight in Biotechnology. The main aim of this Programme is to produce documents for use by national authorities for the regulatory assessment of GMOs or release to the environment. The focus is on GM plants and microorganisms. Home of BIOTRACK, a database of environmental releases from OECD member countries. http://www.oecd.org/topic/0,2686,en_2649_34385_1_1_1_1_37437,00.html
Biosafety Information Network and Advisory Service: BINAS is a service of the United Nations Industrial Development Organization (UNIDO). BINAS monitors global developments in regulatory issues in biotechnology. BINAS tracks regulatory developments from many countries, including the full text of regulations and guidelines http://binas.unido.org/wiki/index.php/Main_Page (The BINAS site was under reconstruction on 18 April 2006). See also the OECD document on Safety Considerations for Recombinant DNA (1986) and Biotechnology (1992) at http://www.oecd.org/dataoecd/8/3/2375496.pdf
Foods
Concepts and principles underpinning Safety Evaluation of Foods Derived by Modern Biotechnology. OECD Group of National Experts on Safety in Biotechnology, OECD, Paris 1993. This key document which contains the highly controversial concept of 'substantial equivalence' is downloadable in Adobe Acrobat PDF format at http://www.oecd.org/dataoecd/57/3/1946129.pdf .
The Food and Agriculture Organisation & World Health Organisation Codex Alimentarius is a United Nations agency which sets international food safety standards. http://www.codexalimentarius.net/index_en.stm
Human Applications
United Nations Education Science and Culture Organisation's (UNESCO) Universal Declaration on the Human Genome and Human Rights was drafted by the International Bioethics Committee and adopted by 186 member states on 11 November 1997. It covers things such as genetic discrimination; genetic reductionism; informed consent; confidentiality; non-peaceful use of genomic data; equitable access to treatment and it encourages research into 'genetically-based and genetically-influenced diseases'. The only biological procedure it expressly does not permit is reproductive cloning. The Universal Declaration on the Human Genome and Human Rights can be found at: http://unesdoc.unesco.org/images/0010/001096/109687eb.pdf .
N.B. The Declaration is not binding. Its principles therefore cannot take shape unless the States assume their role. It is for them to specify the means to be used to reach the goals set out by the document, by drafting legislation, setting up ethics committees and establishing programmes of education in bioethics.
Legal Instruments
Legal instruments addressing GMOs http://www.fao.org/biotech/detail_event.asp?event_id=15569
As part of its FAO Legislative Study series, the FAO Legal Office has published "Law and modern biotechnology: Selected issues of relevance to food and agriculture" by L. Glowka and A. Ingrassia. This 172-page study reviews international, regional and a selection of national laws related to GMOs. Three categories of legal instruments are considered: those dealing with biosafety, food safety and consumer protection. The study includes issues such as public participation in the policy-making and regulatory decision-making process; oversight mechanisms to examine the merits of GMOs in the areas of biosafety, food safety or consumer protection and provides some general conclusions on major gaps and trends of existing biotechnology-related legislation. See http://www.fao.org/DOCREP/006/Y4839E/y4839e00.htm or contact DevLaw@fao.org to request a copy
Coordinated Framework for Regulation of Biotechnology
website at http://usbiotechreg.nbii.gov
Agricultural, Environmental and Food Applications of Genetic Engineering
United States Regulatory Oversight in Biotechnology Presents an overview of the activities of agencies primarily responsible for regulating biotechnology in the United States: the US Department of Agriculture (USDA), Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). Before commercialization, genetically engineered plants/organisms must conform with standards set by State and Federal marketing statutes such as State seed certification laws, the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), and the Federal Plant Pest Act. This is the most comprehensive gateway into this aspect of USA regulatory agencies on the web is at http://www.aphis.usda.gov/brs/.
Permitting, Notification, and Deregulation, Biotechnology Permits Branch, USDA Animal and Plant Health Inspection Service. This page contains detailed information on how the USDA Animal and Plant Health Inspection Service (APHIS) regulates the movement, importation, and field testing of genetically engineered plants and microorganisms through permitting and notification procedures. Other Plant Pest and Quarantine Division (PPQ) websites contain information on permits for other types of regulated articles such as transgenic arthropods as well as non-transgenic articles such as plant pests, plants and plant products. APHIS Veterinary Services regulates the import and export of animals and animal products. http://www.aphis.usda.gov/vs/import_export.htm
Access the USDA Home Page on the World Wide Web at http://www.usda.gov , or more specifically its biotechnology section at http://www.usda.gov/wps/portal/!ut/p/_s.7_0_A/7_0_1OB?navid=BIOTECH&parentnav=AGRICULTURE&navtype=RT
US Department of Agriculture Biotechnology Information Resource of the National Agricultural Library. (good search engine here, e.g. search 'biotechnology').
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition Proposed, pending and final rules and policies regarding food biotechnology.. http://www.foodsafety.gov/ not particularly helpful, but leads to the more relevant link http://vm.cfsan.fda.gov/~lrd/biotechm.html . The draft guidance on voluntary labeling of food from GMOs is available at: http://www.cfsan.fda.gov/~dms/guidance.html , under "Food Labeling".
Toxic Substances Control Act (TSCA) Biotechnology Program This site was created to allow more efficient public, governmental and educational access to the TSCA Biotechnology Program. At this site you will find the regulation under which the Program functions, and the supplementary documents created to support this regulation, as well as status reports on the submissions, reviews, and agreements undertaken by the Program. For those seeking different, or more specific information, we list links to other governmental biotechnology sites, both foreign and domestic, and provide information on the Program representative in each EPA Region. On each page, we have also included an email link to a Program representative at EPA Headquarters in Washington DC. http://www.epa.gov/opptintr/biotech . See also www.epa.gov/pesticides/biopesticides .
European Union: GMOs in General
GMOs are regulated according to whether their use is contained, for instance in laboratory facilities, or released into the environment. The corresponding 'parent' directives are 90/219/EEC (revised in 1998 as 98/81/EC and 90/220/EEC (currently undergoing revision, 12.2000) respectively plus any amendments made since they came into force (e.g. 94/730/EC for simplified procedures relating to release of GM plants). European Community legislation in force is published in the Eur-Lex Official Journal of the European Communities which is available on the Internet in various languages. The English version is at http://europa.eu.int/eur-lex/lex/en/index.htm . Other languages can be reached from that page which includes an indispensable search facility.
European Union: GMOs in Food
The use of GMOs in food is dealt with under the regulation for Novel Foods and Food Ingredients (258/97/EC). This Regulation, which came into force on 15 May 1997, established an EU wide system, which requires that a novel food is assessed for safety before it can be released onto the market. A novel food is a food, which has not been consumed by humans to any wide extent in the EU before. This includes any food containing, or produced from, a GMO.
In September 1998 provision was made for the labeling of foods made from GM soya and maize (1139/98/EC) and subsequently a de minimis threshold for a maximum of 1% adventitious contamination was added as an amendment (49/00/EC). The use of food additives and flavourings containing GMO protein or DNA is regulated by 50/00/EC. 1804/99/EC, amending the organic regulation 2092/91/EC, prohibits the use of GMOs or their derivatives in organic foods. For the text of legislation search the Eur-Lex Official Journal of the European Communities at http://eur-lex.europa.eu/JOIndex.do?ihmlang=en .
European Network on Genetically Modified (GM) Food Crops: "ENTRANSFOOD". An European Network on genetically modified (GM) food crops has been installed which will deal with the problems related to food safety and market introduction of GM-food crops. This Thematic Network project "ENTRANSFOOD" is financed by the European Commission within the 5th frame work programme and is co-ordinated by the State Institute for Quality Control of Agricultural Products (RIKILT), the Netherlands. http://www.entransfood.com
See also European Food Safety Authority: www.efsa.eu.int and http://www.gmo-safety.eu
Human Aspects
'The Council of Europe Convention for the Protection of Human Rights and the Dignity of the Human Being with Regard to the Application of Biology and Medicine' specifically rules out human cloning; human genetic modification which is not for preventive, diagnostic or therapeutic purposes; germ-line genetic modification (i.e. which passes on to descendents). The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except where serious hereditary sex-related disease is to be avoided. For more detail see the text of the Convention: http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm (When this link is not working try http://www.oup.co.uk/pdf/bt/cassese/cases/part3/ch16/1121.pdf )
Additional protocol on the Convention for the Protection of Human Rights and the Dignity of the Human Being with Regard to the Application of Biology and Medicine, ON THE PROHIBITION OF CLONING HUMAN BEINGS. (Signed Paris, January 1998, Treaty number 168) http://conventions.coe.int/Treaty/en/Treaties/Html/168.htm (When this link is not working try http://staminali.aduc.it/php_docushow_84_4_t_l.html ).
European Group on Ethics in Science and New Technologies (EGE) which advises the European Commission has published a report titled Ethical Aspects of Human Stem Cell Research and Use available at http://ec.europa.eu/european_group_ethics/docs/avis15_en.pdf . European Group on Ethics site: http://ec.europa.eu/european_group_ethics/index_en.htm
Umweltbundesamt: http://www.ubavie.gv.at/
Bundesministerium für Gesundheit: http://www.bmg.bund.de/
Bundesumweltministerium: http://www.bmu.de/
Bundeszentrale für gesundheitliche Aufklärung: http://www.bzga.de/
Bundesministerium für Ernährung, Landwirtschaft und Forsten (BML): http://www.bmelv.de/
Bundesamt fuer Verbraucherschutz und Lebensmittelsicherheit (BVL) http://www.bvl.bund.de/
Robert Koch Institut (RKI) http://www.rki.de/
Nationaler Ethikrat
Der Nationale Ethikrat hat 25 Mitglieder, die vom Bundeskanzler für vier Jahre berufen
wurden. Das Gremium trifft sich in der Regel einmal pro Monat zu Sitzungen in Berlin.
Gegründet wurde der Rat durch einen Beschluss der Regierung vom Mai 2001. Die
konstituierende Sitzung fand am 8. Juni 2001 statt. Von 2003 an sollen alle
Plenumssitzungen öffentlich sein. Parallel dazu wird es auch andere Veranstaltungen
geben, bei denen das Publikum mitdiskutieren kann.
Der Ethikrat im Internet: www.ethikrat.org
Standortregister gibt Auskunft über Flächen mit gentechnisch veränderten Pflanzen http://www.bvl.bund.de/standortregister.htm
OGM en questions: site 'Organismes génétiquement modifiés' du ministere de l'Économie, des finances et de l'industrie : tout sur les OGM, définition, actualité, textes de référence, agenda, chantiers réglementaires, commercialisation, étiquetage, recherche, autorisation. Suivez "Liens utiles".
Food Safety Authority of France: http://www.afssa.fr/
Deliberate release of GMOs
In Great Britain, the deliberate release to the environment of genetically modified organisms (GMO's) and the marketing of products containing or consisting of GMO's is controlled by Part 1V of the Environmental Protection Act 1990, and the Genetically Modified Organisms (Deliberate Release) Regulations 1992. Together these implement European Commission Directive 90/220/EEC on the deliberate release into the environment of GMO's. In addition, new Regulations governing the deliberate release of GMO's came into force on March 8th 1995. The Genetically Modified Organisms (Deliberate Release) Regulations 1995 implement a number of simplifications to the existing legislation for certain classes of release. The 1995 Regulations amend the 1992 Regulations to take into account of the European Commission Decision 94/730/EC establishing a First Simplified Procedure for applications to release GM plants. The amended Regulations allow a single consent to cover the experimental release of different GM crop plants of the same species at different sites. Therefore, one consent may cover a programme of work involving releases over a number of years and at different sites. In order to comply with these regulations the GM plant in question must conform to a number of criteria,which include the availability of information on safety to humans and the environment of the GMO.
Deliberate release of GMOs is supervised by the Department for Environment, Food
and Rural Affairs (DEFRA), in particular the Advisory Committee on Releases to the
Environment (ACRE, http://www.defra.gov.uk/environment/acre/index.htm).
Contained use of GMOs
The Genetically Modified (Contained Use) Regulations 2000/2831 implement in Great Britain European Directive 90/219/EEC on the contained use of genetically modified micro-organisms, as amended by Commission Directive 94/51/EC and Council Directive 98/81/EC. The Regulations revoke and replace the Genetically Modified Organisms (Contained Use) Regulations 1992, as amended.
Contained use of GMOs is supervised by the Health and Safety Executive (http://www.hse.gov.uk/ -- search 'GMO') which has two relevant advisory committees: the Advisory Committee on Genetic Modification (ACGM) and Technical Sub-Committee (TSC).
Agricultural, Environmental and Food Applications of Genetic Engineering
Advisory Committee on Releases to the Environment (details above)
Advisory Committee
on Novel Foods & Processes -- considers applications for marketing new
foods derived from GMOs
Advisory
Committee on Animal Feedingstuffs -- e.g. report on GM oilseed rape
The Food Standards Agency -- oversees consumer concerns such as food safety and labeling.
The Agriculture and
Environment Biotechnology Commission
The Commission will:
. offer strategic advice to Government on biotechnology issues which impact on agriculture
and the environment;
. liaise closely with, but not duplicate the work of the other two bodies which together
with the AEBC form the new strategic advisory framework i.e.:
the Human Genetics Commission (HGC) which will advise on genetic
technologies and their impact on humans; and the Food Standards Agency (FSA) which
will include within its responsibilities all aspects of the safety and use of genetically
modified food and animal feed.
Animal Applications of Genetic Engineering
Most animal applications to date (12.2000) are for medical purposes whether for research, the creation of biofactories for pharmaceutical proteins or to supply human-compatible tissues for transplant (xenotransplantation).
UK Xenotransplantation Interim Regulatory Authority (UKXIRA) -- oversees proposals for transplanting animal tissues/organs to humans.
Animal Procedures Committee -- advises Secretary of State on matters concerned with the Animal (Scientific Procedures) Act 1986.
Human Applications of Genetic Engineering
Human Fertilisation and Embryology Authority The HFEA administers the Human Fertilisation and Embryology Act 1990, the key statute covering human embryo creation and manipulation, which would also cover transmissible human genetic modification and cloning (e.g. creation and cloning of human embryonic stem cells for transplantation purposes) because such procedures would require licensing by the authority. But the Act currently authorises experimentation on embryos less than 14 days old for research into infertility, congenital disease, miscarriage, contraception and pre-implantation genetic diagnosis. Parliament is expected to consider extending the purposes to include "therapeutic cloning" in 2001. Specific primary legislation to outlaw reproductive cloning or the mixing of adult (somatic) cells with live animal eggs is still lacking. However, the HFEA will not license such procedures. The HFEA will consider research involving embryo splitting or nuclear replacement in eggs. But the Act would need extending to allow treatment of mitochondrial disease (e.g. using egg cell nuclear replacement). Strictly speaking, this would be a form of germ line genetic modification. There is no primary UK legislation to prevent germ line genetic modification, i.e. creating GM human beings, but the Clothier committee which preceded GTAC (see below) advised that it should not be attempted yet. Anyway, such research would involve both in vitro fertilisation and manipulation of the human embryo and would therefore need to be licensed by the HFEA.
Human Genetics Advisory Commission -- established in December 1996 as a non-statutory advisory body to UK health and industry ministers on issues arising from developments in human genetics and cloning that have social, ethical and/or economic consequences.
Gene Therapy Advisory Committee (GTAC) -- established 1993, non-statutory, advising on clinical protocols and more general issues; gives advice to UK health ministers on developments in the field and their implications.
Advisory Committee on Genetic Testing (ACGT) -- established 1996, non-statutory, advises Ministers on developments in testing for genetic disorders, advises on testing individuals for genetic disorders taking into account ethical, social and scientific aspects and sets quality standards for commercial tests.
The Patent Office -- includes consultation paper on UK implementation of directive 98/44/EC for legal protection of biotech inventions.
Office of Science and Technology -- consults public on developments in biotechnology.
Genetics and Insurance Committee -- set up following public concern about genetic discrimination in insurance.
Medicines and Healthcare products Regulatory Agency -- approvals of new drugs including those made by recombinant DNA technology.
CONABIA-National Commission of Agricultural Biotechnology (Argentina):
http://www.sagpya.mecon.gov.ar/new/0-0/programas/biotecnologia/index_en.php
Agricultural, Environmental and Food Applications of Genetic Engineering
Bureau of Rural Sciences, Department of Agriculture, Fisheries, and Forestry, Australia. http://www.daff.gov.au/brs
Biotechnology Australia. http://www.biotechnology.gov.au
Australia New Zealand Food Authority. http://www.foodstandards.gov.au
Congress on biosafety in Brazil http://www.anbio.org.br
CIGB-Cuba's Genetic Engineering & Biotechnology Center (Cuba): http://www.cigb.edu.cu/
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