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EBSA Events


15th Annual Conference of the European Biosafety Association

Manchester/UK
Workshops: 11 June 2012
Conference: 12 - 13 June 2012

Regulations and Guidelines

The main regulations and guidelines are:

International

Phytosanitary requirements for import

International Plant Protection Convention (IPPC): http://www.ippc.int/IPP/En/default.htm

Convention on Biological Diversity

Cartagena Protocol on Biosafety to the Convention on Biological Diversity - 2000 http://www.biodiv.org/biosafety/default.asp

Access and Benefit Sharing of Genetic Resources

International Treaty on Plant Genetic Resources for Food and Agriculture

http://www.fao.org/ag/cgrfa/itpgr.htm

Transport of GMOs

UN Model Regulations

http://www.unece.org/trans/danger/publi/unrec/rev13/13nature_e.html

CITES

Endangered Species transport

http://www.cites.org/eng/resources/transport/index.shtml


Europe

All documents can be found at the European Union site: http://www.europa.eu

Contained use of genetical modified micro-organisms

Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms

Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms. [OJ of 5.12.98 L330/13-31]

Commission Decision of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms. (2000/608/EC) [OJ of 12.10.200 L258/43-48]

Council Decision of 8 March 2001 supplementing Directive 90/219/EEC as regards the criteria for establishing the safety, for human, health and the environment, of types of genetically modified micro-organisms. (2001/204/EC) [OJ of 15.3.2001 L73/32-34]

Commission Decision of 28 February 2005 establishing guidance notes supplementing part B of Annex II to Council Directive 90/219/EEC on the contained use of genetically modified micro-organisms (2005/174/EC) [OJ of 5.3.2005 L 59/20-26]

Deliberate release of GMOs

Directive 2001/18/EC of the European Parliament and the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC. [OJ of 17.4.2001 L106/1-38]

Council Decision of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Directive 90/220/EEC (2002/811/EC)

[OJ of 18.10.2002 L 280/27-36]

Council Decision of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and the Council, the summary information format relating to the placing on the market of genetically modified organisms as or in products (2002/812/EC)

[OJ of 18.10.2002 L 280/37-61]

Council Decision of 3 October 2002 establishing, pursuant to Directive 2001/18/EC of the European Parliament and the Council, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market (2002/813/EC)

[OJ of 18.10.2002 L 280/62-83]

GMO food and feed

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed

[OJ of 18.10.2003 L 268/1-23]

Labeling and traceability of GMO food and feed

Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products from genetically modified organisms and amending Directive 2001.18/EC

[OJ of 18.10.2003 L 268/24-43]

Cartagena Protocol on Biosafety

Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movments of genetically modified organisms

[OJ of 5.11.2003 L 287/1-10]

Worker protection

Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC)

[OJ of 17.10.2000 L 262/21-45

Phytopathogenic requirements for import

Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community.

- All the amendments of Directive 2000/29/EC

Work with quarantine organisms

Directive 95/44/EC of 26 July 1995 establishing the conditions under which certain harmful organisms, plants, plant products and other objects listed in Annexes I to V to Council Directive 77/93/EEC may be introduced into or moved within the Community or certain protected zones thereof, for trial or scientific purposes and for work on varietal selections.

[OJ of 03.08.1995 L 184/0034-0046]

Dual-use agents

Council Regulation (EC) No 1334/2000 of 22 June 2000 setting up a community regime for the control of exports of dual-use items and technology

[OJ L159/1 of 30.6.2000]

Council Regulation (EC) No1504/2004 of 19 July 2004 amending and updating Regulation (EC) No 1334/2000 setting up a community regime for the control of exports of dual-use items and technology

[OJ L281/1 of 31.8.2004]

Transport by road

ADR regulations

http://www.unece.org/trans/danger/publi/adr/adr_e.html


USA

Plants, plant materials and organisms associated with plants are regulated by US Department of Agriculture (USDA) under Title 7 of the Code of Federal Regulations. Import, export and movement of plant materials and its pathogens is controlled by the Animal and Plant Inspection Service (APHIS) of the USDA.

Genetically engineered plants/organisms and their products are regulated by one or more of the following agencies: USDA/BRS, Environmental Protection Agency (EPA) and Food and Drug Administration (FDA). More information may be obtained at http://www.aphis.usda.gov/index.shtml .

7 CFR 330.200 Subpart M - Movement of Plant Pests Regulated

CFR to be found at http://www.gpoaccess.gov/cfr/index.html search for Movement and Plant and Pest

APHIS PPQ: http://www.aphis.usda.gov/ppq/permits

APHIS Documents such as:

  • Quarantine Facility Guidelines for Microorganisms
  • Containment Guidelines for Nonindigenous, Phytophagous Arthropods and Their Parasitoids and Predators
  • Quarantine Facility Guidelines for the Receipt and Containment of Nonindigenous Arthropod Herbivores, Parasitoids and Predators

NIH Guidelines for Recombinant DNA Research Appendix P: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html

Genetically engineered plants/organisms: Biotechnology Regulatory Services (BRS) http://www.aphis.usda.gov/brs/index.html

  • Genetically engineered arthropods
  • PMIP - plant-manufactured industrial products
  • PMP - plant made pharmaceuticals
NIH Guidelines for Recombinant DNA Research Appendix P(2002):
http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_P.htm

Select Agents and Toxins: 7 CFR Part 331
http://www.gpoaccess.gov/cfr/index.html

Department of Agriculture. Animal and Plant Health Inspection Service 7 CFR Part 331, 9 CFR Part 121 Agricultural Bioterrorism Protection Act of 2002. Listing of Biological Agents and Toxins and Requirements and Procedures for Notification of Possession.

Fed Reg Aug 12, 2002 Vol.67, No.155, p.52383