Iran (Islamic Republic of) | BCH-NR2-IR-102355 | Second National Report on the Implementation of the Cartagena Protocol on Biosafety | Biosafety Clearing-House

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Second National Report on the Implementation of the Cartagena Protocol on Biosafety (NR2)
  |  
BCH-NR2-IR-102355-3   |   PDF   |   Print   |  
published: 28 Sep 2011 last updated: 08 Oct 2011
General Information


Related organizations in biosafety including: <br />- Secretariat of National Biosafety Council, <br />- Department of Environment<br />- Ministry of Science, Research &amp; Technology<br />- Ministry of Agriculture Jihad, <br />- Ministry of Health and Mediacl Education<br />
EN

12 Sep 2007
28 Sep 2011
Party to the Cartagena Protocol on Biosafety
Article 2 – General provisions
A domestic regulatory framework is partially in place
EN
  • One or more national biosafety laws
  • Other laws, regulations or guidelines that indirectly apply to biosafety
No
EN
Yes
EN
Less than 10
EN
Yes
EN
Iran Biosafety Law has been approved in July 2009. Draft of Implementing regulation of National Biosafety Law has been developed and it is to be assessed by National Biosafety Council.
EN
Article 5 – Pharmaceuticals
Yes, to some extent
EN
No
EN
In our country all the pharmaceticals are strictly regulated by the Ministry of Health &amp; Medical Education regulations.
EN
Article 6 – Transit and Contained use
No
EN
No
EN
Laboratory and green house researches are not in the scope of Iran Biosafety Law but procedures for export &amp; import of LMOs for containd use has been mentioned in National Biosafety Law and in more details in implementing regulation of NBL.&nbsp;
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes
EN
No
EN
No
EN
Yes, to some extent
EN
No
EN
No
EN
No
EN
No
EN
None
EN
None
EN
Detailed procedures of AIA has been developed in Implementing regulation of NBL which is to be assessed by National Biosafety Council.
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
No
EN
No
EN
Yes
EN
No
EN
Yes
EN
Yes
EN
None
EN
Less than 5
EN
Less than 5
EN
No
EN
No
EN
Details of the implementation of Article 11, has been developed in the implementing regulation of Iran Biosafety law but at present Ministry of Health and Ministry of Agriculture apply their previous regulations and guidelines that indirectly regulate LMOs as well.
EN
Article 12 – Review of decision
No
EN
No
EN
No
EN
None
EN
In one of the chapters of Implementing Regulation of NBL, it has been explained&nbsp; that the competent authorities has the right to reconsider their decisions.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;
EN
Article 13 – Simplified procedure
No
EN
No
EN
None
EN
In one of the chapters of implementing regulation of NBL, it has been mentioned that the issued permission is valid for one year.
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
EN
Article 15 – Risk assessment
Yes
EN
Yes
EN
No
EN
Yes
EN
No
EN
No
EN
No
EN
No
EN
No
EN
None
EN
n/a
EN
n/a
EN
Based on Our National Biosafety Law, Risk assessment is compulsory for LMOs but required guidelines has not been developed yet. For the time being Ministry of Health follows codex guidelines when it is needed. <br />&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;
EN
Article 16 – Risk management
Yes, to some extent
EN
Yes, to some extent
EN
No
EN
No
EN
No
EN
No
EN
Detalis of Risk management procedure&nbsp; will be developed in a separate regulation.&nbsp; &nbsp;&nbsp;
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
No
EN
Never
EN
In our National Biosafety Law it has been mentioned that in case of emergencies the provision of this article will be consistent with provision of article 17 of Cartagena Protocol.
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
No
EN
Yes, to some extent
EN
Yes, to some extent
EN
Yes, to some extent
EN
Yes, to some extent
EN
Yes, to some extent
EN
Ministry of Health and Ministry of Agriculture consider ISO and Codex&nbsp; manual for detection of LMO-FFPs.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;
EN
Article 19 – Competent National Authorities and National Focal Points
Yes
EN
Yes
EN
Yes, more than one
EN
No
EN
Yes, some information
EN
Yes
EN
Yes, to some extent
EN
Based on National Biosafety Act, Ministry of Agriculture, Ministry of Health and Department of Environment are 3 competent authorities in Iran. As soon as resopnsible persons are designated by these organizations there will be introduced in BCH.
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available but only partially available in the BCH
EN
Information available but only partially available in the BCH
EN
Information not available
EN
Information available but only partially available in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information available but not in the BCH
EN
Information not available
EN
Information not available
EN
Information not available
EN
Information not available
EN
Yes
EN
No
EN
Yes, in some cases
EN
No
EN
No
EN
Most of the available information are registered in BCH. Some information does not exist and Some available information has not been registered in BCH because NBA implementing regulation which oblige different competent authorities to inform BCH about their activities is not approved yet.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;
EN
Article 21 – Confidential information
Yes
EN
Yes, always
EN
procedures to protect confidential information have been developed in Implementing regulation of NBL which is to be assessed by National Biosafety Council.
EN
Article 22 – Capacity-building
Yes
EN
Multilateral channels
EN
Yes
EN
Multilateral channels
EN
Yes
EN
Yes
EN
Average
EN
  • Development of national biosafety frameworks
  • Building Capacity for Effective Participation in the BCH (Phase I)
Yes
EN
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Identification of LMOs, including their detection
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Taking into account risks to human health
Yes
EN
Yes
EN
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Risk management
  • Public awareness, participation and education in biosafety
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Scientific, technical and institutional collaboration at subregional, regional and international levels
  • Technology transfer
  • Identification of LMOs, including their detection
  • Socio-economic considerations
  • Implementation of the documentation requirements under Article 18.2 of the Protocol
  • Handling of confidential information
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
  • Scientific biosafety research relating to LMOs
  • Taking into account risks to human health
No
EN
Yes
EN
GEF approved and provided fund for: (1) Development of Iran National Biosafety Framework which was performed from 2002 to 2004; and (2) BCH capacity building project (phase I) which was performed in 2009, in a reasonable time but for the second phase of Biosafety capacity building project (implementing project) it has been quite a long time that we are waiting to be approved. <br />ِAs well as that ,The Course on ''The Analysis of Agricultural Products for the Presence of Genetically Modified Organisms'' was performed by collaboration of ICGEB and NIGEB from 10-12 May 2009, Tehran, Iran.<br />In a biosafety&nbsp; workshop that was performed in in Lebanon in 2009, one of the lecturers was invited from Agricultural Research Institute of Iran (ABRII). <br />
EN
Article 23 – Public awareness and participation
Yes, to some extent
EN
Yes
EN
Yes, to a limited extent
EN
Yes, to a limited extent
EN
Yes, to a limited extent
EN
Yes
EN
Yes, to a limited extent
EN
Yes
EN
None
EN
Establishment of National BCH through the UNEP-GEF capacity building project, helding several different workshops through NBF development&nbsp; and BCH capacity building projects were very useful for public awareness. Apart from that publication of 37 issue of seasonal biosafety Bulletin by NIGEB and distributing it free of charge among registered scientists, students and other interested people&nbsp; in all over the country has helped for public awareness very much.&nbsp; Moreover a few&nbsp; biosafety workshops are held annually by different related governmental organizations and scientific societies in Iran.
EN
Article 24 – Non-Parties
No
EN
No
EN
No
EN
Article 25 – Illegal transboundary movements
Yes
EN
No
EN
Never
EN
Required measures for illegal transboundary movement has been mentioned in Implementing regulation of NBL which is to be assessed by NBC.&nbsp;
EN
Article 26 – Socio-economic considerations
No
EN
No
EN
Article 27 – Liability and Redress
No
EN
Yes
EN
Text of Nagoya-Kuala Lumpur Supplementary Protocol has been translated to persian and has beeen sent to related organizatons to receive their opinions.
EN
Article 33 – Monitoring and reporting
Yes
EN
Other information
Regular Biosafety workshops and courses are required to teach and train our policy makers, regulators, scientists, students and so on because some of them still do not have a proper knowledge of biosafety and they think biosafety is an obstacle for progress of biotechnology in our country. That is why development and approvement of National Biosafety Law was taken very long time. This is almost our problem for development of the implementing regulation of NBL and we do not exactly know when it will be approved. <br />Apart from that, technical obstacles like equipped laboratories for risk assessment, required facilities for sampling and identification of LMOs&nbsp; for implementation of Article 18 and so on, are major problems for implementation of the protocol.&nbsp; <br />Therefore, we need capacity building and technology transfer and all the needs that have been mentioned in answer to question 147.&nbsp; &nbsp; &nbsp; &nbsp;
EN
Comments on reporting format
With many thanks to the Cartagena Protocol secretariat to provide this format, answering to some questions with Just Yes or No Option was difficult. It was better that at least we could explain about each question in front of itself.
EN
Survey on indicators of the Strategic Plan (2014)
2004
EN
Apart from different secretariats of Ministerial Biosafety Committees with personnels and eqiupments and ordinary activities, the first modern greenhouses cultivation of GM crops was established in Agricultural Biotechnology Research Institute of Iran (ABRII) and the operation was launched in june 2013.
EN
5 per year or more
EN
Biosafety duties-based Educational workshops holding in related organizations
EN
No
EN
In some extent there is a national mechanism for coordinating biosafety capacity building, we hope that it will become functional during the implementation project of NBF.
EN
50,000 USD or more
EN
Yes
EN
As it was mentioned in Q.6 there is some fund for biosafety activities in related ministries but it is not enough to cover the whole required biosafety activities.
EN
None
EN
Yes
EN
Yes
EN
Yes
EN
In executive regulation of Iran biosafety law some parts has been allocated to this issue.
EN
Yes
EN
Minisrty of Health has developed some guidelines based on EU and Codex Allimentarius guidelines
EN
No
EN
Yes
EN
Yes
EN
No
EN
Yes
EN
In executive regulation of Iran biosafety law some parts has been allocated to this issue.
EN
No
EN
It is anticipated that within the 2nd phase of UNEP-GEF project the survey on socio economic considerations will be done by Ministry of Health.
EN
One or more
EN
By Ministry of Health
EN
No Data
EN
Yes
EN
Some measures have been adopted in Executive regulation of Iran Biosafety Law but to be operational it needs capacity building.
EN
10 or more
EN
10 or more
EN
One or more
EN
No
EN
There may be few laboratories but the facilities are not sufficient.
EN
No
EN
No
EN
No
EN
One or more
EN
10 or more
EN
Yes
EN
5 or more
EN
All of them are centralized in capital and should be more equipped.
EN
One or more
EN
There is sufficient potential but there has not been recieved any request so it is not operational yet.
EN
No
EN
Yes
EN
Some measures have been adopted in National Biosafety Law and its Executive regulation of it.
EN
No
EN
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (N/A)
One or more
EN
National Institute for Genetic Engineering and Biotechnology, Agriculture Biotechnology research institute, Biosafety society NGO,
EN
5 or more
EN
A seasonal biosafety bulletin published by National Institute for Genetic Engineering and Biotechnology, Biosafety Journal is published by Biosafety Society of Iran, A BCH Booklet was published by NIGEB and are distributed among stakeholders, etc.
EN
No
EN
No
EN
5 or more
EN
Different seminars and meetings on Biosafety in different related organization were organized. In commemoration of the 25th Ann. of NIGEB a brochure to introduce BCH was published and distributed among participatns . Ministry of Health has performed a National Congress entitled: "The role of Biotechnology in food industry"; Three national workshops also have been performed: (1)Safety Assessment of GMOs, (2)Risk assessment of GM Products, (3) Risk assessment of detection of GM products.
EN
10 or more
EN
Accepted and published sceintific articles in Domestic and International Journals.
EN
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (National web site and National Libraries)
One or more
EN
BCH Capacity Building Project and Building National Capacity to Implement the National Biosafety Framework, attending in Regional and international meetings and workshops. Preparation of Second National reports for the secretariat of Cartagena Protocol. Performing an international workshop on Bioethics and ethical aspects of Biosafety, second congress of Bioethics and so on.
EN
Yes
EN
Ministry of Agriculture, Ministry of Health, Department of environment and Ministry of Science, Research & Technology Biosafety Committees all have had awareness and outreach programmes on Biosafety. (e.g. performing biosafety workshops, seminars and short courses and publications.)
EN
Yes
EN
Through National BCH ; Holding Seminars and Meetings of Ministerial Biosafety Committees, Holding Expert committee meetings of National Biosafety Council and so on.
EN
One or more
EN
Biosafety Bulletin , Journal of Biosafety, Genetic Engineering & Biosafety Journal, BCH Booklet, Bruchures and so on
EN