Pakistan | BCH-NR2-PK-105872 | 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-PK-105872-2   |   PDF   |   Print   |  
last updated: 12 Sep 2014
General Information


All the members of Natioanl Biosafety Committee and Technical Advisory Committee relevant and related Organizations/ Institutes/ Universities/ Ministries/ Depatments were consulted for the review of this report.
EN

01 Jan 2011
31 Dec 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 regulations
  • One or more sets of biosafety guidelines
No
EN
No
EN
Yes
EN
The Establishment of National Biosafety Centre Project was approved by the defunct Ministry of Environment (now renamed as Ministry of Climate Change) and National Biosafety Centre was established in Pakistan Environmental Protection Agency (Pak-EPA) in April, 2006.<br /> In exercise of the powers conferred by section 31 of Pakistan Environmental Protection Act (PEPA) 1997, the Federal Government notified Pakistan Biosafety Rules Vide S.R.O.336(1)/2005 on 21st April, 2005. National Biosafety Guidelines were notified in October, 2005 which provides the procedure for the implementation of Pakistan Biosafety Rules, 2005. Biosafety Guidelines provides procedures for the research and development on LMOs/GMOs and their products, release of LMOs/GMOs and their products for field trials and release of LMOs/GMOs for commercial purpose. <br />National Biosafety Centre has been working to regulate GMOs/LMOS and their products related activities in the country. This Centre provides secretarial services to three committees’ i.e., National Biosafety Committee (NBC), Technical Advisory Committee (TAC) and Institutional Biosafety Committees (IBCs) essential for the implementation of the entire regulatory framework. The Centre is entrusted for the regultory fuctions by the Government of Pakistan essential to regulate GMOs/LMOs and their products in the country. A number of TAC subcommittees had been had been assigned different tasks of monitoring and evaluation of Research and development,Field trials and commercialization of GMOs/LMOs and their products in the country. These subcommittees had been fuctioning as per the directions of TAC and submit their reports to TAC for furnishing recommendations to NBC for decision making. <br />
EN
Article 5 – Pharmaceuticals
No
EN
As per Article 5 of CPB the GMOs/LMOs for pharmaceuticals are not specifically included in the Pakistan Biosafety Regulations of the country. The bioafety regulations of the country would also be applied to GMOs/LMos and their products if any such Pharmaceuticals are derived/ developed and/or imported from GMOs/LMOs and their products.
EN
Article 6 – Transit and Contained use
No
EN
Yes
EN
No
EN
Pakistan Biosafety Clearing House Mechanism is under development for information sharing among all the stakeholders regarding GMOs/LMOs and their products related activities in the country. The information regarding GMOs/LMOs and their products would be&nbsp; submited after completion and launching of the web based Pakistan Biosafety Clearing House (Pak-BCH).
EN
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Yes, to some extent
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
More than 10
EN
None
EN
More than 10
EN
More than 10
EN
No
EN
n/a
EN
n/a
EN
n/a
EN
n/a
EN
  • Approval of the import/use of the LMO(s) with conditions (100)
In some cases only the notifier
EN
Pakistan had approved the import of Genetically Modified (GM) cotton and corn hybrids to be planted for the assessment and evaluation of environmental safety and performance in the agro-climatic conditions of the country.&nbsp; The Confined Field Trials of GM corn hybrids are under way and moved towards the Large Scale Field Trials to establish the economic value of the GM corn crops and impacts on agricultural communities of the country.
EN
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
Yes
EN
Yes
EN
No
EN
Yes
EN
No
EN
No
EN
No
EN
The Pakistan Biosafety regulations and implementation mechanism are in place. But, no application in this regards has been received dring the reporting period. Therefore, no such decision had been made and submitted to the BCH.
EN
Article 12 – Review of decision
Yes
EN
No
EN
No
EN
None
EN
As per Pakistan Biosafety Rules, 2005 the National Bioasfety Committee (NBC) on the recommendations of Technical Advisory Committee (TAC) can review and change its decisions for GMOs/LMOs and their products on receiving applications for the review and change of decision. No request had been made for the review and change of the decision for the intentional transboundary movement of GMOs/LMOs and their products during the reporting period.
EN
Article 13 – Simplified procedure
No
EN
No
EN
None
EN
The mechanism had not been devised and implemented as it is desired that all the applications will follow the normal course of approval process for the decision making.
EN
Article 14 – Bilateral, regional and multilateral agreements and arrangements
No
EN
Not Applicable
EN
Article 15 – Risk assessment
Yes
EN
Yes
EN
No
EN
Yes
EN
No
EN
Yes
EN
No
EN
In some cases only
EN
No
EN
More than 10
EN
No
EN
No
EN
The Risk Assessments had only been conducted for the cases/ applications of intentional release of GMOs/LMOs and their prducts in the environment for field trials testing and evaluation. The Risk Assessments reports submitted by the applicants (developed by exporting and other countries) along with the applications of import of GMOs/LMOs and their products has been reviewed by TAC and its recommendations are considered for decision making by NBC.
EN
Article 16 – Risk management
Yes, to some extent
EN
No
EN
Yes, to some extent
EN
Yes
EN
No
EN
No
EN
The mechanisms for Risk Management after due Risk Assessment have been devised and in place. The risk management operational measures has been applied to the intentional introduction into the environmeent. No application for Food, Feed or for processing of LMOs/GMOs and their products had been received and processed.
EN
Article 17 – Unintentional transboundary movements and emergency measures
Yes
EN
Yes
EN
No
EN
Never
EN
The contacts information for unintentional transboundary movements and emergency measures had been provided to the BCH. The mechanisms addressing emergency measures has been established in consultation of Ministry of Food Security and Research. No information has been received and these measures had been implemented during the reporting period.
EN
Article 18 – Handling, transport, packaging and identification
Yes
EN
No
EN
Yes, to some extent
EN
Yes
EN
Yes
EN
Yes, to some extent
EN
Yes, to some extent
EN
The import of GMOs and their products is governed by Pakistan Biosafety Rules, 2005 and it had been advised to the importing party to follow all the procedures and standards for safe and secure handling/ packing of GM materials. It is required to keep the record of all the movements GMOS/LMOs and their products even with in the country and to inform NBC about all such movements, usage and storageof left over materials. The limited detection facilities had been available for detection using quick identification methods. The procedures for sampling is under development.&nbsp;
EN
Article 19 – Competent National Authorities and National Focal Points
Yes
EN
Yes
EN
Yes, one
EN
n/a
EN
Yes, all information
EN
n/a
EN
Yes, to some extent
EN
All the relevant information had been provided for the National Focal points for CPB, BCH and CNA to the secretriat and BCH.
EN
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
Information available and in the BCH
EN
Information available and in the BCH
EN
Information not available
EN
Information available and in the BCH
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 available but not in the BCH
EN
Information not available
EN
Information not available
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
No
EN
Yes
EN
Yes, always
EN
No
EN
n/a
EN
No
EN
The process is under way to develop a hurdle free mechanism for information sharing with the BCH. The web based Pakistan Biosafety Clearing House for information sharing is under preparation and launching stage.
EN
Article 21 – Confidential information
Yes
EN
Yes, always
EN
The identified confidential information by the applicant is well protected and not shared with irrelevant indiviuals and organizations.
EN
Article 22 – Capacity-building
No
EN
No
EN
Yes
EN
No
EN
  • Development of national biosafety frameworks
Yes
EN
  • Public awareness, participation and education in biosafety
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (Mass awareness and education about biosafety system in the country)
No
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
No
EN
Not applicable
EN
Article 23 – Public awareness and participation
Yes, to some extent
EN
No
EN
Yes, to a limited extent
EN
No
EN
No
EN
No
EN
Yes, to a limited extent
EN
No
EN
None
EN
Not applicable
EN
Article 24 – Non-Parties
No
EN
Yes
EN
No
EN
Yes, always
EN
No
EN
n/a
EN
Not Applicable
EN
Article 25 – Illegal transboundary movements
Yes
EN
No
EN
Never
EN
Not Applicable
EN
Article 26 – Socio-economic considerations
Yes
EN
No
EN
Not Applicable
EN
Article 27 – Liability and Redress
No
EN
No
EN
Process for ratification of Nagoya-Kuala Lumpur will soon be initiated.
EN
Article 33 – Monitoring and reporting
No
EN
  • Lack of financial resources to gather the necessary information
  • Difficulty in compiling the information from various sectors
Other information
Pakistan is a developing country and under financial crunch. It needs financial resources for the effective implementation of the biosafety regulations in the country. The capacities of human resource involved in the implementation of biosafety reguations are not adequate and needs to be enhannced for the further improvement of the mechanisms and streamline procedures to address CPB reguirements and obligations.
EN
Comments on reporting format
This format of reporting is comprehensive.
EN
Survey on indicators of the Strategic Plan (2014)
2006
EN
N/A
EN
1 per year or more
EN
Capacity Building activities arranged in last years are following; i. One day workshop, “Development of National Biosafety Roadmaps in Pakistan”, Organized by KOICA, in collaboration with NBC, Pak-EPA on 1st August, 2007. ii. One day workshop, “Training Workshop for “Heads of Institutional Biosafety Committees (IBCs)” Organized by NBC, Pak-EPA Feb 04, 2008. iii. One day seminar on “Genetically Modified Organisms (GMOs) – Applications and Implications” Organized by NBC, Pak-EPA on May 13, 2008. iv. One day training workshop, “Role of Biosafety Officers for the Implementation of Pakistan Biosafety Rules, 2005” Organized by NBC, Pak-EPA on June 23, 2008. v. Invited Lecture/ Seminar Series “Biodiversity Conservation: Biosafety Perspective” Dept. of Environmental Sciences in collaboration with Dept. of Zoology/Biology, PMAS Arid Agriculture University, Rawalpindi on May 27, 2010. vi. One day Workshop, “Environmental Safety and Stewardship of Biotech Products” organized by NBC in collaboration with M/s Pioneer Pakistan Seed Ltd. on April 4, 2011. vii. One day seminar, “GM Cotton: Food and Feed safety Prospectives” by M/s Pioneer Pakistan Seed Ltd. and NBC on April 5, 2011. viii. An Invited Lecture on “Status of Implementation of Biosafety Regulations in Pakistan” in the “Workshop on Implementation of Biosafety Protocols” Centre of Agriculture Biochemistry and Biotechnology, University of Agriculture, Faisalabad on May 14, 2011. ix. One day International Workshop, “Global Status, Impact and Future Prospects of Biotech Crops” organized by NBC in collaboration with M/s Monsanto Pakistan (Pvt.) Limited, Lahore on January 10, 2012 x. An Invited Lecture titled “Genetically Modified Products and their Regulation in Pakistan” Directorate of Health, Capital Development Authority (CDA), Islamabad on September 17, 2012. xi. An Invited Lecture titled “Biosafety Laws and their Implementation” In the 121th Extra Ordinary General Body Meeting of Farmers Associates Pakistan (FAP), Lahore on November 13, 2012. xii. An Invited Lecture titled “Responsibilities and Functions of Institutional Biosafety Committee under Pakistan Biosafety Rules 2005” at Faculty of Biological Sciences, Quad-i-Azam University, Islamabad on March 28, 2013. xiii. “Capacity Building and Training Presentations on Trait Purity and GM Testing for TAC members and National Biosafety Centre officers” organized by NBC in collaboration with M/s Monsanto Pakistan (Pvt.) Limited, Lahore on April 10, 2013. xiv. “Hazardous Impacts of Pesticides in Environment and their Possible Alternatives” organized by TheNetwork for Consumer Protection at National University of Science and Technology, Islamabad on 10th October, 2013.
EN
No
EN
N/A
EN
n/a
EN
No
EN
N/A
EN
10 or more
EN
Pakistan has established bilateral /multilateral arangements with Korea, Philipines and USA for capacity building activities. The executed activites are listed bellow: i. Three (03) Korean Experts in the Field of Biotechnology, Biotechnology Information System, and Legal Expert in the field of Biosafety were dispatched to NBC/Pak-EPA on 10th of July, 2007 for the period of one month. ii. “Study Visit of Pakistani Government Officials on Crop Biotechnology” at Manila, Philippines (Aug 22-28, 2010). iii. Capacity Building on job training was offered to Pakistan by USDA and and Center for Environmental Risk Assessment (CERA) at Washington, USA. Two officers of National Biosafety Centre received this training in September, 2013. These were one time activities and further capacity building and cooperation and colaborations are required for the effective implementation of the obligations of CPB under CBD. Therefore, further guidance and help is required form the CPB Secretrait for securing bilaterial and multilateral cooperations.
EN
Yes
EN
Yes
EN
Yes
EN
The Guideance on Risk Assessment of Living Modified Organisms developed through the "Open-ended Online Forum" and the Ad Hoc Technical Expert Group (AHTEG) is used as guiding document for the risk assessment of LMOs and their Products.
EN
Yes
EN
The Guideance on Risk Assessment of Living Modified Organisms developed through the "Open-ended Online Forum" and the Ad Hoc Technical Expert Group (AHTEG) is used as guiding document for the risk assessment of LMOs and their Products. This guiding document provides common approcah for risk assessment of LMOs and their products
EN
Yes
EN
Transgenic Cotton and Corn along with other GM crops had been in the research & development stages and evaluation for laboratory research & development and field testing is under process. Pakistan had commercialized eight Bt cotton varieities and one cotton hybrid. Risk assessment of LMOs and their Products is conducted as per the self developed guidelines based on the Guideance on Risk Assessment of Living Modified Organisms developed through the "Open-ended Online Forum" and the Ad Hoc Technical Expert Group (AHTEG).
EN
Yes
EN
Yes
EN
Yes
EN
Yes
EN
Pakistan is following the self developed guidelines for the purpose of ensuring the safe handling, transport, and packaging of LMOs and their products. These guidance are part of National Biosafety Guidelines 2005 for the above mentioned activities of LMOs and their products.
EN
Yes
EN
The socio-economic considerations are part of the evaluation process and these consideration are taken into account for the decision making process for activities of LMOs and their products in the country.
EN
One or more
EN
The published materials regarding socio-economic considerations are used for elaborating national actions during the evaluation process of the applications for activities related to LMOs and their products by Technical Advisory Committee and National Biosafety Committee also gives due weightage to it while considering the case for approval to carry out activities related to LMOs and their products in the country. "BEST PRACTICES FOR ASSESSING THE SOCIAL AND ECONOMIC IMPACTS OF TRANSGENIC CROP VARIETIES ON SMALL-SCALE FARMERS" ,International Food Policy Research Institute, Washington, USA. It is requested that any training material developed by the Secretariat or any country may be shared and if possible the trainings may be arranged for the decsion makers and the evaluators for socio-economic considerations of CPB.
EN
The socio-economic considerations are given high priority while making decisions for the LMOs and their products related activities in the country. The socio-economic impacts are considered to be very important determinants for the biosafety clearance or otherwise specially for the commercial release of LMOs and their products. The possible socio-economic impacts of LMOs and their products related activities are throughly evaluated before reaching any decisionfor their release into environment even for the confined usage for testing. The confined field trials of GM cotton and corn are are approved considering socio-economic impacts on the farmers and society. some was true for the commercial release of Bt cotton in the country. It is desired that trainings for inclusion of socio-economic considerations and evaluation of their impacts may be araanged for the evaluaors and decision makers along with share of any such materials.
EN
No
EN
Pakistan has no capacity to take appropriate measures in the case of unintentional release of LMOS into the environment and there is dire need to enhance the capacity and help in devising mechanisms and measures to control and regulate unintentional release of LMOs and their products in the country.
EN
10 or more
EN
10 or more
EN
10 or more
EN
Yes
EN
There are biotechnolgy laboratories available which are being used for the indentification of LMOs by through gene and gene products. but no specific biosafety laboratoy is available and four biotechnology laboratories of different institutions had been desiganated to carry out identifaction and determination of concentration (Levels) of gene and gene products in different part of plants and other GM materials. Therefor, financial and technical help is required for the establishment of a state of the art laboratory for conducting the monitoring or managing LMOs and that laboratory would also be a training facility for the other institutions and organizations involved in biotechnology and biosafety research and development activities.
EN
No
EN
The Guideance on Risk Assessment of Living Modified Organisms developed through the "Open-ended Online Forum" and the Ad Hoc Technical Expert Group (AHTEG) is being shared with the members of Technical Advisory Committee (TAC), Field Trials Monitoring & Evaluation Committees and commercialization Committees for of GM Cotton and GM corn to evaluate its relevance and usage as guiding document for the risk assessment of LMOs and their Products. Therefore, finances and training materials are required for specific trainings of the members of all the above mentioned committees for effective and efficient evaluation of the risk assessments and risk management of LMOs and their products.
EN
No
EN
No
EN
None
EN
The customs officers had not been trained and they could only be trained to read and understand the information on the labels of the imported items of LMOs and/or the items containing LMOs producs. Therefore, it is requested that training materials developed by the CPB Secretariat or any other country be shared and funding may kindly be provided for the trainings of custom officers for the identification of LMOs and their products imported in the country or exported from Pakistan.
EN
None
EN
Some of the academic institutions may have conducted any such trainings for the laboratory personnels but that specific information is not available with the National Biosafety Centre. The specific training are required and CPB Secretariat is requested to provide funding and training materials for the training of the laboratory personnels for identification, detection of LMOs and their products.
EN
Yes
EN
The four desiganated institutional biotechnolgy laboratories have adequate facilties and experties for the detection of the LMOs and their products. But, the reliability is question mark as these institutions are also the applicant for the research, developement and commercial release of GM producs in the country. Therefore, it is requested that financial and technical support may be provided for the establishment of National Biosafety Laboratories to address the reliability concern and also to provide training facilities to the organizatios and institutes in the field of detection and biosafety studies of LMOs and their products.
EN
One or more
EN
There are no certified laboratories for the detection of LMOs and their products in the country. The National Biosafety Committee had desigated four institutional biotechnology laboratories to carryout identifaction, detection and determination of concentration (Level) of gene and gene products from different part of plants and other GM materials provided for qualitative and quantitative analysis. It is required that a biosafety laboratories facility may kindly be funded and training provided to the personnel of the laboratories for the detection and determination of the LMOs and their products and also to train the other laboratories personnelsin the fields of identification and determination of LMOs and their products.
EN
None
EN
No certified laboratory for the dection of LMOs and their products exists. Only the four designated institutional biotechnology laboratories for the qualitative and quantitative determination of gene and gene products are operational. There is a dire need for the National Biosafety Laboratories to be established for detections, determinations and trainings to labratories personnels to conduct the identification and quantification of LMOs and their products.
EN
No
EN
N/A
EN
Yes
EN
In the Pakistan Biosafety Rules 2005 and National Biosafety Guidelines 2005, the damage to the biodiversity are included but the decision makers, evaluators and monitors of LMOs and their products had not any specific training even to identify the possible/ potential damages to the biodiversity so administrative response measures for damage to biodiversity form LMOs and their products could not be developed. It is requesed that the capacity of the decision makers, evalucators and monitors may kindly be developed through providing training materials and fainances to conduct such trainings.
EN
No
EN
National Biosafety Centre had organized a number of awareness activities for the general Public about the LMOs and their products. The following mass awareness of LMOs and their products measures were taken; i. Public notices were released in the leading Newspapers of the country for information regarding Genetically Modified Organisms (GMOs) are subject to Pakistan Biosafety Rules, 2005. ii. A brochure on “Biosafety & Genetically Modified Organisms” is prepared, approved by competent authority,published and widely distributed. iii. An article “GMOs and Role of National Biosafety Centre” The Diplomatic Insight (2011) 4(6) page # 8 iv. Participate as “Environmental Expert” and delivered talks on Biosafety, LMOs and other environmental issues and their impacts in “Mahool Zaindgi Hai” and other programs on different channels of Radio of Pakistan. v. Participated in a Rohi Television Channel programme to highlight "The GM crops (Bt cotton) and related Biosafety issues". National Biosafety Centre is intrested to develop and publish handbills, brochures and hang ons and posters to educate and inform the public about LMOs and their products. But technical and financial constrians are not allowing to execute such activities. Therefore, it is requested kindly to provide technical and financial support to carry out such activities. The civil society organizations are part of the decision making process and their involvment will be further increased.
EN
  • National website
  • Newspaper
  • Forums
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (The invited lectures were delivered to different stakeholders and general public on biosafety of LMOs and their products.)
Forums
EN
The invited lectures were delivered to different stakeholders and general public on biosafety of LMOs and their products and other issues and concern of biosafety of LMOs and their products to the biodiversity and environment.
EN
5 or more
EN
The universities and other acdemic institutions of the country are offering biosafety related courses in their biotechnology degree curriculums. For example Quaid-i-Azam University, Islambad, PMAS Arid Agriculture University, Rawalpindi, University of Agriculture, Faisalabad, National Institute of Biology and Genetic Engineering, Faisalabad, COMSATS Institute of Information Technology, Islamabad etc.
EN
None
EN
Pakistan had not developed any such biosafety training materials and/or online modules. Therefore, the help of the CPB Secretariat is required to develop biosafety training materials and modules and to made them online available.
EN
Yes
EN
Yes
EN
5 or more
EN
Six national workshop and seminars had been organized in the last two years for the information sharing, awareness and capacity building of the stakeholsders, students and general public in the country. No international activities could be executed due to lack of funds and cooperation form international donors/organizations. The details are as followes: i. One day International Workshop, “Global Status, Impact and Future Prospects of Biotech Crops” organized by NBC in collaboration with M/s Monsanto Pakistan (Pvt.) Limited, Lahore on January 10, 2012. ii. An Invited Lecture titled “Genetically Modified Products and their Regulation in Pakistan” Directorate of Health, Capital Development Authority (CDA), Islamabad on September 17, 2012. iii. An Invited Lecture titled “Biosafety Laws and their Implementation” In the 121th Extra Ordinary General Body Meeting of Farmers Associates Pakistan (FAP), Lahore on November 13, 2012. iv. An Invited Lecture titled “Responsibilities and Functions of Institutional Biosafety Committee under Pakistan Biosafety Rules 2005” at Faculty of Biological Sciences, Quad-i-Azam University, Islamabad on March 28, 2013. v. “Capacity Building and Training Presentations on Trait Purity and GM Testing for TAC members and National Biosafety Centre officers” organized by NBC in collaboration with M/s Monsanto Pakistan (Pvt.) Limited, Lahore on April 10, 2013. vi. “Hazardous Impacts of Pesticides in Environment and their Possible Alternatives” organized by TheNetwork for Consumer Protection at National University of Science and Technology, Islamabad on 10th October, 2013.
EN
None
EN
No biosafety related publication was made available in the country in the last year. The support is requested to develop and publish such materials and made available to the public and stakeholders on the biosafety related issues and concerns.
EN
  • 5B6177DD-5E5E-434E-8CB7-D63D67D5EBED (National web site and National Libraries)
None
EN
N/A
EN
No
EN
N/A
EN
N/A
EN
No
EN
N/A
EN
One or more
EN