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) since 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 />Pak EPA is working to regulate GMOs/LMOs and their products related activities in the country which includes 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. Pak EPA is entrusted for the regulatory functions by the Government of Pakistan essential to regulate GMOs/LMOs and their products in the country. A number of TAC subcommittees 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 functioning as per the directions of TAC and submit their reports to TAC for furnishing recommendations to NBC for decision making.

As per Article 5 of CPB the GMOs/LMOs for pharmaceuticals are not specifically included in the Pakistan Biosafety Regulations of the country. The biosafety regulations of the country are applied to GMOs/LMOs (other than Pharmaceuticals).

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 submitted after completion and launching of the web based Pakistan Biosafety Clearing House (Pak-BCH).

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 and&nbsp; Field Trials of GM corn hybrids are under way to establish the economic value of the GM corn crops and impacts on agricultural communities of the country.&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; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;

The Pakistan Biosafety regulations and implementation mechanism are in place. Four applications have been received and approved recently. However, the same will be submitted to the BCH shortly.

As per Pakistan Biosafety Rules, 2005 the National Biosafety 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.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;

The mechanism had not been devised,&nbsp; all the applications will follow the normal course of approval process for the decision making.&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;

Not Applicable

The Risk Assessments had only been conducted for the cases/ applications of intentional release of GMOs/LMOs and their products 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.The mechanisms for Risk Management after due Risk Assessment have been devised and in place. The risk management operational measure has been applied to the intentional introduction into the environment.

The contacts information for unintentional transboundary movements and emergency measures had been provided to the BCH. The mechanisms addressing emergency measures have been established in consultation with Ministry of Food Security and Research. No information has been received and these measures had been implemented during the reporting period.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;

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 Pak EPA about all such movements, usage and storage of left over materials. The limited detection facilities had been available for detection using quick identification methods.&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;

All the relevant information had been provided for the National Focal points for CPB, BCH and CNA to the secretariat and BCH.&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; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;

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.&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;

The identified confidential information by the applicant is well protected and not shared with irrelevant individuals and organizations.&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; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;

Not Applicable

Pak EPA has conducted number of seminars/workshop for awareness of Public at national level, participated in TV and Radio programms to create awareness of biosafety and through publications in national newspapers.

Not Applicable

Not Applicable

Not Applicable

That allowed a thorough rish assessment

Not Applicable

No such situation arised so far

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 regulations are not adequate and needs to be enhanced for the further improvement of the mechanisms, procedures&nbsp; and available resources.

This format of reporting is comprehensive.