WHAT RESEARCHERS NEED TO KNOW TO COMPLY WITH THE BIOSAFETY ACT DEPARTMENT OF BIOSAFETY MINISTRY OF NATURAL RESOURCES & ENVIRONMENT BIOSAFETY TRAINING WORKSHOP 17 august 2016 universti teknologi malaysia

OUTLINE Notification Process Approval Process 1 Notification Process 2 Approval Process 3 Risk Assessment, Risk Management and ERP 4 What information to submit? 5 What does the IBC do for me? 6 Where are the biosafety resources? What activities are exempted?

WHAT RESEARCHERS NEED TO KNOW ABOUT THE NOTIFICATION PROCESS 1

COMPULSORY Talking Points: All contained use activities are regulated via the Notification Process. Applications must go through the IBC for R&D work. No fees required. Once submitted to the JBK, an initial assessment is done by the JBK. After it is cleared, the DG of Biosafety will issue an acknowledgement. After receiving the acknowledgement the PI can start the activity. The assessment will continue and the NBB will decide in 90 days. 8. Assessment of NBB may result in- No order Order Cessation Impose Terms Order Rectification Other Orders 9. If it is not approved, an appeal may be made to the Minister. 10. Notification decision can be reviewed. 11. Any non compliance may result in a penalty.

FORMS FOR NOTIFICATION Contained use and export Activities Contained use and import for contained use activities Export Biosafety Act: Second Schedule FORM E FORM F COMPULSORY Talking points: Form E is used for getting approval for contained use. The same form is used for all BSL facilities. Form F is used for an export of LMO to another country. Application Forms

ADDITIONAL INFORMATION REQUEST TO COMPLETE FORM 1 original Form E 1 6 identical copies of the form 2 Supporting documents 3 CD with Form and supporting documents 4 IBC Assessment Report 5 WHAT TO SUBMIT? COMPLETE FORM E GMAC JBK RESEARCHER IBC ADDITIONAL INFORMATION REQUEST TO COMPLETE FORM COMPULSORY Talking points: Provide one original form Provide 6 copies. All 6 copies should be identical with the original. Ensure all info provided can be clearly read/seen Any additional information must also be provided (soft copy as well as hard copy) One CD containing the identical Form E submitted as well as any supporting documents must be submitted. One CD for one Notification only. An IBC Assessment Form must be included. Any inspection reports should also be included. Through the assessment, additional information may be requested by the IBC, the Department of Biosafety, or GMAC or clarifications requested . All this expanded information will complete the information docket for the submission of the notification to the NBB.

WHAT RESEARCHERS NEED TO KNOW ABOUT THE APPROVAL PROCESS 2

COMPULSORY Talking Points: All release activities are regulated via the Approval Process. Applications must go through the IBC for field trials. The application will also be reviewed by any relevant Government agencies A public consultation is mandatory for the approval process. NBB will decide in 180 days. Decisions may vary – Approved; Approved with Terms and Conditions; Rejected Activity can start only after getting the Certificate of Approval 8. An approved person shall not undertake any release activity or any importation of LMO other than for which the certificate has been issued 9. If it is not approved, an appeal may be made to the Minister.

FORMS FOR APPROVAL Activities Biosafety Act: Second Schedule Release and Import for Release Activities R&D Field Experiment Other than R&D Field Experiment Biosafety Act: Second Schedule LMO higher plant LMO other than higher plant LMO higher plant & its products LMO other than higher plant & its products LMO & Products COMPULSORY Talking points: Form A is used for field trials involving plants Form B is used for field trials other than plants Form C is used for release of LMO which is a plant or its products Form D is used for release of LMO other than a plant and its products FORM A FORM B FORM C FORM D Application Forms

ADDITIONAL INFORMATION REQUEST TO COMPLETE FORM 1 original Form A/B/C/D 1 6 identical copies of the form 2 Supporting documents 3 CD with Form and supporting documents 4 IBC Assessment Report 5 Proof of payment 6 WHAT TO SUBMIT? COMPLETE FORM GMAC JBK RESEARCHER IBC ADDITIONAL INFORMATION REQUEST TO COMPLETE FORM COMPULSORY Talking points: Provide one original form and 6 copies. All 6 copies should be identical with the original. Ensure all info provided can be clearly read/seen Any additional information must also be provided (soft copy as well as hard copy) One CD containing the identical Form submitted as well as any supporting documents must be submitted. One CD for one application only. An IBC Assessment Form must be included. Any inspection reports of the proposed field trial site should also be included (if any). Proof of payment for the application Through the assessment, additional information may be requested by the IBC, the Department of Biosafety, or GMAC or clarifications requested . All this expanded information will complete the information docket for the submission of the notification to the NBB.

PUBLIC PARTICIPATION Independent process 4 national newspapers (Malay, English, Mandarin & Tamil) 2 announcements in each newspaper Cost of public participation is borne by applicant The applicant will have to submit the draft of fact sheet (in Malay and English) about the application and announcement to be approved by Dept. of Biosafety Guidelines and templates will be provided by Dept. of Biosafety (http://www.biosafety.nre.gov.my/guideline/Guideline s) COMPULSORY Talking points: The public participation is an independent process from the scientific and technical assessment by GMAC. Advertisement in the minimum size of 8 cm X 9.6 cm must be put in 4 national newspapers of the researcher’s choice (Malay, English, Mandarin and Tamil) Two announcements are required in each newspaper with an interval of two weeks. Cost of these announcements will be borne by the applicant. Applicant is required to submit a draft Fact Sheet (in English and Malay) and announcement to JBK for approval Guidelines to develop the announcement and fact sheet is available on the Department of Biosafety website.

PUBLIC PARTICIPATION COMPULSORY Applicant to inform JBK on both dates of publication and closing date (30 days) JBK will upload Fact Sheet and announcement on JBK website (first day of publication) Applicant to provide scanned copy of public announcement as proof from all newspapers JBK will consolidate inputs for a period of 30 days 1. Technical/scientific input will be given to GMAC 3. Other non technical inputs compiled 2. Requested clarifications answered Complete report of inputs will be given to NBB during assessment of the application PUBLIC PARTICIPATION COMPULSORY Duration of the public consultation is for 30 days. The process is as explained in the flow chart.

FEES FOR APPROVAL TYPE OF APPLICATION FEES (RM) Field Experiment below 5 hectares per location 100 Field Experiment 5 to 10 hectares per location 250 Field Experiment above 10 hectares per location 500 Commercial field release (approved LMOs) No charge Other Release activities (Schedule 2 of the Act) 5,000 COMPULSORY Talking points: 1. Fee for the application of approval is as in the table shown.

APPROVAL FOR RELEASE NBB DECISION SCIENTIFIC/ TECHNICAL ASSESSMENT - RISK ASSESSMENT BY EXPERTS EMERGENCY RESPONSE PLAN NBB DECISION POLICY CONSIDERATION – INCLUDING SOCIO ECONOMICS NATIONAL INTERESTS & PRIORITY PUBLIC INPUT THROUGH PUBLIC PARTICIPATION AND RISK COMMUNICATION OPTIONAL Talking points: 1. The NBB makes a decision based on these 3 components.

RESEARCHERS NEED TO CONDUCT RISK ASSESSMENT OF THE ACTIVITY AND DEVELOP RISK MANAGEMENT MECHANISMS AND EMERGENCY REPONSE PLANS PRIOR TO CONDUCTING THE ACTIVITY 3 *RISK ASSESSMENT, RISK MANAGEMENT & EMERGENCY RESPONSE PLAN ARE MANDATORY REQUIREMENTS UNDER S36 OF THE BIOSAFETY ACT

1 2 3 OVERVIEW OF 3-TIER RISK ASSESSMENT PROCESS JBK Applicant Proposes RA/RM/ERP 1 Request Additional Information IBC Review/Endorse JBK 2 GMAC Independent RA Additional RM as conditions 3 NBB COMPULSORY Talking points: The initial RA, RM and ERP is proposed by the applicant in the application form. These will be reviewed by the IBC and endorsed. JBK does initial an preliminary review of RA, RM and ERP. If no immediate concerns in Notification, JBK issues letter of acknowledgement GMAC will conduct an independent assessment and make any additional proposal for mitigation, if necessary The NBB may also include additional mitigation strategies in its decision as terms and conditions. Risk assessment is based on information provided by the applicant, any additional information and clarifications provided. Accuracy of information given is very important. Providing false information, or any misleading information carries a penalty under s67 of the Act. Monitoring by JBK Approved COMPULSORY RM & ERP TO BE IMPLEMENTED

RA & RM & ERP Minimum RM measures required determined by NBB with consultation from GMAC NBB makes decision and issues out T&C (if needed) Applicant to incorporate into design, construction and operation as applicable and carry out & comply these minimum RM to the satisfaction of the NBB Applicant to take the necessary measures in an emergency or shall on conviction be liable. COMPULSORY Talking Points: 1. The minimum RM measures are determined by NBB with consultation form GMAC. If applicant wants to take extra precautions, it is up to them, but not less than what is deemed minimum requirements by the NBB. 2. NBB will then make a decision and issue out any T&C if needed. 3. The applicant is to incorporate and comply with the minimum RM decided by the NBB. 4. In an case of unintended release, or spillage etc, the applicant is to take the necessary measure as proposed and follow the ERP accordingly. 5. Any non compliance to RM or ERP may result in a penalty under the law.

Sample template for risk assessment for contained use RISK ASSESSMENT MATRIX Sample template for risk assessment for contained use HAZARD FROM: IDENTIFICATION OF POTENETIAL HAZARD COMMENT ON RISK RISK MANAGEMENT RESIDUAL RISK ADDITIONAL INFO Science of genetic modification Admin policy, People & Practices Containment Integrity Special risks unique to Notification COMPULSORY Talking points: An example of a risk matrix that is used for risk assessment for a contained use activity. Assessment is done based on the four sources of risk – science of the genetic modification, administration people and practices, containment integrity and special risks to the Notification.

4 RESEARCHERS NEED TO KNOW WHAT INFORMATION TO SUBMIT AND HOW DO YOU DO IT?

WHAT INFORMATION IS NEEDED? Contained Use Field Trial Type of activity conducted Facility used Nature of LMOs being worked on Proposed transport of LMOs outside stated premises and precautions taken Disposal of LMOs Decontaminating equipment Actions and precautions taken to minimise risks posed by proposed activities Etc… Location LMO characteristics Size and scale of trial Survival capabilities of LMO Disposal of LMOs Decontaminating equipment Actions and precautions taken to minimise risks posed by proposed activities Etc… COMPULSORY Talking points: Different types of information is needed for the various types of activities. Examples of information needed are given in the slide. This will enable the evaluation.

SUBMISSION OF INFO Submission of information is subject to s67 of the Biosafety Act – offence to submit misleading or false information Applicant encouraged to provide supporting documents for information provided During assessment, JBK/GMAC/NBB may request for additional information/ clarifications or related documents Any delay in submission of requested info may result in withdrawal of acknowledgement (stop activity) COMPULSORY Talking points: It is an offence to submit misleading or false information Applicants are strongly encouraged to provide all supporting documents for the assessment or clarifications of the activity During the assessment, additional information may be requested by the DG of Biosafety/JBK, GMAC or the NBB Any delay in submission of requested information for Notification may result in withdrawal of acknowledgement. Any delay in submission of requested information by the NBB is an offence and may result in a penalty.

CONFIDENTIAL BUSINESS INFORMATION (CBI) Confidentiality can be claimed for the following: that the information is not known generally among, or readily accessible to, any person within the circle that normally deals with the kind of information sought to be made confidential (unpublished data…) that the information has commercial value because it is secret and that reasonable steps have been taken to keep the information secret COMPULSORY Talking points: 1. An applicant may declare any information as confidential, but it has to fulfill these 3 criteria 22

CRITERIA FOR CBI Any information which is to be treated as CBI should be clearly marked “CBI” in the relevant parts of the submitted forms and any other information given. The following information shall not be considered confidential: The name and address of the applicant A general description of the LMO A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and Any methods and plans for emergency response COMPULSORY Talking points: Any information that is CBI should be marked clearly as “CBI”. This includes any information in the form, any supporting documents, or any request for additional information. The following information will not be granted CBI for an application of approval. 23

RESEARCHERS NEED TO UNDERSTAND THE ROLE OF THE INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) IN THEIR RESPECTIVE INSTITUTES IN BEING COMPLIANT TO THE BIOSAFETY ACT 2007 5

INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) NBB Formal expert committee of an organization undertaking modern biotechnology R&D which involves use of any LMO/rDNA materials – to monitor & ensure compliance to the Biosafety Act 2007 at the institutional level and safe handling of modern biotechnology activities IBC IBC Chair BSO IBC members PI COMPULSORY Talking points: 1. Researcher need to understand the role and responsibilities of the IBC Laboratory Personnel

6 RESEARCHERS NEED TO BE AWARE OF THE VARIOUS RESOURCES AVAILABLE ABOUT BIOSAFETY THAT CAN BE REFERRED TO

BIOSAFETY PUBLICATIONS Can be downloaded at www. biosafety.nre.gov.my COMPULSORY Talking points: There are many biosafety guidelines available in the Department of Biosafety website. All these documents can be downloaded for free in pdf format.

7 RESEARCHERS NEED TO BE AWARE THAT SOME TECHNIQUES AND ACTIVITIES ARE EXEMPTED

EXEMPTIONS The Minister may, upon recommendation of the NBB, exempt from the application of any or all of the provisions of this Act any person, class of persons, activity, category of activities, LMO or products of such organism (s68) This list of Exemptions may be revised from time to time as necessary when more items are found to be safe and need not be regulated COMPULSORY Talking points: The Minister may exempt any provisions of the Act. This list of exempted items may increase from time to time. 29

FIRST SCHEDULE EXEMPTION Activities with LMOs that have been assessed over time as posing a very low risk Contained research involving very well understood organisms and processes for creating and studying LMOs Contained use only! Check conditions for Exemptions No release activity is exempted COMPULSORY Talking points: There are specific exemptions for contained use activity. These activities have low risk but must fulfill certain conditions.

First Schedule *can be downloaded at www. biosafety.nre.gov.my BIOSAFETY REGULATIONS (APPROVAL & NOTIFICATION) REGULATIONS First Schedule *can be downloaded at www. biosafety.nre.gov.my COMPULSORY Talking points: 1. More information for activities that are exempted in contained use may be seen in the First Schedule of the regulations.

EXEMPTED? THEN WHAT? NBB IBC IBC IBC JBK GMAC MODERN BIOTECHNOLOGY ACTIVITIES Release (Field Trial) Application for Certificate of Approval (Form A/Form B) IBC Contained Use Monitoring & Reporting to NBB via IBC Annual Report NBB YES Check for EXEMPTION IBC COMPULSORY Talking points: If your activity is exempted under the law, then it has to be reported to the IBC for monitoring. Further action of the researcher is not needed (no need to fill up the Form E) IBC will monitor and report these activities via the institute’s Annual Report. NO NOTIFICATION Form E IBC JBK GMAC

:Department of Biosafety Malaysia THANK YOU www.biosafety.nre.gov.my Email: biosafety@nre.gov.my : @DOBmy :Department of Biosafety Malaysia