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GUIDELINES IN MAKING PUBLIC ANNOUNCEMENT FOR APPLICATION FOR APPROVAL (RELEASE ACTIVITIES)

Objective The purpose of this Guideline is to assist applicant in inviting the public to participate and give their comments/views/opinion/queries with regard to the application for approval for release activities. This is to comply with the provision under Biosafety Act 2007 [Subsection 14(c) and Subsection 16(3)]. The Requirements for Public Announcement The following are the guidelines need to be followed in making public announcement of the application:

1) Public announcement is in the form of a standard notice published at minimum

in 4 relevant newspapers (i.e. one Bahasa Melayu newspaper, one English newspaper, one in Tamil newspaper, and one in Mandarin newspaper) with nationwide coverage (public announcement in Tamil and Mandarin newspaper are to be made using national language, Bahasa Melayu). Size of the newspaper announcement must be a minimum of 8 cm (height) X 3 columns (approximately 9.6 cm width).

2) Notice shall be made two times in the chosen newspapers at a two week

interval [e.g. 1 August 2013 (first announcement), and 15 August 2013 (second announcement)].

3) The applicant shall provide a scanned copy of the public announcement notice

from each newspaper (i.e. one in Bahasa Melayu newspaper, one in English newspaper, one in Tamil newspaper, and one in Mandarin newspaper) for first and second announcement to the Department of Biosafety by email for records.

4) The applicant shall bear the cost of public announcement.

5) The applicant will prepare the draft of the notice and submit to the Director

General for approval as well as inform the dates of proposed newspaper announcement. Please refer to the Appendix 1 for the sample of announcement.

6) The notice will also be placed on the biosafety website

(www.biosafety.nre.gov.my) to invite public comments.

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7) The notice must contain at minimum the following details:

a) Full name of applicant b) Description of the Living Modified Organism (LMO) or product of such

organism that is proposed to be released (e.g. common name and scientific name)

c) A request that the public submit their written opinions/comments through

email or letter to the Director General within 30 days from the time of the first advertisement. Submissions must be addressed to:

The Director General, Department of Biosafety, Ministry of Natural Resources and Environment, Level 1, Podium 2, Wisma Sumber Asli,

No. 25, Persiaran Perdana, Precinct 4, 62574 Putrajaya, MALAYSIA. Email: biosafety@nre.gov.my. Fax: 03-88904935.

d) A statement informing that the public may access additional information

about the release at the biosafety website (www.biosafety.nre.gov.my)

8) The applicant shall provide the public with necessary information pertaining to the LMO to be released. These information must be prepared in the form of fact sheet (in Bahasa Melayu and English) and should contain the following details:

a) What is the application for?

b) What is the purpose of the import and release?

c) How has the LMO been modified?

d) Characteristics of LMO

Details of the parent organism

Details of the donor organism

Description of the trait(s)and characteristic which have been introduced

or modified

e) Modification method

Characterization of the modification

Safety of the expressed protein

f) Assessment of risks to human health

Nutritional data

Toxicology

Allergenicity

g) Assessment of risks to the environment

h) What is the emergency response plan?

First aid measures

Accidental release measures

Handling and storage

Disposal considerations

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9) The applicant will have to submit the draft fact sheet (in word) together with the draft notice to the Director General for approval. The final fact sheet will be uploaded on the biosafety website for public reference. The applicant may refer to the Appendix 2 or the biosafety website for sample of the fact sheet.

10) The Director General collates all submission of public comments or queries received from the public about the application and shall forward it to the applicant weekly.

11) The applicant shall provide a written reply to the submission of public

comments or queries to the Director General through email or letter within 7 days of receipt of the public comments or queries. The Director General will inform the public accordingly in an appropriate manner.

12) The public comments or queries and response by the applicant to the said

comments or queries shall be reviewed by the National Biosafety Board in the process of making a decision on the application.

Appendix 1

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FIGURE 1: EXAMPLE OF PUBLIC ANNOUNCEMENT FOR RELEASE ACTIVITY FOR SUPPLY OR OFFER TO SUPPLY FOR SALE/PLACING IN THE

MARKET (ENGLISH)

This is to inform the public that the National Biosafety Board (NBB) is currently assessing an application for approval submitted by <company name/applicant’s name*> to release <common name and scientific name of LMO*> for the purpose of supply or offer to supply for sale/placing in the market product <name/type of the product*> with the Reference Number of NBB: JBK(S) 602-1/1/X*. NBB welcomes written submissions of opinions/comments from the public regarding the application.

More information on the application can be obtained from www.biosafety.nre.gov.my

under Public Consultation. Please quote NBB Reference number for correspondence. Submissions must be addressed to: The Director General, Department of Biosafety, Ministry of Natural Resources and Environment, Level 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Precinct 4, 62574 Putrajaya, MALAYSIA. Email: biosafety@nre.gov.my / Fax: 03-88904935 The closing date for submissions is <30 days from the date of first announcement*>. * To be filled by applicant

Appendix 1

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FIGURE 2: EXAMPLE OF PUBLIC ANNOUNCEMENT FOR RELEASE ACTIVITY

FOR SUPPLY OR OFFER TO SUPPLY FOR SALE/PLACING IN THE MARKET

(BAHASA MELAYU)

Orang ramai adalah dimaklumkan bahawa Lembaga Biokeselamatan Kebangsaan (LBK) pada ketika ini sedang membuat penilaian ke atas permohonan untuk mendapatkan kelulusan yang dipohon oleh <nama syarikat/pemohon*> untuk melepaskan <nama biasa dan nama saintifik organisma diubahsuai yang hidup*> bagi tujuan pembekalan atau tawaran untuk membekalkan/menjual di pasaran produk <nama produk / jenis produk*> Nombor Rujukan LBK: JBK(S) 602-1/1/X*. LBK mengalu-alukan pandangan/komen bertulis daripada orang ramai berhubung dengan permohonan tersebut. Maklumat lanjut tentang permohonan boleh di dapati daripada

www.biosafety.nre.gov.my di bawah Konsultasi/Perundingan Awam. Sila nyatakan

Nombor Rujukan LBK apabila berhubung dalam semua surat-menyurat. Segala pandangan/komen hendaklah dialamatkan ke: Ketua Pengarah, Jabatan Biokeselamatan, Kementerian Sumber Asli dan Alam Sekitar, Aras 1, Podium 2, Wisma Sumber Asli, No. 25, Persiaran Perdana, Presint 4, 62574 Putrajaya, MALAYSIA.

Emel: biosafety@nre.gov.my / Faks: 03-88904935

Tarikh tutup serahan adalah pada <30 hari dari tarikh pengumuman pertama*>. * Untuk diisi oleh pemohon

Appendix 2

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FIGURE 3: EXAMPLE OF FACT SHEET FOR RELEASE ACTIVITY FOR SUPPLY OR OFFER TO SUPPLY FOR SALE OR PLACING IN THE MARKET (ENGLISH)

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FIGURE 4: EXAMPLE OF FACT SHEET FOR RELEASE ACTIVITY FOR SUPPLY OR OFFER TO SUPPLY FOR SALE OR PLACING IN THE MARKET (BAHASA MELAYU)

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