(NAR) VOL. 10 NO. 1 / JANUARY - MARCH 1999
(a) | work performed under contained conditions; |
(b) | accidental releases from contained facilities; |
(c) | use of pharmaceutical, processed food, animal feed, industrial, and other products that are already being regulated by other departments, agencies or instrumentalities of the Philippine government; |
(d) | working involving organisms which result from natural reproduction or the use of traditional breeding practices; |
(e) | such other activities as the CNBP may in the future declare to be excluded. |
Members | 1 biological scientist |
1 environmental scientist | |
1 physical scientist | |
1 social scientist | |
2 respected members of the community | |
1 representative each from the Department of Agriculture, Department of Environment and Natural Resources and Department of Health, to be designated by the respective Heads of Offices |
a) | Identify and evaluate potential hazards involved in initiating genetic engineering experiments or the introduction of GMOs and PHES and recommend measures to minimize risks; |
b) | Formulate, review or amend national policies and guidelines on biosafety, such as, the safe conduct of work on genetic engineering, pests, and their genetic materials, for the protection of public health, environment and personnel, and supervise the implementation thereof; |
c) | Formulate, review or amend national policies and guidelines in risk assessment of work in biotechnology, and supervise the implementation thereof; |
d) | Develop working arrangements with the government quarantine services and institutions in the evaluation, monitoring and review of projects vis-a-vis adherence to national policies and guidelines on biosafety; |
e) | Assist in the development of technical expertise, facilities, and other resources for quarantine services and risk assessments; |
f) | Recommend the development and promotion of research programs to establish risk assessment protocols and assessment of long-term environmental effects of biological research covered by these guidelines; |
g) | Publish the results of internal deliberations and agency reviews of the Committee; |
h) | Hold public deliberations on proposed national policies, guidelines and other biosafety issues; |
i) | Provide assistance in the formulation, amendment of pertinent laws, rules and regulations; |
j) | Call upon the assistance in the formulation, amendment of pertinent laws, rules and regulations; |
k) | Review the appointment of the members of the IBC upon recommendation by respective heads of institutions; and |
l) | Hold discussions on the comparative ecological, economic and social impacts of alternative approaches to attain the purposes or objectives of the proposed genetically modified products, services, or both. |
3.2.1 | Composition of the IBC — The IBC shall be composed of at least five (5) members, all of whom must first be approved by the NCBP. At least three (3) members shall be designated as the "scientist-members", and they must posses scientific or technological knowledge and expertise sufficient to enable them to evaluate and monitor properly any work involving GMOs or PHES conducted by the institution. The other members, who shall not be less than two and who shall be designated as "community representatives", must not be affiliated with the institution (apart from their affiliation with the IBC) and must be in a position to represent the interests of the communities surrounding the institution or which may be affected by the planned release. |
3.2.2 | Responsibilities of the IBC Specific to Planned Release — With regard to planned release of GMOs or PHES, the IBC shall have the following responsibilities: |
(a) | Undertake the assessment and review of all planned release proposals to identify potential hazards to human health and the environment and to advise the Project Leader on their proper management; |
(b) | Review the qualification and experience of personnel involved in potentially biohazardous projects; |
(c) | Ensure competence, acceptable professional practices and adequate supervision of project staff; |
(d) | Take necessary steps to inform the public of the proposed planned release and provide the public the opportunity to comment, including, but not limited to, the conduct of public hearings, if so warranted; |
(e) | Submit to the NCBP all required project documents for review and approval; |
(f) | Ensure that all communications from the NCBP are conveyed to and, if applicable, complied with by the Project leader; |
(g) | Ensure that all relevant regulatory agencies have been consulted and necessary permits, licenses or approvals have been obtained before any planned release is made; |
(h) | Visit the release site periodically to monitor and evaluate the biosafety of on-going projects and recommend additional safety measures, if necessary; |
(i) | Notify immediately the NCBP of any accidents or incidents arising from or related to the planned release activity; |
(j) | Keep records of all procedures, decisions and directives relative to the planned release; |
(k) | Submit a terminal report to NCBP at the end of the planned release project; and |
(l) | Submit annual reports to the NCBP, as provided for under Section 3.2.4 hereof. |
3.2.3 | Authority to Formulate Rules — The IBC shall have the power to draft rules and regulations to supplement this Monograph. These rules and regulations may include, but are not limited to, containment procedures and operations and the handling, transport and storage of GMOs and PHES by and within the institution. |
3.2.4 | Annual Report — The IBC shall submit a report to the NCBP not later than the 15th day of March of each year. The report shall be for the period January to December of the preceding year, and shall include the following information: |
(a) | Composition of the Committee; |
(b) | Planned release activities conducted during the year, including any changes of Project Leaders; |
(c) | Modifications in the planned release activities vis-a vis the original proposals submitted to the NCBP; |
(d) | Description of unexpected results from planned release work and its adverse impact to health or the environment; |
(e) | Description of accidents or incidents attributable to the planned release work and the adverse effects thereof; and |
(f) | Any other matters which the IBC may wish to bring to the attention of the NCBP. |
3.2.5 | IBC of Small Institutions — The NCBP recognizes the difficulty that small institutions may have in setting up a comment IBC due to the limited number of scientists who can serve in the IBC. Hence, subject to the prior approval of the NCBP, potentially biohazardous activities of these institutions may be supervised by the IBC from another institutions. However, this arrangement, which shall be in writing, must specify, among others, the following: (i) that the Heads of both institutions shall be jointly responsible in ensuring compliance with these guidelines; and (ii) that a senior member of the supervised institution shall liaise closely with the supervising IBC throughout the conduct of the proposed activity. |
(a) | creating an IBC and providing it with resources necessary to enable it to evaluate and monitor properly projects involving GMOs or PHES; and |
(b) | making sure that necessary resources are provided to employees or researchers for safe work within and outside the institution. |
(a) | Prepare the project proposal in accordance with Annex "B" and submit the same to the IBC for proper action; |
(b) | Conduct an initial evaluation of the project proposal to determine if the same falls within the coverage of the Guidelines. In case of doubt, the Project Leader shall consult the IBC; |
(c) | Provide any information on the project proposal and its conduct which the IBC may require for its assessment and monitoring activities; |
(d) | Comply with NCBP and IBC advice and recommendations on the project proposals; |
(e) | Carry out work under conditions approved by the IBC and NCBP; |
(f) | Ensure that all members of the project staff are aware of any potential hazards of the work and that they have received appropriate training in safety and emergency procedures; |
(g) | Notify the IBC of all changes in the conduct or composition of the project staff involved in the planned release work; |
(h) | Report immediately to the IBC all unexpected results or accidents and unexplained illnesses or absences of personnel which may be attributed to the planned release; |
(i) | Advise the IBC of any intention to import or transport biological materials covered by the Philippine Biosafety Guidelines; |
(j) | Keep such records as are appropriate for each planned release; and |
(k) | Submit a terminal report to the IBC at the end of the project. |
(a) | The project proposals shall be in writing and in accordance with the format. The proponent must answer all questions including the sub-questions, if relevant to the proposal. The answer must be supported by data and relevant scientific literature, all of which shall be appended to the proposal. The proponent must disclose all data or literature that allude to potential adverse effects on human health or the environment by the GMO or PHES to be used. |
(b) | If the project proposal contains any information which the proponent wishes to be kept confidential, the pages containing such information shall be conspicuously marked as "Commercia-in-Confidence". The proponent shall specify in writing why the marked pages should be held in confidence. However, no information pertaining to the potential adverse effects of the organisms on human health or the environment shall be considered confidential. |
(c) | |
The IBC may require the proponent to state in his or her project proposal any information in addition to those required by the NCBP. |
(a) | The IBC shall evaluate the project proposal using the rational risk benefit analysis outlined in Part III. Specifically, the IBC shall evaluate whether data obtained in the laboratory or under contained conditions provide sufficient basis to authorize a planned release of the GMO or PHES into the environment. In making such an evaluation, the IBC must ensure that the planned release does not pose any unnecessary risks to the environment or human health. |
(b) | During the evaluation, the IBC shall consult and discuss with the proponent and, when appropriate, make suggestions for revisions. The IBC may, in its sole discretion, require the proponent to perform additional experiments under contained conditions before acting on the project proposal. |
(c) | The IBC may engage the services of consultants who are experts in the scientific disciplines relevant to the proposed planned release or knowledgeable in the policies of the institution, relevant laws, standards of professional conduct or practice, community attitudes and practices, and the potential environmental and human health impact of the proposed activity. All expenses for consultant services shall be for the account of the proponent, unless the IBC agrees to be liable therefor. |
(d) | After the evaluation, the IBC shall either recommend approval of the project proposal to the NCBP or reject the proposal for failing the rational risk-benefit analysis. |
(a) | Approval by a majority of the IBC members, which must include at least one community representative, shall be necessary before any project proposal may be endorsed for approval by the IBC to the NCBP. Dissenting members of the IBC must indicate the reasons for disapproving the proposal. | |
(b) | The IBC endorsement shall be submitted to the NCBP in twelve (12) copies, and shall include the following: | |
(i) | Cover sheet, in accordance with the format. | |
(ii) | project proposal and its attachments; | |
(iii) | Information sheet for public notification/comment; | |
(iv) | biodata of all individuals involved in the project. | |
The NCBP reserves the right not to act on any project proposal or endorsement which does not comply with the prescribed format or fails to include all the required attachments. | ||
(c) | Materials marked as Commercial-in-Confidence proponent shall be treated as such by the NCBP, unless (i) they contain information pertaining to the potential in adverse effects of the organisms on human health or the environment or (ii) the NCBP, in its sole discretion, determines that there is nothing propriety with the information as would require confidentiality. In the event that the NCBP decides that some disclosure is necessary, the NCBP shall notify the proponent in writing for the purpose of negotiating an acceptable resolution. If agreement is not reached, the proponent must withdraw the proposal; in which case, the NCBP shall be duty bound not to disclose the information deemed confidential by the proponent. |
(a) | Upon receipt of the proposal from the NCBP Secretariat, the NCBP shall create a Scientific and Technical Review Panel (STRP) to evaluate potential adverse effects of the project to human health and environment. The STRP shall be appointed by the Chairman of the NCBP. It shall be composed of at least three (3) members drawn, if possible, from the pool of experts listed in the sectoral councils of the Department of Science and Technology. As far as practicable, no member of the NCBP shall be part of the STRP. |
(b) | The STRP shall be provided copies of the project proposal after they have executed an undertaking to maintain and respect the confidentiality of information declared by the proponent, and approved by the NCBP its recommendations in writing not later than thirty (30) days from receipt of the project proposal from the NCBP Secretariat. |
(a) | Concurrent with the review by the STRP, the NCBP, acting through the IBC, shall take steps to notify the public of the planned release and to invite comments thereon. The following shall be the procedure for the public notification and comment: | |
(i) | The IBC shall post, for three (3) consecutive weeks, the NCBP-approved Project Information Sheet for Purpose of Public Comment/Notification in at least three (3) conspicuous places in the barangay(s) where the test site is located or which may be affected by the proposed release. Proof of posting, which may either be a certification from the duly authorized barangay leader(s) or an affidavit executed by the Project Leader, shall be submitted to the NCBP within ten (10) days from the last day of posting. | |
(ii) | In addition, the IBC shall publish the Project Information Sheet once a week for at least two (2) consecutive weeks in a newspaper of general circulation in the areas where the test site is located or which may be affected by the planned release. Proof of publication, consisting of the Affidavit of Publication duly executed by the publisher of the newspaper or any of his representatives, shall be submitted to the NCBP within ten (10) days from the last day of publication. | |
(iii) | If in the judgment of the IBC, the proposed planned release carries potentially significant risks to human health and the environment, the IBC shall conduct a public hearing not later than ten (10) days from the last day of publication of the Project Information Sheet as required under Section 4.7 (a)(ii) above. | |
(b) | The IBC shall allow at least thirty (30) days from the last posting, the publication or the public hearing, whichever comes later, for the public to comment on the proposed planned release. The public shall be asked to direct all its inquiries to the proponent, whose name and complete address shall be stated in the Project Information Sheet. The proponent shall provide additional information about the project to any requesting party not later than (10) days from receipt of such request. | |
(c) | All comments on the proposed planned release shall be sent by personal service, courier or registered mail to: The Secretariat, National Committee on Biosafety Committee of the Philippines, Department of Science and Technology, Gen. Santos Avenue, Bicutan, Taguig, Metro Manila. | |
(d) | The NCBP shall collate and forward all public comments to the IBC for appropriate response. The proponent, through the IBC, shall respond, in writing to all public comments within fifteen (15) days from receipt thereof. The IBC shall furnish the NCBP a copy of all its responses within the same period. | |
(e) | The proponent, if he so desires, may amend his or her proposal in response to the public comments. The amendments to the project proposal, public comments and the responses thereto shall be immediately transmitted to the NCBP and shall form part of the record to be used by the NCBP in its deliberations. | |
(f) | All expenses incurred in the public notifications and comment shall be for the account of the proponent. |
(a) | In the event that no public comment has been received, the NCBP shall act on the proposal for planned release within sixty (60) days from the end of the period for public comment. Otherwise, it shall act on the proposal within sixty (60) days from submission of the documents mentioned in Section 4.7(e) above. | |
(b) | The NCBP shall base its evaluation on the following: | |
(i) | Project proposal, including amendments and attachments; | |
(ii) | IBC Assessment; | |
(ii) | Comments and recommendations of the STRP; | |
(iv) | Public comments; | |
(v) | Such other documents or information, from whichever source, deemed relevantly by the NCBP. | |
(c) | The NCBP shall notify the proponent in writing of its decision. Approval may be subject to conditions such as, but not limited to, a detailed description of the planned release and mitigating measures, specific time period for release, specific geographical areas for use as test sites, and additional monitoring and reporting requirements. If the proposed activity requires a permit or authority from other government regulatory agencies, and the issuances of the same is conditioned upon approval of the project proposal by the NCBP, the NCBP shall issue an endorsement to facilitate the issuance of the said permit or authority. In case a project proposal is disapproved, the NCBP shall state the reason or reasons for disapproval. |
5.1 | Monitoring — (a) The IBC and appropriate government authorities shall monitor the planned release. The IBC shall submit to the NCBP the results of monitoring activities at intervals specified in the NCBP approval. |
(b) | In accordance with agreements with line agencies, (i) the Department of Agriculture shall be responsible for monitoring the movement and effects of GMOs or PHES approved for release; (ii) the Department of Environment and Natural Resources shall be responsible for monitoring the environmental effects of the planned release; and (iii) the Department of Health shall be responsible for monitoring the effects of such release to human health. |
(c) | The NCBP may inspect the release site(s) at any time. Site inspections shall be carried out in such a manner as to avoid interfering with the activities of the proponent, unless intervention is necessary to avert any imminent danger to human health or the environment. |
5.2 | Reports — (a) Within ninety (90) days from completion of the planned release, the proponent shall submit to the IBC, for review, a detailed terminal report on the project. The report shall specify, among others, whether the objectives of the release were achieved the nature and consequences of the adverse effects, if any of the release; and the fate of the GMO or PHES after the release. |
(b) The IBC shall review the terminal report of the proponent and endorse the same to the NCBP. It shall also submit its own report to the NCBP in accordance with the format. Both the proponent's report and that of the IBC shall be submitted by the IBC to the NCBP not later than one hundred twenty (120) days from completion of the planned release. | |
(c) The NCBP may require the IBC to submit follow-up reports on the long-term effects of the planned release. | |
(d) In case of any accident or untoward incident that may put human health or the environment at risk, the proponent shall immediately report the same to the IBC and the NCBP. The report shall describe the accident or untoward incident, the actions taken to mitigate it, and the persons and government authorities notified. In no case shall reporting the accident or untoward incident to the NCBP relieve the proponent and the institution of their obligation under the law. |
6.1 | Grounds for Revocation of Approval — The following are the grounds for revocation by the NCBP of any project approval: |
(a) Failure of the proponent to comply with the Philippine Biosafety Guidelines or any of the conditions imposed by the NCBP for approval of the project, including, but not limited to failure to adhere to restrictions and schedule of activities and protocols imposed by the NCBP; | |
(b) Receipt by the NCBP of reliable data or information indicating that the planned release may pose a threat to human health or the environment; and | |
(c) Such other grounds as the NCBP may deem reasonable to protect human health or the environment. | |
6.2 | Procedure for Revocation — (a) The NCBP shall advise the proponent in writing of the existence of grounds to revoke the project approval. The proponent shall have an inextendible period of ten (10) days within which to explain in writing why the approval should not be revoked. The NCBP shall render its decision within ten (10) days from receipt of the explanation of proponent. |
(b) In case of imminent danger to human health or the environment, the NCBP Chair may immediately revoke any project approval on his or her own accord, without need of consulting the other members. Thereafter, the NCBP, after deliberation, shall either confirm or lift, in writing, the revocation order issued by the Chair. The NCBP shall have sixty (60) days therefrom to furnish the proponent a written explanation of its action. | |
6.3 | Effect of Revocation — In the event of revocation, any permit or authority issued by other government authorities on the strength of the previous NCBP approval may also be revoked immediately. Further the NCBP may order the proponent or any government authority to destroy the GMO or PHES. |