A CHANGE FOR A BETTER REGULATORY FRAMEWORK:
Virtual Consultations on the Review and Proposed Revisions on the DOST-DA-DENR-DOH-DILG Joint Department Circular#1 Series 2016
The Department of Science and Technology (DOST) through the National Committee on Biosafety of the Philippines (NCBP) held three stakeholders’ consultation on the proposed revision on the DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No. 1 series of 2016, the Rules and Regulations for the Research and Development, Handling and Use, Transboundary Movement, Release into the Environment, and Management of Genetically Modified Plant and Plant Products Derived from the Use of Modern Biotechnology last August 10, 18, and 24, 2021 via Zoom platform.
An Ad Hoc Technical Working Group (AHTWG) was created in May 2019 for the review of the Joint Department Circular#1 s2016. The AHTWG was composed of representatives from concerned Departments, research and academic institutions, collegial bodies, and stakeholders. They were tasked to identify sections and provisions in the Circular that need revisions to address the concerns in the implementation, and proposed changes that will fit into the Philippines’ regulatory set-up.
Supervising Science Research Specialist Mr. Reimond Corona of the NCBP Secretariat pointed out during the presentation that the basis of the review of the Joint Department Circular are: a) to comply with the Ease of Doing Business Law which states that for highly technical applications, the prescribed processing time shall not be longer than twenty (20) working days; b) delays in the issuance of Biosafety Permits; c) delays in the completion of evaluations by the agencies; and, d) non-synchronicity of single and stacked events applied for Direct Use.
Below are the proposed salient revisions on the JDC:
- Creation of Joint Assessment Group (JAG). The Department of Agriculture – Bureau of Plant Industry (DA-BPI) shall establish a Joint Assessment Group (JAG) composed of qualified representatives or personnel from the concerned Departments’ Biosafety Committees and external technical experts. The JAG shall evaluate applications for field trial, commercial propagation, and direct use to determine whether the regulated article does not pose greater risks to human health and the environment compared to its conventional counterpart, and make its recommendations to the BPI Director.” (Art. III, Section 6)
- Establishment of Bureau of Plant Industry Biotechnology Unit. The Department of Agriculture – Bureau of Plant Industry (DA-BPI) shall establish a Biotechnology Unit with dedicated staff to provide frontline services for the processing of applications for field trial, commercial propagation, and direct use permits. The BPI Biotechnology Unit shall also provide technical and administrative assistance to the Joint Assessment Group.
- Procedural Requirements for Securing a Biosafety Permit for Field Trial, Commercial Propagation, and Direct Use as Food and Feed or for Processing. The new procedures for securing a biosafety permit for Field Trial, Commercial Propagation, and Direct Use as Food and Feed or for Processing starting from the receipt of complete application documents up to the issuance of biosafety permit will be covered within 40 working days. However, request for extension of the timeframe for highly technical application under the Ease of Doing Business Law will be made to the Anti-Red Tape Authority (ARTA).
- Policy on Field Trial of Regulated Articles. Application for permits for regulated articles developed in other countries may be filed directly for a Biosafety Permit for Field Trial if the BPI determines that the date set generated on the field trial conducted and/or commercial propagation experience in other countries are applicable to the local setting.
- Posting of Public Information Sheet for Field Trial Applications. In consultation with the LGU(s), the applicant shall post the Public Information Sheet (PIS) in at least two (2) conspicuous places within the vicinity of the city/municipality and at least two conspicuous places within the vicinity of the barangay where the proposed field trials will be conducted. Posting shall be done at least ten (10) working days prior to the public hearing…” (Art. V, Section 13.C)
“Comments may be sent by personal delivery, registered or ordinary mail, courier service, or electronic mail, but must be received by the office of the Director within the ten (10)-working-day posting period….” (Art. V, Section 13.D)
- Publication of Public Information Sheet for Commercial Propagation and Direct Use for Food and Feed or for Processing. The applicant shall publish a copy of the approved PIS for Commercial Propagation in one (1) newspaper of general circulation. The approved PIS shall also be published on the official website of the applicant and the official website of the BPI.
The applicant shall publish a copy of the approved PIS for Direct Use in one (1) newspaper of general circulation. The approved PIS shall also be published on the official website of the applicant and the official website of the BPI.
- Validity of Biosafety Permits for Commercial Propagation and Direct Use. The Biosafety Permit for Commercial Propagation shall be valid unless revoked for any reasons under Section 15.J. Revocation of Biosafety Permit for Commercial Propagation.
The Biosafety Permit for Direct Use shall be valid unless revoked for any reasons under Section 15.J. Revocation of Biosafety Permit for Direct Use.
- Genetically Modified Plants and Plant Products with Stacked Events. Plants produced through conventional breeding of parental lines containing approved individual genetically modified events and their derived products do not require separate regulatory assessment. The BPI can be requested to list stacked events in the BPI Approval Registry for Commercial Propagation or BPI Approval Registry for Direct Use, as the case may be (Section 20. Registration of stacked events).
- Petition for Reconsideration. In case of an application for field trial, commercial propagation, and direct use, an aggrieved party may request for a reconsideration of the decision to the DA Secretary within 15 working days from the announcement of the decision.
The petition for reconsideration may involve payment of fees to cover the cost of re-evaluation of the decision made.
- All existing original and renewed Biosafety Permits for commercial propagation and direct use issued therein shall be valid unless otherwise revoked under conditions set in Section 15.J for Commercial Propagation and Section 18.J for Direct Use of this new JDC.
- This JDC shall take effect 15 days after its publication in two newspapers of general circulation. A copy of this issuance shall also be submitted to the University of the Philippines Law Center.
During the three (3) series of consultations, concerns and some clarificatory questions were raised pertaining to the doability and practicality of the shortened timelines, citing specifically the public consultations/hearings for field trials, which some believe is not enough to generate comments from stakeholders. Another related issue is the whole process itself citing that with the current institutional set-up, it may not be possible to come up with the decision within the time frame – 40 days- allotted for the purpose. However, these concerns and questions were also addressed by the Technical Working Group with assistance from the NCBP Secretariat.
While the revised JDC provides for a streamlined process in handing applications on GMOs, the roles and responsibilities of each concerned departments/agencies in the decision-making process are clearly defined. In addition, transparency and public participation continues to be an essential component of the regulatory process as government departments are committed in adhering with the policies on transparency and accountability by providing accurate information in a timely manner.