The measure revised DOST-DA-DENR-DOH-DILG Joint Department Circular (JDC) No.1, Series of 2016, previously notified as G/SPS/N/PHL/373.
Changes include the creation of a Joint Assessment Group (JAG) tasked to evaluate biosafety permit applications and make recommendations on the approval of a biosafety permit application. The Circular reiterates the function of the Bureau of Plant Industry (BPI) in the processing of biosafety application permits. In compliance to the Ease of Doing Business (EODB) Law, the application procedure for securing a biosafety permit was shortened from 85 working days to 40 working days.
The new JDC provides that application for permits for regulated articles developed in other countries may be filed directly for a Biosafety Permit for Field Trial if BPI determines data set generated in other countries is applicable to the local setting. The JDC also only requires an applicant to publish a copy of the approved Public Information Sheet (PIS) in one newspaper of general circulation and in the official website of the applicant and of the Bureau of Plant Industry.
All biosafety permits for Commercial Propagation and Direct Use for Food and Feed or for Processing to be issued shall be valid unless revoked for:
1. Provision of misleading information in the Application;
2. Discovery of new, relevant, and significant information that the regulated article poses greater risks to human health and the environment compared to its conventional counterpart; 3. Non-compliance with the conditions of the permit; and
4. Other grounds that the regulatory agencies may deem necessary to protect human health and the environment.
The JDC includes a provision stating plants produced through conventional breeding of approved genetically modified parental lines and their derived products are not considered novel. Payment of fees is possible to cover the cost of re-evaluation of the decision made on applications. The Circular also provides regulated articles with existing original and renewed Biosafety Permits under the 2016 version of the document for Commercial Propagation and Direct Use shall remain valid unless otherwise revoked under conditions enumerated in Sections 15.J and Sections 18.J.
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