The document outlines the legislative and regulatory framework for licensing radioactive materials in the Philippines. It describes the laws and regulations governing the Philippine Nuclear Research Institute (PNRI) and its mandate to license radioactive material. The document reviews the Code of PNRI Regulations, which consists of 27 parts establishing the regulatory requirements. It discusses the basic licensing process and requirements for obtaining, renewing, amending, and terminating a radioactive materials license in the Philippines.

1. Presented by:
Ma. Elina Salvacion Kristina V. Ramo
Licensing Review and Evaluation Section
Nuclear Regulatory Division, PNRI

2. Outline
• Legislative and regulatory framework
• The Code of PNRI Regulations
• Basic licensing requirements
• Renewal, amendment, & termination of license
• Personnel Requirements
• Updates
• Review of Forms

3. Philippine Nuclear Research Institute
Laws
Standards,
Rules and
Regulations,
Admin. Orders
Guides, Regulatory
Bulletins, Information Notice
• Republic Act 2067 known as the Science Act of 1958 creating the
Philippine Atomic Energy Comission (PAEC)
• Republic Act 5207 of 1968 also known as An Act Providing for the
Licensing and Regulation of Atomic Energy Facilities and
Materials
• Executive Order 128 of 1987 reorganizing the PAEC to the PNRI
• Code of PAEC/PNRI Regulations (promulgated by PAEC/ PNRI
Director)
• consists of Parts 0-27
• covers radiation protection, transport, security and fees
and practice specific administrative and safety requirements
• Based on IAEA and USNRC CFR & Guides
LEGISLATIVE AND REGULATORY FRAMEWORK

4. 4
REGULATORY MANDATE OF PNRI
The Science Act of 1958 ( 55 yrs old), RA 2067, as amended by RA 3589
• “AN ACT TO INTEGRATE, COORDINATE, AND INTENSIFY SCIENTIFIC AND TECHNOLOGICAL RESEARCH AND
DEVELOPMENT AND TO FOSTER INVENTION; TO PROVIDE FUNDS THEREFOR; AND FOR OTHER PURPOSES”
Atomic Energy Regulatory & Liability Act of 1968 ( 45 yrs old), RA 5207, PD 1584
• “AN ACT PROVIDING FOR THE LICENSING AND REGULATION OF ATOMIC ENERGY FACILITIES AND MATERIALS,
ESTABLISHING THE RULES ON LIABILITY FOR NUCLEAR DAMAGE, AND FOR OTHER PURPOSES”
Executive Order 128 of 1987 for DOST
• “REORGANIZING THE NATIONAL SCIENCE AND TECHNOLOGY AUTHORITY”

5. Philippine Nuclear Research Institute
THE PNRI STRUCTURE
Finance and
Administrative
Division
• Human Resource
Management and
Records and
Communication Section
• Budget Section
• Accounting
Section
• Property and
Procurement
Section
• Cash Section
• General Services
Section
Atomic
Research
Division
• Agriculture Research
Section
• Biomedical Research
Section
• Health Physics
Research
Section
• Applied Physics
Research Section
• Chemistry Research
Section
• Nuclear Materials
Research
Section
Nuclear
Services
Division
• Nuclear Reactor
Operation
Section
• Engineering Services
Section
• Irradiation Services
Section
• Radiation Protection
Services
• Nuclear Analytical
Techniques Application
Section
• Isotope Techniques
Section
Nuclear
Regulatory
Division
• Regulations and
Standards
Development
Section
• Licensing, Review and
Evaluation Section
• Inspection and
Enforcement
Section
• Nuclear Safeguards and
Security
Section
• Radiological Impact
Assessment
Section
Technology
Diffusion
Division
• Nuclear Training Center
• Nuclear Information
and Documentation
Section
• Business Development
Section
• MIS and IT
Section
Office of the Director Planning Section
Office of the Deputy Director
Department of Science and Technology
International Cooperation
Section

6. Philippine Nuclear Research Institute
NRD STRUCTURE
Nuclear
Safeguards and
Security
Section
Regulations and
Standards
Development
Section
Licensing,
Review and
Evaluation
Section
Radiological
Impact
Assessment
Section
Inspection and
Enforcement
Section
Nuclear Regulatory Division

7. Philippine Nuclear Research Institute
CODE OF PNRI REGULATIONS
Document
Code
Document Title
CPR PART 0 PNRI as Regulatory Agency and General Information
CPR PART 2 Licensing of Radioactive Materials
CPR PART 3 Standards for Protection Against Radiation
CPR PART 4
Rules and Regulations on the Safe Transport of Radioactive Materials in
the Philippines
CPR PART 11
Licenses for Industrial Radiography and Radiation Safety Requirements
for Radiographic Operations
CPR PART 12 Licenses for Medical Use of Radioactive Sources in Teletherapy
CPR PART 13 Licenses for Medical Use of Radiopharmaceuticals
CPR PART 14 Licenses for Medical Use of Radioactive Sources in Brachytherapy
CPR PART 15 Licenses for Large Irradiators
CPR PART 16
Licenses for the Use of Radioactive Sources Contained in Industrial
Devices

8. Philippine Nuclear Research Institute
CPR PART 17
Licenses for Commercial Sale and Distribution of Radioactive
Materials
CPR PART 18
Licenses for Use of Radioactive Materials in Research and
Education
CPR PART 20 Licenses to Manufacture and Dispense Radiopharmaceuticals
CPR PART 21
Licensing and Safety Requirements of Particle Accelerator
Facilities for the Production of Radioisotopes
CPR PART 22
Fees and Charges for Radioactive Material Licenses and Other
Related Regulatory Services
CPR PART 23 Licensing Requirements for Land Disposal of Radioactive Waste
CPR PART 25 Licenses for Commercial Providers of Nuclear Technical Services
CPR PART 26 Security of Radioactive Sources
CPR PART 27 Security Requirements in the Transport of Radioactive Material
CODE OF PNRI REGULATIONS

9. Philippine Nuclear Research Institute
Sec. 3, CPR Part 2
Activities Requiring a License
• no person shall manufacture, produce, transfer , sell, receive ,
acquire , own, possess, use, import or export radioactive material
except as authorized in a license issued pursuant to the rules and
regulations

10. Philippine Nuclear Research Institute
Application for RAM License
• must be filed in proper form, PNRI/NRD Form-013 including attachments
• accomplished application form must be affirmed and notarized
• must pay application file/filing fee (CPR Part 22)
• Submit SEC registration and current business permit issued by responsible local
govt. agency
• PNRI may, at any time after the filing of the application, require further
information necessary to enable PNRI to determine whether the application
should be granted or denied.

11. Philippine Nuclear Research Institute
Basic licensing/safety requirements
• Qualified personnel by training and experience
• Description of radioactive material
• Adequately designed facilities, equipment and instruments
• Availability of appropriate radiation monitoring devices and instruments
• Classification and posting of areas
• Radiation safety and security programs/procedures

12. Renewal of License
• Application for renewal of license shall be filed not less than thirty (30)
days prior to the expiration of the existing license;
• a licensee shall file an application in proper form for renewal;
• Such existing license shall remain valid until the application for renewal
has been finally determined by the Institute, but in no case shall be
more than 30 days after the expiration of the license.

13. What to submit for license renewal
• Accomplished application form
• License renewal fee
• Annual Report on the Use of Radioactive Material
• Summary of Doses Received by Personnel (Annual)
• In case of renewal with amendment, submit necessary documents

14. Amendment of License
- can be requested by the licensee anytime within the validity period of the
license
Amendment shall be requested before (Section 9, CPR Part 13):
• Receipt and use of radiopharmaceuticals for clinical procedures other than what
is permitted under the license;
• Procurement of radiopharmaceuticals in excess of the authorized maximum
possession limit or in a form other than previously authorized.
• Permitting anyone to work as an RSO, ARSO, authorized user, medical physicist
or nuclear medicine technologist
• Change or addition of location of use or storage of radioactive materials
• Implementation of a major change in the Radiation Safety Program
• Any substantial change in license conditions, in consultation with PNRI

15. Termination of License
- Procedure for terminating a license may be initiated at any time at the request of
the licensee
Before the license can be terminated, the licensee must (CPR Part 13, Section 12):
- discontinue all activities involving radioactive materials
- transfer or dispose of licensed materials which were in his possession in accordance with the
regulations
- determine by survey or other means that no contamination levels in excess of the limits for
controlled areas
- Assure that the required records are complete and up-to-date

16. Personnel Requirements for Nuclear Medicine
• Radiation Safety Officer (RSO) and Assistant RSO
• Authorized User
• Medical Physicist
• Nuclear Medicine Technologist

17. Requirements for RSO and Assistant RSO
Section 38 of CPR Part 13: Education and Training Requirements
- Endorsed by radiation safety committee
- holds a Bachelor’s degree in natural science, physical science or
engineering, duly licensed by the Philippine Professional Regulations
Commission, if applicable
- completed 200 hours of PNRI-approved classroom training in basic
radionuclide handling techniques
- has at least one (1) year of relevant fulltime experience on radiation safety
under the supervision of an individual identified as an RSO.

18. Requirements for Nuclear Medicine Technologists
Section 41 of CPR Part 13: Education and Training Requirements
- Endorsed by radiation safety committee
- holds a Bachelor’s degree in allied health courses, duly licensed by the
Philippine Professional Regulations Commission
- completed 200 hours of PNRI-approved classroom training in basic
radionuclide handling techniques
- has at least six (6) months of relevant fulltime experience in nuclear
medicine activities under the supervision of an individual identified as a
nuclear medicine technologist.

19. Updates
Extended Validity of Licenses
AO no. 1 – 2017 EXTENDING THE VALIDITY PERIOD OF RADIOACTIVE MATERIAL LICENSES
AO no. 2 – 2017 NEW SCHEDULE OF FEES FOR RAM LICENSE WITH EXTENDED VALIDITY PERIOD AND
LICENSES INCORPORATING AUTHORIZATION TO TRANSPORT RAM, AMENDING FOR
THE PURPOSE OF SECTION 6 OF THE CODE OF PNRI REGULATIONS (CPR) PART 22
REV. 2
Purpose: to apply risk-based regulatory approach on various uses of radioactive materials in order to
optimize the resources of the PNRI as well as that of the applicants/licensees without
compromising safety and security
Extended Validity for Nuclear Medicine Licenses: 3 years

20. Updates
Completeness Review Form
Incomplete application is one of the threats identified for the delay of licensing process.
Initiated as part of the Streamlining and Process Improvements accomplishment goal of the PNRI
Objectives
- Minimize receipt of incomplete applications including unsigned applications, applications that lack
supporting documents
- Have an initial review of basic application requirements before evaluation and with written
evidence
LRE Form-01 was enrolled as an official form last October 2019.

21. Review of Forms
PNRI/NRD Form-013 - Application form
LRE Form-01 - Completeness Review Form

22. Philippine Nuclear Research Institute