1. Presented to TEPRSSC October 1, 2003 Security Products that Use Ionizing Radiation

2. Goals Update Committee on Emerging Issues about Security Products that use Ionizing Radiation Familiarize New Committee Members with these Products Discuss Progress of Previous Recommendations and New Projects Committee Discussion to Support and Guide these Efforts

3. Topics Cabinet X-ray Systems Vehicle and Cargo Scanners New Products Personnel Security Screening Systems FDA Projects Relevant Web Links

4. Cabinet X-ray Systems Security Quality Control

5. Explosive Detection Systems

6. Concerns About Security X-Ray Airport x-ray systems now under Federal Jurisdiction Worker concerns about exposure Especially EDS Systems NIOSH Study

7. Dose Effects from Airport Security Screening No measurable effects Food Drugs Electronics Dose ranges from less than 1 mrem to approximately 120 mrem for EDS systems in worst case mode. Film is the exception Carry on screening usually film safe EDS systems probably not film safe Check film manufacturer website

8. Cargo and Vehicle Systems Fixed Position Truck Scanner Mobile Truck and Cargo Scanner

9. Truck Screening Image Image from Newsweek, taken at the border crossing from Guatemala to Mexico

10. Transportable Vehicle Systems Security System built into ISO containers which can be relocated

11. Vehicle Systems using Linear Accelerators Shaped Energy Accelerator System for Vehicles

12. Cargo, Vehicle, and Personnel Systems Backscatter X-ray System for Cargo, Locating threats in parked vehicles, and Possibly Screening of Pedestrians

13. Transportable Vehicle System

14. Cargo and Vehicle System

15. Cargo and Vehicle Systems 6 MeV Mobile Accelerator for Scanning Cargo Containers Isotope Based System for Scanning Trains – Regulated by NRC

16. Cutting Edge and the Future Backscatter X-Ray Van Portals Occupied Vehicles and Occupants Pedestrians High Energy Accelerators for Cargo Containers Current maximum energy is ~ 6 MeV Machine Produce Neutron Systems Other Unpredicted Technology?

17. PFNA Pulsed Fast Neutron Analysis Reports by NCRP Test Facility being constructed for cargo analysis Mine detection

18. New ANSI Standard for Large Systems for Vehicles or Cargo Systems being Rapidly Deployed Cabinet X-ray Std. not necessarily appropriate Worker Anxiety Control Exposure from Predicted and Emerging Technologies – e.g. Portals

19. Non-medical Exposure to Ionizing Radiation Use justified? Societal benefit from increased security Regulatory approach based on the Linear no threshold model

20. Backscatter X-Ray (Secure 1000) Manufactured by Rapiscan Products Inc.

21. Backscatter X-Ray (Bodysearch) Manufactured by American Science and Engineering, Inc.

22. Transmission X-Ray (Conpass Body Scanner) Manufactured by MMC International

23. Transmission X-Ray

24. FDA Projects Published Consumer / Operator FAQ about Cabinet X-Ray to the Web Participation in development of a Consensus Radiation Safety Standard appropriate for Cargo and Vehicle Systems Drafted Internal Guide of Contacts for Other Agencies Drafting Guidance Documents Manufacturer Guide Recommendations for Users Drafting Proposed Mandatory Performance Standard for Personnel Screening Systems NCRP report on the radiation risk of Personnel Screening Systems

25. Project Details (FAQ) Cabinet X-Ray System Frequently Asked Questions Other Common Names? Agencies Regulating? Is Proximity Safe? Personnel Monitoring Food and Other Products Safe after exposure?

26. Project Details (New Standards) Cabinet X-Ray Standard not Appropriate ANSI N43.3-1993, General Radiation Safety - Installations Using Non-Medical X-Ray and Sealed Gamma-Ray Sources, Energies up to 10 MeV – Not Sufficient Product Proliferation and Need for Safe Use

27. Project Details (Guidance) Internal Directory of Contacts for Outside Agencies – Drafted and in Management Review Manufacturer Guidance (Personnel Scanners) – Drafted & Being Revised Products Evaluated Individually Basis for Regulatory Decisions Support of the Use of N43.17-2002 Radiation Safety For Personnel Security Screening Systems Using X-Rays History Applicable FDA Regulations Announcement of Drafting of Proposed Mandatory Standard Guidance for Users (Personnel Scanners) – Planned Use concepts in N43.17-2002 as the Basis Record Keeping User Training Etc.

28. Project Details (Mandatory Standard) Draft a Proposed Mandatory Radiation Safety Performance Standard for Personnel Scanners – Started Based on Performance Aspects of N43.17-2002 Effective Dose limit of 0.10 microSv Labeling Leakage Test Method for Compliance Check Etc. FDA and TSA contracted NCRP to Write a Report on the Radiation Risk associated with the use of these systems – Report Completed and Delivered

29. Relevant Web Sites FDA Electronic Product Radiation Control http://www.fda.gov/cdrh/comp/eprc.html http://www.fda.gov/cdrh/comp/eprc.html NCRP Report on Screening of Humans http://www.ncrp.com/SC%201-12-Final%20-7-11BW.pdf Cabinet X-Ray FAQ http://www.fda.gov/cdrh/comp/cabinetxrayfaq.html NIOSH – for worker concerns http://www.cdc.gov/niosh