Products to X-ray People for Security Presented to the : Technical Electronic Product Radiation Safety Standards Committee May 22, 2002

ANSI N43.17 Radiation Safety for Personnel Security Screening Systems Using X-rays

Secure 1000 Manufactured by Rapiscan Products Inc.

Bodysearch Manufactured by American Science and Engineering, Inc.

Sep. 1998: TEPRSSC Recommends a Mandatory Standard Apr. 1999: FDA Proposes New Project to ANSI/HPS N43 Nov. 1999: N43.17 TG Convenes June 2001: Draft Standard Submitted to N43 Committee Apr. 2002: Final ANSI Approval Chronology

Summary of Main Requirements Subject dose limits: 0.1  Sv (10 µrem) Effective Dose per Scan 250  Sv (25 mrem) per Year Benefit vs. Risk & Negligible Individual Dose (< 10 µSv/y) Subject Informed of the X-Ray Exposure and Associated Risk

Summary of Main Requirements Radiation Leakage: 2.5  Sv/h ( cm from Surface Bystander Protection: Inspection Zone — 20  Sv/h (2 mrem/h) Safety Interlocks Labeling & Indicators

Summary of Main Requirements Operator Training Manufacturer Records User Facility Records

Informative Annexes Risks and Rationale Measurement Protocol and Estimation of Effective Dose

Transmission X-Ray Products

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

Transmission X-Ray

Specifications (Conpass Body Scanner) Scanning Time: 10 Seconds Anode Voltage: KvP with 10 kV Step Tube Current: 1- 3 mA with 0.5 mA Step Dose to a Subject: 0.5 mrem per Inspection Dose to Operator < 0.5 mrem per hour Note: Other Systems Exist

Mfr’s Proposed Uses Passenger Control Diamond Mines Prisons Public Offices Banks Etc.

Issue Non-medical Exposure to Ionizing Radiation Linear no threshold model Societal benefit from increased security

Principles 1 mrem Negligible Individual Dose 100 mrem Annual Public Effective Dose Limit Individual or Society Receives a Clear and Compelling Benefit that Outweighs Risk Dose as Low as Reasonably Achievable

Negligible Individual Dose NCRP Recommends: An Annual Effective Dose Of 1000 µRem Be Considered A Negligible Individual Dose Per Source Or Practice Magnitude of the dose Difficulty in detection and measurement of dose and health effects Estimated risk for the mean and variance of natural background radiation exposure levels

Transmission vs. Backscatter X-Ray Transmitted Through the Subject Image Interpretation Significantly More Complex Adjustable Technique Factors (More Complex) 100x More Dose to Subject

Regulatory Status They are Not Medical Devices They are Electronic Products that Emit Radiation Currently No Federal Performance Standard Applies to these Products (21 CFR 1010 through 1050)

FDA’s Proposed Response Guidance Document Radiation Safety Recommendation Mandatory Performance Standard New Instruments Suggested State Regulations

Proposed Mandatory Standard Based on ANSI N43.17 Dose Limit Interlocks Labeling & Indicators Controls Product Performance Only Use Covered in a Radiation Safety Recommendation

Discussion Societal Benefit vs. Risk Appropriate Use? Scope of Standard What Products? Alternatives Based on Intended Use? Controls – Fixed or Automatic?