# Presentation: 172074

## 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.

## Chronology

- 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 (0.25 mrem/h) @ 30 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

## Slide 10

## Slide 11

## Slide 12

## Slide 13

## Slide 14

## 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: 70 - 200 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?