Regulations & Compliance

X-ray screening operations exist within a complex regulatory framework spanning aviation security, radiation safety, occupational health, and international trade. Understanding applicable regulations is critical for compliance, certification, and safe operations.

U.S. Federal Regulations

TSA - Transportation Security Administration

49 CFR Part 1540 - Civil Aviation Security: General Rules

Foundation regulation establishing TSA authority and basic security requirements:

• §1540.105: Inspection authority - TSA access to airports and screening areas
• §1540.107: Submission to screening - Passenger and baggage inspection requirements
• §1540.109: Prohibition against interference - Penalties for obstructing screening
• §1540.111: Carriage of weapons, explosives, and incendiaries

49 CFR Part 1542 - Airport Security

Requirements for airport operators:

• Airport Security Program (ASP) development and maintenance
• Security Coordinator designation
• Exclusive Area Access controls
• Law enforcement support requirements
• Incident response protocols

49 CFR Part 1544 - Aircraft Operator Security

Passenger airline security obligations:

• Subpart C: Operations (screening checkpoint procedures)
• §1544.201: Acceptance and screening of individuals
• §1544.203: Acceptance and screening of checked baggage
• §1544.207: Screening of individuals and accessible property
• §1544.229: Fingerprint-based criminal history records checks

49 CFR Part 1546 - Foreign Air Carrier Security

International airline operations at U.S. airports:

• Foreign Air Carrier Security Program requirements
• U.S. equivalency demonstrations
• Last Point of Departure (LPD) airport standards

49 CFR Parts 1548/1549 - Air Cargo Security

• Part 1548: Indirect Air Carrier (IAC) security requirements
• Part 1549: Certified Cargo Screening Program (CCSP) standards
• §1549.7: Approval requirements and procedures
• §1549.101: Acceptance, screening, and transfer of cargo

Security Directives (SDs) and Emergency Amendments (EAs)

Classified operational directives issued by TSA (not publicly available):

Common Security Directives

• SD 1544-21-01: Passenger and Accessible Property Screening Procedures
• SD 1544-04-04: Checked Baggage Screening Procedures
• SD 1544-05-01: Known Crewmember Program
• SD 1546-04-05: Foreign carrier security requirements
• SD 1549-04-01: Air cargo screening procedures

Access and Compliance

Security Directives are:

• Sensitive Security Information (SSI): Protected under 49 CFR Part 1520
• Distribution: Only to individuals with need-to-know (airport/airline security coordinators)
• Effective Date: Immediate upon issuance
• Penalties for Violation: Civil penalties up to $13,910 per violation per day (2026 adjusted)

FDA - Food and Drug Administration

21 CFR Part 1020.40 - Cabinet X-Ray Systems

Federal performance standard for enclosed X-ray screening equipment:

Design Requirements (§1020.40(c))

• Radiation Emission Limit: <0.5 millirem per hour at any point 5cm from external surface
• Primary Protective Barrier: Shielding surrounding X-ray generation and imaging area
• Safety Interlocks: Minimum two independent systems preventing X-ray emission with door open
• Fail-Safe Design: Interlock failure must result in X-ray termination
• Warning Labels: Specific verbiage and placement requirements

Warning Devices (§1020.40(c)(3))

• Visual Indicator: Clearly visible "X-RAY ON" light
• Location: Near all access points to primary barrier
• Activation: Illuminated only when X-rays are being generated

Labeling Requirements (§1020.40(g))

• Manufacturer name and address
• Model and serial number
• Manufacturing date
• Required warning statements (specific FDA text)

21 CFR Part 1002 - Records and Reports

• Manufacturing Reports: Product reports and annual certification
• Assembly Reports: Installation documentation
• Defect Reporting: Notification within 5 business days
• Accidental Radiation Occurrence Reporting: 15-day notification requirement

State Radiation Control Programs

Individual states regulate radiation-producing machines through state health departments:

Registration Requirements

Requirement	Details
Equipment Registration	Pre-operational notification, annual renewal
Inspection Fee	$100-$500 annually (state-dependent)
Radiation Safety Officer	Designated individual for high-energy systems
Operator Training	Documentation of competency (some states)
Shielding Plans	Required for LINAC installations >1 MeV

Conference of Radiation Control Program Directors (CRCPD)

Suggested State Regulations (SSR) provide model legislation:

• Part J: X-Ray and Gamma-Ray Radiographic Installations
• Part G: Use of Radiation Machines in the Healing Arts
• Part H: Requirements for Cabinet X-Ray Systems

OSHA - Occupational Safety and Health Administration

29 CFR 1910.1096 - Ionizing Radiation

Worker protection standards:

Exposure Limits

• Whole Body: 1.25 rem per calendar quarter (5 rem annual)
• Extremities: 18.75 rem per calendar quarter
• Radiation Area: >5 millirem in one hour at 30cm
• High Radiation Area: >100 millirem in one hour at 30cm

Monitoring Requirements

• Personnel Dosimetry: Required for workers potentially exceeding 10% of limits
• Area Surveys: Documented radiation level measurements
• Signage: Caution signs for radiation and high radiation areas
• Training: Annual instruction for exposed workers

International Regulations

ICAO - International Civil Aviation Organization

Annex 17 - Security: Safeguarding International Civil Aviation Against Acts of Unlawful Interference

Global standard for aviation security (binding for 193 contracting states):

Key Provisions

• Standard 4.1: Each contracting state shall establish a national civil aviation security program
• Standard 4.6: 100% screening of passengers and their carry-on baggage
• Standard 4.7: Screening or security controls for checked baggage
• Standard 4.9: Security controls for cargo and mail
• Standard 5.1: Quality control program including testing and compliance inspections

Recommended Practices

• Recommended Practice 4.6.3: Use of dual-energy X-ray or equivalent for baggage screening
• Recommended Practice 4.7.1: Explosive detection systems for checked baggage
• Recommended Practice 4.9.1: X-ray screening for cargo and mail

ICAO Security Manual (Doc 8973)

Restricted distribution guidance document providing detailed implementation procedures (available only to states and authorized entities):

• Volume I: National Organization and Administration
• Volume II: Preventive Security Measures
• Volume III: Response Procedures

ECAC - European Civil Aviation Conference

Doc 30 - Common Evaluation Process

European certification standards for security equipment:

Hold Baggage Screening Standards

Standard	Capability	Technology
Standard 1	Basic threat detection	Single-energy X-ray
Standard 2	Enhanced detection (C-1 explosives)	Dual-energy X-ray
Standard 3	Advanced detection (C-1 to C-4)	CT or advanced dual-energy

Cabin Baggage Screening (C-Points)

• C1: Basic metal detection
• C2: Single-energy X-ray
• C3: Dual-energy X-ray with material discrimination
• C4: Advanced imaging (CT or millimeter wave)
• C5: Explosive detection with automated threat recognition

EU Regulation 2015/1998

European Commission implementing regulation on detailed security measures:

• Screening methodology specifications
• Equipment performance standards
• Screener training requirements (minimum 40 hours initial, 8 hours annual)
• Quality control and testing protocols

Other International Standards

IEC 62523 - Baggage Inspection Equipment

International Electrotechnical Commission standard for determining imaging performance:

• Steel penetration testing methodology
• Wire resolution measurement
• Image quality metrics
• Spatial resolution and contrast sensitivity

ISO/IEC 27001 - Information Security Management

Relevant for systems with networked components and data storage:

• Security of screening image databases
• TIP performance data protection
• Operator credential management

Equipment Certification and Approval

TSA Qualified Products List (QPL)

Checkpoint and checked baggage equipment approved for use:

Certification Process

• Phase 1: Manufacturer submission with technical specifications
• Phase 2: Laboratory testing at TSA Systems Integration Facility
• Phase 3: Operational testing at live airport environments
• Phase 4: Data analysis and determination (6-18 months total)

Performance Metrics Evaluated

• Probability of Detection (Pd): Must exceed 95% for representative threats
• False Alarm Rate (FAR): Typically required <5% for operational efficiency
• Throughput: Minimum bags per hour requirement
• Image Quality: IEC 62523 compliance
• Reliability: Mean Time Between Failures (MTBF)

Air Cargo Screening Technology List (ACSTL)

Equipment certified for air cargo explosive detection:

Certification Categories

• Explosive Detection System (EDS): Automated threat recognition
• Explosive Trace Detection (ETD): Chemical analysis systems
• X-Ray Systems: Transmission imaging (pallet/ULD scanners)
• Multi-Modal Screening: Combined technology systems

Compliance and Enforcement

TSA Inspection Authority

TSA conducts regular compliance inspections under 49 CFR §1540.105:

Inspection Types

• Compliance Inspections: Scheduled audits of Security Programs
• Covert Testing: Unannounced penetration testing with test articles
• Investigation: Response to incidents or allegations
• Random Inspections: Unscheduled operational observations

Civil Penalties

Violation Type	Maximum Penalty (per occurrence)
Screening Procedure Violation	$13,910 (individual) / $556,400 (entity)
Security Program Violation	$556,400 per violation
Interference with Screening	$13,910 (passenger)
Carriage of Weapon	$15,000+ (adjusted 2026)

Note: Penalties adjusted annually for inflation per Federal Civil Penalties Inflation Adjustment Act

State Radiation Control Enforcement

State health departments enforce equipment registration and radiation safety:

Common Violations

• Operation without current registration
• Failure to post required warning labels
• Interlock malfunction or bypass
• Excessive radiation leakage
• Lack of documented operator training

Enforcement Actions

• Notice of Violation: Corrective action required within specified timeframe
• Civil Penalties: $1,000-$10,000 per violation (state-dependent)
• Equipment Seizure: Immediate shutdown for serious hazards
• License Suspension: Prohibition on operation until compliance

Compliance Best Practices

Regulatory Management Program

• Compliance Officer: Designated individual tracking regulatory changes
• Subscription Services: TSA Security Directive distribution, Federal Register monitoring
• Internal Audits: Quarterly self-assessments against Security Program requirements
• Training Documentation: Comprehensive records retention (3-5 years minimum)
• Incident Reporting: Established protocols for regulatory notifications

Equipment Maintenance and Testing

• Preventive Maintenance: Manufacturer-specified service intervals
• Annual Certification: Radiation surveys by qualified health physicist
• Daily Operability Checks: Image quality test patterns
• TIP System Validation: Quarterly verification of threat library
• Spare Parts Inventory: Critical components for rapid repair