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Regulatory Compliance Guide

Overview of federal, state, and institutional regulations for nanomaterial research laboratories

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Disclaimer

This guide provides general information about common regulatory requirements. It is NOT a substitute for formal training or institutional policies. Always consult your institution's Environmental Health & Safety (EHS), legal counsel, and regulatory compliance offices for specific guidance.

Key Federal Regulatory Agencies

OSHA (Occupational Safety and Health Administration)

Mission: Ensure safe and healthful working conditions

Key Standards for Research Labs:

  • 29 CFR 1910.1450 - Laboratory Standard: Chemical hygiene plan, training, exposure monitoring
  • Hazard Communication (HazCom): Safety Data Sheets (SDS), container labeling, employee training
  • Personal Protective Equipment (PPE): Selection, use, and training requirements
  • Bloodborne Pathogens: If working with biological materials
  • Respiratory Protection: Fit testing, medical evaluation for respirator use

Website: www.osha.gov

EPA (Environmental Protection Agency)

Mission: Protect human health and the environment

Key Regulations:

  • RCRA (Resource Conservation and Recovery Act): Hazardous waste identification, storage, disposal
  • TSCA (Toxic Substances Control Act): Chemical inventory, reporting of new chemicals/nanomaterials
  • Clean Air Act: Air emissions from fume hoods and processes
  • Clean Water Act: Wastewater discharge limits

Nanomaterial-Specific:

  • TSCA Section 5 - Pre-manufacture Notice (PMN) for new nanomaterials
  • Significant New Use Rules (SNURs) for certain nanomaterials

Website: www.epa.gov

DEA (Drug Enforcement Administration)

Mission: Enforce controlled substances laws

Requirements:

  • Registration required for Schedule I-V controlled substances
  • Secure storage in locked cabinets or safes
  • Inventory records and usage logs
  • Reporting of theft or significant loss

Note: Only applicable if using controlled substances (e.g., certain precursors or research chemicals)

DOT (Department of Transportation)

Mission: Safe transportation of hazardous materials

Requirements:

  • Proper shipping names and UN identification numbers
  • Packaging requirements (UN-certified containers)
  • Labeling and placarding
  • Shipping papers and emergency response information
  • Training for personnel involved in shipping hazardous materials

Note: Applies when shipping chemicals or nanomaterials to collaborators

Required Documentation & Plans

Chemical Hygiene Plan (CHP)

Required by: OSHA Laboratory Standard

Must Include:

  • Standard operating procedures for handling chemicals
  • Criteria for requiring prior approval
  • PPE selection guidelines
  • Engineering controls (fume hoods, ventilation)
  • Employee training program
  • Medical consultation and examination provisions
  • Chemical Hygiene Officer designation
Safety Data Sheets (SDS)

Required by: OSHA HazCom Standard

Requirements:

  • Maintain SDS for all hazardous chemicals
  • Accessible to all employees during work shifts
  • 16-section GHS format
  • Updated when new information available
  • Electronic or paper format acceptable
Hazardous Waste Records

Required by: EPA RCRA

Must Maintain:

  • Waste determination documentation
  • Satellite accumulation area logs
  • Waste pickup records
  • Training documentation
  • Biennial or annual waste reports (depending on generator status)
  • Retain records for 3 years minimum
Laboratory Safety Manual

Institutional Requirement

Typically Includes:

  • Lab-specific standard operating procedures
  • Emergency procedures and contact information
  • Hazard-specific protocols (nanomaterials, cryogens, etc.)
  • Equipment operating procedures
  • Roles and responsibilities
  • Updated annually or when procedures change

Mandatory Training Programs

All laboratory personnel must complete the following training:

Training Topic Frequency Regulatory Basis
Laboratory Safety Initial + Annual refresher OSHA Lab Standard
Hazard Communication (HazCom) Initial + When new hazards introduced OSHA HazCom
Hazardous Waste Management Initial + Annual refresher EPA RCRA
Personal Protective Equipment Initial + When new PPE required OSHA PPE Standard
Respiratory Protection Initial + Annual (if using respirators) OSHA Respiratory Protection
Fire Safety & Emergency Response Annual OSHA + Local fire codes
Chemical-Specific (if applicable) Before first use OSHA Lab Standard
Equipment-Specific Before operation Institutional policy
Documentation Required: Training records must be maintained including dates, topics, trainers, and attendees. Most institutions use learning management systems (LMS) for tracking.

Laboratory Inspections & Audits

Internal Inspections

Frequency: Typically quarterly or semi-annually

Conducted by: EHS staff or safety committee

Focus Areas:

  • Chemical storage and labeling
  • Waste accumulation compliance
  • PPE availability and use
  • Fume hood function
  • Safety equipment accessibility
Federal/State Inspections

Frequency: Unannounced or complaint-driven

Agencies: OSHA, EPA, state environmental agencies

May Review:

  • Safety programs and documentation
  • Training records
  • Hazardous waste management
  • Chemical inventory
  • Incident reports
Funding Agency Audits

Frequency: As required by grant terms

Agencies: NIH, NSF, DOD, etc.

May Include:

  • Research integrity compliance
  • Safety protocols for funded work
  • Vertebrate animal or human subject protocols
  • Export control compliance

Daily Compliance Checklist

Before Starting Work
  • Review protocol and SDS
  • Verify fume hood operation (> 100 fpm face velocity)
  • Confirm proper PPE available
  • Check emergency equipment accessibility
  • Ensure waste containers properly labeled
End of Day
  • Secure all chemicals in appropriate storage
  • Close and label all waste containers
  • Turn off equipment not requiring continuous operation
  • Clean and decontaminate work surfaces
  • Update laboratory notebook with observations