Comprehensive Compliance Reference for Large Quantity Generators (LQGs), Small Quantity Generators (SQGs), and Individual Sharps Users
Downloadable Attachment: California Waste ManagementGuidelines.pdf
ℹ️ Definitions
According to the California Medical Waste Management Act (MWMA) [Health & Safety Code (HSC) §117600–118360]:
Regulated Medical Waste (RMW): Includes biohazardous waste, sharps waste, trace chemotherapy waste, and other infectious materials generated during medical treatment, research, or diagnostic processes.
Small Quantity Generator (SQG): Generates less than 200 lbs of medical waste per month.
Large Quantity Generator (LQG): Generates 200 lbs or more of medical waste per month.
🏢 Governing Agencies In California
Agency | Role |
California Department of Public Health (CDPH) | Oversees registration and enforcement of the MWMA |
Local Enforcement Agencies (LEAs) | Implement CDPH regulations at the county level |
California Division of Occupational Safety and Health (Cal/OSHA) | Enforces OSHA standards including Bloodborne Pathogens Standard (29 CFR 1910.1030) |
California Department of Resources Recycling and Recovery (CalRecycle) | Regulates household hazardous waste and sharps disposal |
United States Postal Service (USPS) | Governs mail-back of medical waste under Pub 52, Section 346 |
🧾 Requirements for Small Quantity Generators (SQGs)
Registration: Must register with CDPH or LEA as a SQG (HSC §117930)
Medical Waste Management Plan: Not required to submit but must maintain on-site procedures (HSC §117935)
Storage Limits:
Biohazardous waste: ≤7 days at >32°F; ≤90 days refrigerated (HSC §118280)
Sharps: Dispose when 3/4 full; must be in approved sharps container (HSC §118285)
Treatment: May use registered medical waste hauler or approved mail-back system (HSC §118040)
Transportation: May self-transport up to 20 lbs to a consolidation point if registered (HSC §118030)
Training: OSHA BBP training required annually (29 CFR 1910.1030)
📃 Requirements For Large Quantity Generators (LQGs)
Registration: Must register with CDPH or LEA as an LQG (HSC §117950)
Medical Waste Management Plan: Required and must be submitted (HSC §117960)
Storage Limits:
Biohazardous waste: ≤7 days at >32°F; ≤90 days if refrigerated (HSC §118280)
Sharps: Dispose when 3/4 full or per facility's plan (HSC §118285)
Off-site storage: ≤30 days from receipt date (HSC §118310)
Treatment: Must obtain permit to treat on-site (HSC §118130)
Transportation: Must use registered medical waste hauler (HSC §118000)
Recordkeeping: Maintain logs and manifests for 3 years (HSC §118040(f))
Training: OSHA BBP training required annually; keep records (29 CFR 1910.1030)
💉 Requirements For Individual Sharps Users (Home Injection Patients)
Sharps Storage: Must use FDA-cleared sharps container. Dispose when 3/4 full. (CalRecycle Guidance)
Disposal Methods:
Use USPS-compliant mail-back system (USPS Pub 52 Sec. 346)
Or take to the collection site, pharmacy, or HHW facility (HSC §118286)
Prohibited Disposal: Illegal to place sharps in trash or recycling (HSC §118286)
🏢 Storage Time Limits Summary
Waste Type | Storage Location | Max Duration | Citation |
Biohazardous Waste | On-site (>32°F) | ≤7 days | HSC §118280(c) |
Biohazardous Waste | Refrigerated (<32°F) | ≤90 days | HSC §118280(c) |
Sharps Waste | On-site | Until 3/4 full or plan limit | HSC §118285(d) |
All Waste | Off-site storage facility | ≤30 days from receipt | HSC §118310 |
💡 PureWay Compliance Solutions
For SQGs & LQGs:
State-compliant sharps and RMW mail-back systems (USPS UN3291-compliant)
On-site medical waste pickup and disposal
Medical Waste Management Plan templates and documentation tools
OSHA-compliant BBP training for staff
For Home Users:
FDA-cleared sharps containers
USPS-compliant mail-back kits with prepaid return
Learn more: https://www.pureway.com/resources/map-temp
📚 Key Regulatory Sources
California Medical Waste Management Act: HSC §117600–118360
CalRecycle Sharps Disposal Guidance: https://calrecycle.ca.gov/HomeHazWaste/Sharps/
OSHA Bloodborne Pathogens Standard: 29 CFR 1910.1030
USPS Pub 52 Section 346: https://pe.usps.com/text/pub52/pub52c3_032.htm