Healthcare Biohazard Waste Management Regulatory Environment
The Environmental Protection Agency (EPA) is the primary regulating agency for federal programs for proper handling and disposal of any type of waste that may impact human health or the environment. The Food and Drug Administration (FDA) regulates the manufacturing of sharps containers. The Occupational Safety and Health Administration (OSHA) regulates the handling of medical waste by healthcare employees to assure their safety. The Department of Transportation (DOT) oversees regulations for the sorting, packaging, and transportation of biohazard wastes. Individual states have primary authority over how biohazard waste is handled and disposed.
TO WHAT SPECIFIC REGULATIONS DO HEALTHCARE FACILITIES AND/OR THE VENDORS THAT SERVICE THESE FACILITIES ADHERE TO
- The OSHA operates through 24 separate state programs and monitors biohazard waste disposal, including sharp medical equipment, standards for biohazard waste containers, proper labeling, and education/training for medical field employees to maintain a safe environment for healthcare workers. This protects medical employees and consumers from “the risk of exposure to blood borne pathogens.”
- There are state regulations that govern the proper “packaging, storage, and transportation of medical waste.” Individual states regulate whether medical facilities must be permitted and registered to handle biohazard wastes. These may include required contingency plans, methods for the treatment and sterilization of on-site waste, adequate biohazard training for employees, and administrative waste record-keeping with reporting methods to government authorities.
- The US Environmental Protection Agency (EPA) imposes regulations over allowable emissions from medical facilities with biohazard waste products, including waste Incinerators. The EPA also enforces the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which governs biohazard waste treatment facilities that utilize treatment technology and/or waste treatment chemicals.
- Due to serious liabilities and dangers associated with shipping biohazard waste from medical facilities, the DOT oversees and regulates healthcare waste shipments from medical sites to disposal areas.
GOVERNING BODIES THAT OVERSEE THESE REGULATIONS
- The EPA is the primary government agency that regulates and enforces medical waste disposal requirements.
- Numerous other government agencies also enforce laws that concern biohazard waste disposal, including OSHA, the Centers for Disease Control (CDC), the FDA, the DOT, and also the Drug Enforcement Administration (DEA).
- Some departments of health in individual US states also regulate biohazard waste disposal, including Missouri and Oklahoma, and in states such as Colorado, the state department of health serves as the primary authority.
- State medical waste regulations are all governed by the federal Resource Conservation and Recovery Act (RCRA).
- The FDA is the primary government agency that regulates sharp medical equipment container manufacturing.
- The OSHA is the primary governing body that regulates medical waste handling standards, ensuring healthcare employee safety.
- While the DOT monitors how biohazard waste is handled during road-based shipping, the United States Postal Service (USPS) also plays a role in regulating medical waste shipped by mail.
- Each state has individual authority to regulate the final disposal of biohazard waste.
- The EPA also serves to regulate medical waste handling procedures that may affect the environment and/or human health.
HOW OFTEN THESE FACILITIES INSPECTED
- Environmental Health and Safety (EHS) at Weill Cornell Medicine (WCM) provides biohazard waste disposal tracking and documentation for at least two years.
- Medical waste disposal documentation is required to be kept for Environmental Health and Safety (EHS) inspection that occurs every two years.
- Hospitals in the United States produce approximately 5.9 million tons of hazardous medical wastes each year. This amounts to nearly 33 pounds of biohazard waste relative to each staffed hospital bed per day.
- The OSHA conducts medical facility inspections without notice.
- Inspections for regulated medical waste producers are every 5-7 years for producers of less than 50 pounds, every 3-5 years for 50-200 pounds, every two years for 200-300 pounds, once per year for 300-1000 pounds, and twice per year for any greater biohazard production than 1,000 pounds.
REGULATIONS SURROUNDING THESE INDUSTRIES
- The EPA has increased penalties in recent years for improper medical waste disposal, enforcing cooperation with the RCRA.
- It is predicted that further rules and regulations are to be implemented by government agencies for adequate disposal of biohazard waste, expected to improve medical waste management during forecasted healthcare market growth.