The Regulatory Environment

Health care is a resource-intensive industry, receiving significant input of materials, water, and energy that result in output of waste, effluents, and emissions pollution. The health care sector generates waste and emissions in almost every waste/emission category and is subject to oversight from numerous regulatory agencies, which sometimes have overlapping regulations depending on the input (e.g., where the material is generated) and type of output.

Regulations are evolving as new data emerge that show the impacts of climate change, pharmaceuticals found in groundwater, air pollution, and the connection between exposure to chemicals and health. States and the federal government are at various stages in promulgating laws to respond to this information. Understanding what requirements may be around the corner can help health care organizations anticipate regulatory changes and encourage organizational representatives to submit comments to bodies promulgating standards and codes during public comment periods.

Changes in Regulations

One of the easiest ways to keep up with changes in regulations is to use a few different “RSS feeds.” First, go to your state EPA (called many different things by state) and sign up for its RSS feed, checking for relevance to health and welfare regulations. Some vendors have RSS feeds that are terrific sources of information; it’s critical to their business that they get the information right. Make sure you are in the informational loop to be notified of changes.

Regulatory agencies also focus on who (or what) a regulation is designed to protect. The tougher rule, or the one that is more stringent, always trumps. The table on this page provides a brief list of some agencies that oversee waste- and emissions-related compliance.

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Regulatory Agencies that Oversee Health Facility Operations

Agency/Organization Focus Major Areas Related to Waste
U.S. Environmental Protection Agency (EPA)
Protection of the planet, primarily from hazardous chemicals
RCRA—Resource Conservation and Recovery Act (hazardous chemicals)
CWA—Clean Water Act
CAA—Clean Air Act
CERCLA—Comprehensive Environmental Response,
Compensation, and Liability Act (Superfund)
EPCRA—Emergency Planning and Community Right-to-Know Act
TSCA—Toxic Substance Control Act
FIFRA—Federal Insecticide, Fungicide, and Rodenticide Act
U.S. Occupational Safety and Health Administration (OSHA)
Protection of workers from work-related injuries
Bloodborne Pathogens Standard
Hazard Communication Standard
Respiratory Protection Standard
Joint Commission on Accreditation of Healthcare Organizations (Joint Commission)
Protection of patient health and safety
Environment of care
Safety and leadership
U.S. Department of Transportation (DOT)
Protection of public safety by regulation of material transportation on public roads and highways
U.S. Postal Service has mailing requirements for shipment of health care-related items
U.S. Drug Enforcement Agency (DEA)
Protection of the public from controlled substances (pharmaceutical wastes)
DEA-controlled substance management
Nuclear Regulatory Agency (NRC)
Protection of the public from use of radioactive materials and wastes
RCRA also regulates mixed waste.
Centers for Disease Control and Prevention (CDC)
Protection of workers and public health related to regulated medical wastes, infection control, etc.
Guidelines and recommendations for infection control, sterilization, hand hygiene, etc.
U.S. Department of Health and Human Services (HHS)
Provision of regulations overseeing a variety of health care-related issues
Food and Drug Administration (FDA)
Centers for Medicare & Medicaid Services (CMS)
HIPAA

State governments

Public health department
State EPA
Local fire department
Local emergency planning
Regulatory authority in many waste-related areas. In particular, states mandate rules for the management of regulated medical waste.
Have the ability to be more stringent than federal regulations. More stringent regulations always trump those less so.

Local POTWs (publicly owned treatment works)

Water treatment from local and regional communities and businesses
Can set local standard requirements for water discharge allowances and issue permits
Building code and standards organizations All aspects of building design and construction and building-related functions
Various organizations promulgate model building codes for adoption by local authorities having jurisdiction (e.g., the International Code Council's International Green Construction Code (IGCC).
Other organizations publish standards and guidelines also adopted by AHJs in some jurisdictions (e.g., proposed ASHRAE/ASHE Standard 189.2: Design, Construction, and Operation of High-Performance Green Health Care Facilities; the Facility Guidelines Institute's Guidelines for Design and Construction of Health Care Facilities).


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