Regulated Medical Waste Waste Reduction Facilities Management Regulations & Standards

Clean Water Act

Please note that this page refers to federal requirements.  State and local regulations may differ.

Introduction

The Clean Water Act (CWA) is intended to protect the quality of the nation's surface water resources, including both physical and biological aspects.  It gives EPA the authority to regulate the discharge of pollutants.

This section discusses three topics covered by CWA regulations that are of particular relevance for healthcare facilities:


Wastewater regulations

A typical healthcare facility has a wide variety of wastewater sources, such as:

  • lavatories, sinks, and showers
  • laboratories
  • photo processing labs
  • washing machines and dish washers
  • boilers
  • maintenance shops

The facility will fall under one of two sets of regulations, depending on where the water goes next.  Facilities that discharge their wastewater to a municipal sewer system are referred to as indirect dischargers, while those that discharge directly to streams or rivers are considered direct dischargers.

Indirect dischargers

The vast majority of healthcare facilities are indirect discharges.  Such facilities are subject to regulations by their local sewer authority, which are in turn regulated by the CWA (Title 40 CFR Part 403--General Pretreatment Regulations).  Typically, indirect discharges must obtain a permit (called an industrial user permit), and are required to comply with the specific rules stated in the permit.  CWA regulations expressly prohibit any indirect discharger from releasing any of the following into the sewer:

  • fire or explosion hazards
  • corrosive discharges (pH < 5.0)
  • solid or viscous pollutants; heat (in amounts that cause the treatment plant influent to exceed 104oF)
  • pollutants that cause toxic gases, fumes, or vapors
  • any other pollutant (including oil and grease from a cafeteria) that will interfere with or pass through the municipal treatment plant

Beyond that, the local sewer authority will establish rules and limits for the facility that take into account local conditions, and the requirements of the authority's own permit.

Some hospitals, primarily larger ones located in smaller communities, may be designated by their sewer authority as a significant industrial user.  This designation is usually associated with manufacturing facilities (40 CFR 403.3), but a sewer authority can apply the designation if a facility) has a "reasonable potential for adversely affecting” the operation of the sewage treatment plant.  A hospital designated as a significant industrial user must sample and analyze their wastewater and submit reports to the sewer authority twice a year (40 CFR 403.12).

In addition to the specific rules discussed above, the CWA provides municipalities with regulatory flexibility so that they can meet their specific needs.  Many municipalities have chosen to establish local rules that apply specifically to medical waste discharges.  Examples range from blanket prohibitions on "all medical waste" to more specific prohibitions regarding items such as recognizable body parts or radioactive compounds.

Direct dischargers

For hospitals that are direct dischargers, EPA has established national discharge standards, which are numerical limitations for certain specific pollutants.  These standards are much more difficult to meet than the limitations for indirect dischargers, which is understandable, given that the wastewater from direct discharge hospitals flows directly into a stream or river, without having been treated or monitored by a municipal system.  To meet the direct discharge limitations, a hospital would have to obtain a permit from their state environmental agency or EPA (depending on the status of the state agency) and install a complex wastewater treatment plant.  According to the EPA Office of Water, about 34 hospitals in the U.S. have elected to be direct dischargers.


Stormwater

Stormwater carries away dirt and debris, oil from parking lots, lawn chemicals, pesticides, and other pollutants.  To minimize the effect of these pollutants on our waterways, under the authority of the CWA, EPA has promulgated stormwater regulations (40 CFR 122.26 -- Stormwater Discharges). 

 Phase I of the stormwater program was promulgated in 1990 and applied to:

  • medium and large municipalities (stormwater systems serving a population of 100,000 people or more),
  • certain industrial facilities (not hospitals), and
  • any construction activity disturbing greater than 5 acres (“large construction sites”).

Phase II of the stormwater program was promulgated in 1999 and applies to:

  • small municipalities,
  • publicly owned universities, hospitals, and similar facilities located in urban areas, and
  • construction activity greater than 1 acre and less than 5 acres (“small construction sites”).

Construction activities at hospitals are covered by Phase I or II regulations if those activities are meet the threshold acreage requirements.  These rules apply to the construction of a new hospital or to expansion of existing hospitals (e.g., building, parking lots).  To comply with the construction stormwater regulations, a healthcare facility must obtain a permit from their state environmental agency or EPA (depending on the status of the agency) and prepare a stormwater management plan, which includes a pollution prevention element.  Once the construction activity is completed, the facility then submits a notice of permit termination.  More information on construction stormwater permits (including state-specific guidance) is available at the Construction Industry Compliance Assistance (CICA) Center.

If a healthcare facility must meets the definition of a municipal separate storm sewer system (MS4) it must obtain a Phase II permit.  The MS4 definition includes facilities such as hospitals, universities, and prisons that are located in urban areas and are owned or operated by a state, city, town, borough, county, parish, district, association, or other public body and have a system of stormwater conveyances (including roads with drainage systems, municipal streets, catch basins, curbs, gutters, ditches, man-made channels, or storm drains).  Healthcare facilities that fall under the definition of an MS4 must obtain a stormwater discharge permit from their state environmental agency or EPA, abide by the rules stated in the permit, and renew the permit every five years.


Oil storage tanks

If a hospital uses or stores oil it may be subject to the Spill Prevention Control Countermeasure (SPCC) rule.  Hospitals that have a total aboveground oil storage capacity exceeding 1,320 gallons or an underground storage capacity exceeding 42,000 gallons are subject to spill prevention control and countermeasure (SPCC) plan requirements (see guidance documents under More Resources).  Healthcare facilities meeting these criteria must prepare and implement a SPCC plan to prevent any discharge of oil into navigable waters.

Aboveground or Underground Oil Storage Containers

EPA's Oil Program web site, http://www.epa.gov/oilspill/, provides information about EPA's program for preventing, preparing for, and responding to oil spills that occur in and around inland waters of the United States.  If a hospital uses or stores oil it may be subject to the Spill Prevention Control and Countermeasure (SPCC) rule.  Hospitals with an above ground oil storage capacity of greater than 1,320 gallons, or total completely buried oil storage capacity greater than 42,000 gallons must prepare and implement a SPCC plan to prevent any discharge of oil into or upon navigable waters of the United States or adjoining shorelines.

The SPCC rule was originally promulgated on December 11, 1973 and was revised on July 17, 2002.  EPA subsequently extended the regulatory compliance schedule included in the new SPCC rule.

The current compliance dates for the new rule are:

Facilities operating:

Before 8/16/02

Between 8/16/02 ­ 10/31/07

After 10/31/07

Must:

Maintain the facility’s existing SPCC Plan.  Amend and implement the SPCC Plan no later than 10/31/07.

Prepare and implement SPCC Plan no later than 10/31/07.


Prepare and implement SPCC Plan before starting operations.

At all times, facilities are required to maintain their existing SPCC Plan and amend it in accordance with 40 CFR §112.5.


CWA common areas for inspections

Typical records a state or EPA inspector may ask to review during a CWA inspection include:

  • Industrial user (IU) permit for discharges to the local municipality (indirect discharge)
  • Wastewater monitoring data or other forms of records required by the IU permit
  • Spill Prevention, Control, and Countermeasure (SPCC) Plan
  • Construction stormwater permits (Phase I or Phase II) for any construction activity greater than 1 acre
  • Phase II stormwater permits under the NPDES program for public hospitals
  • NPDES general permit for discharging directly to a water body (direct discharge)


More Resources

Profile of the Healthcare Industry (EPA sector notebook, 2005).

EPA’s Stormwater Program.

EPA's oil spill program web site.

EPA’s Office of Water.

Stormwater Phase II Compliance Guide.

Title 40 CFR Part 403--General Pretreatment Regulations For Existing And New Sources Of Pollution.

40 CFR 122.26 Stormwater Discharges

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