• EPA Continues Scrutiny of Health Care Facilities
  • September 16, 2011 | Author: Gregory T. Young
  • Law Firm: Stites & Harbison, PLLC - Nashville Office
  • Three developments highlight EPA’s ongoing efforts to regulate waste disposal at health care facilities.  First, EPA expects to issue final guidance by the end of this year regarding best management practices for unused pharmaceutical disposal at health care facilities.  Second, EPA has proposed to add hazardous pharmaceutical waste to the Universal Waste Rule, and is currently considering ways to address stakeholder concerns over a perceived lack of notification and tracking requirements for facilities that transport and handle universal pharmaceutical wastes.  Third, the US Court of Appeals for the DC Circuit recently upheld EPA’s imposition of more stringent air emissions standards for medical waste incinerators.  These developments show that health care facilities should continue to create and implement systems for identifying and characterizing waste streams, and ensure proper disposal of such wastes.

    EPA Guidance on Pharmaceutical Disposal
    In response to concerns that unused pharmaceuticals were being flushed down toilets into public sewer systems, and thereby affecting public water supplies, the EPA in September 2010 released draft guidance to establish best management practices for disposal of unused pharmaceuticals.  EPA 821-R-10-006.  The key components of this guidance involve conducting an inventory and reducing the amounts of unused pharmaceuticals, and then initiating a system of distinguishing between and properly characterizing pharmaceutical waste streams.

    Private citizens voiced strong support for the guidance, with some commenters suggesting that EPA turn the guidance into a regulation.  The health care industry commented, among other things, on the overlap and apparent disconnect between various regulatory agency (DEA, FDA, and EPA) policies on the subject.  For instance, one commenter noted that FDA apparently maintains a list of 30 drugs that are considered hazardous and must be flushed down the toilet.  EPA continues to seek input, and expects to publish its final guidance by the end of this year.  Additional information is available at: http://water.epa.gov/scitech/wastetech/guide/unusedpharms&under;index.cfm

    Universal Waste Rule
    Universal wastes may exhibit certain hazardous characteristics, but are commonly found throughout society at traditionally non-hazardous waste generators.  Examples of universal waste include batteries, pesticides, and fluorescent light bulbs.  EPA proposed a rule in 2008 that would categorize hazardous pharmaceutical waste as a universal waste.  73 Fed. Reg. 73519.  The result would have been a streamlined process to make it easier to collect and dispose of pharmaceuticals as hazardous waste.  However, several stakeholders commented that there was a lack of notification and tracking requirements for the facilities that would handle and transport universal pharmaceutical waste.  EPA is currently considering options to address those concerns and has not yet provided a projected date for finalizing this rule.  Additional information is available at: http://www.epa.gov/osw/hazard/wastetypes/universal/pharm-rule.htm

    Medical Waste Incinerators
    EPA first proposed air emissions standards for medical waste incinerators in 1997.  After a challenge by environmental groups who argued that the rule was insufficient, in 1999 that rule was remanded to EPA for correction.  However, the 1997 rule was not vacated and remained in effect until EPA issued the current standards in 2009.  In Medical Waste Institute v. EPA, D.C. Cir.., No. 09-1297 (6/24/11), industry groups challenged the 2009 standards as being based on flawed data and claimed that the standards would shut down the industry, with just 57 incinerator units remaining.

    The DC Circuit rejected the industry groups’ arguments, and stated that EPA may have “dithered” for ten years, “[b]ut neither the length of the delay nor the problems caused by that delay affect the ultimate validity of the EPA’s product.”  The court wrote: “Once EPA concluded that the regulatory data it had used in 1997 did not reliably approximate the emissions levels achieved in practice by best performing units, it rightly recognized that it could not continue to use that data set¿Therefore, it chose to use ‘the most reliable’ data available: the actual emissions levels from the 57 units remaining in operation.”  The court concluded that EPA’s efforts constituted a “reasonable attempt at following” the Clean Air Act’s direction in setting emissions standards “at a level achieved by the best performing units.”