EPA announcement in December

There is a growing likelihood that the EPA will use its RCRA authority to expand federal regulation of hazardous waste pharmaceuticals (HWP).  Such an undertaking by the Agency would have consequences for a wide range of facilities that dispose of unused medications and related substances.  The EPA currently lists about 31 chemicals used as pharmaceuticals that meet the RCRA hazardous waste criteria.  But that list was developed in 1980, and the Agency has not revised it since then.  An update may include hundreds of new substances that would be subject to RCRA regulation when generated in threshold quantities.

Specifically, the Food and Drug Administration (FDA) has approved an average of 30 new drugs each year since 1996.  Also, the National Institute for Occupational Safety and Health (NIOSH) has developed a Drug Alert list with 157 drugs NIOSH believes should be handled as hazardous materials to avoid occupational exposure.  If both the FDA and NIOSH lists are included in EPA’s effort, it seems safe to assume that the 1980 inventory of 31 regulated hazardous waste pharmaceuticals will grow considerably.  OSHA also lists 61 pharmaceuticals on its hazardous drug list. 

Universal waste proposal

EPA’s history of addressing hazardous chemicals in pharmaceutical wastes is notable for one significant regulatory failure.  In 2008, the Agency initiated an attempt to produce a universal waste rule for HWPs.  But the EPA eventually dropped the project because of negative public comments the Agency could not resolve. 

In 2010, EPA’s Office of Water took another tack and attempted to compensate for the lack of regulatory action by issuing a draft best management practices (BMPs) document that it said healthcare facilities could use to keep pharmaceuticals out of U.S. waters.  But absent the force of law as well as a revised list of substances that should be managed, the draft has had limited value. 

Workers who manage pharmaceuticals in facilities are also notoriously untrained regarding RCRA regulations as well as the risks to the environment and public health that may by posed by pharmaceuticals disposed of down drains or sent in large quantities to municipal landfills.  While a compendium of BMPs could help educate workers, training in the absence of regulatory necessity would be inconsistent at best.  The Agency has also repeatedly complained that its ability to develop a rule is limited by resources that are stretched very thin. 

Despite its lack of past success, the EPA has announced that it will take a number of steps to address the disposal of hazardous waste pharmaceuticals, including the possibility of rulemaking to expand the list of regulated hazardous wastes.  Also, the Agency has committed to developing additional rulemaking to ensure that facilities do a better job of managing pharmaceutical hazardous wastes. 

Inspector’s report

At least some of this activity was motivated by a critical report by EPA’s Office of Inspector General (OIG) on how the Agency’s Office of Solid Waste and Emergency Response (OSWER) has been addressing HWPs.  After initial resistance to the OIG’s criticisms, OSWER said it would comply with the three recommendations in the report, including the two actions noted above.  

There is no telling exactly where on EPA’s agenda these plans will be placed.  While managers in facilities that handle listed or potentially listed HWPs should, of course, be reviewing and, if needed, improving their approach to HWPs, it is also essential to match new financial, staff, and training commitments to actions the EPA does in fact complete in contrast to those that are only promised.   

15,000 tons a year

In its 2008 proposed universal waste rule, the EPA defined a “pharmaceutical” as any chemical product, vaccine, or allergenic, not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in humans or animals.  This definition also refers to any product with the primary purpose of dispensing or delivering a pharmaceutical.  Pharmaceutical waste includes expired drugs, personal medications, waste materials containing excess drugs (syringes, IV bags, tubing, vials, etc.), and drugs that are intended to be discarded.

Generators of HWPs include pharmacies, physicians’ and dentists’ offices, outpatient care centers, ambulatory healthcare services, residential care facilities, veterinary clinics, and reverse distributors.   According to the EPA, for many years a standard disposal practice at many healthcare facilities was to flush unused pharmaceuticals down the toilet or drain.  The domestic sewage exclusion generally allows facilities to flush pharmaceuticals down the drain, but the EPA opposes the practice.   

Uncontrolled exposure to some pharmaceuticals, such as chemotherapy drugs, presents a danger to human health.  Drugs such as antibiotics, which can affect human hormone development, have been found in drinking water.  The EPA estimates that hospitals and reverse distributors generate about 15,000 tons of HWPs each year.  The Agency has not estimated the volume of pharmaceuticals that are released to the environment.  However, in 2009, the Associated Press conducted a survey that found that over 250 million pounds of 22 pharmaceutical compounds were found in tested water.

Findings and recommendations

According to the OIG, there are at least 100 drugs that NIOSH and OSHA have identified as hazardous, but which may not have been reviewed by the EPA to determine if they qualify for hazardous waste regulation.  The EPA has the authority under RCRA to list unused pharmaceutical products as P or U wastes.  Chemicals are included on the U-list based on toxicity or other characteristics.  Chemicals are included on the P-list if they are acutely toxic, that is, they have been found to be fatal to humans or animals above certain thresholds/doses.  P-list chemicals are regulated when generated in lower quantities than U-list chemicals.  The EPA can regulate a waste as acutely hazardous if it has been shown in studies to have:

• An oral Lethal Dose 50 toxicity for rats of less than 50 milligrams per kilogram (mg/kg),
• An inhalation Lethal Concentration 50 toxicity for rats of less than 2 milligrams per liter, or
• A dermal Lethal Dose 50 toxicity for rabbits of less than 200 mg/kg.

The EPA also can regulate a waste as acutely hazardous if it is capable of causing or significantly contributing to an increase in serious irreversible or incapacitating reversible illness.

In its research, the OIG identified eight chemicals from the NIOSH list of hazardous pharmaceuticals that meet the EPA criteria for regulation as acute hazardous waste but are not regulated.  The OIG also identified three U-list pharmaceuticals that meet P-list criteria based on rat oral LD50 values.  Furthermore, the OIG said it identified at least 21 additional pharmaceuticals with LD50 values between 50 and 500 mg/kg, which are within the range of values found for existing U-list pharmaceuticals.

Listing process

In commenting on a draft of the OIG report, the EPA resisted OIG’s implication that the Agency had no reason not to expand its U-list with HWPs.  The Agency states that the report correctly cites the criteria for listing chemicals as P-listed wastes but adds that the description for U-listed chemicals is much too simplified and does not fully delineate the process for listing a chemical on the U-list.

The EPA goes on to describe part of the process for a U-listing, which begins with the requirement that the Agency demonstrate that the chemical poses a “substantial present or potential hazard to human health or the environment” when improperly managed.  This demonstration must consider multiple factors, including the toxicity and concentration of the hazardous constituents in the waste; the quantity of the waste generated; the potential for the constituents to migrate, persist, and bioaccumulate in the environment; any cases of environmental damage from improper management; and plausible types of management of the waste.

The Agency adds that whether a waste is listed or not depends “to a great degree” on how it is being managed.  That is, the waste must present a ‘substantial’ hazard based on ‘plausible’ management practices.  “This type of assessment requires a large amount of information about a waste, and listing a waste using these criteria requires a significant effort and resources,” the EPA told OIG.

Agency plans

Upon publication of the final report, the OIG indicated that its three recommendations to the EPA were “unresolved.”  But in late August, the OSWER delivered a memo to the OIG, stating agreement with each recommendation and committing to corrective actions as follows:

OIG recommendation 1:  The EPA should identify and review existing pharmaceuticals to determine whether they qualify for regulation as hazardous waste. 

OSWER response: OSWER said it agrees that pharmaceuticals are a category of chemicals that need attention and added that it recently completed a limited research effort to identify and evaluate new and existing pharmaceuticals for potential addition to the lists of regulated hazardous wastes.  Possible next steps include initiating rulemaking where available data indicate that certain pharmaceuticals meet the regulatory standard for acutely hazardous waste or gathering additional existing data on certain pharmaceuticals.  Resources permitting, OSWER says it hopes to identify the next steps in this process by December 31, 2012.

OIG recommendation 2:  Establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste.

OSWER response:  OSWER agrees that due to the rapid development of new pharmaceuticals, this category of chemicals should receive ongoing attention.  As it decides what steps to take next, OSWER says it will also consider how to review new pharmaceuticals by December 31, 2012.  OSWER again emphasizes that any work to review new pharmaceuticals will be conducted in the context of limited resources and competing priorities.

OIG Recommendation 3: Develop a nationally consistent outreach and compliance assistance plan to help states address challenges that healthcare facilities have in complying with RCRA regulations for managing HWPs.

OSWER Response:  OSWER agreed to develop nationally consistent outreach and compliance assistance to help in complying with RCRA regulations for managing HWPs. This will be done in three planned phases:

• Phase 1: Within available resources, continue appropriate outreach and compliance assistance efforts for the current regulations.
• Phase 2:  Propose a rule designed to facilitate proper management of HWPs in the healthcare industry. OSWER anticipates publishing a proposal by August 2013, but this date may change due to the inter- and intra-agency reviews that must occur before signature and publication.
• Phase 3: A communication plan for the revised regulations will be developed as part of the final rule package. OSWER say it will develop a schedule for the final rule after assessing the complexity of the public comments received and how long it will take to develop the rule.

In the latest entry in the exchange, dated September 17, 2012, the OIG notified OSWER that it accepts the responses as meeting the intent of its recommendations. 

Click here to read OIG’s report (12-P-0508).

Click here for the EPA regulations affecting HWPs as well as waste management guidance for healthcare facilities.

William C. Schillaci
BSchillaci@blr.com