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February 24, 2010

EPA published its Preliminary 2010 Effluent Guidelines Program Plan (Preliminary Plan) in a December 28 Federal Register notice .  The Preliminary Plan contains the results of EPA’s 2009 review of existing effluent limitations guidelines (ELGs) and pretreatment standards, as well as its evaluation of indirect discharges without categorical pretreatment standards.  The Preliminary Plan also outlines EPA’s plan for conducting these reviews and evaluations in 2010.

This Advocacy Alert summarizes the Preliminary Plan and seeks member input on issues raised in the Plan.  NACWA has worked with its Pretreatment and Pollution Prevention Committee to gather input of ELGs and pretreatment standards, and now seeks broader input from the membership.  NACWA plans to submit comments on the Preliminary Plan by the February 26 deadline and we request your input for these comments, which will focus on EPA’s plans for establishing best management practices for disposal of unused pharmaceuticals in the Health Services Industry.  Please contact Cynthia Finley at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 202/296-9836 with your input by February 24.

EPA Seeks Comments on Unused Pharmaceutical Management

In 2009, EPA continued its detailed study of the Hospitals category.  The Hospitals category currently only applies to direct discharging facilities with over 1000 beds, but most hospitals are indirect dischargers that have no pretreatment standards.  EPA is considering all hospitals in its detailed study for a potential new category, the Health Services Industry.  This category would also include dental clinics, long-term care facilities, veterinary clinics, and medical laboratories and diagnostic centers.  EPA had planned a survey to collect technical and economic information on disposal practices for unused pharmaceuticals, but the Agency believes it has already collected enough information to develop best practices.  It plans to complete the development of best practices for the final 2010 Effluent Guidelines Plan.

In the Preliminary Plan, EPA lists specific information it would like to receive about unused pharmaceutical disposal practices for the Health Services Industry.  Included in the list is a request for identification of any policies, procedures, or guidelines that govern the disposal of unused pharmaceuticals from health care facilities.  Comments and data are also requested on the main factors that drive current disposal practices, and any barriers preventing the reduction or elimination of unused pharmaceuticals to publicly owned treatment works (POTWs) – in particular, how the Controlled Substances Act complicates effective drug disposal solutions.

NACWA has provided comments to EPA on unused pharmaceutical disposal many times in the past few years.  As part of its detailed study of the Health Services Industry, EPA published an ICR for its proposed “Study of Unused Pharmaceuticals from Medical and Veterinary Facilities.”  In NACWA’s comments  regarding this ICR, the Association expressed its concern about pharmaceuticals that are discharged to the sewer system and its support for reducing these discharges.  NACWA supported the ICR as an appropriate way to gather more data on drug disposal practices and to develop new strategies for reducing drug disposal in the sewer system.  In the Preliminary Plan, EPA has proposed that the survey published with the ICR not be conducted, since it has collected a substantial amount of information during its detailed study of the industry.

Preliminary Plan Supports NACWA-Recommended BMP Approach
EPA states in the Preliminary Plan that it will move forward with developing best management practices (BMPs) for unused pharmaceutical management at health care facilities.  NACWA supported this approach, rather than ELGs, in its comments on the ICR.  NACWA also recommended that the federal government provide consistent guidelines for unused pharmaceutical disposal and break down existing regulatory barriers to pharmaceutical collection and take-back programs.  NACWA cited the February 2007 disposal practices issued by the White House Office of National Drug Control Policy (ONDCP) as an inconsistent message that is delivered to both health care facilities and consumers.  These guidelines were developed in partnership with EPA, but recommended flushing certain drugs.  Due to comments from NACWA and other stakeholders, the ONDCP revised the recommendations to underscore that flushing should be an option of last resort.  However, federal agencies continue to issue conflicting advice on disposal.  NACWA recently sent a letter  to EPA about a new set of recommendations from the Food and Drug Administration (FDA) that, in NACWA’s view, inappropriately recommended disposal of certain drugs by flushing.

In its comments on the 2010 Preliminary Plan, NACWA will request that EPA make public the information that it has collected about unused pharmaceutical disposal practices.  NACWA also plans to reiterate its support for the development of BMPs, but will emphasize that a consistent message needs to be delivered by all federal agencies about the flushing of unused pharmaceuticals.  NACWA requests your comments on these or other issues you have identified regarding unused pharmaceutical disposal.  Please contact Cynthia Finley at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 202/296-9836 with your comments by February 24.

EPA Reviews and Studies Other Categories

In addition to the ongoing study of the Hospitals category, EPA continued its detailed studies of two other categories in 2009:

1. Steam Electric Power Generating Industry – This study has been completed, and EPA has determined that the existing ELG should be revised.  EPA has published a Federal Register notice announcing its plans to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for conducting a survey of the industry to collect detailed technical and financial information before revising the ELG.
    
2. Oil and Gas Extraction Industry – This category has been studied only to assess whether Coalbed Methane (CBM) Extraction should be included as a new subcategory, and the detailed study is ongoing.  EPA has distributed surveys to approximately 250 CBM projects and has visited CBM water treatment sites throughout the country.
    

EPA conducted a screening level review of the 57 existing industrial point source categories, and over 450 subcategories, that are subject to existing ELGs and pretreatment standards, and did not identify any new categories for ELG rulemaking.  The Ore Mining and Dressing category was identified in 2008 for a preliminary category review, and this review is ongoing.

EPA also made progress with several ongoing rulemakings in 2009.  A final ELG for the Construction and Development category was released in December, and a proposed rule for the Airport Deicing Operations category was published in August.  Neither of these rules contained pretreatment standards.  For the Organic Chemicals, Plastics, and Synthetic Fibers (OCPSF) category and the Inorganic Chemicals category, EPA is continuing to gather data for rulemakings to revise existing ELGs and pretreatment standards.

NACWA members with comments about the reviews and studies of these categories should contact Cynthia Finley at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 202/296-9836 by February 24.