Member Pipeline - Regulatory - Alert (RA 04-02)
To: Members & Affiliates, Biosolids Management Committee
From: National Office
Date: January 13, 2004
Subject: EPA’S FINAL RESPONSE TO THE NRC REPORT AND REVIEW OF THE PART 503 BIOSOLIDS REGULATIONS
Reference: RA 04-02
Printer friendly versionOn December 31, 2003, the U.S. Environmental Protection Agency (EPA or Agency) released its final response to the National Research Council’s (NRC) 2002 report on the technical basis of the 40 CFR Part 503 biosolids regulations and the results of the Agency’s review of the existing biosolids regulations (68 Fed. Reg. 75531), reaffirming that “the land application of sewage sludge in compliance with EPA’s regulations is an appropriate choice for communities.” The Federal Register notice is available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2003_register&docid=fr31de03-73.pdf. The NRC report, Biosolids Applied to Land: Advancing Standards and Practices, concluded that there is no scientific evidence that the Part 503 regulations have failed to protect human health, but recommended that additional scientific work be conducted to reduce persistent uncertainty regarding the potential for adverse human health impacts. The December 31 notice outlines EPA’s final action plan for responding to the NRC’s recommendations and identifies 15 pollutants that will undergo a more refined risk assessment and risk characterization to determine whether regulatory controls are necessary.
EPA’s Final Action Plan Contains Key Projects for POTW
Community
In response to several comments that EPA’s April 9, 2003
preliminary strategy needed more specificity, the Agency’s final action plan
presents a list of specific projects to help reduce uncertainty related to the
Part 503 regulations. AMSA’s comments on the April 2003 preliminary strategy are
available at
http://www.amsa-cleanwater.org/private/legreg/outreach/2003-07-08cmts.pdf.
When determining what projects to include in its final action plan, EPA
considered any major concerns presented in the public comments received on the
April 2003 preliminary strategy; the findings of the Water Environment Research
Foundation (WERF) Research Summit in July 2003; EPA’s existing research
commitments; and the feasibility of responding to specific areas given existing
resources.
EPA identifies 14 specific projects that will be completed or at least initiated within the next two to three years in an effort to respond to the NRC’s recommendations and strengthen its biosolids program. Below is a subset of these 14 projects, which AMSA believes will likely have the most impact on the biosolids program and publicly owned treatment works (POTWs):
Project 3: Develop and validate methods for the detection and enumeration of bacteria and viruses in biosolids, soil, water, and air. AMSA’s comments on the April 2003 preliminary strategy highlighted the need for validated test methods for pathogens as a priority of the POTW community as well.
Project 4: Initiate field studies at land application sites to evaluate whether the pathogen and chemical requirements of Part 503 are being met.
Project 5: Conduct a targeted national survey of pollutants (including pathogens) in biosolids, pending results of ongoing EPA research projects and regulatory review. EPA is committed in Fiscal Year 2005 to start a limited survey to address 15 pollutants identified in its regulatory review (see below) and will evaluate the extent to which available resources will allow expansion of the survey to include additional pollutants. AMSA’s comments on EPA’s preliminary survey supported the concept of a targeted survey to fill existing data gaps in lieu of a comprehensive national survey.
Project 6: Participate in an incident tracking workshop. One of the highest priority issues identified in the NRC Report was the need to respond to and investigate reported health effects attributed to biosolids. EPA believes that it should not develop an incident monitoring program on its own and plans, as a first step, to participate in a WERF workshop to be held in 2004 to begin evaluating the elements of an incident investigation program. EPA also states that state health agencies and other federal agencies, such as the Centers for Disease Control and Prevention (CDC) already have the expertise and tools to conduct human health incident reporting and are positioned best to respond to allegations of adverse health effects. On December 23, 2003, EPA sent a letter to the CDC (http://www.amsa-cleanwater.org/private/legreg/outreach/2003-12-23EPACDC.pdf) asking for their assistance, specifically to review reports of potential adverse effects to assess whether additional investigative or tracking steps are warranted.
Project 7: Conduct Exposure Measurement Workshop. EPA plans to build on the 2003 WERF Summit and the 2004 WERF Workshop (see Project 6) by conducting a workshop to examine the exposure measurement tools that researchers or health agencies can use to investigate reports of adverse human health effects from land application of biosolids.
Project 14: Improve Stakeholder Involvement and Risk Communication. The NRC recommended that stakeholders be more involved in EPA’s decision-making process for assessing risks associated with biosolids and the biosolids program in general. AMSA, in its comments on the April 2003 preliminary strategy, suggested that EPA establish a staff position dedicated to improving public awareness of the Part 503 program. In its final action plan, EPA notes that an Information Sharing Group (ISG) has been established, its membership comprised of concerned citizens, health scientists, municipal operators, farmers, biosolids managers, and state and federal regulatory agencies, to work jointly with about 25 scientific experts in a large cooperative study of biosolids. EPA also reaffirms its support of the National Biosolids Partnership’s Environmental Management System.
EPA has decided that two projects identified in the April 2003 preliminary strategy, (1) reevaluation of the risk assessment used for pollutants regulated or evaluated in Round One, and (2) a molecular pathogen tracking exposure study, will not be initiated due in part to changing priorities and limited resources.
Regulatory Review Results
Concurrent with its efforts to develop a response to the NRC
report, EPA conducted a review of the existing biosolids regulations, in
accordance with Section 405(d)(2)(C) of the Clean Water Act, to identify any
additional toxic pollutants requiring regulation. EPA conducted a preliminary
review of publicly available information on the presence of chemicals in biosolids and compiled a list of 803 candidate pollutants for which information
was found. EPA then used a human health-based data evaluation and pollutant
selection process to determine whether the existing data were sufficient for
each of the 803 pollutants to proceed with an exposure and hazard screening
assessment. A pollutant was selected from the list of 803 for an exposure and
hazard screening if it met two criteria: (1) it has been found in U.S. biosolids
based on literature or was included in the 1989 National Sewage Sludge Survey;
and (2) it has a human health benchmark from one of two EPA data sources that
was not undergoing reevaluation as of October 1, 2003. Forty pollutants were
selected to undergo an exposure and hazard screening process.
EPA used a probabilistic hazard assessment model to analyze the 40 identified pollutants. The assessment focused on two primary questions, (1) which environmental pathways are of concern? and (2) what is the potential hazard associated with each pollutant? The screening assessment evaluated the 40 chemicals using three biosolids management scenarios, disposal in a lagoon, application to pastureland and cropland, and incineration. Using both human and ecological receptors, EPA expressed the potential hazard posed by each pollutant as a hazard quotient (HQ)1.
Of the 40 pollutants for which EPA conducted its exposure and hazard screening assessment, 15 have hazard quotients indicating that further investigation is warranted. These are acetone, anthracene, barium, beryllium, carbon disulfide, 4-chloroaniline, diazinon, fluoranthene, manganese, methyl ethyl ketone, nitrate, nitrite, phenol, pyrene, and silver2. This does not mean that EPA believes these pollutants adversely affect human health or the environment or that EPA has decided to regulate these pollutants. EPA’s targeted survey of pollutants in biosolids (Project 6; to be initiated in 2005) will provide the updated pollutant concentration values that EPA will need to conduct more detailed risk assessments for these 15 pollutants. Based on these more detailed assessments, EPA will decided whether additional regulation is warranted.
AMSA’s Biosolids Management Committee will discuss these and other issues at its meeting during the Association’s 2004 Winter Conference in Los Angeles, California, February 3-6. For more information on the conference, please visit: http://www.amsa-cleanwater.org/meetings/04winter/.
1 An HQ greater than one for human health or equal to or greater than 1 for ecological receptors indicates a potential for adverse effects to occur and the need to conduct a more detailed or refined risk assessment and risk characterization.
2 None of the pollutants identified failed the screening assessment for incineration.