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Regulatory Alert - RA 03-06 - EPA SEEKING COMMENTS ON RESPONSE TO NRC BIOSOLIDS REPORT

Member Pipeline - Regulatory - Alert (RA 03-06)

To: Members & Affiliates, Biosolids Management Committee
From: National Office
Date: April 14, 2003
Subject: EPA SEEKING COMMENTS ON RESPONSE TO NRC BIOSOLIDS REPORT
Reference: RA 03-06

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Action Please By:
June 11, 2003

On April 9, 2003, the U.S. Environmental Protection Agency (EPA or the Agency) published Standards for the Use or Disposal of Sewage Sludge; Agency Response to the National Research Council Report on Biosolids Applied to Land and the Results of EPA’s Review of Existing Sewage Sludge Regulations (68 Fed. Reg. 17379). The notice details the Agency’s preliminary review of the July 2002 National Research Council (NRC) report entitled, Biosolids Applied to Land: Advancing Standards and Practices (the NRC Report) as well as the strategy EPA plans to use for responding to the NRC Report’s recommendations. The notice also provides the initial results of the Agency’s review of existing sewage sludge, or biosolids, regulations under the Clean Water Act (CWA).

While the NRC Report concluded that “there is no scientific evidence to indicate that the Part 503 rule has failed to protect human health,” it did make recommendations to reduce lingering uncertainty over the health effects of land application of biosolids. The NRC Report included 57 recommendations to the Agency regarding the biosolids program. In its response, the Agency categorized the recommendations into eight groups: (1) Survey; (2) Exposure; (3) Risk Assessments; (4) Methods Development; (5) Pathogens; (6) Human Health Studies; (7) Regulatory Activities; and (8) Biosolids Management. With the notice, the Agency is giving a 90-day comment period to receive feedback from stakeholders on its responses to the NRC Report and review of the existing sewage sludge regulations. The Association of Metropolitan Sewerage Agencies (AMSA) will submit comments prior to the July 8, 2003 deadline and is seeking member input regarding EPA’s response to the NRC Report by June 11, 2003. Please submit comments to Will Pettit, AMSA, at 202/833-3280 or wpettit@amsa-cleanwater.org.

Overview
Upon initial review of EPA’s response, AMSA identified several key Agency statements that shed light on how the NRC Report may ultimately impact the Part 503 program. The Agency continues to believe that land application of biosolids is an appropriate choice for communities, when conducted in compliance with EPA regulations. Rather than conduct a new national survey of chemicals and pathogens in biosolids as recommended by the NRC, the Agency intends to conduct a less comprehensive and more targeted survey to help fill data gaps and aid in future studies. The response also makes clear that several of the recommendations contained in AMSA’s January 30, 2003 letter to EPA’s Assistant Administrator for Water, G. Tracy Mehan, III, have been accepted by the Agency. The letter is available on AMSA’s web site at http://www.amsa-cleanwater.org/private/legreg/outreach/2003-01-Mehanletter.pdf. For example, the Agency intends to conduct dialogue with other health-based federal agencies, such as the Center for Disease Control (CDC), on the possibility of implementing a system to track incident reports to determine if adverse human health effects can be contributed to biosolids exposure. The Agency also expressed its interest in establishing partnerships and communicating more effectively with outside associations – an initiative that will benefit AMSA and its members by ensuring continued cooperation with EPA on, and input into, the biosolids program. Finally, in preliminary reviews of the existing regulations and available scientific information the Agency has not identified any additional toxic pollutants that warrant regulation in biosolids at this time.

Background
Section 405(d) of the CWA calls for two rounds of sewage sludge regulations and sets dates for their promulgation. The first round of regulations was intended to set numeric limits and management practices for toxic pollutants in biosolids. The second round would address those toxics not regulated in the first round, including dioxins. EPA did not meet the timetable for promulgation of the first round of regulations and was sued (Gearhart v. Whitman). As a result of that suit, a consent decree was entered that established revised schedules for promulgation of both rounds of biosolids rules. The consent decree extended the original deadline of December 15, 2001 for the promulgation of the second round of regulations to October 17, 2003.

To address concerns about the state-of-the-science of biosolids regulations, EPA commissioned the NRC to independently review the technical basis of the chemical and pathogen regulations. The NRC Report was the outcome of that review. Part of the agreement stemming from Gearhart v. Whitman was that EPA would respond to the recommendations of the NRC Report and conduct a review of the sewage sludge regulations, as required by §405(d) of the CWA.

Agency Response to the NRC Report
In addition to responding to the recommendations individually, the Agency identified three main objectives for the biosolids program: (1) update the scientific basis of Part 503 by conducting research in priority areas; (2) strengthen the biosolids program by evaluating results of completed, ongoing, or planned studies both within and outside EPA; and (3) continue ongoing activities for enhancing communication with outside associations and with the public.

Furthermore, the Agency outlined its short and long-term goals of the biosolids program. Major short-term goals (for fiscal years 2003 and 2004) include:

The Agency identified the following long-term goals (fiscal year 2005 and beyond) for the biosolids program:

Update the scientific basis of Part 503 by using FY03/04 research or by conducting research in priority areas;

Agency Responses to NRC Recommendations by Category
What follows is a summary of the important Agency responses to the NRC recommendations by category.

Survey
The NRC recommends that the Agency conduct a new national survey of chemicals and pathogens in biosolids. EPA believes a comprehensive survey of pollutants in biosolids may be useful, but would not provide the most benefit at this time. In its response, EPA proposes a less comprehensive, more targeted survey to help fill data gaps and aid in future studies. EPA intends to initiate the targeted survey in the next 18-24 months.

Exposure
To update and strengthen the scientific basis of the chemical and technology based pathogen standards, the NRC recommends using current exposure information and updated exposure models. To address this, the Agency plans to collect and review available exposure information from a variety of sources, including published literature, federal and state databases, and the NRC Report, in order to identify data gaps.

Risk Assessment
Using new information on exposure and dose-response relationships, the NRC recommends updating the methods for conducting risk assessments that are a part of the 1993 regulations. The Agency will reassess methods and data used for previously evaluated pollutants and apply those findings to new pollutants, involving stakeholders throughout.

Methods Development
The NRC urges the Agency to develop and standardize methods for measuring pathogens in biosolids. The Agency states that ongoing and future field studies, measuring bacteria levels and the presence of viruses up and downwind of biosolids sites, will aid in EPA’s efforts to standardize such methods.

Pathogens
The NRC suggests EPA review microbial analytical methods and risk assessments. In response, the Agency is considering research in: (1) development of improved pathogen analytical techniques; (2) assessment of exposure and risk for critical pathways and pollutants; and (3) evaluation of sludge processing and land application methods. The Agency will continue to support its Pathogen Equivalency Committee, formed in 1995, which provides guidance to permitting authorities and the regulated community on sampling and analysis issues. Additionally, EPA will continue to work with the Water Environment Research Foundation on numerous research projects to better understand and manage biosolids.

Human Health Studies
The NRC Report recommends that the Agency conduct response incident investigations and well-designed epidemiological studies of exposed populations. The Agency may assess the need for future epidemiological studies, but believes that targeted human health studies over the short term might better address potential human health impacts and persistent uncertainties surrounding exposed populations. As noted above, the Agency has initiated a dialogue with the CDC to discuss possible mechanisms for recording and tracking biosolids-related disease incidents.

Regulatory Activities
In its report, the NRC highlights several regulatory revisions or developments that it believes the Agency should consider. Included in the NRC recommendations is a review of biosolids protocols used by other nations and adoption of a national standard treatment design criteria. The Agency considers relevant information and protocols from other nations to be helpful in its decision-making, but recognizes fundamental scientific and programmatic differences between certain international sewage sludge standards and EPA’s standards. In addition, the Agency feels that the establishment of a national standard treatment design criteria may not result in the most efficient site-specific practices for protecting human health. The Agency believes that states and local jurisdictions have better knowledge of local conditions, and are better suited to establish additional management practices.

Biosolids Management
The NRC recommends that the Agency increase the resources devoted to the biosolids program, including an increase in funding to states to implement programs. EPA noted that regulatory staff has been increased recently in the biosolids program, with those staff devoting time to regulatory development, Part 503 updates, and implementation activities. To assist the states and EPA Regions in their oversight of the biosolids program, EPA will continue to support such tools as the National Pollutant Discharge Elimination System (NPDES) Compliance Inspection Manual, which includes a chapter on sewage sludge, compliance web sites such as the National Environmental Compliance Assistance Clearinghouse (http://cfpub.epa.gov/clearinghouse/) and the Local Government Environmental Assistance Network (http://lgean.net), and the Permit Compliance System, the national data system for the NPDES program. In addition, the Agency will continue to work to further the goals of the National Biosolids Partnership and their creation of a voluntary Environmental Management System.

EPA’s Review of Existing Sewage Sludge Regulations
As discussed above, §405(d) of the CWA requires that EPA review the sewage sludge regulations every two years. As part of the agreement with the parties in Gearhart v. Whitman, the Agency collected and conducted a preliminary review of publicly available information on chemical toxicity, mobility, persistence, and concentration in the environment. At this time, the Agency has not identified any additional toxic pollutants that warrant regulation in sewage sludge. In the notice, EPA identifies that the next step will be to conduct a screening analysis of those chemicals for which adequate data and analytical methods are available and for which there is evidence that they may occur in sewage sludge. EPA plans to complete this screening analysis by January 2004. The results of such a screen will determine the need for future regulation of additional toxic pollutants in biosolids – an issue AMSA and the Biosolids Management Committee will be monitoring closely.

Agency Request for Comment
In addition to any general comments, the Agency is specifically seeking comments on the following issues:

For more information on the Agency’s request for comment please see the April 9, 2003 notice in the Federal Register (68 Fed. Reg. 17379). Again, please submit comments to Will Pettit, AMSA, at 202/833-3280 or wpettit@amsa-cleanwater.org by June 11, 2003.