AMSA Legal Alert (Leg02-6)

On April 1, 2002, AMSA and other parties to a thirteen-year-old lawsuit over the U.S. Environmental Protection Agency's (EPA's) Clean Water Act (CWA) sewage sludge regulations agreed to a significant deadline extension for EPA to finalize regulations for dioxins in land-applied biosolids. Gearhart v. Whitman, Civ. No. 89-6266-HO (D. Or.) (Gearhart). EPA originally was required to finalize the regulations by December 15, 2001 under the Gearhart Consent Decree. Last summer, however, EPA notified AMSA, the Natural Resources Defense Council (NRDC), and the citizen parties to the Consent Decree that EPA needed to extend the December deadline because significant new data on dioxins in land-applied biosolids were available. These new data include AMSA's 2000/2001 Survey of Dioxin-like Compounds in Biosolids. After extensive negotiations and two interim extensions of the December deadline, the Joint Stipulation filed with the court this week allows EPA to take public comment on the new data, and gives the Agency until October 17, 2003 to finalize the regulations.

The citizens and NRDC would agree to the deadline extension only if EPA committed to take several additional actions on sewage sludge. Because many of these actions were tangential to EPA's dioxin in biosolids rulemaking activities, it was important to AMSA that they, and other conditions of the deadline extension, be contained in a separate Agreement between the parties. After protracted discussion, the parties agreed to place these items a separate Agreement, which is not part of the Consent Decree and was not filed with the court. EPA, however, will treat the commitments in the Agreement as seriously as the court-filed documents. The Agreement provides that if EPA cannot take any of the outlined actions, the parties may seek enforcement or modification of the Consent Decree, or file a new case.

This Legal Alert summarizes the Joint Stipulation and Agreement. Notably, AMSA will recoup from the government the in-house legal costs incurred to negotiate the Joint Stipulation and Agreement.
The relevant documents are available on AMSA's Member Pipeline at http://www.amsa-cleanwater.org/private/littrack/littrack.cfm#8.

Background
In 1989, Frank Gearhart and other citizens filed suit in Oregon Federal District Court seeking to compel EPA to identify toxic pollutants in sewage sludge and to issue regulations for those pollutants under CWA § 405(d)(2)(A)-(B). AMSA and NRDC intervened in the case. EPA eventually identified dioxins as the toxic pollutants in sewage sludge of concern. Based on an Agency risk assessment, in EPA proposed a 300 parts per trillion (ppt) limit for dioxins in land-applied biosolids, and to take "no action" for dioxins in landfilled or incinerated biosolids. 64 Fed. Reg. 72,045 (Dec. 23, 1999). The Gearhart Consent Decree required EPA to finalize the proposal by December 15, 2001. EPA met the deadline with regard to its "no action" decision for dioxins in landfilled or incinerated sewage sludge. 66 Fed. Reg. 66,228 (Dec. 21, 2001).

As stated above, EPA could not finalize dioxins in land-applied biosolids regulations by the deadline. Since EPA proposed the regulations in 1999, significant new data became available that would affect the final regulations. These data include AMSA's 2000/2001 Survey of Dioxin-like Compounds in Biosolids; a new EPA risk assessment on dioxins in land-applied biosolids; and EPA's own 2001 dioxin in biosolids survey. Further, this spring EPA will complete a decade-long overall evaluation of dioxin (Dioxin Reassessment). This Dioxin Reassessment is expected to make EPA's cancer slope for dioxin significantly more stringent, and thus may affect EPA's decisions in the land application regulations. Accordingly, the April 1, 2002 Joint Stipulation and companion Agreement provide EPA with time to publish Notice of Data Availability (NODA) in the Federal Register on this new dioxin data and information. EPA must finalize the land application rules by October 17, 2003¹.

Issues to be Addressed in the NODA
EPA expects to publish the NODA in May 2002. In the Agreement, EPA commits to take public comment on the NODA for at least 90 days, and to include the following issues:

1) EPA's revised risk assessment, which models specific information and assumptions of the risk to human health from dioxins in land-applied sewage sludge. The NODA will describe the assumptions and information used in the revised risk assessment and risk characterization documents, including:

• assumptions the Agency made concerning application of sewage sludge to the land, and a description of land application practices in the United States;
• the risk to the "highly exposed individual" modeled by summing the exposure to dioxins in land-applied sewage sludge from the relevant multiple pathways modeled in the risk assessment; and
• the exposure scenario for the land application of sludge and the population modeled, key assumptions and data used, and the U.S. population of "highly exposed individuals."

2) Implications for the land application rules of the latest publicly available information on dioxin, including information from EPA's Dioxin Reassessment process, with respect to:

• use of a dioxin-specific cancer slope (potency) factor for assessing cancer risk to human health from dioxins;
• the "margin of exposure" and/or any other approach to evaluating non-cancer adverse health effects from exposure to dioxins; and
• consideration of background levels of dioxin from land application of sewage sludge.

3) Publicly available data, scientific studies, and other relevant information with respect to reasonably anticipated adverse effects on ecological species from exposure to dioxins in land-applied sewage sludge. EPA will use as a starting point a 1999 Screening Ecological Assessment of Chlorinated Aliphatics Waste Management Scenarios. EPA will solicit comment on any reasonable and scientifically defensible regulatory options for protecting the environment from any such reasonably anticipated adverse effects.

4) Sewage sludge data from EPA's 2001 sewage sludge survey for dioxins, data from the AMSA 2000/2001 Survey of Dioxin-like Compounds in Biosolids, and reports analyzing the data from the EPA and AMSA surveys, including:

• a breakdown of dioxin content of each sample in the EPA survey by congener and by the toxic equivalency factor (TEF) for each congener, including whether each congener was detected in the sample;
• an explanation of how EPA compared the dioxin levels in the 1988 National Sewage Sludge Survey samples and dioxin levels in the EPA 2001 survey samples, addressing revisions of the World Health Organization (WHO) TEF values, improved analytic procedures resulting in lower detection limits, and direct measurement of co-planar polychlorinated biphenyls in the EPA 2001 survey data; and
• an analysis of variability in levels of dioxins in sewage sludge based on available data from several wastewater treatment facilities, and possible reasons for increases or decreases in, or the high level of, dioxins in certain current sampling results. EPA will solicit comment on the effect of the variability on the proposed land application rules and proposed monitoring requirements.

5) The risk from land application of sewage sludge from small entities based on the EPA 2001 survey data and the revised risk assessment, and the effect of this data on the proposed small entity exclusion.

National Research Council Study
The Agreement discusses EPA's National Research Council (NRC) study to review risks from toxicants and pathogens in biosolids applied to land. AMSA has been closely tracking the study, which began in January 2001 and should be complete in June 2002. NRDC and the citizen plaintiffs wanted EPA to commit to take action based upon the NRC's recommendations. Accordingly, under the Agreement, EPA will:

• by April 1, 2003,² publish a Federal Register notice explaining how EPA will respond to recommendations in the NRC's report and solicit public comment;
• specify whether EPA is planning any regulatory or non-regulatory means of addressing the NRC recommendations, and the time frame for taking final action on any planned activities, including a time frame for proposing rules, if any; and
• publish its final plan for responding to the NRC recommendations in the Federal Register within nine months of the first notice.

The Agreement specifically states that EPA and AMSA do not concede that these review and notice procedures are required by § 405(d) or any other provision of the CWA.

Identification of Additional Toxic Pollutants in Sewage Sludge
Another point of contention in the negotiations involved NRDC's and the citizen plaintiff's assertions that EPA had failed to adequately perform the required biennial review of the CWA § 405(d) regulations. In order to prevent a future lawsuit over this issue, under the Agreement EPA commits to review the CWA § 405(d) regulations to identify additional toxic pollutants, if any, that may warrant regulation. EPA must complete the review on or before April 1, 2003, or nine months after the NRC report above is issued, whichever is later, but in any event no later than July 1, 2003. EPA commits to evaluate publicly available information, such as sampling data, scientific studies, and other information from national and international government entities, universities, nonprofit organizations, and private entities concerning, at a minimum, the toxicity, persistence, concentration, mobility, and potential for exposure of additional toxic pollutants in sewage sludge.

EPA also commits to publish a Federal Register notice seeking public comment for 60 days on its review. Six months later, EPA will publish a final Federal Register notice with the results of its review. EPA will state in the notice whether it has identified any additional toxic pollutants in sludge that warrant regulation, and will include time frames for proposing and finalizing rules, if any. The Agreement specifically states that EPA and AMSA do not concede that these review and notice procedures are required by CWA § 405(d).

In exchange for these commitments, the citizen plaintiffs, NRDC, and AMSA agree not to sue EPA for failure to comply with CWA § 405(d)(2)(C), preventing additional litigation. The Agreement preserves AMSA's right, however, to intervene in any CWA § 405(d)(2)(C) lawsuit that may be brought by another organization.

Future Meetings and Follow Up with EPA
Under the Agreement, EPA will notify AMSA and the other parties when significant new documents are available. EPA will meet with AMSA, the parties, and our representatives three times a year on EPA's progress toward final land application rules. Under the Joint Stipulation, EPA also will send quarterly reports to AMSA and the parties describing:

• EPA's actions during the immediately preceding quarterly period;
• EPA's future steps toward taking final action on the regulations;
• whether EPA is on, ahead, or behind schedule; and
• delays or obstacles and plans for overcoming them.

These reports and the face-to-face meetings will be a valuable source of information for AMSA's membership on EPA's progress on the regulations.

Next Steps
EPA has posted the new risk assessment for dioxins in land-applied biosolids on its website. These documents include the technical background document, risk characterization, and analytical data sheets from EPA's 2000 dioxin in biosolids survey. External peer review comments are also available. AMSA's Board of Directors has authorized a Technical Action Fund (TAF) project to review these documents to ensure the assessment is reasonable and consistent with EPA policy. AMSA will use the results of the TAF-funded review in our comments on the NODA.

AMSA also will closely monitor EPA's compliance with the terms of the Joint Stipulation and the Agreement, participate in the agreed upon meetings, and evaluate and report to the membership on the results of the NRC biosolids study when it becomes available. Finally, AMSA will prepare a petition to recoup from the government our in-house counsel costs incurred negotiating the Joint Stipulation and Agreement.

¹ The Joint Stipulation provides that if the Dioxin Reassessment is released after May 16, 2003, EPA will have 150 days from its release to finalize the land application regulations. If EPA determines issues in the Dioxin Reassessment, when released, require further public comment on the proposed land application regulations, the Joint Stipulation provides that the deadline for final regulations automatically will be extended to January 16, 2004, and the parties will meet to agree upon a new deadline.

² If NRC issues the final report after June 28, 2002, EPA will have nine months from the date of the final NRC report to publish the notice.

If you have any questions regarding this case or any of AMSA's legal activities, please feel free to contact AMSA's General Counsel Alexandra Dunn at 202/533-1803 or adunn@amsa-cleanwater.org.