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Stage 2 Microbial/Disinfection Byproducts Stakeholder Orientation MeetingStakeholder Orientation Meeting December 15-16, 1998 Prepared by FINAL MEETING SUMMARY CONTENTS
B. 1996-1998 Expedited Rules III. Overview of the Information Collection Rule (ICR)
B. ICR Schedule V. Perspectives on Stage 2 DBPR/LT2ESWTR Issues VI. Stakeholder Involvement Process
B. Proposed Stage 2 Stakeholder Involvement Process
D. Overview of ICR and other surveys/analysis/Other research on Other Treatment Technologies and Analytical Methods [March 10-12, 1999] E. Next Steps/Future Meeting Schedule
ATTACHMENTS 1. Proposed Agenda and Groundrules 2. List of Meeting Participants 3. Stage 1 (92-93) Negotiated Rulemaking & Expedited Committee (97) - presented by Stig Regli, EPA 4. 1996-1998 Expedited Rules - presented by Ephraim King, EPA 5. Overview of the Information Collection Rule - presented by Michael J. McGuire, McGuire Environmental Consultants, Inc. 6. ICR Schedule - presented by Jennifer McLain, EPA 7. Overview of Research - presented by Mike Cox, EPA 8. Status of M-DBP Research Supporting the Development of the Stage 2 DBP, LT2ESTWR, Ground Water Rule, and Filter Backwash Rule - additional background material from the EPA Office of Research and Development, provided by Mike Cox, EPA 9. Critical Technical and Policy Issues For Stage 2 Deliberations - developed and amended by Stakeholders on Dec. 15-16 10. M/DBP Stage II Convening Observations & Recommended Process - presented by Abby Arnold, RESOLVE On December 15 and 16, 1998 U.S. EPA held a Stage 2 Microbial/Disinfection
Byproducts rulemaking (M/DBP) Stakeholder Orientation meeting. Cynthia Dougherty,
Director, Office of Ground Water and Drinking Water, opened the meeting by welcoming
participants and thanking them for their help in developing the Stage 1 DBP and Interim
Enhanced Surface Water Treatment rules over the past seven years. Dougherty also
acknowledged the continued dedication and involvement of stakeholders in the M/DBP
rulemaking process. Dougherty attributed stakeholder participation as a key element in
the Agency's success in developing rules based on a workable agreement. This
partnership, stated Dougherty, based on shared information and trust, will play a crucial
role in development of the Stage 2 rules. In Stage 2, stakeholders will be able to work
from a common baseline of understanding based on On December 16, Chuck Fox, EPA Assistant Administrator for Water, joined the group. Fox thanked the participants for their work in the Stage 1 rules, announced by President Clinton December 4, 1998 in Rhode Island. Fox listed some of the questions he thought this stakeholder group will want to discuss in Stage 2: Do we need to further strengthen DBP regulations? Are their new microbes to focus on? What are the new treatment technologies and costs? EPA has spent tens of millions of dollars on research to ensure that this is a science driven process. Answering these questions and developing the Stage 2 rules will be hard work. Fox closed his remarks by thanking stakeholders for their continued participation. Introduction Abby Arnold, RESOLVE, reviewed the meeting agenda and ground rules [Attachment 1],
asked the group for short introductions around the room [participants list Attachment 2],
and reviewed the purpose of the meeting;
This summarizes presentations and captures the main ideas from each discussion. It follows the topic areas of the agenda, but does not restate the presentations. It focuses on capturing the main ideas from the discussions at the meeting. Ephraim King, EPA, and Stig Regli, EPA, presented the regulatory history of the Stage 1 and Expedited Committee rulemaking leading up to the present Stage 2 rulemaking activities. Stage 1 (92-93) Negotiated Rulemaking & Expedited Committee (97) Stig Regli presented an overview of the Microbial/Disinfection Byproduct (M/DBP) rule development activities between the Stage 1 negotiation (1992) and the Provisions in the 1996 Safe Drinking Water Act Amendments relating to microbial pathogens and DBPs [Attachment 3]. In 1992, EPA was under consent decree to propose Disinfection Byproducts (DBP) regulations by June 1993. EPA's major regulatory concern was ensuring adequate microbial protection while reducing risks from DBPs and preventing major industry shifts to use alternative disinfectants until the associated health risks form their DBPs become apparent Based on recommendations of a feasibility study, conducted by RESOLVE and Endispute, Inc., EPA chose to convene a stakeholder Federal Advisory Committee. The Negotiation Committee was organized under protocol agreed to by all participating parties. This Committee met 7 times between November 1992 and June 1993 and was supported by a technical work group throughout the process and by a drafting group in the latter stages of negotiation. The Committee first agreed to an agreement in principle and then subsequently to rule language. After the final meeting, June 22-23, the drafting group continued to labor over rule language and the preamble. These documents were sent out to Committee members for comment three times, and by the conclusion of this process Committee members agreed to both the preamble and rule language. Unless otherwise noted, the draft rule, published July 1994, adopted the recommendations of the Negotiating Committee and technologies working group and reflected the recommendations in the preamble and proposed regulations. The Committee agreed to develop the DBP and Interim Enhanced Surface Water Treatment Rule (IESWTR) in two stages. The objectives of Stage 1 were tightened DBP control on all system sizes, simultaneous compliance with the DBPR and microbial (IESWTR) rules to account for risk tradeoffs, and avoid influencing major industry shifts toward use of alternative disinfectants. Stage 2 was proposed in 1994, under the agreement that it would be reevaluated in a continued negotiation process based on data collected through the ICR and expanded research after the promulgation of the Stage 1 rule.
Between 1994 and 1996 EPA's M/DBP activities included: promulgation of ICR; the Partnership for Safe Water; expanded research to support Stage 2 DBP, LT2 ESWTR, and the Groundwater Rule; the development of the M/DBP Research Plan; and the development of the M/DBP Research Council. The 1996 Safe Drinking Water Act Amendments supported the 1994 agreement and added more provisions related to the proposed M/DBP rulemaking process. A. 1996-1998 Expedited Rules Ephraim King reviewed M/DBP activities between 1996 and 1998 [Attachment 4]. Following the SDWA 1996 Amendments, EPA faced new statutory deadlines. Between 1996 and 1998 EPA held stakeholder and open technical meetings to discuss various aspects of M/DBP rules. In March 1997, a 17 member Federal Advisory Committee (FACA) was chartered to develop options and recommendations on data collection and assessment. The FACA reviewed new microbial data and technical analysis (not including the ICR) and new DBP data and technical analysis and reached a consensus Agreement in Principle in July 1997. Based on this Agreement, EPA developed two Notices of Data Availability (NODA) in November 1997. In addition, EPA developed another NODA in March 1998 related to new health effects information. The development of these Stage 1 M/DBP rules can be attributed, in large part, to the collaboration and partnership of stakeholders. Future, M/DBP Rules are scheduled to be proposed and promulgated as follows: Schedule For Future M/DBP Rules
Support for the implementation of Stage 1 rules includes upcoming national meetings in Denver (1/13/99) and in D.C. (1/22/99), 8 Guidance Manuals (currently in draft and to be finalized in early 1999), State Implementation Guidance, Factsheets and Overheads, Question and Answer documents, are available by contacting the Drinking Water Hotline at 1-800-426-4791 or the Office of Drinking Water Website - www.epa.gov/ogwdw. Following Regli and King's presentations stakeholders discussed the following points;
III. Overview of the Information Collection Rule (ICR) A. ICR Overview Michael McGuire, McGuire Environmental Consultants, Inc., presented an overview of the Information Collection Rule [Attachment 5]. The ICR is an approximately $130 million effort to collect 18 months of drinking water data from 500 large (those serving greater than 100,000 people) treatment plants across the US. The purpose of the ICR is to obtain microbial, DBP and DBP precursor occurrence and treatment data. ICR data will be used to characterize industry source water, treatment performance and distribution system occurrence on a national and regional level. Data will not be used to determine individual plant compliance. Data is submitted to EPA by utilities and undergoes quality assurance/quality control procedures (QA/QC). Validated ICR data will be entered into the ICR Fed data base. The ICR Data Analysis Plan has been developed by the ICR Technical Working Group to answer questions related to the Stage 2 rulemaking. The Plan is based on the development of 8 auxiliary data bases which will allow the analysis of data from the ICR Fed database in a more manageable form. ICR Fed is too cumbersome to run on an ordinary PC, however, the auxiliary data bases will allow the analysis of different sets of data using manageable software (Microsoft ACCESS) on a PC. The auxiliary data bases were developed based on a list of anticipated questions/uses of the ICR data. Utilities are also conducting treatment studies to gather data on the ability of GAC and membranes to control DBPs and estimate the costs of implementing these technologies. This data is being compiled in a separate data base to ICR Fed and will be available to support the Stage 2 rule development. B. ICR Schedule Jennifer McLain, EPA, presented the ICR data collection schedule, QA/QC, and data availability [Attachment 6]. ICR data was collected from June 1997 through December 1998. The schedule for data download from ICR Fed to Aux 1 is;
The Auxiliary data bases will be built and then tested using "dummy" data. Their anticipated schedule for availability:
Following McGuire and McLain's presentation the following points were discussed:
Mike Cox, EPA, and Stig Regli, EPA, presented the goals, regulatory context, major questions, and emphasis of additional research conducted in support of the Stage 2 rules [Attachment 7 and 8]. Research needs for drinking water regulations can be split into four categories; 1) health effects and assessment, 2) analytical methods, 3) occurrence/exposure, and 4) treatment technologies. The M/DBP research strategy includes a greater than $50 million research effort to better understand the risks from DBPs and microbial pathogens and a $130 million occurrence and treatment effectiveness data collection effort (ICR). In addition, EPA in collaboration with other interested parties has developed an M/DBP Research Plan and a research tracking system. The tracking system is currently being updated and will be available for the February 10-12, 1999 Health Effects Workshop stakeholder meeting. There are approximately 175 DBP research projects being tracked by EPA. Cox reviewed the key questions and issues that the research is addressing. These include;
Regli reviewed the key questions and issues that research is addressing: there are approximately 200 microbial projects being tracked by EPA.
Currently, Cryptosporidium is used as a target organism because of its relatively high resistance to treatment, especially disinfection. New Cryptosporidium detection methods are currently being developed. Certain disinfection and inactivation technologies, such as ozone, chlorine dioxide, and ultra violet (UV), may be effective for inactivating Cryptosporidium and other pathogens (substantially more so than chlorine). Regarding risk balancing for regulatory development, Regli suggested that if criteria could be developed under the LT2 ESTWR that were considered adequate protection for pathogens, this could be the constraint under which further development of Stage 2 DBP could be considered. In other words, the establishment of an appropriate LT2 ESWTR regulatory standard could act as the balance point by which any future DBP controls would be evaluated. The following points were discussed following Cox and Regli's presentation concerning additional research:
Studies
Cryptosporidium
V. Perspectives on Stage 2 DBPR/LT2ESWTR Issues Abby Arnold, RESOLVE, facilitated a discussion by stakeholders on the "Major Issues for Discussion in the Stage 2 Process". A list of these issues was developed on December 15 and reviewed and amended by the group on December 16. See Attachment 9 for the full list of issues identified by stakeholders. VI. Stakeholder Involvement Process The second day of the Stakeholder Orientation meeting, Wednesday, Dec. 16, focused on discussions by participants on the Stakeholder Involvement process for the Stage 2 rulemaking, including the formation of a formal stakeholder process and future meetings to discuss Health Effects and the ICR and other research. A.Convening Process A. Arnold, presented observations from the M/DBP Stage 2 stakeholder convening, conducted by RESOLVE between September - November 1998 and proposed a recommended decision making process for discussion [Attachment 10]. The convening process was initiated by EPA to answer: Is it advisable to convene a formal negotiation process? Based on parties interests, RESOLVE recommended that a formal stakeholder negotiation process be initiated for the Stage 2 rulemaking. However, cautioned Arnold, the Stage 2 stakeholder negotiation presents unique challenges and reaching agreement in Stage 2 may be far more difficult that in Stage 1. These challenges include:
Other observations from the convening are;
In response to questions about what the structure and process of the negotiation committee might be, Chris Kirtz of EPA explained that there is enormous flexibility in the creation of a regulatory negotiation (reg neg) or FACA committee in developing the charter and setting goals. The charter can include a statement of principle that will structure the guidelines for participation in the process. The goals of the committee or operating procedures can be changed by the group. Two weeks are needed for notification of a FACA organizational meeting. A. Proposed Stage 2 Stakeholder Involvement Process Arnold proposed a phased stakeholder involvement process, starting with orientation and education and then moving to analysis, generating proposals and finally a negotiating agreement. (See Chart A herein.) Arnold proposed a Public Health Affects Workshop in February, and subsequent informational meeting on research on other treatment technologies, as well as an in-depth overview of what is included in the ICR. Stakeholders discussed options for stakeholder involvement. Most comments were directed at when a formal negotiation committee would be convened. After hearing from many stakeholders around the table that they would prefer to organize a formal negotiation committee soon. EPA proposed that by the end of March a decision could be made whether formal negotiations will proceed and what type of process will be followed. EPA also listed the four guiding principles that EPA would ask participants to commit to if a formal negotiation committee is formed. All parties invited to sit at the table would be asked to agree to at least the following principals:
2. Agree that the rule will apply to all systems in some way or another. 3. Filter Backwash and LT1 rules are not part of this FACA process. (There will be other stakeholder involvement process for these rules.) 4. A full range of regulatory options will be considered. None of the parties at the table objected to these principals, and many agreed that they were acceptable. Over the next few months Arnold will work with EPA and stakeholders to develop specific protocol language using the 1997 protocol as a starting point, that includes these principles as well as other groundrules for operation of a formal committee. The protocols will be discussed at the first organizational meeting scheduled for March 30, 1999. Additionally, in the next few months EPA would decide who to invite to participate at the table. Stakeholders were invited to submit comments or concerns about who ought to participate on the committee by Wednesday, December 23, 1998 to either C.Dougherty or A.Arnold.
A. Public Health Affects Workshop [February 10-12, 1999] The discussion then turned to the agenda for the Public Health Affects Workshop. Stakeholders reviewed a proposed agenda for the Public Health Workshop presented by Mike Cox [Attachment 11 see Attachment 9 for additional comments]. The draft agenda had been prepared in collaboration with representatives of stakeholders around the table. Participants were invited to participate on a conference call to discuss the agenda and planning for the workshop by submitting their name. The purpose of the Workshop is to:
A. Overview of ICR and other surveys/analysis/Other research on Other Treatment Technologies and Analytical Methods [March 10-12, 1999] The stakeholders agreed to a third orientation meeting, the purpose of this meeting would be to provide an overview and status of the:
A. Next Steps/Future Meeting Schedule Stakeholders agreed to the following schedule for meetings. These include planned meeting and dates set aside, to ensure availability of participants, for future meetings:
The meeting adjourned at 12:00 noon. |
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