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Abstract: A series of articles discussing PBMS progress and topics begins in this issue of ET&A. The current article gives a status report on EPA's PBMS plans, based on presentations from the 14th Annual Waste Testing and Quality Assurance Symposium, July 13-16, 1998 in Alexandria, Virginia. Reports from EPA offices are summarized. Issues raised during the Symposium sessions are noted, and conjectures regarding their impact are made. Articles in upcoming months will address specific topics, such as NELAP and PBMS, audits, confidentiality, implications and applications for field/mobile labs, and proficiency testing. Regular progress reports will continue. 

This article summarizes issues and concerning that lie ahead in developing and implementing Performance Based Measurement Systems. These include: determining when PBMS is appropriate; addressing needs for training; deciding legal issues; changing state regulations to allow PBMS; and understanding the mechanics of method approvals. Recommendations and some results from early studies will be presented.

The conference was held in Arlington, Virginia from Monday, July 13 through Thursday, July 16, 1998.. The big draw for attendees this year was "Performance Based Measurement Systems." Many attendees' primary interest was to learn and more about PBMS. How will EPA implement these self-imposed requirements across EPA's varied programs? What will PBMS mean to other agencies, instrument vendors, engineering firms, states, lawyers, regulated entities, and laboratories? 

Many of the presentations are available on websites of EPA, ACIL, and ACS. 

"Quality Systems, PBMS and NELAC: Putting It All Together": The instructor for this short course was Marilyn Moore. The objectives of the course were: introduction to PBMS; development of a quality system; use of quality principles; auditing of a quality system engaged in PBMS; ramifications of not using an approved reference method; and assuring scientifically and legally sound environmental decisions. Ms. Moore stressed "managing the process" which includes measurements and collected data; making sure DQOs are met; and producing validated data appropriate for making decisions. Projects have to balance "time, cost, and quality." The "Data Life Cycle" is very much like the typical TQM process of Plan, Do, Check, Act, in which planning means development of DQOs and a QAPP. Implementation means field sampling and lab testing. Assessments include statistical distribution, validation, and verification. In data collection activities, methods provide analytical results that are "estimates," not "true values." PBMS should be a statistical approach, implemented by each program, but it should not be used for method-defined parameters, such as TCLP; or where it may be impractical, or cost-prohibitive to validate; or where it may not be used under certain contracts or regulations. PBMS defines QC elements during the DQO process. 

The measurement process includes considerations as: sample integrity; data quality; environmental control; equipment; personnel; method performance; cost of analyses; and record-keeping and documentation. Selection of methods may be made because of regulation, performance criteria, or method sensitivity. 

Audits by PBMS will include: a quality systems approach; evaluation of the control of activities; evaluation of the effectiveness of systems and processes, and the product. Project audit plans should define the information needed from the audit; provide unbiased reviewers, and establish the frequency and scope of the audits.

In the Monday afternoon Plenary Session:

Gail Hansen, USEPA-OSW: The Office of Solid Waste Methods Team plans to take the following actions to update SW-846, and implement PBMS: (COMBINE WITH HER LATER TALK BELOW)

• Remove 14 criteria specifying SW-846, except for method-defined parameters (this is termed the "de-reg regulation" by EPA).
• Update IVA of the methods will be available as part of deregulation.
• Update the oil and grease methods and replace freon extraction with hexane; Method 9070 will become 1664, as produced by the Office of Water.
• Version 2.0 of the SW-846 methods will be available on CD-ROM for update III ($125) and update IV later this year ($75).
• Public outreach, methods Web page, OSW home Web page will be established and updated.
• SW-846 Methods up through update IVA are on the EPA Web page "www.epa.gov/SW846". Other methods and notices will be added.
• Working with ASTM committees to develop methods (13 ready and 7 in process).

Larry Keith, Waste Policy Institute, representing the Environmental Division of the American Chemical Society, a co-sponsor of the Symposium, described a cooperative agreement between EPA and ACS for a comparative study on three basic approaches to environmental assessment methods: A prescriptive approach (what has been used by specifying methods in regulations); a "streamlined" approach, as an interim way to begin implementing PBMS; and a full-fledged PBMS approach. The study will compare relative monitoring performance based on cost, time, savings, problems, advantages and disadvantages. The study has selected several matrixes and methods, and obtained candidate laboratories. More volunteers are needed to help with protocol development and review and peer review.

Stan Laskowski, Director, Environmental Services Division, EPA Region III: Stan presented an update on behalf of the Environmental Monitoring Management Council (EMMC) of EPA. He described the origin of NELAC, how it manages input and coordination and standardization for lab accreditation. It produces guidance manuals, technical standard, and assists in NIST development of reference materials for proficiency testing. Some of these samples will be available in late 1998, for the Office of Water. Agency program offices have to submit plans for approval, so they can start implementing PBMS in FY99. EPA has started briefing the states about PBMS plans and their impacts.

Elisabeth Cotsworth, Acting Director, EPA Office of Solid Waste: Described briefly how OSW will work with NELAC to make PBMS effective. (NEED MORE HERE)

Steve Koorse, from the law firm of Hunton and Williams, raised anxiety levels in the audience when he reminded us there is no established case law about PBMS, and plenty of unknowns. The fear of significant liabilities may deter labs from adopting PBMS approaches. As a rule of law, regulations must be "necessary, reasonable, cost-effective, and clear" to be used in lieu of market forces to achieve a desired regulatory end. There have to be clearly-defined compliance requirements, measures for gauging compliance, and judges to determine compliance. Where compliance is based on a single test's results, the test must be reliable and reproducible. Where more than one test method is available, you need the capability to produce equivalent results. PBMS legal issues may include the following:
· Regulators or third parties may allege data for reference methods are superior to PBMS method. Even if this is not sustained, there will be significant costs to defend against this allegation.

• Regulators or third parties may allege PBMS regulatory data are superior to PBMS lab methods.
• Regulatory data using PBMS or reference methods could be used to contradict previous sampling event test results.
• A company could suffer adverse consequences when switching to another method deemed unlawful later.
• Test of hazardous waste after TCLP may produce conflicting determinations.
• Certain chemical concentrations trigger regulatory requirements for action, treatment, disposal, dependent upon the regulatory-defined method. Different method (PBMS) will have to meet intent or have regulation re-written more flexibly ("de-reg reg"). This may also affect decisions regarding waste de-listing. 

So how can PBMS work? If:

• A broader application is expressly authorized by regulated entity.
• Regulated authority offers to split samples with the regulated entity, and there is a written commitment to refrain from action if the two results conflict.
• Parties have confidence that no-one can allege non-compliance, as long as labs engage in lawful conduct. An informal survey conducted by the Office of Water indicates that the regulated community may not choose to use PBMS, because of the potential liabilities.

Dave Berg, Department of Energy: His office conducted a survey of US environmental industry competitiveness, for the Department of Commerce. Industry-wide growth from 10-15% in 1985-1990 declined to 1-5% between 1991-1996. Virtually all segments display the characteristics of a maturing industry: Decelerating growth, heightened competition, growing customer sophistication, pricing pressure, consolidation of market share in larger players, reduced profitability, and heightened merger and acquisition activity. "Without steady and predictable enforcement, there are big risks to those in the environmental industry." Critical Actions for Industry to take include: Sell value, not technical fix-its. Sell productivity plus compliance. One of the ways Government can act is to encourage systematic use of performance and information-based tools to engage the market and create incentives (i.e., PBMS).

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