ALTC, Activities

SEPTEMBER 28, 1999

5TH ANNUAL “GOOD LABORATORY PRACTICES TECHNICAL CONFERENCE”
VA-AWWA/VWEA LABORATORY PRACTICE COMMITTEE
AT THE OMNI HOTEL, CHARLOTTESVILLE, VA

Focus of Conference: Update the lab community concerning events in State and Federal levels that impact them; provide guidance and research results concerning best practices (analytical, QA, administrative) for effective and efficient laboratory operations. Nearly 200 registered for the conference. There were representatives from state, county, municipal, and commercial labs, as well as vendors. (A registration list is attached to this report.)

The agenda was as follows:
Joint Session—Current Issues and Challenges
NELAC Update (Joel Holtz, ERA)
The Virginia Environmental Laboratory Accreditation Program (Audrey Brubeck, Froehling & Robertson)
New Regulations and the Impact on Laboratories (Jeanne Bailey, AWWA)
Methods Update and Alternate Test Procedure Protocol (Maria Gomez-Taylor, USEPA OW)
An Overview of the Interagency Methods & Data Comparability Board (Richard Ayers, VADEQ)

Split Sessions: (I attended the following)
Simplate—Multiple Enzyme Technology (MET) for the Detection of Heterotrophic Bacteria (Les Flores, IDEXX)
Methods for Evaluating Laboratory Personnel (Laura Conard, Sageworks)
Performing Meaningful Internal Quality Audits in the Laboratory (Tom Modlin, NNSY)
Things You Always Wanted to Know About Standard Methods But Were Too Afraid to Ask a Regulator (Betsy Ziomek, VADEQ)

Below are my summary notes from each presentation.
NELAC Update (Joel Holtz, Environmental Resource Associates)—At the fifth annual National Environmental Laboratory Accreditation Conference (NELAC) held June 28 through July 1, 1998, in Saratoga Springs, New York, the promise of a national environmental laboratory accreditation system became a reality. Eleven states, California, Colorado, Florida, Illinois, Kansas, Louisiana, New York, New Jersey, New Hampshire, Pennsylvania, and Utah, were approved by the National Environmental Laboratory Accreditation Program (NELAP) as Accrediting Authorities. In addition, the 1999 NELAC Standards, standard that will be used for the accreditation of the first class of laboratories, were approved. An understanding of how NELAC will be implemented is important for laboratories throughout the country. Given the fact that Virginia is on track to be a NELAP approved Accrediting Authority next year, a thorough understanding of the process is especially important for laboratories in Virginia. As a result of the NELAC V, laboratories must begin to prepare for accreditation per the NELAC standards. The significant changes that directly impact laboratories include
An expansion of the Proficiency Testing program beyond Water Supply (WS) and Water Pollution (WP) studies.
Significant modifications to NELAC Chapter 5, Quality Systems
Varying Scopes of Accreditation offered by the eleven states
The application process and the impending application deadline of November 2, 1999
Training of state assessors.
A summary of the requirements that must be met prior to obtaining accreditation, including successful PT performance, was presented. Adopted at the NELAC V conference in Saratoga Springs, NY in July, 1999, 11 states were granted accrediting authority status. The first group of laboratories that apply for accreditation will use the 1999 standards. Afterwards, the NELAC standards become effective and enforceable one year after adoption. Note NELAC V now was new language in Chapter 5 addressing improper, unethical or illegal actions 5.5.2 and 5.6.2. Proficiency Testing (PT) samples will be a key to the NELAC program. Until such time as NIST has accredited PT providers, labs are required to obtain PT samples for purposes of NELAC accreditation from a PT provider that has submitted an application to NIST for approval and that has submitted to the laboratory written attestation that it complies with NIST Handbook 150, NIST Handbook 150-19, and EPA’s National Standards for Water Proficiency Testing Criteria Document (dated December 1998 or later). For all other programs and analytes for which NIST/NVLAP accreditation is not available, a provider of PT samples for NELAC accreditation must be accredited by an ANSI/RAB accredited registrar or equivalent PT provider accreditor or provide evidence to the lab of application, for the analytes/matrices offered. Lab application deadline is November 2, 1999. From then until June, 2000, the labs’ first round applications will be reviewed, and many on-site visits will be made. By July 1, 2000, the first class of labs will be announced. From then until June, 2001, the remainder of on-site visits will be made. Labs should select a state to apply to, based on fees, scope of accreditation, geography, and relationships with existing clientele. The application requires responses to 20 detailed items, a selection of the fields of testing, supplying the lab’s quality manual, and signing a certificate of compliance with application requirements. Current issues of concern include assessor training; the scope of accreditation offered by each state accrediting authority; quality system requirements; PBMS; and supplemental requirements. Sources of information about NELAC include the bulletin board at www.epa.gov/ttn/nelac. Another source is www.eraqc.com, sponsored by Environmental Resource Associates.
The Virginia Environmental Laboratory Accreditation Program (Audrey Brubeck, Froehling & Robertson)—New regulations have been written for an accreditation program to go into effect in Virginia (Statute 2.1-424 A4-1998). Laboratories performing testing under the Clean Water Act will be subjected to the program. This means all environmental testing laboratories, most wastewater municipal labs, some drinking water municipal labs and some industrial laboratories will have to secure and maintain NELAC accreditation in Virginia. The scope of the state accreditation program was outlined. There will be two tiers of accreditation: Tier I will be for commercial labs, labs testing for other legal entities, or other labs requesting Tier I testing; Tier II are labs testing for internal monitoring purposes, or for labs requesting Tier II services, and labs performing simple tests (BOD, TDS, TS, TSS, total and fecal coliforms, TVS, TVSS, and SS). Labs will be accredited for 2 years, based on personnel qualifications, on-site assessments, proficiency test results, and QA/QC standards. Exemptions may be given for Tier II labs if all requirements are met for 4 consecutive years. Tier I labs will pay maximum fees of $2800, based on testing fields. Tier II maximum fee will be $1800. Most tests will cost about $250 each, with some discounts for more metals or organics. Other associated costs include on-site inspections (estimated $1000/day), PE samples ($50-$1500 each), and implementation and maintenance costs for the program yet to be determined. A timetable for the implementation of the regulations was presented. Comments on the proposed regulations were solicited.
New Regulations and the Impact on Laboratories (Jeanne Bailey, AWWA)—The current regulatory framework was reviewed, with a history of the Safe Drinking Water Act. Developing regulations (arsenic, radon) were discussed, and an overview of the Unregulated Contaminant Monitoring rule was presented. Special attention was given to the UCMR impact on water utilities and water quality laboratories. The 1996 Safe Drinking Water Act amendments listed radon, arsenic, and sulfate as part of “priority regulations.” EPA issued a proposed Maximum Contaminant Level (MCL) for radon of 300 piC/L, with final status projected for August, 2000, and likely compliance date 2003. EPA’s arsenic proposal is due January, 2000, with a standard likely in the 10-20 ppb range, requiring an analytical method for very low detection levels. A CDC study on sulfate released in February, 1999 showed no adverse effect level could be determined. Sulfate will have an EPA regulatory determination in 2001. Stage 1 regulations were established in 1998 for chlorine, chloramine, and chlorine dioxide as common disinfectants for water treatment. Data from 18 months of water treatment systems are currently being studied to provide information about microbial/disinfection byproducts (M/DBP) clusters of chemicals. EPA has developed 8 guidance manuals for training on effective use of these disinfectants, and compliance with enhanced surface water treatment rules (ESWTR). The “Balance of Radionuclides” rule covering radium-226 and –228, uranium, alpha emitters, and beta and photon emitters has data available for review from a 1999 USGS monitoring study, with a final rule due by December, 2000. EPA must also propose every 5 years a new “Contaminant Candidate List” of chemicals to be regulated, based on health effects and occurrence data for ground. The decision to regulate or not, or to perform more research, will be made by August, 2001, followed by a proposal in 2003, a final rule in 2005, and compliance required by 2008. First five contaminants are expected to be sulfate, MTBE, perchlorate, boron, and manganese. Under an Unregulated Contaminant Monitoring Rule (UCMR), EPA collects monitoring data on occurrence of chemicals. Tier 1 assessment monitoring will include testing all large treatment systems, surface water systems, and ground water systems for 2,4-dinitrotoluene, 2,6-dinitrotoluene, acetochlor, DCPA mono acid degradate, DCPA di acid degradate, 4,4’-DDE, EPETC, molinate, MTBE, nitrobenzene, perchlorate, and terbacil. Tier 2 chemicals in a screening survey will be tested for at 300 randomly-selected treatment systems for 1,2-diphenylhydrazine, 2,4,6-trichlorophenol, 2,3-dichlorophenol, 2,4-dinitrophenol, 2-methyl-1-phenol, alachlor ESA, diazinon, disulfoton, diuron, fonofos, linuron, polonium-210, prometon, RDX, terbufos, and Aeromonas hydrophila. Tier 1 and 2 reporting will feed into EPA’s National Contaminant Occurrence Database (NCOD), now available at www.epa.gov/ncod.
Methods Update and Alternate Test Procedure Protocol (Maria Gomez-Taylor, USEPA OW)—Speaking for Dr. William Telliard of the Office of Water, Dr. Gomez-Taylor discussed the EPA’s responsibilities for developing, approving, and implementing analytical methods, guidance, and programs to support the Clean Water Act, the Safe Drinking Water Act, and other national regulatory directives that protect and restore water resources. Analytical methods for use in wastewater and drinking water compliance monitoring and data gathering are listed at Title 40 CFR parts 136 and 141, respectively. OW provides a wide range of analytical support that includes: procuring analytical services, coordinating sampling and analysis, reviewing laboratory data, creating and validating analytical methods, recommending approval of alternate test procedures, and proposing and promulgating analytical methods. In support of these activities, EPA has established a comprehensive multi-media outreach program to gather and disseminate OW analytical program information. Recent method approvals, method proposals, upcoming proposals, new method development efforts, the status of OW’s PBMS efforts, Alternate Test Procedure protocols, and several novel studies that include the National Study of Chemical Residues in Fish Tissue and OW’s trace metal, whole effluent toxicity (WET) test methods, and detection/quantitation limit validation studies were discussed. Method 1664 for Oil & Grease is available with options for alternative extraction and concentration devices. Method 1613B for analysis of CDDs and CDFs and Method 1631 for mercury in water are both available. Flow injection analysis of cyanide in water, Method 1677, is expected to be promulgated in October, 1999. Metals methods 200.7 and 200.9 are modified for analysis of biosolids and will be published as part of a separate rule at 40 CFR part 503. Promulgation of the following methods is anticipated by December, 1999: EPA 200.8 (ICP/MS metals); EPA 218.6 (hexavalent chromium by ion chromatography); EPA 300.0 (bromide, chloride, nitrate, orthophosphate, and sulfate by ion chromatography); and Standard Method 4500-CI-E (low-level residual chlorine). AN ambient methods rule for biological monitoring will be proposed in FY 2000 at 40 CFR 136 to include Enterococci (Method 1600), Cryptosporidium (Method 1622), and Method 1623 (Cryptosporidium and Giardia). New methods are being developed for determination of metals species for mercury, arsenic, and tin species. Method 1668 for PCB congeners is targeted for use in the National Study of Chemical Residues in Fish Tissue. A sampling and analysis methods compendium is being developed (release date anticipated FY2000) for biosolids. It will include methods for PCBS, dioxins/furans, metals, fecal coliform, salmonella, ammonia, TKN, helminth ova, enteric viruses, nitrate/nitrite, total and fixed volatile solids. The Office of Water is working to develop its final PBMS regulation, and is working with OECA and OGC to resolve enforcement and legal issues over its implementation. Methods being adapted and reviewed for analysis of contaminants in fish tissue include: Method 1656, Organo-halide pesticides in municipal and industrial wastewaters; Method 1625, Semi-volatile organic compounds by Isotope Dilution GC/MS; Method 1668, Toxic PCBs by Isotope Dilution High Resolution GC/High Resolution MS; Method 1632, Inorganic Arsenic in water by hydride generation quartz furnace AA; Method 1637, Trace elements in ambient waters by chelation preconcentration with GFAA; Method 1638, Trace elements in ambient waters by ICP/MS; Method 1639, trace elements in ambient waters by stabilized temperature GFAA; and Method 1640, trace elements in ambient waters bay on-line chelation preconcentration and ICP/MS. These 1600-series methods have been validated in multiple, single-lab studies. A number of other methods are scheduled to undergo detection/quantitation limit studies: EPA Methods 502.2 (VOCs in water by purge and trap capillary column GC with PID/ECD detectors in series), 524.2 (VOCs by GC/MS), 1620 (metals by GFAA and ICP/MS), 200.8 (metals by ICP), 365.2 (phosphorus by colorimetry), 1677 (cyanide by flow injection analysis), 160.2 (TSS by gravimetry), 130.2 (hardness by EDTA), 350.3 (ammonia by electrode), and 1625C (semi-volatile organic compounds by GC/MS). EPA-EAD expects to solicit lab contracts for classical wet chemistry, volatile and semivolatile organics, metals, and dioxins/furans this fall, with 3 labs to be awarded per contract by October 1, 2000.
An Overview of the Interagency Methods & Data Comparability Board (Richard Ayers, VADEQ)—The Board was chartered in 1997 under the National Water Quality Monitoring Council and the Federal Advisory Committee Act in order to provide a framework and a forum for comparing, evaluating and promoting water monitoring approaches. The Board’s challenge is to identify, examine and recommend monitoring approaches that facilitate collaboration and yield comparable data and assessment results. Several key action items in the 1998 Clean Water Action Plan are assigned to the National Council and the Board. The Board is a partnership of water quality experts from federal agencies, states, tribes, municipalities, industry and private organizations. The Board is co-chaired by representatives from USGS and USEPA. The workgroups currently established under the Board are involved in activities related to: PBMS; a National Environmental Monitoring Methods Index; Laboratory Accreditation; Biological Methods Comparability; Nutrient Methods Comparability; and Outreach and Publicity. By 2000, the MDCB is supposed to compare sampling and laboratory methods and protocols leading to performance based acceptable methods, and develop QA and QC guidelines. The MDCB web site is http://wwwdwimdn.er.usgs.gov/pmethods/index.html.

Split Sessions:
Simplate—Multiple Enzyme Technology (MET) for the Detection of Heterotrophic Bacteria (Les Flores, IDEXX)—IDEXX manufactures and distributes an enzymatic test for bacteria in water samples. The enzymes are specific to certain bacteria, and if they are present, their activity will produce chemicals that fluoresce in UV light. This system requires no agar preparation, less QC, fewer dilutions, is easier to read and count the hits, and is less prone to technique errors. It allows higher productivity for lower cost. It has a high correlation with EPA method results, and has been submitted to EPA for alternate method approval.
Methods for Evaluating Laboratory Personnel (Laura Conard, Sageworks)—This paper presented several evaluation techniques developed for employee appraisals, including the “career ladder” concept and “annual reviews.” These were tied to the NELAC requirement for demonstrating proficiency in test methods. Ms. Conard contrasted the employer’s viewpoint of the evaluation process against the “Dilbert” viewpoint of the employee. Frustration was expressed from both sides. Her vision of an ideal evaluation system would instead combine feedback, goal-setting, and advancement opportunities. The strategy involves determining organizational needs, establishing levels and paths of advancement, communicating expectations, development of assessment methods, and following through with administrative procedures. She showed an example, based on a lab she worked with, of establishing necessary functions and manhours as a base for work. The functions were evaluated based on complexity of skills required, and categorized by the proficiencies needed to perform them. Productivity was estimated based on ranges of time for functional tasks. A career ladder using the following basic professional positions was established: Lab Aide (entry level); Lab Analyst (entry level trainee); Mid-Level Analyst (journeyman); and Experienced Level Analyst (master). For supervisory positions, there were Entry Level Supervisor (chemist or microbiologist) and Experienced Supervisor (lab manager). Statements of Expectations were prepared for each position, listing required demonstrations of proficiency, for what tests, and experience. Advancement paths were established that connected the expectations (goals) with annual performance appraisals (achievement measurement). A Test-by-Test Training Manual sets out a training sequence, explanations for each training module, expectations, and a metric for testing proficiency. Documentation requirements are explained so expectations and eligibility for each position are clear.
Performing Meaningful Internal Quality Audits in the Laboratory (Tom Modlin, NNSY)—The reasons for performing internal audits, their objectives and planning considerations were described. The elements of an internal audit and its execution were detailed, and the audit report considerations were discussed. The talk focused on presenting the internal audit objectives as a tool for quality improvements, not an enforcement tool. He stressed that in order to collect accurate and complete information during an internal audit, the trust and cooperation of the personnel interviewed is essential. “Remember, you are auditing the quality system. You are not doing personnel performance evaluations.”
Things You Always Wanted to Know About Standard Methods But Were Too Afraid to Ask a Regulator (Betsy Ziomek, VADEQ)—If a lab cites the Standard Methods for the Examination of Water and Wastewater handbook as a method reference, then the QA and QC required for the analyses must include part 1000. Part 1000 applies to all methods, including method validation and control chart development. She presented an extensive course on construction and interpretation of control charts to comply with these requirements, and please the auditor.