Focus
EPA P l a n s N e w Approach to A n a l y t i c a l Methods
A
fter years of discussion, the U.S. Environmental Protection Agency (EPA)
ries can modify analytical methods. Nevertheless report several sources at EPA, the effort to increase the flexibility in the agency's analytical methods is moving quickly is being funded and is being embraced by several program offices "The last several
instituting a "paradigm shift" in its approach to analytical methods At a May 28 meeting thepolicy council of EPA's Environmental Monitoring Management Council
months h a w hppn
real hich gear " says Carol Finch executive director of the EMMC Fleven n'lot f forts that f 11 tVT ' creasedflexibilityphilosophy
inr»lii/H£io
representatives from all of C-DA'
1 4.
A
EPA s regulatory and research programs, established the goal of agency• 1
1
4-
J
C 41
wide adoption of the perC
1
1
formance-based measurement system (PBMS) approach to environmental momtonng. Although details are still • pp oac is expe give environmental inalysts more treeaom in levciULJiiig n e w aiLaiy uccth
methods ana en using tne
•
ran
are now underway in EPA s wastewater and drinking water programs, as well as in a site-monitonng program to ,i , i, - i ensure that radioacuvely contaminated sites have i
i
i
i
been properly cleaned up. A key factor in the rapid advance of the PBMS proach according to Finch and other sources is that the assistant administrators of EPA the politically anpointed heads of EPA's program sit on EMMC's council optimistn is that it looks we will have some consistency in the administrators and they are tnrl gaged, Finch adds.
Assistant administrators approve performance-based measurements as a goal
deci r*r A S reguiaiory consequences tor commercial testing iaooraLones anu instrument. inaiiuiaciurers wno nave seen very nrxie growtn in tne u.d. market tor environmental services and equipment. Details of how EPA will implement a PBMS in the various agency programs are expected to be open for public discussion early next year EPA's offices for water regulation have already held public meetings in several cities to solicit public comments on their first draft for implementing
a PBMS. Current thinking on the PBMS is that some sort of checklist will be used to ensure that methods meet certain method or data quality objectives (DQOs) and quality control standards (see box on D 736 A) In theory, a PBMS approach would allow analysts to use any method that met these DQOs and QC standards. However by establishing the PBMS as a goal onlv EPA's program offices and state and local environmental regulatory offices will still be able to restrict how significantly laborato-
A tradition of prescriptive methods EPA's analytical program has evolved within a regulatory framework with powers mandated by different pieces of environmental legislation Consequentlv there isn't a single EPA approach to analytical methods but rather different pro-
Analytical Chemistry News & Features, December 1, 1996 7 3 3 A
Focus
Table 1 . Different EPA programs have different analytical approaches Regulatory mission
Ensuring safe municipal drinking water
Regulation of the disposal of pollutants into navigable waterways
Regulation of the disposal and treatment of municipal solid and hazardous wastes
Analytical methods and philosophy
Reference methods for determining specific analytes, flexible methods that can be modified, complex procedure for gaining approval for new methods (a simpler approach will be proposed soon), testing laboratories are accredited
Reference methods for determining specific analytes, generally prescriptive methods (a more flexible approach will be proposed soon), complex procedure for gaining approval for new methods (also to be modified)
Guidance methods for determining specific target analytes (however, alternate methods can be used following a flexible or performancebased approach), plans to implement a full PBMS approach (with a few exceptions)
Program Office
Office of Water
Office of Water
Office of Solid Waste
Legislation
Safe Drinking Water Act
Clean Water Act
Resource Conservation and Recovery Act
grams under different mandates that have required different analytical philosophies (see Table 1). For most of the analytes tracked by these programs, the responsible EPA program offices have published reference methods that have gained almost Bible-like status. The first methods were generally very detailed, says Ivan DeLoatch of EPA's Office of Research and Development and a member of EMMC's PBMS workgroup, because the Agency in its early days needed a "baseline" from which to carry out enforcement actions. In other words, EPA's regulatory mission took precedence over allowing analysts greater latitude in choosing modifying methods It decision suoDorted by many of the industries being regulated which like EPA were worried that method
sands of dollars to develop new methods Newer methods have generally moved away from this prescriptive approach, allow- backed by peer-reviewed journal articles, ing more flexibility in modifying the why should it be easy for others to get a method. For example, analysts can change new method approved? the type of detector or chromatographic On the other hand, under the Recolumn on a gas chromatograph or vary the source Conservation and Recovery Act extraction method. The key is for the labo- (RCRA), which regulates the disposal of ratory to follow the standardized QC proce- all kinds of solid wastes, the regulated dures and meet the QC acceptance criteria community can use any reliable method. in the reference method to ensure that the "Our policy has been that it is up to the modifications meet EPA's regulatory needs. waste generators to demonstrate that they However, the overall pace at which new can see the analytes of interest, in the mareference methods have been introduced trix of interest, at the level of concern," has been frustratingly slow. For example, says Barry Lesnik of the Office of Solid the study by Budde and Hites found that Waste. States, however, are free to take a the 600 series of methods for wastewater more prescriptive approach and require generally used packed columns for GC the use of only the guidance methods. analysis rather than capillary columns. "We sat on capillary columns for a long, long PBMS to the rescue? time," admits Richard Reding with EPA's The current push toward PBMS began, to Office of Water. some degree, because another reform efIn fairness to EPA the process of approv- fort failed. In 1991, EMMC's methods workregulatory conflicts ing methods has been stymied by tight bud- group tried to deal with the overlapping One byproduct of this prescriptive gets, shifting political priorities, and lately by analyte problem by launching an effort to government shutdowns. In addition, the pro- consolidate and integrate methods that alapproach was significant overlap beready existed. "The laboratory and regutween methods. In a 1991 study of EPA's cess of issuing new methods is nearly as lated community are really suffering by the drinking water and wastewater methods, complicated as issuing a new enforcement regulation, requiring that complete methods lack of coordination between program ofWilliam Budde with EPA's Office of Reappear in the Federal Register for public com-fices over differences in analytical methsearch and Development and Ronald ods," says Joseph Slayton, a senior scientist ment before being finalized. Hites of Indiana University cited one example three methods developed in the EPA has had a mechanism for over 15 and technical director with EPA's Region III Central Regional Laboratory (Annapolis late 1970s and early 1980s for drinking years for those outside the Agency to deMD) and one of the chairs of the EMMC's velop new drinking water and wastewater water (524.1, 524.2) and wastewater PBMS workgroup "We service all the pro(624) that all used similar purge-and-trap methods through an alternative test proeTams so it is also a real draff on us " cedure. Although several new metihods procedures and shared 30 of 62 analytes Representative methods from different {Environ. Sci. Technol. 1991 25 9989 were approved by this route, the procedure is complex. In fact, the attitude of programs were selected for integration by 1006) This same problem is found some at EPA was that if the Agency spent EMMC scientists. "Fundamentally, the among other programs which can have years of research and hundreds of thoumethods were the same from program different methods for the same analyte 734 A
Analytical Chemistry News & Features, December 1, 1996
Regulation of air emissions from various sources Reference methods ranging from prescriptive to flexible, program addresses ambient air monitoring, mobile source monitoring (e.g., automobiles), stationary source monitoring (e.g., smokestack monitoring), and indoor air monitoring Office of Air and Radiation Clean Air Act
Cleanup of abandoned hazardous waste sites (Superfund) Contract lab program, analytical procedures specified in the contract, typically prescriptive with methods often borrowed from other programs
Regulation of toxic substances deliberately released into the environment, such as pesticides Good laboratory practices, EPA registers and determines the use of products based on manufacturer-supplied analytical data
____• „^^_____^_^___ _ _ ^ _ _____„^^___ Office of Emergency and Office of Pesticide Programs Remedial Response Comprehensive Environmental Response, Compensation, and Liability Act
office to program office, but the QC [was] drastically different from one office to another," recalls Slayton. A group of metal methods was quickly integrated, but the effort bogged down over other methods such as one for volatile organics. "It was extremely frustrating that we didn't come to closure." Officially, the integration effort continues, but most EPA scientists are skeptical that it will be successful. "It has been a painful three-year process trying to retrofit these existing methods," states Finch. One way to integrate methods, suggests Slayton and other analytical chemists, is to adopt a PBMS approach. "It does away with the procedural steps in a method. In a sense, the PBMS approach decreases the importance of the methods and allows a blending across all programs, because analysts would have the flexibility to use their professional judgment." Thus, instead of a "painful" retrospective integration of methods PBMS-style methods could be integrated from the start because there would also be some consistency in QC requirements across programs There are other arguments for the PBMS approach. "I have always had a problem with prescriptive methods because it is very easy to cop out when you have the wrong method for a particular application—'I don't have to do any more work because this is what I'm supposed to do'," says Lesnik, who is also a chair of EMMC's PBMS workgroup. In fact, Lesnik warns that under RCRA, if generators avoid reporting a violation of the program's regulations by using inappropriate
_________^_ Federal Insecticide, Fungicide, and Rodenticide Act and Toxic Substances Control Act
guidance methods, that won't keep them out of trouble. The PBMS approach also has advocates among critics outside of EPA who are frustrated by what they say is a lack of innovation. Commercial environmental labs, in particular, are caught in a buyer's market and say that they need a PBMS approach to introduce new cheaper-to-run technologies in order to survive. Instrument manufacturers have also seen their U.S. environmental market plummet, and some see the PBMS approach as a way to provide new productt to laboratories. As reported in Analytical Chemistry (Septp 1 1999 p. 529 A) the American Instrument Association has lobbied this year for a Congressional Bill to force the PBMS approach on EPA and the association has worked to build support within EPA's hierarchy for the concept
ever NELAC establishes must comply with EPA's regulations and rules; EPA has played a key role in forming and supporting NELAC, and a number of EPA employees, including Slayton and Lesnik, are delegates to NELAC. PBMS has emerged as one of the cornerstones of NELAC. 'To inspect environmental laboratories for compliance [under NELAC] with all these EPA programs will take an army of inspectors," argues Slayton. "One way around it is to make methods more flexible so inspectors don't need to know 10,000 procedural steps." NELAC has picked up steam in the last two years but can't complete its documents without EPA's language on the PBMS approach. Conference heads have recently written to EPA urging the agency to "get the job done", reports one source. Concerns and limitations "The definition [of a PBMS] is the big issue," says Kathy Hillig, who is wiih BASF (Wyandotte, MI) and is a NELAC participant working on the PBMS problem. "Everyone has a different definition." How the PBMS system is defined and implemented could have significant consequences. "If you have two methods with two different results, which is the right one and how wili you comply [with regulations]?" she asks.
However, whether laboratories will in fact buy equipment not blessed by an EPA reference method is not clear. When the Office of Water proposed to eliminate the alternate test procedure as part of its methods reform, instrument manufacturers objected. "The instrument and equipment people wanted to have that little EPA flower on their devices," says William Telliard of the Office of Water, referring to the Agency's symbol. As a result, the office will keep a modified version of the alternate test procedure.
It's a thought that haunts EPA as well. "If we aren't smart enough in the way we set up our DQOs, someone will come up with a loophole and be able to bypass us with a method that doesn't measure what we want it to," says Reding. Even if EPA comes up with a welldefined PBMS approach for its varrous programs, states can require a more prescriptive approach, especially to support laboratory accreditation activities. Currently, the only federal programs that require accreditation of laboratories are under the safe drinking water program. Typically the accreditation responsibility falls to the state. As a rule, the state auditors who perform this job are poorly paid, and there is frequent turnover. "You have a microbiologist certtfying someone using a GC/MS " says Reding
The other pressure for the PBMS approach comes from the National Environmental Laboratory Accreditation Conference (NELAC), a broad-based group seeking to establish a U.S. environmental laboratory accreditation program. What-
Some states worry that by abandoning prescriptive methods with their convenient checklists, the auditor's job will get even more difficult. That problem would get even worse under the present NELAC plan, which gives states a significant role
Analytical Chemistry News & Features, December 1, 1996 735 A
Focus
EPA's strategy for adopting PBMS
Details to be checked will include parameters such as the new method's sensitivity, precision, recovery, and types and numbers of samples. Data or method quality objectives will ensure that EPA's regulatory needs are met and that the method actually measures the analyte or parameters of concern in the appropriate matrix or matrices. Straightforward modifications of EPA reference methods such as using a different chromatographic column will entail much less work However both simple refer-
ready existing database containing all the approved reference methods along with targeted analytes (Environ, Sci. Technol. 1993,27,39-41). Each program office will decide how it will implement the decisions of the EMMC and develop a timeline for taking action. In a survey of program offices, Analytical Chemistry found that several are already planning action: Wastewater and drinking water. As already reported in Analytical Chemistry (March 1,1996, p. 166 A July 1,1996, p. 403 A), the Offfce of Water launched an effort earlier this year to introduce flexibility in its wastewater methods. According to Telliard, co-chair of EMMC's water methods workgroup, the proposal includes a streamlining effort that encompasses wastewater and drinking water methods. Currently envisioned are posting standardized QC tests for all approved methods ,ncluding older methods harmonization of wastewater and drinking water methods as appropriate increased cooperation between the two water program offices and the freedom to modify reference methods without seeking EPA approval New methods however would still need to be annroved annronriate program office A new threetier annroach is hp'ntr rnn d f r method validation that will supplant the older, more
method modifications and radically new approaches will probably use the same form EPA is also creating an agencywide framework for new method development along with an information system that would track the development as a means to avoid a duplication of efforts and to encourage integration of methods. The system will probably grow from the Agency's Environmental Monitoring Methods Index, an al-
complex alternate test procedure. The tiers are based on the number of matrices and testing laboratories involved and range from approval for a single lab to a national use approval for all matrix types. A detailed proposal of these changes, originally ex„ , , .T , ° . pected before the November elections, is now expected in the Fedoral Register around the December holidays, says Telliard. RCRA methods. Already very flexible about using alternate methods, the
in accrediting laboratories for all EPA programs. As a result, some states are skeptical of the PBMS idea. However, says Slayton, it is unreasonable to expect that any inspector would be well versed in methods ranging from wet chemistries to ICPMS. He says that the inspectors he trains are taught to look at the data. "You need to see the data. If you
get to that level, a performance-based approach is no different." Opposition to PBMS among states is weakening, says Eldert Harwig, who is with the Florida Department of Health and Rehabilitative Services (Jacksonville, FL) and is the elected chair of NELAC. "[The inspections] are going to be most of the time fairly straightforward," he predicts.
Although many of the important details about how EPA would define and promulgate a performance-based measurement system remain to be finalized, some aspects are taking shape. The EMMC workgroup on the PBMS approach is recommending a checklist document modeled after a U.S. tax form. The document will lead the method developer through a series of steps with a description of who needs to fill out each section. A number of probable questions with answers to help method developers find their way through the document are also envisioned
736 A
1
U
4-4-4-
Analytical Chemistry News & &eatures, December 1, 1,96
J
TT.
tf
Office of Solid Waste plans to totally adopt the PBMS approach, Lesnik says. That includes further eliminating requirements to use reference methods as appropriate and adding data quality criteria to the RCRA regulations. The office will still continue to introduce guidance methods as updates to its SW-846 methods Air. One of the demonstration projects for the PBMS approach falls into the Office of Air's Office of Radiation and Indoor Air (and is being developed in cooperation with other agencies such as the Nuclear Regulatory Agency and the Department of Energy)—a PBMS approach to determining when a radioactively contaminated site is remediated. The other Office of Air methods are a complex mix of tests for national ambient air quality (03, SO , particulates CO hydrocarbons NO tomobile and truck emissions and emissions from stationary such as smokestacks "Based on stakeholder information the office has fewer prohlems with dnnlicate methods than other says Segall Air Quality Planning and Standards already has procedures for validating alternative methods but says Segall 4-t.
™
4. i-U 4-
there are many measurements that may l
J 4U
1
4
r>T>i\/rc
never lend themselves to a PBMS approach. Superfund. The program could introduce the PBMS approach in its special or delivery analytical services for atypical analytes.
Indeed, EPA suspects that rather than a flood of new methods, most laboratories will continue to use or modify EPA reference methods. "We will always have a reference method for any analyte that EPA's water offices require laboratories to measure or monitor," saysTelliard. "If they choose not to use it, that's fine." Lesnik, too, says that the Office of Solid
Waste will continue to produce guidance methods for the RCRA program. EPA offices are also talking about workshops to help states adapt to the new methods approach. "There will have to be federal money for training and implementation," says Lesnik. "Otherwise, it will be slapped down [by the states] as an unfunded mandate." Some methods may never be amenable to the PBMS approach. For example, ,he measurement of airborne particulates is defined by the conditions of the sampling and the analytical methods. Thus, the method is integral to the regulation. Other methods will be difficult to modify. "Sample collection in air is not a trivial technique. Unfortunately, it is often difficult to spike [air] samples," says Robin Segall with EPA's Office of Air Quality Planning and Standards a member of the EMMC's PBMS workgroup and a NELAC delegate. Some of the air methods will be difficult to fit into a PBMS mold she predicts N e w role for EPA analytical chemists?
One other group that will certainly be affected by adoption of the PBMS approach is EPA's own analytical chemists. Even before the decisions by the EMMC, there were signs that EPA's analytical chemists are moving away from their traditional role of developing and evaluating new reference methods. For example, in a shakeup of EPA's Office of Research and Development last year, responsibility for proposing and promulgating wastewater methods shifted from the research laboratories in Cincinnati (then known as the Environmental Monitoring Systems Laboratory) to the Office of Water's Office of Science and Technology. That move came as Congress passed a National Technology Transfer and Advancement Act that opens the way for consensus organizations such as AOAC and ASTM to play a much larger role in developing reference methods. "Down the road we hope to see 80-90% of our methods coming from these groups," says Telliard. As for EPA's analytical chemists, they may spend more time working with new technologies, but not necessarily with the goal of a specific application, says Reding. This type of change, he argues, "could attract young scientists." Alan Newman
Now the latest news and information in the world of chemistry is only a bookmark away. Introducing the new Home Page from ACS-
http://pubs.acs.org Now you can find all the information you need on ACS publications with our brand new Home Page, redesigned to make access easier and faster than ever before. Bookmark us today, and you'll be able to visit us again and again for the most up-todate information including: • Hot Articles A special section containing articles and news items of interest. • Advertised Product Information Network (PIN) A new way to get more information electronically on products and services advertised in ACS publications. • Supporting Information FREE to subscribers of all ACS journals. • Books and Journal Information New releases, pricing information, and the full catalog containing descriptions of all ACS books, journals, and magazines. • ACS Job Bank Current listings of jobs available to chemical professionals. Includes classified ads from C&EN, Chemployment (ads from 45 newspapers nationwide), and links to other online job banks. Free to ACS Members. There's also an easy link to the American Chemical Society Home Page (http://www.acs.org) for free information on the Society and its activities. For 24-hour access to the everchanging world of chemistry, bookmark the new ACS Publications Home Page today!
ACS
PUBLICATIONS
Essential Resources for the Chemical Sciences
Analytical Chemistry News & Features, December 1, 1996 737 A
