From the Editor
Below are presentation synopses in chronological order from the 2013 ACIL Policies and Practices Conference in Washington, DC. The articles contain links for members to access the speakers’ visual aids if available.
Policy Meetings (March 20th)
Third-Party Programs to Assess Regulatory Compliance
ACIL members learned about the existence of the Office of Management and Budget’s (OMB) Administrative Conference of the US (ACUS) and its role in advising regulatory agencies on the use of third-party laboratories. In general, according to ACUS’s Deputy General Counsel David Pritzker, ACUS advises that the higher the risk of consequences, the more independence and rigor required.
ACUS Recommendation 2012-7 encourages agencies to glean practical information from the private sector to use in decision making, noting that laboratories have already developed a compendium of best practices. Tasked with increasing government efficiency, ACUS serves as a catalyst for interagency cooperation and invites subject matter experts to committee meetings to help develop recommendations.
To view materials from this presentation, click here. For additional background information, click on Report to the Administrative Conference of the United States.
CMET Advances Personnel Certification Program; Meets with FHWA, FAA and NACLA
After Chris Bowker from the North East Transportation Technician Certification Program (NETTCP) reviewed the NETTCP personnel certification program, and Brian Johnson from AASHTO confirmed the need for hands-on programs like this one, participants discussed using this program as the foundation for ACIL’s Construction Materials Engineering and Testing (CMET) personnel certification program. Newly retained ACIL staff members Jerry Weathers (an ACIL Past President) and Bob Uttenweiler were tasked with drafting a Memorandum of Understanding with NETTCP, targeting Ohio as the first place for implementation.
Mike Rafalowski provided meeting attendees with an update on Federal Highway Administration (FHWA) activities, noting that they have approved funding through September 2014, shielding the agency from the worst effects of sequestration. Mike also discussed the benefits of National Cooperation for Laboratory Accreditation’s (NACLA) sector-specific recognition to augment 17011 and 17025, which are much too generic, and lauded NACLA’s transparent and inclusive membership structure and process.
Greg Cline from the Federal Aviation Administration (FAA) shared upcoming changes to FAA pavement specifications, garnering possible input from ACIL members on P-specs AC to take requirements from a 20- to 40-year timeframe, and additional information on D3740 for P209. To view Greg’s presentation materials, click here.
Bob Uttenweiler from NACLA presented the latest sector-specific recognition initiatives for laboratory accreditation bodies in the US, noting that NACLA exists because numerous US government agencies, including the US Navy, FAA, FHWA and NASA need the more focused sector-specific approach to recognition/accreditation. When ILAC questioned NACLA’s existence, NACLA chose not to be an ILAC MoU signatory. To view Bob’s presentation materials, click here.
For additional information on this policy meeting, members may refer to the CMET Section meeting minutes.
EPA Enlightens Environmental Sciences Members
ACIL members heard from several Environmental Protection Agency (EPA) personnel, including Kim Kirkland (Office of Resource Conservation and Recovery), Lemual Walker (Office of Water’s Office of Science and Technology), and Gregory Carroll and Dan Hauptman (Office of Ground Water and Drinking Water) on the EPA SW-846, Clean Water Act and Safe Drinking Water Act methods programs.
Kim reviewed Update V to SW-846, noting that they plan to remove the MDL requirements from Methods 6010 and 6020 and replace them with the Lower Limit of Quantitation (LLOQ); and that EPA policy permits users to employ the latest edition of an SW-846 method whenever possible. She also reported that the ORCR MICE line item seems safe for this budget cycle.
Furthering the ACIL-EPA partnership, Kim asked laboratories to provide data that demonstrates the equivalence of mercury and non-mercury thermometers, so that EPA may remove current requirements to employ mercury thermometers. ACIL’s David Freidman will coordinate this effort once he determines the data required. To view Kim’s presentation materials, click here.
Lemual reviewed his office’s activities on wastewater testing methodology, including the status of the Methods 624 and 625 update package, noting that they strive to issue a methods update package every 4 years with interim Alternative Test Protocols (ATP) approval packages issued every 2 years. He also requested ILI’s assistance to update Method 608 and possibly address creation of a method for measuring total nitrogen.
Gregory and Dan reported that they have started the third cycle of UCMR laboratory audits and stressed that laboratories must test a trip blank to ensure that the positive result is real when finding positives for an analyte. They also alerted ACIL members to a meeting on May 15, 2013 to discuss the future of the UCMR program. They noted that new methods will emphasize algal toxins and pharmaceuticals, and that the upcoming Method 524.4 adds purge and trap flexibility and the option to employ nitrogen as an alternative purge gas.
On ACIL’s Non-Governmental Accreditation Initiative, ACIL CEO Milton Bush reported that Florida is moving toward a third-party accreditation system, and just issued Request for Application (RFA) to third-party assessment organizations to start implementing the change. New Jersey and Minnesota also are seriously considering non-governmental accreditation.
ACIL’s David Friedman reviewed ILI’s successes, and its current project to develop a generic Solid Phase Extraction (SPE) protocol, bringing together over 9 SPE vendors, the ACIL laboratory community, three EPA program offices and EPA regional laboratories. ILI has developed a draft protocol, and the work group is currently addressing its validation.
ACIL visited EPA senior management following the P2 Conference to share the benefits of continuing the ACIL-EPA partnership through ILI, underscoring the huge amount of scientific help that ACIL members can provide and encouraging EPA to contact ACIL as new issues arise. For additional information on this policy meeting, members may refer to the Environmental Sciences Section Meeting Minutes.
Food Sciences Members Receive Details on FSMA, FDA, Pesticides and Organic Food
ACIL’s Food Safety Modernization Act (FSMA) Consultant John Bode briefed attendees on the current status of FSMA, noting that laboratories can now provide comments on the already issued Produce Safety and Preventative Controls and suggested focusing on the use of accredited laboratories for additional product and water testing while waiting for Food and Drug Administration (FDA) guidance on the FSMA-mandated laboratory accreditation program.
Based on ACIL inquiries, the FDA science staff is investigating delays caused by escalating requests for documentation of routine laboratory quality control information; ACIL also awaits an FDA response on the re-inspection fee issue. Future discussions with FDA will focus on use of accredited laboratories, using Canada as an example of a government program transferring a large part of its regulatory testing to private accredited laboratories.
Joe Konschnik (Restek) continues to work with Jon Wong from the FDA’s CFSAN on the pesticide residue inter-laboratory study to provide data and feedback in the next 3 to 5 months on 204 pesticide compound analytical SOPs received last fall. Jon plans to launch the new inter-laboratory study this fall using state department of agriculture laboratories belonging to USDA’s Pesticide Data Program and ACIL member laboratories. To participate in this study, contact Joe.
ACIL Consultant and former FDA director and chief scientist Mike Olson provided an inside look at the FDA as it relates to private laboratory issues, noting the Office of Regulatory Affairs’ (ORA) primary responsibility for post market surveillance and operational policy in the field, while Product Centers focus on pre-market review, regulatory policy development and program direction. Private laboratory issues arise where policy/program direction ends (Centers) and implementation begins (ORA).
Cheri Courtney enlightened participants on the US Department of Agriculture’s (USDA) organic food program which uses accredited third party certifying agents to review records and inspect food, determining the frequency and method of testing to meet USDA audit sampling requirements. The USDA National Organic Program provides regulatory oversight of the use of “organic” in the promotion and labeling of food. To view materials from Cheri’s presentation, click here.
Conformity Assessment Meetings Cover NIST, International Trade, Energy Star and FCC
Craig Allen from the US Department of Commerce (DOC) International Trade Administration (ITA) discussed negotiations between US trade interests and Chinese negotiators, noting the recent breakthrough, wherein Chinese authorities have unilaterally accepted the principal of “National Treatment” for the first time, treating imports no less favorably than the same or similar domestically-produced goods once they pass customs. Craig suggested a “wait-and-see” attitude on Chinese implementation of National Treatment, and does not expect immediate access for American companies.
Ramona Sarr from the National Institute of Standards (NIST) Mutual Recognition Agreement (MRA) Program Office discussed telecommunications and EMC MRAs currently under development with Mexico, Israel, the European Union and Japan. She noted that Viet Nam is the most active country in APEC, and Mexico is hesitant to finalize its MRA to protect its three laboratories. The MRA with Israel covers test laboratory recognition only for wired and wireless telecommunications equipment, and Ramona asked for ACIL input on standards to include in this MRA. In the European Union, EMC and RTTE directives are changing with the elimination of the notified body statement of opinion. To view Ramona’s presentation materials, click here.
Joe Wereszynski from the US DOC ITA focused on trade with Russia now that it belongs to the World Trade Organization (WTO) and needs to comply with the WTO Technical Barriers to Trade (TBT) agreement, noting that in May they will use the US-Russia Standards Cooperation Engagement Event to assist Russian regulators in developing a framework that conforms to TBT requirements. He also mentioned recent ITA attempts to engage China, Saudi Arabia, India and Taiwan on TBT-related issues. To view Joe’s presentation materials, click here.
NIST Chief of Standards Services Gordon Gillerman discussed NIST’s advisory role in encouraging US regulatory agencies and departments to employ industry consensus standards, and adopt conformity assessment procedures commensurate with the risks raised from non-conformance, stressing that NIST has no regulatory authority to enforce its recommendations.
Eamon Monahan, program analyst with the US Environmental Protection Agency’s (EPA) Energy Star Program, aimed at minimizing the power consumption of consumer products, showed that home electronics fueled the huge rise in Energy Star products since 1995, noting the significant cumulative reduction in energy usage by televisions as a function of screen size between 2009 and 2013. In 2013, EPA adds pool pumps and commercial water heaters to its Energy Star Program with most other categories undergoing revision and/or new developments. To view Eamon’s presentation, click here.
After reviewing the status of the Telecommunications Certification Body (TCB) approval process, knowledge database updates and final US Federal Communications Commission (FCC) rulemaking, George Tannahill from the FCC provided detailed summaries of various FCC Notices of Proposed Rulemaking (NPRMs), including FCC NPRM ET Docket 13-44. To view his presentation, click here.
Business Practices Sessions (March 21st)
Federal Procurement of Laboratory Services
Jack Kelly from OMB’s Office of Federal Procurement Policy (OFPP) discussed his office’s role in strategic sourcing, noting that OMB Circular A-76 requires agencies to compare internal costs versus outsourcing, and performance measurement staff within OMB review metrics to determine cost effectiveness of services. Jack suggested that the Government Accountability Office look at parameters for outsourcing testing.
OFPP’s primarily works to ensure that the government does not overspend its appropriations. Jack also noted that they use the General Services Administration (GSA) Office of Government-Wide Policy to try to change the spending behavior of government organizations.
Marketing and Branding
Bob London, founder of marketing communications firm London Ink, encouraged ACIL members to elevate their marketing efforts and differentiate their companies by making the prospect the focus of business-to-business marketing. He challenged participants to learn about current customer challenges and priorities, and then connect those with laboratory services that help mitigate those issues.
Bob shared specific methods to support this shift, including having non-sales meetings with customers to ask about business challenges and key priorities, ensuring a minimum 25 percent of words in proposals dedicated to the client’s situation and creating websites that focus on who we serve, so that prospects see themselves there. To view Bob’s presentation materials, click here.
Running Effective Meetings
SESCO Vice President Jamie Hasty shared her tips for getting the most out of staff meetings, including providing an agenda beforehand, assigning a presenter and time limits for each topic, setting meeting rules, encouraging feedback and delegating follow-up action items with deadlines that are confirmed in writing via email.
Staff meetings help establish a healthy working environment to develop better solutions, create a cohesive team and ensure that employees are on task with the strategic plan while giving leaders the opportunity to identify employees with leadership potential. For webinars, Jamie recommended sending a practice link in advance to resolve any technology issues, and to take roll.
To view the presentation materials from this session, click here. To access SESCO’s Running Effective Meetings Participant Manual, click here.
Healthcare Reform Act
Nicole Porter from the Small Business Administration and Alex Adler from HGA Financial presented a synopsis of the upcoming Healthcare Reform Act related changes, noting that companies with fewer than 50 employees, as determined based on the prior tax year, are not required to provide health insurance.
For companies providing healthcare, only 9.5 percent of the employee’s W2 can go toward premiums and deductibles. Also, all employees must now receive the same level of healthcare regardless of seniority, rank or level, and no more than a 90-day waiting period is allowed. Beginning in 2014, all pre-existing conditions must be accepted. Companies providing bona fide wellness programs can adjust premiums for participation.
To view Nicole’s presentation materials, click here. To view Alex’s presentation materials, click here.
In This Issue
Save the Date!
2013 Annual Meeting
October 6 - 9
Extend your summer at ACIL’s 2013 annual meeting in Scottsdale, AZ at the beautiful Scottsdale Plaza resort, offering lighted tennis courts, 5 swimming pools and Arizona’s largest whirlpool spa, all in the shadow of famed Camelback Mountain. Enjoy the warm weather while benefitting from a plethora of education and networking opportunities, but save a little time for golf at one of nine nearby courses. Stay tuned for educational programming details as the meeting approaches, sure to include not-to-be-missed sessions on human resources, financial management and information technology.
ACIL Brings New Smart Grid Business to Members
In March, ACIL became a founding member of the Smart Grid Interoperability Panel (SGIP), putting ACIL members at the forefront of this emerging technology and new line of business. ACIL’s voting rights on the SGIP solidifies our role in shaping Smart Grid to benefit our members and US citizens. As an ACIL member, you may display the Smart Grid logo on all company marketing communications such as press releases, web sites, letterhead and trade show booths, sharing your leadership role in Smart Grid development. To download the logo, click here. For more information on getting involved in testing these new products, click here or contact Don Heirman.
Customer Satisfaction Webinar
Join us on April 30th at 1:00 pm ET to learn effective ways to measure customer satisfaction. Lead by Marlene Moore, Program Administrator of the ACIL Seal of Excellence Program, which provides a mechanism for evaluating laboratories and a means to benchmark operations against other laboratories, Marlene shows webinar participants how to use the customer-provided information about management systems operations to help ensure effective operational improvements, and provides examples for obtaining customer feedback that meet the requirements of ISO/IEC17025 Section 4.7.2. For more information and call-in information, contact Beth Horan.
Seal of Excellence
ACIL enters its fourth year of this newly designed program open to member laboratories in all disciplines, providing a benchmarking tool to collect objective client feedback and meet the requirements of ISO/IEC17025 Section 4.7.2. No other program ranks participating laboratories based on customer responses to satisfaction with services or requires a signed code of ethics and data integrity statement by each laboratory location, so sign up today! Program participation runs through October 2013. To learn more about this essential program, click here or contact Marlene Moore.
The NACLA Executive Committee voted in March to formally approve Tracy Szerszen of PJLA and April Fritzsche of NSWC-Corona as the two newest members of the NACLA Board of Directors. April now represents the US Navy, replacing NACLA Past President Arman Hovakemian who became a Metrology Engineer.
ISO/IEC 17025 Overview &
Internal Auditor Training
May 2nd and 3rd, 8:00am – 5:00pm
Cost: ACIL Members $670.50
For more information, click here.
Congrats to H2M!
In March, H2M received accreditation from the US Department of Defense Environmental Laboratory Accreditation Program (DoD-ELAP) to ISO/IEC17025, resulting in upgraded processes across the entire laboratory, according to Senior Vice President Joann Slavin. This allows the laboratory to support environmental restoration programs for US Army, Navy and Air Force projects and provide other services to Federal government clients. Congratulations to H2M on 2 years well spent!
Eurofins Teams with American Water College
Euronfins Eaton Analytical (EEA) has joined with the American Water College to offer no-cost Unregulated Contaminants Monitoring Rule 3 (UCMR3) sampler training for those individuals who need to collect samples under the EPA’s UCMR3 program. UCMR3’s lower reporting limits versus prior UCMRs necessitates specific collection, field blank and sample condition verification requirements for several methods. These make proper sample collection critical to a successful monitoring program, leading to this special online course. In addition, EEA created videos on YouTube to offer utilities an easier way to access this information and simultaneously earn continuing education credits (CEUs).
Thank You Sponsors!
Once again, a sincere thanks to the industry sponsors below, who provide particularly generous support to enable us to offer exceptional ACIL programs.
ACIL National Champion
ACIL Newsletter Staff