Below are general comments concerning the information provided in the NOIRA proposing revisions to 1VAC 30-45.
DCLS Revision 1.Revise Part I of 1VAC30-45 to eliminate the requirements for the initial certification
period.
Support this revision.
DCLS Revision 2.Revise Part I of 1VAC30-45 to simplify the renewal procedural to reduce the burden on laboratories and the agency.
Support this revision.
DCLS Revision 3. Revise the fee provisions of 1VAC30-45-130 so that the fees cover the costs of the program.
I have significant concerns about increasing certification fees considering the serious economic conditions facing the country today. Raising fees places an increased burden on facilities and eventually to Virginia taxpayers. The NOIRA says nothing about the size of the shortfall or whether the agency has had an independent audit of their expenses demonstrating that additional funds are absolutely necessary. Furthermore, DCLS has not proposed any alternatives to reduce their costs, thus removing the need to increase fees. Consider the following:
a.Why is it necessary for non-commercial laboratories to analyze two PT samples annually? Virginia drinking water certified laboratories are only required to analyze one PT each year. Furthermore, Joe Slayton (EPA Region 3 Office of Analytical Services & Quality Assurance) speaking at the VA-AWWA/VWEA Good Laboratory Conference (Aug. 2012) questioned the need of more than one PT each year in laboratory certification programs. There is no legal, regulatory, or data quality need for requiring two PT samples annually to certify laboratories under Chapter 45. By reducing the number of PTs by half, the financial burden on laboratories and DCLS could be reduced. DCLS staff time reviewing and managing laboratory PT data would be cut in half.
b.DCLS should consider reducing the on-site inspection frequency from every two years to every three or four years. This would result in a significant reduction in travel expenses for inspectors as well as reducing paperwork. By doing so, DCLS should be able to reduce the number of inspectors. There are no known reports (after the initial round of DCLS on-site assessments) that there were any wide-spread or significant issues or problems in laboratories such that a reduction in audit frequency would compromise this program.
c.DCLS could partner with existing state-wide organizations with laboratory members (such as VA-AWWA/VWEA Lab Practices Committee, Virginia Rural Water Association, and Virginia Association of Municipal Wastewater Agencies) to improve laboratory performance by developing training programs and other activities. By utilizing existing resources and collaborating more with the laboratory community, continuous improvement in overall laboratory operations could be realized without added costs to the agency, facilities and taxpayers.
d.DCLS states in the NOIRA that a number of “ ...eligible laboratories decided to contract their laboratory work with commercial environmental laboratories instead of becoming certified under the program”, which probably resulted in public/industrial laboratories closing and facility layoffs. Will another round of small laboratories close after this increase in fees? Will moving regulatory testing from on-site laboratories (who have a vested interest in the quality of their data) to a commercial laboratory (who are more concerned with profits) really improve data quality?
e.Finally, DCLS should reconsider their exemption of laboratories as spelled out in 1VAC30-45-30 C and D. By removing the exemptions, the potential pool of paying laboratories would increase.
DCLS Revision 4. Revise the standards in Part II to reflect the changes that will be proposed for 1VAC30-46 commercial laboratories when the changes provide flexibility and reduce the burden on laboratories.
There are numerous changes that can be made to the regulation to eliminate redundant language, provide flexibility and reduce the burden to DCLS and laboratories; but I strongly disagree with changing 1VAC30-45 so that the changes match 1VAC30-46 requirements. This may reduce the burden on DCLS but I have serious doubts that it will reduce the burden on Chapter 45 laboratories.
The original intent of a separate certification program for noncommercial labs (i.e. Chapter 45) was the understanding that these type labs produce quality data since they have essentially one customer and that the documentation and operational requirements defined by a national organization were overly burdensome. The national NELAC standards are developed, written, and modified along the interests dominated by large groups (e.g. commercial laboratory networks, PT providers, and various government agencies). These groups have little concern on the impact their standards will have on small Virginia laboratories or publically owned treatment plant laboratories.
The Chapter 45 laboratory community is willing to assist DCLS in any way to improve these regulations in a cooperative spirit instead of the previous practice of changes being made in a vacuum or in line with those developed outside of Virginia. I recommend that DCLS meet with impacted laboratories, perhaps forming a technical advisory committee to rewrite this chapter, or at a minimum, hold a town hall meeting allowing these facilities to voice their concerns face-to-face with DCLS regulators before releasing a revised document based on regulations for commercial laboratories in 1VAC30-46. Together a program supported by all stakeholders can be developed that reduces costs and provides data of a known and documented quality.
Thank you for the opportunity to provide comments.
