Titles of Regulations: 1VAC30-45. Certification for Noncommercial Environmental Laboratories.

1VAC30-46. Accreditation for Commercial Environmental.

Statutory Authority: §2.2-1105 of the Code of Virginia.

Publication of final regulations: 24:25 VA.R. 3449-3523 August 18, 2008.

Suspension of final stage: The final stage of the regulatory process was suspended on Wednesday, September 17, 2008, pursuant to § 2.2-4007.06 of the Code of Virginia. The reason for the suspension is that at least 25 persons requested additional public comment.

Delay of effective date: The effective date of this regulatory action will be delayed.

Additional public comment: The Division of Consolidated Laboratory Services of the Department of General Services (DGS-DCLS) will hold a 30-day public comment period on the issues raised by those who requested additional public comment. A summary of these issues is provided below. DGS-DCLS will only take comments on the issues that were raised and the specific regulatory provisions set out below.

DGS-DCLS will receive public comments until 5 p.m. on November 12, 2008. DGS-DCLS will not hold a public hearing. Comments may be sent by email or letter to the contact listed below. Any comment sent by email must include the name, address, and phone number of the person sending the comment.

Contact person: Nancy S. Saylor, Consultant to the Division of Consolidated Laboratory Services, Department of General Services, 600 North 5^th Street, Richmond, VA, 23219, telephone (804) 231-7980, email nssaylor@verizon.net.

Summary of issues raised by those persons requesting additional public comment: Citizen water quality monitoring groups have two main concerns. First, fees charged under the environmental laboratory certification program will severely affect the ability of citizen monitoring groups to continue operation. Citizen monitoring groups are funded through grants from the Department of Environmental Quality (DEQ). Grant money is limited. If citizen monitoring groups are charged fees, this grant money will be diverted to DCLS and not used for its intended purpose, to fund the operation of these groups. Second, the final regulations do not take into account the recent changes DEQ has made to its citizen water quality monitoring program. This leads to a conflict between the certification program and the citizen monitoring program. Since 2004, DEQ has developed a three-tiered system to define how the agency will use citizen monitoring data. DEQ has assigned quality assurance and quality control (QA/QC) requirements for each of the tiers. DEQ has approved many QA/QC plans developed by citizen monitoring groups during this time.

Environmental research laboratories at Virginia’s institutions of higher education also raised concerns. First, the impacts of the regulations on research conducted by these laboratories are unclear because the regulations do not specifically address whether these laboratories would be commercial or noncommercial. One commenter from a university laboratory stated that the laboratory performs both research and permit monitoring analysis. Second, these laboratories are concerned about the fees and other costs of the certification program. These costs could have an adverse impact on the operation of the laboratories. Third, providing research analysis to DEQ is different than submitting data for the purpose of complying with a permit. Laboratories providing research analysis should not be subject to the same requirements as those submitting compliance data.

Background: The regulations establish the certification program required by § 2.2-1105 of the Code of Virginia for environmental laboratories submitting data to the Department of Environmental Quality under the state’s air, water and waste laws. There are two regulations, one for noncommercial environmental laboratories (1VAC30-45) and one for commercial environmental laboratories (1VAC30-46). Each regulation is organized into two parts. Part I of each regulation contains the provisions pertaining to the administration of the program. This part describes the process that owners of environmental laboratories must use to be certified and to maintain certification under the program. Part II of each regulation contains the quality assurance and quality control standards that environmental laboratories must meet to be certified under the program. The standards in Part II of Chapter 45 have been developed for Virginia noncommercial environmental laboratories. The standards in Part II of Chapter 46 are the 2003 National Environmental Laboratory Accreditation Conference standards, which are incorporated by reference into the regulation.

The regulations were first proposed in February 2004. DGS-DCLS took written comments for 60 days. DGS-DCLS also held public hearings statewide to hear public comments. At the end of the 60-day public comment period, DGS-DCLS reviewed the public comments and revised the regulations. Because some of the revisions were significant, DGS-DCLS announced an additional 30-day public comment period in September 2004. Following this public comment period, DGS-DCLS made additional changes to the regulations. One of these changes was the elimination from the definition of environmental analysis and from the program requirements of taxonomic identification of samples for which there is no national accreditation standard such as algae or benthic macroinvertebrates. This change was made in response to comments from citizen monitoring groups who commented during the second public comment period, for the first time. DGS-DCLS sent the draft final regulation package for review to the Department of Planning and Budget, the Secretary of Administration, and the Governor’s Policy Office, in March 2005. This executive review was ongoing until July 10, 2008, when the Governor’s Office approved the final regulations to be promulgated in the Virginia Register.

Provisions to be added to 1VAC30-45-30: DGS-DCLS and DEQ have been working together to draft regulatory provisions that address the issues raised by both citizen monitoring groups and laboratories at institutions of higher education. These proposed new provisions are set out below. DGS-DCLS requests comments on the specific language of 1VAC30-45-30 C and D. 1VAC30-45-30 is provided in its entirety. Please comment only on the proposed additional language, which is underlined.

The citizen water quality monitoring program at DEQ has grown since 2004, when DEQ and DGS-DCLS last discussed how the certification program would affect citizen monitoring groups. At that time, seven laboratories were affected and only three of these laboratories would incur significant fees. The program to use citizen monitors was at the beginning of its development. Since 2004, Virginia’s General Assembly and the Environmental Protection Agency (EPA) have encouraged DEQ to increase its use of citizen monitors of the state’s waters. Since 2004, DEQ has created a program that provides separate tiers for different levels of citizen monitoring data usage. As the significance of the data use increases, the requirements for quality assurance and quality control increase. For Tier III, the highest tier, where data are used to list or delist waters on the 303(d) impaired water list, to assess waters for the 305(b) report to EPA, or to use with DEQ data for TMDL development, DEQ requires a quality assurance project plan, laboratory audit, and the submittal of calibration and quality control associated information to DEQ when submitting data. DGS-DCLS and DEQ are proposing (see 1VAC30-45-30 C) to allow citizen monitoring groups and certain affiliated environmental laboratories to meet DEQ’s quality assurance and quality control requirements in lieu of the requirements of the certification program. DGS-DCLS sees no need to override the working quality assurance program that DEQ has developed for citizen monitoring groups. In addition, these groups have limited funds. Any increase in costs would hamper their ability to provide data to DEQ.

DEQ works with many environmental laboratories at institutions of higher education on various research projects that provide information on the environmental health of the state’s waters. Some examples are fish health studies that analyze blood chemistry and organ condition; water quality studies focusing on storm-event patterns to assess metals, pesticides, and organics; benthic biomonitoring; and an assessment of chemistry from fish kill vs. nonfish kill areas. Most of these laboratories only perform research analyses. Some of the laboratories eventually provide analyses that support water standards development or that may be associated with permitting. DEQ proposes to identify and require these laboratories to be certified (see 1VAC30-45-30 D).

DEQ believes that analyses performed by laboratories at institutions of higher education that are used by DEQ and are directly associated with DEQ regulations, permits, compliance and/or enforcement activities must be certified by DGS-DCLS. Analyses performed by laboratories at institutions of higher education and used by DEQ as environmental research do not require certification.

DGS-DCLS and DEQ will treat environmental laboratories at institutions of higher education that perform environmental analysis required by permits or compliance orders for themselves or for others just as they would laboratories owned commercially or by local governments or authorities. If the laboratory does work for other persons, the laboratory would be deemed a commercial laboratory under 1VAC30-46. If the laboratory does work for the institution of higher education of which it is a part, the laboratory would be deemed a noncommercial laboratory and be subject to 1VAC30-45. If the laboratory is a state institution of higher education and works for another state agency, the laboratory would be deemed noncommercial.

Regulatory provisions for review:

1VAC30-45-30. Applicability.

A. This chapter applies to any owner of a noncommercial environmental laboratory.

B. Any environmental laboratory owned by an agency of the federal government may be certified as follows:

1. By DGS-DCLS to the standards set out in this chapter, or

2. By a federal primary accrediting authority to the standards established by the National Environmental Laboratory Accreditation Conference.

C. Citizen monitoring groups. Section 62.1-44.19:11 of the Code of Virginia both establishes a citizen water quality monitoring program for Virginia and encourages the growth of the program. The Department of Environmental Quality (DEQ) has a separate program of quality assurance and quality control (QA/QC) standards for citizen monitoring groups and their laboratories to follow. The following laboratories shall meet the DEQ QA/QC requirements developed for the purposes of citizen monitoring of water quality in lieu of the requirements of 1VAC30, Chapter 45 or 1VAC30, Chapter 46:

1. Laboratories owned by citizen monitoring groups.

2. Laboratories at institutions of higher education affiliated with citizen monitoring groups for the purposes of analyzing samples for the groups.

D. Environmental research performed by environmental laboratories owned by institutions of higher education. Environmental laboratories owned by institutions of higher education located in Virginia that perform analyses for the purpose of providing environmental research data to DEQ at DEQ’s request shall meet the QA/QC requirements specified by DEQ. An environmental laboratory owned by an institution of higher education located in Virginia that performs environmental research for DEQ shall not be subject to the requirements of either 1VAC30, Chapter 45 or 1VAC30, Chapter 46 unless DEQ requires the laboratory to do so.