1VAC30-45 Certification for Noncommercial Environmental Laboratories

REGULATIONS

Vol. 25 Iss. 7 - December 08, 2008

TITLE 1. ADMINISTRATION

DEPARTMENT OF GENERAL SERVICES

Chapter 45

Final Regulation

REGISTRAR'S NOTICE: Due to the length of the regulations, only the sections that have changed since the final regulations were suspended in 25:3 VA.R. 340-342 October 13, 2008, are printed below. Refer to 24:25 VA.R. 3449-3523 August 18, 2008, for the text of the sections not printed below.

Titles of Regulations: 1VAC30-45. Certification for Noncommercial Environmental Laboratories (adding 1VAC30-45-10 through  1VAC30-45-860.

1VAC30-46. Accreditation for Commercial Environmental Laboratories (adding 1VAC30-46-10 through 1VAC30-46-210.

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

Effective Date: January 1, 2009.

Agency Contact: Nancy Saylor, Environmental Policy Consultant, Department of General Services, 600 North 5th Street, Richmond, VA 23219, telephone [phone], FAX [phone], or email [e-mail].

Summary:

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 or operators 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.

Final regulations were published the Virginia Register of Regulations on August 18, 2008 (24:25 VA.R. 3449-3523). The final regulations were suspended on September 17, 2008. A notice of suspension of the regulatory process was published on October 13, 2008 (25:3 VA.R. 340-342). The notice included additional proposed language, 1VAC30-45-30 C and D, in response to the public comments that triggered the suspension. 1VAC30-45-30 C addresses certification of laboratories owned by or affiliated with citizen water quality monitoring groups. This subsection allows these laboratories to meet the DEQ quality assurance and quality control requirements for citizen monitoring groups in lieu of the certification requirements of 1VAC30-45 or 1VAC30-46. 1VAC30-45-30 D addresses environmental research performed by environmental laboratories owned by institutions of higher education. This subsection exempts research performed by these laboratories from the requirements of 1VAC30-45 or 1VAC30-46, unless DEQ requires certification. This proposed additional language is included, without change, in the revised final regulations.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

CHAPTER 45
CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES

1VAC30-45-20. Establishment of certification program.

A. Once the certification program has been established, laboratory certification shall be required before any environmental analyses performed by a noncommercial environmental laboratory may be used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively of the Code of Virginia).

B. The certification program shall be established on the first day of the 25th month following the effective date of this chapter [ October , 2011 January 1, 2012 ].

1VAC30-45-30. Applicability.

A. This chapter applies to any owner or operator 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. A 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 DEG QA/QC requirements developed for the purposes of citizen monitoring of water quality in lieu of the requirements of 1VAC30-45 or 1VAC30-46:

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 1VAC30-45 or 1VAC30-46 unless DEQ requires the laboratory to do so. ]

1VAC30-45-70. Process to apply and obtain certification.

A. Duty to apply. All owners or operators of noncommercial environmental laboratories shall apply for certification as specified by the provisions of this section.

B. Timely initial applications.

1. Owners or operators of noncommercial environmental laboratories applying for certification under this chapter for the first time shall submit an application to DGS-DCLS no later than 240 calendar days after the effective date of this chapter [ May 29, 2009 September 29, 2009 ].

2. Owners or operators of noncommercial environmental laboratories that come into existence after this chapter becomes effective [ October 1, 2009 January 1, 2009, ] shall submit an initial application to DGS-DCLS no later than 180 calendar days prior to beginning operation.

C. Timely renewal applications. The owner or operator of an a certified noncommercial environmental laboratory shall submit an application for renewal of certification at least 90 calendar days prior to expiration of certification.

D. Responsibilities of the owner or and operator when the laboratory is owned by one person and operated by another person.

1. When an environmental laboratory is owned by one person but is operated by another person, the operator may submit the application for the owner.

2. If the operator fails to submit the application, the owner is not relieved of his responsibility to apply for certification.

3. While DGS-DCLS may notify noncommercial environmental laboratories of the date their applications are due, failure of DGS-DCLS to notify does not relieve the owner or operator of his obligation to apply under this chapter.

E. Submission of applications for modifications to certification. An owner or operator of a certified noncommercial environmental laboratory shall follow the process set out in 1VAC30-45-90 B to add a new technology matrix, technology/method, an analyte or a test method analyte group, modify a test method or institute use of a method or technology not in the laboratory's standard operating procedures, including alternative test methods or procedures.

F. Contents of application.

1. Applications shall include the following information and documents:

a. Legal name of laboratory;

b. Name of owner of laboratory;

c. Name of operator of laboratory, if different than owner;

d. Street address and description of location of laboratory;

e. Mailing address of laboratory, if different from street address;

f. Address of owner, if different from laboratory address;

g. Name, address, telephone number, facsimile number and e-mail, as applicable, of responsible official;

h. Name, address, telephone number, facsimile number and e-mail, as applicable, of laboratory manager;

i. Name, address, telephone number, facsimile number and e-mail, as applicable, of designated quality assurance officer;

j. Name title, and telephone number of laboratory contact person;

k. Laboratory type (e.g., public water system, public wastewater system or combination of the two, or industrial (with type of industry indicated));

l. Laboratory hours of operation;

m. Fields of testing (program, test methods, and analytes) certification (matrix, technology/method, and analyte/analyte group) for which certification is sought;

n. Methods employed, including analytes;

o. The results of the three most recent proficiency test studies;

p. Quality assurance manual;

q. Lab identification number (for renewal only); and

r. For mobile laboratories, a unique vehicle identification number, such as a manufacturer's vehicle identification number (VIN#), serial number, or license number.

2. Fee. The application shall include payment of the fee as specified in 1VAC30-45-130.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by the responsible official, by the quality control officer and by the laboratory manager.

b. The certification of compliance shall state: "The applicant understands and acknowledges that the laboratory is required to be continually in compliance with the Virginia environmental laboratory certification program regulation (1VAC30, Chapter 45) and is subject to the provisions of 1VAC30-45-100 in the event of noncompliance. I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the laboratory or those persons directly responsible for gathering and evaluating the information, the information submitted is, to the best of my knowledge and belief, true, accurate and complete. Submitting false information or data shall result in denial of certification or decertification. I hereby further certify that I am authorized to sign this application."

G. Completeness determination.

1. DGS-DCLS shall determine whether an application is complete and notify the laboratory of the result of such determination. Except during During the initial certification period, DGS-DCLS shall provide this notice within 90 calendar days of its receipt of a laboratory's initial application. Following the initial certification period, DGS-DCLS shall provide this notice within 60 calendar days of DGS-DCLS's receipt of the a laboratory's initial application and within 30 calendar days of DGS-DCLS' receipt of a laboratory's renewal application.

2. An application shall be determined complete if it contains all the information required pursuant to subsection F of this section and is sufficient to evaluate the laboratory prior to the on-site assessment. Designating an application complete does not preclude DGS-DCLS from requesting or accepting additional information.

3. If DGS-DCLS determines that an application is incomplete, DGS-DCLS's notification of such determination shall explain why the application is incomplete and specify the additional information needed to make the application complete.

4. Except during the initial certification period, if no determination is made within 60 calendar days of DGS-DCLS's receipt of either (i) the application or (ii) additional information, in the case of an application determined to be incomplete, the application shall be determined to be complete. During the initial certification period, the time period shall be 90 calendar days.

5. If the laboratory has not submitted the required additional information within 90 days of receiving a notice from DGS-DCLS requesting additional information, DGS-DCLS may deny any application from a laboratory and require the laboratory to submit a new application if the laboratory does not submit additional information required by DGS-DCLS within 90 days of receiving a notice that requires additional information return the incomplete application and inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

H. Grant of interim certification pending final determination on application.

1. DGS-DCLS shall grant a laboratory interim certification status under the following conditions:

a. The laboratory's application is determined to be complete;

b. The laboratory has satisfied all the requirements for certification, including all requests for additional information, with the exception of on-site assessment; and

c. DGS-DCLS is unable to schedule the on-site assessment within 90 days of its determination that the application is complete and that the laboratory has satisfied all other requirements for certification (for initial applications) or before the laboratory's certification expires (for renewal applications).

2. A laboratory with interim certification status shall have the same rights and status as a laboratory that has been granted certification by DGS-DCLS.

3. Interim certification expires when DGS-DCLS issues a final determination on certification.

I. On-site assessment.

1. An on-site assessment shall be performed and the follow-up and reporting procedures for such assessments shall be completed in accordance with Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter prior to issuance of a final determination on certification.

2. Alternative on-site assessment option. If DGS-DCLS is unable to schedule an on-site assessment under the conditions of subsection H 1 c of this section, the owner of the applicant laboratory may use third-party on-site assessors instead of DGS-DCLS on-site assessors under the following conditions:

a. The third-party on-site assessors are on a DGS-DCLS-approved list of on-site assessors, and

b. The owner of the applicant laboratory agrees to pay the third-party on-site assessors.

J. Final determination on certification.

1. Upon completion of the certification review process and corrective action, if any, DGS-DCLS shall grant certification in accordance with subsection K of this section or deny certification in accordance with subsection L of this section.

2. Except during the initial certification period, DGS-DCLS shall complete action on a laboratory's application within nine months from the time an a completed application is determined to be complete received from the laboratory.

K. Grant of certification.

1. When a laboratory meets the requirements specified for receiving certification, DGS-DCLS shall issue a certificate to the laboratory. The certificate shall be sent to the laboratory manager, and the responsible official shall be notified.

2. The director of DGS-DCLS shall sign the certificate shall be signed by the director of DGS-DCLS and. The certificate shall include the following information:

a. Name of owner or operator of laboratory;

b. Name of operator of laboratory, if different from owner;

b. c. Name of responsible official;

c. d. Address and location of laboratory;

d. e. Laboratory identification number;

e. f. Fields of testing (program, method certification (matrix, technology/method, analyte or other parameter analyte/analyte group) for which certification is granted;

f. g. Any addenda or attachments; and

g. h. Issuance date and expiration date.

3. The laboratory shall post the most recent certificate of certification and any addenda to the certificate issued by DGS-DCLS in a prominent place in the laboratory facility.

4. Certification shall expire two years after the date on which certification is granted.

L. Denial of certification.

1. DGS-DCLS shall deny certification to an environmental laboratory in total if the laboratory owner or an employee falsifies is found to be falsifying any data or provides providing false information to support certification.

2. Denial of certification in total or in part.

a. DGS-DCLS may deny certification to an environmental laboratory in total or in part if the laboratory owner or an employee fails to do any of the following:

(1) Pay the required fees.

(2) Employ laboratory staff to meet the personnel qualifications as required by Part II (1VAC30-45-200 et seq.) of this chapter.

(3) Successfully analyze and report proficiency testing samples as required by Part II of this chapter.

(4) Submit a corrective action report in accordance with Part II of this chapter in response to a deficiency report from the on-site assessment team within the required 30 calendar days.

(5) Implement the corrective actions detailed in the corrective action report within the time frame specified by DGS-DCLS.

(6) Pass required on-site assessment as specified in Part II of this chapter.

(7) Implement a quality system as defined in Part II of this chapter.

b. DGS-DCLS may deny certification to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 calendar days following notification of incompleteness because the laboratory is delinquent in submitting information required by DGS-DCLS in accordance with this chapter.

c. DGS-DCLS may deny certification to an environmental laboratory in total or in part if the DGS-DCLS on-site assessment team is unable to carry out the on-site assessment pursuant to Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter because an employee, owner, or other a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in its application.

3. To deny certification, DGS-DCLS shall provide by certified mail written notification of denial to the responsible official and manager of the laboratory, including a detailed explanation of the reason for denial and notice of the right to appeal such denial DGS-DCLS shall follow the process specified in 1VAC30-45-110 when denying certification to an environmental laboratory.

M. Reapplication following denial of certification.

1. Upon denial of certification, the laboratory shall wait six months before reapplying for certification.

2. DGS-DCLS shall not waive application fees for a laboratory reapplying for certification.

NOTICE: The forms used in administering the above regulation are not being published; however, the name of each form is listed below. The forms are available for public inspection by contacting the agency contact for this regulation, or at the office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia.

FORMS (1VAC30-45)

Application for Certification of Environmental Laboratories Performing Only Simple Test Procedures Under 1VAC35-45 (with instructions), eff. xx/xx [ DGS/DCLS 1 DGS-21-156 ] [ (eff. 10/08 1/09 ] ).

Application for Certification of General Environmental Laboratories under 1VAC35-45 (with instructions), eff. xx/xx.

CHAPTER 46
ACCREDITATION FOR COMMERCIAL ENVIRONMENTAL LABORATORIES

1VAC30-46-20. Establishment of accreditation program.

A. Once the accreditation program has been established, laboratory accreditation shall be required before any environmental analyses performed by a commercial environmental laboratory may be used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively, of the Code of Virginia).

B. The accreditation program shall be established on the first day of the 25th month following the effective date of this chapter [ October 1, 2011 January 1, 2012 ].

1VAC30-46-30. Applicability.

A. General applicability. This chapter applies to the following:

1. Any owner or operator of a commercial environmental laboratory.

2. Any owner or operator of an environmental laboratory located in jurisdictions outside of Virginia holding NELAP accreditation from a primary accrediting authority who wishes to apply for reciprocal accreditation under 1VAC30-46-140.

B. DGS-DCLS.

1. NELAP-accredited laboratory. DGS-DCLS shall meet the requirements of this chapter through review and accreditation by a NELAP-accredited federal or state accrediting authority. This process shall be completed before the program under this chapter and 1VAC30-45 is established [ October 1, 2011 January 1, 2012 ].

2. Primary accrediting authority. DGS-DCLS shall meet the requirements of the NELAC Standards standards to become the primary accrediting authority for the Commonwealth of Virginia. This review and approval by a NELAP accrediting team shall be completed no later than one year following the effective date of this chapter [ October 1, 2009 January 1, 2010 ].

C. Voluntary accreditation. Any owner or operator of an environmental laboratory may apply for accreditation under this chapter.

D. Environmental laboratories required to obtain drinking water certification under 1VAC30-40. Any owner or operator of an environmental laboratory who must meet the requirements of 1VAC30-40 pertaining to drinking water laboratory certification and either 1VAC30-45 or this chapter may meet those requirements by obtaining accreditation under this chapter.

1VAC30-46-70. Process to apply and obtain accreditation.

A. Duty to apply. All owners or operators of (i) commercial environmental laboratories and (ii) NELAC NELAP-accredited environmental laboratories located outside Virginia applying for reciprocal accreditation shall apply for accreditation as specified by the provisions of this section.

B. Timely initial applications.

1. Owners or operators of commercial environmental laboratories applying for accreditation under this chapter for the first time shall submit an application to DGS-DCLS no later than 180 calendar days after the effective date of this chapter [ March 30, 2009 July 1, 2009 ].

2. Owners or operators of commercial environmental laboratories that come into existence after this chapter becomes effective [ October 1, 2008 January 1, 2009 ], shall submit an initial application to DGS-DCLS no later than 180 calendar days prior to initiating the provision of environmental laboratory services.

3. Owners or operators of NELAC NELAP-accredited environmental laboratories located outside Virginia.

a. During the initial accreditation period, NELAC NELAP- accredited environmental laboratories located outside Virginia shall submit an application to DGS-DCLS no later than 180 calendar days after the effective date of this chapter [ March 30, 2009 July 1, 2009 ].

b. After the program is established, NELAC NELAP-accredited environmental laboratories located outside Virginia shall submit an application to DGS-DCLS no later than 180 calendar days prior to initiating the provision of environmental laboratory services in Virginia.

C. Timely renewal applications. The owner or operator of either an (i) accredited commercial environmental laboratory or (ii) environmental laboratory holding reciprocal accreditation shall submit an application for renewal of accreditation at least 90 calendar days prior to expiration of accreditation.

1. Every two years from the date of initial accreditation, laboratories accredited under this chapter shall submit an application for renewal of accreditation as required by subsection F of this section, including the fees required by 1VAC30-46-150. During this biannual renewal DGS-DCLS shall perform an on-site assessment in addition to a review of the laboratory's application package.

2. Every other year, DGS-DCLS shall renew accreditation for the accredited laboratory provided the laboratory does all of the following:

a. Maintains compliance with this chapter.

b. Attests to this compliance by signing the Certificate of Compliance provided under subdivision F 3 of this section.

c. Reports acceptable proficiency test values for the Fields of Accreditation for which the laboratory held accreditation during the previous year.

The laboratory shall submit the application information required by subdivisions F 1 (except for the quality manual) and F 3 of this section.

3. Renewal application due dates.

a. The owner of either an (i) accredited commercial environmental laboratory or (ii) environmental laboratory holding reciprocal accreditation shall submit an application for renewal of accreditation under subdivision C 1 of this section at least 90 calendar days prior to expiration of accreditation.

b. The owner of either an (i) accredited commercial environmental laboratory or (ii) environmental laboratory holding reciprocal accreditation shall submit an application for renewal of accreditation under subdivision C 2 of this section at least 30 calendar days prior to expiration of accreditation.

D. Responsibilities of the owner or and operator when the laboratory is owned by one person and operated by another person.

1. When an environmental laboratory is owned by one person but is operated by another person, the operator may submit the application for the owner.

2. If the operator fails to submit the application, the owner is not relieved of his responsibility to apply for accreditation.

3. While DGS-DCLS may notify environmental laboratories of the date their applications are due, failure of DGS-DCLS to notify does not relieve the owner or operator of his obligation to apply under this chapter.

E. Submission of applications for modifications to accreditation. An owner or operator of an accredited environmental laboratory shall follow the process set out in 1VAC30-46-90 B to add a new technology matrix technology/method, an analyte or a test method, analyte group, modify a test method or institute use of a method or technology not in the laboratory's standard operating procedures, including alternative test methods or procedures.

F. Contents of application.

1. Applications shall include the following information and documents:

a. Legal name of laboratory;

b. Name of owner of laboratory;

c. Name of operator of laboratory, if different than owner;

d. Street address and description of location of laboratory;

e. Mailing address of laboratory, if different from street address;

f. Address of owner, if different from laboratory address;

g. Name, address, telephone number, facsimile number and e-mail, as applicable, of responsible official;

h. Name, address, telephone number, facsimile number and e-mail, as applicable, of technical director;

i. Name, address, telephone number, facsimile number and e-mail, as applicable, of designated quality assurance officer;

j. Name , title ] and telephone number of laboratory contact person;

k. Laboratory type (e.g., commercial, public wastewater system, mobile);

l. Laboratory hours of operation;

m. Fields of accreditation for which the laboratory is seeking accreditation;

n. Methods employed, including analytes;

o. The results of the three most recent proficiency test studies;

p. Quality assurance manual;

q. Lab identification number (for renewal only); and

r. For mobile laboratories, a unique vehicle identification number, such as a manufacturer's vehicle identification number (VIN #), serial number, or license number.

2. Fee. The application shall include payment of the fee as specified in 1VAC30-46-150.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by the quality assurance officer, and a responsible official or the technical director or both.

b. The certification of compliance shall state: "The applicant understands and acknowledges that the laboratory is required to be continually in compliance with the Virginia environmental laboratory accreditation program regulation (1VAC30 Chapter 46) and is subject to the provisions of 1VAC30-46-100 in the event of noncompliance. I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the laboratory or those persons directly responsible for gathering and evaluating the information, the information submitted is, to the best of my knowledge and belief, true, accurate and complete. Submitting false information or data shall result in denial or withdrawal of accreditation. I further certify that I am authorized to sign this application."

G. Completeness determination.

1. DGS-DCLS shall determine whether an application is complete and notify the laboratory of the result of such determination. Except during During the initial accreditation period, DGS-DCLS shall provide this notice within 60 90 calendar days of DGS-DCLS's its receipt of the initial application. Following the initial accreditation period, DGS-DCLS shall provide this notice as follows:

a. Within 60 calendar days of DGS-DCLS' receipt of a laboratory's initial application.

b. Within 30 calendar days of DGS-DCLS' receipt of a laboratory's renewal application under subdivision C 1 of this section.

c. Within 15 calendar days of DGS-DCLS' receipt of a laboratory's renewal application under subdivision C 2 of this section.

2. An initial application or an application for renewal under subdivision C 1 of this section shall be determined complete if it contains all the information required pursuant to subsection F of this section and is sufficient to evaluate the laboratory prior to the on-site assessment. DGS-DCLS shall consider an application for renewal under subdivision C 2 of this section to be complete if it contains the information required under subdivision C 2 of this section. Designating an application complete does not preclude DGS-DCLS from requesting or accepting additional information.

3. If DGS-DCLS determines that an application is incomplete, DGS-DCLS's notification of such determination shall explain why the application is incomplete and specify the additional information needed to make the application complete.

4. Except during the initial accreditation period, if no determination is made within 60 calendar days of DGS-DCLS's receipt of either (i) the application or (ii) additional information, in the case of an application determined to be incomplete, the application shall be determined to be complete. During the initial accreditation period, the time period shall be 90 calendar days.

5. If the laboratory has not submitted the required additional information within 90 days of receiving a notice from DGS-DCLS may deny any application from a laboratory and require the laboratory to submit a new application if the laboratory does not submit additional information required by DGS-DCLS within 90 days of the mailing date of the notice that requires additional information requesting additional information, DGS-DCLS may return the incomplete application and inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

H. Grant of interim accreditation pending final determination on application.

1. DGS-DCLS shall grant a laboratory interim accreditation status to laboratories applying initially or for renewal under subdivision C 1 of this section under the following conditions:

a. The laboratory's application is determined to be complete;

b. The laboratory has satisfied all the requirements for accreditation, including all requests for additional information, with the exception of on-site assessment; and

c. DGS-DCLS is unable to schedule the on-site assessment within 90 days of its determination that the application is complete and that the laboratory has satisfied all other requirements for accreditation (for initial applications) or before the laboratory's accreditation expires (for renewal applications under subdivision C 1 of this section).

2. DGS-DCLS shall grant interim accreditation status to a laboratory renewing its accreditation under subdivision C 2 of this section during its review of the renewal application if the owner has submitted a complete application as required under subdivision C 2 of this section.

2. 3. A laboratory with interim accreditation status shall have the same rights and status as a laboratory that has been granted accreditation by DGS-DCLS.

3. 4. Interim accreditation expires when DGS-DCLS issues a final determination on accreditation status shall not exceed 12 months.

I. On-site assessment.

1. An on-site assessment shall be performed and the follow-up and reporting procedures for such assessments shall be completed in accordance with Part II (9VAC30-46-200 (1VAC30-46-200 et seq.) of this chapter prior to issuance of a final determination on accreditation.

2. Alternative on-site assessment option. If DGS-DCLS is unable to schedule an on-site assessment under the conditions of subdivision H 1 c of this section, the owner of the applicant laboratory may use third-party on-site assessors instead of DGS-DCLS on-site assessors under the following conditions:

a. The third-party on-site assessors are on a DGS-DCLS-approved list of NELAC-trained on-site assessors, and

b. The owner of the applicant laboratory agrees to pay the third-party on-site assessors.

J. Final determination on accreditation.

1. Upon completion of the accreditation review process and corrective action, if any, DGS-DCLS shall grant accreditation in accordance with subsection K of this section or deny accreditation in accordance with subsection L of this section.

2. Except during the initial accreditation period, DGS-DCLS shall complete action on a laboratory's application within nine months from the time an application is determined to be complete a completed application is received from the laboratory.

3. During the initial accreditation period, DGS-DCLS shall notify applicants of their interim accreditation status under subsection H of this section only after all applications have been reviewed and are determined to be complete.

4. During the final approval process of the initial accreditation period, DGS-DCLS shall notify applicants of their final accreditation status only after all timely and complete applications have been reviewed, all on-site assessments have been completed, and accreditation status has been determined for all applicant laboratories.

5. During the final approval process, DGS-DCLS shall release on-site assessment reports to applicants at the time that applicants are notified of their final accreditation status. If a laboratory is found to have deficiencies during the on-site assessment, DGS-DCLS may provide comments and recommendations aimed at helping the laboratory improve.

K. Grant of accreditation.

1. When a laboratory meets the requirements specified for receiving accreditation, DGS-DCLS shall issue a certificate to the laboratory. The certificate shall be sent to the technical director, and the responsible official shall be notified.

2. The certificate shall be signed by the director of DGS-DCLS shall sign the certificate. The certificate shall be transmitted as a sealed and dated document.

3. The certificate shall include the following information:

a. Name of owner or operator of laboratory;

b. Name of operator of laboratory, if different from owner;

b. c. Name of responsible official;

c. d. Address and location of laboratory;

d. e. Laboratory identification number;

e. f. Fields of accreditation (matrix, technology/method and analyte/analyte group) for which accreditation is granted;

f. g. Any addenda or attachments; and

g. h. Issuance date and expiration date.

4. National Environmental Laboratory Accreditation Program (NELAP) status.

a. Laboratories accredited under this chapter are accredited under the standards of the National Environmental Laboratory Accreditation Conference.

b. The certificate of accreditation shall contain the NELAP insignia.

c. Accredited laboratories shall comply with the provisions of 1VAC30-46-130 with regard to the use of these certificates and their status as NELAP-accredited laboratories.

5. The laboratory shall post the most recent certificate of accreditation and any addenda to the certificate issued by DGS-DCLS in a prominent place in the laboratory facility.

6. Accreditation shall expire two years one year after the date on which accreditation is granted.

L. Denial of accreditation.

1. DGS-DCLS shall deny accreditation to an environmental laboratory in total if the laboratory owner or an employee falsifies is found to be falsifying any data or provides providing false information to support accreditation.

2. Denial of accreditation in total or in part.

a. DGS-DCLS may deny accreditation to an environmental laboratory in total or in part if the laboratory owner or an employee fails to do any of the following:

(1) Pay the required fees;

(2) Employ laboratory staff to meet the personnel qualifications as required by Part II (1VAC30-46-200 et seq.) of this chapter;

(3) Successfully analyze and report proficiency testing samples as required by Part II of this chapter;

(4) Submit a corrective action report in accordance with Part II of this chapter in response to a deficiency report from the on-site assessment team within the required 30 calendar days;

(5) Implement the corrective actions detailed in the corrective action report within the time frame specified by DGS-DCLS;

(6) Pass required on-site assessment as specified in Part II of this chapter;

(7) Implement a quality system as defined in Part II of this chapter.

b. DGS-DCLS may deny accreditation to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 days following notification of incompleteness because the laboratory is delinquent in submitting information required by DGS-DCLS in accordance with this chapter.

c. DGS-DCLS may deny accreditation to an environmental laboratory in total or in part if the DGS-DCLS on-site assessment team is unable to carry out the on-site assessment pursuant to 1VAC30-46-210 B because an employee, owner, or other a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in the laboratory application.

3. To deny accreditation, DGS-DCLS shall provide by certified mail written notification of denial to the responsible officer and the technical director of the laboratory, including a detailed explanation of the reason for denial and notice of the right to appeal such denial. DGS-DCLS shall follow the process specified in 1VAC30-46-110 when denying accreditation to an environmental laboratory.

M. Reapplication following denial of accreditation.

1. Upon denial of accreditation, the laboratory shall wait six months before reapplying for accreditation.

2. DGS-DCLS shall not waive application fees for a laboratory reapplying for accreditation.

NOTICE: The forms used in administering the above regulation are not being published; however, the name of each form is listed below. The forms are available for public inspection by contacting the agency contact for this regulation, or at the office of the Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond, Virginia.

FORMS (1VAC30-46)

Application for Accreditation Certification of Environmental Laboratories under 1VAC30-46 (with instructions), eff. xx/xx, [ DGS-DCLS DGS-21-156 ] (eff. [ 10/08 1/09 ] ).

VA.R. Doc. No. R98-312; Filed November 18, 2008, 11:44 a.m.