BILL NUMBER: AB 1317 CHAPTERED 09/29/05 CHAPTER 406 FILED WITH SECRETARY OF STATE SEPTEMBER 29, 2005 APPROVED BY GOVERNOR SEPTEMBER 29, 2005 PASSED THE ASSEMBLY SEPTEMBER 7, 2005 PASSED THE SENATE SEPTEMBER 6, 2005 AMENDED IN SENATE AUGUST 31, 2005 INTRODUCED BY Assembly Member Ruskin (Principal coauthor: Assembly Member Tran) FEBRUARY 22, 2005 An act to add Sections 100827 and 100829 to, to repeal Sections 100831 and 100835 of, and to repeal and add Sections 100825, 100830, and 100832 of, the Health and Safety Code, relating to environmental laboratories. LEGISLATIVE COUNSEL'S DIGEST AB 1317, Ruskin Environmental laboratories. Existing law requires a laboratory that performs analysis for regulatory purposes of drinking water, wastewater, air, hazardous waste, and contaminated soils or sediments to obtain certification by the State Department of Health Services or, in the alternative, if appropriate, to obtain accreditation under the National Environmental Laboratory Accreditation Program (NELAP). This bill would repeal, recast, and reenact certain of those provisions. Among other things, the bill would authorize the department to offer both state accreditation and NELAP accreditation. The bill would set forth the duties and responsibilities of the department in accrediting and monitoring environmental laboratories, and would authorize the department to adopt regulations. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 100825 of the Health and Safety Code is repealed. SEC. 2. Section 100825 is added to the Health and Safety Code, to read: 100825. (a) This article shall be known, and may be cited, as the Environmental Laboratory Accreditation Act. (b) Laboratories that perform analyses on any combination of environmental samples, or raw or processed agricultural products for regulatory purposes shall obtain a certificate of accreditation pursuant to this article. (c) Unless the express language or context requires otherwise, the definitions in this article shall govern the construction of the article. (1) "Accreditation" means the recognition of a laboratory by the department to conduct analyses of environmental samples for regulatory purposes. (2) "Assessor body" means the organization that actually executes the accreditation process, including receiving and reviewing applications, documents, PT sample results, and onsite assessments. (3) "Certificate" means a document issued by the department to a laboratory that has received accreditation pursuant to this article. (4) "Department" means the State Department of Health Services. (5) "Environmental samples" means potable and nonpotable surface waters or groundwaters, soils and sediments, hazardous wastes, biological materials, or any other sample designated for regulatory purposes. (6) "NELAC" means the National Environmental Laboratory Accreditation Conference. (7) "NELAC standards" refers to the requirements found in EPA publication number 600/R-98/151, November 1998, and any subsequent amendments that are adopted by EPA or the national program. (8) "NELAP" means the National Environmental Laboratory Accreditation Program established by NELAC. (9) "NELAP accreditation" means the accreditation of a laboratory that has met the requirements of the NELAC standards, and the requirements of this article. (10) "NELAP accredited laboratory" means a laboratory that has met the standards of NELAC and has been accredited by a primary or secondary NELAP-recognized accrediting authority. (11) "NELAP-recognized accrediting authority" means a state agency that is authorized by NELAP to accredit laboratories. (12) "NELAP-recognized primary accrediting authority" means a state agency that is responsible for the accreditation of environmental laboratories within that state or that performs the primary accreditation of a lab from a non-NELAP state or where the laboratory's home state does not offer accreditation in a given field of accreditation. (13) "NELAP-recognized secondary accrediting authority" means a state agency that is authorized by NELAP to accredit environmental laboratories within that state that have been accredited by a NELAP-approved accrediting authority in another state. (14) "Proficiency testing (PT)" is a means of evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source. (15) "PT sample" means a sample used for proficiency testing. (16) "Regulatory purposes" means a statutory or regulatory requirement of a state board, office, or department, or of a division or program that requires a laboratory certified under this article or of any other state or federal agency that requires a laboratory to be accredited. (17) "Revocation" means the permanent loss of a certificate of accreditation, including all units and fields of accreditation for state accreditation and all fields of accreditation for NELAP accreditation. (18) "State accreditation" means accreditation of a laboratory, that has met the requirements of this article and regulations adopted by the department pursuant to this article. (19) "Suspension" means the temporary loss of a certificate of accreditation or a unit or field of accreditation. SEC. 3. Section 100827 is added to the Health and Safety Code, to read: 100827. A laboratory accredited by the department shall report, in a timely fashion and in accordance with the request for analysis, the full and complete results of all detected contaminants and pollutants to the person or entity that submitted the material for testing. The department may adopt regulations to establish reporting requirements for this section. SEC. 4. Section 100829 is added to the Health and Safety Code, to read: 100829. The department may do all of the following related to accrediting environmental laboratories in the state: (a) Offer both state accreditation and NELAP accreditation, which shall be considered equivalent for regulatory activities covered by this article. (b) Adopt regulations to establish the accreditation procedures for both types of accreditation. (c) Retain exclusive authority to grant NELAP accreditation. (d) Accept certificates of accreditation from laboratories that have been accredited by other NELAP-recognized accrediting authorities. (e) Adopt regulations to establish procedures for recognizing the accreditation of laboratories located outside California for activities regulated under this article. (f) (1) Adopt regulations for the collection of laboratory accreditation fees. (2) Fees collected under this section shall be adjusted annually as provided in Section 100425. The adjustment shall be rounded to the nearest whole dollar. (3) Fees shall be set for the two types of accreditation provided for in subdivision (a). (4) Programs operated under this article shall be fully fee-supported. SEC. 5. Section 100830 of the Health and Safety Code is repealed. SEC. 6. Section 100830 is added to the Health and Safety Code, to read: 100830. The department may do all of the following: (a) Adopt regulations establishing requirements for both types of accreditation. The regulations shall include, but not be limited to, all of the following: (1) Laboratory personnel. (2) Quality assurance procedures. (3) Laboratory equipment. (4) Facilities. (5) Standard operating procedures. (6) Proficiency testing. (7) Onsite assessments. (8) Recordkeeping. (9) Units and fields of accreditation. (b) Adopt regulations establishing conditions under which the department may issue, deny, renew, or suspend a certificate of accreditation for individual units or fields. Suspension and denial of units or fields of accreditation shall be based on a laboratory's failure to comply with this article and regulations adopted thereunder. SEC. 7. Section 100831 of the Health and Safety Code is repealed. SEC. 8. Section 100832 of the Health and Safety Code is repealed. SEC. 9. Section 100832 is added to the Health and Safety Code, to read: 100832. All regulations adopted by the department pursuant to this article, as they read immediately preceding January 1, 2006, shall remain in full force and effect until repealed or amended by the department in accordance with the rulemaking provisions of the Administrative Procedure Act, Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. SEC. 10. Section 100835 of the Health and Safety Code is repealed.