BILL NUMBER: SB 2096 CHAPTERED 08/14/02 CHAPTER 215 FILED WITH SECRETARY OF STATE AUGUST 14, 2002 APPROVED BY GOVERNOR AUGUST 13, 2002 PASSED THE ASSEMBLY JULY 3, 2002 PASSED THE SENATE MAY 20, 2002 AMENDED IN SENATE APRIL 24, 2002 INTRODUCED BY Committee on Environmental Quality (Senators Sher (Chair), Chesbro, Figueroa, Kuehl, McPherson, and O'Connell) MARCH 21, 2002 An act to amend Sections 100825, 100837, 100840, 100845, 100847, 100850, 100852, 100855, 100865, 100870, 100885, 100895, and 100915 of the Health and Safety Code, relating to laboratory services. LEGISLATIVE COUNSEL'S DIGEST SB 2096, Committee on Environmental Quality. Laboratory services. Existing law requires a laboratory that performs analyses for specified substances, including pesticide residues in food, to either obtain certification by the State Department of Health Services or, in the alternative, to obtain accreditation under the National Environmental Laboratory Accreditation Program (NELAP) if it chooses to meet standards adopted by the National Environmental Laboratory Accreditation Conference (NELAC) and become eligible for recognition by other states and agencies that require or accept NELAP accreditation. Existing law provides that the period of accreditation for NELAP accredited laboratories shall be 12 months. This bill would require that an application for renewal be filed with the department prior to the expiration date of the accreditation, and failure to do so would result in expiration of the accreditation. Existing law requires the department to deny or revoke a certificate if it finds that certain conditions exist. This bill would revise these conditions. The bill would, among other things, include among these conditions failure by the laboratory to analyze proficiency testing samples, and submission by the laboratory, as its own, of proficiency testing sample results generated by another laboratory. This bill would make related and conforming changes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 100825 of the Health and Safety Code is amended to read: 100825. (a) Laboratories that perform, for regulatory purposes, analyses of drinking water, wastewater, air, hazardous wastes, and contaminated soils or sediments, or any combination of these, shall obtain a certificate pursuant to this article. Laboratories that perform analyses for pesticide residues in food pursuant to Section 110490 shall also obtain a certificate pursuant to this article. A laboratory may apply for NELAP accreditation in lieu of certification under this article if it chooses to meet NELAC standards for those fields of testing under Section 100862 that are in common with the two programs. Laboratories meeting the requirements of NELAP accreditation pursuant to this article shall become eligible for recognition by other states and agencies that require or accept NELAP accreditation. (b) In any arrangement between laboratories that involves the transfer of samples or portions of samples, the analyzing laboratory shall be identified in all sample reports and shall be the laboratory for purposes of certification or NELAP accreditation. (c) The following definitions apply for the purposes of this article: (1) "Accreditation" means the recognition of a laboratory that is approved by a NELAP approved accrediting authority to conduct environmental analyses in those fields of testing specifically designated in Section 100862. (2) "Approved third-party laboratory assessor body" means an organization that has been approved as a contractor under NELAC standards to assess environmental laboratories. (3) "Certificate" means a document issued to a laboratory that has received certification or accreditation pursuant to this article. (4) "Certification" means the granting of approval by the department to a laboratory that has met the standards and requirements of this chapter and the regulations adopted thereunder. Certification shall not include NELAP accreditation. (5) "Corrective action report" means a written document signed by or on behalf of a person, entity, or laboratory that states the corrective actions proposed by the person, entity, or laboratory to correct the deficiencies or violations stated in a report of deficiencies. (6) "Deficiency" means noncompliance with one or more of the requirements of this article or any rule or regulation adopted thereunder. (7) "ELAP" means the State Department of Health Services' Environmental Laboratory Accreditation Program. (8) "Laboratory" means any facility or vehicle that is owned by a person, or by a public or private entity, and that is equipped and operated to carry out analyses in any of the fields of testing listed in Section 100860.1 or Section 100862. (9) "NELAC" means the National Environmental Laboratory Accreditation Conference, which is a voluntary organization of state and federal officials. (10) "NELAC standards" refer to the standards found in EPA publication number 600/R-98/151, November 1998, and any subsequent amendments. (11) "NELAP" means the National Environmental Laboratory Accreditation Program established by NELAC. (12) "NELAP accredited laboratory" means a laboratory that has met the standards of NELAC and has been accredited by a primary or secondary NELAP recognized authority. (13) "NELAP approved accrediting authority" means a state agency that is authorized by NELAC to accredit laboratories. (14) "NELAP recognized primary accrediting authority" means a state or federal agency that is responsible for the accreditation of environmental laboratories within that state. (15) "NELAP recognized secondary accrediting authority" means a state or federal agency that grants NELAP accreditation to laboratories based on their accreditation by a NELAP recognized primary accrediting authority. (16) "Performance based measurement system" means a set of processes wherein the data quality needs, mandates, or limitations of a program or project are specified and serve as criteria for selecting appropriate test methods to meet those needs. (17) "Pesticide" means any substance that alone, in chemical combination, or in any formulation with one or more substances, is an "economic poison" within the meaning of Section 12753 of the Food and Agricultural Code or a "pesticide" as defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. Sec. 136 et seq.). (18) "Regulatory agency" means any federal, state, or local governmental agency that utilizes environmental analyses performed by a laboratory regulated under this section. (19) "Regulatory purposes" means the use of laboratory analysis required by a regulatory governmental agency for determining compliance with this section or Chapter 6.5 (commencing with Section 25100) of, Chapter 6.7 (commencing with Section 25280) of, and Chapter 6.8 (commencing with Section 25300) of, Division 20, Article 1 (commencing with Section 116270) of, Article 2 (commencing with Section 116325) of, and Article 3 (commencing with Section 116350) of, Chapter 4 of Part 12 of Division 104, or Division 7 (commencing with Section 13000) of the Water Code, or the regulations adopted under any of the provisions set forth in this paragraph. SEC. 2. Section 100837 of the Health and Safety Code is amended to read: 100837. The department may contract with approved third-party laboratory assessor bodies in accordance with the criteria developed by the NELAC or other federal agencies. SEC. 3. Section 100840 of the Health and Safety Code is amended to read: 100840. Any laboratory requesting ELAP certification or NELAP accreditation under this article shall file with the department an application on forms prescribed by the department containing all of the following: (a) The names of the applicant and the laboratory. (b) The location of the laboratory. (c) A list of fields of testing for which the laboratory is seeking certification, selected from the activities listed in Section 100860.1 or 100862. (d) Evidence satisfactory to the department that the applicant has the ability to comply with this article and the regulations adopted under this article. (e) Any other information required by the department for administration or enforcement of this article or regulations adopted under this article. SEC. 4. Section 100845 of the Health and Safety Code is amended to read: 100845. (a) Each certificate issued pursuant to this article for ELAP certification shall be issued to the owner of the laboratory and shall expire 24 months from the date of issuance. An application for renewal shall be filed with the department prior to the expiration date of the certificate. Failure to make timely application for renewal shall result in expiration of the certificate. (b) A certificate shall be forfeited by operation of law prior to its expiration date when one of the following occurs: (1) The owner sells or otherwise transfers the ownership of the laboratory, except that the certificate shall remain in force 90 calendar days if the department receives written assurance and appropriate documentation within 30 calendar days after the change has occurred that one or more of the conditions in subdivision (c) are met. The department shall accept or reject the assurance in writing within 30 calendar days after it has been received. (2) There is a change in the location of the laboratory (except a mobile laboratory) or structural alteration that may affect adversely the quality of analysis in the fields of testing for which the laboratory has been certified or is seeking certification, without written notification to the department within 30 calendar days. (3) The certificate holder surrenders the certificate to the department. (c) Upon change of ownership of a laboratory, the department may extend a certificate to the expiration date of the original certificate upon written assurance by the new owner that the operation of the laboratory will continue so as not to adversely affect the conditions regulated by this article. (d) The department shall be notified in writing within 30 calendar days whenever there is a change of director or other person in charge of a laboratory certified under this article. The notification shall include documentation of the qualifications of the new director or other person in charge of the laboratory. SEC. 5. Section 100847 of the Health and Safety Code is amended to read: 100847. (a) The period of accreditation for NELAP accredited laboratories shall be 12 months. An application for renewal shall be filed with the department prior to the expiration date of the accreditation. Failure to make timely application for renewal shall result in expiration of the accreditation. (b) The accrediting authority shall be notified in writing within 30 calendar days of the sale or other transfer of ownership of a NELAP accredited laboratory. (c) The accrediting authority shall be notified in writing within 30 calendar days of the change in location of a NELAP accredited laboratory, other than a mobile laboratory. (d) The accrediting authority shall be notified within 30 calendar days whenever there is a change of laboratory director, or other individual in charge of the laboratory. (e) NELAP accredited laboratories shall conspicuously display their most recent NELAP accreditation certificate or their accreditation fields of testing, or both, in a permanent place in their laboratory. (f) NELAP accredited laboratories shall not use their NELAP accreditation document or their accreditation status to imply any endorsement by the accrediting authority. SEC. 6. Section 100850 of the Health and Safety Code is amended to read: 100850. (a) Upon the filing of an application for ELAP certification or NELAP accreditation and after a finding by the department that there is full compliance with this article and regulations adopted under this article, the department shall issue to the owner certification or accreditation in the fields of testing identified in Section 100860.1 or 100862. (b) The department shall deny or revoke a certificate if it finds any of the following: (1) The laboratory fails to report acceptable results in the analysis of proficiency testing samples. (2) The laboratory fails to analyze proficiency testing samples. (3) The laboratory submits, as its own, proficiency testing sample results generated by another laboratory. (4) The laboratory fails to pass an onsite assessment. (5) The laboratory is not in compliance with any other provision of this article or regulations adopted under this article. (c) Provided that there is compliance with all other provisions of this article, the department may restrict a certificate to the fields of testing of Section 100860 or 100862 or subgroups thereof as defined by regulation for which acceptable proficiency testing results have been produced and the onsite assessment was passed. (d) Upon the filing of a complete application for certification or accreditation pursuant to subdivision (a) and Section 100870, the department may issue to a laboratory interim certification or accreditation pending the completion of onsite assessment interim certification and accreditation shall be nonrenewable and shall remain in effect until certification and accreditation is either granted under subdivision (a) or denied under subdivision (b), but not later than one year after the date of issuance. SEC. 7. Section 100852 of the Health and Safety Code is amended to read: 100852. (a) Notwithstanding any other provision of law, the department may issue a certificate to the owner of a laboratory in a field of testing or method adopted by the federal Environmental Protection Agency pursuant to Part 136 of Title 40 of the Code of Federal Regulations, as amended September 11, 1992, as published in the Federal Register (57 FR 41830), or Part 141 of Title 40 of the Code of Federal Regulations, as amended July 17, 1992, as published in the Federal Register (57 FR 31776), and as subsequently amended and published in the Code of Federal Regulations. (b) As a NELAP approved accreditating authority, the department shall accept performance based measurement system methods, when mandated methods are indicated. A fee, as specified in regulations adopted by the department, may be charged for the review of each performance based measurement system method. (c) Notwithstanding any other provision of law, the department shall not be required to meet the requirements of Chapter 3.5 (commencing with Section 11340) of the Government Code in order to issue a certificate pursuant to subdivision (a). SEC. 8. Section 100855 of the Health and Safety Code is amended to read: 100855. Upon the denial of any application for ELAP certification or NELAP accreditation, or the revocation or suspension of ELAP certification or NELAP accreditation, the department shall immediately notify the applicant or organization by certified mail, return receipt requested, of the action and the reasons for the action. Within 20 calendar days of receipt, the applicant or organization may present the department with a written petition for a hearing. Upon receipt in proper form by the department, the petition shall be set for hearing. The proceedings shall be conducted in accordance with Section 100171 and the department has all the powers granted in that section. SEC. 9. Section 100865 of the Health and Safety Code is amended to read: 100865. (a) In order to carry out the purpose of this article, any duly authorized representative of the department may do the following: (1) Enter and inspect a laboratory that is ELAP certified or NELAP accredited pursuant to this article or that has applied for ELAP certification or NELAP accreditation. (2) Inspect and photograph any portion of the laboratory, equipment, any activity, or any samples taken, or copy and photograph any records, reports, test results, or other information related solely to certification under this article or regulations adopted pursuant to this article. (b) It shall be a misdemeanor for any person to prevent, interfere with, or attempt to impede in any way, any duly authorized representative of the department from undertaking the activities authorized by this section. (c) If a laboratory that is seeking ELAP certification, NELAP accreditation, ELAP recertification, or NELAP reaccreditation refuses entry of a duly authorized representative during normal business hours for either an announced or unannounced onsite assessment, the certification, accreditation, recertification, or reaccreditation shall be denied or revoked. (d) Refusal of a request by a NELAP approved accrediting authority, the department, or any employee, agent, or contractor of the department, for permission to inspect, pursuant to this section, the laboratory and its operations and pertinent records during the hours the laboratory is in operation shall result in denial or revocation of ELAP certification or NELAP accreditation. SEC. 10. Section 100870 of the Health and Safety Code is amended to read: 100870. (a) Any laboratory that is ELAP certified or holds NELAP accreditation or has applied for ELAP certification or NELAP accreditation or for renewal of ELAP certification or NELAP accreditation under this article, shall analyze proficiency testing samples, if these testing samples are available. The department shall have the authority to contract with third parties for the provision of proficiency testing samples for those laboratories that hold or are applying for ELAP certification. The samples shall be tested by the laboratory according to methods specifically approved for this purpose by the United States government or the department, or alternate methods of demonstrated adequacy or equivalence, as determined by the department. Proficiency testing sample sets shall be provided, when available, not less than twice, nor more than four times, a year to each certified laboratory that performs analyses of food for pesticide residues. (b) (1) The department may provide directly or indirectly proficiency testing samples to a laboratory for the purpose of determining compliance with this article with or without identifying the department. (2) When the department identifies itself, all of the following shall apply: (A) The results of the testing shall be submitted to the department on forms provided by the department on or before the date specified by the department, and shall be used in determining the competency of the laboratory. (B) There shall be no charge to the department for the analysis. (3) When the department does not identify itself, the department shall pay the price requested by the laboratory for the analyses. (c) If a certified or NELAP accredited laboratory submits proficiency testing sample results generated by another laboratory as its own, the certification or NELAP accreditation shall be immediately revoked. (d) Laboratories shall obtain their proficiency testing samples from proficiency testing sample providers that meet NELAC standards. Laboratories shall bear the cost of any proficiency testing study fee charged for participation. Each laboratory shall authorize the providers of proficiency testing samples to release the report of the study results directly to the department, as well as to the laboratory. SEC. 11. Section 100885 of the Health and Safety Code is amended to read: 100885. (a) Any person who operates a laboratory that performs work that requires certification or NELAC accreditation under Section 25198, 25298.5, 25358.4, 110490, or 116390 of this code, or Section 13176 of the Water Code, who is not certified or NELAC accredited to do so, may be enjoined from so doing by any court of competent jurisdiction upon suit by the department. (b) When the department determines that any person has engaged in, or is engaged in, any act or practice that constitutes a violation of this article, or any regulation or order issued or adopted thereunder, the department may bring an action in the superior court for an order enjoining these practices or for an order directing compliance and affording any further relief that may be required to ensure compliance with this article. SEC. 12. Section 100895 of the Health and Safety Code is amended to read: 100895. (a) Any person who knowingly does any of the following acts may, upon conviction, be punished by a fine of not more than twenty-five thousand dollars ($25,000) for each day of violation, or by imprisonment in the county jail not to exceed one year, or by both the fine and imprisonment: (1) Makes any false statement or representation in any application, record, report, or other document submitted, maintained, or used for the purposes of compliance with this article. (2) Has in his or her possession any record required to be maintained pursuant to this article that has been altered or concealed. (3) Destroys, alters, or conceals any record required to be maintained pursuant to this article. (4) Withholds information regarding an imminent and substantial danger to the public health or safety when the information has been requested by the department in writing and is required to carry out the department's responsibilities pursuant to this article. (b) If the conviction under subdivision (a) is for a violation committed after a first conviction of the person under this section, the person may be punished by imprisonment in the state prison for up to 24 months, or in the county jail for not to exceed one year, or by a fine of not less than two thousand dollars ($2,000) or more than fifty thousand dollars ($50,000) per day of violation, or by both the fine and imprisonment. (c) An ELAP certified or NELAP accredited laboratory, upon suspension, revocation, or withdrawal of its ELAP certification or NELAP accreditation, shall do all of the following: (1) Discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, or their materials that contain reference to their past certification or accreditation status. (2) Return its ELAP certificate or its NELAP accreditation to the department. (3) Cease all testing of samples for regulatory purposes. (d) The penalties cited in subdivisions (a) and (b) shall also apply to NELAP accredited laboratories. SEC. 13. Section 100915 of the Health and Safety Code is amended to read: 100915. (a) The department may temporarily suspend, in whole or in part, ELAP certification or NELAP accreditation prior to any hearing, when it has determined that this action is necessary to protect the public. The department shall notify the owner of the temporary suspension and the effective date thereof and at the same time shall serve the owner with an accusation. Upon receipt of a notice of defense by the owner, the matter shall be set for hearing within 15 calendar days. The hearing shall be held as soon as possible but no later than 30 calendar days after receipt of the notice. The temporary suspension shall remain in effect until the hearing is completed and the department has made a final determination on the merits. However, the temporary suspension shall be deemed vacated if the department fails to make a final determination on the merits within 60 calendar days after the original hearing has been completed. (b) During the suspension, the laboratory shall discontinue the analysis of samples for the specified fields of testing.