Article
3.5. Laboratory Services
9151.
For purposes of this article, the following definitions apply:(a) “Emergency or regulatory condition” includes all diseases or conditions listed as emergency or regulatory conditions in the department’s List of Reportable Conditions for Animals and Animal Products published pursuant to Section 9101.
(b) “Laboratory services” means any of the following:
(1) Providing a residue analysis of animal tissue.
(2) Providing nutrient analysis of animal tissue.
(3) Providing the identification of insects, parasites,
bacteria, viruses, prions, or any pathogenic organisms in animal tissue.
(4) Providing any other services compatible with, or incidental to, those laboratory services provided pursuant to Section 9152.
(c) “Poultry” and “livestock” have the same meanings as defined in Sections 9502 and 9503.
9152.
The department shall do all of the following:(a) Require certification of laboratories providing services in the examination, diagnosis, analysis, testing, quantifying, or identification of any emergency or regulatory condition of poultry or livestock owned or located within the state.
(b) Prescribe procedures and requirements for certification.
(c) Develop and implement regulations necessary to carry out this article.
9152.5.
A laboratory approved, certified, or accredited by the state or the federal government to provide services equivalent to those described in subdivision (a) of Section 9152 is exempt from this article.9153.
(a) A person shall not establish, operate, or maintain a laboratory that provides services in the examination, diagnosis, analysis, testing, quantifying, or identification of any emergency or regulatory condition of poultry and livestock unless the person obtains a certificate from the department pursuant to this article authorizing the person to establish, operate, and maintain a laboratory that provides these services, except as specified in Section 9152.5.(b) A person who desires a certificate pursuant to this section shall file an application with the department for a certificate accompanied by the application fee required pursuant to Section 9154.
(c) The application shall be
on a form prescribed and furnished by the department.
(d) The department shall issue a certificate to an applicant if the department is satisfied that the applicant is documented and verified to have full accreditation and to be in good standing with the American Association of Veterinary Laboratory Diagnosticians or International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) 17025 current general requirements for the competence of testing and calibration laboratories.
(e) A certificate shall expire one year after the date of issuance. A certificate shall be renewed upon payment of the renewal application fee required pursuant to Section 9154 if the applicant is in compliance with this article and the regulations adopted pursuant to this article.
(f) A certified laboratory
shall use an official nationally approved or validated diagnostic test for diseases of regulatory importance. A certified laboratory may request permission from the department to use a nonapproved or nonvalidated test.
(g) A certified laboratory shall report positive and suspect positive test results only to the party who provided the original sample and shall also report the test results as required by Section 9101 or any other law.
9154.
(a) Before issuing a certificate pursuant to Section 9153, the department shall require an applicant for a certificate to pay an application fee.(b) (1) Before January 1, 2023, the application and renewal fees shall be one thousand dollars ($1,000).
(2) On and after January 1, 2023, the department may adjust the application and renewal fees to cover the department’s reasonable costs to implement laboratory certification requirements.
(c) The fees collected pursuant to this section shall be deposited into the Department of Food and Agriculture Fund.
9155.
(a) The department may refuse to approve or renew a certificate or may suspend or revoke a certificate if the applicant or certificate holder is not in compliance with this article or regulations adopted pursuant to this article. The department shall notify an applicant or certificate holder of the reasons for the action and shall approve or reinstate the certificate when the laboratory is in compliance.(b) The department shall review an action taken pursuant to subdivision (a) upon request of any person adversely affected by the action, and the decision is subject to appeal in accordance with Chapter 4.5 (commencing with Section 11400) of Part 1 of Division 3 of Title 2 of the Government Code.
9156.
Test results certified by the department are prima facie evidence of the facts stated in the results for purposes of an action pursuant to subdivision (b) of Section 9157. This section does not apply to a criminal action.9157.
(a) (1) Notwithstanding Section 9166, any person who violates Section 9153 shall be liable for a civil penalty of no more than twenty-five thousand dollars ($25,000) for each act constituting a violation of Section 9153.(2) For the purpose of paragraph (1), an act shall be deemed to be each day a person establishes, operates, or maintains a laboratory without a certificate from the department in accordance with subdivision (a) of Section 9153, or every test conducted that violates subdivision (f) or (g) of Section 9153.
(b) Notwithstanding Section 9166, any person who violates any regulation adopted pursuant to this article shall be liable for a civil penalty
of no more than twenty-five thousand dollars ($25,000) per day, for any acts constituting a violation of any regulation adopted pursuant to this article, so long as the regulation specifies that a violation is subject to enforcement in accordance with this section.
(c) (1) Unless a civil penalty has been imposed pursuant to paragraph (2), the department may administratively impose a civil penalty for a violation described in subdivision (a) or (b).
(2) Unless the department has administratively imposed a civil penalty pursuant to paragraph (1), the Attorney General, upon request of the State Veterinarian, shall petition the Superior Court to impose, assess, and recover a civil penalty for a violation described in subdivision (a) or (b).
(d) The department shall review an action taken pursuant to
paragraph (1) of subdivision (c) upon request of any person adversely affected by the action, and the decision is subject to appeal in accordance with Chapter 4.5 (commencing with Section 11400) of Part 1 of Division 3 of Title 2 of the Government Code.
(e) The proceeds of any civil penalty collected pursuant to this section shall be deposited into the Department of Food and Agriculture Fund.
(f) If the Attorney General prevails in or settles an action under this section, the Attorney General shall receive an amount for reasonable expenses that the court finds to have been reasonably incurred, plus reasonable costs and attorney’s fees. All expenses, costs, and fees shall be awarded against the defendant and under no circumstances shall they be the responsibility of the state.
(g) Notwithstanding Section 9165, a
violation of this article is not a crime.