CA Health & Safety Code Section 25201.15


For the purposes of this section, the following terms have the following meaning:


“Biotechnology manufacturing or biotechnology process development activities” means activities conducted in SIC Code subgroups 283, 2833, 2834, 2835, 2836, 8731, 8732, and 8733, including manufacturing and process development of medicinal chemicals and botanical products, pharmaceutical preparations, in vitro and in vivo diagnostic substances, and biological products, and all associated equipment and vessel cleaning and maintenance operations.


“Biotechnology elementary neutralization activities” means the elementary neutralization of wastes generated by biotechnology manufacturing or biotechnology process development activities.


“SIC Code” has the same meaning as defined in subdivision (u) of Section 25501.


The Legislature hereby finds and declares that the biotechnology industry’s elementary neutralization of hazardous wastes is a common, safe, and standard practice that typically occurs in a wastewater collection system, and that does not warrant extensive regulatory oversight.


Biotechnology elementary neutralization activities are exempt from any requirement imposed pursuant to this chapter, including any regulation adopted pursuant to this chapter, that relates to generators, tanks, and tank systems, and the requirement to obtain a hazardous waste facilities permit or other grant of authorization from the department, except as otherwise provided in subdivision (d), if all of the following conditions are met:


A permit is not required to conduct elementary neutralization under the federal act.


The hazardous wastes are hazardous solely due to acidic or alkaline materials, and are generated by biotechnology process manufacturing or biotechnology process development activities.


Either of the following applies with regard to the biotechnology elementary neutralization activity:


The hazardous wastes in the elementary neutralization unit do not contain more than 10 percent by weight acid or alkaline constituents.


The generator of the hazardous wastes determines that the elementary neutralization process will not raise the temperature of the hazardous wastes to within 10 degrees of the boiling point or cause the release of hazardous gaseous emissions, using either constituent-specific concentration limits or calculations. The generator shall make these calculations in accordance with the regulations adopted by the department, if the department adopts those regulations.


The hazardous wastes are not diluted for the sole purpose of meeting the criteria specified in subparagraph (A) of paragraph (3) and after neutralization the wastewaters do not exhibit the characteristic of corrosivity, as defined in Section 66261.22 of Title 22 of the California Code of Regulations, or any successor regulation.


The temperature of any unit 100 gallons or larger is automatically monitored, and is fitted with a high temperature alarm system, and for closed systems, the unit automatically controls the adding and mixing of corrosive and neutralizing solutions.


The operator of an elementary neutralization unit exempt under this section shall comply with the following requirements:


An operator of an elementary neutralization unit subject to this section shall successfully complete a program of classroom instruction or on-the-job training that includes, at a minimum, instruction for responding effectively to emergencies by familiarizing personnel with emergency procedures, emergency equipment, and emergency systems, including, where applicable, procedures for using, inspecting, repairing, and replacing facility emergency and monitoring equipment, communications, or alarm systems.


Within 10 days of commencing initial operation of the unit, or within any other time period that may be required by the CUPA, the operator shall notify the CUPA of the commencement of operation of the unit under the exemption made pursuant to this section. If the operator is not under the jurisdiction of a CUPA, the notice shall be sent to the officer of the agency authorized, pursuant to subdivision (f) of Section 25404.3, to implement and enforce the requirements of this chapter listed in paragraph (2) of subdivision (c) of Section 25404.


Notwithstanding any other provision of law, unless required by federal law, biotechnology elementary neutralization activities satisfying the requirements of subdivisions (c) and (d) are exempt from any statute or any regulation adopted pursuant to state law requiring the elementary neutralization unit to have secondary containment for piping or ancillary equipment, including, but not limited to, a regulation adopted by the State Water Resources Control Board, the department, or any other state agency.
Last Updated

Aug. 19, 2023

§ 25201.15’s source at ca​.gov