(a)For purposes of this section, the following terms have the following meanings:
(1)“Pharmaceutical manufacturing or pharmaceutical process development activities” means activities conducted in North American Industry Classification System Code subgroups 325411 and 325412, to the extent they meet either of the following:
(A)Research, development, and production activities conducted in relation to an
investigational new drug application or new drug application as set forth in Part 312 (commencing with Section 312.1) of, and Part 314 (commencing with Section 314.1) of, Subchapter D of Chapter 1 of Title 21 of the Code of Federal Regulations, that is filed with the United States Food and Drug Administration, or research and development activities conducted to support the future fili
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(a)
For purposes of this section, the following terms have the following meanings:
(1)
“Pharmaceutical manufacturing or pharmaceutical process development activities” means activities conducted in North American Industry Classification System Code subgroups 325411 and 325412, to the extent they meet either of the following:
(A)
Research, development, and production activities conducted in relation to an
investigational new drug application or new drug application as set forth in Part 312 (commencing with Section 312.1) of, and Part 314 (commencing with Section 314.1) of, Subchapter D of Chapter 1 of Title 21 of the Code of Federal Regulations, that is filed with the United States Food and Drug Administration, or research and development activities conducted to support the future filing of an investigational new drug application or new drug application, or research, development, and production activities that are conducted in relation to a filing with a corresponding governmental authority in the European Union, Japan, or Canada that imposes similar requirements.
(B)
The production of a pharmaceutical product, including starting materials, intermediates, and active pharmaceutical intermediates.
(2)
“Pharmaceutical neutralization activities” means the deactivation of a material
generated by, or used in, pharmaceutical manufacturing or pharmaceutical process development activities through the addition of a reagent, including, but not limited to, a caustic, before management of the material as a hazardous waste subject to this chapter.
(b)
Pharmaceutical 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 (c), if all of the following conditions are met:
(1)
A permit is not required to conduct neutralization under the federal act pursuant to Section 264.1(g)(5) of Title 40 of the Code of Federal Regulations.
(2)
The pharmaceutical manufacturing or pharmaceutical process development activities are conducted in accordance with the United States Food and Drug Administration’s current good manufacturing practices, as set forth in Part 210 (commencing with Section 210.1) of, and Part 211 (commencing with Section 211.1) of, Subchapter C of Chapter 1 of Title 21 of the Code of Federal Regulations.
(3)
The pharmaceutical neutralization activity occurs within a unit that meets the standards of a totally enclosed treatment facility, as defined in Section 260.10 of Title 40 of the Code of Federal Regulations and Section 66260.10 of Title 22 of the California Code of Regulations, that is physically connected to the reactor or vessel where the material being neutralized is created.
(4)
The pharmaceutical neutralization activity is
integral to the manufacturing process and occurs within the manufacturing process area and prior to the transfer of the material to a dedicated hazardous waste storage or treatment unit.
(5)
If the pharmaceutical neutralization activity occurs at greater than 15 pounds per square inch gauge pressure, it shall occur within a unit that meets applicable American Society of Mechanical Engineers (ASME) standards for pressure rated vessels, including the ASME requirements for automatic pressure relief in the event of a system failure, including pressure relief valves, burst discs, or equivalent devices.
(6)
The pharmaceutical neutralization activities do not raise the temperature of the hazardous wastes to within 10 degrees Celsius of the boiling point or cause the release of hazardous gaseous emissions, using either constituent-specific concentration limits or calculations.
(7)
The temperature of any unit 100 gallons or larger is automatically monitored, the unit is fitted with a high-temperature alarm system, and, for closed systems, the adding and mixing of in-process and neutralizing solutions are manually controlled.
(8)
The pharmaceutical neutralization activity occurs within a facility that has design or engineering features, including, but not limited to, trenches, sumps, berming, sloping, or diking, designed to contain all liquid spills from pharmaceutical manufacturing process and neutralization units.
(c)
An owner or operator of a pharmaceutical neutralization unit exempt under this section shall comply with all of the following requirements:
(1)
The owner or operator 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.
(2)
Within 10 days of commencing initial operation of the unit, or within any other time period that may be required by the CUPA, the owner or operator shall notify the CUPA of the commencement of the operation of the unit under the exemption made pursuant to this section. A CUPA is authorized to, and is required to, implement the requirements specified in this section. If the owner or operator is not under the jurisdiction of a CUPA, the notice shall be sent to the officer of the agency authorized, pursuant to subdivision (e) of Section 25404.3, to implement
and enforce the requirements of this chapter listed in paragraph (2) of subdivision (c) of Section 25404.
(3)
The owner or operator shall establish and maintain documentation to substantiate its compliance with all of the requirements and conditions of this section, and shall make the documentation available for inspection upon request of the department or the CUPA.
(d)
Notwithstanding any other provision of law, all air emissions from a pharmaceutical neutralization unit shall be managed in accordance with the requirements of the local air pollution control district or air quality management district.
(e)
All wastes generated as a result of pharmaceutical neutralization activities shall be managed as hazardous wastes in accordance with all applicable requirements of this chapter.