25201.17
. (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.