BILL NUMBER: AB 686 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MAY 7, 2013
AMENDED IN ASSEMBLY MARCH 19, 2013
INTRODUCED BY Assembly Member Quirk
FEBRUARY 21, 2013
An act to amend Section 25201.17 add and
repeal Section 25201.18 of the Health and Safety Code, relating
to hazardous waste.
LEGISLATIVE COUNSEL'S DIGEST
AB 686, as amended, Quirk. Hazardous waste: pharmaceutical
cogeneration activities. facilities.
(1)
Existing law requires hazardous waste facilities, including, but
not limited to, treatment facilities, to operate under hazardous
waste facilities permits or other grants of authorization issued by
the Department of Toxic Substances Control. Existing law exempts
pharmaceutical neutralization activities from certain requirements of
the hazardous waste control laws and certain regulations adopted
pursuant to that law if specified conditions are met with regard to
the pharmaceutical manufacturing or process development activities,
including the management of air emissions and wastes generated as a
result of those activities. A violation of the hazardous
waste control laws is a crime.
This bill would exempt from the hazardous waste control
law, and all of the regulations adopted pursuant to that law,
pharmaceutical cogeneration activities and the cogeneration fuel
components, as defined, if specified conditions are met with regard
to certain federal regulations and other requirements for facility
construction and if the owner or operator of the facility engaged in
that activity complies with certain requirements concerning
emergency-related training, providing notifications, development of a
fuel analysis plan, and maintenance of records. The bill would
require the air emissions and wastes generated as a result of those
activities to be managed, as specified. Since a violation of the
requirements imposed by the bill upon the owner or operator of a
facility engaged in pharmaceutical cogeneration activities would be a
crime, the bill would impose a state-mandated local program by
creating new crimes. require the department, by
January 1, 2015, to develop recommendations for standards and
guidelines for the operation of on-site waste management
and recycling of hazardous waste at facilities engaged in
pharmaceutical manufacturing or pharmaceutical process development.
The department would be required, by January 1, 2015, to submit a
report to the Legislature on those recommendations, including any
recommended statutory and regulatory actions needed to assure the
safe and efficient management of waste from pharmaceutical
manufacturing or pharmaceutical process development actives. The bill
would repeal this report requirement on January 1, 2019.
(2) The California Constitution requires the state to reimburse
local agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes no .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 25201.18 is added to the
Health and Safety Code , to read:
25201.18. (a) On or before January 1, 2015, the department shall
develop recommendations for standards and guidelines for the
operation of on-site hazardous waste management and recycling
activities at facilities engaged in pharmaceutical manufacturing or
pharmaceutical process development. The recommendations shall
consider, but are not limited to, all of the following:
(1) Actions to reduce the production and off-site disposal of
hazardous waste from pharmaceutical manufacturing operations.
(2) Actions to provide incentives to reduce greenhouse gas
emissions through increased energy efficiency.
(3) Recommended permit conditions or other requirements for
on-site waste management within a pharmaceutical manufacturing
facility to ensure the protection of public health and the
environment and that recognize the unique federal and state
requirements that apply to pharmaceutical manufacturing.
(b) On or before January 1, 2015, the department shall submit a
report to the Legislature in compliance with Section 9795 of the
Government Code on the recommendations developed pursuant to
subdivision (a), including any recommended statutory and regulatory
actions needed to assure the safe and efficient management of
hazardous waste from pharmaceutical manufacturing or pharmaceutical
process development activities.
(c) This section shall remain in effect only until January 1,
2019, pursuant to Section 10231.5 of the Government Code and as of
that date is repealed, unless a later enacted statute, that is
enacted before January 1, 2019, deletes or extends that date.
SECTION 1. Section 25201.17 of the Health and
Safety Code is amended to read:
25201.17. (a) For purposes of this section, the following terms
have the following meanings:
(1) (A) "Cogeneration fuel component" means a material generated
by pharmaceutical manufacturing or pharmaceutical process development
activities that meets all of the following conditions:
(i) The material would otherwise be defined as waste or hazardous
waste pursuant to this chapter.
(ii) The materials meet all the physical, viscosity, and
constituent specifications for comparable fuel or syngas fuel under
paragraph (1) or (2) of subsection (a) of Section 261.38 of Title 40
of the Code of Federal Regulations.
(iii) The material meets all other criteria in Section 261.38 of
Title 40 of the Code of Federal Regulations that exclude comparable
and syngas fuels from being classified as a solid waste for purposes
of Subpart A (commencing with Section 261.1) of Part 261 of
Subchapter 1 of Chapter 1 of Title 40 of the Code of Federal
Regulations.
(B) "Cogeneration fuel component" does not include a material that
would otherwise be considered hazardous waste because of the
presence of dioxins or furans.
(2) "Pharmaceutical cogeneration activities" means a
pharmaceutical manufacturing facility's onsite utilization of
specified manufacturing byproducts to generate steam and electricity
to support the facility's pharmaceutical manufacturing process.
(3) "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.
(4) "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.
(5) "Syngas fuel" means synthethesis gas fuel, as specified in
paragraph (2) of Subsection (a) of Section 261.38 of Title 40 of the
Code of Federal Regulations.
(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) Pharmaceutical cogeneration activities and the cogeneration
fuel components are exempt from the requirements imposed pursuant to
this chapter and the regulations adopted pursuant to this chapter,
including, but not limited to, the requirements imposed on
generators, tanks, and tank systems, and the requirement to obtain a
hazardous waste treatment permit or other grant of authorization from
the department, except as otherwise provided in subsection (b) of
Section 261.38 of Title 40 of the Code of Federal Regulations, if all
of the following conditions are met:
(1) The pharmaceutical cogeneration activities meet the comparable
fuel specifications or syngas fuel specification in Section 261.38
of Title 40 of the Code of Federal Regulations and are conducted in
accordance with all conditions specified in that section.
(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 cogeneration activity occurs within a
facility that has design or engineering features, including, but not
limited to, trenches, sumps, berming, sloping, or diking that are
designed to contain all liquid spills from pharmaceutical
manufacturing process and cogeneration units.
(e) (1) An owner or operator of a facility engaged in
pharmaceutical cogeneration activities exempt pursuant to this
section shall comply with all of the following requirements,
consistent with the requirements specified in Section 261.38 of Title
40 of the Code of Federal Regulations:
(A) The owner or operator of a facility engaged in pharmaceutical
cogeneration activities 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, if applicable,
procedures for using, inspecting, repairing, and replacing facility
emergency and monitoring equipment, communications, or alarm systems.
(B) The owner or operator of a facility engaged in pharmaceutical
cogeneration activities submits a one-time notice, except as
otherwise required by state law or Section 261.38 of Title 40 of the
Code of Federal Regulations, to the CUPA in whose jurisdiction the
exclusion is being claimed and where the excluded fuel will be used,
certifying compliance with the conditions of the exclusion.
(C) The owner or operator of a facility engaged in pharmaceutical
cogeneration activities publishes in a major newspaper of general
circulation local to the site where the activities take place, prior
to the commencement of those activities, a notice entitled
"Notification of Burning a Fuel Excluded Under the Resource
Conservation and Recovery Act" and containing a brief, general
description of the process generating the cogeneration fuel
components.
(D) The owner or operator of a facility engaged in pharmaceutical
cogeneration activities develops and follows a written fuel analysis
plan that describes the procedures for sampling and analysis of the
cogeneration fuel component, in accordance with the requirements of
paragraph (4) of subsection (b) of Section 261.38 of Title 40 of the
Code of Federal Regulations.
(E) The owner or operator of a facility engaged in pharmaceutical
cogeneration activities maintains all records required by this
chapter for a period of three years.
(2) The requirements of paragraph (1) do not modify any of the
requirements specified in Section 261.38 of Title 40 of the Code of
Federal Regulations with regard to qualifying for the exclusion from
being classified as a solid waste pursuant to that regulation.
(f) Notwithstanding any other provision of law, all air emissions
from a pharmaceutical neutralization unit or generated as a result of
any pharmaceutical cogeneration activity shall be managed in
accordance with the requirements of the local air pollution control
district or air quality management district.
(g) All wastes generated as a result of pharmaceutical
neutralization activities or pharmaceutical cogeneration activities
shall be managed as hazardous wastes in accordance with all
applicable requirements of this chapter.
SEC. 2. No reimbursement is required by this act
pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.