Amended in Assembly May 7, 2013

Amended in Assembly March 19, 2013

California Legislature—2013–14 Regular Session

Assembly Bill No. 686

Introduced by Assembly Member Quirk

February 21, 2013

An act to begin delete amend Section 25201.17 end delete begin insert add and repeal Section 25201.18 end insert of the Health and Safety Code, relating to hazardous waste.

LEGISLATIVE COUNSEL’S DIGEST

AB 686, as amended, Quirk. Hazardous waste: pharmaceutical begin delete cogeneration activities. end delete begin insert facilities. end insert

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(1) 

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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. begin delete A violation of the hazardous waste control laws is a crime. end delete

This bill would begin delete 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. end delete begin insert 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. end insert

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(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.

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This bill would provide that no reimbursement is required by this act for a specified reason.

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Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program:  begin delete yes end delete begin insert no end insert .

The people of the State of California do enact as follows:

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begin insert SECTION 1. end insert   

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begin insert Section 25201.18 is added to the end insert begin insert Health and
Safety Code end insert begin insert , to read: end insert

begin insert

begin insert 25201.18. end insert   

(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.

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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.

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