BILL ANALYSIS Ó
AB 1202
Page 1
Date of Hearing: April 24, 2013
ASSEMBLY COMMITTEE ON LABOR AND EMPLOYMENT
Roger Hernández, Chair
AB 1202 (Skinner) - As Amended: April 17, 2013
SUBJECT : Occupational safety and health standards: hazardous
drugs.
SUMMARY : Requires the Occupational Safety and Health Standards
Board (Standards Board) to adopt a standard related to the
handling of hazardous drugs, as specified. Specifically, this
bill :
1)Requires the Standards Board to adopt a standard for the
handling of antineoplastic and other hazardous drugs in health
care facilities (regardless of the setting).
2)Defines an "antineoplastic drug" as a chemotherapeutic agent
that controls or kills cancer cells.
3)Defines "hazardous drug" as any drug identified by the
National Institute for Occupational Safety and Health (NIOSH)
or any drug that meets at least one of the following criteria:
a) Carcinogenicity.
b) Teratogenicity or developmental toxicity.
c) Reproductive toxicity in humans.
d) Organ toxicity at low doses in humans or animals.
e) Genotoxicity.
f) New drugs that mimic existing hazardous drugs in
structure or toxicity.
4)Requires the Standards Board to consider input from hospitals,
practicing physicians from impacted specialties including
oncology, organizations representing health care personnel
including registered services, and other stakeholders.
5)Provides that the standard shall, to the extent feasible, be
consistent with and not exceed recommendations in a 2004 NIOSH
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alert entitled, "Preventing Occupational Exposures to
Antineoplastic and Other Hazardous Drugs in Health Care
Settings," as updated.
FISCAL EFFECT : Unknown
COMMENTS : The Standards Board is the standards setting agency
within the Cal/OSHA Program. As such, the Standards Board is
the only agency in the state authorized to adopt, amend or
repeal occupational safety and health standards or orders. In
addition, the Standards Board maintains standards for certain
areas not covered by federal standards or enforcement. These
latter standards apply to elevators, aerial passenger tramways,
amusement rides, pressure vessels, and mine safety training.
Brief Background on the OSHA Standards Board
The Standards Board consists of seven (7) members appointed by
the Governor. Two members are selected from labor, two members
from management, one member from occupational safety, one member
from occupational health, and one member from the general
public. The chairperson is selected and serves at the pleasure
of the Governor. The administration of the Standards Board is
delegated by the Chairperson of the Board to an Executive
Officer, who is selected by the members of the Board and serves
at their pleasure. A small staff assists the Executive Officer
in developing proposals, evaluations, reports, and
recommendations to the Board.
The duties of the Standards Board include the following:
Adopting and maintaining occupational safety and health
regulations.
Considering petitions for new or revised regulations
proposed by any interested person concerning occupational
safety and health.
Granting permanent variances from occupational safety
and health regulations.
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Acting as a review body for any employer or other person
adversely affected by the granting or denial of a temporary
variance by the Division of Occupational Safety and Health.
Holding monthly public meetings to permit interested
persons to address the Standards Board on any occupational
safety and health matters or to propose new or revised
regulations.
The policy of the Standards Board is "that all regulations must
be enforceable, reasonable, understandable, and contribute
directly to the safety and health of California employees. This
basic policy extends to all regulations regardless of the source
with few exceptions for regulations substantially the same as
federal standards. The public hearing and adoption process is
governed by the Administrative Procedure Act in the Government
Code."
After the necessity for a rulemaking action is established,
proposed regulation changes are developed by either the Board's
staff or the Division's staff, generally with the assistance and
recommendations of an advisory committee. Advisory committees
consist of representatives from industry, labor, the public, and
other interested groups. The proposal is then scheduled for
hearing at one of the Board's public hearings. Written and oral
testimony is encouraged and received at public hearings.
Following the public hearing, all testimony is returned to the
originating staff (either the Board staff or the Division) for
review, and the proposed regulation change may be revised in
response to written and oral comments.
When all comments and testimony have been addressed by either
modifying the proposal or providing a satisfactory explanation
for rejection of suggested changes, the Board's staff schedules
the proposed standard for consideration and adoption at the
Board's business meeting.
Following adoption, a copy of the rulemaking file is sent to the
Office of Administrative Law (and for building standards to the
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Building Standards Commission) for approval. After approval,
the regulations are published in Title 8 of the California Code
of Regulations.
Any interested person may petition the Standards Board to adopt,
amend, or repeal an occupational safety and health regulation
(Labor Code Section 142.2). Such proposals may be made orally
or in writing at the Board's public meeting or may be submitted
in writing to the Board at any time. Persons making oral
proposals to the Board will be asked to submit their proposals
in writing stating clearly and concisely (1) the substance or
nature of the regulation, amendment, or repeal requested; and
(2) the reason for the request.
The Standards Board must consider such a petition or proposal
and issue a decision within six (6) months. Petitions must be
referred to the Division for an evaluation (Labor Code Section
147) and the Board's staff also prepares an independent
evaluation of the petition. A proposed decision, prepared by
the Board's staff, is considered by the Board at one of its
business meetings.
Brief Background on Antineoplastic and Other Hazardous Drugs
The National Institute for Occupational Safety and Health
(NIOSH), a division of the Centers for Disease Control and
Prevention (CDC), currently identifies more than 150 drugs as
hazardous. Additionally, the Occupational Safety and Health
Administration (OSHA) has classified chemotherapy drugs,
designed to be toxic and highly absorbable in order to fight
cancers, as hazardous since the 1980s.
However, critics contend that there are insufficient federal or
state regulations to limit healthcare workers' exposure to these
substances. According to the CDC, approximately 8 million
healthcare personnel are involved in nursing, pharmacy,
transport and cleanup of chemotherapy waste. Workers may be
exposed to hazardous drugs throughout their life cycle - from
manufacturing, transporting and distribution, to the use in
healthcare or home settings, to waste disposal. Traces of the
drugs can even be found on the outside of vials from the
manufacturer. This means that a wide array of workers can be
exposed to hazardous drugs - not just those who administer them.
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Workers who are at risk include nurses, pharmacists and
pharmacy technicians, environmental services personnel, shipping
and receiving personnel, and janitorial staff
Hazardous drugs may be invisible, odorless, highly toxic,
permeable and difficult to clean. Healthcare workers who come
into contact with these drugs can face a varying degree of
potential impacts from even low-level exposures. The range of
these impacts includes skin irritations, allergic reactions,
miscarriage, infertility, premature labor and other reproductive
problems, and leukemia and other cancers.
The 2004 NIOSH Alert
In 2004, NIOSH issued an alert entitled, "Preventing
Occupational Exposure to Antineoplastic and Other Hazardous
Drugs in Health Care Settings." That alert stated the
following:
"Recent evidence summarized in this Alert documents that
worker exposure to hazardous drugs is a persistent problem.
Although most air-sampling studies have not demonstrated
significant airborne concentrations of these drugs, the
sampling methods used in the past have come into question
and may not be a good indicator of contamination in the
workplace. In all studies involving examination of surface
wipe samples, researchers have determined that surface
contamination of the workplace is common and widespread.
Also, a number of recent studies have documented the
excretion of several indicator drugs in the urine of health
care workers. Results from studies indicate that worker
exposure to hazardous drugs in health care facilities may
result in adverse health effects.
Appropriately designed studies have begun and are
continuing to characterize the extent and nature of health
hazards associated with these ongoing exposures. NIOSH is
currently conducting studies to further identify potential
sources of exposure and methods to reduce or eliminate
worker exposure to these drugs. To minimize these
potentially acute (short-term) and chronic (long-term)
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effects of exposure to hazardous drugs at work, NIOSH
recommends that at a minimum, employers and health care
workers follow the recommendations presented in this
Alert."
The NIOSH alert made set forth the following recommended
procedures:
Assess the hazards in the workplace:
o Evaluate the workplace to identify and assess
hazards before anyone begins works with hazardous
drugs.
o Regularly review the current inventory of
hazardous drugs, equipment, and practices, seeking
input from affected workers.
o Conduct regular training reviews with all
potentially exposed workers in workplaces where
hazardous drugs are used.
Handle drugs safely:
o Implement a program for safely handling
hazardous drugs at work and review this program
annually on the basis of the workplace evaluation.
o Establish procedures and provide training for
handling hazardous drugs safely, cleaning up spills,
and using all equipment and personal protective
equipment properly.
o Establish work practices related to both drug
manipulation techniques and to general hygiene
practices.
Use and maintain equipment properly:
o Develop workplace procedures for using and
maintaining all equipment that functions to reduce
exposure - such as ventilated cabinets, closed-system
drug-transfer devices, needless systems, and personal
protective equipment.
Recent Washington State Legislation
Washington appears to be the first state to have taken steps to
address these concerns by establishing laws for protecting
healthcare personnel handling hazardous drugs in the workplace.
Washington's law went into effect in 2011 and (like this bill)
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directs the state to enforce safe-handling rules based on NIOSH
guidelines.
ARGUMENTS IN SUPPORT :
According to the author, millions of healthcare workers are at
risk of being exposed to hazardous drugs on a daily basis.
Workers can be exposed to contamination without even knowing it.
This occurs when they create aerosols, generate dust, mix
liquids, clean up spills or touch contaminated surfaces when
they prepare, administer or dispose of hazardous drugs.
Regardless of early concerns about exposure to hazardous drugs,
current law provides no enforceable standards for the handling
of hazardous drugs to ensure healthcare workers are protected.
Unlike radiation, there are no federal or state regulations to
limit healthcare workers' exposure to hazardous drugs.
Implementing and regulating improved safety guidelines and
standards will significantly reduce the risk of healthcare
workers and patients being exposed to hazardous drugs. This
includes developing procedures for properly using and
maintaining equipment designed to protect workers from hazardous
drug exposure.
This bill is sponsored by Becton Dickinson and Company (BD
Medical), which is a global medical technology company that
states that it has "pioneered the development of
safety-engineered medical devises" and has "been at the
forefront of this field for over two decades." BD Medical
argues that while national guidelines have been established by
NIOSH for handling hazardous drugs, compliance is voluntary and
has been reported to be sporadic. They contend that it is
imperative that California develop comprehensive standards that
require healthcare facilities that handle hazardous drugs to
take the necessary steps to protect their workforce.
The California Nurses Association (CNA) supports this bill,
stating that registered nurses and healthcare workers must be
protected on the job after providing critical services to their
communities.
CNA argues that registered nurses and healthcare workers by the
nature of their work, which involves ill patients, contagious
diseases, medical equipment and chemical exposures, are in
constant danger of being exposed to a variety of illnesses, and
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becoming sick or injured by their cumulative exposure. Because
of the nature of patient care, combined with rising patient
acuity, more work related injuries and higher levels of exposure
to infectious disease are occurring. In many cases nurses can
be exposed to harmful substances without even knowing it.
Nurses and other healthcare workers who transport, prepare,
administer and dispose of hazardous drugs can be exposed to
these toxic agents in the air or on work surfaces, clothing,
medical equipment and other surfaces. As a result, nurses,
other healthcare workers and nonclinical workers are at risk for
exposure when they create aerosols, mix liquids, generate dust,
or touch contaminated surfaces if safe handling precautions are
not followed. Exposure to hazardous drugs can cause cancer,
reproductive and developmental problems, allergic reactions and
other adverse effects that can be irreversible even after
low-level exposures.
REGISTERED SUPPORT / OPPOSITION :
Support
Becton Dickinson and Company (sponsor)
California Healthcare Institute
California Labor Federation, AFL-CIO
California Nurses Association
National Lawyers Guild & Labor Committee
Worksafe
Opposition
None on file.
Analysis Prepared by : Ben Ebbink / L. & E. / (916) 319-2091