BILL ANALYSIS Ó
SB 1014
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator Jerry Hill, Chair
2013-2014 Regular Session
BILL NO: SB 1014
AUTHOR: Jackson
AMENDED: As Introduced
FISCAL: Yes HEARING DATE: March 26, 2014
URGENCY: No CONSULTANT: Karen Morrison
SUBJECT : PHARMACEUTICAL WASTE: HOME-GENERATED
SUMMARY :
Existing federal law :
1) Under the Food, Drug, and Cosmetic Act, the Food and Drug
Administration (FDA) is authorized to oversee the safety of
food, drugs, and cosmetics.
2) Under the Resource Conservation and Recovery Act (RCRA) of 1976,
the management of solid and hazardous wastes is regulated. In
the context of pharmaceuticals, RCRA imposes strict protocols
for the collection of controlled substances.
3) The Secure and Responsible Drug Act of 2010 eases the
restrictions on the collection of controlled substances; final
regulations are currently under development, and are expected to
be published in March 2014.
Existing state law :
1) Under the California Hazardous Substances Act, the Department of
Toxic Substances Control (DTSC) is authorized to regulate
hazardous materials and wastes in accordance with RCRA.
2) Under the California Integrated Waste Management Act:
a) Requires the Department of Resources Recycling and
Recovery (CalRecycle) to implement a statewide household
hazardous waste substance information and collection program.
b) Authorizes local jurisdictions to include in their
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Household Hazardous Waste Elements a program for the safe
management of sharps waste.
c) Requires pharmaceutical manufacturers that sell or
distribute a medication in California that is self-injected
at home through the use of a hypodermic needle, pen needle,
intravenous needle, or any other similar device to submit to
CalRecycle a plan that describes what actions, if any, the
manufacturer supports for the safe management of sharps
waste.
3) Under the Medical Waste Management Act (MWMA):
a) Requires the California Department of Public Health (DPH)
to regulate the management and handling of medical waste.
b) Defines "pharmaceuticals" as a prescription or
over-the-counter human or veterinary drug. "Pharmaceutical"
does not include any pharmaceutical that is regulated
pursuant to either RCRA or the Radiation Control Law and
certain items, such as household waste, are specifically
excluded from the definition of medical waste.
c) Defines "pharmaceutical waste" as any pharmaceutical that
for any reason may no longer be sold or dispensed for use as
a drug and excludes from this definition those
pharmaceuticals that still have potential value to the
generator because they are being returned to a reverse
distributor for possible manufacturer credit.
d) Specifies that waste comprised only of pharmaceuticals is
biohazardous, and is considered "medical waste."
This bill :
1) Establishes the Home-Generated Pharmaceutical Waste Collection
and Disposal Act.
Stewardship plan:
2) Requires a producer of a pharmaceutical sold in this state,
individually or through a stewardship organization, to submit a
stewardship plan to CalRecycle by July 1, 2015, which provides
for the development of a program to collect, transport, and
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dispose of home-generated pharmaceutical waste that includes
information on tracking, education, placement in retail stores,
and cost allocation.
3) Requires updated stewardship plans to be submitted to CalRecycle
at least every three years; CalRecycle must review the plans and
may set performance goals for the program.
4) Requires a producer or stewardship organization, on or before
July 1, 2016, and every year thereafter, to prepare and submit
to CalRecycle an annual report describing the activities carried
out pursuant to the plan during the previous calendar year.
5) Requires CalRecycle to post on its Internet Web site a list of
producers for which CalRecycle has approved a plan and a list of
producers that CalRecycle has deemed to be noncompliant.
Fees:
6) Requires the producer or stewardship organization to pay
CalRecycle an administrative fee in an amount that is sufficient
to cover CalRecycle's costs of administering and enforcing these
provisions and deposits the fees in the Home-Generated
Pharmaceutical Waste Program Account.
Penalties:
7) Authorizes CalRecycle to impose an administrative order or an
administrative civil penalty and fine on a producer who violates
the requirements, and to deposit those fines and penalties into
the Home-Generated Pharmaceutical Waste Program Penalty Account,
and requires CalRecycle to enact regulations that describe these
provisions.
Collection facilities:
8) Authorizes pharmacies to accept home-generated pharmaceutical
waste from a consumer but does not require a retailer to host a
collection site.
Definition of waste stream:
9) Defines "home-generated pharmaceutical waste" as specified drugs
derived from a household.
10)Requires CalRecycle to adopt regulations for the appropriate
management of home-generated pharmaceutical waste, including,
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but not limited to, handling, storage, containment, tracking,
transportation and disposal.
COMMENTS :
1) Purpose of Bill . According to the author, "In response to the
growing problem of prescription drug abuse, accidental
poisonings, and the detection of pharmaceutical products in
California waters, local governments throughout the state have
struggled to establish safe and convenient medication take-back
programs. The public demand and need for such programs has been
tremendous - even limited programs have collected hundreds of
pounds of drugs. Law enforcement, federal agencies, public
health and environmental professionals agree that take-back
programs are the safest way to dispose of unused medicines.
"Establishing these disposal programs on a city by city (county)
basis is haphazard, inefficient and expensive for local
ratepayers. It also means that not all consumers have access to
take-back locations, perpetuating a lack of harmonized messaging
to the public about safe drug disposal.
"In an effort to manage the clear societal and environmental
impacts of unused medications, SB 1014 would require producers
of pharmaceuticals, as defined, to create, finance and manage a
collection system for California consumers to safely and
conveniently take back unwanted pharmaceuticals - a system
structured after an existing program in Canada which the
industry has effectively operated for 15 years."
2) Background on environmental effects .
a) Environmental contamination . A study conducted by the
United States Geological Survey from 1999-2000 sampled 139
streams across 30 states and found that 80% had measurable
concentrations of prescription and nonprescription drugs,
steroids, and reproductive hormones. Since the USGS released
its report in 2002, a number of studies have demonstrated the
low-level presence of pharmaceutical agents throughout the
environment and water supply.
b) Sources of contamination . There are two general sources
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of pharmaceutical contamination in the environment: human
excretion and disposal. Estimates suggest that 3 to 50% of
prescriptions become waste. United States hospitals and
long-term care facilities annually flush approximately 250
million pounds of unused pharmaceuticals down the drain.
It is unknown (if not impossible) to determine how much
household pharmaceutical waste is flushed down the toilet.
However, anecdotally waste water treatment facilities note
that scraping pills off of water filtration systems is a
problem, in addition to the removal of pharmaceutical agents
from the water.
c) Effects to environmental health . While the human effects
of pharmaceutical agents in the environment are not fully
understood, harm to aquatic organisms and ecosystems due to
low levels of pharmaceutical agents are clearly established.
Life-long exposure to ppb levels of an estrogen-based synthetic
hormone resulted in complete population failure in fish due
to the males failing to develop properly.
Mood altering drugs, such as Prozac, lead to changes in the
behavior of fish, making them easier prey.
The presence of persistent antibiotics, particularly downstream
from hospitals, has been partially credited for the rise in
resistant bacterial strains, which may also have an indirect
human impact.
3) Background on diversion .
a) President Bush's Administration Recommendations . In
February 2007, the White House Office of National Drug
Control Policy, the Health and Human Services Agency, and the
US Environmental Protection Agency released new Federal
prescription drug disposal guidelines urging Americans to
utilize pharmaceutical take-back locations because "improper
drug disposal is a prescription for environmental and
societal concern."
b) Substance Abuse and Mental Health Services
Administration's National Survey on Drug Use and Health
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(NSDUH) . According to the 2011 NSDUH more than six million
Americans abuse prescription drugs. That same study revealed
more than 70% of people abusing prescription pain relievers
got them through friends or relatives, a statistic that
includes raiding the family medicine cabinet.
c) President Obama's Administration's National Drug Control
Strategy . In 2011, President Obama released a statement to
Congress stating, "Every sector of our society is affected by
drug use and the consequences of drug use. Drug use and its
consequences hamper our Nation's ability to out-educate our
global competitors and increase graduation rates. It lessens
the ability of our workforce to be fully productive, and it
takes the lives of too many fellow Americans.
"Prescription drug abuse is America's fastest-growing drug
problem, and one largely fed by an unlikely source-Americans'
medicine cabinets. The passage of the Secure and Responsible
Drug Disposal Act of 2010 will save lives by providing
patients with safe, environmentally sound ways to dispose of
unused or expired prescription drugs.
"By taking a balanced approach to drug policy, one that
emphasizes both public health and public safety, we can help
make our neighborhoods and communities even stronger."
d) National Strategy on Preventing Prescription Drug Abuse .
The Obama administration has identified four major areas to
reduce prescription drug abuse: education, monitoring, proper
medication disposal, and enforcement. In particular, the
national strategy includes action to "develop convenient and
environmentally responsible prescription drug disposal
programs to help decrease the supply of unused prescription
drugs in the home."
4) Current federal guidelines for pharmaceutical disposal . The US
FDA and the White House Office of National Drug Control Policy
have developed the following guidelines for proper disposal of
prescription drugs:
Follow any specific disposal instructions on the drug
label or patient information that accompanies the medication.
Do not flush prescription drugs down the toilet unless this
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information specifically instructs you to do so.
Take advantage of community drug take-back programs that
allow the public to bring unused drugs to a central location
for proper disposal. Call your city or county government's
household trash and recycling service (see blue pages in
phone book) to see if a take-back program is available in
your community.
The Drug Enforcement Administration (DEA), working with state
and local law enforcement agencies, is sponsoring National
Prescription Drug Take Back Days ( www.deadiversion.usdoj.gov )
throughout the United States.
IF no instructions are given on the drug label AND no
take-back program is available in your area, throw the drugs
in the household trash, but first:
1. Take them out of their original containers.
2. Mix them with an undesirable substance, such as used
coffee grounds or kitty litter. (The medication will be
less appealing to children and pets, and unrecognizable to
people who may intentionally go through your trash.)
3. Put them in a sealable bag, empty can, or other
container to prevent the medication from leaking or
breaking out of a garbage bag.
4. Throw them in the trash can.
1) Background on take-back programs .
a) DEA take-back programs . "Drug Take-Back Days," which are
typically administered by law enforcement in conjunction with
county health offices or other local government agencies, are
one-time events that allow for individuals to dispose of
prescription or non-prescription medications; following the
collection, the pharmaceuticals are taken to a safe disposal
site.
The DEA's seventh National Take-Back Day in October 2013
collected 324 tons of expired and unwanted medications across
all 50 states. Since the inception of the National Take-Back
Day in 2010, the DEA has collected over 3.4 million pounds of
medicine from circulation. The next national collection
event is scheduled for April 26, 2014.
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b) Disposal of controlled substances . RCRA sets up strict
protocols for the collection of controlled substances to
prevent their illegal diversion and abuse such that only law
enforcement officials can handle certain pharmaceutical
wastes; there is no equivalent law in any other country.
The Secure and Responsible Drug Act of 2010 should make this
process easier by allowing take-back disposal options for
pharmaceutical waste. Regulations are currently in
development by the DEA. The draft regulations allowed
pharmacies to accept controlled substances for disposal, and
final regulations are expected to be published in March 2014.
c) International take-back programs . In 1999, British
Columbia established the "Post-Consumer Pharmaceutical
Stewardship Association" (PCPSA) to establish a
pharmaceutical drug take-back program funded by
manufacturers. Manufacturers are required to pay for the
cost of collecting and managing the program; they are not
required to pay for cost of agency oversight. Currently,
over 100 companies participate in the PCPSA.
Within British Columbia, 95% of pharmacies choose to
participate in the program, accounting for over 1,000
collection sites. In 2009, the program diverted 112,000
pounds of medication from improper disposal or abuse for an
estimated cost of $400,000.
Australia established a national collection system in place
since 1998.
The European Union has required a national collection system
for unused or expired medicines since 2004.
d) Take-back programs in the US . Locally run take-back
programs are prevalent throughout the US. A few states, such
as Michigan and Maine, have enacted laws to facilitate the
collection of pharmaceutical waste at locations such as
pharmacies (MI) or to create mail-back programs for
pharmaceutical waste (ME).
In light of the new statute in Colorado, the Colorado Springs
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Airport has installed two marijuana take-back bins, providing
a location for travelers to safely and legally dispose of
their marijuana. Although recreational marijuana is legal in
Colorado, it is highly regulated at the federal level and has
a high diversion potential.
e) SB 966 Model Guidelines in CA . Under the California
Integrated Waste Management Act (SB 966, Simitian, 2007),
CalRecycle created a model collection program for household
hazardous substances, such as pharmaceuticals, and evaluated
how local programs implemented take-back programs. Programs
that followed the model guidelines were released from any
liability associated with collecting home-generated
pharmaceuticals. The model program sunsetted on January 1,
2013.
f) Local programs in CA . In 2010, CalRecycle identified 297
take-back programs in California. This includes one-time
take-back events, continuous take-back programs, and
mail-back programs. The majority of these programs are
funded and run by local governments, although San Francisco
has a program that is partially funded by PhRMA and Genetech.
Recently, Alameda County passed a first in the nation Safe Drug
Disposal Ordinance that requires producers of covered drugs
to operate take-back programs, including the creation,
administration, promotion, and payment of the program. The
ordinance was challenged by Pharmaceutical Research and
Manufacturers of America, Generic Pharmaceutical Association,
and Biotechnology Industry Organization on the basis that the
ordinance violates the dormant Commerce Clause for interstate
commerce and discriminates against out-of-county producers.
In August 2013, the U.S. District Court upheld the ordinance,
although litigation is ongoing. Several other California
counties are considering similar ordinances.
g) Costs associated with take-back programs . CalRecycle
reported in 2010 that the average cost of current take-back
programs in California vary from $3-$7 a pound. Although a
statewide program would lower the per-pound cost, estimates
vary for the ultimate price. Costs associated with storage,
training, processing, and disposal are all factors.
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2) Home-generated pharmaceutical waste . Although home-generated
pharmaceutical waste is not defined in statute or regulations,
the California Department of Public Health views the
consolidation and disposal of pharmaceutical waste as a public
health necessity and regulates this waste stream as medical
waste.
3) Regulatory agencies . Although CalRecycle has expertise handling
solid wastes, pharmaceuticals have historically been regulated
by DPH and DTSC.
4) Arguments in support . Supporters of the bill state that there
have been inadequate programs to safely dispose of unused
medications and that there is no cohesive statewide policy for
collection and disposal of unused medications.
This bill would provide a stewardship system, requiring producers
of pharmaceuticals to develop and implement better, safer, and
more convenient collection programs for household pharmaceutical
wastes throughout the state.
The support states that this bill is a free-market approach that
allows manufacturers to design the program in whatever way is
most cost effective - with minimal oversight from state
regulators.
5) Arguments in opposition . The opposition states that several
safe and secure ways already exist to dispose of unused
medicines.
The opposition argues that drug take-back programs do not address
the issue of pharmaceuticals in the environment.
The opposition also argues that research demonstrates that
household trash disposal is effective for disposing of unused
medicines.
The opposition suggests that a statewide program would increase the
cost of pharmaceuticals.
Finally, the opposition suggests that this bill creates a rigid
program with tight bureaucratic controls.
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6) Technical amendments . A technical amendment is needed in Public
Resources Code Section 47122 to correct a code reference to
controlled substances.
7) Recommended amendments .
a) Producer definition . The author may wish to work to
clarify the definition of producer to ensure the bill
includes the full universe of medication in need of disposal.
b) Regulating the waste stream . The bill removes
home-generated pharmaceutical waste from the Medical Waste
Management Act and requires CalRecycle to develop an entirely
new waste stream for its management while providing minimal
guidelines for the regulation of that waste stream. The DEA
has detailed specific procedures for the management of
controlled substances (21 USC 801-971 and 21 CFR 1300-1321),
and updates to the federal regulations are expected under the
Secure and Responsible Drug Disposal Act of 2010 this year.
An amendment would clarify the handling and tracking of waste
under SB 1014 to be consistent with federal regulations.
8) Related bills .
AB 333 (Wieckowski) of 2013 makes various changes to the Medical
Waste Management Act. The bill is currently in the Senate
Environmental Quality Committee.
AB 467 (Stone) of 2013 creates a licensure category for a surplus
medication collection and distribution intermediary. The bill
is currently in the Assembly for concurrence of Senate
amendments.
AB 1727 (Rodriguez) of 2014 restricts certain pharmaceuticals
from county operated prescription drug collection and
redistribution programs. The bill is currently in the Assembly
Health Committee.
ACR 93 (Buchanan) of 2014 would declare March 2014 as Drug Abuse
Awareness Month in California, and encourage all citizens to
participate in prevention programs and activities and to pledge
to "Spread the Word? One Pill Can Kill." The resolution is
currently on the Assembly Floor.
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9) Double Referral to Senate Business, Professions and Economic
Development Committee . If this measure is approved by the
Senate Environmental Quality Committee, the do pass motion must
include the action to re-refer the bill to the Senate Business,
Professions and Economic Development Committee.
SOURCE : Alameda County
California Product Stewardship Council
California Alliance for Retired Americans
City and County of San Francisco
Clean Water Action
SUPPORT : Alameda County Board of Supervisors (co-sponsor)
Alameda County District Attorney's Office
Alameda County Sheriff's Office
Ashland Cherryland Together
Breast Cancer Fund
Butte County Public Health Department
Butte County Sheriff's Office
California Alliance for Retired Americans
(co-sponsor)
California Association of Sanitation Agencies
California Nurses Association
California Police Chiefs Association
California Product Stewardship Council (co-sponsor)
California Resource Recovery Association
California Rural Legal Assistance Foundation
California School Employees Association
California State Association of Counties
California State Sheriff's Association
California Teamsters Public Affairs Council
California Water Environment Association
Californians Against Waste
Center for Biological Diversity
Central Contra Costa County Sanitary District
Central Contra Costa Solid Waste Authority
City and County of San Francisco (co-sponsor)
City of Chula Vista Mayor Cheryl Cox
City of Chula Vista Police Department
City of Corona Mayor Karen Spiegel
City of Fortuna
City of Livermore
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City of Los Altos
City of Millbrae Mayor Wayne J. Lee
City of Palo Alto Mayor Nancy Shepherd
City of Porterville Mayor Cameron J. Hamilton
City of Roseville Mayor Susan Rohan
City of Sacramento
City of San Diego Environmental Services Department
City of San Jose
City of San Mateo
City of San Rafael
City of San Rafael Fire Department
City of Santa Maria Mayor Alice M. Patino
City of Santa Monica Mayor Pam O'Connor
City of Santa Rosa Mayor Scott P. Bartley
City of Sunnyvale Mayor Jim Griffith
City of Torrance Mayor Frank Scotto
City of Ukiah Mayor Phil Baldwin
Clean Water Action (co-sponsor)
Clover Flat Resource Recovery Park
Consumer Federation of California
CommPre/Horizons, Inc.
Community Prevention Partners of Santa Cruz County
Community Water Center
Contra Costa County Board of Supervisors
Contra Costa County Prescription Drug Abuse
Prevention Coalition
County of Santa Barbara
County of Santa Clara
County of Santa Cruz Board of Supervisors -
Supervisors Neal Coonery & Bruce McPherson
Defenders of Wildlife
Delta Diablo
East Bay Municipal Utility District
Eastern Municipal Water District
Ecology Action
Ecology Center
El Dorado Irrigation District
Environment California
Environmental Working Group
Goleta Sanitary District
Goleta West Sanitary District
Gray Panthers of San Francisco
Heal the Bay
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Horsnyder Pharmacy, Santa Cruz
Hospice of Santa Cruz County
Las Gallinas Valley Sanitary District
Las Virgenes-Triunfo Joint Powers Authority
League of California Cities
League of Women Voters of California
Leucadia Wastewater District
Los Angeles County Sheriff's Department
Los Angeles County Solid Waste Management Committee/
Integrated Waste Management Task Force
Mammoth Community Water District
Marin County Board of Supervisors
Marin County Hazardous and Solid Waste Joint Powers
Authority
Mendocino Solid Waste Management Authority
Metropolitan Water District of Southern California
Midway City Sanitary District
Monterey Regional Waste Management District
Mt. View Sanitary District
Napa County Board of Supervisors
Napa Sanitation District
National Coalition Against Prescription Drug Abuse
Natural Resources Defense Council
North American Hazardous Materials Management
Association
OWL, San Francisco Chapter
Pajaro Valley Water Management Agency
Pharamacists Planning Service, Inc.
Physicians for Social Responsibility - Los Angeles
Product Stewardship Institute
Rural County Representatives of California
Russian River Watershed Association
Sacramento Regional County Sanitation District
Sacramento State Student Health Services Pharmacy
San Francisco Public Utilities Commission
Santa Cruz Desal Alternatives
Scotts Valley Police Department
Seventh Generation Advisors
Sierra Club California
Silicon Valley Clean Water Action
Sonoma County Waste Management Agency
Sonoma County Water Agency
Stege Sanitary District
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StopWaste
Tehama County Sanitary Landfill Agency
Teleosis Foundation
Town of Windsor
Union Sanitary District
Upper Valley Disposal & Recycling
UPSTREAM
Vallejo Sanitation & Flood Control District
Victor Valley Wastewater Reclamation Authority
Watsonville Pharmacy
West County Wastewater District
Women's Recovery Services
4 Individuals
OPPOSITION : BayBio
BIOCOM
California Chamber of Commerce
California Healthcare Institute
Consumer Healthcare Products Association
California Manufacturers and Technology Association
Generic Pharmaceutical Association
Healthcare Distribution Management Association
Pharmaceutical Researchers and Manufacturers of
America
Silicon Valley Leadership Group
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