BILL ANALYSIS �
SB 727
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator Jerry Hill, Chair
2013-2014 Regular Session
BILL NO: SB 727
AUTHOR: Jackson
AMENDED: April 3, 2013
FISCAL: Yes HEARING DATE: May 1, 2013
URGENCY: No CONSULTANT: Rachel Machi
Wagoner
SUBJECT : PRESCRIPTION DRUGS: EXTENDED PRODUCER RESPONSIBILITY
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 federal Resource Conservation and Recovery Act (RCRA)
of 1976, the management of solid and hazardous wastes is
regulated.
3)Under the California Hazardous Substances Act, the Department
of Toxic Substances Control is authorized to regulate hazardous
materials and wastes to ensure that the state is delegated
authority in accordance with RCRA.
Existing state law :
4) Under the California Integrated Waste Management Act,
a) Requires the Department of Resources Recycling and
Recovery (CalRecycle) to implement a statewide household
hazardous substance information and collection program.
b) Authorizes local jurisdictions to include in their
Household Hazardous Waste Elements, a program for the safe
management of sharps waste.
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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.
5) Under the Medical Waste Management Act,
a) Requires the Department of Public Health to
regulate the management and handling of medical
waste,
b) Defines "pharmaceuticals" as a prescription
or over-the-counter human or veterinary drug
including, but not limited to, a drug as defined in
the Sherman Food, Drug and Cosmetic Law or the
Federal Food, Drug, and Cosmetic Act.
"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 hazardous, and is considered
"medical waste," although it is not subject to
hazardous waste laws, as specified.
This bill :
1) Creates the Drug Abuse Prevention and Safe Disposal Program
stewardship program.
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2) Requires a producer of a pharmaceutical sold in this state,
individually or through a stewardship organization, to submit
a plan to CalRecycle by January 1, 2015.
3) Requires the plan to provide for the development of a program
to collect, transport, and process home-generated
pharmaceutical drugs and to include specified aspects,
including the minimum amount of collection sites, including by
January 1, 2016, at least one collection service within 10
miles per person in the state.
4) Requires CalRecycle to post on its Internet Web site a list of
the producers or stewardship organizations that have submitted
a plan within 10 days of receipt of the plan.
5) Provides for the review and approval of the plan by the
department, within 90 days of receipt of the plan.
6) Requires CalRecycle to post on its Internet Web site a list of
producers for which CalRecycle has approved a plan and the
bill would require CalRecycle to update this list no less than
once every 6 months.
7) Requires a producer or stewardship organization, on or after
April 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.
8) Requires the producer or stewardship organization to pay
CalRecycle an annual administrative fee in an amount that is
sufficient to cover CalRecycle's costs of administering and
enforcing these provisions.
9) Requires CalRecycle to deposit the fees in the Drug Abuse
Prevention and Safe Disposal Program Account, which is
established in the Integrated Waste Management Fund, and
authorizes CalRecycle to expend the moneys in that account
upon appropriation by the Legislature, to administer and
enforce the bill's requirements.
10)Requires CalRecycle to enforce these provisions and authorizes
CalRecycle to impose an administrative civil penalty on a
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person who violates the requirements or impose a fine on a
producer or stewardship organization if a stewardship plan is
not submitted by January 1, 2015.
11)Requires CalRecycle to deposit these fines and penalties into
the Drug Abuse Prevention and Safe Disposal Program Penalty
Account, which is established in the Integrated Waste
Management Fund, and authorizes CalRecycle to expend the
moneys in that account upon appropriation by the Legislature,
to enforce the bill's requirements.
COMMENTS :
1) Purpose of Bill . According to the author serious social and
environmental problems persist from lack of appropriate
disposal options for pharmaceuticals. The stockpiling of
unused medications in the home allow for easier access for
children and teens, thus fueling youth drug abuse. Poisoning
is the fastest rising cause of accidental death among older
adults. For example, unintentional poisoning of adults over
60 resulting in hospitalization increased by 43% in Alameda
County from1998 to 2006. Flushing medications into sewage
systems harms the environment and contaminates the water we
drink. A 2010 Associated Press investigation found
medications in watersheds near Los Angeles, Riverside and Long
Beach leading to increased public health concerns about
bacterial resistance to antibiotics and endocrine disruption
in aquatic organisms.
The author states that SB 727 is a pure Extended Producer
Responsibility policy approach for home-generated
pharmaceuticals. It would require the producers of
pharmaceuticals to develop and implement a collection system
with oversight by CalRecycle, thereby establishing an
effective and convenient collection program.
2) The United States Geological Survey (USGS) . The USGS
conducted a study in 2002 sampling 139 streams across 30
states and found that 80 percent had measurable concentrations
of prescription and nonprescription drugs, steroids, and
reproductive hormones. Exposure, even to low levels of
pharmaceuticals, has been shown to have negative effects on
fish and other aquatic species and may have negative effects
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on human health.
3) Substance Abuse and Mental Health Services Administration's
National Survey on Drug Use and Health (NSDUH) . According to
the 2011 NSDUH more than six million Americans abuse
prescription drugs. That same study revealed more than 70
percent of people abusing prescription pain relievers got them
through friends or relatives, a statistic that includes
raiding the family medicine cabinet.
4) Senate Bill 966 (Simitian, Chapter 542, Statutes of 2007) . SB
966 required CalRecycle to develop, in consultation with
manufacturers, retailers, and appropriate government agencies,
voluntary model program guidelines for the collection and
proper disposal of home-generated pharmaceutical waste. SB
966 required CalRecycle submit a report to the Legislature
that: evaluated model programs for efficacy, safety, statewide
accessibility, and cost effectiveness; considered the
incidence of drug diversion for unlawful sale and use, if any
and make recommendations for potentially implementing a
statewide program and statutory changes. Based on
CalRecycle's findings, CalRecycle considered four options and
recommends the Legislature pursue the following:
Establish clear state agency roles and
responsibilities;
Improve model guidelines and enforcement,
and convert guidelines to regulation;
Implement product stewardship
According to the CalRecycle Internet web site, implementing
these options would address key barriers and provide for a
sustainable system of collection programs by:
Providing clear state agency roles and
responsibilities;
Clearly defining home-generated
pharmaceutical wastes, consolidated home-generated
pharmaceutical wastes, and acceptable management
practices;
Supporting safe collection, transport and
management of home-generated pharmaceuticals;
Offering flexibility and allowing multiple
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types of collection systems;
Providing sustainable program funding; and,
Encouraging cost-efficiency.
1) Extended Producer Responsibility (EPR) and Product Stewardship
in California . Extended producer responsibility (EPR), and
take-back laws in particular, provides that manufacturers
should be forced to internalize disposal costs and
environmental externalities associated with their products.
EPR involves: 1) the shifting of responsibility (physically
and/or economically; fully or partially) upstream toward the
producer and away from the municipalities; and, 2) to provide
incentives to producers to incorporate environmental
considerations in the design of their products. This bill
retains the core concept of EPR in that producers'
environmental responsibility (EPR) for products extends beyond
the factory door to the post-consumer stage, but is more of a
hybrid of two other waste management theories: product
stewardship and advance recovery fee (ARF).
Product Stewardship is closely related to EPR. Product
stewardship programs usually involve voluntary approaches and
multi-stakeholder dialogues between state governments,
industry, and consumer and environmental groups to arrive at
better management practices for particular products. Product
stewardship differs from EPR in that responsibility is shared
across the chain of custody.
A consumer-financed ARF is an alternative to producer-financed
systems. Typically, retailers forward the proceeds to a
governmental authority that would fund municipal collection
centers and subsidize private recycling operations to make
recycling economical. Tax incidence theory holds that some of
the ARF would actually be absorbed by manufacturers or
retailers, so the burden of funding the new recycling
infrastructure would be shared. In California, e-waste is an
example of an ARF program.
Over the years, CalRecycle's predecessor, the California
Integrated Waste Management Board, engaged in a variety of
program activities concerning products and their impact on the
environment. These efforts continue as CalRecycle seeks a
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comprehensive approach for advancing EPR, building upon the
efforts elsewhere in the world.
Most CalRecycle activities in the past have focused on better
managing the impacts of product discards, rather than focusing
on how to eliminate waste in the first place. EPR is a waste
reduction strategy. By shifting costs and responsibilities of
product discards to producers and others who directly benefit,
EPR provides an incentive to eliminate waste and pollution
through product design changes. It allows CalRecycle to better
carry out its mission for the citizens of California.
In February 2007, the California Integrated Waste Management
Board adopted a set of Strategic Directives that included
Strategic Directive 5: Producer Responsibility: This policy
directs staff to seek statutory authority to foster
"cradle-to-cradle" producer responsibility and develop
producer-financed and producer-managed systems for product
discards.
2) Federal Drug Enforcement Agency (DEA) Efforts . On April 27th
the DEA conducted its sixth prescription drug take-back event
nationwide since 2010. Americans took unwanted, unused, and
expired prescription drugs to collection sites located
throughout the United States as part of DEA's National
Prescription Drug Take-Back Day.
At the September 2012 event DEA's state, local, and tribal law
enforcement partners worked at more than 5,263 locations, and
collected 488,395 pounds (244 tons) of prescription
medications from members of the public. When added to the
collections from DEA's previous four Take-Back events, more
than 2 million pounds (1,018 tons) of prescription medications
were removed from circulation.
The National Prescription Drug Take-Back Day aims to provide a
safe, convenient, and responsible means of disposal, while
also educating the general public about the potential for
abuse of these medications.
The DEA's Take-Back events are a significant piece of the
White House's prescription drug abuse prevention strategy
released in 2011 by the Office of National Drug Control
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Policy. Disposal of unwanted, unused or expired drugs is one
of four strategies for reducing prescription drug abuse and
diversion laid out. The other strategies include education of
health care providers, patients, parents and youth; enhancing
and encouraging the establishment of prescription drug
monitoring programs in all the states; and increased
enforcement to address doctor shopping and pill mills.
Shortly after DEA's first Take-Back Day event two years ago,
Congress passed, and President Obama signed, the Secure and
Responsible Drug Disposal Act of 2010, which amended the
Controlled Substances Act (CSA), allowing DEA to develop
permanent, ongoing, and responsible methods for disposal.
Prior to the passage of the Disposal Act, the CSA provided no
legal means for transferring possession of controlled
substance medications from users to other individuals for
disposal. DEA is currently in the rulemaking process for
adoption of regulations, but until the creation of permanent
regulations, DEA will continue to hold Take-Back Days.
7)The Alameda County Safe Medication Disposal Ordinance .
Alameda's ordinance was unanimously passed by the Alameda
County Board of Supervisors on July 24, 2012. Alameda County is
the first in the nation to require pharmaceutical producers to
be responsible for take-back and proper disposal of unused or
expired medications. The ordinance is based on a producer
responsibility model and does the following:
a) Requires pharmaceutical companies that sell
drugs in Alameda County to establish a
producer-financed and managed take-back program, as is
done in other countries including Canada, Australia,
and France;
b) Prohibits producers from charging visible fees,
forcing internalization of costs, to implement the
stewardship program so take-back is just a cost of
doing business;
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c) Requires outreach and promotion campaigns
including prominently displayed signage;
d) Requires producers to pay an oversight fee to
the county (just like our state bills requiring
reimbursement for oversight);
e) Excludes controlled substances from the
ordinance for now, awaiting DEA findings on the issue;
f) Provides that failure to comply allows a
maximum penalty of up to $1,000 per day fine.
8)The Pharmaceutical Research and Manufacturers of America
("PhRMA"), the Biotechnology Industry Organization ("BIO"), and
the Generic Pharmaceutical Association ("GPhA") filed a
Complaint in the U.S. District Court for the Middle District of
California, contending that the Alameda County ordinance is a
per se violation of the Commerce Clause of the U.S.
Constitution and violates 42 U.S.C. �1983. According to the
trade groups:
The Ordinance represents a per se violation of the
Commerce Clause for three distinct reasons. First,
it directly regulates and burdens interstate commerce
and its primary purpose and clear effect is to shift
the costs of a local regulatory program directly onto
interstate commerce and out-of-county consumers.
Second, the Ordinance discriminates against
interstate commerce by targeting interstate commerce
and products delivered from outside the County for
burdens. Finally, the Ordinance favors local
interests by deliberately shifting costs away from
local consumers and taxpayers and onto drug
manufacturers and pharmaceutical consumers
nationwide.
And even if the ordinance is not a per se
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infringement of the Commerce Clause it is still
unconstitutional, say the trade groups, because
"[i]ts burden on interstate commerce is inherently
excessive because the County could accomplish all of
the purported benefits of a take-back program without
any interstate burden," such as "by developing and
conducting the take-back program through government
officials paid by the local taxpayers or consumers
served by the program.
The suit alleges, "If this novel ordinance were permissible,
then Alameda County could likewise require interstate news
publications to conduct the county's paper recycling program or
require interstate food producers to collect and dispose of all
spoiled food or similar garbage."
The suit asks that the ordinance be declared unconstitutional
and that its implementation be stopped. It also asks for
unspecified costs and attorneys' fees.
9)Arguments in Support .
According to the League of Cities, "Often unaware of how to
properly dispose of home-generated pharmaceutical drugs,
consumers stockpile medications, discard in the trash, or flush
unwanted medication down the toilet, polluting waterways and
creating significant challenges for local agencies that operate
wastewater treatment facilities.
The League of Cities states that "managing the waste stream is
a very expensive and often burdensome task for local
governments. Cities and counties spend upwards of $500 million
annually to manage products prohibited from landfills as well
as those lawfully disposed of at the landfill -- a cost that
local governments ultimately pass along to the consumer in the
form of fees on solid waste services. SB 727 takes an
important step in managing home-generated pharmaceutical drugs
by requiring product producers to address end-of-life issues
for their products, thereby keeping them out of the local
waterway."
The Breast Cancer Fund asserts that "while environmental
impacts are serious in their own right, they also serve as a
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warning about the potential effects on human health and safety.
This is especially alarming given the growing body of research
demonstrating that low level exposures to endocrine disrupting
and other chemicals, as well as cumulative exposures over time
and exposures to chemical mixtures can have serious health
effects. Vulnerable populations, such as children, pregnant
women and the elderly are especially at risk."
10) Arguments in Opposition .
Opponents state that SB 727 establishes a new, expansive
statewide program and mandates that pharmaceutical companies
pay for 100% of CalRecycle's costs to administer the new
program. Opponents argue that the presumed costs to implement
SB 727 are tremendous and non-absorbable, which is why the bill
mandates that impacted companies must prove they have a
dedicated funding stream to pay for the new state program. The
opponents continue, in addition to fully funding the new
statewide program, the companies are also subject to new harsh
penalties. Opponents argue that beyond fully funding the new
statewide program and being subject to severe penalties, the
impacted companies are also responsible for all costs
associated with the implementation of their mandated
stewardship plan. The opponents believe that placing new,
considerable cost pressures on the industry is inconsistent
with the Legislature's and manufacturers' shared goal to keep
the cost of medicine affordable. The opponents state that as
SB 727 is attempting to find a solution for "end-of-life
management" of medicines, it ignores the fact that the
end-of-life for most drugs is ingestion by the patient and
therefore the medicine is not returnable to a collection site.
11) It is clear from CalRecycle's report to the Legislature,
Recommendations for Home-Generated Pharmaceutical Collection
Programs in California , that proper drug disposal mechanisms
need to be put in place on a statewide basis. The author
should work with CalRecycle and stakeholders to address the
issues raised in that report and incorporate the CalRecycle
recommendations in SB 727.
SOURCE : California Product Stewardship Council
Clean Water Action
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SUPPORT : Alameda County Board of Supervisors
Alameda County District Attorney
Bay Area Pollution Prevention Group
Breast Cancer Action
Breast Cancer Fund
California Alliance for Retired Americans
California Association of Sanitation Agencies
California Coastkeeper Alliance
California State Association of Counties
California Veterinary Medical Association
Californians Against Waste
Castro Valley Community Action Network
Center for Environmental Health
Central Contra Costa Sanitary District
City of Chula Vista Mayor Cheryl Cox
City of Covina City Manager Daryl Parrish
City of Monterey Mayor Chuck Della Sala
City of Palo Alto Mayor and City Manager
City of Roseville Mayor Susan Rohan
City of Sunnyvale Mayor Anthony Spitaleri
City of Torrance Mayor Frank Scotto
City of Ukiah
CLEAN South Bay
Clean Water Action
Community Prevention of Alcohol & Drug- Related
Problems
Community Water Center
Consumer Federation of California
Contra Costa Clean Water Program
Contra Costa County Board of Supervisors
Crockett Community Services District
Delta Diablo Sanitation District
Dublin San Ramon Services District
East Bay Municipal Utility District
Environment California
Environmental Justice Coalition For Water
Environmental Working Group
Green Cities California
Heal the Bay
Health Care Without Harm
Keep California Beautiful
League of California Cities
League of Women Voters of California
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Los Angeles County Solid Waste Management
Committee/
Integrated Waste Management Task Force
Marin County Hazardous & Solid Waste Management
Joint
Powers Authority
Monterey Regional Waste Management District
National Coalition Against Prescription Drug Abuse
Natural Resources Defense Council
Placer County Juvenile Justice/Delinquency
Prevention
Commission
Pharmacists Planning Service, Inc.
Physicians for Social Responsibility, Los Angeles
Product Stewardship Institute
Sacramento Regional County Sanitation District
San Francisco Public Utilities Commission
San Mateo County Board of Supervisors
Santa Barbara County Board of Supervisors
Santa Clara County Board of Supervisors
SEIU United Long Term Care Workers
Sierra Club, California
Sierra Club, Loma Prieta Chapter
Sonoma County Waste Management Agency
Sonoma County Water Agency
St. Mary's Center
StopWaste.org
Tamalpais Community Services District
Vallejo Sanitation & Flood Control District
West Contra Costa Integrated Waste Management
Authority
West County Wastewater District
Yolo County Waste Advisory Committee
3 Individuals
OPPOSITION : BayBio
BIOCOM
California Chamber of Commerce
California Healthcare Institute
California Manufacturers and Technology
Association
California Taxpayers Association
Consumer Healthcare Products Association
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Generic Pharmaceutical Association
Pharmaceutical Research and Manufacturers of
America
Silicon Valley Leadership Group
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