BILL ANALYSIS
SB 966
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator S. Joseph Simitian, Chairman
2007-2008 Regular Session
BILL NO: SB 966
AUTHOR: Simitian/ Kuehl
AMENDED: As Introduced
FISCAL: Yes HEARING DATE: March 26, 2007
URGENCY: No CONSULTANT: Rachel Machi
SUBJECT : PHARMACEUTICAL DRUG DISPOSAL
SUMMARY :
Existing law :
1) Under the United States Federal 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.
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.
4) Under the California Integrated Waste Management Act, the
California Integrated Waste Management Board implements a
statewide household hazardous substance information and
collection program.
5) Under the Medical Waste Management Act the State Department
of Health Services regulates the management and handling of
medical waste. Certain items, such as household waste, are
specifically excluded from the definition of medical waste.
This bill requires every retailer of pharmaceutical drugs on
and after July 1, 2008, to have in place a system for the
acceptance and collection of pharmaceutical drugs for proper
disposal that includes specified elements. Any person who
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violates those provisions shall, if convicted, be guilty of a
misdemeanor, and subject to specified civil and criminal
penalties.
COMMENTS :
1)Purpose of bill . The United States Geological Survey
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 on human health.
Without a safe and effective method for disposal,
prescription drugs may be left indefinitely in medicine
cabinets where they pose a threat of potential prescription
drug misuse or abuse.
According to the author, SB 966 provides a safe and
environmentally sound method for the disposal of unused
prescription drugs. Currently, when an individual needs to
dispose of expired or left over medications, the only safe
way to do so is to take it to a household hazardous waste
collection site. Most often drugs are either flushed down
the toilet or thrown in the garbage where they can pose a
threat to the environment and contaminate our waterways.
2) Response to Bush Administration recommendations . In an
attempt to address the potential health and environmental
risks associated with prescription drug disposal, in
February, the White House Office of National Drug Control
Policy, the Health and Human Services Agency, and the
Environmental Protection Agency released new Federal
prescription drug disposal guidelines urging Americans to
utilize pharmaceutical take-back locations. However, there
are few of these programs in existence.
3)Other state programs . The State of Washington is currently
implementing a pharmacy-based take-back program pilot
project. Maine has adopted legislation to implement a
mail-back program to the Maine Drug Enforcement Agency.
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Several other states have introduced legislation to address
this issue.
4)British Columbia program . The Medications Return Program
has been operated in British Columbia since 1996. It is
administrated by the Residuals Management Group Ltd., an
industry association. It is funded by a fee on
pharmaceutical manufacturers. Pharmacies participate
voluntarily at a rate of 90%. In 2004, 52,800 pounds of
drugs were collected.
5)Take-back events . In 2006, a coalition of 23 state and
local agencies, as well as local organizations participated
in 38 regional collection events in the San Francisco Bay
area. They collected 3,685 pounds of drugs from 1500
residents.
6)Amendments needed . The Board of Pharmacy does not currently
have a position on the bill but has provided technical
advice on the definition of "pharmaceutical drug,"
recommending that the definition be changed to reflect the
definition of drug in the Business and Profession Code
Section 4025. Under that provision:
""Drug" means any of the following:
(a) Articles recognized in the official United
States Pharmacopoeia, official National Formulary
or official Homeopathic Pharmacopoeia of the
United States, or any supplement of any of them.
(b) Articles intended for use in the diagnosis,
cure, mitigation,
treatment, or prevention of disease in humans or
other animals.
(c) Articles (other than food) intended to affect
the structure or any function of the body of
humans or other animals.
(d) Articles intended for use as a component of
any article specified in subdivision (a), (b), or
(c)."
Federal law prohibits anyone other than law enforcement from
taking possession of drugs once they are prescribed and
dispensed. Therefore controlled substances should be exempt
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from the provisions of this bill.
A criminal penalty was inadvertently added. An amendment is
needed to remove that provision to this bill and should be
stricken.
The California Veterinary Medical Association has a "support
if amended" position and has requested an amendment to
clarify that veterinarians would only be responsible for
having to dispose of the drugs that they personally sold and
not the human drugs that a client would have purchased at
another retail establishment.
Related legislation . SB 1305 (Figueroa) Chapter 64,
Statutes of 2006, prohibits a person from knowingly placing
home-generated sharps waste in the commercial and
residential solid waste collection containers after
September 1, 2008.
7)Arguments in support . Californians Against Waste (CAW)
state that there are currently few safe and convenient ways
for consumers to dispose of unused prescription drugs. A
2006 study showed that only 5% of pharmacies had a
consistent message to patients on the safe disposal of
pharmaceuticals. Nearly all unused pharmaceuticals enter
either our solid waste system or our sewage system. Neither
disposal methods are environmentally sound. According to
CAW, pharmaceuticals flushed down the toilet pass through
our sewage treatment plants - which are generally not
designed to screen for these chemicals. Pharmaceuticals
discarded in landfills can seep into the surrounding
watertable.
Supporters argue that the take back provisions of SB 966
will provide consumers with a safe and convenient system for
the environmentally sound management of unused prescription
drugs. Supporters believe that pharmacies represent a
logical and convenient collection point for consumers and
pharmacies are in a strong position to negotiate with
pharmaceutical manufacturers for a 'shared responsibility'
for any costs associated with the proper management of
pharmaceuticals.
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8)Arguments in opposition . Opponents argue that pharmacies
will incur substantial costs by participating in a mandated
drug disposal program, and in addition to labor costs
associated with such a program, there will be notification
and outreach costs.
According to the opposition, other states that have
established drug disposal programs have made them voluntary
and have allowed pharmacies to charge a nominal fee to cover
the cost associated with the program. In addition, some
states have established voluntary take back days in which
drugs from each store and properly dispose of them.
SOURCE : Abe Binder, Santa Clara resident and Rebecca
Kassel, Santa Cruz resident
SUPPORT : American Federation of State, County and
Municipal
Employees, Breast Cancer Fund, Californians Against
Waste, California Association of Sanitation Agencies,
California Product Stewardship Council, California
Veterinary Medical Association (support if amended),
Central Contra Costa Sanitary District, City of Benicia, City
of Palo Alto, City and County of San Francisco, Clean Water
Action, EXP Pharmaceutical Services Corp., Maine
Benzodiazepine Study Group, Maine Unused Drug Disposal Group,
Mt. View Sanitary District, Orange County Sanitation
District, San Francisco Public Utilities Commission, Sierra
Club California
OPPOSITION :
California Grocers Association, California Retailers
Association, Rite Aid