BILL ANALYSIS Ó
-----------------------------------------------------------------
|SENATE RULES COMMITTEE | SB 423|
|Office of Senate Floor Analyses | |
|(916) 651-1520 Fax: (916) | |
|327-4478 | |
-----------------------------------------------------------------
THIRD READING
Bill No: SB 423
Author: Bates (R)
Amended: 8/31/15
Vote: 27 - Urgency
SENATE ENVIRONMENTAL QUALITY COMMITTEE: 7-0, 7/15/15
AYES: Wieckowski, Gaines, Bates, Hill, Jackson, Leno, Pavley
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/27/15
AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza, Nielsen
SUBJECT: Retail nonprescription surplus products:
determinations for reuse
SOURCE: Author
DIGEST: This bill establishes a process for the handling and
management of retail nonprescription pharmaceutical surplus
products.
ANALYSIS:
Existing federal law:
1)Authorizes, under the Food, Drug, and Cosmetic Act, the Food
and Drug Administration (FDA), to oversee the safety of food,
drugs, and cosmetics.
2)Regulates, under the Resource Conservation and Recovery Act
(RCRA) of 1976, the management of solid and hazardous wastes.
In the context of pharmaceuticals, RCRA imposes strict
protocols for the collection of controlled substances.
Existing state law:
SB 423
Page 2
1)Provides that under the Medical Waste Management Act (MWMA),
administered by the State Department of Public Health:
a) Regulates the management, handling, and disposal of
medical waste, as defined, including pharmaceutical waste.
b) 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.
c) Defines "pharmaceutical" 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.
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.
2)Provides that under the Hazardous Waste Control Act (HWCA),
administered by the Department of Toxic Substances Control
(DTSC), regulates the management, handling and disposal of
hazardous waste, as defined.
This bill:
1)Establishes, until January 1, 2022, criteria to be followed
for the handling and management of retail nonprescription
pharmaceutical surplus products, as defined, if a reasonable
determination for reuse has been made or when a reasonable
determination for reuse cannot be made but the product has
been recalled as required by law.
2)Authorizes DTSC to adopt regulations as deemed necessary to
SB 423
Page 3
establish standards for the proper and safe handling of retail
nonprescription pharmaceutical surplus products.
3)Specifies that a facility that elects to follow the procedures
in this bill is not subject to regulation of specified
products by the MWMA.
4)Declares the urgency of this statute.
Background
Risks of pharmaceuticals in the environment. A study conducted
by the United States Geological Survey (USGS) from 1999-2000
sampled 139 streams across 30 states and found that 80% had
measurable concentrations of both 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.
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.
As California further explores the re-utilization of water
through water recycling, prevention of contamination becomes
crucial to prevent public health exposure through water.
Health risks associated with incineration. Incinerators are
known to release numerous toxic chemicals into the atmosphere
and to produce ashes and other solid waste residues that
contaminate the air, water and soil as well as vegetation in the
vicinity of the facility. Adverse health effects associated
with incineration are of great concern as large population
groups and workers may be exposed to derived toxic substances.
Many of these chemicals are known to be persistent,
bioaccumulative, carcinogenic or endocrine disruptors.
Populations living near incinerators are potentially exposed to
chemicals by way of inhalation of contaminated air, consumption
of contaminated foods, water or dermal contact with contaminated
SB 423
Page 4
soil. Additionally, there are occupational hazards for
incinerator workers.
Comments
The confusion over "pharmaceutical waste." According to federal
and California law, a pharmaceutical is anything that contains a
"drug fact" label. A drug fact label is affixed to any product
that makes a health claim. These products must meet specified
FDA ingredient testing, disclosure, labeling and verification of
health claim requirements. This includes prescription and
over-the-counter drugs as well as some consumer products that
make health claims, such as sunscreen, toothpastes, mouthwashes
or lotions that contain sunscreen.
Pharmaceuticals are medical waste and are required to be managed
under MWMA, which is designed to ensure that medical waste does
not enter the environment and does not present a risk to public
health.
However, toothpaste, mouthwashes, lotions and other
over-the-counter products that do not contain drug facts are not
medical waste. Depending on their characteristics and risks
posed they must be handled pursuant to either hazardous or solid
waste statutes, as defined and specified.
Retail establishments argue that the various statutory and
regulatory requirements of when a product becomes a waste and
how it must be handled make it difficult for their employees to
determine the appropriate handling. Additionally, MWMA requires
that medical waste be incinerated. The retailers argue that
because of the complexity of the current regulatory scheme, they
are currently not separating products that may be able to be
donated or liquidated from those that are deemed waste if there
is any question that they may instead be required to be disposed
of, in order to ensure that they don't violate the various
statutory waste handling requirements. The retailers assert
that the result is a far greater than necessary rate of
disposal/incineration of items that could have been retained for
their useful life.
Striking a balance. MWMA, HWCA and other state and federal
SB 423
Page 5
waste laws have specific requirements for handling,
transportation and disposal to protect public health and the
environment. When alternative management standards are adopted,
the standards are narrowly crafted and contain specific
conditions for tracking, handling, transportation and disposal
to accommodate the unique nature of the wastestream. SB 423
recognizes the public policy benefit of diverting more waste and
crafts an alternative management scheme that provides some
flexibility within the statute for the point at which this
category of items is determined to be a waste. While it is
important in providing this flexibility, it is equally important
that it be balanced with appropriate tracking and accountability
to ensure safe handling and enforceability of the statute.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
According to the Senate Appropriations Committee this bill will
have unknown costs to the Hazardous Waste Control Account for
DTSC to "register" specified entities.
SUPPORT: (Verified8/27/15)
California Retailers Association
CVS Health
OPPOSITION: (Verified8/27/15)
None received
Prepared by:Rachel Machi Wagoner / E.Q. / (916) 651-4108
8/30/15 19:48:52
**** END ****
SB 423
Page 6