BILL ANALYSIS Ó
SENATE COMMITTEE ON ENVIRONMENTAL QUALITY
Senator Wieckowski, Chair
2015 - 2016 Regular
Bill No: SB 423
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|Author: |Bates |
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|Version: |7/6/2015 |Hearing |7/15/2015 |
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|Urgency: |Yes |Fiscal: |Yes |
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|Consultant:|Rachel Machi Wagoner |
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SUBJECT: Retail nonprescription surplus products:
determinations for reuse.
ANALYSIS:
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.
Existing state law:
1) Under the Medical Waste Management Act (MWMA), administered
by the State Department of Public Health (DPH),
a) Regulates the management, handling, and disposal of
medical waste, as defined, including pharmaceutical waste.
b) 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,
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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.
2) Under the Hazardous Waste Control Act (HWCA), administered by
the Department of Toxic Substances Control, regulates the
management, handling and disposal of hazardous waste, as
defined.
This bill:
1) Until January 1, 2022, would establish 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
establish standards for the proper and safe handling of
retail nonprescription pharmaceutical surplus products.
3) Declares the urgency of this statute.
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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
soil. Additionally, there are occupational hazards for
incinerator workers.
Comments
1) Purpose of Bill. According to the author, SB 423 is intended
to build on recent California legislation that has helped to
streamline the safe and efficient handling of
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pharmaceuticals, other health care products, and household
consumer products sold by retailers in this state. The
author states that when these products are not sold at an
initial point of sale for various reasons, the products are
often processed at a reverse distribution center where the
center performs various activities such as consolidation,
repackaging, donation, disposal upon completion of any of
these management activities. The author further states that
jurisdiction over these products at the point they are
considered discarded or recycled under current law, including
when they are considered stored or accumulated for discard or
recycling, can fall under either the California Medical Waste
Management Act or hazardous and solid waste provisions of the
Health and Safety Code. The author asserts that this dual
jurisdiction has led to confusion in the regulated community
and threatens to undermine positive aspects of the reverse
distribution system for managing pharmaceuticals, including
over-the-counter pharmaceuticals and household consumer
products in California.
The author states that multiple stakeholder discussions have
taken place on the issues of retail waste, including
over-the-counter pharmaceutical waste in California. The
author believes that SB 423 would provide waste management
options that would reconcile the confusion over dual
jurisdiction by providing a unified waste management option
for the over-the-counter pharmaceuticals.
2) 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 federal Food and Drug Administration
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.
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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.
3) Striking a balance. MWMA, HWCA and other state and federal
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.
4) Does this bill indicate (again) a need to reform MWMA for
pharmaceutical waste? The California Legislature has heard
bills each year reforming the MWMA for the management
concerning the reuse of unused prescription drugs, transport
of unused prescription drugs from retails, take-back of
prescription drug waste for disposal, take back and disposal
of sharps waste. Is this bill further indication that MWMA
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needs to be reformed to better accommodate pharmaceutical
waste?
Related/Prior Legislation
SB 1014 (Jackson, 2014) would have required 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. The plan would have needed 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.
AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) defines
pharmaceutical waste for purposes of the Medical Waste
Management Act, and exempts a pharmaceutical waste generator or
parent organization that employs health care professionals who
generate pharmaceutical waste from specified medical waste
hauling requirements if the generator, health care professional,
or parent organization retains specified documentation and meets
specified requirements and if the facility receiving the medical
waste retains specified documentation and meets specified
requirements. This bill also authorizes pharmaceutical waste to
be transported by the generator or health care professional who
generated the pharmaceutical waste, a staff member of the
generator or health care professional, or common carrier, as
defined, pursuant to these provisions.
SOURCE: California Retailers Association
SUPPORT:
CVSHealth
OPPOSITION:
None received
ARGUMENTS IN
SUPPORT: Proponents for SB 423 state their support for SB 423
but have concerns where they seek additional amendments:
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The purpose of SB 423 is to add a new provision of the Health
and Safety Code, relating to the reverse distribution of unsold
household consumer products, and to amend the California Medical
Waste Management Act (Act) to provide an alternative management
option for unsold non-prescription drugs. SB 423 is needed to
address regulatory confusion under current law regarding reverse
distribution and strengthen environmental protection programs at
retail facilities in California. This legislation could
potentially create an opportunity for waste minimization by
chain drug stores and others that manage large volumes of unsold
consumer products and non-prescription drugs, also known as
over-the-counter pharmaceuticals (OTCs).
Current law can be read to require that all unsold consumer
products are potential solid, hazardous, or medical wastes at
retail locations unless the retailer knows with certainty at the
store that the product can be reused for its intended purpose or
reclaimed by thousands of original manufacturers. The timing of
this knowledge does not match typical retail processes that rely
on reverse distribution to consolidate products for business
purposes, including potential donation, sale to third-party
liquidators, and waste minimization, prior to any decision to
discard the products. Further, and related to this product
management, the Act can be read to require that OTCs must be
managed and incinerated as medical waste.
Currently, recycling or waste minimization is not an option for
OTCs because the Act can be read to mandate incineration.
Mandatory incineration for OTCs is excessive and contrary to
good environmental stewardship where there may be other options
for managing these products when they can no longer be sold to
the public.
Primary areas for further discussion should the bill move
forward include:
1) Regarding generator knowledge, retailers do not know at
retail locations whether a product will be donated or
liquidated. The role of the reverse distributor is to help
direct the products for reuse or return to the manufacturer,
manufacturer's agent or vendor. Thus, so long as the retail
location does not know that the ultimate disposition of the
product will be disposal, and the product is in a condition
that it can be reused, we trust this is sufficient knowledge
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by the retailer to qualify for the option.
2) Regarding licensing for reverse distributors and reverse
distribution centers, further clarification is needed to know
whether there is flexibility on these requirements because
reverse distributors under SB 423 should not need the same
licensing as those facilities under AB 1442 that are
accepting prescription and dangerous drugs for disposal.
3) Regarding transportation requirements, because retailers
will be shipping surplus products back in a manner like the
products are shipped to stores, we trust that the packaging
and transportation requirements for surplus product shipments
can match as close as possible current safe and secure
transport practices that must meet the requirements of other
laws.
4) Regarding product tracking requirements, we would hope to
rely on current shipping documentation such as bills of
lading to track surplus products. Because these shipments
are valuable to retailers for credit, tax purposes and
inventory, documentation exists today to track these
shipments that could be used for purposes of SB 423. We
trust there is flexibility on this point as well.
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