BILL ANALYSIS Ó
SB 423
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Date of Hearing: June 28, 2016
ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS
Luis Alejo, Chair
SB
423 (Bates) - As Amended June 21, 2016
SENATE VOTE: 40-0 (vote not relevant to current version of the
bill)
SUBJECT: Pharmaceutical and consumer product waste: management.
SUMMARY: Exempts non-prescription pharmaceutical products from
the Medical Waste Management Act (MWMA). Specifically, this
bill:
1)Requires, until January 1, 2022, a pharmaceutical that is
offered for sale without a prescription to be managed as
hazardous waste if it meets the definition of hazardous waste.
2)Requires, until January 1, 2022, a pharmaceutical that is
offered for sale without a prescription, if it is not a
hazardous waste, to be managed either as a medical waste or a
solid waste.
3)Requires the California Department of Toxic Substances Control
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(DTSC) to convene a Retail Waste Working Group to identify
regulatory and policy directives that need clarification for
managing consumer products, and adopt consensus
recommendations for waste reduction opportunities.
4)Requires, by March 1, 2017, the Retail Waste Working Group to
identify a list of issues for discussion and resolution, and
requires, by June 1, 2017, to report to the Legislature the
consensus recommendations to the Legislature.
EXISTING LAW:
1) Defines "drug" under the Federal Food, Drug, and Cosmetic
Act as any article recognized in the official United States
Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
United States, or official National Formulary, or any
supplement to any of them. (21 United States Code Sec. 231
(g)(1))
2) Establishes the MWMA to govern medical waste management at
any facility where waste is generated, at transfer stations,
and at treatment facilities. (Health & Safety Code (H&S) §
117600, et seq.)
3) Defines "pharmaceutical waste" as a prescription or
over-the-counter human or veterinary drug, including, but
not limited to, a drug as defined in Section 109925 of the
Federal Food, Drug, and Cosmetic Act. (H&S § 117747 (a))
4) Exempts from the definition of pharmaceutical waste any
pharmaceutical that is regulated pursuant to the federal
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Resource Conservation and Recovery Act (RCRA) or the
Radiation Control Law. (H&S § 117747 (b)) Exempts from the
definition of pharmaceutical waste any pharmaceutical that
is being sent offsite to or by a reverse distributor for
treatment and disposal by a reverse distributor that is
licensed as a wholesaler of dangerous drugs. (H&S § 117690
(b)(3)(A)-(B))
5) Requires, under the California Hazardous Waste Control Act
(HWCA) of 1972, DTSC to regulate the appropriate handling,
processing and disposal of hazardous and extremely hazardous
waste to protect the public, livestock, and wildlife from
hazards to health and safety. (H&S § 25100)
6) Defines hazardous waste as a waste that may cause, or
significantly contribute to, an increase in mortality or an
increase in serious irreversible, or incapacitating
reversible, illness; pose a substantial present or potential
hazard to human health or the environment, due to factors
including, but not limited to, carcinogenicity, acute
toxicity, chronic toxicity, bioaccumulative properties, or
persistence in the environment, when improperly treated,
stored, transported, or disposed of, or otherwise managed.
(H&S § 25141) Hazardous waste includes hazardous waste
covered under RCRA. (H&S § 25117)
7) Defines reverse distributor as every person who acts as an
agent for pharmacies, drug wholesalers, third-party
logistics providers, manufacturers, and other entities by
receiving, inventorying, warehousing, and managing the
disposition of outdated or non-saleable dangerous drugs.
(Business & Professions Code (BP) § 4040.5)
8) Authorizes the establishment of a voluntary drug
repository and distribution program for the purpose of
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distributing surplus medications to persons in need of
financial assistance to ensure access to necessary
pharmaceutical therapies. (BP § 150200)
FISCAL EFFECT: Unknown. The Senate Appropriations Committee
analyzed a previous version of the bill.
COMMENTS:
Need for the 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 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 MWMA 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 in
California. The author believes that SB 423 would provide clear
waste management options for over the counter pharmaceutical
products by explicitly allowing these products to be scrutinized
under existing hazardous waste laws when disposed rather than
only the MWMA.
The author also states that multiple stakeholder discussions
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have taken place on the issues of retail waste, including
over-the-counter pharmaceutical waste in California. DTSC
created a Retail Waste Workgroup a few years ago to identify the
regulatory requirements that are in need of clarification for
retailers. SB 423 provides goals for the Retail Waste Workgroup
to work towards developing consensus policy recommendations on
these outstanding waste management issues in CA. This will
ensure both the regulators and the regulated community have a
defined timeline by which agreement on these issues is to be
attained.
Regulating pharmaceuticals: The MWMA vests the California
Department of Public Health (CDPH) with authority to regulate
the generation, handling, storage, treatment, and disposal of
medical waste.
Pharmaceutical wastes were added to the MWMA in 1996 (SB 1996,
Wright, Chapter 536). That legislation moved the regulation of
pharmaceutical waste as hazardous waste by DTSC to the
Department of Healthcare Services (now the Department of Public
Health) because pharmaceutical waste was not considered
hazardous waste under federal law or as medical waste under the
MWMA. SB 1996 did not, however, include under the definition of
"pharmaceutical wastes" any pharmaceutical wastes regulated as
solid waste pursuant to the California Integrated Waste
Management Act.
AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) excluded
pharmaceuticals being sent to reverse distributors from the
storage, disposal, and transport requirements of the MWMA. It
also relaxed hauling requirements for pharmaceutical medical
waste that is not reverse-distributed if the generator meets
certain conditions. As a result, any non-saleable pharmaceutical
that is returned to a licensed reverse distributor (and that is
not hazardous under RCRA or radioactive under the federal
Radiation Control Law) is not considered pharmaceutical or
medical waste, and is therefore not regulated by the MWMA. This
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has the effect of allowing most non-saleable pharmaceuticals to
be transferred to reverse distributors without fear of violating
the strict disposal and transportation requirements for medical
waste.
Regulatory confusion: Despite AB 1442, much regulatory confusion
remains. DTSC has authority over hazardous materials and
hazardous wastes. CDPH has authority over cosmetics,
pharmaceuticals and medical waste. The Department of Resources
Recycling and Recovery has authority over solid wastes and
universal wastes.
According to federal and state 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.
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 of a product. 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 be risking violation of
various statutory waste handling requirements. The retailers
assert that the result is a far greater than necessary rate of
disposal or destruction of items that could have been retained
for their useful life.
Retail Waste Workgroup: Retailers that operate stores in
California and those that sell goods in California through the
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Internet, mail-order catalogs, door-to-door sales and other
outlets are all subject to California's medical waste and/or
hazardous waste laws and regulations.
In an effort to clarify California's hazardous waste regulatory
requirements, DTSC is gathering information and developing an
understanding of hazardous waste management practices at various
types of retailers.
In 2015, DTSC created a Retail Waste Workgroup to identify
regulatory requirements that need clarification and to provide
that clarification. The Retail Waste Workgroup consists of large
and small retailers, District Attorneys from multiple counties,
Certified Unified Program Agency representatives, consultants,
non-government organizations, California Department of Public
Health and DTSC. The most recent meeting was June 2, 2016.
The Retail Waste Workgroup is an ongoing process working through
the issues for which SB 423 is raising. SB 423 is proposing to
turn the fruits of those discussions into policy recommendations
for broader consumer product management by codifying the Retail
Waste Working Group and establishing a date-certain for
consensus policy recommendations to be made to the Legislature.
The bill proposes a slightly different scope of work than the
Retail Waste Workgroup is currently working on, which may narrow
the goal to identify and clarify policy and regulatory
requirements for products that are eventually considered
hazardous wastes.
The Committee may wish to consider amending the provision of the
bill codifying the Retail Waste Workgroup to clarify the intent
and the goals.
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Federal action to eliminate retail confusion: The US EPA has
indicated that the issue of regulating the management of surplus
consumer products is larger than pharmaceuticals; it has
acknowledged the challenges regarding the regulation of retail
hazardous waste, has provided data on retail hazardous waste
generation, and has invited public comment on issues specific to
retail hazardous waste.
Using 2007 census data, the US EPA identified 13 retail sectors
(including vehicle service stations, electronics and appliance
stores, food and beverage stores) comprising 1.6 million
facilities that generate hazardous waste. Only about 41,000
(4.6%) of this total are registered as hazardous waste
generators in the RCRAInfo database, which is a federal program
management and inventory system about hazardous waste handlers.
It is likely that some retailers do not view themselves as
hazardous waste generators who may be subject to regulation.
For example, retailers may not be aware that products returned
to them by the purchaser may be RCRA hazardous waste. The US
EPA acknowledged the uncertainty faced by retailers in managing
the wide range of retail products that may become wastes if
unsold, returned, or removed from shelves for inventory changes.
Regulation of hazardous waste, including medical wastes,
generated by the retail sector presents unique challenges. The
retail sector handles a large number of diverse products (for
example, one retailer has reported to the US EPA about a million
products and 4,000 facilities nationwide), many of which may
potentially become regulated as medical or hazardous waste when
discarded. Thus, retailers are required to make numerous medical
and hazardous waste determinations at thousands of sites,
generally by store employees with limited experience with the
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RCRA, HWCA, or MWMA regulations.
SB 423 is proposing to ease the regulatory requirements of
pharmaceuticals under the MWMA with a blanket exemption, and
ease the waste determination made by retailers by offering the
option of managing wastes as solid waste if the waste is not
hazardous.
SB 423 does not, however, address the outstanding confusion
retailers have over when a product (in this case, a
pharmaceutical) is a hazardous waste.
Under the MWMA, non-RCRA pharmaceuticals are exempt. In theory,
that would mean if a product is exempt from the MWMA, as it
would be under SB 423, it would be treated as solid waste since
it's not covered under RCRA. But, California's HWCA does not
perfectly align with RCRA, and, in many cases, is more
stringent. There are, in fact, many nonprescription
pharmaceuticals that would have to be treated as hazardous
waste. Anything that might fail DTSC's regulatory aquatic
toxicity test would be a hazardous waste. Medicated shampoos,
pain killers, and vitamin supplements are some examples. It is
easy to understand the existing confusion over pharmaceutical
product management.
What is a nonprescription pharmaceutical? The bill doesn't
define a pharmaceutical that is sold without a prescription, but
it includes a broad range of products, from vitamins and
supplements, pain killers, allergy and antihistamine drugs,
laxatives, spermicides, anti-inflammatory drugs, cough and cold
medications, steroids, anti-fungal drugs, as well as products
that include anything with a chemical or pharmaceutical element,
such as, but not limited to, toothpaste, medicated shampoos
(dandruff, lice shampoos), mouthwash, Sun Protection Factor
(SPF)-containing lotions and chap sticks, cosmetics, and any
other over-the-counter drugs.
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What does this bill do, exactly? SB 423 exempts all
nonprescription pharmaceuticals from the MWMA and gives
retailers the option of managing these pharmaceuticals, once the
waste determination has been made, as either a solid waste or a
medical waste, unless the pharmaceutical is hazardous waste.
This is problematic because the MWMA exists for a clear and
specific reason: to manage medical waste, which includes
pharmaceutical waste, in carefully specified ways to protect
public health and the environment. Under the MWMA,
pharmaceutical waste has to be incinerated at a permitted
medical waste treatment facility; treated temperatures in excess
of 1300 degrees Fahrenheit; or steam sterilized at a permitted
medical waste treatment facility. (H&S § 118215)
Exempting pharmaceuticals from the MWMA would eliminate
important protections we have in place to prevent pharmaceutical
contamination and threats to the environment.
Contaminants of emerging concern: Our water supplies are
increasingly contaminated with chemicals of concerns. Numerous
contaminants, such as pharmaceuticals, personal care products
(antibacterial soaps, sunscreen, bath gels, etc.), and other
constituents of emerging concern, are more likely to be present
in municipal wastewater than in other water sources. Although
they typically exist in small concentrations, there is growing
concern about the impact of constituents of emerging concern,
and other unregulated compounds, on public health and the
environment. By allowing OTC pharmaceuticals to be treated as
solid waste, this bill would be creating a greater risk of
pharmaceutical contamination in our water supplies, thus
exacerbating the conundrum of contaminants of emerging concern.
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Committee amendments: Given the policy concerns around the
changes to the MWMA the bill is proposing, the Committee may
wish to consider the following amendments:
1. Strike Sections 1, 2 and 3 from the bill, entirely.
2. Clarify the goals of the Retail Waste Working Group to
be more consistent with the current goals of the Working
Group and the US EPA's efforts to clarify policy
requirements for managing consumer products that are
considered hazardous waste at the time of disposal. This
amendments would be drafted as follows:
(a) The Department of Toxic Substances Control shall convene a
Retail Waste Working Group comprised of representatives of large
retailers, small retailers, district attorneys, certified
unified program agencies, nongovernment organizations, State
Department of Public Health, manufacturers, other relevant state
agencies as determined by DTSC , reverse distributors, and other
stakeholders to do both of the following to consider and make
recommendations on the following :
(1) Identify Regulatory and policy directives requirements
that may be considered confusing, and/or may need
clarification or specification when applied to the overall
management of consumer products that are wastes, including
those that are considered hazardous when the waste
determination is made.
(2) Adopt consensus policy and/or regulatory
recommendations to facilitate and increase sustainable
practices and waste reduction opportunities for consumer
products and clarify hazardous waste management in the
retail industry to encourage safe and efficient options for
managing the flow of waste and surplus household consumer
products through the reverse supply chain .
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(b) By March 1, 2017 June 1, 2017 , the Retail Waste Working
Group shall identify a list of issues for discussion and
resolution and, thereafter, shall meet regularly to assist and
advise the Legislature, and shall report the consensus
recommendations to the Legislature by June 1, 2017 .
REGISTERED SUPPORT / OPPOSITION:
Support
American Cleaning Institute
California Chamber of Commerce
California Manufacturers and Technology Association
California Retailers Association
Consumer Specialty Products Association
Industrial Environmental Association
National Federation of Independent Businesses
Opposition
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None on file
Analysis Prepared by:Paige Brokaw / E.S. & T.M. / (916)
319-3965