BILL ANALYSIS Ó
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
SB 423 (Bates) - Retail nonprescription surplus products:
determinations for reuse
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|Version: July 6, 2015 |Policy Vote: E.Q. 7 - 0 |
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|Urgency: Yes |Mandate: Yes |
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|Hearing Date: August 17, 2015 |Consultant: Marie Liu |
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This bill meets the criteria for referral to the Suspense File.
Bill
Summary: AB 423 would establish a process for the handling and
management of retail nonprescription pharmaceutical surplus
products.
Fiscal
Impact:
Unknown costs to the Hazardous Waste Control Account (special)
to the Department of Toxic Substances Control (DTSC) to permit
additional new transfer stations.
Unknown potential costs to the Hazardous Waste Control Account
(special) to DTSC to develop necessary regulations.
Background: The Department of Public Health (DPH) regulates the
management, handing, and disposal of medical waste under the
Medical Waste Management Act. Medical waste includes
pharmaceutical waste, which under federal and California law is
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any product that includes a "drug fact" label that is affixed to
any product that makes a health claim. This definition includes
some consumer products that make health claims, such as
sunscreen, toothpaste, mouthwash, or lotions.
DTSC regulates the management, handling, and disposal of
hazardous waste, as defined, in accordance with the Hazardous
Waste Control Act.
Proposed Law:
This bill would establish a handling and management process
for retail nonprescription pharmaceutical surplus products. This
process would require the product to be transported to a reverse
distributor or a reverse distribution center for evaluation,
liquidation, donation, or transfer back to a manufacturer or
supplier. The product must be transported with a tracking
document that identifies specific information including the UPC
label and the name and contact information of the generator.
The reverse distributor or reverse distribution center would be
required to maintain tracking documents for three years, submit
a hazardous materials business plan, and be licensed by the
California State Board of Pharmacy as a wholesaler of dangers
drugs. The reverse distributor would also be required to be
permitted by DTSC as a transfer station and registered by DTSC
as a hazardous waste generator, transfer facility, or storage
facility.
This process would only apply to a pharmaceutical that may be
sold without a prescription and has been either determined to be
eligible for reuse by a waste generator or is a recalled
product. A pharmaceutical that is eligible for reuse would be
defined as a product that is in unadulterated packaging, in a
condition suitable for resale, and not designated for disposal.
Staff
Comments: This bill authorizes DTSC to develop regulations to
implement this new waste management process for nonprescription
pharmaceuticals. At this time DTSC does not know the universe of
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products to which this bill may apply and whether any of these
products can be considered hazardous. Depending on the size and
characteristics of the products that could follow the process
created by this bill, DTSC may need regulations of unknown
complexity or none at all.
The new handling and management process established by this bill
may prompt more facilities seeking to be permitted by DTSC as a
transfer station in order to comply with the bill's requirement.
A straightforward transfer station permit typically takes
$156,000 in staff time to review and process. However, the
permit fee is only between $8,500 and $50,600, with the balance
of the costs being covered by the Hazardous Waste Control Act.
Depending on the number of facilities that would seek permitting
by DTSC, which is unknown, costs could be minor to the millions
of dollars. Staff notes that DTSC currently has a significant
backload in addressing permit applications. The additional
facilities seeking permitting to comply with this bill could
potentially exasperate this backlog. Staff notes that DPH also
permits transfer stations and it may be the author's intent that
this requirement is in reference to DPH's permits.
This bill also requires that a reverse distributor be
"registered" with the DTSC as a hazardous waste generator,
transfer facility, or storage facility. It is unclear the cost
implications of this provision as transfer and storage
facilities are "permitted" and hazardous waste generators are
neither "registered" or "permitted." Staff recommends that this
bill be clarified.
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