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 ----------------------------------------------------------------- | | | | | | ----------------------------------------------------------------- |--------------------------------+--------------------------------| | | | |Version: July 6, 2015 |Policy Vote: E.Q. 7 - 0 | | | | |--------------------------------+--------------------------------| | | | |Urgency: Yes |Mandate: Yes | | | | |--------------------------------+--------------------------------| | | | |Hearing Date: August 17, 2015 |Consultant: Marie Liu | | | | ----------------------------------------------------------------- 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 SB 423 (Bates) Page 1 of ? 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 SB 423 (Bates) Page 2 of ? 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. -- END --