Solid waste: pharmaceutical and sharps waste stewardship.

The California Integrated Waste Management Act of 1989, administered by the Department of Resources Recycling and Recovery (CalRecycle) , generally regulates the disposal, management, and recycling of solid waste. Former law, repealed as of January 1, 2013, required CalRecycle to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of pharmaceutical drug waste, and to make the model programs available to eligible participants, as specified. Existing law, the Medical Waste Management Act administered by the State Department of Public Health, regulates the management and handling of medical waste, as defined. Existing regulations authorize pharmacies, hospitals or clinics with onsite pharmacies, distributors, and reverse distributors licensed by the California State Board of Pharmacy to offer, subject to prescribed requirements, specified prescription drug take-back services through collection receptacles or mail back envelopes or packages to provide options for the public to discard unwanted, unused, or outdated prescription drugs. This bill would establish a stewardship program, under which a manufacturer or distributor of covered drugs or sharps, or other entity defined to be covered by the bill, would be required to establish and implement, either on its own or as part of a group of covered entities through membership in a stewardship organization, a stewardship program for covered drugs or for sharps, as applicable. The bill would impose various requirements on a covered entity or stewardship organization that operates a stewardship program, including submitting a proposed stewardship plan, an initial stewardship program budget, an annual budget, annual report, and other specified information to CalRecycle. The bill would provide that all reports and records provided to CalRecycle pursuant to the bill are provided under penalty of perjury. By expanding the scope of the crime of perjury, the bill would impose a state-mandated local program. The bill would require proprietary information, as defined, submitted pursuant to the bill to be kept confidential. The bill would require a stewardship plan for covered drugs to contribute to meeting specified minimum requirements for authorized collection sites in each county in which the plan will be implemented, including, as applicable, a minimum of one authorized collection site per 50,000 people in the county and a minimum of 5 collection sites in the county. The bill would authorize an operator of a stewardship program for covered drugs, if authorized by the department, after the stewardship plan has been approved, to establish a mail-back program or alternative collection program for covered products, or both, for a county in which it operates that does not have the minimum number of authorized collection sites, as specified. The bill would require a retail pharmacy to make a reasonable effort to serve as an authorized collector as part of a stewardship program for covered drugs and would require a retail pharmacy chain operating in a county to have at least one location or 15% of its store locations, whichever is greater, in the county serve as authorized collectors if the above-specified minimum authorized collection site requirements for the county are not met. The bill would require each covered entity, either individually or through the stewardship organization of which it is a part, to pay all administrative and operational costs associated with establishing and implementing the stewardship program in which it participates. The bill would also require a covered entity to pay a quarterly administrative fee in the amount adequate to cover any regulatory costs incurred by a state agency in administering and enforcing the provisions of the bill, to be deposited in the Pharmaceutical and Sharps Stewardship Fund, which the bill would create. The bill would authorize moneys in the fund to be expended, upon appropriation by the Legislature, for the regulatory activities of state agencies of administering and enforcing the bill. The bill would authorize CalRecycle to impose an administrative penalty on a covered entity, program operator, stewardship organization, or authorized collector that sells, offers for sale, or provides a covered product in violation of the bill's provisions, to be deposited in the Pharmaceutical and Sharps Stewardship Penalty Account, which the bill would create. The bill would require CalRecycle to adopt regulations for the administration of the bill's provisions, with an effective date of no later than January 1, 2021, and would authorize the state board to adopt regulations for the administration of the portions of these provisions for which it has been given responsibilities. Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest. This bill would make legislative findings to that effect. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.