Proposed Pharmaceutical and Sharps Waste Stewardship Program Regulations


SCH Number
Public Agency
California Department of Resources Recycling and Recovery
Document Title
Proposed Pharmaceutical and Sharps Waste Stewardship Program Regulations
Document Type
NOE - Notice of Exemption
Document Description
In 2018, the Legislature enacted SB 212 (Stats.2018, c. 1004; Public Resources Code, §§42030-42036.4) which establishes stewardship programs, for the proper collection, transportation, and disposal of covered drugs and sharps from consumers. To accomplish this, a covered entity responsible for covered drugs or sharps, is required to establish and implement, either on its own or as a member of a stewardship organization, a stewardship program. The covered entity or stewardship organization that operates a stewardship program, must submit a proposed stewardship plan, an initial stewardship program budget, an annual budget, annual report, and other specified information to CalRecycle. Each covered entity, either individually or through the stewardship organization of which it is a part, must pay all administrative and operational costs associated with establishing and implementing the stewardship program. CalRecycle has developed a proposed regulation to establish administrative procedures to enable CalRecycle to fulfill its responsibilities under SB 212.

Contact Information

Jason Smyth
Agency Name
Department of Resources Recycling and Recovery
Contact Types
Lead/Public Agency

Agency Name
Department of Resources Recycling and Recovery
Contact Types
Project Applicant



Notice of Exemption

Exempt Status
Categorical Exemption
Type, Section or Code
14 CCR Sections 15378(a), 15378(b)(1)
Reasons for Exemption
The adoption of the regulation is exempt from the California Environmental Quality Act (CEQA) because it is not a “project,” as that term is defined in the CEQA Guidelines (Cal. Code of Regs, Title 14, §§ 15000 et seq.). A “project” is an activity “which has a potential for resulting in either a direct physical change in the environment, or a reasonably foreseeable indirect physical change in the environment…” (CEQA Guidelines, § 15378(a).) The regulation only establishes administrative procedures for CalRecycle, covered drug and sharp manufacturers, and other covered entities subject to the underlying statute. The adoption of the regulation will have no direct effect on the environment and no reasonably foreseeable indirect effect on the environment. Although the regulation allows the submission of Pharmaceutical and Sharps plans in the future, there are no plan requirements in the proposed regulation from which any environmental impacts, direct or indirect, can be discerned. There are no standards or targets set in the proposed regulation on which to base an objective analysis of any potential impacts. To impute any general or specific environmental effects from the regulation would be entirely speculative, and CEQA does not require a lead agency to speculate as to the potential impacts of a project. Accordingly, the adoption of the regulation is exempt from consideration under CEQA.


Disclaimer: The Governor’s Office of Planning and Research (OPR) accepts no responsibility for the content or accessibility of these documents. To obtain an attachment in a different format, please contact the lead agency at the contact information listed above. You may also contact the OPR via email at or via phone at (916) 445-0613. For more information, please visit OPR’s Accessibility Site.

Download CSV New Search Print