Description

Senate Bill (SB) 212 (Jackson, Chapter 1004, Statutes of 2018) was enacted on September 30, 2018 to establish safe and convenient collection and disposal options for covered drugs and home-generated sharps waste (covered products). CalRecycle is required to adopt regulations for the implementation of SB 212 with an effective date of no later than January 1, 2021.

SB 212 requires covered entities, individually or through a stewardship organization, to design, fund, and implement stewardship programs for the proper collection and disposal of covered products. Covered entities, as defined in statute, can be manufacturers, distributors, re-packagers, the owner or licensee of a covered product, or importer of a covered product in or into California.

For covered drugs, a stewardship program must establish secure collection receptacles throughout the state and fulfill specific convenience standards. For home-generated sharps waste, a stewardship program must distribute sharps waste containers and mail-back materials, at no cost to the ultimate user. Additionally, local agencies may request management or reimbursement for home-generated sharps waste collected at local household hazardous waste facilities. 

Finally, the statute requires a certain level of program participation from retail pharmacies and retail pharmacy chains, and imposes certain record-keeping requirements on all retailers of covered products. 

Current Status

On January 7, 2021, the Office of Administrative Law approved the Pharmaceutical and Sharps Waste Stewardship Regulations, after minor non-substantial edits were made, and forwarded them to the California Secretary of State for publishing. CalRecycle requested an early effective date, which was granted; therefore the regulations were effective immediately on January 7, 2021. The final regulatory text is published and available online.

Formal Rulemaking Documents

• Pharmaceutical and Sharps Waste Stewardship Regulations, as approved by the Office of Administrative Law on January 7, 2021 | nonsighted version. Minor non-substantial edits were made after the Proposed Pharmaceutical and Sharps Waste Stewardship Regulations were submitted to the Office of Administrative Law on November 19, 2020 and can be found in sections 18972 [deleted], 18972.1(a)(3), page 1, 18973(a), page 3, 18973.2(f), page 8, 18973.3(e), page 13, 18973.6(b)(3), page 26, 18974(b), page 28, and 18974.1, page 28.
• Proposed Pharmaceutical and Sharps Waste Stewardship Program Regulations, as approved by CalRecycle on September 30, 2020 | nonsighted version
• Notice of Changes to Proposed Regulations (August 21, 2020) 
• Third Draft Proposed Regulations for 15-day Comment Period, August 2020 | nonsighted version
• Revised Economic and Fiscal Impact Statement  (August 2020)
• 15-day Comment Period Extension Notice (July 28, 2020)
• Notice of Changes to Proposed Regulations (July 14, 2020)
• Second Draft Proposed Regulations for 15-day Comment Period, July 2020 | nonsighted version
• First Draft Proposed Regulations for 45-day Comment Period, December 2019 | nonsighted version
• Notice of Proposed Rulemaking
• Initial Statement of Reasons, including a listing of the technical studies, reports, or documents relied upon to develop the proposed regulations.
• Economic and Fiscal Impact Statement
• Economic and Fiscal Impact Statement Appendix
• A Request for Approval to Initiate Formal Rulemaking, which was presented at the CalRecycle Monthly Meeting on October 15, 2019. 

Informal Rulemaking Documents

• Pharmaceutical and Sharps Waste Stewardship Program, Informal Draft Regulatory Text, dated May 6, 2019
• CalRecycle’s SB 212 June 17, 2019 informal rulemaking workshop presentation document
• CalRecycle’s SB 212 May 17, 2019 informal rulemaking workshop presentation document 
• CalRecycle’s SB 212 February 27, 2019 informal rulemaking workshop discussion document.
• CalRecycle’s SB 212 January 30, 2019 informal rulemaking workshop discussion document. 

Stakeholder Input

• Comments received in response to CalRecycle’s SB 212 45-day formal public comment period.
• Comments received in response to CalRecycle’s SB 212 January 30, 2019 and February 27, 2019 informal rulemaking workshops. 
• Comments received in response to CalRecycle’s SB 212 May 17, 2019 and June 17, 2019 informal rulemaking workshops.  

Additional Documents

This section lists additional documents relied upon by CalRecycle in developing the regulations.

• Senate Bill (SB) 212 (Jackson, Chapter 1004, Statutes of 2018).
  
• Title 21 Code of Federal Regulations, Part 1317.
  
• 16 California Code of Regulations Sections 1776-1776.6.

Rulemaking History

• August 21, 2020 – September 4, 2020. CalRecycle held a public comment period for the Third Draft Proposed Regulations for 15-day Comment Period, August 2020. 
• July 15, 2020 – August 3, 2020: CalRecycle held a public comment period for the Second Draft Proposed Regulations for 15-day Comment Period, July 2020. 
• February 19, 2020: CalRecycle held a public hearing to accept stakeholder comments and conclude the 45-day formal public comment period. 
• January 3, 2020-February 19, 2020: CalRecycle held a 45-day formal public comment period for the proposed regulations. 
• January 3, 2020: The Office of Administrative Law published to the California Regulatory Notice Register a notice of the regulations to implement SB 212.
• June 17, 2019: CalRecycle held an informal rulemaking workshop to solicit stakeholder feedback on informal draft regulatory text.
• May 17, 2019: CalRecycle held an informal rulemaking workshop to solicit stakeholder feedback on informal draft regulatory text 
• February 27, 2019: CalRecycle held an informal rulemaking workshop to present draft regulatory concepts and solicit stakeholder feedback on Articles 4-7.
  
• January 30, 2019: CalRecycle held an informal rulemaking workshop to present draft regulatory concepts and solicit stakeholder feedback on Articles 1-3.