Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Rule

Introduction

On August 21, 2019, the United States Environmental Protection Agency’s (U.S. EPA) Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Rule went into effect.

The Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Rule includes:

• The addition of the new subpart P under 40 Code of Federal Regulations part 266, which sets forth new regulations for healthcare facilities and reverse distributors managing pharmaceuticals that are hazardous waste
• A ban on healthcare facilities and reverse distributors flushing pharmaceuticals that are hazardous waste down the drain (“sewer ban”)
• Removal of nicotine patches, gums, and lozenges that are FDA-approved over the counter (OTC) nicotine replacement therapies (NRTs) from the P075 acute hazardous waste listing

The following guidance and resources can be accessed for more information about the rule:

• Final Rule: Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine web page
• The Federal Register contains detailed information regarding U.S. EPA’s rationale for adopting the various provisions of the rule
• U.S. EPA presented a webinar on the rule in April 2019

U.S. EPA has identified the entire new subpart P under 40 Code of Federal Regulations part 266, which includes the “sewer ban,” to be more stringent than current federal standards. As an authorized state, California is required to adopt revisions that are more stringent than current state standards in order to administer California’s hazardous waste program in lieu of the federal program pursuant to the Resource Conservation and Recovery Act (RCRA). If elements of the California’s state program are more stringent than the new subpart, California may retain those more stringent elements. California is evaluating the rule to determine which federal provisions are more stringent than current state provisions.

Most provisions of the rule do not take effect in California until DTSC adopts the rule, or parts thereof, via the rulemaking process. Note that the ban on healthcare facilities and reverse distributors flushing hazardous waste pharmaceuticals (“sewer ban”) was finalized under federal Hazardous and Solid Waste Amendments (HSWA) authority and took effect in all states on August 21, 2019. While the state must still adopt HSWA-related provisions to retain authorization, U.S. EPA implements the HSWA provisions until the state is granted authorization to do so.

Mandatory Provisions

DTSC is required to evaluate provisions of the rule that U.S. EPA has identified as more stringent than U.S. EPA’s previous regulations. DTSC is required to adopt provisions of the rule that are more stringent than California’s current hazardous waste laws and implementing regulations in order to maintain authorization. 

Optional Provisions

DTSC may also adopt other provisions of the rule identified as either less stringent or neither more nor less stringent than U.S. EPA’s previous regulations. To adopt, amend, or repeal current regulations, the Legislature must grant DTSC rulemaking authority, and the changes would require a regular rulemaking.

Next Steps

DTSC is currently evaluating subpart P under 40 CFR part 266 to determine which regulations are more stringent and mandatory for California adoption. DTSC will have a proposed decision on what provisions or amendments California is statutorily required to adopt by February 2021.

Additionally, DTSC is pursuing the removal of FDA-approved OTC NRTs from the P075 hazardous waste listing in California. DTSC submitted a regulatory package for this regulatory change as a nonsubstantive rulemaking to the Office of Administrative Law (OAL) on November 17, 2020 as required per the Administrative Procedure Act (APA). OAL has 30 working days and an additional 120 calendar days to conduct a review of the rulemaking record and make a decision, which will conclude on May 4, 2021. If OAL approves the rulemaking action, the regulations become effective upon approval. This regulatory change will not be effective unless OAL approves the regulatory package. 

Still Have Questions?

If you have additional questions about the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine Rule or DTSC’s regulation adoption activities, please email retail@dtsc.ca.gov. This webpage serves to provide information and updates on the status of this rule in California. To receive e-mail updates on this rule, subscribe to the DTSC EList. When signing up, check the option DTSC: Retail Waste Workgroup.