.,gr 0 Siq,1, J S UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

## o ; WASHINGTON, D.C. 20460

U= PNO OFFICE OF SOLID WASTE AND EMERGENCY

RESPONSE

Dear Honorable Leader:

This letter is to notify you that the U.S. Environmental Protection Agency (EPA) is initiating consultation and coordination with the federally recognized tribes on the following three proposed rulemakings: (1) the Hazardous Waste Generator Improvements Rule; (2) the Hazardous Waste Pharmaceuticals Rule; and (3) the Non-hazardous Secondary Materials Rule.

The first two of these proposals would affect entities that generate hazardous waste under the Resource Conservation and Recovery Act (RCRA) and, in the case of the Hazardous Waste Pharmaceuticals Rule, healthcare facilities (including retail pharmacies) and reverse distributors that manage hazardous waste pharmaceuticals being sent for disposal (a reverse distributor manages many of the logistics for healthcare facilities that return unsold pharmaceuticals). The third proposed rule for consultation and coordination would potentially affect how certain types of treated wood that are taken out of service and burned are defined under RCRA, which affects how the units burning this wood are regulated under the Clean Air Act.

Please note that these proposals do not impact household hazardous waste, including programs designed to collect and manage household hazardous waste on tribal lands.

More specifically, the EPA is soliciting your input on the following changes to the RCRA regulations:



### Hazardous Waste Generator Improvements Proposed Rule

- This rule proposes a number of changes to the RCRA regulations that apply to generators of hazardous waste in order to improve understanding of and compliance with these regulations. The rule also proposes to update the regulations to be more consistent with existing EPA guidance in a number of areas. For example, the proposed regulation would update the RCRA biennial reporting and hazardous waste determination provisions to reflect current EPA guidance and instructions. The rule also proposes to reorganize the regulations to make it easier for the regulated community to locateand understand which regulations they need to follow, and to reduce potentially confusing crossreferencing. In addition, the proposed rule provides some additional flexibility for certain types of smaller generators who occasionally generate a larger amount of hazardous waste, or when a single entity is responsible for hazardous waste management at a number of very small sites. Another aspect of the proposal is an update to the RCRA emergency preparedness and response regulations to fit in with current emergency response infrastructure.



### 2. Hazardous Waste Pharmaceuticals Proposed Rule

- This rule proposes tailored, sector-specific RCRA regulations for managing pharmaceuticals that are hazardous waste when disposed. The proposal addresses the unique challenges faced by generators of hazardous waste pharmaceuticals in complying with the current RCRA regulations. These challenges include the large number of employees at pharmacies and healthcare facilities that must manage these materials, the difficulty of making hazardous waste determinations for thousands of drugs that

### are managed by healthcare facilities, and the intersection with Drug F,nforcement Administration

regulations.



### 3. The Non-hazardous Secondary Materials Proposed Rule - This proposed rule addresses whether certain types of treated wood are defined as a"solid waste" under RCRA, specifically with regard to how certain combustion units burning this wood are regulated under the Clean Air Act. Treated wood used for railroad, highway, and building structures that is taken out of service, for example, can be burned for energy recovery. This rulemaking would define whether various types of treated wood would need to be burned in combustion units regulated under Clean Air Act Section 129 (i.e., units that burn materials defined as "solid waste" under RCRA), or in combustion units regulated under Clean Air Act Section 112 (i.e., units that burn materials that are not "solid waste" under RCRA).
The consultation and coordination process for these three proposed rules is scheduled for February 20 to March 23, 2015. EPA invites you and your designated consultation representative(s) to participate in this process by submitting written comments to EPA ( GeneratorConsultationiia

~ epa. o g

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### by March 23, 2015, and/or verbally on a government-to-government consultation conference call.

Date Event Information March 3, 2015 3:00 pm EST Government-to-Government

Consultation Conference Call Call-in number: (866) 299-3188 Passcode: 7033478975

Written comments can also be submitted by fax to (703) 308-0514 or by mail to Kathy Lett, Office of Resource Conservation and Recovery, 1200 Pennsylvania Avenue, NW, Mail Code 5304P, Washington, DC 20460.

Thank you for your engagement on this issue. The EPA appreciates the input from our tribal partners. If you have any questions, please contact Kathy Lett, at lett.kathti ,epa.v,ov 

### or by phone at (703) 605- 0761.

Sincerely,



### Barnes Johnson Director

Attachment

2EPA Tribal Consultation and Coordination Plan for Proposed RCRA Regulations for Hazardous

Waste Generator Improvements, Hazardous Waste Pharmaceuticals, and Non-hazardous Secondary Materials

This 

### consultation and coordination plan lays out the Office of Solid Waste and Emergency Response's process for seeking valuable input from federally recognized tribes on the three proposed rulemakings, all of which address the hazardous waste generator or waste identification regulations in the Resource Conservation and Recovery Act (RCRA). This consultation and coordination is being undertaken in compliance with the EPA Policy on Consultation and Coordination with Indian Tribes, May 4, 2011. The consultation and coordination will include informing federally recognized tribes of the upcoming actions, hosting a conference call to discuss the rulemakings, and providing a 

### month-long comment period in which to receive comments.

The rules we are initiating consultation and coordination on are the following: (1) the Hazardous WasteGenerator Improvements Rule; (2) the Hazardous Waste Pharmaceuticals Rule; and (3) the Nonhazardous Secondary Materials Rule. The first two of these proposals would affect entities that.generate hazardous waste under RCRA and, in the case of the Hazardous Waste Pharmaceuticals rule, healthcare facilities 

### (including retail pharmacies) and reverse distributors that manage hazardous waste pharmaceuticals being sent for disposal (a reverse distributor manages many of the logistics for healthcare facilities that return unsold pharmaceuticals). The third proposed rule for consultation would potentially affect how certain types of treated wood that are taken out of service and burned are defined under RCRA, which affects how the units burning this wood are regulated under the Clean Air Act. Some further information on each rule is provided below:



### 1. Hazardous Waste Generator Improvements Proposed Rule - This rule proposes a number of changes to the RCRA regulations that apply to generators of hazardous waste in order to improve understanding of and compliance with these regulations. The rule also proposes to update the regulations to be more consistent with existing EPA guidance in a number of areas. For example, the proposed regulation would update the RCRA biennial reporting and hazardous waste determination provisions to reflect current EPA guidance and instructions. The rule also proposes to reorganize the regulations to make it easier for the regulated community to locateand understand which regulations they need to follow, and to reduce potentially confusing crossreferencing. In addition, the proposed rule provides some additional flexibility for certain types of smaller generators who occasionally generate a larger amount of hazardous waste, or when a single entity is responsible for hazardous waste management at a number of very small sites. Another aspect of the proposal is an update to the RCRA emergency preparedness and response regulations to fit in with current emergency response infrastructure.



### 2. Hazardous Waste Pharmaceuticals Proposed Rule - This rule proposes tailored, sector-specific RCRA regulations for managing pharmaceuticals that are hazardous waste when disposed. The proposal addresses the unique challenges faced by generators of hazardous waste pharmaceuticals in complying with the current RCRA regulations. These challenges include the large number of employees at pharmacies and healthcare facilities that must manage these materials, the difficulty of making hazardous waste determinations for thousands of drugs that are managed by healthcare facilities, and the intersection with Drug Enforcement Administration regulations.

3

### 3. The Non-hazardous Secondary Materials Proposed Rule - This proposed rule addresses

whether certain types of treated wood are defined as a"solid waste" under RCRA, specifically with regard to how certain combustion units burning this wood are regulated under the Clean Air Act. Treated wood used for railroad, highway, and building structures that is taken out of service, for example, can be burned for energy recovery. This rulemaking would define whether various types of treated wood would need to be burned in combustion units regulated under Clean Air Act Section 129 (i.e., units that burn materials defined as"solid waste" under RCRA), or in combustion units regulated under Clean Air Act Section 112 (i.e., units that burn materials that are not "solid waste" under RCRA).

Tribal Consultation and Coordination Timeline Date Event Information February 20, Review and Comment Kathy Lett 2015 - March 23, Period Phone: (703) 605-0761 2015 Fax: (703) 308-0514 Email: GeneratorConsultation@epa.gov

March 3, 2015 Government-to- Call-in number: (866) 299-3188 3:00 pm EST Government Consultation Passcode: 7033478975

Conference call March 23, 2015 Deadline for Submittal of Kathy Lett

Comments Phone: (703) 605-0761 Fax: (703) 308-0514 

### Email: GeneratorConsultation('

~ 

### epa.gov Mail: Office of Resource Conservation and Recovery 1200 Pennsylvania Avenue, NW Mail Code 5304P Washington, DC 20460

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