.,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 locate 

and 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. og~v)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 

2 
EPA 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 Waste 

Generator 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 locate 

and 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 

El