### SUPPORTING STATEMENT FOR

**INFORMATION COLLECTION REQUEST NUMBER 2317.0 2**  **“GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES”** 

**(RENEWAL)**
**June 20**  **12**

Office of Resource Conservation and Recovery United States Environmental Protection Agency

Washington, D.C. 20460i 

### TABLE OF CONTENTS 1. IDENTIFICATION OF THE INFORMATION COLLECTION
................................ ................................ ........... 1 1(a) Title and Number of the Information Collection

................................ ................................ ........................... 1 1(b) Short Characterization

................................ ................................ ................................ ................................ ... 1 2. NEED FOR AND USE OF THE COLLECTION
................................ ................................ ................................ .. 8 2(a) Need and Authority for the Collection

................................ ................................ ................................ ........... 8 2(b) Practical Utility and Users of the Data

................................ ................................ ................................ ........ 11 3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA
................................ .. 14 3(a) Nonduplication

................................ ................................ ................................ ................................ ............ 14 3(b) Public Notice

................................ ................................ ................................ ................................ ............... 14 3(c) Consultations

................................ ................................ ................................ ................................ ............... 14 3(d) Effects o f Less Frequent Collection

................................ ................................ ................................ ............. 14 3(e) General Guidelines

................................ ................................ ................................ ................................ ...... 15 3(f) Confidentiality

................................ ................................ ................................ ................................ ............. 15 3(g) Sensitive Questions

................................ ................................ ................................ ................................ ...... 15 4. THE RESPONDENTS AND THE INFORMATION REQUESTED
................................ ................................ .. 16 4(a) Respondents and NAICS Codes

................................ ................................ ................................ .................. 16 4(b) Information Requested

................................ ................................ ................................ ................................ . 16 5. THE INFORMATION COLLECTED: AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT
................................ ................................ ................................ .................... 28 5(a) Agency Activities

................................ ................................ ................................ ................................ ........ 28 5(b) Collection Methodology and Management

................................ ................................ ................................ .. 29 5(c) Small Entity Flexibility

................................ ................................ ................................ ................................ 29 5(d) Collection Schedule

................................ ................................ ................................ ................................ ..... 29 6. ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION
................................ .................. 34 6(a) Estimating Respondent Burden Hours

................................ ................................ ................................ ......... 34 6(b) Estimating Respondent Costs

................................ ................................ ................................ ...................... 34 6(c) Estimating Agency Hour and Cost Burden

................................ ................................ ................................ .. 35 6(d) Estimating the Annual Respondent Universe and Total Hour and Cost Burden

................................ ......... 35 6(e) Bottom Line Hour and Cost Burden

................................ ................................ ................................ ............ 45 6(f) Reasons for Change In Burden

................................ ................................ ................................ .................... 46 6(g) Public Burden Statement

................................ ................................ ................................ ............................. 46 AT TA CHMENT 1
- BURDEN ESTIMATE METHODOLOGY ............................................. 52 AT TA CHMENT 2
- SUMMARY OF UNIVERSE CALCULATIONS ....................................... 561

**1. IDENTIFICATION OF THE INFORMATION COLLECTION**  **1(a) Title and Number of the Information Collection**  This Information Collection Request (ICR) is entitled “Generator Standards Applicable to Laboratories Owned b y Eligible Academic Entities ( Renewal ) ,” EPA I CR Number 2317.0 2 , OMB Number 2050
- 0204
. **1(b) Short**  **Characterization** The U.S. Environmental Protection Agency (EPA) has promulgated an alternative set of generator requirements applicable to laboratories owned b y eligible academic entities, as defined in the final rule published at 73 FR 72912, December 1, 2008 . The rule, which establishes a new Subpart K within 40 CFR Part 262, provides a flexible and protective set of regulations that address the specific nature of hazardous waste generation and accumulation in laboratories owned by colleges and universities, and teaching hospitals and non

-profit research institutes that are either owned by or formall y affiliated with a college or university . In addition, the final rule allows colleges and universities and these other eligible academic entities formally affiliated with a college or university the discretion to determine the most appropriate and effective method of compliance with these requirements by allowing them the choice of managing their hazardous wastes in acco rdance with the new alternative regulations as set forth in Subpart K or remaining subject to the existing generator regulations. In Sections 1 through 5 of this document, EPA presents a comprehensive description of the information collection requirements in Subpart K . In Section 6, EPA estimates the total annual hour and cost burden to respondents associated with these new paperwork requirements. In addition, EPA estimates the total annual burden impacts to respondents for being relieved of some existing requirements. In the following paragraphs, EPA describes the information collec tion requirements in Subpart K

. **(1) Notification of Intent to Comply with Subpart K and Recordkeeping of**  **Agreements** 40 CFR 262.203(a) provides that an eligible academic entity must notify

the appropriate EPA Regional Administrator in writing, using the RCRA Subtitle C Site Id entification Form (EPA Form 8700

- 12), that it is electing to be subject to the requirements of Subpart K for all the laboratories owned b y the eligible academic entity under the same EPA Identification Number. An eligible academic entity that is a conditionally

exempt small quantity

generator and does not have an EPA Identification Number must notify

that it is electing to be subject to the requirements of Subpart K for all the laboratories owned by the eligible academic entity that are on

- site. An eligible academic entity

must submit a separate notification (Site Identification Form) for each2

EPA Identif

ication Number (or site, for conditionally exempt small quantity

generators) that is electing to be subject to the requirements of Subpart K. When submitting the Site Identification Form, the eligible academic entity must, at a minimum, fill out the field s on the form that are specified at section 262.203(b)(1)

- (11). Section 262.203(c) provides that an eligible academic entity must keep a copy

of the notification on file at the eligible academic entity for as long as its laboratories are subject to Subpart K. Section 262.203(d) provides that a teaching hospital that is not owned by a college or university

must keep a copy

of its formal written affiliation agreement with a college or university

on file at the teaching hospital for as long as its laboratori es are subject to Subpart K. Section 262.203(e) provides that a non

- profit research institute that is not owned by a college or university must keep a cop y of its formal written affiliation agreement with a college or university on file at the non

-profit research institute for as long as its laboratories are subject to Subpart K. **(2) Notification of Withdrawal from Subpart K**  40 CFR 262.204(a) provides that an eligible academic entity must notify

the appropriate EPA Regional Administrator in writing, using the RCRA Subtitle C Site Id entification Form (EPA Form 8700

- 12), that it is electing to no longer be subject to the requirements of Subpart K for all the laboratories owned by the eligible academic entity under the same EPA Identification Number. An eligible academic entity that is a conditionally

exempt small quantity

generator and does not have an EPA Identification Number must n otify

that it is withdrawing from the requirements of Subpart K for all the laboratories owned b y the eligible academic entity that are on

- site. An eligible academic entity must submit a separate notification (Site Identification Form) for each EPA Id enti fication Number (or site, for conditionall y exempt small quantity generators) that is withdrawing from the requirements of Subpart K. When submitting the Site Identification Form, the eligible academic entity must, at a minimum, fill out the fields on the form that are specified at section 262.204(b)(1)

- (11). Section 262.204(c) provides that an eligible academic entity must keep a copy

of the withdrawal notice on file at the eligible academic entity for three ye ars from the date of the notification. **(3) Labeling of Containers of Unwanted Material in the Laboratory**  40 CFR 262.206 provides that an eligible academic entity must label and manage3

containers of unwanted material while in the laboratory in accordance with the requirements in section 262.206. Section 262.206(a)(1) requires that the following information must be affixed or attached to the container: the words ”unwanted material” or another equally effective term that is to be used consistently by the eligible academic entity and that is identi fied in Part Iof the Laboratory

Management Plan (262.206(a)(1)(i)), and sufficient information to alert emergency

responders to the contents of the container (262.206(a)(1)(ii)). Section 262.206(a)(2) provides that the following information may be affixe d or attached to the container, but must at a minimum associated with the container: the date that the unwanted material first began accumulating in the container (262.206(a)(2)(i)) and information sufficient to allow a trained professional to properly identify whether an unwanted material is a solid and hazardous waste and to assign the proper hazardous waste code(s), pursuant to section 262.11 (262.206(a)(2)(ii)). **(4) Training**  40 CFR 262.207 provides that an eligible academic entity must provide training to all individuals working in a laboratory at that eligible academic entity , as specified. Section 262.207(a) requires that training for laboratory workers and students must be commensurate with their duties so they understand the requirements in Subpart K and can implement them. Section 262.207(b) provides that an eligible academic entity can provide training for laboratory

workers and students in a variety of way s (e.g., instruction b y the professor or laboratory

manager before or during an experiment, formal classroom training, electronic/written training). Section 262.207(c) provides that an eligible academic entity that is a large quantity generator must maintain documentation demonstrating training for all laboratory workers. Section 262.207(c) requires that the information must be sufficient to determine whether laboratory

workers have been trained and must be retained for the durations specified in section 265.16(e). Sections 262.207(c)(1)

- (4) provides examples of documentation demonstrating training. **(5) Removing Containers of Unwanted Material from**  **the Laboratory** 40 CFR 262.208(a) establishes standards for removing containers of unwanted material on a regular schedule. An eligible academic entity must either: remove all containers of unwanted material from each laboratory on a regular interval, not to exceed 6 months ( 262.208(a)(1)); or remove containers of unwanted material from each laboratory

within 6 months of each container’s accumulation start date (262.208(a)(2)). Section 262.208(b) requires that the eligible academic entity must specify

in Part I of its L aboratory

Management Plan whether it will comply with section 262.208(a)(1) or4

(a)(2) for the regular removal of unwanted material from its laboratories. Section 262.208(c) requires that the eligible academic entity must specify

in Part II of its Laboratory Management Plan how it will comply with section 262.208(a)(1) or (a)(2) and develop a schedule for regular removals of unwanted material from its laboratories. Section 262.208(d) establishes standards for removing containers of unwanted material when maximum volumes are exceeded. Section 262.208(d)(1) provides that, if a laboratory

accumulates more than 55 gallons of unwanted material (including reactive acutel y hazardous unwanted material) before the regularl y scheduled removal, the eligible academic entity

must ensure that all containers of unwanted material (including reactive acutel y hazardous unwanted material): must have the date that 55 gallons is exceeded on the label that is associated with the container (262.208(d)(1)(i)); and are removed fro m the laboratory within 10 calendar day s of the date that 55 gallons was exceeded, or at the next regularl y scheduled removal, whichever comes first (262.208(d)(1)(ii)). Section 262.208(d)(2) provides that, if a laboratory accumulates more than 1 quart o f reactive acutely

hazardous unwanted material before the regularl y scheduled removal, then the eligible academic entity must ensure that all containers of reactive acutel y hazardous unwanted material: must have the date that 1 quart is exceeded on the lab el that is associated with the container (262.208(d)(2)(i)); and are removed from the laboratory

within 10 calendar days of the date that 1 quart was exceeded, or at the next regularl y scheduled removal, whichever comes first (262.208(d)(2)(ii)). **(6) Wher**  **e and When to Make the Hazardous Waste Determination and Where to Send Containers of Unwanted Material**  40 CFR 262.209(a) establishes standards for when and where large quantity generators and small quantity generators may

make the hazardous waste determin ation. An eligible academic entity must ensure that a trained professional makes a hazardous waste determination, pursuant to section 262.11, for unwanted material in any of the following areas:



###  In the laboratory

before the unwanted material is removed f rom the laboratory , in accordance with section 262.210.



###  Within 4 calendar days of arriving at an on

- site central accumulation area, in accordance with section 262.211.



###  Within 4 calendar days of arriving at an on

- site treatment, storage or disposal faci lity , in accordance with section 262.212. Section 262.209(b) establishes standards for when and where conditionally exempt small quantity

generators may

make hazardous waste determinations. An eligible5

academic entity

must ensure that a trained professional makes a hazardous waste determination, pursuant to section 262.11, for unwanted material in the laboratory before the unwanted material is removed from the laboratory , in accordance with 262.210. **(7 )**  **Making the Hazardous Waste Determination in the Laboratory** 40 CFR 262.210 provides that, if an eligible academic entity makes the hazardous waste determination, pursuant to section 262.11, for unwanted material in the laboratory before the unwanted material is removed from the laboratory , it must comply with the specified requirements. Section 262.210(a) requires that a trained professional must make the hazardous waste determination, pursuant to section 262.11, before the unwanted material is removed from the laboratory

. Section 262.210(b) provides that, if an unwanted material is a hazardous waste, the eligible academic entity must write: the words “hazardous waste” on the container label that is affixed or attached to the container, before the haz ardous waste may be removed from the laboratory (262.210(b)(1)) and the appropriate hazardous waste codes(s) on the label that is associated with the container (or on the label that is affixed or attached to the container, if that is preferred) before the hazardous waste may be transported off

- site (262.210(b)(2)). [Note: OMB guidance indicates that, if a person is requested or directed to post a label disclosing information completely defined by

a Federal agency , the information collection is exempted f rom OMB review and approval. For this reason, in this I CR, the addition of the words “hazardous waste” to the container label is not considered an information collection and thus is not examined in the remainder of this document.] **(8) Making the Hazard**  **ous Waste Determination in an On -**  **site Central Accumulation Area**  40 CFR 262.211 provides that, if an eligible academic entity makes the hazardous waste determination, pursuant to section 262.11, for unwanted material at an on

- site central accumulation are a, it must comply with requirements in 262.211: Section 262.211(d) requires that a trained professional must determine, pursuant to §262.11, if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials’ arrival at the on

- site central accumulation area. Section 262.211(e) provides that, if the unwanted material is a hazardous waste, the eligible academic entity must write the words ”hazardous waste” on the container label that is affixed or attached to the container, within 4 calendar days of arriving at the on - site central accumulation area and before the hazardous waste may be removed from the on

- site central accumulation area (262.211(e)(1)) and write the appropriate hazardous waste code(s) on the container label that is associated with the container (or on the label that is affixed or attached to the container, if that is preferred) before the hazardous waste6

may be treated or disposed on

- site or transported off

- site (262.211(e)(2)). [Note: OMB guidance indicates th at, if a person is requested or directed to post a label disclosing information completely

defined by

a Federal agency , the information collection is exempted from OMB review and approval. For this reason, in this I CR, the addition of the words “hazardous waste” to the container label is not considered an information collection and thus is not examined in the remainder of this document.] **(9) Making the Hazardous Waste Determination at an On**  **- site Interim Status or**  **Permitted Treatment, Storage, or Disposa l Facility**  40 CFR 262.212 provides that, if an eligible academic entity makes the hazardous waste determination, pursuant to section 262.11, for unwanted material at an on

- site interim status or permitted treatment, storage or disposal facility , it must c omply with the requirements in section 262.212. Section 262.212(d) requires that a trained professional must determine, pursuant to section 262.11, if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials’ arrival at an on - site interim status/permitted treatment, storage or disposal facility

. Section 262.212(e) provides that, if the unwanted material is a hazardous waste, the eligible academic entity must write the words ”hazardous waste” on the container label that is affixed or attached to the container within 4 calendar days of arriving at the on - site interim status or permitted treatment, storage or disposal facility and before the hazardous waste may

be removed from the on

- site interim status or permitted treatment, storage or disposal facility (262.212(e)(1)) and write the appropriate haza rdous waste code(s) on the container label that is associated with the container (or on the label that is affixed or attached to the container, if that is preferred) before the hazardous waste may be treated or disposed on

- site or transported off

- site (262 .212(e)(2)). [Note: OMB guidance indicates that, if a person is requested or directed to post a label disclosing information completely

defined by

a Federal agency , the information collection is exempted from OMB review and approval. For this reason, in this I CR, the addition of the words “hazardous waste” to the container label is not considered an information collection and thus is not examined in the remainder of this document.] **(10) Laboratory Clean**  **- outs**  40 CFR 262.213(a) provides that one time per 12 month period per laboratory , an eligible academic entity

may opt to conduct a laboratory clean

- out that is subject to all the applicable requirements of Subpart K, except as specified otherwise in section 262.213(a). Section 262.213(a)(4) requires that an eligible academic entity must document the activities of the laboratory clean

- out, as specified. The eligible academic entity must maintain the records for a period of three ye ars from the date the clean

- out ends.7

**(11) Laboratory Management Pl**  **an** 40 CFR 262.214 provides that an eligible academic entity must develop and retain a written Laboratory

Management Plan, or revise an existing written plan. The Laboratory

Management Plan is a site

- specific document that describes how the eligible acad emic entity

will comply

with Subpart K. An eligible academic entity may write one Laboratory

Management Plan for all the laboratories owned b y the eligible academic entity that have opted into Subpart K, even if the laboratories are located at sites with different EPA Identification Numbers. The Laboratory

Management Plan must contain two parts with a total of nine elements identified in section 262.214(a) and (b). In Part I of its Laboratory Management Plan, an eligible academic entity must describe its procedures for each of the elements listed in section 262.214(a). An eligible academic entity must implement and comply with the specific provisions that it develops to address the elements in Part I of the Laboratory

Management Plan. In Part II of its Laboratory Management Plan, an eligible academic entity must describe its best management practices for each of the elements listed in section 262.214(b). The specific actions taken b y an eligible academic entity to implement each element in Part II of it s Laboratory Management Plan may

vary from the procedures described in the eligible academic entity ’s Laboratory Management Plan, without constituting a violation of Subpart K. An eligible academic entity may include additional elements and best management practices in Part II of its L aboratory Management Plan if it chooses. Section 262.214(c) provides that an eligible academic entity must make its Laboratory

Management Plan available to laboratory workers, students, or any others at the eligible academi c entity who request it. Section 262.214(d) requires that an eligible academic entity must review and revise its Laboratory

Management Plan, as needed.8

**2. NEED FOR AND USE OF THE COLLECTION**  **2(a) Need and Authority for the Collection**  The Subpart K regulations within 40 CFR Part 262 are promulgated under the authority of Sections 2002, 3001, 3002, and 3004 of the Solid Waste Disposal Act (SWDA) of 1970, as amended by the Resource Conservation and Recovery Act (RCRA) of 1976, as amended b y the Hazardous and Solid Waste Amendments of 1984 (HSWA). EPA believes there is a clear need for the Subpart K regulations . The Agency has identified four primary

differences between laboratory operations at colleges, universities, and other eligible academic entities and ty pical industrial production facilities. These differences provide the rationale for the rule at 73 FR 72912 . First, laboratories owned b y colleges, universities and, teaching hospitals and non

- profit research institutes that are either owned b y or f ormally affiliated with a college or university have a large number of points of generation (i.e., points where waste is originall y generated) such as multiple laboratory benchtops within a single laboratory and laboratories located at several areas on a s ingle campus. Second, these laboratories tend to generate relativel y small volumes of each hazardous waste at each of these points of generation. Third, the hazardous wastes generated in these laboratories tend to vary over time, as areas of research change. In contrast, industrial generators tend to generate a relativel y smaller number of predictable wastestreams in large quantities at relativel y few generation points. Fourth, and of particular note, is that most individuals involved in hazardous waste generation activities at eligible academic entity laboratories are students. Students are inherentl y transient, which makes it more difficult to train them. This fourth difference sets eligible academic entity laboratories apart not only from typical production facilities, but also from non

- academic, commercial laboratories. At industrial production facilities and non

- academic, commercial laboratories, employees who generate hazardous waste are professionall y trained in managing hazardous wastes and are held accountable due to their employee status. **(1) Notification of Intent to Comply with Subpart K and Recordkeeping of**  **Agreements** Because the rule provides eligible academic entities the option to manage their hazardous wastes from laboratories under the existing hazardous waste generator regulations or their laboratories’ unwanted materials under Subpart K, it is important that EPA, or the authorized State, know which set of regulations apply to an eligible academic entity ’s laboratories. Therefore, the rule requires that an eligible academic entity choosing to manage its unwanted materials in compliance with the alternative set of generator requirements of Subpart K to submit a Site Identification Form on a one

- time basis to the appropriate EPA Regi onal Administrator or, when appropriate, State Director in authorized States that have adopted the final rule. Should an eligible academic entity decide not to opt into Subpart K, it will continue to operate under existing regulations and it does not nee d to notify

.9 EPA believes the Site Identification Form will simplify this notification process in comparison with other types of notification methods. Regulated entities and authorized States are already familiar with the form because it must be submitt ed under other RCRA provisions (e.g., RCRA 3010 Notifications, Hazardous Waste Report). Further, some eligible academic entities may have retained a copy

that they had completed and submitted under another provision. A pre

- populated form will greatl y eas e the process of completing the form to opt into Subpart K. **(2) Notification of Withdrawal from Subpart K**  It is possible that after an eligible academic entity has chosen to manage its unwanted materials under the Subpart K regulations and has gained so me experience with the program, it may

decide that this approach is not meeting its needs, and that it would prefer to return to regulation under the standard 40 CFR Part 262 applicable generator regulations. Under the final rule, an eligible academic entity that chooses to end its participation in the Subpart K program will be required to submit another Site Id entification Form to the EPA Regional Administrator or State Director in authorized States checking the box for withdrawing from 40 CFR Part 262, S ubpart K. Then, the eligible academic entity ’s laboratories will no longer be subject to Subpart K and would be subject to the existing applicable generator regulations. **(3) Labeling of Containers of Unwanted Material in the Laboratory**  Eligible academic entities must label containers of unwanted materials managed in a laboratory , as specified. These labeling requirements are necessary to demonstrate compliance with the rule and alert anyone handling the containers of unwanted materials of what is enclos ed in the container so that proper handling may occur. The labeling requirements also would assist trained professionals in properly identifying whether an unwanted material is a hazardous waste and to assign the appropriate hazardous waste code(s). **(4) Training**  Eligible academic entities must train all individuals working in a laboratory commensurate with their duties. This training is necessary to ensure that individuals perform their duties in a way that ensures compliance with the Subpart K requirem ents. It also will enable individuals to manage unwanted materials safely and in an environmentally

sound manner, while in the laboratory

. In addition, eligible academic entities that are large quantity generators (LQGs) must maintain training records f or laboratory

workers. These records are necessary to ensure compliance with the Subpart K training requirements. **(5) Removing Containers of Unwanted Material from the Laboratory**  Eligible academic entities must label containers with the date the 55 gallons of10

unwanted material, or the 1 quart of acutel y reactive unwanted material, is exceeded. This information is needed for enforcement and monitoring purposes. **(6) Where and When**  **to Make the Hazardous Waste Determination and Where to Send Containers of Unwanted Material**  The rule specifies three on

- site locations at which a hazardous waste determination can be made:



###  In the laboratory

before the unwanted material is removed from the laboratory , in accordance with section 262.210.



###  Within 4 calendar days of arriving at an on

- site central accumulation area, in accordance with section 262.211.



###  Within 4 calendar days of arriving at an on

- site interim status or permitted treatment, s torage or disposal facility , in accordance with section 262.212. This provision is needed to clarify where and when the hazardous waste determination must be made. Without time limits, EPA would not be able to ensure that eligible academic entities were making their determinations in a timely manner and managing their hazardous waste in accordance with the hazardous waste regulations. **(7) Making the Hazardous Waste Determination in the Laboratory**  As provided at section 262.210, if an unwanted material meets the definition of hazardous waste per 40 CFR 261.3, the appropriate hazardous waste code(s) must be placed on the container label that is associated with the container. This information is needed to alert anyone handling the container that hazardous waste is enclosed in the container so that proper handling may occur. **(8) Making the Hazardous Waste Determination in an On**  **- site Central**  **Accumulation Area** As provided at section 262.211, if an unwanted material meets the definition of hazardous waste per 40 CFR 261.3, the appropriate hazardous waste code(s) must be placed on the container label that is associated with the container. This information is needed to alert anyone handling the container that hazardous waste is enclosed in the container so that proper handling may occur. **(9) Making the Hazardous Waste Determination at an On**  **- site Interim Status or**  **Permitted Treatment, Storage, or Disposal Facility** As provided at section 262.212, if an unwanted material meets the definition of hazardous waste per 40 CFR 261.3, the appropriate hazardous waste code(s) must be placed on the container label that is associated with the container. This information is11

nee ded to alert anyone handling the container that hazardous waste is enclosed in the container so that proper handling may occur. **(10) Laboratory Clean**  **- outs**  Eligible academic entities must develop and maintain documentation on laboratory

clean

- outs. This information is needed to ensure compliance with the laboratory

clean

- out requirements. For example, the documentation must show the dates when the clean

- out began and ended. This information will hold the eligible academic entity accountable for adhering to the 30

- day clean

- out time limit, as well as other stipulations in the final rule. **(11) Laboratory Management Plan**  Performance

- based standards set the framework for managing unwanted materials generated in laboratories owned by eligible academic entities. The Laboratory Management Plan required under 40 CFR 262.214 is the mechanism for implementing the alternative program. This plan is needed to ensure that eligible academic entities seeking flexibility

in managing the unwanted materials from their l aboratories will do so in a thoughtful manner by documenting their practices. **2(b) Practical Utility and Users of the Data**  **(1) Notification of Intent to Comply with Subpart K and Recordkeeping of**  **Agreements** Because the rule establishes an alternative set of generator requirements that is self

- implementing, EPA has determined that it is necessary to require eligible academic entities to submit a one

- time notification to the appropriate EPA Regional Administrator or State Director indicating that they are electing to be subject to the Subpart K requirements as specified. EPA and States will use this information to identify the entities and sites subject to the Subpart K requirements and ensure that all of these sites are managing their unwanted materials in a manner that is protective of human health and the environment. **(2) Notification of Withdrawal from Subpart K**  Eligible academic entities that elected to compl y with the Subpart K requirements may elect, at any time, to withdraw from the Subpart K p rogram. Because a site’s withdrawal would be self

- implementing (i.e., done at its own discretion), EPA has determined that it is necessary to require entities to submit a one

- time withdrawal notification to the appropriate EPA Regional Administrator indic ating that they will again begin to manage their hazardous waste pursuant to section 262.34(c) (or section 261.5 for conditionally

exempt small quantity

generators). EPA and States will use this information to identify

the sites subject to the Subpart K requirements and ensure that all of these sites are managing their unwanted materials in a manner that is protective of human health and the environment.12

**(3) Labeling of Containers of Unwanted Material in the Laboratory**  The labeling requirements are neces sary to alert anyone handling the containers of unwanted materials of what is enclosed in the containers so that proper handling or inspection may

occur. The labeling requirements also assist RCRA

- trained individuals in properl y identifying whether an unw anted material is a hazardous waste and to assign the appropriate hazardous waste code(s). **(4) Training**  Eligible academic entities must train all individuals working in a laboratory commensurate with their duties. This training will enable individuals to manage unwanted materials safely and in an environmentally sound manner, while in the laboratory

. In addition, L QGs must maintain training records for laboratory workers. Entities will use this information to demonstrate compliance with the Subpart K requirements. EPA will use the information during inspections and for enforcement purposes. **(5) Removing Containers of Unwanted Material from the Laboratory**  Eligible academic entities will use the information on the date the 55 gallons of unwanted material, or the 1 quart of acutel y reactive unwanted material, was exceeded to maintain compliance with Subpart K. EPA will use the information during inspections and for enforcement purposes. **(6) Where and When to Make the Hazardous Waste Determination a**  **nd Where to Send Containers of Unwanted Material**  The rule clarifies where the hazardous waste determinations can be made, as well as the timing of them. Eligible academic entities will follow these procedures to ensure that they are making their determinations in a timely manner and managing their hazardous wastes in accordance with the hazardous waste regulations. **(7) Making the Hazardous Waste Determination in the Laboratory**  Eligible academic entities will use the hazardous waste code information to ensure that the hazardous waste is managed in a manner that is protective of human health and the environment. **(8) Making the Hazardous Waste Determination in an On**  **- site Central**  **Accumulation Area** Eligible academic entities will use the hazardous waste code information to ensure that the hazardous waste is managed in a manner that is protective of human13

health and the environment. **(9) Making the Hazardous Waste Determination at an On**  **- site Interim Status or**  **Permitted Treatment, Storage, or Disposal Faci lity**  Eligible academic entities will use the hazardous waste code information to ensure that the hazardous waste is managed in a manner that is protective of human health and the environment. **(10) Laboratory Clean**  **- outs**  Eligible academic entities must develop and maintain documentation on laboratory

clean

- outs. They

will use this information to demonstrate compliance with the Subpart K requirements. EPA will use the information during inspections and for enforcement purposes

. **(11) Laboratory Management**  **Plan** Eligible academic entities must develop, implement, and retain a Laboratory Management Plan. They will use the Laboratory Management Plan to document their practices for compl ying with the performance

- based requirements of Subpart K.14

**3. NONDUPLIC**  **ATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA**  **3(a) Nonduplication**  None of the information required b y the Subpart K regulations is duplicative with any information required by

the existing Federal regulations. **3(b) Public Notice**  In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the Agency issued a notice in the Federal Register on March 20, 2012 (77 FR 16222) , soliciting public comments on the accuracy of the burden estimates in this supporting statement. No comments were re ceived. **3(c) Consultations**  The regulations covered by this ICR were promulgated using proper rulemaking procedures. In updating this I CR, EPA spoke with a number of industry representatives. Their feedback is reflected in this I CR. EPA’s Burden Estimate Methodology , which is appended as Attachment 1 , provides information on the consultations. The following members of the regulated community were contacted:

– Jeremy Kuhar, Gettysburg College (717

- 337
- 6261)

– Aisha Holloman, Gateway University Research Park (336

- 375
- 9232)

– Eric Engelberger, Southern Arkansas University (870

- 235
- 4196)

– Jen Stones, University

of Utah (801

- 581
- 6590)

– Craig Barnhart, Butler University ( cbarnhar@butler.edu)

– Victoria Justus, WasteS trategies (717

- 418
- 3342; vjustus@wastestrategies.com) , a consultant to Milwaukee School of Engineering, Lakewood College and Philadelphia University **3(d) Effects of Less Frequent Collection**  EPA has carefull y considered the information collection burden imposed by the final rule promulgating the Subpart K regulations . EPA is confident that those activities required of respondents are necessary , and to the extent possible, the Agency has attempted to minimize the burden imposed. A number of the required activities, for example, will be performed once (e.g., one

- time notifications). EPA believes strongl y that, if the minimum information collection requirements of the rule are not met, EPA will not be able to ensure that the unwanted material generated in laboratories is being properl y managed and do not pose a threat to human health and the environment

.15 **3(e) General Guidelines**  This I CR adheres to the guidelines stated in the Paperwork Reduction Act of 1995, OMB’s implementing regulations, EPA’s ICR Handbook, and other applicable OMB guidance. **3(f) Confidentiality**  EPA does not expect to deem any information collected under the rule to be CBI (Confidential Business Information). If such a claim were asserted, EPA must and will treat the information in accordance with the applicable regulations (e.g., 40 CFR Part 2, Subpart B). EPA also will assure that this information collection complies with the Privacy Act of 1974 and OMB Circular 108. **3(g) Sensitive Questions**  No questions of a sensitive nature are included in the information collection requirements associated with the rule.16

**4. THE RESPONDENTS AND THE INFORMATION REQUESTED**  **4(a) Respondents and NAICS Codes**  The following is a list of North American Industry Classification System (NAICS) codes associated with industries most likely affected by

the information coll ection requirements covered in this I CR. **NAICS Codes of Entities Potentially Affected by**  **the Subpart K Regulations Description of NAICS Code**  **NAICS Codes Colleges and Universities**  Ju nior Colleges 6112, 61121, 611210 Colleges, Universities, and Professional Schools 6113, 61131, 611310 Technical and Trade Schools 6115, 61151 Other Technical and Trade Schools 611519 Fine Arts Schools 61161, 611610 **Teaching Hospitals** Veterinary Services (Animal Hospitals) 54194, 541940 Hospitals 622 General Medical and Surgical Hospitals 6221, 62211, 622110 Psychiatric and Substance Abuse Hospitals 6222, 62221, 622210 Specialty (except Psychiatric and Substance Abuse) Hospitals 6223, 62231, 622310 **Non -**  **Profit Research Institutes**  Research and Development in the Physical, Engineering, and Life Sciences 5417, 54171, 541710 Research and Development in the Social Sciences and Humanities 54172, 541720 **4(b) Information Requested**  **(1) Notification of Intent to Comply with**  **Subpart K and Recordkeeping of Agreements**  40 CFR 262.203(a) provides that an eligible academic entity must notify

the appropriate EPA Regional Administrator in writing, using the RCRA Subtitle C Site Id entification Form (EPA Form 8700

- 12), that it is ele cting to be subject to the requirements of Subpart K for all the laboratories owned b y the eligible academic entity under the same EPA Identification Number. An eligible academic entity that is a conditionally

exempt small quantity

generator and does not have an EPA Identification Number must notify

that it is electing to be subject to the requirements of Subpart K for all the laboratories owned by the eligible academic entity that are on

- site. An eligible academic entity

must submit a separate notificati on (Site Identification Form) for each EPA Identification Number (or site, for conditionally exempt small quantity

generators) that is electing to be subject to the requirements of Subpart K.17 When submitting the Site Identification Form, the eligible academic entity must, at a minimum, fill out the fields on the form that are specified at section 262.203(b)(1)

- (11). Section 262.203(c) provides that an eligible academic entity must keep a copy

of the notification on file at the eligible academic entity while its laboratories are subject to Subpart K. Section 262.203(d) provides that a teaching hospital that is not owned by a college or university

must keep a copy

of its formal written affiliation agreement with a college or university

on file at the te aching hospital while its laboratories are subject to Subpart K. Section 262.203(e) provides that a non

- profit research institute that is not owned by a college or university must keep a cop y of its formal written affiliation agreement with a college or university on file at the non

-profit research institute while its laboratories are subject to Subpart K. (i) Data Items:



###  A Site Identification Form with the following fields filled out, at a minimum:

-- Reason for Submittal;

-- Site EPA Identification Number (except for conditionally exempt small quantity

generators);

-- Site Name;

-- Site Location Information;

-- Site L and T yp e;

-- North American Industry Classification System (NAI CS) Code(s) for the Site;

-- Site Mailing Address;

-- Site Contact Person;

-- Operator and Legal Owner of the Site;

-- Ty

pe of Regulated Waste Activity ; and

-- Certification.



###  A cop y of the formal written affiliation agreement with a college or university , as specified under section 262.203(d).



###  A cop y of the formal wri tten affiliation agreement with a college or university , as specified under section 262.203(e).18 (ii) Respondent Activities:



###  Eligible academic entities electing to be subject to the requirements of Subpart K must perform the following:

-- Prepare and submit Site Identification Form; and

-- Keep a cop y of the notification on file.



###  Teaching hospitals that are not owned b y a college or university must keep a cop y of their formal written affiliation agreement with college or university on file while its laboratories are subject to Subpart K.



###  Non
-profit research institutes that are no t owned by a college or university must keep a cop y of the formal written affiliation agreement with a college or university

on file at the non

- profit research institute while its laboratories are subject to Subpart K. **(2) Notification of Withdrawal from**  **Subpart K** 40 CFR 262.204(a) provides that an eligible academic entity must notify

the appropriate EPA Regional Administrator in writing, using the RCRA Subtitle C Site Id entification Form (EPA Form 8700

- 12), that it is electing to no longer be subject to the requirements of Subpart K for all the laboratories owned b y the eligible academic entity under the same EPA Identification Number. An eligible academic entity that is a conditionally

exempt small quantity

generator and does not have an EPA Identification Number must notify

that it is withdrawing from the requirements of Subpart K for all the laboratories owned b y the eligible academic entity that are on

- site. An eligible academic entity must submit a separate notification (Site Identification Form) f or each EPA Id entification Number (or site, for conditionall y exempt small quantity generators) that is withdrawing from the requirements of Subpart K. When submitting the Site Identification Form, the eligible academic entity must, at a minimum, fill out the fields on the form that are specified at section 262.204(b)(1)

- (11). Section 262.204(c) provides that an eligible academic entity must keep a copy

of the withdrawal notice on file at the eligible academic entity for three ye ars from the date of the notification. (i) Data Items:



###  A Site Identification Form with the following fields filled out, at a minimum:

-- Reason for Submittal;

-- Site EPA Identification Number (except for conditionally exempt small quantity

generators);19 -- Site Name;

-- Site Lo cation Information;

-- Site L and T yp e;

-- North American Industry Classification System (NAI CS) Code(s) for the Site;

-- Site Mailing Address;

-- Site Contact Person;

-- Operator and Legal Owner of the Site;

-- Ty

pe of Regulated Waste Activity ; and

-- Certification. (ii) Respondent Activities:



###  Prepare and submit Site Identification Form; and



###  Keep a cop y of the withdrawal notice on file. **(3) Labeling of Containers of Unwanted Material in the Laboratory**  40 CFR 262.206 provides that an eligible academic entity must label and manage containers of unwanted material while in the laboratory in accordance with the requirements in section 262.206. Section 262.206(a)(1) requires that the following information must b e affixed or attached to the container: the words ”unwanted material” or another equally effective term that is to be used consistently by the eligible academic entity and that is identified in Part Iof the Laboratory

Management Plan (262.206(a)(1)(i)), and sufficient information to alert emergency

responders to the contents of the container (262.206(a)(1)(ii)). Section 262.206(a)(2) provides that the following information may be affixed or attached to the container, but must at least be associated with t he container: the date that the unwanted material first began accumulating in the container (262.206(a)(2)(i)) and information sufficient to allow a trained professional to properl y identify whether an unwanted material is a solid and hazardous waste and to assign the proper hazardous waste code(s), pursuant to section 262.11 (262.206(a)(2)(ii)). (i) Data Items:



###  In formation that is affixed or attached to the container, including:

-- Words ”unwanted material” or another equally effective term that is to be used consistently by the eligible academic entity and that is identified in Part Iof the Laboratory Management Plan; and

-- Sufficient information to alert emergency responders to the contents of the container. Examples of information that would be sufficient to alert emergency responders to the contents of the container include, but are not limited to, the following:20 - Name of the chemical(s).

- Ty

pe or class of chemical, such as organic solvents or halogenated organic solvents.



###  In formation that may be affixed or attached to the container, but that must at least be associated with the container, including:

-- Date that the unwanted material first began accumulating in the container; and

-- In formation sufficient to allow a trained professional to properl y identify whether an unwanted material is a solid and hazardous waste and to assign the proper hazardous waste code(s), pursuant to section 262.11. For example, the following in formation may be associated with the container:

- The name and/or description of the chemical contents or composition of the unwanted material, or, if known, the product of the chemical reaction;

- Whether the unwanted material has been used or is unused;

- A description of the manner in which the chemical was processed, if applicable. (ii) Respondent Activities:



###  Label the containers as specified. **(4) Training**  40 CFR 262.207 provides that an eligible academic entity must provide training to all individuals working in a laboratory at that eligible academic entity , as specified. Section 262.207(a) requires that training for laboratory workers and students must be commensurate with their duties so they understand the requirements in Subpart K and can implement them. Section 262.207(b) provides that an eligible academic entity can provide training for laboratory

workers and students in a variety of way s (e.g., instruction by the professor or laboratory

manager before or during an experiment, formal classroom training, electronic/written training). Section 262.207(c) provides that an eligible academic entity that is a large quantity generator must maintain documentati on demonstrating training for all laboratory workers. Section 262.207(c) requires that the information must be sufficient to determine whether laboratory

workers have been trained and for the durations specified in section 265.16(e). Sections 262.207(c)( 1)

- (4) provides examples of documentation demonstrating training.21 (i) Data Items:



###  Documentation demonstrating training for all laboratory workers. Examples of documentation demonstrating training can include, but are not limited to, the following:

-- S ign

- in/attendance sheet(s) for training session(s); or

-- Syllabus for training session; or

-- Certificate of training completion; or

-- Test results. (ii) Respondent Activities:



###  Provide training to all individuals working in a laboratory

.


###  Maintain documentation demonstrating training for all laboratory workers (LQGs onl y). **(5) Removing Containers of Unwanted Material from the Laboratory**  40 CFR 262.208(a) establishes standards for removing containers of unwanted material on a regular schedule. An eligible academic entity must either: remove all containers of unwanted material from each laboratory on a regular interval, not to exceed 6 months (262.208(a)(1)); or remove containers of unwanted material from each laboratory

within 6 months of each container’s accumulation start date (262.208(a)(2)). Section 262.208(b) requires that the eligible academic entity must specify

in Part I of its L aboratory

Management Plan whether it will comply with section 262.208(a)(1) or (a)(2) for the regular removal of unwanted material from its laboratories. Section 262.208(c) requires that the eligible academic entity must specify

in Part II of its Laboratory

Management Plan how it will comply with section 262.208(a)(1) or (a)(2) and develop a schedule for regular removals of unwanted material from its laboratories. [Note: The data items and respondent activities associated with these requirements are presented under “Laboratory Management Plan.”] Section 262.208(d) establishes standards for removing containers of unwanted material when maximum volumes are exceeded. Section 262.208(d)(1) provides that, if a laboratory

accumulates more than 55 gallons of unwanted material before the regularl yscheduled removal, the eligible academic entity must ensure that all co ntainers of unwanted material (including reactive acutel y haz ardous unwanted material): must have the date that 55 gallons is exceeded on the label that is associated with the container (262.208(d)(1)(i)); and are removed from the laboratory within 10 calendar days of the date that 55 gallons was exceeded, or at the next regularl y scheduled removal, whichever comes first (262.208(d)(1)(ii)). Section 262.208(d)(2) provides that, if a laboratory accumulates more than 1 quart of reactive acutely

hazardous unwanted material before the regularl y scheduled removal,22

then the eligible academic entity must ensure that all containers of reactive acutel y hazardous unwanted material: must have the date that 1 quart is exceeded on the label that is associated with the container (262.208(d)(2)(i)); and are removed from the laboratory

within 10 calendar days of the date that 1 quart was exceeded, or at the next regularl y scheduled removal, whichever comes first (262.208(d)(2)(ii)). (i) Data Items:



###  Date that the laborato ry accumulated more than 55 gallons of unwanted material.



###  Date that the laboratory accumulated more than 1 quart of reactive acutel y hazardous unwanted material. (ii) Respondent Activities:



###  Ensure that containers of unwanted material that exceed volume limits have the date of the exceedence on the label. **(6) Where and When to Make the Hazardous Waste Determination and Where**  **to Send Containers of Unwanted Material** 40 CFR 262.209(a) establishes standards for where and when large quantity generators and s mall quantity generators may

make hazardous waste determinations. An eligible academic entity

must ensure that a trained professional makes a hazardous waste determination, pursuant to section 262.11, for unwanted material in any of the following areas:



###  In the laboratory before the unwanted material is removed from the laboratory , in accordance with section 262.210. [Note: The data items and respondent activities associated with this requirement are presented in “Making the Hazardous Waste Determination in the Laboratory .”]



###  Within 4 calendar days of arriving at an on

- site central accumulation area, in accordance with section 262.211. [Note: The data items and respondent activities associated with this requirement are presented in “Making the Hazardous Waste Determination in an On

- site Central Accumulation Area.”]



###  Within 4 calendar days of arriving at an on

- site treatment, storage or disposal facility , in accordance with section 262.212. [Note: The data items and respondent activities associated with this requirement are presented in “Making the Hazardous Waste Determination at an On

- site Interim Status or Permitted Treatment, Storage, or Disposal Facility.”]23 Section 262.209(b) establishes standards for where and when conditionally exempt small quantity

generators may

make hazardous waste determinations. An eligible academic entity

must ensure that a trained professional makes a hazardous waste determination, pursuant to section 262.11, for unwanted material in the laboratory before the unwanted mate rial is removed from the laboratory , in accordance with 262.210. [Note: The data items and respondent activities associated with this requirement are presented in “Making the Hazardous Waste Determination in the L aboratory .”] **(7) Making the Hazardous Wa**  **ste Determination in the Laboratory** 40 CFR 262.210 provides that, if an eligible academic entity makes the hazardous waste determination, pursuant to section 262.11, for unwanted material in the laboratory before the unwanted material is removed from the laboratory , it must comply with the requirements in section 262.210. Section 262.210(a) requires that a trained professional must make the hazardous waste determination, pursuant to section 262.11, before the unwanted material is removed from the laboratory
. Section 262.210(b)(2) provides that, if an unwanted material is a hazardous waste, the eligible academic entity must write the appropriate hazardous waste codes(s) on the label that is associated with the container before the hazardous waste may be transpo rted off

- site. (i) Data Items:



###  Hazardous waste determination.



###  EPA Hazardous waste codes on the label. (ii) Respondent Activities:



###  Make the hazardous waste determination; and



###  Write hazardous waste codes on the container label. **(8) Making the Hazard**  **ous Waste Determination in an On -**  **site Central Accumulation Area**  40 CFR 262.211 provides that, if an eligible academic entity makes the hazardous waste determination, pursuant to section 262.11, for unwanted material at an on

- site central accumulation are a, it must comply with requirements in 262.211. Section 262.211(d) requires that a trained professional must determine, pursuant to section 262.11, if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials’ arrival at the on

- site central accumulation area.24 Section 262.211(e)(2) provides that, if the unwanted material is a hazardous waste, the eligible academic entity must write the appropriate hazardous waste code(s) on the container label that is associated with the container before the hazardous waste may be treated or disposed on

- site or transported off

- site. (i) Data Items:



###  Hazardous waste determination.



###  EPA Hazardous waste codes on the label. (ii) Respondent Activities:



###  Make the hazardous waste determination; and



###  Write hazardous waste codes on the container label. **(9) Making the Hazardous Waste Determination at an On**  **- site Interim Status or**  **Permitted Treatment, Storage, or Disposal Facility** 40 CFR 262.212 provides that, if an eligible academic entity makes the hazardous waste determination, pursuant to section 262.11, for unwanted material at an on

- site interim status or permitted treatment, storage or disposal facility , it must comply with the requirements in section 262.212. Section 262.212(d) requires that a trained professional must determine, pursuant to section 262.11, if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials’ arrival at an on

- site interim status or permitted treatment, storage or disposal facility. Section 262.212(e)(2) provides that, if the unwanted material is a hazardous waste, the eligible academic entity must write the appropriate hazardous waste code(s) on the container label that is associated with the container before the hazardous waste may be treated or disposed on

- site or transported off

- site. (i) Data Items:



###  Hazardous waste determination.



###  EPA Hazardous waste codes on the label. (ii) Respondent Activities:



###  Make the hazardous waste determination; and25



###  Write hazardous waste codes on the container label. **(10) Laboratory Clean**  **- outs**  40 CFR 262.213(a) provides that one time per 12 month period per laboratory, an eligible academic entity

may opt to conduct a laboratory clean

- out that is subject to all the applicable requirements of Subpart K, except as specified otherwise in section 262.213(a). Section 262.213(a)(4) requires that an eligible academic entity must document the activities of the laboratory clean

- out, as specified. The eligible academic entity must maintain the records for a period of three ye ars from the date the clean

- out en ds. (i) Data Items:



###  Documentation that, at a minimum, identifies the laboratory being cleaned out, the date the laboratory clean

- out begins and ends, and the volume of hazardous waste generated during the laboratory clean

- out. (ii) Respondent Activitie s:



###  Document the activities of the laboratory clean

- out; and



###  Maintain records of the clean

- out. **(11) Laboratory Management Plan**  40 CFR 262.214 provides that an eligible academic entity must develop and retain a written Laboratory

Management Plan, or revise an existing written plan. The Laboratory

Management Plan is a site

- specific document that describes how the eligible academic entity

will comply

with Subpart K. An eligible academic entity may write one Laboratory

Management Plan for all the laboratories owned by the eligible academic entity that have opted into Subpart K, even if the laboratories are located at sites with different EPA Identification Numbers. The Laboratory

Management Plan must contain two parts with a total of nine elements identi fied in section 262.214(a) and (b). In Part I of its Laboratory Management Plan, an eligible academic entity must describe its procedures for each of the elements listed in section 262.214(a). An eligible academic entity must implement and comply with th e specific provisions that it develops to address the elements in Part I of the Laboratory

Management Plan. In Part II of its Laboratory Management Plan, an eligible academic entity must describe its best management practices for each of the elements listed in section 262.214(b). The specific actions taken b y an eligible academic entity to implement each element in Part II of its Laboratory Management Plan may

vary from the procedures26

described in the eligible academic entity ’s Laboratory Management Plan, without constituting a violation of Subpart K. An eligible academic entity may include additional elements and best management practices in Part II of its L aboratory Management Plan if it chooses. Section 262.214(c) provides that an eligible academic entity must make its Laboratory

Management Plan available to laboratory workers, students, or any others at the eligible academic entity who request it. Section 262.214(d) requires that an eligible academic entity must review and revise its Laboratory

Management Plan, as needed. (i) Data Items:



###  A Laboratory

Management Plan that includes Part Iand II. In Part I of the Laboratory

Management Plan, an eligible academic entity must:

-- Describe procedures for container labeling in accordance with section 2 62.206(a), including:

- Id entifying whether the eligible academic entity will use the term “unwanted material” on the containers in the laboratory . If not, identify the equall y effective term that will be used in lieu of “unwanted material” and consistently by the eligible academic entity

.

- Id entifying the manner in which information that is “associated with the container” will be imparted.

-- Id entify

whether the eligible academic entity will comply

with section 262.208(a)(1) or section 262.208(a)(2) for regularl y scheduled removals of unwanted material from the laboratory

. In Part II of the Laboratory Management Plan, an eligible academic entity must:

-- Describe procedures for container labeling and management standards, including how the eligible acad emic entity will manage containers used for in

- line collection of unwanted materials, such as with liquid chromatographs and other laboratory equipment.

-- Describe how the eligible academic entity will provide training for laboratory

workers and students commensurate with their duties.

-- Describe how the eligible academic entity will provide training to ensure safe on

- site transfers of unwanted material and hazardous waste b y trained professionals.

-- Describe procedures for removing unwanted material from the laboratory , including:

- For regularl y scheduled removals

– Develop a regular schedule for identifying and removing unwanted materials from its laboratories.

- For removals when maximum volumes are exceeded:27 - Describe procedures for removing unwanted materials from the laboratory within 10 calendar days when unwanted materials have exceeded their maximum volumes.

- Describe how and to whom laboratory workers or students will communicate that unwanted materials have exceeded their maximum volum es.

-- Describe procedures for making hazardous waste including specifying the duties of the individuals involved in the process.

-- Describe procedures for laboratory clean

- outs, if the eligible academic entity

plans to use the incentives for laboratory clean

outs provided in section 262.213, including:

- Procedures for conducting laboratory clean

- outs in accordance with section 262.213; and

- Procedures for documenting laboratory clean

- outs in accordance with section 262.213(a)(4).

-- Describe emergency prevention procedures, including:

- Procedures for emergency prevention, notification, and response, appropriate to the hazards in the laboratory ; and

- A list of chemicals that the eligible academic entity has, or is likely to have, that become more dange rous when they exceed their expiration date and/or as they degrade; and

- Procedures to safel y dispose of chemicals that become more dangerous when they exceed their expiration date and/or as they

degrade; and

- P rocedures for the timel y characterization of unknown chemicals. (ii) Respondent Activities:



###  Develop a Laboratory Management Plan or revise an existing written plan;



###  Retain, review and revise the Laboratory Management Plan; and



###  Make Laboratory

Management Plan available to laboratory workers, s tudents, or any others at the eligible academic entity who request it.28

**5. THE INFORMATION COLLECTED: AGENCY ACTIVITIES,**  **COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT**  **5(a) Agency Activities**  **(1) Notification of Intent to Comply with Subpart K and**  **Recordkeeping of Agreements**  Under 40 CFR 262.203(a), the Agency will conduct the following activities:



###  Review and process Site Identification Forms. **(2) Notification of Withdrawal from Subpart K**  Under 40 CFR 262.204(a), the Agency will conduct the following activities:



###  Review and process Site Identification Forms. **(3) Labeling of Containers of Unwanted Material in the Laboratory**  There is no Agency

activity under 40 CFR 262.206. **(4) Training**  There is no Agency

activity under 40 CFR 262.207. **(5) Removing Containers of Unwanted Material from the Laboratory**  There is no Agency

activity under 40 CFR 262.208. **(6) Where and When to Make the Hazardous Waste Determination and Where**  **to Send Container s of Unwanted Material**  There is no Agency

activity under 40 CFR 262.209. **(7) Making the Hazardous Waste Determination in the Laboratory**  There is no Agency

activity under 40 CFR 262.210. **(8) Making the Hazardous Waste Determination in an On**  **- site Central**  **Accumulation Area** There is no Agency

activity under 40 CFR 262.211.29

**(9) Making the Hazardous Waste Determination at an On**  **- site Interim Status or**  **Permitted Treatment, Storage, or Disposal Facility** There is no Agency

activity under 40 CFR 262.212. **(10) Laboratory Clean**  **- outs**  There is no Agency

activity under 40 CFR 262.213. **(11) Laboratory Management Plan**  There is no Agency

activity under 40 CFR 262.214. **5(b) Collection Methodology and Management**  In collecting and anal yz ing the information associated with this I CR, EPA and authorized States may

use a telephone system, personal computers, and applicable database software. They

will ensure the accuracy

and completeness of collected information by

reviewing the submittals. They will keep records of this information in file cabinets and/or computer systems. **5(c) Small Entity Flexibility**  The Subpart K regulations allow eligible academic entities the flexibility to tailor their laboratory

operations to meet their individual circumstances, and remain protective of human health and the environment. Performance

- based standards for management of hazardous wastes generated in laboratories provide a better opportunity for them to evaluate their overall hazardous waste management program, and tailor it in such a way that facilitates the efficient and safe management of hazardous waste and minimizes burden, while at the same time maintaining a high standard of protection of human health and the environment. The alternative approach will help each eligible academic entity centralize and coordinate its chemical management practices and achieve sound environmental performance. In addition, eligible academic entities have the choice to manage their hazardous waste in accordance with the alternative set of regulations or remain subject to the existing generator regulations in 40 CFR 262.34(c) (or section 261.5 for conditionally exempt small quantity

generators). Thus, they

have the option to comply with the set of regulations that best suits their circumstances. **5(d) Collection Schedule**  **(1) Notification of Intent to Comply with Subpart K and Recordkeeping of**  **Agreements** Under 40 C

FR 262.203(a), an eligible academic entity must notify

the appropriate30

EPA Regional Administrator in writing, using the RCRA Subtitle C Site I dentification Form (EPA Form 8700

- 12), that it is electing to be subject to the requirements of Subpart K for all the laboratories owned by the eligible academic entity under the same EPA Id entification Number. An eligible academic entity that is a conditionally

exempt small quantity generator and does not have an EPA Identification Number must notify for all the lab oratories owned by the eligible academic entity that are on

- site. An eligible academic entity

must submit a separate notification (Site Identification Form) for each EPA Identification Number (or site, for conditionally exempt small quantity

generators) that is electing to be subject to the requirements of Subpart K. This is a one

- time notification. Section 262.203(c) provides that an eligible academic entity must keep a copy

of the notification on file at the eligible academic entity while its laboratories are subject to Subpart K. Section 262.203(d) provides that a teaching hospital that is not o wned by a college or university

must keep a copy

of its formal written affiliation agreement with a college or university

on file at the teaching hospital while its laboratories are subject to Subpart K. Section 262.203(e) provides that a non

- profit re search institute that is not owned by a college or university must keep a cop y of the formal written affiliation agreement with a college or university on file at the non

-profit research institute while its laboratories are subject to Subpart K. **(2) Notif** 

**ication of Withdrawal from Subpart K** Under 40 CFR 262.204(a), an eligible academic entity must notify

the appropriate EPA Regional Administrator in writing, using the RCRA Subtitle C Site I dentification Form (EPA Form 8700

- 12), that it is electing to no l onger be subject to the requirements of Subpart K for all the laboratories owned b y the eligible academic entity under the same EPA Identification Number. An eligible academic entity that is a conditionally exempt small quantity

generator and does not hav e an EPA Identification Number must notify for all the laboratories owned b y the eligible academic entity that are on

- site. An eligible academic entity

must submit a separate notification (Site Identification Form) for each EPA Identification Number (or s ite, for conditionally exempt small quantity generators) that is withdrawing from the requirements of Subpart K. This is a one

- time notification. Section 262.204(c) provides that an eligible academic entity must keep a copy

of the withdrawal notice on f ile at the eligible academic entity for three ye ars from the date of the notification. **(3) Labeling of Containers of Unwanted Material in the Laboratory**  40 CFR 262.206(a) requires that specified information must be affixed or attached31

to, or otherwise as sociated with, the container while in the laboratory

. **(4) Training**  40 CFR 262.207 provides that an eligible academic entity must provide training to all individuals working in a laboratory at that eligible academic entity , as specified. Section 262.207(c) provides that an eligible academic entity that is a large quantity generator must maintain documentation demonstrating training for all laboratory workers. The information must be retained for the durations specified in section 265.16(e ). [Note: Existing 40 CFR 265.16(e) requires that training records on current personnel must be kept until closure of the facility. Training records on former employees must be kept for at least three years from the date the emplo yee last worked at the f acility . Personnel training records may accompany

personnel transferred within the same company.] **(5) Removing Containers of Unwanted Material from the Laboratory**  40 CFR 262.208(d)(1)(i) provides that, if a laboratory accumulates more than 55 gallons of unwanted material before the regularl y scheduled removal, the eligible academic entity

must ensure that all containers of unwanted material (including reactive acutel y haz ardous unwanted material) have the date that 55 gallons is exceeded on the label that is associated with the container. Section 262.208(d)(2)(i) provides that, if a laboratory accumulates more than 1 quart of reactive acutel y hazardous unwanted material before the regularl y scheduled removal, then the eligible academic entity must ensure that all containers of reactive acutel y hazardous unwanted material have the date that 1 quart is exceeded on the label that is associated with the container. **(6) Where**  **and When to Make the Hazardous Waste Determination and Where to Send Containers of Unwanted Material**  40 CFR 262.209(a) establishes standards for where and when large quantity generators and small quantity generators may

make hazardous waste determinations . An eligible academic entity

must ensure that a trained professional makes a hazardous waste determination, pursuant to section 262.11, for unwanted material in any of the following areas:



###  In the laboratory before the unwanted material is removed from the laboratory , in accordance with section 262.210.



###  Within 4 calendar days of arriving at an on

- site central accumulation area, in accordance with section 262.211.



###  Within 4 calendar days of arriving at an on

- site treatment, storage or32 disposal facility , in accordance with section 262.212. Section 262.209(b) establishes standards for where and when conditionally exempt small quantity

generators may

make hazardous waste determinations. An eligible academic entity

must ensure that a trained professional makes a hazardous waste determination, pursuant to section 262.11, for unwanted material in the laboratory before the unwanted material is removed from the laboratory , in accordance with 262.210. **(7) Making the Hazardous Waste Determination in the Labor**  **atory** 40 CFR 262.210(a) requires that a trained professional must make the hazardous waste determination, pursuant to section 262.11, before the unwanted material is removed from the laboratory

. Section 262.210(b)(2) provides that, if an unwanted material is a hazardous waste, the eligible academic entity must write the appropriate hazardous waste codes(s) on the label that is associated with the container before the hazardous waste may be transpo rted off

- site. **(8) Making the Hazardous Waste Determination in an On**  **- site Central**  **Accumulation Area** 40 CFR 262.211(d) requires that a trained professional must determine, pursuant to section 262.11, if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials’ arrival at the on

- site central accumulation area. Section 262.211(e)(2) provides that, if the unwanted material is a hazardous waste, the eligible academic entity must write the appropriate hazardous waste code (s) on the container label that is associated with the container before the hazardous waste may be treated or disposed on

- site or transported off

- site. **(9) Making the Hazardous Waste Determination at an On**  **- site Interim Status or**  **Permitted Treatment, Stora ge, or Disposal Facility**  40 CFR 262.212(d) requires that a trained professional must determine, pursuant to section 262.11, if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials’ arrival at an on

- site interim statu s or permitted treatment, storage or disposal facility

. Section 262.212(e)(2) provides that, if the unwanted material is a hazardous waste, the eligible academic entity must write the appropriate hazardous waste code(s) on the container label that is ass ociated with the container before the hazardous waste may be treated or disposed on

- site or transported off

- site.33

**(10) Laboratory Clean**  **- outs**  40 CFR 262.213(a) provides that one time per 12 month period per laboratory, an eligible academic entity

may opt to conduct a laboratory clean

- out that is subject to all the applicable requirements of Subpart K, except as specified otherwise in section 262.213(a). Section 262.213(a)(4) requires that an eligible academic entity must document the activities of the laboratory clean

- out, as specified (a clean

- out may last up to 30 calendar days, as specified). The eligible academic entity must maintain the records for a period of three ye ars from the date the clean

- out ends. **(11) Laboratory Management Plan**  40 CFR 262.214 provides that an eligible academic entity must develop, implement, and retain a written Laboratory Management Plan, or revise an existing written plan. Section 262.214(c) provides that an eligible academic entity must make its Laboratory Management Plan available to laboratory workers, students, or any others at the eligible academic entity who request it. Section 262.214(d) requires that an eligible academic entity must review and revise its Laboratory

Management Plan as needed.34

**6. EST**  **IMATING THE HOUR AND COST BURDEN OF THE COLLECTION**  **6(a) Estimating Respondent Burden Hours**  Exhibit 1 provides estimates of the respondent hourly burden associated with the rule’s paperwork requirements. Exhibit 1 includes burden hours (total and by labor ty pe) per respondent, as well as the overall burden hours for all respondents. **6(b) Estimating Respondent Costs**  Exhibit 1 provides estimates of the annual respondent costs associated with the rule’s paperwork requirements. These costs are based on the cost of labor, capital, and operation and maintenance (O&M). **(1) Labor Costs**  EPA estimates an average loaded respondent hourly labor rate of $ 99.56 for legal staff, $82 .25 for managerial staff, $ 4 3
. 92 for technical staff, and $23 .27 for clerical staff. These hourl y labor rates are based on the most current estimates of national cross

industry wages by the U.S. Bureau of Labor Statistics 1 for the following occupational groups , respectively , multiplied by a factor2 of 1.6741 to account for fringe benefits 3 and overhead4 : SOC 23
- 1011: L awye rs; SOC 11
- 1021: General & Operations Managers; SOC 17
- 2081: Environmental Engineers and SOC 1 7
- 3025 : Environmental Engineering Technicians and SOC 19
- 4031: Chemical Technicians ; and SOC 43
- 9061: Office Clerks, General

. Using the total burden hours discussed in Section 6(a) and the hourl y wage rates outlined in this section, Exhibit 1 estimates the labor costs associated with the information collection requirements covered in this I CR. **(2) Capital Costs** 

1 US Bur eau of Labor Statistics (BLS) Occupational Employment Statistics (OES) for May 2011 National Occupational Employment and Wage Estimates. The wage rate for legal and managerial are specific to colleges and universities industry and can be found at http://www.bls.gov/oes/current/naics4_611300.htm#11

- 0000 2 = [1+ (Fringe Benefits %) / (100%

- Fringe Benefits %)] x (1+ Overhead %) 3 Applied “All goods

-producing” industry group fringe benefits percentage of 33.1% from “Table 6. Private industry, by major industry group” of the US Bureau of Labor Statistics (BLS) “Employer Costs for Em ployee Compensation” (ECEC), December 2010 at http://www.bls.gov/schedule/archives/eci_nr.htm

. 4 In absence of data specific to industry, applied 12% Federal civilian overhead cost factor from Figure C1 of the REVISED February OMB Circular A

- 76 at http://www. whitehouse.gov/omb/circulars_a076_a76_incl_tech_correction/

.35 Capital costs usually

include any

produced phys ical good needed to provide the needed information, such as machinery , computers, and other equipment. EPA does not anticipate that respondents will incur capital costs in carrying out the info rmation collection requirements covered in this I CR. **(3) Operation & Maintenance Costs**  O&M costs are those costs associated with a paperwork requirement incurred continually

over the life of the I CR. This ICR includes O&M costs for postage (i.e., $2.95 currentl y for certified mail) and envelope (i.e., $0.01 1 ). The IC R includes $ 0.14 per container label. To update the O&M costs in the previous I CR (2317.01), which were based mainly on the 200 8 costs, EPA referred to the U.S. Bureau of Labor Statistics (BLS)’s Consumer Price Index data for all urban consumers (1982

– 84 index = 100) at http://www.bls.gov/cpi/cpi_dr.htm . EPA used the December 200 8 index (2 10. 228 ) and December 2011 index (2 25.67 2 ) to develop an adjustment factor of 1.0 7 35 (= 225. 67 2 / 2 10
. 228 ). **6(c) Estimating Agency Hour and Cost Burden**  The final rule promulgating the Subpart K regulations will be administered by RCRA
- authorized State government regulatory programs. EPA estimated the foll owing average loaded hourl y wage rates for government labor: $67 .27 per hour for legal staff, $67 .32 per hour for managerial staff, $5 5.62 per hour for technical staff, and $2 5.99 per hour for clerical staff. These hourl y labor rates are based on the most current estimates of State government wages by the U.S. Bureau of Labor Statistics 5 for occupational groups SOC 23
- 1011: L awye rs; SOC 11
- 1021: General & Operations Managers; SOC 17

- 2081: Environmental Engineers; and SOC 43

- 9061: Office Clerks, General, re spectively , multiplied by

a factor 6 of 1.7073 to account for fringe benefits 7 and overhead 8

. Hour and cost burden to the Agency is estimated in Exhibit 3. **6(d) Estimating the Annual Respondent Universe and Total Hour and Cost**  **Burden** In this section, EP A first describes the estimated respondent universe under the rule. EPA then estimates the annual burden to respondents under the rule’s paperwork

5 US Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) for May 2011 National Industry

- Specific Occupational Employment & Wage Estimates for NAICS 999200 State Government: http://www.bls.gov/oes/current/naics4_999200.htm 6 = [1+ (Fringe Benefits %) / (100%

- Fringe Benefits %)] x (1+ Overhead %) 7 Applied 34.4% fringe benefits percentage from “Table 3. State and local government, by major occupational and industry group” of the US Bureau of Labor Statistics (BLS) “Employe r Costs for Em ployee Compensation” (ECEC), December 2010 at http://www.bls.gov/schedule/archives/eci_nr.htm

. 8 In absence of data specific to industry, applied 12% Federal civilian overhead cos t factor from Figure C1 of the REVISED February OMB Circular A

- 76 at http://www. whitehouse.gov/omb/circulars_a076_a76_incl_tech_correction/

.36

requirements. Finally , EPA estimates the burden impacts to respondents under the existing RCRA generator pa perwork standards. EPA obtained most of the data and assumptions for the burden calculations in the previous IC R (2317.01) from EPA’s impact assessment developed for the final rule promulgating the Subpart K regulations

. For this ICR renewal, EPA consulted with a number of industry

officials to update and/or verify respondent burden estimates for the Subpart K regulatory

activities. See Attachment 1

- Burden Estimate Methodology

. **(1) Respondent Universe**  Table 1 present s the total number of sites at eligible academic entities that are expected to opt into Subpart K during the three

- ye ar period covered b y this ICR. The table shows the number of large quantity generators (LQGs), small quantity generators (SQGs), and condi tionally exempt small quantity

generators (CESQGs). It also shows the number of sites with and without an on

- site central accumulation area (CAA). In total, EPA expects eligible academic entities to opt in for 99 of their sites ; see Attachment 2

– Summ ary of Universe Calculations . Of these, EPA estimates that 48 will be LQGs , 27 will be SQGs , and 24 will be CESQGs . EPA estimates that 67 sites will have a CAA and 32 will not have a CAA. These 32 sites without a CAA will ship their hazardous waste off

- site directly

from the laboratories. Table 2 presents the average number of laboratories per site and the average annual number of containers of unwanted material per laboratory . Information is presented onl y for those sites expected to opt into Subpart K, as shown in Table 1 Table 3 presents the total aggregate annual number of containers of unwanted material generated at sites expected to opt into Subpart K. The table is based on the data pre sented in Tables 1 and 2. Specificall y, EPA multiplied the total number of sites opting into Subpart K (see Table 1) b y each site’s average number of laboratories and containers of unwanted materials per laboratory (see Table 2). This produced the total aggregate number of containers of unwanted materials expected to be generated annually under Subpart K. In total, EPA estimates that 742,442 containers of unwanted materials will be generated in laboratories under Subpart K annually . Of these, EPA esti mates that 732,410 containers will be generated b y sites with CAAs and 10,032 will be generated b y sites without CAAs. EPA used the above data to estimate the annual respondent burden in this ICR. **(2) Annual Respondent Burden under**  **Subpart K** Based on the respondent universe data presented in Tables 1 through 3, EPA estimates the annual incremental hour and cost burden to respondents under the Subpart37

K regulations in Exhibit 1. A discussion of the assumptions used in the development of these burden estimates is presented in the following subsections. **(a) Reading the Regulations**  EPA estimates that eligible academic entities will opt in for 99 of their sites (i.e., 48 LQ Gs + 27 SQGs + 24 CESQGs ) during the three

- ye ar life of this ICR. EPA expects that employees at these sites will read the Subpart K regulations once during the three

- ye ar life of this I CR. In estimating the annual incremental burden to respondents over the three

- ye ar period covered b y this ICR, EPA annualized the burden of this one - time activity

by dividing the number of respondents by three. Thus, EPA estimates that, on average, 3 3 sites (i.e., 99 sites / 3 years) will read the regulations each year.38 **Table 1 Total Number of Sites at Eligible Academic Entiti**  **es Opting into Subpart K**

**During Three -** **Year Life of ICR a** 

**Size LQGs**  **SQGs CESQGs**  **Total**

**with CAA without CAA**  **Total with CAA**  **without CAA Total**  **with CAA without**  **CAA Total**  **with CAA without**  **CAA Total**  **4 -**  **Year Colleges and Universities and Non -**  **Profit Research Institutes**  Large b 45 0 45 11 0 11 0 0 0 56 0 56 Small c 0 0 0 8 8 16 0 24 24 8 32 40 Subtotal 45 0 45 19 8 27 0 24 24 64 32 96 **2 -**  **Year Colleges and Universities** Large b 0 0 0 0 0 0 0 0 0 0 0 0 Small c 0 0 0 0 0 0 0 0 0 0 0 0 Subtotal 0 0 0 0 0 0 0 0 0 0 0 0 **Vocation Schools** Large b 0 0 0 0 0 0 0 0 0 0 0 0 Small c 0 0 0 0 0 0 0 0 0 0 0 0 Subtotal 0 0 0 0 0 0 0 0 0 0 0 0 **Teaching Hospitals** Very Large d 0 0 0 0 0 0 0 0 0 0 0 0 Large e 3 0 3 0 0 0 0 0 0 3 0 3 Small f 0 0 0 0 0 0 0 0 0 0 0 0 Very Small g 0 0 0 0 0 0 0 0 0 0 0 0 Subtotal 3 0 3 0 0 0 0 0 0 3 0 3 **Total 48**  **0 48**  **19 8**  **27 0**  **24 24**  **67 32**  **99** a. Data updated per Attachment 2

– Summary of Industry Universe Calculations. b. Defined as sites with more than 50 labs, more than 5 studios. c. Defined as sites with less than 50 labs, less than 5 studios. d. Defined as sites with more than 50 labs. e. Defined as sites with 15 labs. f. Defined as sites with 6 labs. g. Defined as sites with 2 labs.39 **Table 2 Number of Laboratories Per Site and Number**  **of Unwan ted Material Containers Per Laboratory**  **(Data are presented only for sites opting into Subpart K a** **)**

**Size LQG**  **SQG CESQG** 

**With CAA Without CAA**  **With CAA Without CAA**  **With CAA Without**  **CAA 4**  **- Year Colleges and Universities and Non**  **- Profit Research Institutes**  Large b 850 labs and

19 containers / lab * 62 labs and 5 containers / lab * * * Small c * * 18 labs and 0 containers / lab 33 labs and

18 containers / lab * 10 labs and 22 containers / lab **2 -**  **Year Colleges and Universities** Large b * * * * * * Small c * * * * * * **Vocational Schools** Large b * * * * * * Small c * * * * * * **Teaching Hospitals** Very Large d 501 labs and

34 containers / lab * * * * * Large e 15 labs and

50 containers / lab * * * * * Small f * * 6 labs and 7 containers / lab 6 labs and

7 containers / lab * 2 labs and 5 containers / lab Very Small g * * * * * * a. Data updated per Attachment 1

– Burden Estimate Methodology

. b. Defined as sites with more than 50 labs, more than 5 studios. c. Defined as sites with less than 50 labs, less than 5 studios. d. Defined as sites with more than 50 labs. e. Defined as sites with 15 labs. f. Defined as sites with 6 labs. g. Defined as sites with 2 labs.40 **Table 3 Total Annual Number of Containers of Unwanted Material**  **Generated at Sites Opting into Subpart K** **a**

**Size LQGs**  **SQGs CESQGs**  **Total**

**with CAA without** 

**CAA Total**  **with CAA without**  **CAA Total**  **with CAA without**  **CAA Total**  **with CAA without**  **CAA Total**  **4 -**  **Year Colleges and Universities and Non -**  **Profit Research Institutes** Large b 726,750 0 726,750 3,41 0 0 3,410 0 0 0 730,160 0 730,160 Small c 0 0 0 0 4 , 752 4 , 752 0 5,28 0 5,280 0 10 , 032 10,032 Subtotal 726,750 0 726,750 3,410 4,752 8 ,1 62 0 5,280 5,280 730,160 10,032 740 ,1 92 **2 -**  **Year Colleges and Universities** Large b 0 0 0 0 0 0 0 0 0 0 0 0 Small c 0 0 0 0 0 0 0 0 0 0 0 0 Subtotal 0 0 0 0 0 0 0 0 0 0 0 0 **Vocational Schools** Large b 0 0 0 0 0 0 0 0 0 0 0 0 Small c 0 0 0 0 0 0 0 0 0 0 0 0 Subtotal 0 0 0 0 0 0 0 0 0 0 0 0 **Teaching Hospitals** Very Large d 0 0 0 0 0 0 0 0 0 0 0 0 Large e 2,250 0 2 ,250 0 0 0 0 0 0 2 , 25 0 0 2 ,250 Small f 0 0 0 0 0 0 0 0 0 0 0 0 Very Small g 0 0 0 0 0 0 0 0 0 0 0 0 Subtotal 2 , 25 0 0 2 , 250 0 0 0 0 0 0 2 ,500 0 2 , 250 **Total 729,000**  **0 729,000**  **3,410 4,752**  **8,162 0**  **5,280 5,280**  **732,410 10**  **, 032**  **742 ,**  **442** a. Numbers in the table are based on the data in Tables 1 and 2. b. Defined as sites with more than 50 labs, more than 5 studios. c. Defined as sites with less than 50 labs, less than 5 studios. d. Defined as sites with more than 50 labs. e. Defined as sites with 15 labs. f. Defined as sites with 6 labs. g. Defined as sites with 2 labs.41 **(b) Notification of Intent to Comply with Subpart K and Recordkeeping**  **of Agreements** An eligible academic entity must submit the Site Identification Form to notify EPA or the authorized State that it i s electing to be subject to Subpart K for all laboratories owned b y the eligible academic entity under the same EPA Id entification Number. An eligible academic entity that is a conditionally

exempt small quantity generator and does not have an EPA Identif ication Number must notify for all laboratories that are owned or operated b y the eligible academic entity that are on

- site. In estimating the annual incremental burden to respondents over the three

- ye ar period covered b y this ICR, EPA annualized the burden of this one

- time activity by dividing the number of Site Identification Forms by three. Thus, EPA estimates that, each year, 3 3 forms (i.e., 99 forms/3 ye ars) will be prepared, submitted, and retained. Teaching hospitals opting into Subpart K must keep a cop y of their formal written affiliation agreement with a college or university on file if they

are not owned by

a college or university

. EPA has made the simplifying assumption that 50 percent of teaching hospitals opting into Subpart K ( 3 sites x 50% = 2 sites ) are not owned by a college or university

and must keep these agreements on file. Inestimating the annual incremental burden to them over the three

- ye ar period covered by this I CR, EPA annualized the burden of this one

- time activity by dividing the number of respondents by three. Thus, EPA estimates that, each ye ar, one site (i.e., 3 sites x 50% / 3 years) will retain the agreements on file. Non
-profit research institutes not owned by a college or university opting into Subpart K must keep a copy of the formal written affiliation agreement with a college or university on file. The impact assessment developed for the final rule promulgating the Subpart K regulations does not estimate the number of non

-profit research institutes opting into Subpart K separatel y from four

- ye ar colleges and universities that are opting in. Rather, it estimates the combined number of sites at four

- ye ar colleges and universities and non -p rofit research institutes opting into Subpart K (i.e., 96 sites in total). For purposes of this I CR, EPA has made the simplifying assumption that approximately five percent of these sites are non

-profit research institutes (i.e., 5 sites). 9 Inestimating the annual incremental burden to them over the three

- ye ar period covered by this ICR, EPA annualized the burden of this one

- time activity by dividing the number of respondents b y three. Thus, EPA estimates that, each ye ar, two sites (i.e., 5 sites/3 year s) will retain the agreement on file.

9
. To derive this 5

-percent estimate, EPA referred to the impact assessment to obtain the total number of college and university sites (1,256 sites) and non

-profit research sites (61 sites) that are eligible for Subpart K. EPA then calculated the percentage of non

-profit research sites from the combined total of 1,317 sites (i.e., 61 sites / 1,317 = 5%). EPA applied this 5

-percent estimate to the 96 sites, to estimate that 4 5 are non -profit research sites.42 **(c) Notification of Withdrawal from Subpart K**  EPA does not expect any eligible academic entity to submit a withdrawal notification during the three

- ye ar period covered by this ICR. **(d) Labeling of Containers of**  **Unwanted Material in the Laboratory** As shown in Table 3, EPA estimates that eligible academic entities subject to Subpart K will generate a total of 742,442 containers of unwanted materials each ye ar. They must label the containers as specified at section 262.206. **(e) Training**  Under section 262.207, individuals working in a laboratory at the 99 sites must be trained commensurate with their duties. In addition, L QGs must maintain training records for laboratory

workers. EPA’s impact assessment es timates that 56% of the LQGs opting into Subpart K will shift in generator status to SQGs because of the laboratory

clean

- out incentives. 10 Hence, 27 (= 48 x 56% ) LQGs will be subject to the recordkeeping provision. Note: EPA believes that, under existing regulations (e.g., OSHA and EPA regulations) and standard industry practices, a variety

of training is provided to individuals that use and/or manage chemicals, hazardous materials, and hazardous wastes as part of their job responsibilities. EPA has fo und, for example, that the predominant practice b y colleges and universities currentl y is to provide training to students regarding proper laboratory

and waste management. In addition, contractors/consultants that provide support services to eligible academic entities (e.g., brokers that provide hazardous waste management support to CESQGs) must train their employees, as applicable. Thus, EPA believes that the training requirements under the rule do not impose incremental burden on respondents. 11 **(f) Re**  **moving Containers of Unwanted Material from the Laboratory** EPA assumes that all eligible academic entities under Subpart K will remove their containers of unwanted material and reactive acutely hazardous unwanted materials from each laboratory

on a regular basis. Because of this, EPA anticipates that none of the laboratories will accumulate more than 55 gallons of unwanted material or 1 quart of acutel y reactive unwanted material before the regularly scheduled removal. As a result, EPA estimates that non e of the entities will need to label any of its containers with the date the 55 gallons or the 1 quart of unwanted material is exceeded.

10
. 14 of the 25 LQGs studied previously, per “T ab le 5

- 2. Number of Facilities Expected to Adopt the Final Rule by Institution Type, Lab System Size, Generator Status, and CAA Operation.” (p. 64) of EPA’s im pact assessment. 11
. See pages 55 and 56 of EPA’s impact assessment for an additional discussion of EPA’s rationale.43 **(g) Making the Hazardous Waste Determination in the Laboratory**  EPA estimates that 32 sites under Subpart K will not have an on

- site CAA. Rather, they

will make their hazardous waste determinations in the laboratory . EPA expects that a hazardous waste determination will be made for each container of unwanted material in these laboratories . Based on the data in Table 3, EPA estimates that, each ye ar, hazardous waste determinations will be made in the laboratory for 742,442 containers of unwanted materials. EPA assumes that unwanted materials in all of these containers will be determined to be hazardous waste, and thus, the appropriate hazardous waste code(s) will be added to the label that is associated with the containers. EPA notes that, for purposes of this anal ys is, only the addition of the appropriate hazardous waste code(s) to the container labels is considered incremental burden. Under existing regulations (40 CFR 262.11), generators must determine if their waste is hazardous per 40 CFR 261.3. Thus, the hazardous waste determination does not impose incremental burden on respondents. **(h) Making the Hazardous Waste Determination in an On**  **- site Central**  **Accumulation Area** EPA estimates that 10 sites under Subpart K will have an on

- site CAA at which they will make their hazardous waste determinations. EPA expects that a hazardous wast e determination will be made for each container of unwanted material at the CAAs. Based on the data in Table 3, EPA estimates that, each ye ar, hazardous waste determinations will be made at CAAs for 732,410 containers of unwanted materials. EPA assumes that unwanted materials in all of these containers will be determined to be hazardous waste and thus, the appropriate hazardous waste code(s) will be added to the label that is associated with the containers. EPA notes that, for purposes of this anal ys is, only the addition of the appropriate hazardous waste code(s) to the container labels is considered incremental burden. Under existing regulations (40 CFR 262.11), generators must determine if their waste is hazardous. Thus, the hazardous waste determination does not impose incremental burden on respondents. **(i) Making the Hazardous Waste Determination at an On**  **- site Interim**  **Status or Permitted Treatment, Storage, or Disposal Facility** EPA expects that no hazardous waste determinations will be made at an on - site interim status or permitted TSDF during the three

- ye ar period covered by this I CR.44 **(j) Laboratory Clean**  **- outs**  EPA estimates that 20 percent of the laboratories at each site under Subpart K will conduct a laboratory

clean

- out annually . In additio n, EPA estimates that 10 percent of all of the containers of unwanted material generated by these laboratories during the ye ar will originate from their laboratory clean

- out. Hence, EPA multiplied the total number of containers in Table 3 b y 20 percent an d 10 percent, to estimate that 14,849 containers will originate from laboratory clean

- outs annuall y (i.e., 732,442 x 20% x 10% = 7,056 14,849 ). EPA estimates that personnel will spend two minutes per container to document the clean

- out and two minutes per container to maintain documentation of the clean

- out. 12 **(k) Laboratory Management Plan**  Eligible academic entities are required to develop a Laboratory Management Plan or modify an existing plan for their sites under Subpart K. For purposes of this I CR, EPA assumes that they will revise an existing plan (e.g., Chemical Hygiene Plan) to compl y with the L aboratory

Management Plan requirement. In estimating the annual incremental burden to respondents over the three

- ye ar period covered b y this ICR, EPA annualized the burden of this one

- time activity by dividing the number of Laboratory Management Plans by three. Thus, EPA estimates that, on average, eligible academic entities will prepare 3 3 Laboratory

Management Plans per year (i.e., 99 Plans / 3 years). EPA also estimates that each site will review, revise, and keep records of its Laboratory

Management Plan each year. 13 Finally , the eligible academic entities must make the Laboratory Management Plan available to others (e.g., laboratory workers, students). **(3) Annual Respondent Hour and Cost Impacts under Existing**  **Paperwork Re quirements**  Some eligible academic entities may be relieved of some of the existing generator standards under the rule, e.g., if they shift downward in generator status under Subpart K. The impact assessment developed b y EPA for the final rule promulgating the Subpart K regulations estimates that 14 LQGs will shift to SQGs and 7 SQGs will shift to CESQGs because of Subpart K’s laboratory clean

- out incentives. 14 As a result, these sites will see some burden relief from the existing paperwork requirements.

12
. See page 46 of EPA’s impact assessment for an additional discussion of EPA’s assumptions. 13
. EPA’s impact assessment estimates that eligible academic entities will spend 4 hours every 3 years to maintain and update the Laboratory Management Plan (p. 47). In preparing this ICR, EPA annualized the 4 hours over three years, to estimate that eligibl e academic entities will spend 1.33 hours per year to review, revise and keep records of each of the 99 Laboratory Management Plans. 14
. See page 64 of EPA’s impact assessment for additional information (i.e., “Table 5

- 2. Number of Facilities Expected to Adopt the Final Rule by Institution Type, Lab System Size, Generator Status, and CAA Operation.”).45 Exhibit 2 presents the total annual burden under the Subpart K’s paperwork requirements, as well as the annual burden impacts (i.e., burden relief) under the existing paperwork requirements. The burden relief under the existing requirements is presented according to the approved I CR in which the requirements are addressed. Below is a brief discussion of these ICRs, along with a description of relevant capital and O&M costs affected:

 Requirements for Generators, Transporters, and Waste Management Facilities under the RCRA Hazardous Waste Manifest Sy stem (EPA ICR Number 801). EPA estimates that some eligible academic entities will see some efficiencies in the movement of their hazardous waste under the final rule, resulting in fewer manifests being prepared. In addition, EPA estimates that sites that drop in generator status (e.g., change from LQG to SQG) will need to prepare fewer manifests because they will not need to ship their waste offsite as often as under the baseline. There are annual c apital cost savings of $244 for fewer file cabinets needed to keep records of manifests. There are annual O&M cost savings of $998 for fewer transmittals of manifests by mail.

 Hazardous Waste Generator Standards (EPA ICR Number 820). EPA estimates that sites that drop in generator status under Subpart K will see savings from reduced generator requirements. There are no capital cost savings. There are annual savings in O&M costs of $19. These savings are associated with the photocopying and transmittal of fewer records.

 The Hazardous Waste Report (EPA I CR Number 976). EPA estimates that L QGs that drop in generator status to SQGs under Subpart K will see savings for no longer preparing/submitting a Hazardous Waste Report. There are no capital cost savings. There are annual savings in O&M costs of $14. These savings are associated with the transmittal and recordkeeping of fewer forms. **6(e) Bottom Line Hour and Cost Burden**  **(1) Respondent Tally**  As shown in Exhibit 2, EPA estimates the total annual burden to respondents under the new paperwork requirements to be 2 7 , 719 hours and $ 1, 322 , 414 . Taking into account the annual burden relief to respondents under the existing paperwork requirements, the total net annual burden to respondents is estimated to be 2 5 , 817 hours and $ 1, 221 , 967 . The bottom

- line burden over three ye ars is estimated to be 77 , 450 hours and 3, 665 , 900
.46 **(2) Agency Tally**  As shown in Exhibit 3, EPA estimates the total annual burden to the government under the new paperwork requirements to be 25 hours and $888 . The bottom

- line burden over three years is estimated to be 75 hours and $2,664

. **6(f) Reasons for Change In Burden**  In establishing Subpart K , EPA has established some information collection requirements to ensure that the hazardous wastes at eligible academic entities are managed in a manner that is protective of human health and the environment. EPA believes these requirements are justified because the Subpart K regulations allow eligible academic entities flexibility to tailor their laboratory

operations to meet their individual circumstances, and remain protective of human health and the environment. Performance

- based standards for the man agement of hazardous wastes generated in laboratories provide a better opportunity for eligible academic entities to evaluate their overall hazardous waste management program, and tailor it in such a way that facilitates efficient and safe management of hazardous waste and minimizes burden, while at the same time maintaining a high standard of protection of human health and the environment. The alternative approach will help them centralize and coordinate their chemical management practices and achieve sound environmental performance. The annual respondent burden in this current ICR (#2317.02) is estimated to be 2 7 , 719 hours, which is an increase of 1 3 , 260 hours from the previousl y approved ICR

. This increase is an adjustment to the existing estimates bas ed on data gathered through industry consultations and review of the Resource Conservation and Recovery Act In formation (RCRAInfo) national database (see Attachments 1 and 2), not due to program changes. **6(g) Public Burden Statement**  The annual public reporting and recordkeeping burden for this collection of information is estimated to average .04 hours per response. The hourl y reporting burden associated with Subpart K is estimated to be 10 minutes per respondent. This includes time for preparing and submitting a Site Id entification Form to opt into Subpart K. The hourly recordkeeping burden associated with Subpart K is estimated to be approximately 2 80 hours per respondent. This includes time for reading the regulations, labeling containers, and preparing and maintaining specified documents (e.g., L aboratory Management Plan). To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket under Docket ID Number EPA
- HQ
- RCRA
- 2012
- 0 163 , which is available for online viewing at www.regulations.gov, or in person viewing at the Resource Conservation and Recovery Act (RCRA) Docket in the EPA Docket Center (EPA/DC),47

EPA West, Room 3334 , 1301 Constitution Avenue, NW, Washington, D.C. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday , excluding legal holidays. The telep hone number for the Reading Room is (202) 566

- 1744, and the telephone number for the Resource Conservation and Recovery Act (RCRA) Docket is ( 202 ) 566
- 0270. An electronic version of the public docket is available at http: **//**www.regulations.gov. This sit e can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically . When in the sy stem, select "search," then key

in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA
- HQ
- RCRA
- 2012
- 0 163 , and OMB Control Number 2050

–0204 in any correspondence.48

**EXHIBIT 1** GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES a ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN Hours and Costs per Respondent Total Hours and Costs Legal Manager Technical Clerical Respon. Hours/ Activity Labor

Cost/ Activity Capital/

Startup Cost O&M

Cost/ Activity Number of

Respondents/ Activities Total

Hours/ Year Total

Cost/ Year INFORMATION COLLECTION ACTIVITY $99.56/Hr $82.25/Hr $43.92/Hr $23.27/Hr **REA DING THE REGULA**  **TIONS** Read the regulations 0.00 0.00 1.00 0.00 1.00 $43.92 $0.00 $0.00 33 33.00 $1,449.36 **Subtotal** 0.00 0.00 1.00 0.00 1.00 $43.92 $0.00 $0.00 33 33.00 $1,449.36 **NOTIFICA**

**TION OF INTENT TO COMPLY WITH SUBPA RT K A**  **ND RECORDKEEPING OF A GREEMENTS (40**  **CFR 262.203)**  **Eligible A**

**cademic Entities** Prepare and submit Site Identification Form 0.00 0.10 0.30 0.10 0.50 $23.73 $0.00 $3.41 33 16.50 $895.64 Keep a c opy of the notification on file 0.00 0.00 0.00 0.10 0.10 $2.33 $0.00 $0.00 33 3.30 $76.89 **Teaching Hospitals**  Keep a copy of the formal written affiliation agreement on file 0.00 0.00 0.00 0.10 0.10 $2.33 $0.00 $0.00 1 0.10 $2.33 **Non -**  **Prof it Research Institutes**  Keep a copy of the formal written affiliation agreement on file 0.00 0.00 0.00 0.10 0.10 $2.33 $0.00 $0.00 2 0.20 $4.66 **Subtotal** 0.00 varies varies varies varies varies $0.00 varies varies 20.10 $979.52 **NOTIFICA**

**TION OF WITHDRA**

**WA L FROM SUBPA**  **RT K (40 CFR**  **262.204)** Prepare and submit Site Identification Form 0.00 0.10 0.30 0.10 0.50 $23.73 $0.00 $3.41 0 0.00 $0.00 Keep a copy of the withdrawal notice on file 0.00 0.00 0.00 0.10 0.10 $2.33 $0.00 $0.00 0 0.00 $0.00 **Subtotal** 0.00 0.10 0.30 0.20 0.60 $26.06 $0.00 $3.41 0 0.00 $0.00 **LA BELING**  **OF CONTA INERS OF UNW**  **AN TED M**  **ATERI AL** **IN THE LA BORA**  **TORY (40 CFR**  **262.206)** Label the containers as specified 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.14 742,442 12,621.51 $660,439.43 **Subtotal** 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.14 742,442 12,621.51 $660,439.43 **TR AI**  **NIN G (40**  **CFR 262.207)**  Provide training to all individuals in a laboratory 0.00 0.00 0.00 0.00 0.00 $0.00 $0.00 $0.00 99 0.00 $0.00 Maintain documentation demonstrating training for all laboratory workers (LQGs only) 0.00 0.00 0.00 0.00 0.00 $0.00 $0.00 $0.00 27 0.00 $0.00 **Subtotal** 0.00 0.00 0.00 0.00 0.00 $0.00 $0.00 $0.00 varies 0.00 $0.0049

**EXHIBIT 1 (continued)** GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES a ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN Hours and Costs per Respondent Total Hours and Costs Legal Manager Technical Clerical Respon. Hours/ Activity Labor

Cost/ Activity Capital/

Startup Cost O&M

Cost/ Activity Number of

Respondents/ Activities Total

Hours/ Year Total

Cost/ Year INFORMATION COLLECTION ACTIVITY $99.56/Hr $82.25/Hr $43.92/Hr $23.27/Hr **REMOVING CONTA INERS OF UNW**  **AN TED M**  **ATERI AL** **FROM THE LA BORA**  **TORY (40 CFR**  **262.208)** Ensure that containers of unwanted ma terial that exceed volume limits have the date of the exceedence on the label 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 0 0.00 $0.00 **Subtotal** 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 0 0.00 $0.00 **MA KING T**  **HE HA**

**ZA RDOUS W**  **AS TE DETERMINA**  **TION IN THE LA BORA**  **TORY (40 CFR**  **262.210)** Make the hazardous waste determination 0.00 0.00 0.00 0.00 0.00 $0.00 $0.00 $0.00 10,032 0.00 $0.00 Place ha zardous waste codes on the container label 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 10,032 170.54 $7,524.00 **Subtotal** 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 10,032 170.54 $7,524.00 **MA KING T**  **HE HA**

**ZA RDOUS W**  **AS TE DETERMINA**  **TION IN A N ON**  **- SITE CENTRA** **L ACCUMULA**  **TION A RE**  **A (40**  **CFR 262.211)**  Make hazardous waste determination 0.00 0.00 0.00 0.00 0.00 $0.00 $0.00 $0.00 732,410 0.00 $0.00 Place ha zardous waste codes on the container label 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 732,410 12,450.97 $549,307.50 **Subtotal** 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 732,410 12,450.97 $549,307.50 **MA KING T**  **HE HA**

**ZA RDOUS W**  **AS TE DETERMINA**  **TION A T**  **AN ON -**  **SITE INTERIM STA TUS OR PERMITTED TREA**  **TM ENT, STORAGE, OR DISPOSA** **L FA CILITY (40**  **CFR 262.212)**  Make hazardous waste determination 0.00 0.00 0.00 0.00 0.00 $0.00 $0.00 $0.00 0 0.00 $0.00 Place ha zardous waste codes on the container label 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 0 0.00 $0.00 **Subtotal** 0.00 0.00 0.017 0.00 0.017 $0.75 $0.00 $0.00 0 0.00 $0.00 **LA BORA** 

**TORY CLEA N**  **- OUTS (40**  **CFR 262.213)**  Document the activities of the laboratory clean
- out 0.00 0.00 0.03 0.00 0.03 $1.32 $0.00 $0.00 14,849 445.47 $19,600.47 Maintain records of the clean
- out 0.00 0.00 0.00 0.03 0.03 $0.70 $0.00 $0.00 14,849 445.47 $10,394.19 **Subtotal** 0.00 0.00 0.03 0.03 0.06 $2.02 $0.00 $0.00 14,849 890.94 $29,994.66 **LA BORA** 

**TORY M AN**  **AG EMENT PLA** **N (40 CFR**  **262.214)** Develop Laboratory Management Plan, or revise an existing written plan 0.00 5.12 35.80 0.00 40.92 $1,993.46 $0.00 $0.00 33 1,350.36 $65,784.18 Retain, review and revise the Laboratory Management Plan 0.00 0.00 1.33 0.00 1.33 $58.41 $0.00 $0.00 99 131.67 $5,782.59 Make the Laboratory Management Plan available to others 0.00 0.00 0.00 0.50 0.50 $11.64 $0.00 $0.00 99 49.50 $1,152.36 **Subtotal** 0.00 varies varies varies varies varies $0.00 $0.00 varies 1,531.53 $72,719.13 **TOTA L**  0.00 varies varies varies varies varies $0.00 varies varies 27,718.59 $1,322,413.60 a Exhibit contains rounding error.50

**EXHIBIT 2** GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES a ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN
- NEW AND EXISTING PAPER WORK REQUIREMENTS

**ICR Number Hours/Year**  **Labor Cost/Year Capital**  **Cost/Year O&M** 

**Cost/Year Total** 

**Cost/Year Paperwork Requirements**  **New Paperwork Requirements** Generator Standards Applicable to Laboratories at Eligible Academic Entities 2317 27,719 $1,218,69 4 $0 $103,720 $1,322,414 **Existing Paperwork Requirements** Requirements for Generators, Transporters, and Waste Management Facilities under the RCRA Hazardous Wa ste Manifest System 801 (1,612) ($81,667) ($244) ($998) ($82,909)

Hazardous W aste Generator Standards 820 (249) ($15,845) $0 ($19) ($15,864)
The Hazardous W aste Report 976 (41) ($1,660) $0 ($14) ($1,674) Subtotal: Existing Paperwork Requirements (1,902) ($99,172) ($244) ($1,031) ($100,447) Total under the Final Rule: New and Existing Paperwork 25,817 $1,119,521 ($244) $102,689 $1,221,967
a Table includes rounding error. Savings shown in parentheses.51

EXHIBIT 3 GENERATOR STANDARDS APPLICABLE TO LABORATORIES OWNED BY ELIGIBLE ACADEMIC ENTITIES a ESTIMATED ANNUAL AGENCY HOUR AND COST BURDEN
Hours and Costs per Respondent Total Hours and Costs
Legal Manager Technical Clerical Agency Hours/ Activity Labor

Cost/ Activity Capital/

Startup Cost O&M

Cost/ Activity Number of

Agency Activities Total

Hours/ Year Total

Cost/ Year INFORMATION COLLECTION ACTIVITY $67.27/Hr $67.32/Hr $55.6 2/Hr $25.99/Hr **NOTIFICA**

**TION OF INTENT TO COMPLY WITH SUBPA RT K A**  **ND RECORDKEEPING OF A GREEMENTS (40**  **CFR 262.203)**  Review and process Site Identification Forms 0.00 0.00 0.25 0.50 0.75 $26.90 $0.00 $0.00 33 24.75 $887.70 **Subtotal** 0.00 0.00 0.25 0.50 0.75 $26.90 $0.00 $0.00 33 24.75 $887.70 **NOTIFICA**

**TION OF WITHDRA**

**WA L FROM SUBPA**  **RT K (40 CFR**  **262.204)** Review and process Site Identification Forms 0.00 0.00 0.25 0.50 0.75 $26.90 $0.00 $0.00 0 0.00 $0.00 **Subtotal** 0.00 0.00 0.25 0.50 0.75 $26.90 $0.00 $0.00 0 0.00 $0.00 **TOTA L**  0.00 0.00 varies varies varies varies $0.00 $0.00 varies 24.75 $887.70
a Exhibit contains rounding error.52 

## ATTACHMENT **1 INFORMATION COLLECTION REQUEST**  **2317.02 BURDEN**  **ESTIMATE METHODOLOGY**

**Introduction** The Academic Laboratories Rule of 40 CFR part 262 subpart K, (also known as the “Labs Rule” or “Subpart K”) allows eligible academic entities to opt into an alternative set of generator regulations in lieu of the standard set of RCRA generator regulations. Opting into Subpart K entails some amount of burden for those choosing to opt in. In accordance with the 1995 Paperwork Reduction Act (as amended), EPA must estimate respondent burden associated with all regulatory

activities. Once burden estimates are developed, EPA submits an Information Collection Request (I CR) to the Office of Management and Budget (OMB) for approval. This document describes the methodology for updated burden estimates for the renewal of the ICR covering the regulatory

activities cited above. EPA consulted with six individuals about a total of eight different institutions: seven institutions that have already chosen to opt into Subpart K and one institution that is in the planning stages of opting in. **Summary of Consultations** Jeremy Kuhar (717

- 337
- 6261) wears several hats at Gettysburg College; he is an instructor, Chemical Hygiene Officer, and Lab Coordinator. He confirmed that Getty sburg College opted into Subpart K. He indicated that although Gettysburg College probabl y qualifies as a conditionally

exempt small quantity

generator (CESQG), the school notified and op erates as a RCRA small quantity

generator (SQG), just to be on the safe side. His institution has approximately

60 labs and a central accumulation area. He estimates the labs at the school generate 80
- 100 containers of hazardous waste per year. When he developed the school’s laboratory

management plan (LMP), he incorporated it into the school’s chemical hygi ene plan (CHP), a plan that is required by OSHA. He estimates that developing both plans (and reading the Federal Register notice) took 100

- 150 hour s. His school has not conducted any “documented” laboratory clean

- outs since he did not anticipate that it would affect the school’s hazardous waste generator status. Aisha Holloman (336

- 375
- 9232) is the Environmental Health & Safety M anager at Gateway University Research Park, a new non

-profit research institute that opened in December 2011. She confirmed that the research park is an SQG that has opted into Subpart K. The research park has 15 labs and two central accumulation areas. Given that the re search park is so new, she does not have an estimate of the number of containers of hazardous waste that each lab generates per ye ar and she has not had the need to conduct laboratory clean

- outs. She estimates that it took 60 hours to develop the LMP and the CHP together.53

Eric Engelberger (870

- 235
- 4196) is the Safety Officer at Southern Arkansas University. He confirmed that Souther Arkansas University has opted into Subpart K and that his school is a SQG. His school has 21

- 22 labs and a central accumulation area. He said that the laboratories do not generate containers of hazardous waste except during laboratory clean

- outs. He said that the Science Department is currentl y writing the LMP and incorporating it into the school’s OSHA CHP. He estimates that it will take 80 hours to develop the LMP and the CHP together. His school has conducted laboratory clean

- outs when they

moved into a new science building. Based on the amount of hazardous waste generated during the laboratory clean

- out, the school w ould have become an LQG if it had not been operating under Subpart K, but it stayed an SQG. Jen Stones (801

- 581
- 6590) is the Hazardous Materials Manager at the University of Utah. She confirmed that her school is an LQG that has opted into Subpart K. H er school has 800
- 900 labs and a central accumulations area. She estimates that the laboratories generate 22

- 28 55
- gallons drums of hazardous waste per month. She developed the LMP as a separate document and estimates that it took 40 hours to write. Her school has not conducted laboratory clean

- outs. Craig Barnhart ( cbarnhar@bulter.edu) works at Butler University . He confirmed that his school has opted into Subpart K and is an SQG. The school has 65

- 70 laboratories and a central accumulation area. He estimates that is laboratories generate 3500

- 4000 pounds of hazardous waste per ye ar . Working in tandem with another person, he estimates that it took 2

- 3 full working day s to develop the LMP, which is a separate document. His school has not conducted any laboratory

clean

- outs. Victoria Justus (717

- 418
- 3342) is a consultant with Was teStrategies. She works with colleges and universities, assisting them with their environmental compliance, which sometimes includes opting into Subpart K. She discussed three institutions with us: Milwaukee School of Engineering (MSOE), Lakewood Colleg e, and Philadelphia University (which is in the process of opting in). Victoria confirmed that MSOE opted into Subpart K for two sites

– one is CESQG and one is an SQG. The CESQG site has 9

- 10 labs and no central accumulation area while the SQG site ha s 50
- 65 laboratories and a central accumulation area. The CESQG site generates 4
- 5 drums of hazardous waste per year, while the SQG site generates 400

- 450 containers per year (1 liter

– 5 gallon containers). She developed one LMP for both MSOE sites as p art of OSHA’s CHP and estimates it took 100 hours. MSOE has conducted laboratory

clean

- outs and would have become an LQG if it had not been operating under Subpart K; but remained CESQG and SQG. Victoria confirmed that Lakewood College opted into Subpar t K and is an SQG. The school has 20

- 25 labs and no central accumulation area. The school’s laboratories generate 150
- 200 containers of hazardous waste per year. She does not have an estimate of the number of hours it took to develop the school’s LMP. The school has not conducted any l aboratory clean

- outs.54

Victoria informed us that Philadelphia University , an SQG, is in the process of opting into Subpart K. The school has 40

- 45 laboratories, with 30 more opening over the next 2 ye ars. The school does not have a central accumulation area currently , but plans to establish one. She estimates that the school’s laboratories generate 12

- 15 drums and 300 containers of hazardous waste per ye ar. The school’s LMP is currently under development and they

have n ot yet conducted any laboratory clean

- outs.
**Estimates of Burden** The estimates of burden associated with all regulatory activities identified in the Academic Laboratories ICR are updated based on the information obtained from the six consultations described above. If no information was obtained or available on an activity , it was assumed that the burden information contained in the previous pertinent I CR ( 2317.01 ) did not change for that activity . For this renewal, it was assumed that all L QGs have a c entral accumulation area because the waste quantities generated necessitate one and that no CESQGs have a central accumulation area, because the regulations do not provide for one. In several cases during the consultations, a range was given for the numb er of laboratories at an eligible academic entity . In these cases, the average was taken to establish the number of laboratories. Only one consultation was with an eligible academic entity that is an LQG. It has a central accumulation area, and 850 labo ratories, so it is a large LQG. Seven sites are SQGs. Five of the SQG sites have central accumulation areas, three of which have more than 50 laboratories, 2 of which of less than 50 laboratories. Two of the SQG sites do not have central accumulation ar eas and both have fewer than 50 laboratories so they are considered small SQGs. Only

one of the sites consulted was a CESQG. It did not have a central accumulation area and with only

10 laboratories, it is considered a small CESQG. For categories of sch ools and hospitals not represented via consultations, the number of laboratories is assumed to be the same as in the previous pertinent I CR. When asked how many containers of hazardous waste are generated in the laboratories each ye ar, respondents provided answers in ranges and in various units. For example, the University

of Utah said they

generate 22
- 28 55
- gallon drums per month. To arrive at a number of containers when a range was given, the average was taken to establish the number of containers. T o convert 55
- gallon drums to a number of containers per year, we assumed that the average container size for collecting hazardous waste in a laboratory is 1 gallon. Therefore, each 55
- gallon drum generated equates to 55 1

- gallons containers. The consultant for MSOE also reported the volume of hazardous waste at the CESQG site in the number of 55

- gallon drums it generates. The same conversion was used for MSOE. Butler University provided its estimate of hazardous waste in pounds. To convert this to a number of containers, it was assumed that each 1
- gallon container weighs 8 pounds (the approximate weight of a gallon of water). Gateway University

Research Park indicated that since the facility just opened in December 2011, it does not have an estimate of the number of containers of hazardous waste its laboratories generate, so this was excluded. Southern Arkansas University stated that it does not routinely generate containers of hazardous waste except during laboratory clean

- outs, so the number of containers per year is assumed to be zero.55

When calculating the average number of hours that it took an eligible academic entity to develop its LMP, the following assumptions were made. If an answer was provided that was a range, an average was taken to establish the number of hours. Butler University reported their answer in “working day s.” It was assumed that a working day was eight hours. If a respondent indicated that the LMP was developed as part of updating its OSHA CHP, the number of hours reported was divided by

two; half the time was assumed to be taken to develop or update the CHP and half the time was assumed to be taken to develop the LMP. Most respondents indicated that they

wrote the LMP and management reviewed it. It was assumed that the bulk of the time was spend writing the LMP (7/8 of the time) and a much small portion was spent reviewing it (1/8 of the time). Jeremy Kuhar of Getty sburg College said that his time estimate included reading the Federal Register notice, so two hours was su btracted to account for this. The number of hours for reviewing and making revisions to the LMP as well as making it available to others is assumed to be the same as in the previous pertinent ICR.56 

## ATTACHMENT 2 **Summary of Universe Calculations**
The Academic Laboratories Rule (the “Labs Rule” or “Subpart K”) was finalized in December 2008. It is optional for eligible academic entities to use the Labs Rule in lieu of standard RCRA generator regulations. Since the rule became effective, 39 eligible ac ademic entities have opted into the rule, according to the data in Resource Conservation and Recovery Act Information (RCRAInfo) national database 15 . The generator status of each of the 39 facilities was also determined using data available in RCRAInfo. Two of the eligible academic entities did not have a generator status listed in RCRAInfo. These two were eliminated from the universe calculations. **Eligible Academic Entities (EAEs) Opting into Subpart K, cumulative by year**

**Year EAEs opting in (cumulative)**  2009 1 2010 19  2011 28  2012 37 (as of May 3, 2012) **Eligible Academic Entities (EAEs) Opting into Subpart K, by year:**

**Year EAEs**  **opting in each year** 2009 1 2010 18 2011 9 2012 9 (as of May 3, 2012) 22 (projected for all of 2012) **Generator Status of Eligible Academic Entities (EAEs) that have Opted into Subpart K:**

15 RCRAInfo is a national system and database which EPA and States use to record and track information provided by the regulated community concerning the generation, shipment, treatment, and disposal of hazardous wastes

. This database is an EPA computer system for the use of EPA employees, as well as State and Territorial environmental agencies, working in their official capacities (see http://www.epa.gov/enviro/html/rcris/index.html ). Public access to RCRA Info and Biennial Report data can be found on

- line through the use of EPA's Envirofacts Data Warehouse http://www.epa.gov/enviro/html/rcris/rcris_query_java.html

.
 Excludes an entity that opted in but that does not have a generator status in RCRAInfo. Assumed not to be eligible to opt in.57 **Generator Status Number of EAEs**  **Percent of total EAEs** LQG 18 49% SQG 10 27% CESQG 9 24% Total 37 100% Since the data are not complete for 2012, we must project how many schools will opt into Subpart K for the remainder of 2012. If we project the same rate of adoption for the remainder of 2012, we should expect to see 13 more eligible academic entities opt in, for a total of 22 eligible academic entities opting in during 2012. Excluding 2009, since the rule was new and states were just beginning to adopt the L abs Rule, the average number of eligible academic entities that have opted in during the three ye ar period of 2010

- 2012, is 16 per year. If we project the same rate of adoption over the next three ye ars (2013

- 2015), 49 new eligible academic entities will have adopted b y the end of the next three ye ar period. Adding the 49 new eligible academic entities to the projected 13 more for 2012, we estimate that there will be 62 new eligible academic entities using Subpart K. If we add this to the existing 37 existing eligible academic entities already us ing the rule, we project a total of 99 eligible academic entities will have adopted b y the end of the 2015. If we project that the 62 new eligible academic entities will have the same proportion of LQGs, SQGs, and CESQGs, then we would expect to see the f ollowing: **Generator Status of Eligible Academic Entities (EAEs) that Will Opt into Subpart K:**

**Generator Status Projected Number**  **of New EAEs Projected Number of**  **total EAEs** LQG 30 48 SQG 17 27 CESQG 15 24 Total 62 99 When eligible academic entities opt into Subpart K they must notify as either a college/university (C/U), a non

-profit research institute (NPRI), a teaching hospital, or any combination of the above. Using data from RCRAInfo, the type of eligible academic entity was determined for each eligible academic entity that has opted into Subpart K. Then the percentage of each typ e of eligible academic entity was calculated by

generator status. These same percentages were used to project the proportion of the ty p es of eligible academic entities that will opt into Subpart K over the next three year period. Eligible academic entities that notified as both a college/university and a teaching hospital were counted as college/universities since based on professional e xperience, the number of teaching and research laboratories at that part of the58

institution usually

outnumber those found at the teaching hospital. This information was used to update Table 1 of the Supporting Statement for the I CR renewal.