SUPPORTING STATEMENT FOR 

INFORMATION COLLECTION REQUEST NUMBER 2317.02

“GENERATOR STANDARDS APPLICABLE TO LABORATORIES 

OWNED BY ELIGIBLE ACADEMIC ENTITIES”

(RENEWAL)

June 2012

Office of Resource Conservation and Recovery

United States Environmental Protection Agency

Washington, D.C. 20460
i

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 of 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

ATTACHMENT 1 - BURDEN ESTIMATE METHODOLOGY.............................................52

ATTACHMENT 2 - SUMMARY OF UNIVERSE CALCULATIONS .......................................56
1

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 by Eligible Academic Entities (Renewal),” EPA ICR 

Number 2317.02, 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 by 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 formally 

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 accordance 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 collection 

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 

Identification 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 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 each 
2

EPA Identification 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 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 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 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 copy 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 

Identification 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 notify that it is withdrawing from 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 each EPA 

Identification Number (or site, for conditionally 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 years 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 manage 
3

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 identified in 

Part I of 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 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 ways (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 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 Laboratory Management Plan whether it will comply with section 262.208(a)(1) or 
4

(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 

acutely hazardous unwanted material) before the regularly scheduled removal, the 

eligible academic entity must ensure that all containers of unwanted material (including 

reactive acutely 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 from the laboratory within 10 calendar days of the date that 55 gallons was 

exceeded, or at the next regularly 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 regularly scheduled removal, 

then the eligible academic entity must ensure that all containers of reactive acutely 

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 

regularly scheduled removal, whichever comes first (262.208(d)(2)(ii)).

(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 when and where large quantity 

generators and small quantity generators may make the hazardous waste determination. 

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 or 

disposal facility, 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 eligible 
5

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 hazardous 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 from OMB review and approval. 

For this reason, in this ICR, 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 Hazardous 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 area, 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 waste 
6

may be treated or disposed on-site or transported off-site (262.211(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 ICR, 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 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/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 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 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 ICR, 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 years from the date the clean-out ends.
7

(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 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 by an eligible academic entity to implement each 

element in Part II of its 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 Laboratory 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.
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 by 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 typical industrial production 

facilities. These differences provide the rationale for the rule at73 FR 72912. First, 

laboratories owned by colleges, universities and, teaching hospitals and non-profit 

research institutes that are either owned by or formally affiliated with a college or 

university have a large number of points of generation (i.e., points where waste is 

originally generated) such as multiple laboratory benchtops within a single laboratory and 

laboratories located at several areas on a single campus. Second, these laboratories tend 

to generate relatively 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 

relatively smaller number of predictable wastestreams in large quantities at relatively 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 inherently 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 professionally 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 Regional 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 need 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 submitted 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 greatly ease 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 some 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 

Identification Form to the EPA Regional Administrator or State Director in authorized 

States checking the box for withdrawing from 40 CFR Part 262, Subpart 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 enclosed 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 requirements. 

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 for 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 of 
10

unwanted material, or the 1 quart of acutely 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, storage 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 is 
11

needed 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 laboratories 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 comply with the Subpart K requirements 

may elect, at any time, to withdraw from the Subpart K program. 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 indicating 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 necessary 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 

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 will enable individuals to manage 

unwanted materials safely and in an environmentally sound manner, while in the 

laboratory.

In addition, LQGs 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 acutely 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 and 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 human 
13

health and the environment.

(9) Making the Hazardous Waste Determination at an On-site Interim Status or 

Permitted Treatment, Storage, or Disposal Facility

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 complying with the performance-based requirements of Subpart K.
14

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 

CRITERIA

3(a) Nonduplication

None of the information required by 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 received.

3(c) Consultations

The regulations covered by this ICR were promulgated using proper rulemaking

procedures. In updating this ICR, EPA spoke with a number of industry representatives. 

Their feedback is reflected in this ICR. 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, WasteStrategies (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 carefully 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 strongly 

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 

properly managed and do not pose a threat to human health and the environment.
15

3(e) General Guidelines

This ICR 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 

collection requirements covered in this ICR.

NAICS Codes of Entities Potentially Affected by the Subpart K Regulations

Description of NAICS Code NAICS Codes

Colleges and Universities

Junior 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 

Identification 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 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 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 teaching 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 copy 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 Land Type;

-- North American Industry Classification System (NAICS) Code(s) 

for the Site;

-- Site Mailing Address;

-- Site Contact Person;

-- Operator and Legal Owner of the Site;

-- Type of Regulated Waste Activity; and

-- Certification.

 A copy of the formal written affiliation agreement with a college or 

university , as specified under section 262.203(d). 

 A copy of the formal written 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 copy of the notification on file.

 Teaching hospitals that are not owned by a college or university must keep 

a copy 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 not owned by a college or university

must keep a copy 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 

Identification 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 notify that it is withdrawing from 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 each EPA 

Identification Number (or site, for conditionally 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 years 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 Location Information;

-- Site Land Type;

-- North American Industry Classification System (NAICS) Code(s) 

for the Site;

-- Site Mailing Address;

-- Site Contact Person;

-- Operator and Legal Owner of the Site;

-- Type of Regulated Waste Activity; and

-- Certification.

(ii) Respondent Activities:

 Prepare and submit Site Identification Form; and

 Keep a copy 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 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 identified in 

Part I of 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 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)). 

(i) Data Items:

 Information 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 I of 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).

- Type or class of chemical, such as organic solvents or 

halogenated organic solvents.

 Information 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

-- 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. For example, the following information 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 ways (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 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 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:

-- Sign-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 only).

(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 Laboratory 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 regularlyscheduled removal, the eligible academic entity must ensure that all containers of 

unwanted material (including reactive acutely 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 from the laboratory within 10 calendar days of the 

date that 55 gallons was exceeded, or at the next regularly 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 regularly scheduled removal, 
22

then the eligible academic entity must ensure that all containers of reactive acutely 

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 

regularly scheduled removal, whichever comes first (262.208(d)(2)(ii)).

(i) Data Items:

 Date that the laboratory accumulated more than 55 gallons of unwanted 

material.

 Date that the laboratory accumulated more than 1 quart of reactive acutely 

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 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. [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 material 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 Laboratory.”]

(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 

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 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.

(8) Making the Hazardous 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 area, 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; and
25

 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 years from the date the clean-out ends.

(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 Activities:

 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 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 by an eligible academic entity to implement each 

element in Part II of its Laboratory Management Plan may vary from the procedures 
26

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 Laboratory 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 I and II. In Part I of the 

Laboratory Management Plan, an eligible academic entity must:

-- Describe procedures for container labeling in accordance with 

section 262.206(a), including:

- Identifying whether the eligible academic entity will use 

the term “unwanted material” on the containers in the 

laboratory. If not, identify the equally effective term that 

will be used in lieu of “unwanted material” and consistently

by the eligible academic entity.

- Identifying the manner in which information that is 

“associated with the container” will be imparted.

-- Identify whether the eligible academic entity will comply with 

section 262.208(a)(1) or section 262.208(a)(2) for regularly 

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 academic 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 by trained professionals.

-- Describe procedures for removing unwanted material from the 

laboratory, including:

- For regularly 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 volumes.

-- 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 cleanouts 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 dangerous when they

exceed their expiration date and/or as they degrade; and 

- Procedures to safely dispose of chemicals that become 

more dangerous when they exceed their expiration date 

and/or as they degrade; and

- Procedures for the timely 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, 

students, 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 Containers 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 analyzing the information associated with this ICR, 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 CFR 262.203(a), an eligible academic entity must notify the appropriate 
30

EPA Regional Administrator in writing, using the RCRA Subtitle C Site Identification 

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 

Identification 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 laboratories 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 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 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 copy 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

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 Identification 

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 

notify 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 

each EPA Identification Number (or site, 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 file at the eligible academic entity for three years 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 attached 
31

to, or otherwise associated 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 employee last worked at 

the facility. 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 regularly scheduled removal, the eligible 

academic entity must ensure that all containers of unwanted material (including reactive 

acutely hazardous 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 acutely hazardous unwanted material before the regularly scheduled 

removal, then the eligible academic entity must ensure that all containers of reactive 

acutely 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 or 
32

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 Laboratory

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 transported 

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, Storage, 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 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.
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 years 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. ESTIMATING 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 type) 

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, $43.92 for technical staff, and $23.27 for clerical staff. 

These hourly labor rates are based on the most current estimates of national crossindustry wages by the U.S. Bureau of Labor Statistics1

for the following occupational 

groups, respectively, multiplied by a factor2of 1.6741 to account for fringe benefits3and 

overhead4: 

SOC 23-1011: Lawyers; 

SOC 11-1021: General & Operations Managers; 

SOC 17-2081: Environmental Engineers and SOC 17-3025: 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 hourly wage rates 

outlined in this section, Exhibit 1 estimates the labor costs associated with the 

information collection requirements covered in this ICR. 

(2) Capital Costs

 

1 US Bureau 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 

Employee 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 physical 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 information 

collection requirements covered in this ICR.

(3) Operation & Maintenance Costs

O&M costs are those costs associated with a paperwork requirement incurred 

continually over the life of the ICR. This ICR includes O&M costs for postage (i.e., 

$2.95 currently for certified mail) and envelope (i.e., $0.011). The ICR includes $0.14

per container label.

To update the O&M costs in the previous ICR (2317.01), which were based 

mainly on the 2008 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 2008 index (210.228) and 

December 2011 index (225.672) to develop an adjustment factor of 1.0735 (= 225.672 / 

210.228). 

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 following 

average loaded hourly wage rates for government labor: $67.27 per hour for legal staff, 

$67.32 per hour for managerial staff, $55.62 per hour for technical staff, and $25.99 per 

hour for clerical staff. These hourly labor rates are based on the most current estimates of 

State government wages by the U.S. Bureau of Labor Statistics5for occupational groups 

SOC 23-1011: Lawyers; SOC 11-1021: General & Operations Managers; SOC 17-2081: 

Environmental Engineers; and SOC 43-9061: Office Clerks, General, respectively, 

multiplied by a factor6of 1.7073 to account for fringe benefits7and overhead8. 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, EPA 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) “Employer Costs for 

Employee 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 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/.
36

requirements. Finally, EPA estimates the burden impacts to respondents under the 

existing RCRA generator paperwork standards. 

EPA obtained most of the data and assumptions for the burden calculations in the 

previous ICR (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 presents the total number of sites at eligible academic entities that are 

expected to opt into Subpart K during the three-year period covered by this ICR. The 

table shows the number of large quantity generators (LQGs), small quantity generators 

(SQGs), and conditionally 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 – Summary 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 only 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 

presented in Tables 1 and 2. Specifically, EPA multiplied the total number of sites opting 

into Subpart K (see Table 1) by 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 estimates that 

732,410 containers will be generated by sites with CAAs and 10,032 will be generated by 

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 Subpart
37

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 LQGs + 27 SQGs + 24 CESQGs) during the three-year life of this ICR. EPA expects 

that employees at these sites will read the Subpart K regulations once during the 

three-year life of this ICR. In estimating the annual incremental burden to respondents 

over the three-year period covered by 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, 33 sites (i.e., 99 sites / 3 years) will read the regulations each year.
38

Table 1

Total Number of Sites at Eligible Academic Entities Opting into Subpart K

During Three-Year Life of ICRa

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

Largeb45 0 45 11 0 11 0 0 0 56 0 56

Smallc0 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

Largeb0 0 0 0 0 0 0 0 0 0 0 0

Smallc0 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

Largeb0 0 0 0 0 0 0 0 0 0 0 0

Smallc0 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 Larged0 0 0 0 0 0 0 0 0 0 0 0

Largee3 0 3 0 0 0 0 0 0 3 0 3

Smallf0 0 0 0 0 0 0 0 0 0 0 0

Very Smallg0 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 Unwanted Material Containers Per Laboratory

(Data are presented only for sites opting into Subpart Ka)

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

Largeb850 labs and

19 containers / lab

*

62 labs and

5 containers / lab

* * *

Smallc

* *

18 labs and

0 containers / lab

33 labs and

18 containers / lab

*

10 labs and

22 containers 

/ lab

2-Year Colleges and Universities

Largeb* * * * * *

Smallc* * * * * *

Vocational Schools

Largeb* * * * * *

Smallc* * * * * *

Teaching Hospitals

Very Larged501 labs and 

34 containers / lab

* * * * *

Largee15 labs and 

50 containers / lab

* * * * *

Smallf

* *

6 labs and 

7 containers / lab

6 labs and 

7 containers / lab

*

2 labs and 

5 containers / 

lab

Very Smallg* * * * * *

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 Ka

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

Largeb726,750 0 726,750 3,410 0 3,410 0 0 0 730,160 0 730,160

Smallc0 0 0 0 4,752 4,752 0 5,280 5,280 0 10,032 10,032

Subtotal 726,750 0 726,750 3,410 4,752 8,162 0 5,280 5,280 730,160 10,032 740,192

2-Year Colleges and Universities

Largeb0 0 0 0 0 0 0 0 0 0 0 0

Smallc0 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

Largeb0 0 0 0 0 0 0 0 0 0 0 0

Smallc0 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 Larged0 0 0 0 0 0 0 0 0 0 0 0

Largee2,250 0 2,250 0 0 0 0 0 0 2,250 0 2,250

Smallf0 0 0 0 0 0 0 0 0 0 0 0

Very Smallg0 0 0 0 0 0 0 0 0 0 0 0

Subtotal 2,250 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 is electing to be subject to Subpart K for all 

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 notify for all 

laboratories that are owned or operated by the eligible academic entity that are on-site. In 

estimating the annual incremental burden to respondents over the three-year period 

covered by 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, 33

forms (i.e., 99 forms/3 years) will be prepared, submitted, and retained.

Teaching hospitals opting into Subpart K must keep a copy 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. In estimating the annual 

incremental burden to them over the three-year period covered by this ICR, EPA 

annualized the burden of this one-time activity by dividing the number of respondents by

three. Thus, EPA estimates that, each year, 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 separately from four-year colleges and universities that are opting 

in. Rather, it estimates the combined number of sites at four-year colleges and 

universities and non-profit research institutes opting into Subpart K (i.e., 96 sites in total). 

For purposes of this ICR, EPA has made the simplifying assumption that approximately

five percent of these sites are non-profit research institutes (i.e., 5 sites).9 In estimating

the annual incremental burden to them over the three-year period covered by this ICR, 

EPA annualized the burden of this one-time activity by dividing the number of 

respondents by three. Thus, EPA estimates that, each year, two sites (i.e., 5 sites/3 years) 

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-year 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 year. 

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, LQGs must maintain training 

records for laboratory workers. EPA’s impact assessment estimates 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 found, for example, that the predominant 

practice by colleges and universities currently 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) Removing 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 

acutely reactive unwanted material before the regularly scheduled removal. As a result, 

EPA estimates that none 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 “Table 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 

impact 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 year, 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 analysis, 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 

waste determination will be made for each container of unwanted material at the CAAs. 

Based on the data in Table 3, EPA estimates that, each year, 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 analysis, 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-year period covered by this ICR.
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 addition, EPA estimates that 10 percent of all 

of the containers of unwanted material generated by these laboratories during the year 

will originate from their laboratory clean-out. Hence, EPA multiplied the total number of 

containers in Table 3 by 20 percent and 10 percent, to estimate that 14,849 containers 

will originate from laboratory clean-outs annually (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 ICR, EPA 

assumes that they will revise an existing plan (e.g., Chemical Hygiene Plan) to comply 

with the Laboratory Management Plan requirement. In estimating the annual incremental 

burden to respondents over the three-year period covered by 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 33 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 Requirements

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 by 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 eligible 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 ICR 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 System (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 

capital 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 ICR Number 976). EPA estimates 

that LQGs 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 27,719 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 25,817 hours 

and $1,221,967. The bottom-line burden over three years 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 management 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 

27,719 hours, which is an increase of 13,260 hours from the previously approved ICR. 

This increase is an adjustment to the existing estimates based on data gathered through 

industry consultations and review of the Resource Conservation and Recovery Act 

Information (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 hourly reporting burden associated with Subpart K is estimated to be 10 

minutes per respondent. This includes time for preparing and submitting a Site 

Identification Form to opt into Subpart K. The hourly recordkeeping burden associated 

with Subpart K is estimated to be approximately 280 hours per respondent. This includes 

time for reading the regulations, labeling containers, and preparing and maintaining 

specified documents (e.g., Laboratory 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-2012-0163, 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 telephone 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 site 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 system, 

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-2012-0163, 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

READING THE REGULATIONS

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

NOTIFICATION OF INTENT TO COMPLY WITH SUBPART K AND RECORDKEEPING OF AGREEMENTS (40 CFR 262.203)

Eligible Academic 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 copy 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-Profit 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

NOTIFICATION OF WITHDRAWAL FROM SUBPART 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

LABELING OF CONTAINERS OF UNWANTED MATERIAL IN THE LABORATORY (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

TRAINING (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 $0.00
49

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 CONTAINERS OF UNWANTED MATERIAL FROM THE LABORATORY (40 CFR 262.208)

Ensure that containers of unwanted 

material 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

MAKING THE HAZARDOUS WASTE DETERMINATION IN THE LABORATORY (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 hazardous 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

MAKING THE HAZARDOUS WASTE DETERMINATION IN AN ON-SITE CENTRAL ACCUMULATION AREA (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 hazardous 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

MAKING THE HAZARDOUS WASTE DETERMINATION AT AN ON-SITE INTERIM STATUS OR PERMITTED TREATMENT, STORAGE, OR DISPOSAL FACILITY (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 hazardous 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

LABORATORY CLEAN-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 

LABORATORY MANAGEMENT PLAN (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

TOTAL 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 ENTITIESa

ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN - NEW AND EXISTING PAPERWORK 

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 $1,218,694 $0 $103,720 $1,322,414 

Existing Paperwork Requirements

Requirements for Generators, 

Transporters, and Waste Management 

Facilities under the RCRA Hazardous 

Waste Manifest System

801 (1,612) ($81,667) ($244) ($998) ($82,909)

Hazardous Waste Generator Standards 820 (249) ($15,845) $0 ($19) ($15,864)

The Hazardous Waste 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 $55.62/Hr $25.99/Hr

NOTIFICATION OF INTENT TO COMPLY WITH SUBPART K AND RECORDKEEPING OF AGREEMENTS (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

NOTIFICATION OF WITHDRAWAL FROM SUBPART 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

TOTAL 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 (ICR) 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 Gettysburg 

College opted into Subpart K. He indicated that although Gettysburg College probably qualifies 

as a conditionally exempt small quantity generator (CESQG), the school notified and operates 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 hygiene plan 

(CHP), a plan that is required by OSHA. He estimates that developing both plans (and reading 

the Federal Register notice) took 100-150 hours. 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 Manager 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 research park is so 

new, she does not have an estimate of the number of containers of hazardous waste that each lab 

generates per year 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 currently 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 

would 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. Her 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 year. Working in tandem with another person, he estimates that it took 2-3 full 

working days 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 WasteStrategies. 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 College, 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 has 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 part 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 Subpart 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 laboratory 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 

years. 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 year. The school’s LMP is currently under 

development and they have not 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 ICR (2317.01) did not 

change for that activity. For this renewal, it was assumed that all LQGs have a central 

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 number 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 laboratories, 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 areas 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 schools 

and hospitals not represented via consultations, the number of laboratories is assumed to be the 

same as in the previous pertinent ICR.

When asked how many containers of hazardous waste are generated in the laboratories 

each year, 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. To 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 days.” 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 Gettysburg College said that his time estimate 

included reading the Federal Register notice, so two hours was subtracted 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 academic 

entities have opted into the rule, according to the data in Resource Conservation and Recovery

Act Information (RCRAInfo) national database15. 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 Labs 

Rule, the average number of eligible academic entities that have opted in during the three year 

period of 2010-2012, is 16 per year. If we project the same rate of adoption over the next three 

years (2013-2015), 49 new eligible academic entities will have adopted by the end of the next 

three year 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 using the rule, we project a total of 99 

eligible academic entities will have adopted by 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 following:

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 type of eligible academic entity was calculated by generator status. These same 

percentages were used to project the proportion of the types 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 experience, the number of teaching and research laboratories at that part of the 
58

institution usually outnumber those found at the teaching hospital. This information was used to 

update Table 1 of the Supporting Statement for the ICR renewal.