SUPPORTING STATEMENT FOR 

EPA INFORMATION COLLECTION REQUEST NUMBER 2486.01

REPORTING AND RECORDKEEPING REQUIREMENTS FOR THE 

PROPOSED RULE ON MANAGEMENT STANDARDS FOR 

HAZARDOUS WASTE PHARMACEUTICALS 

June 2015
ii

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...............................................................3

2(a) Need and Authority for the Collection ....................................................................3

2(b) Practical Utility and Users of the Data ...................................................................3

3. NONDUPLICATION, CONSULTATIONS, AND OTHER 

COLLECTION CRITERIA ................................................................................................3

3(a) Nonduplication ........................................................................................................3

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

3(c) Consultations ...........................................................................................................4

3(d) Effects of Less Frequent Collection ........................................................................4

3(e) General Guidelines ..................................................................................................4

3(f) Confidentiality .........................................................................................................4

3(g) Sensitive Questions..................................................................................................4

4. THE RESPONDENTS AND THE INFORMATION REQUESTED.................................5

4(a) Respondents and SIC/NAICS Codes.......................................................................5

4(b) Information Requested ............................................................................................5

5. THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT.......................................16

5(a) Agency Activities ..................................................................................................16

5(b) Collection Methodology and Management ...........................................................16

5(c) Small Entity Flexibility ...................................................................17

5(d) Collection Schedule .......................................................................17

6. ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION...............17

6(a) Estimating Respondent Burden .............................................................................17

6(b) Estimating Respondent Costs ...............................................................................17

6(c) Estimating Agency Burden and Costs ...................................................................18

6(d) Estimating the Respondent Universe and Total Burden and Costs .......................18

6(e) Bottom Line Burden Hours and Costs...................................................................21

6(f) Reasons for Change in Burden .............................................................................22

6(g) Burden Statement ..................................................................................................22
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EXHIBITS

Estimated Annual Respondent Burden and Costs (Exhibit 1)............................................23

Estimated Annual Respondent Burden and Cost Savings 

And Net Annual Respondent Burden and Costs.............................................................24
1

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title and Number of the Information Collection

This information Collection Request (ICR) is entitled “Reporting and Recordkeeping 

Requirements for the Proposed Rule on Management Standards for Hazardous Waste 

Pharmaceuticals,” EPA ICR Number 2486.01.

1(b) Short Characterization

Section 3001 of the Resource Conservation and Recovery Act (RCRA) of 1976, as 

amended, requires the Environmental Protection Agency (EPA) to identify which solid wastes 

are hazardous wastes and therefore must be managed as hazardous waste during treatment, 

storage, or disposal. Under this authority, EPA established four hazardous waste characteristics 

(toxicity, reactivity, ignitability, and corrosivity), and listed specific wastes that must be 

managed as hazardous wastes. A small portion of pharmaceuticals are regulated as hazardous 

waste under Subtitle C of RCRA when discarded. However, healthcare (and associated) 

facilities that generate hazardous waste pharmaceuticals have reported having difficulties 

complying with the manufacturing-oriented framework of the Subtitle C hazardous waste 

regulations for several reasons, including the following:

 Healthcare workers are typically unfamiliar with the hazardous waste regulations, as their 

primary focus is to provide healthcare to their patients.

 Healthcare facilities stock thousands of items in their drug formularies and may find it 

difficult to ascertain which items are hazardous wastes when disposed.

 Some pharmaceuticals are listed as acute hazardous wastes under RCRA, which are 

stringently regulated even in small amounts. 

To facilitate compliance and to respond to the above concerns, EPA is proposing to 

revise the regulations to improve management and disposal of hazardous waste pharmaceuticals

and tailor them to address the specific issues that hospitals, pharmacies and other healthcarerelated facilities face. The revisions are also intended to clarify regulation of the reverse 

distribution mechanism used by healthcare facilities for management of unused and/or expired 

pharmaceuticals. In 2008, the Agency proposed to address pharmaceutical hazardous waste 

management issues by adding them to the Universal Waste program (73 FR 73520; December 2, 

2008). However, in order to address the adverse comments received on the 2008 proposal, EPA 

is now re-proposing sector specific regulations for the management of hazardous waste 

pharmaceuticals.

In the current proposal, EPA is adding a new subpart P under part 266. This new subpart 

is a tailored, sector-specific regulatory framework for managing hazardous waste 
2

pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. If finalized, 

healthcare facilities that are currently small quantity generators (SQGs) or large quantity 

generators (LQGs) and all pharmaceutical reverse distributors, regardless of RCRA generator 

category, will be required to manage hazardous waste pharmaceuticals under this new subpart P 

of part 266, in lieu of part 262. That is, the proposed standards are not an optional alternative to 

managing hazardous waste pharmaceuticals under part 262, they are mandatory standards. 

Briefly, healthcare facilities will have different management standards for their noncreditable and creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste 

pharmaceuticals will be managed on-site similar to how they would have been under the 2008 

Universal Waste proposal for pharmaceutical waste. When they are shipped off-site, they must 

be transported as hazardous wastes and sent to a RCRA interim status or permitted hazardous 

waste facility. On the other hand, healthcare facilities will continue to be allowed to send 

creditable hazardous waste pharmaceuticals to reverse distributors for processing manufacturers’ 

credit. In response to comments received on the Universal Waste proposal, EPA is proposing 

standards to ensure the safe and secure delivery of the creditable hazardous waste 

pharmaceuticals to reverse distributors. 

EPA is also proposing standards for the accumulation of the creditable hazardous waste 

pharmaceuticals at reverse distributors. Similar to healthcare facilities, reverse distributors will 

not be regulated under part 262 as generators, nor will they be regulated under parts 264, 265 and 

270 as TSDFs. The proposal regards reverse distributors as a new type of hazardous waste entity

called pharmaceutical reverse distributors. The proposed standards for reverse distributors are, 

in many respects, similar to the LQGs standards, with some supplementary standards that were 

added to respond to commenters’ concerns. 

The key provisions of EPA’s proposal are:

 Sewer disposal of hazardous waste pharmaceuticals is prohibited.

 Hazardous waste pharmaceuticals managed under the new rule are not counted toward a 

facility’s RCRA generator status.

 Long-term care facilities currently exempt from RCRA under the household hazardous 

waste exclusion must comply with the rule requirements.

 Potentially creditable hazardous waste pharmaceuticals sent to a reverse distributor must 

ship with a return receipt notification.

 Reverse distributors must comply with LQG-like standards regardless of the quantity of 

hazardous waste pharmaceuticals that they manage.
3

2. NEED FOR AND USE OF THE COLLECTION

2(a) Need and Authority for the Collection

The requirements covered in this ICR are necessary for EPA to identify the universe of 

healthcare facilities and pharmaceutical reverse distributors managing hazardous waste 

pharmaceuticals under 40 CFR part 266 subpart P. The notification requirements are needed to 

assist the Agency and regulated facilities in tracking hazardous waste pharmaceuticals. In 

addition, EPA is proposing to require that healthcare facilities and pharmaceutical reverse 

distributors must keep records of any test results, waste analyses or other determinations made 

on hazardous waste pharmaceuticals for three years from the date that the hazardous waste 

pharmaceuticals were sent for treatment, storage and disposal.

2(b) Practical Utility and Users of the Data

EPA will use the collected information to ensure that hazardous waste pharmaceuticals

are being managed in a protective manner. The tracking requirements ensure that these 

hazardous wastes arrive at their intended destinations rather than facilities not equipped to 

manage these hazardous wastes. These tracking requirements will also help facilities identify

shipments that do not arrive at their destination as planned, allowing generators to take corrective 

action that will ensure that future shipments are transported to the appropriate location. In 

addition, during a facility inspection, information kept in facility records will help EPA and state 

environmental regulatory agencies determine whether or not regulatory requirements are being 

followed. Information marked on pharmaceutical waste containers will assist handlers and 

transporters in ensuring proper management during storage and shipment.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 

CRITERIA 

3(a) Nonduplication

None of the information required by the proposed rule would duplicate information 

required by existing RCRA regulations.

3(b) Public Notice

In compliance with the Paperwork Reduction Act of 1995, EPA will open a 90-day

public comment period at the time that this proposed rule is published in the Federal Register. 

To assist the public in commenting on the proposal, EPA raised a number of issues in the 

preamble to the proposed rule and asked for the public to comment on them. At the end of the 

comment period, EPA will review public comments received in response to the notice and will 

address comments received, as appropriate.
4

3(c) Consultations

EPA consulted and collected information from interested parties over several years to 

support the proposed amendment to the Universal Waste Rule (the 2008 proposal). EPA staff 

made site visits to hospitals and other pharmaceutical waste generators, met with reverse 

distributors, and communicated with states and other interested parties. The summaries of the 

site visits, meetings, and telephone conversations with interested parties are available in the 

docket for the proposed rule (Docket ID No. EPA-HQ-RCRA-2007-0932). Additional site visits 

and consultations have been made to support this new proposal.

3(d) Effects of Less Frequent Collection

EPA has carefully considered the burden imposed upon the regulated community by the 

proposed rule. 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. EPA believes 

strongly that, if the minimum information collection requirements of the proposed rule are not 

met, neither the industry nor EPA will be able to ensure that pharmaceutical wastes are being 

managed in a manner protective of human health and the environment.

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

Section 3007(b) of RCRA and 40 CFR Part 2, Subpart B, which defines EPA’s general 

policy on public disclosure of information, contain provisions for confidentiality. However, the 

Agency does not anticipate that businesses will assert a claim of confidentiality covering all or 

part of the proposed rule. If such a claim were asserted, EPA must and will treat the information 

in accordance with the regulations cited above. 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 proposed rule.
5

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) Respondents and NAICS Codes

The following is a list of North American Industrial Classification System (NAICS) 

codes associated with the facilities most likely to be affected by the information collection 

requirements covered in this ICR.

NAICS Facility Type

44611 Pharmacies

54194 Veterinary Clinics

6211 Physicians’ Offices

6212 Dentists’ Offices

6213 Other Health Practitioners (e.g. chiropractors)

6214 Outpatient Care Centers

6219 Other Ambulatory Health Care Services

622 Hospitals

6231 Nursing Care Facilities (e.g., assisted

living facilities, nursing homes, veterans 

domiciliary centers)

623311 Continuing Care Retirement Communities

(e.g., assisted living facilities with 

on-site nursing facilities)

Subset of 92219 Medical Examiners and Coroners’ Offices

Various NAICS Reverse Distributors (RDs)

4(b) Information Requested

This section describes reporting and recordkeeping requirements for facilities managing 

hazardous waste pharmaceuticals under the proposed rule. 

(1) Healthcare Facilities Managing Non-Creditable Hazardous Waste Pharmaceuticals

Under 40 CFR § 266.502.

(A) Notification. A healthcare facility must notify the EPA Regional Administrator,

using the Site Identification Form (EPA form 8700-12), that it is a healthcare facility operating 

under this subpart. A healthcare facility is not required to fill out Box 11 (Description of 

Hazardous Waste) of the Site Identification Form with respect to its hazardous waste 
6

pharmaceuticals. A healthcare facility must submit a separate notification (Site Identification 

Form) for each site or EPA Identification Number.

(i) A healthcare facility that already has an EPA identification number must re-notify the 

EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a 

healthcare facility, within 60 days of the effective date of this subpart.

(ii) A healthcare facility that does not have an EPA identification number must obtain one 

by notifying the EPA Regional Administrator, using the Site Identification form (EPA form 

8700-12), that it is a healthcare facility, within 60 days of the effective date of this subpart.

(iii) A healthcare facility must keep a copy of its notification on file for as long as the 

facility is subject to this subpart.

(B) Notification of Withdrawal. A healthcare facility that operated under this subpart but 

is no longer subject to this subpart, because it is a conditionally exempt small quantity generator 

under 40 CFR § 261.5, and elects to withdraw from this subpart, must notify the appropriate 

EPA Regional Administrator using the Site Identification Form (EPA form 8700-12) that it is no 

longer operating under this subpart. A healthcare facility is not required to fill out Box 11 

(Description of Hazardous Waste) of the Site Identification Form with respect to its hazardous 

waste pharmaceuticals. A healthcare facility must submit a separate notification (Site 

Identification Form) for each EPA Identification Number.

(i) A healthcare facility must submit the Site Identification Form notifying that it is 

withdrawing from this subpart before it begins operating under the conditional exemption of § 

261.5(b). 

(ii) A healthcare facility must keep a copy of its withdrawal on file for three years from 

the date of signature on the notification of its withdrawal.

(C) Labeling. A healthcare facility must label or clearly mark each container of 

hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals.” 

(D) Accumulation Time. A healthcare facility that accumulates non-creditable hazardous 

waste pharmaceuticals on-site must demonstrate the length of time that the hazardous waste 

pharmaceuticals have been accumulating, starting from the date it first becomes a waste. A 

healthcare facility may make this demonstration by any of the following methods:

(i) Marking or labeling the container of non-creditable hazardous waste pharmaceuticals 

with the date that hazardous waste pharmaceuticals became a waste;

(ii) Maintaining an inventory system that identifies the date the non-creditable hazardous 

waste pharmaceutical being accumulated first became a waste;
7

(iii) Placing the non-creditable hazardous waste pharmaceuticals in a specific area and 

identifying the earliest date that any of the non-creditable hazardous waste pharmaceuticals in 

the area became a waste; or

(iv) Any other method which clearly demonstrates the length of time that the noncreditable hazardous waste pharmaceuticals have been accumulating from the date it first became 

a waste. 

(E) Tracking Rejected/Returned Shipment. Upon receipt of the returned shipment, the 

healthcare facility must:

(i) sign either

(a) Item 18c of the original manifest, if the original manifest was used for the 

returned shipment; or

(b) Item 20 of the new manifest, if a new manifest was used for the returned 

shipment; 

(ii) Provide the transporter a copy of the manifest; 

(iii) Within 30 days of delivery of the rejected shipment, send a copy of the manifest to 

the designated facility that returned the shipment to the healthcare facility; and

(iv) Transport or offer for transport the returned shipment in accordance with the 

shipping standards of § 266.508(a).

(F) Exception report for a missing copy of the manifest. For shipments from a 

healthcare facility to a designated facility: If a healthcare facility does not receive a copy of the 

manifest with the handwritten signature of the owner or operator of the designated facility within 

60 days of the date the non-creditable hazardous waste pharmaceuticals were accepted by the 

initial transporter, the healthcare facility must submit:

(i) A legible copy of the original manifest, indicating that the healthcare facility has not 

received confirmation of delivery, to the EPA Regional Administrator for the Region in which 

the healthcare facility is located, and

(ii) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, 

stating that the return copy was not received and explaining the efforts taken to locate the noncreditable hazardous waste pharmaceuticals and the results of those efforts.

For shipments rejected by the designated facility and shipped to an alternate facility: If a 

healthcare facility does not receive a copy of the manifest for a rejected shipment of the noncreditable hazardous waste pharmaceuticals that is forwarded by the designated facility to an 

alternate facility (using appropriate manifest procedures), with the handwritten signature of the 

owner or operator of the alternate facility within 60 days of the date the waste was accepted by
8

the initial transporter forwarding the shipment of non-creditable hazardous waste 

pharmaceuticals from the designated facility to the alternate facility, the healthcare facility must 

submit:

(iii) A legible copy of the original manifest, indicating that the healthcare facility has not 

received confirmation of delivery, to the EPA Regional Administrator for the Region in which 

the healthcare facility is located, and

(iv) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, 

stating that the return copy was not received and explaining the efforts taken to locate the noncreditable hazardous waste pharmaceuticals and the results of those efforts.

(G) Additional reports. The EPA Regional Administrator may require healthcare 

facilities to furnish additional reports concerning the quantities and disposition of non-creditable 

hazardous waste pharmaceuticals.

(H) Recordkeeping.

(i) A healthcare facility must keep a copy of each manifest signed in accordance with § 

262.23(a) for three years or until it receives a signed copy from the designated facility which 

received the non-creditable hazardous waste pharmaceuticals. This signed copy must be retained 

as a record for at least three years from the date the waste was accepted by the initial transporter.

(ii) A healthcare facility must keep a copy of each exception report for a period of at least 

three years from the date of the report.

(iii) A healthcare facility must keep records of any test results, waste analyses, or other 

determinations made to support its hazardous waste determination(s) for at least three years from 

the date of the test, analysis, or other determination.

(iv) The periods of retention referred to in this section are extended automatically during 

the course of any unresolved enforcement action regarding the regulated activity, or as requested 

by the EPA Regional Administrator.

(2) Healthcare Facilities Managing Potentially Creditable Hazardous Waste 

Pharmaceuticals Under 40 CFR § 266.503.

(A) Hazardous Waste Determination. A healthcare facility that generates a solid waste that 

is a potentially creditable pharmaceutical must determine whether the potentially creditable solid 

waste pharmaceutical is a potentially creditable hazardous waste pharmaceutical (i.e., it’s listed 

in part 261 subpart D or exhibits a characteristic identified in part 261 subpart C). A healthcare 

facility may choose to manage its potentially creditable solid waste pharmaceuticals as 

potentially creditable hazardous waste pharmaceuticals under § 266.509 even if the solid waste 

pharmaceuticals do not exhibit a characteristic identified in part 261 subpart C and are not listed 

in part 261 subpart D. 
9

(B) Recordkeeping. A healthcare facility that initiates a shipment of potentially creditable 

hazardous waste pharmaceuticals to a pharmaceutical reverse distributor must keep the following 

records (paper of electronic) for each shipment of potentially creditable hazardous waste 

pharmaceuticals to a pharmaceutical reverse distributor, for 3 years from the date of shipment:

(i) a copy of the advance notification provided to the pharmaceutical reverse distributor

(ii) the confirmation of delivery and

(iii) the shipping papers or bill of lading.

The periods of retention referred to in this section are extended automatically during the 

course of any unresolved enforcement action regarding the regulated activity, or as requested by

the EPA Regional Administrator.

(3) Shipping Non-Creditable Hazardous Waste Pharmaceuticals from a Healthcare 

Facility or Evaluated Hazardous Waste Pharmaceuticals from a Pharmaceutical 

Reverse Distributor Under 40 CFR § 266.508.

(A) Packaging. A healthcare facility or pharmaceutical reverse distributor must package 

the waste in accordance with the applicable Department of Transportation regulations on 

packaging under 49 CFR parts 173, 178, and 179.

(B) Labeling. Label each package in accordance with the applicable Department of 

Transportation regulations on hazardous materials under 49 CFR part 172.

(C) Marking. Mark each package of hazardous waste pharmaceuticals in accordance with 

the applicable Department of Transportation regulations on hazardous materials under 49 CFR 

part 172; Mark each container of 119 gallons or less used in such transportation with the 

following words and information in accordance with the requirements of 49 CFR 172.304:

HAZARDOUS WASTE—Federal Law Prohibits Improper Disposal. If found, contact the nearest police or 

public safety authority or the U.S. Environmental Protection Agency.

Healthcare Facility’s or Pharmaceutical Reverse Distributor’s Name and Address _____.

Healthcare Facility’s or Pharmaceutical Reverse Distributor’s EPA Identification Number_____.

Manifest Tracking Number _____.

(D) Placarding. Placard or offer the initial transporter the appropriate placards according 

to Department of Transportation regulations for hazardous materials under 49 CFR part 172, 

subpart F.

(E) Shipping Papers. Prepare shipping papers in accordance with 40 CFR 172 Subpart C.

(F) Manifesting. The requirements of part 262 subpart B, except that:
10

(i) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals is 

not required to list hazardous waste codes in box 13 of EPA Form 8700-22. 

(ii) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals must 

write the words “hazardous waste pharmaceuticals” in Box 14 (the special handling instructions 

and additional information) of EPA Form 8700-22.

(G) Exporting Requirements. A healthcare facility or pharmaceutical reverse distributor

that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste 

pharmaceuticals is subject to part 262 subpart E.

(H) Importing Requirements. Any person that imports non-creditable hazardous waste 

pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to part 262 subpart F. 

A healthcare facility or pharmaceutical reverse distributor may not accept imported noncreditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, 

unless they have a permit or interim status that allows them to accept hazardous waste from offsite. 

(4) Shipping Potentially Creditable Hazardous Waste Pharmaceuticals from a 

Healthcare Facility or a Pharmaceutical Reverse Distributor to a Pharmaceutical 

Reverse Distributor Under 40 CFR § 266.509.

(A) Advance Notice. A healthcare facility or a pharmaceutical reverse distributor who 

transports or offers to transport potentially creditable hazardous waste pharmaceuticals off-site to 

a pharmaceutical reverse distributor must provide advance notice (paper or electronic) to the 

pharmaceutical reverse distributor of the intent to ship potentially creditable hazardous waste 

pharmaceuticals to the receiving pharmaceutical reverse distributor before each shipment of 

potentially creditable hazardous waste pharmaceuticals is sent to a pharmaceutical reverse 

distributor, and comply with the pre-transport requirements of 266.508(a)(1)(i) – (v).

(B) Delivery Confirmation. Upon receipt of each shipment of potentially creditable 

hazardous waste pharmaceuticals, the receiving pharmaceutical reverse distributor must provide

confirmation (paper or electronic) to the healthcare facility or pharmaceutical reverse distributor

that initiated the shipment that the shipment of potentially creditable hazardous waste 

pharmaceuticals has arrived. If a healthcare facility or pharmaceutical reverse distributor 

initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a 

pharmaceutical reverse distributor and does not receive delivery confirmation within seven 

calendar days from the date that the shipment of potentially creditable hazardous waste 

pharmaceuticals was sent, the healthcare facility or pharmaceutical reverse distributor that 

initiated the shipment must contact the shipper and the intended recipient (i.e., the 

pharmaceutical reverse distributor promptly to report that the confirmation was not received and 

to determine the status of the potentially creditable hazardous waste pharmaceuticals.
11

(C) Exporting Requirements. A healthcare facility or pharmaceutical reverse 

distributor that sends potentially creditable hazardous waste pharmaceuticals to a foreign 

destination must comply with the following requirements in addition to paragraphs (a) – (c) of 

this section:

(i) Comply with the requirements applicable to a primary exporter at 40 CFR 262.53, 

262.56(a)(1) through (4), (6) and (b) and 262.57;

(ii) Export such potentially creditable hazardous waste pharmaceuticals only upon 

consent of the receiving country and in conformance with the EPA Acknowledgement of 

Consent as defined in part 262 subpart E; and

(iii) Provide a copy of the EPA Acknowledgement of Consent for the shipment to the 

transporter transporting the shipment for export.

(D) Transporting Requirements to a Foreign Destination. A transporter of potentially

creditable hazardous waste pharmaceuticals to a foreign destination other than those OECD 

countries specified 40 CFR 262.58(a)(1) (in which case the transporter is subject to the 

requirements of 40 CFR part 262 subpart H) may not accept a shipment if the transporter knows 

the shipment does not conform to the EPA Acknowledgment of Consent. In addition the 

transporter must ensure that:

(i) A copy of the EPA Acknowledgment of Consent accompanies the shipment; and

(ii) The shipment is delivered to the facility designated by the person initiating the 

shipment.

(E) Importing Requirements. Any person that imports potentially creditable hazardous 

waste pharmaceuticals into the United States is subject to paragraphs (a) – (c) of this section in 

lieu of 40 CFR part 262 subpart F.

(5) Pharmaceutical Reverse Distributors Managing Potentially Creditable and 

Evaluated Hazardous Waste Pharmaceuticals Under 40 CFR § 266.510.

(A) Notification. A pharmaceutical reverse distributor must notify the EPA Regional 

Administrator, using the Site Identification Form (EPA form 8700-12), that it is a pharmaceutical 

reverse distributor operating under this subpart.

(i) A pharmaceutical reverse distributor that already has an EPA identification number 

must re-notify the EPA Regional Administrator, using the Site Identification Form (EPA form 

8700-12), that it is a pharmaceutical reverse distributor, as defined in § 266.500, within 60 days 

of the effective date of this subpart, or within 60 days of becoming subject to this subpart.

(ii) A pharmaceutical reverse distributor that does not have an EPA identification number 

must obtain one by notifying the EPA Regional Administrator, using the Site Identification Form 
12

(EPA form 8700-12), that it is a pharmaceutical reverse distributor, as defined in § 266.500, 

within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this 

subpart.

(B) Inventory. A pharmaceutical reverse distributor must maintain an inventory of all the 

potentially creditable and evaluated hazardous waste pharmaceuticals that are accumulated onsite.

(i) A pharmaceutical reverse distributor must inventory each potentially creditable

hazardous waste pharmaceutical upon arrival at the pharmaceutical reverse distributor.

(ii) The inventory must include the identity (e.g., name or national drug code (NDC)) and 

quantity of each potentially creditable hazardous waste pharmaceutical and evaluated hazardous 

waste pharmaceutical.

(C) Accumulation Time. A pharmaceutical reverse distributor may accumulate 

potentially creditable hazardous waste pharmaceutical and evaluated hazardous waste 

pharmaceuticals on-site for 90 calendar days or less. The 90-days start when the potentially

creditable hazardous waste pharmaceutical arrives at the pharmaceutical reverse distributor and 

applies to all hazardous waste pharmaceuticals accumulated on-site, regardless of whether they

are destined for another pharmaceutical reverse distributor (i.e., potentially creditable hazardous 

waste pharmaceuticals), or a permitted or interim status treatment, storage or disposal facility

(i.e., evaluated hazardous waste pharmaceuticals). 

(i) A pharmaceutical reverse distributor may request an extension of its 90-day

accumulation time limit for hazardous waste pharmaceuticals from the EPA Regional 

Administrator due to unforeseen circumstances beyond the control of the pharmaceutical reverse 

distributor, or if the potentially creditable hazardous waste pharmaceutical or evaluated 

hazardous waste pharmaceuticals are involved in litigation or a recall. 

(ii) A written request must be sent to the EPA Regional Administrator (paper or 

electronic). The request for an extension must include an explanation of the reason an extension 

is requested, the approximate volume or weight of the hazardous waste pharmaceuticals that will 

be accumulated for more than 90 days, and the amount of additional time requested. The amount 

of time granted for an extension is at the discretion of the EPA Regional Administrator on a 

case-by-case basis.

(D) Contingency Plan. A pharmaceutical reverse distributor that accepts potentially

creditable hazardous waste pharmaceuticals from off-site must prepare a contingency plan and 

comply with the other requirements of 40 CFR part 265 subpart D.

(E) Reporting. A pharmaceutical reverse distributor must submit an unauthorized 

hazardous waste report if the pharmaceutical reverse distributor receives hazardous waste from 

off-site that it is not authorized to receive (e.g., non-creditable hazardous waste pharmaceuticals, 

non-pharmaceutical hazardous waste). The pharmaceutical reverse distributor must prepare and 
13

submit an unauthorized waste report to the EPA Regional Administrator within 15 days after 

receiving the unauthorized hazardous waste and the pharmaceutical reverse distributor must send 

a copy of the unauthorized waste report to the healthcare facility (or other entity) that sent the 

unauthorized hazardous waste. The pharmaceutical reverse distributor must manage the 

unauthorized hazardous waste in accordance with all applicable regulations for generators of 

non-pharmaceutical hazardous waste. The unauthorized waste report must be signed by the 

owner or operator of the pharmaceutical reverse distributor, or his authorized representative, and 

contain the following information:

(i) The EPA identification number, name and address of the pharmaceutical reverse 

distributor;

(ii) The date the pharmaceutical reverse distributor received the hazardous waste;

(iii) The EPA identification number, name and address of the healthcare facility that 

shipped the hazardous waste, if available;

(iv) A description and the quantity of each unauthorized hazardous waste the 

pharmaceutical reverse distributor received;

(v) The method of treatment, storage, or disposal for each unauthorized hazardous waste; 

and

(vi) A brief explanation of why the waste was unauthorized, if known.

(F) Additional Reports. The EPA Regional Administrator may require pharmaceutical 

reverse distributors to furnish additional reports concerning the quantities and disposition of 

potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste 

pharmaceuticals.

(G) Recordkeeping. A pharmaceutical reverse distributor must keep the following 

records (paper or electronic):

(i) A copy of its notification on file for as long as the facility is subject to this subpart

(ii) A copy of the advance notification, delivery confirmation and the shipping papers or 

bill of lading for each shipment of potentially creditable hazardous waste pharmaceuticals that it 

receives for at least three years from the date it receives the shipment.

(iii) A copy of its inventory; and

(iv) The periods of retention referred to in this section are extended automatically during 

the course of any unresolved enforcement action regarding the regulated activity, or as requested 

by the EPA Regional Administrator.
14

(H) Additional Records. A pharmaceutical reverse distributor must keep the following 

records (paper or electronic) for each shipment of potentially creditable hazardous waste 

pharmaceuticals that it initiates to another pharmaceutical reverse distributor, for at least three 

years from the date of shipment:

(i) a copy of the advance notification provided to the pharmaceutical reverse distributor

(ii) the confirmation of delivery, and

(iii) the shipping papers or bill of lading.

(I) Labeling. A pharmaceutical reverse distributor accumulating evaluated hazardous 

waste pharmaceuticals in containers in an on-site accumulation area must label the containers 

with the words, "hazardous waste pharmaceuticals";

(J) Marking. Containers of evaluated hazardous waste pharmaceuticals must be marked 

with the applicable hazardous waste number(s) (i.e., hazardous waste code(s)) prior to being 

transported off-site.

(K) Managing Rejected Shipments. A pharmaceutical reverse distributor who sends a 

shipment of evaluated hazardous waste pharmaceuticals to a designated facility with the 

understanding that the designated facility can accept and manage the waste, and later receives 

that shipment back as a rejected load in accordance with the manifest discrepancy provisions of § 

264.72 or § 265.72 of this chapter, may accumulate the returned waste pharmaceuticals on-site 

for up to an additional 90 days in the on-site accumulation area provided the rejected or returned 

shipment is managed in accordance with paragraph (a) of this section. Upon receipt of the 

returned shipment, the pharmaceutical reverse distributor must:

(i) Sign either item 18c of the original manifest if the original manifest was used for 

the returned shipment or Item 20 of the new manifest if a new manifest was used for the 

returned shipment;

(ii) Provide the transporter a copy of the manifest;

(iii) Within 30 days of delivery of the rejected shipment of the evaluated hazardous 

waste pharmaceuticals, send a copy of the manifest to the designated facility that returned the 

shipment to the pharmaceutical reverse distributor; and

(L) Reporting for Evaluated Hazardous Waste Pharmaceuticals. A pharmaceutical 

reverse distributor that ships evaluated hazardous waste pharmaceuticals off-site must prepare 

and submit a single copy of a biennial report to the EPA Regional Administrator by March 1 of 

each even numbered year in accordance with § 262.41, except § 262.41(a)(7).

(M) Exception reporting for a missing copy of the manifest. For shipments from a 

pharmaceutical reverse distributor to a designated facility:
15

(i) If a pharmaceutical reverse distributor does not receive a copy of the manifest with 

the handwritten signature of the owner or operator of the designated facility within 35 days 

of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial 

transporter, the pharmaceutical reverse distributor must contact the transporter or the owner 

or operator of the designated facility to determine the status of the evaluated hazardous waste 

pharmaceuticals.

(ii) A pharmaceutical reverse distributor must submit an exception report to the EPA 

Regional Administrator for the Region in which the pharmaceutical reverse distributor is 

located if it has not received a copy of the manifest with the handwritten signature of the 

owner or operator of the designated facility within 45 days of the date the evaluated 

hazardous waste pharmaceutical was accepted by the initial transporter. The exception report 

must include: (a) A legible copy of the manifest for which the pharmaceutical reverse 

distributor does not have confirmation of delivery; and (b) A cover letter signed by the 

pharmaceutical reverse distributor, or its authorized representative, explaining the efforts 

taken to locate the evaluated hazardous waste pharmaceuticals and the results of those 

efforts.

(N) Rejected Shipments. For shipments rejected by the designated facility and 

shipped to an alternate facility:

(i) A pharmaceutical reverse distributor that does not receive a copy of the manifest 

with the handwritten signature of the owner or operator of the alternate facility within 35 

days of the date the evaluated hazardous waste pharmaceutical was accepted by the initial 

transporter must contact the transporter or the owner or operator of the alternate facility to 

determine the status of the hazardous waste. The 35 day timeframe begins the date the waste 

is accepted by the transporter forwarding the hazardous waste shipment from the designated 

facility to the alternate facility.

(ii) A pharmaceutical reverse distributor must submit an Exception Report to the EPA 

Regional Administrator for the Region in which the pharmaceutical reverse distributor is 

located if it has not received a copy of the manifest with the handwritten signature of the 

owner or operator of the alternate facility within 45 days of the date the hazardous waste was 

accepted by the initial transporter. The 45-day timeframe begins the date the hazardous 

waste is accepted by the transporter forwarding the hazardous waste shipment from the 

designated facility to the alternate facility. The Exception Report must include: (a) A legible 

copy of the manifest for which the generator does not have confirmation of delivery; (b) A 

cover letter signed by the pharmaceutical reverse distributor, or its authorized representative, 

explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the 

results of those efforts.
16

(O) Recordkeeping for evaluated hazardous waste pharmaceuticals.

(i) A pharmaceutical reverse distributor must keep a log (written or electronic) of the 

weekly inspections of the on-site accumulation area, required by paragraph (c)(2) of this 

section. This log must be retained as a record for at least three years from the date of the 

inspection.

(ii) A pharmaceutical reverse distributor must keep a copy of each manifest signed in 

accordance with § 262.23(a) for three years or until it receives a signed copy from the 

designated facility which received the evaluated hazardous waste pharmaceutical. This 

signed copy must be retained as a record for at least three years from the date the evaluated 

hazardous waste pharmaceutical was accepted by the initial transporter.

(iii) A pharmaceutical reverse distributor must keep a copy of each biennial report for 

at least three years from the due date of the report.

(iv) A pharmaceutical reverse distributor must keep a copy of each exception report 

for at least three years from the submission of the report.

(v) A pharmaceutical reverse distributor must keep records to document personnel 

training, in accordance with § 265.16.

5. THE INFORMATION COLLECTED --AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT 

5(a) Agency Activities 

Most of the information that is required of facilities managing hazardous waste

pharmaceuticals would be kept on site and not be submitted to EPA for review. The exception is 

re-notifications by facilities that have previously notified as SQGs or LQGs and notifications by

facilities that did not have to notify previously. However, as stated earlier, it is being assumed 

that LQGs and SQGs have previously notified EPA of their hazardous waste management 

activities under RCRA and have received an EPA Identification number. Nevertheless, they

would be required to re-notify the Agency under the proposed rule to indicate that they are 

operating under this new part 266 subpart p. This should not cause a significant increase in 

burden to the Agency compared to existing burden.

5(b) Collection Methodology and Management

The information collected (re-notifications and notifications) will be managed in a similar 

manner to previous notifications received by EPA. EPA will use equipment such as personal 

computers and applicable database software.
17

5(c) Small Entity Flexibility 

The proposed rule is not expected to cause a significant impact on small quantity

generators (SQGs) of hazardous waste pharmaceuticals. Under the proposed rule, SQGs will 

benefit due to greater flexibility in how they train staff and manage their hazardous waste.

Hazardous waste pharmaceuticals will no longer be counted against a facility’s hazardous waste 

generator category. In addition, EPA allows conditionally exempt small quantity generators 

(CESQGs) to manage their hazardous waste pharmaceuticals either under the specific provisions 

of the proposed rule or under the existing CESQG exemption in 40 CFR 261.5. 

5(d) Collection Schedule

As stated in 5(a) above, most of the information that is required of facilities managing 

hazardous waste pharmaceuticals would be kept on site and not be submitted to EPA for review. 

Facilities will be required to submit re-notification or a new notification to EPA in order to 

indicate that they are operating under the new part 266 subpart P. A new notification must be 

submitted within 60 days of when a facility becomes subject to the rule and a re-notification on 

existing schedule (i.e., as part of biennial reporting). 

6. ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION 

6(a) Estimating Respondent Burden

In Exhibit 1, EPA presents the estimates of the annual respondent burden associated with 

the new information collection requirements in the proposed rule. As shown in the exhibit, EPA 

estimates that the total annual respondent burden for the new paperwork requirements in the rule 

is 53,602 hours.

 

6(b) Estimating Respondent Costs

EPA also presents in Exhibit 1 estimates of the total annual respondent cost for the new 

paperwork requirements in the proposed rule. The total annual respondent cost is $3,388,492. 

This cost includes annual labor, capital, and operation and maintenance (O&M) costs to be 

incurred by respondents affected by the information collection requirements covered in this ICR. 

Specific data and/or assumptions used in developing these costs are described below.

Labor Costs 

For purposes of this analysis, EPA estimates an average hourly respondent labor cost of 

$108 for legal staff, $79 for managerial staff, $49 for technical staff, and $29 for clerical staff. 

These hourly labor costs were obtained from the economics background document developed for 

the proposed rule (see “Regulatory Impact Analysis for EPA’s Proposed Healthcare FacilitySpecific Regulations for the Management of Hazardous Waste Pharmaceuticals,” which is 

available in the public docket identified under Section 6(g)).
18

Annual Capital and Operation & Maintenance Costs

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 of the 

proposed rule.

O&M costs are those costs associated with paperwork requirements incurred continually over the 

life of the ICR. They are defined by the EPA as “the recurring dollar amount of costs associated 

with O&M or purchasing services.” For this ICR, O&M costs would be for mailing and

photocopying.

6(c) Estimating Agency Burden and Costs

The annual burden and costs to the Agency for collecting information under the rule 

would be negligible. This is because the Agency is not requiring respondents to submit any

information for its review and approval under the proposed rule. Also, respondents would keep 

all records required under the proposed rule on-site.

6(d) Estimating the Respondent Universe and Total Burden and Costs

Respondent Universe 

In Exhibit 1, EPA provides estimates of the annual number of respondents that will be 

required to comply with the new paperwork requirements in the proposed rule. The number of 

respondents varies based on type of paperwork requirement. This is because the paperwork 

requirements are not the same for all respondents (i.e., LQGs, SQGs, and CESQGs). Table 1 

presents the number of respondents that could potentially be affected by the proposed rule.1 It

shows that EPA estimates 174,023 LQG, SQG, and CESQG facilities handle hazardous waste 

pharmaceuticals each year. However, there are no paperwork requirements in the proposed rule 

for CESQGs (except for CESQG reverse distributors).

 

1

These universe assumptions are based on the economics background document developed for the proposed 

rule: “Regulatory Impact analysis for EPA’s Proposed Healthcare Facility-Specific Regulations for the Management 

of Hazardous Waste Pharmaceuticals.” 
19

TABLE 1

NUMBER OF FACILITIES POTENTIALLY AFFECTED BY

THE PROPOSED RULE

Type of Respondent Number of Facilities

Large Quantity Generators (LQG) 5,302

Small Quantity Generators (SQG) 23,314

Conditionally Exempt Small 

Quantity Generators (CESQG)

145,407

Total 174,023

Respondent Burden and Cost

Based on the universe data presented in Table 1 and information contained in the 

economics background document developed for the proposed rule, EPA estimated the respondent 

burden and cost associated with all of the new information collection requirements covered in 

this ICR in Exhibit 1. A discussion of the assumptions used in developing these burden and cost 

estimates follows. 

Reading the Regulations

As shown in Exhibit 1, EPA estimates that 28,637 facilities will need to read the rule in 

order to understand and comply with the new information collection requirements. (This 

assumes CESQGs, except for CESQG reverse distributors, are unlikely to read the rule because 

there are no new information collection requirements for CESQGs in the proposed rule). For 

purpose of this analysis, we assumed that the hours required for reading/reviewing this new rule 

would be similar to the hours used in EPA’s assessment of the impacts associated with 

reading/reviewing the 2009 Final Rule governing the Exporting of Spent Lead-Acid Batteries 

(SLAB). EPA estimated 3.5 hours per respondent for reading the rule for the 28,637 

respondents. This resulted in total burden of 100,230 hours, at total cost of $5,759,784, for all of 

the respondents reading the rule. In estimating the annual respondent burden and cost over the 

three year period covered by this ICR, EPA annualized the burden and cost of this one-time

activity by dividing the number of hours and cost for this activity by three. This resulted in total 

annual burden of 33,410 hours, at a total cost of $1,919,928 (see Exhibit 1).
20

Notifications and Re-Notifications to EPA

Under current RCRA Subtitle C regulations, LQGs and SQGs are required to notify EPA

and obtain an EPA ID number prior to managing hazardous wastes. LQGs and some SQGs are 

also subject to biennial reporting. Therefore, there are no additional notification costs to 

generators that are already submitting a biennial report, since they can notify when they submit 

their biennial report. The initial notification and re-notification costs are estimated only for 

CESQGs operating as reverse distributors (this is because all reverse distributors (RDs), 

including CESQG RDs, are proposed to be regulated as LQGs and required to notify), SQGs and 

LQGs that previously had a household waste exemption, and SQGs in states without biennial 

reporting requirements. EPA estimated that there are 21 CESQG RDs, 834 SQGs with 

household waste exemption, and 137 LQGs with household waste exemption that will be 

required to notify and 18,703 SQGs in states without biennial reporting requirements that must 

re-notify. EPA also estimated a one-time cost of approximately $53 for initial notification and a

one-time cost of approximately $37 for re-notification. Based on these data, the total additional 

annual respondent burden for notifications is estimated to be 1,276 hours, at cost of $70,100 (see 

Exhibit 1).

Labeling

Under current RCRA Subtitle C regulations, LQGs and SQGs are required to label all 

containers holding hazardous waste. Thus, there would be no change in burden and costs

associated with labeling for LQG and SQG healthcare facilities that use containers. The 

additional burden and costs for labeling are result of LQG and SQG healthcare facilities that 

previously used sewer and also because some facilities were exempt as household hazardous 

waste generators and are now regulated. EPA estimated approximately 1.5 hours annually for 

labeling at each LQG healthcare facility and approximately 0.5 hour annually at each SQG 

healthcare facility. The estimated annual labor cost for labeling was $73.45 at each LQG 

healthcare facility and $24.48 at each SQG healthcare facility. Based on these data, the total 

additional annual respondent burden for labeling is estimated to be 9,918 hours, at cost of 

$485,672 (see Exhibit 1).

Recordkeeping

Under current RCRA Subtitle C regulations, LQGs and SQGs are required to keep

records of waste characterization for three years from the date the last waste, including 

hazardous waste pharmaceuticals, was sent off site. The proposed rule does not include waste 

characterization recordkeeping requirements for hazardous waste pharmaceuticals generated by

healthcare facilities. Reverse distributors, however, are required to keep these records. Reverse 

distributors, however, are required to keep records of waste characterization for three years under 

the proposed rule. This represents additional burden and costs for CESQG reverse distributors. 

LQG and SQG reverse distributors incur these costs already under the current regulations. EPA 

estimated that there are 21 CESQG RDs that will be required to keep records. EPA also 

estimated the time required for recordkeeping to be 0.1 hour annually per respondent, at cost of 

$4.90. There is an additional annual O&M cost of $0.40 per respondent. Based on these data, 
21

the total additional annual respondent burden for recordkeeping is estimated to be 2 hours, at 

cost of $111 (see Exhibit 1).

Manifests

Under current RCRA Subtitle C regulations, LQGs and SQGs are required to prepare a 

manifest that, among other information, includes the RCRA waste codes for each hazardous 

waste shipment. There are no manifest requirements for CESQGs. However, under the 

proposed rule, LQG and SQG healthcare facilities must complete manifests for non-creditable

pharmaceuticals shipped to a TSDF, but need not include RCRA waste codes on these manifests. 

Also, under the proposed rule, healthcare facilities are not required to prepare manifests for 

potentially creditable hazardous waste pharmaceuticals shipped to a reverse distributor. Instead, 

shipping documents with return receipt notifications are required. EPA assumes that each health 

care facility sends four shipments of pharmaceuticals to a reverse distributor each year at an 

estimated cost of $8.49 per shipment. This represents an additional cost for LQG and SQG 

healthcare facilities. For reverse distributors, the proposed rule would require a full manifest 

(including waste codes) for hazardous waste pharmaceuticals shipped to a TSDF, as is currently 

required. No manifest, however, is required for shipments of hazardous waste pharmaceuticals 

between reverse distributors, though shipping documents with return receipts are required. As 

result of these changes in manifest requirements, EPA estimated that the total annual burden on 

the 28,637 affected facilities for preparing manifests would be 10,251 hours, at cost of $981,667 

(see Exhibit 1).

Total Respondent Burden and Costs

In Exhibit 2, EPA presents a summary of the total estimated annual respondent burden 

and costs savings and net annual respondent burden and costs associated with this ICR. The 

specific information collection activities of the new paperwork requirements are described 

throughout this ICR, and the total annual burden and cost estimates associated with them are 

presented in Exhibit 1. The cost savings come from additional flexibility provided to healthcare 

facilities and reverse distributors under the proposed rule.

6(e) Bottom Line Burden Hours and Costs

Respondent Tally

In Exhibit 2, EPA presents the net annual respondent burden hours and costs associated 

with the new information collection requirements in the proposed rule. As described specifically

in Section 6(d) above, the new information collection requirements apply to as many as 28,637 

affected facilities (respondents). As shown in Exhibit 2, the total annual respondent burden for 

these new paperwork requirements is approximately 54,857 hours, at an annual cost of 

approximately $3,457,478. As also shown in Exhibit 2, the total annual respondent burden 

savings from these new paperwork requirements, compared to the existing paperwork 

requirements, is approximately 26,197 hours, at an annual cost savings of approximately

$1,155,605. In the same Exhibit 2, EPA then combines the burden and cost impacts under both 
22

new and existing paperwork requirements and estimates the net annual respondent burden and 

costs for all information collection activities at approximately 28,660 hours, at an annual cost of 

approximately $2,301,873. 

6(f) Reasons for Change in Burden 

EPA is proposing a new set of sector-specific regulations for healthcare facilities and 

reverse distributors in 40 CFR part 266 subpart P in lieu of the standard RCRA generator 

regulations of 40 CFR part 262. Specifically, the proposed rule includes several requirements to 

ensure the responsible management of hazardous waste pharmaceuticals. The key provisions of 

the proposed rule have been described earlier in Section 1(b).

6(g) Burden Statement

The estimated annual burden for this collection of information ranges from 0.1 to 3.5 

hours per response for the 28,637 respondents. Burden means the total time, effort, or financial 

resources expended by persons to generate, maintain, retain, or disclose or provide information 

to or for a Federal agency. This includes the time needed to review instructions; develop, 

acquire, install, and utilize technology and systems for the purposes of collecting, validating, and 

verifying information, processing and maintaining information, and disclosing and providing 

information; adjust the existing ways to comply with any previously applicable instructions and 

requirements; train personnel to be able to respond to a collection of information; search data 

sources; complete and review the collection of information; and transmit or otherwise disclose 

the information. An agency may not conduct or sponsor, and a person is not required to respond 

to, a collection of information unless it displays a currently valid OMB control number. The 

OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. 

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 for this ICR under 

Docket ID Number EPA-HQ-RCRA-2007-0932, which is available for online viewing at 

www.regulations.gov, or in person viewing at the RCRA Docket in the EPA Docket Center 

(EPA/DC), 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 RCRA Docket is (202) 566-0270. An electronic version 

of the public docket is available at 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-2007-0932 and OMB Control Number 

2050-NEW in any correspondence.
23

Exhibit 1 - Estimated Annual Respondent Burden and Costs

 Hours and Costs per Respondent Total Hours and Costs

INFORMATION

ACTIVITY

Leg.

$108/Hr

Mgr.

$79/Hr

Tech.

$49/Hr

Cler.

$29/Hr

Resp. 

Hours/Yr

Labor 

Cost/Yr

Capital/

Startup Cost

O & M 

Cost

Number 

of Resp.

Total 

Hours/Yr

Total Cost/Yr

RESPONDENTS (LQGs, SQGs, and CESQG RDs)

Reading the Rule 0.0 0.33 0.83 0.0 3.5 $201 0.0 0.0 28,637 33,410 $1,919,928

LQGs, SQGs, and CESQG RDs

Notification 0.0 0.08 varies 0.08 varies varies 0.0 $3.31 19,695 1,276 $70,100

LQGs, SQGs, and CESQG RDs

Labeling 0.0 0.0 varies 0.0 varies varies 0.0 0.0 21,068 9,918 $485,672

CESQG RDs

Recordkeeping 0.0 0.0 0.1 0.0 0.1 $4.90 0.0 $0.40 21 2 $111

LQGs, SQGs, and CESQG RDs

Manifests 0.0 varies varies varies varies varies 0.0 $34 28,637 10,251 $981,667

Total varies varies varies varies varies 0.0 $37.71 varies 54,857 3,457,478

Agency Data Sources:

Wage Rate Data: Exhibit 3-2 in the “Regulatory Impact analysis for EPA’s Proposed Healthcare Facility-Specific Regulations for the Management of 

Hazardous Waste Pharmaceuticals.”

Labor Hours: Supporting Statement for EPA Information Collection Number 2308.02: Revisions to the Requirements for Export Shipments of Spent 

Lead Acid Batteries (December 2009) and “Regulatory Impact analysis for EPA’s Proposed Healthcare Facility-Specific Regulations 

for the Management of Hazardous Waste Pharmaceuticals.”

O&M Cost: “Regulatory Impact analysis for EPA’s Proposed Healthcare Facility-Specific Regulations for the Management of Hazardous Waste 

Pharmaceuticals.”
24

Exhibit 2 – Estimated Annual Respondent Burden and Cost Savings and Net Annual Respondent Burden and Costs

Activity Affected 

Facilities

Number of 

Respondents

Total Labor Hours Total Labor Cost Total Capital/Startup 

and O&M Cost

Total Annual Cost

Labeling LQGs & 

SQGs

varies (1,118) ($54,743) $0 ($ 54,743)

Biennial Reports LQGs & 

SQGs

varies (5,333) ($311,206) ($665) ($311,871)

Recordkeeping LQGs & 

SQGs

varies (2,761) ($135,198) ($11,044) ($146,242)

Manifests LQGs & 

SQGs

varies (16,985) ($638,063) ($4,686) ($642,749)

Total Annual Respondent Burden and Cost savings (26,197) ($1,139,210) ($16,395) ($1,155,605)

Pharmaceutical ICR 2486.01 Varies 54,857 N/A N/A $3,457,478

Net Annual Respondent Burden and Costs of 

Pharmaceutical ICR

28,660 $2,301,873

Agency Data Sources: “Regulatory Impact analysis for EPA’s Proposed Healthcare Facility-Specific Regulations for the Management of Hazardous Waste 

Pharmaceuticals.”