2486ss03

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SUPPORTING STATEMENT FOR

EPA INFORMATION COLLECTION REQUEST NUMBER 2486.03

REPORTING AND RECORDKEEPING REQUIREMENTS FOR THE FINAL RULE ON MANAGEMENT STANDARDS FOR

HAZARDOUS WASTE PHARMACEUTICALS

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 14

5(a) Agency Activities 14

5(b) Collection Methodology and Management 15

5(c) Small Entity Flexibility ………………………………………………………….15

5(d) Collection Schedule ……………………………………………………………..15

6. ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION 15

6(a) Estimating Respondent Burden 15

6(b) Estimating Respondent Costs 15

6(c) Estimating Agency Burden and Costs 16

6(d) Estimating the Respondent Universe and Total Burden and Costs 16

6(e) Bottom Line Burden Hours and Costs 23

6(f) Reasons for Change in Burden 23

6(g) Burden Statement 24

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) Title and Number of the Information Collection

This information Collection Request (ICR) is entitled “Management Standards for Hazardous Waste Pharmaceuticals,” OMB Control No. 2050-0212, EPA ICR Number 2486.03.

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.

EPA added a new subpart P under part 266. This new subpart is a tailored, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and reverse distributors. Healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all 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 final standards are not an optional alternative to managing hazardous waste pharmaceuticals under part 262, they are mandatory standards.

The requirements covered in this ICR are for the requirements that healthcare facilities (including retail facilities) and reverse distributors managing hazardous waste pharmaceuticals have under 40 CFR part 266 subpart P.

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 (including retail facilities) and 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, the tracking requirements will help EPA and facilities ensure that hazardous waste pharmaceuticals arrive at their intended destination rather than at facilities not equipped to manage these wastes.

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 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 covered in this information collection is duplicative with information required by other existing Federal regulations.

3(b) Public Notice

In compliance with the Paperwork Reduction Act of 1995, EPA issued a public notice in the Federal Register on October 12, 2021 (86 FR 56704). No comments were received.

3(c) Consultations

In compliance with the Paperwork Reduction Act of 1995, EPA consulted with the following healthcare facilities:

Thomas Hospital, Fairhope Alabama

Omnicare Of Huntsville

Walmart Supercenter in Raleigh North Carolina

Sentara General Hospital in Virginia Beach

Pillpack LLC

Doctors Hospital of Augusta Georgia

There are no changes to the burden calculations based on these consultations.

3(d) Effects of Less Frequent Collection

EPA has carefully considered the burden imposed upon the regulated community. 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 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. 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 this ICR.

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
4242	Drug Wholesalers
44511	Supermarkets and Other Grocery (except convenience) Stores
44611	Pharmacies and Drug Stores
452311	Warehouse Clubs and Supercenters
54194	Veterinary Clinics
6211	Physicians’ Offices
6212	Dentists’ Offices
6213	Other Health Practitioners
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)
Various NAICS	Reverse Distributors

4(b) Information Requested

This section describes reporting and recordkeeping requirements for facilities managing hazardous waste pharmaceuticals.

(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 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 notify the EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a healthcare facility as part of its next Biennial Report, if it is required to submit one; or if it is not required to submit a Biennial Report, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to his 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, as part of its next Biennial Report, if it is required to submit one; or if not required to submit a Biennial Report, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to 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 very small quantity generator under 40 CFR § 262.14, 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 § 262.14.

(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 non-creditable hazardous waste pharmaceuticals with the phrase “Hazardous Waste Pharmaceuticals.”

(D) Maximum 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;

(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.

(E) Tracking Rejected Shipments. 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 receipt of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment to the healthcare facility; and

(iv) Within 90 days of receipt of the rejected shipment, 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 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 non-creditable 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 non-creditable hazardous waste pharmaceuticals that is forwarded by the designated facility to an alternate facility (using appropriate manifest procedures), with the signature of the owner or operator of the alternate facility within 60 days of the date the waste was accepted by 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 non-creditable 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 the waste was last sent to on-site or off-site treatment, storage, or disposal. A healthcare facility that manages all of its non-creditable non-hazardous waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals is not required to keep documentation of hazardous waste determinations.

(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.

(v) A healthcare facility that accepts hazardous waste pharmaceuticals from off site VSQG healthcare facilities must keep records of the shipments it receives from off site for three years from the date the shipment is received.

(2) Healthcare Facilities Managing Potentially Creditable Hazardous Waste Pharmaceuticals Under 40 CFR § 266.503.

(A) Recordkeeping. A healthcare facility that initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor must keep the following records (paper or electronic) for each shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor, for 3 years from the date of shipment:

(i) the confirmation of delivery and

(ii) the shipping papers prepared in accordance with 49 CFR part 172 subpart C, if applicable..

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 Reverse Distributor Under 40 CFR § 266.508.

(A) Labeling. A healthcare facility or reverse distributor must label each package in accordance with the applicable Department of Transportation regulations on hazardous materials under 49 CFR part 172 subpart E.

(B) 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 Subpart D; 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 Reverse Distributor’s Name and Address _____.

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

Manifest Tracking Number _____.

(C) 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.

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

(i) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals is not required to list all applicable hazardous waste numbers (i.e., hazardous waste codes) in Item 13 of EPA Form 8700-22.

(ii) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals must write the words “PHARMS” in Item 13 of EPA Form 8700-22.

(E) Exporting Requirements. A healthcare facility or reverse distributor that exports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to part 262 subpart H.

(F) Importing Requirements. Any person that imports non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals is subject to part 262 subpart H. A healthcare facility or reverse distributor may not accept imported non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, unless they have a permit or interim status that allows them to accept hazardous waste from off-site.

(4) Shipping Potentially Creditable Hazardous Waste Pharmaceuticals from a Healthcare Facility or a Reverse Distributor to a Reverse Distributor Under 40 CFR § 266.509.

(A) Delivery Confirmation. Upon receipt of each shipment of potentially creditable hazardous waste pharmaceuticals, the receiving reverse distributor must provide confirmation (paper or electronic) to the healthcare facility or reverse distributor that initiated the shipment that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived at its destination and is under the custody and control of the reverse distributor. If a healthcare facility or reverse distributor initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor and does not receive delivery confirmation within 35 calendar days from the date that the shipment of potentially creditable hazardous waste pharmaceuticals was sent, the healthcare facility or reverse distributor that initiated the shipment must contact the carrier and the intended recipient (i.e., the reverse distributor) promptly to report that the delivery confirmation was not received and to determine the status of the potentially creditable hazardous waste pharmaceuticals.

(B) Exporting Requirements. A healthcare facility or reverse distributor that sends potentially creditable hazardous waste pharmaceuticals to a foreign destination must comply with the applicable sections of 40 CFR part 262 subpart H, except the manifesting requirements of § 262.83(c), in addition to paragraph (A) of this section.

(C) Importing Requirements. Any person that imports potentially creditable hazardous waste pharmaceuticals into the United States is subject to paragraphs (A) of this section in lieu of 40 CFR part 262 subpart H.

(5) Reverse Distributors Managing Potentially Creditable and Evaluated Hazardous Waste Pharmaceuticals Under 40 CFR § 266.510.

(A) Notification. A reverse distributor must notify the EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a reverse distributor operating under this subpart.

(i) A reverse distributor that already has an EPA identification number must notify the EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a 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 reverse distributor 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 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 reverse distributor must maintain an inventory of all the potentially creditable and evaluated hazardous waste pharmaceuticals that are accumulated on-site.

(i) A reverse distributor must maintain a current inventory each potentially creditable hazardous waste pharmaceutical within 30 calendar days of arriving at the 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) Maximum Accumulation Time. A reverse distributor that accumulates potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site may choose to demonstrate the length of time that the hazardous waste pharmaceuticals have been accumulating. EPA assumes they will use their inventory to keep track of how long have been accumulating.

(D) Contingency Planning. A reverse distributor must prepare a contingency plan and comply with the other requirements of 40 CFR 262 subpart M.

(E) Reporting. A reverse distributor must submit an unauthorized hazardous waste report if the reverse distributor receives waste from off-site that it is not authorized to receive (e.g., non-pharmaceutical hazardous waste, regulated medical waste). The reverse distributor must prepare and submit an unauthorized waste report to the EPA Regional Administrator within 45 calendar days after the unauthorized waste arrives at the reverse distributor and the reverse distributor must send a copy of the unauthorized waste report to the healthcare facility (or other entity) that sent the unauthorized waste. The pharmaceutical reverse distributor must manage the unauthorized waste in accordance with all applicable regulations. The unauthorized waste report must be signed by the owner or operator of the reverse distributor, or its authorized representative, and contain the following information:

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

(ii) The date the reverse distributor received the unauthorized waste;

(iii) The EPA identification number, name and address of the healthcare facility that shipped the unauthorized waste, if available;

(iv) A description and the quantity of each unauthorized waste the reverse distributor received;

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

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

(F) Additional Reports. The EPA Regional Administrator may require 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 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 delivery confirmation and the shipping papers for each shipment of potentially creditable hazardous waste pharmaceuticals that it receives for at least three years from the date the shipment arrives at the reverse distributor.

(iii) A copy of its current inventory for as long as the facility is subject to this subpart.

(H) Additional Records. A reverse distributor must keep the following records (paper or electronic) for each shipment of potentially creditable hazardous waste pharmaceuticals that it initiates to another reverse distributor, for at least three years from the date of shipment:

(i) the confirmation of delivery, and

(iii) the shipping papers prepared in accordance with 49 CFR part 172 subpart C, if applicable.

(H) Labeling. A 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";

(I) Marking. Prior to shipping evaluated hazardous waste pharmaceuticals off site, all containers must be marked with the applicable hazardous waste numbers (i.e., hazardous waste codes).

(J) Managing Rejected Shipments. Upon receipt of the returned shipment, the 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 reverse distributor; and

(iv) Within 90 days of receipt of the rejected shipment, transport or offer for transport the returned shipment of evaluated hazardous waste pharmaceuticals in accordance with the shipping standards of § 266.508(a) or (b).

(K) Biennial Reporting for Evaluated Hazardous Waste Pharmaceuticals. A 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.

(L) Exception reporting for a missing copy of the manifest. For shipments from a reverse distributor to a designated facility:

(i) If a reverse distributor does not receive a copy of the manifest with the 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 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 reverse distributor must submit an exception report to the EPA Regional Administrator for the Region in which the reverse distributor is located if it has not received a copy of the manifest with the 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 reverse distributor does not have confirmation of delivery; and (b) A cover letter signed by the reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.

(M) Rejected Shipments. For shipments rejected by the designated facility and shipped to an alternate facility:

(i) A reverse distributor that does not receive a copy of the manifest with the signature of the owner or operator of the alternate facility within 35 days of the date the evaluated hazardous waste pharmaceuticals were 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 evaluated hazardous waste pharmaceuticals are accepted by the transporter forwarding the hazardous waste shipment from the designated facility to the alternate facility.

(ii) A reverse distributor must submit an Exception Report to the EPA Regional Administrator for the Region in which the reverse distributor is located if it has not received a copy of the manifest with the 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 evaluated hazardous waste pharmaceuticals are 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 reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.

(N) Recordkeeping for evaluated hazardous waste pharmaceuticals.

(i) A reverse distributor must keep a log (written or electronic) of the 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 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 reverse distributor must keep a copy of each biennial report for at least three years from the due date of the report.

(iv) A reverse distributor must keep a copy of each exception report for at least three years from the submission of the report.

(v) A reverse distributor must keep records to document personnel training, in accordance with § 262.17(a)(7)(iv).

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 Agency will collect a limited amount of information from healthcare facilities and reverse distributors in states that are not authorized to operate their RCRA Subtitle C hazardous waste program. In general, however, most authorized state programs will collect information in lieu of EPA. In states that are not authorized to operate their RCRA Subtitle C hazardous waste program, EPA will collect information related to notification, Biennial Reporting, and exception reporting. EPA will receive notifications from healthcare facilities and reverse distributors when they begin operating under subpart P. However, as stated earlier, it is 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 will be required to notify the Agency 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. EPA will also receive exception reports from healthcare facilities and reverse distributors when they do not receive a copy of the manifest with the signature of the owner or operating of the designated facility. EPA will also receive biennial reports from healthcare facilities and reverse distributors. However, these facilities are already estimated to be preparing biennial reports in the baseline, and thus it should not cause an increase in burden to the Agency.

5(b) Collection Methodology and Management

The information collected will be managed in a similar manner to previous notifications and exception reporting received by EPA. EPA will use equipment such as personal computers and applicable database software.

5(c) Small Entity Flexibility

Healthcare facilities, including healthcare facilities currently operating as small quantity generators (SQGs) benefit due to greater flexibility in how they manage their hazardous waste. Hazardous waste pharmaceuticals will no longer be counted against a facility’s hazardous waste generator status. In addition, EPA allows flexibility for very small quantity generators (VSQGs) in managing their hazardous waste pharmaceuticals.

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 a notification to EPA in order to indicate that they are operating under the new part 266 subpart P. A notification must be submitted within 60 days of when a facility becomes subject to the rule.

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 information collection requirements in this ICR. As shown in the exhibit, EPA estimates that the total annual respondent burden for the paperwork requirements in the rule is 39,469 hours.

6(b) Estimating Respondent Costs

In Exhibit 1, EPA also presents estimates of the total annual respondent costs. EPA expects a total annual respondent cost of $3,528,423. This includes annual labor, capital, and operation and maintenance (O&M) costs. Specific data and/or assumptions used in developing these costs are described below.

Labor Costs

Derivation of Respondent Hourly Labor Wage Rates Used in this ICR

Labor Category	Standard Occupational Code	2020 Unloaded Average (Mean) Hourly Wage Rate	2021 Adjustment Factor	Fringe Benefits Cost Factor	Overhead Cost Factor	Loaded Average (Mean) Hourly Wage Rate
A	B	C	D	E	F	G = [C x D x E x F]
1. Legal	23-1011 Lawyers	$71.59	1.045	1.294	1.336	$129.33
2. Managerial	11-1021 General & Operations Managers	$60.45	1.045	1.294	1.336	$109.21
3. Technical	17-2081 Environmental Engineers	$46.58	1.045	1.294	1.336	$84.15
4. Clerical	43-9061 Office Clerks, General	$18.16	1.045	1.294	1.336	$32.81

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 this ICR.

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

Although the Agency will review biennial reports from reverse distributors for their hazardous waste pharmaceuticals in these states, EPA expects that the Agency will already review biennial reports from reverse distributors due to their non-pharmaceutical hazardous waste, and thus will not face any burden under this ICR.

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

Respondent Universe

TABLE 1 Respondent Type
	Large Quantity Generators (LQGs)	Small Quantity Generators (SQGs)
SUBPART_P_HEALTHCARE	223	1,624
SUBPART_P_REVERSE_DISTRIBUTOR	9
SUBPART_P_WITHDRAWAL	2	2
Total	6,537	1,626

Respondent Burden and Cost

A discussion of the assumptions used in developing these burden and cost estimates follows.

Reading the Regulations

As shown in Table 1, EPA estimates that 8,163 facilities will need to read the rule in order to understand and comply with the new information collection requirements. EPA estimated 3.5 hours per respondent, resulting in a total burden of 28,571 hours, at a total cost of $2,612,160, for all of the respondents reading the rule.

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 costs are estimated only for SQGs that will also be healthcare facilities operating under subpart P located in states that do not require SQGs to submit biennial reports. The burden associated with this activity is covered by OMB Control No. 2050-0024 “RCRA Subtitle C Reporting Instructions and Forms”.

Labeling

Healthcare facilities and reverse distributors are required to label containers holding non-creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals with the words “Hazardous Waste Pharmaceuticals,” but are not required to mark an indication of the hazards of the contents of the container or the accumulation start date on the container (which is required under RCRA Subtitle C regulations for LQGs and SQGs). To ensure compliance with accumulation time limits, however, it is likely most facilities will label the accumulation start date on the container. According to RCRAInfo 6,537 LQGs and 1,626 SQGs complied with subpart P in 2021. EPA estimates that healthcare facilities under subpart P will spend .25 hours labeling containers in their primary storage area and .25 hours labeling containers in their satellite storage area. Based on this information, the total respondent burden is estimated to be 10,620 hours at a cost of $891,954.

Rejected Shipments and Exception Reporting

Healthcare facilities and reverse distributors must track or manage rejected shipments by signing an item on the manifest, providing the transporter with a copy of the manifest, and sending a copy of the manifest to the designated facility that returned or rejected the shipment. Additionally, healthcare facilities and reverse distributors must submit exception reports for a missing copy of a manifest. EPA estimates it will take a healthcare facility and reverse distributor 1.10 hours to prepare and submit an exception report and 0.1 hours to keep a copy of the exception report. EPA assumes it will take a similar amount of time for a healthcare facility or reverse distributor to track or manage rejected shipments by signing an item on the manifest, providing the transporter with a copy of the manifest, and sending a copy of the manifest to the designated facility that returned or rejected the shipment. In line with the Final Fee Rule ICR, EPA estimates that 1% of the manifests sent offsite will require an exception report. EPA assumes a similar number of rejected shipments will need to be tracked or managed by healthcare facilities and reverse distributors. EPA assumes that healthcare facilities will send one shipment of non-creditable hazardous waste pharmaceuticals to a designated facility annually that requires a manifest and a revere distributor will send 4 shipments of evaluated hazardous waste pharmaceuticals to a designated facility annually that require a manifest (assuming that facilities will accumulate hazardous waste pharmaceuticals on site for the maximum allowed time under subpart P). EPA estimates the total respondent burden is estimated to be 276 hours at a cost of $24,120.

Recordkeeping

Reverse distributors and healthcare facilities must keep a signed copy of each manifest for three years and a copy of their notification on file as long as they are subject to this subpart. The burden associated with this activity is covered under OMB Control No. 2050-0039 “Requirements for Generators, Transporters, and Waste Management Facilities under the RCRA Hazardous Waste Manifest System”, and OMB Control No. 2050-0024 “RCRA Subtitle C Reporting Instructions and Forms”.

Manifests and Shipping

Healthcare facilities must complete manifests for non-creditable pharmaceuticals shipped to a TSDF, but need not include RCRA waste codes on these manifests. The burden associated with this activity is covered under OMB Control No. 2050-0039 “Requirements for Generators, Transporters, and Waste Management Facilities under the RCRA Hazardous Waste Manifest System”.

Contingency Planning

A reverse distributor must comply will the contingency plan requirements of 40 CFR 262 subpart M. This ICR assumes that reverse distributors have already prepared contingency plans. Therefore, only reverse distributors that need to amend their contingency plans annually will have a paperwork burden under this provision of this ICR for a total burden of 9 hours at a cost of $525.

Unauthorized Waste Reporting

A reverse distributor must submit an unauthorized hazardous waste report if it receives waste it is not authorized to receive. EPA estimates that 1% of the shipments that go from a healthcare facility to a reverse distributor will be waste that the reverse distributor is not authorized to receive. EPA estimates healthcare facilities send 4 shipments of hazardous waste pharmaceuticals to reverse distributors annually.¹ Thus, EPA estimates in total that healthcare facilities will send between 47,556-52,384 shipments to the 27 reverse distributors annually, resulting in an estimated 476-534 shipments that healthcare facilities send to the 27 reverse distributors annually that they are not authorized to receive. EPA estimates that each reverse distributor will therefore submit 18-20 unauthorized waste reports per year. EPA assumes it will a similar amount of time to submit an unauthorized waste report as it does to submit an exception report. Thus, EPA estimates it will take 0.5 hours of management time, 0.5 hours of technician time, and 0.1 hours of administrative time to submit an unauthorized waste report. On average, each reverse distributor will therefore spend 9.5 hours of management time, 9.5 hours of technician time, and 1.9 hours of administrative time submitting unauthorized waste reports. EPA estimates the burden associated with submitting unauthorized waste reports will result in a total burden of 576 hours annually at a cost of $51,192.

Biennial Reports

Hazardous waste pharmaceuticals are no longer counted toward a healthcare facility’s generator status and need not be included in facilities’ Biennial Report submissions. Reverse distributors will still be required to submit a biennial report if they ship evaluated hazardous waste pharmaceuticals off site. The burden associated with this activity is covered under OMB Control No. 2050-0024 “RCRA Subtitle C Reporting Instructions and Forms”.

Containers

Reverse distributors must mark containers of evaluated hazardous waste pharmaceuticals with the applicable hazardous waste codes prior to being shipped off site. EPA estimates it takes a similar amount of time to mark the containers with the hazardous waste code as it does to mark the containers with an indication of the hazards of the contents. The total burden is 2 hours at a cost of $189.

6(e) Bottom Line Burden Hours and Costs

Respondent Tally

In Exhibit 1, EPA presents the annual respondent burden hours and costs associated with the new information collection requirements in this ICR. As described specifically in Section 6(d) above, the information collection requirements apply to affected facilities (respondents). As shown in Exhibit 1, the total annual respondent burden for these paperwork requirements is approximately 40,045 hours at an annual cost of approximately $3,580,140, which includes $0 in capital startup and operation and maintenance cost.

6(f) Reasons for Change in Burden

There is a decrease of 3,532 hours compared to the currently approved ICR due to a decrease in the universe. The universe estimates are based on real data for this renewal.

6(g) Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 5 hours per response.

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, 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 2050-0212 in any correspondence.

EXHIBIT 1
Information Activity
	Leg. $129.33/Hr	Mgr. $109.21/Hr	Tech. $84.15/Hr	Cler. $32.81/Hr	Resp. Hours/Yr	Labor Cost/Yr	Capital/ Startup Cost	O&M Cost	Number of Resp.	Total Hours/Yr	Total Cost/Yr
Reading the Rule
Reading the Rule	0	1.00	2.50	0	3.50	$320	$0	0	8,163	28,571	$2,612,160
Labeling
Label containers in primary storage area (LQG)	0	0	1	0	1.00	$84	$0	$0	6,537	6,537	$549,108
Label containers in primary storage area (SQG)	0	0	0.25	0	0.25	$21	$0	$0	1,626	407	$34,146
Label containers in satellite storage area (LQG)	0	0	0.5	0	0.50	$42	$0	$0	6,537	3,269	$274,554
Label containers in satellite storage area (SQG)	0	0	0.25	0	0.25	$21	$0	$0	1,626	407	$34,146
Subtotal										10,620	$891,954
Exception Reporting and Rejected Shipment
Submit exception report	0	0.5	0.5	0.1	1.10	$99	$0	$0	120	132	$11,880
Keep copy of exception report	0	0	0	0.1	0.10	$3	$0	$0	120	12	$360
Track or manage rejected shipment	0	0.5	0.5	0.1	1.10	$99	$0	$0	120	132	$11,880
Subtotal										276	$24,120
Contingency Planning
Amend contingency plan	0	0	1.5	1.5	3.00	$175	$0	$0	3	9	$525
Unauthorized Waste
Submit unauthorized waste report	0	9.5	9.5	1.9	21.00	$1,896	$0	$0	27	567	$51,192
Containers
Mark containers with waste codes	0	0	0.08	0	0.08	$7	$0	$0	27	2	$189
TOTAL										40,045	$3,580,140

1 The assumptions for the manifest estimates are based on the economics background document developed for the final rule: “Regulatory Impact Analysis for EPA’s Final Regulations for the Management of Hazardous Waste Pharmaceuticals.”