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

Table of Contents

 TOC \f

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
……………………………………………………………..1
7

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

	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.	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 healthcare-related
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 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 non-creditable 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.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.

 3(c)	Consultations tc \l2 "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 tc \l2 "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 tc \l2 "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 tc \l2 "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 tc \l2 "3(g)	Sensitive Questions

No questions of a sensitive nature are included in the information
collection requirements associated with the proposed rule.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED tc \l1 "4.	THE
RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents and NAICS Codes tc \l2 "4(a)	Respondents and SIC/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 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;

(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 non-creditable 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 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
handwritten 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 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.

(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:

(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
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 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.

(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 (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 on-site.

(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 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.

(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:

(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.

(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.

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 Facility-Specific Regulations for the Management of
Hazardous Waste Pharmaceuticals,” which is available in the public
docket identified under Section 6(g)).

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.  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).

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).

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, 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 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
HYPERLINK "http://www.regulations.gov"  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<PHONE_NUMBER>, and the telephone number for the
RCRA Docket is<PHONE_NUMBER>.  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.

	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.”

	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.”

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.”

 PAGE

 PAGE   iii


[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62688-62691]
[FR Doc No: 2014-24777]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73348; File No. SR-ICEEU-2014-17]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Rules and Procedures

October 14, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 3, 2014, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule changes described in Items I, II and III below, which
Items have been prepared primarily by ICE Clear Europe. ICE Clear
Europe filed the proposal pursuant to Section 19(b)(3)(A) of the
Act,\3\ and Rules 19b-4(f)(4)(i) thereunder,\4\ so that the proposal
was effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(4)(i).
---------------------------------------------------------------------------

I. Self-regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The principal purpose of the proposed changes is to accommodate the
transition of trading in certain cleared financial and soft commodity
contracts from the LIFFE Administration & Management (``LIFFE'') market
to ICE Futures Europe.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of these statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    ICE Clear Europe currently acts as the clearing organization for
futures and option contracts traded on the LIFFE market. These
contracts consist of futures and options contracts involving financial
instruments (including interest rate futures and option contracts and
equity futures and option contracts) and so-called ``soft'' commodities
(including futures and option contracts on cocoa, wheat, coffee and
sugar) (collectively, ``financials and softs contracts''). As has been
publicly announced,

IntercontinentalExchange Group, Inc. (``ICE Group''), the parent of ICE
Clear Europe and LIFFE, has determined to transition the trading of
such contracts from LIFFE to ICE Futures Europe (which is also a
subsidiary of ICE Group). ICE Clear Europe also acts as the clearing
organization for the ICE Futures Europe market, and ICE Clear Europe
will continue to clear the transitioning financials and softs contracts
following the transition. To facilitate an orderly transition in
trading activity and to accommodate operational requirements of the
clearing house, the exchanges and other market participants, it is
expected that the transition will occur in several stages commencing in
late September 2014 and concluding in mid-November 2014. Each stage
will involve transition of a set of products in a particular category
(such as soft commodity, fixed income or equity contracts).
    In connection with the transition, ICE Clear Europe proposes to
make certain amendments to its Rules and Procedures to reflect the
change in trading market and make various related conforming changes.
ICE Clear Europe does not propose to change the clearing resources
supporting the clearing of these products, including the margin
methodology for the products and the guaranty fund supporting clearing
of the products, or to materially change its risk management framework
for these contracts. In addition, ICE Clear Europe does not propose to
change its rules in a manner that conflicts with the terms of the
exemptive order granted by the Commission to ICE Clear Europe from
clearing agency registration in connection with the clearing of the
LIFFE securities products (the ``ICEU Exemptive Order''),\5\ and ICE
Clear Europe will continue to satisfy the conditions of such order.
Furthermore, despite the change in trading venue from LIFFE to ICE
Futures Europe and the proposed rule changes, the controls put into
place by ICE Clear Europe pursuant to the ICEU Exemptive Order to
prevent U.S. persons from clearing transactions in U.S. securities and
to comply with the other conditions in the order will remain in place
and continue to be satisfied.\6\
---------------------------------------------------------------------------

    \5\ Order Pursuant to Section 17A of the Securities Exchange Act
of 1934 Granting Exemption from the Clearing Agency Registration
Requirement under Section 17A(b) of the Exchange Act for ICE Clear
Europe Limited in Connection With its Proposal to Clear Contracts
Traded on the LIFFE Administration and Management Market, Exchange
Act Release No. 34-69872 (June 27, 2013).
    \6\ These include controls implemented as part of the clearing
membership and account set-up process. ICE Clear Europe also notes
in this regard that consistent with the class no-action relief
provided by the Division of Trading and Markets for foreign options
markets (LIFFE A&M and Class Relief, SEC No-Action Letter (July 1,
2013)), LIFFE equity options on securities of U.S. issuers are not
available for sale to U.S. persons. This restriction will continue
to apply following the transition of trading in such options to ICE
Futures Europe. See Representation Letter from ICE Futures Europe
(March 28, 2014).
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    ICE Clear Europe submits revisions to Parts 1, 2, 4, 9, 11 and 12
of the Rules and a new Part 21 of the Rules. ICE Clear Europe also
submits certain conforming changes to its Procedures, including the
Clearing Procedures, Finance Procedures, Delivery Procedures General
Contract Terms, Complaint Resolution Procedures and FX Procedures.
    Throughout the Rules and Procedures, references to ``LIFFE
Contracts'' and related definitions referring to ``LIFFE'' have been
changed to ``Financials & Softs Contracts'' and corresponding related
terms, as described herein. Accordingly, the current LIFFE segment of
the F&O product category will become known as the Financials & Softs
segment of the F&O product category. During the phased transition
period, the Financials & Softs segment will include both those former
LIFFE contracts that have transitioned to trading on ICE Futures Europe
and those LIFFE contracts that have not yet been transferred.
    In Part 1 of the Rules, Rule 101 is modified to add new defined
terms and revise existing definitions in connection with the
transition. The definitions of ``Energy'' and ``Energy Transaction''
have been revised to exclude ICE Futures Europe transactions that are
Financials & Softs transactions. A new set of Financials & Softs
related definitions has been added based on the existing LIFFE contract
related definitions, including ``Financials & Softs'', ``Financials &
Softs Block Contract'', ``Financials & Softs Block Trade Facility'',
``Financials & Softs Block Transaction'', ``Financials & Softs Clearing
Member'', ``Financials & Softs Contract'', ``Financials & Softs Matched
Contract'', ``Financials & Softs Matched Transaction'', and
``Financials & Softs Transaction''. These are substantially the same as
the corresponding definitions for LIFFE products, but reflect the fact
that Financials & Softs contracts will be traded on ICE Futures Europe
and, prior to the transition, on LIFFE. Certain other definitions have
been added to address particular LIFFE trading functionalities,
including ``Basis Trades'' and ``Soft Commodity EFRP,'' which are used
in the definition of Financials & Softs Block Transaction and are
defined by reference to the relevant ICE Futures Europe rules or LIFFE
rules. Various other conforming changes to definitions have been made,
principally to refer to ``Financials & Softs'' instead of ``LIFFE''
and/or to refer to ICE Futures Europe instead of (or in addition to)
the LIFFE market. In addition, the definition of ``Continuing CDS Rule
Provisions'' is modified such that references to ``LIFFE Contracts'' in
Rule 209 thereof will be deemed to be ``Financials & Softs Contracts''
as defined in the Rules.
    Rule 102(f), which addresses relevant documentation governing
transactions, has been revised to reference the relevant LIFFE rules in
the case of Financials & Softs Contracts traded on LIFFE and the
relevant ICE Futures Europe rules in the case of Financials & Softs
Contracts traded on ICE Futures Europe.
    In Rules 201(a), 207(g) and 208(e) various conforming changes are
made to refer to Financials & Softs Transactions and Contracts instead
of LIFFE Transactions and Contracts, as appropriate. In Rule 207(g), a
further clarification is made that the restriction therein on U.S.
clearing members clearing Financials & Softs Contracts in U.S.
securities does not apply to clearing of futures contracts on exempted
securities.
    Rule 401, which addresses contract formation, has been revised to
refer to Financials & Softs Transactions and Contracts instead of LIFFE
Transactions and Contracts and Financials & Softs Clearing Members
instead of LIFFE Clearing Members, and to refer to the ICE Futures
Europe Rules, as appropriate. Similarly, conforming changes to the use
of the term Financials & Softs Clearing Member has been made in Rule
404(a).
    In Rules 908 and 909, various conforming references to defined
terms referencing LIFFE have been changed to Financials & Softs.
Similarly, a conforming change in Rule 1101 has been made to refer to
Financials & Softs instead of LIFFE.
    The amendments also revise Part 12 of the Rules, which addresses UK
Settlement Finality Regulations and the Companies Act 1989, to refer to
Financials & Softs transactions and to change the defined term ``LIFFE
Delivery Order'' to ``Security Derivative Delivery Order.''
    The amendments include a new Part 21 of the Rules, which adopts
transitional provisions for the LIFFE Contracts moving to ICE Futures

Europe. Rule 2102 \7\ adopts definitions for the various stages of the
transition and the particular contracts being moved to ICE Futures
Europe. It is contemplated that the transition will take place in five
stages. The first stage (expected to occur at the end of September
2014) will consist of soft commodity futures and option contracts; the
second, third and fourth stages (expected to occur during October 2014
and early November 2014) will consist of government bond futures and
options contracts; and the fifth phase (expected to occur in mid-
November 2014) will consist of equity futures and option contracts.
Rule 2103 \8\ provides that the transition of trading will occur for
each stage of the transition at the specified transition time. Rule
2104 \9\ provides for the redesignation of contracts as Financials &
Softs Contracts for purposes of the Rules.
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    \7\ In ICE Clear Europe's filing, it referenced Rule 2101.
Following confirmation from ICE Clear Europe, Staff has changed this
reference to Rule 2102.
    \8\ In ICE Clear Europe's filing, it referenced Rule 2102.
Following confirmation from ICE Clear Europe, Staff has changed this
reference to Rule 2103.
    \9\ In ICE Clear Europe's filing, it referenced Rule 2103.
Following confirmation from ICE Clear Europe, Staff has changed this
reference to Rule 2104.
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    In the Clearing Procedures, paragraph 1 has been revised to refer
to ``Financials & Softs'' instead of LIFFE and to refer to various
successor operational systems that may be used by ICE Clear Europe.
Similarly, in the Finance Procedures, references to ``LIFFE Contracts''
have been changed to ``Financials & Softs Contracts.''
    ICE Clear Europe also proposes to make conforming changes to the
Delivery Procedures. References to ``LIFFE'' have been changed to
``Financials & Softs.'' In addition, parallel references to ICE Futures
Europe and the ICE Futures Europe Rules have been added as appropriate
to existing references to LIFFE and the LIFFE Rules, including in
connection with delivery specifications. Certain references to LIFFE
contract terms have been changed to relevant contract terms to reflect
the transition to ICE Futures Europe. References to the ``LIFFE
Guardian'' electronic grading and delivery system for softs have been
changed to ``Guardian'' or any successor system. In addition, certain
obsolete references to raw sugar contracts (which are not currently
traded on LIFFE or ICE Futures Europe) have been removed in paragraph
8.
    In the General Contract Terms, references to LIFFE Contracts are
changed to Financials & Softs Contracts and a reference to the ICE
Futures Europe Rules is added. Other conforming changes to defined
terms (based on prior amendments to the Rules) are also made, including
to the use of the terms ``Buying Counterparty,'' ``Selling
Counterparty'' and ``Clearing Counterparty''. The ``Waiver'' and
``Entire Agreement'' provisions in new paragraphs 3(o) and (p) were
inadvertently deleted in a prior amendment \10\ and are reinstated in
relevant part.
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    \10\ Exchange Act Rel. No. 34-72582 (July 10, 2014), 79 FR 41320
(July 15, 2014) (SR-ICEEU-2014-11).
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    In the Complaint Resolution Procedures, a reference to Financials &
Softs Clearing Members is added in paragraph 1.5. In paragraph 1.31 of
the FX Procedures, a conforming change is made to reflect a change in
defined terms under the Rules.
2. Statutory Basis
    ICE Clear Europe believes that the proposed rule changes are
consistent with the requirements of Section 17A of the Act \11\ and the
regulations thereunder applicable to it, including the standards under
Rule 17Ad-22.\12\ The amendments will accommodate the transition of
trading of certain cleared Financials & Softs contracts from trading on
LIFFE to trading on ICE Futures Europe, while maintaining clearing at
ICE Clear Europe. The existing clearing arrangements and related
financial safeguards, protections, risk management procedures,
settlement procedures, clearing membership standards and default
management procedures for such contracts at ICE Clear Europe will
continue to apply, as discussed herein. ICE Clear Europe does not
propose to change any rules in a manner that conflicts with the terms
of the ICEU Exemptive Order and will continue to satisfy the conditions
of such order. Furthermore, despite the change in trading venue from
LIFFE to ICE Futures Europe and the proposed rule changes, the controls
put into place by ICE Clear Europe pursuant to the ICEU Exemptive Order
to prevent U.S. persons from clearing transactions in U.S. securities
and to comply with the other conditions in the order will remain in
place and continue to be satisfied. As a result, the transition, and
the related amendments to the ICE Clear Europe rules and procedures,
are consistent with the prompt and accurate clearance of and settlement
of securities transactions and derivative agreements, contracts and
transactions cleared by ICE Clear Europe, the safeguarding of
securities and funds in the custody or control of ICE Clear Europe and
the protection of investors and the public interest, within the meaning
of Section 17A(b)(3)(F) of the Act.\13\
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    \11\ 15 U.S.C. 78q-1.
    \12\ 17 CFR 240.17Ad-22.
    \13\ 15 U.S.C. 78q-1(b)(3)(F).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed rule and procedure
changes would have any impact, or impose any burden, on competition not
necessary or appropriate in furtherance of the purposes of the Act. As
discussed above, the amendments are intended to accommodate the
transitioning of trading for the relevant contracts from LIFFE to ICE
Futures Europe, and the clearing arrangements for those contracts are
not expected to change in any material respect. In particular, the
contract terms and clearing membership standards will not change in any
material respect, and the availability of clearing and the costs and
requirements for clearing of the contracts are not expected to change
in any material respect as a result of the transition. The rule changes
should therefore not affect access to clearing in these products by
clearing members or their customers. Accordingly, ICE Clear Europe does
not believe that the proposed rule changes will impose any burden on
competition among clearing members or their customers not appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed changes to the rules have
not been solicited or received. ICE Clear Europe will notify the
Commission of any written comments received by ICE Clear Europe.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A) \14\ of the Act and Rule 19b-4(f)(4)(i) \15\
thereunder because it effects a change in an existing service of a
registered clearing agency that does not adversely affect the
safeguarding of securities or funds in the custody or control of the
clearing agency or for which it is responsible and does not
significantly affect the respective rights or obligations of the
clearing agency or

persons using the service, within the meaning of Rule 19b-4(f)(4)(i).
As discussed above, ICE Clear Europe is currently the clearing
organization for the transitioning LIFFE contracts, and will continue
to clear such contracts following the transition of trading to ICE
Futures Europe. The contract terms of the transitioning contracts are
not changing in any material respect, and ICE Clear Europe will
continue to use substantially the same risk management, margin,
guaranty fund, settlement and other policies and procedures following
the transition as are currently used with respect to such contracts.
The amendments to the Rules and Procedures discussed herein generally
consist of conforming changes to defined terms and related transitional
provisions that will accommodate the transition of trading activity. In
ICE Clear Europe's view, these changes will thus not significantly
affect the safeguarding of funds or securities in the custody or
control of ICE Clear Europe, or otherwise significantly affect the
rights or obligations of the Clearing House and its Clearing Members.
At any time within 60 days of the filing of the proposed rule change,
the Commission summarily may temporarily suspend such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
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    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(i).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or send an email to<EMAIL_ADDRESS>
Please include File Number SR-ICEEU-2014-17 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICEEU-2014-17. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings will also be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICEEU-2014-17
and should be submitted on or before November 10, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-24777 Filed 10-17-14; 8:45 am]
BILLING CODE 8011-01-P