 

SUPPORTING STATEMENT FOR 

EPA INFORMATION COLLECTION REQUEST NUMBER 2324.01 REPORTING AND
RECORDKEEPING REQUIREMENTS FOR THE PROPOSED RULE ON ADDING
PHARMACEUTICALS TO THE UNIVERSAL WASTE RULE (Proposed Rule)

September 2008

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	2

2(a)	Need and Authority for the Collection	2

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

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER 

	COLLECTION CRITERIA 	3 

3(a)	Nonduplication	3

3(b)	Public Notice	3

3(c)	Consultations	3

3(d)	Effects of Less Frequent Collection	3

3(e)	General Guidelines	3

3(f)	Confidentiality	4

3(g)	Sensitive Questions	4

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED	4

4(a)	Respondents and SIC/NAICS Codes	4

4(b)	Information Requested	4

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT	7

5(a)	Agency Activities	7

5(b)	Small Entity Flexibility	7

6.	ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION	8

6(a)	Estimating Respondent Burden	8

6(b)	Estimating Respondent Costs	8

6(c)	Estimating Agency Burden and Costs	9

6(d)	Estimating the Respondent Universe and Total Burden and Costs	9

6(e)	Bottom Line Burden Hours and Costs	12

6(f)	Reasons for Change in Burden	12

6(g)	Burden Statement	13

 



	EXHIBITS

Estimated Annual Respondent Burden and Cost (Exhibit
1).............................................14

Estimated Annual Respondent Burden for Existing ICRs

(Including Net Impact from Pharmaceutical Rule
ICR)....................................................15



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 Adding
Pharmaceuticals to the Universal Waste Rule (Proposed Rule),” EPA ICR
Number 2324.01.

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. 
Some pharmaceutical wastes are hazardous because they contain listed
hazardous waste chemicals or they exhibit one of the four hazardous
waste characteristics.  As a result, these pharmaceutical wastes are
currently subject to strict controls under RCRA Subtitle C hazardous
waste regulations.  However, health care facilities report that they
struggle to familiarize their time-constrained workers with the RCRA
hazardous waste regulations.  The lack of time and hazardous waste
management knowledge on the part of health care workers makes it
difficult for them to determine which wastes are RCRA hazardous, whether
they are listed or characteristic hazardous wastes, and what the proper
management techniques are for those wastes.

After consideration of the issues, EPA is proposing to add hazardous
pharmaceutical wastes to the existing universal waste rule (UWR) at 40
CFR Part 273.  The existing universal waste regulations, published on
May 11, 1995, provide streamlined procedures for certain widely
generated wastes identified as universal wastes (60 FR 25492).  The
universal waste standards are designed to accomplish the following
general goals: 

• Encourage resource conservation while ensuring protection of human
health and the environment.

• Improve implementation of the current RCRA Subtitle C hazardous
waste regulatory program. 

• Simplify the hazardous waste regulatory requirements and to
encourage individuals and organizations to collect the unregulated
portion of these wastes and manage them using the same system developed
for the regulated portion.  That is, this removes otherwise unregulated
wastes from the municipal waste stream, minimizing the placement of
hazardous constituents into municipal landfills, combustors and
composting projects, as well as to wastewater treatment plants. 

The UWR is specifically designed to reduce the complexity of the RCRA
hazardous waste generator regulations for universal wastes.  It
streamlines the collection and handling requirements for
widely-dispersed hazardous wastes and facilitates their inclusion in the
hazardous waste management system.  By proposing to incorporate
hazardous pharmaceutical waste in the universal waste regulations, EPA
expects improved management of hazardous and non-hazardous
pharmaceutical wastes, as well as decreased regulatory burden for many
hazardous pharmaceutical waste generators.  This proposal thus provides
a solution to many of the issues facing health care facilities and other
pharmaceutical waste generators.

Furthermore, while the UWR regulates only RCRA hazardous wastes, the
Agency anticipates that including hazardous pharmaceutical wastes in the
UWR will encourage persons to manage other pharmaceutical wastes in the
same manner as universal wastes, particularly those wastes that are not
hazardous under RCRA but which may nonetheless pose risks.  Moreover,
EPA expects that including hazardous pharmaceutical wastes in the UWR
will ease the regulatory burden on generators that want to collect these
wastes, facilitating the implementation of pharmaceutical take-back
programs.  The proposed rule is also designed to reduce the quantity of
RCRA hazardous waste pharmaceuticals managed in municipal solid waste
systems.  Thus, expansion of the universal waste system to include
hazardous pharmaceutical wastes would lead to better management of these
wastes by providing a more streamlined, but effective waste management
system.  

This ICR is a comprehensive description of the information collection
requirements for handlers of hazardous pharmaceutical wastes under the
universal waste requirements. 

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 obtain
general information on universal pharmaceutical waste regulated entities
and to facilitate enforcement of Part 273 regulations.  The notification
requirements are needed to assist the Agency in identifying and tracking
large quantity handlers of universal pharmaceutical waste.  EPA requires
large quantity handlers to mark and track pharmaceutical waste shipments
to help ensure these wastes are being accumulated responsibly.  EPA also
requires tracking of universal pharmaceutical waste shipments to help
ensure these wastes are being properly treated, recycled, or disposed. 

2(b) 	Practical Utility and Users of the Data 

EPA will use the collected information to ensure that universal
pharmaceutical wastes are being managed in a protective manner.  This
information aids the Agency in tracking universal pharmaceutical waste
shipments and identifying improper management practices.  In addition,
information kept in facility records will help handlers demonstrate, and
on-site inspectors ensure, that facilities are managing pharmaceutical
wastes properly.  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
60-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 amendment to the UWR.  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).

 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

622	Hospitals

6211	Physicians’ Offices

6212	Dentists’ Offices

6213	Other Health Practitioners 

(e.g., chiropractors)                      

6214	Outpatient Care Centers

6219	Other Ambulatory Health Care Services

623	Residential Care Facilities

Various NAICS3	Reverse Distributors

54194	Veterinary Clinics



4(b)	Information Requested

This section describes information collection requirements applicable to
universal pharmaceutical waste regulated entities that would be affected
by the rule. 

Notification 

(i) Data items: 

The proposed rule, based on the existing UWR regulations for large
quantity handlers, requires that large quantity handlers of universal
pharmaceutical waste must send written notification of their universal
waste management to the Regional Administrator, and receive an EPA
identification number.  Specifically, the large quantity handlers must
send written notification before meeting or exceeding the 5,000 kilogram
accumulation limit of universal waste. Large quantity handlers who have
already notified EPA of their hazardous waste management activities
under RCRA or pesticide management under FIFRA and have received an EPA
Identification number are not required to re-notify. 

The notification must include the following data items: 

The universal waste handler's name and mailing address; 

The name and business telephone number of the person at the universal
waste handler's site who should be contacted regarding universal waste
management activities; 

The address or physical location of the universal waste management
activities;

A list of all types of universal waste managed by the handler; and

A statement indicating that the handler is accumulating 5,000 kilograms
or more of universal waste at one time. 

(ii) Respondent activities: 

Large quantity handlers of universal pharmaceutical waste must prepare
and submit written notification of their universal waste management to
the Regional Administrator.  However, it is reasonable to assume that
large quantity handlers have previously notified EPA of their hazardous
waste management activities under RCRA or pesticide management under
FIFRA and have received an EPA Identification number.  Therefore, they
would not be required to re-notify under the proposed rule. 

Labeling/Marking 

(i) Data items: 

Small and large quantity handlers are required to mark or label their
universal pharmaceutical waste materials in accordance with the
following procedures: 

All containers must be marked with the words “Universal Waste -
Pharmaceuticals” or “Waste Pharmaceuticals.” 

(ii) Respondent Activities: 

Handlers must mark or label the universal pharmaceutical waste or the
containers holding universal pharmaceutical waste.  However, the small
and large quantity generators under RCRA Subtitle C requirements must
also mark all containers with the words “Hazardous Waste” and the
accumulation start date.  Therefore, the labeling requirements under the
proposed rule would not result in any additional burden to the handlers.


Accumulation Time Limits 

(i) Data items: 

Small quantity and large quantity handlers are required to demonstrate
the length of time that the pharmaceutical material has been accumulated
from the date it was received or became a waste. 

(ii) Respondent Activities: 

Handlers must demonstrate the length of time that pharmaceutical
material has been accumulated from the date it was received or became a
waste.  As with the Labeling/Marking requirements for small and large
quantity generators under RCRA Subtitle C that are described above, the
handlers can continue to mark all containers with the accumulation start
date.  Therefore, this activity should not result in any additional
burden to the handlers.

Tracking Pharmaceutical Waste Shipments 

(i) Data items: 

The rule requires large quantity handlers to keep records of each
incoming or outgoing universal pharmaceutical waste shipment.  Records
of shipments must be kept for a period of three years from the day of
receipt or the day the shipment left the facility. 

The data items required are: 

Records of incoming and outgoing shipments must contain the following
information: 

Name and address of the originating or destination facility; 

Quantity of universal pharmaceutical waste received or sent; and 

Date the shipment was sent or received. 

(ii) Respondent activities: 

Large quantity handlers must: 

Maintain records of all shipments for a period of three years. 

Exports 

(i) Data Items: 

The proposed rule, based on the existing UWR regulations for exports,
requires that shipments of universal pharmaceutical waste to a foreign
destination must comply with the same requirements as shipments of
hazardous waste (i.e., 40 CFR 262, Subparts E or H).  These reporting
and recordkeeping activities are not evaluated in this ICR because they
already are addressed in the "Requirements for Generators, Transporters,
and Waste Management Facilities under the RCRA Hazardous Waste Manifest
System" (ICR No. 801) and in the "Exports from and Imports to the U.S.
under the Organization for Economic Cooperation and Development (OECD)
Decision" (ICR No. 1647). 

5.	THE INFORMATION COLLECTED --AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT 

5(a)	Agency Activities 

Most of the information that is required of universal pharmaceutical
waste handlers would be kept on site and not be submitted to EPA for
review.  The exception is a notification requirement for large quantity
handlers of universal pharmaceutical waste.  However, as stated earlier,
it is being assumed that large quantity handlers have previously
notified EPA of their hazardous waste management activities under RCRA
or pesticide management under FIFRA and have received an EPA
Identification number.  Therefore, they would not be required to
re-notify the Agency under the proposed rule, and the Agency does not
have to review any new notifications.

5(b)	Small Entity Flexibility 

By adding hazardous pharmaceutical waste to the federal list of
universal wastes, the proposed rule will provide regulatory relief from
the full Subtitle C management requirement for entities involved in
pharmaceutical waste management.  These entities include generation and
transportation facilities.  Small quantity generators (SQGs) of
hazardous pharmaceutical waste will become small quantity handlers
(SQHs) of universal pharmaceutical waste.  Regulatory requirements for
small quantity handlers of universal waste are considerably simpler than
those applicable to small quantity generators of hazardous waste. 

Further, EPA relieved small quantity handlers from several
administrative requirements applicable to large quantity handlers.  For
example, the proposed rule does not require small quantity handlers to
submit notifications of universal pharmaceutical waste management or to
obtain an EPA identification number.  EPA also does not require small
quantity handlers to keep records of their universal pharmaceutical
waste shipments.   EPA believes these exemptions would encourage small
businesses to safely manage universal pharmaceutical waste in compliance
with the regulation.  In addition, EPA allows conditionally exempt small
quantity generators (CESQGs) to manage their hazardous pharmaceutical
waste either under the specific provisions of the proposed rule or under
the existing CESQG exemption in 40 CFR 261.5. 

Finally, the proposed rule to add pharmaceuticals to the universal waste
rule is a regulatory relief initiative that should reduce regulatory
burden and costs for all universal waste handlers, but should
particularly benefit small entities. 

6.	ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION  

6(a)	Estimating Respondent Burden

	In exhibit 1, EPA estimates the respondent burden associated with the
new paperwork 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 approximately 960 hours per
year.

 	6(b)	Estimating Respondent Costs

EPA also estimates in Exhibit 1 that the total annual respondent cost
for the new paperwork requirements in the rule is approximately $54,000.
 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 $102 for legal staff, $71 for managerial staff,
$48 for technical staff, and $26 for clerical staff.  These hourly labor
costs were obtained from the economics background document developed for
the proposed rule.

 

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 from
photocopying shipping papers.

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 pharmaceutical universal waste handlers to submit any
information for its review and approval under the proposed rule.  Under
the proposed rule, large quantity handlers (LQHs) of universal waste
must notify EPA and obtain an EPA identification number.  However, a LQH
is not required to notify if it has previously notified EPA and obtained
an identification number as a large quantity generator (LQG) under RCRA
Subtitle C hazardous waste requirements.  We are assuming that all
existing/new LQHs of universal pharmaceutical waste have previously
notified EPA and obtained an identification number.  The pharmaceutical
universal waste handlers 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 likely choose to comply with the new paperwork requirements in
the proposed rule.  This is because the respondent paperwork
requirements for the existing small and large quantity handlers under
the UWR will be more streamlined (resulting in lower burden) compared to
the RCRA Subtitle C hazardous waste regulations.  In the same exhibit,
EPA estimates respondent burden and costs associated with the new
paperwork requirements.  Table 1 presents the number of respondents that
could potentially be affected by the proposed rule.  It shows that EPA
estimates 634,552 small and large facilities handle hazardous
pharmaceutical waste each year.  The conditionally-exempt small quantity
generators (CESQGs) of hazardous pharmaceutical waste are already
subject to very minimum waste management requirements under the existing
RCRA Subtitle C hazardous waste regulations.  Because the burden from
new paperwork requirements for CESQGs under the amended UWR would be
higher than the existing paperwork requirements, we are assuming that
CESQGs are unlikely to choose to manage their pharmaceutical wastes
under the amended UWR. 



TABLE 1

NUMBER OF FACILITIES POTENTIALLY AFFECTED BY 

THE PROPOSED RULE

Type of Respondent	Number of Facilities

Small Quantity Handlers (CESQGs under Subtitle C regulations)	633,433

Small Quantity Handlers (SQGs under Subtitle C regulations)	1,083

Large Quantity Handlers (LQGs under Subtitle C regulations)	36

Total 	634,552



Respondent Burden and Cost

Based on the universe data presented in Table 1, EPA estimated the
respondent burden 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 estimates follows.  

Reading the Regulations

As shown in Exhibit 1, EPA estimates that 1,119 potentially affected
facilities will read the rule on adding pharmaceuticals to the universal
waste rule (facilities that are currently classified as CESQGs are
unlikely to read the rule because the proposed rule would not decrease
their paperwork burden).  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 required for this activity by three. 

Record of Shipments for Generators	

The SQHs of universal waste are not required to maintain any records of
universal waste shipments.  LQHs, however, must record all shipments
received or shipped.  Logs, invoices, bills of lading, or other shipping
documents constitute acceptable forms of records.  These records must be
maintained for at least three years.  Based on the quantity of universal
pharmaceutical waste managed by LQHs, it was estimated that an average
of about eight shipments of universal pharmaceutical waste would be made
annually by each LQH.  The cost to complete and maintain a record of
universal waste shipment was estimated to be $10 per shipment in the
economics background document developed for the proposed rule.

	Total Respondent Burden and Cost

In Exhibit 2, EPA presents a summary of the total annual respondent
burden and costs associated with both new and existing paperwork
requirements.  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 calculated in
Exhibit 1, summarized in Exhibit 2, and briefly described below.  The
existing paperwork requirements are those that are contained in the
current RCRA regulations and that apply to generators of hazardous
pharmaceutical wastes.  These existing requirements, the existing ICRs
with which they are associated, and the total annual burden and cost
associated with them also are summarized in Exhibit 2 and briefly
described below.

New Paperwork Requirements

EPA presents the total respondent burden and costs for all of the new
information collection activities associated with the proposed rule in
exhibit 1.  As noted above, this exhibit presents the annual burden and
costs over the three-year effective life of the ICR.  The exhibit
calculates the burden and cost of one-time activities by dividing the
total number of burden hours by three.  In Exhibit 2, EPA summarizes the
total annual respondent burden and cost of these new paperwork
requirements derived in Exhibit 1.

Existing Paperwork Requirements

In addition to the new paperwork requirements in the proposed rule, EPA
also estimated the burden and cost savings that hazardous pharmaceutical
waste handlers would expect for no longer following the existing RCRA
information collection requirements.  In Exhibit 2, EPA presents the
total annual respondent burden and cost savings under the existing
paperwork requirements, broken out by the four existing EPA ICRs that
are affected by the proposed rule.  In developing Exhibit 2, EPA
reviewed each of the affected ICRs to identify the existing information
collection activities that are currently undertaken by hazardous
pharmaceutical waste handlers, calculated the associated burden and
costs (or savings), and presented the totals in the exhibit.

The total costs in Exhibit 2 are broken down into labor and operation
and maintenance (O&M) costs.  In Section 6(b), EPA presents a discussion
of the capital and O&M costs associated with new paperwork requirements
from the proposed rule.  In the following paragraph, EPA presents a
brief discussion of the O&M costs associated with each of the existing
ICRs that are affected by the proposed rule.  

For the Manifest ICR (ICR No. 801), the O&M costs are associated with
postage for sending and returning copies of the manifest form.  For the
Generator Standards ICR (ICR No. 820), O&M costs are associated with
copying training materials.  For the Biennial Report ICR (ICR No. 976),
O&M costs are associated with mailing costs and maintaining copies of
Waste Generation and Management (GM) and Waste Received from Off-Site
(WR) forms.  For the Land Disposal Restrictions ICR (ICR No. 1442), O&M
costs are associated with mailing costs and maintaining copies of
notification.

6(e)	Bottom Line Burden Hours and Costs

Respondent Tally

In Exhibit 2, EPA presents the total annual respondent burden and cost
for both new and existing paperwork requirements associated with the
proposed rule.  As described specifically in Section 6(d) above, these
new and existing paperwork requirements apply to universal
pharmaceutical waste handlers.  As shown in Exhibit 2, the total annual
respondent burden for these new paperwork requirements is approximately
960 hours, at an annual cost of approximately $54,000.  As also shown in
Exhibit 2, the total annual respondent burden savings under the existing
paperwork requirements, which are associated with four existing EPA
ICRs, is approximately 1,900 hours, at annual cost savings of
approximately $93,000.  In the same Exhibit 2, EPA then combines the
burden and cost impacts under both new and existing paperwork
requirements and estimates the total annual respondent burden savings
for all information collection activities at approximately 935 hours and
an annual cost savings of approximately $39,000.

The bottom line respondent burden hours saved over the three-year period
covered by this ICR is approximately 2,805 hours, at a total cost
savings of $117,000.

6(f)	Reasons for Change in Burden 

As shown in exhibit 2, EPA expects that the proposed rule will result in
a reduction in burden to the hazardous pharmaceutical waste generators
complying with UWR requirements.  This is because universal
pharmaceutical waste generators no longer would be subject to full
Subtitle C requirements.  Following is a list of primary RCRA reporting
and recordkeeping requirements that hazardous pharmaceutical waste
generators may be relieved of: 

Reporting and recordkeeping under the hazardous waste manifest
requirements, as covered in ICR No. 801, Manifest ICR; 

Recordkeeping and/or reporting of personnel training, contingency plan,
and emergency procedures under the generator standards of 40 CFR Part
262, as covered in ICR No. 820, Hazardous Waste Generator Standards ICR.


Reporting waste generation data for the EPA’s Biennial Report, as
covered in ICR No. 976, Biennial Report ICR; and

Reporting and recordkeeping under the land disposal restrictions (LDRs)
program of 40 CFR Part 268, as covered in ICR No. 1442, Land Disposal
Restrictions ICR; 

6(g)	Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 0.8 hours per response
for a small quantity handler and 2.5 hours per response for a large
quantity handler.  However, in addition to the new paperwork
requirements in the proposed rule, the Agency also estimated the annual
respondent burden savings that generators could expect as result of no
longer having to follow information collection requirements under four
existing EPA ICRs (Manifest ICR, Generator Standards ICR, Biennial
Report ICR, and Land Disposal Restrictions ICR).  Taking both the new
proposed and existing RCRA information collection requirements into
account, EPA expects the proposed rule will result in a net reduction in
annual reporting and recordkeeping burden of approximately 0.5 hour per
response for a small quantity handler and 11 hours per response for a
large quantity handler.  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 (202) 566-1744, and the telephone number for the
RCRA Docket is (202) 566-0270.  An electronic version of the public
docket is available at www.regulations.gov.  This site can be used to
submit or view public comments, access the index listing of the contents
of the public docket, and to access those documents in the public docket
that are available electronically.  When in the system, select
“search,” then key in the Docket ID Number identified above.  Also,
you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ-RCRA-2007-0932 and OMB Control Number
2050-NEW in any correspondence.

	Exhibit 1 - Estimated Annual Respondent  Burden and Cost



                                                           Hours and
Costs per Respondent                                                    
                                                   Total Hours and Costs



INFORMATION COLLECTION

ACTIVITY	

Leg.

$102/Hr	

Mgr.

$71/Hr	

Tech.

$48/Hr	

Cler.

$26/Hr	

Respon. Hours/Yr	

Labor Cost/Yr	

Capital/

Startup Cost	

O & M 

Cost	

Number of Respondents

	

Total Hours/Yr	

Total Cost/Yr



RULE FAMILIARIZATION – Read the rule



Small Quantity

Handler	0.0	0.3	0.5	0.0	0.8	$45.00	0.0	0.0	1,083	866	$48,735.00

Large Quantity Handler	0.2

	0.3	0.5	0.0	1.0	$66.00	0.0	0.0	36	36	$2,376.00



 

RECORDKEEPING – Keep records of shipments



Large Quantity Handlers 	0.0	0.0	1.5	0.0	1.5	$72.00	0.0	$29.00	36	54
$2621.00



Total	varies	varies 	varies	0.0	varies	varies	0.0	varies	Varies	956
$53,732.00



Agency Data Sources:

Wage Rate Data: 	 “Assessment of the Potential Costs, Benefits, and
Other Impacts of Adding Pharmaceuticals to the Universal Waste Rule, as
Proposed.”

Labor Hours:	“Supporting Statement for EPA Information Collection
Number 1597.07: Reporting and Recordkeeping Requirements for the final
Rule on Adding Mercury-Containing Equipment to the Universal Waste
Rule.”

	

O&M Cost:	“Supporting Statement for EPA Information Collection Number
1597.07: Reporting and Recordkeeping Requirements for the final Rule on
Adding Mercury-Containing Equipment to the Universal Waste Rule.”

	Exhibit 2 – Estimated Annual Respondent Burden for Existing ICRS
(Including Net Impact from Pharmaceutical Rule ICR)



ICR Name	

ICR Number	

Respondents

	

Total Labor Hours	

Total Labor Cost	

Total O&M Cost	

Total Annual Cost



Manifest ICR	801	1,119	(1,591)	($76,368.00)	($2,258.00)	($ 78,626.00)



Generator Standards	820	36	(22)	($572.00)	($360.00)	($932.00)

Biennial Report	976	36	(170)	($8,172.00)	($84.00)	($8,256.00)

Land Disposal Restrictions	1442	36	(108)	($5,184.00)	($48.00)
($5,232.00)



	Subtotal Other ICRs 	(1,891)	($90,296.00)	($2,750.00)	($93,046.00)



Pharmaceutical ICR	2324.01	Varies	956	$53,703.00	$29.00	$53,732.00



	                 Net Impact (Pharmaceutical ICR + Other ICRs) =        
                                	(935)	($36,593.00)	($2,721.00)	($39,314
.00)



Agency Sources:

Labor Hours & Cost:  	“Assessment of the Potential Costs, Benefits,
and Other Impacts of Adding Pharmaceuticals to the Universal Waste Rule,
as Proposed.”

“Supporting Statement for EPA Information Collection Number 1597.07:
Reporting and Recordkeeping Requirements for the final Rule on Adding
Mercury-Containing Equipment to the Universal Waste Rule.”

O&M Cost:	“Supporting Statement for EPA Information Collection Number
1597.07: Reporting and Recordkeeping Requirements for the final Rule on
Adding Mercury-Containing Equipment to the Universal Waste Rule.”

These universe assumptions are based on the document, “Assessment of
the Potential Costs, Benefits, and Other Impacts of Adding
Pharmaceuticals to the Universal Waste Rule, as Proposed.”

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