# Regulatory Impact Analysis of EPA's Proposed Regulations for the Management of Hazardous Waste Pharmaceuticals at

Healthcare Facilities

June 201 5i 

### ACKNOWLEDGEMENTS

The Agency recognizes Industrial Economics, Inc. (IEc), for the overall organization and development of this report. DPRA, Inc. provided assistance with the compilation of waste generation and unit cost information. Rachel Horton, Lee Hofmann, Amy Newman, Scott Palmer, and Kristin Fitzgerald provided guidance and review.ii 

### TABLE OF C ONTENTS

LIST OF ACRONYMS

EXECUTIVE SUMMARY

C HAPTER 1 | IN TRODUCTION



### Introduction 1


### Problem Statement 1 

### Summary of the Propos ed Rule and Regulatory Alternatives 2 

### Report Organization 1 7



### CHAPTER 2 | POTENTIALLY IM PACTED INDUSTRIES



### Introduction 18


### Profile of Affected Industries 1 8


### Recent Market Trends 29 

### Universe of Facilities Affected by the Proposed Rule 34


### Hazardous Waste Generation Among Healthc are Facilities and Reverse

Distributors 43



### CHAPTER 3 | ASSESSMENT OF COSTS



### Introduction 61 

### Baseline Specification 61 

### Cost Methodology 63


### Results 97 

### Sensitivity Analyses 101 

### Analytic Limitations 111



### CHAPTER 4 | BENEFITS



### Introduction 113 

### Potential Cost Savings 115 

### Occurrence of APIs in U.S. Surface Waters and Drinking Water 129


### Wastewater Treatment Plant Removal Efficiencies for Pharmaceutical Wastes 138 

### Aquatic Ecosystems and the Effects on Fish and Animal Popula tions 144


### Human Health Effects 146


### Presence of APIs in the Food Supply 150 

### Potential Benefits Related to Enhanced Recreational Opportunities 151


### Other Potential Benefits 15 3 

### Sensitivity Analyses 154iii 

### CHAPTER 5 | SUMMAR Y OF REGULATORY BENE FITS & COSTS 163



### CHAPTER 6 | EQUITY CONSIDERAT IONS AND OTHER IMPAC TS 

### Regulatory Planning and Review 165 

### Regulatory Flexibility 1 6 6 

### Employment Impact Analysis 17 1 

### Unfunded Mandates Analysis 17 2 

### Federalism Analysis 17 3 

### Tribal Governments Analysis 1 7 5 

### Energy Impact Analys is 1 7 6 

### Environmental Justice Analysis 17 7 

### Children’s Health Protection Analysis 18 3 

### Joint Impact of Rules 1 8 5iv 

### LIST OF A CRONYMS

(ADIs) Acceptable Daily Intakes

(ACGME) Accreditation Council for Graduate Medical Education database

(APIs) Active Pharmaceutical Ingredients

(ACS) American Community Survey

(AHD) American Hospital Directory

(AWWARF) American Water Works Association Research Foundation

(BR) Biennial Report

(CTC) Chlorotetracycline

(CSA) Closure of Container Storage Areas

(CAFOs) Concentrated Animal Feeding Operations

(CESQGs) Conditionally Exempt Small Quantity Generators

(CECs) Contaminants o f Emerging Concern

(DEA) Drug Enforcement Agency

(D&B) Dun & Bradstreet

(EDCs) Endocrine

- Disrupting Chemicals

(EJ) Environmental Justice

(ETC) Epitetracycline

(EO) Executive Order

(HW) Hazardous Waste

(IHS) Indian Health Service

(LQGs) Large Quantity Generators

(MECs) Measured Environmental Concentrations

(MiniQGs) Minimum Quantity Generators

(MPCA) Minnesota Pollution Control Agency

(MSW) Municipal Solid Waste

(MSWLF) Municipal Solid Waste Landfillsv 

### (OIRA) Office of Information and Regulatory Affairs

(OMB) Office of Management and Budget

(OWCs) Organic Wastewater Contaminants

(PPCPs) Pharmaceuticals and Personal Care Products

(PhATE) Pharmaceutical Assessment and Transport Evaluation

(PECs) Predicted Environmental Concentrations

(PNECs) Predicted No Effect Co ncentrations

(POTW) Publicly Owned Treatment Works

(QPhRA) Quantitative Pharmaceutical Risk Assessment

(RFA) Regulatory Flexibility Act

(RIA) Regulatory Impact Analysis

(RACER) Remedial Action Cost Engineering and Requirements

(RCRA) Resource Conservation and Recovery Act

(RDs) Reverse Distributors

(SBA) Small Business Administration

(SBREFA) Small Business Regulatory Enforcement Fairness Act of 1996

(SQGs) Small Quantity Generators

(TC) Tetracycline

( T T C ) Threshold of Toxicologi cal Concern

(TSDFs) Treatment, Storage, a nd Disposal Facilities

(USGS) U.S. Geological Survey

(UMRA) Unfunded Mandates Reform Act

(UW) Universal Waste

(WWTP) Wastewater Treatment PlantES

- 1 

### E XECUTIVE S UMMARY

B ACKGROUND


### This document presents EPA’s analysis of the costs, benefits, and economic impacts of the proposed management standards for hazardous waste pharmaceuticals. The proposed rule would prohibit generators of hazardous waste pharmaceuticals from managing these wastes through sewer disposal but would also relax certain requirements related to the handling of these materials at generator facilities. 1 

### For the purposes of this document, generator facilities include healthcare facilities and
reverse distributors th at generate hazardous waste pharmaceuticals.

Under the current regulatory requirements of RCRA, a small portion of pharmaceuticals are regulated as hazardous wastes when disposed. Hospitals, clinics, nursing homes, and other facilities that generate hazardous waste pharmaceuticals

, however, have experienced difficulty complying with the industry

- focused framework
of the RC RA hazardous waste regulations, and EPA is concerned that many facilities sewer their hazardous waste pharmaceuticals to circumvent regulations that are incompatible with the operations and structure of healthcare (and associated) facilities. The Agency is also concerned that those pharmaceuticals that are not sewered are not safely and properly transported and disposed. Many health care facilities use reverse distribution to manage unused and/or expired pharmaceuticals, but this management method is not recognized under the current regulatory scheme.

SUMMARY OF THE PROPO SED RULE AND R EGULATORY A LTERNATIVES


### The proposed rule includes several requirements to ensure the responsible management of hazardous waste pharmaceuticals, as well as provisions granting regulated facilities greater flexibility in their management of hazardous waste pharmaceuticals. The ke y provisions of the rule, referred to as the Proposed Option throughout this document, include the following:

 Sewer disposal of hazardous waste pharmaceuticals is prohibited.

 Hazardous waste pharmaceuticals managed under the proposed rule are not
counted t oward a facility’s RCRA generator status.

 Long

- term care facilities currently exempt from RCRA under the household hazardous waste exclusion must comply with the proposed rule requirements.

1 As described in the summary of the rule below, EPA also considered other regulatory options for the proposed rule,
one of which does not prohibit the sewering of hazardous waste pharmaceuticals for CESQG healthcare facilities

.ES

- 2 

###  Potentially creditable hazardous waste pharmaceuticals sent to a r everse distributor must ship with a return receipt notification.

 Reverse distributors must comply with standards similar to those of large quantity generators (LQGs) regardless of the quantity of hazardous waste pharmaceuticals that they manage.

 Hospitals must provide general awareness training for personnel who handle hazardous waste pharmaceuticals on the proper handling and emergency procedures for these wastes. Personnel who handle hazardous waste pharmaceuticals but no other hazardous wastes will no l onger be required to go through the full RCRA hazardous waste management training

. This provision will most likely affect the training required for nurses.

These and other elements of the Proposed Option would help ensure that the management of hazardous waste pharmaceuticals is more protective of human health and the environment than current practice. In particular, the prohibition on sewer disposal would c urtail this practice, thereby reducing releases of hazardous waste pharmaceuticals to the nation’s waterways. The rule’s tracking requirements for hazardous waste pharmaceuticals and the new standards proposed for reverse
distributors would also facilitat e the safe transport and disposal of these wastes.

In addition to the Proposed Option, this Regulatory Impact Analysis ( RIA ) also examines two regulatory alternatives: the More Stringent Option and the Less Stringent Option. The More Stringent Option in cludes many of the same provisions as the Proposed Option, including the prohibition on sewer disposal, but differs in several important ways, including the following:

 Hazardous waste pharmaceuticals count toward a facility’s generator status
under the Mor e Stringent Option but not under the Proposed Option.

 The More Stringent Option requires a more formal training program for healthcare facility employees than the Proposed Option.

 Reverse distributors are required to obtain a RCRA storage permit under the More Stringent Option.

The Less Stringent Option examined in this RIA is the same as the Proposed Option except that healthcare facilities

— but not reverse distributors

— that are conditionally exempt small quantity generators (CESQGs) are not prohibited from sewering their hazardous waste pharmaceuticals.ES

- 3 U NIVERSE OF A FFECTED F ACILITIES AND

G ENERATION OF H AZARDOUS W ASTE P HARMACEUTICALS


### The proposed rule may affect several different types of healthcare facilities, including hospitals, physicians’ offices, dentists’ offices, outpatient care centers, pharmacies, veterinary clinics, nursing care facilities, coroners’ offices, other health practitioners, and other ambulatory care services, as well as reverse distributors. Exhibit ES

- 1 summarizes
the estimated number of facilities

— by NAICS code and RCRA generator status

— that the proposed rule would regulate. The estimates in the exhibit reflect establishment counts from the 2007 Economic Census, state

- level data on the percentage of healthcare facilities that are hazardous waste generators, and data from RCRAInfo on the distribution of healthcare facilities and reverse distributors across different generator categories. Physicians’ offices make up approximat ely 35 percent of the regulated
universe (i.e., 60, 823 of 174,023 regulated facilities) , followed by dentists’ offices and other health practitioners, each representing 20 percent of regulated facilities. In addition, as indicated in the exhibit, the vast majority of facilities likely to be affected by the rule are conditionally exempt small quantity generators (CESQGs) under the proposed rule

.

Estimates of the generation of hazardous waste pharmaceuticals were developed from multiple sources, including EPA’s biennial report database and facility level data obtained from the States of Maine, Minnesota, and New Jersey. Exhibit ES

- 2
summarizes the estimated generation of hazardous waste pharmaceuticals by NAICS. As indicated in the exhibit, this RIA estimates that the generation of hazardous waste pharmaceuticals is highest among hospitals, physicians’ offices, and other health practitioners. Alt hough hospitals account for a small percentage of potentially affected facilities (see Exhibit ES

- 1 below ), the per

- facility generation of hazardous waste pharmaceuticals for hospitals is higher than for all other facilities, with the exception of

reverse distributors. For additional perspective, Exhibit ES

- 3 presents the generation of hazardous waste pharmaceuticals by generator status. As indicated in the exhibit, small quantity generators ( SQGs ) and large quantity generators ( LQGs ) combined account for more than 80 percent of hazardous waste pharmaceuticals, although they account for just 16 percent of all generators in the potentially affected universe.ES

- 4

EXHIBIT ES

- 1. NUMBER OF LQG s , SQG s , AND CESQG s IN THE AFFECTED UNIV ERSE BY FACILITY TYP E

NAICS FACILITY TYPE TOTAL

GENERATORS LQG SQG CESQG

% OF

GENERATORS 1 NUMBER OF

FACILITIES % OF

GENERATORS 1 NUMBER OF

FACILITIES % OF

GENERATORS 1 NUMBER OF

FACILITIES

44611 Pharmacies 11,617 5.1% 589 19.5% 2,271 75.4% 8,757

54194 Veterinary Clinics 7,847 2.6% 204 12.1% 951 85.3% 6,692

6211 Physicians’ Offices 60,823 3.7% 2,275 12.1% 7,381 84% 51,167

6212 Dentists’ Offices 35,106 0.1% 44 5.4% 1,890 94.5% 33,172

6213 Other Health Practitioners (e.g.,

chiropractors) 34,555 0.0% 0 15.1% 5,216 85% 29,339

6214 Outpatient Care Centers 8,227 4.7% 388 19.5% 1,602 75.8% 6,237

6219 Other Ambulatory Health Care

Services 2,586 2.5% 65 22.8% 589 74.7% 1,932

622 Hospitals 6,505 23.9% 1,553 36.8% 2,397 39.3% 2,555

6231 Nursing Care Facilities 4,508 1.5% 67 16.4% 740 82.1% 3,701

623311 Continuing Care Retirement

Communities 1,641 0.5% 9 5.7% 94 93.7% 1,538

Subset of 92219 Medical Examiners and Coroners'

Offices 552 14.5% 80 31.9% 176 53.6% 296

Various NAICS Reverse Distributors 56 50.0% 28 12.5% 7 37.5% 21

TOTAL 174,023 3.0% 5,302 13.4% 23,314 83.6% 145,407

Notes:
1. Data from EPA’s RCRAInfo used to the estimate the percentage of facilities that are hazardous waste generators.ES

- 5 EXHIBIT ES

- 2 . AGGREG ATE ANNUAL HAZARDOUS WASTE PHAR MACEUTICALS
GENERATION BY FACILI TY TYPE FOR ALL FACI LITIES (TONS)

NAICS FACILITY TYPE NUMBER OF

FACILITIES TOTAL

HAZARD OU S

WASTE 1,2 HAZARDOUS WASTE

PHARMACEUTICALS 2

HE A LTHCARE FACILITIES A S DEFINED BY THIS RU LE

44611 Pharmacies 11,617 12,400 2,990

54194 Veterinary Clinics 7,847 5,330 1,280

6211 Physicians’ Offices 60,823 47,500 11,400

6212 Dentists’ Offices 35,106 10,700 2,570

6213 Other Health

Practitioners (e.g., chiropractors) 34,555 17,900 4,300

6214 Outpatient Care

Centers 8,227 8,530 2,050

6219 Other Ambulatory

Health Care Services 2,586 2,380 570

622 Hospitals 6,505 28,000 8,650

6231 Nursing Care

Facilities 4,508 3,070 740

623311 Continuing Care

Retirement
Communities 1,641 570 140

Subset of
92219 Medical Examiners

and Coroners’ Offices 552 1,210 290

REVERSE DISTRIBUTERS

Various
NAICS Reverse Distributors 56 1,290 1,220

TOTAL 174,023 139,000 36,200
Notes:
1. Estimates may not sum due to rounding.
2. Estimates reflect acute and non

- acute hazardous waste (pharmaceuticals).ES

- 6 EXHIBIT ES

- 3. HAZARDOUS WASTE PHARMACEUTICALS GENERATION BY GENERA TOR STATUS (TONS)

GENERATOR

STATUS NUMBER OF

FACILITIES TOTAL HAZARDUOS WAST E 1 ,2 HAZARDOUS WASTE

PHARMACEUTICAL S 2

LQG 5,302 56,500 15,900 SQG 23,314 58,000 14,400
CESQG 145,407 24,500 5,920

TOTAL 174,023 139,000 36,200

Notes:
1. Estimates may not sum due to rounding.
2. These estimates reflect both acute and non

- acute hazardous waste (pharmaceuticals).

A SSESSMENT OF C OSTS



### To assess the cost impacts of the rule, this RIA uses a model facility approach in which costs are estimated for a limited number of representative facilities and then extrapolated to the full universe of facilities affected by the rule. While this RIA would ideally e xamine costs individually for each affected facility, the data necessary for a facility

- specific assessment of costs are not readily available. In the absence of such data, this RIA uses the limited data that are available to specify 16 representative
mod el facilities, which are defined according to three variables:

1. Baseline RCRA generator status. The stringency of the RCRA requirements related to storage, transportation, and other hazardous waste management activities varies with the RCRA generator statu s of facilities. Because these requirements affect facilities’ waste management costs, this RIA includes generator status in its specification of model facilities.

2. Industry . The cost impacts of the rule for a given facility are likely to depend
on the a mount of hazardous waste pharmaceuticals that it generates, and generation per facility is likely to vary by industry. This RIA classifies facilities into one of three industry groups: hospitals, other healthcare facilities, and reverse distributors.

3. Fac ility size. The costs of several RCRA requirements, including training and inspections, depend in part on the physical size and complexity of a facility.

Exhibit ES

- 4 report s the annualized costs of each policy option relative to the full compliance baseline by waste management activity

. As indicated in the exhibit, the incremental costs are significantly higher under the More Stringent Option than under the Proposed Option a nd the Less Stringent Option. The largest source of the
difference in costs is attributable to the shorter accumulation time limits under the More Stringent Option, which results in facilities managing a larger number of containers for hazardous waste pha rmaceuticals. This is reflected in the higher costs of container management, transportation, and disposal relative to the Proposed and Less Stringent Options.ES

- 7 EXHIBIT ES

- 4 . TOTAL ANNUALIZED BASELINE COSTS AND INCREMENTA L COSTS

BY WASTE MANAGEMENT ACTIVITY, 7 PERCENT DISCOUNT RATE ($2011 MILLIONS)

RO
W WASTE MANAGEMENT

ACTIVITY TOTAL
ANNUALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COSTS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification 2 $0. 00 $0.07 $0.07 $0.07

2 Training $79. 65 $1.53 $1.53 $1.53

3 Manifest Training $6.3 0 $0.23 $0.23 $0.23

4 Contingency Plan Updating $4.9 1 $0.16 $0.00 $0.00

5 Container Management $28.8 4 $5.31 $2.67 $2.28

6 Labeling $0.4 4 $0.52 $0.48 $0.48

7 Inspections $94. 25 $3.15 $0.05 $0.05

8 Warehousing $0.0 0 $0.01 $0.00 $0.00

9 Closure $4.5 1 $1.24 $1.21 $1.21

10 RCRA Storage Permit $0.0 0 $0.68 $0.00 $0.00

11 Sorting $27. 05 $5.12 $5.12 $5.09

12 Biennial Reports $ 2

. 24 $0.07 $0.00 $0.00

13 Recordkeeping 3 $0.1 5 $0.01 $0.00 $0.00

14 Manifests and Other Tracking $1.0 3 $0.98 $0.49 $0.49

15 Transportation $72. 67 $3.19 $1.79 $1.79

16 Disposal $554. 59 $23.45 $22.91 $21.47

17 TOTAL $876. 62 $45.71 $36.56 $34.69

Notes: For consistency across all the exhibits in this RIA, all rule provisions are included even if there are no costs or cost savings (i.e., because the requirements have not changed relative to the baseline) or benefits were not monetized because sufficient da ta were not available.
1. For some provisions there are no costs (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.
2. Notification c osts are included in biennial reports, presented elsewhere in this table, for facilities that are required to submit biennial reports (all LQGs and SQGs in states that require biennial reporting for SQGs) to avoid double

- counting.
3. Recordkeeping costs reflect the cost of maintaining records for waste characterizations. Recordkeeping costs for manifests are included in the manifest costs presented
elsewhere in this table.ES

- 8 

### Exhibit ES

- 5 distrib ute s the incremental costs of each policy option across the three RCRA generator categories (i.e., LQGs, SQGs, and CESQGs) f or hospitals, other healthcare facilities, and reverse distributors

. As indicated in the exhibit, the estimated costs of each option are higher for other healthcare facilities than for reverse distributors, due in large part to the higher number of the fo rmer. The same is true, albeit to a lesser degree, for the higher costs borne by hospitals than for reverse
distributors. From a mong all generator categories, the costs are highest for SQG
healthcare facilitie s. This partly reflects the large number of SQG healthcare facilities relative to LQGs, as SQGs account for approximately 13 percent of affected facilities while LQGs account for less than 3 percent. The high SQG healthcare facility costs also reflect the high per

- facility costs of the proposed rul e for these facilities relative to CESQGs. Because CESQGs in several states can manage their hazardous waste pharmaceuticals through MSW disposal (which costs less than incineration) under the More Stringent and Proposed Options, they incur lower incremen tal costs. Under the Less Stringent Option, there are no incremental disposal costs for CESQGs, while sewering is banned for SQGs.

EXHIBIT ES

- 5 . ANNUALIZED INCREM ENTAL COSTS OF PROPO SED RULE BY BASELINE GENERATOR

STATUS AND FACILITY TYPE , 7 PERCENT DISCOUNT RATE ($2011 MILLIONS)

GENERATOR
STATUS FACILITY TYPE NUMBER OF
FACILITIES MORE STRINGENT

OPTION PROPOSED

OPTION LESS STRINGENT

OPTION
CESQG Hospitals 2,555 $0.06 $0.06 $0.00

SQG Hospitals 2,397 $1.69 $1.42 $1.42

LQG Hospitals 1,553 $6.16 $6.14 $6.07

CESQG Other Healthcare Facilities 142,831 $1.41 $1.41 $0.00

SQG Other Healthcare Facilities 20,910 $24.94 $18.65 $18.41

LQG Other Healthcare Facilities 3,721 $10.58 $8.71 $8.63

CESQG Reverse Distributors 21 $0.41 $0.11 $0.11

SQG Reverse Distributors 7 $0.11 $0.01 $0.01

LQG Reverse Distributors 28 $0.35 $0.04 $0.04

TOTAL 174,023 $45.71 $36.56 $34.69ES

- 9 A SSESSMENT OF B ENEFITS


### The proposed rule for the management of hazardous waste pharmaceuticals yield s a range of environmental benefits as hospitals, medical clinics, and other healthcare facilities divert their hazardous waste pharmaceuticals from disposal in sewers, municipal solid waste landfills (MSWLF), municipal solid waste (MS W) incinerators, and medical waste autoclaves and incinerators to disposal in hazardous waste incinerators. In particular, the reduced sewering of hazardous waste pharmaceuticals and the corresponding avoidance
of waste releases to U.S. surface waters is expected to reduce the risk of adverse human health and ecosystem impacts. The proposed rule is also projected to result in cost savings for some healthcare facilities and reverse distributors by affording certain types of facilities greater flexibility i n how they train staff and generally manage their hazardous waste pharmaceuticals. These include potential cost savings for facilities whose RCRA generator status changes (e.g., from LQG to SQG) as a result of the rule, greater regulatory clarity for heal thcare facilities, and greater regulatory certainty for
reverse distributors.

Under the Proposed and the Less Stringent Options, training costs for hospitals are expected to decline by approximately $19 million relative to the baseline. This cost saving s reflects the less stringent training requirements as they apply to hospital nurs ing
staff. This savings is limited to hospital nurses and not to other hospital staff or nurses at
other healthcare facilities. These two latter groups most likely handle a wide range of hazardous wastes generated by their facilities and must therefore meet the full RCRA training requirements. In addition, some facilities will experience a cost savings due to a change in their RCRA generator status , as hazardous waste pharm aceuticals are no longer counted against a facility’s generator status under the Proposed and Less Stringent Options

.
Exhibit ES

- 6 summarizes the estimated cost savings associated with the additional flexibility provided to healthcare facilities and revers e distributors under the proposed
rule and other regulatory alternatives

. As shown in the exhibit, the Proposed and Less Stringent Options are estimated to result in a cost savings for several specific waste management activities. The More Stringent Opti on is estimated to result in cost savings
associated with only avoided contaminated wastewater treatment.ES

- 10 EXHIBIT ES

- 6. ANNUALIZED BASEL INE COSTS AND INCREM ENTAL COST

SAVINGS OF PROPOSED RULE BY WASTE MANAGEMENT ACTIVITY, 7 PERCENT DISCOUNT RATE ($2011 MILLIONS)

ROW WASTE MANAGEMENT

ACTIVITY TOTAL
ANNUALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COST
SAVINGS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification $0. 00 $0.00 $0.00 $0.00

2 Training $79. 65 $0.00 $19.17 $19.17

3 Manifest Training $6.3 0 $0.00 $0.00 $0.00

4 Contingency Plan Updating $4.9 1 $0.00 $0.03 $0.03

5 Container Management $28.8 4 $0.00 $0.15 $0.18

6 Labeling $0.4 4 $0.00 $0.05 $0.05

7 Inspections $94. 25 $0.00 $0.00 $0.00

8 Warehousing $0.0 0 $0.00 $0.00 $0.00

9 Closure $4.5 1 $0.00 $0.00 $0.00

10 RCRA Storage Permit $0.0 0 $0.00 $0.00 $0.00

11 Sorting $27. 05 $0.00 $0.00 $0.00

12 Biennial Reports $ 2

. 24 $0.00 $0.31 $0.31

13 Recordkeeping $0.1 5 $0.00 $0.15 $0.15

14 Manifests and Other Tracking $1.0 3 $0.00 $0.15 $0.15

15 Transportation $72. 67 $0.00 $0.003 $0.003

16 Disposal $554. 59 $4.28 $4.28 $3.46

17 TOTAL $876. 62 $4.28 $24.29 $23.50

Notes: For consistency across all the exhibits in this RIA, all rule provisions are included even if there are no costs or cost savings (i.e., because the requirements have not changed relative to the baseline) or benefits were not monetized because sufficient da ta were not available.
1. For some provisions there are no cost savings (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.ES

- 11 

### Exhibit ES

- 7 distrib ute s the incremental cost savings of each policy option across the three RCRA generator categories (i.e., LQGs, SQGs, and CESQGs) for hospitals,
other healthcare facilities and reverse distributors

. As indicated in the exhibit, the estimated cost savings are largest for LQG and SQG hospi tals due to the proposed changes in the requirements for nurse training.

EXHIBIT ES

- 7 . ANNUALIZED COST SAVINGS OF PROPOSED RULE BY BASELINE GENERATOR S TATUS

AND FACILITY TYPE , 7 PERCENT DISCOUNT RATE ($2011 MILLIONS )

GENERATOR
STATUS FACILITY TYPE NUMBER OF
FACILITIES MORE STRINGENT

OPTION PROPOSED

OPTION LESS STRINGENT

OPTION
CESQG Hospitals 2,555 $0.02 $0.02 $0.00

SQG Hospitals 2,397 $0.18 $7.02 $7.05

LQG Hospitals 1,553 $0.64 $13.31 $13.31

CESQG Other Healthcare Facilities 142,831 $0.80 $0.80 $0.00

SQG Other Healthcare Facilities 20,910 $1.74 $1.92 $1.92

LQG Other Healthcare Facilities 3,721 $0.91 $1.17 $1.17

CESQG Reverse Distributors 21 $0.00 $0.00 $0.00

SQG Reverse Distributors 7 $0.00 $0.0006 $0.0006

LQG Reverse Distributors 28 $0.00 $0.05 $0.05

TOTAL 174,023 $4.28 $24.29 $23.50



### In addition to these cost savings, the proposed rule is likely to yield additional non

monetized benefits associated with the reduced sewering of hazardous waste pharmaceuticals. This practice is believed to be one of the most widespread methods of disposal , and also leads to releases of active pharmaceutical ingredients (APIs) to the environment because wastewater treatment facilities are designed to remove conventional pollutants such as suspended solids and biodegradable organic compounds from wastewater, but not pharmaceuticals. 2



### To estimate the reduction in the sewer disposal of hazardous waste pharmaceuticals, this RIA uses a model facility approach similar to that described above for the cost analysis. Under this approach, the change in sewering under the proposed rule and alternative options is estimated on a per facility basis for a series of model facilities. These per facility values are then extrapolated to the corresp onding facilities in the regulated universe.

Exhibit ES

- 8 presents the estimated change in sewering, on an annual basis, under each option. The results in the exhibit show that the estimated reduction in sewering is expected to be the same under the M ore Stringent and Proposed Options. This reflects the fact that both options prohibit sewering for all facilities, regardless of their generator status. The projected reduction in sewering is somewhat lower under the Less Stringent Option, as this option allows CESQG healthcare facilities to sewer their hazardous waste pharmaceuticals.

2 U.S. EPA, Unused Pharmaceuticals in the Health Care Industry: Interim Report, August 2008 , accessed at
http://water.epa.gov/scitech/swguidance/ppcp/upload/2 010_1_11_ppcp_hcioutreach.pdf

.ES

- 12 EXHIBIT ES

- 8 . ANNUAL REDUCTION I N THE SEWERING OF HA ZARDOUS WASTE PHARMACEUTICALS (TON S)

BASELINE
GENERATOR
STATUS FACILITY TYPE MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION
CESQG Hospitals 24 24 0

CESQG Other Healthcare
Facilities 1,208 1,208 0

CESQG Reverse Distributors 0 0 0

SQG Hospitals 265 265 265

SQG Other Healthcare
Facilities 2,617 2,617 2,617

SQG Reverse Distributors 0 0 0

LQG Hospitals 962 962 962

LQG Other Healthcare
Facilities 1,366 1,366 1,366

LQG Reverse Distributors 0 0 0

TOTAL 6,44 0 6,44 0 5,2 10

Notes:
Totals may not sum due to rounding.



### In addition to benefits from the reduced sewering of hazardous waste pharmaceuticals, the proposed rule may yield other benefits. In particular, t he proposed rule may lead to reductions in the amount of hazardous waste pharmaceuticals managed as MSW or medical waste. 3 

### Although the rule does not include any new restrictions on the manageme nt of hazardous waste pharmaceuticals as MSW or medical waste, it may raise awareness of existing RCRA requirements among facilities that engage in these management practices, leading some to dispose
of their hazardous waste pharmaceuticals through inciner ation instead . Because the regulatory options considered by EPA do not include any new restrictions on the management of hazardous waste pharmaceuticals as MSW or medical waste, the magnitude of any diversions away from these practices is uncertain and no t estimated
in this RIA.

The proposed rule will also provide greater regulatory clarity for healthcare facilities with respect to the management of hazardous waste pharmaceuticals. As discussed above, healthcare facilities often experience difficulty co mplying with existing RCRA regulations because of the industry

- focused framework of these regulations and because of healthcare workers’ relative lack of familiarity with RCRA regulations as they relate to hazardous waste pharmaceuticals. The proposed rul e addresses both of these issues by (1) stipulating regulatory requirements specific to healthcare facilities generating hazardous waste pharmaceutica ls and (2) ensuring that healthcare facil ity employees receive the information and training necessary to m anage these wastes in a manner that is protective of human health and the environment. Together, thes e elements of the rule will help healthcare facilities better integrate the responsible management of hazardous waste pharmaceuticals into their operatio ns, thereby

3 MSW disposal is a compliant method for CESQGs in select states, as discussed earlier in this chapter and in Chapter 3.ES

- 13 

### reducing releases of these wastes into the environment. Similarly, the rule will provide greater regulatory certainty to reverse distributors in terms of when unused or expired pharmaceuticals are considered a hazardous waste. This will allow reverse distributors to make long

- term operational and investment decisions based on these requirements.

Finally, the rule’s provisions for improved tracking of hazardous waste pharmaceuticals will help EPA and regulated facilities ensure that these waste s arrive at their intended destinations rather than facilities not equipped to manage these wastes. These tracking requirements will also help facilities identify shipments that do not arrive at their destination as planned, allowing generators to take co rrective action that will ensure that future shipments are transported to the appropriate
location. Exhibit ES

- 9 summarizes these benefits.ES

- 14

EXHIBIT ES

- 9

. BENEFITS SUMMARY FOR THE PROPOSED OPTION

BENEFIT CATEGORY MONETIZED OR QUANTIF IED
VALUE DESCRIPTION

Regulatory cost savings $ 24

. 29 million per year  For some healthcare facilities, the rule
will reduce the regulatory costs
associated with hazardous waste pharmaceuticals. Most of these savings
relate to the personnel training provisions
of the rule. Human health and ecosystem improvements, enhanced opportunities for aquatic and marine
recreation due to r educed s ewering
of h azardous w aste p harmaceuticals 6,440 tons of hazardous waste pharmaceuticals diverted from sewering on an annual basis.  To the extent that the rule reduces
concentrations of hazardous waste pharmaceuticals in surface waters, it may reduce negative impacts to aquatic and riparian ecosystems and the associated reduction in exposure c ould reduce the
incidence of adverse human health impacts.

 Improvements in water quality associated with the proposed rule may improve the per trip welfare that individuals derive from aquatic and or marine recreation, and may also increase the number of s uch trips taken. Human health and ecosystem improvements, enhanced recreation opportunities due to reduction in quantity of hazardous waste pharmaceuticals managed as MSW or
medical waste Exact reduction uncertain. However, approximately 4,400

tons are managed as MSW in the baseline and 29,800 are managed as medical waste.

Greater regulatory clarity for
healthcare facilities Not calculable  The proposed rule may help healthcare facilities better integrate the responsible management of hazardous waste pharmaceuticals into their operations.

 The rule will provide greater regulatory certainty to reverse distributors in terms of when unused or expired pharmaceuticals are considered a
hazardous waste.

Improved tracking of hazardous waste pharmaceuticals Not calculable  Better tracking will help ensure that hazardous waste pharmaceuticals arrive
at their intended destination rather than facilities not equipped to manage these

wastes.

NET BENEFITS



### Exhibit ES

- 10 reports the net benefits of the proposed rule using a discount rate of 7 percent. However, benefits were not monetized for several categories of benefits because sufficient data were not available. Therefore, the net benefits for several provisions of t he proposed rule are presented as negative. These negative values, however, do not reflect the significant benefits summarized above that EPA was unable to monetize. In excluding these benefits, the negative values in the exhibit
underestimate the net be nefits associated with individual provisions of the proposed
rule.ES

- 15

EXHIBIT ES

- 10

. NET BENEFITS OF THE PROPOSED RULE BY WAS TE MANAGEMENT ACTVIT IY , 7 PERCENT DISCOUNT RATE ($2011 MILLIONS )

ROW WASTE

MANAGEMENT
ACTIVITY TOTAL

ANNUALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE INCREMENTAL COSTS AN D BENEFITS

MORE STRINGENT OPTIO N PROPOSED OPTION LESS STRINGENT OPTIO N

ANNUALIZED
COSTS ANNUALIZED

BENEFITS 1 NET

BENEFITS ANNUALIZED

COSTS ANNUALIZED

BENEFITS 1 NET

BENEFITS ANNUALIZED

COSTS ANNUALIZED

BENEFITS 1 NET

BENEFITS

1 Notification $0.00 $0.07

Not
Monetized ($0.07) $0.07 $0.00 ($0.0 7 ) $0.07 $0.00 ($0.0 7 )

2 Training $79.65 $1.53 ($1.53) $1.53 $19.17 $17.64 $1.53 $19.17 $17.64

3 Manifest Training $6.30 $0.23 ($0.23) $0.23 $0.00 ($0.23) $0.23 $0.00 ($0.23)

4 Contingency Plan Updating $4.91 $0.16 ($0.16) $0.00 $0.03 $0.03 $0.00 $0.03 $0.03

5 Container Management $28.84 $5.31 ($5.31) $2.67 $0.15 ($2.52) $2.28 $0.18 ($2.10)

6 Labeling $0.44 $0.52 ($0.52) $0.48 $0.05 ($0.43) $0.48 $0.05 ($0.43)

7 Inspections $94.25 $3.15 ($3.15) $0.05 $0.00 ($0.05) $0.05 $0.00 ($0.05)

8 Warehousing $0.00 $0.01 ($0.01) $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

9 Closure $4.51 $1.24 ($1.24) $1.21 $0.00 ($1.21) $1.21 $0.00 ($1.21)

10 RCRA Storage Permit $0.00 $0.68 ($0.68) $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

11 Sorting $27.05 $5.12 ($5.12) $5.12 $0.00 ($5.12) $5.09 $0.00 ($5.09)

12 Biennial Reports $2.24 $0.07 ($0.07) $0.00 $0.31 $0. 31 $0.00 $0.31 $0. 31

13 Recordkeeping $0.15 $0.01 ($0.01) $0.00 $0.15 $0.15 $0.00 $0.15 $0.15

14 Manifests and Other Tracking $1.03 $0.98 ($0.98) $0.49 $0.15 ($0.34) $0.49 $0.15 ($0.34)

15 Transportation $72.67 $3.19 ($3.19) $1.79 $0.003 ($1.79) $1.79 $0.003 ($1.78)

16 Disposal $554.59 $23.45 $4.28 ($19.17) $22.91 $4.28 ($18.63) $21.47 $3.46 ($18.01)

17 TOTAL $876.62 $45.71 $4.28 ($41.34) $36.56 $24.29 ($12.2 7 ) $34.69 $23.50 ($11. 19 )

Notes:
1. S everal categories of benefits were not monetized for because sufficient data were not available. Therefore, the net benefits for several provisions of the proposed rule are presented as negative. These negative values, however, do not reflect the benefits this RIA was unable to monetize.ES

- 16 EQUITY CONSIDERATION S AND OTHER IMPACTS


### As required by applicable statutes and executive orders, this RIA examines equity considerations and other regulatory concerns associated with the proposed rule. Specifically, this RIA assesses the following (discussed further in Chapter 6 ):

 Regulatory p lanning and review : Pursuant to the terms of Executive Order 12866, as amended by Executive Order 13563

, the Agency has determined that this proposed rule is a significant regulatory action because it contains novel policy issues, as defined under part 3(f)(4) of the Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB)
for review

. Any changes made in response to OMB recommendations have
been documented in the docket for this action.

 Regulatory flexibility: The aver age per

- facility cost impacts developed in
this RIA suggest that the proposed rule will not have significant economic impacts on a substantial number of small entities.

 Employment impacts: I nsufficient data are available to quantify the potential impact o f the proposed rule on employment. The economics literature suggests, however, that t he costs imposed on directly regulated sectors may raise production costs and put some specific jobs at risk, while at the same time, environmental regulation may create jobs in the regulated
sector or other sectors that contribute to environmental protection

. 4



###  Unfunded mandates: Signed into law on March 22, 1995, the Unfunded Mandates Reform Act (UMRA) requires federal agencies, unless otherwise prohibited by law, to as sess the effects of their regulatory actions on state, local, and tribal governments and on the private sector, to determine whether any proposed rulemaking may result in “any Federal mandate that may result in the expenditure by State, local, and tribal g overnments, in the aggregate, or by the private sector, of $100 million or more in any one year.” Based on the magnitude of the rule’s estimated cost impacts, EPA expects that the rule
would not result in annual expenditures exceeding $100 million for eit her the private sector or state, local, and tribal governments in the aggregate.

 Federalism: Th e proposed rule is not expected to result in substantial direct compliance costs for hospitals owned by state and local governments.
Insufficient data were available to make an assessment for the other types of facilities in the regulated universe that may be owned by state or local
governments.

 Tribal governments: The estimated costs of the rule for tribal entities suggest that the rule will not impose a sub stantial burden on tribal
government s

.

4 Berman, E. and L. T. M. Bui (2001). “Environmental Regulation and Labor Demand: Evidence from the Sou th Coast Air

Basin.” Journal of Public Economics 79 (2): 265

- 295; and, Richard D. Morgenstern, William A. Pizer, and Jhih

- Shyang
Shih. (2002) “Jobs Versus the Environment: An Industry

- Level Perspective.” Journal of Environmental Economics and
Management, Vo l. 43, no. 3, pp. 412

- 436.ES

- 17 

###  Environmental justice: Overall, EPA expects that the proposed rule may positively affect U.S. environmental justice populations , although the sign of the impacts will vary by facility. Specifically, the reduction in sewering expected under the proposed rule may benefit relatively large minority and
low

- income populations in close proximity to or downstream from wastewater treatment plants. The diversion of hazardous waste pharmaceuticals to combustion facilities, how ever, may increase the environmental burden borne by populations near these facilities. Although these effects offset each other to a certain degree, the number of minority and
low

- income individuals near wastewater treatment facilities greatly exceeds
th e number near hazardous waste combustion facilities. This suggests that, on the whole, the proposed rule may benefit environmental justice populations.

 Children's health protection: The rule is not expected to result in a disproportionate adverse health impact on children.

 Energy Impacts: The proposed rule is not expected to have a significant adverse effect on energy supply, distribution, or use. In addition, no measurable adverse impacts are expected on energy prices or foreign supplies.

 Joint impac ts of rules: To ensure that DEA controlled substances that are
also hazardous wastes are managed safely when disposed of and to provide clarity to healthcare facilities on the appropriate management of these substances, the proposed rule conditionally exem pts controlled substances that are also hazardous waste from RCRA so long as they are (1) managed in accordance with DEA regulations, (2) not sewered, and (3) sent to a municipal solid waste combustor or a hazardous waste incinerator.1 

### CHAPTER 1 | INTROD UCTION

INTRODUCTION


### This document presents EPA’s analysis of the costs, benefits, and economic impacts of the proposed management standards for hazardous waste pharmaceuticals. The proposed rule would prohibit generators of hazardous waste pharmaceuticals from managing these wastes through sewer disposal but would also relax certain requirements related to the handling of these materials at generator facilities. 5 

### Consistent with EPA’s mandate under the Resource Conservation and Recovery Act (RCRA) to protect human health and the environment, the proposed rule promotes the environmentally sound management and disposal of hazardous waste pharmaceuticals that might otherwise be managed outside of the RCRA hazardous waste management
system.

PROBLEM STATEMENT



### Under the current r egulatory requirements of RCRA, a small portion of pharmaceuticals are regulated as hazardous wastes when disposed. Hospitals, clinics, nursing homes, and other facilities that generate hazardous waste pharmaceuticals have experienced difficulty complying with the industry

- focused framework of the RCRA hazardous waste regulations. This difficulty arises 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 house thousands of items in their formulary and may find
it difficult to ascertain which are hazardous wastes when they do dispos al

.

 Some pharmaceuticals are listed as acute hazardous wastes under RCRA, which are stringently regulated even in small amounts. Therefore, healthcare facilities are often required to comply with the most stringent aspects of the RCRA hazardous waste regulations, yet are unaware that they must comply
with the se regulations.

Due to these factors, EPA is concerned that many facilities sewer their hazardous waste pharmaceuticals to circumvent regulations that are incompatible with the operations and structure of healthcare (and associated) facilities. The Agency is also concerned that those pharmaceuticals that are not sewered are not safely and properly transported and disposed. Many healthcare facilities use reverse distribution to

5 As described in the summary of the rule below, EPA also considered other regulatory options for the proposed rule,
one of which does not prohibit the sewering of hazardous waste pharmaceuticals for CESQG healthcare facilities

.2 

### manage unused and/or expired pharmaceuticals, but this management method is not recognized under the current regulatory scheme.

To address these concerns, EPA issued a proposal in December 2008 to add hazardous waste pharmaceuticals to the Federal Universal Waste (UW) Program. The UW Program is a set of simplified hazardous waste ma nagement standards for a small group of hazardous wastes which currently include batteries, pesticides, lamps, and

mercury

- containing equipment. UWs are typically low

- risk during accumulation and transport and are generated in a variety of settings other than the industrial setting (e.g., retail stores, office buildings, and households). In developing the 2008 proposed rule, EPA believed that adding hazardous waste pharmaceuticals to the UW program would have simplified the management of these wastes for the healthcare industry while encouraging proper disposal. However, based on public comments received on the proposal, particularly comments raising concerns over the diversion of such wastes due to the lack of notification and manifest requirements under the UW program, EPA has decided that the Universal Waste Rule is not the appropriate regulatory approach to address the management of hazardous waste pharmaceuticals. EPA is therefore developing a new Proposed Pharmaceuticals Rule that will follow a
diff erent, more comprehensive regulatory approach.

SUMMARY OF THE PROPO SED RULE AND R EGULATORY A LTERNATIVES



### Exhibits 1

- 1 and 1

- 2 detail the provisions of the three regulatory options considered in
this Regulatory Impact Analysis ( RIA ) for healthcare facilities and reverse distributors, respectively.

The key provisions of EPA’s Proposed Option include the following:

 Sewer disposal of hazardous waste pharmaceuticals is prohibited.

 Hazardous waste pharmaceuticals managed under the proposed 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 proposed 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.

 Hospitals must provide general awareness training for personnel who handle hazardous waste pharmaceuticals on the proper handling and emergency procedures for these wastes. Personnel who handle hazardous waste pharmaceuticals but not other hazardous waste s will no longer be req uired to go through the full RCRA hazardous waste management training

. This provision will most likely affect the training required for nurses.

These and other provisions of the Proposed Option would help ensure that the management of hazardous waste phar mace uticals is more protective o f human health
and the environment than current practice. In particular, the prohibition on sewer disposal would reduce releases of hazardous waste pharmac euticals to the nation’s3 

### waterways. The rule’s tracking requirement s for hazardous waste pharmaceuticals and the new standards proposed for reverse distributors would also facilitate the safe transport and disposal of these wastes.

As outlined in Exhibits 1

- 1 and 1

- 2, this RIA examines two regulatory alternatives in addition to the Proposed Option: the More Stringent Option and the Less Stringent Option

. The More Stringent Option includes many of the same provisions as the Proposed Option, including the prohibition on sewer disposal, but differs in several important ways, including the following :

 Hazardous waste pharmaceuticals count toward a facility’s generator status under the More Stringent Option but not under the Proposed Option.

 The More Stringent Option requires a more formal training program for healthcare facility employees than the Proposed Option.

 Unlike the Proposed Option, the More Stringent Option requires that healthcare facilities conduct periodic inspections of hazardous waste pharmaceutical storage are as and containers.

The Less Stringent Option examined in this RIA is the same as the Proposed Option except that healthcare facilities

— but not reverse distributors

— that are conditionally exempt small quantity generators may sewer their hazardous waste pha rmaceuticals.

As context for the stringency of the Proposed Option, Exhibit 1

- 3 summarizes the
baseline hazardous waste generator requirements and highlights key differences between these requirements and the Proposed Option.

MARKET FAILURES ADDR ESSED BY T HE RULE 

### The proposed rule and regulatory alternatives outlined in Exhibits 1

- 1 and 1

- 2 would
address several market failures related to the issues identified in the Problem
Statement above. First, there are environmental externalities associated with the sewering of hazardous waste pharmaceuticals

. When hazardous waste pharmaceuticals are sewered rather than managed at a permitted hazardous waste disposal facility, they may be released by wastewater treatment plants into U.S. surface waters, potentially e xposing human populations and ecosystems to harmful
contaminants. The rule would address these negative externalities by prohibiting the sewering of hazardous waste pharmaceuticals and internalizing the costs of their safe disposal

. Second, healthcare facilities must comply with a variety of regulations related to the
management of pharmaceuticals, and in some situations different regulatory requirements may call for different management approaches. The proposed rule addresses this issue by attempting to harmonize RCRA regulations with Drug Enforcement Agency regulations for those hazardous waste pharmaceuticals that are
considered controlled substances. Finally, t he proposed r ule is better tailored to
h ealthcare facilities and EPA believes it makes the requirements of the rule easier to understand and to comply with than the current RCRA provisions.4

EXHIBIT 1

- 1. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WASTE

PHARMACEUTICALS GENE RATED BY HEALTHCARE FACILITIES

MORE

- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTIO N

SQG S LQG S PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY CREDITAB LE
HW PHARMACEUTICALS
GOING TO AN RD PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY
CREDITABLE HW
PHARMACEUTICALS
GOING TO AN RD

Is Sewer Disposal
Allowed ?  No

 CESQG healthcare facilities are also prohibited from sewering their hazardous waste pharmaceuticals.  No

 CESQG healthcare facilities are also prohibited from sewering their hazardous waste pharmaceuticals.  CESQG healthcare facilities may sewer their hazardous waste pharmaceuticals. Sewer disposal is prohibited for all other
healthcare facilities.

Generation
Threshold for
Hazardous

Waste
Generation  Greater than 100 kg

but less than 1,000 kg
of hazardous waste per calendar month,
and

 Less than or equal to1 kg of acute hazardous waste per month.  Greater than or equal to 1,000 kg of hazardous waste in a calendar month, or

 More than 1 kg of acute hazardous waste per month.  Greater than 100 kg of hazardous waste per calendar month, or

 1 kg or more of acute hazardous waste per month.  Same as Proposed Option.

Counting
Hazardous

Waste
Pharmaceuticals
Toward
Generator
Status  All HW pharms are

counted toward HCF’s generator status, regardless of
destination.  All HW pharms are counted toward HCF’s generator status, regardless of
destination.  No hazardous waste pharmaceuticals that are managed
under new standards are counted toward HCF’s generator status.  Same as Proposed Option.

Long Term Care Facilities (HCFs or Households)  Nursing facilities and

continuing care
retirement
communities are HCFs
& must follow full SQG requirements.  Nursing facilities and continuing care retirement
communities are HCFs & must follow full LQG requirements.  Nursing care facilities and continuing care retirement communities must operate as HCFs and follow the standards under this proposed option; unless they generate less than or equal to 100 kg of hazardous waste per month a nd less than or equal to 1 kg acute hazardous waste per month.  Same as Proposed Option.

Accumulation
Volume Limit  ≤6,000 kg of

hazardous waste AND

 ≤1 kg of acute
hazardous waste.  None.  None.  Same as Proposed Option.5

EXHIBIT 1

- 1. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WASTE

PHARMACEUTICALS GENE RATED BY HEALTHCARE FACILITIES

MORE

- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTIO N

SQG S LQG S PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY CREDITAB LE
HW PHARMACEUTICALS
GOING TO AN RD PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY
CREDITABLE HW
PHARMACEUTICALS
GOING TO AN RD

Notification Requirements  Notify EPA and obtain EPA ID number.  Notify EPA as a healthcare facility and obtain EPA ID
number OR

 If a facility already has an EPA ID number, notify as a healthcare facility under the proposed rule

.  Same as Proposed Option.

Accumulation
Time Limits  180

– 270 days.  90 days.  One year.  None.  Same as Proposed Option.

Labeling/ Marking Requirements  All containers must be marked with the words

“Hazardous Waste” and the accumulation start date.  All containers must be
marked with the
words “Hazardous

Waste
Pharmaceuticals.”  No Container Marking.  Same as Proposed Option.

Container Management Requirements  Containers must be in good condition and compatible

with wastes stored.

 Containers must be closed during storage except when adding or removing waste.  Containers must be in good condition and compatible with
wastes stored.

 Must secure containers to prevent access to

contents.  None.  Same as Proposed Option.

Inspection Requirements  Weekly inspections of storage containers and areas.  None.  Same as Proposed Option.6

EXHIBIT 1

- 1. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WASTE

PHARMACEUTICALS GENE RATED BY HEALTHCARE FACILITIES

MORE

- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTIO N

SQG S LQG S PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY CREDITAB LE
HW PHARMACEUTICALS
GOING TO AN RD PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY
CREDITABLE HW
PHARMACEUTICALS
GOING TO AN RD

Employee Training  Generator must

ensure that all employees are thoroughly familiar with proper waste handling and

emergency procedures relevant
to their responsibilities during normal facility operations and emergencies.  Training program required for all employees.

 Training program must be documented and records kept for each employee. Annual refresher training is required.  Ensure that all employees that manage hazardous waste pharmaceuticals are thoroughly familiar with proper waste handling and emergency procedur es relevant to their responsibilities during normal facility operations and emergencies.

 Documentation of training not required.  Same as Proposed Option.

Preparedness
and Prevention and Emergency Response  Facilities must be maintained and operated to prevent

fire, explosion, or release of hazardous waste. Appropriate equipment and procedures must be in place. Arrangements must be made with local
authorities.

 Facility must have a designated emergency coo rdinator.

 Emergency information must be posted at the facility.  Determine whether residues from releases are hazardous wastes. If they are, manage the residues and any other materials resulting from a release (e.g., cleanup equipment, contaminated soils, etc.) under the regulations for patient care HW pharmaceuticals.  Same as Proposed Option.7

EXHIBIT 1

- 1. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WASTE

PHARMACEUTICALS GENE RATED BY HEALTHCARE FACILITIES

MORE

- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTIO N

SQG S LQG S PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY CREDITAB LE
HW PHARMACEUTICALS
GOING TO AN RD PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY
CREDITABLE HW
PHARMACEUTICALS
GOING TO AN RD

Pre

- Transport Requirements  Containers must be labeled with specific Hazardous Waste language from EPA and in compliance with DOT hazardous materials requirements.

 Hazardous waste may only be transported by a registered hazardous waste transporter.

 The generator must placard the transportation vehicle with the appropriate DOT placard.  Containers must be labeled with specific
Hazardous Waste language from EPA
and in c ompliance
with DOT hazardous
materials requirements.

 Hazardous waste may only be transported by a registered
hazardous waste transporter.

 The generator must placard the transportation vehicle with the appropriate DOT placard.  Containers do not need a
label

.

 Must call the RD to provide an alert that a shipment is coming.

 Can use common carriers
such as UPS.

 Must ship in compliance with DOT regulations.  Same as Proposed Option.

Manifests  Hazardous waste manifest must be prepared for each

offsite shipment of hazardous waste including hazardous
waste codes.  Hazardous waste
manifest must be prepared for each offsite shipment of
hazardous waste pharmaceuticals.

 Hazardous waste
codes DO NOT need to
be on the manifest.  No manifest required.

 Must ship with a return receipt notification.

 Waste codes do not need to be on shipping papers.  Same as Proposed Option.8

EXHIBIT 1

- 1. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WASTE

PHARMACEUTICALS GENE RATED BY HEALTHCARE FACILITIES

MORE

- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTIO N

SQG S LQG S PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY CREDITAB LE
HW PHARMACEUTICALS
GOING TO AN RD PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY
CREDITABLE HW
PHARMACEUTICALS
GOING TO AN RD

Reporting & Recordkeeping  Keep copies of signed

manifests for three

years.

 Records of waste
characterizations and
back

- up for three years from last waste

sent off site.  Comply with all SQG recordkeeping requirements.

 Submit data to EPA for biennial reporting.

 Maintain copies of biennial report submittals for three

years.  Keep copies of signed
manifests for three

years.

 HW pharmaceuticals not required to be on

H CF’s biennial report.  Must keep return receipt and shipping papers for all shipments shipped for at least three years.

 HW pharmaceuticals not required to be on HCF’s biennial report.  Same as Proposed Option.

Controlled
Substances that
are also
Hazardous

Waste  Must be managed in accordance with both RCRA HW

regulations and DEA regulations (i.e. must go to a HW incinerator that is also a DEA registrant or is sewered).  Conditionally exempt controlled substances that are also HW pharmaceuticals as long as the y are:

o M anaged in accordance with DEA regulations,

o NOT sewered, and

o S ent to, at a minimum, a municipal solid waste
combustor or a HW incinerator.  Same as Proposed Option.

Whether
Pharmaceuticals
Must Go to a
TSDF  Yes all HW pharmaceuticals must go to a RCRA

permitted TSDF (RDs accepting HW pharmaceuticals must have a RCRA storage permit).  Yes  It can go to an RD that is a TSDF, but it is not required.  Same as Proposed Option.

Whether
Hazardous

Waste
Pharmaceuticals May Go to an RD  No, none of the HW pharmaceuticals can go to an

unpermitted RD.  No  Yes  Same as Proposed Option.9

EXHIBIT 1

- 1. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WASTE

PHARMACEUTICALS GENE RATED BY HEALTHCARE FACILITIES

MORE

- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTIO N

SQG S LQG S PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY CREDITAB LE
HW PHARMACEUTICALS
GOING TO AN RD PATIENT CARE HW
PHARMACEUTICALS POTENTIALLY
CREDITABLE HW
PHARMACEUTICALS
GOING TO AN RD

Management of
Containers that
are Not RCRA Empty per RCRA
Standards  Fully dispensed containers that once held P

- listed wastes must be managed as acute hazardous waste. No triple rinsing allowed to render containers RCRA empty.  For blister packs, dispensing bottles, cups, and patch wrappers, removing the P

- listed hazardous waste pharmaceutical is the same as triple rinsing and the
container is not hazardous waste.

 For syringes, conditional exemption if the syringe was
used to administer a P

- listed, U

- listed or characteristic drug and i s disposed of in the sharps container.

 All other containers managed as hazardous waste.  Same as Proposed Option.

Abbreviations HCF = healthcare facility
HW = hazardous waste
RD = reverse distributor SQGs = Small Quantity Generators LQGs = Large Quantity Generators CESQGs = Conditionally Exempt Small Quantity Generators DEA = Drug Enforcement Administration DOT = Department of Transportation10

EXHIBIT 1

- 2. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WAST E

PHARMACEUTICALS GENE RATED BY REVERSE DIS TRIBUTORS

MORE STRINGENT OPTIO N PROPOSED OPTION AND LESS STRINGENT O PTION

HAZARDOUS WASTE PHAR MACEUTICALS
THAT GO FROM RD TO T SDF HAZARDOUS WASTE PHAR MACEUTICALS
THAT GO FROM RD TO A NOTHER RD

Is Sewer Disposal
Allowed ?  Sewer disposal of hazardous waste pharmaceuticals prohibited.  Sewer disposal of hazardous waste pharmaceuticals prohibited.

Generation
Threshold  None. Any RD has to meet the same standards regardless of

quantity of HW pharmaceuticals it accepts.  None

- Any RD has to meet the same standards regardless of quantity of HW pharmaceuticals it accepts.

Accumulation
Volume Limit  None.  None

Notification Requirements  Notify EPA as a Reverse Distributor and obtain EPA ID number, OR if

already have an EPA ID number, re

- notify as a reverse distributor.  Notify EPA as a Reverse Distributor and obtain EPA ID number, OR

 If already have an EPA ID number, notify as a reverse distributor under the proposed
rule

.

Accumulation
Time Limits  Not applicable.  90 days at each stop: 1 st RD, 2 nd RD, Manufacturer accepting returns; each facility tracks accumulation time via the inventory requirement.
Labeling/ Marking Requirements  All containers must be marked with the words “Hazardous Waste”

and the accumulation start date.  All containers must be marked with
the words “Hazardous Waste.”  None

Container Management Requirements  Containers must be in good condition and compatible with wastes

stored.

 Containers must be closed during storage except when adding or removing waste.  Containers must be in good condition and compatible with wastes stored.

 Containers must be closed during storage except when adding or removing waste.

Inspection Requirements  Develop inspection schedule, conduct weekly inspections of storage

containers and areas, and maintain records of inspections for three

years.  Weekly inspections of storage containers and areas.

Employee Training  LQG Training Requirements:

o Training program required for all employees.

o Training program must be documented and records kept for each employee.

o Annual refresher training is required  LQG Training Requirements:

o Training program required for all employees.

o Training pr ogram must be documented and records kept for each employee.

o Annual refresher training is required11

EXHIBIT 1

- 2. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WAST E

PHARMACEUTICALS GENE RATED BY REVERSE DIS TRIBUTORS

MORE STRINGENT OPTIO N PROPOSED OPTION AND LESS STRINGENT O PTION

HAZARDOUS WASTE PHAR MACEUTICALS
THAT GO FROM RD TO T SDF HAZARDOUS WASTE PHAR MACEUTICALS
THAT GO FROM RD TO A NOTHER RD

Whether an RD
Must Obtain a RCRA Storage
Permit  RCRA storage permit required for all reverse distributors.  RCRA storage permit NOT required.

Pre

- Transport Requirements  Containers must be labeled with specific Hazardous Waste language

from EPA and in compliance with DOT hazardous materials requirements.

 Hazardous waste may only be transported by a registered hazardous waste transporter.

 The generator must pla card the transportation vehicle with the appropriate DOT placard.  Containers must be labeled with specific Hazardous Waste language from EPA and in compliance with DOT hazardous materials requirements.

 Hazardous waste may only be transported by a registered hazardous waste transporter.

 The generator must placard the transportation vehicle with the appropriate DOT placard.  Containers do not need a label.

 Must call the RD to provide an alert that a shipment is coming.

 Can use common carriers such as UPS.

 Must ship in compliance with DOT regulations.

Manifests  Hazardous waste manifest must be prepared for each offsite

shipment of hazardous waste.  Hazardous waste manifest must be prepared for each offsite shipment of
hazardous waste.  No manifest required.

 Must ship with a return receipt
notification.

Reporting & Recordkeeping  Keep copies of signed manifests for three years.

 Records of waste characterizations and back

- up for three years
from last waste sent off site.  Keep copies of signed manifests for three years.

 Records of waste characterizations
and back

- up for three years from last
waste sent off site.

 HW pharms going to TSDF do not need to be reported on biennial report  Must keep return receipt and shipping papers for all shipments sh ipped for at least three years.

 Do not need to include HW pharms going to another RD on biennial report.12

EXHIBIT 1

- 2. COMPARISON OF MOR E STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTIO N FOR HAZARDOUS WAST E

PHARMACEUTICALS GENE RATED BY REVERSE DIS TRIBUTORS

MORE STRINGENT OPTIO N PROPOSED OPTION AND LESS STRINGENT O PTION

HAZARDOUS WASTE PHAR MACEUTICALS
THAT GO FROM RD TO T SDF HAZARDOUS WASTE PHAR MACEUTICALS
THAT GO FROM RD TO A NOTHER RD Preparedness
and
Prevention
and Emergency Response  Prepare and maintain contingency plan.

 All Proposed Option requirements.  Facilities must be maintained and operated to prevent fire, explosion, or release of hazardous waste. Appropriate equipment and procedures must be in place. Arrangements must be made with local authorities

 Facility must have a designated emergency coordinator

 Emergency inf ormation must be posted at the facility

Inventory  None.  Keep an up

- to date inventory of the HW pharmaceuticals that are on

- site (can be
used to determine 90

- day accumulation time limit).

Secure Facility  All RDs are required to secure facility in accordance with RCRA

Storage Permit.  Keep a secure facility so that people and animals cannot inadvertently come into contact with HW pharmaceuticals.
Abbreviations HCF = healthcare facility
HW = hazardous waste
RD = reverse distributor SQGs = Small Quantity Generators LQGs = Large Quantity Generators CESQGs = Conditionally Exempt Small Quantity Generators DEA = Drug Enforcement Administration DOT = Department of Transportation13

EXHIBIT 1

- 3. COMPARISON OF CU RRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE

PROPOSED OPTION

CESQG s SQG s LQG s KEY DIFFERENCES WITH THE PROPOSED OPTION
FOR HEALTHCARE
FACILITIES FOR REVERSE
DISTRIBUTORS

Generation
Threshold  Less than or equal to

100 kg of hazardous waste per month,
and

 Less than or equal to 1 kg of acute hazardous waste per
month.  Greater than 100 kg but less than 1,000 kg of hazardous waste per calendar month,
and

 Less than or equal to 1 kg or
acute hazardo us waste per
month.  Greater than or equal to 1,000 kg of hazardous waste in a calendar month, or

 More than1 kg of acute hazardous waste per month.  T he Proposed Option applies only to SQGs and LQGs, with the exception of the sewering ban.  U nder the Propose d Option, there are no generation thresholds. All
reverse distributors must comply with the same requirements.

Accumulation
Volume Limit None  ≤6,000 kg of hazardous waste

 ≤1 kg of acute hazardous

waste None  The Proposed Option represents a change for SQGs in that it includes no
accumulation volume limit
for hazardous waste pharmaceuticals.  Unlike the baseline, the Proposed Rule would set
no accumulation volume
limit on reverse
distributors.

Notification Requirements None  Notify EPA and obtain EPA ID number  Upon re

- notification, facilities must notify as a healthcare facility or reverse distributor under the Proposed Option and, if other hazardous waste is generated onsite, as a hazardous waste generator.

Accumulation
Time Limits None  180

– 270 days  90 days  For healthcare facilities,
the accumulation time
limits increase for both SQGs and LQGs to one year under the Proposed Option.  For current SQG reverse distributors, the
accumulation time limit decreases to 90 days.14

EXHIBIT 1

- 3. COMPARISON OF CU RRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE

PROPOSED OPTION

CESQG s SQG s LQG s KEY DIFFERENCES WITH THE PROPOSED OPTION
FOR HEALTHCARE
FACILITIES FOR REVERSE
DISTRIBUTORS

Labeling/ Marking Requirements None  All containers must be marked with the words “Hazardous Waste”
and the accumulation start date.  For patient care pharmaceuticals from healthcare facilities, the Proposed Option requires that labels say “Hazardous
Waste Pharmaceuticals”
instead of just “Hazardous
Waste” but the
accumulation start date does not need to appear
on the label.  No labeling required for pharmaceuticals shipped
to a reverse distributor under the Proposed Option.

Container Management Requirements None  Containers must be in good condition and compatible with wastes
stored.

 Containers must be closed during storage except when adding or removing waste.  The Proposed Option
includes no container management requirements for pharmaceuticals shipped from a healthcare facility

to a reverse distributor.  No change relative to the baseline for LQGs and SQGs. CESQGs must now comply with same standards as LQGs and SQGs.

Inspection Requirements None  Weekly inspections of storage containers and areas.  For healthcare facilities,
the Proposed Option requires no inspections for
areas where hazardous waste pharmaceuticals are
stored.  No change relative to the baseline for LQGs and SQGs. CESQGs must now comply with same standards as LQGs and SQGs.

Employee Training None  Generator must ensure that all employees are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies.  Training program required for all employees.

 Train ing program must be documented and records kept for each employee. Annual refresher training is required.  For healthcare facilities, training requirements imply less intensive training for hospital

nurses. 

###  All reverse distributors must provide LQG

- level training to employees, regardless of their RCRA generator status.15

EXHIBIT 1

- 3. COMPARISON OF CU RRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE

PROPOSED OPTION

CESQG s SQG s LQG s KEY DIFFERENCES WITH THE PROPOSED OPTION
FOR HEALTHCARE
FACILITIES FOR REVERSE
DISTRIBUTORS

Transportation None  Containers must be labeled with specific Hazardous Waste language from EPA and in compliance with DOT hazardous materials requirements.

 Hazardous waste may only be transported by a registered hazardous waste transporter.

 The generator must placard the transportation vehicle with the appropriate DOT placard.  For potentially creditable
hazardous waste pharmaceuticals shipped to a reverse distributor, the Proposed Optio n stipulates that the RD must be called to provide an alert that a shipment is

en route.  For shipments between
reverse distributor s , the Proposed Option stipulates
that the RD receiving the
hazardous waste pharmaceuticals must be called to provide an alert that a shipment is en

route.

Manifests None  Hazardous waste manifest must be prepared for each offsite shipment of hazardous waste. Manifests must include RCRA waste
codes.  Potentially creditable
hazardous waste pharmaceuticals shipped

to a reverse distributor must ship with a return receipt notification under the Proposed Option.

 Manifests for patient care
hazardous waste pharmaceuticals shipped
to a reverse distributor not required to have
waste codes under the Proposed Option.  No manifest required for shipments between reverse distributors, but each shipment must be shipped with a return receipt.

Recordkeeping None  Keep copies of signed manifests for three years.

 Records of waste
characterizations and back

- up for three years from last
waste sent off site.

 Exception reporting.  Comply with all SQG recordkeeping requirements.

 Submit data to EPA for biennial reporting.

 Maintain copies of biennial report submittals f or three

years.  Proposed Option does not require biennial reporting
for hazardous waste pharmaceuticals.

 Records of waste
characterizations need not
be stored

.  Proposed Option does not require biennial reporting
for hazardous waste pharmaceuticals.16

EXHIBIT 1

- 3. COMPARISON OF CU RRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE

PROPOSED OPTION

CESQG s SQG s LQG s KEY DIFFERENCES WITH THE PROPOSED OPTION
FOR HEALTHCARE
FACILITIES FOR REVERSE
DISTRIBUTORS Preparedness
and
Prevention
and Emergency Response None  Facilities must be maintained and operated to prevent fire, explosion, or release of hazardous waste. Appropriate equipment and procedures must be in place. Arrangements must be made
with local authorities.

 Facility must have a designated emergency coo rdinator.

 Emergency information must be posted at the facility.  Baseline and Proposed Option requirements are similar.

Long

- term
Care Facilities  Long

- term care facilities exempt from RCRA requirements under the household hazardous

waste exclusion

.  Long

- term care facilities
must meet all rule requirements under the Proposed Option, unless they are CESQGs.  Not applicable.

Sewer Disposal  Sewer disposal allowed if facilities notify their local POTW.  Sewer disposal of hazardous waste pharmaceuticals prohibited.17 REPORT ORGANIZATION


### EPA has prepared this RIA consistent with the requirements of Executive Order 12866, as amended by Executive Order 13563, and OMB Circular A

- 4. 6 

### The assessment of the rule’s costs, benefits, and other economic impacts is presented in subsequent chapters as
follows:

 Chapter 2

– Potentially Impacted Industries: To provide context for the assessment of costs and benefits, this chapter characterizes the universe of facilities likely to be affected by the rule and presents estimates of their annual generation of hazardous waste pharmaceuticals and their total hazardous waste generation (pharmaceuticals and non

- pharmaceuticals combined).

 Chapter 3

– Ass essment of Costs: This chapter explains the methods employed by EPA for assessment of the proposed rule’s cost impacts and presents detailed
cost estimates consistent with these methods.

 Chapter 4

– Benefits: Following the assessment of costs, this chapter assesses the benefits that may result from the rule.

 Chapter 5

– Summary of Regulatory Benefits and Costs: This chapter compares the benefits and costs of the proposed rule.

 Chapter 6

– Equity Considerations and Other Impacts: The RIA concludes by assessing distributional and other impacts of the proposed rule, including small entity impacts, environmental justice implications, children's health, impacts to Tribal Governments, assessment of the potential for unfunded mandates, federalism implication s, employment impacts, and energy impacts resulting from
the rule.

6 Executive Order 12866, Regulatory Planning and Review, October 4, 1993; Executive Order 13563, Improving Regulation and
Regulatory Review, January 18, 2011; Office of Management and Budget, Circular A

- 4, September 17, 2003.18 

### CHAPTER 2 | POTENT IALLY I MPACTED I NDUSTRIES

INTRODUCTION


### This chapter provides an overview of the universe of healthcare facilities and reverse distributors potentially affected by the proposed management standards for hazardous waste pharmaceuticals. The proposed rule may affect several different types of
heal thcare facilities, including hospitals, physicians’ offices, dentists’ offices, outpatient care centers, pharmacies, veterinary clinics, nursing care facilities, coroners’ offices, other health practitioners, and other ambulatory care services, as well as reverse distributors. The information in this chapter provides context for the analysis of the costs and benefits associated with the proposed rulemaking. First, this chapter provides a profile of the industries potentially affected by the proposed rule, their geographic distribution across the U.S., and their contribution to the overall economy. Second, it describes recent market trends affecting these industries. Third, it estimates the number of healthcare facilities and reverse distributors likely t o be affected by the rule. Finally, this chapter characterizes the generation of hazardous waste pharmaceuticals and hazardous waste more broadly among these facilities.

Due to the limited availability of national data on healthcare facilities the EPA ne eded to make some assumptions where data was limited in order to estimate the costs and benefits of this proposed rule. For example, the small percentage of hospitals and RDs reporting waste generation data to EPA suggests a lack of compliance with baseli ne rules regarding the management of hazardous waste pharmaceuticals. This led EPA to conduct a sensitivity analysis with an assumption of less than full baseline compliance. The purpose of this chapter is to explain many of the assumptions, statistics, and methods
used to estimate underlying statistics on healthcare facilities and reverse distributors relative to the proposed rule

.

PROFILE OF AFFECTED INDUSTRIES


### According to the 2007 Economic Census and data from the Drug Enforcement Agency

, approximatel y 612,600 facilities make up the healthcare and reverse distributor sector s

. These are primarily comprised of physicians’ offices (36 percent), dentists’ offices (21 percent), other health practitioners (20 percent), and pharmacies (7 percent). In additi on, there are 6,505 hospitals, 16,320 nursing care facilities, and 5,939 continuing care retirement communities in the United States, which collectively account for approximately 5 percent of U.S. healthcare facilities. Exhibit 2

- 1 shows the estimated

num ber of healthcare facilities and reverse distributors by facility type. The data included
in Exhibit 2

- 1 and other exhibits throughout this section reflect all healthcare facilities and reverse distributors in the U.S. However, because not all facilities are hazardous19 

### waste generators, not all of these facilities will be affected by the proposed rule. EPA
estimates that 174,023 healthcare facilities and reverse distributors generate hazardous waste and thus may be affected by the proposed regulations for the management of hazardous waste pharmaceuticals. See the section entitled, "Universe of Facilities Affected by The Proposed Rule" for details about the number of healthcare facilities and reverse distributors that are likely to be hazardous waste gener ators.20 EXHIBIT 2

- 1. HEALTHCARE FACIL ITIES AND REVERSE DI STRIBUTORS BY NAICS 1 , 2

NAICS FACILITY TYPE NUMBER OF
FACILITIES % OF

REGULATED
UNIVERSE NUMBER OF

FIRMS AVG. NUMBER OF

FACILITIES PER
FIRM

44611 Pharmacies 42,045 7% 19,067 2.2

54194 Veterinary Clinics 28,400 5% 26,642 1.1

6211 Physicians’ Offices 220,131 36% 192,880 1.1

6212 Dentists’ Offices 127,057 21% 121,048 1.0

6213 Other Health Practitioners

(e.g., chiropractors) 125,063 20% 112,814 1.1

6214 Outpatient Care Centers 29,776 5% 14,599 2.0

6219 Other Ambulatory Health

Care Services 9,358 2% 6,070 1.5

622 Hospitals 6,505 1% 3,681 1.8

6231 Nursing Care Facilities (e.g.,

assisted living facilities, nursing homes, veterans domiciliary centers) 16,320 3% 8,628 1.9

623311 Continuing Care Retirement

Communities (e.g., assisted living facilities with on

- site nursing facilities) 5,939 1% 3,615 1.6

Subset of
92219 Medical Examiners and

Coroners’ Offices 3 1,998 <1%

- -

Various
NAICS Reverse Distributors (RDs) 4 56 <1% 47 1.2

TOTAL 612,648 100% 509,091 1.2

Notes:
1. Data collected from U.S. Census Bureau, 2007 Economic Census (unless otherwise noted). EPA also considered other long

- term care facilities included in NAICS codes 6232 (Residential Mental Retardation, Mental Health and Substance Abuse Facilities), 623312 (Homes for the Elderly), and 6239 (Other Residential Care Facilities), but did not include them because they are not covered in the proposed rule’s definition of healthcare facility due to the household hazard ous waste exclusion.
2. The data presented in this exhibit include all healthcare facilities in industries potentially affected by the proposed rule. Only those facilities that generate hazardous waste pharmaceuticals, however, will actually be affected by t he rule.
3. Estimates from Bureau of Justice Statistics, Medical Examiners and Coroners’ Offices, 2004, June 2007.
4. RDs are represented by multiple NAICS codes that include a broad range of industries. RDs were
identified in EPA’s Biennial Report database by matching facility names with the names of known RDs identified by the U.S. Drug Enforcement Administration through 2008. These facilities represent at least 85 percent of the market based on data presented in Charlotte Smith’s, "Environmental Stewardship of Waste Pharmaceuticals from a Hospital Perspective," presentation at the 2005 meetings of EPA's National Center for Environmental Research, August 24, 2005.



### In addition to reporting the number of healthcare facilities and reverse distributors by facility type, Exhibit 2

- 1 also reports the number of firms for each facility type. These data show that hospitals, pharmacies, nursing care facilities, and other amb ulatory healthcare services tend to be concentrated in the hands of fewer firms that own multiple facilities. On the other hand, dentists’ offices, physicians’ offices, offices of other21 

### healthcare practitioners, and veterinary clinics tend to have owners operating just one facility.

The facility counts presented above are from the Census Bureau’s 2007 Economic Census with the exception of reverse distributors (RDs) and coroners’ offices, which are from
other sources noted in Table 2

- 1. This RIA relies pr edominately on the 2007 Economic Census for these estimates in favor of other sources that may provide more recent data because the Economic Census provides the most comprehensive collection of industry statistics, including: the number of facilities, firm s, and employees, as well as annual payrolls and revenues. County Business Patterns, an annual survey also conducted by the Census Bureau, provides more frequent industry statistics, but does not include
information on the number of firms and annual reven ues. The most recent publication of County Business Patterns contains industry data for 2011, which do not show significant changes in the number of healthcare facilities since 2007.

The information from the Economic Census was also compared against data from Dun & Bradstreet (D&B), a leading private source of commercial information that maintains a database containing more than 200 million business records. Updated on a monthly basis, these data tend to capture a broader range of facilities than the Eco nomic Census because: (1) different departments within a single healthcare facility (e.g., a hospital) may be counted as separate facilities; (2) different business names and/or street addresses may be used for the same facility, resulting in that facility being counted more than once; and (3) all corporate, subsidiary, and affiliated entities for a given facility are also counted even if they are not in the same industry (i.e., they have a different NAICS code). For these reasons, a query of the D&B data for a particular NAICS code will likely overstate the actual number of facilities in that industry. For example, D&B reports that there are approximately 24,295 hospitals in the U.S. compared to 6,505 recorded by the 2007 Economic Census. However, an ana lysis of the data suggests that many of these are duplicate entries for single facilities or are misclassified. Because the D&B data tend to overstate the number of facilities, it is not feasible to use these data as the basis for
characterization of U.S. healthcare facilities and reverse distributors.

The geographic distribution of healthcare facilities and reverse distributors in the U.S. is roughly proportional to the distribution of the U.S. population. The most populated states (i.e., California, Flo rida, New York, and Texas) account for the highest concentration of healthcare facilities. More hospitals and other ambulatory healthcare service facilities are located in Texas than in any other state, and California accounts for the largest number of

ne arly all other types of facilities. One exception is the number of medical examiners and coroners’ offices, which is determined by whether the state uses a centralized medical examiner system (16 states), a county medical examiner system (7 states), a cou nty coroner system (14 states), or a combination of these (13 states). 7 

### Since the exact number of medical examiners and coroners’ offices per state is not known, this RIA assumes for states that have a centralized system, one facility per state, and all r emaining coroners’

7 U.S. Department of Justice, Bureau of Justice Statistics, Special Report: Medical Examiners and Coroners’ Offices, 2004.

June 2007.22 

### offices/medical examiners are distributed to states in proportion to the number of counties
in each state. Exhibit 2

- 2 shows the geographic distribution of healthcare facilities and reverse distributors by state.

In total, healthcare fa cilities accounted for approximately $1.6 trillion in annual revenue and 13.1 million jobs in 2007. 8 

### Hospitals accounted for the largest share of healthcare facilities in terms of annual revenues ($703 billion), payroll ($265 billion), and employment (5.5 million employees) that year. Physicians’ offices, which represent the largest number of healthca re facilities, accounted for the second largest share in terms of annual revenues ($336 billion), payroll ($147 billion), and employment (2.1 million employees). Exhibit 2

- 3 presents economic summary data for each type of healthcare facility relative to a ll healthcare facilities.

8 All dollar figures in this section are reported in 2007 dollars. In addition, financial data specific to reverse distributors were
not readily available. The financial data presented in this chapter are for healthcare facilities only.23

EXHIBIT 2

- 2. GEOGRAPHIC DISTR IBUTION OF HEALTHCAR E FACILITIES AND REV ERSE DISTRIBUTORS24 EXHIBIT 2

- 3. ECONOMIC SUMMARY DATA BY HEALTHCARE F ACILITY TYPE (IN 200 7 DOLLARS) 1

NAICS FACILITY TYPE ECONOMIC DATA BY IND USTRY

ANNUAL REVENUES PAYROLL EMPLOYEES

($ MILLIONS) % OF

FACILITIES ($ MILLIONS) % OF
FACILITIES # % OF
FACILITIES
44611 Pharmacies 202,042 12% 22,385 4% 814,836 6%

54194 Veterinary Clinics 24,568 2% 8,549 1% 292,940 2%

6211 Physicians’ Offices 336,282 21% 147,214 25% 2,109,762 16%

6212 Dentists’ Offices 93,930 6% 34,325 6% 825,447 6%

6213 Other Health Practitioners

(e.g., chiropractors) 50,318 3% 19,352 3% 614,836 5%

6214 Outpatient Care Centers 74,092 5% 27,672 5% 655,149 5%

6219 Other Ambulatory Health

Care Services 26,136 2% 9,354 2% 273,080 2%

622 Hospitals 702,960 43% 264,977 45% 5,528,843 42%

6231 Nursing Care Facilities 92,517 6% 41,657 7% 1,591,190 12%

623311 Continuing Care

Retirement Communities 26,030 2% 10,104 2% 442,219 3%

Subset of 92219 Medical Examiners and

Coroners’ Offices 718 0%

- - 7,320 0%

Various NAICS Reverse Distributors 2

- - - - - - TOTAL 1,629,593 100% 585,590 100% 13,155,622 100%
Notes:
1. The data in the exhibit represent all healthcare facilities in the U.S. Only those that are hazardous waste generators may be affected by the proposed rule.
2. RDs are represented by multiple NAICS codes that include a broad range of industries. Since individual firms are not identifi able in the Economic Census, values for just these facility types cannot be reported. Furthermore, calculating a weighted average f or all NAICS codes represented by reverse distributors may overestimate or underestimate actual values because it would reflect other faci lity types that may not be RDs.
Source: U.S. Census Bureau, 2007 Economic Census.25 

### Exh ibit 2

- 4 shows the distribution of healthcare facilities by firm

- level revenues by facility type. Note that a firm may own more than one facility. For example, there are 17,217 firms that own 42,045 pharmacies in the U.S. Of the 42,045 pharmacies,

appro ximately 3,200 pharmacies are owned by firms with revenues below $1 million per year, while 20,300 pharmacies are owned by firms with revenues exceeding $250 million per year. The exhibit shows that hospitals, pharmacies, and nursing care facilities are

p redominantly owned by firms with more than $100 million in annual revenues. Outpatient care centers and other ambulatory healthcare services are more evenly distributed between large and small owners. Finally, dentists’ offices, physicians’ offices, vete rinary clinics, and offices of other health practitioners are predominantly owned by firms with less than $5 million in annual revenues.

On a per facility basis, hospitals are by far the largest type of healthcare facility in terms of average annual revenu es ($108 million) and average number of employees (850 employees). Several other types of healthcare facilities also have average annual revenues exceeding $1 million, including nursing care facilities ($5.6 million), pharmacies ($4.8 million), other ambu latory healthcare services ($2.8 million), outpatient care centers ($2.5 million), and physicians’ offices ($1.5 million). Exhibit 2

- 5 shows the average revenues, employee salary, and number of employees on a per facility basis for the various types of healthcare facilities likely to be affected by the proposed rule. For comparison, in 2007 the U.S. personal median income was $26,625 and personal mean income was $38,174. 9

9 U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplem ents, 2010. Table P

- 10. Age

– People
(Both Sexes Combined

— All Races) by Median and Mean Income: 1974 to 2010. Accessed on July 9, 2012 at
http://www.census.gov/hhes/www/income/ data/historical/people/

.26

EXHIBIT 2

- 4. NUMBER OF FACILI TIES BY FIRM

- LEVEL REVENUES



### NAICS 621 1 : Physicians’ Offices27

EXHIBIT 2

- 4. NUMBER OF FACILI TIES BY FIRM

- LEVEL REVENUES (CONT INUED)28

EXHIBIT 2

- 4. NUMBER OF FACILI TIES BY FIRM

- LEVEL REVENUES (CONTINUED)29 EXHIBIT 2

- 5. AVERAGE SIZE OF HEALTHCARE FACILITIE S ON A PER FACILITY BASIS

NAICS FACILITY TYPE AVERAGE REVENUE
PER FACILITY (MILLIONS OF $2007) AVERAGE

EMPLOYEE
SALARY ($2007) AVERAGE

EMPLOYMENT
SIZE
44611 Pharmacies $4.81 $27,500 19

54194 Veterinary Clinics $0.87 $29,200 10

6211 Physicians’ Offices $1.53 $69,800 10

6212 Dentists’ Offices $0.74 $41,600 6

6213 Other Health

Practitioners (e.g., chiropractors) $0.40 $31,500 5

6214 Outpatient Care Centers $2.49 $42,200 22

6219 Other Ambulatory Health

Care Services $2.79 $34,300 29

622 Hospitals $108.06 $47,900 850

6231 Nursing Care Facilities $5.67 $26,200 97

623311 Continuing Care

Retirement Communities $4.38 $22,800 74

Subset of
92219 Medical Examiners and

Coroners’ Offices $0.36

- 3

Various NAICS Reverse Distributors

- - - TOTAL $2.66 $44,500 21

Source: U.S. Census Bureau, 2007 Economic Census.

RECENT MARKET TRENDS


### This section describes recent market trends affecting the healthcare sector. Between 1997 and 2007, overall revenues for U.S. healthcare facilities grew approximately 49 percent in
real dollar terms. 10 

### This rate of growth outpaced that of the overall U.S. economy, which grew roughly 34 percent during the same time period. 11 

### In real dollar terms, hospitals and physicians’ offices accounted for nearly two

- thirds of total revenue growth in the healthcare sector. However, continuing care retirement communities and other ambulatory healthcare services experienced the highest gr owth rates, with revenues more than doubling over the decade.

The number of healthcare facilities increased approximately 17 percent between 1997 and 2007 compared to approximately 13 percent for all U.S. business establishments. Growth
in the number of h ealthcare facilities has been concentrated in segments of the healthcare sector that have historically been primarily small quantity generators or conditionally exempt small quantity generators of hazardous waste, such as other health practitioners,

10 U.S. Census Bureau, 1997 and 2007 Economic Census. All statistics in this section exclude veterinary clinics, medical
examiners and coroners’ offices, and reverse distributors, for which data are unavailable.

11 U.S. Bureau of Ec onomic Analysis, National Income and Product Accounts, Table 1.1.6, February 29, 2012.30 

### physic ians’ offices, and dentists’ offices. Additionally, over the last decade, continuing care retirement communities have nearly doubled in quantity. On the other hand, the number of hospitals, pharmacies, and nursing care facilities has remained relatively stable since 1997; however, these industries have experienced a significant degree of consolidation in recent years

— meaning there are fewer firms controlling a greater share of the market. For example, since 2004, national or large regional chains have ac counted for more than half of all nursing care facilities in the United States. 12 

### Furthermore, healthcare mergers and acquisitions have increased significantly over the last decade. 13 

### Analysts also expect the Patient Protection and Affordable Care Act to f oster further industry consolidation, as hospitals try to position themselves better to negotiate for insurance contracts and attract physicians. 14 

### Exhibit 2

- 6 illustrates recent market trends in the healthcare industry for selected types of facilities. T he left

- hand axis in each graph shown in the exhibit represents the number of healthcare facilities and firms and the right

hand axis shows annual revenues by NAICS code.

12 Centers for Disease Control, 2004 National Nursing Home Survey

– Facilities, Table 1: Number and Percent Distribution of
Nursing Homes by Selected Facility Characteri stics, 2007. Accessed on July 10, 2012 at
http://www.cdc.gov/nchs/fastats/nursingh.htm

.

13 Galloro, V, Picking Up Speed
, Modern Healthcare; 41(3): 22

- 26, 28

- 31, Jan. 17, 2010.

14 Clark, C. Hospital Deals are Part of Growing Consolidation Trend, Say Analysts , HealthLeaders Media, March 26, 2010.31

EXHIBIT 2

- 6. RECENT ECONOMIC TRENDS 15

15 Data are not available for veterinary clinics in 1997.32

EXHIBIT 2

- 6. RECENT ECONOMIC TREN DS (CONTIUED)33

EXHIBIT 2

- 6. RECENT ECONOMIC TRENDS (CONTINUED)34 UNIVERSE OF FACILITI ES AFFECTED BY THE P ROPOSED RULE

ESTIMATING THE NUMBE R OF HEALTHCARE FACI LITIES AND REVERSE

DISTRIBUTORS THAT GENERATE H A ZARDOUS WASTE 

### Building on the healthcare sector data presented above, this section presents an assessment of the number of facilities likely to be regulated under the proposed rule. As indicated in the previous section, data from the Economic Census suggest that there are approximately 612,600 healthcare facilities in the U.S. Not all of these facilities, however, will be affected by the proposed rule, as many healthcare facilities are not hazardous waste generators. This RIA assumes, however, that all reverse distributors are hazardous waste generators.

To estimate the percentage of healthcare facilities that generate hazardous waste, generator data were examined from several states known to compile data on hazardous waste generators across al l generator classes (i.e., large quantity generators (LQGs), small quantity generators (SQGs), and conditionally exempt small quantity generators (CESQGs)). 16 

### The percentage of healthcare facilities that are hazardous waste generators may be estimated as t he ratio of (1) the number of healthcare facilities identified in state hazardous waste generator data and (2) the number of healthcare facilities located in those states, as estimated from the Economic Census data summarized in the previous section. Equa tion 2

- 1 illustrates this approach.

(2

- 1) P

G 

### = F G
F HC 

### Where P G 

### = percent of healthcare facilities that are hazardous waste generators;

F G 

### = number of healthcare facilities in the state hazardous waste generator data; and

F HC 

### = total number of healthcare facilities in the same state s as reflected in the Economic Census data

While several states provided information , the data from just two state s , Massachusetts
and Minnesota, provide a sufficient level of detail to estimate the percentage of heal thcare facilities that are hazardous waste generators in their state

. 17 

### The re are a similar number of generators in the two states

, approximately 22,000 in Massachusetts and 23, 35 0 in Minnesota. Minnesota provided NAICS and SIC codes for many of these fac ilities, while
Massachusetts did not have NAICS/SIC codes or other industry

- specific information. The data from other states are insufficient for estimating this value because (1) the states do not provide facility

- level data , or (2) the data do not refle ct all generators in a given state (in comparison with the number of facilities reported in the Economic Census)

.

16 S tates contacted include California, Florida, Maine, Massachusetts, Minnesota, New Je rsey, Washington, and Wisconsin.

17 Massachusetts data were obtained from the Massachusetts Office of E nergy and Environmental Affairs Department of

Environmental Protection website at http://www.mass.gov/eea/agencies/massdep/recycle/hazardous/hwgen.html on February 18, 2014. Minnesota data were provided by Kathy Gedde of the Minnesota Pollution Control Agency on October 24,

2012.35 

### Using the two sufficient state data sources

, healthcare facilities that are hazardous waste generators are identified as follows:

1) First, healthcare facilities are identified using existing NAICS codes provided by
Minnesota. 18 

### Massachusetts did not provide NAICS information.

2) Then, for generators that did not have NAICS information, state data are cross

walked with EPA’s RCRAInfo database usi ng unique facility EPA ID numbers to identify healthcare

- related NAICS codes. 19



### 3) For the remaining Massachusetts and Minnesota facilities that did not have
NAICS information or entries in RCRAInfo (mostly CESQGs), a keyword search of facilities names was conducted to identify healthcare facilities using common industry terms. 20



### In applying this methodology , a manual review was performed to exclude facilities that were captured by a keyword search, b ut are not likely to be healthcare facilities (e.g., auto doctor, tree surgery, drug manufacturer). In general, even partially relying on keyword searches to identify healthcare facilities may lead to underestimation of the number of hazardous waste gener ators because keywords are unlikely to identify all healthcare
facilities

. 21 

### For example, a number of facilities use an owner name as the facility name. While some of these hazardous waste generators may be healthcare facilities (e.g., physicians’ offices ), the data suggest that they span a broad range of industries including automotive care, photography, retail, 22 

### wholesale, and household goods repair and
maintenance.

The percentage of healthcare facilities that are hazardous waste generators is then
estim ated by totaling the number in each of the states and dividing this number by the total number of healthcare facilities reported by the 2007 Economic Census for each

18 Minnesota provided NAICS codes for approximat ely 74 percent of generators in the state.

19 Using this method, NAICS codes were identified for approximately one

- third of the generators in Massachusetts, primarily
LQGs and SQGs. NAICS codes were identified for less than 10 additional facilities in Minne sota.

20 The following keywords were used to identify healthcare facilities: hospital, pharmacy, clinic, critical care, dental,
dentist, drug, medical, veterinary/veterinarian, pet/animal care, outpatient, inpatient, surgery, ambulance, ambulatory,
oral, ortho, nursing care, chiropractor, coroner, oncology, periodontics, podiatry, radiology, dermatology, endodontic, and
mammogram. In addition, individual practitioners were identified by titles indicating advanced medical degrees, including:
MD, DDS, DPM, DC, PA, and DR.

21 The Minnesota Pollution Control Agency also noted that in the process of merging data from a few of the Minneapolis/St.
Paul metro counties, the agency may have double counted some currently active SQGs. This may result in an overestimate of
the number of generators; however, the number of facilities potentially affected by this issue is less than 700 of more than
26,000 and less than 20 percent of those are likely to be healthcare facilities.

22 Because retailers were not included in the keyword search, some retailers with pharmacies on site (e.g., Target) may have
been excluded, thereby reducing the number of facilities captured

.36 

### state. 23

, 24 

### Exhibit 2

- 7 summarizes the Massachusetts and Minnesota generator data
relative to the number of healthcare facilities for those states included in the 2007 Economic Census. As indicated in the exhibit, these data suggest that all hospitals in
the se state s generate hazardous waste and that approximately 28 percent of the other
healt hcare facilities in the se state s generate hazardous waste. 25 

### Therefore, an estimated
72 percent of other healthcare facilities in the two states do not generate hazardous waste.

23 For Massachusetts, the analysis excludes generators of state hazardous wastes (i.e., waste oils, paint w astes, & PCBs) that
do not generate RCRA hazardous waste

.

24 For Minnesota, the analysis includes facilities identified as minimum quantity generators (MiniQGs), which are defined by
the state as CESQGs that generate less than 100 pounds of hazardous waste and no acute waste i n a year. Minnesota has two
additional categories: “temporary” and “other” generators. Temporary generators are clean

- up sites that are issued
temporary waste IDs for waste to be shipped off

- site (e.g., a police department has to clean up a meth lab). Temporary sites
are expected to be closed within six months. B ased on communication with Kathy Gedde of the MPCA, 69 healthcare
facilities identified as temporary generators were likely misclassified by the state and should be counted as M iniQGs ; these
facilities are included in the state generator estimate. However, the analysis excludes 183 facilities identified as “other”
generators that manage potentially exempt feedstocks, which are not subject to Federal RCRA requirements.

25 For repor ting purposes, this RIA uses a weighted average estimate suggesting that 27.6 percent of healthcare facilities are
hazardous waste generators based on the Massachusetts and Minnesota data combined in the main body of this report. Later
in the report , sens itivity analyses are presented using the individual estimates for Massachusetts (16.2 percent) and
Minnesota (44.0 percent) separately.37

EXHIBIT 2

- 7. PERCENTAGE OF HEALTH CARE FACILITIES THAT ARE HAZARDOUS W ASTE GENERATORS

STATE

[A] GENERATOR

STATUS

[B] NUMBER OF HAZARDOUS WASTE GENE RATORS
BASED ON STATE DATA U.S. 2007 ECONOMIC
CENSUS DATA PERCENTAGE OF HEALTH CARE
FACILITIES THAT GENE RATE
HAZARDOUS WASTE 1

HOSPITALS

[C] OTHER

HEALTHCARE
FACILITIES [D] TOTAL

NUMBER OF
GENERATORS [E] PERCENTAGE

OF FACILITIES
WITH NAICS 2 [F] HOSPITALS

[G] OTHER

HEALTHCARE
FACILITIES [H] HOSPITALS 3

[I=C/G] OTHER

HEALTHCARE
FACILITIES [J=D/H]

Massachusetts LQG 26 118 523 98.3%
SQG 75 498 2,636 75.0%
CESQG 47 1,388 14,148 30.1%

non

- RCRA 4 N/A N/A 4,703 13.6%

Subtotal 148 2,004 22,010 33.6% 127 12,408 100% 16.2%

Minnesota LQG 22 40 382 99.0%
SQG 36 74 1,366 73.3%
CESQG 82 2,381 12,154 69.2%

Other 5 35 1,334 9,450 78.6%

Subtotal 175 3,829 23,352 73.7% 142 8,703 100% 44.0%

TOTAL 323 5,833 45,362 54.3% 269 21,111 100% 27.6%

Notes:
1. Estimated percentages assume the states maintain a comprehensive list of generators.
2. Includes facilities with state

- reported NAICS codes, NAICS identified using RCRAInfo, and healthcare facilities identified using keyword searches.
3. The number of hospitals identified by both states is greater than the number reported by the Economic Census, which may occur because the state data are more recent. The Economic Census does not provide a list of facility names for comparison.
4. For Massachusetts, generators of state hazardous wastes (i.e., waste oils, paint wastes, & PCBs) that do not generate RCR A hazardous waste are
excluded.
5. For Minnesota, this category includes facilities identified as minimum quantity generators (MiniQGs), which are defined by th e state as CESQGs that generate less than 100 pounds of hazardous waste and no acute waste in a yea r. In addition, the Minnesota Other Healthcare Facility category includes
two additional sub

- categories: “temporary” and “other” generators. Temporary generators are clean

- up sites that are issued temporary waste IDs for waste to be shipped off

- site (e.g., a police department has to clean up a meth lab). Temporary sites are expected to be closed within six months. Based on personal communication with Kathy Gedde of the MPCA, 69 healthcare facilities identified as “temporary” generators were li kely misclassi fied by the state and should be counted as MiniQGs; these facilities are included in the state generator estimate. However, this analysis excludes 183 facilities identified as “other” generators that manage potentially exempt feedstocks, which are not subj ect to Federal RCRA requirements.38 

### E xtrapolating the percentage of healthcare facilities that generate hazardous waste from
the Massachusetts and Minnesota data to the entire U.S. suggests that approximately 174,000 of the 612,600 healthcar e facilities nationwide are hazardous waste generators,
as shown in Exhibit 2

- 8. I t was not possible to estimate the corresponding percentages
for reverse distributors based on the state data. However, b ecause all reverse distributors manage recalled or expired pharmaceuticals, this RIA assumes that all reverse distributors are hazardous waste generators.

While the approach described in this section yields reasonable estimates of the number of
healthcare facilities and reverse distributors that are haza rdous waste generators, it is important to note the uncertainty inherent in this estimate. As described above, this RIA
relies on data from just two states to estimate the percentage of healthcare facilities that are hazardous waste generators nationwide . To the extent that the data from these state s are not representative of the entire U.S., relying on these data may lead to overestimation
or underestimation of the number of healthcare facilities in the U.S. that are hazardous
waste generators.39 EXHIBIT 2

- 8. ESTIMATED NUMBER OF HEALTHCARE FACILI TES AND REVERSE

DISTIRBUTORS THAT AR E HAZARDOUS WASTE GE NERATORS

NAICS [A] FACILITY TYPE

[B] TOTAL NUMBER

OF FACILITIES
IN THE U.S. 1 (FROM EXHIBIT
2

- 1) [C] % OF FACILITIES THAT

ARE HAZARDOUS
WASTE GENERATORS (FROM EXHIBIT 2

- 7) [D] NUMBER OF

FACILITIES THAT
GENERATE
HAZARDOUS
WASTE [E=C × D]

44611 Pharmacies 42,045

27.6% 11,617

54194 Veterinary Clinics 28,400 7,847

6211 Physicians’ Offices 220,131 60,823

6212 Dentists’ Offices 127,057 35,10 6

6213 Other Health

Practitioners 125,063 34,555

6214 Outpatient Care Centers 29,776 8,227

6219 Other Ambulatory Health

Care Services 9,358 2,586

622 Hospitals 6,505 100% 6,505

6231 Nursing Care Facilities 16,320

27.6% 4,50 8

623311 Continuing Care

Retirement Communities 5,939 1,641

Subset of
92219 Medical Examiners and

Coroners’ Offices 2 1,998 552

Various
NAICS Reverse Distributors

(RDs) 3 56 100% 56

TOTAL 612,648 174,02 3

Notes:
1. Data collected from U.S. Census Bureau, 2007 Economic Census (unless otherwise noted).
2. Estimates from Bureau of Justice Statistics, Medical Examiners and Coroners’ Offices, 2004, June
2007.
3. RDs are represented by multiple NAICS codes that include a broad range of industries. RDs were
identified in th e BR database by matching facility names with the names of known RDs identified by the U.S. Drug Enforcement Administration through 2008. These facilities represent at least 85 percent of the market based on data presented in Charlotte Smith’s, "Environme ntal Stewardship of Waste Pharmaceuticals from a Hospital Perspective," presentation at the 2005 meetings of EPA's National Center for Environmental Research, August 24, 2005.40 A SSESSING THE GENERATOR STATUS FOR HEALTHCARE FACIL ITIES AND REVERSE

DISTRIBUTORS THAT GE NERATE HAZARDOUS WAS TE 

### As described in more detail in Chapter 3, the cost impact of the rule for individual healthcare facilities will depend, in part, on their generator statu s under RCRA. To inform assessment of the rule’s cost impacts, this chapter distributes the 174,000 facilities affected by the proposed rule across the LQG, SQG, and CESQG RCRA generator status categories. For reference, Exhibit 2

- 9 describes the generat ion thresholds for the three categories.

EXHIBIT 2

- 9. RCRA SUBTITLE C HAZARDOUS WASTE GENE RATION THRESHOLDS

CESQG SQG LQG

 Less than or equal to 100 kg of hazardous waste per month, and

 Less than or equal to 1 kg of acute hazardous waste per
month.  Greater than 100 kg and less than 1,000 kg of hazardous waste per calendar month, and

 Less than or equal to 1 kg
of acute hazardous waste per month.  Greater than or equal to 1,000 kg of hazardous
waste in a calendar month, or

 Greater than 1 kg of
acute haz ardous waste per month.



### To estimate the distribution of healthcare facilities in the regulated universe across the LQG, SQG, and CESQG categories, this RIA relies on data reported in EPA’s RCRAInfo database. Although RCRAInfo lacks detailed data on every healthcare facility that may be affected by the proposed rule, it d oes include information on a portion of the healthcare facilities for each facility type. In particular, it includes information on the generator status of a number of healthcare facilities across each facility type. T hese RCRAInfo data are extrapolated to estimate the total number of hazardous waste generators in each generator category potentially affected by the rule based on the following approach:

 First, healthcare facilities identified in RCRAInfo as non

- generators and those with an unknown generat or status in RCRAInfo are excluded.

 After excluding non

- generators and those of unknown status from the RCRAInfo data, the percentage of facilities classified as LQGs, SQGs, and CESQGs was estimated for each type of facility. These percentages were then applied to the total number of facilities that are hazardous waste generators. For example, there are 1,989 hospitals in RCRAInfo. Of these, 475, or 23.9 percent, are LQGs. Therefore, of the 6,505 hospitals in the potentially regulated universe, it is
estimated that 23.9 percent, or 1,553 hospitals, are LQGs. 26

26 This approach may potentially overstate the proportion of LQGs because in many cases SQGs and CESQGs are not required
to report information to RCRAInfo. RCRAInfo only includes facilities regulated under RCRA; in comparison, the Economic
Census includes all facilities regardless of whether they are regulated under RCRA.41 

### Based on this approach, Exhibit 2

- 10 summarizes the distribution of LQGs, SQGs, and CESQGs by facility type. 27 

### As indicated in the exhibit, the RCRAInfo data suggest t hat, in aggregate, 83.6 percent of all healthcare facilities and reverse distributors that generate hazardous waste are CESQGs, while 13.4 percent are SQGs and 3.0 percent are LQGs. The types of healthcare facilities with the highest proportion of CESQGs include veterinary clin ics, physicians’ offices, dent ists’ offices, other health practitioners, nursing care facilities, and continuing care retirement communities. Conversely, the health care facility types that have the highest proportion of LQGs are RDs (50 percent), hospital s (24 percent), and medical examiners and coroners’ offices (14 percent). Additionally, hospitals, medical examiners and coroners’ offices, pharmacies, other ambulatory healthcare services, and outpatient care centers have a higher proportion of SQGs rela tive to other healthcare facility types (ranging from 19 to 37 percent). However, in terms of the total number of healthcare facilities, physician’s offices, other health practitioners, and pharmacies account for approximately two

- thirds of all healthcare facilities that are LQGs or SQGs.

27 The data in Exhibit 2

- 10 do not include pharmacies that are located in grocery stores or large retail facilities (e.g.,
Target). The U.S. Census data for pharmacies only include facilities for which NAICS 44611 is reported as the primary NAICS
code for the facility. Larger retailers such as Walmart and T arget are categorized as NAICS 452 (General Merchandise Stores)
and grocery stores are categorized as NAICS 4451. While some general merchandise and grocery store locations have
pharmacies, they are not identifiable in the available data and not all facili ties in NAICS 452 or NAICS 4451have pharmacies.
Therefore, including NAICS 452 or NAICS 4451 in the regulated universe would likely overstate the number of affected

facilities.42

EXHIBIT 2

- 10. NUMBER OF LQG s , SQG s , AND CESQG s IN THE AFFECTED UNIV ERSE BY FACILITY TYP E

NAICS FACILITY TYPE TOTAL
GENERATORS LQG SQG CESQG

% OF
GENERATORS 1 NUMBER OF

FACILITIES % OF

GENERATORS 1 NUMBER OF

FACILITIES % OF

GENERATORS 1 NUMBER OF

FACILITIES

44611 Pharmacies 11,617 5.1% 589 19.5% 2,271 75.4% 8,757

54194 Veterinary Clinics 7,847 2.6% 204 12.1% 951 85.3% 6,692

6211 Physicians’ Offices 60,823 3.7% 2,275 12.1% 7,381 84% 51,167

6212 Dentists’ Offices 35,106 0.1% 44 5.4% 1,890 94.5% 33,172

6213 Other Health Practitioners (e.g.,

chiropractors) 34,555 0.0% 0 15.1% 5,216 85% 29,339

6214 Outpatient Care Centers 8,227 4.7% 388 19.5% 1,602 75.8% 6,237

6219 Other Ambulatory Health Care

Services 2,586 2.5% 65 22.8% 589 74.7% 1,932

622 Hospitals 6,505 23.9% 1,553 36.8% 2,397 39.3% 2,555

6231 Nursing Care Facilities 4,508 1.5% 67 16.4% 740 82.1% 3,701

623311 Continuing Care Retirement

Communities 2 1,641 0.5% 9 5.7% 94 93.7% 1,538

Subset of
92219 Medical Examiners and Coroners'

Offices 552 14.5% 80 31.9% 176 53.6% 296

Various
NAICS Reverse Distributors 56 50.0% 28 12.5% 7 37.5% 21

TOTAL 174,023 3.0% 5,302 13.4% 23,314 83.6% 145,407

Notes:
1. Data from EPA’s RCRAInfo used to the estimate the percentage of facilities that are hazardous waste generators.
2. For NAICS 623311, insufficient data are available to estimate the number of LQGs and SQGs; therefore, this RIA relies on the distribution among these categories for NAICS 6231 and applies this ratio to the total number of non

- CESQG generators in NAICS 623311.43 HAZARDOUS WASTE GENE RATION AMONG HEALTHC ARE FACILITIES AND

REVERSE DISTRIBUTORS



### This section characterizes the amount of hazardous waste generated by healthcare facilities and reverse distributors in the potentially regulated universe. This chapter presents separate generation estimates for overall hazardous waste (pharmaceutical and

non

- pharmaceutical combined) and hazardous waste pharmaceuticals among healthcare facilities and reverse distributors, as both of these unique quantities are important for estimating the cost impacts of the proposed rule. The tonnage of hazardous waste pharmaceuticals is relevant to estimating the cost of managing this waste in accordance with the provisions of the rule, and the tonnage of all hazardous waste will inform assessment of those cost elements dictated by a facility’s RCRA generator status. 28 

### As indicated in Chapter 1, the proposed rule (under the Proposed Option and the Less Stringent Option) excludes hazardous waste pharmaceuticals from being counted toward determining a facility’s generator status, provided the hazardous waste pharmaceutic als are managed according to the provisions of the proposed rule . The generator status of facilities may therefore change from LQG to SQG or from SQG to CESQG under the
rule . In more extreme cases, generator status may change from LQG to CESQG.

The methodology for estimating the quantities of pharmaceutical and total hazardous waste generation varies by facility type due to limitations in the available data. Where possible, this RIA relies on generation data from EPA’s 2009 Biennial Report (BR) database. First, the BR database is used to develop annual aggregate and per facility generation estimates for LQG hospitals and LQG reverse distributors. In order to make use of some limited data to estimate the amount of hazardous waste generated accor ding to hospital size, EPA did a statistical analysis to understand the relationship between hospital characteristics and the quantities of hazardous waste pharmaceuticals they produce. For all other types of facilities, however, the data available from t he BR database are, alone, insufficient to develop nationwide hazardous waste generation estimates. Consequently, for SQGs and CESQGs, generation estimates are derived by extrapolating from facility

- level generation data obtained from the states of Maine, Minnesota, and New Jersey. 29 

### For LQGs other than hospitals and RDs, this RIA uses data from these states in conjunction with data from the 2009 BR.

The remainder of this chapter describes the steps used to estimate hazardous waste generation at healthcar e facilities and reverse distributors, as follows:

28 For the purposes of this report, “ tons ” are U.S. short tons (1 ton = 2,000 pounds).

29 As indicated above, data from Maine and New Jersey are not comprehensive enough to estimate the percentage of
healthcare facilities that are hazardous waste generators. More specifically, it is not possible to identify all healthcare

facilities in the Ma ine and New Jersey data because they lacked NAICS/SIC codes. Based on keyword searches, however, a
portion of the healthcare facilities were identified in the data from these states. Because data on all healthcare facilitie s is
not necessary to derive an approximation of per facility hazardous waste generation, the Maine and New Jersey data are

include d in the sample of facilities in order to have a more robust data set with which to estimate the average amount of
hazardous waste generated per healthcare facility.44 

### 1. Hazardous waste generation data available in EPA’s BR database are analyzed to assess their suitability to inform assumptions regarding hazardous waste generation for facilities potentially affected by the rule.

2. The BR data are used in conjunction with information from the American Hospital Directory (AHD) database to estimate hazardous waste generation quantities on a per facility basis for LQG hospitals. 30



### 3. The BR data are also used to estimate hazardous waste generation for LQG reverse distributors on a per facility basis.

4. Data provided by the States of Maine, Minnesota, and New Jersey, in combination with the BR data or independently, are used to estimate hazardous waste generation on a per facility basi s for other facilities potentially affected by the rule (i.e., non

- LQG hospitals and reverse distributors and facilities other than hospitals and reverse distributors).

5. Finally, the aggregate hazardous waste generation quantities of potentially
affected fa cilities are estimated by applying the per facility estimates described in this chapter to the facility counts presented in Exhibit 2

- 10.

HAZARDOUS WASTE GENE RATION REPORTED IN T HE BR DATABASE


### EPA’s 2009 BR database is the primary data source for estimatin g hazardous waste generation (pharmaceuticals and otherwise) for LQG hospitals and LQG reverse distributors, and serves as one of several data sources for estimating generation among other LQGs affected by the rule. Facilities that are considered LQGs und er RCRA are required to report on the generation and management of their hazardous waste on a biennial basis. The BR database is the Agency’s primary repository for the information reported by these facilities. SQGs and CESQGs are not subject to Federal reporting requirements, but may be required to submit the biennial data in states with more stringent reporting requirements. With respect to hazardous waste pharmaceuticals, the database includes generation and management data provided by reporting facil ities; however, only a small fraction of the facilities likely to be affected by the proposed rule submit biennial reporting data. This reflects the fact that SQGs and CESQGs are not subject to the Federal reporting requirements and that non

- compliance wi th these reporting requirements may exist among LQGs.

Another limitation of this database is that it does not include a systematic and consistent approach for identifying a wastestream as hazardous waste pharmaceuticals. While there
are some RCRA waste co des for listed hazardous waste pharmaceuticals, this represents a small subset of the drugs considered hazardous waste when disposed. Therefore, identifying hazardous waste pharmaceuticals in the BR database requires a close
examination of each wastestrea m generated by a healthcare facility.

30 American Hospital Directory. a ccessed at http://www.ahd.com/ on April 12, 2012.45 

### To identify wastestreams likely to be hazardous waste pharmaceuticals in the BR database, this RIA examines reporting by healthcare facilities and follows the three

- step approach outlined below:

1. Identify wastestreams g enerated that are unlikely to be pharmaceutical wastes. As an initial step in identifying those wastestreams generated by healthcare facilities that are likely to be pharmaceuticals, this approach first identifies those that most likely are not pharmaceuti cal wastes, such as remediation wastes, solvent wastes, and lead

- containing equipment. Appendix A documents the approach for identifying these wastestreams.

2. Filter based on information in description field: After removing wastestreams from the inventory b ased on Step 1, this approach examines the remaining wastestreams to determine whether they are likely to be pharmaceuticals. Wastestreams with any of the following terms in the description field in the BR data are assumed to be pharmaceuticals:

a. Pharma

b. Me dic 31



### c. Dental

d. Vaccine

e. Antiseptic

f. Hydrogen peroxide

3. Filter based on waste codes: Waste streams with any of the waste codes listed in
Exhibit 2

- 11 are also assumed to be pharmaceuticals.

F or reverse distributors, only the first step in this process applies. The written descriptions of wastestreams provided by reverse distributors are much more detailed than the descriptions provided by other facilities, including information on the specifi c pharmaceuticals in their wastestreams. A review of these wastestreams suggests that most of the reverse distributor wastestreams remaining after Step 1 above are pharmaceuticals with two exceptions: (1) compressed gases and (2) contaminated paper
and cl othing. These categories are therefore excluded from the inventory of hazardous wastestreams that include pharmaceuticals. While a small proportion of compressed gases may also be hazardous waste pharmaceuticals (e.g., general anesthesia), there are

not sufficient data to distinguish these wastestreams from others.

31 Excluding wastestreams for medical equipment (e.g., mercury).46 EXHIBIT 2

- 11. WASTE CODES FOR SELECT HAZARDOUS WAS TE PHARMACEUTICALS

HAZARDOUS WASTE CODE

 P001

– Warfarin  U121

– Trichloromonofluromethane

 P012

– Arsenic Trioxide  U122

– Formaldehyde

 P046

– Phentermine  U129

– Lindane

 P075

– Nicotine  U132

– Hexachlorophene

 P188

– Physostigmine Salicylate  U150

– Melphalan

 P204

– Physostigmine  U151

– Mercury

 U010

– Mitomycin C  U182

– Paraldehyde

 U015

– Azaserine  U187

– Phenacetin

 U034

– Chloral  U188

– Phenol

 U035

– Chlorambucil  U200

– Reserpine

 U044

– Chloroform  U201

– Resorcinol

 U058

– Cyclophosphamide  U205

– Selenium Sulfide

 U059

– Daunomycin  U206

– Streptozotocin

 U075

– Dichlorodifluoromethane  U237

– Uracil Mustard

 U089

– Diethylstilbestrol  U248

– Warfarin

Notes: Warfarin is listed twice under EPA’s hazardous waste codes, as an acute hazardous waste (p

listed) and as a toxic waste (u

- listed).



### Exhibit 2

- 12 shows total hazardous waste and hazardous waste pharmaceuticals generation by facility type as reported in the BR database. Nationwide, LQGs are required to submit BR records to EPA. Some states also require SQG and/or CESQG facilities to submit hazardous waste generation information to the State, which is also reported to EPA. 32 

### Therefore, the BR data represent a sample of facilities that include LQGs, SQGs, and CESQGs. BR data for SQGs and CESQGs, however, are extremely limited. Therefore, this RIA relies on the BR data only for LQGs. As described below,
these data are used to inform assumptions regarding hazardous waste generation on a per facility basis for LQGs. As shown in Exhibit 2

- 12, hospitals and RDs represent the only industries for which the BR contains data for more than 10 percent of the estimated number of potenti ally affected LQG facilities ( 249 of 1,553 LQG hospitals and 11 of 28 reverse distributors). 33 

### Based on this level of reporting, the BR data alone could support an analysis of waste generation and management at LQG hospitals and LQG RDs, but not
for other types of facilities likely to be affected by the proposed rule. The small percentage of hospitals and RDs reporting data for the BR suggests a lack of compliance with baseline rules regarding the management of hazardous waste pharmaceuticals. This

32 The following 13 states and the District of Columbia require SQGs and/or CESQGs to submit biennial reports of their
hazardous waste generation activity: AK, DC, IN, MD, MT, NH, ND, OR, PA, RI, SC, VT, VA, and WV.

33 LQG f acility counts are from Exhibit 2

- 10.47 

### led EP A to conduct a sensitivity analysis with an assumption of less than full baseline compliance. For details, see the sensitivity analysis for the partial compliance baseline in Chapters 3 and 4.

The data reported in Exhibit 2

- 12 are used to inform two key assumptions that are used in the report. First, the data in Column C are used to estimate the average quantity of
overall hazardous waste generated per LQG facility. 34 

### Second, the data in Column F and Column H are used to estimate the percentage of total hazardous waste comprised of hazardous waste pharmaceuticals, shown in Exhibit 2

- 13. This percentage is applied to the per facility estimates of hazardous waste generation (for LQGs, SQGs, and CESQGs) to develop per facility generation estimates for haza rdous waste pharmaceuticals. This percentage is based on data for only those facilities that reported on the generation of hazardous waste pharmaceuticals (as opposed to all of the healthcare facilities in the BR)

. As described earlier in this document, many facilities that generate hazardous waste pharmaceuticals (as determined through the three

- step process above) are likely not to be in compliance with RCRA in their management of these wastes. Thus, it is likely that many of the healthcare facilities that do not report any hazardous waste pharmaceuticals generation in the BR (again, as determined through the three

- step process above) are under

- reporting due to non

- compliance. 35 

### Due to this potential for under

- reporting

among non

- compliant facilities, this RIA concludes that the data for those healthcare facilities known to generate hazardous waste pharmaceuticals would provide a more reliable estimate of the percentage of hazardous waste made up of hazardous waste pharmaceuticals.

34 For LQGs other than hospitals and reverse distributors, the BR data were used in conjunction with data obtained from the
states of Maine, Minnesota, and New Jersey, as described below.

35 Personal communication with Selin Hoboy, Stericycle, August 6, 2012 and personal communication with Phil Retallick and
John Kelsey of Clean Harbors, April 16, 2012.48

EXHIBIT 2

- 12. 2009 BIENNIAL R EPORT HAZARDOUS WAST E GENERATION DATA BY FACILITY TYPE (IN TO NS)

NAICS [A] FACILITY TYPE

[B] ALL HEALTHCARE FACIL ITIES HEALTHCARE FACILITIE S THAT REPORT GENERA TING
HAZARDOUS WASTE PHAR MACEUTICALS

TOTAL
HAZARDOUS
WASTE 1 [C] ACUTE

HAZARDOUS
WASTE [D] NUMBER OF

FACILITIES
IN 2009 BR
DATABASE [E] TOTAL

HAZARDOUS
WASTE [F] ACUTE

HAZARDOUS
WASTE [G] HAZARDOUS

WASTE
PHARMA

CEUTICALS [H] ACUTE

HAZARDOUS
WASTE
PHARMA

CEUTICALS [I] NUMBER OF

FACILITIES
IN 2009 BR
DATABASE [J]

44611 Pharmacies 41.28 13.96 4 13.96 13.96 13.96 13.96 1

54194 Veterinary Clinics 87.60 0.02 5 14.47 0.02 0.57 0.00 1

6211 Physicians’ Offices 30.89 3.07 7 23.63 1.97 4.15 1.96 5

6212 Dentists’ Offices

- - 0

- - - - 0

6213 Other Health Practitioners

(e.g., chiropractors) - - 0

- - - - 0

6214 Outpatient Care Centers 97.10 5.98 12 68.15 5.98 11.43 4.16 9

6219 Other Ambulatory Health

Care Services 10.00 1.19 2 10.00 1.19 1.19 1.19 2

622 Hospitals 3,592.14 649.67 249 2,648.12 630.15 818.26 568.87 170

6231 Nursing Care Facilities 2.13 0.00 1

- - - - 0

623311 Continuing Care

Retirement Communities - - 0

- - - - 0

Subset
of 92219 Medical Examiners and

Coroners’ Offices 108.67 0.10 11

- - - - 0

Various
NAICS Reverse Distributors 498.43 207.88 11 498.43 207.88 469.97 207.88 11

TOTAL 4,468.24 881.86 302 3,276.76 861.14 1,319.53 798.03 199

Notes:
1. “

- ” indicates data are unavailable.49 

### The BR data summarized in columns F, G, and I of Exhibit 2

- 12 are also used to estimate the percentage of hazardous waste made up of acute hazardous waste and the percentage made up of acute hazardous waste pharmaceuticals. These percentages are applied t o the per facility hazardous waste generation estimates for LQGs to estimate the generation quantities of acute hazardous waste and acute hazardous waste pharmaceuticals among these facilities. Due to data limitations, acute hazardous waste generation qua ntities are not estimated separately from other hazardous waste for SQGs or CESQGs, though acute hazardous waste is reflected in this RIA’s overall hazardous waste generation estimates
for these facilities.

Exhibit 2

- 13 presents estimates of the percenta ge of overall hazardous waste generation comprised of hazardous waste pharmaceuticals by facility type. As indicated in the exhibit, the proportion comprised of hazardous waste pharmaceuticals is, on average, 94.3 percent for RDs, 30.9 percent for hospita ls, and 24.0 percent for other types of healthcare facilities. The exhibit also presents the corresponding percentages for acute hazardous waste and acute hazardous waste pharmaceuticals for LQGs.

EXHIBIT 2

- 13. OVERALL HAZARDOU S WASTE GENERATION S CALING FACTORS

FACILITY TYPE PERCENTAGE OF OVERAL L HAZARDOUS WASTE CO MPRISED OF:

HAZARDOUS WASTE
PHARMACEUTICALS 2 ACUTE HAZARDOUS
WASTE (FOR LQG s ) 3 ACUTE HAZARDOUS
WASTE
PHARMACEUTICALS (FOR LQG s ) 3
Hospitals 1 30. 9 % 23. 8 % 21. 5 %

RDs 94.3% 41.7% 41.7%

Other Healthcare Facilities (excluding Hospitals and RDs) 2 4

. 0 % 17.7 % 16.3 %

Notes:
1. Percentages do not add up to 100 percent across the columns because the categories are not mutually exclusive.
2. Values applied to LQGs, SQGs, and CESQGs.
3. Values applied to LQGs only. Insufficient data available to distinguish between acute and

non

- acute hazardous waste for SQGs and CESQGs.

LQG HOSPITAL HAZARDO US WASTE GENERATION


### For hospitals considered to be LQGs under RCRA, this RIA relies on the BR data to estimate hazardous waste generation quantities (overall generation and hazardous waste pharmaceuticals only) for different types of hospitals. Specifically, the analysis loo ks at healthcare facility characteristics that may be correlated with hazardous waste generation. Information on these characteristics is gathered from the AHD database. 36 

### The AHD database contains information on more than 6,000 hospitals from public and private sources, such as Medicare claims data, hospital cost reports, and commercial licensors.

36 American Hospital Directory. Accessed at http://www.ahd.com/ on April 12, 2012.50 

### Key statistics from the database include: number of beds, gross patient revenues, discharges, patient days, and teaching status. 37



### This RIA considers these char acteristics in its assessment of hazardous waste generation among LQG hospitals but not among other types of facilities affected by the rule because of the richness of the data available for hospitals relative to other facilities. In addition,
as presente d below, although hospitals account for just 3.7 percent of regulated facilities, they account for approximately 24 percent of hazardous waste pharmaceuticals generation.

In order to make use of some limited data to estimate the amount of hazardous waste

g enerated according t o hospital size

, EPA did a statistical analysis to understand the relationship between hospital characteristics and the quantities of hazardous waste pharmaceuticals they produce. Exhibit 2

- 14 reports the correlation coefficients betwe en the hospital characteristics outlined above and hazardous waste generation quantities. As indicated in the exhibit, hazardous waste generation is correlated with each of the explanatory variables describing hospital characteristics. 38 

### The statistical r esults are categorically similar, although just slightly weaker, when considering hazardous waste pharmaceuticals instead of total hazardous waste. Therefore, only one set of results is reported. Appendix E provides additional detail on a regression

- base d approach for estimating hazardous waste generation for LQG hospitals.

Based on the statistically significant correlation values summarized in Exhibit 2

- 14 , this RIA uses a series of “model hospitals” as the basis for estimating the generation of
overal l hazardous waste and hazardous waste pharmaceuticals among LQG hospitals. There are two motivating factors for using a model facility approach over a regression

based estimation approach: (1) because the regression results are based on data for LQG hospi tals and may not be applicable to SQG and CESQG hospitals, EPA would need information on the generator status of all hospitals in the AHD data to identify LQGs (EPA can only confidently match data for a subset of hospitals in the AHD to the BR database, so it is useful to use a model facility approach); 39 

### a nd (2) there is a high

- degree of multicollinearity among the regressors in the statistical analysis so the coefficient estimates are highly sensitive to small changes in the model and the data (thus, given the lack of stability in the model parameters, EPA is more confident using the model facility

approa ch). For SQG and CESQG hospitals, a different approach is outlined later in this

37 Teaching status is defined as either a ctive involvement in ACGME

- accredited specialty and sub

- specialty programs or
membership in the Council of Teaching Hospitals and Health Services. Sources: Accreditation Council for Graduate Medical
Education database (ACGME), American Medical Association, 2011 and Association of American Medical Colleges, Division of
Health Care Affairs, Council of Teaching Hospitals, 2012.

38 Correlation coefficients can range from

- 1 to1, with positive values representing a direct linear relationship and negative

values r epresenting an inverse linear relationship. Values closer to 1 (or

- 1) indicate that variables are strongly correlated,
while values closer to 0 indicate weak or no linear correlation. Levels of statistical significance, while related to the

correlation co efficient, are also dependent on the standard deviation and sample size.

39 Applying the results of the regression

- based approach to all hospitals would likely overestimate the hazardous waste
generation of SQG and CESQG hospitals.51 

### chapter. The estimated generation of hazardous waste for LQG model hospitals is based
on the LQG hospital data for all states included in the BR database. The generation

es timates for each model hospital are applied to the corresponding number of LQG hospitals in the regulated universe.

EXHIBIT 2

- 14. CORRELATION ANA LYIS OF HAZARDOUS WA STE GENERATION AND H OSPITAL
CHARACTERISTICS 1

HAZARDOUS
WASTE
GENERATION REVENUES DISCHARGES PATIENT
DAYS BEDS TEACHING
STATUS

HW GENERATION 1

REVENUES 0.5420*** 1

DISCHARGES 0.5656*** 0.8588*** 1

PATIENT DAYS 0.5441*** 0.8596*** 0.9452*** 1

BEDS 0.5302*** 0.8367*** 0.9118*** 0.9635*** 1

TEACHING
STATUS 0.2754*** 0.3259*** 0.3620*** 0.3705*** 0.3540*** 1

Notes: ***Significant at the 99% level
1. Hazardous waste generation quantities are not normally distributed (based on the Shapiro

- Wilk test for normality) due to outliers in the data, which may cause the magnitude of the correlation coefficients to be underestimated. As a sensitivity analysis, the n th root of hazardous waste generation is
calculated for several values of n in order to ac hieve a more normal distribution (e.g., the fourth root of hazardous waste generation is approximately normally distributed) and to compute correlation
coefficients. At each value of n , the coefficients increased and the levels of statistical significance improved, suggesting stronger relationships between hazardous waste generation and each of the explanatory variables if the normality of the distribution is taken into consideration.



### LQG model hospitals are defined based on (1) their teaching status and (2) the number of beds at each hospital. 40 

### As discussed in greater detail below, on average, teaching hospitals generate significantly more hazardous waste than non

- teaching hospitals. In addition, hazardous waste generation tends to increase with the num ber of hospital beds per facility. 41 

### Data from the AHD database indicate that approximately 27 percent of all hospitals in the U.S. are teaching hospitals and that the median number of beds per

40 The cost analysis in Chapter 3 also uses facility size (i.e., small or large) to define model facilities. This variable is n ot
used in this chapter because it does not affect hazardous waste generation. For example, generation is the same for the

small SQG hospital as for the large SQG hospital.

41 The statistical analysis for hospital hazardous waste generation yielded similar correlation coefficients (ranging from 0.53
to 0.57) for revenues, discharges, patient days, and the number of beds. Because the number of beds is likely to be the most
stable over time relative to the other variables, bed count was used to define the set of model hospitals rather than the

other variables.52 

### hospital for LQG hospitals (identified in the BR database) is 370. The AHD data also suggest that the vast majority of non

- teaching hospitals have less than 370 beds. Therefore, all non

- teaching hospitals are estimated to have less than 370 beds . For teaching hospitals, this RIA contemplates three categories based on the number of hospital beds: below the 50th percentile (less than 370 beds), the 50th to the 90th percentile (370 to 799 beds), and the top 10 percent (800 beds or more). Thus, fou r model hospitals are specified: three model teaching hospitals and a single LQG model hospital to represent all hospitals that are not teaching hospitals.

To estimate the number of hospitals within each type of model hospital, this RIA uses the
followin g approach:

1. First, it is assumed that all hospitals in the top two categories in terms of hazardous waste generation (i.e., all teaching hospitals with 370 or more beds) are LQGs. Based on this assumption and the bed count data in the AHD database, this a pproach estimates that the universe of hospitals in the U.S. includes 480 teaching hospitals with 370 to 799 beds and 82 teaching hospitals
with 800 or more beds.

2. Given that the regulated universe includes 1,553 LQG hospitals (see Exhibit 2

- 10) and that th e two largest model hospitals represent 562 hospitals (see Step 1), the two smaller model hospitals (i.e., non

- teaching hospitals and teaching hospitals with less than 370 beds) account for 991 hospitals across the U.S. To estimate the number of hospitals represented by each of these smaller model hospitals, the distribution of hospitals across these two categories is assumed to be proportional to their representation in the BR database. Within the BR database, the analysis identified 80 hospitals with fe wer than 370 beds: 34 non

teaching hospitals and 46 teaching hospitals. Based on this ratio and the number of LQG hospitals not represented by one of the two largest model hospitals (i.e., 991 hospitals), the population of U.S. hospitals is estimated to include 421 LQG

non

- teaching hospitals and 570 LQG teaching hospitals with less than 370 beds (e.g., 34/80 × 991 = 421 hospitals).

Exhibit 2

- 15 describes annual average hazardous waste generation per facility for LQG model hospitals based on the BR data. The generation of acute hazardous waste, hazardous waste pharmaceuticals, and acute hazardous waste pharmaceuticals are estimated using the scaling factors from Exhibit 2

- 13. It is important to note that some hospitals may have relatively low total hazard ous waste generation quantities and attain their LQG generator status due to their generation of acute hazardous waste rather than their generation of overall hazardous waste.53 EXHIBIT 2

- 15. ANNUAL HAZARDOU S WASTE GENERATION P ER FACILITY FOR

MODEL LQG HOSPITALS (TONS)

HAZARDOUS WASTE GENERATION (TONS) NON

TEACHING
HOSPITALS TEACHING HOSPITALS 1

LESS THAN
370 BEDS 370 TO 799

BEDS 800 OR MORE

BEDS

Total Hazardous Waste 4. 68 8.50 23. 71 41.65

Acute Hazardous Waste 1.11 2.02 5.64 9.91

Hazardous Waste
Pharmaceuticals 1.45 2.63 7.33 12.87

Acute Hazardous Waste
Pharmaceuticals 1.01 1.83 5.09 8.95

Number of LQG Hospitals 421 570 480 82

Proportion of LQG Hospitals 27.1% 36.7% 30.9% 5.3%

Notes:
1. Excludes data for the Mayo Clinic Psychiatry and Psychology Treatment Center in Rochester, MN; this facility is co

- located and affiliated with Saint Mary’s Hospital and Rochester Methodist Hospital. This facility has approximately 100 beds, but most patients are treated on an outpatient basis. While this hospital generates large quantities of hazardous waste pharmaceuticals, it may not be representative of other hospitals of a similar size due to its unique management and integrated operations with each of the co

- located hospitals.

LQG REVERSE DISTRIBUTOR HAZARDOU S WASTE GENERATION


### This RIA also relies on the BR data to estimate hazardous waste generation for RDs that are LQGs. Among the industries potentially affected by the rule, RDs are second only to hospitals in terms of hazardous waste ge neration reported in EPA’s BR database. Even though only 11 RDs reported to EPA, these facilities collectively generated approximately 500 tons of hazardous waste in 2009. From the waste descriptions in the BR database, this RIA estimates that approximat ely 94.3 percent of this waste is hazardous waste pharmaceuticals and 41.7 percent is acute hazardous waste pharmaceuticals. Based on these data from the BR database, Exhibit 2

- 16 reports the mean hazardous waste generation quantities for LQG RDs on a per facility basis. Generation estimates for SQG and CESQG RDs are presented later in this chapter.54 EXHIBIT 2

- 16. ANNUAL HAZARDOUS WASTE GENERATION PER

FACILITY FOR LQG REV ERSE DISTRIBUTORS (TONS)

CATEGORY HAZARDOUS WASTE GENERATION (TONS)

Total Hazardous Waste 45.31

Acute Hazardous Waste 18.90

Hazardous Waste Pharmaceuticals 42.72

Acute Hazardous Waste
Pharmaceuticals 18.90

Number of RDs in BR database 11

HAZARDOUS WASTE GENE RATION BY OTHER FACI LITY TYPES (NON

- LQG HOSPITALS

AND REVERSE DISTRIBU TORS, ALL OTHER HEAL THCARE FACILITIES)



### Due to the limited information in the BR database for healthcare facilities other than LQG hospitals and RDs, this RIA does not rely solely on the BR data for estimation of
hazardous wast e generation. Instead, for CESQGs and SQGs, this RIA relies on facility

level data collected from Maine, Minnesota, and New Jersey. 42 

### For LQGs other than hospitals and RDs, data from these states are used in conjunction with data from the BR.
Exhibit 2

- 17 provides a summary of the data collected from the three states. Some of the states provided data on facilities outside of the heal thcare sector; however, Exhibit 2

- 17 reports data only for healthcare facilities. To use the state data, this RIA took the following steps:

 First, healthcare facilities were identified using NAICS/SIC codes or a keyword search of facility names;

 Second, generation quantities were converted to a standard unit of measurement (tons) and scaling factors from Exhibit 2

- 13 were applied to estimate the amounts of overall hazardous waste and hazardous waste pharmaceuticals generated by each facility. As indicate d in Exhibit 2

- 17, the Minnesota data include facility

level generation estimates only for hazardous waste pharmaceuticals. To estimate overall hazardous waste generation for the Minnesota facilities, the pharmaceutical generation estimates for these faci lities were divided by the percentage of hazardous waste made up of hazardous waste pharmaceuticals, as presented in Exhibit 2

- 13. Equation 2

- 2 summarizes this approach.

42 Email communication with Kathy Gedde, Minnesota Pollution Control Agency, on October 17, 2012; Email communication
with Mike Hastry, New Jersey Department of Environmental Protection, on October 19, 2012; Email communication with

Che r rie Plummer, Maine Department of Environmental Protection, on October 26, 2012.55 EXHIBIT 2

- 17. HAZARDOUS WASTE GENERATOR DATA COLLE CTED FROM SELECT

STATES

STATE NUMBER OF

HEALTHCARE
FACILITIES WITH
GENERATION DATA 1,2 SUMMARY OF GENERATIO N DATA
AMONG HEALTHCARE FAC ILITIES

Maine Total: 85

LQG: 11 SQG: 7 CESQG: 67  Maine’s data reflect overall hazardous waste (HW) generation among healthcare facilities; generation amounts for HW pharmaceuticals were not provided.

 Avg. 5.12 tons of overall HW for LQGs

 Avg. 2.06 tons of overall HW for SQGs

 Avg. 0.16 tons of overall HW for CESQGs

Minnesota Total: 244

LQG: 27 SQG: 37 CESQG: 180  Minnesota’s data reflect generation of HW pharmaceuticals for healthcare facilities; overall HW generation amounts were not provided.

 Avg. 3.06 tons of HW pharmaceuticals for LQGs

 Avg. 0.74 tons of HW pharmaceuticals for SQ Gs

 Avg. 0.03 tons of HW pharmaceuticals for CESQGs

New Jersey Total: 44

LQG: 0 SQG: 7 CESQG: 37  New Jersey’s data reflect overall HW generation for healthcare facilities; generation amounts for HW pharmaceuticals were not provided.

 Avg. 2.33 tons of overall HW for SQGs

 Avg. 0.47 tons of overall HW for CESQGs

 No data for LQGs

TOTAL Total: 373

LQG: 38 SQG: 51 CESQG: 284  Generation not summed because some states provide generation estimates for all HW and others provide estimates only for HW pharmaceuticals.

Notes:
1. This exhibit includes data only for healthcare facilities.
2. In cases where the overall HW generation quantity exceeds a generator status threshold (e.g., a facility that generates more than 13.22 tons per year or 1,000kg/month is an LQG under RCRA) and the state data indicate otherwise, this RIA assumes the facilit y should have the higher generator status. This may occur in the data because the generator status data lag the generation quantity data (i.e., in one year a facility may be an SQG, but the next year generate a greater amount of HW and become an LQG; howev er, the state database does not immediately record this change in status).56 

### (2

- 2) W haz 

### = W pharm

p



### Where W

haz 

### = generation of all hazardous waste, by facility;

W pharm 

### = generation of hazardous waste pharmaceuticals, by facility, and

p = percent of hazardous waste made up of hazardous waste pharmaceuticals. The values for p are reported in Exhibit 2

- 13.

In contrast to the Minnesota data, the data from Maine and New Jersey include estimates of overall hazardous waste generation by facility. To de velop estimates
of hazardous waste pharmaceuticals generation for these facilities, the total hazardous waste generation estimates for these facilities were multiplied by the percentage of hazardous waste made up of hazardous waste pharmaceuticals, as

summ arized by Equation 2

- 3.

(2

- 3) W pharm 

### = W haz 

### × p

Where, W

pharm 

### , W

haz 

### , and p are as defined above.

 Finally, facilities were grouped according to their generator status, as indicated by the data provided by the states. In most cases, the generator status indicated by the state was used. However, in cases where the overall hazardous waste generation quantity exceeds a generator status threshold (e.g., a facility that generates more than 13.22 tons per year or 1,000kg/month is an LQG under RCRA) and the state indicated a lower generator status, this RIA assumes the facility should have the higher generator status.

After following the steps above to derive overall generation and hazardous waste pharmaceuticals generation estimates for the 373 facilitie s in the Maine, Minnesota, and New Jersey datasets, these data were used to develop per facility generation estimates for CESQGs, SQGs, and LQGs other than hospitals and reverse distributors. Estimates for each facility type were derived as follows:

CESQG s. 284 CESQGs were identified in the Maine, Minnesota, and New Jersey datasets. On average, these facilities generate 0.17 tons of hazardous waste per year. As
indicated in Exhibit 2

- 13, 30.8 percent of hazardous waste generated by hospitals is made

up of pharmaceuticals and the corresponding figures for reverse distributors and other healthcare facilities are 94.3 percent and 22.4 percent, respectively. Applying these values to the 0.17 tons of hazardous waste generated by CESQGs annually, this RIA

est imates annual hazardous waste pharmaceuticals generation of 0.05 tons for hospitals, 0.16 tons for reverse distributors, and 0.04 tons for other healthcare facilities.

SQGs. Across the Maine, Minnesota, and New Jersey datasets, 51 SQGs were identified.
B ased on the data for these facilities, it is estimated that SQG healthcare facilities, on average, generate 2.49 tons of hazardous waste per year. Applying the hazardous waste pharmaceuticals percentages from Exhibit 2

- 13 to this value, this RIA estimates annual57 

### hazardous waste pharmaceuticals generation of 0.77 tons per year for SQG hospitals, 2.34 tons for SQG reverse distributors, and 0.56 tons for other SQG healthcare facilities.

LQGs (excluding hospitals and reverse distributors). To estimate annual generation for LQGs other than hospitals and reverse distributors, this RIA relies on the state data
summarized in Exhibit 2

- 17 as well as data from the 2009 BR database. The BR data
includes records for 42 LQG healthcare facilities (o ther than hospitals and RDs), and the data provided by Maine and Minnesota include 11 and 27 LQGs, respectively. Eight of the LQGs in the Maine data, however, are hospitals, and 21 of the LQGs in the Minnesota data are also hospitals. This leaves three L QGs for Maine and six for Minnesota. Of these nine LQGs, one (in Minnesota) is already included in the 2009 BR data and is therefore excluded to avoid double counting, leaving three LQGs for Maine and five for Minnesota. Combined with the BR data, this y ields a dataset of 50 LQGs. Based on the data for these facilities, this RIA estimates annual hazardous waste generation of 9.03 tons for LQGs other than hospitals and reverse distributors. Applying the percentages
from Exhibit 2

- 13 to this value, the ty pical LQG (excluding hospitals and RDs) is estimated to generate 2.17 tons of hazardous waste pharmaceuticals on an annual basis,
1.60 tons of acute hazardous waste, and 1.47 tons of acute hazardous waste pharmaceuticals.

HAZARDOUS WASTE GENE RATION PER FAC ILITY ACROSS ALL FAC ILITY TYPES


### Based on the information presented in the previous sections, Exhibit 2

- 18 presents this RIA’s estimates of hazardous waste generation on a per facility basis for all facility types affected by the rule. As the exhibit shows , hazardous waste generation quantities are estimated for 12 types of facilities. The estimates presented in the exhibit include those
derived from the data collected from the states as well as those derived from the 2009 BR data. As noted above, the gen eration of acute hazardous waste was estimated only for LQGs, as insufficient data were available for SQGs and CESQGs.

The data in the exhibit show that generation for hazardous waste overall and hazardous waste pharmaceuticals is highest, on a per facilit y basis, for large teaching hospitals and reverse distributors and, as expected, smallest for CESQGs. Also, within the SQG and CESQG categories, per facility generation of hazardous waste pharmaceuticals is highest
for reverse distributors. The data in t he exhibit also suggest that hazardous waste generation among LQGs is lowest for non

- teaching LQG hospitals.58 EXHIBIT 2

- 18. ANNUAL HAZARDOUS WASTE GENERATED ON A PER FACILITY BASIS ( TONS)

GENERATOR
STATUS FACILITY TYPE TOTAL
HAZARDOUS
WASTE ACUTE

HAZARDOUS
WASTE HAZARDOUS

WASTE
PHARMCEUTICALS ACUTE
HAZARDOUS
WASTE
PHARMCEUTICALS

LQG Hospitals, non

- teaching 4.68 1.11 1.45 1.01

Hospitals, teaching, less than 370 beds 8.50 2.02 2.63 1.83
Hospitals, teaching, 370 to 799 beds 23.71 5.64 7.33 5.09
Hospitals, teaching, 800 beds or more 41.65 9.91 12.87 8.95

Reverse Distributors 45.31 18.90 42.72 18.90

Other healthcare facilities (excluding hospitals and RDs) 9.03 1.60 2.17 1.47

SQG Hospitals

2.49 0.77

Reverse Distributors 2.34

Other healthcare facilities (excluding hospitals and RDs) 0.60

CESQG Hospitals

0.17 0.05

Reverse Distributors 0.16

Other healthcare facilities (excluding hospitals and RDs) 0.0459 AGGREGATE GENERATION OF HAZARDOUS WASTE AMON G FACILITIES POTENTI ALLY

AFFECTED BY THE RULE


### Using the per facility generation quantities reported above, the aggregate annual tonnage of hazardous waste and hazardous waste pharmaceuticals was estimated by multiplying these values by the number of healthcare facilities affected by the proposed rule nationwide. This RIA estimates that approximately 139,000 tons of hazardous waste

, including approximately 36,200 tons of hazardous waste pharmaceuticals

, is generated by
healthcare facilit ies annually. By comparison, EPA ’s National Biennial Report estimates that approximately 35 million tons of hazardous waste was generated in the United States
in 2009. 43 

### Exhibit 2

- 19 summarizes hazardous waste generation by facility type, and
Exhibit 2

- 20 presents hazardous waste generation by generator status (i.e., LQG, SQG, and CESQG). 44 

### The values reported in both exhibits represent the average estimates for aggregate annual hazardous waste generation.

As indicated in Exhibit 2

- 19, this RIA estimates that the generation of hazardous waste pharmaceuticals is highest among hospitals, physicians’ offices, and other health practitioners. For the latter two, this reflects that while hazardous waste generation is relatively low at these facilities on a per facility basis

— approximately 85 percent are CESQGs

— they constitute more than half of the total number of generators affected by the rule. In contrast, while hospitals and reverse distributors account for a small percentage of the potentially affected fac ilities, they account for a significantly larger proportion of hazardous waste pharmaceuticals generated on an annual basis. As
indicated in Exhibit 2

- 20, this RIA estimates that SQGs and LQGs combined account for more than 80 percent of hazardous waste p harmaceuticals, although they account for just 16 percent of generators in the potentially affected universe.

43 U.S. EPA, The National Biennial RCRA Hazardous Waste Report (based on 2009 data), accessed at
http://www.epa.gov/epawaste/inforesources/data/br09/national09.pdf on July 10, 2013. Note that the quantity presented
in the Biennial Report likely represents an underestimate due to under

- reporting of hazardous waste pharmaceuticals.

44 Appendix B presents estimates by facility type and generator status.60 EXHIBIT 2

- 19. AGGREGATE ANNUAL HAZARDOUS WASTE PHAR MACEUTICALS

GENERATION BY FACILI TY TYPE FOR ALL FACI LITIES (TONS)

NAICS FACILITY TYPE NUMBER OF
FACILITIES TOTAL HAZARDUOS

WASTE 1,2 HAZARDOUS WASTE

PHARMACEUTICALS 2
44611 Pharmacies 11,617 12,400 2,990

54194 Veterinary Clinics 7,847 5,330 1,280

6211 Physicians’ Offices 60,823 47,500 11,400

6212 Dentists’ Offices 35,106 10,700 2,570

6213 Other Health

Practitioners (e.g., chiropractors) 34,555 17,900 4,300

6214 Outpatient Care

Centers 8,227 8,530 2,050

6219 Other Ambulatory

Health Care Services 2,586 2,380 570

622 Hospitals 6,505 28,000 8,650

6231 Nursing Care

Facilities 4,508 3,070 740

623311 Continuing Care

Retirement
Communities 1,641 570 140

Subset of
92219 Medical Examiners

and Coroners’ Offices 552 1,210 290

Various
NAICS Reverse Distributors 56 1,290 1,220

TOTAL 174,023 139,000 36,200
Notes:
1. Estimates may not sum due to rounding.
2. Estimates reflect acute and non

- acute hazardous waste (pharmaceuticals).

EXHIBIT 2

- 20. HAZARDOUS WASTE PHARMACEUTICALS GENERATION BY GENERA TOR

STATUS (TONS)

GENERATOR
STATUS NUMBER OF

FACILITIES TOTAL

HAZARDO U S
WASTE 1 ,2 ACUTE

HAZARDOUS
WASTE HAZARDOUS WASTE

PHARMACEUTICAL S 2 ACUTE
HAZARDOUS
WASTE
PHARMACEUTIALS LQG 5,302 56,500 11,600 15,900 10,700 SQG 23,314 58,000 N/A 14,400 N/A
CESQG 145,407 24,500 N/A 5,920 N/A

TOTAL 174,023 139,000 11,600 36,200 10,700

Notes:
1. Estimates may not sum due to rounding.
2. These estimates reflect both acute and non

- acute hazardous waste (pharmaceuticals).61 

### CHAPTER 3 | ASSESS MENT OF COSTS

INTRODUCTION


### This chapter assesses the costs of managing hazardous waste pharmaceuticals under baseline conditions and under the provisions set forth in the three regulatory options outlined in Chapter 1. Based on the estimated costs for the baseline and each regulatory option, this chapter al so reports the costs of each option incremental to the baseline. The assessment of costs in this chapter begins with specification of the baseline against which this RIA estimates the costs of each regulatory scenario. The chapter then provides a
detaile d description of the methodology for the cost analysis. This includes discussion of EPA’s approach for estimating costs based on the limited facility

- level data summarized in Chapter 2 and identification of the variables likely to have the most significan t impact on costs. Based on these methods, the chapter presents the total annualized costs under the baseline scenario and each policy option. The chapter concludes with a discussion of analytic limitations.

BASELINE SPECIFICATI ON



### OMB Circular A

- 4 direct s Federal agencies to specify a baseline that represents their “best assessment of the way the world would look absent the proposed action.” 45 

### As indicated in Chapter 2, however, the available data on the universe of facilities and quantity of hazardous w aste pharmaceuticals affected by the rule are extremely limited. Similarly, information on the management of these wastes is also limited. To comply with RCRA requirements, healthcare facilities and reverse distributors may dispose of hazardous waste pha rmaceuticals by incinerating them in a permitted hazardous waste incinerator or by sewering them and notifying their publicly owned treatment works (POTW) under the domestic sewage exclusion. Comprehensive information on the extent
to which facilities rel y on each management method is not readily available. In addition,
information from industry experts suggests that many facilities may currently not be in compliance with RCRA in their management of these wastes. 46 

### For example, many facilities may be sewe ring their hazardous waste pharmaceuticals without notifying their local POTW or by discarding them with medical waste or municipal solid waste (MSW).

T his RIA’s assessment of the proposed rule’s cost impacts examines costs incremental to a full compliance baseline , which assumes all facilities manage their hazardous waste pharmaceuticals in compliance with existing RCRA regulations. However, t o address

45 U.S. Office of Management and B udget, Circular A

- 4, September 17, 2003.

46 For additional detail, see the discussion in the sensitivity analysis for the partial compliance baseline at the end of this
chapter.62 

### uncertainty regarding the baseline management of hazardous waste pharmaceuticals, this
RIA also presents the cost of the proposed rule incremental to a partial compliance
baseline as a sensitivity analysis . The partial compliance baseline reflects the likelihood that many facilities may not manage their hazardous waste pharmaceuticals in a manner
consistent with RCRA requirements. Assessing impacts incremental to these two distinct baselines is consistent with OMB guidance in Circular A

- 4, which states, “When more than one baseline is reasonable and the choice of baseline will significantly affect
estimated benefits and costs, you should consider measuring benefits and costs against
alternative baselines.” 47 

### The se sensitivity analyses and associated results are covered later in this chapter.

Under the full compliance baseline, facilities affected by the rule are assumed to be in complete compliance with all RCRA requirements. These requirements differ for expired, recalled, and otherwise unused pharmaceuticals sent to reverse distributors for manufacturer credit versus partially used patient care pharmaceuticals discarded by hospitals and other healthcare facilities. Because the former are not yet discarded, they are not considered solid wastes under RCRA and are therefore not subject to RCRA requirements for the management of hazardous waste. In contrast, patient care pharmaceuticals that are discarded by healthcare facilities and that meet the RCRA hazardous waste criteria (i.e., are either listed hazardous wastes or exhibit one or more of
the characteristics of a hazardous waste

— ignitability, corrosivity, reactivity, and toxicity) are considered solid wastes and must be managed in compliance with RCRA. The exception to this is hazardous waste pharmaceuticals generated by nursing care facil ities and continuing care retirement communities. These facilities are considered households under RCRA and are therefore not subject to RCRA regulations in the baseline . In addition, pharmaceuticals discarded by a reverse distributor that meet the hazar dous waste criteria are also considered to be solid waste and must be managed in compliance with RCRA regulations. This RIA’s key assumptions for the full compliance baseline are
as follows: 48



###  Reverse distributors: Although a significant portion of the haz ardous waste pharmaceuticals sent to a reverse distributor are subsequently sent to another reverse distributor, this RIA assumes that these wastes are ultimately managed through hazardous waste incineration.

 SQG and LQG healthcare facilities: Pharmacy was te generated by SQG and LQG healthcare facilities is assumed to be sent to a reverse distributor and subsequently incinerated. For patient care hazardous waste pharmaceuticals generated by these facilities, this RIA assumes that some percentage is sewered (as described below) after facilities notify their local wastewater treatment plant,
while the remainder is incinerated.

47 OMB, Circular A

- 4, September 17, 2003, p. 15.

48 This information is presented in greater detail later in Exhibit 3

- 9.63 

###  CESQG healthcare facilities: Similar to SQG and LQG healthcare facilities, pharmacy waste generated by CESQG healthcare facilities is assumed to be sent to a reverse distributor and subsequently incinerated. Patient care hazardous waste pharmaceuticals generated by CESQG healthcare facilities are split between three management metho ds: sewering with notification , MSW disposal,
and incineration. This RIA assumes that facilities that do not incinerate and are located in states that allow CESQGs to dispose of their hazardous waste as M SW
would choose this second option. Currently, 58 percent of healthcare facilities are located in states that allow MSW disposal. 49 

### All remaining patient care hazardous waste pharmaceuticals generated by CESQGs are assumed to be
incinerated.

COST METHODOLOGY



### This section presents the methods employed in this RIA to assess the cost impacts of the proposed rule. To provide context for the presentation of these methods, this section begins by outlining the scope of cost impacts examined in this RIA. The discussion of methods then describes the use of model facilities for the assessment of cost impacts. Following this description, the methods discussion outlines the key assumptions reflected in several components of the cost analysis. A detailed acc ounting of the unit costs associated with the waste management activities affected by the rule is then presented. For each activity, this section describes differences in requirements between the baseline and each of the three regulatory options, and also presents unit cost values that inform the assessment of costs for each scenario (including the baseline).

SCOPE OF COST IMPACT S EXAMINED



### A priori , the proposed rule could result in either an increase in costs or a cost savings for facilities that genera te hazardous waste pharmaceuticals. In the first case, the proposed rule could increase the waste management costs of facilities because it includes new restrictions on the management of hazardous waste pharmaceuticals (e.g., they may no longer be sewered ). Alternatively, the proposed rule could reduce pharmaceutical waste generators' management costs for activities for which the rule requirements are less stringent than baseline requirements. Facilities may also experience cost savings for the

49 This RIA assumes that CESQGs can manage HW pharmaceuticals as MSW in States that do not ban the disposal of liquid
waste in MSW landfills. These states include Alabama, Alaska, Arizon a, Delaware, the District of Columbia, Florida, Georgia,
Hawaii, Idaho, Indiana, Iowa, Kansas, Maryland, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey,
New York, North Dakota, Oklahoma, Oregon, South Carolina, South Dakota, Tenness ee, Texas, Utah, Vermont, Virginia,
Washington, and Wyoming. This list was derived from (1) White, M., Health and Safety Annex CESQGs, WAAC Newsletter,
September 1998, Volume 20, Number 3, available at http://cool.conservation

- us.org/waac/wn/wn20/wn20

- 3/wn20

-
306.html ; (2) Arkansas Department of Environmental Quality, Overview of Regulatory Requirements for Hazardous Waste
Generators in Arkansas, accessed at http://www.adeq.st ate.ar.us/hazwaste/branch_ie/hwgen.htm on July 10, 2013; (3)
Communication with Kristin Fitzgerald of EPA ’s Office of Resource Conservation and Recovery on December 12, 2012; and (4)
Northeast Recycling Council, prepared for ReCommunity, Disposal Bans & Ma ndatory Recycling in the United States, June 24,
2011. The count of facilities in the states identified from these sources was developed based on data from the 2007

Economic Census.64 

### managemen t of hazardous wastes other than pharmaceuticals if their RCRA generator status (i.e., LQG, SQG, or CESQG) changes as a result of the rule. Because the management requirements with which a generator must comply depend heavily upon the facility’s generator status, a change in status could affect a facility’s management costs
for all of its hazardous waste.

To illustrate the potential savings associated with a change in generator status, consider a hospital that generates 700 pounds of non

- acute, non

- pharmac eutical hazardous waste in a given calendar month, but also generates 10 pounds of acute hazardous waste pharmaceuticals (e.g., warfarin waste

– RCRA waste code P001). Under current regulations, the hospital would be considered an LQG because it generates more than 1 kg ( 2.2 pounds ) of acute hazardous waste per month. If the hospital were to manage its hazardous waste pharmaceuticals separately, however, its generator status would change from LQG to SQG under the Proposed Option and the Less Stringent Opt ion. Due to this

re

- classification, the hospital's management costs for its non

- pharmaceutical waste would likely decline. It is important to note, however, that t his chapter assesses the incremental costs of the proposed rule. Potential cost savings are discussed in Chapter 4 along with other benefits of the proposed rule.

To develop comprehensive estimates of the rule’s cost impacts that reflect the various regulatory provisions outlined in Chapter 1

, as well as the potential for cost savings, this

R IA estimates costs for a range of waste management activities that may be affected by the rule. These activities and a summary of the baseline requirements for each are as
follows:

 Notification: Under RCRA Subtitle C, facilities are required to notify E PA and obtain an EPA ID number prior to managing hazardous wastes.

 Training: Facilities are required to conduct training to ensure employees are familiar with proper waste handling and emergency procedures. LQGs are also required to develop training

- rel ated documents and maintain records on

- site for three years.

 Manifest Training: LQG and SQG staff must be trained to complete hazardous
waste manifests.

 Contingency Plan Updating: LQGs are required to prepare a contingency plan
for hazardous waste

- rel ated emergencies, designate an emergency coordinator, and coordinate with local response agencies. These facilities must also review, update, and distribute the contingency plan annually.

 Container Management: Hazardous wastes must be stored in containe rs that are structurally sound and compatible with the contained wastes. Additionally, incompatible wastes must not be placed in the same container, and containers must be closed while in storage except when adding or removing waste.
Facilities that sewe r their hazardous waste pharmaceuticals are assumed not to purchase containers to manage their hazardous wastes.

 Labeling/Marking: All containers in primary accumulation areas must be
marked with the words “Hazardous Waste” and the accumulation start dat e.65 

### Additionally, containers in satellite accumulation areas must be marked as hazardous waste, while the accumulation start date begins when the container is full or moved to the primary storage area.

 Inspections: LQGs and SQGs are required to conduct we ekly inspections of all hazardous waste storage areas, except for satellite accumulation areas.

 Warehousing (Secure Facility): While no specific security provisions are required under RCRA, facilities are responsible for the safe storage of hazardous

wast e pharmaceuticals and the prevention of any related accidents while wastes
are stored on

- site.

 Closure: Under RCRA Subtitle C, LQGs are required to develop a closure plan to close container storage areas in a manner that meets the RCRA closure
standard an d ensure proper disposal or decontamination of equipment, structures,
and soils.

 RCRA Storage Permit: Although some healthcare facilities and reverse distributors may have RCRA Part B storage permits, there are no RCRA storage permit requirements in the baseline. 50



###  Sorting: Facilities must separate hazardous waste pharmaceuticals from nonhazardous pharmaceutical waste for appropriate disposal.

 Biennial Reports: LQGs are required to submit biennial reports of their hazardous waste generation activity t o EPA or their state environmental protection authority.

 Recordkeeping: LQGs and SQGs are required to maintain records of waste characterizations for three years from the date the last waste was sent off site.

 Manifests: A manifest for each hazardous w aste shipment from LQGs and SQGs must be prepared and maintained for three years.

 Transportation: Hazardous waste generators must arrange for their waste to be transported to a facility for appropriate management (if it cannot be managed onsite at the generating facility). Under RCRA Subtitle C, waste generated by an LQG or an SQG must be transporte d by a licensed hazardous waste transporter.

 Disposal: LQG and SQG generators of hazardous waste pharmaceuticals must dispose of these materials by sending them to a hazardous waste incineration 51 

### unit or by sewering them and notifying their local POTW (un der the domestic sewer exclusion). 52 

### CESQGs may manage their hazardous waste

50 As described in Chapter 1, a RCRA storage permit is required of reverse distributors under the More Stringent Option.

51 Dan Twomey, MEDEP Air Bureau Section Chief/Chemist PowerPoint Presentation entitled Pharmaceutical and Personal Care
Product (PPCP) Test Burn Results from the NEWMOA webinar was on Feb 12, 2015 and is in the docket for the proposed
pharmaceuticals rule. This presentation provides some information on incineration.

52 Under RCRA requirements, arsenic trioxide waste must be managed through stabilization and disposal in a hazardous waste

landfill. Due to the lack of readily available data on this hazardous waste pharmaceutical, this RIA does not estimate
disposal costs specific to arsenic trioxide. These costs, however, are likely to be the same under the baseline and the66 

### pharmaceuticals as MSW under Federal regulations, but many states restrict this practice.

MODEL FACILITY APPRO ACH


### To assess the cost impacts of the rule, this RIA uses a model facility approach in which costs are estimated for a limited number of representative facilities and then extrapolated to the full universe of facilities affected by the rule. While this RIA would ideally examine costs individually for each affected facil ity, the data necessary for a facility

specific assessment of costs are not readily available, as discussed in Chapter 2. In the absence of such data, this RIA uses the limited data that are available to specify 16 representative model facilities, which a re defined according to three variables:

1. Baseline RCRA generator status. The stringency of the RCRA requirements related to storage, transportation, and other hazardous waste management activities varies with the RCRA generator status of facilities. Beca use these requirements affect facilities’ waste management costs, this RIA includes generator status in its specification of model facilities.

2. Industry . The cost impacts of the rule for a given facility are likely to depend on
the amount of hazardous was te pharmaceuticals that it generates, and generation per facility is likely to vary by industry. The availability of data on the generation of hazardous waste pharmaceuticals, however, also varies by industry. As indicated in Chapter 2, the readily avail able sources on hazardous waste generation for the healthcare sector include data for several hospitals and reverse distributors, but more limited data for facilities in other segments of the
healthcare sector.

Drawing from the relatively detailed data ava ilable for hospitals and reverse distributors, this RIA uses model facilities specific to these industries. Among LQG hospitals, model facilities are also specified according to the number of beds at a hospital and a hospital’s teaching status, as outline d in Chapter 2. For all other industries affected by the rule (i.e., healthcare facilities other than hospitals), the available generation data cover a limited number of facilities in each sector. Thus, it was not possible to specify industry

- specific mo del facilities for these industries (e.g., sufficient data were not available to specify a model facility for physicians’ offices). In the absence of these detailed data, this RIA estimates costs for model facilities representing “other healthcare facilit ies” that encompass all healthcare facilities other than hospitals.

3. Facility size. The costs of several RCRA requirements, including training and inspections, depend in part on the physical size and complexity of a facility.
Since data on the size of f acilities in the regulated universe are unavailable, this RIA relies on the Small Business Administration’s (SBA) Table of Small Business Size Standards to estimate, by industry, the proportion of regulated

various policy options, so there are no i ncremental costs associated with the disposal of arsenic trioxide under each policy
option.67 

### facilities owned by firms that qualify as a small business under the SBA standards. This is used as a proxy for the percentage of small facilities in the regulated universe (in terms of their size and complexity). 53 

### SBA’s size standards, which are usually stated in terms of the number of employees or

av erage annual revenues, indicate the largest size firm that would be classified as a small business for SBA and Federal contracting programs. The definition of “small” varies by industry. For example, the size standard for hospitals is $34.5
million in an nual revenues, while the size standard for dentists’ offices is $7.0
million. 54 

### Size standards apply to the firm level; no such criteria ex ist for
individual facilities.

This RIA assumes that all facilities owned by large firms are large facilities and
all facilities owned by small firms are small facilities. This may overstate or understate the actual percentage of small facilities in the regulated universe. Based on industry input, this RIA assumes that reverse distributors that are SQGs or CESQGs are s mall facilities because the reverse distributor market

— and their overall hazardous waste generation

— is heavily concentrated among a relatively small number of LQGs. 55 

### All LQG reverse distributors are therefore assumed to be large.

This RIA estimates the co st impacts of the proposed rule for each representative model facility defined according to these characteristics. The number of facilities associated with each model facility was derived using data from the 2007 Economic Census, the American Hospital Dir ectory, and the SBA’s Table of Small Business Size Standards. 56 

### To estimate annual costs under each baseline and policy scenario, the per

- facility costs for each model facility were applied to all of the facilities represented by each model facility.

Exhib it 3

- 1 describes each representative model facility categorized according to the variables described above and reports the number of actual facilities represented by each model facility. The exhibit also reports the mean generation of hazardous waste phar maceuticals for each representative model facility based on information collected from the BR database and a limited number of states, as described in more detail in Chapter 2.

53 SBA’s Table of Small Business Size Standards is available at http://www.sba.gov/con tent/table

- small

- business

- size

standards , accessed on February 4, 2012.

54 The reported thresholds are based on SBA’s Table of Small Business Size Standards effective November 5, 2010.

55 Communication with Charlotte Smith of Waste Management Healthcare Sol utions on August 2, 2012.

56 U.S. Census Bureau, 2007 Economic Census; American Hospital Directory, accessed at http://www.ahd.com/ on April 12,
2012; SBA, Table of Small Business Size Standards, available at http://www.sba.gov/content/table

- small

- business

- size

standards, accessed on February 4, 2012.68 EXHIBIT 3

- 1. MODEL FACILITIES FOR ASSESSMENT OF CO ST IMPACTS

BASELINE
GENERATOR
STATUS INDUSTRY FACILITY
SIZE NUMBER OF

FACILITIES
REPRESENTED BY
MODEL FACILITY MEAN GENERATION OF
HAZARDOUS WASTE
PHARMACEUTICALS (TONS PER YEAR)
CESQG Hospitals Small 836 0.05

CESQG Hospitals Large 1,719 0.05

CESQG Other healthcare facilities Small 123,957 0.04

CESQG Other healthcare facilities Large 18,874 0.04

CESQG Reverse Distributors Small 21 0.16

SQG Hospitals Small 785 0.77

SQG Hospitals Large 1,612 0.77

SQG Other healthcare facilities Small 18,147 0.60

SQG Other healthcare facilities Large 2,763 0.60

SQG Reverse Distributors Small 7 2.34

LQG Other healthcare facilities Large 3,721 2.17

LQG Reverse Distributors Large 28 42.72

LQG Non

- teaching hospitals Large 421 1.45

LQG Teaching hospitals, less

than 370 beds Large 570 2.63

LQG Teaching hospitals, 370 to

799 beds Large 480 7.33

LQG Teaching hospitals, 800 or

more beds Large 82 12.87

TOTAL 174,023 Not Applicable

Source : The values reported in this exhibit were derived from data obtained from several sources. These
include U.S. Census Bureau, 2007 Economic Census; American Hospital Directory, accessed at http://www.ahd.com/ on April 12, 2012; SBA, Table of Small Business Size Standards, available at http://www.sba.gov/content/table

- small

- business

- size

- standards , accessed on February 4, 2012; EPA, 2009 Biennial Report Database; Email communication with Kathy Gedde of the Minnesota Pollution Control Agency, on October 17, 2012; Email communication with Mike Hastry of the New Jersey Department of Environmental Protection on October 19, 2012; and Email communicatio n with
Che r rie Plummer of the Maine Department of Environmental Protection on October 26, 2012.69 GENERAL ASSUMPTIONS


### The assessment of costs presented in this chapter relies upon several assumptions that
influence the estimated costs of managing hazardous waste pharmaceuticals in the baseline and under the policy options under consideration by EPA. Some of these assumptions affect several components of the analysis. These include assumptions regarding (1) how hazardous waste pharmaceuti cals are managed, (2) the containers in which these wastes are stored and disposed of, (3) the exemption of certain facilities from RCRA in the baseline, (4) hourly labor costs that determine the costs associated with the various provisions of the rule, an d (5) the discount rate. These assumption s are outlined
in detail below.

Hazardous Waste Pharmaceuticals Management


### As described above, this RIA assumes that generators of hazardous waste pharmaceuticals manage patient care hazardous waste pharmaceuticals (i.e., discarded patient care pharmaceuticals) and pharmacy waste separately. Specifically, this RIA
assumes that hazardous waste pharmaceuticals generated by retail, hospital, or other pharmacies are sent to reverse distributors for (potential) manufact urer credit and that all patient care hazardous waste pharmaceuticals are disposed of. Based on input provided by a waste management firm that serves the healthcare industry, approximately 20 percent of hazardous waste pharmaceuticals generated by hospita ls are pharmacy waste rather than patient care waste. 57 

### This RIA applies the 20 percent value to all hospitals. In addition, according to the U.S. Economic Census, approximately 7 percent of “other healthcare facilities” are pharmacies, which are assumed to generate no patient care hazardous waste pharmaceuticals. 58



### The assessment of costs in this RIA also accounts for the shipment of hazardous waste pharmaceuticals between reverse distributors. As outlined in Chapter 1, some of the requirements of the r ule for reverse distributors differ for hazardous waste pharmaceuticals shipped from reverse distributors to treatment, storage, and disposal facilities (TSDFs) versus pharmaceuticals sent between reverse distributors. Based on input provided by a reverse distributor representative, this RIA assumes that approximately 65 percent of hazardous waste pharmaceuticals from reverse distributors are shipped between reverse distributors before being transported to the manufacturer or a
TSDF. 59



### Consistent with curre nt generator requirements under RCRA, the policy options considered in this RIA would allow CESQGs to manage their hazardous waste pharmaceuticals as MSW. Several states, however, either: (1) require that CESQGs send their waste to a TSDF; (2) prohibit th e disposal of liquid wastes in MSW landfills; or (3) prohibit the disposal of pharmaceuticals in MSW landfills. 60 

### Facilities in states that do

57 Personal communication with John Kelsey of Clean Harbors on August 17, 2012.

58 The 7 percent figure was derived from U.S. Census Bureau, 2007 Economic Census.

59 Personal communication with Charlotte Smith of Waste Management Healthcare Solutions on January 8, 2013.

60 States that ban the disposal of hazardous waste pharmaceuticals in MSW landfills include: Arkansas, California, Colorado,
Connecticut, Illinois, Kentucky, Louisiana, Maine, Massachusetts, Minnesot a, New Hampshire, New Mexico, North Carolina,70 

### not include any of these restrictions account for approximately 58.4 percent of the regulated universe. 61 

### Thus, t his RIA assumes that 58.4 percent of the hazardous waste pharmaceuticals generated by CESQGs may be managed as MSW under the policy options included in this RIA.

Container Types and Capacity


### This RIA relies on information from waste management firms that serve the healthcare industry to estimate the type and capacity of containers used to manage hazardous waste pharmaceuticals. Generally, facilities are assumed to collect patient care pharmaceutical
waste in reusable 18

- gallon drums, which are stored in s atellite storage areas. The wastes collected in these drums are then brought to primary storage areas where they are sorted and placed into 55

- gallon drums, which are then transported to disposal sites and
incinerated. This RIA assumes that full 55

- gallo n drums hold approximately 250 pounds of hazardous waste pharmaceuticals per drum, while partially

- filled 18

- gallon drums hold approximately 25 pounds per drum prior to being consolidated into 55

- gallon drums. 62


### Furthermore, this RIA assumes that facilitie s need to maintain a sufficient number of containers to manage all of their hazardous waste pharmaceuticals that are not being sewered. With respect to transportation, the RIA assumes that a standard 18

- wheeler trailer can carry up to eighty 55

- gallon dru ms. 63

Household Hazardous Waste Exemption


### Household waste, including hazardous household waste, is exempt from Federal hazardous waste regulations and liability under RCRA. Under current regulation, nursing care facilities and continuing care retirement c ommunities are considered to be households and therefore are not subject to RCRA regulation. When counted as generators, these facilities would account for approximately 3.7 percent of LQGs, 4.0 percent of SQGs, and 2.0 percent of CESQGs within the “other healthcare facility” model
facilities shown in Exhibit 3

- 1.

Hourly Labor Costs


### Many of the unit costs presented later in this chapter reflect the time required of technicians, attorneys, and other staff for various hazardous waste management activities.

Ohio, Pennsylvania, Rhode Island, West Virginia, and Wisconsin. This list was derived from (1) White, M., Health and Safety
Annex CESQGs, WAAC Newsletter, September 1998, Volume 20, Number 3, available at http: //cool.conservation

us.org/waac/wn/wn20/wn20

- 3/wn20

- 306.html; (2) Arkansas Department of Environmental Quality, Overview of Regulatory
Requirements for Hazardous Waste Generators in Arkansas, accessed at
http://www.adeq.state.ar.us/hazwaste/branch_ie/hwgen .htm on July 10, 2013; (3) Communication with Kristin Fitzgerald
of EPA on December 12, 2012; and (4) Northeast Recycling Council, prepared for ReCommunity, Disposal Bans & Mandatory
Recycling in the United States, June 24, 2011.

61 This value is based o n data from the 2007 Economic Census.

62 Correspondence with John Kelsey of Clean Harbors on September 17, 2012.

63 J. Wideberg, E. Dahlberg, and M. Svensson, Study of Stability Measures and Legislation of Heavy Articulated Vehicles in

Different OECD Countri es, University of Seville, KTH, and Scania, May 2006. Available at:
http://www.mne.psu.edu/ifrtt/ConferenceProceedings/ISHVWD_9_2006/docs/p dfs/session%206/s6

- 2%2090.pdf

.71 

### The costs associated with this time are estimated as a function of the hourly labor costs associated with various professional and clerical positions. Exhibit 3

- 2 reports the mean hourly labor costs for the personnel working in the healthcare sector and other personnel, including lawyers and office clerks, who will likely implement the requirements associated with the proposed rule. The hourly costs in the exhibit reflect unloaded hourly wages reported by BLS based on a full time employee working 40 hou rs a week. These hourly wage rates are adjusted for fringe benefits (e.g., insurance, disability income protection, retirement benefits, sick leave, vacation, etc.) using a factor of approximately
1.4. 64 

### They are also adjusted to include overhead costs us ing a factor of approximately
1.336. 65

64 The BLS fringe benefit cost factor is 39.92 percent ($8.71/hour total benefits ÷ $21.82/hour total wages and salary =
0.3992) for Health Services professionals.

65 Loaded labor rates are adjusted to include 2 percent general and administrative overhead, 16.6 percent fixed overhead, 5
percent insurance, and 10 percent profit (1 + 0.02 + 0.166 + 0.05 + 0.10 = 1.336) estimated using RACER cost estimating

software 2005 defaults. General and administrative cost overhead can include expenses such as human resources, payroll,
accounting, sales personnel, executive salaries, legal fees, office supplies, equipment, communications, administrative
buildings, office space, trave l, subscriptions, and other overhead items related to administrative activities that support
operating labor. Fixed overhead can include a proportion of the cost of building services (e.g., medical, safety, recreation
, general engineering, general plant m aintenance, janitorial, and cafeteria), electricity, heating, interplant transportation,
warehouses, shipping and receiving facilities, insurance, and other resources shared throughout the organization in support
of operating labor.72 EXHIBIT 3

- 2. HOURLY LABOR COS TS

BLS OCCUPATION CATEO GRY MEAN LOADED HOURLY
LABOR COST ($2011) 1,2,3,4 Medical and Health Services Managers $78.73
Registered Nurses $62.10

Miscellaneous Healthcare Practitioner and Technical Workers $48.97
Office Clerks, General $28.88

Lawyers $108.26

Source:
1. Bureau of Labor Statistics, National Compensation Survey: Occupational Earnings in the United States, 2010; Occupational Earnings Tables: United States, December 2009

– January 2011, Table 4: Full

- time Private Industry Workers: Mean and Median Hourly, Weekly, and Annual Earnings and Mean Weekly and Annual Hours. http://www.bls.gov/ncs/ocs/sp/nctb1 478.pdf

. 2. Fr inge benefit cost factor calculated from Bureau of Labor Statistics, Employer Costs for Worker Compensation, released March 14, 2012. Table 10: Employer Costs per Hour Worked for Employee Compensation and Costs as a Percent of Total Compensation: Private Workers, by Industry Group, December 2011. http://www.bls.gov/news.release/ecec.t10.htm

. 3. Overhead loading factor calculated from Remedial Action Cost Engineering and Requirements (RACER) cost e stimating software 2005 defaults.
4. Inflation factor based on December 2011 cost index using Bureau of Labor Statistics, Employment Cost Index Historical Listing Current

- dollar March 2001

– June 2012, Table 1: Employment Cost Index for Total Compensation, by Occupational Group and Industry (Seasonally Adjusted).

Discount Rates


### In estimating the costs of managing hazardous waste pharmaceuticals, this RIA uses a discount rate of 7 percent to annualize one

- time costs (e.g., notification). This RIA also presents the estimated costs of the proposed rule using a discount rate of 3 percent as part
of the sensitivity analysis near the end of this chapter.

UNIT COST VALUES


### This section describes the unit costs associated with each of the waste management
acti vities presented above for each representative model facility. For each activity, unit costs are estimated for the baseline and each of the three policy options under consideration by EPA. 66

Notification



### Baseline: Under RCRA Subtitle C, LQGs and SQGs are required to notify EPA and obtain an EPA ID number prior to managing hazardous wastes. Specifically, facilities are

66 In addition to the it ems outlined below, the rule also contains provisions related to the management of fully dispensed
pharmaceuticals containers that are not RCRA empty. A container that has held an acute hazardous waste is not considered

to be RCRA empty unless it meets on e of the requirements in 40 CFR 261.7(b)(3). Due to the lack of data readily available on
these containers, the costs of these provisions are not estimated in this RIA.73 

### required to complete and submit EPA Site ID Form 8700

- 12. This RIA estimates one

time notification costs of $53.05 per facility, while the subsequent re

- notification costs are estimated at $36.89 per facility. 67 

### These one

- time costs are annualized over a 20

- year period, assuming a 20

- year gap between notifications. Facilities that submit biennial
reports o f their hazardous waste generation activity to EPA or state authorities

— all LQGs and SQGs located in states with BR reporting requirements for SQGs

— are in compliance with the notification requirements in the baseline. To avoid double

- counting, these costs are presented in a later section o f the RIA describing the rule provision related to biennial
reports. N o additional facilities are estimated to notify for the first time (or re

- notify) in
the baseline due to the 20

- year gap between notifications and the baseline notification exemptions f

or long

- term care facilities and CESQGs. Therefore, this RIA does not
estimate any notification costs in the baseline.

Policy Options: Under each of the regulatory options, LQGs, SQGs, and CESQG RDs and LQG, SQG healthcare facilities would have to submit a one

- time notification that they are operating under the proposed rule. (See 40 CFR 266.502(a) for healthcare
facilities and 40 CFR 266.510(a)(1) for RD’s) . This represents a new one

- time notification cost for generators that did n ot previously have to notify in the baseline, including (1) nursing care facilities and continuing care retirement communities formerly qualifying for the household exemption in the baseline and (2) CESQGs operating as
reverse distributors. This RIA estim ates that these facilities would incur a one

- time notification cost of $53.05 per facility (or $5.01 on an annualized basis).

Facilities that previously notified in the baseline would also have to notify that they are operating under the proposed rule. Facilities that submit biennial reports o f their hazardous waste generation activity to EPA or state authorities would comply with this requirement by submitting a BR after the promulgation of the proposed rule. However, SQGs healthcare facilities and RDs located in states that do not require biennial reporting for SQGs would be required to submit a one

- time notification under the proposed rule within 60 days . Since these facilities have already compiled the information necessary to comply with notificati on requirements in the baseline, EPA estimates that the one

- time
notification cost would be similar to the re

- notification burden described above . Thus, this RIA estimates that SQGs that do not submit biennial reports to EPA or state
authorities would inc ur a one

- time notification cost of $36.89 per facility (or $3.48 on an annualized basis).

Training



### Baseline: Under the baseline, LQGs and SQGs are required to conduct annual employee training. There are no training requirements for CESQGs. Exhibit 3

- 3 presents the estimated cost to conduct annual training for four categories of facilities based on

67 Notification and re

- notification costs from U.S. EPA, Supporting Statement for ICR N umber 976.15 "2011 Hazardous Waste
Report, Notification of Regulated Waste Activity, and Part A Hazardous Waste Permit Application and Modification," August

2011. Although the rule does not include provisions for re

- notification, this RIA assumes that fac ilities will re

- notify,
consistent with the assessment of costs in the above referenced ICR supporting statement. This assumption has minimal
impact on the estimated costs of the rule.74 

### physical size and generator status. As shown in the exhibit, large facilities are assumed to train four technicians and two managers, while small facilities are assumed to train two technicians and one manager. 68 

### SQGs are expected to conduct informal training that requires approximately four hours of a manager’s time to prepare (including pulling together EPA guidance, fact sheets, and relevant facility standard operating procedures). LQGs are expected to conduc t more formal training using an online training course supplemented with facility

- specific information. The class fee is approximately $125 per
trainee. 69 

### The total cost of training includes the cost of training materials and the cost of
the staff time as sociated with the training.

EXHIBIT 3

- 3. ANNUAL COST OF H AZARDOUS WASTE HANDL ING AND EMERGENCY

PROCEDURES TRAINING

GENERATOR
STATUS FACILITY

SIZE STAFF

REQUIRING
TRAINING TRAINING

TIME PER
EMPLOYEE TRAINING MATERIALS REQUIRED TOTAL COST
OF TRAINING

SQG Small 2 technicians, 1 manager 4 hours 4 hours of manager’s time to develop training $1,022

SQG Large 4 technicians, 2 managers 4 hours 4 hours of manager’s time to develop training $1,728

LQG Small 2 technicians, 1 manager 8 hours $125 class fee per trainee, plus 0.6 hours for
administrative requirements $1,808

LQG Large 4 technicians, 2 managers 8 hours $125 class fee per trainee, plus 0.6 hours for
administrative requirements $3,596



### In addition, LQG and SQG hospitals are assumed to provide awareness training to nurses to ensure that they are familiar with proper waste handling and emergency procedures for any hazardous wastes that they handle. This RIA assumes that most nurses receive awareness training from a nurse manager in groups at the ir hospital location, with approximately 24 nurses per group. Based on input from waste management firms that serve hospitals, this awareness training would last approximately 20 minutes. 70 

### The

68 Assumptions based on training cost assumptions in EPA’s Regulatory I mpact Analysis for the 2008 Final Rule Amendments to
the Industrial Recycling Exclusions of the RCRA Definition of Solid Waste, September 25, 2008.

69 Based on the average cost of online providers, including: http:// www.eduwhere.com
, http://www.thelearningcenter.com
, http://www.gvltec.edu
, http://www.epaalliance.com
, http://www.distance

- education.org
, http://ww.iesshop.ies.ncsu.edu
, http:///www.osha.com
, http://www.epainstitute.com , and http://www.training

classes.com

.

70 Personal communication with Charlotte Smith of Waste Management Healthcare Solutions on December 5, 2012.75 

### average one

- time class fee for nurse manager training is appr oximately $3,962. 71 

### This RIA assumes large facilities will train four nurse managers and small facilities will train two nurse managers once every five years. Therefore, the annualized cost (over five years) to train nurse managers is approximately $1,581 for large facilities and $1,274 for
small facilities.

Data on the number of registered nurses per hospital that will receive training are not readily available. In the absence of such information, this RIA estimates the number of nurses per facility. According to the Bureau of Labor Statistics, there are approximately 2,724,570 registered nurses in the U.S. 72 

### Of these, approximately 62.2 percent (or 1,694,700 nurses) are currently employed in hospital settings. 73 

### As described in Chapter 2, there are 6, 505 hospitals in the United States and there are, on average, approximately 156 hospital beds per hospital. 74 

### Therefore, the nurse to bed ratio is approximately 1.67 ([2,724,570 × 62.2%] ÷ [6,505 × 156] = 1.67). This ratio is applied to the number of beds per model hospital to estimate the number of registered nurses per facility. Exhibit 3

- 4 reports the estimated annual cost of nurse training for each representative model hospital in the baseline based on the above data and assumptions.

In addition to t he above costs, LQGs are also required to develop training

- related
documents at a one

- time cost of approximately $4,537 per facility (an annualized cost of approximately $428 over a 20

- year period). 75 

### The cost to develop training

- related
documents for nurs e managers is included in the cost to train nurse managers. LQGs must also maintain records for three years documenting job titles, employee names, written job descriptions, and the successful completion of training at a cost of approximately $3.20 per fa cility per year. 76

71 Business Training Wo rks, cost of full

- day session of "Train the Trainer Training for Safety and Health Instructors" for up to 6 participants, converted to $2011 using the BEA GDP implicit price deflator. Accessed at
http:// www.businesstrainingworks.com on October 3, 2012.

72 Bureau of Labor Statistics, State Occupational Employment Statistics Survey, May 2011, as reported by the Henry J. Kaiser
Family Foundation, StateHealthFacts, http://www.statehealthfacts.org/comparemaptable.jsp?ind=438&cat=8 , accessed
December 11, 2012.

73 U.S. Department of Health & Human Services, Health Resources and Services Administration, The Registered Nurse
Population: Findings from the 2008 National Sample Survey of Registered Nurses, September 2010.

74 American Hospital Directory Database, www.ahd.com , accessed on April 3, 2012.

75 U.S. EPA, Supporting Statement for EPA Information Col lection Request Number 1573.12, “Part B Permit Application,
Permit Modifications, and Special Permits” (Renewal), November 2009.

76 U.S. EPA, ICR 0820.10 Hazardous Waste Generator Standards, June 2011.76 EXHIBIT 3

- 4. ANNUAL COST OF A WARENESS TRAINING FO R NURSES

UNDER THE BASELINE

GENERATOR
STATUS FACILITY TYPE AVERAGE
NUMBER
OF BEDS 1 AVERAGE

NUMBER OF
NURSES 2 ANNUAL COST

OF NURSE
TRAINING
SQG All Hospitals 107 3 179 $3,90 2

LQG Non

- teaching

hospitals 94 158 $3,441

LQG Teaching hospitals,

less than 370 beds 193 323 $7,043

LQG Teaching hospitals,

370 to 799 beds 516 864 $18,806

LQG Teaching hospitals,

800 or more beds 1,031 1,727 $37,593

Source:
1. American Hospital Directory Database, www.ahd.com , accessed on April 3,
2012.
2. Based on a nurse

- to

- bed ratio of 1.67. T he average number of nurses reported in this column may differ slightly from 1.67 × the number of beds due to rounding.
3. SQG hospitals, on average, have more beds than LQG non

- teaching hospitals because some SQG hospitals are teaching hospitals, which typically have
more beds than non

- teaching hospitals.



### Summary of Training Requirements under Each of the Rule Options

More Stringent Option: Under the More Stringent Option, all reverse distributors will be required to conduct annual employee training subject to the requirements equivalent to an LQG facility under the baseline. This repres ents an incremental cost for SQG and CESQG reverse distributors relative to the baseline. Because the training requirements for LQG and SQG healthcare facilities are the same under this option as under the baseline, training costs for these facilities do not change relative to the baseline. CESQG healthcare facilities incur no training costs under this option, consistent with the baseline.

Proposed and Less Stringent Options: Training costs under these options relative to the baseline vary by facility typ e. For reverse distributors, the training costs under these options are expected to be the same as the training costs incurred un der the More Stringent Option. For healthcare facilities, the Proposed and Less Stringent Options

, a s indicated in Chapter 1, require that employees handling hazardous waste pharmaceuticals be informed of their responsibilities regarding the proper handling and emergency procedures for hazardous waste pharmaceuticals. This information may be disseminated verbally to employees rather through formal training. Therefore, the 20

- minute training provided to nurses in the baseline may be shortened to a short verbal presentation
delivered to nurses that summarizes this information. This RIA estimates that this presentation may be de livered in five minutes. Thus, t raining costs for LQG and SQG hospitals may decline under these policy options relative to the baseline. These potential cost savings are reflected in the rule benefits presented in Chapter 4.

The training cost impacts of the Proposed and Less Stringent Options will likely be limited to nursing personnel. For other hospital employees, training costs are not77 

### expected to change under these options relative to the baseline. While hazardous waste pharmaceuticals are the only hazardous wastes that nurses generally handle, other hospital staff also handle other hazardous wastes and must therefore continue to receive the full RCRA generator training on an annual basis.

Training costs for other healthcare facilities that are LQG s or SQGs are likely to be the same under the Proposed and Less Stringent Options as under the baseline. For many of the facilities included in this category (e.g., physicians’ offices), the same staff are likely to have responsibility for managing hazard ous waste pharmaceuticals as well as other hazardous wastes. These individuals must continue to receive the full generator training required under RCRA. CESQG healthcare facilities, including hospitals, have no RCRA training requirements under this optio n, just as under the baseline.

Manifest Training



### Baseline: RCRA regulations require that LQGs and SQGs train employees to complete hazardous waste manifests. This RIA assumes each LQG and SQG trains one manager and one technician to complete manifests. Personnel are expected to receive a four hour
manifest trai ning session once every three years. As part of this training, this RIA
assumes facilities will use EPA’s free online hazardous waste manifest video. 77 

### The cost of manifest training includes four hours of a manager’s time and four hours of a
technician’s time; it also includes one hour of a manager’s time to compile EPA’s hazardous waste manifest instructions and other training materials. Approximately 0.3 hours of administrative time will likely be incurred to schedule the training every three years. Ba sed on these estimates, the annualized cost of manifest training is approximately $228 per facility. There are no manifest training requirements for CESQGs.

Policy Options: Under each of the policy options, manifest training requirements are the

same as u nder the baseline for all facilities, with the exception of (1) nursing care facilities and continuing care retirement communities qualifying for the household exemption in the baseline and (2) CESQGs operating as reverse distributors. These
facilities mu st perform manifest training under each policy option but not under the baseline and therefore incur incremental manifest training costs of approximately $228 per facility under the policy options. All other facilities experience no change in manifest

tra ining costs relative to the baseline.

Congtingency Plan Updating



### Baseline: Under the baseline RCRA requirements for prevention, preparedness, and emergency response, LQGs must prepare a contingency plan, coordinate with local response agencies, and update the plan as needed. As part of this plan, a designated emergency coordinator must be on call at all times to respond to emergencies. The estimated cost to develop a contingency plan is approximately $6,423 ($606 on an

77 U.S. Environmental Protection Agency, Hazardous Waste Manifest System, accessed at
http://www.epa.gov/osw/hazard/transportation/manifest/index.htm on December 24, 2012.78 

### annualized basis). 78 

### The annual cost to review, update, and distribute the contingency plan is approximately $344, under the assumption that an update would require four hours of managerial labor and one hour of clerical labor.

Policy Options: Under the More Stringent Option, LQG healthcar e facilities and all reverse distributors are required to prepare a contingency plan. This represents an incremental cost for all SQG and CESQG reverse distributors. Under the Proposed and Less Stringent Options, requirements for contingency planning are the same as under the baseline. Thus, the unit costs estimated for the baseline also apply to these options.

Container Management



### Baseline: Under the baseline, facilities must store hazardous waste pharmaceuticals in containers that are structurally sound and compatible with the contained wastes. Additionally, incompatible wastes must not be placed in the same container and
containers must b e closed while in storage except when adding or removing waste. This
RIA assumes that healthcare facilities maintain reusable 18

- gallon drums in satellite storage areas to temporarily store hazardous waste pharmaceuticals generated as floor waste for up t o one month. 79 

### Based on average price data from online vendors, 18

- gallons drums are estimated to cost approximately $80 per drum. 80 

### Additionally, based on input from waste management firms that serve the healthcare industry, facilities generally replace t hese containers at a rate of 10 percent per year due to contamination or improper placement of medical waste into a container. 81 

### This implies an average lifespan of 10 years for these containers. Applying this value to the per

- drum cost of $80 yields

an a nnualized cost of $11.39 (based on a 7 percent discount rate).

The wastes collected in 18

- gallon drums are brought to primary storage areas where they are sorted and placed into 55

- gallon drums, which are then transported to disposal sites
and incinerated. The 55

- gallon drums are incinerated along with their contents, so they must be replaced, at a cost of approximately $74.22 per drum. 82 

### Facilities that sewer their hazardous waste pharmaceuticals or manage them as MSW or medical waste are assumed not to p urchase hazardous waste containers.

More Stringent and Proposed Options: Under both the More Stringent and Proposed Options, the sewering of hazardous waste pharmaceuticals is prohibited for all healthcare facilities and reverse distributors, including CE SQGs. Facilities that sewer or manage

78 Derived from labor hours estimates for contingency plans in U.S. EPA, Supporting Statement for EPA Information Collection
Request Number 1573.12, “Part B Permit Application, Permit Modifications, and Special Permits” (Renewal), November 2009.

79 Because reverse distributors do not generate hazardous waste pharmac euticals in a healthcare facility setting, this RIA
assumes that they do not use 18

- gallon drums.

80 Average price of an 18

- gallon drum based on: http://www.activeforever.com/p

- 3813

- covidien

- sharpsafety

- large

- volume

sharps

- containers.aspx?utm_source=shp&utm_medium=csc&utm_content=B1148104& utm_campaign=medical

supplies&CMPID=SHP ; http://www.impactwaste.com/large_containers.htm ; and
http://www.dhphomedelivery.com/productcart/pc/viewPrd.asp?idcategory=86&idproduct=582

.

81 Based on personal communication with John Kelsey of Clean Harbors on August 24, 2012.

82 Based on the average cost of a 55

- gallon steel drum, including a drum liner , based on RACER 2010 costs inflated to $2011
using the BEA GDP implicit price deflator.79 

### their hazardous waste pharmaceuticals as MSW in the baseline therefore incur costs
associated with the 18

- and 55

- gallon drums necessary for the storage and disposal of their hazardous waste pharmaceuticals. Also, be cause the accumulation time limits for hazardous waste pharmaceuticals are shorter under the More Stringent Option (and the baseline) than under the Proposed Option, 55

- gallon drums containing hazardous waste pharmaceuticals must be shipped offsite for dis posal more frequently. The number of drums needed by facilities under the More Stringent O ption may therefore be slightly higher than under the Proposed Option for some facilities. 83 

### For example , SQG hospitals

are specifically estimated to generate six pa rtially filled 55

- gallon drums of hazardous waste pharmaceuticals each year under the baseline and the More Stringent Option. However, due to the longer accumulation time limits under the Proposed Option, these
facilities could consolidate the same volume of waste (in addition to waste that is no longer sewered) into five more full 55

- gallon drums, resulting in a minor cost savings. These cost savings are reflected in the rule benefits presented in Chapter 4. Exhibit 3

- 5
summarizes the number of 18

- and 55

- gallon drums used per facility under these options
and each of the other scenarios examined in this RIA.

83 55

- gallon drums are typically incinerated with the hazardous waste contained within them. Because the accumulation
time limits are shorter under the More Stringent Option than the Proposed Option, more partially filled drums will be
disposed of under the former than the latter. Some facilities will therefore need more drums under the More Stringent
Option than under the Proposed Option.80

EXHIBIT 3

- 5 . ESTIMATED NUMBER OF DRUMS USED PER FA CILITY FOR THE MANAG EMENT OF HAZARDOUS W ASTE

PHARMACEUTICAL S , BY MODEL FACILITY AND SCENARIO

ROW BASELINE
GENERATOR
STATUS FACILITY TYPE FACILITY
SIZE FULL COMPLIANCE

BASELINE MORE STRINGENT
OPTION PROPOSED

OPTION LESS STRINGENT

OPTION

18

- gal.
drums 55

- gal.

drums 18

- gal.

drums 55

- gal.

drums 18

- gal.

drums 55

- gal.

drums 18

- gal.

drums 55

- gal.

drums

1 CESQG Hospitals Small 1 1 1 1 1 1 1 1

2 CESQG Hospitals Large 1 1 1 1 1 1 1 1

3 CESQG Other Healthcare Facilities Small 1 1 1 1 1 1 1 1

4 CESQG Other Healthcare Facilities Large 1 1 1 1 1 1 1 1

5 CESQG Reverse Distributors Small 0 1 0 4 0 4 0 4

6 SQG Hospitals Small 4 6 5 6 5 5 4 5

7 SQG Hospitals Large 4 6 5 6 5 5 4 5

8 SQG Other Healthcare Facilities Small 3 4 4 6 4 5 3 5

9 SQG Other Healthcare Facilities Large 3 4 4 6 4 5 3 5

10 SQG Reverse Distributors Small 0 8 0 8 0 8 0 8

11 LQG Other Healthcare Facilities Large 12 16 14 20 14 17 12 17

12 LQG Reverse Distributors Large 0 120 0 120 0 120 0 120

13 LQG Non

- teaching Hospitals Large 7 8 8 12 8 10 7 10

14 LQG Teaching Hospitals, less than 370

beds Large 12 16 15 20 15 17 12 17

15 LQG Teaching Hospitals, 370 to 799 beds Large 33 40 40 48 40 47 33 47

16 LQG Teaching Hospitals, 800 or more beds Large 57 68 69 84 69 83 57 8381 

### Less Stringent Option: As described in Chapter 1, the sewering of hazardous waste pharmaceuticals is permitted under the Less Stringent Option for CESQGs. For this segment of the regulated universe, the amount of hazardous waste pharmaceuticals shipped offsite for incineration ( per facility ) is therefore the same as under the full compliance baseline. In addition, because of the longer accumulation time limit under this option for LQG and SQG healthcare facilities (one year) relative to the baseline,
some of these facilities m ay be able to consolidate their hazardous waste pharmaceuticals
into fewer 55

- gallon drums for disposal than under the full compliance baseline. These potential cost savings are presented in Chapter 4.

Labeling



### Baseline: Under the baseline, all containers at LQGs and SQGs must be marked with the words “Hazardous Waste” and the accumulation start date. Additionally, containers in satellite accumulation areas must be marked as hazardous waste, while the accumulation

start date begins when the container is full or moved to the primary storage area. This RIA assumes that a trained technician would label containers in primary and satellite accumulation areas. The annual costs of labeling are reported in Exhibit 3

- 6 . Facilit ies that sewer their hazardous waste pharmaceuticals are assumed not to incur labeling costs in the baseline. Additionally, there are no labeling requirements for CESQGs.

EXHIBIT 3

- 6 . ANNUAL COST OF LA BELING

GENERATOR
STATUS LOCATION ESTIMATED
TIME ESTIMATED

LABOR COST ANNUAL COST OF

LABELING PER FACILIT Y

SQG Primary Storage Area 0.25 hours 1 $12.24 Primary & Satellite Storage Areas Combined:

$24.48 Satellite Storage Areas 0.25 hours 1 $12.24

LQG Primary Storage Area 1.0 hour 2 $48.97 Primary & Satellite Storage Areas Combined:

$73.45 Satellite Storage Areas 0.5 hours 3 $24.48

Source:
1. U.S. EPA, ICR 0820.10 Hazardous Waste Generator Standards, June 2011, Section 262.34(d)(4).
2. U.S. EPA, ICR 0820.10 Hazardous Waste Generator Standards, June 2011, Section 262.34(a)(2) and (3).
3. U.S. EPA, ICR 0820.10 Hazardous Waste Generator Standards, June 2011, Section 262.34(c)(1) and (2).



### More Stringent Option: Under the More Stringent Option, labeling requirements for LQG and SQG healthcare facilities are the same as under the baseline. For LQG and SQG facilities that sewer in the baseline (or mange hazardous waste pharmaceuticals as MSW or medical waste), how ever, the costs of labeling will increase relative to the baseline (because they do not store any hazardous waste pharmaceuticals in the baseline). The More Stringent Option also requires that all reverse distributors label all of their
containers. This represents a cost increase for CESQG reverse distributors relative to the baseline. The per

- facility labeling costs for these facilities are assumed to be the same as for SQG reverse distributors.82 

### Proposed and Less Stringent Options: Under these options, healthcare facilities are required to label containers holding patient care hazardous waste pharmaceuticals with the words “Hazardous Waste Pharmaceuticals,” but are not required to mark the accumulation start date on the container. To ensure compliance w ith accumulation time limits, however, it is likely many facilities will do so. Thus, healthcare facilities that label in the baseline will likely realize no change in labeling costs on a per drum basis under the Proposed and Less Stringent Options. Simi lar to the More Stringent Option, the costs of labeling under the Proposed and Less Stringent Options represent a new cost to LQG and SQG healthcare facilities that sewer in the baseline.

However, n o labeling is required for containers holding potentiall y creditable pharmacy waste going to a reverse distributor. As indicated above, healthcare facilities send approximately 20 percent of their hazardous waste pharmaceuticals to a reverse
distributor. 84 

### Therefore, LQG and SQG hospitals are estimated to expe rience a cost savings relative to the baseline. This RIA estimates that per facility labeling costs for healthcare facilities are approximately 20 percent lower under the Proposed and Less Stringent Options than under the More Stringent Option.

Consistent with the More Stringent Option, the Proposed and Less Stringent Options require labeling for containers holding hazardous waste pharmaceuticals at all reverse distributors, resulting in an increase in costs for CESQG reverse distributors relative to
the b aseline. However, unlike the More Stringent Option, the Proposed and Less Stringent Options do not require l abeling for hazardous waste pharmaceuticals shipped
from one reverse distributor to another. Based on input from an industry source this

accounts for approximately 65 percent of the hazardous waste pharmaceuticals managed by reverse distributors

. 85 

### Thus, LQG and SQG reverse distributors are estimated to avoid costs associated with labeling that are incurred in the baseline

. All cost savings describ ed above are reflected in the benefits presented in Chapter 4.

Inspections



### Baseline: Under the baseline, LQGs and SQGs are required to conduct weekly (or 52 per year) inspections of hazardous waste storage areas. This RIA assumes that a technician would require two hours to inspect a large facility and one hour for a small facility.
Bas ed on the hourly labor costs presented above, this implies that the annual cost of inspections is $5,093 for a large facility and $2,546 for a small facility.

More Stringent Option: Inspection requirements for LQG and SQG healthcare facilities
are the sa me under the More Stringent Option as under the baseline. Inspection costs for
these facilities are therefore assumed to be the same as under the baseline. The one exception is nursing care facilities and continuing care retirement communities . Because these facilities are considered households in the baseline, inspections represent a new cost
for these facilities.

84 Personal communication with John Kelsey of Clean Harbors on August 17, 2012.

85 Personal communication with Charlotte Smith of Waste Management Healthcare Solutions on January 8, 2013.83 

### All reverse distributors are subject to the inspection requirements of TSDFs under this option. The requirements are similar to those for LQ Gs and SQGs in the baseline (i.e., weekly inspections of storage areas), but facilities must also maintain inspection records. The annual cost of maintaining these records is estimated at $0.08 per record. 86 

### The cost of maintaining records represents the only inspection

- related increase in costs for LQG and SQG reverse distributors under this option. For CESQG reverse distributors, however, the full cost of inspections represents an increase in costs relative to the
baseline. Per

- facility inspection cost s for CESQG reverse distributors are equal to the

per

- facility inspection costs for small facilities described above plus the cost of maintaining inspection records.

Proposed and Less Stringent Options: Under these policy options, healthcare facilities

w ould not be required to perform inspections of areas where hazardous waste pharmaceuticals are stored. LQG and SQG healthcare facilities, however, would be likely to continue performing inspections because they generate and store other hazardous
wastes fo r which inspections would be necessary. 87 

### This RIA therefore assumes that inspection costs for these facilities are the same under the Proposed and Less Stringent Options as under the baseline. Similar to the baseline, inspections are not required of CESQ G healthcare facilities under this option.

All reverse distributors are required to conduct weekly inspections under these options. For SQGs and LQGs, this requirement is the same as under the baseline, so their inspection costs are assumed to remain cons tant under this option. For CESQG reverse distributors, however, inspections represent a new cost relative to the baseline. All CESQG reverse distributors are assumed to incur the small facility inspection costs
described in the baseline discussion above

.

Warehousing (Secure Facility)



### Baseline: While no specific security provisions are required of generators under RCRA, LQGs and SQGs are responsible for the safe storage of hazardous waste pharmaceuticals and the prevention of any related accidents while wastes are stored on

- site. Under the baseline, all facilities are assumed to have adequate security measures in place to ensure safe storage of hazardous waste pharmaceuticals.

More Stringent Option: Under the More Stringent Option, all reverse distribu tors are required to obtain a RCRA storage permit and secure their facility in accordance with the permit. Reverse distributors would likely store hazardous waste pharmaceuticals in a warehouse setting with an area inside the building fenced off to secure ly store hazardous waste pharmaceuticals. This RIA assumes that such an area would be secured with fencing on three sides and the building wall on the fourth side. The cost for a linear foot

86 U.S. EPA, Supporting Statement for Information Collection Request Number 801.18 "Requirements for Generators,
Transporters, and Waste Management Facilities Under the RCRA Hazardous Waste Manifest System.," January 2012.

87 CESQGs also generate hazardous wa stes other than hazardous waste pharmaceuticals, but these facilities are not required
to conduct inspections in the baseline.84 

### of fencing is approximately $47. 88 

### This RIA assumes that the st orage area would be sufficiently large to securely manage the maximum number of 55

- gallon drums that a reverse distributor would likely have to store, considering the 90

- day accumulation time limit under this option. This cost is annualized over a 20

- year period. The average annualized costs are approximately $60 for a CESQG or SQG and $16 3 for an LQG. 89



### Proposed and Less Stringent Options: No facilities are required to obtain a RCRA storage permit and comply with the associated security requirements unde r these options. Healthcare facilities and reverse distributors are expected to incur no new facility security costs under these options incremental to the baseline.

Closure



### Baseline: Under the baseline, LQGs are required to develop a closure plan to clo se container storage areas in a manner that meets the RCRA closure standard and ensure proper disposal or decontamination of equipment, structures, and soils. In addition, facilities are expected to remove all hazardous waste pharmaceuticals prior to clos ure of the storage area. This RIA assumes that the cost to develop a closure plan is approximately $8,267 (an annualized cost of $780 over a 20

- year period). 90



### Additionally, LQGs must clean storage areas at the time of closure. The estimated cost of
cle aning these areas is approximately $167 per drum stored. 91 

### Annualized over an assumed facility life of 20 years, this translates to approximately $16 per drum.

There are no specific closure requirements for SQGs and CESQGs and therefore no
closure costs for these facilities in the baseline.

Policy Options: Under each option, LQGs that sewer their hazardous waste pharmaceuticals in the baseline will store larger quantities of hazardous waste pharmaceuticals onsite prior to disposal. This will increase the number of drums stored, necessitating a larger storage area and increased cleaning costs at the time of closure
relative to the baseline.

The More Stringent O ption also requires that all reverse distributors develop closure plans at an annualized cost of $780 per facility. This represents a new cost for SQG and CESQG reverse distributors but is consistent with baseline costs for reverse distributors

88 DPRA Inc., U.S. EPA Office of Resource Conservation and Recovery Economics and Risk Analysis Staff Unit Cost
Compendium, Septem ber 26, 2011, inflation

- adjusted to 2011 dollars using the BEA GDP implicit price deflator.

89 This RIA estimates that LQG reverse distributors would require fencing enclosing approximately 170 square feet, and that
SQGs and CESQGs would require fencing enc losing approximately 24 square feet. These values are based on the generation
of hazardous waste pharmaceuticals by reverse distributors and the maximum length of time waste would be stored onsite,
as dictated by the RCRA accumulation time limits.

90 Costs derived from Supporting Statement for EPA Information Collection Request Number 1573.12, "Part B Permit
Application, Permit Modifications, and Special Permits" (Renewal), November 2009.

91 This estimate is based on a cost of $15,000 to clean a 5,000

- gallon container storage area, as presented in Appendix B:
Cost Estimating Worksheets Used to Estimate the Costs of Closure of Container Storage Areas (CSA)

– author and date of
document not provided. Information obtained from EPA website: http://www.epa.gov/osw/hazard/tsd/permit/perm

docket/5app_b.pdf

.85 

### that are L QGs. The Proposed and Less Stringent Options include no new closure plan requirements.

RCRA Storage Permit



### Baseline: Under the baseline, none of the facilities covered by the rule are required to have RCRA storage permits. This RIA therefore estimates no permit costs under the
baseline.

More Stringent Option: Under the More Stringent Option, all reverse distributors are required to obtain a RCRA storage permit. The general permit requirements include the costs to prepare a written description of the gen eral facility standards, waste analysis plan, security procedures, equipment requirements, inspection schedule, contingency plan, compliance plan, and training documents, and also to collect other analytical information required under 270.14(b)(2). This R IA assumes the general permit requirement costs are approximately $135,100 (an annualized cost of $12,753 over a 20

- year period). 92 

### Additional costs of permit requirements specific to Part B are an estimated $4,794 (an annualized cost of $453 over a 20

- yea r period). The costs of periodic modifications to the permit are estimated to be $419 annually. Facilities are also required to renew their permit after 10 years at a cost of approximately $6,059 (an annualized cost of $291 over a 10

- year period when dis counted to the present ). The costs of developing training

- related documents, a contingency plan, and a closure plan are netted out of the general permit requirement costs because they are included elsewhere in
this RIA.

Proposed and Less Stringent Option s: Similar to the baseline, these options do not require facilities affected by the rule to obtain a RCRA storage permit. Therefore, no
such permit costs are estimated for these options.

Sorting



### Baseline: Under the baseline, facilities that manage their hazardous waste pharmaceuticals through incineration must separate hazardous waste pharmaceuticals from pharmaceuticals that are not hazardous wastes. 93 

### Facilities can separate wastes using an internal tech nician or by hiring an outside environmental contractor to sort the waste. Based on input from hospital waste management firms, facilities can separate approximately four 18

- gallon drums (or approximately 100 pounds) of waste in an hour. 94



### Based on the la bor cost estimates presented above, this translates to sorting costs of approximately $12.24 per drum.

92 All of the permit costs presented in this paragraph are derived from Supporting Statement for EPA Information Collection
Request Number 1573.12, "Part B Permit Application, Permit Modifications, and Special Permits" (Renewal), November 2009; labor rates inflated to $2011 using the BLS Employment Cost Index and operations and management costs inflated to $2011
using the BEA GDP impli cit price deflator.

93 See the Baseline Specification discussion above for information on which facilities are assumed to incinerate their
hazardous waste pharmaceuticals under each of the two baselines.

94 Personal communication with John Kelsey of Clean Ha rbors on August 23, 2012.86 

### More Stringent and Proposed Options: Under both of these options, the sewering of hazardous waste pharmaceuticals is prohibited. Therefore, hazardous wa ste pharmaceuticals that are sewered in the baseline must be sorted from nonhazardous pharmaceutical waste and incinerated. 95

, 96 

### As presented in Chapter 4, approximately 6,400 tons of hazardous waste pharmaceuticals are sewered under the full compliance
bas eline.

Less Stringent Option: Because the Less Stringent Option does not prohibit CESQG
healthcare facilities from sewering their hazardous waste pharmaceuticals, sorting costs under this option are assumed to be the same as under the full compliance bas eline for these facilities. For all other facility types, sorting costs are assumed to be the same as under the More Stringent and Proposed Options.

Biennial Reports



### Baseline: Under current regulations, LQGs and SQGs located in states with BR reporting

req uirements for SQGs must submit biennial reports of their hazardous waste generation activity (for pharmaceuticals and other hazardous wastes) to EPA or state authorities.
The fixed costs of preparing a biennial report include the time to read the instruct ions, complete the site ID form, submit the report to state authorities or EPA, and maintaining a copy of the report for three years. Based on EPA’s ICR for the 2011 Hazardous Waste Report, the annualized cost of these activities is approximately $128 per facility. 97 

### In addition, the variable annualized costs of completing one Waste Generation and Management Form ( GM form ) for the BR is $10.55. 98

, 99



### Based on the 2009 BR data, LQG hospitals submitted an average of 19 GM forms per facility. Of these, approximately 13 were for non

- pharmaceutical hazardous wastes. To estimate the number of GM forms submitted by facilities other than hospitals, this RIA
scales the number of GM forms f or hospitals based on the hazardous waste generation of other facility types relative to hospitals. For example, on a per

- facility basis, LQG reverse distributors generate more hazardous waste than LQG hospitals by a factor of approximately 3

- to

- 1 . Apply ing this figure to the number of GM forms completed by hospitals, this RIA estimates approximately 6 0 GM forms per LQG reverse distributor.
For LQG other healthcare facilities, this approach suggests the completion of 12 GM

95 As described above, approximately 58 percent of hazardous waste pharmaceuticals generated by CESQGs may be managed
as MSW under the More Stringent and Proposed Options and would not require sorting. This is reflected in the sor ting costs
presented in this chapter.

96 Hazardous waste pharmaceuticals managed as MSW or medical waste in the baseline in violation of RCRA are assumed to
be managed through incineration under the More Stringent and Proposed Options (excluding waste gene rated by CESQGs in
states that allow MSW disposal for these facilities) and would therefore need to be sorted from non

- hazardous
pharmaceutical waste under these options.

97 Supporting Statement for EPA Information Collection Request 0976.15, "2011 Hazardou s Waste Report, Notification of
Regulated Waste Activity, and Part A Hazardous Waste Permit Application and Modifications, August 2011.

98 Ibid.

99 The GM form is the form on which hazardous waste generators provide information on their waste generation acti vity (e.g.,
quantity generated, method of managing each hazardous waste stream, etc.).87 

### forms per facility. For both r everse distributors and other healthcare facilities, this RIA distributes GM forms between hazardous waste pharmaceuticals and other hazardous wastes in proportion to the generation of each

, per facility, as reported in Chapter 2. This implies that 5 7 of the 6 0 GM forms completed per reverse distributor are for hazardous waste pharmaceuticals and that the remaining three are for other hazardous wastes. For LQG other healthcare facilities, this RIA estimates that three of the 12 GM forms per facility are f

or hazardous waste pharmaceuticals and the other nine are for other
hazardous wastes.

Based on BR data from states with BR reporting requirements for SQGs, this RIA estimates that SQG hospitals and other healthcare facilities submit an average of 8 GM
form s per reporting cycle. Of these, on average, 6 GM forms were for non

pharmaceutical hazardous wastes . Applying the same methodology as described above for LQG reverse distributors, this RIA estimates that SQG reverse distributors submit an average of 4 G M forms per reporting cycle. 100 

### For SQG reverse distributors, EPA estimates that all GM forms are for hazardous waste pharmaceuticals.

CESQGs are not required by EPA to submit biennial reports and therefore incur no biennial reporting costs in the baseline

. More Stringent Option: Under the More Stringent Option, biennial report data for hazardous waste pharmaceuticals must be submitted by LQGs

, SQGs located in states with BR reporting requirements for SQGs, and all reverse distributors. This represents a cost increase for SQG and CESQG reverse distributors in states without BR reporting requirements for SQGs and CESQGs incremental to the baseline. Using the approach described above in the baseline discussion, this RIA estimates that SQG reverse
distribut ors submit four GM forms per facility and that CESQGs submit one GM form per facility.

Proposed and Less Stringent Options: Under the Proposed and Less Stringent Options, hazardous waste pharmaceuticals do not need to be included in biennial report
submi ssions. Therefore, the number of GM forms that they prepare and submit will be lower than in the baseline, resulting in a cost savings relative to the baseline. These potential cost savings are assessed in Chapter 4.

Recordkeeping for Waste Characteriz ations 101



### Baseline: Under the baseline, LQGs and SQGs are required to maintain records of waste characterizations for three years from the date the last waste, including hazardous waste pharmaceuticals, was sent off site. The estimated cost of maintaining these records is $ 5.30 per facility per year. 102 

### There are no recordkeeping requirements for CESQGs in
the baseline.

100 For LQG reverse distributors, the ratio of hazardous waste generation relative to LQG hospitals is 3

- to

- 1. For SQG reverse
distributors, this ratio is 0.2

- to

- 1.

101 Recordkeeping costs for manifests are covered in the “Manifests” section below.

102 Per facility cost estimate obtained from U.S. EPA, ICR 0820.10 Hazardous Waste Generator Standards, June 2011.88 

### More Stringent Option: Under the More Stringent Option, recordkeeping requirements
for waste characterizations are the same for healthcare facilities as under the baseline. However, all reverse distributors are required to maintain records of waste characterization for three years. This represents a cost increase for CESQG reverse distributors relative to the baseline; LQG and SQG reverse distributors incur t hese costs
under the baseline.

Proposed and Less Stringent Options: The Proposed and Less Stringent Options include no waste characterization recordkeeping requirements for hazardous waste pharmaceuticals generated by healthcare facilities. These facilit ies therefore realize a cost savings under these options relative to the baseline. These potential cost savings are analyzed in Chapter 4. Reverse distributors, however, are required to maintain records of waste characterizations for three years under th is option. Similar to the More Stringent Option, this represents a cost increase for CESQG reverse distributors relative to the baseline; LQG and SQG reverse distributors incur these costs under the baseline.

Manifests



### Baseline: Under RCRA, 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. This RIA estimates the baseline cost to complete a manifest to be approximat ely $21 per shipment for LQGs and $13 per shipment for SQGs. 103 

### This cost includes an average of 0.26 hours for a technician to complete a manifest and 0.28 hours of administrative time, plus 0.5 hours of a managerial time to complete an exception report

— wh ich occurs for approximately 0.5 percent of manifests. In addition to completing manifests, LQGs and SQGs must also maintain a signed copy of each manifest for three years. The estimated cost to maintain a manifest for three years is approximately $0.08 p er manifest.

Healthcare facilities are assumed not to manifest for potentially creditable pharmaceuticals shipped to reverse distributors in the baseline. Under current regulations, pharmaceuticals are not considered to be discarded when sent to a reve rse distributor and are therefore not solid wastes under RCRA.

More Stringent Option: Under the more stringent option, LQGs, SQGs, and all reverse distributors are required to prepare manifests for each shipment of hazardous waste pharmaceuticals shipped offsite. In addition to hazardous waste pharmaceuticals shipped to a TSDF, this includes hazardous waste pharmaceuticals shipped from a healthcare facility to a reverse distributor and shipments between reverse distributors. The More Stringent Option als o requires LQGs, SQGs, and all reverse distributors to maintain a signed copy of each manifest for three years.

This option represents an increase in costs for CESQG reverse distributors, as they are not required to manifest in the baseline. Similarly, th is option results in an increase in costs for LQGs and SQGs shipping hazardous waste pharmaceuticals to a reverse

103 Manifest costs presented in this paragraph are derived from U.S. EPA, Supporting Statement for Information Collection
Request Number 801.18 "Requirements for Generators, Transporters, and Waste Management Facilities Under the RCRA
Hazardous Waste Manifest System." January 2012.89 

### distributor for manufacturer credit and reverse distributors shipping hazardous waste pharmaceuticals to other reverse distributors. Informat ion on the frequency of shipments to reverse distributors was not readily available. This RIA assumes that LQG and SQG healthcare facilities make four shipments per year (i.e., quarterly) to reverse distributors
and that reverse distributors send four shi pments per year to other reverse distributors.

Proposed and Less Stringent Options: Under the Proposed and Less Stringent Options, LQG and SQG healthcare facilities must complete manifests for patient care pharmaceuticals shipped to a TSDF, but need not include RCRA waste codes on these manifests. This represents a cost savings of appro ximately 0.1 hours per shipment for a
technician to document waste codes. 104 

### Also under these options, 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. This RIA estimates the cost of these alternative shipping documents to be $8.49 per shipment. 105 

### As indicated above, this RIA assumes that each healthcare facility sends four shipm ents of pharmaceuticals to a reverse distributor each year. This represents an incremental cost for LQG and SQG healthcare
facilities relative to the baseline. As a result of opposing cost factors

— the avoided costs
of providing RCRA waste codes on manife sts versus the incremental cost of shipping
documents

— some facilities may incur new net costs while others may experience a net cost savings. New estimated net costs associated with manifesting are highlighted in
Exhibit 3

- 11 below, while any cost savings associated with this provision are assessed separately in Chapter 4.

For reverse distributors, the Proposed Option requires a full manifest (including waste codes) for hazardous waste pharmaceuticals shipped to a TSDF. No manifest, however, is required for shipments of hazardous waste pharmaceuticals between reverse distributors, though shipping documents with return receipts are required. As indicated above, the cost of these documents is approximately $8.49 per shipment. The
incremental cost of these documents represents the only change in manifest costs for reverse distributors under the Proposed Option.

Transportation



### Baseline: As described above, the full compliance baseline assumes that hazardous waste pharmaceuticals are incinerated, managed as MSW, or sewered, or that they are shipped to a reverse distributor for manufacturer credit. Because sewered pharmaceuticals are not transported, this RIA estimates transportation costs under the full compliance baseline only for hazardous wast e pharmaceuticals that are incinerated, managed as MSW, or shipped to reverse distributors. In addition, because the rule may lead to changes in RCRA generator status for some facilities, it may also lead to changes in their transportation costs due to ch anges in the accumulation time limit that applies to them.

104 Ibid.

105 Estimate derived from U.S. EPA, Modification of the Hazardous Waste Program: Hazardous Waste Lamps, Final Economic

Assessment , March 11, 1999 and U.S. EPA, Economic Analysis of Including Mercury Containing Devices in the Universal Waste
System, Notice of Proposed Rulemaking , Februar y 15, 2002.90 

### To ensure that this cost impact is fully captured, this RIA estimates the cost of transporting hazardous waste pharmaceuticals and the other hazardous wastes generated by affected facilities.

To estimate the cost of transporting hazardous waste pharmaceuticals and other hazardous waste, this RIA assumes that these wastes are transported in 55

- gallon drums loaded onto a truck with a capacity of 80 drums per truck. Under the assumption that
each tr uckload is shipped 300 miles, this RIA estimates transportation costs of $31 per
drum. 106 

### In addition, facilities are assumed to pay a premium of $44 per shipment for partial shipments. 107 

### The transportation costs associated with MSW disposal are
estimated to be $9.76 per ton. This reflects transportation costs of $0.20 per ton mile and
an assumed 50

- mile travel distance. 108 

### For potentially creditable pharmacy waste being shipped to a reverse distributor, this RIA estimates that facilities use a common carri er at an average cost of $0.48 per pound (or $960 per ton) plus a special hazmat labeling fee of $27.50 per shipment. 109



### Exhibit 3

- 7 summarizes the unit costs of the various transportation methods included in
this RIA.

Policy Options: Transportation requirements under each of the policy options are similar to those under the baseline for hazardous waste (pharmaceuticals and otherwise) shipped to a TSDF. However, for potentially creditable pharmacy waste, facilities are required to

not ify reverse distributors that a shipment will be sent to them. This RIA assumes that this notification process would require 0.2 hours of a technician’s time per shipment, which represents a cost of approximately $9.79 per shipment based on the hourly lab or costs in Exhibit 3

- 2. In addition, as indicated above, this RIA assumes that healthcare facilities make four shipments to reverse distributors per year and that reverse distributors make four shipments to other reverse distributors each year.

For each of the policy options, the estimation of transportation costs accounts for the proportion of hazardous waste pharmaceuticals that may be managed as MSW. As indicated in the General Assumptions discussion above, an estimated 58.4 percent of CESQGs are ass umed to be allowed to manage their patient care hazardous waste pharmaceuticals as MSW. Also, under the Proposed and Less Stringent Options, the number of hazardous waste shipments to TSDFs declines for some facilities relative to
the baseline due to the longer accumulation limits under these options , which reduces the

106 Estimated using RACER 2010 cost estimating software inflated to $2011 using the BEA GDP implicit price deflator. Mileage

estimate based on DPRA Inc., U.S. EPA Office of Resource Conservation and Recovery Economics and Risk Analysis Staff Uni t
Cost Compendium, September 26, 2011

.

107 Ibid.

108 U.S. Environmental Protection Agency, 2008 Final Rule Amendments to the Industrial Recycling Exclusions of the RCRA Definition of Solid Waste, September 25, 2008, inflated to $2011 using GDP implicit price deflator, Bureau of Economic
Analysis.

109 Based on UPS 2012 Ground Rates for single packages plus a special handling hazardous material fee of $27.50 per
shipment, accessed at http://www.ups.com/media/en/standard_list_rates.pdf on August 12, 201291 

### transportation costs incurred by these facilities. These potential cost savings are assessed in Chapter 4.

EXHIBIT 3

- 7 . UNIT TRANSPORTATI ON COSTS (YEAR 2011$ )

TRANSPORTATION COST 1 DESTINATION

TSDF 1 MEDICAL WASTE

MANAGEMENT
FACILITY 1 MSW

LANDFILL 2 REVERSE

DISTRIBUTOR (USING A COMMON CARRIER) 3 Fixed Cost per shipment (premium per partial shipment) $44.21 $0 $0

Fixed Cost per shipment (hazmat labeling fee) $27.50

Variable Cost (per drum) $31.29 $31.29 4

Variable Cost (per ton) $9.76 $960.00

Average distance 300 miles 300 miles 50 miles 50 miles

Notes:
1. Estimated using RACER 2010 cost estimating software inflated to $2011 using the BEA GDP implicit price deflator.
2. U.S. Environmental Protection Agency, 2008 Final Rule Amendments to the Industrial Recycling Exclusions of the RCRA Definition of Solid Waste, September 25, 2008, inflated to $2011 using the BEA GDP implicit price deflator.
3. Based on UPS 2012 Ground Rates for si ngle packages, accessed at http://www.ups.com/media/en/standard_list_rates.pdf on August 12, 2012.
4. Transportation cost for medical waste assumed to be the same for full shipments of hazardous waste shipped to a TSDF because medical waste is considered hazardous under class 6.2 of DOT regulations.

Disposal



### Baseline: Under the full compliance baselin e, facilities are assumed to dispose of their hazardous waste pharmaceuticals by sending them to a hazardous waste incineration unit, managing them as MSW, or by sewering them under the domestic sewage exclusion and notifying their local POTW. 110

, 111 

### The cos ts of hazardous waste incineration include an average loading cost of $6.16 per drum

, 112 

### and incineration costs of approximately $2.09

110 Under the baseline and the policy options considered by EPA, arsenic trioxide waste must be managed through stabilization and disposal in a hazardous waste landfill. The available data on the generation of hazardous waste pharmaceuticals, howev er, do not identify specific wastestreams as containing arsenic trioxide, and no information is available on its prevalence among hazardous wastes pharmaceuticals. Disposal costs specific to arsenic trioxide are

therefore not estimated in this RIA. These costs, however, are likely to be the same under the baseline and the various policy options, so there are no incremental costs associated with the disposal of this specific hazardous waste pharmaceutical under each policy option.

111 See the discussion abov e in the Baseline Specification section on this RIA’s assumptions regarding which facilities incinerate their hazardous waste pharmaceuticals under the full compliance baseline and which sewer them.

112 Estimated using RACER 2010 cost estimating software inf lated to $2011 using the BEA GDP implicit price deflator.92 

### per pound, as shown in Exhibit 3

- 8

. 113 

### The cost of MSW disposal is an estimated $49.27
per ton, 114 

### and the cost of sewering, e xcluding notification, is an estimated $3.79 per 1,000 gallons. 115

, 116 

### To convert this sewering cost to an estimated cost per ton ($0.91 per ton), this RIA assumes that sewered pharmaceuticals have the same density as water (8.34 pounds per gallon). The cost of notifying POTWs is assumed to be similar to the
cost of RCRA n otification to EPA. As indicated in the notification section above, this cost is $53.05 per facility. T his translates to an annualized cost of $5.01 over 20 years

.
Exhibit 3

- 9 shows the distribution of hazardous waste pharmaceuticals across these

manage ment methods under the full compliance and partial compliance baseline. Note that the partial compliance baseline is discussed as a sensitivity analysis later in this chapter. All hazardous wastes other than pharmaceuticals generated by healthcare
facili ties and reverse distributors are assumed to be managed through incineration. 117

113 The incineration cost of $2.09 per pound is from Alan Davidner of Vestara, Inc., as quoted in Jeff Donn, Martha Mendoza, and Justin Pritchard, "AP IMPACT: Health care industry sends tons of drugs into nation's wastewater system." September 14,

2008. Available at http://hosted.ap.org/specials/interactives/pharmawater_site/sept14a.html . The value from this sourc e was inflated to $2011 using the BEA GDP implicit price deflator. To convert from a cost per pound to a cost per drum, this RIA assumed 250 pounds per drum, based on input provided by John Kelsey of Clean Harbors on September 17, 2012.

114 Shawn Right, "Tipping fees vary across the U.S.," Waste & Recycling News, July 20, 2012.

115 Raftelis Financial Consulting, 2008 Water and Wastewater Rate Survey, as cited in DPRA Inc., U.S. EPA Office of Resource Conservation and Recovery Economics and Ris k Analysis Staff Unit Cost Compendium, September 26, 2011, inflated to $2011 using the BEA GDP implicit price deflator.

116 $3.79 reflects the best available estimate for an average nationwide POTW rate. However, costs are uncertain and can
vary widely from city to city and plant to plant. There are significant economies of scale in sewage treatment and cost is
highly sensitive to POTW capacity (as well as cost of capital and age). Furthermore, some POTWs bill according to the
concentration, rather than volum e, of the waste. Therefore, there are numerous variables that make generalizing treatment costs challenging. Several additional sources discuss local POTW rates ranging from approximately $1.00 to $5.50 per 1,000
gallons (this RIA uses an estimate around t he midpoint of this range , adjusted for inflation ), including: RGF Environmental
Group, Wash Water Recycling Makes Dollars & Sense for Heavy Equipment Industry, Table 1: National Industrial Water &
Sewer Costs, accessed at http://www.rgf.com/published_article_content.cfm?ArticleID=8 ; City of Lafayette, Indiana, Water
Pollution Control, Profile of Current Facilities, accessed at http://www.lafayette.in.gov/department/index.php?fDD=17

- 0 ; City of Greeley, Colorado, Water and Sewer, Facility Specifications/Statistics from the year 2012, accessed at
http://greeleygov.com/Water/wastewatertreatment.aspx

.

117 These hazardous wastes may be managed through other methods. Nevertheless, assuming that these wastes are incinerated for the purposes of this RIA has little to no impact on the estimated cost of each option incremental to the baseline because this RIA assumes that these wastes will be incinerated in the baseline and under each policy option. Therefore, the costs for these wastes net out between the baseline and each policy option.93 EXHIBIT 3

- 8 . UNIT COSTS OF DIS POSAL PRACTICES (YEA R 2011$)

METHOD COST

Incineration 1  Cost to load drum : $6.16 per drum

 Cost of incineration : $2.09 per pound MSW Disposal 2  Variable cost of MSW disposal: $49.27 per ton

Sewering 3  Annualized cost of POTW Notification : $5.01 per facility

 Variable cost of sewering: $0.91 per ton Medical Waste Disposal 4  Variable cost of medical waste disposal: $213 per ton

Notes:
1. Cost to load drum from RACER 2010 cost estimating software, inflated to $2011 using the BEA GDP implicit price deflator. Cost of incineration from Alan Davidner of Vestara , Inc., as quoted in Jeff Donn, Martha Mendoza, and Justin Pritchard, "AP IMPACT: Health care industry sends tons of drugs into nation's wastewater system." September 14, 2008.
Available at http://hosted.ap.org/specials/interactives/pharmawater_site/sept14a.html
2. Shawn Right, "Tipping fees vary across the U.S.," Waste & Recycling News, July 20, 2012.
3. Notification costs derived from U.S. EPA, Supporting Statement for ICR Number 976.15 "2011 Hazardous Waste Report, Notification of Regulated Waste Activity, and Part A Hazardous Waste Permit Application and Modification," August 2011. Variable cost of sewering from Raftelis Financial Consulting, 2008 Water and Wastewater Ra te Survey, as cited in DPRA Inc., U.S. EPA Office of Resource Conservation and Recovery Economics and Risk Analysis Staff Unit Cost Compendium, September 26, 2011, inflated to $2011 using the BEA GDP implicit price deflator.

4. Derived from U.S. EPA, Economic Impacts of Revised MACT Standards for Hospital/ Medical/Infectious Waste Incinerators, Final Report, July 2009. Estimate reflects the weighted average of medical waste incineration and autoclaving medical waste and disposing of it as MSW.9 4

EXHI BIT 3

- 9 . DISPOSAL METHOD A SSUMPTIONS (PERCENTA GE OF HAZARDOUS WAST E PHARMACEUTICALS B Y MANAGEMENT METHOD)

GENERATOR TYPE
AND SIZE FULL COMPLIANCE BASE LINE PARTIAL COMPLIANCE B ASELINE 2 MORE STRINGENT OPTIO N /
PROPOSED RULE LESS STRINGENT OPTIO N Hospitals

CESQG For CESQGs:

 Sewering with notification: 1 18%

 MSW Disposal: 3,4 36%

 HW Incineration: 4 26%

 Sent to RD: 5 20% For CESQGs: 6

 Sewering (no notification): 18%

 MSW Disposal: 8%

 Medical Waste Disposal: 54%

 Sent to RD: 5 20% For CESQGs:

 No Sewering

 MSW Disposal: 3,13 47%

 HW Incineration: 13 33%

 Sent to RD: 5 20% For CESQGs:

 Sewering with notification: 15 18%

 MSW Disposal: 3,15 36%

 HW Incineration: 15 26%

 Sent to RD: 5 20%

SQG For LQGs and SQGs:

 Sewering with notification: 1 14%

 HW Incineration: 7 66%

 Sent to RD: 5 20% For LQGs and SQGs: 8

 Sewering (no notification): 14%

 MSW Disposal: 6%

 Medical Waste Disposal: 43%

 HW Incineration: 16%

 Sent to RD: 5 20% For LQGs and SQGs:

 No Sewering

 HW Incineration: 14 80%

 Sent to RD: 5 20% For LQGs and SQGs:

 No Sewering

 HW Incineration: 14 80%

 Sent to RD: 5 20%

LQG

Other Healthcare Facilities

CESQG For CESQGs:

 Sewering with notification: 1 21%

 MSW Disposal: 3,4 42%

 HW Incineration : 4 30%

 Sent to RD: 9 7% For CESQGs and SQGs: 10

 Sewering (no notification): 21%

 MSW Disposal: 9%

 Medical Waste Disposal: 63%

 Sent to RD: 9 7% For CESQGs:

 No Sewering

 MSW Disposal: 3,13 54%

 HW Incineration: 13 39%

 Sent to RD: 9 7% For CESQGs:

 Sewering with notification: 15 21%

 MSW Disposal: 3,15 42%

 HW Incineration: 15 30%

 Sent to RD: 9 7%

SQG For SQGs:

 Sewering with notification: 1 21%

 HW Incineration: 7 72%

 Sent to RD: 9 7% For LQGs and SQGs:

 No Sewering

 HW Incineration: 14 93%

 Sent to RD: 9 7% For LQGs and SQGs:

 No Sewering

 HW Incineration: 14 93%

 Sent to RD: 9 7%

LQG For LQGs:

 Sewering with notification: 1 17%

 HW Incineration: 7 76%

 Sent to RD: 9 7% For LQGs: 11

 Sewering (no notification): 17%

 HW Incineration: 18%

 MSW Disposal: 8%

 Medical Waste Disposal: 51%

 Sent to RD: 9 7%
Reverse Distributors

CESQG For all RDs:

 No sewering

 HW Incineration: 35%

 Sent RD

- to

- RD: 12 65% For all RDs:

 No sewering

 HW Incineration: 35%

 Sent RD

- to

- RD: 12 65% For all RDs:

 No sewering

 HW Incineration: 35%

 Sent RD

- to

- RD: 12 65% For all RDs:

 No sewering

 HW Incineration: 35%

 Sent RD

- to

- RD: 12 65% SQG

LQG95

Notes:
1. Under the full compliance baseline, the percentage of hazardous waste pharmaceuticals sewered is assumed to be the same as un der the partial compliance baseline.
2. This RIA assumes that 80% (for LQG/SQG hospitals and LQG other healthcare facilities) or 100% (for CESQG hospitals and SQG/CE SQG other healthcare facilities) of patient care HW pharmaceuticals are not incinerated. Based on personal communication with Selin Hoboy of Stericycle on August 6, 2012 and personal communication with Phil Retallick and John Kelsey of Clean Harbors on April 16, 2012. For HW pharmaceuticals not being incinerated, 22.5% is assumed to be sewered, 10% managed as MSW, and 67.5% managed as medical waste. Based on personal communication with Charlotte Smith of Waste Management Healthcare Solutions on December 5, 2 012 and personal communication with John Kelsey of Clean Harbors on December 2, 2012.
3. This RIA assumes that CESQGs can manage HW p harmaceuticals as MSW in States that permit this practice, across both baseline options and all three policy options. States that allow MSW disposal account for approximately 58.4% of potentially affected facilities (see main text for source informat ion).
4. For CESQGs under the full compliance baseline, this RIA assumes that pharmaceutical waste not sewered or sent to an RD is sen t to an MSW landfill or incinerated. States allowing MSW disposal (see note 3) account for 58.4 percent of facilities. Thus, 36% ((100%

- 20% sent to RD

- 18% sewered) × 58.4% = 36%) of CESQG hospitals and 42% ((100%

- 7% sent to RD

- 21% sewered) × 58.4% = 42%) of CESQG other HCFs are assumed to dispose in MSW landfills.
5. The RIA assumes that 20% of HW pharmaceuticals generated by hospitals are pharmacy waste (i.e., expired, recalled, and otherwise unused pharmaceuticals) rather than patient care waste. Based on personal communication with John Kelsey of Clean Harbors on August 17, 2012. For all facility t ypes, pharmacy waste is as sumed to be sent to reverse distributors for manufacturer credit.
6. For CESQG hospitals, patient care HW pharmaceuticals (80% of all HW pharmaceuticals) are assumed not to be managed in complia nce with RCRA regulations. Of this, 22.5% is assumed to be sewer ed, 10% managed as MSW, and 67.5% managed as medical waste (see note 2). Thus, 18% is assumed to be sewered (22.5% x 80% = 18 %), 8% managed through MSW disposal (10% x 80% = 8%), and 54% managed as medical waste (67.5% x 80% = 54%).
7. For the full compliance baseline, this RIA assumes that all patient care pharmaceuticals that are not sewered by LQG and SQG HCFs are incinerated.
8. This RIA assumes that 20% of LQG and SQG hospitals incinerate their patient care HW pharmaceuticals. Based on personal commun icatio n with Selin Hoboy of Stericycle on August 6, 2012 and personal communication with Phil Retallick and John Kelsey of Clean Harbors on April 16, 2012. As noted a bove, patient care pharmaceuticals represent 80% of hospital HW pharmaceuticals. Thus, 16% (80% × 20% = 16%) of HW pharmaceuticals are incinerated. Of the remainder, 22.5% is assumed to be sewered, 10% managed as MSW, and 67.5% managed as medical waste (see note 2). Thus, the RIA assumes that 14% is sewered (80% × 80% x 22.5% =14%), 6% managed as M SW (80% x 80% × 10% = 6%), and 43% managed as medical waste (80% x 80% × 67.5% = 43%).
9. According to the 2007 Economic Census, approximately 7% of other healthcare facilities are pharmacies, which are assumed to g enerate no patient care HW pharmaceuticals. As noted above, all unused pharmacy waste is assumed to be sent to a reverse distributor.
10. For CESQG and SQG other healthcare facilities, patient care HW pharmaceuticals (93% of all HW pharmaceuticals, i.e., those no t generated by pharmacies) are assumed no t to be managed in compliance with RCRA. Of this, 22.5% is assumed to be sewered, 10% managed as MSW, and 67.5% managed as medi cal waste. Thus, 21% (93% × 22.5% = 21%) are sewered, 9% (93% × 10% = 9%) are managed as MSW, and 63% (93% × 67.5% = 63%) are man aged as medical waste.
11. This RIA assumes that 20% of LQG other healthcare facilities incinerate their patient care HW pharmaceuticals, excluding nurs ing care facilities and continuing care retirement communities, which are considered households under RCRA ( approximately 4% of other healthcare facilities). This also excludes pharmacies, which do not generate patient care waste (see footnote 9 above indicating that 7% of HCFs are pharmacies). Thus, 18% (20% × 93% × 96% = 1 8%) of HW pharmaceuticals are inciner ated. Of the remainder, 22.5% is assumed to be sewered, 10% managed as MSW, and 67.5% managed as medical waste (see note 2). Thus, 17% (75% × 22.5% = 17%) is sewered, 8% (75% × 10% = 8%) is managed as MSW, and 51% (75% × 67.5% = 51%) is managed as medical waste. 12. This RIA assumes that 65% of HW pharmaceuticals from reverse distributions are shipped between reverse distributors before be ing transported to the manufacturer or a TSDF. Based on personal communication with Charlotte Smith of Waste Management Heal thcare Solutions on January 8, 2013.
13. For the More Stringent and Proposed Options, 58 percent of patient care hazardous waste pharmaceuticals generated by CESQG HC Fs (i.e., those not sent to an RD) are assumed to be managed as MSW (see note 3 above), and th e remainder is assumed to be incinerated. Thus, for CESQG hospitals, 47% (80% × 58.4% = 47%) of HW pharmaceuticals are assumed to be managed as MSW, and for CESQG other healthcare facilities 54% (93% ×58.4% = 54%) are assume d to be managed as MSW.
14. All p atient care waste generated SQG and LQG HCFs is assumed to be incinerated under all three policy options.
15. For the Less Stringent Option, CESQGs are assumed to sewer the same amount as under the partial compliance baseline. In addi tion, 58 percent of pati ent care hazardous waste pharmaceuticals that are not sewered by CESQG HCFs (which excludes those going to an RD) are assumed to be managed as M SW (see footnote 3 above), and the remainder is assumed to be incinerated. Thus, for CESQG hospitals, 36% (62% × 58.4% = 36%) of HW pharmaceuticals are assumed to be managed as MSW and for, CESQG other healthcare facilities, 42% (72% ×58.4% = 42%) of HW pharmaceuticals are assumed to be managed as MSW.96 

### More Stringent Option: Under the More Stringent Option, sewering is prohibited for all hazardous waste pharmaceuticals, including those generated by CESQGs. Thus, all hazardous waste pharmaceuticals generated by LQGs and SQGs must be incinerated under this option, though some pharmacy waste is first sent to reverse distributors and some waste from reverse distributors is sent to other reverse distributors. The sewering ban would not require that all hazardous waste pharmaceuticals generated by CESQGs be
incinerated. Under Fed eral regulation, CESQGs may dispose of their hazardous wastes as MSW. As described in the General Assumptions section above, however, this RIA estimates that state regulations would preclude MSW disposal of patient care hazardous waste pharmaceuticals for approximately 41.6 percent of CESQGs. This RIA therefore assumes that 58.4 percent of the patient care hazardous waste pharmaceuticals generated by CESQGs could be managed as MSW under the More Stringent Option. Exhibit 3

- 9
shows the distribution of haz ardous waste pharmaceuticals across these various management methods under the More Stringent Option.

Similar to the baseline, all hazardous waste pharmaceuticals generated by reverse distributors are assumed to be incinerated under this option, though som e are shipped to another reverse distributor prior to incineration. In addition, all hazardous wastes other than pharmaceuticals are assumed to be managed through incineration under this option.

Proposed Option: Similar to the More Stringent Option, the P roposed Option prohibits the sewer disposal of hazardous waste pharmaceuticals. Disposal costs under this option are therefore similar to disposal costs under the More Stringent Option. However, because of the longer accumulation time limit for hazardous waste pharmaceuticals under the Proposed Option ( one year for healthcare facilities), facilities may send fewer partially filled drums offsite for disposal. In other words, the longer accumulation time
limit allows for the consolidation of hazardous wast e pharmaceuticals into fewer drums, reducing the drum loading costs incurred by regulated facilities. This implies lower disposal costs than under the More Stringent Option (though still higher than under the baseline because of the sewering ban). 118 

### Exhib it 3

- 9 shows the distribution of hazardous waste pharmaceuticals by management method under the Proposed Option and documents how this distribution was developed.

Less Stringent Option: Under the Less Stringent Option, disposal requirements for
hazardous w aste pharmaceuticals are similar to the More Stringent and Proposed Options, with the exception that sewering (with notification) is permitted for CESQG healthcare
facilities . Thus, all reverse distributors (including CESQGs) , LQG and SQG hospitals,
and L QG and SQG other healthcare facilities are assumed to incinerate all of their patient care hazardous waste pharmaceuticals. In contrast, CESQG healthcare facilitie s may sewer their patient care hazardous waste pharmaceuticals, incinerate them, or manage

118 Similar savi ngs were not assumed for the disposal of hazardous wastes other than pharmaceuticals if a facility’s generator
status changes under the rule (e.g., from LQG to SQG). Because it is uncertain whether these wastes are managed through

incineration or some oth er means, disposal costs for these wastes were assumed to be the same under the baseline and each
policy option. The estimated disposal cost impacts in this RIA therefore reflect only hazardous waste pharmaceuticals. For
other waste management activities (e.g., biennial reporting, transportation, etc.), this RIA does assess potential cost savings
associated with a change in generator status, as the costs of these activities are not sensitive to the choice of disposal

method.97 

### t hem as MSW. Exhibit 3

- 9 shows this RIA’s assumed distribution across these management methods.

Facilities that incinerate their hazardous waste pharmaceuticals in the baseline may realize a disposal cost savings under this option due to the longer accumulation time limits under this option relative to the baseline. Longer time limits will allow some facilities to consolidate their hazardous waste pharmaceuticals into fewer drums, thereby reducing the costs associated with loading drums for disposal

.

RESULTS



### Exhibit 3

- 1 0 report s the annualized costs for potentially affected facilities under the full compliance baseline and the annualized costs of each policy option relative to the
baseline. As the exhibit shows, disposal represents the most signific ant waste management activity with respect to costs. This reflects the high costs of disposal, particularly incineration, relative to other waste management activities for healthcare
facilities. As indicated in the exhibit, incremental costs are signific antly higher under the More Stringent Option than under the Proposed Option and the Less Stringent Option. The largest source of the difference in costs is attributable to the shorter accumulation time limits under the More Stringent Option, which results in facilities managing a larger number of containers for hazardous waste pharmaceuticals. This is reflected in the higher costs of container management, transportation, and disposal relative to the Proposed and Less Stringent Options.98 EXHIBIT 3

- 1 0 . TOTAL ANNUALIZED BASELINE COSTS AND INCREMENTAL COSTS BY

WASTE MANAGEMENT ACT IVITY, 7 PERCENT DIS COUNT RATE ($2011 MILLIONS)

ROW WASTE MANAGEMENT

ACTIVITY TOTAL
ANN UALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COSTS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification 2 $0. 0 0 $0. 07 $0.07 $0.07

2 Training $79. 6 5 $1.5 3 $1.5 3 $1.5 3

3 Manifest Training $6.3 0 $0.23 $0.23 $0.23

4 Contingency Plan Updating $4.9 1 $0.16 $0.00 $0.00

5 Container Management $28.8 4 $5.31 $2.67 $2.28

6 Labeling $0.4 4 $0.52 $0.48 $0.48

7 Inspections $94. 2 5 $3.15 $0.05 $0.05

8 Warehousing $0.0 0 $0.01 $0.00 $0.00

9 Closure $4.5 1 $1.24 $1.21 $1.21

10 RCRA Storage Permit $0.0 0 $0.68 $0.00 $0.00

11 Sorting $27. 05 $5.12 $5.12 $5.09

12 Biennial Reports $ 2

. 2 4 $0.0 7 $0.00 $0.00

13 Recordkeeping 3 $0.1 5 $0.01 $0.00 $0.00

14 Manifests and Other Tracking $1.0 3 $0.98 $0.49 $0.49

15 Transportation $72. 67 $3.19 $1.79 $1.79

16 Disposal $554. 59 $23.45 $22.91 $21.47

17 TOTAL $876. 6 2 $45. 71 $36. 56 $34.6 9

Notes:
1. For some provisions there are no costs (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.
2. Notification c osts are included in biennial reports, presented elsewhere in this table, for facilities that are required to submit biennial reports (all LQGs and SQGs in states that require biennial reporting for SQGs) to avoid double

- counting.
3. Recordkeeping costs reflect the cost of mainta ining records for waste characterizations. Recordkeeping costs for manifests are included in the manifest costs presented elsewhere in
this table.



### Exhibit 3

- 11 reports the distribut ion of the incremental costs for each policy option across the three RCRA generator categories (i.e., LQGs, SQGs, and CESQGs) for healthcare
facilities and reverse distributors . As indicated in the exhibit, the estimated costs of each option are higher for healthcare facilities than for reverse distributors, due in large part to
the larger number of the former. Among healthcare facilities, costs are highest for SQGs. This partly reflects the large number of SQG healthcare facilities relative to LQGs, as SQGs account for approximately 1 3 percent of affect ed facilities while LQGs account for approximately 3 percent. The SQG healthcare facility costs also reflect the high er per

-99 

### facility costs of the proposed rule for these facilities relative to CESQGs (see Exhibit 3

- 12 ). B ecause CESQGs in several states can manage their hazardous waste pharmaceuticals through MSW disposal (which costs less than incineration) under the More Stringent and Proposed Options, they incur lower incremental costs. Under the Less Stringent Option, there are no i ncremental disposal costs for CESQGs, whi le sewering is banned for SQGs.

EXHIBIT 3

- 1 1 . ANNUALIZED INCREM ENTAL COSTS OF PROPO SED RULE BY BASELINE GENERATOR

STATUS AND FACILITY TYPE , 7 PERCENT DISCOUNT RATE ($2011 MILLIONS )

GENERATOR
STATUS FACILITY TYPE NUMBER OF
FACILITIES MORE STRINGENT

OPTION PROPOSED

OPTION LESS STRINGENT

OPTION
CESQG Hospitals 2,555 $0. 06 $0. 06 $0. 0 0

SQG Hospitals 2,397 $1. 69 $1.4 2 $1.4 2

LQG Hospitals 1,553 $6. 16 $6.1 4 $6. 07

CESQG Other Healthcare Facilities 142,831 $1.4 1 $1.4 1 $0. 0 0

SQG Other Healthcare Facilities 20,910 $24.9 4 $18.6 5 $18.4 1

LQG Other Healthcare Facilities 3,721 $10. 58 $8.7 1 $8.6 3

CESQG Reverse Distributors 21 $0.41 $0.11 $0.11

SQG Reverse Distributors 7 $0.11 $0.01 $0.01

LQG Reverse Distributors 28 $0.35 $0.04 $0.04

TOTAL 174,023 $45. 71 $36. 56 $34.6 9



### Exhibit 3

- 12 presents the estimated cost impacts on a per facility basis incremental to the baseline for each model facility. 119 

### This RIA estimates that cost impacts per facility (incremental to the full compliance baseline) are highest under the Proposed Option for reverse distributors, and in particular CESQG reverse distributors. This reflects the relatively low costs that thes e facilities incur in the baseline (because they are CESQGs) and the increased stringency of the requirements for these facilities under the Proposed Option. For healthcare facilities (which does not include reverse distributors), costs per facility for L QGs and SQGs are higher than the per

- facility costs for CESQGs, as many of the Proposed Option provisions apply to LQGs and SQGs only.

119 Under the proposed rule, app roximately 3,870 long

- term care facilities that are currently exempt from RCRA under the
household hazardous waste exclusion would have to comply with RCRA requirements for healthcare facilities. For LQGs (137
facilities) and SQGs (834 facilities) this wou ld increase costs associated with obtaining an EPA ID number, developing a
contingency plan, developing a closure plan, conducting manifest training, completing manifests, and transporting and
disposing hazardous waste in compliance with RCRA regulations. Incremental to the baseline, this RIA estimates that these costs are $1.2 million on an annualized basis. The average cost per long

- term care facility is estimated to be approximately $320. By generator status, the average cost per long

- term care facility is estimated to be approximately $3,800 for LQGs and $860 for SQGs. There are no estimated costs for CESQG long

- term care facilities.100 EXHIBIT 3

- 12 . ANNUALIZED INCREM ENTAL COSTS PER FACI LITY BY MODEL FACILI TY, 7

PERCENT DISCOUNT RAT E ($2011)

ROW BASELINE
GENERATOR
STATUS FACILITY TYPE FACILITY
SIZE MORE

STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 CESQG Hospitals Small $20 $20 $0

2 CESQG Hospitals Large $20 $20 $0

3 CESQG Other Healthcare Facilities Small $10 $10 $0

4 CESQG Other Healthcare Facilities Large $10 $10 $0

5 CESQG Reverse Distributors Small $19,400 $5,300 $5,300

6 SQG Hospitals Small $700 $590 $590

7 SQG Hospitals Large $700 $590 $590

8 SQG Other Healthcare Facilities Small $1,200 $890 $880

9 SQG Other Healthcare Facilities Large $1,300 $920 $900

10 SQG Reverse Distributors Small $15,400 $1,200 $1,200

11 LQG Other Healthcare Facilities Large $2,800 $2,300 $2,300

12 LQG Reverse Distributors Large $12,300 $1,400 $1,400

13 LQG Non

- teaching Hospitals Large $1,600 $1,400 $1,400

14 LQG Teaching Hospitals, less than 370

beds Large $2,500 $2,300 $2,200

15 LQG Teaching Hospitals, 370 to 799 beds Large $6,500 $6,800 $6,700

16 LQG Teaching Hospitals, 800 or more

beds Large $11,600 $12,200 $12,100101 SENSITIVITY ANALYSES


### As described throughout this chapter, there are uncertainties in several aspects of this
RIA’s assessment of the proposed rule’s costs. This section presents sensitivity analyses
related to the most significant of these uncertainties. These uncertainties and the corresponding sensitivity analyses are as follows:

 Baseline management of hazardous waste pharmaceutical s : Although the cost estimates presented above assume that healthcare facilities manage their hazardous waste pharmaceuticals in compliance with RCRA regulations, many of these facilities may not be in compliance. To test the sensitivity of this RIA’s

cost r esults to this baseline assumption, t his section estimates costs incremental to an alternative, partial compliance baseline in which many facilities are non

compliant.

 Size of the universe: The size of the affected universe of facilities, as presented
abov e, is based in part on data from both Massachusetts and Minnesota characterizing the percentage of healthcare facilities that are hazardous waste generators. While the analysis presented above combines the data from these two states, the data from each st ate individually would suggest different estimates of this percentage. As a sensitivity analysis, this RIA generates two alternative estimates of regulatory costs: one in which the size of the universe is based on the Minnesota data only and a second in w hich the size of the universe is based on
the Massachusetts data.

 Alternative cost of incineration: As indicated in Exhibit 3

- 11 above, disposal costs account for a significant portion of the costs associated with the rule. These costs are highly depende nt on the cost of incineration , which is variable . As a sensitivity analysis, this section examines the estimated costs of the proposed rule using alternative per unit costs for incineration.

 Discount rate: The cost estimates presented above reflect a di scount rate of 7 percent. This section presents results based on an alternative discount rate of 3
percent.

SENSITIVITY ANALYSIS : PARTIAL COMPLIANCE BASELINE


### As described earlier in this chapter, the baseline management practices for hazardous waste pharm aceuticals are uncertain. While the results presented above assume that healthcare facilities manage hazardous waste pharmaceuticals in full compliance with RCRA requirements, information from industry experts suggests that many healthcare
facilities may not manage hazardous waste pharmaceuticals in compliance with RCRA. To address this uncertainty with respect to facility compliance, this RIA estimates the
costs of the rule incremental to a partial compliance baseline

. The k ey assumptions for
the partial compliance baseline are as follows:

 Reverse distributors are compliant: Because reverse distributors’ operations require the sorting of pharmaceuticals to identify drugs that may be sent back to manufacturers, these facilities are likely to have ef fective systems in place to102 

### identify pharmaceuticals that must be disposed of in accordance with RCRA. These facilities are therefore assumed to manage their hazardous waste pharmaceuticals in compliance with RCRA. Although a significant portion of the
h azardous waste pharmaceuticals sent to a reverse distributor are subsequently sent to another reverse distributor, this RIA assumes that these wastes are ultimately managed through hazardous waste incineration.

 Pharmacy waste is compliant: H azardous waste pharmaceuticals generated by pharmacies

—

both in hospitals and at the retail level

— are assumed to be in compliance with RCRA, as these entities typically send their hazardous waste pharmaceuticals to reverse distributors. Industry sources suggest that 20 p ercent of the hazardous waste pharmaceuticals at hospitals are generated by on

- site pharmacies, 120 

### while data from the Economic Census indicate that approximately 7 percent of non

- hospital healthcare facilities are pharmacies. 121



###  Patient care hazardous wast e pharmaceuticals are partially compliant: For patient care pharmaceuticals, input from waste management firms that serve hospitals suggests that as few as 20 percent of hospitals manage their patient care hazardous waste pharmaceuticals in compliance wit h RCRA. 122 

### This RIA assumes that this 20 percent compliance figure applies to LQG and SQG hospitals as well as other healthcare facilities that are LQGs. 123 

### Thus, 80 percent of patient care pharmaceuticals from these facilities are assumed not to be managed in compliance with RCRA regulations. For other healthcare facilities (i.e., CESQG hospitals and non

- hospital healthcare facilities that are SQGs or CESQGs), the rate of non

- compliance for patient care pharmaceuticals is assumed to be 100 percent. Non

- com pliant facilities may use a variety of methods to manage their hazardous waste pharmaceuticals. Based on input from industry sources, this RIA assumes that 22.5 percent of non

- compliant patient care hazardous waste pharmaceuticals are sewered, 10 percent are managed as MSW, and 67.5 percent are managed as medical waste. 124

120 Personal communication with John Kelsey of Clean Harbors on August 17, 2012.

121 U.S. Census Bureau, 2007 Economic Census.

122 Personal communication with Selin Hoboy of Stericycle on August 6, 2012 and personal communication with Phil Retallick
and John Kelsey of Clean Harbors on April 16, 2012.

123 Because CESQG hospitals face limited requirements under RCRA, waste management firms are likely to have limited
experience working with them. Thus, it is unclear that the 20 percent compliance figure derived from contacts at these
firms would apply to CE SQG hospitals. Also, this RIA applies the 20 percent compliance rate to LQG healthcare facilities
other than hospitals but not to SQGs and CESQGs because other healthcare facilities (non

- hospitals) that are LQGs are
assumed to be more likely than SQGs or CESQGs to achieve a compliance rate similar to that of hospitals.

124 Values based on personal communication with Charlotte Smith of Waste Management Healthcare Solutions on December 5,
2012 and personal communication with John Kelsey of Clean Harbors on Dec ember 2, 2012.103 

### The assessment of costs under the partial compliance baseline further assumes that non

compliance is limited only to the management of hazardous waste pharmaceuticals. Most
of the facilit ies affected by the rule generate other hazardous wastes and are assumed to manage these wastes in compliance with RCRA for the purpose of this analysis. In addition, the partial compliance baseline assumes that these facilities meet all facility

wide gen erator requirements that are not specific to any type of hazardous waste (e.g., notification). Thus, non

- compliance is assumed to be limited to the variable costs associated with the management of hazardous waste pharmaceuticals. 125



### For example, in the part ial compliance baseline firms that are required to submit BR records to EPA or their authorized state agency are assumed to submit GM forms for non

pharmaceutical hazardous wastes. T he 2009 BR data suggest that hospitals submitted an average of 6 GM forms for hazardous waste pharmaceuticals and 13 GM forms for non

pharmaceutical hazardous wastes

— a total of 19 GM forms per facility. The partial compliance baseline assumes that non

- com pliant firms submit GM forms for other hazardous wastes, but not hazardous waste pharmaceuticals.

For transportation, the partial compliance baseline applies the same unit costs as the full compliance baseline. While under the partial compliance basel ine some hazardous waste pharmaceuticals may be managed as medical waste

, t ransportation costs for medical waste are assumed to be the same as for hazardous waste because regulated medical waste is considered hazardous under DOT regulations. 126

, 127



### The most significant difference between the full compliance baseline and the partial compliance baseline involv es assumptions regarding hazardous waste disposal methods

. These assumptions themselves are earlier described in detail in Exhibit 3

- 9

. Under the partia l compliance baseline, methods employed for the disposal of hazardous waste pharmaceuticals vary more than under the full compliance baseline. D isposal methods in the partial compliance baseline include incineration, sewering without notification, MSW
dis posal, and medical waste disposal

. Overall, baseline costs for facilities potentially affected by the rule under the partial compliance baseline are approximately 12 percent lower than under the full compliance baseline. Because fewer hazardous waste ph armaceuticals are incinerated under the partial compliance baseline than the full compliance baseline, costs are generally lower. Although the partial compliance baseline conservatively assumes widespread non

compliance with RCRA with respect to the manag ement of hazardous waste pharmaceuticals, the difference in costs between the two baselines is not larger for two reasons. First, as described earlier in this chapter, RCRA non

- compliance specific to hazardous waste pharmaceuticals is assumed to affect so me, but not all, waste

125 Of the cost items listed in the section entitled “Scope of Cost Impacts Examined” below, these variable costs include
sorting, container management, labeling, transport, manifests, disposal, and biennial reporting.

126 See U.S. DOT Hazardous Materials Table at 49 CFR 172.101.

127 This RIA does not estimate any partial shipment surcharges for medical waste because hazardous waste pharmaceuticals,
if disposed as medical waste, represent just a fraction of the medical waste likely to be generated by a healthcare facility.104 

### management activities. Because regulated facilities generate hazardous wastes other than hazardous waste pharmaceuticals, this RIA assumes that these facilities comply with facility

- wide RCRA requirements (e.g., for training) under the partial compliance baseline. The second (and related) reason why the cost difference between the two baselines is not larger is because the cost estimates reflect the c ost of managing hazardous wastes other than pharmaceuticals. Because the Proposed Option and Less Stringent Option do not count hazardous waste pharmaceuticals toward a facility’s generator status, the generator status of some facilities may change as a r esult of the rule. To capture the cost savings associated with such a change, it was necessary to include costs associated with hazardous wastes other than pharmaceuticals in the assessment of costs for the baseline and for each policy option. 128 

### The manag ement of these (non

- pharmaceutical)
hazardous wastes is assumed not to differ between the two baselines.

Exhibit 3

- 13 reports the annualized costs for potentially affected facilities under the partial compliance baseline and the incremental annualized cost s of each policy option
relative to this baseline

. The estimated cost impacts of each policy option are more than
three times greater incremental to the partial co mpliance baseline than the full compliance
baseline. Under each of the policy options, annu alized incremental costs exceed $100 million. However, some of these costs are offset by potential cost savings of the proposed rule, which are described in Chapter 4.

128 As indicated in a previous footnote, the cost savings associated with a change in generator status in this RIA do not include
disposal cost savings, due to uncertainty regarding the disposal methods used by healthcare facilities and reverse distributo rs

f or their non

- pharmaceutical hazardous waste.105 EXHIBIT 3

- 1 3 . TOTAL ANNUALIZED PARTIAL COMPLIANCE B ASELINE COSTS AND

INCREMENTAL COSTS BY WASTE MANAGEMENT ACTIVITY, 7
PERCENT DISCOUNT RAT E ($2011 MILLIONS)

ROW WASTE MANAGEMENT

ACTIVITY TOTAL
ANNUALIZED
COSTS IN

THE PARTIAL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COSTS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification 2 $0. 0 0 $0.07 $0.07 $0.07

2 Training $79.6 5 $1.53 $1.53 $1.53

3 Manifest Training $6.3 0 $0.23 $0.23 $0.23

4 Contingency Plan Updating $4.9 1 $0.16 $0.00 $0.00

5 Container Management $27. 09 $7.06 $4.28 $3.85

6 Labeling $0. 09 $0.87 $0.78 $0.78

7 Inspections $94.2 5 $3.15 $0.05 $0.05

8 Warehousing $0.0 $0.01 $0.00 $0.00

9 Closure $4.5 1 $1.24 $1.21 $1.21

10 RCRA Storage Permit $0.0 $0.68 $0.00 $0.00

11 Sorting $7.8 4 $24.34 $24.34 $24.30

12 Biennial Reports $2.0 0 $0.31 $0.00 $0.00

13 Recordkeeping 3 $0.1 5 $0.01 $0.00 $0.00

14 Manifests and Other Tracking $1.0 3 $0.98 $0.49 $0.49

15 Transportation $67.8 4 $8.02 $6.63 $6.62

16 Disposal $473.2 4 $104.80 $104.26 $102.82

17 TOTAL $768. 88 $153.45 $143.86 $141.96

Notes:
1. For some provisions there are no costs (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.
2. Notification c osts are included in biennial reports, presented elsewhere in this table, for facilities that are required to submit biennial reports (all LQGs and SQGs in states that require biennial reporting for SQGs) to avoid double

- counting.
3. Recordkeeping costs reflect the cost of maintaining records for waste characterizati ons. Recordkeeping costs for manifests are included in the manifest costs presented elsewhere in
this table.

SENSITIVITY ANALYSIS : SIZE OF THE POTENT IALLY AFFECTED UNIVE RSE


### As indicated in Chapter 2, a key calculation in this RIA is the estimation of the
percentage of healthcare facilities that are hazardous waste generators. To inform this calculation, this RIA relies on datasets provided by t wo states

— Massachusetts and
Minnesota

— that include complete list s of hazardous waste generators in each state and
that also contain facility

- specific information

, including a unique EPA or state ID106 

### number, address, facility name, and generator status (i.e., LQG, SQG, or CESQG). 129



### T his RIA estimates the percentage of hea lthcare facilities that are hazardous waste generators as the combined number of LQG, SQG, and CESQG healthcare facilities in these states divided by the total number of healthcare facilities reported by the U.S.
Economic Census for the two states combined

. As shown in Chapter 2, 100 percent of hospitals in both states are estimated to be hazardous waste generators, while 16.2 percent of other healthcare facilities in Massachusetts and 44.0 percent of other healthcare
facilities in Minnesota are estimated to be hazardous waste generators. Combined, these two values yield a weighted average of 27.6 percent.
This section provides a sensitivity analysis using the Massachusetts and Minnesota data, separately, to estimate a range of costs for the proposed rule based on assumptions for the size of the potentially affected universe. Using the Massachusetts data to extrapolate to the number of hazardous waste generators nationwide, this RIA estimates that approximately 104, 5 00 healthcare facilities and reverse dis tributors would by potentially affected by the proposed rule. In comparison, using the Minnesota data, this RIA estimates that approximately 273,200 hazardous waste generators would be potentially affected by the proposed rule. In both cases, the estimat ed number of hospitals and
reverse distributors is the same. Therefore, the estimated number of other healthcare
facilities potentially affected by the proposed rule is approximately 97,900 with the
Massachusetts data and 266,700 based on the Minnesota da ta

.
Exhibit 3

- 14 reports the low and high end estimate of the number of potentially affected
healthcare facilities and reverse distributors as well as the annualized incremental costs under each policy option given the size of the regulatory universe. As shown in the exhibit, under the proposed option the annualized cost of the proposed rule is between $24.6 and $53. 6 million. A nnualized cost s are estimated to be between $30. 4 and $67. 6
million under the More S tringent O ption and between $23. 5 and $50. 7 million under the
Less S tringent O ption.

129 Minnesota data were provided by Kathy Gedde of the Minnesota Pollution Control Agency (MPCA) on October 24, 2012.
Massachusetts data were obtained from Massachusetts Energy and Environmental Affairs’ Departmen t of Environmental

Protection at http://www.mass.gov/eea/agencies/massdep/recycle/hazardous/hwgen.html on February 18, 2014.107

EXHIBIT 3

- 1 4 . ANNUALIZED INCREM ENTAL COSTS OF PROPO SED RULE BY BASELINE GENERATOR STATUS AND FACILITY TYPE , 7 PERCENT DISCOUNT

RATE , LOW AND HIGH END U NIVERSE ESTIMATES ($2011 MILLIONS)

GENERATOR
STATUS FACILITY TYPE LOW END ESTIMATE (BASED ON MASSACHUSE TTS DATA) HIGH END ESTIMATE (BASED ON MINNESOTA DATA)

NUMBER OF
FACILITIES MORE

STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION NUMBER OF

FACILITIES MORE

STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION
CESQG Hospitals 2,555 $0.1 $0.1 $0.0 2,555 $0.1 $0.1 $0.0

SQG Hospitals 2,397 $1.7 $1.4 $1.4 2,397 $1.7 $1.4 $1.4

LQG Hospitals 1,553 $6.2 $6.1 $6.1 1,553 $6.2 $6.1 $6.1

CESQG Other Healthcare Facilities 83,495 $0. 8 $0. 8 $0.0 227,433 $2.3 $2.3 $0.0

SQG Other Healthcare Facilities 12,223 $1 4

. 6 $1 0

. 9 $1 0

. 8 33,295 $39. 7 $29. 7 $29. 3

LQG Other Healthcare Facilities 2,174 $6. 2 $5. 1 $5. 0 5,923 $16.8 $13.9 $13.7

CESQG Reverse Distributors 21 $0.41 $0.11 $0.11 21 $0.41 $0.11 $0.11

SQG Reverse Distributors 7 $0.11 $0.01 $0.01 7 $0.11 $0.01 $0.01

LQG Reverse Distributors 28 $0.35 $0.04 $0.04 28 $0.35 $0.04 $0.04

TOTAL 104,453 $3 0

. 4 $2 4

. 6 $2 3

. 5 273,21 2 $67. 6 $53. 6 $50. 7108 SENSITIVITY ANALYSIS : A LTERNATIVE C OST OF I NCINERATION


### As indicated in the results presented above, changes in disposal costs, in particular the cost of diverting hazardous waste pharmaceuticals from their baseline waste management methods to incineration, represent a significant portion of the rule’s cost impacts. To estimate the rule’s disposal cost impacts, this RIA assumes that the cost of incineration is approximately $2.09 per pound. 130 

### However, the re adily available data suggest a potential disparate range of incineration costs. On the low end of the range, an industry source indicates that the cost of incineration for hazardous waste pharmaceuticals may be as low as $1 per pound. 131 

### Conversely, the RA CER cost estimating software indicates an incineration cost of approximately $3.44 per pound. 132 

### The selection of the unit cost value of $2.09 per pound used in the RIA is further supported by the range of estimates described above, as it is close to the mi dpoint of this range.

To assess the sensitivity of the estimated cost impacts of the rule to alternative incineration costs, this RIA estimates the costs of the rule with both the low end ($1 per pound) and high end ($3.44 per pound) values referenced abov e. The associated results (and those based on the primary incineration cost of $2.09 per pound) are presented in
Exhibit 3

- 15

. Based on these results, the estimated costs of the Proposed and Less Stringent Options are approximately 30 percent lower when assuming an incineration cost of $1 per pound and 40 percent higher when using an incineration cost of $3.44 per pound.

130 Obtained from Alan Davidner of Vestara, Inc ., as quoted in Jeff Donn, Martha Mendoza, and Justin Pritchard, "AP IMPACT:
Health care industry sends tons of drugs into nation's wastewater system." September 14, 2008. Available at
http://hosted.ap.org/specials/interactives/pharmawater_site/sept14a.ht ml.

131 The $1 per pound estimate is from personal communication with John Kelsey of Clean Harbors on August 17, 2012.

132 RACER 2010 cost estimating software.109 EXHIBIT 3

- 1 5 . ANNUALIZED INCREM ENTAL COSTS OF THE P ROPOSED RULE WITH

ALTERNATIVE INCINERA TION COSTS, 7 PERCENT DISCOUNT RATE ($2011 MILLIONS)

COST OF INCINERATION ($/POUND) MORE STRINGENT
OPTION PROPOSED OPTION LESS STRINGENT
OPTION $1 (low

- end estimate) 1 $33. 3 $24. 2 $23. 4
$2.09 (primary estimate) 2 $45. 7 $36. 6 $34. 7
$3.44 (high

- end estimate) 3 $61. 1 $51. 9 $48. 7

Notes:
1. Low

- end incineration estimate of $1 per pound obtained from personal communication with John Kelsey of Clean Harbors on August 17, 2012.
2. Primary estimate for the cost of incineration ($2.09 per pound) obtained from Alan Davidner of Vestara, Inc., as quoted in Jeff Donn, Martha Mendoza, and Justin Pritchard, "AP IMPACT: Health care industry sends tons of drugs into nation's wastewater system." September 14, 2008.
Available at http://hosted.ap.org/specials/interactives/pharmawater_site/sept14a.html

. 3. High

- end incineration estimate of $3.44 per pound derived from RACER 2010 cost estimating
software.



### The proportional difference is slightly less pronounced under the More Stringent Option. Under this option, the use of the low

- end incineration value reduces cost impacts by 2 7 percent incremental to the full compliance baseline. Using the high

- end incineration value, the change in costs associated with the More St ringent Option is 3 4 percent higher incremental to the baseline. The proportional change is lower under the More Stringent Option because disposal costs comprise a larger share of the overall costs under the Proposed and Less Stringent Options. Hazardous waste generators, particularly reverse distributors, must comply with more regulations under the More Stringent Option; therefore, the proportional impact of higher disposal costs is moderated by higher costs associated with other requirements.

SENSITIVIT Y ANALYSIS: DISCOUNT RATE


### This RIA reports costs of the proposed rule using a discount rate of 7 percent. Some economists believe the social rate of time preference is actually closer to 3 percent. The real rate of return on long

- term government debt may provide a reasonable proxy for the
rate the average saver uses to discount future consumption . Over the last thirty years, this rate has averaged approximately 3.1 percent in real terms on a pre

- tax basis. 133 

### The costs presented in this RIA do not appear to be sensitive to changes in the discount rate. The similarity in costs using different discount rates reflects the fact that the costs largely represent ongoing operation and maintenance costs rather than one

- time capital expenditures. Exhibit 3

- 16 reports the incremental costs of each policy option relative to the full compliance baseline using a discount rate of three percent.

133 The U.S. Office of Management and Budget (OMB) requires Federal agencies to report results using discount rates of
three and seven percent (see OMB, Circular A

- 4, 2003).110 EXHIBIT 3

- 1 6 . TOTAL ANNUALIZED BASELINE COSTS AND I NCREMENTAL COSTS

BY WASTE MANAGEMENT ACTIVITY, 3 PERCENT DISCOUNT RAT E ($2011 MILLIONS)

RO
W WASTE MANAGEMENT

ACTIVITY TOTAL
ANNUALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COSTS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification 2 $0.00 $0.05 $0.05 $0.05

2 Training $78.38 $1.51 $1.51 $1.51

3 Manifest Training $5.85 $0.21 $0.21 $0.21

4 Contingency Plan Updating $4.01 $0.13 $0.00 $0.00

5 Container Management $28.25 $5.24 $2.60 $2.28

6 Labeling $0.44 $0.52 $0.48 $0.48

7 Inspections $94.25 $3.15 $0.05 $0.05

8 Warehousing $0.00 $0.00 $0.00 $0.00

9 Closure $3.21 $0.88 $0.86 $0.86

10 RCRA Storage Permit $0.00 $0.49 $0.00 $0.00

11 Sorting $27.05 $5.12 $5.12 $5.09

12 Biennial Reports $2.24 $0.07 $0.00 $0.00

13 Recordkeeping 3 $0.15 $0.01 $0.00 $0.00

14 Manifests and Other Tracking $1.03 $0.98 $0.49 $0.49

15 Transportation $72.67 $3.19 $1.79 $1.79

16 Disposal $554.34 $23.70 $23.16 $21.51

17 TOTAL $871.86 $45.26 $36.34 $34.32

Notes:
1. For some provisions there are no costs (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.
2. Notification c osts are included in biennial reports, presented elsewhere in this table, for facilities that are required to submit biennial rep orts (all LQGs and SQGs in states that require biennial reporting for SQGs) to avoid double

- counting.
3. Recordkeeping costs reflect the cost of maintaining records for waste characterizations. Recordkeeping costs for manifests are included in the manifest c osts presented elsewhere
in this table.111 ANALYTIC LIMITATIONS


### This section describes the analytic limitations of the cost analysis presented in this chapter. Given the limited data available on the generation and management of
hazardous waste pharmaceuticals, this RIA develops reasonable estimates of the proposed rule’s cost impacts. Nevertheless, it is important to highlight the most significant limitations of the cost analysis, as summarized below:

 The hazardous waste generation quanti ties contemplated in the analysis are highly uncertain. While this RIA uses the best available information from EPA’s Biennial Report database and a limited number of states on the generation of hazardous waste pharmaceuticals, these data are only availab le for a small proportion of facilities nationwide. It cannot be determined whether the facilities in these sources are generally representative of all facilities that may be affected by the proposed rule. It is therefore uncertain whether use of these d ata leads to overestimation or underestimation of the rule’s cost impacts.
As described above, while relatively more data are available for hospitals and reverse distributors, there are insufficient data to further stratify generation quantities among other facility types. Therefore, the “other healthcare facilities” generation estimates used in this chapter may lead to overestimation or underestimation of the rule’s cost impacts for specific types of facilities represented by the “other healthcare fac ilities” model facilities (e.g., physicians’ offices, veterinary clinics, nursing care facilitie s, etc.).

Uncertainty regarding hazardous waste generation quantities for the regulated universe also presents limitations for estimating the number of potent ially affected facilities that are LQGs, SQGs, or CESQGs. As shown in Exhibit 3

- 1 3

, costs per facility vary significantly according to a facility’s RCRA generator status. This RIA may therefore overestimate or underestimate the potential
incremental cost s of the proposed rule depending on the accuracy of the assumed distribution of facilities by generator status, as presented in Chapter 2.

 The methodology used in this RIA is limited by uncertainty regarding hazardous waste management methods under the bas eline. As described earlier in this chapter, this RIA contemplates two baseline scenarios to account for uncertainty with respect to compliance with existing RCRA regulations: a full compliance baseline and a partial compliance baseline. Each of these

sc enarios makes several assumptions regarding the management of hazardous waste pharmaceuticals by facilities in the regulated universe. Although these assumptions may be reasonable, the management methods employed by regulated facilities in the baseline ar e highly uncertain and likely to vary significantly, even among facilities represented by the same model facility. Therefore, to the extent that the baseline management assumptions used in this RIA are not representative of the baseline practices of regul ated facilities, this RIA may underestimate or overestimate the cost impacts of the rule. For112 

### example, this RIA may overstate the incremental costs of the policy options if
fewer facilities sewer in the baseline than is assumed here.

 The analytic result s are highly sensitive to the estimated costs of disposal. The most significant cost component of the proposed rule is the disposal of hazardous waste pharmaceuticals, in particular incineration. As indicated in the sensitivity analysis in the previous se ction, the cost of incineration is somewhat uncertain, ranging from as little as $1 per pound to as much as $3.44 per pound. Due to this uncertainty, this RIA may underestimate or overestimate the cost impacts of the rule.

 The disposal costs in this RIA may also vary regionally. Even if the average unit costs for disposal used in this RIA are representative of the national average, the costs of disposal on a per

- drum or per

- ton basis are likely to vary by region. Therefore, the average compliance costs per facility, as presented in this chapter, may not reflect the actual cost impacts of the rule for facilities where disposal costs differ significantly from the national average.

 Potential for CESQGs to manage hazardous waste pharmaceuticals as
MSW. As described earlier in this chapter, Federal regulations allow CESQGs to dispose of their hazardous waste as MSW, but several states either (1) require that CESQGs send their waste to a TSDF; (2) prohibit the disposal of liquid wastes in MSW landfills; or (3 ) prohibit the disposal of pharmaceuticals in MSW landfills. The assessment of cost impacts in this chapter assumes that CESQG facilities in the regulated universe incinerate their hazardous waste pharmaceuticals under the More Stringent and Proposed Opti ons if they are located in any of these states. In practice, however, CESQGs in these states may send their hazardous waste pharmaceuticals to states where hazardous wastes from CESQGs may be disposed of in MSW landfills. Decisions to pursue this approac h would depend on the cost of transporting hazardous waste pharmaceuticals across state lines relative to the cost savings associated with not sending these wastes to an incineration facility. To the extent that CESQGs would send their hazardous waste pha rmaceuticals across state lines to avoid the costs of incineration, this RIA may overestimate the costs of the rule.

 Disposal Cost Impacts for Non

- pharmaceutical Waste. Due to uncertainty regarding the disposal methods used by healthcare facilities and rev erse distributors for their non

- pharmaceutical hazardous waste, this RIA does not estimate the potential cost savings for non

- pharmaceutical waste that may result from a change in a facility’s RCRA generator status under the rule. This RIA may therefore u nderestimate any cost savings associated with the rule.113 

### CHAPTER 4 | BENEFI TS

INTRODUCTION

OVERVIEW


### The proposed rule for the management of hazardous waste pharmaceuticals may yield a range of environmental benefits as hospitals, medical clinics, and other healthcare facilities divert their hazardous waste pharmaceuticals from disposal in sewers, municip al solid waste landfills (MSWLF), municipal solid waste (MSW) incinerators, and medical waste autoclaves and incinerators to disposal in hazardous waste incinerators. The projected impacts of this proposed rule encompass a variety benefit categories relat ed to environmental human health and ecosystem benefits, as well as regulatory cost savings. In particular, the reduced sewering of hazardous waste pharmaceuticals and the corresponding avoidance of waste releases to U.S. surface waters may reduce the ris k of adverse human health and ecosystem impacts

. T he proposed rule may also result in cost savings for some healthcare facilities and reverse distributors by affording certain types
of facilities greater flexibility in how they train staff and generally manage their
hazardous waste pharmaceuticals

. The re shall also be potential cost savings for facilities whose RCRA generator status changes (e.g., from LQG to SQG) as a result of the rule

. This rule shall also provide both greater regulatory clarity for healthcare facilities, and greater regulatory certainty for reverse distributors. Exhibit 4

- 1 summarizes these
benefits.

Much of t his chapter focuses on water effects, and in particular, sewering for a number of reasons. This type of disposal leads t o releases of active pharmaceutical ingredients (APIs) to the environment because wastewater treatment facilities are designed to remove conventional pollutants such as suspended solids and biodegradable organic compounds from wastewater, not pharmaceutica ls. 134 

### Sewering is believed to be the most deleterious

non

- compliant disposal method due to the concentration of APIs in surface waters, as well as an increased potential for dissolution in water and absorption by humans and other organisms. Additionally, while APIs enter U

. S

. surface waters through many pathways (including excretion and concentrated animal feeding operations [ CAFOs ], among others) and the contribution of sewering compared to these other sources is uncertain, sewering of hazardous waste pha rmaceuticals at healthcare facilities represents
one of the mo re direct conduits of APIs to surface water.

134 U.S. EPA, Unused Pharmaceuticals in the Health Care Industry: Interim Report, August 2008.114

EXHIBIT 4

- 1

. BENEFITS SUMMARY FOR THE PROPOSED OPTION

BENEFIT CATEGORY MONETIZED OR QUANTIF IED
VALUE DESCRIPTION

Regulatory c ost s avings $ 24.29 million per year  For some healthcare facilities, the rule will
reduce the regulatory costs associated with hazardous waste pharmaceuticals. Most of these savings relate to the personnel training provisions of the rule. Human health and ecosystem improvements, enhanced opportunities for aquatic and marine
recreation due to r educed s ewering
of h azardous w aste p harmaceuticals 6,440 tons of hazardous waste pharmaceuticals diverted from sewering on an annual basis.  To the extent that the rule reduces

c oncentrations of hazardous waste pharmaceuticals in surface waters, it may reduce negative impacts to aquatic and riparian ecosystems and the associated reduction in exposure could reduce the incidence of adverse human health impacts.

 Improvements in water quality associated with the proposed rule may improve the per trip welfare that individuals derive from aquatic and or marine recreation, and may also increase the number of such trips taken. Human health and ecosystem improvements, enhanced recreation opportunities due to reduction in quantity of hazardous waste pharmaceuticals managed as MSW or
medical waste Exact reduction uncertain. However, approximately 4,400 tons are managed as MSW in the baseline and 29,800 are managed as medical waste.

Greater regulatory clarity for
healthcare facili ties Not calcu l able  The proposed rule may help healthcare facilities better integrate the responsible management of hazardous waste pharmaceuticals into their operations.

 The rule will provide greater regula tory certainty to revers e distributors in terms of when unused or expired pharmaceuticals are
considered a hazardous waste.

Improved tracking of hazardous waste pharmaceuticals Not calcu l able  Better tracking will help ensure that hazardous

waste pharmaceuticals arrive at their intended destination rather than facilities not equipped to manage these wastes.



### To estimate the benefits of the proposed rule related to reduced sewering, this RIA would ideally use the following steps: (1) quantify the reduction in sewering associated with the rule, (2) estimate the corresponding reduction in hazardous waste pharmaceuticals discharges to the environment, and (3) translate these reduced discharges t o reductions in adverse ecosystem and/or human health impacts. Based on the hazardous waste pharmaceuticals generation and management data presented in Chapter 2, the reduction in sewering likely to result from the rule may be quantified (Step 1). Estima ting the corresponding reduction in hazardous waste pharmaceuticals discharges from wastewater treatment plants and the associated benefits to human populations and ecosystems (Steps 2 and 3), however, requires more detailed data than are readily available . Estimating the former would require detailed information on the extent to which hazardous waste pharmaceuticals are captured by wastewater treatment systems, while estimation of the latter would require data on exposure pathways, fate and transport, and dose

- response relationships for a multitude of pharmaceutical compounds considered hazardous when disposed. Although some limited information is available on the removal of APIs (hazardous and non

- hazardous) from wastewater and the risks posed by APIs fo und in115 

### surface and drinking water, this information lacks the specificity required for quantification of human health and ecological impacts. For example, dose

- response information on the adverse health effects associated with exposure to many hazardous

w aste pharmaceuticals is not readily available.

Absent the detailed data necessary for quantification of the rule’s impact on hazardous waste phar maceutical releases to the environment and the associated human health and ecological impacts, this chapter su mmarizes the published literature concerning the occurrence of APIs in U.S. surface and drinking water, wastewater treatment systems’ removal efficiency for APIs, and the ecological and human health risks associated with pharmaceutical releases to the envi ronment. While much of this literature focuses on APIs not considered hazardous under RCRA, the general conclusions from this literature may nonetheless shed light on the potential ecological and human health benefits of the proposed rule. For example, th e range of wastewater treatment plant removal efficiencies
for non

- hazardous waste pharmaceuticals may provide an approximation of the range of removal efficiency values relevant to hazardous waste pharmaceuticals.

ORGANIZATION OF CHAP TER



### The assessment of benefits presented in this chapter begins with a quantitative analysis of potential cost savings associated with the proposed rule. T he chapter then presents an

assessment of the proposed rule’s impact on the quantity of hazardous waste pharmaceuticals s ewered by healthcare facilities. Following this analysis, th e chapter provides an overview of the available data on the prevalence of APIs in U.S. surface

waters , as well as a detailed review of the literature examining wastewater treatment plant
removal efficiencies for pharmaceutical compounds. The chapter then summarizes the published literature characterizing the human health and ecological impacts of APIs in the
environment , and the literature estimating the welfare value of enhanced recreational

opp ortunities associated with improvements in water quality . After reviewing this literature, t he chapter concludes with a discussion of other potential benefits that may
result from the rule.

POTENTIAL COST S AVINGS



### T he Proposed Option and the Less Stringent Option may result in potential cost savings
associated with the additional flexibility afforded to certain types of healthcare facilities
and reverse distributors under these options

. In addition, some facilities may experience

a cost savings due to a ch ange in their RCRA generator status , as hazardous waste pharmaceuticals are no longer counted against a facility’s generator status under the Proposed and Less Stringent Options

. There are no anticipated cost savings under the More Stringent Option. T he remainder of this section describes potential cost savings associated with specific rule provisions as well as the total estimated cost savings for the proposed rule.116 TRAINING


### As indicated in Chapter 3, training costs for LQG and SQG hospitals may decrease relative to the baseline because nurses could receive general awareness training on proper handling and emergency procedures for hazardous waste pharmaceuticals , rather than
f ormal training on all RCRA hazardous waste management. Exhibit 4

- 2 summarizes the
annual cost savings associated with the training requirements for nurses under the Proposed and Less Stringent options.

EXHIBIT 4

- 2 . ANNUAL COST SAVINGS OF AWARENESS TRAINING FOR NURSES

UNDER THE PROPOSED A ND LESS STRINGENT OP TIONS

GENERATOR
STATUS FACILITY TYPE AVERAGE
NUMBER
OF BEDS 1 AVERAGE

NUMBER OF
NURSES 2 ANNUAL

COST OF
NURSE
TRAINING (BASELINE) ANNUAL

COST OF
NURSE
TRAINING (PROPOSED
AND LESS
STRINGENT OPTIONS) ANNUAL

COST
SAVINGS
PER
FACILITY

SQG All Hospitals 107 3 179 $3,90 2 $1,123 $2,779

LQG Non

- teaching

hospitals 94 158 $3,441 $991 $2,451

LQG Teaching hospitals,

less than 370 beds 193 323 $7,043 $2,027 $5,015

LQG Teaching hospitals,

370 to 799 beds 516 864 $18,806 $5,414 $13,392

LQG Teaching hospitals,

800 or more beds 1,031 1,727 $37,593 $10,822 $26,771

Notes:
1. Based on American Hospital Directory Database, www.ahd.com , accessed on April 3, 2012.
2. Based on a nurse

- to

- bed ratio of 1.67.
3. SQG hospitals, on average, have more beds than LQG non

- teaching hospitals because some SQG hospitals are teaching hospitals, which typically have more beds than non

- teaching hospitals.

CONTAINER MA NAGEMENT



### Under the baseline, healthcare facilities are estimated to generate several 55

- gallon drums
worth of hazardous waste that must be shipped off

- site each year in partially filled
containers due to R CRA accumulation time limits. Therefore, longer ac cumulation time limits under the Proposed and Less Stringent Options would allow these facilities to
consolidate waste into fewer full 55

- gallon drums. However, the sewering ban is estimated to offset this potential benefit for most facility types because more storage containers would be needed. Therefore, only SQG hospitals are estimated to experience a cost savings associated with container management. Under the Proposed Option, this cost savings is estimated to be the avoided purchase of one 55

- gallon drum, or approximately $63 per facility. Under the Less Stringent Option, this cost savings is estimated to be the avoided purchase of one 55

- gallon drum and one 18

- gallon drum, or approximately $74 per facility (on an annualized basis).117 LABELING



### As de scribed in Chapter 3, under the Proposed and Less Stringent Options n o labeling is required for containers holding potentially creditable pharmacy waste going to a reverse
distributor. This RIA estimates that per facility labeling costs for healthcare fac ilities are approximately 20 percent lower under the Proposed and Less Stringent Options than the Baseline (and the More Stringent Option ) , as presented in Chapter 3

. L abeling is also not required for hazardous waste pharmaceuticals shipped from one reverse distributor to
another. 135 

### Due to this rule provision, t his RIA estimates that per facility labeling costs for reverse distributors are 65 percent less under the Proposed and Less Stringent Options
than t he Baseline. Exhibit 4

- 3 reports the savings associated with avoided labeling costs under the Proposed and Less Stringent Options.

EXHIBIT 4

- 3 . ANNUAL COST SAVINGS OF LABELING UNDER THE PROPOSED

AND LESS STRINGENT O PTIONS

GENERATOR
STATUS FACILITY TYPE ANNUAL COST SAVINGS PER FACILITY (PROPOSED AND LESS STRINGENT O PTIONS) SQG Hospitals $5

SQG Other Healthcare Facilities $0

SQG Reverse Distributors $16

LQG Hospitals $15

LQG Other Healthcare Facilities $2

LQG Reverse Distributors $65

BIENNIAL REPORTS



### Under the Baseline , LQGs and SQGs located in states with BR reporting requirements for SQGs must submit biennial reports of their hazardous waste generation activity (for pharmaceuticals and other hazardous wastes) to EPA or state authorities. Under the Proposed and Less Stringent Options, hazardous waste pharmaceuticals do not need to be
included in biennial report submissions. Therefore, b ased on the GM form information
included in the baseline discussion in Chapter 3 , this RIA estimates that LQG hospitals submit 13 GM forms per facility under the Proposed and Less Stringent Options rather
than 19 as under the b aseline. Similarly, the data presented in Chapter 3 indicate that LQG reverse distributors submit an estimated three GM forms per facility rather than 6 0

, and other health care facilities submit nine GM forms per facility instead of the 12
submitted in the baseline. SQG hospitals and other healthcare facilities are estimated to submit six GM forms per facility rather than eight in the baseline and SQG reverse
distributors a re not estimated to submit any GM forms post

- rule because hazardous waste pharmaceuticals do not need to be included in biennial report submissions

. Exhibit 4

- 4

135 Based on personal communication with Charlotte Smith of Waste Management Healthcare Solutions on January 8, 2013,
this accounts for approximately 65 percent of the hazardous waste pharmaceuticals managed by reverse distributors.118 

### reports the annualized cost savings associated with biennial reporting under the Proposed
and Less Stringent Options.

EXHIBIT 4

- 4

. ANNUALIZED COST SAVI NGS OF BIENNIAL REPO RTING UNDER THE
PROPOSED AND LESS S TRINGENT OPTIONS

GENERATOR
STATUS FACILITY TYPE NUMBER OF
GM FORMS (BASELINE) NUMBER OF GM

FORMS (PROPOSED
AND LESS
STRINGENT OPTIONS) ANNUALIZED

COST SAVINGS
PER FACILITY
SQG 1 Hospitals 8 6 $4

SQG 1 Other Healthcare

Facilities 8 6 $3

SQG 1 Reverse Distributors 4 0 $24

LQG Hospitals 19 13 $63

LQG Other Healthcare

Facilities 12 9 $30

LQG Reverse Distributors 60 3 $743

Notes:
1. Cost savings are only estimated for SQGs in states that require SQGs to submit biennial reports . These include: AK, DC, IN, MD, MT, NH, ND, OR, PA, RI, SC, VT, VA, and WV

.

RECORDKEEPING


### As described in Chapter 3, there are no recordkeeping requirements for waste characterizations for healthcare facilities under the Proposed and Less Stringent Options. This would result in a cost savings relative to the baseline for LQG and SQG healthcare facilities, reflect ing the avoided costs of maintaining records of waste characterizations for three years . Recordkeeping requirements would remain the same for LQG and SQG reverse distributors or increase in the case of CESQG reverse distributors. Exhi bit 4

- 5 reports the annual cost savings for avoided recordkeeping under the Proposed and Less Stringent Options , based on the cost data presented in Chapter 3

.

EXHIBIT 4

- 5

. ANNUAL COST SAVINGS OF RECORDKEEPING UND ER THE

PROPOSED AND LESS S TRINGENT OPTION S

GENERATOR
STATUS FACILITY TYPE ANNUAL COST SAVINGS
SQG Hospitals $5

S QG Other Healthcare

Facilities $5

LQG Hospitals $5

LQG Other Healthcare

Facilities $5119 MANIFESTS


### Under the Proposed and Less Stringent Options, LQG and SQG healthcare facilities do not need to include RCRA waste codes on manifests for patient care pharmaceuticals shipped to a TSDF, resulting in a cost savings of 0.1 hours of a technician’s time.

However , while healthcare facilities are not required to prepare manifests for potentially creditable hazardous waste pharmaceuticals shipped to a reverse distributor , they must complete shipping documents with a return receipt notification

— at a cost of $8.49 per shipment. As described in Chapter 3 , this RIA assumes that each health care facility sends four shipments of pharmaceuticals to a reverse distributor each year. As a result of these

counter

- opposing cost factors, some facilities may incur a cost savings relative to the
baseline. Exhibit 4

- 6 reports the estimated annual cost savings of manifests under the Proposed and Less Stringent Options , based on the cost information presented above and in Chapter 3

.

EXHIBIT 4

- 6

. ANNUALIZED COST SAVI NGS OF MANIFESTS UNDER THE

PROPOSED AND LESS S TRINGENT OPTIONS

GENERATOR
STATUS FACILITY TYPE ANNUAL COST SAVINGS
LQG Other Healthcare Facilities $32

LQG Reverse Distributors $27

LQG Non

- teaching Hospitals $32

LQG Teaching Hospitals, less than

370 beds $32

LQG Teaching Hospitals, 370 to

799 beds $0

LQG Teaching Hospitals, 800 or

more beds $0

COST SAVINGS ASSOCIA TED WITH A CHANGE IN GENERATOR STATUS


### As indicated in Chapter 3, affected facilities will no longer be required to count hazardous waste pharmaceuticals toward their RCRA generator status (under the Proposed and Less Stringent Option s ). This may lead to changes in generator status for some facilities, enabling them to realize a cost savings. The extent to which such changes in generator status will occur under the rule is uncertain, but these changes would be most
li kely for those facilities for which hazardous waste pharmaceuticals make up a large portion of their overall hazardous waste generation (i.e., reverse distributors).

A change in generator status may result in longer storage accumulation time limits, which could reduce transportation and disposal costs because fewer partially filled containers need to be shipped off site each year. Based on the cost data presented in Chapter 3, t his would result in a cost savings of $31 for transportation and $14 for dispos al per facility for reverse distributors that experience a change in their generator status from SQG

- to

CESQG, and a cost savings of $99 for transportation and $21 for disposal per facility among reverse distributors that go from LQG

- to

- SQG. It will also reduce costs for other120 

### requirements associated with LQG status, such as contingency plan updating (an annual cost savings of $950).

SEWERING IMPACTS


### This section presents the estimated quantity of hazardous waste pharmaceuticals likely to
be diverted from sewering to more environmentally protective disposal methods as a result of the rule. A reduction in sewering may benefit aquatic organisms by reducing their exposure to potentially harmful APIs and, by extension, reducing the incidence of any adverse ef

fects associated with exposure to these compounds. With respect to human populations, although the few studies examining the human health risks of pharmaceuticals in the environment suggest that such risks are limited (see the literature review below) , it is uncertain whether the findings in these studies, which focus on pharmaceuticals that are not considered hazardous when disposed, apply to hazardous

waste pharmaceuticals as well. Thus, to the extent that hazardous waste pharmaceuticals
in the environm ent pose risks to human health, the rule may result in health improvements for human populations. While it is not possible to quantify the changes in ecological and human health risk associated with changes in the management of hazardous waste pharmaceuti cals resulting from the rule, the estimated reduction in sewering presented in this section may shed light on the potential magnitude of these risk impacts.

Reductions in sewering are likely to vary across the regulatory options under consideration by EPA. For example, the Less Stringent Option does not prohibit sewer disposal for CESQG healthcare facilities and will therefore result in no sewering
reductions for these facilities, though it will lead to reductions for other facilities. In contrast, the Pr oposed Option and the More Stringent Option both prohibit sewer disposal
for all healthcare facilities and reverse distributors. Thus, the reduction in sewering under these options will be equal to the amount of sewering occurring in the baseline.
Assess ment of the reduction in sewering under these options therefore requires reliable estimates of the annual tonnage of hazardous waste pharmaceuticals sewered in the
baseline.

Sewering in the Baseline


### To estimate the amount of sewering that occurs in the bas eline, this chapter uses a model facility approach based on that employed in the cost analysis in Chapter 3. As indicated in that analysis, detailed facility

- level data on the generation and management of hazardous waste pharmaceuticals are not readily av ailable. In the absence of such detailed data, Chapter 3 estimates costs for a series of model facilities and extrapolates these per facility costs to all facilities in the regulated universe that correspond to each model facility. Consistent with that a pproach, this chapter’s assessment of sewering in the baseline estimates the amount of sewering for each of the model facilities outlined in Chapter 3 and applies each model facility sewering value to the corresponding facilities121 

### in the regulated universe. As outlined in Chapter 3, the model facilities are defined by facility type (e.g., hospital, reverse distributor) and RCRA generator status as follows: 136



###  CESQG hospitals

 CESQG reverse distributors

 CESQG other healthcare facilities (e.g., physicians’ offices and dentists)

 SQG hospitals

 SQG reverse distributors

 SQG other healthcare facilities

 LQG non

- teaching hospitals

 LQG teaching hospitals with less than 370 beds

 LQG teaching hospitals with 370 to 799 beds

 LQG teaching hospitals with 800 or more beds

 LQG reverse distributors

 LQG other healthcare facilities
Consistent with the cost analysis presented in Chapter 3, this chapter estimates the amount of hazardous waste pharmaceuticals sewered in the full compliance baseline

. Under the full compliance base line, facilities may manage their hazardous waste pharmaceuticals by incinerating them or by sewering them and notifying their local POTW that they are doing so. In addition, CESQGs may also manage these wastes as MSW if they are located in states where t his practice is permitted. This RIA assumes the following with respect to the distribution of hazardous waste pharmaceuticals across these management methods under the full compliance baseline: 137



###  For each model facility, t he percentage of hazardous waste p harmaceuticals
sewered in the full compliance baseline is as described in Exhibit 3

- 9.

 Also for all model facilities, the amount of hazardous waste pharmaceuticals sent to a reverse distributor under the full compliance baseline is as described in
Exhibit 3

- 9.

 For LQGs and SQGs, all hazardous waste pharmaceuticals not sewered or sent to a reverse distributor are assumed to be managed in a hazardous waste incinerator.

 For CESQGs, all hazardous waste pharmaceuticals not sewered or sent to a
reverse distributo r are assumed to be split between MSW disposal and incineration. Based on the fact that approximately 58.4 percent of regulated

136 For some of the facility types listed below, Chapter 3 distinguishes between “small” and “large” facilities (e.g., small SQG
hospitals versus large SQG hospitals). Making this distinction between small and large was not necessary for the purposes of
this chapter because it has n o bearing on the generation and sewering of hazardous waste pharmaceuticals (e.g., both the
small SQG model hospital and the large SQG model hospital sewer the same amount of hazardous waste pharmaceuticals).

137 The assumptions outlined below regarding the management of hazardous waste pharmaceuticals under the two baselines
are also presented in Chapter 3. They are included here as well for the convenience of the reader.122 

### facilities are located in states that allow MSW disposal for CESQGs 138 

### , this RIA assumes that 58.4 percent of CESQG waste that is not either sent to a reverse distributor or sewered is managed as MSW and that the remainder is sent to a
hazardous waste incinerator.

Exhibit 4

- 7 presents the estimated tonnage of hazardous waste pharmaceuticals sewered annually under the full compliance baseline. As indicated in the exhibit, approximately 6,4 4 0 tons of hazardous waste pharmaceuticals are sewered annually. Th is figure
represent s 18 percent of the total amount of hazardous waste pharmaceuticals generated annually ( 36,200 tons), as estima ted in Chapter 2. The es timates presented in Exhibit 4

- 7 also show that other healthcare facilities account for nearly all of the hazardous waste pharmaceuticals sewered under the baseline. This reflects the fact that these facilities
account for more th an 80 percent of the hazardous waste pharmaceuticals generated by facilities affected by the rule.

EXHIBIT 4

- 7

. ESTIMATED AMOUNT OF HAZARDOUS WASTE

PHARMACEUTICALS SEWE RED IN THE BASELINE ON AN ANNUAL BASIS (TON S)

BASELINE
GENERATOR
STATUS FACILITY TYPE AMOUNT SEWERED IN TH E
BASELINE

CESQG Hospitals 24

CESQG Other Healthcare Facilities 1,208

CESQG Reverse Distributors 0

SQG Hospitals 265

SQG Other Healthcare Facilities 2,617

SQG Reverse Distributors 0

LQG Hospitals 962

LQG Other Healthcare Facilities 1,366

LQG Reverse Distributors 0

TOTAL 6,44 0

Estimated Reductions in Sewering


### The policy options under consideration by EPA may have a significant effect on the amount of hazardous waste pharmaceuticals sewered on an annual basis. As noted above, sewering is prohibited under the More Stringent Option and the Proposed Option. Thus,

138 This 58.4 percent figure is derived from (1) White, M., Health and Safety Annex CESQ Gs, WAAC Newsletter, September
1998, Volume 20, Number 3, available at http://cool.conservation

- us.org/waac/wn/wn20/wn20

- 3/wn20

- 306.html; (2)
Arkansas Department of Environmental Quality, Overview of Regulatory Requirements for Hazardous Waste Generators i n Arkansas, accessed at http://www.adeq.state.ar.us/hazwaste/branch_ie/hwgen.htm on July 10, 2013; (3) Communication
with Kristin Fitzgerald of EPA on December 12, 2012; and (4) Northeast Recycling Council, prepared for ReCommunity,
Disposal Bans & Mandato ry Recycling in the United States, June 24, 2011.123 

### the reduction in sewering associated with these scenarios is equal to the quantity of hazardous waste pharmaceuticals sewered in the baseline. Under the Less Stringent Option, sewering is also prohibited for LQGs

, SQGs, and CESQG reverse distributors but is allowed for all other CESQGs. Thus, the change in sewering under this option is expected to be lower than under the More Stringent and Proposed Options. 139



### Exhibit 4

- 8 present s the estimated change in sewering, on an annual basis, under each option relative to the full compliance baseline. The results in the exhibit show that the
estimated reduction in sewering is expected to be the same under the More Stringent and Proposed Op tions. This reflects the fact that both options prohibit sewering for all facilities, regardless of their generator status. The projected reduction in sewering is somewhat lower under the Less Stringent Option, as this option allows CESQG
healthcare faci lities to sewer their hazardous waste pharmaceuticals.

EXHIBIT 4

- 8 . ANNUAL REDUCTION I N THE SEWERING OF HA ZARDOUS WASTE

PHARMACEUTICALS, INC REMENTAL TO THE FULL COMPLIANCE BASELINE (TONS)

BASELINE
GENERATOR
STATUS FACILITY TYPE MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION
CESQG Hospitals 24 24 0
CESQG Other Healthcare Facilities 1,208 1,208 0
CESQG Reverse Distributors 0 0 0

SQG Hospitals 265 265 265
SQG Other Healthcare Facilities 2,617 2,617 2,617
SQG Reverse Distributors 0 0 0

LQG Hospitals 962 962 962
LQG Other Healthcare Facilities 1,366 1,366 1,366
LQG Reverse Distributors 0 0 0

TOTAL 6,44 0 6,44 0 5,2 10

Notes:
Total s may not sum due to rounding.

Cost Savings Associated with Reduced Contaminated Wastewater Treatment


### As described above, this chapter estimates that the proposed rule would prevent approximately 6,44 0 tons of hazardous waste pharmaceuticals from being sewered under the Proposed and More Stringent Options (and approximately 5,2 10 tons under the Less Stringent Option). Any water that is flushed down the drain with these hazardous waste pharmaceuticals represents a cost for wastewater treatment systems. Thus, t o the extent
that reduced sewering reduces the amount of wastewater sent to wastewater treatment

139 This RIA assumes that all facilities are in full compliance with RCRA regulations under each regulatory option, which
implies that facilities managing their hazardous waste pharmaceuticals as MSW may sewer them under the Less Stringent
Option.124 

### plants, these facilities will realize a cost savings. To estimate the amount of additional wastewater generated each year from the sewering of hazardous waste pharmaceuticals

, this economic assessment relies on information on the dist ribution of waste s and disposal methods provided by waste management firms as described in Exhibit 4

- 9

.

EXHIBIT 4

- 9

. KEY ASSUMPTIONS FOR MONETIZING BENEFITS OF AVOIDED WASTEWATE R TREATMENT

CATEGORY ASSUMPTION SOURCE

Distribution of patient care pharmaceuticals Tablets/capsules: 2.5% 1

Liquids: 60% 2 Solids (e.g., inhalers/creams/vials): 37.5% Correspondence with Charlotte Smith of PharmEcology on May 2, 2014 and Correspondence with John Kelsey of Clean Harbors on May 13, 2014.

Percentage of

waste sewered Tablets/capsules: 25% 3

Liquids: 28.6% 4
Solids: 0% Overall: 18% Correspondence with Charlotte Smith of PharmEcology on May 2, 2014 (and December 5, 2012) and Correspondence with John Kelsey of Clean Harbors on May 13, 2014 (and December 2, 2012)

. Average patient
dose Tablets/capsules: 400mg ( < 1 to 500mg)

Liquids: 100 to 3,000mL 5 Average d ose strength of tablets/capsules based on

c orrespondence with Charlotte Smith of PharmEcology on May 2, 2014

. Disposal method (sewering) Tablets/capsules: toilet

Liquids: sink Correspondence with Charlotte Smith of PharmEcology on May 2, 2014 and Correspondence with John Kelsey of Clean Harbors on May 13, 2014.

Amount of water
used Toilet: 2.2 gallons per flush (1.6 to 3.5

gallons per flush) 6 Sink: negligible Massachusetts Water Resources Authority, Facts About Ultra Low Flush Toilets, http://www.mwra.com/publications/ulftoilets.pdf accessed on May 7, 2014.
Notes:
1. This represents an average of estimates ranging from 2% to 3% (for tablets/capsules as a percentage of total patient care pharmaceuticals).
2. This represents an average of estimates ranging from 50% to 70% (for liquids as a percentage of total patient care pharmaceuticals).
3. This represen ts an average of estimates ranging from 20% to 30% (for the percentage of tablets/capsules that are sewered).
4. This chapter estimates that 6,4 40 tons of waste pharmaceuticals are sewered (18% of 36,200 tons) each year

. It
further estimates that 25% of table t/capsules , which comprise 2.5% of all waste pharmaceuticals, are sewered and other solids (e.g., inhalers/vials) are not sewered

. Therefore, the remainder of the sewered waste is assumed to be patient care liquids. Thus, (6,4 4 0 tons sewered

– 36,200 tons × 2.5% tablets × 25% sewered) ÷ 60% liquids ÷ 36,200 tons total waste = 28.6% of waste liquids are sewered.
5. While doses for IV treatments are prepped individually for patients, about 20% are not fully administered and would be put down the drain or discard ed in a red sharps container (or, if the facility has implemented a pharmaceutical waste management program, a hazardous or non

- hazardous pharmaceutical waste container).
6. Since 1994, Federal standards have required the manufacture of ultra

- low flush toilets (1.6 gallon

- per

- flush models) for commercial buildings. Prior to this, most post

- 1980 models used about 3.5 gallons per flush. Assuming an average facility lifespan of 30 years, we estimate that toilets installed in the last 20 years use 1.6 gallon s (about 2/3 of all toilets) and older toilets use 3.5 gallons (about 1/3 of all toilets) per flush . Using these figures, we calculate a weighted

- average of 2.2 gallons per flush for all toilets.



### Based on the information presented in Exhibit 4

- 9 , liquids account for approximately 96 percent of all waste that is sewered. 140 

### This implies that tablets/capsules account for

140 In total, the healthcare industry generates about 36,200 tons of hazardous waste each year. Overall, about 18 percent of
36,200 tons (or 6,440 tons) of hazardous waste pharmaceuticals are sewered. Of all waste pharmaceuticals generated,125 

### approximately 4 percent of sewered wastes. As described in the exhibit, liquid waste is assumed to be put down the sink, while tablets/cap sules are flushed down the toilet. 141 

### With respect to tablets/capsules, hospitals typically administer individually packaged drugs, with an average dose of about 400mg. 142 

### Overall, tablets/capsules account for approximately 2.5 percent of patient care pharma ceuticals. Of the doses that end up as waste pharmaceuticals, approximately 25 percent are sewered. It is further assumed that leftover pharmaceuticals are immediately sewered and not combined with other wastes.

T he potential cost savings of avoided wast ewater treatment is dependent on the number
of doses sewered and the amount of water sewered with each dose , as follows :

Gallons sewered = D × G

w here: D = number of doses sewered; and G = gallons of water sewered with each dose

Variable D in the equati on above will depend on the total volume of patient care pharmaceutica ls and the percentage of drugs not fully administered to patients that are
sewered

. As described above, this RIA assumes 25 percent of unused tablets /capsules are sewered and 28.6 percent of unused liquids are sewered. Based on these values and the average mass per dose in Exhibit 4

- 9, this RIA estimates that between 2 and 6 0 million doses of liquid hazardous waste pharmaceuticals and more than 5 1 0 million doses of tablets/cap sules are sewered each year

. Variable G will depend on whether hazardous waste pharmaceuticals are sewered down sink drains or flushed down the toilet and the amount of water per toilet flush. The costs (and avoided costs) of treating sewered
hazardous w aste pharmaceuticals are reflected in Chapter 3 of the RIA. Therefore, to avoid double counting, this analysis does not present avoided treatment costs for these wastes. However, it quantifies the cost savings for contaminated excess water used to

sewer hazardous waste pharmaceuticals. For the sewering of liquids, t he typical practice is for a nurse to allow an unfinished IV bag to drain into a sink (without the water running) while the nurse attends to other patients. 143 

### On the other hand, tablets/capsul es are assumed to be flushed down the toilet, since they would not easily be put into the sink
drain. As these patient care pharmaceuticals are individually packaged, it is assumed they are not combined with other wastes prior to being sewered. As shown in Exhibit 4

- 9 , the average toilet is assumed to use 2.2 gallons per flush (with ultra

- low flush toilets using 1.6 gallons per flush and older models using 3.5 gallons per flush). This implies that on a per facility basis, CESQG healthcare facilities use 1,500 gallons (the equivalent

approximately 60 percent is liquids and 28.6 percent of all liquid waste is sewered. Thus, 36,200 tons × 60% liquids × 28.6%

sewered ÷ 6,440 tons = 96% of all sewered hazardous waste pharmaceuticals are liquids.

141 Based on person al communication with Charlotte Smith of PharmEcology on May 2, 2014 and John Kelsey of Clean Harbors
on May 13, 2014.

142 400mg = 0.0000004 tons.

143 Based on personal communication with Charlotte Smith of PharmEcology on May 2, 2014 and John Kelsey of Clean Harbors
on May 13, 2014.126 

### of about 700 flushes) per year and the largest LQG hospitals use about 325,000 gallons (about 148,000 flushes) per year to sewer hazardous waste pharmaceuticals

. Thus, each year approximately 1.13 billion gallons of wastewate r contaminated with hazardous waste pharmaceuticals from healthcare facilities will no longer be sent to POTWs.

Based on this information, Exhibit 4

- 1 0 reports the cost savings for avoided wastewater treatment associated with the sewering of hazardous waste pharmaceutical tablets/capsules on a per facility basis. As described in Chapter 3, the cost of sewering (excluding notification) is estimated to be $3.79 per 1,000 gallons. 144 

### Note that the costs/cost savings of sewering liquids and tablets/capsules are already reflected in Chapter 3

. The costs below only represent the costs associated with excess contaminated

wastewater.

E XHIBIT 4

- 1 0 : ANNUAL COST SA VINGS ASSOCIATED WIT H AVOIDED WASTEWATER TREATMENT ($2011)

GENERATOR
STATUS

[A] FACILITY TYPE

[B] ESTABLISHMENTS

[C] TONS OF WASTE

SEWERED (TABLETS/CAPSULES)

[D] GALLONS

OF WATER
USED 1

[E] POTW WASTE

WATER
TREATMENT
COSTS 2

[F] TOTAL COST

SAVINGS 3

[G=C×F]

CESQG Hospitals 2,555 0.0003 1,600 $6 $15,900

Other Healthcare
Facilities 142,831 0.0003 1,500 $6 $802,000

Reverse Distributors 21 0 0 $0 $0

SQG Hospitals 2,397 0.0039 19,400 $73 $176,000

Other Healthcare
Facilities 20,910 0.0039 21,900 $84 $1,740,000

Reverse Distributors 7 0 0 $0 $0

LQG Other Healthcare

Facilities 3,721 0.0129 64,300 $244 $907,000

Reverse Distributors 28 0 0 $0 $0

Non

- teaching Hospitals 421 0.0073 36,500 $138 $58,000

Teaching Hospitals,
less than 370 beds 570 0.0133 66,300 $251 $143,000

Teaching Hospitals,
370 to 799 beds 480 0.0371 185,000 $701 $336,000

Teaching Hospitals,
800 or more beds 82 0.0651 325,000 $1,231 $101,000

TOTAL 174,023 N/A N/A N/A $4,280,000

Notes:
1. Estimated water usage based on an average dose size of 400mg being flushed down the toilet, assuming 2.2 gallons of water per flush. Values are r ounded to three significant digits.
2. Assumes a rate of $3.79 per 1,000 gallons.
3. Total costs may not sum due to rounding. Values are r ounded to three significant digits.

144 Raftelis Financial Consulting, 2008 Water and Wastewater Rate Survey, as cited in DPRA Inc., U.S. EPA Office of Resource Conservation and Recovery Economics and Risk Analysis Staff Unit Cost Compendium, September 26, 2011, inflated to $2011
using the BEA GDP impli cit price deflator.127 

### Based on the costs reported in Exhibit 4

- 1 0 , this chapter estimates that the rule may result in annual cost savings for avoided wastewater treatment of approximately $4.3 million under the Propose d and More Stringent Options. 145 

### Under the Less Stringent Option, the annual cost savings is approximately $3.5 million. 146 

### Under the Proposed and More Stringent Options, these results imply that 45 percent of the aggregate cost savings are experienced by SQ Gs ( primarily other healthcare facilities ) , 36 percent of cost savings are experienced by LQGs, and 19 percent of cost savings are experienced by CESQGs.

Therefore, d ue to th e sewer ban, EPA estimates that each year approximately 1.13 billion gallons of wastewater contaminated with hazardous waste pharm aceuticals from healthcare facilities will no longer be sent to POTWs. This avoided wastewater treatment
is estimated to result in annual cost savings of $4.3 million under the Proposed and More Stringe nt Options (and $3.5 million under the Less Stringent Option).

SUMMARY OF COST SAVI NGS



### Exhibit 4

- 11 summarizes the estimated cost savings associated with the additional flexibility provided to healthcare facilities and reverse distributors under the prop osed rule. As described above, the Proposed and Less Stringent Options are estimated to result in a cost savings for several waste management activities. In particular, training costs for nurses are expected to decline by approximately $19 million under these options. This cost savings reflects the less stringent training requirements as they apply to hospital
nurse staff. This savings is limited to hospital nurses and not to other hospital staff or nurses at other healthcare facilities. These two grou ps most likely handle a wide range of hazardous wastes generated by their facilities and must therefore meet the full RCRA training requirements. The More Stringent Option is only estimated to result in cost savings associated with avoided contaminated wa stewater treatment.

Exhibit 4

- 12 summarizes the cost savings of the proposed rule by generator status and facility type. Among the model facilities that realize a cost savings under the Proposed Option, the per

- facility savings are most significant for LQG teaching hospitals with 800 or more beds. This reflects the size of these facilities. On a per

- facility basis, these facilities generate more hazardous waste pharmaceuticals than any other healthcare facility. 147 

### The savings that accrue to LQG healthc are facilities on a variable basis (per ton, per shipment, or per nurse) are therefore most significant for these facilities (e.g., reduced training costs for hospital nurses

, avoided biennial reporting costs , etc.)

.

145 For the Proposed and More Stringent Options, multiplying Column F by Column C (the number of establishments) in Exhibit 2 and summing the results (Column G) yields a total cost savings of $4.3 million.

146 The Less Stringent Option woul d not ban sewering for CESQGs; therefore, we use the same approach as described in
Footnote 4, but sum the cost savings only for SQGs and LQGs.

147 This excludes reverse distributors, which are not considered healthcare facilities.128 EXHIBIT 4

- 11. ANNUALIZED BASELINE COSTS AND I NCREMENTAL COST SAVI NGS

OF PROPOSED RULE BY WASTE MANAGEMENT ACT IVITY, 7
PERCENT DISCOUNT RAT E ($2011 MILLIONS)

ROW WASTE MANAGEMENT

ACTIVITY TOTAL
ANNUALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COST
SAVINGS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification $0. 00 $0.00 $0.00 $0.00

2 Training $79. 65 $0.00 $19.17 $19.17

3 Manifest Training $6.3 0 $0.00 $0.00 $0.00

4 Contingency Plan Updating $4.9 1 $0.00 $0.03 $0.03

5 Container Management $28.8 4 $0.00 $0.15 $0.18

6 Labeling $0.4 4 $0.00 $0.05 $0.05

7 Inspections $94. 25 $0.00 $0.00 $0.00

8 Warehousing $0.0 0 $0.00 $0.00 $0.00

9 Closure $4.5 1 $0.00 $0.00 $0.00

10 RCRA Storage Permit $0.0 0 $0.00 $0.00 $0.00

11 Sorting $27. 05 $0.00 $0.00 $0.00

12 Biennial Reports $ 2

. 24 $0.00 $0.31 $0.31

13 Recordkeeping $0.1 5 $0.00 $0.15 $0.15

14 Manifests and Other Tracking $1.0 3 $0.00 $0.15 $0.15

15 Transportation $72. 67 $0.00 $0.003 $0.003

16 Disposal $554. 59 $4.28 $4.28 $3.46

17 TOTAL $876. 62 $4.28 $24.29 $23.50

Notes:
1. For some provisions there are no cost savings (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.129

EXHIBIT 4

- 12 . ANNUALIZED COST SAVINGS OF PROPOSED RULE BY BASELINE GENERATOR S TATUS

AND FACILITY TYPE , 7 PERCENT DISCOUNT RATE ($2011 MILLIONS )

GENERATOR
STATUS FACILITY TYPE NUMBER OF
FACILITIES MORE STRINGENT

OPTION PROPOSED

OPTION LESS STRINGENT

OPTION
CESQG Hospitals 2,555 $0.02 $0.02 $0.00

SQG Hospitals 2,397 $0.18 $7.02 $7.05

LQG Hospitals 1,553 $0.64 $13.31 $13.31

CESQG Other Healthcare Facilities 142,831 $0.80 $0.80 $0.00

SQG Other Healthcare Facilities 20,910 $1.74 $1.92 $1.92

LQG Other Healthcare Facilities 3,721 $0.91 $1.17 $1.17

CESQG Reverse Distributors 21 $0.00 $0.00 $0.00

SQG Reverse Distributors 7 $0.00 $0.0006 $0.0006

LQG Reverse Distributors 28 $0.00 $0.05 $0.05

TOTAL 174,023 $4.28 $24.29 $23.50

OCCURRENCE OF API s IN U.S. SURFACE WATE RS AND DRINKING WATE R


### The benefits of the proposed rule are in part dependent on the extent to which the rule reduces the occurrence of hazardous waste pharmaceuticals in U.S. surface waters and drinking water. To scope the potential m agnitude of the rule’s benefits, this chapter summarizes available data on the concentrations of APIs in U.S. surface and drinking water supplies. 148 

### Setting aside any differences in the potency and toxicity of individual APIs, l ow concentrations would suggest relatively modest benefits, while high concentrations would suggest that the benefits of the rule may be more significant. The studies summarized in this section evaluate pharmaceutical concentrations for a multitude
of dru gs, many of which are not considered hazardous wastes under RCRA. Concentration data from these studies, however, may still provide valuable insights into the likely prevalence of hazardous APIs in U.S. surface waters and drinking water.

Research on ster oids, pharmaceuticals, and potential endocrine disrupting compounds in U.S. water supplies has increased over the past decades, as these compounds have increasingly become a concern for water quality control in drinking water supplies. 149



### One of the most co mprehensive datasets on APIs in U.S. surface waters was developed from a 2002 monitoring study conducted by the U.S. Geological Survey (USGS). This study compiled data from 139 streams in 30 states sampled during the 1999

- 2000

148 Because there are thousands of approved drugs on the market in the United States, it would be infeasible for studies
examining APIs in surface water, drinking water, or wastewater treatment plant effluent to examine all of them. Thus, the

studies summari zed in this and later sections necessarily had to limit testing to a small fraction of the pharmaceuticals

available on the market.

149 Shane A, Snyder et al. Toxicological Relevance of EDCs and Pharmaceuticals in Drinking Water. American Water Works

Assoc iation Research Foundation. 2008

.130 

### period. 150 

### Exhibit 4

- 1 3 shows the location of the streams sampled for the analysis. These sampling sites were selected from streams thought to be susceptible to contamination from agriculture or urban activities. For sampled areas, the USGS analyzed water samples for 95 different org anic wastewater contaminants (OWCs), 51 of which were APIs. Target compounds were selected for analysis from the large number of possible chemicals based upon estimates of usage, toxicity, potential hormonal activity, and persistence in the environment.

EXHIBIT 4

- 1 3

. LOCATION OF STREAMS SAMPLED IN USGS PHAR MACEUTICALS

STUDY

150 Kimberlee Barnes, Dana Kol p in, Michael Meyer, Michael Thurman, Edward Furlong, Steven Zaugg, and Larry Barber

. Water

- Quality Data for Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999

- 2000. USGS. Iowa City, Iowa. 2002. Available at: http://toxics.usgs.gov/pubs/OFR

- 02

- 94/index.html ; and Dana W. Kolpin
, Edward T. Furlong, Michael T. Meyer, E. Michael Thurman, Steven D. Zaugg, Larry B. Barber, and Herbert T. Buxton,
“Pharmaceuticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999

- 2000: A National
Reconnaissance,” Environ. Sci. Technol . 2002, 36, 1202

- 1211.131 

### Exhibit 4

- 1 4 presents the sampling results from the USGS study for the prescription and

non

- prescription drugs targeted in the analysis 151 

### . The prescription drugs appearing in the greatest portion of samples include dehydronifedipine (an antianginal), diltiazem (an antihypertensive), and codeine (an analgesic). In those samples where prescription drugs were found, the median concentrations across drugs ranged from 0.01 micrograms per liter (μg/L) to 0.074 μg/L. As indicated in the exhibit, non

- prescription drugs were found in a greater portion of samples than prescription drugs, with caffeine found in more than 60 percent of samples and co tinine (a nicotine metabolite) in more than 30 percent.
Median concentrations for individual non

- prescription drugs ranged from 0.024 to 0.20 μg/L.

151 There are thousands of FDA approved drugs available with a prescription. Any study necessarily has to limit testing to a
small fraction of those drugs.132 EXHIBIT 4

- 1 4

. SUMMARY OF 2002 USGS STREAM SAMPLES FOR A PI s

ROW DRUG NUMBER
OF
STREAMS
SAMPLED FREQ

(%) MAXIMUM

( μg /L) MEDIAN

( μg /L) USE

PRESCRIPTION DRUGS 1

1 Albuterol 84 0 ND ND Antiasthmatic

2 Cimetidine 84 9.5 0.58 0.074 Antacid

3 Codeine* 46 6.5 0.019 0.012 Analgesic

4 Codeine** 85 10.6 1.0 0.2 Analgesic

5 Dehydronifedipine 84 14.3 0.03 0.012 Antianginal

6 Digoxin 46 0 ND ND Cardiac stimulant

7 Digoxigenin 84 0 ND ND Digoxin metabolite

8 Diltiazem 84 13.1 0.049 0.021 Antihypertensive

9 Enalaprilat 84 1.2 0.046 0.046 Metabolite

10 Fluoxetine 84 1.2 0.012 0.012 Antidepressant

11 Gemfibrozil 84 3.6 0.79 0.048 Antihyperlipidemic

12 Metformin 84 4.8 0.15 0.11 Antidiabetic

13 Paroxetine metabolite 84 0 ND ND Metabolite

14 Ranitidine 84 1.2 0.01 0.01 Antacid

15 Warfarin 84 0 ND ND Anticoagulant

NON

- PRESCRIPTION DRUGS 1

16 Acetaminophen 84 23.8 10 0.11 Antipyretic

17 Caffeine* 84 61.9 6.0 0.081 Stimulant

18 Caffeine** 85 70.6 5.7 0.1 Stimulant

19 Cotinine* 84 38.1 0.90 0.024 Nicotine
metabolite

20 Cotinine** 54 31.5 0.57 0.05 Nicotine
metabolite

21 1, 7

- dimethylxanthine 84 28.6 3.1 0.11 Caffeine
metabolite

22 Ibuprofen 84 9.5 1.0 0.2 Anti

- inflammatory

Notes:
1. Some of the drugs listed are available both by prescription and over

- the

- counter, including: cimetidine, ranitidine, acetaminophen, and ibuprofen

. ND: non

- detect
* Results based on Test Method 3 described in the USGS report. **Results based on Test Method 4 described in the USGS report. Source: Dana W. Kolpin, Edward T. Furlong, Michael T. Meyer, E. Michael Thurman, Steven D. Zaugg, Larry B. Barber, and Herbert T. Buxton, “Pharmaceu ticals, Hormones, and Other Organic Wastewater Contaminants in U.S. Streams, 1999

- 2000: A National Reconnaissance,” Environ. Sci. Technol. 2002, 36, 1202

- 1211.



### In a more recent survey, USGS conducted an integrated chemical and biological study to examine the occurrence of a broad suite of chemicals, including APIs, in wastewater133 

### treatment plant (WWTP) effluent and at sites upstream and downstream from the WWTP
ef fluent discharge point. 152 

### Samples of surface water, wastewater effluent, and bed sediment were collected through out Minnesota during 2009 and analyzed for selected
APIs and other chemicals of concern. Sampling locations included surface water and

wastewate r

- treatment plant effluent, but the study did not distinguish between surface water samples and effluent samples. Twenty

- five wastewater

- treatment plants were selected throughout Minnesota in varying land

- use settings. Water samples were analyzed for major ions, nutrients, trace elements, APIs, phytoestrogens, alkylphenols and other neutral organic chemicals, carboxylic acids, and steroidal hormones. The bed

- sediment samples were analyzed for carbon, wastewater

- indicator chemicals, and steroidal
hormones.

Exhibit 4

- 1 5 summarizes the results of the 2009 USGS study with respect to the 16 APIs and two surrogate chemicals analyzed. As indicated in the exhibit, observed concentrations of APIs ranged from 0.002 μg/L (low end of the range for fluoxetine and carbamazepine) to 11.5 μg/L (high end of the range for caffeine). Most of the estimated concentrations were less than 1 μg/L. This is consistent with the concentrations reported in the 2002 USGS study.

In a companion to the USGS Minnesota study, another team of USGS researchers examined sample data from targeted sites across the U.S. including 25 ground

- and 49
surface

- water sources of drinking water serving populations ranging from one family to more than 8 million people. 153 

### Despite low detection levels, 60 percent of the nearly 40 APIs (including prescription drugs and antibiotics) analyzed were not detected in any water sample, as shown in Exhibit 4

- 1 6 . The study authors note, however, that many pharmaceutical compounds are likely to transform or degra de as they are transported through the environment due to natural attenuation processes and that many of the resulting transformation compounds were not examined in the collected samples. Among the APIs detected, maximum concentrations range from 0.019 to 0.3 μg/L.

152 Kathy Lee, Susan Langer, Larry Barber, Jeff Writer, Mark F errer, Heik o Schoenfuss, Edward Furlong, William Foreman,

James Gray, Rhiannon ReVello, Dalma Martinovic, Olivial Woodruff, Staffanie Keefe, Greg Brown, Howard Taylor, Imma
Ferrer, Michael Thurman

. Endocrine Active Chemicals, Pharmaceuticals, and Other Chemicals of Concern in Surface Water,

Wastewater

- Treatment Plant Effluent, and Bed Sediment, and Biological Characteristics in Selected Streams, Minnesota

— Design, Methods, and Data, 2009 . U.S. Geological Survey, Reston, Virginia: 2011

.

153 MJ Focazio et al, A nationa l reconnaissance for pharmaceuticals and other organic wastewater contaminants in the United

States

— II) Untreated drinking Water Sources, Sci Total Environ (2008), doi:10.1016/j.scitotenv.2008.02.021134 EXHIBIT 4

- 1 5

. SUMMARY OF API CONCE NTRATIONS IN SURFACE WATER

SAMPLES ANALYZED IN USGS MINNESOTA STUDY

CHEMICAL RANGE IN DETECTED CO NCENTRATIONS ( μg /L) Acetaminophen nd

Albuterol nd

Caffeine 0.051

– 11.5
Carbamazepine 0.002

– 0.393

Codeine 0.006

– 0.079

Cotinine 0.009

– 0.22
Dehydronifedipine 0.004

Diltiazem 0.011

– 0.046

1,7

- Dimethylxanthine 0.073

– 4.32
Diphenhydramine 0.009

- 0.127

Fluoxetine 0.002

– 0.066

Ranitidine 0.015

– 0.13

Sulfamethoxazole 0.004

– 0.289

Thiabendazole nd
Trimethoprim 0.006

– 0.35

Warfarin nd

Notes: μg/L, microgram per liter nd, not detected

Source: Kathy Lee, Susan Langer, Larry Barber, Jeff Writer, Mark Ferrer, Heiko Schoenfuss, Edward Furlong, William Foreman, James Gray, Rhiannon ReVello, Dalma Martinovic, Olivial Woodruff, Staffanie Keefe, Greg Brown, Howard Taylor, Imma Ferrer, Michael Thurman. Endocrine Active Chemicals, Pharmaceuticals, and Other Chemicals of Concern in Surface Water, Wastewater

- Treatment Plant Effluent, and Bed Sediment, a nd Biological Characteristics in Selected Streams, Minnesota

— Design, Methods, and Data, 2009 . U.S. Geological Survey, Reston, Virginia: 2011.135 EXHIBIT 4

- 1 6

. USGS SAMPLING RESULT S FOR 25 GROUND AND 49 SURFACE WATER

SOURCES

ROW CHEMICAL REPORTING
LEVEL ( μg /L) N UMBER

OF
SAMPLES PERCENT

DETECTED MAXIMUM

CONCENTRATION ( μg /L) TYPICAL USE

VETERINARY AND HUMAN ANTIBIOTICS

1 carbodox 0.1 73 0 ND antibiotic

2 chlortetracycline 0.05 73 0 ND antibiotic

3 ciprofloxacin 0.02 73 1.4 0.03 antibiotic

4 demeclocycline 0.05 73 0 ND antibiotic

5 doxycycline 0.1 73 0 ND antibiotic

6 enrofloxacin 0.02 73 6.8 0.04 antibiotic

7 erythromycin

H2O 0.05 73 8.1 0.3 erythromycin
metabolite

8 lincomycin 0.05 73 0 ND antibiotic

9 methotrexate 0.05 73 0 ND antibiotic

10 minocycline 0.05 73 0 ND antibiotic

11 norfloxacin 0.02 73 0 ND antibiotic

12 oxytetracycline 0.1 73 0 ND antibiotic

13 roxithromycin 0.03 73 0 ND antibiotic

14 sara floxacin 0.02 73 1.4 0.02 antibiotic

15 sulfadimethoxine 0.05 72 0 ND antibiotic

16 sulfamerazine 0.05 73 0 ND antibiotic

17 sulfamethazine 0.05 73 0 ND antibiotic

18 sulfamethizole 0.05 73 0 ND antibiotic

19 sulfamethoxazole 0.023 74 2.7 UC antibiotic

20 sulfathiazole 0.1 73 0 ND antibiotic

21 tetracycline 0.05 73 0 ND antibiotic

22 trimethoprim 0.014 71 6.8 0.02 antibiotic

23 tylosin 0.05 73 0 ND antibiotic

24 virginiamycin 0.1 73 0 ND antibiotic

PRESCRIPTION DRUGS
25 albuterol 0.029 74 0 ND antiasthmatic

26 cimetidine 0.007 74 0 ND antacid

27 codeine 0.24 74 2.7 <RL analgesic

28 carbamazepine 0.011 74 21.6 0.19 anticonvulsant

29 dehydronifedipine 0.01 74 4.1 0.019 antianginal

30 diltiazem 0.012 74 1.4 <RL antihypertensive

31 diphenhydramine 0.01 74 5.4 0.023 antihistamine

32 fluoxetine 0.018 74 1.4 <RL antidepressant

33 gemfibrozil 0.015 74 0 ND antihyperlipidemic

34 ranitidine 0.01 74 0 ND antacid136 EXHIBIT 4

- 1 6

. USGS SAMPLING RESULT S FOR 25 GROUND AND 49 SURFACE WATER

SOURCES

ROW CHEMICAL REPORTING
LEVEL ( μg /L) N UMBER

OF
SAMPLES PERCENT

DETECTED MAXIMUM

CONCENTRATION ( μg /L) TYPICAL USE

35 warfarin 0.001 74 0 ND anticoagulant

NON

- PRESCRIPTION DRUGS

36 1,7

- dimethylxanthine 0.018 73 23 0.3 caffeine
metabolite

37 acetaminophen 0.009 74 8.1 0.16 antipyretic

38 caffeine 0.014 74 7.5 0.27 stimulant

39 cotinine 0.023 74 35.1 0.1 nicotine
metabolite

40 ibuprofen 0.018 74 1.4 0.27 anti

- inflammatory

Notes:
ND = non

- detect <RL = Less than reporting level UC = Unquantified concentration estimated to exceed reporting level

Source: MJ Focazio et al, A national reconnaissance for pharmaceuticals and other organic wastewater
contaminants in the United States

— II) Untreated drinking Water Sources, Sci Total Environ (2008), doi:10.1016/j.scitotenv.2008.02.021



### In addition to the USGS studies, a 2008 Associated Press series published the results of a nationwide investigation of water testing records across much of the U.S. and found medicines in the drinking water of 24 major metropolitan areas serving 41 million Americans. Frequently detected compounds were atenolol (heart medication), carbamazepine (mood

- stabilizer), gemfibrozil (anti

- cholesterol), meprobamate (tranquilizer), naproxen (pain

- killer), phenytoin (anti

- seizure medication),
sulfamethoxazole and trim ethoprim (antibiotics). 154 

### As part of the investigation, the AP reported on APIs detected within the watersheds of 28 metropolitan areas, based on a survey of 62 major water providers and data obtained from indep endent researchers.
Exhibit 4

- 1 7 identifies the watersheds where APIs were detected and, where possible, the specific APIs identified. Although many of the APIs identified are not hazardous under RCRA, the presence of APIs in the watersheds listed in Exhibit 4

- 1 7 may suggest the presence of hazardo us APIs as well. Along the same lines, Appendix F presents a detailed compilation of published positive occurrence data for APIs in finished drinking

water. The shaded rows represent select data on negative occurrence (data of absence)

. 155

154 AP Investigation: Pharmaceuticals Found in Drinking Water . (2008). See:
http://hosted.ap.org/specials/interactives/pharmawater_site/

155 Daughton CG "Pharmaceutical Ingredients in Drinking Water: Overview of Occurrence and Significance of Human

Exposure," In: Contaminants of Emerging Concern in the Environment: Ecological and Human Health Considerations, Rolf

Halden (Ed.), ACS Symposium Series 1048 , American Chemical Society: Washington, D.C., Chapter 2, p 9

- 68, 2 November137 EXHIBIT 4

- 1 7

. WATERSHED AREAS WHER E API s ARE DETECTED

CITY (NUMBER OF API s DETECTED IN

WATERSHED) EXAMPLES OF PHARMACE UTICALS FOUND IN WAT ERSHED

Arlington, Texas (5) Unspecified

Atlanta, Georgia (10) Caffeine, sulfamethoxazole, diltiazem , acetaminophen, trimethoprim, cotinine and paraxanthine

Cincinnati, Ohio (4) Gemfibrozil, ibuprofen, sulfamethaxazole and ethinyl
estradiol

Columbus, Ohio (15) Azithromycin, erythromycin, roxithromycin, tylosin, ciprofloxacin, ofloxacin and caffeine
Concord, California (unspecified) Unspecified
Denver, Colorado (unspecified) Unspecified antibiotics
Detroit, Michigan (unspecified) Carbamazepine, caffeine, cotinine

Fairfax, Virginia (8) Erythromycin, lincomycin, trimethoprim, tylosin, ciprofloxacin, ofloxacin and sulfamethoxazole
Indianapolis, Indiana (2) Caffeine and cotinine

Las Vegas, Nevada (9) Sulfamethoxazole, atenolol, trimethoprim, meprobamate, phenytoin, carbamazepine and gemfibrozil
Long Beach, California (9) Unspecified
Los Angeles, Cal ifornia (9) Unspecified
Louisville, Kentucky (2) Ibuprofen and naproxen
Milwaukee, Wisconsin (1) Cotinine
Minneapolis, Minnesota (3) Acetaminophen, caffeine and cotinine

New York, NY (16) Atenolol, trimethoprim, carbamazepine, ibuprofen, estrogen, acetaminophen and diazepam

Northern New Jersey (13) Acetaminophen, carbamazepine, codeine, dehydronifedipine, erythromycin, lincomycin and
sulfadimethoxine

Oklahoma City, OK (12) Acetaminophen, fluoxetine, gemfibrozil, ibuprofen, iopromide, sulfamethoxaz ole and iopromide
Omaha, Nebraska (2) Caffeine and sulfamethoxazole

Philadelphia, Pennsylvania (63) Amoxicillin, aspirin, atorvastatin, bacitracin, diclofenac, phenytoin and fluoxetine Prince George’s

- Montgomerey Counties, Maryland (3) Caffeine, carbamazepine and cotinine

Riverside County, California (9) Unspecified
San Diego, California (12) Clofibrate, clofibric acid, and ibuprofen
San Francisco, California (1) Estrone

2010; DOI: 10.1021/bk

- 2010

- 1048.ch002; pre

- publication version: http://www.epa.gov/esd/bios/daughton/ACS

- S S1048

- 2010.pdf138 EXHIBIT 4

- 1 7

. WATERSHED AREAS WHER E API s ARE DETECTED

CITY (NUMBER OF API s DETECTED IN

WATERSHED) EXAMPLES OF PHARMACE UTICALS FOUND IN WAT ERSHED

Santa Clara, California (unspecified) Unspecified

Southern California (9) Atenolol, phenytoin, fluoxetine, gemfibrozil, meprobamate, naproxen and trimethoprim
Virginia Beach, VA (4) Fluoxetine, estradiol, acetaminophen and ibuprofen

Washington, DC (5) Monensin, ibuprofen, caffeine, carbamazepine and
sulfamethoxazole
Source: Associated Press, Pharmawater

- Watersheds: AP investigation details APIs found in watersheds of 28 major metro areas, http://hosted.ap.org/specials/interactive s/pharmawater_site/day1_07.html

.



### Consistent with the findings from the Associated Press series, a study commissioned by
the American Water Works Association Research Foundation examining 20 drinking water utilities across the U.S. found that APIs were pr esent in their source waters as well as their finished drinking water. 156 

### Carbamazepine, phenyoin , sulfamethoxazole, and meprobamate were the APIs that most frequently occurred in raw drinking water (>80 percent of samples), while meprobamate, phenyoin , ibu profen, and iopromide were the APIs of greatest occurrence in finished drinking water (>65 percent of samples). Hormones occurred infrequently or not at all, while APIs were present in varying concentrations in raw and finished drinking waters.

WASTEWATER TREATMENT PLANT REMO VAL EFFICIENCIES FOR PHARMACEUTICAL

WASTES


### The human health and ecosystem benefits associated with the reduction in sewering resulting from the rule depend, in part, on the extent to which wastewater treatment plants
remove APIs from w astewater before releasing their effluent. Because wastewater treatment plants are not designed to remove the myriad APIs that may be present in wastewater, a significant portion of the APIs included in treatment plant influent may also be present in thei r effluent. Any removal of APIs would be purely incidental. 157 

### This would suggest that a reduction in the sewering of hazardous waste pharmaceuticals would
also reduce the release of these wastes to the environment via the effluent. However, it is

156 Shane Snyder, Eric C. Wert; Hongxia (Dawn) Lei; Paul Westerhoff; and Yeomin Yoon. Removal of EDCs and
Pharmaceuticals in Drinking and Reuse Treatment Processes. 2007. American Water Works Association Research Foundation
(AWWARF) and IWA P ublishing.

157 Unused Pharmaceuticals in the Health Care Industry: Interim Report (August 2008); EPA
http://water.epa.gov/scitech/swguidance/ppcp/upload/2010_ 1_11_ppcp_hcioutreach.pdf139 

### worth no ting that there are some instances in which, due to the presence of reversible conjugates, the concentration of effluent will increase despite a reduction in sewering. 158



### To inform water resource planning and protection efforts in individual watersheds, a
si gnificant body of research has examined wastewater treatment plant removal efficiencies for numerous contaminants of emerging concern (CECs). 159 

### In 2010, EPA’s Office of Water completed a report describing its CECs Removals Database , a Microsoft
Access data base designed to store and manage information from published scientific
studies on the removal of CECs from water and wastewater. 160 

### The report contains the
results of an extensive review of the recent literature on wastewater treatment technologies and incl udes results on laboratory

- scale (a system that is operated from a laboratory bench and tests are run in batches), pilot

- scale (a system that runs as a non

permanent subunit of a full

- scale system), and full

- scale (a fully

- functioning, permanent

treatment system) wastewater treatment systems. Exhibit 4

- 1 8 presents a summary of the municipal wastewater removal efficiencies included in the database for APIs and personal care products entering full scale treatment systems with activated sludge or biological

p hosphorus removal. The term “removal” means less of the target chemical was observed after treatment than before treatment. The removal efficiency for each pharmaceutical is defined as follows:

158 Daughton CG "The Matthew Effect and widely prescribed pharmaceuticals lacking environmental monitoring: Case study of

an exposure

- assessment vulnerability," Science of the Total Environment, 2014, 466

– 467:315

– 325; available:
http://dx.doi.org/10.1016/j.scitotenv.2013.06.111

159 Chemicals are being discovered in water that previously had not been detected or are being detected at levels that may
be significantly diffe rent than expected. These are often generally referred to as “contaminants of emerging concern”
(CECs) because the risk to human health and the environment associated with their presence, frequency of occurrence, or
source may not be known. See: http://water.epa.gov/scitech/cec/

.

160 U.S. Environmental Protection Agency Office of Water
, Treating Contaminants of Emerging Concern A Literature Review

Database. August 2010. EPA

- 820

- R

- 10

- 002. Washington, D.C. The database includes information on seven categories of
CECs: (1) nonlyphenols, octylphenol, and alkylphenol ethoxylate compounds; (2) polynuclear aromatic hydrocarbons; (3)
polybrominated biphenyl ethers; (4) pesticides; (5) pharmaceuticals and persona l care products; (6) steroids and hormones;
and (7) other.140

EXHIBIT 4

- 1 8

. SUMMARY OF SELECT PH ARMACEUTICAL REMOVAL EFFICIENCY V ALUES FROM EPA CONTA MINANTS OF EMERGING

CONCERN DATABASE (PE RCENT REMOVED)

ROW CEC ACTIVATED SLUDGE PHOSPHORUS REMOVAL ( BIOLOGICAL)

MIN MAX AVG COUNT
OF
PLANTS MIN MAX AVG COUNT
OF
PLANTS

1 Acebutolol 85 85 85 1

- - - -

2 Acetaminophen >90 >100 97 4 >99 >99 99 1

3 Acetylsalicylic acid >90 >90 90 1

- - - -

4 Amoxicillin 93 93 93 1

- - - -

5 Atenolol <10 <84 61 4 84 84 84 1

6 Azithromycin 30 93 54 3

- - - -

7 Bezafibrate 35 100 74 12 97 97 97 1

8 Biosol > 99 >99 99 1 >99 >99 99 1

9 Caffeine >85 >100 94 7 100 100 100 1

10 Carbamazepine <10 <60 22 5

- - - -

11 Cefaclor 96 96 96 1

- - - -

12 Celiprolol 36 36 36 1 36 36 36 1

13 Cephalexin 100 100 100 1

- - - -

1 4 Chloramphenicol 94 96 95 2

- - - -

1 5 Ciprofloxacin 59 89 73 5

- - - -
16 Clarithromycin 9 91 35 5 54 54 54 1

17 Clofibric acid 28 52 43 3 52 52 52 1

18 Codeine 29 29 29 1

- - - -

19 Crotamiton 98 98 98 2

- - - -

20 Diclofenac >7.1 >99 44 23 18 35 27 2

21 Dipyrone 65 65 65 1

- - - -

22 Erythromycin

- H2 O 6 92 31 5 25 25 25 1141

EXHIBIT 4

- 1 8

. SUMMARY OF SELECT PH ARMACEUTICAL REMOVAL EFFICIENCY V ALUES FROM EPA CONTA MINANTS OF EMERGING

CONCERN DATABASE (PE RCENT REMOVED)

ROW CEC ACTIVATED SLUDGE PHOSPHORUS REMOVAL ( BIOLOGICAL)

MIN MAX AVG COUNT
OF
PLANTS MIN MAX AVG COUNT
OF
PLANTS

23 Gabapentin >99 >99 99 1 >99 >99 99 1

24 Gemfibrozil >38 >99 77 13 68 68 68 1

25 Glibenclamide 45 45 45 1

- - - -
26 Hydrochlorothiazide 76 76 76 1

- - - -

27 Ibuprofen >43 >100 90 32 87 96 92 2

28 Indomethacin >23 >99 78 8

- - - -
29 Ketoprofen >9.0 >99 71 11 77 77 77 1

30 Lincomycin 17 17 17 1

- - - -

31 Mefenamic Acid 29 72 52 3

- - - -

32 Metoprolol <10 <65 32 4 65 65 65 1

33 Naproxen >47 >100 85 18 88 88 88 1

34 Norfloxacin 85 85 85 1

- - - -

35 Ofloxacin 24 98 69 3

- - - -
36 Paroxetine 91 91 91 1

- - - -

37 Penicillin 40 40 40 1

- - - -

38 Phenobarbital >99 >99 99 1 >99 >99 99 1

39 Phenytoin 44 44 44 1 44 44 44 1

40 Pravastatin 62 62 62 1

- - - -

41 Propranolol 28 65 47 2 65 65 65 1

42 Propyphenazone 43 43 43 1

- - - -

43 Ranitidine 42 42 42 1

- - - -

44 Roxithromycin 20 93 44 9 33 33 33 1142

EXHIBIT 4

- 1 8

. SUMMARY OF SELECT PH ARMACEUTICAL REMOVAL EFFICIENCY V ALUES FROM EPA CONTA MINANTS OF EMERGING

CONCERN DATABASE (PE RCENT REMOVED)

ROW CEC ACTIVATED SLUDGE PHOSPHORUS REMOVAL ( BIOLOGICAL)

MIN MAX AVG COUNT
OF
PLANTS MIN MAX AVG COUNT
OF
PLANTS

45 Sotalol 26 75 50 3 48 48 48 1

46 Sulfadiazine 97 97 97 2

- - - -

47 Sulfamethoxazole 9 99 58 15 24 24 24 1

48 Sulfapyridine 47 95 67 3

- - - -
49 Sulfathiazole 50 50 50 1

- - - -

5 0 Tetracycline 33 85 66 3

- - - -

5 1 Thymol >78 >91 85 2

- - - -

5 2 Trimethoprim 8.5 100 60 10 69 69 69 1

5 3 Valproic acid >99 > 99 99 1 >99 >99 99 1143 

### (1) Removal efficiency = 100 × ( influent concentration

− effluent concentration ) influent concentration



### For each pharmaceutical and treatment technology, the exhibit includes the minimum, maximum, and mean control efficiency and a count of the number of plants whe re data were available. As indicated in the exhibit, removal efficiencies vary signif icantly by API. For example, removal efficiencies for several APIs such as acetaminophen are near 100 percent, whereas the removal efficiency for several other drugs (e. g., lincomycin and glibenclamide) is less than 50 percent. In addition, for a given pharmaceutical, the estimated removal efficiency may vary by treatment technology.

A separate EPA OW study assessed the occurrence of CECs in the influent and effluent
of nine publicly owned treatment works (POTW). 161 

### Of the 72 APIs and pharmaceuticals
and personal care products (PPCPs) in the study, 44 were detected in at least one sample
of POTW influent collected and 33 were detected in at least one effluent sample. Exhi bit
4

- 1 9 summarizes the detected PPCPs in POTW influent and effluent samples. As indicated in the exhibit, thirteen PPCPs were detected or quantified in at least one influent sample and no effluent samples, and another thirteen PPCPs were quantified in at least one influent sample and one or more effluent samples at concentrations at least one order of magnitude less than influent samples. In addition, seven PPCPs were quantified in at least one influent sample and one or more effluent samples at concentr ations similar to influent samples.

The findings summarized in Exhibit 4

- 1 9 suggest that the ability of wastewater treatment plants to effectively remove APIs from wastewater varies considerably by pharmaceutical. This conclusion is also likely to apply to APIs considered to be hazardous waste under RCRA. Thus, while the reduction in sewering resulting from the proposed rule is likely to reduce the release of APIs to the environment, the percentage reduction in releases may vary by pharmaceutical.

161 U.S. Environmental Protection Agency Office of Water
, Occurrence of Contaminants of Emerging Concern in Wastewater
From Nine Publicly Owned Treatment Works. August 2009. EPA

- 821

- R

- 09

- 00. Washin gton, D.C.144 EXHIBIT 4

- 19

. COMPARISON OF PPCPS DETECTED IN POTW INF LUENT AND EFFLUENT

DETECTED IN AT LEAST
ONE INFLUENT SAMPLE
AND NO EFFLUENT
SAMPLES QUANTIFIED IN AT LEA ST ONE INFLUENT SAMPLE AND

ONE OR MORE EFFLUENT
SAMPLES AT CONCENTRA TIONS
AT LEAST ONE ORDER O F
MAGNITUDE LESS THAN AT
LEAST ONE INFLUENT S AMPLE ONE OR MORE EFFLUENT AT
CONCENTRATIONS SIMIL AR
TO INFLUENT SAMPLES
Antibiotics 4

- Epitetracycline (ETC)

Minocycline 1
Sulfamerazine
Sulfathiazole
Cloxacillin 1
Penicillin V 1 Virginiamycin 1 Doxycycline
Sulfamethoxazole Ciprofloxacin Clarithromycin Erythromycin

- Total
Oflo xacin Chlorotetracy c line (CTC) Tetracycline (TC)
Sulfadiazine Trimethoprim

Other PPCPs Acetaminophen

Caffeine
Miconazole Ibuprofen
Triclosan
Warfarin 1 Cotinine
Gemfibrozil Naproxen
Triclocarban
Cimetidine
Metformin
Ranitidine Carbamazepine
Fluoxetine
Thiabendazole

Notes:
1. All influent results for which the analyte was detected. No numerical values are associated with these
results. Note: Tylosin and cefotaxime were detected in POTW effluent and no samples of POTW influent. They are
not included on this table.
Eleven APIs were detected in at least one influent and one effluent sample but were not quantified in both influent and effluent samples. Consequently, their influent and effluent concentrations could not be compared and they are not included on this table. Source: U.S. Environmental Protection Agency Office o f Water, Occurrence of Contaminants of Emerging Concern in Wastewater From Nine Publicly Owned Treatment Works. August 2009. EPA

- 821

- R

- 09

- 00. Washington, D.C.

AQUATIC ECOSYSTEMS A ND THE EFFECTS ON FI SH AND ANIMAL POPULA TIONS


### To the extent that the proposed rule reduces surface water concentrations of hazardous waste pharmaceuticals, the rule may yield benefits associated with the avoidance of adverse ecosystem impacts. As outlined below, a number of studies have shown that
AP Is may cause detrimental effects to aquatic organisms and ecosystems. Continuous input of APIs into rivers and streams, through wastewater treatment systems, may adversely affect the aquatic ecosystems of receiving water bodies due to the intrinsic biolog ical activity of these compounds. Aquatic pollution is particularly troublesome because aquatic organisms are captive to continual life

- cyc l e, multigenerational exposure. According to Daughton and Ternes ( 1999): 162

162 Daughton CG and Ternes TA "Pharmaceuticals and Personal Care Products in the Environment: Agents of Subtle Change?"
Environ. Health Perspect . 1999, 107(suppl 6), 907

- 938; doi:10.2307/3434573;
http://www.epa.gov/nerlesd1/bios/daughton/errata.pdf

.145 

### T he possibility for continual but undetec table or unnoticed effects on aquatic organisms is particularly worrisome because effects could accumulate so that major change goes undetected until the cumulative level of these effects finally cascades to irreversible change

— change that would otherwise be attributed to natural adapta tion or ecologic succession[...] As opposed to the conventional, persistent priority pollutants, PPCPs need not be persistent if they are continually introduced to surface waters, even at low parts

- per

- trillion/parts

-

per

billion concentrations (ng

- μg/L). Even though some PPCPs are extremely persistent and introduced to the environment in very high quantities and perhaps have already gained ubiquity worldwide, others could act as if they were

pe rsistent, simply because their continual infusion into the aquatic environment serves to sustain perpetual life

- cycle exposures for aquatic organisms.

To ascertain the ecological risks of API exposure in the receiving waters of wastewater treatment plants , Ginebreda et al . (2009) performed an environmental risk assessment for ecosystems in the lower part of the Llobregat River basin in northeastern Spain. 163 

### Spanning seven sampling points where data were collected on 29 common APIs belonging to different th erapeutic classes (e.g., analgesics, psychiatric drugs, etc.), the risk assessment estimated hazard quotient indices for three bioassays commonly used in environmental toxicology: fish, Daphnia , and algae. The authors found that hazard quotients were less than unity

— the level indicative of no risk

— at only three sites (out of the seven studied) for fish, four for Daphnia, and one for algae. Only one site showed the three indices below unity. Comparing across the three bioassays, algae appear to be the

mos t sensitive, followed by fish and Daphnia

. The literature examining the ecological effects of APIs in surface waters increasingly shows that wild populations of both estuarine and freshwater fish are being exposed to
endocrine

- disrupting chemicals (EDCs) i n concentrations sufficient to cause disruption of their reproductive physiology. In particular, the occurrence of intersex fish in a number of countries has been associated with the proximity of these fish to point source sewage effluent discharges due t o exposure to EDCs

. In severely feminized fish, fertility is reduced and the contribution of these fish to the growth rate of the population is likely to
be reduced. 164



### Results from a whole

- lake experiment conducted by Kidd et al . (2007) demonstrate that

c ontinued inputs of natural and synthetic estrogens to the aquatic environment in municipal wastewaters decrease the reproductive success and sustainability of fish

163 A Ginebreda et al, Environmental risk assessment of pharmaceuticals in rivers: Relationships between hazard indexes and
aquatic macroinvertebra te diversity indexes and aquatic macroi nvertebrate diversity indexes in the Llobregat River (NE
Spain)

. Environ Int (2009), doi:10.1016/j.envint.2009.10.003

164 Susan Jobling , et al . Predicted Exposures to Steroid Estrogens in U.K. Rivers Correlate with Widespread Sexual Disru ption
in Wild Fish Population. Environmental Health Perspectives . Volume 114. SUPPLEMENT 1. April 2006.146 

### populations. As measured by the authors, chronic exposure of fathead minnow to a
potent syn thetic estrogen led to feminization of males and eventual population collapse. 165



### Short

- lived fish species such as fathead minnows may generally be at greatest risk from exposure to estrogens and their mimics, but chronic exposure of longer

- lived species to these substances may result in the loss of these populations as well. 166



### Also focusing on endocrine

- disrupting chemicals, Jobling et al . (2004) examine how exposure to four individual estrogenic chemicals and a mixture containing these chemicals (treated s ewage effluent) impacts embryo production in the prosobranch mollusk (a type of snail) and egg production in various species of freshwater fish. 167 

### The
lab

- based studies showed that all of the tested chemicals affected embryo and egg production. Furthermo re, exposure to estrogen induced similar reproductive responses in the snails as in the fathead minnow, stimulating egg/embryo production at low doses (up to 1 ng/L in the minnow and 25 ng/L in the snail) and causing inhibitory effects at higher
doses. The se data suggest that both the nature of the response and the relative sensitivities to environmental estrogens in the snails and different fish species are comparable.

Brain et al . (2004) examine the effects of 25 APIs, including 22 antibiotics, on the aqu atic higher plant Lemna gibba

. 168 

### Based on their assessment of phytotoxicity across multiple endpoints, the authors found that APIs from the fluoroquinolone, sulfonamide, and tetracycline classes of antibiotics displayed significant phytotoxicity. 169 

### The mos t toxic members of each of these classes tested were lomefloxacin, sulfamethoxazole, and
ch lortetracycline, respectively.

HUMAN HEALTH EFFECTS


### Reducing the concentration of hazardous waste pharmaceuticals in U.S. surface water and drinking water supplies may yield human health improvements from reduced exposure to
these substances. The fact that APIs are manufactured with the intention to cause biological effects has raised concerns about the impacts of unintentional pharmaceutical

165 The concentrations of EE2 achieved in the experimental lake, Lake 260, during the 3 years of additions were within the
range of those observed in unt reated and treated municipal wastewaters and below the total E2 equivalents (with EE2
having an E2 equivalent of 0.19

– 1.9) measured in effluents and receiving waters . Seasonal mean ± SD EE2 concentrations in
Lake 260 were 6.1 ± 2.8 (n = 189), 5.0 ± 1.8 (n = 169), and 4.8 ± 1.0 (n = 170) ng·L

- 1 in 2001

– 2003, respectively

.

166 KA Kidd
, PJ Blanchfield, KH Mills, VP Palace, RE Evans, JM Lazorchak et al. Collapse of a fish population after exposure to
a synthetic estrogen. Proc Nat Acad Sci USA. 2007; 104:8897

– 8 90

.

167 S. Jobling, D. Casey, T. Rodgers

- Gray, J. Oehlmann, U. Schulte

- Oehlmann, S. Pawlowski, T. Braunbeck, A.P. Turner, C. R
Tyler. Comparative responses of mollusks and fish to environmental estrogens and an estrogenic effluent. Aquat. Toxicol.

200 4
, 66
, 20 7

- 22 2

.

168 RA Brain, DJ Johnson, SM Richards, H Sanderson, PK Sibley, KR Solomon. 2004. Effects of 25 pharmaceutical compounds to
Lemna gibba using a seven

- day static

- renewal test. Environ. Toxicol. Chem. 23(2): 371

- 82.

169 The authors report that 25 pharmaceuticals, including 22 antibiotics, were assessed for phytotoxicity to the aquatic higher
plant Lemna gibba. A 7

- d static

- renewal test was used, and plants were treated with 0, 10, 30, 100, 300, and 1,000
microg/L of pharmaceutical containi ng growth media.147 

### exposure on the health of human and ecological communities. Whereas the occurrence of APIs in the environment is fairly well established, their long

- term effects and environmental consequences are still a matter of active research. Although this research is ongoing, the important elements of the problem can be summarized in the following
facts: 170



### 1. Pharmaceuticals are intrinsically bioactive compounds; therefore, they a re able to cause potential effects on living systems.

2. There is a continuous and worldwide increase in their use and, thus, on their subsequent input into the environment.

3. Thousands of different pharmaceuticals are currently and regularly used
simultaneousl y, which are susceptible to interaction and synergistic effects that are basically unknown.

Using EPA recommended approaches for exposure assessment, many studies have examined exposure to PPCPs through oral ingestion, which generally happens during consumption of finished drinking water and/or fish. 171 

### Other indirect exposure scenarios are also possible, such as: consumption of food crops and/or vegeta bles irrigated with reclaimed wastewater or grown on sewage

- sludge

- amended soil; inhalation of APIs during application of reclaimed wastewater for irrigation purposes; and dermal exposure. Potential food supply impacts are discussed in the following secti on. S tudies examining exposure to APIs through these and other pathways typically examine the effect of
exposure to one API at a time, though in actuality individuals may be exposed to multiple APIs simultaneously. B ased on information about the activity and potential toxicity of APIs, it has been suggested that possible health effects of long

- term exposure to APIs in drinking water could include endocrine disrupting activity, induction of antibiotic resistance, genotoxicity, carcinogenicity, or allergic reactions, as well as effects on reproduction or fetal/child development. 172



### Bercu et al . (2008) evaluate the risks from residues of atomoxetine (a selective norepinephrine reuptake inhibitor prescribed for attention

- deficit hyperactivity disorder),
duloxe tine (an anti

- depressa nt), and olanzapine (an anti

- psy c h otic, typically prescribed for schizophrenia), all of which may be found in U.S. surface waters. Using preclinical safety studies and human clinical data, the authors estimated acceptable daily intake s (ADIs) and predicted no

- effect concentrations for each of the three APIs analyzed. The ADI for each compound was calculated using uncertainty factors to account for

170 A. Ginebreda et al, Environmental risk assessment of pharmaceuticals in rivers: Relationships between hazard indexes and
aquatic macroinvertebra te diversity indexes and aquatic macroinvertebrate diversity indexes in the Llobregat River (NE
Spain)

. Environ Int (2009), doi:10.1016/j.envint.2009.10.003

.

171 Arun Kumar, Biao Chang, and Irene Xagoraraki. Human Health Risk Assessment of Pharmaceuticals in Water: Issues and
Challenges Ahead. Int. J. Environ. Res. Public Health 2010, 7 , 3929

- 3953 ; doi:10.3390/ijerph7113929

.

172 Shane Snyder, et al. Toxicological Relevance of EDCs and Pharmaceuticals in Drinking Water. AWWA Research Foundation.

2008.148 

### variability within the human population, including sensitive subpopulations. Based on th e ADIs

, predicted no

- effect concentrations

, and the estimated exposure concentrations, the authors concluded that no appreciable human health risks exist from exposure to the highest 99th percentile of predicted residue levels in surface waters under low

- f low
conditions. 173



### Using a quantitative pharmaceutical risk assessment (QPhRA) framework 174 

### , Kumar et al

. (2010) examined the health risks associated with accidental exposures to meprobamate, carbamazepine, and phenytoin through stream water, fish consumptio n, and direct ingestion of finished drinking water for children and adults. 175 

### The researchers focused on these three APIs because they have been frequently detected in U

. S

. waters and have toxic effects on pregnant women and children. Under both scenarios examined in the study, the calculated hazard quotients were small and indicated no potential risks of
adverse health effects. In addition, pharmaceutical concentrations in the study were observed to be lower than their respective acce ptable daily intake

- equivalent drinking water levels, suggesting no potential human health risks.

Schwab et al . (2005) present a detailed risk assessment for 26 APIs and/or their metabolites, representing 14 classes of drugs. 176

, 177 

### Based on acceptable daily intakes (ADIs) derived from published information on active pharmaceutical ingredients, the authors estimated the predicted no effect concentrations (PNECs) for two sources of potential human exposure: drinking water and fish ingestion. The authors then compared the estimated PNECs to measured environmental concentrations (MECs) from the published literature and to maximum predicted environmental concentrations (PECs) generated from the PhATE model. 178 

### The PhATE predictions reflect the conservative

173 J.P. Bercu, N.J. Parke, J.M. Fiori, and R.D. Meyerhoff (2008). Human health risk assessments for th ree neuropharmaceutical compounds in surface waters. Regul atory Toxicol ogy and Pharmacol ogy

. Volume 50, Issue 3, April
2008, Pages 420

– 427

.

174 The QPhRA process helps in estimating the nature and probability of adverse health effects in humans who may be

ex posed to pharmaceuticals from cont aminated environmental media . It primarily involves four major steps: (1) h azard
identification, (2) e xposure assessment, (3) d ose

- response relationship, and (4) r isk characterization . (See Kumar, Chang,

and Xagoraraki (20 10)).

175 Arun Kumar, Irene Xagoraraki, Human health risk assessment of pharmaceuticals in water: An uncertainty analysis for
meprobamate, carbamazepine, and phenytoin

. Regulatory Toxicology and Pharmacology 57 (2010) 146

– 156

.

176 These include acetaminophen, cimetidine, ciprofloxacin, codeine, dehydronifedipine, digoxigenin, digoxin, diltiazem,
doxycycline, enalaprilat, erithromycin

- H2O, fluoxetine, gemfibrozil, ibuprofen, lincomycin, metformin, norfloxacin,
oxytetracycline, parox etine metabolite, ranitidine, sulfamethoxazole, sulfathiazole, tetracycline, trimethoprim, and

warfarin

.

177 R.W. Schwab, E.P. Hayes, J.M. Fiori, F.J. Mastrocco, N.M. Roden, D. Cragin, R.D. Meyerhoff, V.J. D’Aco, P.D. Anderson

. Human pharmaceuticals in US su rface waters: A human health risk assessment. Regul. Toxicol. Pharmacol. 2005
, 42 , 296

-
312.

178 The PhATE (Pharmaceutical Assessment and Transport Evaluation) model is a watershed

- based approach that was
developed as a tool to more realistically estimate con centrations of active pharmaceutical ingredients (APIs) discharged to
U.S. surface waters through consumption of medicines. (Southwest Hydrology, Volume 2 Number 6 November/December

2003 , 20

- 21). See discussion in Cunningham VL. "Environmental Exposure Mod elling: Application of PhATETM and GREAT

- ER to149 

### assumpt ions of low river flow and no depletion (i.e., no metabolism, no removal during water treatment, and no in

- stream depletion). For all 26 compounds, the MEC

- to

- PNEC
and PEC

- to

- PNEC ratios were low, suggesting minimal human health risk from the presence of the tested APIs in surface water and drinking water.

Cunningham et al . (2009) use a similar approach to assess the potential impact to human health from environmental exposures for 44 APIs, representing approximately 22 general pharmacological classes for a broad spectrum of therapeutic activities. 179 

### The authors characterized risk for these APIs by calculating the ratio of the 90th percentile PECs to the pharmaceutical

- specific PNECs. Across the 44 pharmaceutical ingredients analyzed,
these ratios varied f

rom 7x10

- 2 

### to 6x10

- 11 

### , or significantly less than 1.0. These low values indicate that, based upon currently available data, the compounds analyzed do not appear to pose an appreciable risk to human health from potential environmental exposure from
drinkin g water and fish consumption.

Focusing on the APIs clofibrate, indomethacin, acetylsalicylic acid, and cyclophosphamide, Schulman et al . (2002) estimated safe water quality limits for these APIs using EPA’s Methodology for Deriving Ambient Water Quality Cr iteria for the Protection of Human Health and compared these values to concentrations found in the
environment. 180 

### The study took into account human exposure to contaminated water, intake via bioaccumulation in fish, the toxicological and pharmacological na ture of each compound, and the environmental fate and transport of each pharmaceutical. Based on these factors, the study found that the concentration of each pharmaceutical product in the aquatic environment was below the safe limits derived for the stud y and that they do not pose an appreciable risk to human health.

To provide perspective on the possible cancer risk from exposure to APIs in drinking water, Snyder et al . (2008) compared the relative carcinogenic risk of gemfibrozil and phenytoin to the risks of agents found in different food products and drugs taken for therapeutic purposes. 181 

### Estimates of risk were based on chemical

- specific carcinogenic potency data from the Carcinogenic Potency Project at the Lawrence Berkeley Laboratory at the Unive rsity of California. The authors’ comparison found that the carcinogenic risk of exposure to gemfibrozil and phenytoin is on the order of more than
one million times lower than carcinogenic risks from daily ingestions of alcoholic

Human Pharmaceuticals in the Environment" in Pharmaceuticals in the e nvironment

- Sources, f ate, e ffects and r isks, 3rd

E d.; Kümmerer K, Ed., Springer; Berlin Heidelberg, Germany, 2008, Chapter 10, pp 133

- 146; doi:10.1007/978

- 3

- 540

- 74664

- 5_10

.

179 V.L. Cunningham, S.P. Binks, M.J. Olson . Human health risk assessment from the presence of human pharmaceuticals in
the aquatic environment. Regul. Toxicol. Pharmacol. 2009
, 53
, 39

- 45.

180 U.S. EPA, Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000) Technical
Support Document Volume 1: Risk Assessment, EPA

- 822

- B

- 00

- 005, October 2000.

181 Snyder, Shane A, et al. Toxicological Relevance of EDCs and Pharmaceuticals in Drinkin g Water. Awwa Research

Foundation. 2008.150 

### bev erages and consumptio n of other compounds present in food (such as afla toxin, a fungal toxin; or caffeic acid, coumarin, and d

- l imonese, all natural pesticides).

While the studies summarized above suggest that exposure to many APIs in surface water or drinking water does not r epresent an appreciable risk to human health, the occurrence of antibiotics in hospital sewage effluent raises concern of antimicrobial resistance, which is an important threat to public health , as emphasized in Executive Order 13676

. 182 

### As example s of anti biotic releases in hospital effluent , ciprofloxacin has been responsible for bacterial DNA damage in German hospital effluents and bacterial (E. coli) resistance (along with norfloxacin) in Vietnamese hospital effluents. 183



### As discussed, there are document ed cases of the increasing occurrence of micropollutants in the environment. In a review, Tijani et al (2013) 184 

### , assess the availability of information on these emerging micropollutants and their effects as well as examine potential techniques for their removal. The study highlights the potentially harmful
effects of bioaccumulation of PPCPs (p harmaceuticals and personal care products) including, d ecreased fecundity and increased inciden ce of breast and testosterone cancers

. In addition, there has been a widespread increase in antibacterial resistance, which
contributes to adverse health outcomes as well as higher medical costs due to both longer hospital stays and more treatment. The Ce nters for Disease Control and Prevention estimates that, annually, at least 2 million illnesses and 23,000 deaths in the U.S. are caused by antibiotic

- resistant bacteria. 185

PRES ENCE OF API s IN THE FOOD SUPPLY


### Another source of indirect exposure to APIs is t hrough our food supply. Malchi et al (2014) 186 

### aim ed to quantify the amount of pharmaceutical compounds (PCs) in root vegetables that were irrigated with treated wastewater. The authors examined carrots and sweet potatoes, and found that there were significantly higher concentrations of nonionic PCs as compared to concentrations of ionic PCs. The threshold of toxi c o lo gical concern ( TTC ) approach was used to translate these findings to the health risk of consuming

wastewater

- irrigated root vegetables. Based on these findings , the study recommended

182 Executive Order 13676. Combating Antibiotic

- Resistant Bacteria. September 23, 2014.

183 Kevin V. Thomas and Katherine H. Langford. “Point Sources of Human Pharmaceuticals into the Aquatic Environment,” in

Green and Sustainable Pharmacy . Edited by Klaus Kummerer and Maximilian Hempel. Springer

- Verlag. 2010.

184 Tijani J, Fatoba O, and Petrik LF. "A Review of Pharmaceuticals and Endocrine

- Disrupting Compounds: Sources, Effects,
Removal, and Detections." Water, Air, & So il Pollution 2013, 224(11):1

- 29; doi:10.1007/s11270

- 013

- 1770

- 3.

185 Centers for Disease Control and Prevention, as cited in I nteragency Task Force for Combating Antibiotic

- Resistant

Bacteria
, “National Action Plan for Combating Antibiotic

- Resistant Bacteria,” March 2015, available at
https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic

resistant_bacteria.pdf.

186 Malchi T, Maor Y, Tadmor G, Shenker M, and Chefetz B. "Irrigation of Root Vegetables with Treated Wastewater:
Evaluating Uptake of Pharmaceuticals and the Associated Human Health Risks." Environmental Science & Technology 2014;

doi:10.1021/es5017894.151 

### that PCs in root vegetables that appear in high concentrations (higher than the TTC value) should be classified as contaminants of emerging concern.

Daughton and Brooks (2011) review the presence of APIs in the tissues of aquatic organisms t h rough an examination of API exposure factors and the current methods used
to understand the connection between e xposure and effects thresholds

. 187 

### In doing so, the authors highlight the apparent knowledge gap on the relati onship between API tissue concentrations in aquatic organisms and how these levels might translate to human exposure through fish or other aquatic life consumption. Some origins of APIs significant to aquatic exposure include, but are not limited to, huma n and veterinary medications, excretion, runoff, bathing, and commercial use. However, these sources are subject to several external factors such as hydrology and wastewater treatment technologies that can contribute a great deal of variability to API val ues. While a few models have been developed, t he combination or the various origins, external factors, and little empirical data on the uptake and bioconcentration of APIs by aquatic organisms, make it difficult to assess aquatic tissue concentrations and subsequent human exposure.

POTENTIAL BENEFITS R ELATED TO E NHANCED R ECREATIONAL O PPORTUNITIES


### Another potential benefit of the proposed rule is enhanced recreational opportunities in aquatic and marine environments currently impacted by hazardous waste pharmaceuticals. To the extent that the rule leads to improved water quality in these environments, individuals who recreate in affected waters may realize a welfare gain as the quality of their recreational experience improves. In addition, improvements in water quality could lead to increased recreation, which would also represent a welfare improvement. While the available data are not sufficient to quantify the improvements in water quality likely to result from the rule or the impact in recreational participation associated with these changes in quality, the economics literature includes several studies linking changes in water quality to changes in the economic value of recreation in the marine and/or aquatic environments.

Using survey data on reveal ed and stated preferences with respect to recreation,
Whitehead et al . (2000) calculated the societal benefits associated with improving the water quality for the Albemarle and Pamlico Sounds in North Carolina

. 188 

### Aggregating

over 800,000 households in the 41 counties of eastern North Carolina , Whitehead et al.
estimated that the consumer surplus for the Albermarle and Pamlico Sounds with water quality at the time of the study was $107 million. If the quality of the area were to improve to pre

- 1981 levels, the authors estimated that aggregate consumer surplus of

187 Daughton CG and Brooks BW “Active Pharmaceutical Ingredients and Aquatic Organisms," In: Environment al Contaminants
in Biota: Interpreting Tissue Concentrations, W. Nelson Beyer and James P. Meador (Eds.), 2nd ed., CRC Press, Taylor and
Francis, Boca Raton, FL; Chapter 8, p 287

- 347, 2011; accessible at http://www.epa.gov/esd/bios/daughton/APIs

aquaticbiota.pdf

.

188 J Whitehead et al, Measuring recreation benefits of quality improvements with revealed and stated behavior data.
Resource and Energy Economics (2000), http://dx.doi.org/10.1016/S0928

- 7655(00)00023

- 3152 

### approximately $138 million, which represents a welfare gain of $31 million relative to
baseline conditions

. In another study focusing on the Albemarle

- Pamlico Estuary of North Carolina, Kaoru (1995) examined the benefits of water quality improvements for marine recreational fishing. 189 

### With a focus on catch

- rate improvements as a result of
certain pollution controls (an indicator of water quality) , the average additional
recreational benefits range d from $0.09 to $5.16 per trip

, per individual

. Carson & Mitchell (2010) sought to quanti fy the national benefits resulti ng from freshwater pollution control. 190 

### Through a contingent evaluation su rvey, they gathered
data on 813 individuals’ willingness to pay, an estimate of consumer surplus, for improved boatable, fishable

, and swimmable waters nationwide

. With a baseline of unusable water, the authors estimated a willingness to pay for swimmable quality water
of $ 46.7 billion (1990 dollars). The authors compared these estimated benefits to Department of Commerce data which placed water pollution control costs at $37.3 billion ( in 1990 dollars) for the year 1988.

Examining Clear Lake in Iowa

, Azevedo , Herriges & Kling (2001) also examined willingness to pay as a measure of the benefits associated with certain water quality improvements. 191 

### The study found that the average visitor ’s willingness to pay was significantly greater for high quality im provement s to the lake versus low quality improvement s , $ 425 per visitor compared to $ 8 5 per visitor , respectively. Respondents also indicated that with low quality improvements they would take an average of 7.03 trips per season and under high quality im provements , they would take 10.32 trips per

season

. In another study based in Iowa, Egan et al

. (2009) examined three scenarios that
described various levels of physical water quality improvements for 129 lakes. 192 

### Designations of water quality were based o n water clarity, nutrient levels and bacteria
levels. The first scenario improves the water quality of all 129 lakes to the physical water quality of the least affected and most pristine lake in the study, West Okoboji Lake. The second scenario improves 9 lakes to the supreme water quality of West Okoboji Lake and the third scenario improves 65 impaired lakes (as designated by EPA standards) to median physical water quality levels. The study found household welfare gains across all three scenarios, with the greatest under Scenario 1 ($151). Welfare improvements were greater under the second scenario ($19) than the third ($11), suggesting that the benefits

189 Y Kauru, Measuring marine recreation benefits of water quality improvements by the nested random utility model,
Resource and Energy Economics (1995)

.

190 RT Carson and RC Mitchell, The value of clean water: The public’s willingness to pay for boatable, fishable, swimmable
quality water. Water Resources Research (1993) DOI: 10.1029/93WR00495

191 C Azevedo, J Herriges, C Kling, Valuing Preservation and Improve ments of Water Quality in Clear Lake. Center for
Agricultural and Rural Development, Iowa State University (2001)

192 KJ Egan et al, Valuing water quality as a function of water quality measures, Amer. J. Agr. Econ (2009) ; 91(1):106

- 123.
DOI: 10.1111/j.1467

- 8276.2008.01182.x153 

### of improving a limited number of lakes to a high level of water quality exceed the
benefits from mor e modest improvements to all impaired lakes.

OTHER POTENTIAL BENE FITS


### In addition to the benefits presented above regarding reductions in the sewering of hazardous waste pharmaceuticals, the proposed rule may also lead to reductions in the
amount of hazardous waste pharmaceuticals managed as MSW or medical waste , which are both noncompliant management methods

. 193 

### Although the rule does not include any

new restrictions on the management of hazardous waste pharmaceuticals as MSW or medical waste, it may raise awareness of existing RCRA requirements among facilities that engage in these management practices, leading some to divert their hazardous waste pharmaceuticals to incineration. Because the regulatory options considered by EPA do not include any new restrictions on the management of hazardous waste pharmaceuticals as MSW or medical waste, the magnitude of any diversions away from these practices is
uncertain and not estimated in this RIA.

The proposed rule will also provide greater regulatory clari ty for healthcare facilities with respect to hazardous waste pharmaceuticals. As indicated in Chapter 1, healthcare facilities often experience difficulty complying with existing RCRA regulations because of the industry

- focused framework of these regulati ons and because of healthcare workers’ relative unfamiliarity with RCRA regulations as they relate to hazardous waste pharmaceuticals. The proposed rule addresses both of these issues by (1) stipulating regulatory requirements specific to healthcare facil ities generating hazardous waste pharmaceutica ls and (2) ensuring that healthcare facil ity employees receive the information and training necessary to manage these wastes in a manner that is protective
of human health and the environment. Together, thes e elements of the rule will help healthcare facilities better integrate the responsible management of hazardous waste pharmaceuticals into their operations, thereby reducing releases of these wastes into the environment. Similarly, the rule will provide gr eater regulatory certainty to reverse distributors in terms of when unused or expired pharmaceuticals are considered a hazardous waste. This will allow reverse distributors to make long

- term operational and investment decisions based on these requirements

. Finally, the rule’s provisions for improved tracking of hazardous waste pharmaceuticals will help EPA and regulated facilities ensure that these wastes arrive at their intended destinations rather than facilities not equipped to manage these wastes. The se 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.

193 MSW disposal is a compliant method for CESQGs in select states, as discussed earlier in this chapter and in Chapter 3.154 SEN SITIVITY ANALYSES

SENSITIVITY ANALYSIS : PARTIAL COMPLIANCE BASELINE


### To test the sensitivity of the results presented above to assumptions regarding the baseline compliance of facilities affected by the rule, this section presents the benefits of the rule incremental to a partial compliance baseline that reflects current no n

- compliance in the management of hazardous waste pharmaceuticals. More specifically, the partial compliance baseline assumes that n on

- compliant facilities manage their hazardous waste pharmaceuticals in three ways: sewer disposal (without notifying their local POTW), dispos al of these wastes with their municipal solid waste, or disposal as regulated medical wastes (e.g., with latex gloves, used dressings, etc.). Expert input from firms that provide hazardous waste management services to hospitals suggest s that the distribution across these management methods (for hazardous waste pharmaceuticals not managed in compliance with RCRA ) is 10 percent MSW disposal , 67 percent medical waste disposal

, and 23 percent sewered. 194 

### This distribution is applied to all p atient care hazardous waste pharmaceuticals assumed not to be managed in compliance with RCRA under the partial compliance baseline. The percentage of hazardous waste pharmaceuticals that are not managed in compliance with RCRA is assumed to vary by gener ator status and facility type (i.e., hospitals, other healthcare facilities, and reverse distributors). This RIA assumes the following with respect to compliance and non

- compliance:

 LQG and SQG Hospitals: Compliance for LQG and SQG hospitals varies
betwee n patient care hazardous waste pharmaceuticals generated on the hospital floor and waste generated by the hospital pharmacy. Based on input provided by industry, approximately 80 percent of hospital hazardous waste pharmaceuticals are patient care waste a nd the remaining 20 percent are pharmacy waste. 195 

### This RIA assumes that all hospital pharmacy waste is sent to a reverse distributor and ultimately managed in compliance with RCRA. For patient care hazardous waste pharmaceuticals, this RIA assumes that 20 percent is managed in compliance with RCRA, based on input from industry contacts. 196 

### Thus, approximately 64 percent of all hazardous waste pharmaceuticals generated by LQG and SQG hospitals is assumed not to be managed in compliance with RCRA (0.8 × 0.8= 0.64). This waste is assumed to be distributed between MSW disposal, medical waste disposal, and sewering (without notification) in proportion to the percentages presented above.

 CESQG Hospitals: This RIA assumes that all patient care hazardous waste phar maceuticals generated by CESQG hospitals are not managed in compliance

194 Based on personal communication with Charlotte Smith, Waste Management Healthcare Solutions, December 5, 2012 and

p ersonal communication with John Kelsey, Clean Harbors, December 2, 2012.

195 Personal communication with John Kelsey of Clean Harbors, August 17, 2012.

196 This figure is based on personal communication with Selin Hoboy of Stericycle on August 6, 2012 and pers onal
communication with Phil Retallick and John Kelsey of Clean Harbors on April 16, 2012.155 

### with RCRA under the partial compliance baseline. As stated above, patient care pharmaceuticals are estimated to account for 80 percent of the hazardous waste pharmaceuticals generated by a hospital. This RIA therefore assumes that 80 percent of all the hazardous waste pharmaceuticals generated by CESQG hospitals are not managed in compliance with RCRA. This waste is assumed to be distributed between MSW disposal, medical waste disposa l, and sewering (without notification) in proportion to the percentages presented above.

 LQG Other Healthcare Facilities: Among other healthcare facilities, an estimated 7 percent are pharmacies. 197 

### These facilities are assumed to send their
hazardous waste pharmaceuticals to a reverse distributor that manages the waste in compliance with RCRA. Among the remaining 93 percent of facilities, 20 percent are assumed to manage their hazardous waste pharmaceuticals in compliance with RCRA (i.e., incinerate the wa ste) and 80 percent are assumed not to be in compliance. 198 

### The non

- compliant waste is assumed to be distributed between MSW disposal, medical waste disposal, and sewering (without notification) in proportion to the percentages presented above.

 SQG and CESQ G Other Healthcare Facilities: Other than the 7 percent of hazardous waste pharmaceuticals generated by pharmacies 199 

### , all hazardous waste pharmaceuticals generated by SQG and CESQG other healthcare facilities are assumed not to be managed in compliance with RCRA and distributed between MSW disposal, medical waste disposal, and sewering (without notification) in proportion to the percentages presented above.

 Reverse Distributors (LQGs, SQGs, and CESQGs): All reverse distributors are assumed to be in complianc e with RCRA.

Exhibit 4

- 20 presents additional details on the sewering of hazardous waste pharmaceuticals under the partial compliance baseline

. In addition, Exhibit 3

- 9 in Chapter 3 documents in detail this RIA’s assumptions regarding the distribution of hazardous waste pharmaceuticals across different management methods under the partial and full compliance baselines and each of the regulatory options

.

197 Based on data from U.S. Census Bureau, 2007 Economic Census, accessed at http://www.census.gov/econ/census/

.

198 This figure is based on the value obtained for hospitals through personal communication with Selin Hoboy of Stericycle on
August 6, 2012 and personal communication with Phil Retallick and John Kelsey of Clean Harbors on April 16, 2012. This RIA

assumes t hat the 20 percent compliance rate for patient hazardous waste pharmaceuticals generated by hospitals applies to
LQG other healthcare facilities as well.

199 U.S. Census, op cit.156

EXHIBIT 4

- 20 ASSUMPTIONS REGARDIN G THE MANAGEMENT OF HAZARDOUS WASTE P HARMACEUTICALS UNDER THE BASELINE

FACILITY TYPE PARTIAL COMPLIANCE B ASELINE

LQGs SQGs CESQGs

Reverse
Distributors  No sewering for LQG, SQG, or CESQG reverse distributors.

Hospitals  Hazardous waste pharmaceuticals from hospital pharmacy not sewered.

 80 percent 1 of patient care hazardous waste pharmaceuticals are assumed not to be managed in compliance with RCRA regulations. Of this, 23 percent is assumed to be sewered (and 10 percent managed as MSW and 67 percent managed as regu lated medical waste). 2 Thus, this RIA estimates that 18 percent (80 percent × 23 percent) of patient care hazardous waste pharmaceuticals are sewered under the partial compliance baseline.  Hazardous waste pharmaceuticals from hospital pharmacy not sewer ed.

 Patient care hazardous waste pharmaceuticals assumed not to be managed in compliance with RCRA. 3 Approximately 23 percent of this waste is assumed to be sewered without notifying
the local POTW. 2 Approximately 10 percent of patient care hazardous was te pharmaceuticals are managed as MSW and 67 percent are managed as medical waste. 2

Other Healthcare
Facilities  Pharmacies assumed not to sewer.

 Nursing care facilities and continuing
care retirement communities assumed to

sewer.

 Among the remaining other healthcare facilities, 80 percent 1 are assumed not to manage their hazardous waste pharmaceuticals in accordance with RCRA. Of these, 23 percent are assumed to sewer (and 10 percent manage as MSW and 67 percent manage as regulated medical waste). 2  Phar macies assumed not to sewer.

 Nursing care facilities and continuing care retirement communities assumed to

sewer.

 All other facilities assumed not to manage their hazardous waste pharmaceuticals in compliance with RCRA. 4 Of these facilities, 23 percent ar e assumed sewer, 10 percent manage their hazardous waste pharmaceuticals as MSW, and 67 percent manage it as medical waste. 2

FACILITY TYPE FULL COMPLIANCE BASE LINE

All Facility Types Quantity of hazardous waste sewered assumed to be the same as under the partial compliance baseline, but with notification of
the local POTW.157

EXHIBIT 4

- 20 ASSUMPTIONS REGARDIN G THE MANAGEMENT OF HAZARDOUS WASTE P HARMACEUTICALS UNDER THE BASELINE

Notes:
1. Based on personal communication with Selin Hoboy, Stericycle, August 6, 2012 and personal communication with Phil Retallick a nd John Kelsey of Clean Harbors, April 16, 2012.
2. B ased on personal communication with Charlotte Smith, Waste Management Healthcare Solutions, December 5, 2012 and personal com munication with John Kelsey, Clean Harbors, December 2, 2012.
3. The 80 percent non

- compliance figure applied to LQG and SQG hospitals is not applied to CESQG hospitals because the industry experts consulted for this analysis had limited information on pharmaceuticals management at CESQG hospitals.
4. The 80 percent non

- compliance rate applied to LQG other healthcare facilities is not appli ed to SQG and CESQG facilities because it is unclear
whether this non

- compliance rate, which industry contacts provided for hospitals, would be applicable to small healthcare facilities.158 

### Exhibit 4

- 21 reports the annualized cost savings of each policy option relative to the partial compliance baseline

. The estimated cost savings incremental to the partial compliance baseline are slightly less than cost savings relative to the full compliance
baseline because fewer healthcare facilities are assumed to incur all of the costs of compliance in the partial compliance baseline. However, the majority of cost savings are due to avoided training costs, which are unchanged in the partial compliance baseline relative to the full compliance baselin e.

EXHIBIT 4

- 21. ANNUALIZED PART IAL COMPLIANCE BASEL INE COSTS AND

INCREMENTAL COST SAV INGS OF PROPOSED RULE BY WASTE MANAGEMENT ACTIVITY, 7 PERCENT DISCOUNT R ATE ($2011 MILLIONS)

ROW WASTE MANAGEMENT

ACTIVITY TOTAL
ANNUALIZED
COSTS IN

THE
PARTIAL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COST
SAVINGS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification $0.00 $0.00 $0.00 $0.00

2 Training $79.65 $0.00 $19.17 $19.17

3 Manifest Training $6.30 $0.00 $0.00 $0.00

4 Contingency Plan Updating $4.91 $0.00 $0.03 $0.03

5 Container Management $27.09 $0.00 $0.00 $0.00

6 Labeling $0.09 $0.00 $0.002 $0.002

7 Inspections $94.25 $0.00 $0.00 $0.00

8 Warehousing $0.0 $0.00 $0.00 $0.00

9 Closure $4.51 $0.00 $0.00 $0.00

10 RCRA Storage Permit $0.0 $0.00 $0.00 $0.00

11 Sorting $7.84 $0.00 $0.00 $0.00

12 Biennial Reports $2.00 $0.00 $0.07 $0.07

13 Recordkeeping $0.15 $0.00 $0.15 $0.15

14 Manifests and Other Tracking $1.03 $0.00 $0.15 $0.15

15 Transportation $67.84 $0.00 $0.003 $0.003

16 Disposal $473.24 $4.28 $4.28 $3.46

17 TOTAL $768.88 $4.28 $23.85 $23.03

Notes:
1. For some provisions there are no cost savings (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.159 

### The reduction in sewering incremental to the partial compliance baseline is estimated to be the same as incremental to the full compliance baseline. This reflects the fact that the
amount sewered is the same under both baselines. Thus, the sewering impac ts presented
above in Exhibit 4

- 1 0 apply to the rule options relative to both baselines. This RIA assumes that all facilities are in full compliance with RCRA regulations under each regulatory option, which implies that facilities managing their hazardous waste pharmaceuticals as MSW or medical waste under the partial compliance option may sewer them under the Less Stringent Option. This shift would result in an increase in sewering under this option relative to the partial compliance baseline. This RIA recognizes, however, that facilities managing their hazardous waste pharmaceuticals as MSW or medical waste may continue to do so (in violation of RCRA) under the Less Stringent Option, in which case the amount of hazardous waste pharmaceuticals sewered

wo uld not change under this option incremental to the partial compliance baseline.

As an upper bound estimate of the potential diversion from hazardous waste pharmaceuticals managed as MSW or medical waste

, Exhibit 4

- 2 2 shows the estimated
amount of hazardou s waste pharmaceuticals managed annually as MSW or medical waste under the partial compliance baseline . Consistent with the baseline data presented above for sewering, the data in Exhibit 4

- 2 2 suggest that other healthcare facilities (e.g., physicians’ of

fices) account for the majority of the hazardous waste pharmaceuticals managed as MSW or medical waste. This reflects the large quantity of hazardous waste pharmaceuticals generated by these facilities. As noted above, they account for approximately 80 p ercent of the hazardous waste pharmaceuticals generated in the U.S. (excluding waste generated by households).

EXHIBIT 4

- 2 2 . MANAGEMENT OF HAZA RDOUS WASTE PHARMACE UTICALS AS MSW OR

MEDICAL WASTE UNDER THE PARTIAL COMPLIAN CE BASELINE

BASELINE
GENERATOR
STATUS FACILITY TYPE MSW DISPOSAL QUANTITY (TONS/YR) MEDICAL WASTE DISPOS AL QUANTITY (TONS/YR)
CESQG Hospitals 11 72

CESQG Other healthcare facilities 896 6,051

CESQG Reverse Distributors 0 0

SQG Hospitals 118 795

SQG Other healthcare facilities 1,942 13,109

SQG Reverse Distributors 0 0

LQG Hospitals 427 2,885

LQG Other healthcare facilities 1,014 6,842

LQG Reverse Distributors 0 0

TOTAL 4,410 29,750

Notes: Values may not sum due to rounding.160 SENSITIVITY ANALYSIS : SIZE OF THE POTENT IALLY AFFECTED UNIVERSE


### As indicated in Chapter 2, a key calculation in this RIA is the estimation of the percentage of healthcare facilities that are hazardous waste generators. To inform this calculation, this RIA relies on information provided by Massachusetts and Minnesota

. This section provides a sensitivity analysis using the Massachusetts and Minnesota data, separately, to estimate a range of cost savings associated with the proposed rule based on assumptions regarding the size of the potentia lly affected universe.

Exhibit 4

- 2 3 reports the low and high end estimate of the number of potentially affected healthcare facilities and reverse distributors as well as the annualized cost savings under each policy option given the size of the regulator y universe. As shown in the exhibit, the cost saving estimates are not highly sensitive to different assumptions regarding the size of the potentially affected universe. This is d ue to the fact that the most significant cost savings are experienced by ho spitals, for which the data provided by Massachusetts and
Minnesota suggest an identical approach to estimating the size of the universe. Similarly,
there is no difference in the estimated number of reverse distributors based on these two approaches. The refore, while t he estimated number of other healthcare facilities potentially affected by the proposed rule is between approximately 97,900 and 266,700

, there are less overall cost savings experienced by these facilities.161

EXHIBIT 4

- 2 3

. ANNUALIZED COST SAVINGS OF PROPOSED RULE BY BASELINE GENERATOR S TATUS AND FACILITY TYPE , 7 PERCENT DISCOUNT RATE
,

LOW AND HIGH END UNI VERSE ESTIMATES ($2011 MILLIONS)

GENERATOR
STATUS FACILITY TYPE LOW END ESTIMATE (BASED ON MASSACHUSE TTS DATA) HIGH END ESTIMATE (BASED ON MINNESOTA DATA)

NUMBER OF
FACILITIES MORE

STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION NUMBER OF

FACILITIES MORE

STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION
CESQG Hospitals 2,555 $0.02 $0.02 $0.00 2,555 $0.02 $0.02 $0.00

SQG Hospitals 2,397 $0.18 $7.0 3 $7.0 6 2,397 $0.1 7 $7.0 2 $7.0 4

LQG Hospitals 1,553 $0.6 7 $13.3 4 $13.3 4 1,553 $0.6 2 $13. 29 $13. 29

CESQG Other Healthcare Facilities 83,49 5 $0.4 9 $0.4 9 $0.00 227,43 3 $1.2 4 $1.2 4 $0.00

SQG Other Healthcare Facilities 12,223 $1.0 7 $1. 17 $1. 17 33,29 5 $2. 68 $2.9 6 $2.9 6

LQG Other Healthcare Facilities 2,17 4 $0.5 6 $0. 71 $0. 71 5,92 3 $1.4 0 $1.8 1 $1.8 1

CESQG Reverse Distributors 21 $0.00 $0.00 $0.00 21 $0.00 $0.00 $0.00

SQG Reverse Distributors 7 $0.00 $0.000 6 $0.000 6 7 $0.00 $0.000 6 $0.000 6

LQG Reverse Distributors 28 $0.00 $0.05 $0.05 28 $0.00 $0.05 $0.05

TOTAL 104, 453 $2. 99 $22. 81 $22.33 273,21 2 $6. 1 2 $26. 39 $25. 17162 SENSITIVITY ANALYSIS : DISCOUNT RATE


### The cost savings presented above are based on a discount rate of seven percent, consistent with the primary cost results presented in Chapter 3. To gauge the sensitivity of these results to an alternative discount rate, this section examines the cost savi ngs of the rule based on an alternative discount rate of three percent. Exhibit 4

- 2 4 reports the results of this sensitivity analysis. These results are almost identical to those presented above based on a seven percent discount rate. Th is similarity in results reflects the fact that the cost savings resulting from the rule largely represent ongoing operation and maintenance costs
that are not amortized over time rather than one

- time capital expenditures.

EXHIBIT 4

- 24. ANNUALIZED BASE LINE COSTS AND INCREMENTAL COST SAV INGS

OF PROPOSED RULE BY WASTE MANAGEMENT ACT IVITY, 3
PERCENT DISCOUNT RAT E ($2011 MILLIONS)

ROW WASTE MANAGEMENT

ACTIVITY TOTAL
ANNUALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE ANNUALIZED INCREMENT AL COST
SAVINGS 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

1 Notification $0.00 $0.00 $0.00 $0.00

2 Training $78.38 $0.00 $19.17 $19.17

3 Manifest Training $5.85 $0.00 $0.00 $0.00

4 Contingency Plan Updating $4.01 $0.00 $0.02 $0.02

5 Container Management $28.25 $0.00 $0.16 $0.18

6 Labeling $0.44 $0.00 $0.05 $0.05

7 Inspections $94.25 $0.00 $0.00 $0.00

8 Warehousing $0.00 $0.00 $0.00 $0.00

9 Closure $3.21 $0.00 $0.00 $0.00

10 RCRA Storage Permit $0.00 $0.00 $0.00 $0.00

11 Sorting $27.05 $0.00 $0.00 $0.00

12 Biennial Reports $2.24 $0.00 $0.31 $0.31

13 Recordkeeping $0.15 $0.00 $0.15 $0.15

14 Manifests and Other Tracking $1.03 $0.00 $0.15 $0.15

15 Transportation $72.67 $0.00 $0.003 $0.003

16 Disposal $554.34 $4.28 $4.28 $3.46

17 TOTAL $871.86 $4.28 $24.29 $23.49

Notes:
1. For some provisions there are no cost savings (as indicated by a $0 value) because there are no changes in requirements relative to the baseline.163 

### CHAPTER 5 | S UMMARY OF REGULATORY BENEFI TS & COSTS

This chapter compares the costs and benefits of the proposed hazardous waste pharmaceuticals rule as estimated in Chapter 3 and 4 of this RIA. Specifically, this chapter calculates the net benefits of the proposed rule (i.e., benefits minus costs). From an economic perspective, the proposed rule would enhance economic efficiency if benefits (cost savings) exceed costs. However, f ocusing solely on these or other cost

benefit measures provides an incomplete view of the effects of the proposed rule because many positive impacts of the rule cannot feasibly be monetized, such as human health improvements from reduced exposure to hazardous waste pharmaceuticals in U.S. surface
water and dr inking water supplies

.
Exhibit 5

- 1 reports the net benefits of the proposed rule using a discount rate of 7 percent. However, b enefits were not monetized for several categories of benefits because sufficient data were not available. Therefore, the net be nefits for several provisions of the proposed rule are presented as negative. The se negative values, however, do not reflect the benefits presented in Chapter 4 that EPA was unable to monetize. In excluding these benefits, the negative values in the exhi bit underestimate the net benefits associated with individual provisions of the proposed rule.164

EXHIBIT 5

- 1

. NET BENEFITS OF THE PROPOSED RULE BY WAS TE MANAGEMENT ACTVIT IY , 7 PERCENT DISCOUNT RATE ($2011 MILLIONS )

ROW WASTE

MANAGEMENT
ACTIVITY TOTAL

ANNUALIZED
COSTS IN

THE FULL
COMPLIANCE
BASELINE INCREMENTAL COSTS AN D BENEFITS

MORE STRINGENT OPTIO N PROPOSED OPTION LESS STRINGENT OPTIO N

ANNUALIZED
COSTS ANNUALIZED

BENEFITS 1 NET

BENEFITS ANNUALIZED

COSTS ANNUALIZED

BENEFITS 1 NET

BENEFITS ANNUALIZED

COSTS ANNUALIZED

BENEFITS 1 NET

BENEFITS

1 Notification $0.00 $0.07

Not
Monetized ($0.07) $0.07 $0.00 ($0.0 7 ) $0.07 $0.00 ($0.0 7 )

2 Training $79.65 $1.53 ($1.53) $1.53 $19.17 $17.64 $1.53 $19.17 $17.64

3 Manifest Training $6.30 $0.23 ($0.23) $0.23 $0.00 ($0.23) $0.23 $0.00 ($0.23)

4 Contingency Plan Updating $4.91 $0.16 ($0.16) $0.00 $0.03 $0.03 $0.00 $0.03 $0.03

5 Container Management $28.84 $5.31 ($5.31) $2.67 $0.15 ($2.52) $2.28 $0.18 ($2.10)

6 Labeling $0.44 $0.52 ($0.52) $0.48 $0.05 ($0.43) $0.48 $0.05 ($0.43)

7 Inspections $94.25 $3.15 ($3.15) $0.05 $0.00 ($0.05) $0.05 $0.00 ($0.05)

8 Warehousing $0.00 $0.01 ($0.01) $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

9 Closure $4.51 $1.24 ($1.24) $1.21 $0.00 ($1.21) $1.21 $0.00 ($1.21)

10 RCRA Storage Permit $0.00 $0.68 ($0.68) $0.00 $0.00 $0.00 $0.00 $0.00 $0.00

11 Sorting $27.05 $5.12 ($5.12) $5.12 $0.00 ($5.12) $5.09 $0.00 ($5.09)

12 Biennial Reports $2.24 $0.07 ($0.0 7 ) $0.00 $0.31 $0. 31 $0.00 $0.31 $0. 31

13 Recordkeeping $0.15 $0.01 ($0.01) $0.00 $0.15 $0.15 $0.00 $0.15 $0.15

14 Manifests and Other Tracking $1.03 $0.98 ($0.98) $0.49 $0.15 ($0.34) $0.49 $0.15 ($0.34)

15 Transportation $72.67 $3.19 ($3.19) $1.79 $0.003 ($1.79) $1.79 $0.003 ($1.78)

16 Disposal $554.59 $23.45 $4.28 ($19.17) $22.91 $4.28 ($18.63) $21.47 $3.46 ($18.01)

17 TOTAL $876.62 $45.71 $4.28 ($41.34) $36.56 $24.29 ($12.2 7 ) $34.69 $23.50 ($11. 19 )

Notes:
1. S everal categories of benefits were not monetized for because sufficient data were not available. Therefore, the net benefits for several provisions of the proposed rule are presented as negative. These negative values, however, do not reflect the benefits this RIA was unable to monetize.165 

### CHAPTER 6 | EQUITY CONSIDERAT IONS AND OTHER IMPAC TS

As required by applicable statutes and executive orders, this chapter summarizes EPA’s analysis of equity considerations and other regulatory concerns associated with the proposed rule. This chapter assesses potential impacts, with respect to the following
issues:

 

### Regulatory planning and review : requires examination and quantification of costs and benefits of regulating with and without the proposed ru le;

 

### Regulatory flexibility: focuses on the potential effects of the proposed rule on small entities;

 

### Employment i mpact s : assesses the potential impact of the proposed rule on employment;

 

### Unfunded mandates: examines the implications of the proposed rule w ith respect to unfunded mandates;

 

### Federalism: considers potential issues related to state sovereignty;

 

### Tribal governments: extends the discussion of federal unfunded mandates to include impacts on Native American tribal governments and their communities;

 

### Environmental justice: considers potential issues for minority and low

- income populations ;

 

### Children's health protection: examines the potential impact of the proposed rule on the health of children;

 

### Energy Impacts: examines the impacts of the proposed rule on energy use, supply, and distribution; and

 

### Joint impacts of rules: considers the combined effect of the proposed rule with other regulations affecting the healthcare sector.

REGULATORY PLANNING AND REVIEW 

### Under Executive Order (EO) 12866 [58 FR 51735 (October 4, 1993)], as amended by
Executive Order 13563

, the Agency, in conjunction with the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA), must determine whether a regulatory action is “s ignificant” and therefore subject to OMB review and the full requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 millio n or more or adversely affect in a material way the economy, a sector of the economy, productivity,166 

### competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or o therwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy i ssues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866 , as affirmed in Executive Order 13563

, the Agency has determined that this proposed rule is a significant regulatory action because it contains novel policy issues, as defined under part 3(f)(4) of the Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866. Any changes made in respo nse to OMB recommendations
have been documented in the docket for this action.

Findings for the economic assessment indicate that the rule, as proposed, is projected to result in aggregate annual costs of approximately $ 36.5 million (based on a discount rate of 7 percent). This value is below t he $100 million threshold established under part 3(f)(1) of the Order. Therefore, the proposed rule is not considered to be an economically significant action.

In addition to callin g for assessment of regulatory costs, the Executive Order also requires Federal agencies to assess benefits and, “recognizing that some costs and benefits are difficult to quantify, propose or adopt a regulation only upon a reasoned determination
that the benefits of the intended regulation justify its costs.” 200 

### As described in Chapter 4 of this RIA, monetization of the rule’s benefits was possible for some categories of benefits but not all, given limitations in the available data. In particular, the rule is projected to lead to annual cost savings for affected facilities of $ 24.2 million. T his RIA
also estimates that the proposed rule will lead to the diversion of approximately 6

, 4 00 tons of hazardous waste pharmaceuticals from sewer disposal to hazardou s waste incineration on an annual basis. This reduction in sewering will likely reduce the concentration of active pharmaceutical ingredients in the nation’s waterways, potentially benefiting both ecosystems and human populations. Other benefits of the r ule include safer management practices of hazardous wastes more generally and clearer information about safe disposal requirements.

REGULATORY FLEXIBILI TY 

### The Regulatory Flexibility Act (RFA) as amended by the Small Business Regulatory
Enforcement Fairness Act of 1996 (SBREFA), 5 USC 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other

200 See Section 1(b)(6) of Executive Order 12866.167 

### statute. This analysi s must be completed unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. Based on EPA’s RFA/SBREFA analytic guidance, a rule is not expected to
result in a significant economic impact for a substantial number of small entities if the costs of the regulation for a facility are less than 1 percent of annual revenues. 201



### Ideally, asses sment of the rule’s small entity impacts would identify specific entities affected by the rule as small and assess impacts for these entities. As described in previous chapters of this RIA, however, detailed data necessary for the assessment of regulatory impacts for individual facilities are not readily available. In the absence of such information, this RIA uses average cost impacts for the model facilities outlined in Chapters 2 and 3 in conjunction with revenue data from the 2007 Economic Census for

t he industries affected by the rule to gauge potential small entity impacts. The steps in this process are as follows:

1. To assess the number of small entities in the regulated universe, EPA consulted
NAICS

- level data from the 2007 Economic Census and tallie d the number of facilities, by NAICS code, owned by entities with revenues below the Small Business Administration (SBA) threshold for consideration as small. For each NAICS code, the Economic Census indicates the number of entities owned by
firms with re venues within the following ranges:

 Less than $250,000

 $250,000 to $499,999

 $500,000 to $999,999

 $1,000,000 to $2,499,999

 $2,500,000 to $4,999,999

 $5,000,000 to $9,999,999

 $10,000,000 to $24,999,999

 $25,000,000 to $49,999,999

 $50,000,000 to $99,999,999

 $100,000,000 to $249,999,999

 $250,000,000 or more.

In those cases where one of the above revenue categories is below the SBA threshold, all entities within that revenue category are considered small. Similarly, entities in revenue categories above the SB A threshold are not

201 U.S. EPA, Final Guidance for EPA Rulewriters: Regulatory Flexibility Act as amended by the Small Business Regulatory
Enforcement Fairness Act, November 2006.168 

### considered small. For some NAICS codes, the SBA threshold for consideration as small is between the revenue boundaries used by the Economic Census. In these cases, entities within each revenue category are assumed to be uniformly
dist ributed across the category. For example, the $7.5 million SBA threshold for dentists’ offices is between the Economic Census revenue boundaries of $5 million and $10 million. Assuming that dentists’ offices are uniformly distributed across this range of revenues, approximately 40 percent of dentists in the $5 million to $9.9 million category are assumed to have revenues below $7.5 million and qualify as small under the SBA standard.

Based on this approach, the percentage of facilities that qualify as sma ll under the SBA standards may be estimated for each industry affected by the rule. These percentages were applied to the number of facilities in the regulatory universe, as presented in Chapter 2 (see Exhibit 6

- 1).169 EXHIBIT 6

- 1. SBA 2014 SMALL BUSINESS SIZE STANDARDS (USING 200 7 NAICS

CODES)

FACILITY TYPE SBA SIZE

STANDARD
(FIRM

- LEVEL
, ANNUAL REVENUE ) PERCENTAGE OF

GENERATORS

CONSIDERED “SMALL”

UNDER SBA STANDARD NUMBER OF

GENERATORS

THAT ARE

SMALL

Pharmacies $27.5 million 46% 5,390
Veterinary Clinics $7.5 million 95% 7,416
Physicians’ Offices $11.0 million 88% 53,577

Dentists’ Offices $7.5 million 97% 33,932

Other Health Practitioners (e.g., chiropractors) $7.5 million 93% 32,036

Outpatient Care Centers (ex

kidney dialysis centers) $15.0 million 68% 4,787

Outpatient Care Centers (kidney dialysis centers) $38.5 million 14% 161

Other Ambulatory Health
Care Services $15.0 million 66% 1,707

Hospitals $38.5 million 25% 1,634 Nursing Care Facilities (e.g., assisted living facilities, nursing homes, U.S. veterans domiciliary centers) $15.0 million 44% 1,985

Continuing Care Retirement
Communities $27.5 million 62% 1,023

Medical Examiners and
Coroners' Offices Size standards not
established 100% 552

Reverse Distributors Various NAICS 50% 28

Total Number of Small Facilities 144,228

Source:
U.S. Small Business Administration
, Table of Small Business Size Standards Matched to North American Industry Classification System Codes
, effective July 14, 2014.



### 2. After estimating the number of small entities by NAICS code, the average costs per small entity were estimated based on the model facility costs presented in Chapter 3. The costs for “small” facilities, as defined for the purposes of Chapter 3 are assumed to apply to entities that qualify as small under the SBA
definition. 202

202 For each of the facility types represented by the model facilities, the weighted average of the values for small model
facilities, as defined in Chapter 3, was applied. For example, the per

- facility cost for small hospitals is the weighted average
of the per facility costs for the small CESQG model hospital and the small SQG model hospital presented in Cha pter 3. No
LQG hospitals are assumed to be small.170 

### 3. Determining whether the per facility costs incurred by small entities represent
more than1 percent of annual revenues requires estimation of small entities’

average annual revenues. 203 

### For each NAICS, the average revenue per facility for
entities considered small under the SBA standard was estimated based on data
from the 2007 Economic Census. Average annual revenues were calculated on an aggregate basis (i.e., the s um of total revenues for all small firms divided by the number of small firms from Step 1) because firm

- level data are not available
from the Economic Census. The revenues of large firms were excluded from this analysis.

For reverse distributors, the Agen cy was unable to apply the steps outlined above and assess potential small entity effects. Because no single NAICS code exists for reverse distributors, it was not possible to determine the appropriate threshold for consideration
as small.

Based on Ste ps 1 through 3 as outlined above, Exhibit 6

- 2 presents the estimated impacts of all three regulatory options to small entities on a per facility basis. The exhibit also compares these impacts to average revenues per small entity and presents the estimated
number of small entities. S mall entity impacts are presented incremental to the full compliance baseline

. 204 

### As shown in the exhibit, the annual per facility costs incremental to both baselines are much less than 1 percent of average annual revenues. Of the facility types represented in “other healthcare facilities,” other health practitioners (e.g., chiropractors) have the lowest average annual revenues per facility, approximately $390,000. 205 

### For this industry, under the More Stringent Option, incrementa l costs are approximately 0.017 percent of annual revenues. Since the incremental impact to the smallest healthcare facilities in terms of revenue is less than 1 percent of average annual revenues, the rule is not expected to cause a significant impact to a substantial number of
small businesses.

203 Since the SBA small business size standards are measured in 2014 dollars, the Economic Census data are measured in 2007
dollars, and the average per facility revenues in this RIA are estimated in 2011 do llars, all dollar figures were converted to a
constant dollar year for purposes of comparison.

204 See chapter 3 for a detailed description of the full compliance baseline.

205 Revenue value obtained from U.S. Census Bureau, 2007 Economic Census.171 EXHIBIT 6

- 2. SUMMARY OF POTEN TIAL IMPACTS TO SMAL L ENTITIES USING A 7
PERCENT DISCOUNT RAT E

FACILITY TYPE NUMBER OF

FACILITIES AVERAGE

ANNUAL
REVENUES PER
FACILITY PER FACILITY IMPACTS INCREMENTAL TO

THE FULL COMPLIANCE BASELINE

(YEAR 2011$) 1

MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION

Hospitals 1,634 $ 15.1 million $350 [0.002%] $300

[0.002%] $290

[0.002%]
Other healthcare
facilities 142,566 $ 1.0 million $160 [0.017%] $120

[0.013%] $110

[0.012%]

Reverse
Distributors 28 Unknown $18,400 $4,300 $4,300

Notes:
1. Values in brackets represent per facility costs as a percent of per facility revenues.

EMPLOYMENT IMPACT AN ALYSIS 

### Executive Order 13563 “Improving Regulation and Regulatory Review” (76 FR 3821; January 18, 2011) requires Federal agencies to consider the employment impacts of regulatory policy. Specifically, Executive Order 13563 states, “Our regulatory system must protect public health, w elfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” Consistent with the requirements of the Executive Order, this RIA considers the employment impacts of the proposed rule. Ideally, this RIA would include a quantitative assessment of these impacts, but insufficient data are available to quantify changes in employment associated with the rule. This RIA therefore presents a qualitative assessment of the rule’s potential employment impacts.

In general, an environmental regulation can be understood as an increase in demand for a particular output: environmental quality. Meeting this new demand can result in increased demand for the various factors of production (including labor) available to the economy. However, the regulated sector generally relies on revenues generated by their other market outputs to cover the costs of supplying increased environmental quality. This can lead to reduced demand for labor and other factors of production used to produce the market output. Thus, as described in Berman and Bui (2001) and Morgenstern, Pizer and Shih (2002), the net effect of an environmental regulation on employment in regulated sectors and the overall economy is indeterminate. 206 

### The costs impos ed on directly regulated sectors may raise production costs and put some specific jobs at risk, while at the same time, environmental regulation may create jobs in the regulated sector or other sectors that contribute to environmental protection.

206 Source s : Berman, E. and L. T. M. Bui (2001). “Environmental Regulation and Labor Demand: Evidence from the South Coast

Air Basin.” Journal of Public Economics 79 (2): 265

- 295; and, Richard D. Morgenstern, William A. Pizer, and Jhih

- Shyang Shih.
(2002) “Jobs Versus t he Environment: An Industry

- Level Perspective.” Journal of Environmental Economics and Management
, Vol. 43, no. 3, pp. 412

- 436.172 

### Employme nt impacts, both positive and negative, in sectors upstream and downstream from the regulated sector may also occur.

EPA estimates that the proposed rule may result in changes to the mix of labor hours required to comply with the hazardous waste management regulations. For example, the proposed rule will result in less than 10,000 total hours in new paperwork requirements, primarily associated with the labeling of hazardous waste containers. However, the
added fle xibility regarding labeling and reporting requirements for pharmacy waste and waste sent to reverse distributors will result in a cost savings of nearly 25,000 hours. Furthermore, the most significant cost savings of the proposed rule are attributable to more flexible requirements for general training activities

— which will greatly reduce the labor burden for nurses and nurse managers. The overall regulatory costs of the proposed rule represent a small percentage of the overall costs of operating a healthc are facility or
reverse distributor. The extent to which these costs cause prices to rise depends on
market concentration and other factors in the affected industries. This RIA does not estimate the proportion of costs that will be passed onto consumers other than to note that prices are not expected to increase by an amount more than the increase in costs. The increase in prices could reduce demand for healthcare, but given the low cost of the proposed rule, EPA estimates that the decrease in demand for healthcare and the impact on employment due to this effect will be negligible.

UNFUNDED MANDATES AN ALYSIS 

### Among its other purposes and federal agency rulemaking requirements, the Unfunded Mandates Reform Act (UMRA) requires federal agencies, unless other wise prohibited by law, to assess the effects of their regulatory actions on state, local, and tribal governments and on the private sector, to determine whether any proposed rulemaking may result in

“ any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year.”

Section 202 of UMRA requires federal agencies that propose rules that are likely to exceed this expenditure threshold to prepare a “Written Statement” containing the following five components, supply the statement to OMB, and summarize it in the Federal Register notice for the CCR rule:

1. Identification of the applicable authorizing federal law;

2. Qualitative and quantitative assessmen t of the anticipated costs and benefits of the rule including the costs and benefits to state, local, and tribal governments or the private sector, and an analysis of whether federal resources may be available to pay these costs;

3. Estimates of future compli ance costs and any disproportionate budgetary effects;

4. Estimates of effects on the national economy such as productivity, economic growth, employment, job creation, international competitiveness; and

5. Description and summary of agency’s prior consultation w ith elected representatives of the affected state, local and tribal governments.173 

### As indicated above, the annual cost of the proposed rule is estimated to be $ 36.5 million (based on a discount rate of 7 percent). Determining the private sector and

s tate/lo cal/tribal government shares of these costs requires information on the extent to which regulated facilities are owned by these two groups. Such information is not readily available for most types of facilities affected by the rule. Such information was identified for hospitals and coroners’ offices/medical examiners, as summarized in the Federalism Analysis section below.
Based on the magnitude of the rule’s estimated cost impacts, EPA expects that the rule
would not result in annual expenditure s exceedi ng $100 million incremental to the Full Compliance Baseline.

FEDERALISM ANALYSIS 

### The 1999 Federalism Executive Order 13132 furthers the policies of UMRA by establishing federalism principles, federalism policymaking criteria, and a state and local government consultation process for the development of federal regulations with implicati ons for federalism. These include regulations and other federal policies and actions that have substantial direct effects on states, on the relationship between the federal government and the states, or on the distribution of power and responsibilities

amo ng the various levels of government.

Pursuant to the consultation process of Executive Order 13132, this section evaluates
whether the proposed rule may “impose substantial direct compliance costs” on state and local governments. EPA’s 2008 guidance for compliance with Executive Order 13132 describes two numerical methods for evaluating whether an EPA rule may have federalism implications with respect to “substantial direct compliance costs”: 207



### 1. The $25 million test . Annualized direct compliance cost expen ditures to state and local governments in aggregate of $25 million or more.

2. The 1 percent test. Annualized direct compliance costs faced by state and local governments are likely to equal or exceed 1 percent of their annual revenues.

As indicated in the UM RA discussion above, the detailed data necessary to distinguish facilities owned by state and local governments from those that are privately owned are not readily available for most facility types. Such information, however, is available for hospitals. In addition, all coroners’ offices and medical examiners are assumed to be part of state or local government. This section therefore examines the cost impacts of the regulatory options for hospitals owned by state and local governments as well as

coroners ’ offices and medical examiners.

Based on data from the American Hospital Directory, an estimated 20.9 percent of hospitals are owned by State or local entities. 208 

### Exhibit 6

- 3 shows the distribution of these hospitals by teaching status, number of beds, and RCRA generator status. The

207 The two methods are from “EPA’s Action Development Process

-- Guidance on Executive Order 13132: Federalism,” OPEI
Regulatory Development Series, Nov 2008, at http://intranet.epa.gov/adplibrary/documents/federalismguide11

- 00

- 08.pdf.

208 American Hospital Directory. Accessed at http://www.ahd.com on April 12, 2012.174 

### exhibit also shows the distribution of coroners’ offices and medical examiners across the various generator categories. Based on these data, the proposed rule will affect at least 2,282 facilities owned by state and local g overnments.

EXHIBIT 6

- 3. HOSPITALS AND CO RONERS’ OFFICES/MEDICAL EXAM INERS’

OWNED AND OPERATED B Y STATE AND LOCAL GO VERNMENT

FACILITY TYPE LQGS SQGS CESQGS TOTAL

Hospitals 1 325 2 501 534 1,360

Non

- teaching hospitals 87 501 534 1, 122
Teaching, less than 370 beds 120 120
Teaching, 370 to 799 beds 100 100
Teaching, 800 or more beds 17 17

Coroners’ Offices and Medical
Examiners 133 295 494 922

Notes:
1. Includes hospitals in government hospital districts, city

- owned hospitals, city/county

owned hospitals, county

- owned hospitals, state

- owned hospitals, and other non

- federal governmental hospitals.
2. Sum of LQG hospital values does not equal the reported total due to rounding. See the Sources description below for additional detail s.

Sources: Hospital estimates derived from percent of hospitals owned by state and local governments, as reported in American Hospital Directory
, a ccessed at http://www.ahd.com on April 12, 2012. These percentages were applied to the hospital facility counts obtained
from the 2007 Economic Census. Estimates for coroners’ offices are derived from Bureau of Justice Statistics, Medical Examiners and Coroners’ Offices, 2004, June 2007.



### Applying the model facility costs derived in Chapter 3 to the hospitals and coroners’ offices/medical examiners represented in Exhibit 6

- 3, Exhibit 6

- 4 presents the estimated costs incurred by these facilities under each regulatory option. As indicated in the exhibit, hospitals owned by state and local governments are expected to incur annual
costs of no more than $ 1.6 million under the Proposed Option and may realize a cost savings (incremental to the full compliance baseline ). Under the More Stringent O ption,
the $ 1.7 million in annual costs incremental to the partial compliance baseline represents the highest cost estimate across all three options.

Based on data from the American Hospital Directory indicating that hospitals owned by state and local gov ernments generate $329 billion in annual revenues, the cost estimates for both the More Stringent Option and Proposed Option represent less than 0. 001 percent of their annual revenues, well below the 1 percent threshold included in the EPA guidance for Exe cutive Order 13132. 209 

### This suggests that the proposed rule will not result in substantial direct compliance costs, as defined in the EPA guidance, for hospitals owned by state and local governments. Because revenue information for coroners’

209 American Hospital Directory, accessed at http://www.ahd.com on April 12, 2012.175 

### offices and me dical examiners were not readily available, it was not possible to perform the 1 percent test for these facilities.

EXHIBIT 6

- 4. INCREMENTAL COST OF RULE FO R HOSPITALS AND CORO NERS’

OFFICES/ MEDICAL EXAMINERS' OWNED AND OPERATED BY STATE
AND LOCAL GOVERNMENT USING A 7 PERCENT DI SCOUNT RATE (MILLIONS OF YEAR 20 11$)

FACILITY TYPE MORE
STRINGENT
OPTION PROPOSED

OPTION LESS

STRINGENT
OPTION Annual Costs Incremental to Full Compliance Baseline
Hospitals $1.6 5 $1.59 $1.56

Coroners’ Offices and Medical Examiners $0.7 7 $0.5 9 $0.5 8



### When examined in conjunction with the cost results presented in Chapter 3, the limited information available on state and local government ownership of facilities affected by the rule suggests that the proposed rule will not have a substantial direct effec t on states

. In addition, EPA does not expect that the rule will affect the relationship between the federal government and the states or on the distribution of power and responsibilities among the various levels of government. In the spirit of Executive Order 13132 and consistent with EPA policy to promote communications between EPA and state and local governments, however, EPA specifically solicits comment on this proposed rule from
state and local officials.

TRIBAL GOVERNMENTS A NALYSIS 

### Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory polic ies that have tribal implications.”

To assess the potential tribal implications of the rule, EPA compiled data on the number of tribally run healthcare facilities in the U.S. and estimated the costs of the rule for these
facilities. Estimates of triball y run healthcare facilities were obtained from the U.S. Department of Health and Human Services’ Indian Health Service (IHS), as summarized
in Exhibit 6

- 5. 210 

### Data were not readily available on the size or hazardous waste generation amounts for the faciliti es identified by the IHS. To estimate the potential costs of each regulatory option for these facilities, per facility costs derived in Chapter 3 were applied to the IHS facility counts. 211 

### Based on these values, Exhibit 6

- 5 summarizes the

210 Indian Health Service (IH S), U.S. Department of Health and Human Services, IH S Year 2013 Profile, available at http://www.ihs.gov/PublicAffairs/IHSBrochure/Profile.asp, accessed December 20, 2012.

211 The per facility hospital costs from Chapter 3 were applied to the hospitals identified by the IHS and the “other healthcare facilities” per facility costs were applied to the other IHS facility types. For each, the weighted average of the corresponding model facility costs was used

. For example, the values for hospitals represent the weighted average costs for the various model hospitals included in Chapter 3.176 

### costs that triba lly run healthcare facilities will incur under each regulatory option. The costs presented in the exhibit suggest that the proposed rule will not impose a substantial burden on tribal government.

EXHIBIT 6

- 5. COST IMPACTS FOR HEALTHCARE FACILITIE S OWNED AND OPERATED

BY NATIVE AMERICAN T RIBES U SING A 7 P ERCENT D ISCOUNT R ATE
(MILLIONS OF YEAR 20 11$)

FACILITY TYPE NUMBER OF
FACILITIES 1 MORE STRINGENT

OPTION PROPOSED

OPTION LESS STRINGENT
OPTION Total Annual Costs Incremental to Full Compliance Baseline Hospitals 16 $0.0 19 $0.019 $0.018

Tr i bal Operated
Facilities 16

$0.113 $0. 088 $0.0 83 Health Centers 258 Alaska Village Clinics 164
Health Stations 75
TOTAL 529 $0.1 3 3 $0. 107 $0. 101

Notes:

1. Indian Health Service (HIS), U.S. Department of Health and Human Services, IHS Year 2013 Profile, available at http://www.ihs.gov/PublicAffairs/IHSBrochure/Profile.asp , accessed December 20, 2012.
2. Estimate reflects annual cost impact for tribal operated facilities, health centers, Alaska village clinics, and health stations combined.

ENERGY IMPACT ANALYS IS 

### Executive Order 13211, “Actions Concerning Regulations that Affect Energy Supply, Distribution, or Use” (May 18, 2001), addresses the need for regulators to more fully consider the potential energy impacts of regulatory action. Under this e xecutive o rder, agencies are required to prepare a Statement of Energy Effects when a regulatory action may have significant adverse effects on energy supply, distribution, or use, including impacts on price and foreign supplies. Additionally, the requirements obligate agencies to consider reasonable alternatives to regulatory actions with adverse effects and the impacts that such alternatives might have on energy supply, distribution, or use.

The Proposed Rule does not directly regulate energy production or consumption. In
addition , w ith annual cos ts of approximately $ 36.5 million (based on a discount rate of 7 percent)

, the cost s of this proposed rule are not considered economically significant under Executive Order 12866. As such, the rule is not sub ject to Executive Order 13211.

Changes in the management of hazardous waste pharmaceuticals stipulated in the proposed rule are not expected to impact energy production or distribution. Similarly, the management requirements outlined in the rule will have minimal impact on energy consumption (e.g., from transporting hazardous waste pharmaceuticals that otherwise would have been sewered). While the incineration of hazardous waste pharmaceuticals may require the consumption of fossil fuels, the magnitude of such an effect is uncertain and would depend on the extent to which hazardous waste pharmaceuticals are incinerated with high

- Btu wastes that do not require fossil fuels to sustain combustion.

B ecause the changes in energy production and consumption under the rule are lik ely to be177 

### minimal, the rule is not expected to have a significant adverse effect on energy supply, distribution, or use. In addition, no measurable adverse impacts are expected on energy prices or foreign supplies.

ENVIRONMENTAL JUSTICE ANALYSIS 

### Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low

- income populations in the United States. Among other actions, the Order directs agencies to improve research and data collection rega rding health and environmental effects in minority and low

- income communities.

To meet the requirements of Executive Order 12898, the following sections address potential environmental justice (EJ) impacts associated with the diversion of hazardous
waste p harmaceuticals from sewer disposal to hazardous waste combustion facilities. As described in Chapter 1, both the More Stringent Option and Proposed Option prohibit the sewering of hazardous waste pharmaceuticals. In addition, the Less Stringent Option

pr ohibits sewering for LQGs, SQGs, and CESQG reverse distributors. Populations living near and downstream from wastewater treatment plants may benefit from this
restriction. 212 

### To the extent that minority and/or low

- income populations in these areas make up a disproportionately high portion of the overall population, all three policy options may result in positive environmental justice impacts.

Waste diverted from sewering under these options, however, will likely be managed at
commercial hazardous waste comb ustion facilities, which include hazardous waste incinerators and hazardous waste burning cement and kilns and lightweight aggregate
kilns. 213

, 214 

### If low

- income and minority populations near these facilities account for a larger share of the population than they do nationally or state

- wide, the rule may lead to adverse environmental justice impacts.

To assess the potential for both positive and negative environmental justice impacts, this section presents two demographic analyses: one examining the characteri stics of populations living near or in the catchment of wastewater treatment plants and a second assessing populations living in close proximity to commercial hazardous waste
combustion facilities

. The methods and results of these analyses are presented b elow.

212 See Chapter 4 for a detailed discussion of the benefits of the rule.

213 These facilities were all identified in U.S. EPA, Assessment of the Potential Costs, Benefits, & Other Impacts of the Hazardous Waste Combustion MACT Final Rule Standards, September 2005.

214 The term “commercial hazardous waste combustion facility” includes hazardous waste incinerators located at facilities whose primary business is waste disposal and hazardous waste burning cement kilns and lightweight aggregate kilns. Although many manufac turing facilities have industrial boilers and incinerators permitted to burn hazardous waste, these are

not considered to be commercial hazardous waste combustion facilities because they largely burn hazardous waste generated

on site rather than waste gener ated by other facilities. These combustion facilities that mostly burn waste generated onsite are not included in this analysis.178 METHODOLOGY FOR ASSE SSING ENVIRONMENTAL JUSTICE IMPACTS 

### The demographic analysis presented in this section focuses on populations near (1) non

agricultural wastewater treatment facilities identified in the EPA Clean Watershed Needs database and (2) commercial hazardous waste combustion facilities included in EPA’s
RIA for the 2005 hazardous waste combustion MACT emission standards. 215 

### Of the 16,675 non

- agricultural wastewater treatment facilities identified in the Needs database, 208 either lacked location information altogether or had faulty location information (i.e., the latitude and longitude coordinates suggested they were locate d on open water or in another country). This analysis therefore considers the demographics of populations living near 16,467 facilities across the United States. Reliable latitude and longitude
coordinates were available for all 26 of the commercial haza rdous waste combustion
facilities included in the hazardous waste combustion MACT standards RIA. All 26 of these facilities are included in the demographic analysis presented in this document.

The geographic scope of the demographic analysis for each faci lity type is defined according to the following variables:

1. Radii from Facilities. This RIA evaluates the demographic characteristics of populations within a one

- mile radius of each wastewater treatment plant. To the extent that wastewater discharges conta ining active pharmaceutical ingredients infiltrate into groundwater, this radius approximates the population most likely to be affected. The RIA also examines the nature of the populations within a one

mile and three

- mile radius of each hazardous waste com bustion facility. These radii capture the populations most likely to be affected by any air releases associated with the combustion of hazardous waste pharmaceuticals.

2. Watershed catchment areas downstream of wastewater treatment plants.
Catchment areas in this context refer to the downstream area that receives surface

water runoff and releases from waste water treatment plants. This analysis considers population s in all catchments within 24 hours of downstream travel
time from a given wastewater treatment facility under mean surface water flow conditions, to approximate a high

- end estimate of populations potentially affected by hazardous waste pharmaceuticals. Unlike the one

- mile radius population, catchment areas do not include upstream populations, but t ypically encompass larger populations overall.

T his RIA compares the demographic characteristics of the populations within these areas against average characteristics at the national and state levels.

The demographic data for this analysis were obtained from a 2005

- 2009 synthetic population dataset generated from U.S. Census 2005

- 2009 American Community Survey

215 U.S. EPA Clean Watershed Needs Database, a ccessed on August 24, 2012 at http://ofmpub.epa.gov/portal/page/portal/CWNS%20Reports/download and U.S. EPA, Assessment of the Potential Costs, Benefits, & Other Impacts of the Hazardous Waste Combustion MACT Final Rule Standards, September 2005

.179 

### (ACS) data. 216 

### Using these data, this RIA estimate s the percent of the population below the poverty line and the percent characterized as racial or e thnic minorities . These values were estimated both plant

- by

- plant and for all wastewater treatment facilities and hazardous waste combustion facilities in aggregate. The aggregate values do not double count individuals in overlapping areas. For example, if a household is 0.5 miles from one wastewater treatment plant and 0.8 miles from another, the estimated number of low

income individuals living within one mile of wastewater treatment plants does not count
the household twice.

R ESULTS OF D EMOGRAPHIC A NA LYSIS 

### The demographic characteristics of populations near wastewater treatment plants and hazardous waste combustion facilities are compared below, separately, to both the nation

wide demographics of the U.S. and the demographics of the states where these facilities
are located. Exhibit 6

- 6 also provides a summary of these data. Some of the primary
conclusions drawn from these data are as follows:

 Racial and ethnic minorities make up a smaller share of the population near wastewater treatment plants than the national average. This is true for the one

mile buffer and wastewater treatment plant catchment zone.

 Low

- income inhabitants’ share of the population near wastewater treatment plants slightly exceeds the national average for the one

- mile buffer, but is below the national average for the plant catchments.

 For hazardous waste combustion facilities, the percentage of the population characterized as a racial or ethnic minority is below the national average within a

one

- mile radius of these facilities, but above the national average when the radius
is extended to three miles.

 Low

- income inhabitants’ share of the population near hazardous waste combustion facilities is greater than the national average within both a one

- mile
and a three

- mile buffer.

National

- level demographic comparison

Of the 27.4 million people living within one mile of the wastewater treatment plants for which location data were available, 6.2 million, or 22.6 percent, belong to a minority group. This is more than two percentage points below the national average, as shown in
Exhibit 6

- 6. In addition, 14.0 percent of the population within one mile of wastewater treatment plants is below the Federal Poverty Level, which exceeds the nationwide benchmark by more than 2.5 percentage p oints. At the facility level, the minority share of the population within one mile of wastewater treatment plants exceeds the national average for 3,233 of the 16,467 wastewater treatment plants included in this analysis. In

216 For Information on the data sources and derivations for the synthetic population dataset, see RTI International, U.S.
Synthesized Population 2005

– 2009 Version 2.0, August 2012, available at
https://www.epimodels.org/midasdocs/SynthPop/2005

- 2009_synth_pop_ver2_quickstart.pdf

.180 

### addition, 7,866 of the 16,467 plants are located in areas where the low income population within one mile of the plant is disproportionately high relative to the national average.

These results are considerably different when examining the demographics of catchment zones rather than po pulations within one mile of each plant. The catchment areas for these plants encompass approximately 44.2 million l ocal inhabitants, of which 3.8 million, or 8.6 percent belong to a minority group (compared with 24.7 percent nationally and 22.6 percent w ithin a one mile radius ) . In addition, 2.2 million inhabitants, or 4.9 percent of the catchment populations, live below the Federal Poverty Level, compar ed
with 11. 4 percent nationally. Focusing on individual catchment areas, minority groups’
share of th e population exceeds the national average in 3,151 of the 16, 467 wastewater treatment plant catchments. Low

- income inhabitants make up a greater percentage of the population than the national average in 7,358 of the wastewater treatment plant
catchments.181 EXHIBIT 6

- 6. DEMOGRAPHICS FOR POPULATIONS NEAR WASTEWATER TREATMENT

FACILITIES & COMMERC IAL HAZARDOUS WASTE COMBUSTION FACILITIE S

GEOGRAPH IC AREA MINORITY
POPULATION LOW

- INCOME

POPULATION % OF NATIONAL POPULATION

RACIAL & ETHNIC
MINORIT IES LOW

- INCOME

POPULATION
Wastewater treatment plant s,

one

- mile radius 6.2 million (22.6%) 1 3.8 million

(1 4

. 0 %) 1

24.7% 11.4% Wastewater treatment plant s, catchment areas 3.8 million (8.6%) 1 2.2 million

(4.9%) 1
Hazardous waste combustion facilities, one

- mile radius 3,578 (18.7%) 1 3,130

(16.3%) 1
Hazardous waste combustion facilities, three

- mile radius 67,329 (26.6%) 1 42,782

(16.9%) 1

GEOGRAPH IC AREA NO. OF FACILITIES EXCEEDING:

NATIONAL AVG. MINORITY PCT. NATIONAL AVG.
LOW

- INCOME PCT.
Wastewater treatment plant s,

one

- mile radius 3,233 7,886

Wastewater treatment plant s catchment areas 3,151 7,358

Hazardous waste combustion facilities, one

- mile radius 6 4

Hazardous waste combustion facilities, three

- mile radius 7 4

GEOGRAPH IC AREA NO. OF FACILITIES EXCEEDING:

STATE AVG. MINORITY PCT. STATE AVG. LOW

- INCOME PCT.
Wastewater treatment plant s,

one

- mile radius 3,596 7,949

Wastewater treatment plant s, catchment areas 3,562 7,391

Hazardous waste combustion facilities, one

- mile radius 7 13

Hazardous waste combustion facilities, three

- mile radius 8 16

Notes:
1. Values in parentheses represent the proportion of the population considered a racial or ethnic minority or below the Federal Poverty Level.

Sources: RTI International, U.S. Synthesized Population 2005

– 2009 Version 2.0, August 2012; U.S. EPA Clean Watershed Needs Database; and U.S. EPA, Assessment of the Potential Costs, Benefits, & Other Impacts of the Hazardous Waste Combustion MACT Final Rule Standards, September 2005.



### One contributing factor to the disparity between the catchment zone demographics and the demographic characteristics of populations within one mile of each plant is the difference in geographic coverage between the two areas. On average, catchments cover 15.5 square miles of area, while the one mile radius area only covers 3.1 square miles per facility. In total, the Agency analyzed approximately 650,866 square miles of catchment area, or over 12 times more surface area than in the one

- mil e buffer analysis, which covered 51,053 square miles.182 

### Among the 19,200 individuals living within one mile of commercial hazardous waste combustion facilities, an estimated 3,578, or 18.7 percent, belong to a minority group. This figure is six percentage p oints below the nationwide average of 24.7 percent. In addition, approximately 16.3 percent of the inhabitants within one mile of combustion facilities are below the Federal Poverty Level, which is five percentage points above the corresponding nationwide value of 11.4 percent. Across the 26 combustion facilities, minority populations’ share of the population exceeds the national average in the one

mile zone for six facilities. Similarly, four combustion facilities are located in areas
where low

- income in dividuals make up a greater share of the population in the one

- mile buffer than the national average.

Expanding to a three

- mile buffer around combustion facilities, the total population is 253,200 inhabitants. Of these, 67,329 (26.6 percent) belong to a minority group and 42,782 (16.9 percent) are below the Federal Poverty Level. In proportional terms, both values are greater than the corresponding national averages, as shown in Exhibit 6

- 6. Of the 26 combustion facilities, seven are located in areas wh ere racial and ethnic minorities
within a three

- mile radius make up a greater share of the population than the national average. Low

- income inhabitants’ share of the population exceeds the national average
in the three

- mile buffer area for four of the com bustion facilities.

State

- level demographic comparison

This analysis also considers the demographics of populations near wastewater treatment and hazardous waste combustion facilities relative to state populations

. Among the one

mile buffers around the 16, 467 wastewater treatment plants, racial and ethnic minorities’ share of the population exceeds the corresponding state

- wide average for 3,596 . In addition, the percentage of inhabitants living below the poverty line exceeds the corresponding state perc entage for 7,949 of the one

- mile buffers around these facilities. With respect to the wastewater treatment plant catchment zones, racial and ethnic minorities make up a greater share of the population than the corresponding state average for 3,562 catchm ent areas, and the poverty rate exceeds the state average in 7,391 of the
catchment areas.

Of the 26 hazardous waste combustion facilities, seven are located in areas where racial and ethnic minorities make up a greater share of the population in the one

- mile buffer than the state average. This figure expands to eight with the three

- mile buffer. Low

income inhabitants account for a larger share of the population than is typical within the state for 13 of the combustion facility one

- mile buffers. Using the three

- mile buffer, 16 of the hazardous waste combustion facilities are located in areas where the proportion of the population living below the Federal Poverty Level exceeds the state average.

IMPACT OF PROPOSED RULE OPTION S ON EJ POPULATIONS 

### Overall , EPA expects that the proposed rule may positively affect U.S. EJ populations, although the sign of the impacts will vary by facility. As suggested by Exhibit 6

- 6, the reduction in sewering expected under the proposed rule may benefit relatively large
mi nority and low

- income populations in close proximity to or downstream from wastewater treatment plants. The diversion of hazardous waste pharmaceuticals to183 

### combustion facilities, however, may increase the environmental burden borne by EJ populations near these facilities. Although these effects offset each other to a certain degree, the number of minority and low

- income individuals near wastewater treatment facilities greatly exceeds the number near hazardous waste combustion facilities. This suggests th at, on the whole, the proposed rule may benefit EJ populations. This tentative conclusion, however, does not account for differences between the environmental impacts associated with sewering hazardous waste pharmaceuticals and the impacts of burning
them in a hazardous waste combustion facility.

LIMITATIONS OF ENVIRONMENTAL JUSTICE ASSESSMENT 

### While the demographic analysis presented above provides a reasonable basis for assessing the environmental justice impacts of the rule, it is subject to a number o f important limitations. In particular, the analysis does not assess how reductions in sewering would affect the health and welfare of minority and low

- income populations near and downstream from wastewater treatment plants. The analysis similarly does n ot estimate the changes in air emissions associated with the diversion of hazardous waste pharmaceuticals to combustion facilities or the health impacts associated with these emissions for environmental justice populations near these facilities.

The demogr aphic analysis is also limited in accounting only for those populations that
live near affected facilities

. Individuals who work near these facilities or who are frequently in close proximity to these facilities for other reasons (e.g., visit family, purs ue recreational opportunities, etc.) may also be affected by changes in the sewering or combustion of hazardous waste pharmaceuticals.

CHILDREN’S HEALTH PR OTECTION ANALYSIS 

### Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR. 19885, April 23, 1997) applies to any rule that: (1) is determined to be “economically significant” as defined under E.O. 12866, or (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potenti ally effective and reasonably feasible alternatives considered by the Agency. This action may be subject to EO 13045 because the high

- end of the estimated cost range is economically significant as defined in EO 1286 6.

To examine whether the proposed rule h as a disproportionate impact on children, this RIA uses a geographic analysis of demographics near wastewater treatment plants and hazardous waste combustion facilities, following the same methodology described above
for the assessment of environmental justice impacts. Exhibit 6

- 7 summarizes the results of this analysis. As indicated in the exhibit, this analysis finds that children (i.e., individuals under the age of 18) account for a slightly larger share of the population (28.5
percent ) in the one

- mile radius around wastewater treatment plants than they account for nationally (25.3 percent). Among the catchment zones of wastewater treatment plants, however, children make up a much smaller portion of the population (9.8 percent).184 

### Withi n both the one

- and three

- mile buffers around hazardous waste combustion facilities, children’s share of the population slightly exceeds their share nationally.

These data suggest that the rule will not result in a disproportionate adverse impact on children. Because children’s share of the population near hazardous waste combustion facilities is near the national average, any increase in the combustion of hazard ous waste combustion that occurs as a result of the rule is unlikely to have a significant disproportionate impact on children’s health. The data in Exhibit 6

- 7 also show that the number of children living in close proximity to wastewater treatment plants , in areas likely to benefit from the rule, far exceeds the number of children who live near hazardous waste combustion facilities. This suggests that the diversion of hazardous waste pharmaceuticals from wastewater treatment plants to combustion faciliti es will benefit a much greater number of children than it may put at greater risk of adverse health
effects.

The data in Exhibit 6

- 7 also show the number of wastewater treatment plants and
hazardous waste combustion facilities in areas where children’s s hare of the population exceeds the corresponding state and national averages. Among the one

- mile buffers around the 16, 467 wastewater plants, children represent a larger portion of the population than the national average in 8,908. When comparing the buf fer population to state averages, this figure increases to 8,992. Both values decrease significantly when examining populations in the wastewater treatment plant catchment zones. The data suggest that children make up a greater share of the population th an the national average in 5,171 of the catchment zones and a greater share than the corresponding state average in 5,149 of the catchment areas.

Among the 26 hazardous waste combustion facilities, the population of children in the

one

- mile buffer zone i s disproportionately high for 11 to 14 facilities. The precise value depends on whether children’s share of the population is compared to the national or state average and whether children’s share of the population near these facilities is estimated
withi n the one

- mile buffer or the three

- mile buffer.185 EXHIBIT 6

- 7

. SUMMARY OF CHILDREN' S HEALTH ASSESSMENT

GEOGRAPHIC AREA NUMBER OF CHILDREN
IN AREA NATIONAL % OF POPULATION
UNDER THE AGE OF 18
Wastewater treatment plants, one

mile radius 7.8 million (28.5%) 1

25.3% Wastewater treatment plants,
catchment areas 4.4 million (9.8%) 1
Hazardous waste combustion facilities, one

- mile radius 5,012 (26.1%) 1
Hazardous waste combustion facilities, three

- mile radius 64,710 (25.6%) 1

GEOGRAPHIC AREA NUMBER OF FACILIT IES WHERE CHILDREN’S SHARE OF THE
LOCAL POPULATION EXC EEDS NATIONAL AVG. %
Wastewater treatment plants, one

mile radius 8,908

Wastewater treatment plants,
catchment areas 5,171

Hazardous waste combustion facilities, one

- mile radius 13

Hazardous waste combustion facilities, three

- mile radius 11

GEOGRAPHIC AREA NUMBER OF FACILIT IES WHERE CHILDREN’S SHARE OF THE
LOCAL POPULATION EXC EEDS STATE AVG. %
Wastewater treatment plants, one

mile radius 8,992

Wastewater treatment plants,
catchment areas 5,149

Hazardous waste combustion facilities, one

- mile radius 14

Hazardous waste combustion facilities, three

- mile radius 11

Notes:
1. Values in parentheses represent children’s proportion of the population.
Sources: RTI International, U.S. Synthesized Population 2005

– 2009 Version 2.0, August 2012; U.S. EPA Clean Watershed Needs Database; and U.S. EPA, Assessment of the Potential Costs, Benefits, & Other Impacts of the Hazardous Waste Combustion MACT Final Rule Standards, September 2005.

J OINT IMPACTS OF RULE S 

### Healthcare facilities affected by the proposed rule are also subject to regulations issued by the Drug Enforcement Agency (DEA) pertaining to controlled substances. Some of the controlled substances subject to DEA regulation also qualify as a hazardous wa ste under RCRA. To ensure that these substances are managed safely when disposed of and to provide clarity to healthcare facilities on the appropriate management of these substances, the proposed rule conditionally exempts controlled substances that are a lso hazardous waste from RCRA so long as they are (1) managed in accordance with DEA regulations, (2) not sewered, and (3) sent to a municipal solid waste combustor or a
hazardous waste incinerator.