Regulatory Impact Analysis of EPA's Proposed Regulations 

for the Management of Hazardous Waste Pharmaceuticals at 

Healthcare Facilities

June 2015
i

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 CONTENTS

LIST OF ACRONYMS

EXECUTIVE SUMMARY

CHAPTER 1 | INTRODUCTION 

Introduction 1

Problem Statement 1

Summary of the Proposed Rule and Regulatory Alternatives 2

Report Organization 17

CHAPTER 2 | POTENTIALLY IMPACTED INDUSTRIES

Introduction 18

Profile of Affected Industries 18

Recent Market Trends 29

Universe of Facilities Affected by the Proposed Rule 34

Hazardous Waste Generation Among Healthcare 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 Populations 144

Human Health Effects 146

Presence of APIs in the Food Supply 150

Potential Benefits Related to Enhanced Recreational Opportunities 151

Other Potential Benefits 153

Sensitivity Analyses 154
iii

CHAPTER 5 | SUMMARY OF REGULATORY BENEFITS & COSTS 163

CHAPTER 6 | EQUITY CONSIDERATIONS AND OTHER IMPACTS

Regulatory Planning and Review 165

Regulatory Flexibility 166

Employment Impact Analysis 171

Unfunded Mandates Analysis 172

Federalism Analysis 173

Tribal Governments Analysis 175

Energy Impact Analysis 176

Environmental Justice Analysis 177

Children’s Health Protection Analysis 183

Joint Impact of Rules 185
iv

LIST OF ACRONYMS

(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 of 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 Landfills 
v

(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 Concentrations 

(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 

(TTC) Threshold of Toxicological Concern 

(TSDFs) Treatment, Storage, and Disposal Facilities 

(USGS) U.S. Geological Survey 

(UMRA) Unfunded Mandates Reform Act 

(UW) Universal Waste 

(WWTP) Wastewater Treatment Plant 
ES-1

EXECUTIVE SUMMARY

BACKGROUND

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 that 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 RCRA 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 healthcare 

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 PROPOSED RULE AND REGULATORY ALTERNATIVES

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 key 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 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.

 

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 reverse 

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 longer 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 curtail 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 facilitate 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 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.

 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

UNIVERSE OF AFFECTED FACILITIES AND

GENERATION OF HAZARDOUS WASTE PHARMACEUTICALS

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 approximately 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. Although 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 LQGs , SQGs , AND CESQGs IN THE AFFECTED UNIVERSE BY FACILITY TYPE

NAICS FACILITY TYPE

TOTAL 

GENERATORS

LQG SQG CESQG

% OF 

GENERATORS1

NUMBER OF 

FACILITIES

% OF 

GENERATORS1

NUMBER OF 

FACILITIES

% OF 

GENERATORS1

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. AGGREGATE ANNUAL HAZARDOUS WASTE PHARMACEUTICALS 

GENERATION BY FACILITY TYPE FOR ALL FACI LITIES (TONS)

NAICS FACILITY TYPE

NUMBER OF 

FACILITIES

TOTAL 

HAZARDOUS 

WASTE1,2

HAZARDOUS WASTE 

PHARMACEUTICALS2

HEALTHCARE FACILITIES AS DEFINED BY THIS RULE

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 GENERATOR 

STATUS (TONS)

GENERATOR 

STATUS

NUMBER OF 

FACILITIES

TOTAL HAZARDUOS WASTE

1,2

HAZARDOUS WASTE 

PHARMACEUTICALS

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).

ASSESSMENT OF COSTS

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 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 

model 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 status 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 amount 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. Facility 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 reports 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 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. 
ES-7

EXHIBIT ES-4. TOTAL ANNUALIZED BASELINE COSTS AND INCREMENTAL 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 INCREMENTAL COSTS1

MORE 

STRINGENT 

OPTION

PROPOSED 

OPTION

LESS 

STRINGENT 

OPTION

1 Notification2 $0.00 $0.07 $0.07 $0.07

2 Training $79.65 $1.53 $1.53 $1.53 

3 Manifest Training $6.30 $0.23 $0.23 $0.23 

4 Contingency Plan Updating $4.91 $0.16 $0.00 $0.00 

5 Container Management $28.84 $5.31 $2.67 $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 $0.01 $0.00 $0.00 

9 Closure $4.51 $1.24 $1.21 $1.21 

10 RCRA Storage Permit $0.00 $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 Recordkeeping3 $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 $554.59 $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 data 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 costs 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 distributes the incremental costs 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 costs of each option are higher for other healthcare facilities than for 

reverse distributors, due in large part to the higher number of the former. The same is 

true, albeit to a lesser degree, for the higher costs borne by hospitals than for reverse 

distributors. From among all generator categories, the costs are highest for SQG

healthcare facilities. 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 rule 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 incremental costs. Under the 

Less Stringent Option, there are no incremental disposal costs for CESQGs, while 

sewering is banned for SQGs.

EXHIBIT ES-5. ANNUALIZED INCREMENTAL COSTS OF PROPOSED 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 $34.69 
ES-9

ASSESSMENT OF BENEFITS

The proposed rule for the management of hazardous waste pharmaceuticals yields 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 (MSW) 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 in 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 healthcare 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 

savings reflects the less stringent training requirements as they apply to hospital nursing

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 pharmaceuticals 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 reverse 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 Option is estimated to result in cost savings 

associated with only avoided contaminated wastewater treatment.
ES-10

EXHIBIT ES -6. ANNUALIZED BASELINE COSTS AND INCREMENTAL 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 INCREMENTAL COST 

SAVINGS1

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 $28.84 $0.00 $0.15 $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 $4.51 $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 $554.59 $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 data 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 distributes 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 hospitals due to the proposed 

changes in the requirements for nurse training.

EXHIBIT ES -7. ANNUALIZED COST SAVINGS OF PROPOSED 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 $0.02 $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 nonmonetized 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 corresponding 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 More 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/2010_1_11_ppcp_hcioutreach.pdf. 
ES-12

EXHIBIT ES-8. ANNUAL REDUCTION IN THE SEWERING OF HAZARDOUS WASTE 

PHARMACEUTICALS (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 6,440 6,440 5,210

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, the 

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 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 dispose 

of their hazardous waste pharmaceuticals through incineration 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 not 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 complying 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 rule addresses both of 

these issues by (1) stipulating regulatory requirements specific to healthcare facilities 

generating hazardous waste pharmaceuticals and (2) ensuring that healthcare facility 

employees receive the information and training necessary to manage these wastes in a 

manner that is protective of human health and the environment. Together, these 

elements of the rule will help healthcare facilities better integrate the responsible 

management of hazardous waste pharmaceuticals into their operations, 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 wastes 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 corrective 

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 QUANTIFIED 

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 reduced sewering 

of hazardous waste pharmaceuticals

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 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 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 the 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 benefits associated with individual provisions of the proposed 

rule. 
ES-15

EXHIBIT ES -10. NET BENEFITS OF THE PROPOSED RULE BY WASTE MANAGEMENT ACTVITIY, 7 PERCENT DISCOUNT RATE ($2011 MILLIONS )

ROW

WASTE 

MANAGEMENT 

ACTIVITY

TOTAL 

ANNUALIZED 

COSTS IN 

THE FULL 

COMPLIANCE

BASELINE

INCREMENTAL COSTS AND BENEFITS

MORE STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

ANNUALIZED 

COSTS

ANNUALIZED 

BENEFITS1

NET 

BENEFITS

ANNUALIZED 

COSTS

ANNUALIZED 

BENEFITS1

NET 

BENEFITS

ANNUALIZED 

COSTS

ANNUALIZED 

BENEFITS1

NET 

BENEFITS

1 Notification $0.00 $0.07 

Not 

Monetized

($0.07) $0.07 $0.00 ($0.07) $0.07 $0.00 ($0.07)

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 ($12.27) $34.69 $23.50 ($11.19)

Notes:

1. Several 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 CONSIDERATIONS 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 planning 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 average 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: Insufficient data are available to quantify the 

potential impact of the proposed rule on employment. The economics 

literature suggests, however, that the 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 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.” 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 either the 

private sector or state, local, and tribal governments in the aggregate. 

 Federalism: The 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 substantial burden on tribal 

governments.

 

4

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 the Environment: An Industry-Level Perspective.” Journal of Environmental Economics and 

Management, Vol. 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, however, 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 

the 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 impacts 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 exempts 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 | INTRODUCTION

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 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 

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 disposal. 

 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 these 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 management 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 

different, more comprehensive regulatory approach.

SUMMARY OF THE PROPOSED RULE AND REGULATORY ALTERNATIVES

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 wastes will no longer 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 provisions 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 reduce releases of hazardous waste pharmaceuticals to the nation’s 
3

waterways. The rule’s tracking requirements 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 areas 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 pharmaceuticals.

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 ADDRESSED BY THE 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 exposing 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, the proposed rule is better tailored to 

healthcare 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 MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY HEALTHCARE FACILITIES

MORE- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

SQGS LQGS

PATIENT CARE HW 

PHARMACEUTICALS

POTENTIALLY CREDITABLE 

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 and 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 MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY HEALTHCARE FACILITIES

MORE- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

SQGS LQGS

PATIENT CARE HW 

PHARMACEUTICALS

POTENTIALLY CREDITABLE 

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 MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY HEALTHCARE FACILITIES

MORE- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

SQGS LQGS

PATIENT CARE HW 

PHARMACEUTICALS

POTENTIALLY CREDITABLE 

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 procedures 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 coordinator.

 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 MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY HEALTHCARE FACILITIES

MORE- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

SQGS LQGS

PATIENT CARE HW 

PHARMACEUTICALS

POTENTIALLY CREDITABLE 

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 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.

 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 MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY HEALTHCARE FACILITIES

MORE- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

SQGS LQGS

PATIENT CARE HW 

PHARMACEUTICALS

POTENTIALLY CREDITABLE 

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 

HCF’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 they are:

o Managed in accordance with DEA regulations,

o NOT sewered, and 

o Sent 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 MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY HEALTHCARE FACILITIES

MORE- STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

SQGS LQGS

PATIENT CARE HW 

PHARMACEUTICALS

POTENTIALLY CREDITABLE 

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 is 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 Transportation
10

EXHIBIT 1-2. COMPARISON OF MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY REVERSE DISTRIBUTORS

MORE STRINGENT OPTION

PROPOSED OPTION AND LESS STRINGENT OPTION

HAZARDOUS WASTE PHARMACEUTICALS 

THAT GO FROM RD TO TSDF

HAZARDOUS WASTE PHARMACEUTICALS 

THAT GO FROM RD TO ANOTHER 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: 1st RD, 2nd 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 program must be documented and records kept for each employee.

o Annual refresher training is required
11

EXHIBIT 1-2. COMPARISON OF MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY REVERSE DISTRIBUTORS

MORE STRINGENT OPTION

PROPOSED OPTION AND LESS STRINGENT OPTION

HAZARDOUS WASTE PHARMACEUTICALS 

THAT GO FROM RD TO TSDF

HAZARDOUS WASTE PHARMACEUTICALS 

THAT GO FROM RD TO ANOTHER 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 placard 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 shipped 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 MORE STRINGENT OPTION, PROPOSED OPTION, AND LESS STRINGENT OPTION FOR HAZARDOUS WASTE 

PHARMACEUTICALS GENERATED BY REVERSE DISTRIBUTORS

MORE STRINGENT OPTION

PROPOSED OPTION AND LESS STRINGENT OPTION

HAZARDOUS WASTE PHARMACEUTICALS 

THAT GO FROM RD TO TSDF

HAZARDOUS WASTE PHARMACEUTICALS 

THAT GO FROM RD TO ANOTHER 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 information 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 Transportation
13

EXHIBIT 1-3. COMPARISON OF CURRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE 

PROPOSED OPTION

CESQGs SQGs LQGs

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 hazardous 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.

 The Proposed Option 

applies only to SQGs and 

LQGs, with the exception 

of the sewering ban.

 Under the Proposed 

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 CURRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE 

PROPOSED OPTION

CESQGs SQGs LQGs

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. 

 Training 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 CURRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE 

PROPOSED OPTION

CESQGs SQGs LQGs

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 Option 

stipulates that the RD 

must be called to provide 

an alert that a shipment is 

en route.

 For shipments between 

reverse distributors, 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 for 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 CURRENT BASELINE RCRA SUBTITLE C HAZARDOUS WASTE REQUIREMENTS & THE NEW REQUIREMENTS OF THE 

PROPOSED OPTION

CESQGs SQGs LQGs

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 coordinator.

 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 – Assessment 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 implications, 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 | POTENTIALLY IMPACTED INDUSTRIES 

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 

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. 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 to 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 needed 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 baseline 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, 

approximately 612,600 facilities make up the healthcare and reverse distributor sectors. 

These are primarily comprised of physicians’ offices (36 percent), dentists’ offices (21 

percent), other health practitioners (20 percent), and pharmacies (7 percent). In addition, 

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 

number 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 hazardous 
19

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 generators. 
20

EXHIBIT 2-1. HEALTHCARE FACILITIES 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’ Offices3

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 hazardous 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 the 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 ambulatory 

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 other 
21

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 predominately 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, firms, 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 revenues. 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 Economic 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 analysis 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, Florida, 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 

nearly 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 county 

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 remaining 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 facilities 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 healthcare 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 all 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 DISTRIBUTION OF HEALTHCARE FACILITIES AND REVERSE DISTRIBUTORS
24

EXHIBIT 2-3. ECONOMIC SUMMARY DATA BY HEALTHCARE FACILITY TYPE (IN 2007 DOLLARS) 1

NAICS FACILITY TYPE

ECONOMIC DATA BY INDUSTRY

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 Distributors2- - - - - -

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 identifiable in the 

Economic Census, values for just these facility types cannot be reported. Furthermore, calculating a weighted average for all NAICS 

codes represented by reverse distributors may overestimate or underestimate actual values because it would reflect other facility 

types that may not be RDs.

Source: U.S. Census Bureau, 2007 Economic Census.
25

Exhibit 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, 

approximately 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 

predominantly 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, veterinary 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 revenues ($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 ambulatory 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 Supplements, 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 FACILITIES BY FIRM-LEVEL REVENUES 
27

EXHIBIT 2-4. NUMBER OF FACILITIES BY FIRM-LEVEL REVENUES (CONTINUED)
28

EXHIBIT 2-4. NUMBER OF FACILITIES BY FIRM-LEVEL REVENUES (CONTINUED)
29

EXHIBIT 2-5. AVERAGE SIZE OF HEALTHCARE FACILITIES 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 growth 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 healthcare 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 Economic Analysis, National Income and Product Accounts, Table 1.1.6, February 29, 2012. 
30

physicians’ 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 accounted 

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 foster 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. The left-hand axis in each graph 

shown in the exhibit represents the number of healthcare facilities and firms and the righthand 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 Characteristics, 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 TRENDS (CONTIUED)
33

EXHIBIT 2-6. RECENT ECONOMIC TRENDS (CONTINUED)
34

UNIVERSE OF FACILITI ES AFFECTED BY THE PROPOSED RULE

ESTIMATING THE NUMBER OF HEALTHCARE FACI LITIES AND REVERSE 

DISTRIBUTORS THAT GENERATE HAZARDOUS 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 all 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 the 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. Equation 2-1 illustrates this approach.

(2-1) PG =

FG

FHC

Where PG = percent of healthcare facilities that are hazardous waste 

generators;

FG = number of healthcare facilities in the state hazardous waste 

generator data; and

FHC = total number of healthcare facilities in the same states as 

reflected in the Economic Census data

While several states provided information, the data from just two states, Massachusetts 

and Minnesota, provide a sufficient level of detail to estimate the percentage of healthcare 

facilities that are hazardous waste generators in their state.

17

 There are a similar number 

of generators in the two states, approximately 22,000 in Massachusetts and 23,350 in 

Minnesota. Minnesota provided NAICS and SIC codes for many of these facilities, 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 reflect all generators in a given 

state (in comparison with the number of facilities reported in the Economic Census).

 

16 States contacted include California, Florida, Maine, Massachusetts, Minnesota, New Jersey, Washington, and Wisconsin.

17 Massachusetts data were obtained from the Massachusetts Office of Energy 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 crosswalked with EPA’s RCRAInfo database using 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, but 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 generators 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 

estimated 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 approximately 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 Minnesota.

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 

these states generate hazardous waste and that approximately 28 percent of the other 

healthcare facilities in these states 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 wastes, & 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 in 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. Based 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 MiniQGs; 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 reporting 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, sensitivity analyses are presented using the individual estimates for Massachusetts (16.2 percent) and 

Minnesota (44.0 percent) separately.
37

EXHIBIT 2-7. PERCENTAGE OF HEALTHCARE FACILITIES THAT ARE HAZARDOUS WASTE GENERATORS

STATE

[A]

GENERATOR 

STATUS

[B]

NUMBER OF HAZARDOUS WASTE GENERATORS

BASED ON STATE DATA

U.S. 2007 ECONOMIC 

CENSUS DATA

PERCENTAGE OF HEALTHCARE 

FACILITIES THAT GENERATE 

HAZARDOUS WASTE1

HOSPITALS

[C]

OTHER 

HEALTHCARE 

FACILITIES

[D]

TOTAL 

NUMBER OF 

GENERATORS

[E]

PERCENTAGE 

OF FACILITIES 

WITH NAICS2

[F]

HOSPITALS

[G]

OTHER 

HEALTHCARE 

FACILITIES

[H]

HOSPITALS3

[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-RCRA4 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%

Other5 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 RCRA hazardous waste are 

excluded.

5. For Minnesota, this category 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 in a year. 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 likely misclassified 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 subject to Federal RCRA requirements.
38

Extrapolating 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 healthcare facilities nationwide are hazardous waste generators, 

as shown in Exhibit 2-8. It was not possible to estimate the corresponding percentages 

for reverse distributors based on the state data. However, because 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 hazardous 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 states

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 FACILITES AND REVERSE 

DISTIRBUTORS THAT ARE HAZARDOUS WASTE GENERATORS

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 35,106

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%

4,508

623311 Continuing Care 

Retirement Communities 5,939 1,641

Subset of 

92219

Medical Examiners and 

Coroners’ Offices2

1,998 552

Various 

NAICS

Reverse Distributors 

(RDs)3

56 100% 56

TOTAL 612,648 174,023

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 the 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, "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.
40

ASSESSING THE GENERATOR STATUS FOR HEALTHCARE FACILITIES AND REVERSE 

DISTRIBUTORS THAT GENERATE HAZARDOUS WASTE

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 status 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 generation thresholds for the three 

categories.

EXHIBIT 2-9. RCRA SUBTITLE C HAZARDOUS WASTE GENERATION 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 hazardous 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 does 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. These 

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 generator 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 that, 

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 clinics, physicians’ offices, dentists’ offices, other health practitioners, nursing 

care facilities, and continuing care retirement communities. Conversely, the healthcare 

facility types that have the highest proportion of LQGs are RDs (50 percent), hospitals 

(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 relative 

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 Target 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 facilities 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 LQGs , SQGs , AND CESQGs IN THE AFFECTED UNIVERSE BY FACILITY TYPE

NAICS FACILITY TYPE

TOTAL 

GENERATORS

LQG SQG CESQG

% OF 

GENERATORS1

NUMBER OF 

FACILITIES

% OF 

GENERATORS1

NUMBER OF 

FACILITIES

% OF 

GENERATORS1

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 

Communities2

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 GENERATION AMONG HEALTHCARE 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 pharmaceuticals 

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 according 

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 the 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 healthcare 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 Maine 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 facilities is 

not necessary to derive an approximation of per facility hazardous waste generation, the Maine and New Jersey data are 

included 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 basis 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 facilities are estimated by applying the per facility estimates described in 

this chapter to the facility counts presented in Exhibit 2-10.

HAZARDOUS WASTE GENERATION REPORTED IN THE BR DATABASE

EPA’s 2009 BR database is the primary data source for estimating 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 under 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 facilities; 

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 with 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 codes 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 wastestream generated by a healthcare facility.

 

30 American Hospital Directory. accessed 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 generated 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 pharmaceutical 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 based 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. Medic31

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.

For 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 specific 

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 clothing. 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 WASTE 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 (plisted) 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 potentially 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 facility counts are from Exhibit 2-10.
47

led EPA 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 hazardous 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 REPORT HAZARDOUS WASTE GENERATION DATA BY FACILITY TYPE (IN TONS)

NAICS

[A]

FACILITY TYPE

[B]

ALL HEALTHCARE FACILITIES

HEALTHCARE FACILITIES THAT REPORT GENERATING 

HAZARDOUS WASTE PHARMACEUTICALS

TOTAL 

HAZARDOUS 

WASTE1

[C]

ACUTE 

HAZARDOUS 

WASTE

[D]

NUMBER OF 

FACILITIES 

IN 2009 BR 

DATABASE

[E]

TOTAL 

HAZARDOUS 

WASTE

[F]

ACUTE 

HAZARDOUS 

WASTE

[G]

HAZARDOUS 

WASTE 

PHARMACEUTICALS

[H]

ACUTE 

HAZARDOUS 

WASTE 

PHARMACEUTICALS

[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 to 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 quantities 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 percentage 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 hospitals, 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 HAZARDOUS WASTE GENERATION SCALING FACTORS

FACILITY TYPE

PERCENTAGE OF OVERALL HAZARDOUS WASTE COMPRISED OF:

HAZARDOUS WASTE 

PHARMACEUTICALS2

ACUTE HAZARDOUS 

WASTE

(FOR LQGs)

3

ACUTE HAZARDOUS 

WASTE 

PHARMACEUTICALS

(FOR LQGs)

3

Hospitals1 30.9% 23.8% 21.5%

RDs 94.3% 41.7% 41.7%

Other Healthcare Facilities 

(excluding Hospitals and RDs) 24.0% 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 HAZARDOUS 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 looks 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 characteristics 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 presented 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 

generated according to 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 between 

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 results 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-based 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 

overall hazardous waste and hazardous waste pharmaceuticals among LQG hospitals. 

There are two motivating factors for using a model facility approach over a regressionbased estimation approach: (1) because the regression results are based on data for LQG 

hospitals 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 and (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 

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

 

37 Teaching status is defined as either active 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 representing 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 coefficient, 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 

estimates for each model hospital are applied to the corresponding number of LQG 

hospitals in the regulated universe. 

EXHIBIT 2-14. CORRELATION ANALYIS OF HAZARDOUS WASTE GENERATION AND HOSPITAL 

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 nth root of hazardous waste generation is 

calculated for several values of n in order to achieve 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 number 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 not 

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, four 

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 

following 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 approach 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 the 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 fewer than 370 beds: 34 nonteaching 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 hazardous 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 HAZARDOUS WASTE GENERATION PER FACILITY FOR 

MODEL LQG HOSPITALS (TONS)

HAZARDOUS WASTE 

GENERATION (TONS)

NONTEACHING 

HOSPITALS

TEACHING HOSPITALS1

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 HAZARDOUS 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 generation 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 approximately 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 REVERSE 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 GENERATION BY OTHER FACI LITY TYPES (NON-LQG HOSPITALS 

AND REVERSE DISTRIBUTORS, ALL OTHER HEALTHCARE 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 waste generation. Instead, for CESQGs and SQGs, this RIA relies on facilitylevel 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 healthcare 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 indicated in Exhibit 2-17, the Minnesota data include facilitylevel generation estimates only for hazardous waste pharmaceuticals. To 

estimate overall hazardous waste generation for the Minnesota facilities, the 

pharmaceutical generation estimates for these facilities 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 

Cherrie Plummer, Maine Department of Environmental Protection, on October 26, 2012.
55

EXHIBIT 2-17. HAZARDOUS WASTE GENERATOR DATA COLLECTED FROM SELECT 

STATES

STATE

NUMBER OF 

HEALTHCARE 

FACILITIES WITH 

GENERATION DATA1,2

SUMMARY OF GENERATION DATA 

AMONG HEALTHCARE FACILITIES

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 SQGs

 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 facility 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; however, the state database does not 

immediately record this change in status).
56

(2-2) Whaz =

Wpharm

p

Where Whaz = generation of all hazardous waste, by facility;

Wpharm = 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 develop 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 

summarized by Equation 2-3.

(2-3) Wpharm = Whaz × p

Where, Wpharm, Whaz, 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 facilities 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:

CESQGs. 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 

estimates 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. 

Based 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 annual 
57

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 (other 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 LQGs 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 yields 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 typical 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 GENERATION PER FACILITY ACROSS ALL FACILITY 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 generation 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 facility 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 the 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) 0.04
59

AGGREGATE GENERATION OF HAZARDOUS WASTE AMONG FACILITIES POTENTIALLY 

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 facilities 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 facilities, 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 pharmaceuticals, 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 PHARMACEUTICALS 

GENERATION BY FACILITY TYPE FOR ALL FACI LITIES (TONS)

NAICS FACILITY TYPE

NUMBER OF 

FACILITIES

TOTAL HAZARDUOS 

WASTE1,2

HAZARDOUS WASTE 

PHARMACEUTICALS2

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 GENERATOR 

STATUS (TONS)

GENERATOR 

STATUS

NUMBER OF 

FACILITIES

TOTAL 

HAZARDOUS 

WASTE1,2

ACUTE 

HAZARDOUS 

WASTE

HAZARDOUS WASTE 

PHARMACEUTICALS

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 | ASSESSMENT 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 also 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 

detailed 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 significant 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 SPECIFICATION

OMB Circular A-4 directs 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 waste 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 pharmaceuticals 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 rely 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 sewering their hazardous waste pharmaceuticals without notifying their 

local POTW or by discarding them with medical waste or municipal solid waste (MSW).

This 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, to address 

 

45 U.S. Office of Management and Budget, 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 These 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 facilities 

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 hazardous 

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 hazardous 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 waste 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 methods: 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 MSW 

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 accounting 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 IMPACTS EXAMINED

A priori, the proposed rule could result in either an increase in costs or a cost savings for 

facilities that generate 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, Arizona, 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, Tennessee, 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.state.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 & Mandatory 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

management 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-pharmaceutical 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 Option. 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 this 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 

RIA 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 EPA 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-related 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-related 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 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 be closed while in storage except when adding or removing waste. 

Facilities that sewer 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 date. 
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 weekly 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 

waste 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 and 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 to 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 waste 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 transported 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 incineration51

unit or by sewering them and notifying their local POTW (under 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 the 
66

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

practice.

MODEL FACILITY APPROACH

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 facility, the data necessary for a facilityspecific 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 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 status 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 amount of hazardous waste 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 available 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 available 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 outlined 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 model 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 facilities” 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 facilities 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 incremental 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 

average 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 annual revenues, while the size standard for dentists’ offices is $7.0 

million.54 Size standards apply to the firm level; no such criteria exist 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 small 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 cost 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 Directory, 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.

Exhibit 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 

pharmaceuticals 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/content/table-small-business-sizestandards, 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 Solutions 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-sizestandards, accessed on February 4, 2012.
68

EXHIBIT 3-1. MODEL FACILITIES FOR ASSESSMENT OF COST 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 communication with 

Cherrie 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 pharmaceuticals 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, and (5) the discount rate. These assumptions 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) manufacturer 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 hospitals 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 rule 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 current 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 the 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, Minnesota, 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, this 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 satellite 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-gallon 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 facilities 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 drums.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 communities 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.conservationus.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 on 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 Countries, University of Seville, KTH, and Scania, May 2006. Available at: 

http://www.mne.psu.edu/ifrtt/ConferenceProceedings/ISHVWD_9_2006/docs/pdfs/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 hours 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 using 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, travel, 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 maintenance, 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 COSTS

BLS OCCUPATION CATEOGRY

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/nctb1478.pdf.

2. Fringe 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 estimating 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 

activities 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 items 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 one 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 onetime 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 of 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 of the RIA describing the rule provision related to biennial 

reports. No 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 for 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 not 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 estimates 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 of 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 notification 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 incur 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 Number 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 facilities 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 conduct 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 associated with the training.

EXHIBIT 3-3. ANNUAL COST OF HAZARDOUS WASTE HANDLING 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 their 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 Impact 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.trainingclasses.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 approximately $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 the 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 nurse 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 facility per year.76

 

71 Business Training Works, 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 Collection 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 AWARENESS TRAINING FOR NURSES 

UNDER THE BASELINE

GENERATOR 

STATUS FACILITY TYPE

AVERAGE 

NUMBER 

OF BEDS1

AVERAGE 

NUMBER OF 

NURSES2

ANNUAL COST 

OF NURSE 

TRAINING

SQG All Hospitals 1073 179 $3,902

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. The 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 represents 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 type. For reverse distributors, the training costs under these 

options are expected to be the same as the training costs incurred under the More 

Stringent Option. For healthcare facilities, the Proposed and Less Stringent Options, as 

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 delivered in five minutes. Thus, training 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 not 
77

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 LQGs 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 hazardous 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 option, 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 training 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. Based 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 under 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 must 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 

training 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 healthcare 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 be 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 to 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 these 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 annualized 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 purchase 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 CESQGs. 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 pharmaceuticals 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-volumesharps-containers.aspx?utm_source=shp&utm_medium=csc&utm_content=B1148104&utm_campaign=medicalsupplies&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, because 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 disposal more frequently. The number of 

drums needed by facilities under the More Stringent Option may therefore be slightly 

higher than under the Proposed Option for some facilities.83 For example, SQG hospitals 

are specifically estimated to generate six partially 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 FACILITY FOR THE MANAGEMENT OF HAZARDOUS WASTE

PHARMACEUTICALS, 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 83
81

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 may 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. Facilities 

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 LABELING

GENERATOR 

STATUS LOCATION

ESTIMATED 

TIME

ESTIMATED 

LABOR COST

ANNUAL COST OF 

LABELING PER FACILITY

SQG

Primary Storage Area 0.25 hours1 $12.24 Primary & Satellite 

Storage Areas Combined: 

Satellite Storage Areas 0.25 hours $24.48 1 $12.24

LQG

Primary Storage Area 1.0 hour2 $48.97 Primary & Satellite 

Storage Areas Combined: 

$73.45 Satellite Storage Areas 0.5 hours3 $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), however, 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 with 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. Similar 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, no labeling is required for containers holding potentially 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 experience 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 baseline. However, unlike the More Stringent Option, the Proposed and Less 

Stringent Options do not require labeling 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 described 

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. 

Based 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 same 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 LQGs 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 costs 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 

would 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 for 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 

CESQG 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 constant 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 distributors 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 securely 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 wastes 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 storage 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 $163 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 under 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 close 

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 closure 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 

cleaning 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 Option 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, September 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 enclosing 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/permdocket/5app_b.pdf. 
85

that are LQGs. 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 general 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 RIA 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-year 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 discounted 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 Options: 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 technician 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 labor 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 implicit 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 Harbors 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 waste 

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 

baseline. 

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 baseline 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 

requirements 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 instructions, 

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 for 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. Applying this figure to the number of GM forms completed by 

hospitals, this RIA estimates approximately 60 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 sorting 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 generated 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 Hazardous 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 activity (e.g., 

quantity generated, method of managing each hazardous waste stream, etc.).
87

forms per facility. For both reverse 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 57 of the 60 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 for 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 

forms per reporting cycle. Of these, on average, 6 GM forms were for nonpharmaceutical 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 GM 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 

distributors 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 

submissions. 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 these 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 facilities 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 this 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 approximately $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—which 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 per 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 reverse 

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 also 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, this 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. Information 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 shipments 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 approximately 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 shipments 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 manifests 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 waste 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 changes 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, February 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 truckload 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 carrier 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 

notify 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 labor 

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 assumed 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 Unit 

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, 2012
91

transportation costs incurred by these facilities. These potential cost savings are assessed

in Chapter 4.

EXHIBIT 3-7. UNIT TRANSPORTATION COSTS (YEAR 2011$)

TRANSPORTATION COST1

DESTINATION

TSDF1

MEDICAL WASTE 

MANAGEMENT 

FACILITY1

MSW 

LANDFILL2

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 $31.294

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 single 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 baseline, 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 costs 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, however, 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 above 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 inflated 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, excluding 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 notification to EPA. As indicated in the notification section above, this 

cost is $53.05 per facility. This translates to an annualized cost of $5.01 over 20 years. 

Exhibit 3-9 shows the distribution of hazardous waste pharmaceuticals across these 

management 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 

facilities 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 source 

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 Risk 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 volume, 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 the 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 DISPOSAL PRACTICES (YEAR 2011$)

METHOD COST

Incineration1

 Cost to load drum: $6.16 per drum

 Cost of incineration: $2.09 per pound

MSW Disposal2  Variable cost of MSW disposal: $49.27 per ton

Sewering3

 Annualized cost of POTW Notification: $5.01 per facility

 Variable cost of sewering: $0.91 per ton

Medical Waste Disposal4  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 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 

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.
94

EXHIBIT 3-9. DISPOSAL METHOD ASSUMPTIONS (PERCENTAGE OF HAZARDOUS WASTE PHARMACEUTICALS BY MANAGEMENT METHOD)

GENERATOR TYPE 

AND SIZE FULL COMPLIANCE BASELINE PARTIAL COMPLIANCE BASELINE2

MORE STRINGENT OPTION / 

PROPOSED RULE LESS STRINGENT OPTION

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

LQG
95

Notes:

1. Under the full compliance baseline, the percentage of hazardous waste pharmaceuticals sewered is assumed to be the same as under 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/CESQG 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, 2012 and personal 

communication with John Kelsey of Clean Harbors on December 2, 2012.

3. This RIA assumes that CESQGs can manage HW pharmaceuticals 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 information).

4. For CESQGs under the full compliance baseline, this RIA assumes that pharmaceutical waste not sewered or sent to an RD is sent 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 types, pharmacy waste is assumed 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 compliance with RCRA regulations. Of this, 22.5% 

is assumed to be sewered, 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 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. As noted above, 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 MSW (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 generate 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 not generated by pharmacies) are assumed not 

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 medical waste. Thus, 21% (93% × 22.5% = 

21%) are sewered, 9% (93% × 10% = 9%) are managed as MSW, and 63% (93% × 67.5% = 63%) are managed as medical waste.

11. This RIA assumes that 20% of LQG other healthcare facilities incinerate their patient care HW pharmaceuticals, excluding nursing 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% = 18%) 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, 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 being transported to the manufacturer or a 

TSDF. Based on personal communication with Charlotte Smith of Waste Management Healthcare Solutions on January 8, 2013.

13. For the More Stringent and Proposed Options, 58 percent of patient care hazardous waste pharmaceuticals generated by CESQG HCFs (i.e., those not sent to an RD) are 

assumed to be managed as MSW (see note 3 above), and the 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 assumed to be managed as MSW. 

14. All patient 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 addition, 58 percent of patient care hazardous 

waste pharmaceuticals that are not sewered by CESQG HCFs (which excludes those going to an RD) are assumed to be managed as MSW (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 Federal 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 hazardous 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 some 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 Proposed 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 waste 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 Exhibit 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 waste 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 LQG and SQG other healthcare facilities are assumed to incinerate all of their patient 

care hazardous waste pharmaceuticals. In contrast, CESQG healthcare facilities may 

sewer their patient care hazardous waste pharmaceuticals, incinerate them, or manage 

 

118 Similar savings 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 other 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

them 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 3-10 reports 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 significant 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 significantly 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 3-10. TOTAL ANNUALIZED BASELINE COSTS AND INCREMENTAL COSTS BY 

WASTE MANAGEMENT ACTIVITY, 7 PERCENT DISCOUNT RATE 

($2011 MILLIONS)

ROW

WASTE MANAGEMENT 

ACTIVITY

TOTAL 

ANNUALIZED 

COSTS IN 

THE FULL 

COMPLIANCE

BASELINE

ANNUALIZED INCREMENTAL COSTS1

MORE

STRINGENT 

OPTION

PROPOSED 

OPTION

LESS 

STRINGENT 

OPTION

1 Notification2 $0.00 $0.07 $0.07 $0.07

2 Training $79.65 $1.53 $1.53 $1.53

3 Manifest Training $6.30 $0.23 $0.23 $0.23 

4 Contingency Plan Updating $4.91 $0.16 $0.00 $0.00 

5 Container Management $28.84 $5.31 $2.67 $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 $0.01 $0.00 $0.00 

9 Closure $4.51 $1.24 $1.21 $1.21 

10 RCRA Storage Permit $0.00 $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 Recordkeeping3 $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 $554.59 $23.45 $22.91 $21.47 

17 TOTAL $876.62 $45.71 $36.56 $34.69

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 costs 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. 

Exhibit 3-11 reports the distribution 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 13 percent of affected facilities while LQGs account for 

approximately 3 percent. The SQG healthcare facility costs also reflect the higher per-
99

facility costs of the proposed rule for these facilities relative to CESQGs (see Exhibit 3-

12). 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 incremental costs. Under the 

Less Stringent Option, there are no incremental disposal costs for CESQGs, while 

sewering is banned for SQGs.

EXHIBIT 3-11. ANNUALIZED INCREMENTAL COSTS OF PROPOSED 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 $34.69

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 these 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 LQGs 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, approximately 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 would 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 INCREMENTAL COSTS PER FACI LITY BY MODEL FACILITY, 7 

PERCENT DISCOUNT RATE ($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 $12,100 
101

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 pharmaceuticals: 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 results to this baseline assumption, this section estimates costs incremental to 

an alternative, partial compliance baseline in which many facilities are noncompliant.

 Size of the universe: The size of the affected universe of facilities, as presented 

above, 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 state 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 which 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 dependent 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 discount 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 pharmaceuticals 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 key 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 effective systems in place to 
102

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 

hazardous 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: Hazardous 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 percent 

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 waste 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 with 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-compliant 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 CESQG 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 December 2, 2012.
103

The assessment of costs under the partial compliance baseline further assumes that noncompliance is limited only to the management of hazardous waste pharmaceuticals. Most 

of the facilities 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 facilitywide generator 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 partial compliance baseline firms that are required to submit BR 

records to EPA or their authorized state agency are assumed to submit GM forms for nonpharmaceutical hazardous wastes. The 2009 BR data suggest that hospitals submitted an 

average of 6 GM forms for hazardous waste pharmaceuticals and 13 GM forms for nonpharmaceutical hazardous wastes—a total of 19 GM forms per facility. The partial 

compliance baseline assumes that non-compliant 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 baseline some hazardous waste 

pharmaceuticals may be managed as medical waste, transportation 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 involves assumptions regarding hazardous waste disposal methods. 

These assumptions themselves are earlier described in detail in Exhibit 3-9. Under the 

partial compliance baseline, methods employed for the disposal of hazardous waste 

pharmaceuticals vary more than under the full compliance baseline. Disposal methods in 

the partial compliance baseline include incineration, sewering without notification, MSW 

disposal, 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 pharmaceuticals are incinerated under the 

partial compliance baseline than the full compliance baseline, costs are generally lower. 

Although the partial compliance baseline conservatively assumes widespread noncompliance with RCRA with respect to the management 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 some, 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 cost 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 result 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 management 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 costs 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 compliance baseline than the full compliance 

baseline. Under each of the policy options, annualized 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 distributors 

for their non-pharmaceutical hazardous waste.
105

EXHIBIT 3-13. TOTAL ANNUALIZED PARTIAL COMPLIANCE BASELINE COSTS AND 

INCREMENTAL COSTS BY WASTE MANAGEMENT ACTIVITY, 7 

PERCENT DISCOUNT RATE ($2011 MILLIONS)

ROW

WASTE MANAGEMENT 

ACTIVITY

TOTAL 

ANNUALIZED 

COSTS IN 

THE PARTIAL

COMPLIANCE

BASELINE

ANNUALIZED INCREMENTAL COSTS1

MORE 

STRINGENT 

OPTION

PROPOSED 

OPTION

LESS 

STRINGENT 

OPTION

1 Notification2 $0.00 $0.07 $0.07 $0.07 

2 Training $79.65 $1.53 $1.53 $1.53 

3 Manifest Training $6.30 $0.23 $0.23 $0.23 

4 Contingency Plan Updating $4.91 $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 $94.25 $3.15 $0.05 $0.05 

8 Warehousing $0.0 $0.01 $0.00 $0.00 

9 Closure $4.51 $1.24 $1.21 $1.21 

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

11 Sorting $7.84 $24.34 $24.34 $24.30 

12 Biennial Reports $2.00 $0.31 $0.00 $0.00 

13 Recordkeeping3 $0.15 $0.01 $0.00 $0.00 

14 Manifests and Other Tracking $1.03 $0.98 $0.49 $0.49 

15 Transportation $67.84 $8.02 $6.63 $6.62 

16 Disposal $473.24 $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 costs 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. 

SENSITIVITY ANALYSIS : SIZE OF THE POTENTIALLY 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 datasets provided by two states—Massachusetts and 

Minnesota—that include complete lists of hazardous waste generators in each state and 

that also contain facility-specific information, including a unique EPA or state ID 
106

number, address, facility name, and generator status (i.e., LQG, SQG, or CESQG).129 

This RIA estimates the percentage of healthcare 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 104,500 healthcare facilities and reverse distributors 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 estimated 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 data.

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. Annualized costs are estimated to be between $30.4 and $67.6

million under the More Stringent Option and between $23.5 and $50.7 million under the 

Less Stringent Option.

 

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’ Department of Environmental 

Protection at http://www.mass.gov/eea/agencies/massdep/recycle/hazardous/hwgen.html on February 18, 2014.
107

EXHIBIT 3-14. ANNUALIZED INCREMENTAL COSTS OF PROPOSED RULE BY BASELINE GENERATOR STATUS AND FACILITY TYPE, 7 PERCENT DISCOUNT

RATE, LOW AND HIGH END UNIVERSE ESTIMATES ($2011 MILLIONS)

GENERATOR 

STATUS FACILITY TYPE

LOW END ESTIMATE 

(BASED ON MASSACHUSETTS 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 $14.6 $10.9 $10.8 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 $30.4 $24.6 $23.5 273,212 $67.6 $53.6 $50.7
108

SENSITIVITY ANALYSIS : ALTERNATIVE COST OF INCINERATION

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 readily 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 RACER 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 midpoint 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 above. 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.html.

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 3-15. ANNUALIZED INCREMENTAL COSTS OF THE PROPOSED RULE WITH

ALTERNATIVE INCINERATION 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 27

percent incremental to the full compliance baseline. Using the high-end incineration 

value, the change in costs associated with the More Stringent Option is 34 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.

SENSITIVITY 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 3-16. TOTAL ANNUALIZED BASELINE COSTS AND INCREMENTAL COSTS 

BY WASTE MANAGEMENT ACTIVITY, 3 PERCENT DISCOUNT RATE

($2011 MILLIONS)

RO

W

WASTE MANAGEMENT 

ACTIVITY

TOTAL 

ANNUALIZED 

COSTS IN 

THE FULL 

COMPLIANCE

BASELINE

ANNUALIZED INCREMENTAL COSTS1

MORE 

STRINGENT 

OPTION

PROPOSED 

OPTION

LESS 

STRINGENT 

OPTION

1 Notification2 $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 Recordkeeping3 $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 costs 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. 
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 quantities 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 available 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 data 

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 facilities” model facilities (e.g., physicians’ 

offices, veterinary clinics, nursing care facilities, etc.). 

Uncertainty regarding hazardous waste generation quantities for the regulated 

universe also presents limitations for estimating the number of potentially 

affected facilities that are LQGs, SQGs, or CESQGs. As shown in Exhibit 3-13, 

costs per facility vary significantly according to a facility’s RCRA generator 

status. This RIA may therefore overestimate or underestimate the potential 

incremental costs 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 baseline. 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 

scenarios 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 are 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 regulated facilities, this 

RIA may underestimate or overestimate the cost impacts of the rule. For 
112

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 results 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 section, 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 Options 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 approach 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 pharmaceuticals 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 reverse 

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 underestimate any cost savings associated with the rule.
113

CHAPTER 4 | BENEFITS

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, municipal 

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 related 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 risk of 

adverse human health and ecosystem impacts. The 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. There 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 this chapter focuses on water effects, and in particular, sewering for a number of 

reasons. This type of disposal 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, not pharmaceuticals.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 pharmaceuticals at healthcare facilities represents 

one of the more 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 QUANTIFIED 

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 reduced sewering 

of hazardous waste pharmaceuticals

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 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 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.

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 to 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). Estimating 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 found in 
115

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 

waste pharmaceuticals is not readily available. 

Absent the detailed data necessary for quantification of the rule’s impact on hazardous 

waste pharmaceutical releases to the environment and the associated human health and 

ecological impacts, this chapter summarizes 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 environment. 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, the 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 CHAPTER

The assessment of benefits presented in this chapter begins with a quantitative analysis of 

potential cost savings associated with the proposed rule. The chapter then presents an 

assessment of the proposed rule’s impact on the quantity of hazardous waste 

pharmaceuticals sewered by healthcare facilities. Following this analysis, the 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 

opportunities associated with improvements in water quality. After reviewing this 

literature, the chapter concludes with a discussion of other potential benefits that may 

result from the rule.

POTENTIAL COST SAVINGS

The 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 change 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. The 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 

formal 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 AND LESS STRINGENT OPTIONS

GENERATOR 

STATUS FACILITY TYPE

AVERAGE 

NUMBER 

OF BEDS1

AVERAGE 

NUMBER OF 

NURSES2

ANNUAL 

COST OF 

NURSE 

TRAINING

(BASELINE)

ANNUAL 

COST OF 

NURSE 

TRAINING

(PROPOSED 

AND LESS 

STRINGENT 

OPTIONS)

ANNUAL 

COST 

SAVINGS

PER 

FACILITY

SQG All Hospitals 1073 179 $3,902 $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 MANAGEMENT

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 RCRA accumulation time limits. Therefore, longer accumulation 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 described in Chapter 3, under the Proposed and Less Stringent Options no 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 facilities 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. Labeling is also not 

required for hazardous waste pharmaceuticals shipped from one reverse distributor to 

another.135 Due to this rule provision, this RIA estimates that per facility labeling costs 

for reverse distributors are 65 percent less under the Proposed and Less Stringent Options 

than the 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 OPTIONS)

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, based 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 baseline. Similarly, the data presented in Chapter 3 indicate that 

LQG reverse distributors submit an estimated three GM forms per facility rather than 60, 

and other healthcare 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 are 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 SAVINGS OF BIENNIAL REPO RTING UNDER THE 

PROPOSED AND LESS STRINGENT OPTIONS

GENERATOR 

STATUS FACILITY TYPE

NUMBER OF 

GM FORMS 

(BASELINE)

NUMBER OF GM 

FORMS (PROPOSED 

AND LESS 

STRINGENT 

OPTIONS)

ANNUALIZED 

COST SAVINGS

PER FACILITY

SQG1 Hospitals 8 6 $4

SQG1 Other Healthcare 

Facilities 8 6 $3

SQG1 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, reflecting 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. Exhibit 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 UNDER THE 

PROPOSED AND LESS STRINGENT OPTIONS

GENERATOR 

STATUS FACILITY TYPE ANNUAL COST SAVINGS

SQG Hospitals $5

SQG Other Healthcare 

Facilities $5

LQG Hospitals $5

LQG Other Healthcare 

Facilities $5
119

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 healthcare 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 SAVINGS OF MANIFESTS UNDER THE 

PROPOSED AND LESS STRINGENT 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 ASSOCIATED 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 Options). 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 

likely 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, this 

would result in a cost savings of $31 for transportation and $14 for disposal per facility 

for reverse distributors that experience a change in their generator status from SQG-toCESQG, 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 other 
120

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 effects 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 environment 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 pharmaceuticals 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 Proposed 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. 

Assessment 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 baseline, 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 available. 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 approach, 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 facilities 
121

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 baseline, 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 this 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, the percentage of hazardous waste pharmaceuticals 

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 distributor 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 no 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 CESQGs138, 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

6,440 tons of hazardous waste pharmaceuticals are sewered annually. This figure 

represents 18 percent of the total amount of hazardous waste pharmaceuticals generated 

annually (36,200 tons), as estimated in Chapter 2. The estimates 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 than 80 percent of the hazardous waste pharmaceuticals generated by 

facilities affected by the rule.

EXHIBIT 4-7. ESTIMATED AMOUNT OF HAZARDOUS WASTE 

PHARMACEUTICALS SEWERED IN THE BASELINE ON 

AN ANNUAL BASIS (TONS)

BASELINE 

GENERATOR 

STATUS FACILITY TYPE

AMOUNT SEWERED IN THE 

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 6,440

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 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.
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 presents 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 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. 

EXHIBIT 4-8. ANNUAL REDUCTION IN THE SEWERING OF HAZARDOUS WASTE 

PHARMACEUTICALS, INCREMENTAL 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 6,440 6,440 5,210

Notes:

Totals 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 6,440 tons of hazardous waste pharmaceuticals from being sewered under 

the Proposed and More Stringent Options (and approximately 5,210 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, to 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 distribution of wastes and disposal 

methods provided by waste management firms as described in Exhibit 4-9. 

EXHIBIT 4-9. KEY ASSUMPTIONS FOR MONETIZING BENEFITS OF AVOIDED WASTEWATER 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 3,000mL5

Average dose strength of tablets/capsules based on 

correspondence 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 represents an average of estimates ranging from 20% to 30% (for the percentage of tablets/capsules that are 

sewered).

4. This chapter estimates that 6,440 tons of waste pharmaceuticals are sewered (18% of 36,200 tons) each year. It 

further estimates that 25% of tablet/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, (6,440 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 discarded 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 gallons (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/capsules 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 pharmaceuticals. 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.

The potential cost savings of avoided wastewater treatment is dependent on the number 

of doses sewered and the amount of water sewered with each dose, as follows:

Gallons sewered = D × G

where: D = number of doses sewered; and 

G = gallons of water sewered with each dose

Variable D in the equation above will depend on the total volume of patient care 

pharmaceuticals 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 60 million

doses of liquid hazardous waste pharmaceuticals and more than 510 million doses of 

tablets/capsules 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 waste 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, the 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/capsules 

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 personal 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 wastewater contaminated with hazardous 

waste pharmaceuticals from healthcare facilities will no longer be sent to POTWs.

Based on this information, Exhibit 4-10 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.

EXHIBIT 4-10: ANNUAL COST SAVINGS ASSOCIATED WITH AVOIDED WASTEWATER TREATMENT ($2011)

GENERATOR 

STATUS

[A]

FACILITY TYPE

[B]

ESTABLISHMENTS

[C]

TONS OF WASTE 

SEWERED 

(TABLETS/CAPSULES)

[D]

GALLONS 

OF WATER 

USED1

[E]

POTW WASTEWATER 

TREATMENT 

COSTS2

[F]

TOTAL COST 

SAVINGS3

[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 rounded 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 rounded 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 implicit price deflator.
127

Based on the costs reported in Exhibit 4-10, this chapter estimates that the rule may result 

in annual cost savings for avoided wastewater treatment of approximately $4.3 million 

under the Proposed 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 SQGs (primarily other healthcare facilities), 36 percent of cost savings 

are experienced by LQGs, and 19 percent of cost savings are experienced by CESQGs.

Therefore, due to the sewer ban, EPA estimates that each year approximately 1.13 billion 

gallons of wastewater contaminated with hazardous waste pharmaceuticals 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 

Stringent Options (and $3.5 million under the Less Stringent Option). 

SUMMARY OF COST SAVINGS

Exhibit 4-11 summarizes the estimated cost savings associated with the additional 

flexibility provided to healthcare facilities and reverse distributors under the proposed 

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 groups 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 wastewater 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 healthcare 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 would 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 INCREMENTAL 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 INCREMENTAL COST 

SAVINGS1

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 $28.84 $0.00 $0.15 $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 $4.51 $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 $554.59 $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 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 $0.02 $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 WATERS AND DRINKING WATER

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 magnitude 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, low 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 drugs, 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 steroids, 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 comprehensive 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 summarized 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 

Association Research Foundation. 2008.
130

period.150 Exhibit 4-13 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 organic 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 4-13. LOCATION OF STREAMS SAMPLED IN USGS PHARMACEUTICALS 

STUDY

 

150 Kimberlee Barnes, Dana Kolpin, 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 4-14 presents the sampling results from the USGS study for the prescription and 

non-prescription drugs targeted in the analysis151. 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 cotinine (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 4-14. SUMMARY OF 2002 USGS STREAM SAMPLES FOR API s

ROW DRUG

NUMBER 

OF 

STREAMS 

SAMPLED

FREQ 

(%)

MAXIMUM 

(μg/L)

MEDIAN 

(μg/L) USE

PRESCRIPTION DRUGS1

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 DRUGS1

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, “Pharmaceuticals, 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 wastewater 
133

treatment plant (WWTP) effluent and at sites upstream and downstream from the WWTP 

effluent discharge point.152 Samples of surface water, wastewater effluent, and bed 

sediment were collected throughout Minnesota during 2009 and analyzed for selected 

APIs and other chemicals of concern. Sampling locations included surface water and 

wastewater-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 4-15 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 4-16. The study authors note, however, that many 

pharmaceutical compounds are likely to transform or degrade 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 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, 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 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
134

EXHIBIT 4-15. SUMMARY OF API CONCENTRATIONS IN SURFACE WATER 

SAMPLES ANALYZED IN USGS MINNESOTA STUDY

CHEMICAL RANGE IN DETECTED CONCENTRATIONS (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, and Biological Characteristics in Selected Streams, Minnesota—Design, 

Methods, and Data, 2009. U.S. Geological Survey, Reston, Virginia: 2011.
135

EXHIBIT 4-16. USGS SAMPLING RESULTS FOR 25 GROUND AND 49 SURFACE WATER 

SOURCES

ROW CHEMICAL

REPORTING 

LEVEL 

(μg/L)

NUMBER 

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

erythromycinH2O 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 sarafloxacin 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 antacid 
136

EXHIBIT 4-16. USGS SAMPLING RESULTS FOR 25 GROUND AND 49 SURFACE WATER 

SOURCES

ROW CHEMICAL

REPORTING 

LEVEL 

(μg/L)

NUMBER 

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 trimethoprim (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 independent researchers. 

Exhibit 4-17 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 4-17 may suggest the 

presence of hazardous 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 November 
137

EXHIBIT 4-17. WATERSHED AREAS WHERE API s ARE DETECTED

CITY (NUMBER OF APIs DETECTED IN 

WATERSHED) EXAMPLES OF PHARMACEUTICALS FOUND IN WATERSHED

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, California (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, sulfamethoxazole 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-SS1048-

2010.pdf
138

EXHIBIT 4-17. WATERSHED AREAS WHERE API s ARE DETECTED

CITY (NUMBER OF APIs DETECTED IN 

WATERSHED) EXAMPLES OF PHARMACEUTICALS FOUND IN WATERSHED

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/interactives/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 present 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, ibuprofen, 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 wastewater 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 their 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 Publishing.

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.pdf
139

worth noting 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 

significant 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 database 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 includes 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 nonpermanent subunit of a full-scale system), and full-scale (a fully-functioning, permanent 

treatment system) wastewater treatment systems. Exhibit 4-18 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 

phosphorus 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 different 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 personal care products; (6) steroids and hormones; 

and (7) other.
140

EXHIBIT 4-18. SUMMARY OF SELECT PHARMACEUTICAL REMOVAL EFFICIENCY VALUES FROM EPA CONTAMINANTS OF EMERGING 

CONCERN DATABASE (PERCENT 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 - - - -

14 Chloramphenicol 94 96 95 2 - - - -

15 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-H2O 6 92 31 5 25 25 25 1
141

EXHIBIT 4-18. SUMMARY OF SELECT PHARMACEUTICAL REMOVAL EFFICIENCY VALUES FROM EPA CONTAMINANTS OF EMERGING 

CONCERN DATABASE (PERCENT 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 1
142

EXHIBIT 4-18. SUMMARY OF SELECT PHARMACEUTICAL REMOVAL EFFICIENCY VALUES FROM EPA CONTAMINANTS OF EMERGING 

CONCERN DATABASE (PERCENT 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 - - - -

50 Tetracycline 33 85 66 3 - - - -

51 Thymol >78 >91 85 2 - - - -

52 Trimethoprim 8.5 100 60 10 69 69 69 1

53 Valproic acid >99 >99 99 1 >99 >99 99 1
143

(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 where data 

were available. As indicated in the exhibit, removal efficiencies vary significantly 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. Exhibit 

4-19 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 concentrations similar to 

influent samples. 

The findings summarized in Exhibit 4-19 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. Washington, D.C.
144

EXHIBIT 4-19. COMPARISON OF PPCPS DETECTED IN POTW INFLUENT AND EFFLUENT

DETECTED IN AT LEAST

ONE INFLUENT SAMPLE 

AND NO EFFLUENT 

SAMPLES

QUANTIFIED IN AT LEAST ONE INFLUENT SAMPLE AND

ONE OR MORE EFFLUENT

SAMPLES AT CONCENTRATIONS 

AT LEAST ONE ORDER OF 

MAGNITUDE LESS THAN AT 

LEAST ONE INFLUENT SAMPLE

ONE OR MORE EFFLUENT AT 

CONCENTRATIONS SIMILAR 

TO INFLUENT SAMPLES

Antibiotics 4-Epitetracycline (ETC) 

Minocycline1

Sulfamerazine 

Sulfathiazole 

Cloxacillin1

Penicillin V1

Virginiamycin1

Doxycycline 

Sulfamethoxazole 

Ciprofloxacin 

Clarithromycin 

Erythromycin-Total 

Ofloxacin

Chlorotetracycline (CTC) 

Tetracycline (TC) 

Sulfadiazine 

Trimethoprim

Other PPCPs Acetaminophen 

Caffeine 

Miconazole

Ibuprofen 

Triclosan 

Warfarin1

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 of 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 AND THE EFFECTS ON FI SH AND ANIMAL POPULATIONS

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 

APIs 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 

biological activity of these compounds. Aquatic pollution is particularly troublesome 

because aquatic organisms are captive to continual life-cycle, 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

The possibility for continual but undetectable 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 adaptation 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-perbillion 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 

persistent, 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 therapeutic 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 

most 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) in 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 to 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 

continued 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 macroinvertebrate diversity indexes and aquatic macroinvertebrate 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 Disruption 

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 synthetic 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 sewage 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. Furthermore, 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. These 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 aquatic 

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 most toxic 

members of each of these classes tested were lomefloxacin, sulfamethoxazole, and 

chlortetracycline, 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 untreated 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-1in 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; 104:8897–890.

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.

2004, 66, 207-222.

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 containing 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 are 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 

simultaneously, 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 vegetables 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 section. Studies 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. Based 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), 

duloxetine (an anti-depressant), and olanzapine (an anti-psychotic, 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 intakes 

(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 macroinvertebrate 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 the

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-flow 

conditions.173 

Using a quantitative pharmaceutical risk assessment (QPhRA) framework174, Kumar et al. 

(2010) examined the health risks associated with accidental exposures to meprobamate, 

carbamazepine, and phenytoin through stream water, fish consumption, 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 acceptable 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 three 

neuropharmaceutical compounds in surface waters. Regulatory Toxicology and Pharmacology. 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 

exposed to pharmaceuticals from contaminated environmental media. It primarily involves four major steps: (1) hazard 

identification, (2) exposure assessment, (3) dose-response relationship, and (4) risk characterization. (See Kumar, Chang, 

and Xagoraraki (2010)). 

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, paroxetine 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 surface 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 concentrations 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 Modelling: Application of PhATETM and GREAT-ER to 
149

assumptions 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 from 7x10-2to 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 

drinking 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 Criteria 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 nature 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 study 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 University 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 environment - Sources, fate, effects and risks, 3rd 

Ed.; 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 Drinking Water. Awwa Research 

Foundation. 2008.
150

beverages and consumption of other compounds present in food (such as aflatoxin, a 

fungal toxin; or caffeic acid, coumarin, and d-limonese, all natural pesticides).

While the studies summarized above suggest that exposure to many APIs in surface water 

or drinking water does not represent 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 

examples of antibiotic 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 documented 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 (pharmaceuticals and personal care products) 

including, decreased fecundity and increased incidence 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 Centers 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

PRESENCE OF API s IN THE FOOD SUPPLY

Another source of indirect exposure to APIs is through our food supply. Malchi et al

(2014)186 aimed 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 toxicological 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, & Soil Pollution 2013, 224(11):1-29; doi:10.1007/s11270-013-1770-3.

185 Centers for Disease Control and Prevention, as cited in Interagency 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_antiboticresistant_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 through an examination of API exposure factors and the current methods used 

to understand the connection between exposure and effects thresholds.

187 In doing so, the 

authors highlight the apparent knowledge gap on the relationship 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, human 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 values. While a few 

models have been developed, the 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 RELATED TO ENHANCED RECREATIONAL OPPORTUNITIES

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 revealed 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: Environmental 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/APIsaquaticbiota.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)00023-3
152

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 ranged from $0.09 to $5.16 per trip, per individual.

Carson & Mitchell (2010) sought to quantify the national benefits resulting from 

freshwater pollution control.190 Through a contingent evaluation survey, 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 improvements to the lake versus low quality 

improvements, $425 per visitor compared to $85 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 improvements, 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 on 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 Improvements 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.x
153

of improving a limited number of lakes to a high level of water quality exceed the 

benefits from more modest improvements to all impaired lakes. 

OTHER POTENTIAL BENEFITS 

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 clarity 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 regulations 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 facilities generating hazardous waste 

pharmaceuticals and (2) ensuring that healthcare facility employees receive the 

information and training necessary to manage these wastes in a manner that is protective 

of human health and the environment. Together, these 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 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 wastes 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 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

SENSITIVITY 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 non-compliance in the 

management of hazardous waste pharmaceuticals. More specifically, the partial 

compliance baseline assumes that non-compliant facilities manage their hazardous waste 

pharmaceuticals in three ways: sewer disposal (without notifying their local POTW), 

disposal 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 suggests 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 patient 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 generator 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 

between 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 and 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 

pharmaceuticals 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 

personal 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 personal 

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 disposal, 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 waste) 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 CESQG Other Healthcare Facilities: Other than the 7 percent of 

hazardous waste pharmaceuticals generated by pharmacies199, 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 compliance 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 that 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 REGARDING THE MANAGEMENT OF HAZARDOUS WASTE PHARMACEUTICALS UNDER THE BASELINE

FACILITY TYPE

PARTIAL COMPLIANCE BASELINE

LQGs SQGs CESQGs

Reverse 

Distributors

 No sewering for LQG, SQG, or CESQG reverse distributors.

Hospitals

 Hazardous waste pharmaceuticals from hospital pharmacy not sewered.

 80 percent1 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 regulated 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 sewered.

 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 waste 

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 percent1 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 

 Pharmacies 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 are assumed sewer, 10 

percent manage their hazardous waste pharmaceuticals as MSW, and 67 percent 

manage it as medical waste.2

FACILITY TYPE FULL COMPLIANCE BASELINE

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 REGARDING THE MANAGEMENT OF HAZARDOUS WASTE PHARMACEUTICALS UNDER THE BASELINE

Notes:

1. Based on personal communication with Selin Hoboy, Stericycle, August 6, 2012 and personal communication with Phil Retallick and John Kelsey of 

Clean Harbors, April 16, 2012. 

2. Based on personal communication with Charlotte Smith, Waste Management Healthcare Solutions, December 5, 2012 and personal communication 

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 applied 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 baseline.

EXHIBIT 4-21. ANNUALIZED PARTIAL COMPLIANCE BASELINE COSTS AND 

INCREMENTAL COST SAVINGS OF PROPOSED RULE BY WASTE 

MANAGEMENT ACTIVITY, 7 PERCENT DISCOUNT RATE ($2011 

MILLIONS)

ROW

WASTE MANAGEMENT 

ACTIVITY

TOTAL 

ANNUALIZED 

COSTS IN 

THE 

PARTIAL

COMPLIANCE

BASELINE

ANNUALIZED INCREMENTAL COST 

SAVINGS1

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 impacts presented 

above in Exhibit 4-10 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 

would 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 4-22 shows the estimated 

amount of hazardous 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 4-22 suggest that other healthcare facilities (e.g., 

physicians’ offices) 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 percent of the hazardous waste pharmaceuticals generated in the U.S. 

(excluding waste generated by households).

EXHIBIT 4-22. MANAGEMENT OF HAZARDOUS WASTE PHARMACEUTICALS AS MSW OR 

MEDICAL WASTE UNDER THE PARTIAL COMPLIANCE BASELINE

BASELINE 

GENERATOR 

STATUS FACILITY TYPE

MSW DISPOSAL 

QUANTITY 

(TONS/YR)

MEDICAL WASTE DISPOSAL 

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 POTENTIALLY 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 potentially affected universe. 

Exhibit 4-23 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 regulatory 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 due to the fact that the most significant cost 

savings are experienced by hospitals, 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. Therefore, while the 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 4-23. ANNUALIZED COST SAVINGS OF PROPOSED RULE BY BASELINE GENERATOR STATUS AND FACILITY TYPE, 7 PERCENT DISCOUNT RATE, 

LOW AND HIGH END UNIVERSE ESTIMATES ($2011 MILLIONS)

GENERATOR 

STATUS FACILITY TYPE

LOW END ESTIMATE 

(BASED ON MASSACHUSETTS 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 $7.03 $7.06 2,397 $0.17 $7.02 $7.04

LQG Hospitals 1,553 $0.67 $13.34 $13.34 1,553 $0.62 $13.29 $13.29

CESQG Other Healthcare Facilities 83,495 $0.49 $0.49 $0.00 227,433 $1.24 $1.24 $0.00 

SQG Other Healthcare Facilities 12,223 $1.07 $1.17 $1.17 33,295 $2.68 $2.96 $2.96

LQG Other Healthcare Facilities 2,174 $0.56 $0.71 $0.71 5,923 $1.40 $1.81 $1.81

CESQG Reverse Distributors 21 $0.00 $0.00 $0.00 21 $0.00 $0.00 $0.00 

SQG Reverse Distributors 7 $0.00 $0.0006 $0.0006 7 $0.00 $0.0006 $0.0006

LQG Reverse Distributors 28 $0.00 $0.05 $0.05 28 $0.00 $0.05 $0.05 

TOTAL 104,453 $2.99 $22.81 $22.33 273,212 $6.12 $26.39 $25.17
162

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 savings of the rule 

based on an alternative discount rate of three percent. Exhibit 4-24 reports the results of 

this sensitivity analysis. These results are almost identical to those presented above based 

on a seven percent discount rate. This 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 SAVINGS

OF PROPOSED RULE BY WASTE MANAGEMENT ACTIVITY, 3

PERCENT DISCOUNT RATE ($2011 MILLIONS)

ROW

WASTE MANAGEMENT 

ACTIVITY

TOTAL 

ANNUALIZED 

COSTS IN 

THE FULL 

COMPLIANCE

BASELINE

ANNUALIZED INCREMENTAL COST 

SAVINGS1

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 | SUMMARY OF REGULATORY BENEFITS & 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, focusing solely on these or other costbenefit 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 drinking water supplies.

Exhibit 5-1 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 the 

proposed rule are presented as negative. These 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 exhibit underestimate the net benefits associated with 

individual provisions of the proposed rule. 
164

EXHIBIT 5-1. NET BENEFITS OF THE PROPOSED RULE BY WASTE MANAGEMENT ACTVITIY, 7 PERCENT DISCOUNT RATE ($2011 MILLIONS )

ROW

WASTE 

MANAGEMENT 

ACTIVITY

TOTAL 

ANNUALIZED 

COSTS IN 

THE FULL 

COMPLIANCE

BASELINE

INCREMENTAL COSTS AND BENEFITS

MORE STRINGENT OPTION PROPOSED OPTION LESS STRINGENT OPTION

ANNUALIZED 

COSTS

ANNUALIZED 

BENEFITS1

NET 

BENEFITS

ANNUALIZED 

COSTS

ANNUALIZED 

BENEFITS1

NET 

BENEFITS

ANNUALIZED 

COSTS

ANNUALIZED 

BENEFITS1

NET 

BENEFITS

1 Notification $0.00 $0.07 

Not 

Monetized

($0.07) $0.07 $0.00 ($0.07) $0.07 $0.00 ($0.07)

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 ($12.27) $34.69 $23.50 ($11.19)

Notes:

1. Several 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 CONSIDERATIONS AND OTHER IMPACTS

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 rule;

 Regulatory flexibility: focuses on the potential effects of the proposed rule on 

small entities; 

 Employment impacts: assesses the potential impact of the proposed rule on 

employment; 

 Unfunded mandates: examines the implications of the proposed rule with 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 “significant” 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 million 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 otherwise 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 issues 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 response 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 the $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 calling 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. This RIA 

also estimates that the proposed rule will lead to the diversion of approximately 6,400 

tons of hazardous waste pharmaceuticals from sewer disposal to hazardous 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 rule include 

safer management practices of hazardous wastes more generally and clearer information 

about safe disposal requirements.

REGULATORY FLEXIBILITY

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 analysis 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, assessment 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 

the 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 tallied 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 revenues 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 SBA 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 

distributed 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 small 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 2007 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 (exkidney 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 Chapter 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 sum 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 Agency 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 Steps 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. Small 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, incremental 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 dollars, 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 POTENTIAL IMPACTS TO SMALL ENTITIES USING A 7

PERCENT DISCOUNT RATE

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 ANALYSIS 

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, welfare, 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 

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. 

 

206 Sources: 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 the Environment: An Industry-Level Perspective.” Journal of Environmental Economics and Management, 

Vol. 43, no. 3, pp. 412-436.
172

Employment 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 flexibility 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 healthcare 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 ANALYSIS

Among its other purposes and federal agency rulemaking requirements, the Unfunded 

Mandates Reform Act (UMRA) requires federal agencies, unless otherwise 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 assessment 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 compliance 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 with 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 

state/local/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 expenditures exceeding $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 

implications 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 

among 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 expenditures 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 UMRA 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 governments.

EXHIBIT 6-3. HOSPITALS AND CORONERS’ OFFICES/MEDICAL EXAMINERS’ 

OWNED AND OPERATED BY STATE AND LOCAL GOVERNMENT

FACILITY TYPE LQGS SQGS CESQGS TOTAL

Hospitals1 3252 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/countyowned 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 details.

Sources: Hospital estimates derived from percent of hospitals owned by state and local 

governments, as reported in American Hospital Directory, accessed 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 Option, 

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 governments 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 Executive 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 medical 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 FOR HOSPITALS AND CORONERS’ 

OFFICES/MEDICAL EXAMINERS' OWNED AND OPERATED BY STATE 

AND LOCAL GOVERNMENT USING A 7 PERCENT DI SCOUNT RATE

(MILLIONS OF YEAR 2011$)

FACILITY TYPE

MORE 

STRINGENT 

OPTION

PROPOSED 

OPTION

LESS 

STRINGENT 

OPTION

Annual Costs Incremental to Full Compliance Baseline

Hospitals $1.65 $1.59 $1.56

Coroners’ Offices and Medical Examiners $0.77 $0.59 $0.58

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 effect 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 ANALYSIS

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 policies 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 tribally 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 facilities 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 (IHS), 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.

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 tribally 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 FACILITIES OWNED AND OPERATED 

BY NATIVE AMERICAN TRIBES USING A 7 PERCENT DISCOUNT RATE

(MILLIONS OF YEAR 2011$)

FACILITY TYPE

NUMBER OF 

FACILITIES1

MORE STRINGENT 

OPTION

PROPOSED 

OPTION

LESS STRINGENT 

OPTION

Total Annual Costs Incremental to Full Compliance Baseline

Hospitals 16 $0.019 $0.019 $0.018

Tribal Operated 

Facilities 16

Health Centers 258 $0.113 $0.088 $0.083

Alaska Village Clinics 164

Health Stations 75

TOTAL 529 $0.133 $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 executive order,

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, with annual costs of approximately $36.5 million (based on a discount rate of 7 

percent), the costs of this proposed rule are not considered economically significant under 

Executive Order 12866. As such, the rule is not subject 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. 

Because the changes in energy production and consumption under the rule are likely to be 
177

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 regarding 

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 pharmaceuticals 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 

prohibits 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 combustion 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 characteristics 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 below. 

 

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 manufacturing 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 

onsite rather than waste generated by other facilities. These combustion facilities that mostly burn waste generated onsite 

are not included in this analysis.
178

METHODOLOGY FOR ASSESSING ENVIRONMENTAL JUSTICE IMPACTS

The demographic analysis presented in this section focuses on populations near (1) nonagricultural 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 located 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 hazardous 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 facility 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 containing 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 onemile and three-mile radius of each hazardous waste combustion 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 wastewater treatment plants. This analysis 

considers populations 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 typically encompass 

larger populations overall.

This 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, accessed 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 estimates the percent of the population below 

the poverty line and the percent characterized as racial or ethnic 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 lowincome individuals living within one mile of wastewater treatment plants does not count 

the household twice.

RESULTS OF DEMOGRAPHIC ANALYSIS

The demographic characteristics of populations near wastewater treatment plants and 

hazardous waste combustion facilities are compared below, separately, to both the nationwide 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 onemile 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 points. 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 populations within one mile of each plant. The catchment areas for 

these plants encompass approximately 44.2 million local 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 within a one mile radius). In addition, 2.2 million inhabitants, or 4.9 

percent of the catchment populations, live below the Federal Poverty Level, compared 

with 11.4 percent nationally. Focusing on individual catchment areas, minority groups’ 

share of the 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 & COMMERCIAL HAZARDOUS WASTE COMBUSTION FACILITIES

GEOGRAPHIC AREA

MINORITY 

POPULATION

LOW-INCOME 

POPULATION

% OF NATIONAL POPULATION

RACIAL & ETHNIC 

MINORITIES

LOW-INCOME 

POPULATION

Wastewater treatment plants, 

one-mile radius

6.2 million

(22.6%)1

3.8 million

(14.0%)1

24.7% 11.4%

Wastewater treatment plants,

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

GEOGRAPHIC AREA

NO. OF FACILITIES EXCEEDING:

NATIONAL AVG. MINORITY PCT.

NATIONAL AVG. 

LOW-INCOME PCT.

Wastewater treatment plants,

one-mile radius 3,233 7,886

Wastewater treatment plants

catchment areas 3,151 7,358

Hazardous waste combustion 

facilities, one-mile radius 6 4

Hazardous waste combustion 

facilities, three-mile radius 7 4

GEOGRAPHIC AREA

NO. OF FACILITIES EXCEEDING:

STATE AVG. MINORITY PCT. STATE AVG. LOW-INCOME PCT.

Wastewater treatment plants,

one-mile radius 3,596 7,949

Wastewater treatment plants,

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-mile 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 points 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 onemile zone for six facilities. Similarly, four combustion facilities are located in areas 

where low-income individuals 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 where 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 combustion 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 onemile 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 percentage 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 catchment 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. Lowincome 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 OPTIONS 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 

minority and low-income populations in close proximity to or downstream from 

wastewater treatment plants. The diversion of hazardous waste pharmaceuticals to 
183

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 that, 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 of 

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 not 

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 demographic 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, pursue 

recreational opportunities, etc.) may also be affected by changes in the sewering or 

combustion of hazardous waste pharmaceuticals. 

CHILDREN’S HEALTH PROTECTION 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 potentially 

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 12866.

To examine whether the proposed rule has 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

Within 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 hazardous 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 facilities 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 share 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 buffer 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 than 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 is 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 

within 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, onemile radius7.8 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 FACILITIES WHERE CHILDREN’S SHARE OF THE 

LOCAL POPULATION EXCEEDS NATIONAL AVG. %

Wastewater treatment plants, onemile 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 FACILITIES WHERE CHILDREN’S SHARE OF THE 

LOCAL POPULATION EXCEEDS STATE AVG. %

Wastewater treatment plants, onemile 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.

JOINT IMPACTS OF RULES

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 waste 

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 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.