Vol. 80 Friday, 

No. 186 September 25, 2015 

Part III 

Environmental Protection Agency 

40 CFR Parts 261, 262, 266, et al. 

Management Standards for Hazardous Waste Pharmaceuticals; Proposed 

Rule 


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58014 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 261, 262, 266, 268, and 

273 

[EPA–HQ–RCRA–2007–0932; FRL–9924–08– 

OSWER] 

RIN 2050–AG39 

Management Standards for Hazardous 

Waste Pharmaceuticals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: Some pharmaceuticals are 

regulated as hazardous waste under the 

Resource Conservation and Recovery 

Act (RCRA) when discarded. Healthcare 

facilities that generate hazardous waste 

pharmaceuticals as well as associated 

facilities have reported difficulties 

complying with the Subtitle C 

hazardous waste regulations for a 

number of reasons. First, healthcare 

workers, whose primary focus is to 

provide care for patients, are not 

knowledgeable about the RCRA 

hazardous waste regulations, but are 

often involved in the implementation of 

the regulations. Second, a healthcare 

facility can have thousands of items in 

its formulary, making it difficult to 

ascertain which ones are hazardous 

wastes when disposed. Third, some 

active pharmaceutical ingredients are 

listed as acute hazardous wastes, which 

are regulated in small amounts. To 

facilitate compliance and to respond to 

these concerns, the U.S. Environmental 

Protection Agency (EPA or the Agency) 

is proposing to revise the regulations to 

improve the management and disposal 

of hazardous waste pharmaceuticals and 

tailor them to address the specific issues 

that hospitals, pharmacies and other 

healthcare-related facilities face. The 

revisions are also intended to clarify the 

regulation of the reverse distribution 

mechanism used by healthcare facilities 

for the management of unused and/or 

expired pharmaceuticals. 

DATES: Comments must be received on 

or before November 24, 2015. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

RCRA–2007–0932, to the Federal 

eRulemaking Portal: http://

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Once submitted, comments cannot be 

edited or withdrawn. The EPA may 

publish any comment received to its 

public docket. Do not submit 

electronically any information you 

consider to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Multimedia submissions (audio, video, 

etc.) must be accompanied by a written 

comment. The written comment is 

considered the official comment and 

should include discussion of all points 

you wish to make. The EPA will 

generally not consider comments or 

comment contents located outside of the 

primary submission (i.e. on the web, 

cloud, or other file sharing system). For 

additional submission methods, the full 

EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Kristin Fitzgerald, Office of Resource 

Conservation and Recovery (5304P), 

Environmental Protection Agency, 1200 

Pennsylvania Avenue NW., Washington, 

DC 20460; telephone number: 703–308– 

8286; email address: fitzgerald.kristin@

epa.gov or Josh Smeraldi, Office of 

Resource Conservation and Recovery 

(5304P), Environmental Protection 

Agency, 1200 Pennsylvania Avenue 

NW., Washington, DC 20460; telephone 

number: 703–308–0441; email address: 

smeraldi.josh@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

Does this action apply to me? 

This is a proposed rule. If finalized, 

this rule would apply to healthcare 

facilities, pharmaceutical reverse 

distributors, and owners or operators of 

treatment, storage, and disposal 

facilities engaged in the management of 

hazardous waste pharmaceuticals. The 

list of NAICS codes for the potentially 

affected entities, other than RCRA 

treatment, storage and disposal facilities 

(TSDFs), are presented in Table 1. More 

detailed information on the potentially 

affected entities is presented in Section 

V.A and Section V.B.1 of this preamble. 

TABLE 1—NAICS CODES OF ENTITIES POTENTIALLY AFFECTED BY THIS FINAL RULE—HEALTHCARE FACILITIES AND

PHARMACEUTICAL REVERSE DISTRIBUTORS

NAICS codes Description of NAICS code 

44611 .............................................. Pharmacies. 

54194 .............................................. Veterinary Clinics. 

6211 ................................................ Physicians’ Offices. 

6212 ................................................ Dentists’ Offices. 

6213 ................................................ Other Health Practitioners (e.g., chiropractors). 

6214 ................................................ Outpatient Care Centers. 

6219 ................................................ Other Ambulatory Health Care Services. 

622 .................................................. Hospitals. 

6231 ................................................ Nursing Care Facilities (e.g., assisted living facilities, nursing homes, U.S. veterans domiciliary centers). 

623311 ............................................ Continuing Care Retirement Communities (e.g., assisted living facilities with on-site nursing facilities). 

Subset of 92219 .............................. Medical Examiners and Coroners’ Offices. 

Various NAICS ................................ Pharmaceutical Reverse Distributors. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities potentially 

impacted by this action. This table lists 

examples of the types of entities of 

which EPA is aware that could 

potentially be affected by this action. 

Other types of entities not listed could 

also be affected. To determine whether 

your entity, company, business, 

organization, etc. is affected by this 

action, you should examine the 

applicability criteria in this rule. If you 

have questions regarding the 

applicability of this action to a 

particular entity, consult the person 

listed in the preceding FOR FURTHER

INFORMATION CONTACT section of this 

document. 

Preamble Outline 

I. Statutory Authority 

II. List of Abbreviations and Acronyms 

III. Summary of the Proposed Rule 

IV. Background 


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A. What is the history of hazardous waste 

pharmaceutical management under 

RCRA? 

B. What are the rationale and goals for this 

proposed rule? 

C. What was the 2008 pharmaceutical 

universal waste proposal? 

D. EPA’s Office of Inspector General Report 

V. Detailed Discussion of the Proposed Rule 

A. What terms are defined in this proposed 

rule? 

B. What is the scope of this proposed rule? 

C. What are the proposed standards for 

healthcare facilities that manage noncreditable hazardous waste 

pharmaceuticals? 

D. How does this proposed rule address 

healthcare facilities that accumulate 

potentially creditable hazardous waste 

pharmaceuticals prior to shipment to 

pharmaceutical reverse distributors? 

E. What are the proposed novel 

prohibitions, exemptions and other 

unique management requirements for 

hazardous waste pharmaceuticals? 

F. What are the proposed standards for 

shipping hazardous waste 

pharmaceuticals? 

G. What are the proposed standards for 

pharmaceutical reverse distributors? 

VI. Implementation and Enforcement 

A. Healthcare Facilities 

B. Pharmaceutical Reverse Distributors 

C. Healthcare Facilities and 

Pharmaceutical Reverse Distributors 

Managing Non-Pharmaceutical 

Hazardous Waste in Accordance With 40 

CFR Part 262 or Part 273 

D. State Enforcement Activities and 

Interpretations 

VII. Request for Comment on EPA’s Efforts 

To Identify Additional Pharmaceuticals 

as Hazardous Wastes 

VIII. Request for Comment on EPA’s Efforts 

To Amend the Acute Hazardous Waste 

Listing for Nicotine and Salts (Hazardous 

Waste No. P075) 

A. Background 

B. Basis for Original Listing 

C. Rationale for EPA’s Efforts To Amend 

the P075 Listing 

D. Two Possible Approaches for Amending 

the P075 Listing 

E. Request for Comments 

IX. State Authorization 

A. Applicability of Rules in Authorized 

States 

B. Effect on State Authorization 

C. Effect on State Authorization in States 

That Have Added Pharmaceuticals to the 

Universal Waste Program 

X. Adding and Reserving Part 266, Subpart 

O 

XI. Summary of the Regulatory Impact 

Analysis 

XII. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

B. Paperwork Reduction Act (PRA) 

C. Regulatory Flexibility Small Business 

Analysis 

D. Unfunded Mandates Reform Act 

(UMRA) 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

I. Statutory Authority 

These regulations are proposed under 

the authority of §§ 2002, 3001, 3002, 

and 3004 of the Solid Waste Disposal 

Act (SWDA) of 1970, as amended by the 

Resource Conservation and Recovery 

Act (RCRA) of 1976, as amended by the 

Hazardous and Solid Waste 

Amendments of 1984 (HSWA), 42 

U.S.C. 6921, 6922, 6923, and 6924. 

II. List of Abbreviations and Acronyms 

AARP American Association of Retired 

Persons 

AEA Atomic Energy Act 

API Active Pharmaceutical Ingredient 

BDAT Best Demonstrated Available 

Technology 

CERCLA Comprehensive Environmental 

Response, Compensation and Liability Act 

CESQG Conditionally Exempt Small 

Quantity Generator 

CFR Code of Federal Regulations 

CSA Controlled Substances Act 

CWA Clean Water Act 

DEA Drug Enforcement Administration 

DHHS Department of Health and Human 

Services 

DOE Department of Energy 

DOT Department of Transportation 

EPA Environmental Protection Agency 

EO Executive Order 

FDA U.S. Food and Drug Administration 

FR Federal Register 

HIPAA Health Insurance Portability and 

Accountability Act 

HSWA Hazardous and Solid Waste 

Amendments 

LQG Large Quantity Generator 

LQUWH Large Quantity Universal Waste 

Handler 

LTCF Long-term Care Facility 

LTCP Long-term Care Pharmacy 

MSWLF Municipal Solid Waste Landfill 

NIOSH National Institute for Occupational 

Safety and Health 

NPRM Notice of Proposed Rulemaking 

NRC Nuclear Regulatory Commission 

OIG Office of Inspector General 

OMB Office of Management and Budget 

ONDCP Office of National Drug Control 

Policy 

OSHA U.S. Department of Labor’s 

Occupational Safety and Health 

Administration 

OSWER Office of Solid Waste and 

Emergency Response 

OSWI Other Solid Waste Incinerators 

OTC Over-the-counter 

POTW Publicly Owned Treatment Works 

RCRA Resource Conservation and Recovery 

Act 

RQ Reportable Quantity 

SQG Small Quantity Generator 

SQUWH Small Quantity Universal Waste 

Handler 

SWDA Solid Waste Disposal Act 

TC Toxicity Characteristic 

TCLP Toxicity Characteristic Leaching 

Procedure 

TSDF Treatment, Storage and Disposal 

Facility 

III. Summary of the Proposed Rule 

EPA is proposing to add a subpart P 

under 40 CFR part 266. Part 266 is 

entitled, ‘‘Standards for the 

Management of Specific Hazardous 

Wastes and Specific Types of Hazardous 

Waste Management Facilities.’’ This 

new subpart P is a tailored, sectorspecific regulatory framework for 

managing hazardous waste 

pharmaceuticals at healthcare facilities 

and pharmaceutical reverse distributors. 

If finalized, healthcare facilities that are 

currently small quantity generators 

(SQGs) or large quantity generators 

(LQGs) and all pharmaceutical reverse 

distributors, regardless of their RCRA 

generator category, will be required to 

manage their hazardous waste 

pharmaceuticals under subpart P of 40 

CFR part 266, instead of 40 CFR part 

262. That is, the proposed standards are 

not an optional alternative to managing 

hazardous waste pharmaceuticals under 

40 CFR part 262; they are mandatory 

standards. 

Briefly, healthcare facilities will have 

different management standards for 

their non-creditable and creditable 

hazardous waste pharmaceuticals. Noncreditable hazardous waste 

pharmaceuticals (i.e., those that are not 

expected to be eligible to receive 

manufacturer’s credit) will be managed 

on-site similar to how they would have 

been under a previous proposal for 

managing these wastes: The 2008 

Universal Waste proposal for 

pharmaceutical waste (73 FR 73520; 

December 2, 2008). When shipped offsite, they must be transported as 

hazardous wastes, including the use of 

the hazardous waste manifest, and sent 

to a RCRA interim status or permitted 

facility. On the other hand, healthcare 

facilities will continue to be allowed to 

send potentially creditable hazardous 

waste pharmaceuticals to 

pharmaceutical reverse distributors for 

processing manufacturers’ credit. In 

response to comments received on the 

Universal Waste proposal, EPA is 

proposing standards to ensure the safe 

and secure delivery of the creditable 


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58016 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

1RCRA also governs the disposal of nonhazardous solid wastes; however, state and/or local 

environmental regulatory agencies predominantly 

administer the regulations pertaining to the 

management of non-hazardous wastes. 

2For more information on RCRA State 

Authorization, see: http://www.epa.gov/osw/lawsregs/state/index.htm. 

3For more information on hazardous waste 

generators, please see: http://www.epa.gov/waste/

hazard/generation/index.htm. 

4See 40 CFR 261.2 for the definition of solid 

waste. 

5The waste determination process includes 

determining if the waste is specifically excluded or 

exempted from the RCRA hazardous waste 

regulations. If not, then the entity must determine 

if the waste is listed by EPA under the F-, K-, Por U-lists of hazardous wastes (§§ 261.31–33). If the 

waste is not listed, then it must be determined if 

the waste exhibits a characteristic of a hazardous 

waste: Ignitability, corrosivity, reactivity, or toxicity 

(§§ 261.21–24). 

hazardous waste pharmaceuticals to 

pharmaceutical reverse distributors. 

EPA is also proposing standards for 

the accumulation of the creditable 

hazardous waste pharmaceuticals at 

pharmaceutical reverse distributors. 

Like healthcare facilities, 

pharmaceutical reverse distributors will 

not be regulated under 40 CFR part 262 

as hazardous waste generators, nor will 

they be regulated under 40 CFR parts 

264, 265 and 270 as treatment, storage, 

and disposal facilities (TSDFs). Rather, 

the proposal establishes a new category 

of hazardous waste entity, called 

pharmaceutical reverse distributors. The 

proposed standards for pharmaceutical 

reverse distributors are, in many 

respects, similar to the LQGs standards, 

with supplementary standards added to 

respond to commenters’ concerns. 

For both healthcare facilities and 

reverse distributors, EPA is proposing to 

prohibit facilities from disposing of 

hazardous waste pharmaceuticals down 

the toilet or drain (i.e, flushed or 

sewered). Further, EPA proposes that 

hazardous waste pharmaceuticals 

managed under subpart P will not be 

counted toward calculating the site’s 

generator category. Additionally, EPA is 

proposing a conditional exemption for 

hazardous waste pharmaceuticals that 

are also DEA controlled substances. 

Finally, EPA is proposing management 

standards for hazardous waste 

pharmaceutical residues remaining in 

containers. 

IV. Background 

A. What is the history of hazardous 

waste pharmaceutical management 

under RCRA? 

1. What Is the Resource Conservation 

and Recovery Act? 

The Resource Conservation and 

Recovery Act governs the management 

and disposal of hazardous wastes.1

Under Subtitle C of RCRA, EPA has 

established a comprehensive set of 

regulations for hazardous waste 

management, generation, transportation, 

treatment, storage, and disposal. EPA 

can authorize an individual state 

hazardous waste program to operate in 

lieu of the federal program provided the 

authorized state’s program is at least as 

stringent as, and consistent with, the 

federal program.2 However, EPA 

maintains oversight of the authorized 

state’s hazardous waste program and the 

authority to take independent 

enforcement actions. RCRA regulates 

pharmaceutical wastes that meet a 

listing of hazardous waste or exhibit one 

or more characteristics of hazardous 

waste. Accordingly, hospitals, 

pharmacies, reverse distributors and 

other healthcare-related establishments 

that generate hazardous wastes, 

including hazardous waste 

pharmaceuticals, are required to manage 

and dispose of their hazardous wastes in 

accordance with applicable federal, 

state, and/or local environmental 

regulations. 

2. What are the current standards for 

generators of hazardous waste? 

Currently, there are no RCRA Subtitle 

C regulations that focus specifically on 

the management of hazardous wastes 

from hospitals, pharmacies, reverse 

distributors and other healthcare-related 

facilities. Rather, healthcare facilities 

are currently required to comply with 

the same RCRA hazardous waste 

regulations as many other industries 

that generate hazardous waste. While 

the RCRA Subtitle C program has 

requirements for all aspects of 

hazardous waste management, 

including those generating (referred to 

as ‘‘generators’’ by RCRA), transporting, 

storing, treating, and disposing of 

hazardous wastes, it is the generator 

requirements found under 40 CFR part 

262 that will typically be most pertinent 

to healthcare-related facilities. 

Under the federal RCRA regulations, 

the standards for hazardous waste 

generators are divided into three 

categories—LQGs, SQGs, and 

Conditionally Exempt Small Quantity 

Generators (CESQGs) depending upon 

the total amount of hazardous waste a 

facility generates per calendar month. It 

is the facility’s generator category that 

determines the applicable RCRA 

hazardous waste management 

requirements with which the generator 

must comply.3

A generator that generates a solid 

waste 4 is required by § 262.11 to 

determine whether such waste meets 

the definition of RCRA hazardous 

waste.5 If the waste meets the RCRA 

definition of a hazardous waste, then 

the generator must manage the waste in 

accordance with the regulations that 

apply to its hazardous waste generator 

category (see § 261.5 and 40 CFR part 

262 for the generator regulations). In 

particular: 

• Facilities qualify as LQGs if in a 

calendar month they generate 1,000 kg 

or more of hazardous waste or more 

than 1 kg of acute hazardous waste (i.e., 

P-listed waste), or more than 100 kg of 

any residue or contaminated soil, waste, 

or other debris resulting from the cleanup of a spill, into or on any land or 

water, of any acute hazardous wastes 

listed in §§ 261.31 or 261.33(e). Federal 

regulations for LQGs include, but are 

not limited to the following: Obtaining 

an EPA Identification number; a 90-day 

limit for accumulating hazardous waste 

on-site (with relevant standards for the 

accumulation of hazardous waste) 

without having to obtain a RCRA permit 

or comply with the interim status 

standards, provided that they comply 

with the conditions for exemption set 

forth in § 262.34(a) such as management 

and labeling standards specific to the 

type of accumulation unit (e.g., 

container, tank); RCRA training of 

personnel; contingency planning; 

manifesting and recordkeeping and 

reporting (biennial report). 

• Facilities qualify as SQGs if in a 

calendar month they generate more than 

100 kg but less than 1,000 kg of 

hazardous waste. SQGs are subject to 

fewer requirements than LQGs and are 

given additional flexibility. For 

example, SQGs have a longer on-site 

accumulation time limit (180 or 270 

days vs. 90 days for LQGs), with fewer 

standards for the accumulation of 

hazardous waste, without having to 

obtain a RCRA permit or comply with 

the interim status standards, provided 

that they comply with the conditions set 

forth in § 262.34(d) (which have fewer 

personnel training and contingency 

planning obligations than in the 

conditions for exemption for LQGs); and 

do not need to complete a biennial 

report (BR). 

• Facilities qualify as CESQGs if in a 

calendar month they generate less than 

or equal to 100 kg of hazardous waste, 

and less than or equal to 1 kg of acutely 

hazardous waste (i.e., P-listed), and less 

than or equal to 100 kg of any residue 

or contaminated soil, waste, or other 

debris resulting from the clean-up of a 

spill, into or on any land or water, of 

any acute hazardous wastes listed in 


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6EPA recommends that facilities that qualify as 

CESQGs under the federal regulations contact their 

state and/or local environmental regulatory 

agencies, as authorized states can be more stringent 

than the federal regulations. As a result, not all 

authorized states recognize the CESQG category or 

they may have more stringent regulatory 

requirements for CESQGs. 

7For clarification on household hazardous waste 

collection issues, please see the November 1, 1988 

memo from Win Porter to the Regional Waste 

Management Division Directors (RCRA Online # 

11377) at: http://yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

2FD51915214EF63C8525670F006BDC88/$file/

11377.pdf. 

8Commercial chemical product refers to a 

chemical substance which is manufactured or 

formulated for commercial or manufacturing use 

which consists of the commercially pure grade of 

the chemical, any technical grades of the chemical 

that are produced or marketed and all formulations 

in which the chemical is the sole active ingredient 

(§ 261.33(d)). 

9The P- and U-lists deem as hazardous certain 

commercial chemical products when they are 

discarded or intended to be discarded. These 

listings consist of commercial chemical products 

having the generic names listed, off-specification 

species, container residues, and spill residues. 

Chemicals on the P-list are identified as acute 

hazardous wastes and are regulated at lower 

amounts than those on the U-list. 10The toxicity characteristic (TC) indicates that 

the waste is likely to leach concentrations of 

contaminants that may be harmful, and TC waste 

is identified using the Toxicity Characteristic 

Leaching Procedure (see § 261.24). Examples of TC 

constituents that may be present in pharmaceuticals 

include, but are not limited to: Arsenic, barium, 

cadmium, selenium, silver, chloroform, lindane and 

m-cresol. 

11 In addition, in December 2008, the Agency 

proposed to regulate hazardous waste 

pharmaceuticals under the Universal Waste rule. 

However, based on the comments received, the 

Agency decided not to finalize that proposal and to 

proceed with a sector-based approach. (See section 

IV.C. of the preamble for further discussion of the 

Universal Waste proposal.) 

12Memo from Devlin to RCRA Division Directors, 

February 17, 2012 (RCRA Online #14831) http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

A5C07D01188ECA59852579EA0067CDB1/$file/

14831.pdf. 

13Memo December 1, 1994 (RCRA Online 

#13718) http://yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

1C1DEB3648A62A868525670F006BCCD2/$file/

13718.pdf. 

14Memo from Dellinger to Smith, March 18, 2003 

(RCRA Online #14654) http://yosemite.epa.gov/

osw/rcra.nsf/0c994248c239947e85256d090071175f/

7ACFEC572DE8897F85256D1600748BCB/$file/

14654.pdf. 

15Memo from Brandes to Knauss, April 6, 1998 

(RCRA Online #14175) http://yosemite.epa.gov/

osw/rcra.nsf/0c994248c239947e85256d090071175f/

7417D2556AD322FA852568E300468198/$file/

14175.pdf. 

16Memo from Dellinger to Smith, August 23, 

2010 (RCRA Online #14817) http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

209444BADDA4ECDC852577ED00624E8F/$file/

14817.pdf. 

§§ 261.31, or 261.33(e).6 CESQGs are 

subject to very few of the RCRA Subtitle 

C hazardous waste regulations, provided 

that they comply with the conditions set 

forth in § 261.5(f)(3) and (g)(3). 

Finally, under the household 

hazardous waste exemption in 

§ 261.4(b)(1), hazardous wastes 

generated by households are not subject 

to the RCRA hazardous waste 

regulations. This exemption from the 

Subtitle C requirements extends to any 

household wastes collected during 

community-oriented take-back programs 

or events, as long as these collected 

household hazardous wastes are 

managed separately from regulated 

hazardous wastes.7 However, while 

collected household hazardous wastes 

are not regulated under the federal 

standards, more stringent state 

standards may apply. 

3. Are pharmaceuticals considered 

hazardous wastes under RCRA? 

A portion of the pharmaceuticals 

currently on the market meets RCRA’s 

definition of hazardous waste when 

discarded. As previously explained, it is 

the responsibility of the generator of a 

solid waste to determine if the waste is 

hazardous; this includes solid wastes 

that are pharmaceuticals. If the 

pharmaceutical waste meets RCRA’s 

definition of hazardous waste, then the 

generator must manage it in accordance 

with all applicable federal, state, and/or 

local environmental regulations. A 

pharmaceutical is considered a 

hazardous waste under RCRA in one of 

two ways. First, a discarded 

pharmaceutical can be a listed 

hazardous waste if it is a commercial 

chemical product 8 that is listed under 

RCRA’s P- or U-list, and the 

pharmaceutical has not been used for its 

intended purpose (§ 261.33 (e) and (f), 

respectively).9 A few examples of 

pharmaceuticals that are considered 

P-listed wastes when discarded are 

arsenic trioxide (P012), smoking 

cessation products with nicotine as the 

sole active ingredient (P075), and 

pharmaceuticals with greater than 0.3% 

warfarin (and salts) as the sole active 

ingredient, such as Coumadin (P001). 

Some examples of pharmaceuticals that 

are considered U-listed wastes are: 

Cyclophosphamide (U058), mitomycin 

C (U010), streptozotocin (U206) and 

warfarin and salts (≤0.3%) as the sole 

active ingredient (U248). 

Second, if the discarded 

pharmaceutical is not on the P- or U-list, 

then the pharmaceutical may be a 

hazardous waste if it exhibits one or 

more of the hazardous waste 

characteristics. Under the federal 

requirements (§ 261.21–24), a waste is a 

characteristic hazardous waste if it is 

ignitable (D001), corrosive (D002), 

reactive (D003) or toxic (D004–D043).10

A number of pharmaceuticals are 

prepared in alcohol, which may cause 

the waste to be hazardous due to 

ignitability (D001), even if the active 

pharmaceutical ingredient itself is not 

considered hazardous waste. The 

Regulatory Impact Analysis for this 

proposed rule includes a list of 

pharmaceuticals that, to our knowledge, 

are hazardous waste when disposed, 

although this list should not be 

considered exhaustive (see the docket 

for this proposed rule EPA–HQ–RCRA– 

2007–0932). 

Since the hazardous waste rules were 

initially promulgated, EPA has issued 

several clarifications regarding the 

regulatory status of certain commercial 

chemical products on the P- and U-lists, 

and these clarifications have affected 

the regulatory status of some active 

pharmaceutical ingredients.11 For 

example, EPA recently clarified that 

phentermine hydrochloride and other 

phentermine salts are not included 

within the scope of the P046 

(phentermine) listing.12 Similarly, EPA 

has also clarified that epinephrine salts 

are not included in the epinephrine 

listing (P042).13 In addition, medicinal 

nitroglycerin typically is not considered 

P081 since the medicinal form of this 

compound generally does not exhibit 

the characteristic of reactivity for which 

nitroglycerin was originally listed.14

Furthermore, in a 1998 memo, EPA 

clarified that the U034 listing includes 

both anhydrous chloral and chloral 

hydrate.15 And in a 2010 memo, EPA 

stated that unused nicotine patches, 

gums and lozenges are finished dosage 

forms of nicotine and therefore are 

regulated as P075 when discarded.16

Finally, EPA has developed a 

‘‘Hazardous Waste Pharmaceuticals 

Wiki’’ as a platform to facilitate the 

sharing of expertise among the 

healthcare industry and other 

stakeholders in order to help make 

accurate hazardous waste 

determinations for waste 

pharmaceuticals and increase 

compliance with the hazardous waste 

regulations. The Hazardous Waste 

Pharmaceuticals Wiki will also help 

users find guidance documents, statespecific information, and 

manufacturers’ information. The 

Hazardous Waste Pharmaceuticals Wiki 

can be viewed at: http://

hwpharms.wikispaces.com. EPA 

encourages healthcare stakeholders to 

use the Wiki to share information 

regarding federal hazardous waste 


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58018 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

17Anyone may view the Wiki. Those in the 

healthcare community who wish to contribute 

content or edit the Wiki can register by sending an 

email request to HWPharmsWiki@epa.gov. 

18Executive Order 13563 was signed by President 

Obama on January 18, 2011 and published in the 

Federal Register on January 21, 2011 (76 FR 3821). 

In response to the Executive Order, EPA solicited 

comments on ‘‘Improving EPA Regulations,’’ in a 

Federal Register notice published on February 23, 

2011 (76 FR 9988). See docket number EPA–HQ– 

OA–2011–0160 for public comments related to 

waste. 

19P-listed hazardous waste residues in containers 

are themselves considered P-listed hazardous 

wastes (see § 261.33(c)), unless the container is 

considered ‘‘RCRA empty’’ either by undergoing 

triple-rinsing with an appropriate solvent; or 

cleaning with a method that has been proven in 

scientific literature or tests conducted by the 

generator to achieve equivalent removal (see 

§ 261.7(b)(3)). 

20On November 4, 2011, ORCR issued a memo to 

the Regional RCRA Division Directors highlighting 

three acceptable approaches, beyond triple-rinsing 

containers, that healthcare facilities can employ 

when managing P-listed container residues. Please 

see: Memo from Suzanne Rudzinski to RCRA 

Division Directors (RCRA Online #14827) http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

57B21F2FE33735128525795F00610F0F/$file/

14827.pdf. 

pharmaceuticals, as well as state-only 

hazardous waste pharmaceuticals.17

B. What are the rationale and goals for 

this proposed rule? 

1. Sector-Based Approach 

The impetus behind this proposal is 

to address the various concerns raised 

by stakeholders regarding the difficulty 

in implementing the Subtitle C 

hazardous waste regulations for the 

management of hazardous waste 

pharmaceuticals generated at healthcare 

facilities. EPA has met with various 

stakeholders to learn about compliance 

challenges, and it has received input 

from stakeholders through more formal 

mechanisms. For instance, when EPA 

solicited stakeholder input in response 

to Executive Order 13563 (Improving 

Regulation and Regulatory Review), 

retailers submitted comments detailing 

compliance challenges with hazardous 

waste pharmaceuticals in their stores.18

Further, EPA’s Office of Inspector 

General (OIG) published a report citing 

the need to clarify how hazardous waste 

pharmaceuticals are regulated (for more 

information on both of these reports, see 

the next section). These two reports and 

input from healthcare (and associated) 

facilities identified a number of ways in 

which a healthcare facility differs from 

a manufacturing facility when it comes 

to applying the RCRA Subtitle C 

program for generating and managing 

hazardous waste. 

First, in the healthcare setting, many 

hazardous waste pharmaceuticals are 

generated unpredictably and in 

relatively small quantities by a number 

of different employees across the 

facility. This situation differs from a 

manufacturing facility where fewer 

employees in a few locations generate 

comparatively much larger volumes of a 

smaller range of hazardous wastes. 

Second, under the current hazardous 

waste regulatory scheme, healthcare 

workers, whose primary focus is to 

provide care for patients, are typically 

responsible for making hazardous waste 

determinations since they are at the 

point of generation (e.g., a patient’s 

bedside). Yet, healthcare workers, such 

as nurses and doctors, do not typically 

have the expertise to make hazardous 

waste determinations. 

Third, a healthcare facility can have 

thousands of items in its formulary at 

any one time and these may vary over 

time. In addition, pharmaceutical 

wastes come in many different forms, 

such as pills, patches, lozenges, gums, 

creams, and liquids, and are delivered 

by a variety of devices, such as 

nebulizers, intravenous (IV) tubing, 

syringes, etc. The combination of having 

thousands of different pharmaceutical 

products and little expertise in 

hazardous waste regulations makes it 

difficult for healthcare workers to make 

appropriate hazardous waste 

determinations when pharmaceuticals 

are disposed. This situation differs from 

manufacturing, where fewer, more 

predictable waste streams are generated. 

Fourth, several of the hazardous waste 

pharmaceuticals that are generated by 

healthcare facilities are P-listed acute 

hazardous wastes (see § 261.33(e)), 

which are regulated at much smaller 

amounts. If a facility generates more 

than 1 kg of acute hazardous waste per 

calendar month or accumulates that 

amount at any time, it is regulated as an 

LQG. In addition to the 

pharmaceuticals, residues within 

pharmaceutical containers that 

contained P-listed commercial chemical 

products must be managed as acute 

hazardous waste even if the 

pharmaceutical was fully dispensed,19

unless the container is RCRA-empty 

(e.g., by triple-rinsing the container). 

Triple rinsing can be impractical with 

certain medical devices, such as 

syringes and paper cups, so healthcare 

facilities often end up managing these 

containers as hazardous waste, which 

can result in the facilities being subject 

to the most stringently regulated 

generator category (i.e., LQG).20

To facilitate compliance among 

healthcare facilities and to respond to 

these concerns, EPA is proposing a new 

set of sector-specific regulations to 

improve the management and disposal 

of hazardous waste pharmaceuticals at 

healthcare facilities. This proposed rule 

also intends to clarify the regulatory 

status of a major practice used by 

healthcare facilities for management of 

unused and/or expired pharmaceuticals, 

known as reverse distribution (see 

Sections V.D.1 and V.G). 

In addition to improving compliance 

and responding to stakeholder concerns, 

the Agency has two additional goals for 

this proposal. The first is to reduce the 

amount of pharmaceuticals that are 

disposed of ‘‘down the drain.’’ This is 

presently an allowable and common 

disposal practice among healthcare 

facilities (as long as the pharmaceutical 

waste is not ignitable (see the Clean 

Water Act regulations of 40 CFR 

403.5(b)(1)) and provided certain 

conditions are met (see the Clean Water 

Act regulations of 40 CFR 403.12(p)). 

Studies have found that many 

healthcare facilities, particularly long 

term-care facilities, are using drain 

disposal as a routine disposal method 

for pharmaceutical wastes. Although 

pharmaceuticals are also entering the 

environment through excretion, 

reducing sewer disposal is one 

mechanism to help reduce the 

environmental loading of 

pharmaceuticals into our Nation’s 

waters. For more information about 

sewer disposal and pharmaceuticals in 

water, see Section V.E.1. 

The second goal is to address the 

overlap between EPA’s RCRA hazardous 

waste regulations and the controlled 

substances regulations of the Drug 

Enforcement Administration (DEA). 

Stakeholders have indicated that 

hazardous waste pharmaceuticals that 

are also controlled substances are 

stringently regulated and expensive to 

dispose of in accordance with both sets 

of requirements when sent for 

incineration. In addition, stakeholders 

have indicated that those regulated 

hazardous waste pharmaceuticals that 

are also controlled substances are most 

likely to be sewer disposed to avoid the 

costs of compliant incineration. EPA 

plans to address this overlap in this 

proposed rule, as this is an unnecessary 

burden for healthcare facilities and 

revised requirements will help to reduce 

sewer disposal. 

2. Executive Order 13563 for the 

Retrospective Review of Existing 

Regulations 

On January 18, 2011, President 

Obama issued Executive Order 13563, 

which directed all federal agencies to 

perform periodic retrospective reviews 

of existing regulations to determine 

whether any should be modified, 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58019 

21For a copy of Executive Order 13563, please 

see: http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/

pdf/2011-1385.pdf. 

22US EPA. Improving Our Regulations: Final 

Plan for Periodic Retrospective Reviews of Existing 

Regulations. http://www.epa.gov/regdarrt/

retrospective/documents/eparetroreviewplanaug2011.pdf. 

23See page 45, item 2.2.17 of EPA’s ‘‘Improving 

Our Regulations: Final Plan for Periodic 

Retrospective Reviews of Existing Regulations’’ at 

http://www.epa.gov/regdarrt/retrospective/

documents/eparetroreviewplan-aug2011.pdf. 

24The current federal universal wastes include 

hazardous waste batteries, certain hazardous waste 

pesticides, mercury-containing equipment, and 

hazardous waste lamps. 

25The 5,000 kilogram accumulation criterion 

applies to the quantity of all universal wastes 

accumulated. 

26See docket EPA–HQ–RCRA–2007–0932 at 

www.regulations.gov for public comments: http://

www.regulations.gov/#!docketDetail;D=EPA-HQRCRA-2007- 

0932;dct=FR%252BPR%252BN%252BO%252BSR. 

streamlined, expanded, or repealed.21

EPA made its preliminary plan available 

for public review and comment during 

the spring of 2011 and released the final 

version of the plan in August 2011.22

During the public comment process, 

EPA received requests to clarify and 

make more effective the hazardous 

waste regulations as they pertain to 

discarded retail products, including 

pharmaceutical wastes. In response to 

this specific issue, EPA agreed to review 

data and information currently in its 

possession as part of the development 

for a rulemaking to address 

pharmaceutical waste management 

issues.23 This Notice of Proposed 

Rulemaking provides notice that EPA 

has completed its review and has 

satisfied this part of its obligation for 

retail hazardous waste pharmaceutical 

management issues. 

3. Retail Notice of Data Availability 

EPA published a Notice of Data 

Availability (NODA) for the Retail 

Sector on February 14, 2014 (79 FR 

8926), in which the Agency requested, 

among other things, comment on a 

series of topics related to retail 

operations in order to better understand 

the issues retail stores/establishments 

face in complying with RCRA 

regulations. Many retail commenters 

mentioned that because nicotine is an 

acute hazardous waste (P075), they are 

considered LQGs when they discard 

more than 1 kg per month of unused 

nicotine-containing products (e.g., 

e-cigarettes and smoking cessation 

products such as gums, patches and 

lozenges). Retailers discard these 

products mainly because they are either 

expired or they are returned by 

customers and the retailer does not 

restock them due to safety concerns. In 

comments to the NODA, retailers urged 

the EPA to provide them some 

regulatory relief with regard to nicotinecontaining products. See Section VIII of 

this preamble for a discussion of EPA’s 

potential future efforts to amend the 

acute hazardous waste listing for 

nicotine and salts (P075). 

C. What was the 2008 Pharmaceutical 

Universal Waste proposal? 

1. The 2008 Proposal To Add Hazardous 

Waste Pharmaceuticals to the Federal 

Universal Waste Program 

On December 2, 2008, EPA proposed 

to add hazardous waste pharmaceuticals 

to the existing federal universal waste 

program, which would have provided a 

streamlined approach to facilitate the 

proper management and disposal of 

hazardous waste pharmaceuticals 

generated at pharmacies, hospitals, 

reverse distributors, and other 

healthcare-related facilities. 

Specifically, under the universal waste 

program, handlers and transporters who 

generate or manage items designated as 

a universal waste 24 are subject to the 

management standards under part 273, 

rather than the full RCRA subtitle C 

hazardous waste regulations. Universal 

waste handlers include universal waste 

generators and collection facilities. The 

regulations distinguish between ‘‘large 

quantity handlers of universal waste’’ 

(or those who handle more than 5,000 

kilograms of total universal waste at any 

one time) and ‘‘small quantity handlers 

of universal waste’’ (or those who 

handle 5,000 kilograms or less of 

universal waste at any one time).25 The 

streamlined requirements for all types of 

universal waste include modified 

requirements for storage, labeling and 

marking, preparing the waste for 

shipment off-site, employee training, 

response to releases and notification. 

Transporters of universal waste are 

also subject to less stringent 

requirements than the full RCRA 

subtitle C hazardous waste 

transportation regulations. However, the 

primary difference between the 

universal waste transportation 

requirements and full RCRA subtitle C 

requirements is that no hazardous waste 

manifest is required for the transport of 

universal waste. 

Destination facilities under the 

universal waste program are those 

facilities that treat, store, dispose of, or 

recycle universal wastes. Universal 

waste destination facilities are subject to 

all currently applicable requirements for 

hazardous waste treatment, storage, and 

disposal facilities (TSDFs), including 

the requirement to obtain a RCRA 

permit for such activities. (See 73 FR 

73520, December 2, 2008, for a more 

detailed discussion of the proposed 

universal waste program for 

pharmaceutical wastes.) 

2. What were the public comments to 

the 2008 Pharmaceutical Universal 

Waste proposal? 

EPA received approximately 100 

public comments on the 2008 proposal 

to add hazardous waste pharmaceuticals 

to the universal waste program.26

Generally, public commenters 

supported the Agency’s desire to 

address the issue of hazardous waste 

pharmaceutical management. However, 

although there were several aspects of 

the proposal that were well supported 

(e.g., training requirements, 

accumulation times, and hazardous 

waste pharmaceuticals not being 

counted towards the generator category), 

public commenters expressed concern 

over the lack of notification and tracking 

requirements for small quantity 

handlers of universal waste and the 

reduced notification and tracking 

requirements for large quantity 

handlers. As a result, commenters, 

including state environmental 

regulatory agencies, expressed concern 

that they would not be informed of 

hazardous waste pharmaceutical 

generation, management, and 

transportation in their regulatory 

jurisdictions. Furthermore, public 

commenters expressed concern that 

because the universal waste program 

does not require a hazardous waste 

manifest or another tracking 

mechanism, the hazardous waste 

pharmaceuticals could be vulnerable to 

diversion. Public commenters argued 

that hazardous waste pharmaceuticals 

are different from the other federal 

universal wastes (batteries, mercurycontaining equipment, lamps, and 

pesticides) in that the pharmaceuticals, 

as well as their containers, still retain 

considerable value upon disposal and 

can be easily diverted for illicit 

purposes. Therefore, tracking 

requirements beyond the requirements 

included in the current universal waste 

program were considered necessary by 

the majority of the public commenters. 

In addition to the public comments 

about the strengths and weaknesses of 

using the universal waste program to 

address the disposal of hazardous waste 

pharmaceuticals, EPA received other 

comments expressing concern with the 

proposal, including the following: The 

point of generation of hazardous waste 

pharmaceuticals as it pertains to reverse 

distribution; the management of 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58020 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

27For a copy of the report, please see: http://

www.epa.gov/oig/reports/2012/20120525-12-P0508.pdf or see the docket for this proposed rule: 

EPA–HQ–RCRA–2007–0932. 

containers that contain hazardous waste 

pharmaceutical residues; the variability 

in the land disposal restriction (LDR) 

treatment standards for hazardous waste 

pharmaceuticals; the overlap of EPA 

and DEA regulations for the 

management of hazardous waste 

pharmaceuticals that are also controlled 

substances; and the lack of activity to 

add pharmaceutical wastes to the 

hazardous waste listings. The Agency 

provides additional discussion on these 

specific comments within this 

preamble. 

3. Why is EPA not finalizing the 2008 

Pharmaceutical Universal Waste 

proposal? 

Based on the adverse comments 

received on the 2008 Pharmaceutical 

Universal Waste proposal regarding the 

lack of notification and tracking 

requirements for small quantity 

universal waste handlers, the reduced 

notification and tracking requirements 

for large quantity universal waste 

handlers, as well as the other issues 

raised in public comments, the Agency 

has decided to not finalize the proposal 

to add hazardous waste pharmaceuticals 

to the Universal Waste program. In fact, 

EPA has concluded that the universal 

waste program is not appropriate for 

managing hazardous waste 

pharmaceuticals because, among other 

things, we are unable to adequately 

address the notification and tracking 

concerns raised by the public comments 

within the Universal Waste program. 

Under the Universal Waste 

regulations, there are eight factors to 

consider when determining whether it 

is appropriate to add a new hazardous 

waste or category of hazardous waste to 

the Universal Waste program (§ 273.81). 

A hazardous waste does not need to 

meet every factor in order to be added 

to the Universal Waste program. Rather, 

the Agency’s decision is ‘‘based on the 

weight of evidence showing that 

regulation under part 273 is appropriate 

for the waste or category of waste, will 

improve management practices for the 

waste or category of waste, and will 

improve implementation of the 

hazardous waste program’’ (§ 273.80(c)). 

The Agency has concluded based on 

the comments received that the weight 

of evidence does not show that 

regulation under the Universal Waste 

program is appropriate for hazardous 

waste pharmaceuticals. Specifically, we 

find the Universal Waste program to be 

lacking with regard to the factor in 

§ 273.81(e), which states that the risk 

posed by the waste being considered for 

universal waste be relatively low 

compared to other hazardous wastes 

and that the management standards 

would be protective of human health 

and the environment during 

accumulation and transport. Although 

we continue to believe that potentially 

creditable pharmaceuticals en route to 

reverse distributors pose a low risk for 

leaks and other releases to the 

environment, commenters urged us to 

consider the unique risk posed by the 

accumulation and transport of 

hazardous waste pharmaceuticals: the 

risk of diversion. Although it is rare that 

a hazardous waste is so valuable that it 

is sought for abuse or sale on the black 

market, EPA believes that the diversion 

of hazardous waste pharmaceuticals for 

illicit use is a risk to human health. 

The Universal Waste program does 

not include sufficient tracking 

requirements to address the potential for 

diversion. Under part 273, tracking is 

not required for shipments by small 

quantity handlers of universal waste; 

certain tracking of shipments is required 

only for large quantity handlers of 

universal waste and destination 

facilities. More importantly, these basic 

tracking requirements consist only of 

recordkeeping of shipments sent and 

received and no tracking is required to 

ensure delivery. Commenters noted that 

these tracking requirements are not 

sufficient given the high value of many 

of the unused pharmaceuticals en route 

to reverse distribution and the potential 

for diversion. 

Accordingly, the Agency is proposing 

to amend § 273.80 to state that 

hazardous waste pharmaceuticals may 

not be added as a category of hazardous 

waste for management under the 

Universal Waste program. See Section 

IX State Authorization of the preamble 

for a discussion on the effect on the two 

states that have adopted 

pharmaceuticals under the Universal 

Waste program (Michigan and Florida). 

By proposing a new set of 

management standards outside the 

confines of the Universal Waste 

program, it allows us greater flexibility 

in addressing the tracking of such 

shipments, as well as additional 

pharmaceutical waste management 

issues raised by stakeholders, such as 

drain disposal, container residues, 

pharmaceutical reverse distribution, and 

the overlap with DEA regulation. This 

new action will address the original 

stakeholder concerns that resulted in 

the 2008 Pharmaceutical Universal 

Waste proposal, as well as the 

comments received on that proposal. 

To reiterate, EPA is not adding 

hazardous waste pharmaceuticals to the 

federal Universal Waste program. 

Rather, we are proposing sector-specific 

regulations for the management of 

hazardous waste pharmaceuticals by 

healthcare facilities and pharmaceutical 

reverse distributors. If finalized, these 

regulations will be codified in 40 CFR 

part 266, separate from both the 

generator regulations (40 CFR part 262) 

and the Universal Waste program (40 

CFR part 273). This new proposed 

rulemaking will pertain to those waste 

pharmaceuticals that meet the current 

definition of a RCRA hazardous waste 

and are generated by healthcare-related 

facilities and managed by 

pharmaceutical reverse distributors, as 

defined by this proposal. Finally, as this 

current proposal is a direct result of the 

comments received on the December 2, 

2008, Pharmaceutical Universal Waste 

proposal, the Agency considers the 2008 

Pharmaceutical Universal Waste 

proposal obsolete. Therefore, EPA is 

withdrawing the Universal Waste 

proposal for pharmaceutical waste, and 

does not seek comment on any 

provisions of the 2008 Pharmaceutical 

Universal Waste proposal or the current 

Universal Waste program. The Agency 

will only be accepting comments from 

the public on the provisions of this new 

proposed rulemaking. 

D. EPA’s Office of Inspector General 

Report 

On May 25, 2012, the EPA’s Office of 

Inspector General (OIG) issued the 

report, ‘‘EPA Inaction in Identifying 

Hazardous Waste Pharmaceuticals May 

Result in Unsafe Disposal’’ (Report No. 

12–P–0508).27 The OIG reviewed EPA’s 

process for identifying and listing 

pharmaceuticals as hazardous wastes. 

Because of this review, the OIG 

provided the following 

recommendations to the Assistant 

Administrator for the Office of Solid 

Waste and Emergency Response 

(OSWER): 

(1) Identify and review existing 

pharmaceuticals to determine whether 

they qualify for regulation as hazardous 

waste. 

(2) Establish a process to review new 

pharmaceuticals to determine whether 

they qualify for regulation as hazardous 

waste. 

(3) Develop a nationally consistent 

outreach and compliance assistance 

plan to help states address challenges 

that healthcare facilities, and others as 

needed, have in complying with RCRA 

regulations for managing HWPs 

[hazardous waste pharmaceuticals] 

(Report No. 12–P–0508). 

As detailed in OSWER’s response to 

OIG, this proposal fulfills our obligation 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58021 

28For a copy of OSWER’s full response to OIG, 

please see: http://www.epa.gov/oig/reports/2012/12- 

P-0508_Agency%20Response.pdf. 

29 Including dietary supplements under the 

definition of pharmaceutical for this regulation does 

not supersede the requirements of the Dietary 

Supplement Health and Education Act of 1994, the 

Federal Food, Drug and Cosmetic Act, or FDA 

regulations. 

30The substance of the definition is: a product 

(other than tobacco) intended to supplement the 

Continued 

for addressing the third 

recommendation.28 EPA does not 

address the OIG’s first two 

recommendations as part of this 

proposed rulemaking; however, in 

Section VII of this preamble, we solicit 

comment on our ongoing efforts to 

identify additional pharmaceuticals as 

hazardous wastes. 

V. Detailed Discussion of the Proposed 

Rule 

EPA is proposing an entirely new set 

of regulations (40 CFR part 266, subpart 

P) for managing hazardous waste 

pharmaceuticals at both healthcare 

facilities and pharmaceutical reverse 

distributors. This section discusses in 

detail the major features of the proposal. 

The Agency also presents other options 

that it is considering or were considered 

in developing the proposed rule. EPA 

welcomes comments on all aspects of 

this proposed rule, and on options 

under consideration. Throughout this 

section, EPA requests comments on 

specific options and on specific issues, 

but comments are welcome on all 

provisions of this proposal. 

A. What terms are defined in this 

proposed rule? 

All the definitions that appear in this 

proposal are for the purposes of 40 CFR 

part 266, subpart P only. Therefore, the 

definitions are relevant only to 

healthcare facilities and pharmaceutical 

reverse distributors that are subject to 

these proposed standards. For the 

purposes of this regulation, the Agency 

is proposing and soliciting public 

comment on the following terms and 

their definitions presented below: 

‘‘evaluated hazardous waste 

pharmaceutical,’’ ‘‘hazardous waste 

pharmaceutical,’’ ‘‘healthcare facility,’’ 

‘‘household waste pharmaceutical,’’ 

‘‘long-term care facility,’’ ‘‘noncreditable hazardous waste 

pharmaceutical,’’ ‘‘non-hazardous waste 

pharmaceutical,’’ ‘‘non-pharmaceutical 

hazardous waste,’’ ‘‘pharmaceutical,’’ 

‘‘pharmaceutical reverse distributor,’’ 

and ‘‘potentially creditable hazardous 

waste pharmaceutical.’’ Although the 

proposed definitions appear in 

alphabetical order in the regulations, we 

have chosen to discuss the proposed 

definitions in a different order in the 

preamble. 

1. What is the proposed definition of 

‘‘pharmaceutical’’? 

This proposed rule defines 

‘‘pharmaceutical’’ as any chemical or 

biological product that is intended for 

use in the diagnosis, cure, mitigation, 

care, treatment, or prevention of disease 

or injury of a human or other animal; or 

any chemical or biological product that 

is intended to affect the structure or 

function of the body of a human or other 

animal. This definition includes, but is 

not limited to: dietary supplements as 

defined by the Federal Food, Drug and 

Cosmetic Act (FD&C Act), prescription 

drugs, over-the-counter drugs, residues 

of pharmaceuticals remaining in 

containers, personal protective 

equipment contaminated with residues 

of pharmaceuticals, and clean-up 

material from the spills of 

pharmaceuticals. 

This proposed definition of 

‘‘pharmaceutical’’ is intended to include 

all dose forms, including, but not 

limited to tablets, capsules, medicinal 

gums or lozenges, medicinal liquids, 

ointments and lotions, intravenous (IV) 

or other compounded solutions, 

chemotherapy pharmaceuticals, 

vaccines, allergenics, medicinal 

shampoos, antiseptics, and any delivery 

device, including medicinal dermal 

patches, with the primary purpose to 

deliver or dispense the pharmaceutical. 

As a rule of thumb, if an over-thecounter product is required by the FDA 

to include ‘‘Drug Facts’’ on the label, it 

would be considered a pharmaceutical 

for the purposes of this rule. EPA asks 

for comment to identify additional types 

or forms of pharmaceuticals that are not 

adequately captured by the definition. 

EPA previously proposed to define 

the term ‘‘pharmaceutical’’ in the 

December 2008 Pharmaceutical 

Universal Waste proposal to mean ‘‘any 

chemical product, vaccine or allergenic 

(including any product with the primary 

purpose to dispense or deliver a 

chemical product, vaccine or 

allergenic), not containing a radioactive 

component, that is intended for use in 

the diagnosis, cure, mitigation, 

treatment or prevention of disease or 

injury in man or other animals; or any 

chemical product, vaccine, or allergenic 

(including any product with the primary 

purpose to dispense or deliver a 

chemical product, vaccine, or 

allergenic), not containing a radioactive 

component, that is intended to affect the 

structure or function of the body in man 

or other animals. This definition 

includes products such as transdermal 

patches, and oral delivery devices such 

as gums or lozenges. This definition 

does not include sharps or other 

infectious or biohazard waste, dental 

amalgams, medical devices not used for 

delivery or dispensing purposes, 

equipment, contaminated personal 

protective equipment or contaminated 

cleaning materials.’’ This definition was 

adapted from FD&C Act’s definition for 

‘‘drug’’ 21 U.S.C. 321(g). 

Based on the comments received in 

response to the Pharmaceutical 

Universal Waste proposal, the Agency is 

continuing to rely primarily on the 

FD&C Act’s definition for ‘‘drug’’ for the 

definition of pharmaceutical in this 

proposal and has preserved most of the 

definition proposed in the previous 

proposal. However, EPA is proposing to 

expand on its previous proposed 

definition of pharmaceutical based on 

stakeholder input. In particular, 

stakeholders requested that the Agency 

take a broad view in delineating what 

items are included in the definition of 

pharmaceutical so that the proposed 

standards apply broadly. Stakeholders 

indicated a preference for managing 

more items under the new standards 

than trying to determine how to apply 

the existing RCRA framework to 

pharmaceutical related items. Thus, the 

proposed definition of pharmaceutical 

no longer excludes pharmaceuticals 

with a radioactive component and 

includes items not specifically 

recognized by the U.S. Food and Drug 

Administration (FDA) as drugs, such as 

dietary supplements and 

pharmaceutical residues in containers 

(including delivery devices), personal 

protective equipment contaminated 

with residues of pharmaceuticals, and 

clean-up material from spills of 

pharmaceuticals. 

EPA’s decision to include dietary 

supplements under this rulemaking’s 

proposed definition of hazardous waste 

pharmaceutical reflects our interest in 

promoting a management scheme for all 

types of pharmaceuticals, and is based 

upon our understanding that dietary 

supplements are commonly found in 

various healthcare settings because they 

are recommended or prescribed by 

healthcare providers to patients.29

Further, retail pharmacies routinely sell 

vitamins and other medicinal minerals 

and supplements. 

When EPA uses the term ‘‘dietary 

supplements’’ in our proposed 

definition of ‘‘pharmaceutical,’’ EPA is 

referencing the definition for dietary 

supplement used by the FD&C Act, as 

amended by the Dietary Supplement 

Health and Education Act of 1994 (21 

U.S.C. 321(ff)).30 EPA understands that 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58022 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

diet that bears or contains one or more of the 

following dietary ingredients: (A) a vitamin; (B) a 

mineral; (C) an herb or other botanical; (D) an 

amino acid; (E) a dietary substance for use by man 

to supplement the diet by increasing the total 

dietary intake; or (F) a concentrate, metabolite, 

constituent, extract, or combination of any 

ingredient described in clause (A), (B), (C), (D), or 

(E); For the complete definition for dietary 

supplement, please see: http://www.gpo.gov/fdsys/

pkg/USCODE-2013-title21/pdf/USCODE-2013- 

title21-chap9-subchapII-sec321.pdf. 

31For more information regarding dietary 

supplements, please see: http://www.fda.gov/Food/ 

DietarySupplements/default.htm. 

32 It is the responsibility of the manufacturers to 

ensure their dietary supplements are safe and that 

all claims on labels are true and accurate. 

Nevertheless, FDA has the authority to take action 

against any unsafe dietary supplements, as well as 

to take action against any products with false and 

misleading claims. 

33See Section VI, Chapter 2 of OSHA’s Technical 

Manual (paragraph V.C.1.b.) https://www.osha.gov/ 

dts/osta/otm/otm_vi/otm_vi_2.html. 

34For additional information about RCRA 

hazardous waste listings and characteristics, see: 

http://www.epa.gov/osw/hazard/wastetypes/

index.htm. 

the FDA does not recognize dietary 

ingredients or dietary supplements 

under its definition of ‘‘drug,’’ but rather 

categorizes such items under the general 

umbrella of foods and therefore, does 

not review them before being 

marketed.31 32 For the purposes of this 

proposed rule, however, EPA recognizes 

that healthcare facilities may benefit 

from managing dietary supplements 

along with other drugs under the 

regulatory scheme being proposed, and 

thus, is including it in the proposed 

definition of pharmaceutical. Although 

dietary supplements would be 

considered pharmaceuticals under this 

proposed definition, only the dietary 

supplements that meet the definition of 

hazardous waste (e.g., exhibits the 

toxicity characteristic for metal content) 

would be regulated under part 266, 

subpart P as hazardous waste 

pharmaceuticals (see the definition of 

‘‘hazardous waste pharmaceutical’’). We 

seek public comment on the Agency’s 

decision to recognize dietary 

supplements as pharmaceuticals under 

this regulation. 

The Agency also is clarifying that its 

proposed definition includes any items 

containing pharmaceutical residuals, 

such as dispensing bottles, IV bags and 

tubing, vials, unit dose packages, and 

delivery devices, such as syringes and 

patches. In addition, EPA is proposing 

that items contaminated with or 

containing residual pharmaceuticals, 

such as personal protective equipment 

containing trace amounts of 

pharmaceuticals or related spill cleanup materials (including loose tablets 

accumulated during pharmacy floor 

sweepings) also meet this proposed 

definition of pharmaceutical. However, 

this proposed definitions does not 

include sharps (e.g., needles from IV 

bags or syringes). Used sharps, such as 

needles or syringes with needles, are not 

included under the proposed rule 

because sharps are considered medical 

wastes, presently regulated at the state 

and local level. In addition, sharps pose 

both an unreasonable physical danger 

and biohazard danger so have not been 

included in the definition of 

pharmaceutical under this proposed 

rule. OSHA’s Technical Manual 

incorporates a recommendation from 

the American Society of Hospital 

Pharmacists that ‘‘all syringes and 

needles used in the course of 

preparation be placed in ‘‘sharps’’ 

containers for disposal without being 

crushed, clipped or capped.’’ 33 Further, 

as discussed in Section V.E.3.c of this 

preamble, EPA is proposing to 

conditionally exclude the residues of 

hazardous waste pharmaceuticals 

remaining in fully dispensed syringes 

from RCRA regulation. However, EPA is 

concerned about the possibility that 

some syringes may be disposed of in 

sharps containers that may contain 

significant amounts of undispensed 

pharmaceutical. EPA seeks comment on 

the prevalence of this situation. 

The Agency solicits public comment 

on the proposed definition of 

‘‘pharmaceutical’’ in its entirety, and 

particularly on EPA’s decision to 

incorporate dietary supplements and 

items containing pharmaceutical 

residuals as part of the definition of 

pharmaceutical. 

2. What is the proposed definition of a 

‘‘hazardous waste pharmaceutical’’? 

This proposed rule defines 

‘‘hazardous waste pharmaceutical’’ as a 

pharmaceutical that is a solid waste, as 

defined in § 261.2, and is listed in part 

261, subpart D, or exhibits one or more 

characteristics identified in part 261, 

subpart C. See Section IV.A.3. of this 

preamble for a discussion of 

pharmaceuticals that may be listed or 

characteristic hazardous wastes.34

The Agency is proposing to define the 

term ‘‘hazardous waste pharmaceutical’’ 

in order to clarify its intent that only 

pharmaceuticals (as defined in this 

proposal) that meet the definition of 

hazardous waste when disposed or 

discarded need to be managed under 

these proposed management standards. 

This means that any pharmaceutical 

waste that meets the definition of 

hazardous waste is a hazardous waste 

pharmaceutical for the purposes of this 

rule. For example, the prescription 

pharmaceutical warfarin (brand name 

Coumadin) is a listed hazardous waste 

and when discarded meets the 

definition of a hazardous waste 

pharmaceutical. EPA requests public 

comment on the proposed definition for 

‘‘hazardous waste pharmaceutical.’’ The 

Agency also solicits information on 

whether any dietary supplements 

currently on the market meet or 

potentially could meet RCRA’s 

definition of a hazardous waste. 

3. What is the proposed definition of a 

‘‘potentially creditable hazardous waste 

pharmaceutical’’? 

In order to distinguish hazardous 

waste pharmaceuticals that are 

transported to RCRA treatment, storage 

and disposal facilities (TSDFs) from 

those hazardous waste pharmaceuticals 

being returned by a healthcare facility to 

a pharmaceutical reverse distributor for 

a determination or verification of 

manufacturer’s credit, the Agency is 

proposing a definition for ‘‘potentially 

creditable hazardous waste 

pharmaceutical.’’ 

The proposed rule defines 

‘‘potentially creditable hazardous waste 

pharmaceutical’’ to mean a hazardous 

waste pharmaceutical that has the 

potential to receive manufacturer’s 

credit and is 

(1) unused or un-administered; and 

(2) unexpired or less than one year 

past expiration date. 

The term does not include ‘‘evaluated 

hazardous waste pharmaceuticals,’’ 

residues of pharmaceuticals remaining 

in containers, contaminated personal 

protective equipment, and clean-up 

material from the spills of 

pharmaceuticals. 

Whether a pharmaceutical is eligible 

for manufacturer’s credit is determined 

solely by the manufacturer’s return 

policy. Based on comments received for 

the 2008 Universal Waste proposed rule 

and through discussions with various 

stakeholders, the Agency understands 

that the return policies of manufacturers 

change regularly. As a result, 

pharmacies are not always aware if a 

particular pharmaceutical will be 

creditable at the time that it is pulled 

from the shelves. However, the Agency 

also understands that there are instances 

where it is well known that a 

pharmaceutical will not be creditable. 

Examples of these instances include the 

following: if the pharmaceutical has 

been removed from the original 

container and re-packaged for 

dispensing purposes; if an attempt was 

made to administer a pharmaceutical, 

but the patient refused to take it; if the 

hazardous waste pharmaceutical was 

generated during patient care; if the 

pharmacy receives a return of a 

dispensed pharmaceutical for which 


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they had already received compensation 

by a third-party payer; or if the 

pharmaceutical is more than one year 

past its expiration date. In these 

instances, as well as others, the 

healthcare facility knows that it will not 

receive manufacturer’s credit. It is the 

Agency’s intent for the proposed 

definition of potentially creditable 

hazardous waste pharmaceuticals to 

allow the return of hazardous waste 

pharmaceuticals to reverse distributors 

for the determination of credit. It is not 

the Agency’s intent, however, for 

reverse distributors to serve in the 

capacity as TSDFs when it is well 

known that the manufacturer will not 

give credit for those hazardous waste 

pharmaceuticals. 

Also, based on communication with 

stakeholders and the public comments 

received on the 2008 Universal 

Pharmaceutical Waste proposal, EPA 

understands that pharmaceutical 

manufacturers’ policies often allow for 

credit to be received on the return of 

‘partials.’ Partials is a term used in the 

industry to refer to opened containers 

that have had some contents removed. 

Under the proposed definition, the 

Agency would consider partials to be 

potentially creditable hazardous waste 

pharmaceuticals. 

The Agency is soliciting comment on 

the proposed definition of ‘‘potentially 

creditable hazardous waste 

pharmaceutical’’ and whether the 

definition is broad enough to encompass 

the various types of hazardous waste 

pharmaceuticals that are shipped to 

reverse distributors for manufacturer’s 

credit, while also ensuring that noncreditable hazardous waste 

pharmaceuticals are not inappropriately 

shipped to reverse distributors solely for 

waste management purposes. Finally, 

the Agency is seeking comment on 

additional situations where it is well 

known that a returned pharmaceutical 

will or will not receive manufacturer’s 

credit. 

4. What is the proposed definition of 

‘‘non-creditable hazardous waste 

pharmaceutical’’? 

As discussed previously, there are 

instances when it is well known that 

credit will not be received for certain 

hazardous waste pharmaceuticals. In 

order to distinguish hazardous waste 

pharmaceuticals that have the potential 

for credit from those that have no 

expectation of receiving credit, the 

Agency is proposing to define the term 

‘‘non-creditable hazardous waste 

pharmaceutical.’’ The proposed 

definition of a ‘‘non-creditable 

hazardous waste pharmaceutical’’ is a 

hazardous waste pharmaceutical that is 

not expected to be eligible for 

manufacturer’s credit. Examples 

include, but are not limited to: if the 

pharmaceutical has been removed from 

the original container and re-packaged 

for dispensing purposes; if an attempt 

was made to administer a 

pharmaceutical, but the patient refused 

to take it; if the hazardous waste 

pharmaceutical was generated during 

patient care; if the pharmacy receives a 

return of a dispensed pharmaceutical for 

which they had already received 

compensation by a third-party payer 

(e.g. health insurance company); or if 

the pharmaceutical is more than one 

year past its expiration date. EPA 

requests comment on the proposed 

definition and seeks additional 

examples of hazardous waste 

pharmaceuticals that have no 

expectation of receiving manufacturer’s 

credit. 

5. What is the proposed definition of 

‘‘evaluated hazardous waste 

pharmaceutical’’? 

After potentially creditable hazardous 

waste pharmaceuticals arrive at a 

pharmaceutical reverse distributor, they 

are evaluated to determine whether they 

are eligible for manufacturer’s credit, or 

whether they need to be transferred to 

another pharmaceutical reverse 

distributor for additional verification of 

manufacturer’s credit. Hazardous waste 

pharmaceuticals that need to be 

transferred to another pharmaceutical 

reverse distributor for additional 

verification of manufacturer’s credit will 

continue to be considered potentially 

creditable hazardous waste 

pharmaceuticals. EPA is proposing that 

hazardous waste pharmaceuticals for 

which manufacturer’s credit has been 

issued (and no further verification of 

credit is required), as well as those that 

have been deemed non-creditable, be 

referred to as ‘‘evaluated hazardous 

waste pharmaceuticals.’’ EPA is 

proposing to define ‘‘evaluated 

hazardous waste pharmaceutical’’ as a 

hazardous waste pharmaceutical that 

was a potentially creditable hazardous 

waste pharmaceutical but has been 

evaluated by a pharmaceutical reverse 

distributor to establish whether it is 

eligible for manufacturer’s credit and 

will not be sent to another 

pharmaceutical reverse distributor for 

further evaluation or verification. It is 

important to define this term since the 

proposed management and shipping 

standards for potentially creditable 

hazardous waste pharmaceuticals differ 

from the proposed management and 

shipping standards for evaluated 

hazardous waste pharmaceuticals. For a 

discussion of the proposed management 

and shipping standards for potentially 

creditable hazardous waste 

pharmaceuticals, see Section V.F.2. For 

a discussion of the proposed 

management and shipping standards for 

evaluated hazardous waste 

pharmaceuticals, see Section V.F.1.b. 

6. What is the proposed definition of 

‘‘household waste pharmaceutical’’? 

We are proposing to define the term 

‘‘household waste pharmaceutical’’ as a 

solid waste, as defined in § 261.2, that 

also meets the definition of 

pharmaceutical, as defined in this 

proposed rule, but is not a hazardous 

waste because it is exempt from RCRA 

Subtitle C regulation by the household 

waste exclusion in § 261.4(b)(1). We are 

proposing this term to distinguish this 

type of waste pharmaceutical from the 

hazardous waste pharmaceuticals that 

are proposed to be regulated under this 

new subpart. This proposed rule does 

not apply to pharmaceutical waste that 

is exempt due to the household waste 

exclusion. 

7. What is the proposed definition of 

‘‘non-hazardous waste pharmaceutical’’? 

We are proposing to define the term 

‘‘non-hazardous waste pharmaceutical.’’ 

While hazardous waste pharmaceuticals 

are proposed to be regulated under this 

new subpart, non-hazardous waste 

pharmaceuticals will not be regulated 

under this new subpart, nor the RCRA 

subtitle C hazardous waste regulations. 

The Agency is proposing to include this 

definition since we believe it important 

to delineate what is and is not regulated 

under this new subpart. We propose to 

define the term ‘‘non-hazardous waste 

pharmaceutical’’ to mean a 

pharmaceutical that is a solid waste, as 

defined in § 261.2, but that is not a 

listed hazardous waste and does not 

exhibit any characteristics of hazardous 

waste (i.e., ignitable, corrosive, reactive, 

toxic). 

8. What is the proposed definition of 

‘‘non-pharmaceutical hazardous waste’’? 

Like the previous definition, we are 

proposing a definition for nonpharmaceutical hazardous waste to help 

us delineate what is and what is not 

regulated under this new subpart. We 

are proposing to define the term ‘‘nonpharmaceutical hazardous waste’’ as a 

solid waste, as defined in § 261.2, that 

is either a listed hazardous waste or 

exhibits one or more characteristics of 

hazardous waste, but does not meet the 

definition of a pharmaceutical, as 

proposed under this new subpart. The 

management of non-pharmaceutical 

hazardous wastes is not regulated under 

this subpart; rather generators of nonVerDate Sep<11>2014 19:46 Sep 24, 2015 Jkt 235001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 E:\FR\FM\25SEP3.SGM 25SEP3

tkelley on DSK3SPTVN1PROD with PROPOSALS3
58024 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

35 45 CFR part 160 http://aspe.hhs.gov/

admnsimp/final/pvctxt01.htm. 

36For more information on the disposal process, 

please see: Ruhoy, I.S. and Daughton, C.G. ‘‘Types 

and Quantities of Leftover Drugs Entering the 

Environment via Disposal to Sewage—Revealed by 

Coroner Records,’’ Sci. Total Environ., 2007, 388(1– 

3):137–148. http://www.epa.gov/nerlesd1/bios/

daughton/SOTE2007.pdf. 

pharmaceutical hazardous wastes, 

including healthcare facilities and 

reverse distributors, remain subject to 

the existing Subtitle C hazardous waste 

regulations for the management of those 

hazardous wastes. Examples of nonpharmaceutical hazardous wastes that 

healthcare facilities may generate 

include cleaning solutions, solvents, 

and laboratory wastes. Some hazardous 

wastes exist in pharmaceutical form and 

non-pharmaceutical form. For example, 

warfarin, nicotine, and lindane were all 

originally listed as hazardous waste 

because they were pesticides, not 

medicines. If these products are not 

intended for human or animal use, they 

would be considered nonpharmaceutical hazardous wastes and 

remain subject to the existing RCRA 

hazardous waste regulations, not part 

266, subpart P. 

9. What is the proposed definition of a 

‘‘healthcare facility’’? 

These proposed regulations differ 

from those in the Pharmaceutical 

Universal Waste proposal in that they 

apply based not only on the type of 

hazardous waste generated, but also on 

the sector generating the waste. 

Accordingly, EPA is proposing a 

definition for ‘‘healthcare facility’’ so 

that it is clear to whom these proposed 

regulations apply. This proposed 

definition is adapted from the definition 

of ‘‘health care’’ that the Department of 

Health and Human Services (DHHS) 

promulgated as a result of the Health 

Insurance Portability and 

Accountability Act of 1996 (HIPAA) (45 

CFR part 160.103).35 Thus, for the 

purposes of these proposed regulations, 

EPA is proposing that ‘‘healthcare 

facility’’ means any person that (1) 

provides preventative, diagnostic, 

therapeutic, rehabilitative, maintenance 

or palliative care, and counseling, 

service, assessment or procedure with 

respect to the physical or mental 

condition, or functional status, of a 

human or animal or that affects the 

structure or function of the human or 

animal body; or (2) sells or dispenses 

over-the-counter or prescription 

pharmaceuticals. This definition 

includes, but is not limited to, hospitals, 

psychiatric hospitals, ambulatory 

surgical centers, health clinics, 

physicians’ offices, optical and dental 

providers, chiropractors, long-term care 

facilities, ambulance services, coroners 

and medical examiners, pharmacies, 

long-term care pharmacies, mail-order 

pharmacies, retailers of over-the-counter 

medications; and veterinary clinics and 

hospitals. Thus, these proposed 

regulations will be applicable to any 

healthcare facility for human or animal 

which generates hazardous waste 

pharmaceuticals on its premises. 

EPA proposes to include coroners in 

the definition of a healthcare facility 

despite the fact that the services 

coroners provide occur after life. 

Coroners will often inventory, and then 

dispose of, any pharmaceuticals that 

may be found at the scene of a death. 

A common method of disposal is 

sewering. In order to reduce the sewer 

disposal practices of coroners, and to 

provide the same management options 

that are available to other healthcare 

facilities, EPA has decided to include 

‘‘coroners’’ within the definition of 

healthcare facility, although the Agency 

solicits comment on including coroners 

within the definition of healthcare 

facility.36

Under the proposed definition, 

healthcare facilities include locations 

that sell pharmaceuticals over the 

internet, through the mail, or through 

other distribution mechanisms. A 

pharmacy does not necessarily have to 

have a ‘‘brick and mortar’’ or ‘‘store 

front’’ presence to be considered a 

healthcare facility for the purposes of 

this proposed rule. The proposed 

definition of a ‘‘healthcare facility’’ also 

applies to entities that engage in drug 

compounding. In general, compounding 

is a practice in which a licensed 

pharmacist, a licensed physician, or, in 

the case of an outsourcing facility, a 

person under the supervision of a 

licensed pharmacist, combines, mixes, 

or alters ingredients of a drug to create 

a medication tailored to the needs of an 

individual patient. The proposed 

definition of ‘‘healthcare facility’’ 

applies to state-licensed pharmacies, 

Federal facilities, and licensed 

physicians that compound drugs in 

accordance with section 503A of the 

FD&C Act, and to outsourcing facilities 

that compound drugs in accordance 

with section 503B of the FD&C Act. The 

Agency is soliciting comment on the 

proposed definition of ‘‘healthcare 

facility,’’ including whether it is 

appropriate to consider these 

compounders as healthcare facilities 

within the scope of this proposed rule. 

The proposed definition of 

‘‘healthcare facility’’ does not apply to 

pharmaceutical manufacturers and their 

representatives, wholesalers, or any 

other entity that is involved in the 

manufacturing, processing or wholesale 

distribution of over-the-counter or 

prescription pharmaceuticals, unless 

they meet the definition of a ‘‘reverse 

distributor’’ as discussed in this section 

and in Section V.G. The purpose for 

these sector-based regulations is to 

address the various issues that 

healthcare facilities and reverse 

distributors face when managing 

hazardous waste pharmaceuticals. As 

noted previously, the Agency does not 

anticipate that manufacturing facilities, 

which predictably generate a known 

range of hazardous wastes, face the 

same issues as healthcare facilities. 

10. What is the proposed definition of 

a ‘‘long-term care facility’’? 

The term ‘‘long-term care facility’’ 

does not have a standardized, industry 

definition. EPA is, therefore, proposing 

the following definition for ‘‘long-term 

care facility’’ (LTCF): a licensed entity 

that provides assistance with activities 

of daily living, including managing and 

administering pharmaceuticals to one or 

more individuals at the facility. This 

definition includes, but is not limited 

to, assisted living, hospices, nursing 

homes, skilled nursing facilities, and the 

assisted living and skilled nursing care 

portions of continuing care retirement 

communities. Not included within the 

scope of this definition are group 

homes, independent living 

communities, and the independent 

living portions of continuing care 

retirement communities. 

The included facilities are licensed 

care facilities that are more similar to 

hospitals than to standard residences. 

Although group homes may be licensed 

care facilities, they are typically very 

small (under 10 beds). Independent 

living communities are not licensed care 

facilities, but rather are residences made 

up of individual units such as 

townhomes or apartments. Finally, 

private residences with visiting nurses 

are not considered long-term care 

facilities. EPA requests public comment 

on the proposed definition of long-term 

care facility, and the inclusion of 

assisted living facilities, skilled nursing 

facilities and other LTCFs that 

administer their residents’ 

pharmaceuticals as an integral part of 

their services within the definition of 

‘‘healthcare facility.’’ 

The DEA’s definition of ‘‘long term 

care facility’’ is ‘‘a nursing home, 

retirement care, mental care or other 

facility or institution which provides 

extended health care to resident 

patients’’ (21 CFR 1300.01). EPA’s 

definition is more descriptive, and 

includes a list—which is not 


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Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58025 

37As noted in the definition of ‘‘potentially 

creditable hazardous waste pharmaceutical,’’ credit 

is provided for those pharmaceuticals that are less 

than one year past the expiration date. 

38Through the return of pharmaceuticals by a 

pharmacy for manufacturer’s credit, manufacturers 

are able to maintain control of the pharmaceutical 

up to the point of its disposal, thereby, decreasing 

the risk of diversion of the pharmaceutical. 

39On September 9, 2014, DEA finalized new 

definitions for ‘‘reverse distribute’’ and ‘‘reverse 

distributor.’’ Please see 79 FR 53520. The term 

‘‘reverse distributor’’ is defined as ‘‘a person 

registered with the Administration [DEA] as a 

reverse distributor.’’ 

40 In order for a reverse distributor to be able to 

accept controlled substances, the reverse distributor 

must be a DEA registrant. See 21 CFR part 1308 for 

a complete list of controlled substances. 

41 79 FR 46748; August 11, 2014. The PHMSA’s 

proposed definition of reverse logistics ‘‘is the 

process of moving goods from their final destination 

for the purpose of capturing value, recall, 

replacement, proper disposal, or similar reason.’’ 

exhaustive—of examples of long-term 

care facilities. We feel this a more 

flexible way to define the universe. 

Although the definitions differ, they are 

not necessarily incompatible. 

11. What is the proposed definition of 

a ‘‘pharmaceutical reverse distributor’’? 

As more fully discussed in Section 

V.G.1 of this preamble, pharmaceutical 

manufacturers often offer credit to 

healthcare facilities on the return of 

unused and/or expired 

pharmaceuticals.37 Stakeholders have 

informed the Agency that manufacturers 

issue credit for a variety of reasons. For 

example, it is a marketing incentive tool 

that helps ensure against illicit 

diversion 38 or improper disposal, and it 

allows manufacturers to collect data on 

the returned items, which then can be 

used to help plan for future 

pharmaceutical production. Reverse 

distributors are contracted by both 

pharmaceutical manufacturers and 

healthcare facilities to facilitate the 

crediting process. 

Some of the pharmaceuticals returned 

for credit will meet RCRA’s definition of 

a hazardous waste. Due to the fact that 

the vast majority of pharmaceuticals 

that are returned for manufacturer’s 

credit are disposed of once credit 

eligibility is determined, EPA is 

proposing new standards for shipment 

of potentially creditable hazardous 

waste pharmaceuticals (see Section 

V.F.2.) and the management of 

potentially creditable hazardous waste 

pharmaceuticals by reverse distributors 

(see Section V.G). Thus, EPA is 

proposing to define pharmaceutical 

reverse distributor to clearly delineate 

which types of facilities are subject to 

this proposed rule. In keeping with how 

the term is commonly used in the 

healthcare sector, EPA is proposing to 

define a ‘‘pharmaceutical reverse 

distributor’’ as any person that receives 

and accumulates potentially creditable 

hazardous waste pharmaceuticals for 

the purpose of facilitating or verifying 

manufacturer’s credit. Any person, 

including forward distributors and 

pharmaceutical manufacturers, that 

processes pharmaceuticals for the 

facilitation or verification of 

manufacturer’s credit is considered a 

pharmaceutical reverse distributor. 

The Agency also needs to clarify the 

difference between what is defined as a 

pharmaceutical reverse distributor for 

the purpose of these proposed 

regulations and how DEA regulations 

define ‘‘reverse distribute.’’ The recently 

amended DEA regulatory definition of 

‘‘reverse distribute’’ is to ‘‘acquire 

controlled substances from another 

registrant or law enforcement for the 

purposes of: (1) Return to the registered 

manufacturer or another registrant 

authorized by the manufacturer to 

accept returns on the manufacturer’s 

behalf; or (2) Destruction (21 CFR 

1300.01).39

Under DEA’s definition, a reverse 

distributor does not necessarily process 

pharmaceuticals for the purpose of 

determining manufacturer’s credit; 

rather, their main function under DEA’s 

definition is to destroy the controlled 

substances. Under EPA’s proposed 

definition, however, a pharmaceutical 

reverse distributor is defined more 

broadly as a facility that can accept 

potentially creditable pharmaceuticals 

for the purposes of determining 

manufacturer’s credit. These potentially 

creditable pharmaceuticals may or may 

not be identified as controlled 

substances by DEA.40 Therefore, a DEAregistered reverse distributor may or 

may not meet EPA’s definition of a 

pharmaceutical reverse distributor and 

vice versa. For example, a 

pharmaceutical reverse distributor that 

accepts controlled substances (that are 

also hazardous wastes) for the sole 

purpose of destruction (e.g., 

incineration) would be regulated as a 

DEA-registered reverse distributor and 

as a RCRA TSDF, and not as a 

pharmaceutical reverse distributor 

under the RCRA hazardous waste 

regulations. Conversely, a 

pharmaceutical reverse distributor that 

processes pharmaceuticals for 

manufacturer’s credit, but is not a DEA 

registrant and therefore, cannot accept 

controlled substances, would meet the 

RCRA pharmaceutical reverse 

distributor definition, but not DEA’s 

reverse distributor definition. However, 

EPA has heard from stakeholders that 

many, if not all, entities that facilitate 

manufacturer’s credit are also DEAregistered reverse distributors. 

Therefore, such pharmaceutical reverse 

distributors would meet both EPA’s 

proposed definition of pharmaceutical 

reverse distributor, as well as the DEA’s 

definition of reverse distributor. Lastly, 

we would note that EPA’s definition for 

reverse distribution does not alter or 

supersede the requirements of the 

Controlled Substances Act and DEA 

regulations. 

In addition, the Department of 

Transportation’s Pipeline and 

Hazardous Materials Safety 

Administration (PHMSA) has defined 

the closely related term, ‘‘reverse 

logistics,’’ in a recent proposed 

rulemaking.41 The EPA has been 

coordinating with the PHMSA to ensure 

that our rules are compatible, even if the 

definitions differ. It is important to note 

that, when finalized, the PHMSA rule 

will not supersede EPA’s RCRA Subtitle 

C regulations for when something is 

considered a solid or hazardous waste 

or how a hazardous waste must be 

managed. 

The Agency solicits public comment 

on its proposed definition of a 

‘‘pharmaceutical reverse distributor.’’ 

Specifically, EPA asks for comment on 

whether the definition of 

‘‘pharmaceutical reverse distributor’’ 

captures the universe of facilities acting 

as reverse distributors for 

pharmaceuticals. In addition, the 

Agency asks for comment regarding the 

intersection of DEA and EPA’s 

definitions. 

B. What is the scope of this proposed 

rule? 

1. What facilities are subject to this 

rulemaking? 

a. Healthcare facilities. The Agency is 

proposing that healthcare facilities that 

are currently considered either SQGs or 

LQGs will be required to manage all 

hazardous waste pharmaceuticals 

generated at their facilities in 

accordance with the standards proposed 

in this document. In other words, these 

management standards will apply to any 

healthcare facility that generates (or 

accumulates) more than 100 kg of 

hazardous waste per calendar month or 

more than 1 kg of acute hazardous waste 

per calendar month (e.g., P-listed 

hazardous waste) or more than 100 kg 

of any residue or contaminated soil, 

waste, or other debris resulting from the 

clean-up of a spill, into or on any land 

or water, of any acute hazardous wastes 

listed in §§ 261.31, or 261.33(e) per 

calendar month. All healthcare facilities 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
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42See November 13, 1984; 49 FR 44978. 

43AARP Public Policy Institute, INSIGHT on the 

Issues 58, Assisted Living and Residential Care in 

the States in 2010, April 2012. http://www.aarp.org/ 

content/dam/aarp/research/public_policy_institute/

ltc/2012/residential-care-insight-on-the-issues-july2012-AARP-ppi-ltc.pdf or see the docket for this 

proposed rulemaking (EPA–HQ–RCRA–2007–0932). 

44 2009 Overview of Assisted Living; a 

collaborative research project of AAHSA, ASHA, 

ALFA, NCAL & NIC. 

45 Ibid. 

46Net weight (without packaging) of types of 

pharmaceuticals wastes, including those that are 

RCRA hazardous, non-RCRA hazardous, DEA 

controlled, prescription and over-the-counter. 

Memo from Lillian Gonzalez, Colorado Department 

of Public Health and Environment to Kristin 

Fitzgerald, EPA; January 9, 2013, see the docket for 

this proposed rulemaking (EPA–HQ–RCRA–2007– 

0932). 

that meet these applicability criteria 

will be subject to the same set of 

standards for the management of their 

hazardous waste pharmaceuticals. That 

is, subpart P is not optional for 

healthcare facilities that generate above 

the CESQG monthly quantity limits (see 

Section V.B.1.c. of the preamble for a 

discussion of what regulations apply to 

CESQGs). EPA is proposing to make 

subpart P mandatory to promote 

national consistency, a goal championed 

by stakeholder comments as well as 

EPA. In addition, having one set of 

standards applicable to pharmaceutical 

waste will be less confusing to the 

regulated community, which should 

lead to better compliance. The 

stringency of the subpart P management 

standards for hazardous waste 

pharmaceuticals do not change if a 

healthcare facility generates more 

hazardous waste pharmaceuticals from 

one month to another. The generator 

categories—that is, LQG, SQG, and 

CESQG—under the part 262 RCRA 

requirements will only be relevant for 

the healthcare facilities’ nonpharmaceutical hazardous waste 

because non-pharmaceutical hazardous 

waste remain subject to the 40 CFR part 

262 generator regulations (see Section 

VI. Implementation and Enforcement for 

further discussion). 

b. Long-term care facilities subject to 

this rule. Long-term care facilities are 

included within the proposed definition 

of healthcare facility. Further, EPA is 

proposing to change its policy regarding 

the management of hazardous waste and 

hazardous waste pharmaceuticals 

generated on the premises of long-term 

care facilities. Under current federal 

RCRA interpretation (see 73 FR 73525, 

December 2, 2008), hazardous wastes 

(including pharmaceuticals) generated 

on the premises of a long-term care 

facility can fall under two categories: (1) 

RCRA Subtitle C hazardous waste or (2) 

household hazardous waste that is 

exempt from RCRA Subtitle C 

regulation. As explained in the 

preamble to the proposal to add 

pharmaceuticals to the Universal Waste 

program, ‘‘the [long-term care] facility 

itself may generate hazardous wastes as 

a result of its central management of 

pharmaceuticals in its pharmacy or 

pharmacy-like area. These hazardous 

pharmaceutical wastes would be subject 

to the RCRA hazardous waste generator 

regulations since the pharmaceuticals 

are under the control of the facility, and 

thus, the resulting wastes are generated 

by that facility. However, patients and 

residents in long-term care facilities 

may generate hazardous wastes. Those 

pharmaceuticals that are under the 

control of the patient or resident of the 

long-term care facility, when discarded, 

would be subject to RCRA’s household 

hazardous waste exclusion 

(§ 261.4(b)(1)). Hazardous 

pharmaceutical wastes generated by the 

resident are excluded from regulation 

because they are considered to be 

derived from a household’’ (see 

December 2, 2008; 73 FR 73525). 

The Agency is now providing notice 

that it intends to revise this 

interpretation. Specifically, hazardous 

waste (including pharmaceuticals) 

generated at long-term care facilities 

will no longer be considered exempt as 

household hazardous waste. It will be 

regulated as hazardous waste, subject to 

the appropriate RCRA Subtitle C 

management standards, including the 

standards being proposed. The Agency 

is revising its interpretation with regard 

to hazardous wastes generated at longterm care facilities based on a 

reevaluation of how such facilities 

operate. Specifically, in order for 

hazardous waste to qualify for the 

household hazardous waste exemption 

of § 261.4(b)(1), it must meet two 

criteria: (1) The hazardous waste must 

be generated by individuals on the 

premises of a household, and (2) the 

hazardous waste must be composed 

primarily of materials found in the 

wastes generated by consumers in their 

homes.42 EPA now believes that 

hazardous waste generated at long-term 

care facilities, even when those 

pharmaceuticals are under the control of 

the patient or resident, does not meet 

either criterion for the household 

hazardous waste exemption. 

First, a long-term care facility is more 

akin to a hospital than it is a typical 

residence and EPA does not consider 

hospitals to be households. Long-term 

care facilities are licensed, residential 

care settings that offer their residents a 

wide range of services, many of which 

are centered on administering 

medications and providing healthcare 

by various professional healthcare 

providers, such as medical technicians, 

nurse’s aides, nurses, and doctors. Other 

services provided involve assistance in 

performing activities of daily living, 

such as bathing, and eating. A 2012 

American Association of Retired Person 

(AARP) Public Policy Institute report 

indicates that there is an average of 24 

beds per licensed residential care 

facilities (excluding nursing homes).43

Based on another report prepared as a 

collaborative project of the American 

Association of Homes and Services for 

the Aging (AAHSA), American Seniors 

Housing Association (ASHA), Assisted 

Living Federation of America (ALFA), 

National Center for Assisted Living 

(NCAL) and National Investment Center 

for the Seniors Housing and Care 

Industry (NIC), there is an average of 54 

units (e.g., rooms) for all types of 

assisted living/dementia care 

properties.44 Unlike other multiple 

dwellings, approximately 81 percent of 

these facilities store medications in a 

central location and 89 percent 

administer medications to their 

residents.45 Given that long-term care 

facilities are licensed settings for the 

care of their residents and routinely 

provide healthcare services, we believe 

that long-term care facilities more 

closely resemble hospitals than typical 

residences. 

Second, the hazardous wastes 

generated by long-term care facilities do 

not meet the second criteria for the 

waste to be considered household 

hazardous waste. This is primarily due 

to the quantity of pharmaceutical wastes 

that are often generated on the premises 

of long-term care facilities when 

compared to a typical residence. For 

example, the Colorado Department of 

Public Health and Environment 

estimates that a 100-bed nursing home 

might expect to generate approximately 

120 to 336 pounds of pharmaceutical 

waste per year.46 In addition, long-term 

care facilities, such as assisted living 

facilities and nursing homes, generate a 

greater variety of hazardous waste 

pharmaceuticals and a greater quantity 

of hazardous waste than a typical 

household generates. The AARP Public 

Policy Institute report indicates that 

‘‘residents take an average of seven or 

eight different prescriptions and two 

OTC [over-the-counter] medications 

daily.’’ This number is larger than what 

we would expect a typical household to 

generate. This distinction about volume 

of waste is analogous to the distinction 

that EPA has made in the past about 

contractor or do-it-yourself waste from 


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Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58027 

47Memo from Petruska to McNally, February 28, 

1995; RCRA Online #11897 that discusses the 

distinction about what renovation waste is 

household hazardous waste and what is not. 

48See the docket for this rulemaking for data 

about long-term care facilities which was developed 

using data in the economic analysis: EPA–HQ– 

RCRA–2007–0932. 

49Not all authorized states recognize the CESQG 

category and may have more stringent regulatory 

requirements for CESQGs. Therefore, as noted 

previously, EPA recommends that facilities that 

qualify as CESQGs under the federal regulations 

contact their state and/or local environmental 

regulatory agencies to determine whether more 

stringent regulatory requirements apply to CESQGs 

in their state. 

households: waste from ‘‘routine 

residential maintenance’’ is exempt as 

household hazardous waste, while 

waste from ‘‘building construction, 

renovation, demolition’’ is not 

exempt.47 Therefore, EPA is providing 

notice that if this rule is finalized, longterm care facilities may no longer use 

the household hazardous waste 

exemption. If this rule is finalized, longterm care facilities would need to 

manage their hazardous waste 

pharmaceuticals in accordance with the 

healthcare facility specific management 

standards in this proposal and their 

non-pharmaceutical hazardous wastes 

in accordance with the applicable RCRA 

hazardous waste generator requirements 

in § 261.5 (for CESQGs) or part 262 (for 

SQGS and LQGs). However, even 

though long-term care facilities will no 

longer be considered eligible to use the 

household hazardous waste exemption, 

our data show that only 28% of longterm care facilities generate hazardous 

waste pharmaceuticals, and of those, 

85% are small enough to be considered 

CESQGs of hazardous waste (regulated 

under § 261.5) and therefore not subject 

to part 266, subpart P (except the sewer 

ban).48 The Agency seeks comment on 

whether this proposed change to 

consider long-term care facilities to be 

healthcare facilities instead of 

households is appropriate. We also 

seeking comment on the extent to which 

long-term care facilities will pass the 

cost of compliance onto its customers. 

Until this rule is finalized, the current 

interpretation from the Universal Waste 

preamble will stand regarding 

hazardous waste from long-term care 

facilities. 

c. Conditionally exempt small 

quantity generators (CESQGs). As 

discussed in the Background Section 

(Section IV.A.2), CESQGs are subject to 

a limited set of federal RCRA Subtitle C 

hazardous waste regulations, provided 

that they comply with the conditions set 

forth in § 261.5.49 This proposed 

rulemaking will preserve this current 

regulatory structure for the most part; 

therefore, healthcare facilities that 

generate hazardous waste 

pharmaceuticals and qualify as CESQGs, 

will maintain their conditional 

exemption under § 261.5 and will not be 

subject to most aspects of this proposal. 

However, as part of this rulemaking, 

EPA is proposing a ban on sewer 

disposal of hazardous waste 

pharmaceuticals by all healthcare 

facilities and reverse distributors. EPA 

is proposing that the sewer ban would 

apply to all healthcare facilities, 

including CESQG healthcare facilities. 

Please see Section V.E.1 of this 

preamble for a more detailed discussion 

on this proposed sewer prohibition. 

EPA asks for comment on whether the 

proposed healthcare facility standards, 

in addition to the sewer ban, should 

apply to CESQG healthcare facilities. 

EPA is proposing one additional 

change for CESQGs in order to allow 

them to continue to send their 

potentially creditable hazardous waste 

pharmaceuticals to a pharmaceutical 

reverse distributor. Currently, under 

§ 261.5, CESQGs are limited in where 

they may send their hazardous waste for 

treatment and disposal (see 

§ 261.5(f)(3)(i)-(vii) for acute hazardous 

waste and § 261.5(g)(3)(i)-(vii) for 

hazardous waste). However, in 

§ 266.504(a) we are proposing to allow 

CESQGs to send their potentially 

creditable hazardous waste 

pharmaceuticals to a pharmaceutical 

reverse distributor. Without this change, 

CESQGs would be required to send all 

their hazardous waste pharmaceuticals, 

including those that are potentially 

creditable, to one of the types of 

facilities in § 261.5, which does not 

include a pharmaceutical reverse 

distributor. Although we are proposing 

to make this change within part 266, 

subpart P, we request comment on 

whether stakeholders would prefer this 

change to be made within § 261.5 

instead. CESQGs will still be required to 

send their non-pharmaceutical 

hazardous waste and their noncreditable hazardous waste 

pharmaceuticals to one of the types of 

facilities listed in § 261.5. 

In addition, it has been suggested that 

EPA seek comment on providing a 

rebuttable presumption that LTCFs with 

fewer than 10-beds are assumed to be 

CESQGs and thus would not be required 

to count the amount of hazardous waste 

generated each month. Under this 

presumption, they would be subject to 

all the requirements for CESQGs as 

described elsewhere in this proposal, 

including the requirement not to sewer 

hazardous waste pharmaceuticals. 

Therefore, EPA asks for comment on 

this rebuttable presumption and 

specifically whether the 10-bed cut off 

is appropriate or whether there are other 

criteria EPA should take into account. 

Further, EPA asks for commenters to 

submit data to support a 10-bed cut off 

to show that LTCFs with fewer than 10- 

beds are generally CESQGs. 

Alternatively, if comments wish to 

support a different cut-off for the 

rebuttable assumption, EPA also asks 

that the commenters submit 

information/data to support their 

suggested cut-off. 

d. Pharmaceutical reverse 

distributors. EPA is proposing that 

pharmaceutical reverse distributors, 

including pharmaceutical 

manufacturers, which accumulate 

potentially creditable hazardous waste 

pharmaceuticals or evaluated hazardous 

waste pharmaceuticals are subject to 

this rule. Pharmaceutical reverse 

distributors are only subject to this 

proposed rule for the accumulation of 

potentially creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals; if a 

reverse distributor also treats and/or 

disposes of hazardous waste 

pharmaceuticals, it is subject to the 

applicable RCRA Subtitle C TSDF 

regulations, including the requirement 

to have a permit or interim status. 

Stakeholders have indicated a strong 

preference for EPA to clarify how 

pharmaceutical reverse distributors are 

regulated under RCRA, as states have 

applied varied hazardous waste 

regulatory approaches to 

pharmaceutical reverse distributors. 

EPA is proposing specific standards in 

40 CFR part 266, subpart P for 

pharmaceutical reverse distributors (as 

defined in this proposed rule) that 

incorporate various generator standards, 

as well as some TSDF standards. See 

Section V.G for more information. 

2. To what facilities does this rule not 

apply? 

a. Pharmaceutical manufacturers. 

EPA does not intend for these proposed 

regulations to apply to hazardous waste 

pharmaceuticals that are generated by 

pharmaceutical manufacturers or 

wholesalers. Pharmaceutical 

manufacturers and wholesalers do not 

face the same challenges that healthcare 

facilities experience when managing 

hazardous waste pharmaceuticals and 

potentially creditable hazardous waste 

pharmaceuticals in accordance with the 

federal RCRA subtitle C requirements 

(for an explanation of the challenges 

healthcare facilities face, see discussion 

in section IV.B.1 of the preamble). These 

entities (i.e., manufacturers and 

wholesalers) generate hazardous waste 

pharmaceuticals that are more 

predictable and the staff have the 


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50See 49 FR 44978; November 13, 1984. 

51See memo November 1, 1988, from Porter to 

Regions (RCRA Online #11377). http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

2FD51915214EF63C8525670F006BDC88/$file/

11377.pdf. 

52See memo September 26, 2012, Rudzinski to 

the Regional RCRA Division Directors (RCRA 

Online# 14833). http://yosemite.epa.gov/osw/

rcra.nsf/0c994248c239947e85256d090071175f/

FCB11DD6F61D4B1685257AFE005EB5CE/$file/

14833.pdf. 

53Since pharmaceutical collection programs 

typically co-mingle DEA controlled substances with 

non-controlled substances, this requirement is 

included in a section of the regulations that pertains 

to controlled substances. 

54See 21 CFR 1308 for a complete list of 

controlled substances. 

55Final rule: September 9, 2014; 79 FR 53520. 

56Proposed rule: December 21, 2012; 77 FR 

75784, see page 75803; and final rule: September 9, 

2014; 79 FR 53520, see page 53548). 

necessary expertise to determine which 

pharmaceutical waste is hazardous 

waste. However, as mentioned 

previously, when any facility, including 

a pharmaceutical manufacturer, meets 

the definition found in this proposal for 

a ‘‘pharmaceutical reverse distributor,’’ 

it would be subject to the proposed 

regulations for pharmaceutical reverse 

distributors with respect to those 

operations. 

b. Households. The Agency would 

like to emphasize that the regulatory 

requirements in this proposed rule do 

not apply to households or to household 

pharmaceutical collection and take-back 

events and programs. (For information 

regarding collection programs, see 

Section V.E.2.) Pharmaceuticals that are 

unwanted by consumers (households) 

are not regulated as hazardous waste 

and are generally considered municipal 

solid wastes. While a small percentage 

of these household waste 

pharmaceuticals meet the definition of 

hazardous waste under RCRA, the 

federal RCRA hazardous waste 

regulations include an exclusion for all 

hazardous wastes generated by 

households (see the ‘‘household 

hazardous waste’’ exclusion at 

§ 261.4(b)(1)). Thus household waste 

pharmaceuticals—like other household 

hazardous wastes—are not subject to the 

federal RCRA hazardous waste 

regulations. 

‘‘EPA excluded household wastes 

because the legislative history of RCRA 

indicated an intent to exclude such 

wastes, though not because they 

necessarily pose no hazard.’’ 50 Some 

household products, including 

pharmaceuticals, contain ignitable, 

corrosive, reactive, or toxic ingredients. 

As a result, for household hazardous 

waste collected at a take-back event or 

program, the Agency has historically 

recommended that communities 

operating the collection programs 

manage the collected household 

hazardous wastes as hazardous waste, 

even though it is not required by 

RCRA.51 Furthermore, the Agency has 

recently recommended that collected 

household waste pharmaceuticals be 

incinerated—preferably at a permitted 

hazardous waste incinerator, but when 

that is not feasible, at a large or small 

municipal waste combustor.52 The 

Agency believes that this practice is 

already common among collection 

programs since one goal of many 

collection programs is to divert 

pharmaceuticals from municipal 

landfills. Nevertheless, the Agency is 

proposing to make this recommendation 

a requirement for collected household 

waste pharmaceuticals in § 266.506.53

The Agency seeks comment on changing 

this recommendation to a requirement 

for pharmaceutical collection programs. 

The Agency recommends that, 

whenever possible, households utilize 

pharmaceutical collection and take-back 

events as the disposal option for their 

unwanted pharmaceuticals. For 

consumers without access to a 

pharmaceutical take-back event, FDA 

provides information on the disposal of 

unused pharmaceuticals and step-bystep guidance for disposing of 

pharmaceuticals in the household trash. 

For more information on the safe 

disposal of household pharmaceuticals, 

please see: http://www.fda.gov/Drugs/

ResourcesForYou/Consumers/

BuyingUsingMedicineSafely/

EnsuringSafeUseofMedicine/

SafeDisposalofMedicines/

ucm186187.htm. 

3. Which hazardous wastes are 

addressed by this proposed rule? 

a. Hazardous waste pharmaceuticals. 

If finalized, these regulations will only 

pertain to those pharmaceutical wastes 

that are RCRA hazardous wastes 

generated by healthcare facilities or 

managed by pharmaceutical reverse 

distributors. Under this rulemaking, 

EPA is not proposing to add additional 

pharmaceuticals to the hazardous waste 

listings or to expand the hazardous 

waste characteristics to include 

additional pharmaceuticals. See Section 

VII of the preamble, Request for 

Comment on EPA’s Efforts to Identify 

Additional Pharmaceuticals as 

Hazardous Waste, for a discussion of 

possible future actions by EPA to 

regulate additional pharmaceuticals as 

hazardous waste. 

b. How does this proposal affect 

hazardous waste pharmaceuticals that 

are also regulated by other federal or 

state regulations? The management, 

transportation, treatment, storage and 

disposal of hazardous waste 

pharmaceuticals are regulated under 

RCRA Subtitle C. However, hazardous 

waste pharmaceuticals may also be 

subject to a number of other statutes and 

implementing regulations administered 

by state or other federal agencies. 

Examples include pharmaceuticals that 

are subject to the Controlled Substances 

Act and DEA regulations; infectious 

pharmaceutical wastes that are subject 

to state and local medical waste 

regulations; and pharmaceuticals with a 

radioactive component that are subject 

to the Atomic Energy Act (AEA). These 

potentially overlapping requirements 

make the appropriate management of 

pharmaceutical wastes a complex 

matter. The following discusses the 

impact of this proposed rule on various 

dually regulated hazardous waste 

pharmaceuticals. 

i. Hazardous waste pharmaceuticals 

that are also controlled substances. 

Under current regulations, any 

healthcare facility generating or 

managing a RCRA hazardous waste 

pharmaceutical that is also a controlled 

substance listed in Schedule II–V 54

must comply with the RCRA hazardous 

waste requirements, as well as the 

requirements of the Controlled 

Substances Act and DEA regulations. 

Recently revised DEA regulations to 

implement the Secure and Responsible 

Drug Disposal Act of 2010 require that 

controlled substances be destroyed so 

that they are ‘‘non-retrievable.’’ 55 In the 

preamble to both the proposed and final 

rules, DEA has stated that flushing alone 

will not meet DEA’s new nonretrievable standard.56 Stakeholders 

have told EPA that it is expensive and 

difficult to incinerate controlled 

substances that are also hazardous 

wastes under both DEA and EPA 

regulatory schemes. As a result, 

healthcare facilities with hazardous 

waste pharmaceuticals that are also 

controlled substances have often 

sewered on-site in order to avoid the 

expense of complying with dual 

regulation that would apply if they were 

incinerated. Due to difficulties 

associated with managing these 

hazardous waste pharmaceuticals that 

are also controlled substances, the 

Agency is proposing to conditionally 

exempt from RCRA regulatory 

requirements those pharmaceuticals that 

are both a RCRA hazardous waste and 

a DEA controlled substance, provided 

the hazardous waste pharmaceuticals 

that are also DEA controlled substances 

are combusted at a permitted or interim 


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57The NRC regulates radioactive wastes 

generated by commercial or non-DOE facilities, 

whereas DOE regulates radioactive wastes generated 

by DOE facilities. 

58Published in 2006, the development of the 

original Blueprint was funded by the Office of Solid 

Waste and Emergency Response and managed by 

EPA Region 1. The 2008 revision of the Blueprint 

was funded by the Healthcare Environmental 

Resource Center. http://practicegreenhealth.org/

sites/default/files/upload-files/

pharmwasteblueprint.pdf 

status hazardous waste incinerator, or a 

permitted municipal solid waste 

incinerator. A more detailed discussion 

of this exemption is found in Section 

V.E.2 of this proposal, Conditional 

Exemption for Hazardous Waste 

Pharmaceuticals that are also 

Controlled Substances. 

ii. Hazardous waste pharmaceuticals 

that are also medical wastes. There are 

instances when a hazardous waste 

pharmaceutical will also exhibit a 

biological hazard. The healthcare 

industry often refers to pharmaceutical 

wastes that are both RCRA hazardous 

and a biological hazard as ‘‘dual 

wastes,’’ and such wastes must be 

managed in accordance with RCRA and 

state and/or local medical waste 

regulations. As a result, the healthcare 

facility must send these dual wastes to 

a hazardous waste treatment, storage 

and disposal facility that is also 

permitted to accept medical wastes. 

Some examples of dual wastes include 

un-administered syringes containing 

hazardous waste pharmaceuticals (e.g., 

physostigmine) or IV bags containing 

residues of a hazardous waste 

pharmaceutical that are attached to the 

tubing and needles used to administer 

the pharmaceutical. The RCRA 

hazardous waste pharmaceutical portion 

of these ‘‘dual’’ wastes are included 

within these proposed management 

standards so that healthcare facilities 

can obtain the benefits of this proposal, 

while ensuring the hazardous waste 

portion of the waste is managed 

appropriately and ultimately delivered 

to RCRA-permitted TSDFs. In addition, 

healthcare facilities must still manage 

the biological hazard in accordance with 

state and/or local medical waste 

requirements. EPA notes that 

autoclaving is not an acceptable method 

of treating hazardous wastes that are 

also medical waste. In addition, as 

discussed in Section V.E.3.c of this 

preamble, EPA is proposing to 

conditionally exclude the residues of 

hazardous waste pharmaceuticals 

remaining in fully dispensed syringes 

from RCRA regulation. 

iii. Hazardous waste pharmaceuticals 

that contain a radioactive component. 

Hazardous waste pharmaceuticals that 

also contain a radioactive component 

subject to the Atomic Energy Act of 

1954 (AEA) (i.e., ‘‘mixed waste’’) are 

regulated by multiple agencies. The 

hazardous waste component is regulated 

under EPA or the authorized state RCRA 

programs, while either the Nuclear 

Regulatory Commission (NRC) or the 

Department of Energy (DOE) regulates 

the radioactive component of the waste 

under the AEA.57 Healthcare facilities 

would be able to use this rule (if 

finalized) to comply with the hazardous 

waste component for hazardous waste 

pharmaceuticals. Although we do not 

believe that anything in this proposal is 

inconsistent with the AEA, § 1006(a) of 

RCRA states that if the RCRA 

requirements are inconsistent with the 

AEA requirements, then the RCRA 

requirements do not apply. Therefore, if 

a healthcare facility that manages 

hazardous waste pharmaceuticals 

encounters specific RCRA requirements 

that are inconsistent with specific AEA 

requirements, only the AEA 

requirements would apply. 

As is discussed in the Joint NRC/EPA 

Guidance on Testing Requirements for 

Mixed Radioactive and Hazardous 

Waste (62 FR 62079, 62085; November 

20, 1997), an inconsistency occurs when 

compliance with one statute or set of 

regulations would necessarily cause 

non-compliance with the other statute 

or set of regulations. Relief from the 

regulatory inconsistency would be 

provided by the AEA requirement 

overriding the specific RCRA 

requirement. It is important to note, 

however, that the determination of an 

inconsistency would relieve the 

healthcare facility only from compliance 

with the specific RCRA requirement(s) 

that is deemed inconsistent with the 

AEA requirement(s); it would still be 

required to comply with all of the other 

hazardous waste pharmaceutical 

management standards. 

4. Management of Wastes Generated at 

Healthcare Facilities That Are Not 

Included in the Scope of this Proposed 

Rule 

Wastes that are not included in the 

scope of this proposed rule include nonhazardous wastes or nonpharmaceutical hazardous wastes. 

Pharmaceutical wastes that are not 

listed or characteristic hazardous wastes 

under RCRA Subtitle C may nonetheless 

pose some risks to public health and the 

environment. These wastes are 

discussed further below. 

a. How should non-hazardous waste 

pharmaceutical be disposed? A large 

portion of the pharmaceutical wastes 

generated at healthcare facilities will 

not meet the definition of a RCRA 

hazardous waste under RCRA Subtitle 

C. This proposal, therefore, does not 

require that healthcare facilities manage 

these waste pharmaceuticals under the 

RCRA subtitle C hazardous waste 

regulations, including this proposed 

rule. However, a healthcare facility may 

choose to manage its solid and 

hazardous waste pharmaceuticals 

together (as hazardous waste 

pharmaceuticals) under these new 

proposed regulations. Because all 

healthcare facilities operating under this 

subpart are regulated in the same way 

regardless of quantity of pharmaceutical 

hazardous waste generated, managing 

non-hazardous waste pharmaceuticals 

as hazardous waste under this subpart 

would not affect the facility’s hazardous 

waste generator category. While not 

regulated by the federal RCRA 

hazardous waste requirements, nonhazardous waste pharmaceuticals are 

still considered solid wastes under the 

federal regulations and must be 

managed in accordance with applicable 

federal, state and/or local regulatory 

requirements. 

If a healthcare facility decides to 

segregate its hazardous and nonhazardous pharmaceuticals, EPA 

recommends that healthcare facilities 

follow the best management practices 

(BMPs) outlined in the ‘‘Managing 

Pharmaceutical Waste: A 10-Step 

Blueprint for Healthcare Facilities in the 

United States’’ (Practice Greenhealth, 

Revised August 2008) 58 for the 

management, treatment, storage and 

disposal of non-hazardous waste 

pharmaceuticals. The following 

summarizes the recommended BMPs 

found in the Blueprint for various 

categories of pharmaceutical wastes, 

including those wastes that possess 

hazardous waste-like qualities yet are 

not regulated as hazardous waste under 

RCRA Subtitle C. 

i. Recommended BMPs for healthcare 

facilities managing non-hazardous 

waste pharmaceuticals possessing 

hazardous waste-like qualities. 

Currently, most pharmaceuticals are not 

regulated as RCRA hazardous wastes 

when discarded by healthcare facilities. 

These ‘‘non-RCRA-hazardous’’ 

pharmaceuticals can be divided into 

two categories: those that possess 

hazardous waste-like qualities and those 

that do not. As outlined in the 

Blueprint, there are pharmaceuticals 

that possess hazardous waste-like 

qualities, but for various reasons, are not 

regulated by the RCRA Subtitle C 

hazardous waste regulations. The 

Agency supports the Blueprint’s 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58030 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

59As noted in the comment after § 261.33(d), the 

phrase ‘‘commercial chemical product’’ includes 

formulations in which the P- or U-listed chemical 

is the sole active ingredient. Therefore, 

formulations with more than one active ingredient 

do not meet the specifications of the P- and Ulistings even if one, two or all of the active 

ingredients are listed on the P- and/or U-lists. 

60The descriptions ‘‘bulk’’ and ‘‘trace’’ when 

applied to chemotherapeutic wastes are industry 

terms and are not defined by the federal RCRA 

regulations. 

61NIOSH List of Antineoplastic and Other 

Hazardous Drugs in Healthcare Settings 2012. 

http://www.cdc.gov/niosh/docs/2012-150/. 

62OSHA Technical Manual, Section VI: Chapter 

2, Appendix VI: 2–1. http://www.osha.gov/dts/osta/ 

otm/otm_vi/otm_vi_2.html. 

63Barnes, K.K., Christenson, S.C., Kolpin, D.W., 

Focazio, M.J., Furlong, E.T., Zaugg, S.D., Meyer, 

M.T. and Barber, L.B. (2004), Pharmaceuticals and 

Other Organic Waste Water Contaminants Within a 

Leachate Plume Downgradient of a Municipal 

Landfill. Groundwater Monitoring & Remediation, 

24: 119–126. 

64Buszka, P.M., Yeskis, D.J., Kolpin, D.W., 

Furlong, E.T., Zaugg, S.D., and Meyer, M.T. (June 

2009), Waste-Indicator and Pharmaceutical 

Compounds in Landfill-Leachate-Affected Ground 

Water near Elkhart, Indiana, 2000–2002. Bulletin of 

Environmental Contamination and Toxicology, 

V82.6:635–659. 

recommendation of hazardous waste 

incineration as the BMP for healthcare 

facilities and pharmaceutical reverse 

distributors discarding pharmaceuticals 

that may possess hazardous waste-like 

qualities, but are not regulated as RCRA 

hazardous waste. This recommendation 

would apply to pharmaceuticals with 

more than one active ingredient listed 

on the P- or U-lists,59 chemotherapeutic 

agents characterized as bulk wastes,60

pharmaceuticals which meet the NIOSH 

Hazardous Drug Criteria,61

pharmaceuticals listed in Appendix VI 

of the OSHA Technical Manual,62

pharmaceuticals with LD50s ≤50 mg/kg, 

pharmaceuticals that are carcinogenic or 

endocrine disrupting compounds, and 

vitamin/mineral preparations 

containing heavy metals. 

ii. Recommended best management 

practices for other non-hazardous 

pharmaceutical wastes (i.e., those not 

possessing hazardous waste likequalities). As far as other non-hazardous 

waste pharmaceuticals (i.e., those not 

possessing hazardous waste-like 

qualities), disposing of non-hazardous 

waste pharmaceuticals at healthcare 

facilities via drain disposal is strongly 

discouraged and not recommended by 

EPA. Therefore, EPA endorses the 

Blueprint’s recommendation of 

municipal solid waste or medical waste 

incineration for any non-hazardous 

waste pharmaceuticals, even when they 

do not possess hazardous waste-like 

qualities. The potential risk remains for 

active pharmaceutical ingredients (APIs) 

to be released into the environment if 

municipal solid waste landfills or 

medical waste autoclaves are used for 

the purposes of pharmaceutical waste 

treatment and disposal. For example, 

autoclaves are designed to kill 

pathogens and do not achieve the 

temperatures required to destroy most 

APIs during the autoclaving process. As 

a result, there is the potential for 

wastewater containing APIs to be 

generated and discharged into the 

sewer. In addition, some limited studies 

have shown APIs present in landfill 

leachate collected in municipal solid 

waste landfill leachate systems.63 64

Typically, the collected landfill leachate 

is subsequently sent to wastewater 

treatment plants for treatment, but their 

treatment technologies are not designed 

to remove all APIs from the wastewater 

(See Section V.E.1 for more information 

regarding sewering and APIs). 

b. Non-pharmaceutical hazardous 

wastes. These proposed regulations will 

only pertain to hazardous waste 

pharmaceuticals. Therefore, other types 

of hazardous wastes generated at 

healthcare facilities that do not meet the 

definition of a hazardous waste 

pharmaceutical cannot be managed in 

accordance with these proposed 

regulations. For example, hazardous 

wastes generated in hospital laboratories 

or during cleaning and maintenance of 

the facility are not considered 

hazardous waste pharmaceuticals and 

are not included within the scope of this 

proposal. The generation of nonpharmaceutical hazardous wastes is 

often more routine and does not trigger 

the same concerns that healthcare 

facilities experience when managing 

hazardous waste pharmaceuticals. 

After a healthcare facility determines 

it is subject to this proposed rule and 

manages its hazardous waste 

pharmaceuticals under part 266, subpart 

P, it is no longer required to count the 

hazardous waste pharmaceuticals that it 

generates towards its generator category. 

As a result, the healthcare facility may 

experience a change in RCRA generator 

category for its non-pharmaceutical 

hazardous waste. For example, a 

healthcare facility may shift from being 

an LQG to a SQG or even CESQG by not 

counting its hazardous waste 

pharmaceuticals toward its generator 

category, especially when acute 

hazardous waste pharmaceuticals such 

as warfarin (brand name: Coumadin) no 

longer need to be counted. A shift in 

generator category, should it occur, 

would allow a healthcare facility to 

manage its non-pharmaceutical 

hazardous waste, such as hazardous 

waste from laboratories, according to the 

reduced generator requirements. It is 

important to note that only when a 

healthcare facility is managing its 

hazardous waste pharmaceuticals under 

the new proposed subpart does it have 

the benefit of not counting them 

towards its generator category (see 

Section VI. Implementation and 

Enforcement for further discussion). 

C. What are the proposed standards for 

healthcare facilities that manage noncreditable hazardous waste 

pharmaceuticals? 

This section discusses the proposed 

management standards for healthcare 

facilities (except CESQGs) that manage 

non-creditable hazardous waste 

pharmaceuticals, which include the 

following: 

(1) Notification requirements for 

healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(2) personnel training requirements 

for healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(3) making a hazardous waste 

determination for non-creditable 

hazardous waste pharmaceuticals; 

(4) elimination of central 

accumulation area and satellite 

accumulation area requirements for 

healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(5) container standards for healthcare 

facilities managing non-creditable 

hazardous waste pharmaceuticals; 

(6) labeling standards on containers 

for healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(7) accumulation time limits for 

healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(8) land disposal restrictions for noncreditable hazardous waste 

pharmaceuticals; 

(9) procedures for shipping noncreditable hazardous waste 

pharmaceuticals off-site from healthcare 

facilities; 

(10) procedures for managing rejected 

shipments of non-creditable hazardous 

waste pharmaceuticals from healthcare 

facilities; 

(11) reporting requirements for 

healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(12) recordkeeping requirements for 

healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(13) procedures for responses to 

releases by healthcare facilities 

managing non-creditable hazardous 

waste pharmaceuticals; 


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65A generator is a CESQG if it generates less than 

or equal to 100 kg of hazardous waste per calendar 

month, and less than or equal to 1 kg of acute 

hazardous waste per calendar month and <100 kg 

of any residue or contaminated soil, waste or other 

debris resulting from the clean-up of a spill, into or 

on any land or water, of any acute hazardous waste 

listed in § 261.31 or § 261.33(e) per calendar month, 

provided it does not accumulate on-site at any time 

>1 kg of acute hazardous waste or >1000 kg of 

hazardous waste. 

66For information on the current Site 

Identification Form, please see: http://

www.epa.gov/wastes/inforesources/data/form8700/

8700-12.pdf. 

67The Information Collection Request (ICR) for 

the Site Identification Form (87000–12) is updated 

every three years and must be approved by the 

Office of Management and Budget (OMB). These 

updates and OMB approvals are published in the 

Federal Register and are subject to public comment. 

(14) special requirements for longterm care facilities managing noncreditable hazardous waste 

pharmaceuticals; 

(15) conditions for healthcare 

facilities that accept hazardous waste 

pharmaceuticals from off-site CESQGs; 

and 

(16) a prohibition of sewering 

hazardous waste pharmaceuticals for all 

healthcare facilities; (see section V.E.1. 

of the preamble, Sewer Disposal 

Prohibition). 

The proposed management standards 

discussed in this section only apply to 

hazardous waste pharmaceuticals that 

are non-creditable hazardous waste 

pharmaceuticals (i.e., they are destined 

for a RCRA permitted or interim status 

TSDF). They do not apply to those 

hazardous waste pharmaceuticals that 

meet the definition of a ‘‘potentially 

creditable hazardous waste 

pharmaceutical.’’ Please refer to Section 

V.D for the proposed healthcare facility 

management standards for potentially 

creditable hazardous waste 

pharmaceuticals that are transported to 

reverse distributors for the processing of 

manufacturer’s credit. 

1. Notification Requirements for 

Healthcare Facilities Managing NonCreditable Hazardous Waste 

Pharmaceuticals 

In order to address commenters’ 

concerns from the 2008 Pharmaceutical 

Universal Waste proposal that 

regulatory agencies are unaware of 

hazardous waste pharmaceutical 

management activities, EPA is 

proposing to require that a healthcare 

facility that does not qualify as a CESQG 

to submit a one-time notification as a 

‘‘healthcare facility’’ to the appropriate 

EPA Regional Administrator. Healthcare 

facilities subject to 40 CFR part 266, 

subpart P will have to submit 

notification even if the healthcare 

facility has previously obtained an EPA 

identification number. The required 

notification will enable EPA and state 

regulatory agencies to identify the 

universe of healthcare facilities 

managing hazardous waste 

pharmaceuticals subject to the 40 CFR 

part 266, subpart P requirements. In 

addition, having this information allows 

EPA and state environmental regulatory 

agencies to track healthcare facilities for 

enforcement and inspection purposes, 

ensuring the hazardous waste 

pharmaceuticals are managed in 

accordance with the regulations. 

At any point a healthcare facility’s 

hazardous waste pharmaceutical 

generation may change due to waste 

minimization efforts or other reasons, 

causing the facility to legitimately 

decrease its total monthly hazardous 

waste generation enough to qualify as a 

CESQG. In this case, if the healthcare 

facility plans to withdraw from the 40 

CFR part 266, subpart P requirements 

due to qualifying as a CESQG, it will be 

required to re-notify EPA of its choice 

to withdraw. 

Alternatively, if a healthcare facility 

determines that it is a CESQG,65 but 

does not want to keep track of the 

amount of hazardous waste generated 

and whether it is above or below the 

CESQG threshold limit, it can choose to 

operate under this proposed rule. By 

choosing to operate under this proposed 

rule, the CESQG healthcare facility must 

comply with all of the requirements and 

must submit the one-time notification 

that it is operating under 40 CFR part 

266, subpart P. Healthcare facilities that 

are not CESQGs, however, are required 

to operate under 40 CFR part 266, 

subpart P for the management of their 

hazardous waste pharmaceuticals. 

The Agency is proposing that this 

notification occur via the RCRA Subtitle 

C Site Identification Form (EPA Form 

8700–12; or Site Identification Form).66

EPA believes that notification via the 

Site Identification Form is the preferred 

approach for notification purposes for 

several reasons. First, both state 

environmental regulatory agencies and 

hazardous waste generators are familiar 

with the form, as it is the form currently 

used by hazardous waste generators to 

notify regulators of their RCRA Subtitle 

C activities. Second, as stated 

previously, the use of the Site 

Identification Form will allow for EPA 

and state regulatory agencies to monitor 

the healthcare facilities utilizing the 

new regulatory requirements. Lastly, 

public comments received on previous 

EPA actions (e.g., Academic 

Laboratories Rulemaking (73 FR 72912; 

December 1, 2008)) have indicated that 

notification via the Site Identification 

Form is the notification approach 

typically preferred by the regulated 

community. We are proposing that 

healthcare facilities can submit their 

notification as part of the Biennial 

Report, if the healthcare facility will be 

required to submit a Biennial Report 

due to its non-pharmaceutical 

hazardous waste. Otherwise, healthcare 

facilities are required to notify within 60 

days of this new subpart becoming 

effective, or within 60 days of becoming 

subject to this new subpart. 

If this notification requirement is 

finalized, the Site Identification Form 

will be modified by EPA in a separate 

action.67 Specifically, the Agency 

intends to amend the Site Identification 

Form by adding a section to the form for 

a healthcare facility to indicate the type 

of entity it is (e.g., a hospital, a doctor’s 

office, a veterinary clinic, a pharmacy, 

an assisted living facility, etc.) and to 

indicate that it generates hazardous 

waste pharmaceuticals. The healthcare 

facility will no longer be required to 

identify on the Site Identification Form 

the specific types of hazardous waste 

pharmaceuticals it generates. The 

Agency also intends to add a checkbox 

to the section in order to allow a 

healthcare facility to indicate that its 

generator category is changing to a 

CESQG and it is no longer managing its 

hazardous waste pharmaceuticals 

according to 40 CFR part 266, subpart P. 

The Agency does not anticipate that 

this proposed notification requirement 

will place any undue economic burden 

upon healthcare facilities or the 

environmental regulatory agencies that 

process these notifications (see the 

Regulatory Impact Analysis for the 

proposed rule in the rulemaking docket 

EPA–HQ–RCRA–2007–0932). In fact, 

under these proposed regulations, 

healthcare facilities would no longer 

need to count the hazardous waste 

pharmaceuticals managed under 40 CFR 

part 266, subpart P towards a healthcare 

facility’s generator category. As a result, 

EPA anticipates that many healthcare 

facilities will change their generator 

category to either a SQG or CESQG for 

their other, non-pharmaceutical 

hazardous wastes. So while the 

notification requirement ensures that 

the environmental regulatory agencies 

are informed of all hazardous waste 

pharmaceutical management activities 

subject to the 40 CFR part 266, subpart 

P requirements in their jurisdictions, the 

fact that some healthcare facilities will 

no longer qualify as LQGs will reduce 

the number of healthcare facilities in the 

LQG universe. Because LQGs are 

inspected more frequently than SQGs or 

CESQGs, EPA expects this could result 

in an overall decrease in burden for both 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58032 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

the healthcare facilities and the 

environmental regulatory agencies. 

The Agency is soliciting comment on 

the notification requirement for 

healthcare facilities, the method of 

notification via the Site Identification 

Form, and whether this notification 

requirement will result in any undue 

burden to either healthcare facilities or 

state environmental regulatory agencies. 

2. Personnel Training Requirements for 

Healthcare Facilities Managing NonCreditable Hazardous Waste 

Pharmaceuticals 

Under the current RCRA Subtitle C 

regulations, an LQG healthcare facility 

must provide RCRA training to its 

healthcare workers involved in the 

generation and/or management of 

hazardous waste. Under § 262.34(a)(4), 

LQGs are required to comply with the 

personnel training requirements for 

interim status TSDFs (which are found 

in § 265.16). These personnel training 

requirements include either classroom 

instruction or on-the-job training in 

RCRA and state that the facility must 

maintain training documents and 

records for each trained staff person. On 

the other hand, under current 

regulation, healthcare facilities that are 

SQGs must meet a performance-based 

standard when training their healthcare 

workers. This entails ensuring ‘‘that all 

employees are thoroughly familiar with 

proper waste handling and emergency 

procedures relevant to their 

responsibilities during normal facility 

operations and emergencies’’ 

(§ 262.34(d)(5)(iii)). For comparative 

purposes, healthcare facilities that are 

considered CESQGs do not have any 

personnel training requirements under 

the current federal regulations. 

Similarly, generators, including 

healthcare facilities, are not required to 

provide RCRA training to personnel that 

only work in satellite accumulation 

areas regulated under § 262.34(c). 

However, healthcare personnel that are 

involved in the generation of 

pharmaceutical waste must be familiar 

enough with the pharmaceuticals with 

which they are working to know when 

they have generated a hazardous waste 

so that it will be managed in accordance 

with the RCRA regulations. 

EPA believes that the LQG RCRA 

training requirement is excessive for 

healthcare workers who sporadically 

generate hazardous waste 

pharmaceuticals at healthcare facilities, 

but believe it is necessary to have some 

familiarity with the dangers that 

hazardous waste pharmaceuticals can 

pose. Therefore, the Agency is 

proposing healthcare facility-specific 

personnel training requirements that are 

akin to the training requirements for 

SQGs and small quantity universal 

waste handlers. Specifically, healthcare 

facilities managing their hazardous 

waste pharmaceuticals in accordance 

with the proposed healthcare facility 

standards must inform all employees 

that handle or have responsibility for 

generating and/or managing hazardous 

waste pharmaceuticals of the proper 

handling and emergency procedures 

appropriate to their responsibilities 

during normal facility operations and 

emergencies. This training information 

can be disseminated through verbal 

communication or through distribution 

of pamphlets or other documentation. 

However, a healthcare facility that is an 

LQG due to its non-pharmaceutical 

hazardous wastes may choose to 

continue to use its existing training 

program as an LQG so as not to have 

different training programs and that 

would be acceptable, as well. 

The Agency solicits comments on the 

personnel training requirements 

proposed in this document for 

healthcare facilities managing 

hazardous waste pharmaceuticals. 

Specifically, the Agency is seeking 

comment regarding the appropriateness 

of these personnel training requirements 

and if these requirements will be 

sufficient for communicating key 

procedures to healthcare workers that 

generate and/or manage hazardous 

waste pharmaceuticals. 

EPA is seeking comment on whether 

documentation of training is necessary 

in order to verify compliance with the 

training requirement. Based on the 

comments received, we may include a 

requirement in the final rule for 

documenting and retaining records of 

healthcare personnel training. Finally, 

the Agency wants to reiterate that these 

proposed personnel training 

requirements only apply to staff 

generating and/or managing hazardous 

waste pharmaceuticals. The training 

requirements of 40 CFR part 262 will 

continue to apply to staff generating 

and/or managing other types of 

hazardous wastes at the healthcare 

facility. 

3. Making a Hazardous Waste 

Determination for Non-Creditable 

Hazardous Waste Pharmaceuticals 

Similar to the current RCRA Subtitle 

C generator requirements, healthcare 

facilities will still be required to make 

a hazardous waste determination on 

pharmaceutical wastes prior to 

managing them under the proposed 

cradle-to-grave standards. Therefore, 

when a healthcare facility generates a 

solid waste pharmaceutical, the 

healthcare facility must determine if the 

pharmaceutical waste is listed in 40 

CFR part 261, subpart D and if it 

exhibits one or more of the four 

characteristics of hazardous waste 

identified in 40 CFR part 261, subpart 

C. However, unlike the existing 

generator requirements, the healthcare 

facility does not need to identify the 

specific waste codes applying to the 

pharmaceutical wastes. If the 

pharmaceutical waste is determined to 

be a hazardous waste, then the 

healthcare facility must manage the 

hazardous waste pharmaceuticals in 

accordance with these proposed 

requirements instead of 40 CFR part 

262. Pharmaceutical wastes not meeting 

the definition of a hazardous waste (i.e., 

non-hazardous waste pharmaceuticals) 

must be managed in compliance with 

applicable federal, state and local 

regulations. 

EPA understands that healthcare 

facilities utilize various approaches 

when making hazardous waste 

determinations. For example, healthcare 

facilities may hire contractors to review 

their formularies and identify those 

pharmaceuticals that are hazardous 

wastes when discarded. These facilities 

may then identify hazardous waste 

pharmaceuticals at the pharmacy level, 

marking these pharmaceuticals with a 

special label so that healthcare 

personnel know how to properly 

dispose of the pharmaceutical when it 

becomes a waste. Other healthcare 

facilities may instruct personnel to 

dispose of all pharmaceutical wastes 

into one RCRA hazardous waste 

collection container. These facilities 

may then choose to manage all of the 

contents of the container as hazardous 

waste or they may choose to sort the 

hazardous waste portion from the nonhazardous waste pharmaceutical portion 

in the central accumulation area. Due to 

the various ways that healthcare 

facilities make the hazardous waste 

determination, the Agency is not 

proposing that a specific approach be 

utilized when making the 

determination, only that the facility 

performs the waste determination. 

However, healthcare facilities may 

choose to manage all of their 

pharmaceutical wastes as hazardous, 

and thus, if a healthcare facility chooses 

this approach, they would not need to 

make individual hazardous waste 

determinations, but would have made a 

generic decision that all of their waste 

pharmaceuticals are hazardous and 

manage them as hazardous waste 

pharmaceuticals in accordance with the 

proposed requirements in 40 CFR part 

266, subpart P. 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58033 

68See § 262.34(c) for the satellite accumulation 

requirements. For additional information on 

satellite accumulation areas, please see the 

memorandum from Robert Springer to the EPA 

Regional RCRA Directors, ‘‘Frequently Asked 

Questions about Satellite Accumulation Areas’’ 

(RCRA Online #14703) http://yosemite.epa.gov/

osw/rcra.nsf/0c994248c239947e85256d090071175f/

0AC9E15424B2897D8525770600609793/$file/

14703.pdf. 

69The container standards proposed do not apply 

to the various packaging, blister packs, bottles, 

vials, IV bags, etc., in which pharmaceuticals are 

stored prior to being dispensed or administered. 

4. No Central Accumulation Area and 

Satellite Accumulation Area 

Requirements for Healthcare Facilities 

Managing Non-Creditable Hazardous 

Waste Pharmaceuticals 

Hazardous waste pharmaceuticals are 

generated at numerous locations across 

a healthcare facility. Under the current 

RCRA Subtitle C requirements, each 

location at the healthcare facility with a 

RCRA hazardous waste receptacle for 

the disposal of hazardous waste 

pharmaceuticals is considered a satellite 

accumulation area and is subject to 

volume accumulation limits and other 

requirements.68 Of particular concern 

regarding the satellite accumulation 

requirements for healthcare facilities is 

the one quart accumulation limit for 

acute hazardous wastes (i.e., P-listed 

wastes). Under the December 2008 

Pharmaceutical Universal Waste 

proposal, no accumulation areas, central 

or satellite, were proposed to be 

established for hazardous waste 

pharmaceuticals. This proposed 

approach was consistent with the 

current federal universal waste program, 

since facilities are not required to 

designate a special centralized area for 

the accumulation of universal wastes 

nor are they required to have satellite 

accumulation areas for universal wastes. 

Nevertheless, EPA understands that 

facilities that handle universal wastes 

will often accumulate their universal 

wastes within their 90- or 180-day 

hazardous waste accumulation areas. 

For the reasons articulated in the 

Pharmaceutical Universal Waste 

proposal, the Agency has decided that a 

healthcare facility accumulating 

hazardous waste pharmaceuticals will 

not be subject to the satellite 

accumulation area regulations or the 

central accumulation area regulations 

(also sometimes called less than 90- or 

180-day areas), but rather to the 

proposed accumulation time limits and 

container standards. 

A healthcare facility may choose to 

accumulate hazardous waste 

pharmaceuticals within its 90- or 180- 

day central accumulation area if it has 

one established for its other hazardous 

wastes as long as it maintains 

compliance with the proposed 

accumulation time limit and container 

requirements of 40 CFR part 266, 

subpart P. The Agency notes that even 

if the hazardous waste pharmaceuticals 

are accumulated in a 90- or 180-day 

central accumulation area, these 

hazardous waste pharmaceuticals are 

not subject to the 90- or 180-day 

requirements. EPA solicits public 

comment on its decision to not require 

hazardous waste pharmaceuticalspecific central and satellite 

accumulation area requirements. 

5. Container Standards for Healthcare 

Facilities Managing Non-Creditable 

Hazardous Waste Pharmaceuticals 

The container standards discussed in 

this section apply to those containers 

used by healthcare facilities to 

accumulate, store and transport noncreditable hazardous waste 

pharmaceuticals.69 First, we would note 

that due to the relatively small 

quantities of hazardous waste 

pharmaceuticals that are typically 

accumulated and stored at a healthcare 

facility, the Agency understands that 

other types of waste management units, 

such as tanks, are not used for the 

management of waste pharmaceuticals. 

Therefore, we are only proposing 

standards for containers. However, the 

Agency solicits comment as to whether 

other types of waste management units 

are also used by healthcare facilities to 

accumulate and store hazardous waste 

pharmaceuticals and whether EPA 

should establish technical standards for 

other types of waste management units. 

The Agency is proposing to require 

that healthcare facilities pack hazardous 

waste pharmaceuticals into containers 

that are structurally sound and that are 

compatible with the hazardous waste 

pharmaceuticals that will be contained 

within them. EPA intends this 

requirement to mean that containers 

used for holding hazardous waste 

pharmaceuticals must be in good 

condition, with no severe rusting, 

apparent structural defects, or 

deterioration. Containers also must not 

have any evidence of leakage, spillage or 

damage that could result in the release 

of waste under reasonably foreseeable 

circumstances. Furthermore, the Agency 

is proposing to require that 

incompatible wastes not be placed in 

the same container, unless the comingling of incompatible hazardous 

wastes is conducted in such a way that 

it does not have the potential to (1) 

generate extreme heat or pressure, fire 

or explosion, or violent reaction; (2) 

produce uncontrolled toxic mists, 

fumes, dusts, or gases in sufficient 

quantities to threaten human health; (3) 

produce uncontrollable flammable 

fumes or gases in sufficient quantities to 

pose a risk of fire or explosions; (4) 

damage the structural integrity of the 

facility or container containing the 

hazardous waste pharmaceuticals; or (5) 

through other like means threaten 

human health or environment. For 

example, the majority of a healthcare 

facility’s non-creditable hazardous 

waste pharmaceuticals are likely organic 

in nature, and thus, compatible with 

each other and can be accumulated 

together, especially since they will most 

likely be incinerated once they are 

transported to a TSDF. However, some 

non-creditable hazardous waste 

pharmaceuticals, such as metal bearing 

wastes not containing sufficient 

organics, are prohibited from being 

incinerated (e.g., P012, arsenic trioxide). 

The hazardous waste pharmaceuticals 

that cannot be incinerated must be 

accumulated separately from organic 

wastes destined for incineration. 

The Agency believes that these 

technical standards, like similar 

technical standards that EPA has 

promulgated in § 265.17 for interim 

status TSDFs, would ensure that 

hazardous waste pharmaceuticals are 

properly managed and would not be 

released into the environment, while at 

the same time providing flexibility to 

the healthcare facility in selecting those 

containers that are most appropriate for 

their situation. 

In addition to the proposed container 

standards, the Agency is also proposing 

that accumulation containers for 

hazardous waste pharmaceuticals be 

secured in a manner that prevents 

unauthorized access to the contents in 

order to prevent the pilfering of 

hazardous waste pharmaceuticals or 

inadvertent exposures to them. As we 

have noted previously, hazardous waste 

pharmaceuticals still retain considerable 

value and can easily be diverted for 

illicit purposes. To ensure this does not 

occur, we believe it is important to 

propose a requirement that would 

prevent the unauthorized access to the 

contents of these containers. EPA 

intends this requirement to be 

performance-based and does not intend 

to propose prescriptive regulatory 

requirements for this standard. The 

Agency believes that healthcare 

facilities can choose to utilize 

containers that have built-in 

mechanisms to prevent access to their 

contents or can choose to store 

containers in locked storage lockers, 

closets or rooms where the public does 

not have access to the containers or 

their contents. 


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58034 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

70See the preamble to the Universal Waste final 

rule: May 11, 1995; 60 FR 25492 (page 25526). 

71While the proposed rules do not require 

healthcare facilities to comply with the central 

accumulation requirements under 262.34, a 

healthcare facility may have a central accumulation 

area for the other hazardous wastes that it generates. 

The Agency is seeking comment on 

the appropriateness of the proposed 

container management standards. In 

addition, the EPA is soliciting comment 

on the proposed requirement for 

ensuring that the hazardous waste 

pharmaceuticals contained in collection 

containers remain secure. 

6. Labeling Standards on Containers for 

Healthcare Facilities Managing NonCreditable Hazardous Waste 

Pharmaceuticals 

During the period of accumulation 

and storage, the Agency is proposing 

that containers of hazardous waste 

pharmaceuticals be marked with the 

words ‘‘Hazardous Waste 

Pharmaceuticals.’’ The Agency is not 

proposing to require that the hazardous 

waste numbers (often referred to as 

hazardous waste codes) of the 

container’s contents be listed on the 

label. The personnel at healthcare 

facilities that typically generate the 

hazardous waste pharmaceuticals will 

be healthcare workers (e.g., nurses). 

Healthcare workers are not usually 

intimately familiar with RCRA and its 

regulations and are primarily focused on 

patients and their health. In addition, 

while a healthcare facility may have an 

environmental compliance manager or 

environmental consultant that is 

knowledgeable about RCRA and its 

regulations and can make hazardous 

waste determinations, this individual 

cannot be present to assign a hazardous 

waste code and label the collection 

receptacle each time a pharmaceutical 

waste is generated. For these reasons, 

EPA does not believe it is necessary to 

require individual waste codes on the 

hazardous waste pharmaceutical 

collection container at the healthcare 

facility. The Agency is soliciting 

comment on the appropriateness of the 

proposed general labeling requirement. 

The Agency also requests comment on 

security concerns regarding having the 

word ‘‘pharmaceutical’’ marked on the 

containers. 

7. Accumulation Time Limits for 

Healthcare Facilities Managing NonCreditable Hazardous Waste 

Pharmaceuticals 

Several hazardous waste 

pharmaceuticals are P-listed, acute 

hazardous wastes (e.g., nicotine, 

warfarin, etc.). Under current 

regulations, if a generator generates 

more than 1 kg of acute hazardous waste 

per calendar month or accumulates 

more than1 kg of acute hazardous waste 

at any time, the generator is regulated as 

an LQG. Due to this low generation/

accumulation threshold associated with 

P-listed wastes, healthcare facilities are 

often LQGs. However, while healthcare 

facilities can generate enough P-listed 

waste to become LQGs, they often do 

not generate sufficient amounts of 

hazardous waste pharmaceuticals 

within the allowed accumulation period 

of 90 days to make off-site shipments 

using a hazardous waste transporter 

cost-effective. 

Under the 2008 Pharmaceutical 

Universal Waste proposal, universal 

waste handlers would have had one 

year for accumulation of its hazardous 

waste pharmaceuticals in order to 

facilitate proper treatment and disposal. 

Commenters on the 2008 Universal 

Waste proposed rule indicated support 

for the one-year accumulation time 

limit. Thus, the Agency is proposing to 

allow healthcare facilities to accumulate 

hazardous waste pharmaceuticals for up 

to one year, without having interim 

status or a RCRA permit. As with 

Universal Waste, one year is an 

appropriate timeframe because it strikes 

a balance between allowing healthcare 

facilities enough time to accumulate 

amounts of hazardous waste 

pharmaceuticals to make it 

economically viable for transporting 

their hazardous waste pharmaceuticals 

off-site while ensuring that the 

hazardous wastes are not accumulated 

beyond the one year storage limit under 

the land disposal restrictions programs 

(see § 268.50).70

Healthcare facilities will have various 

approaches to demonstrate the length of 

time that hazardous waste 

pharmaceuticals are accumulated onsite. For example, a healthcare facility 

can choose to mark the container label 

with the date that accumulation first 

began, maintain an inventory system 

that identifies dates when the hazardous 

waste pharmaceuticals were first 

accumulated, identify in the central 

accumulation area 71 the earliest date 

that a hazardous waste pharmaceutical 

became a waste, or any other method 

that clearly demonstrates the length of 

time that the hazardous waste 

pharmaceutical has been accumulated 

from the date it became a hazardous 

waste. The Agency assumes that any 

accumulation for up to one year is for 

the purpose of facilitating proper 

treatment and disposal. EPA proposes to 

require that any healthcare facility 

needing a longer accumulation time for 

any unforeseen circumstances beyond 

the control of the healthcare facility 

(e.g., a recall or litigation) request an 

extension from the appropriate EPA 

Regional Administrator. This request 

must be sent in writing (electronic or 

paper) explaining the need for the 

extension, the approximate amount of 

hazardous waste pharmaceuticals 

accumulated beyond the one year, and 

the amount of extra time requested. An 

extension period will be granted at the 

discretion of the Regional Administrator 

on a case-by-case basis. 

Finally, the Agency reiterates that the 

one-year accumulation time limit only 

applies to a healthcare facility’s noncreditable hazardous waste 

pharmaceuticals and does not apply to 

any other types of hazardous waste 

generated on-site or to potentially 

creditable hazardous waste 

pharmaceuticals. EPA solicits comment 

on the proposed accumulation time 

limit of one year in order to allow 

healthcare facilities to generate enough 

non-creditable hazardous waste 

pharmaceuticals for cost-effective 

shipment, and solicits comment on the 

proposed mechanism to request a time 

extension. 

8. Land Disposal Restrictions for NonCreditable Hazardous Waste 

Pharmaceuticals 

Similar to the current RCRA Subtitle 

C generator requirements, healthcare 

facilities must comply with the land 

disposal restrictions (LDR) prior to land 

disposal of the hazardous waste 

pharmaceuticals they generate. Since 

healthcare facilities are generators, even 

though they are not subject to the 40 

CFR part 262 requirements for the 

management of hazardous waste 

pharmaceuticals, they must comply 

with the land disposal restrictions 

found at 40 CFR part 268. The land 

disposal restrictions are in place to 

ensure that toxic constituents present in 

hazardous waste are properly treated to 

reduce their mobility or toxicity before 

hazardous waste is placed into or onto 

the land (i.e., land disposed). With 

limited exceptions, hazardous waste 

must be treated by a RCRA permitted or 

interim status TSDF. Again, EPA notes 

that autoclaving is not an acceptable 

method of treating hazardous waste. 

In general, generators of hazardous 

waste assign the appropriate hazardous 

waste numbers codes to allow TSDFs to 

determine the specific treatment 

standard(s) for each prohibited waste. 

The Agency is proposing that healthcare 

facilities generating non-creditable 

hazardous waste pharmaceuticals do not 

have to assign hazardous waste codes to 

these wastes, but rather label them as 

‘‘hazardous waste pharmaceuticals’’. 

They do, however, need to be aware that 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58035 

while most of the hazardous waste 

pharmaceuticals are likely organic in 

nature and will be incinerated, some of 

their hazardous waste pharmaceuticals 

may not be suitable for incineration and 

therefore must be segregated from the 

organic wastes. The pharmaceutical 

hazardous wastes not suitable for 

incineration include characteristic metal 

wastes prohibited from being combusted 

because of the dilution prohibition of 

§ 268.3(c), as well as the listed wastes 

U151 (mercury), U205 (selenium 

sulfide), and P012 (arsenic trioxide), 

unless they contain greater than 1% 

total organic carbon. In order to comply 

with the LDRs, healthcare facilities will 

need to segregate these wastes from the 

organic pharmaceutical hazardous 

wastes so that they can be properly 

treated by the TSDF. The Agency seeks 

comment on whether it is necessary to 

incorporate into the regulations a 

requirement to segregate these wastes 

and whether additional labeling 

requirements are necessary to identify 

the hazardous waste pharmaceuticals 

that are not suitable for incineration. 

Tables 2 through 4 list the hazardous 

waste pharmaceuticals with their 

hazardous waste codes and their LDR 

treatment standards. 


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Table 2: Waste Codes of Characteristic Hazardous Waste Pharmaceuticals 

Was.~e Desctription ' Non-Wastewater 

Code .. ·. ·. : ·.· .. ·· ·. .. · ... . Treatment Standard 

DOOI Ignitable 

Ignitable All DOOI, except DEACT and UTS or 

high TOC DOOI 261.2l(a)(l) RORGS or 

CMBST 

Ignitable High TOC DOOI RORGS or 

based on 261.2l(a)(l) CMBSTor 

POLYM 

D002 Corrosivity DEACT 

and UTS 

D004 * Arsenic 5. 0 mg/L TCLP 

and UTS 

D005 * Barium 21 mg/L TCLP 

and UTS 

D006 * Cadmium 0.11 mg/L TCLP 

and UTS 

D007 * Chromium 0.60 mg/L TCLP 

and UTS 

D008 * Lead 0.75 mg/L TCLP 

and UTS 

D009* Mercury 

Mercury 2':260 mg/kg total Hg IMERC or RMERC (high mercury organics) 

Mercury < 260 mg/kg total 

Hg & are not 0.025 mg/L TCLP 

residues from RMERC and UTS 

(low mercury) 

DOlO* Selenium 5. 7 mg/L TCLP 

and UTS 

DOll* Silver 0.14 mg/L TCLP 

and UTS 

D013 Lindane 

Lindane alpha-BHC 0.066 mg/kg 

and UTS 

Lindane beta-BHC 0.066 mg/kg 

and UTS 

Lindane delta-BHC 0.066 mg/kg 

and UTS 

Lindane gamma-BHC 0.066 mg/kg 

and UTS 

D022 Chloroform 6.0 mg/kg 

and UTS 
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58037 


tkelley on DSK3SPTVN1PROD with PROPOSALS3EP25SE15.001</GPH>

Wast.e 

Code 

D024 m-Cresol 

Non-Wastewater 

Treatnie11t Standard 

5.6 mg/kg 

and UTS 

*Waste code may not be treated by combustion unless the waste meets one of the criteria in § 

268.3(c) (e.g., has >1% total organic carbon) 

BOLD indicates that the waste is an organic waste with a concentration-based treatment standard 

UTS =Universal Treatment Standards in § 268.48 

Table 3: P-listed Hazardous Waste Pharmaceuticals 

Waste Description •·· • N~n:"Witste~ater .·.·· · 

Code .• .. · ... . Treattne:ntStandatd 

POOl Warfarin CMBST 

(concentration> 0.3%) 

P012 * Arsenic trioxide 5. 0 mg/L TCLP 

P042 Epinephrine CMBST 

P046 Phentermine CMBST 

P075 Nicotine CMBST 

P081 Nitroglycerin CMBST 

Pl88 Physostigmine salicylate 1.4 mg/kg 

orCMBST 

P204 Physostigmine 1.4 mg/kg 

orCMBST 

*Waste code may not be treated by combustion unless the waste meets one of the criteria in § 

268.3(c) (e.g., has >1% total organic carbon) 

Table 4: U-listed Hazardous Waste Pharmaceuticals 

Waste··. Descriptio». Noll ... wastewat~r ·· 

.Code· : ..•.... . ···· Treatment Standard 

UOIO Mitomycin CMBST 

U015 Azaserine CMBST 

U034 Chloral hydrate CMBST 

U035 Chlorambucil CMBST 

U044 Chloroform 6.0 mg/kg 

U058 Cyclophosphamide CMBST 

U059 Daunomycin CMBST 

U075 Dichlorodifluoromethane 7.2 mg/kg 
58038 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

The organic hazardous waste 

pharmaceuticals (other than arsenic 

trioxide) may all be incinerated at RCRA 

permitted or interim status hazardous 

waste combustors. As noted in Tables 

2–4, most of the organic wastes have a 

specified treatment standard of 

combustion (CMBST). The remaining 

seven organics (lindane, chloroform, mcresol, dichlorodifluoro methane, 

trichloromonofluoromethane, 

phenacetin and phenol) have numerical 

treatment standards, such that no 

particular treatment technology is 

specified or required in order to achieve 

the numerical treatment standards. 

While these wastes may be incinerated, 

the incinerator residue (ash) must be 

analyzed for these seven organic 

constituents to demonstrate compliance 

with the LDR treatment standards before 

that ash can be disposed. 

As mentioned earlier, because this 

proposed rule does not require that 

healthcare facilities label their waste 

with the hazardous waste codes, the 

TSDF must always analyze the 

incinerator ash for these seven 

constituents—lindane, chloroform, mcresol, dichlorodifluoro methane, 

trichloromonofluoromethane, 

phenacetin, and phenol—according to 

their waste analysis plan, as they could 

possibly be present in any shipment of 

organic hazardous waste 

pharmaceuticals. 

a. Alternative treatment standards 

considered. In their comments to the 

2008 Universal Waste proposal, 

Environmental Technology Council 

(ETC) suggested revising the treatment 

standards for the organic hazardous 

waste pharmaceuticals that have 

numerical treatment standards to the 

specified treatment standard of 


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Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58039 

72See comment number 0125 in the docket for 

this rulemaking. EPA–HQ–RCRA–2007–0932. 73The Agency is not aware of any hazardous 

waste pharmaceuticals that would be considered 

U151 because mercury would have to be the sole 

active ingredient. 

74Combustors that burn hazardous waste include 

the following types of combustion units: 

Incinerators, cement kilns, lightweight aggregate 

kilns, industrial boilers and process heaters, and 

hydrochloric acid production furnaces. 

75EPA is not aware of any testing done to 

demonstrate the effectiveness of this treatment 

method specifically for thimerosal-containing 

hazardous wastes, so vendors performing such 

treatment may need to do treatability studies to 

identify optimal use of stabilization/solidification 

treatment technologies. 

combustion.72 Specifying combustion 

would relieve the TSDFs from 

demonstrating compliance with the 

numerical treatment standards. EPA 

explored the feasibility of making 

combustion an alternative treatment 

standard for the seven organic 

hazardous waste pharmaceuticals that 

currently have numeric treatment 

standards. In fact, EPA notes that the 

numerical treatment standards were 

developed based on levels achieved 

through combustion. However, in order 

to allow maximum flexibility, EPA has 

indicated a preference for numerical 

treatment standards over specifying 

treatment standards whenever possible. 

Furthermore, it is not clear that 

pharmaceuticals would be the sole 

source of the seven organic constituents 

in question. Therefore, even if we 

proposed an alternative treatment 

standard of combustion for the seven 

organic pharmaceuticals, hazardous 

waste incinerators would still be 

required to test their ash for these 

constituents to demonstrate compliance 

with numeric treatment standards if 

they received the organics from another, 

non-pharmaceutical source. 

b. Incineration of mercury-containing 

hazardous waste pharmaceuticals. It is 

rare, but some pharmaceuticals contain 

mercury (e.g., thimerosal, a mercurycontaining preservative). When 

discarded, a mercury-containing 

pharmaceutical would be a D009 

hazardous waste if the leachate 

generated by the toxicity characteristic 

leaching procedure (TCLP), or if the 

pharmaceutical itself (when the waste 

contains < 0.5% filterable solids), 

contains ≥ 0.2 mg/L mercury (see 

§ 261.24).73 As indicated in Table 2, a 

D009 hazardous waste with mercury 

content ≥ 260 mg/kg of total mercury 

and that also contains organics, must be 

treated by IMERC (incineration) or 

RMERC (mercury retorting). However, 

hazardous waste pharmaceuticals that 

are D009 are expected to have mercury 

content <260 mg/kg, in which case the 

treatment standards are numeric and 

treatment by RMERC or IMERC is not 

required. With numeric treatment 

standards, the generator has flexibility 

regarding which hazardous waste 

treatment method to use to meet the 

treatment standard. As explained 

previously, incineration of mercurybearing hazardous waste with >1% total 

organic carbon is not considered 

impermissible dilution (see § 268.3(c)) 

and therefore is an allowable form of 

treatment. 

Emissions from combustion units that 

burn hazardous waste 74 are regulated 

under RCRA and the Clean Air Act 

(CAA). The implementing regulations 

under these statutory authorities 

include emission limits for new and 

existing combustion units for mercury, 

semi-volatile metals (cadmium and 

lead), low volatility metals (arsenic, 

beryllium, and chromium), particulate 

matter, chlorinated dioxins and furans, 

other toxic organic compounds, 

hydrogen chloride and chlorine. The 

regulations also (1) specify when and 

how combustion sources must comply 

with the emission standards and 

operating requirements, (2) prescribe 

detailed monitoring requirements to 

show continuous compliance with the 

emission standards, and (3) prescribe 

performance testing requirements to 

demonstrate compliance with the 

emission standards (see 40 CFR part 63, 

subpart EEE). 

To ensure continuous compliance 

with the emission limits, hazardous 

waste combustors are required to 

establish limits on (1) the feedrate of 

metals (including mercury), chlorine, 

and (for some types of hazardous waste 

combustors) ash; (2) combustor 

operating parameters such as minimum 

combustion chamber temperature; and 

(3) operating parameters of the air 

pollution control device. For mercury, 

continuous compliance requirements 

would generally include a limit on the 

total feedrate of mercury in all 

feedstreams to the combustion unit, 

limits on the operation of a wet scrubber 

(depending on the species of mercury in 

the combustion gases, wet scrubbers can 

be efficient at removing mercury), and 

operating limits on the activated carbon 

injection or carbon bed system, if such 

systems are used. 

In addition, RCRA directs permitting 

authorities to impose additional terms 

and conditions on a site-specific basis as 

may be necessary to protect human 

health and the environment (see 

§ 270.32(b)). Thus, if the mercury 

emission limits specified previously are 

not protective in an individual instance, 

the permit writer will establish permit 

limits that are protective. 

Nevertheless, EPA is aware that some 

stakeholders are concerned about the 

risks associated with incinerating 

mercury-bearing hazardous wastes and 

we encourage healthcare facilities and 

pharmaceutical reverse distributors to 

consider the use of treatment 

technologies other than incineration for 

meeting the numeric treatment 

standards for mercury-bearing 

hazardous waste pharmaceuticals. 

Thimerosal-containing pharmaceuticals 

are expected to be non-wastewaters as 

defined by § 268.2, because they have 

more than 1% total organic carbon. For 

low mercury non-wastewaters, the 

numeric treatment standard can be 

achieved by stabilization/solidification, 

either with or without subsequent 

encapsulation.75

9. Shipments of Non-Creditable 

Hazardous Waste Pharmaceuticals Offsite From Healthcare Facilities 

The Agency is proposing to maintain 

the current RCRA Subtitle C tracking 

requirement by requiring that a 

hazardous waste manifest be prepared 

for each off-site shipment of noncreditable hazardous waste 

pharmaceuticals from healthcare 

facilities. Accordingly, each off-site 

shipment of hazardous waste 

pharmaceuticals must be transported to 

an interim status or permitted TSDF via 

a hazardous waste transporter. However, 

the Agency is proposing that for 

hazardous waste pharmaceuticals 

shipped by healthcare facilities, the 

RCRA hazardous waste codes do not 

need to be listed on the manifest. This 

is intended to accommodate the fact that 

healthcare providers generating the 

hazardous waste pharmaceuticals are 

generally unfamiliar with RCRA and are 

focused on providing healthcare to 

patients. One function of the hazardous 

waste codes is to determine the 

appropriate hazardous waste treatment 

standards under the land disposal 

restrictions (part 268). However, 

virtually all hazardous waste 

pharmaceuticals sent for off-site 

treatment are sent to hazardous waste 

incinerators, even when the treatment 

standard does not require incineration. 

The fact that EPA is proposing to not 

require hazardous waste codes for 

shipping hazardous waste 

pharmaceuticals is not intended to alter 

or impact any Department of 

Transportation (DOT) requirements for 

the shipment of these hazardous wastes. 

For a more detailed discussion of these 

proposed requirements, as well as the 

basis for these requirements, please see 

Section V.F.1 of this document. 


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58040 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

76 § 262.40 requires that generators keep a copy of 

each BR for a period of at least three years from the 

due date of the report. However, since we are not 

requiring a healthcare facility to include its 

hazardous waste pharmaceuticals on its a BR, the 

Agency is also not including in subpart P a 

requirement that a BR be kept at the healthcare 

facility. If healthcare facility must submit a BR due 

to its non-pharmaceutical hazardous waste, the 

§ 262.40 recordkeeping requirements will apply (see 

the discussion under Reporting Requirement for 

Healthcare Facilities Managing Non-creditable 

Hazardous Waste Pharmaceuticals for the Agency’s 

basis of not requiring healthcare facilities to include 

hazardous waste pharmaceuticals on the BR. 

10. Rejected Shipment From Healthcare 

Facilities of Non-creditable Hazardous 

Waste Pharmaceuticals 

In rare circumstances, a healthcare 

facility may send its non-creditable 

hazardous waste pharmaceuticals to a 

designated facility that is unable to 

manage the hazardous waste. For such 

situations, we are proposing that 

healthcare facilities follow the same 

procedures listed in 40 CFR part 262 

(see § 262.23(f)). Specifically, if a 

designated facility is unable to accept 

the hazardous waste pharmaceuticals, 

and it returns the hazardous waste 

pharmaceuticals to the healthcare 

facility, the healthcare facility must sign 

the manifest that was used to return the 

shipment, provide the transporter a 

copy of the manifest, send a copy of the 

manifest within thirty days to the 

designated facility that returned the 

shipment and retain a copy of the 

manifest for three years from the date of 

delivery of the returned shipment. EPA 

believes that it is appropriate to 

continue current practices for rejected 

shipments that are part of the generator 

regulations of 40 CFR part 262 because 

rejected shipments are relatively rare 

and the procedures currently used for 

rejected shipments is relatively 

straightforward. In addition, healthcare 

facilities should be familiar with these 

procedures already. 

11. Reporting Requirements for 

Healthcare Facilities Managing NonCreditable Hazardous Waste 

Pharmaceuticals 

The Agency is proposing that 

healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals have reporting 

requirements similar to SQGs s 

regulated under 40 CFR part 262—that 

is, the exception reporting requirement 

under § 262.44(b) and the additional 

reporting requirement under § 262.44(c). 

In addition, we are proposing that 

healthcare facilities that are LQGs 

would no longer be required to include 

their hazardous waste pharmaceuticals 

on their biennial report (BR). Each of 

these reporting requirements for 

healthcare facilities is discussed below. 

First, as part of the current RCRA 

Subtitle C generator requirements, 

healthcare facilities that are LQGs must 

submit a BR to the Regional 

Administrator by March 1st of every 

even numbered year (see § 262.41). 

Among other requirements, the BR must 

include a description (EPA hazardous 

waste number and DOT hazard class) 

and quantity of each hazardous waste 

shipped off-site to a TSDF during each 

odd numbered year. If a healthcare 

facility is an LQG due to its nonpharmaceutical hazardous waste, it will 

continue to be required to submit a BR. 

However, it need not include its 

hazardous waste pharmaceuticals in its 

BR. As discussed previously, the 

Agency is no longer requiring healthcare 

facilities to count hazardous waste 

pharmaceuticals when determining 

their generator category. Instead, all 

healthcare facilities, with the exception 

of CESQGs, will be subject to this 

proposed rule. The Agency has 

determined that it does not need the 

information to be included in the BR 

because this proposed rule will bring a 

consistent approach to managing 

pharmaceutical hazardous wastes. 

Nevertheless, the Agency is soliciting 

public comment on whether the Agency 

should require healthcare facilities— 

that is, all healthcare facilities subject to 

the 40 CFR part 266, subpart P 

requirements—to submit a BR, and if so, 

the type of information that should be 

included. 

Second, the Agency is proposing that 

healthcare facilities follow the same 

reporting procedures for exception 

reporting that generators operating 

under the 40 CFR part 262 must follow. 

We are proposing to incorporate the 

generator exception reporting 

procedures in this new subpart. 

Specifically, if a healthcare facility does 

not receive a copy of the hazardous 

waste manifest from the designated 

facility within 60 days, the healthcare 

facility must submit to the EPA Regional 

Administrator a copy of the manifest 

with a statement that the healthcare 

facility did not receive confirmation of 

the hazardous waste pharmaceuticals’ 

delivery along with an explanation of 

the efforts taken to locate the hazardous 

waste pharmaceuticals and the results of 

those efforts. Likewise, if a shipment of 

hazardous waste pharmaceuticals from a 

healthcare facility is rejected by the 

designated facility and it is shipped to 

an alternate facility and if the healthcare 

facility does not receive a signed copy 

of the hazardous waste manifest from 

the alternate facility within 60 days, it 

must submit to the EPA Regional 

Administrator a copy of the hazardous 

waste manifest with a statement that the 

healthcare facility did not receive 

confirmation of the hazardous waste 

pharmaceuticals’ delivery along with an 

explanation of the efforts taken to locate 

the hazardous waste pharmaceuticals 

and the results of those efforts. Again, 

the Agency believes it is advantageous 

to use established procedures that 

should be familiar to healthcare 

facilities, especially given that rejected 

shipments are relatively rare. 

Finally, the Agency proposes that the 

Administrator may require healthcare 

facilities to furnish additional reports 

concerning the quantities and 

disposition of hazardous waste 

pharmaceuticals. This is already the 

case for generators operating under the 

40 CFR part 262 requirements. As with 

40 CFR part 262, it is a codification of 

statutory authority under §§ 2002(a) and 

3002(a)(6) that provides the Agency 

some flexibility in what reports may be 

required. The Agency solicits public 

comment on the proposed reporting 

requirements for healthcare facilities 

managing their hazardous waste 

pharmaceuticals in accordance with the 

standards proposed in this document. 

12. Recordkeeping Requirements for 

Healthcare Facilities Managing NonCreditable Hazardous Waste 

Pharmaceuticals 

The Agency is proposing that 

healthcare facilities managing noncreditable hazardous waste 

pharmaceuticals maintain records 

similar to the records that must be kept 

by generators regulated under 40 CFR 

part 262 (see § 262.40). Specifically, 

healthcare facilities must keep a signed 

copy of each hazardous waste manifest 

as a record for three years from the date 

that the non-creditable hazardous waste 

pharmaceutical was accepted by the 

initial hazardous waste transporter. If 

the healthcare facility is required to file 

an exception report because it does not 

receive a signed copy of the manifest 

from the designated facility within 60 

days of the date that the hazardous 

waste pharmaceutical was accepted by 

the initial transporter, then the 

healthcare facility must keep a copy of 

the each exception report for a period of 

at least three years from the due date of 

the report.76 In addition, EPA is 

proposing that a healthcare facility must 

keep records of any test results, waste 

analyses or other determinations made 

on hazardous waste pharmaceuticals 

regarding which pharmaceuticals are 

hazardous wastes for three years from 

the date of the test, analysis, or other 

determination. 


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Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58041 

77http://www.epw.senate.gov/cercla.pdf. 

78 DEA’s final rule for disposal of controlled 

substances: 79 FR 53520; September 9, 2104. 

79Unlike other sub-sections of Section V.C., 

which discusses the proposed standards for 

healthcare facilities managing non-creditable 

hazardous waste pharmaceuticals, this sub-section 

addresses both non-creditable and creditable 

hazardous waste pharmaceuticals. 

80Potentially creditable hazardous waste 

pharmaceuticals include pharmaceuticals that are: 

(1) Unused or un-administered, (2) unexpired or 

Continued 

The Agency is also proposing that any 

of the retention periods be extended 

during the course of enforcement 

actions against any activity associated 

with hazardous waste pharmaceutical 

management or as requested by the 

Administrator to ensure that the 

appropriate records are available and 

can be reviewed as part of any 

enforcement action. The Agency solicits 

public comment on the proposed 

recordkeeping requirements for 

healthcare facilities managing their noncreditable hazardous waste 

pharmaceuticals in accordance with the 

standards proposed in this document. 

13. Response to Releases by Healthcare 

Facilities Managing Non-Creditable 

Hazardous Waste Pharmaceuticals 

For hazardous waste pharmaceuticals 

generated and managed by healthcare 

facilities under the proposed standards, 

the Agency is proposing basic release 

responses, including the requirement 

that healthcare facilities immediately 

contain all releases of, and other 

residues from, hazardous waste 

pharmaceuticals. In addition, this 

proposal would require healthcare 

facilities to determine whether any 

material, residue, or debris resulting 

from the release is or contains a 

hazardous waste pharmaceutical and, if 

so, to manage it under the management 

standards for hazardous waste 

pharmaceuticals proposed in this 

document. These proposed release 

response procedures are the same as 

those under the Universal Waste 

program (see § 273.17 for small quantity 

universal waste handlers, and § 273.37 

for large quantity universal waste 

handlers). Commenters to the 1993 

proposed rule that established the 

Universal Waste program 

overwhelmingly supported the release 

response measures (60 FR 25528; May 

11, 1995). Thus, we believe it is 

appropriate to include it again in this 

proposal. 

Any releases of hazardous waste 

pharmaceuticals not cleaned up 

immediately would generally constitute 

illegal disposal, which may result in 

further action by EPA or an authorized 

state under RCRA. In addition, 

hazardous wastes under RCRA are 

included in the definition of hazardous 

substances for purposes of the 

Comprehensive Environmental 

Response Compensation, and Liability 

Act (CERCLA) (see CERCLA Section 

101(14) 77). Thus, any releases into the 

environment of hazardous substances 

above the reportable quantity (RQ) 

thresholds must be reported under 

CERCLA (see CERCLA Section 103). 

That is, since hazardous waste 

pharmaceuticals are hazardous wastes 

and, hazardous substances under 

CERCLA, reporting for hazardous waste 

pharmaceutical releases is required 

when RQs are exceeded (see 40 CFR 

302.4 for a list of RQs and hazardous 

substances). Such reports provide 

notification to the Agency (through the 

National Response Center) concerning 

releases into the environment and help 

inform whether EPA should take action, 

if necessary, under either RCRA or 

CERCLA. 

The Agency solicits comment 

regarding the proposed standard for the 

response to releases of hazardous waste 

pharmaceuticals at healthcare facilities. 

14. Long-Term Care Facilities Managing 

Non-Creditable Hazardous Waste 

Pharmaceuticals 

Long-term care facilities differ in one 

respect from other types of healthcare 

facilities subject to these proposed 

standards. Unlike hospitals, who own 

the pharmaceuticals they dispense to 

patients, many of the hazardous waste 

pharmaceuticals generated at long-term 

care facilities belong to the residents of 

the facility. That is, the pharmaceuticals 

are dispensed under the patient’s name. 

However, as previously discussed in 

this preamble, EPA is proposing to no 

longer allow hazardous waste 

pharmaceuticals generated at long-term 

care facilities (as defined under this 

proposed regulation) to be eligible for 

the household hazardous waste 

exemption. As a result, long-term care 

facilities must manage all hazardous 

waste pharmaceuticals generated onsite, regardless of ownership, in 

accordance with these same proposed 

management standards for healthcare 

facilities. EPA understands that while 

long-term care facilities often maintain 

each individual’s pharmaceuticals in a 

centralized location, such as a 

pharmaceutical cart, there are instances 

where some individuals may keep and 

self-administer their own 

pharmaceuticals. EPA is proposing that 

the long-term care facilities collect and 

manage all hazardous waste 

pharmaceuticals generated at their 

facilities in accordance with these 

proposed requirements. This 

requirement means that in addition to 

the hazardous waste pharmaceuticals 

kept in the centralized location, longterm care facilities will need to collect 

all other hazardous waste 

pharmaceuticals from individuals that 

self-administer these pharmaceuticals 

and manage them in accordance with 

these proposed standards, which, 

among other things, prohibits the 

sewering of hazardous waste 

pharmaceuticals. The Agency solicits 

comment on the extent to which longterm care facilities keep an inventory of 

the pharmaceuticals that individuals 

self-administer, as this would facilitate 

the collection of the hazardous waste 

pharmaceuticals for proper disposal. 

Although long-term care facilities 

would not be required under this rule to 

collect non-hazardous waste 

pharmaceuticals, or hazardous waste 

pharmaceuticals from the independent 

living portion of a continuing care 

facility, EPA recommends that longterm care facilities collect all waste 

pharmaceuticals to ensure proper 

management, avoid flushing, and 

minimize the potential for accidental 

poisonings, misuse or abuse. As 

discussed later in this preamble, DEA 

regulations govern the management of 

controlled substances (see Section 

V.E.2.a of the preamble for a discussion 

of DEA’s 2014 final rule for the disposal 

of controlled substances and the 

implications of that rule and this 

proposed rule for long-term care 

facilities.78) Also discussed later in 

more detail, EPA is proposing to exempt 

from RCRA those hazardous waste 

pharmaceuticals that are also controlled 

substances, provided they are 

combusted at a permitted or interim 

status hazardous waste incinerator or 

permitted municipal solid waste 

incinerator and managed in compliance 

with applicable DEA regulations (see 

Section V.E.2 of the preamble for a 

detailed discussion of the exemption). 

The Agency solicits comment 

regarding this requirement, and 

specifically requests comment on the 

various approaches that long-term care 

facilities use, or could use in collecting 

hazardous waste pharmaceuticals from 

individuals that self-administer their 

pharmaceuticals. 

15. Healthcare Facilities That Accept 

Hazardous Waste Pharmaceuticals From 

Off-Site Conditionally Exempt Small 

Quantity Generators (CESQGs) 79

Typically, hazardous waste 

pharmaceuticals from healthcare 

facilities are transported either to a 

reverse distributor, if it is potentially 

creditable,80 or to a permitted or interim 


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58042 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

less than one year past the expiration date; or (3) 

in unopened or opened packaging or containers. 81 DEA controlled substances can be returned to 

a long-term care pharmacy only if they are subject 

to a recall (see 21 CFR 1317.85(a)). 82See notes from 11–15–12 site visit to Omnicare, 

Inc. in the docket for this proposed rule (EPA–HQ– 

RCRA–2007–0932). 83 Due to the DEA regulations, a DEA registered 

long term care pharmacy may not accept returns of 

a controlled substances. DEA regulations define 

‘‘reverse distribute’’ and reverse distributor’’ in 21 

CFR 1300.01. A pharmacy is not authorized to 

accept returns of controlled substances from 

patients or reverse distribute (see 21 CFR 

1301.13(e)(1)(iv)). 84Under these proposed requirements, hazardous 

waste pharmaceuticals will not count towards a 

facility’s generator category. Therefore, EPA expects 

that long-term care facilities will remain CESQGs, 

even though the Agency is proposing that all 

hazardous waste pharmaceuticals generated on the 

premises must be managed in accordance with 

these proposed requirements. 85See notes from 11–28–12 meeting with U.S. 

Army Institute of Public Health in the docket for 

this proposed rule (EPA–HQ–RCRA–2007–0932). 

86Barnes, K. K., Christenson, S. C., Kolpin, D. W., 

Focazio, M. J., Furlong, E. T., Zaugg, S. D., Meyer, 

M. T. and Barber, L. B. (2004), Pharmaceuticals and 

Other Organic Waste Water Contaminants Within a 

Leachate Plume Downgradient of a Municipal 

Landfill. Groundwater Monitoring & Remediation, 

24: 119–126. 

87Buszka, P.M., Yeskis, D.J., Kolpin, D.W., 

Furlong, E.T., Zaugg, S.D., and Meyer, M.T. (June 

2009), Waste-Indicator and Pharmaceutical 

Compounds in Landfill-Leachate-Affected Ground 

Water near Elkhart, Indiana, 2000–2002. Bulletin of 

Environmental Contamination and Toxicology, 

V82.6:635–659. 

88For purposes of this provision, ‘‘control’’ 

means the power to direct the policies of the 

healthcare facility, whether by the ownership of 

stock, voting rights, or otherwise, except that 

contractors who operate facilities on behalf of a 

different person shall not be deemed to control such 

healthcare facility. 

89This condition is only applicable if the 

receiving healthcare facility is also a CESQG, since 

healthcare facilities that are SQGs and LQGs must 

comply with the requirements proposed in 40 CFR 

part 266 subpart P. 

status hazardous waste TSDF. However, 

stakeholders have informed EPA that in 

some cases, hazardous waste 

pharmaceuticals are transported to 

another healthcare facility. We are 

aware of at least two situations in which 

this is occurring. First, patients at longterm care facilities who receive their 

pharmaceuticals from an off-site longterm care pharmacy sometimes return 

their unused pharmaceuticals to the 

long-term care pharmacy.81 Upon 

return, the long-term care pharmacy 

sorts through the returned 

pharmaceuticals to determine whether 

they will be disposed or restocked for 

reuse. Due to many factors, such as 

Medicare regulations and the cost of the 

pharmaceutical as compared to the cost 

of repackaging and restocking, only a 

small fraction of the returned 

pharmaceuticals are restocked for 

potential reuse. One long-term care 

pharmacy estimated that approximately 

10 percent of the pharmaceuticals it 

sends to long-term care facilities come 

back as returns.82 Some portion of the 

returns would be considered hazardous 

waste pharmaceuticals when 

discarded.83 In the second situation, the 

Army has established off-post health 

clinics to provide easier access to 

healthcare for military personnel, 

including veterans. The pharmacies at 

the off-post clinics receive their 

pharmaceutical products via couriers 

that deliver the pharmaceuticals from 

the on-post, main pharmacy. The offpost pharmacies also return their 

unused pharmaceuticals to the on-post, 

main pharmacy via courier. 

EPA data indicates that the majority 

of long-term care facilities are 

CESQGs 84 and the Army has informed 

EPA that their off-post clinics are 

generally CESQGs, as well.85 The 

existing CESQG regulations do not 

allow a generator to send its hazardous 

waste off-site to another hazardous 

waste generator, unless the receiving 

generator is also one of the seven types 

of facilities listed in § 261.5(f)(3) for 

acute hazardous waste or § 261.5(g)(3) 

for hazardous waste, including 

municipal and non-municipal nonhazardous solid waste landfills. The 

Agency does not think that disposal in 

landfills is the best option for hazardous 

waste pharmaceuticals. Limited studies 

have shown active pharmaceutical 

ingredients are present in landfill 

leachate that is collected in municipal 

solid waste landfill leachate collection 

systems.86 87 Landfill leachate is then 

typically transported to a wastewater 

treatment plant for treatment; however, 

active pharmaceutical ingredients can 

pass through the treatment system and 

into our Nation’s waters. 

EPA thinks it would be preferable to 

allow healthcare facilities that are 

CESQGs to send their hazardous waste 

pharmaceuticals to another healthcare 

facility rather than send it to a 

municipal or non-municipal nonhazardous solid waste landfill. 

Therefore, EPA is proposing to allow 

healthcare facilities that are CESQGs 

operating under this subpart to send 

their hazardous waste pharmaceuticals 

to an off-site healthcare facility, without 

a hazardous waste manifest, provided 

four conditions are met. First, the 

receiving healthcare facility must be 

contracted to supply pharmaceutical 

products to the CESQG long-term care 

facility, or the CESQG healthcare facility 

and the receiving healthcare facility 

must both be under the control 88 of the 

same person, as defined by § 260.10 

(e.g., the Army). Second, the receiving 

healthcare facility must be managing its 

hazardous waste pharmaceuticals in 

accordance with the regulations of this 

proposed rule.89 Third, the hazardous 

waste pharmaceuticals from the CEQSG 

must be managed by the receiving 

healthcare facility as hazardous waste 

pharmaceuticals in accordance with the 

regulations of this proposed rule once it 

arrives at the receiving healthcare 

facility. Fourth, the receiving healthcare 

facility must keep and maintain records 

of the hazardous waste pharmaceuticals 

received from the off-site CESQG 

healthcare facilities for three years from 

receipt of shipment. These conditions 

should ensure the proper management 

of the hazardous waste pharmaceuticals, 

in that once they are received by the 

healthcare facility, they are subject to 

the same management standards EPA is 

proposing for hazardous waste 

pharmaceuticals managed by healthcare 

facilities, while at the same time would 

not impose an undue burden on 

healthcare facilities that are CESQGs, 

especially since these healthcare 

facilities always have the option of 

sending their hazardous waste 

pharmaceuticals to a municipal or nonmunicipal solid waste landfill. 

The Agency solicits comment on this 

new provision under this subpart, 

including whether any additional 

conditions should be imposed. In 

recommending any additional 

conditions, the Agency requests that 

commenters provide their rationale for 

the additional condition(s), as well as 

why such additional condition(s) would 

not pose an undue burden on healthcare 

facilities that are CESQGs. In addition, 

the Agency solicits comment on 

whether it might be appropriate to allow 

facilities, other than those meeting the 

proposed definition of a healthcare 

facility, to accept hazardous waste 

pharmaceuticals from an off-site CESQG 

(e.g., a military medical logistics 

facility). 

D. How does this proposed rule address 

healthcare facilities that accumulate 

potentially creditable hazardous waste 

pharmaceuticals prior to shipment to 

pharmaceutical reverse distributors? 

1. Potentially Creditable Hazardous 

Waste Pharmaceuticals Are Not 

Products 

One difference between this proposal 

and the 2008 Pharmaceutical Universal 

Waste proposal is the proposed 

interpretation of how RCRA applies to 

pharmaceuticals that are returned to 

reverse distributors to obtain 

manufacturers’ credit. Two previous 

agency policy memos set out EPA’s 

existing understanding of the status of 

these ‘‘creditable’’ pharmaceuticals. The 


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90Alan Corson to Steven Wittner on May 13, 1981 

(RCRA Online #11012) http://yosemite.epa.gov/

osw/rcra.nsf/0c994248c239947e85256d090071175f/

B630CD51DC85EDC58525670F006BCE84/$file/

11012.pdf. 

91Sylvia Lowrance to Mark J. Schulz on May 16, 

1991 (RCRA Online #11606) http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

A3A7A7A8F297438B8525670F006BE5D8/$file/

11606.pdf. 

92 73 FR 73525; December 2, 2008. 

93Comment EPA–HQ–RCRA–2007–0932–0125. 

94Comment EPA–HQ–RCRA–2007–0932–0068. 

95Comment EPA–HQ–RCRA–2012–0426–0025. 

96Content is copied from http://www.ncsl.org/

research/health/state-prescription-drug-returnreuse-and-recycling.aspx (accessed May 13, 2015). 

97Any facility, including a pharmaceutical 

manufacturer engaged in processing pharmaceutical 

hazardous waste for facilitation or verification of 

manufacturer’s credit would be considered a 

pharmaceutical reverse distributor under the 

proposed rule with respect to those operations, and 

would be subject to the proposed regulations for 

pharmaceutical reverse distributors. 

first, a letter to Merck Sharp & Dohme 

in 1981, explained that pharmaceuticals 

sent for credit may be reclaimed and are 

not wastes since the decision to discard 

a particular material does not occur 

until after the product has been returned 

to the manufacturing plant.90 The 

second, a letter to BFI Pharmaceutical 

Services, Inc. in 1991 states, ‘‘to the 

extent that the materials involved are 

unused commercial chemical products 

with a reasonable expectation of being 

recycled in some way when returned, 

the materials are not considered as 

wastes until a determination has been 

made to discard them.’’ 91 In addition to 

these letters, EPA’s 2008 Pharmaceutical 

Universal Waste proposal stated, 

‘‘Because unused or expired 

pharmaceuticals are returned (via the 

reverse distributor) for possible 

manufacturer’s credit, they still have 

potential value to the pharmacy or 

hospital and are thus not considered 

wastes.’’ 92

In this action, we are proposing to 

modify EPA’s position regarding the 

waste status of creditable 

pharmaceuticals. Because we 

understand that many participants in 

this sector have relied on the 

interpretations in the two letters and the 

2008 Pharmaceutical Universal Waste 

preamble, we are providing notice of a 

change in EPA’s position and providing 

an opportunity for public comment. 

Until this rule is final and effective, 

however, EPA’s previous interpretations 

will continue to be in effect. 

In terms of the concept that returned 

pharmaceuticals have value and are not 

waste, EPA confirms the general rule 

under RCRA that materials that are 

discarded are solid wastes, regardless of 

the economics of the system in which 

those discarded materials are handled. 

Therefore, the fact that a material may 

have monetary value (e.g., through a 

manufacturer’s credit) does not 

determine whether that material is a 

solid waste. Rather, the ‘‘decision 

point’’ on whether a pharmaceutical is 

a solid waste is when it has been 

discarded, or the decision has been 

made to discard the material. That is, a 

discarded pharmaceutical may retain 

value in the reverse distribution system, 

but still be considered a solid waste. 

Additionally, the economic value of 

hazardous waste can be one important 

consideration in determining whether a 

hazardous waste is legitimately recycled 

(see, for example, the discussion of 

Useful Economic Information in the 

2008 Definition of Solid Waste final 

rule, 73 FR 84706–07, October 30, 2008) 

and therefore excluded from being a 

solid waste. The definition of legitimate 

recycling is codified at 40 CFR 260.43 

and is discussed in the 2015 Definition 

of Solid Waste final rule (80 FR 1694, 

January 13, 2015). 

Commenters to the 2008 

Pharmaceutical Universal Waste 

proposal, the 2014 Retail Notice of Data 

Availability (NODA), stakeholders, and 

pharmaceutical reverse distributors 

themselves have informed EPA that 

pharmaceuticals transported to reverse 

distributors to receive credit are rarely, 

if ever, repurposed, recycled, or reused. 

One commenter wrote, ‘‘. . . EPA’s 

belief that reverse distributors first 

arrange to transport and receive the 

drugs, and then determine whether the 

drugs are useful products or wastes, is 

pure fiction.’’ 93 Another commenter 

wrote, ‘‘. . . the vast majority of the 

returned pharmaceuticals are to be 

collected for disposal or destruction 

once credit has been given.’’ 94 A third 

commenter wrote, ‘‘. . . drugs sent 

through reverse distribution are not 

reused or recycled due to economic and 

safety reasons.’’ 95 Regulations 

pertaining to the repurposing of 

pharmaceuticals vary by state, as they 

are established by each state’s Board of 

Pharmacy. However, stakeholders have 

overwhelmingly declared that state 

Boards of Pharmacy only allow 

pharmaceuticals to be repurposed under 

very narrow circumstances—that is, 

when a specific set of conditions are 

followed to ensure the viability and 

integrity of the pharmaceutical. The set 

of conditions vary by state; however, 

states have some restrictions in common 

when it comes to repurposing drugs. 

According to the National Conference of 

State Legislatures (NCSL), ‘‘Virtually all 

[state] laws include some restrictions 

designed to assure purity, safety and 

freshness of the products. Unless 

otherwise noted, all programs require: 

D All donated drugs must not be 

expired and must have a verified future 

expiration date. 

D Controlled substances, defined by 

the federal Drug Enforcement 

Administration (DEA) usually be 

excluded and prohibited. 

D A state-licensed pharmacist or 

pharmacy to be part of the verification 

and distribution process. 

D Each patient who is to receive a 

drug must have a valid prescription 

form in his/her own name.’’ 96

Thus, in most, if not all cases, 

pharmaceuticals that are transported 

back to a reverse distributor for credit 

are discarded by the reverse 

distributor.97 For that reason, the 

decision to send a pharmaceutical to a 

reverse distributor is essentially a 

decision to discard the pharmaceutical. 

Therefore, EPA is proposing to 

reinterpret its position such that the 

decision to send a pharmaceutical to a 

reverse distributor is the point at which 

a decision has been made to discard the 

pharmaceutical. As a result, once the 

decision is made to send a hazardous 

waste pharmaceutical to a reverse 

distributor, it is a solid waste at the 

healthcare facility. In this document, 

EPA is proposing to define the term 

‘‘potentially creditable hazardous waste 

pharmaceutical.’’ A portion of the 

potentially creditable pharmaceuticals 

at healthcare facilities that are 

transported to reverse distributors will 

likely meet the definition of hazardous 

waste. Of the set of pharmaceuticals that 

are hazardous wastes, only ‘‘potentially 

creditable’’ hazardous waste 

pharmaceuticals may be transported to 

a reverse distributor for manufacturer’s 

credit (see definition Section V.A.3). 

The Agency notes that the 

management standards discussed below 

pertain only to potentially creditable 

hazardous waste pharmaceuticals that 

are managed via reverse distribution 

and do not apply to the reverse 

distribution or reverse logistics systems 

that may exist for other consumer 

products. In addition to the standards 

discussed in this section, EPA is 

proposing standards for shipping 

potentially creditable hazardous waste 

pharmaceuticals to pharmaceutical 

reverse distributors as well as associated 

recordkeeping (see Section V.F.2. of the 

preamble). 

2. Hazardous Waste Determination for 

Potentially Creditable Hazardous Waste 

Pharmaceuticals 

As with non-creditable hazardous 

waste pharmaceuticals discussed 


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98See 73 FR 73529; December 2, 2008. 

99Commenter #EPA–HQ–RCRA–2007–0932– 

0091. 100Charlotte Smith, RPH, MS; Managing 

Pharmaceutical Waste: A New Implementation 

Blueprint; Pharmacy Practice News, Special 

Edition, 2011. 

previously, a healthcare facility must 

determine which potentially creditable 

pharmaceuticals are listed or 

characteristic hazardous wastes, in 

order to determine which potentially 

creditable pharmaceuticals are subject 

to regulation under this subpart. 

Potentially creditable hazardous waste 

pharmaceuticals must be managed 

under this subpart, while 

pharmaceuticals that do not meet the 

definition of hazardous waste but are 

potentially creditable, do not have to be 

managed under this subpart. However, a 

healthcare facility may choose to 

manage all of its potentially creditable 

pharmaceuticals (both hazardous and 

non-hazardous) as potentially creditable 

hazardous waste pharmaceuticals while 

accumulating on-site and when 

shipping off-site. If a healthcare facility 

chooses this approach, it would not 

need to make individual hazardous 

waste determinations, but would have 

made a generic decision that all of their 

potentially creditable waste 

pharmaceuticals are hazardous and 

manage them as potentially creditable 

hazardous waste pharmaceuticals in 

accordance with the proposed 

requirements in 40 CFR part 266, 

subpart P. 

3. Accumulation Time, Container 

Management, and Labeling for 

Potentially Creditable Hazardous Waste 

Pharmaceuticals at Healthcare Facilities 

Typically, EPA requires specific 

management standards for containers 

that hold hazardous waste. However, 

potentially creditable hazardous waste 

pharmaceuticals appear to pose lower 

environmental risk of release than 

patient care hazardous waste 

pharmaceuticals or traditional industrial 

hazardous waste. The risk of release is 

lower for several reasons. First, 

potentially creditable hazardous waste 

pharmaceuticals that are prepared for 

shipment to a reverse distributor are 

usually in their original containers as 

well as outer packaging, providing two 

layers of protection from leaks or 

spills.98 Second, potentially creditable 

hazardous waste pharmaceuticals are 

typically generated in the pharmacy 

area of a healthcare facility where there 

is restricted access, creating a layer of 

security for these pharmaceuticals. 

Third, EPA has been informed that it is 

common practice at healthcare facilities 

for potentially creditable 

pharmaceuticals that are destined for a 

reverse distributor to be taken from the 

shelves of the pharmacy periodically 

and promptly boxed for off-site 

shipment. EPA anticipates that this 

relatively quick timing is largely driven 

by the economic value of the 

manufacturer’s credit for the returned 

pharmaceuticals. Therefore, because of 

the lower risk these pharmaceuticals 

pose, EPA is not proposing specific 

management standards for healthcare 

facilities that accumulate containers of 

potentially creditable hazardous waste 

pharmaceuticals. For the same reasons, 

we also are not proposing a limit on 

how long healthcare facilities may 

accumulate containers of potentially 

creditable hazardous waste 

pharmaceuticals. EPA requests 

comment on the assumption that 

healthcare facilities promptly remove 

potentially creditable hazardous waste 

pharmaceuticals from pharmacy shelves 

and send them to reverse distributors. 

EPA asks for comment on whether the 

expectation of credit provides sufficient 

incentive to ensure that the hazardous 

waste pharmaceuticals will be managed 

appropriately or whether it is necessary 

to establish management standards and/ 

or a maximum time limit for the 

accumulation of potentially creditable 

hazardous waste pharmaceuticals prior 

to off-site shipment. 

In the 2008 Pharmaceutical Universal 

Waste proposal, EPA specifically 

solicited comment on whether 

stakeholders have knowledge of 

problems with mixing incompatible 

pharmaceuticals during accumulation. 

In response, one commenter indicated 

that there were no issues encountered 

with the compatibility of 

pharmaceuticals during storage.99 Since 

then, a 2011 article by Charlotte Smith 

states, ‘‘oxidizers, acids, and bases also 

are incompatible, but they occur 

infrequently as finished dosage 

forms.’’ 100 It is important to note that 

the accumulation of some potentially 

creditable hazardous waste 

pharmaceuticals, such as liquids and 

aerosols, may pose more of a risk than 

solid pills due to possible spillage or 

leakage. However, EPA believes that the 

small quantities in which the liquid and 

aerosol potentially creditable hazardous 

waste pharmaceuticals are generated, 

along with the DOT packaging 

requirements (49 CFR parts 173, 178, 

and 180), would likely obviate these 

risks. In addition, to further mitigate the 

potential for spillage or leakages, as a 

best management practice, EPA 

encourages healthcare facilities to place 

the original containers and packaging 

containing liquids and aerosols 

pharmaceuticals in separate individual 

containers, such as a sealed storage bag 

before placing them in the container 

that will be shipped. 

EPA also is proposing not to require 

specific labeling standards for 

containers holding potentially 

creditable hazardous waste 

pharmaceuticals, while they accumulate 

on-site. EPA does not want to deter the 

practice of co-mingling potentially 

creditable hazardous waste 

pharmaceuticals with potentially 

creditable non-hazardous waste 

pharmaceuticals since both are typically 

transported to a reverse distributor 

together. 

In addition, due to concerns regarding 

diversion of pharmaceuticals, EPA 

believes that it is safer not to call 

attention to the fact that these 

containers hold pharmaceuticals. Unlike 

floor waste or patient care 

pharmaceutical waste, or most 

hazardous waste, the hazardous waste 

pharmaceuticals returned to a reverse 

distributor often have high street value 

that makes them susceptible to 

diversion. Thus, EPA is not proposing to 

require a label for potentially creditable 

hazardous waste pharmaceuticals 

during accumulation at a healthcare 

facility. The Agency seeks comment on 

its proposal not to require specific 

accumulation, container management or 

labeling standards for potentially 

creditable hazardous waste 

pharmaceuticals that will be transported 

to a reverse distributor, including no 

specific labeling standards for 

containers holding potentially 

creditable hazardous waste 

pharmaceuticals on-site prior to 

shipment off-site. 

E. What are the proposed novel 

prohibitions, exemptions and other 

unique management requirements for 

hazardous waste pharmaceuticals? 

1. Sewer Disposal Prohibition 

a. Regulatory background on the 

domestic sewage exclusion. Under 

RCRA and the Subtitle C hazardous 

wastes regulations, if a material is not a 

solid waste, then it cannot be 

considered a hazardous waste. Under 

§ 261.4(a)(1)(ii) of the RCRA regulations, 

‘‘Any mixture of domestic sewage and 

other wastes that passes through a sewer 

system to a publicly-owned treatment 

works for treatment’’ is not a solid waste 

for purposes of Subtitle C regulation. 

This exclusion was finalized by EPA on 

May 19, 1980, based on the reasoning 

that ‘‘Mixed waste streams that pass 

through sewer systems to publiclyowned treatment works (POTW’s) will 

be subject to controls under the Clean 


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101 Kansas State University. January 31, 2008. 

Nancy J. Larson. Pharmaceutical Waste Outreach 

Project. 

102 King County Pharmaceutical Waste Survey 

Final Report. King County, Washington. April 2003. 

103The Albany Medical Center, October 29, 2009, 

Russell F. Mankes, Progress Report on the Source 

Reduction Demonstration Project, EPA Grant #X9– 

97256506–0. 

104Health Services Industry Study: Management 

and Disposal of Unused Pharmaceuticals (Interim 

Technical Report) August 2008; EPA–821–R–08– 

013. 

105Ruhoy and Daughton; Beyond the medicine 

cabinet: An analysis of where and why medications 

accumulate; Environment International 34(2008) 

1157–1169. 

106EPA, Occurrence of Contaminants of Emerging 

Concern in Wastewater from Nine Publicly Owned 

Treatment Works, August 2009; EPA–821–R–09– 

009. 

107Eggen RI, Hollender J, Joss A, Scha ̈rer M, 

Stamm C, ‘‘Reducing the Discharge of 

Micropollutants in the Aquatic Environment: The 

Benefits of Upgrading Wastewater Treatment 

Plant.’’ Environmental Science and Technology 

2014, 48(14) 7683–7689. 

108Health Services Industry Study: Management 

and Disposal of Unused Pharmaceuticals (Interim 

Technical Report) August 2008; EPA–821–R–08– 

013. 

Water Act. The Agency’s construction 

grants program provides financial 

assistance for the proper treatment of 

these wastes. In addition, the Agency’s 

pretreatment program provides a basis 

for EPA and the local communities to 

ensure that users of sewer and treatment 

systems do not dump wastes in the 

system that will present environmental 

problems’’ (45 FR 33097). 

In 1984, Congress enacted the 

Hazardous and Solid Waste 

Amendments (HSWA) to the Solid 

Waste Disposal Act (SWDA), as 

amended by RCRA. HSWA included a 

new Section 3018, entitled Domestic 

Sewage. This section directed EPA to do 

two things with respect to the 

261.4(a)(1)(ii) exclusion for mixtures of 

domestic sewage and other wastes: (1) 

Submit a Report to Congress (RTC) that 

describes the types, size and number of 

generators which dispose of such wastes 

in this manner, the types and quantities 

of wastes disposed of in this manner, 

and identify significant generators, 

wastes and waste constituents not 

regulated under existing Federal law or 

regulated in a manner sufficient to 

protect human health and the 

environment; and (2) based on the 

report, revise the existing regulations 

that are necessary to ‘‘ensure that 

substances . . . which pass through a 

sewer system to a publicly owned 

treatment works are adequately 

controlled to protect human health and 

the environment.’’ 

EPA submitted its Report to Congress 

on February 7, 1986 (Domestic Sewage 

Study). Subsequent to the Report to 

Congress, EPA issued an advance notice 

of proposed rulemaking (ANPR) on 

August 22, 1986 (51 FR 30166); a 

response to comments on the ANPR on 

June 22, 1987 (52 FR 23477); a notice of 

proposed rulemaking (NPR) on 

November 23, 1988 (53 FR 47632); and 

a final rule on July 24, 1990 (55 FR 

30082). That final rule prohibits the 

discharge of pollutants which create a 

fire or explosion hazard in the POTW, 

which includes, but is not limited to, 

wastestreams with a closed cup 

flashpoint of less than 140 degrees 

Fahrenheit or 60 degrees Celsius using 

the test methods specified in 40 CFR 

261.21’’ (55 FR 30087). Although the 

exclusion for mixtures of domestic 

sewage and other wastes is found under 

the RCRA regulations in § 261.4(a)(1)(ii), 

the sewer ban of liquid ignitable 

hazardous wastes (i.e., with the 

hazardous waste code D001) was 

established under 40 CFR 403.5(b)(1), 

which is under the Clean Water Act 

(CWA) regulations. The Agency seeks 

comment on whether it would be 

helpful to incorporate in 40 CFR 

261.4(a)(1)(ii), a cross-reference to the 

CWA regulations prohibiting the 

sewering of liquid ignitable hazardous 

wastes. 

b. Prevalence of flushing in lieu of 

hazardous waste management. In the 

preamble to the July 1990 final rule, 

EPA stated its intent ‘‘to carefully 

review the effect of this rule and 

promulgate in the future any additional 

regulations that experience reveals are 

necessary to improve control over 

hazardous waste and other industrial 

user discharges to POTWs’’ (55 FR 

30084). Since then, studies have found 

that many healthcare facilities, 

particularly long term-care facilities, use 

drain disposal as a routine disposal 

method for pharmaceutical wastes in 

lieu of collection and shipment off-site 

for management. For example, 

• A 2008 study of 59 long-term care 

facilities showed that 46 percent of the 

long-term care facilities dispose of their 

pharmaceuticals by dumping them 

down the drain.101

• A 2003 King County, Washington 

survey of healthcare facilities showed 

that the vast majority of liquids, and 

nearly half of the pills, were disposed of 

down the drain.102

• In a study by The Albany Medical 

Center, funded by an EPA Pollution 

Prevention Grant, the author states, ‘‘up 

to now, toilet wasting has been the 

common practice for drug wasting by 

patient care staff.’’ 103

• In a detailed study about the waste 

management practices within the 

healthcare industry, EPA’s Office of 

Water also found that sewering of waste 

pharmaceuticals was common 

practice.104

• EPA staff from the Office of 

Research and Development (ORD) have 

published numerous articles on the 

subject of active pharmaceutical 

ingredients (APIs) in the environment. 

One such paper states that ‘‘unitpackaged pills are probably not 

frequently disposed via toilets, whereas 

liquids are probably routinely poured 

down drains,’’ although the authors 

acknowledge that ‘‘gaining an 

understanding of the types and 

quantities of APIs introduced directly 

and purposefully to the environment by 

the disposal of unwanted, leftover drugs 

has been more problematic because of a 

dearth of comprehensive or reliable 

data.’’ 105

c. Inadequacy of POTW treatment to 

remove pharmaceuticals. Under the 

Clean Water Act (CWA), EPA 

establishes national regulations (called 

effluent limitations guidelines and 

pretreatment standards) to reduce 

discharges of pollutants from industries 

to surface waters and POTWs. However, 

there are currently no national effluent 

limitations or pretreatment standards 

that apply to discharges of 

pharmaceuticals by healthcare facilities 

to POTWs. Furthermore, traditional 

wastewater treatment operations 

implemented in the 1970s and 1980s at 

POTWs are designed to remove 

conventional pollutants, such as 

suspended solids and biodegradable 

organic compounds. They are not 

designed to remove pharmaceuticals 

that are present in discharges from 

medical and veterinary facilities. While 

some POTWs may have implemented 

advanced treatment technologies at their 

facilities, these technologies are also not 

designed to remove pharmaceuticals. 

EPA released a study in 2009 in which 

over 100 chemicals (including some 

pharmaceuticals) were analyzed in the 

influent and effluent at nine POTWs.106

Although it was a limited study and 

difficult to generalize the results to all 

POTWs, it does indicate that the 

capabilities of treatment technologies 

currently employed by POTWs does not 

include treatment to remove APIs.107 In 

addition, as stated in the Health 

Services Industry study, ‘‘synthetic 

compounds, such as pharmaceuticals, 

are often manufactured to be resistant to 

metabolic transformation. As a result, 

some pharmaceutical compounds that 

are present in the influent to POTWs 

may pass through treatment systems at 

conventional POTWs and discharge to 

receiving waters.’’ 108

d. Adverse impacts to human health 

and the environment due to 

pharmaceuticals in the environment. 


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109A. Ginebreda et al, Environmental risk 

assessment of pharmaceuticals in rivers: 

Relationships between hazard indexes and aquatic 

macroinvertebrate diversity indexes in the Llobregat 

River (NE Sapin). Environ Int. (2009), doi:10.1016/ 

j.envint.2009.10.003. 

110Proposed rule: December 21, 2012; 77 FR 

75784 (see page 75803) and Final rule: September 

9, 2014; 79 FR 53520 (see page 53548). 111September 9, 2014; 79 FR 53520 (see page 

53548). 112 Illinois Public Act 096–0221. 113Nicknamed Bateman’s Law, after Senator 

Christopher ‘‘Kip’’ Bateman (R-Somerset) that 

sponsored the legislation. 114Humphreys, et al. Environmental Health 

Perspectives. 2008 March; 116(3) 297–302. 

115Title 22–B Chapter 5 Safe Disposal of Unused 

Pharmaceuticals in Health Care Facilities. 

The pharmaceuticals entering the 

environment, through flushing or other 

means, are having a negative effect on 

aquatic ecosystems and on fish and 

animal populations. The Regulatory 

Impact Analysis for this proposed 

rulemaking summarizes the scientific 

literature with regard to ecological 

effects (see the Regulatory Impact 

Analysis in the docket for this proposed 

rule EPA–HQ–RCRA–2007–0932). The 

scientific research with regard to human 

health effects due to pharmaceuticals in 

the environment is still ongoing. 

Nevertheless, the important features and 

risks of the problem can be summarized 

as follows: 109

(1) Pharmaceuticals are intrinsically 

bioactive compounds; therefore, they 

are potentially able to impact living 

systems. 

(2) There is a continuous and 

worldwide increase in their use and, 

thus, on their subsequent input into the 

environment. 

(3) Many of the hundreds of 

frequently prescribed pharmaceuticals 

are known for targeted effects and 

adverse off-target side effects, a problem 

that can be exacerbated by interactive 

effects during therapy involving coadministration. 

e. Banning sewering of hazardous 

waste pharmaceuticals. Given the 

demonstrated negative ecological effects 

and the potential for negative human 

health effects, EPA is proposing to 

impose a sewer ban on all hazardous 

waste pharmaceuticals managed by 

healthcare facilities and pharmaceutical 

reverse distributors that are subject to 

this proposed rule—that is, they are 

prohibited from disposing of 

pharmaceuticals that are listed 

hazardous waste and/or exhibit one or 

more of the four hazardous waste 

characteristics (i.e., ignitability, 

corrosivity, reactivity, or toxicity) by 

putting them down a drain (e.g., sink, 

toilet, or floor drain). 

In addition, while healthcare facilities 

that are CESQGs are generally not 

subject to this proposed rule, EPA is 

proposing that the sewer ban of 

hazardous waste pharmaceuticals also 

apply to healthcare facilities that are 

CESQGs. The vast majority of healthcare 

facilities are CESQGs (84 percent). Some 

particular types of healthcare facilities 

have an even larger proportion of 

CESQGs: Over 94 percent of dental 

offices are CESQGs, and 94 percent of 

continuing care retirement communities 

are CESQGs (see the Regulatory Impact 

Analysis in the docket for this proposed 

rule EPA–HQ–RCRA–2007–0932. 

EPA is concerned that these smaller 

healthcare facilities are more likely to 

dispose of their hazardous waste 

pharmaceuticals via the sewer. EPA 

estimates that there are more than 

145,000 healthcare facilities that are 

CESQGs. Given this large number, the 

combined impact of sewer disposal by 

healthcare facilities that are CESQGs has 

an even greater potential to provide a 

substantial impact on the environment, 

as well as human health. 

EPA solicits comment on EPA’s 

proposal to ban the sewer disposal of 

hazardous waste pharmaceuticals at all 

healthcare facilities, including 

healthcare facilities that are CESQGs 

that generate such wastes. As part of its 

solicitation of comments, the Agency 

especially requests comment on the 

risk-risk tradeoffs inherent in 

prohibiting sewer disposal, which 

extends the life cycle of pharmaceutical 

waste, resulting in additional 

opportunities for diversion and 

increasing the possibility of inadvertent 

exposures for certain workers (and 

possibly even patients or visitors) as a 

tradeoff for a reduction in aquatic risks. 

EPA also solicits comment on whether 

the ban on sewer disposal should be 

limited to those healthcare facilities that 

are currently LQGs and SQGs, and not 

extended to CESQGs. 

Under 40 CFR 403.12(p) of the CWA 

regulations, industrial users that 

discharge a substance to a POTW that, 

if otherwise disposed of, would be a 

hazardous waste, must notify in writing 

the POTW, the EPA Regional Waste 

Management Division Director and State 

hazardous waste authorities. POTWs 

should be made aware that under this 

proposal, if made final, the notifications 

they receive from healthcare facilities 

will no longer include hazardous waste 

pharmaceuticals since the healthcare 

facilities will be prohibited from 

sewering their hazardous waste 

pharmaceuticals. 

We note that EPA’s proposed ban on 

sewering hazardous waste 

pharmaceuticals is consistent with other 

federal and state actions. For example, 

the Drug Enforcement Administration 

(DEA) has finalized new regulations to 

implement the Secure and Responsible 

Drug Disposal Act of 2010 (September 9, 

2014; 79 FR 53520). DEA’s new 

regulations require a ‘‘non-retrievable’’ 

method of destruction of controlled 

substances. The preambles to DEA’s 

proposed and final rules state that 

flushing does not meet the nonretrievable standard for destruction.110

According to the preamble of the DEA 

final rule, DEA received 20 comments 

supporting their position against 

flushing controlled substances.111 The 

comments supporting the prohibition 

against sewering came from states, 

regional and local hazardous waste 

management programs, recycling 

associations, non-governmental 

organizations (NGOs), trade associations 

and environmental organizations. Many 

of these commenters noted that 

wastewater treatment systems do not 

eliminate many of the drugs that are 

flushed into the sewers and requested 

that DEA clearly state in the regulatory 

language, not just preamble, that 

sewering is not allowable as a means of 

destruction. 

In addition, three states and the 

District of Columbia have taken action 

to limit the sewering of pharmaceuticals 

and a third has introduced a bill. In 

2009, Illinois passed the Safe 

Pharmaceutical Disposal Act, which 

prohibits healthcare facilities from 

flushing any unused medication into 

public sewers or septic systems.112 In 

2012, New Jersey passed a similar law 

that prohibits healthcare facilities from 

discharging prescription medications 

into public sewers or septic systems.113

In 2002, California banned the use of 

lindane in pharmaceuticals after it 

found that lindane was adversely 

impacting wastewater quality. The 

authors of the paper ‘‘Outcomes of the 

California Ban on Pharmaceutical 

Lindane: Clinical and Ecologic Impacts 

state that ‘‘This is the first time that a 

pharmaceutical has been outlawed to 

protect water quality.’’ 114 After 

researching and documenting 

environmental benefits of the ban, the 

authors conclude, ‘‘This ban serves as a 

model for governing bodies considering 

limits on the use of lindane or other 

pharmaceuticals.’’ And the District of 

Columbia has promulgated municipal 

regulations, effective January 1, 2011, 

that prohibits healthcare facilities from 

flushing pharmaceutical products.115

The Connecticut legislature has also 

considered a bill to ban the discharge of 

medication into public or private waste 

water collection systems or septic 


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116State of Connecticut General Assembly, 

January Session 2013, Raised Bill No. 6439. An Act 

Concerning the Disposal and Collection of Unused 

Medication. 

117http://www.fda.gov/downloads/Drugs/

ResourcesForYou/Consumers/

BuyingUsingMedicineSafely/

EnsuringSafeUseofMedicine/

SafeDisposalofMedicines/UCM337803.pdf. 

118http://www.fda.gov/downloads/Drugs/

ResourcesForYou/Consumers/

BuyingUsingMedicineSafely/

EnsuringSafeUseofMedicine/

SafeDisposalofMedicines/UCM337803.pdf. 

systems, although it has not yet become 

law.116

Finally, we would note that although 

the sewer ban is limited to 

pharmaceuticals that are RCRA 

hazardous wastes, EPA strongly 

recommends as a best management 

practice to not sewer any waste 

pharmaceutical (i.e., hazardous or nonhazardous), except when sewering is 

specifically directed by FDA guidance 

(as noted on pharmaceutical 

packaging).117

For household pharmaceutical waste, 

we refer the public to the guidelines 

developed by the U.S. Office of National 

Drug Control Policy (ONDCP), the FDA, 

and EPA for the disposal of unwanted 

household pharmaceuticals. In 

summary, these guidelines are as 

follows: 

(1) Use a drug take-back event or 

program, when available; 

(2) Dispose in household trash, after 

mixing the unwanted medicines with an 

undesirable substance such as kitty 

litter or coffee grounds and placing in a 

sealed container; and 

(3) Only if the drug label specifically 

instructs you to, flush the unwanted 

medicine down the toilet.118

2. Conditional Exemption for Hazardous 

Waste Pharmaceuticals That Are Also 

Controlled Substances 

When a pharmaceutical that is 

discarded is both a hazardous waste and 

a controlled substance, its management 

and disposal is regulated under both the 

RCRA Subtitle C hazardous waste 

regulations, which is under EPA’s or the 

authorized state’s purview, and the 

Controlled Substances Act (CSA) and its 

implementing regulations, which is 

under DEA’s purview. EPA understands 

that only a handful of pharmaceuticals 

are in common usage that are both 

hazardous waste and controlled 

substances and therefore subject to dual 

regulation by both EPA and the DEA. 

These are identified in Table 5: 

Chloral hydrate, U034, is the only 

dually regulated hazardous waste/

controlled substance that is a listed 

hazardous waste. It is listed for toxicity 

(note that EPA’s U034 listing includes 

chloral hydrate, see memo dated April 

6, 1998; Brandes to Knauss, RCRA 

Online #14175). On the other hand, the 

remaining four dually regulated 

hazardous wastes/controlled substances 

in common use are considered 

hazardous because they exhibit the 

characteristic of ignitibility (D001). 

However, the active ingredient is not 

ignitable, but these particular forms of 

the pharmaceuticals are ignitable 

because they are prepared in ignitable 

solutions, such as alcohol. 

EPA is aware of three additional 

hazardous waste pharmaceuticals that 

are DEA controlled substances, but it is 

our understanding that they are no 

longer in common usage, although there 

may be legacy supplies remaining in 

healthcare facilities. See Table 6. 


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119Pathways for Environmental Releases of 

Unused Pharmaceuticals, October 12, 2009, Memo 

from ERG to EPA, EPA–HQ–OW–2008–0517–0518. 

Similarly, as noted in Table 7, 

phentermine is a controlled substance, 

but the medical form is a phentermine 

salt, and the salts are no longer 

considered to be within the scope of the 

P046 listing (see memo dated February 

17, 2012; from Devlin to RCRA Division 

Directors, RCRA Online #14831). 

EPA requests comment on whether 

these are, indeed, the only 

pharmaceuticals in common usage that 

are regulated both as DEA controlled 

substances, and when discarded, RCRA 

hazardous waste. 

Common practices that healthcare 

facilities have used in the past in order 

to comply with the DEA regulations for 

destroying controlled substances 

include sewering and incineration. 

However, DEA’s new regulation requires 

that controlled substances must be 

destroyed, such that they are ‘‘nonretrievable.’’ As discussed previously, 

the preambles for DEA’s proposed and 

final rules state that flushing will not 

meet their new non-retrievable 

standard, a position which EPA fully 

supports. However, EPA is concerned 

that flushing will continue to be used by 

healthcare facilities for eliminating their 

controlled substances. In part, this 

concern is due to a 2009 EPA report 

which concluded, ‘‘controlled 

substances are the pharmaceuticals most 

commonly poured down the drain, 

especially the partially-used IVs 

containing controlled substances.’’ 119 In 

addition, stakeholders have informed 

EPA that it is expensive and difficult to 

manage controlled substances that are 

also hazardous wastes under both DEA 

and EPA regulatory schemes and 

therefore the unintended consequence is 

that they are often sewered on-site in 

order to avoid the expense of complying 

with dual regulation en route to 

incineration. 


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120See 40 CFR 403.5 for specific pretreatment 

prohibitions. 

121See DEA letter to registrants re: clarifying 

disposal of pharmaceutical wastage dated Oct 17, 

2014; http://www.deadiversion.usdoj.gov/drug_

disposal/dear_practitioner_pharm_waste_

101714.pdf. 122 Ibid. 

EPA wants to eliminate the flushing 

of pharmaceuticals in order to reduce 

potential environmental contamination. 

Sewering hazardous wastes that are 

ignitable (D001) is already banned and 

EPA is now proposing to eliminate the 

sewering of all other hazardous waste 

pharmaceuticals.120 To eliminate 

duplicative regulation and thereby 

further reduce the incidence of flushing, 

EPA is proposing to conditionally 

exempt from RCRA Subtitle C regulation 

those hazardous wastes that are also 

DEA controlled substances. Specifically, 

EPA is proposing that hazardous wastes 

that are also controlled substances will 

be exempt from all RCRA Subtitle C 

requirements, including 40 CFR part 

266, subpart P, provided they meet two 

conditions: (1) They are combusted at a 

permitted large or small municipal 

waste combustor or a permitted or 

interim status hazardous waste 

combustor (incinerator or cement kiln), 

and (2) they are managed and disposed 

of in compliance with all applicable 

DEA regulations for controlled 

substances. 

The first condition is to ensure that 

the controlled substances are destroyed 

in an environmentally protective 

manner by a high-temperature 

combustor, such as a large or small 

municipal waste combustor or a 

permitted or interim status hazardous 

waste combustor (incinerator or cement 

kiln). The majority of the hazardous 

wastes that are also controlled 

substances are hazardous because they 

exhibit the characteristic of ignitability. 

The best demonstrated available 

technology (BDAT) developed for 

ignitable hazardous waste under the 

LDRs includes combustion (see 

§ 268.40). In addition, although chloral 

hydrate (U034) is listed because of its 

toxicity, its BDAT is also combustion. 

Therefore, in an effort to eliminate the 

sewering of these dually regulated 

hazardous wastes/controlled substances, 

and because combustion of these 

pharmaceuticals is a suitable technology 

for destruction, EPA is proposing to 

allow the few hazardous wastes 

pharmaceuticals that are also controlled 

substances to be combusted at 

municipal solid waste combustors, 

although as noted previously, a 

hazardous waste incinerator (permitted 

or interim status) would also be 

allowed. 

We realize that DEA may allow a 

technology other than combustion to be 

used to destroy controlled substances. 

However, if the RCRA hazardous waste 

pharmaceuticals that are DEA controlled 

substances are exempt from RCRA, the 

other destruction technologies may lack 

environmental controls and permits. 

Therefore, combustion of the hazardous 

wastes/controlled substances, which 

requires permitting, operating and 

monitoring standards, is a condition of 

the exemption. EPA requests comment 

on whether there are additional 

technologies that would be appropriate 

to include for the destruction of 

hazardous waste pharmaceuticals that 

are also controlled substances. Under 

this proposal, if DEA allows a 

technology other than incineration for 

the destruction of controlled substances, 

it would be allowed only for DEA 

controlled substances, but not for those 

that are also RCRA hazardous wastes. 

The second condition is to ensure that 

dually regulated hazardous wastes/

controlled substances are managed 

under another rigorous regulatory 

program since they will not be managed 

in accordance with the RCRA Subtitle C 

regulations. Although developed for 

different reasons, both EPA’s hazardous 

waste and DEA’s controlled substance 

regulatory programs are designed to 

track the regulated material from cradle 

to grave. DEA regulations have 

requirements similar to EPA’s 

hazardous waste manifest. In particular, 

in order to ship a schedule II controlled 

substance, a DEA registrant must submit 

a DEA Form 222 to the supplier of the 

schedule II controlled substance. The 

DEA Form 222 is a numerically 

controlled form issued by the DEA to 

authorized registrants, containing 

certain pre-printed information. The 

supplier must indicate on the DEA Form 

222, the quantity of packages shipped 

and the date the packages were shipped. 

Like a hazardous waste manifest, a copy 

of Form 222 must accompany the 

shipment and it must be kept by both 

the supplier and purchaser for at least 

two years (copies of manifests must be 

kept for three years). Suppliers and 

distributors may utilize the electronic 

version of the DEA Form 222, which 

requires the same information and 

retention period. Similarly, DEA 

Schedule III, IV and V controlled 

substances must be accompanied by an 

invoice, which also must include a 

detailed inventory of the contents 

shipped. A copy of the invoice must 

also be retained by the supplier and 

purchaser of the controlled substances 

for a period of two years. EPA believes 

that the DEA tracking and shipping 

requirements are sufficient to act in lieu 

of the RCRA hazardous waste manifest 

and hazardous waste transporter 

requirements. EPA requests comment on 

this assessment. 

DEA has previously stated that 

controlled substance ‘‘pharmaceutical 

wastage’’ may be disposed of in 

accordance with applicable federal, 

state, and local laws, regulations, and 

healthcare facility policies, to include 

sewering or putting down the drain.121

The term ‘‘pharmaceutical wastage’’ 

refers to leftover, unadministered 

pharmaceuticals (‘‘e.g., some of the 

substance remains in a vial, tube, 

transdermal patch, or syringe after 

administration but cannot or may not be 

further utilized’’ 122). EPA is proposing 

that the few hazardous waste 

pharmaceuticals that are also controlled 

substances would be exempt from 

RCRA, but only on the condition that 

they are incinerated at a permitted 

hazardous waste or municipal solid 

waste incinerator and managed in 

accordance with DEA regulations. As a 

result, if pharmaceutical wastage is both 

hazardous waste and controlled 

substance it would not be allowed to be 

sewered; it would have to be 

incinerated. Prior to incineration, the 

pharmaceutical wastage would be 

exempt from RCRA and could be 

collected in a container at the healthcare 

facility. As an alternative, we request 

comment on whether to allow the 

sewering of the pharmaceutical wastage 

for the five hazardous wastes that are 

also controlled substances. We are 

concerned, however, that this 

alternative approach will lead to the 

sewering of all pharmaceutical wastage 

as healthcare providers are unlikely to 

keep track of which hazardous waste 

pharmaceuticals are allowed to be 

sewered and which are not. We request 

comment on these approaches for 

pharmaceutical wastage and request 

data on the impact on healthcare 

facilities of not allowing pharmaceutical 

wastage to be sewered. 

a. Long-term care facilities and the 

DEA final rule. As discussed previously, 

EPA is proposing that hazardous waste 

from long-term care facilities will no 

longer be considered exempt as 

household hazardous waste. Instead it 

will need to be managed as regulated 

hazardous waste. This interpretation 

will apply to all the hazardous waste 

generated by a long-term care facility, 

not just its hazardous waste 

pharmaceuticals, although the Agency 

expects that much of the hazardous 

waste generated by long-term care 

facilities consists of hazardous waste 

pharmaceuticals. However, there are 


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58050 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

123See the docket for this rulemaking for data 

about long-term care facilities which was developed 

using data in the economic analysis: EPA–HQ– 

RCRA–2007–0932. 

two exceptions. First, hazardous waste 

pharmaceuticals that are also controlled 

substances will not be subject to RCRA, 

provided they meet two conditions: (1) 

They are combusted at a permitted large 

or small municipal waste combustor or 

a permitted or interim status hazardous 

waste combustor (incinerator or cement 

kiln), and (2) they are managed and 

disposed of in compliance with all 

applicable DEA regulations for 

controlled substances. Second, as 

discussed previously, EPA estimates 

that only 28% of long-term care 

facilities generate hazardous waste 

pharmaceuticals and of those, 85% 

generate small enough quantities of 

hazardous waste that they will qualify 

as CESQGs and will be subject to the 

reduced regulatory requirements of 40 

CFR 261.5, and only the sewer ban 

provision of this new subpart.123

DEA’s new regulations to implement 

the Secure and Responsible Drug 

Disposal Act of 2010 are expected to 

help alleviate the problem that longterm care facilities face when discarding 

controlled substances. DEA’s new 

regulations allow retail pharmacies and 

hospital/clinics with an on-site 

pharmacy that are DEA registrants to 

modify their registrations and become 

‘‘collectors’’ to place collection 

receptacles at long-term care facilities 

(or at the retail pharmacy or hospital/

clinic with an on-site pharmacy) for the 

collection of controlled substances from 

ultimate users (i.e., consumers). 

Under the new DEA regulations, longterm care facilities have three options, 

two of which are new, for managing 

their patients’ controlled substances. 

First, if a DEA registered retail 

pharmacy or hospital/clinic with an onsite pharmacy places a collection 

container at a long-term care facility, the 

staff from the long-term care facility 

may place the patients’ controlled 

substances in the collection receptacles. 

Second, although long-term care 

facilities will not be able to conduct 

collection events for their patients’ 

controlled substances for mail-back 

programs, they will be allowed to assist 

patients who choose to use a mail-back 

program for their own controlled 

substances, on an individual-byindividual basis. And third, law 

enforcement will continue to be allowed 

to pick up patients’ controlled 

substances for disposal. With these 

changes to DEA’s regulation, long-term 

care facilities can now dispose of 

patients’ controlled substances in a 

more environmentally protective way. 

Because we are proposing that 

hazardous waste pharmaceuticals that 

are also controlled substances are 

conditionally exempt from RCRA, these 

wastestreams may also be managed in 

any of these three ways allowed by 

DEA, provided the waste is managed to 

meet the conditions of the RCRA 

conditional exemption. 

The new DEA regulations do not 

mandate the placement of collection 

receptacles or patient participation in 

mail-back programs or take-back events. 

However, if long-term care facilities are 

prohibited from disposing of 

pharmaceuticals down the toilet or 

drain under RCRA (and as a method of 

destruction under DEA regulations), 

then the only way for patients at longterm care facilities to lawfully dispose 

of DEA controlled substances that are 

also RCRA hazardous wastes would be 

through participation in one of DEA’s 

collection methods. Long-term care 

facilities are allowed to place patients’ 

hazardous waste pharmaceuticals that 

are controlled substances in the DEA 

collection receptacles; the other 

hazardous waste pharmaceuticals 

generated by long-term care facilities 

must be managed under the proposed 

RCRA management standards for 

healthcare facilities. However, we note 

that if the long-term care facility is a 

CESQG, we are proposing as an 

acceptable method of disposal of the 

long-term care facility’s hazardous 

waste pharmaceuticals would be to 

place them in a DEA collection 

receptacle, even if they are not 

controlled substances (see § 266.504(b)). 

DEA already allows controlled 

substances to be co-mingled with noncontrolled substances. Therefore, EPA 

believes it is consistent to allow CESQG 

hazardous waste pharmaceuticals that 

are not controlled substances to be 

placed in DEA collection receptacles 

with controlled substances. EPA 

believes that management of CESQGs’ 

hazardous wastes as DEA controlled 

substances is preferable to management 

as municipal solid waste because it 

provides greater protection to patients, 

visitors and workers at long-term care 

facilities to have the hazardous waste 

pharmaceuticals in DEA collection 

receptacles rather than in the regular 

trash. See Table 8 for a summary of the 

intersection of RCRA and DEA 

regulations for the disposal of hazardous 

waste pharmaceuticals at long-term care 

facilities: 

TABLE 8—RCRA & DEA REGULATIONS AT LONG-TERM CARE FACILITIES

Types of pharmaceutical waste at long-term care facilities 

Regulatory requirements 

RCRA 

DEA Authorized collection 

methods allowed for patients’ 

pharmaceuticals 

Hazardous Waste Pharmaceuticals that are also Controlled 

Substances.

Conditionally exempt from RCRA ..................... Yes. 

Hazardous Waste Pharmaceuticals that are not Controlled 

Substances.

...........................................................................

if LTCF is a CESQG ................................................................... 261.5 and sewer ban ........................................ Yes. 

if LTCF is not a CESQG ............................................................. Part 266, subpart P .......................................... No. 

b. Household hazardous waste 

collected in DEA authorized collection 

receptacles. In response to questions 

that EPA has received since the DEA 

rule was published, we are taking this 

opportunity to clarify the current RCRA 

regulatory status of the pharmaceuticals 

collected in DEA authorized collection 

receptacles. DEA’s regulations allow the 

co-mingling of controlled substances 

and non-controlled substances in its 

collection receptacles. In some 

instances, the pharmaceuticals that are 

collected by retail pharmacies and law 

enforcement in DEA authorized 

collection receptacles may contain 

pharmaceuticals that are RCRA 

hazardous waste. However, as 

household wastes, these hazardous 

waste pharmaceuticals would be 

excluded from regulation by 


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124 DEA regulations also prohibits retail pharmacy 

stock/inventory from being placed in the collection 

receptacle or mail-back envelopes (see 21 CFR 

1317.05(a)). 

125 DEA does not prohibit co-mingling of 

controlled substances with non-controlled 

substances provided they are all then managed as 

controlled substances. 

126Rudzinski to RCRA Division Directors, 

September 26, 2012, RCRA Online #14833 http://

yosemite.epa.gov/osw/rcra.nsf/0c994248c23994

7e85256d090071175f/fcb11dd6f61d4

b1685257afe005eb5ce!OpenDocument. 

127Additionally, acute hazardous wastes are 

included on the F-list of § 261.31; however none of 

those acute hazardous wastes are pharmaceuticals. 

128We are assuming that containers that hold 

pharmaceuticals are in containers less than 119 

gallons in size. 

§ 261.4(b)(1) because the exclusion 

applies even when the household 

hazardous wastes are collected. It is 

important to note that in order to 

maintain the exclusion, a retail 

pharmacy (or other DEA authorized 

collector pharmacy) can use the DEA 

authorized collection receptacle to 

collect waste generated only at 

households and brought to the store for 

collection. The hazardous waste 

generated by the retail pharmacy and 

store, including hazardous waste 

pharmaceuticals, are not excluded 

household wastes under RCRA and may 

not be placed in the DEA authorized 

receptacle.124 Furthermore, states 

generally regulate non-hazardous waste 

and they may have licensing or 

permitting requirements for the 

collection of solid waste. Because EPA 

would like to see the use of DEA 

authorized collection receptacles 

become widespread, we encourage 

states to streamline any requirements 

that may create a barrier to the use of 

the collection receptacles. 

Under this proposal, pharmaceuticals 

collected in DEA authorized collection 

receptacles will continue to be excluded 

from regulation as household hazardous 

waste, with some conditions. The 

Agency has a long-standing 

recommendation that household 

hazardous waste collection programs 

manage the collected waste as 

hazardous waste. We strongly believe 

that if a program goes to the expense of 

collecting the waste, including waste 

pharmaceuticals, it should manage the 

waste as hazardous waste, rather than 

manage it as municipal solid waste, 

which the household could do absent 

the collection program. However, the 

current household waste exemption 

does not require an entity that hosts a 

household hazardous waste collection 

event to manage the collected waste as 

hazardous waste. Typically, the parties 

conducting household hazardous waste 

collection events have been government 

entities—municipalities and counties. It 

is relatively new that retail pharmacies 

and others are becoming interested in 

performing this function. To encourage 

this practice, while at the same time 

ensuring that collection programs are 

managing the collected waste properly, 

we are proposing that pharmaceuticals 

that are household hazardous waste 

(i.e., ‘‘household waste 

pharmaceuticals’’) and are collected in 

DEA authorized collection receptacles 

where they may be co-mingled 125 with 

controlled substances continue to be 

excluded from RCRA regulation, 

provided they are: 

(1) Combusted at a municipal solid 

waste or hazardous waste combustor, 

and 

(2) managed in accordance with all 

applicable DEA regulations (see 

§ 266.506(a)(2)).The Agency solicits 

comments on all these provisions. 

On a separate, but related matter, EPA 

has received a number of inquiries 

about the exemption in the Clean Air 

Act regulations for Other Solid Waste 

Incinerator (OSWI) ‘‘units that combust 

contraband or prohibited goods’’ (see 

the exemption at 40 CFR 60.2887(p) for 

new OSWIs and 40 CFR 60.2993(p) for 

existing OSWIs). As indicated in a 

previous guidance memo, EPA does not 

consider pharmaceuticals, voluntarily 

collected from ultimate users in a takeback program, to be contraband or 

prohibited goods.126 Likewise, EPA will 

not consider pharmaceuticals that are 

voluntarily dropped off at collection 

receptacles to be contraband or 

prohibited goods. Therefore, the OSWI 

exemption does not apply and law 

enforcement may not destroy 

voluntarily collected pharmaceuticals in 

the same way that it is allowed to 

destroy contraband or prohibited goods. 

3. Management of Residues in 

Pharmaceutical Containers 

a. Regulatory background. Over the 

years, EPA has received numerous 

inquiries regarding the regulatory status 

of various types of containers that once 

held pharmaceuticals that are 

considered hazardous waste when 

discarded because of the hazardous 

waste residue in the containers. 

Stakeholders have been particularly 

concerned about containers that once 

held pharmaceuticals that are on the ‘‘Plist’’ of acutely hazardous commercial 

chemical products in § 261.33(e) 

because a generator becomes an LQG if 

it generates more than 1 kg of acute 

hazardous waste per calendar month or 

accumulates more than 1 kg of acute 

hazardous waste at any time.127 The 

current regulatory status of acute and 

non-acute commercial chemical product 

residues remaining in a container are 

specifically addressed in § 261.33: 

The following materials or items are 

hazardous wastes if and when they are 

discarded or intended to be discarded 

. . . 

(c) Any residue remaining in a 

container or in an inner liner removed 

from a container that has held any 

commercial chemical product or 

manufacturing chemical intermediate 

having the generic name listed in 

paragraphs (e) or (f) of this section, 

unless the container is empty as defined 

in § 261.7(b). [emphasis added] 

According to § 261.7(b)(1), there are 

two ways a container that held a nonacute hazardous waste can be 

considered ‘‘empty’’: 

A container or an inner liner removed 

from a container that has held any 

hazardous waste, except a waste that is 

a compressed gas or that is identified as 

an acute hazardous waste listed in 

§ 261.31 or § 261.33(e) of this chapter is 

empty if: 

(i) All wastes have been removed that 

can be removed using the practices 

commonly employed to remove 

materials from that type of container, 

e.g., pouring, pumping, aspirating, and 

(ii) No more than 2.5 centimeters (one 

inch) of residue remain on the bottom 

of the container or inner liner, or 

(iii) 

(A) No more than 3 percent by weight 

of the total capacity of the container 

remains in the container or inner liner 

if the container is less than or equal to 

119 gallons in size; or 

(B) No more than 0.3 percent by 

weight of the total capacity of the 

container remains in the container or 

inner liner if the container is greater 

than 119 gallons in size. 

Therefore, if the container that held 

the non-acute hazardous waste 

pharmaceutical does not have its 

contents removed by a commonly 

employed practice and either has one 

inch or less of residue remaining or has 

3 percent or less by weight of the total 

capacity of the container remaining,128

then the container is not considered 

‘‘RCRA empty,’’ even though the 

pharmaceutical may have been fully 

dispensed. If the container is not ‘‘RCRA 

empty,’’ then the residues are regulated 

as hazardous waste (since the residues 

are within the container, the container 

must be managed as hazardous waste, as 

well, even if it is not itself hazardous 

waste). On the other hand, if the 

contents of the container have been 

removed by a commonly employed 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58052 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

129Rudzinski to RCRA Division Directors, 

November 11, 2011, RCRA Online #14827 http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

57B21F2FE33735128525795F00610F0F/$file/

14827.pdf. 

practice and either have one inch or less 

of residue remaining, or 3 percent or 

less of weight of the total capacity of the 

container remaining, then the container 

is considered ‘‘RCRA empty,’’ and may 

be managed as non-hazardous waste. 

Likewise, according to § 261.7(b)(3), 

there are three ways that a container 

that held an acute hazardous waste can 

be considered ‘‘empty’’: 

A container or an inner liner removed 

from a container that has held an acute 

hazardous waste listed in §§ 261.31 or 

261.33(e) is ‘‘empty’’ if: 

(i) The container or inner liner has 

been triple rinsed using a solvent 

capable of removing the commercial 

chemical product or manufacturing 

chemical intermediate; 

(ii) The container or inner liner has 

been cleaned by another method that 

has been shown in the scientific 

literature, or by tests conducted by the 

generator, to achieve equivalent 

removal; or 

(iii) In the case of a container, the 

inner liner that prevented contact of the 

commercial chemical product or 

manufacturing chemical intermediate 

with the container, has been removed. 

Therefore, if the container that held 

the P-listed pharmaceutical is not triple 

rinsed, or cleaned by another method 

that has been demonstrated to achieve 

equivalent removal, or had the inner 

liner removed, the container is not 

considered ‘‘RCRA empty,’’ even though 

the pharmaceutical may have been fully 

dispensed. If the container is not ‘‘RCRA 

empty,’’ then the residues are regulated 

as acute hazardous waste. 

In November 2011, EPA issued 

guidance about containers that once 

held P-listed pharmaceuticals 129 that 

provides three possible regulatory 

approaches for generators: 

(1) Count only the weight of the 

residue toward generator category 

(2) Demonstrate an equivalent 

removal method to render containers 

RCRA empty 

(3) In the case of warfarin, show that 

the concentration in the residue is 

below the P-listed concentration. 

This guidance was intended as a 

short-term solution that worked within 

the confines of the existing RCRA 

hazardous waste regulations and EPA 

indicated at the time that a more 

comprehensive solution would require 

notice and public comment that occurs 

during a rulemaking. We are proposing 

to amend the regulations that pertain to 

containers that once held 

pharmaceuticals that are RCRA 

hazardous wastes. We are proposing 

different regulatory solutions for 

different types of containers found in 

healthcare settings. Specifically, we 

address the following three types of 

containers: (1) Unit-dose containers 

(e.g., packets, cups, wrappers, blister 

packs, and delivery devices) and 

dispensing bottles and vials; (2) 

dispensed syringes; and (3) other 

containers, including delivery devices. 

If finalized, these new regulations for 

pharmaceutical containers would 

replace the November 2011 guidance; 

however, in the meantime, the guidance 

remains in effect. 

b. Unit-dose containers. First, with 

regard to unit-dose containers and 

dispensing bottles and vials up to 1 liter 

or 1000 pills, we are proposing a 

conditional exemption from the empty 

container regulations of § 261.7 for 

containers from which the 

pharmaceuticals have been fully 

dispensed. Specifically, we are 

proposing that the removal of the 

pharmaceuticals from the unit-dose 

containers, and dispensing bottles and 

vials (up to 1 liter or 1000 pills), is 

equivalent to rendering the container 

‘‘RCRA empty.’’ Therefore, for 

containers that once held non-acute 

hazardous wastes, it will not be 

necessary to measure the remaining 

contents, and for containers that once 

held acute hazardous wastes, it will not 

be necessary to triple-rinse the 

containers or demonstrate an equivalent 

removal method. Rather, if the contents 

of the container have been fully 

dispensed by removing all 

pharmaceuticals that can be removed 

using the practices commonly employed 

to remove materials from that type of 

container, the residues (and therefore 

the container) may be disposed of as 

non-hazardous waste. 

We are proposing this conditional 

exemption for two reasons. First, we 

want to eliminate the sewering of 

pharmaceuticals. We are particularly 

concerned that in a healthcare setting, 

when containers are triple rinsed, the 

rinsate will be poured down the drain 

which is not a good environmental 

practice. We think it is important that 

the residues be managed in a more 

controlled manner—such as municipal 

solid waste management—rather than 

poured down the drain. Second, 

although the ‘‘empty container’’ 

regulations of § 261.7 apply to all sizes 

of containers, they were developed with 

larger, industrial-sized containers in 

mind. For the most part, the containers 

that hold pharmaceuticals range in size 

from a few milliliters (e.g., packaging for 

nicotine gum, paper cups used to 

dispense pharmaceuticals to in-patients) 

to a liter (e.g., bottles that hold bulk 

quantities of pills). In rare 

circumstances, containers with 

pharmaceuticals are as large as two or 

three liters (e.g., powders that are 

reconstituted with water). This differs 

significantly from the 55-gallon drums 

that are typically used in other sectors 

that generate hazardous waste. 

Consequently, the amount of residues in 

the containers was anticipated to be 

much more substantial than is the case 

for containers typically used for 

pharmaceuticals. 

EPA has received data from three 

stakeholders demonstrating that there is 

very little residue remaining in fully 

dispensed containers of 

pharmaceuticals. In addition, EPA’s 

ORD conducted similar research. The 

results from each of the four sources are 

summarized below; the full results are 

included in the docket for this proposed 

rulemaking (EPA–HQ–RCRA–2007– 

0932). 

i. Consulting Firm. One stakeholder, 

with a hazardous medical materials 

consulting firm, provided some 

laboratory testing. They had the 

residues from single-unit dose 

packaging of four different P-listed 

pharmaceuticals tested using gas 

chromatography/mass spectrometry 

(GC/MS) and high performance liquid 

chromatography/ultraviolet detector 

(HPLC/UV). The amount of active 

pharmaceutical ingredient in the 

residues remaining in containers was 

quantified and the results from 

containers that had been triple rinsed 

were compared with containers that had 

not been triple rinsed. For the 

containers that were triple rinsed, the 

active ingredient in the residues was 

non-detect in all cases. For the 

containers that were not triple rinsed, 

the highest level detected was 35.8 mg 

(or 0.0358 mg). The laboratory results 

submitted to EPA are summarized in 

Table 9; the full laboratory results are 

included in the docket for this 

rulemaking (EPA–HQ–RCRA–2007– 

0932). 


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130See Exhibit 2 of the CUPA Forum Board Trust 

Fund Grant Report submitted by the Riverside 

County Department of Environmental Health at the 

conclusion of the grant. 

ii. Large Retailer. The second 

stakeholder that submitted data to EPA 

was a large retailer. Their data provide 

the weight of active pharmaceutical 

ingredient residues remaining in bulk 

containers (i.e., 100-count) of various 

dosage strengths of warfarin. The 

residues were quantified using HPLC– 

UV/Vis (high performance liquid 

chromatography/ultraviolet/visible light 

detector). The data are summarized in 

Table 10; the full results submitted to 

EPA are included in the docket for this 

proposed rulemaking (EPA–HQ–RCRA– 

2007–0932). 

The results from each of the first two 

stakeholders reflect only the weight of 

the active pharmaceutical ingredient, 

not the full weight of the hazardous 

waste residues. Since it is the Agency’s 

position that it is the full weight of the 

hazardous waste residues and not just 

the weight of the active pharmaceutical 

ingredients that must be counted in 

determining generator status, we have 

used the results to calculate the weight 

of the total residues. In the retailer’s 

case, they have informed EPA that a 

typical pill with a 10 mg dose of 

Coumadin (brand name of warfarin) 

weighs 200 mg. The active ingredient 

represents 10 mg, or 5% of the weight 

of the pill, while 190 mg, or 95% of the 

weight of the pill, consists of 

ingredients other than the active 

ingredient. As indicated in Table 10, the 

average weight of warfarin residue 

remaining in a fully dispensed bottle of 

the high dose of warfarin (10 mg) is 

1.196 mg. If we assume that the residue 

in the container has the same 

proportions of ingredients (i.e., 5% of 

the residue is warfarin and 95% of the 

residue are other ingredients), then 

there would be an average of 23.92 mg 

of total hazardous waste residue 

remaining in a 100-count bottle of 10 mg 

pills of warfarin. The amount of 

hazardous waste residue remaining in a 

100-count bottle of pills is very small 

compared with the residue that would 

remain in a 55-gallon drum, which is 

what the regulations for container 

residues envisaged. 

iii. Riverside County. The third 

stakeholder that provided data to EPA 

was the Riverside County Department of 

Environmental Health, Hazardous 

Materials Management Branch. The 

county received a grant from the 

California Certified Unified Program 

Agency (CUPA) Forum Board to 

conduct a study of residues remaining 

in pharmaceutical containers. 

Researchers at the University of 

California, Riverside (UCR) conducted 

the study and provided their results in 

a report to Riverside County entitled, 

Residue Analysis of P-Listed 

Pharmaceutical Containers for Warfarin 

and Nicotine. The results are 

summarized below, but UCR’s full 

results are in the docket for this 

proposed rulemaking (EPA–HQ–RCRA– 

2007–0932).130

The intent of the study was to 

investigate the third regulatory 

approach suggested in the November 

2011 memo discussed previously. That 


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58054 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

is, the study investigated whether the 

concentration of warfarin in the 

residues of warfarin pill bottles was 

greater than 0.3% and therefore met the 

listing criteria for P001 or whether the 

residues were at or below 0.3% and 

therefore met the listing criteria for 

U248. Although nicotine is not a 

concentration-based P-listing, packaging 

from nicotine-containing products were 

also investigated to determine total 

remaining residues. 

The researchers collected a total of 59 

samples containers, including 44 

sample containers that had held 

warfarin pills but had been fully 

dispensed and another 15 sample 

containers from nicotine-containing 

products. The samples included 

warfarin and nicotine from several 

manufacturers, in a range of dose 

strengths and in various container types. 

The residues were solvent-extracted and 

then dried by rotary evaporation to 

determine the total weight of residues. 

Subsequently, the residues were redissolved in methanol and analyzed 

using HPLC to determine the 

concentration of the active 

pharmaceutical within the residues. 

The majority of warfarin containers 

were plastic bottles, but some containers 

were blister packs and three samples 

were 30-pill blister packs, sometimes 

referred to as a ‘‘bingo card.’’ The results 

indicate that the concentration of the 

active pharmaceutical ingredient 

warfarin in the residues in plastic 

bottles was usually over the 0.3% 

concentration. However, the 

concentration of warfarin in the 

residues on blister packs, including the 

30-pack blister pack, was consistently 

below 0.3%. Overall, in the majority of 

cases, the warfarin within the residues 

was present at a high enough 

concentration to be considered P001 (33 

of 44 samples, 75 percent of the 

samples). 

However, the results also confirm the 

results from the first two stakeholders. 

That is, the total weight of residues 

remaining in the containers after they 

were emptied of the warfarin pills is 

negligible. For the plastic bottles, the 

total weight of residue ranged from 4.3– 

82.3 mg. For the single-dose blister 

packs, the total weight of residue ranged 

from 3.5–7.6 mg. And for the 30-pack 

blister pack, the total weight ranged 

from 134.8–273 mg. Taking the smallest 

amount of residue of 3.5 mg, it would 

take close to 300,000 containers per 

month to exceed the 1 kg threshold to 

be an LQG. Even on the conservative 

side, taking the largest amount of 

residue of 273 mg, it would take close 

to 4000 containers per month to exceed 

the 1 kg threshold to be an LQG. 

The results for nicotine residues were 

similar. For containers of gum and 

patches, the weight of total residues 

ranged from 9–111.2 mg, although the 

two containers of liquid nicotine 

solution contained more residues—1301 

and 1616 mg. Although nicotine is not 

a concentration-based listing, it is worth 

noting that the active pharmaceutical 

ingredient of nicotine in the residues 

was below the quantifiable limit of 1.5 

mg/ml in 8 of the 15 samples and for the 

other 7 samples, the concentration of 

nicotine ranged from 0.01–0.09%. 

iv. EPA’s Office of Research and 

Development. Finally, EPA’s ORD 

conducted an analysis to evaluate 

whether simply removing a drug from 

the container is equivalent to triple 

rinsing the container. ORD’s results are 

summarized in Table 11, but the Final 

Project Report containing the full results 

is in the docket for this proposed 

rulemaking (EPA–HQ–RCRA–2007– 

0932). ORD analyzed three different Plisted pharmaceuticals: Warfarin, 

nicotine and physostigmine salicylate. 

Table 11 lists the 18 different 

combinations of active pharmaceutical 

ingredients, form, dosage strengths and 

packaging combinations that ORD 

analyzed. 

TABLE 11—PHARMACEUTICAL COMBINATIONS TESTED BY EPA’S ORD 

Active pharmaceutical 

ingredient Manufacturer/Brand name Form Dosage Packaging type 

Warfarin ..................... Taro Pharmaceutical Industries, Ltd. ............. Tablet .......

Tablet .......

Tablet .......

Tablet .......

1 mg .........

5 mg .........

10 mg .......

2 mg .........

Plastic bottle. 

Plastic bottle. 

Plastic bottle. 

Single-dose blister pack. 

Upsher-Smith/Jantoven .................................. Tablet .......

Tablet .......

1 mg .........

10 mg .......

Single-dose blister pack 

Single-dose blister pack. 

Nicotine ...................... GlaxoSmithKline/Nicorette ............................. Gum .........

Gum .........

2 mg .........

4 mg .........

Single-dose blister pack. 

Single-dose blister pack. 

Rugby Laboratories ........................................ Gum .........

Gum .........

2 mg .........

4 mg .........

Single-dose blister pack. 

Single-dose blister pack. 

GlaxoSmithKline/Nicorette ............................. Lozenge ...

Lozenge ...

2 mg .........

4 mg .........

Plastic vial 

Plastic vial. 

Rugby Laboratories ........................................ Patch ........ 7 mg ......... Peel-off plastic. 

Habitrol ........................................................... Patch ........ 14 mg ....... Peel-off plastic. 

Rugby Laboratories ........................................ Patch ........ 21 mg ....... Peel-off plastic. 

Pfizer/Nicotrol ................................................. Spray .......

Inhaler ......

10 mg/ml ..

10 mg .......

Glass vial. 

Plastic container. 

Physostigmine Salicylate.Akron Inc. ....................................................... Liquid ....... 1 mg/ml .... Glass ampoule. 

All combinations in Table 11 were 

analyzed in triplicate using the 

following three-step approach: 

(1) After removing the tablets, gum, 

lozenges, etc from the containers, the 

amount of total residuals remaining in 

the container was determined using a 

sensitive balance to weigh the container 

before and after triple rinsing, 

(2) The ‘‘maximum possible weight of 

residual drug/total residual/container’’ 

was calculated for each compound and 

packaging combination. This calculated 

result was used to infer a theoretical 

upper limit for the amount of active 

pharmaceutical compound in the total 

residue remaining in the container, and 

(3) Thermal gravimetric analysis 

(TGA) was used to qualitatively evaluate 

the presence of active pharmaceutical 

ingredient in the residuals removed 

from the containers before and after 

triple-rinsing. 

With respect to the weight of the 

remaining residuals in the containers, 

ORD’s results are similar to the results 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58055 

131Optimizing drug dose is a major factor in 

improving the sustainability of healthcare. The 

prescriber needs to be cognizant that prescribed 

treatments can have unanticipated, collateral 

impacts that reach far beyond the healthcare setting. 

See: Daughton and Ruhoy, Lower-dose prescribing: 

Minimizing ‘‘side effects’’ of pharmaceuticals on 

society and the environment; Sci Total Environ, 

443(2013), pp. 324–336, which presents a critical 

examination of the multi-faceted potential role of 

drug dose in reducing the ambient levels of APIs 

in the environment and in reducing the incidence 

of drug wastage, which ultimately necessitates 

disposal of leftovers. (http://sciencedirect.com/

science/article/pii/S004896712013927#) 

132 December 1994, RCRA Online #13718 http:// 

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

1C1DEB3648A62A868525670F006BCCD2/$file/

13718.pdf. 

133Memo from Dellinger to Chilcott, April 14, 

2008, RCRA Online #14788 http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

6A5DEDF2FBA24FE68525744B0045B4AF/$file/

14788.pdf. 

134Note that since this Q&A was issued, EPA 

issued guidance indicating that epinephrine salts 

are not included in the scope of the P042 listing and 

therefore, most, if not all, medical applications of 

epinephrine are not P042 (October 15, 2007; RCRA 

Online #14778) 

from the first three sources. That is, the 

weight of the total residuals remaining 

in the packaging of P-listed 

pharmaceuticals is minimal. For singledose blister packs, lozenge vials and the 

peel-off plastic from nicotine patches 

the weight of the residuals was 

negligible and within the range of error 

of the balance, but all results were 

below 0.0002 grams. For plastic 

containers that held tablets, the weight 

of residuals were higher, but still very 

low, ranging from 0.0152–0.0157 grams. 

For containers that held liquids, the 

weight of residuals was the highest, but 

still very low, ranging from 0.0472 

grams for glass vials of nicotine spray, 

to 0.0651 grams for glass ampoules that 

held liquid physostigmine salicylate. 

The residuals in the nicotine inhaler 

were not experimentally determined; 

rather, the manufacturer (Pfizer) states 

on the packaging that the 10 mg 

cartridge delivers a 4 mg dose, so the 

residuals are assumed to be 6 mg (or 

0.006 grams).131

Unlike the quantitative results from 

the HPLC analyses from outside 

stakeholders, the results from the TGA 

are qualitative only. That is, the TGA 

was only intended to evaluate the 

presence of the API and compare the 

results from containers that had been 

triple rinsed with those that had not 

been triple rinsed. Using TGA, the API 

was not detected in the residuals, with 

one exception: The liquid nasal spray 

(note that TGA was not used on the 

nicotine inhaler residuals). In most 

cases, the TGA detected other, 

unspecified ingredients in the residuals, 

but not the active pharmaceutical 

ingredient on the P-list. The total weight 

of the residues was well under a gram 

and the active pharmaceutical 

ingredient is a small proportion of the 

total weight of the tablet, gum, etc. As 

a result, with the exception of the 

nicotine nasal spray, the TGA was not 

sensitive enough to detect the presence 

of the active pharmaceutical ingredient, 

regardless of whether the container had 

been triple rinsed or not. 

EPA is aware that there are certain 

limitations with the data from the four 

sources. For instance, in the case of the 

consulting firm, no replicate samples 

were tested. In the case of the retailer, 

only warfarin residues were tested. 

However, given the size of the 

containers involved and the nominal 

quantities of residues involved, the 

Agency is proposing to allow the 

residues in single-unit dose containers/ 

packaging and dispensing bottles, vials 

and ampules that once held 

pharmaceuticals to be managed as nonhazardous waste pharmaceuticals 

provided the pharmaceutical product 

has been fully dispensed (e.g., all pills 

have been removed). EPA is soliciting 

comment on whether these studies are 

representative of the spectrum of 

formulations and containers that might 

be encountered. 

Finally, we note that the Agency is 

concerned about the potential for 

diversion of the pharmaceutical 

containers that may occur when the 

pharmaceutical residues and containers 

are discarded in the municipal waste 

stream. In such instances, we are 

concerned that the containers could be 

diverted from the municipal waste 

stream and used for illicit purposes, 

such as packaging counterfeit 

pharmaceuticals. Therefore, EPA is 

proposing that ‘‘RCRA empty’’ 

pharmaceutical containers that are 

original pharmaceutical packages (and 

therefore are susceptible to diversion) 

should be destroyed prior to placing 

them in the trash. These types of 

containers would include dispensing 

bottles, vials or ampules typically used 

in pharmacies, but would not include 

paper or plastic cups, or blister packs 

used for dispensing singles doses to 

patients. The means of destruction 

could include crushing or shredding the 

container. We do not believe that simply 

defacing the label would be sufficient to 

avoid diversion, since labels could be 

replaced if the container is intact. 

We request comment on these 

proposed provisions, including whether 

it is necessary to limit the size of the 

dispensing bottle to which this 

provision would apply. In our 

observation, EPA has rarely seen 

pharmaceutical dispensing bottles that 

are larger than 1000-count, which are 

approximately 1 liter in size. EPA 

requests comment on whether larger 

containers are used for dispensing 

pharmaceuticals and, if so, which 

pharmaceuticals they are used for and 

what RCRA hazardous waste codes 

apply. We also seek comment as to 

whether ‘‘RCRA empty’’ pharmaceutical 

containers that are the original 

pharmaceutical packages should be 

destroyed prior to placing them in the 

trash. 

c. Dispensed syringes. With regard to 

dispensed syringes, EPA is proposing a 

conditional exemption for syringes that 

have been used to administer 

pharmaceuticals that are listed or 

characteristic hazardous waste when 

discarded. The residues remaining in a 

dispensed syringe would not be 

regulated as hazardous waste provided 

the syringe has been used to administer 

a pharmaceutical to a patient and the 

syringe is placed in a sharps container 

(if appropriate) and is managed in 

accordance with all applicable state and 

federal medical waste regulations. This 

would apply to syringes used to 

administer pharmaceuticals that are Por U-listed, or exhibit a hazardous waste 

characteristic. 

EPA issued guidance regarding the 

regulatory status of residues in syringes 

in December 1994 132 and April 2008.133

In the December 1994 RCRA/Superfund 

Hotline Q&A about whether 

epinephrine in a discarded syringe 

would be P042, EPA stated, ‘‘Drug 

residues often remain in a dispensing 

instrument after the instrument is used 

to administer medication. EPA 

considers such residues remaining in a 

dispensing instrument to have been 

used for their intended purpose. The 

epinephrine remaining in the syringe, 

therefore, is not a commercial chemical 

product and not a P042 hazardous 

waste. The epinephrine could be a 

RCRA hazardous waste, however, if it 

exhibits a characteristic of hazardous 

waste.’’ 134

In the April 2008 memo, EPA clarified 

that the 1994 interpretation extends to 

other P- and U-listed pharmaceuticals 

that have been used to administer the 

pharmaceutical by syringe. This 

proposed conditional exemption for 

syringes, in large part, would maintain 

the existing interpretation. The primary 

difference is that under the proposed 

conditional exemption, healthcare 

facilities would not be required to 

determine if the residues in the syringes 

meet a listing description or exhibit a 

hazardous waste characteristic. 


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58056 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

135 Daughton CG, Drugs and the Environment: 

Stewardship & Sustainability, National Exposure 

Research Laboratory, Environmental Sciences 

Division, U.S. EPA, Las Vegas, NV; NERL–LV–ES 

10/081, EPA/600/R–10/106; September 2010 

(http://www.epa.gov/nerlesd1/bios/daughton/

APM200-2010.pdf.) 

EPA believes this conditional 

exemption is important to minimize the 

potential for exposures to healthcare 

workers, which can happen if they are 

accidentally stuck with a needle. 

Typically, sharps containers are more 

readily available to a medical 

practitioner than a hazardous waste 

container. Therefore, the used syringe 

will be discarded more quickly into a 

sharps container and there will be less 

opportunity for accidental sticks to 

occur en route to disposing the sharp. 

However, we also note that syringes 

in sharps containers are typically 

autoclaved prior to disposal. EPA is 

concerned that the residues remaining 

in the syringes could be aerosolized 

during autoclaving and inadvertently 

expose workers to the aerosolized 

hazardous waste residues, posing risks 

(via pulmonary exposure) to those 

present during venting of the autoclave. 

Research suggests that autoclaving may 

even increase the toxicity of certain 

drugs.135 EPA seeks comment on the 

extent of risks associated with 

autoclaving hazardous waste residues 

leftover in syringes and whether it is 

necessary to place a limit on the volume 

of residue or the volume of the syringe 

to which this conditional exemption 

would apply or whether any other 

conditions would be appropriate. For 

instance, stakeholders have informed us 

that they will squirt the residues 

remaining in a syringe onto a gauze pad 

prior to placing the syringe in the sharps 

container. Then, if the residues on the 

gauze pad are hazardous waste, the 

gauze pad is managed as hazardous 

waste, while allowing the syringe to be 

fully dispensed before placing it in the 

sharps container. In EPA’s view, this 

method of managing excess residues is 

preferred over another practice that is 

commonly used: The disposal of excess 

residues down the drain. 

d. Other containers, including 

delivery devices. With regard to other 

containers, including delivery devices, 

EPA is proposing that the residues 

remaining in unused or used containers 

(such as IV bags and tubing, inhalers, 

aerosols, nebulizers, tubes of ointment, 

gels, or creams) would be regulated as 

hazardous waste if the residues are a Por U-listed hazardous waste or exhibit a 

hazardous waste characteristic. In some 

cases, such as with IV bags, the volume 

of hazardous waste is much larger than 

with residues contained in syringes or 

unit-dose containers. Stakeholders have 

stated that it is common practice for the 

leftover contents of IV bags and tubing 

to be emptied into a sink, which is a 

practice we are striving to eliminate. It 

is extremely difficult to determine how 

much residue remains in tubes of 

ointment, gel or cream. In the case of 

aerosols, it would be inadvisable to 

remove the contents of the container. 

Since hazardous waste pharmaceuticals 

managed under this proposed rule 

would not be counted towards a 

facility’s generator category, managing 

these residues and containers as 

hazardous waste under proposed 40 

CFR part 266, subpart P should not pose 

the same burden that generators 

currently face with keeping track of the 

monthly amount of residues in 

containers that are not ‘‘RCRA empty.’’ 

Further, comments on the 2008 

Pharmaceutical Universal Waste 

proposal indicated that stakeholders 

prefer clear distinctions in regulating 

the hazardous waste from healthcare 

facilities and this proposed standard for 

container residues responds to that 

comment. EPA seeks comment on 

whether these proposed provisions 

address stakeholder concerns, while 

protecting human health and the 

environment. 

F. What are the proposed standards for 

shipping hazardous waste 

pharmaceuticals? 

1. Shipping Standards for NonCreditable Hazardous Waste 

Pharmaceuticals and Evaluated 

Hazardous Waste Pharmaceuticals to 

Treatment, Storage, and Disposal 

Facilities 

a. Shipping Standards for NonCreditable Hazardous Waste 

Pharmaceuticals From Healthcare 

Facilities to TSDFs 

Typically, hazardous waste 

pharmaceuticals generated in a 

healthcare facility fall into two 

categories: (1) Non-creditable (e.g., 

patient care) hazardous waste 

pharmaceuticals and (2) potentially 

creditable hazardous waste 

pharmaceuticals. This section discusses 

the proposed requirements for shipping 

of non-creditable, patient care/floor 

hazardous waste pharmaceuticals. For 

information regarding the shipment of 

potentially creditable hazardous waste 

pharmaceuticals from healthcare 

facilities and pharmaceutical reverse 

distributors, see Section V.F.2 of the 

preamble. 

Generally, patient care/floor 

hazardous waste pharmaceuticals differ 

from potentially creditable hazardous 

waste pharmaceuticals in that they have 

been partially administered and often 

are not in their original packaging. In 

addition, patient care/floor hazardous 

waste pharmaceuticals cannot receive 

manufacturer’s credit and therefore may 

not be shipped to a reverse distributor. 

EPA is proposing that patient care/floor 

hazardous waste pharmaceuticals 

generated at healthcare facilities, when 

shipped off-site, must be shipped to a 

designated facility (i.e., an interim 

status or permitted hazardous waste 

TSDF), as currently required (unless the 

healthcare facility has interim status or 

a RCRA permit to store or treat 

hazardous waste). Specifically, EPA 

proposes that non-creditable hazardous 

waste pharmaceuticals must continue to 

comply with the existing pre-transport 

requirements for packaging, labeling 

and marking, and that the noncreditable hazardous waste 

pharmaceuticals must continue to be 

shipped using a hazardous waste 

transporter and tracked with a 

hazardous waste manifest. However, to 

avoid unnecessarily burdening the 

healthcare facility staff, who are 

unfamiliar with RCRA, EPA proposes 

that the hazardous waste numbers (often 

called hazardous waste codes) are not 

required to be entered into the 

hazardous waste manifest for noncreditable hazardous waste 

pharmaceuticals. In lieu of hazardous 

waste codes, EPA is proposing that the 

words, ‘‘hazardous waste 

pharmaceuticals’’ must be entered in the 

‘‘special handling and additional 

information’’ box on the manifest (box 

# 14). All existing RCRA recordkeeping 

requirements regarding hazardous waste 

manifesting continue to apply, (see 

Section V.C.12), as well as all applicable 

DOT shipping requirements. EPA 

requests comment on this proposed 

approach for manifesting non-creditable 

hazardous waste pharmaceuticals from a 

healthcare facility. 

b. Shipping Standards for Evaluated 

Hazardous Waste Pharmaceuticals From 

Pharmaceutical Reverse Distributors to 

TSDFs 

For pharmaceutical reverse 

distributors, once potentially creditable 

hazardous waste pharmaceuticals have 

been deemed non-creditable or credit 

has been issued and they do not require 

any additional verification of credit, 

EPA is proposing that the hazardous 

waste pharmaceuticals be referred to as 

‘‘evaluated hazardous waste 

pharmaceuticals.’’ As with shipping 

non-creditable hazardous waste 

pharmaceuticals, when evaluated 

hazardous waste pharmaceuticals are 

shipped off-site, EPA is proposing that 

they must be shipped in accordance 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58057 

136The Controlled Substances Import and Export 

Act prohibits controlled substances from being 

imported or exported unless permitted by DEA, 

even when the controlled substances are wastes. 

See 21 U.S.C. 952 and 953. 

137EPA sent nine pharmaceutical reverse 

distributors a letter asking for more information 

about their business practices in an effort to more 

fully understand reverse distribution of 

pharmaceuticals. The seven responses representing 

the views of eight reverse distributors can be found 

in the docket of this proposed rulemaking (EPA– 

HQ–RCRA–2007–0932). 

with the existing pre-transport 

requirements for packaging, labeling 

and marking, and that evaluated 

hazardous waste pharmaceuticals must 

be shipped via a hazardous waste 

transporter using a hazardous waste 

manifest to a designated facility. This 

continues current practices under 

existing regulations for this type of 

hazardous waste pharmaceutical and 

does not represent an increase in 

burden. EPA believes that use of a 

hazardous waste manifest and a 

hazardous waste transporter are 

appropriate at this point for two 

reasons. First, once credit for the 

hazardous waste pharmaceuticals has 

been issued and verified, the potential 

for mismanagement is greater. This is 

because the pharmaceuticals have lost 

their value and will cost the reverse 

distributor money to dispose. Second, 

TSDFs are accustomed to receiving 

hazardous waste via a hazardous waste 

transporter with a hazardous waste 

manifest and it would place 

administrative and compliance burdens 

on the receiving TSDF to accept 

shipments of hazardous waste with 

alternative tracking. 

EPA is proposing that the 

pharmaceutical reverse distributor list 

the appropriate hazardous waste codes 

on the manifest (even though the 

healthcare facility is not required to 

provide such information to the reverse 

distributor). Hazardous waste 

pharmaceuticals received by 

pharmaceutical reverse distributors are 

in their original packaging with their 

label, so the information to determine 

the appropriate hazardous waste codes 

should be readily available. Also, 

reverse distributors are currently 

required to include hazardous waste 

codes on the manifest and it is expected 

that they have the necessary expertise in 

the management of these hazardous 

wastes that healthcare workers lack. As 

described in Section V.G.3 

(pharmaceutical reverse distributor 

management standards), reverse 

distributors must keep copies of 

hazardous waste manifests for three 

years from the date of shipment. 

EPA requests comment regarding the 

proposed manifest and transportation 

requirements for non-creditable 

hazardous waste pharmaceuticals from 

healthcare facilities and evaluated 

hazardous waste pharmaceuticals from 

pharmaceutical reverse distributors. 

c. Importing/Exporting Non-Creditable 

or Evaluated Hazardous Waste 

Pharmaceuticals 

Under the existing regulations, a 

healthcare facility or pharmaceutical 

reverse distributor may not import 

hazardous waste pharmaceuticals unless 

it has a RCRA permit or interim status 

that allows it to accept hazardous waste 

from off-site and complies with the 

requirements for importing hazardous 

waste in 40 CFR part 262, subpart F. 

This proposal does not change the 

regulations as they apply to the import 

of non-creditable or evaluated 

hazardous waste pharmaceuticals. 

Likewise, under existing regulations, a 

healthcare facility or pharmaceutical 

reverse distributor may not export (noncreditable or evaluated) hazardous 

waste pharmaceuticals unless it 

complies with requirements for 

exporting hazardous waste in 40 CFR 

part 262, subpart E. This proposal also 

does not change the regulations as they 

apply to the export of (non-creditable or 

evaluated) hazardous waste 

pharmaceuticals.136

EPA requests comment on the 

likelihood that non-creditable 

hazardous waste pharmaceuticals that 

are shipped from a healthcare facility to 

a domestic TSDF, would then be 

exported to a TSDF in a foreign country. 

In addition, EPA does not anticipate 

that hazardous waste pharmaceuticals 

would be destined for transboundary 

shipments for purposes of recovery 

operations and therefore potentially 

subject to 40 CFR part 262, subpart H; 

however, we also request comment on 

whether this is the case. 

2. Shipping Standards for Potentially 

Creditable Hazardous Waste 

Pharmaceuticals 

This section discusses the proposed 

requirements for shipping potentially 

creditable hazardous waste 

pharmaceuticals from healthcare 

facilities to pharmaceutical reverse 

distributors and between 

pharmaceutical reverse distributors. The 

return of potentially creditable 

pharmaceuticals (hazardous and nonhazardous) to reverse distributors can 

involve multiple shipping steps before 

the pharmaceuticals are transported for 

ultimate treatment and disposal. In 

comments on the 2008 Pharmaceutical 

Universal Waste proposal and in 

response to EPA’s request for 

information,137 pharmaceutical reverse 

distributors explained various scenarios 

that require extra shipping steps. For 

example, a healthcare facility typically 

sends pharmaceuticals to the reverse 

distributor with which it has a contract. 

However, some manufacturers will only 

provide manufacturer’s credit after the 

pharmaceuticals have been returned to 

the reverse distributor with which the 

manufacturer has a contract. Thus, if the 

reverse distributor with which the 

healthcare facility has a contract differs 

from the reverse distributor with which 

the manufacturer has a contract, then 

the healthcare facility’s reverse 

distributor must send the 

pharmaceuticals on to the 

manufacturer’s reverse distributor for 

the manufacturer’s credit to be given to 

the healthcare facility. In some cases, a 

pharmaceutical manufacturer may 

require the reverse distributor to ship 

the returned pharmaceuticals to the 

manufacturer so that the manufacturer 

itself can verify pharmaceutical 

amounts and credits. The estimate of the 

amount of pharmaceuticals transported 

from reverse distributors to 

manufacturers for verification varies. 

Based on our request for information, 

reverse distributors have indicated that 

the percent of potentially creditable 

pharmaceuticals transported to 

manufacturers ranged from an estimated 

25 percent to 93 percent, depending on 

the contractual agreement between the 

reverse distributor and the 

manufacturer. Both of the scenarios 

described previously happen routinely 

and are part of the business of returning 

pharmaceuticals to reverse distributors 

(including manufacturers) for 

manufacturer’s credit. 

As explained in Section V.D.1, EPA is 

proposing that pharmaceuticals 

transported to pharmaceutical reverse 

distributors for credit are solid wastes, 

some of which will also be considered 

hazardous wastes. Under the current 

RCRA Subtitle C regulations, hazardous 

waste, including hazardous waste 

pharmaceuticals must be manifested to 

a permitted or interim status TSDF and 

shipped using a hazardous waste 

transporter to ensure the cradle-to-grave 

system of RCRA is maintained. 

However, compared to other hazardous 

wastes, EPA believes that the risk of 

environmental release posed by most 

potentially creditable hazardous wastes 

pharmaceuticals during accumulation 

and transport are relatively low. The 

risk is low because of the form and 

packaging of most potentially creditable 

hazardous waste pharmaceuticals, 

which is typically in small, individually 

packaged doses (such as with many 

tablets and capsules) or small vials. 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58058 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

138Pharmaceutical Universal Waste proposal, 73 

FR 73529; December 2, 2008. 

139Note EPA is not endorsing the use of any of 

the shipping companies cited. 

These small volumes of individually 

wrapped or packaged pharmaceuticals, 

when aggregated in a larger container, 

are unlikely to spill or be released into 

the environment since they are 

essentially double-packed when 

transported to a reverse distributor.138

Potentially creditable hazardous waste 

pharmaceuticals that are in liquid and 

aerosol forms may pose more of a risk 

during accumulation and transport due 

to possible spillage or leakage, but the 

small quantities in which they are 

generated, along with the DOT 

packaging requirements of 49 CFR parts 

173, 178, and 180, would likely mitigate 

this risk (see EPA’s recommendation 

regarding liquids and aerosols in 

Section V.D.2.). Further, the 2008 

Pharmaceutical Universal Waste 

proposal specifically sought comment 

regarding the risks of transportation of 

hazardous waste pharmaceuticals and 

no commenters identified 

environmental risks. 

Due to the low risk of release to the 

environment described previously, EPA 

is proposing to allow potentially 

creditable hazardous waste 

pharmaceuticals to be shipped without 

a hazardous waste manifest and without 

the use of hazardous waste transporters. 

However, this exemption from 

manifesting and use of hazardous 

wastes transporters only applies if the 

healthcare facility is sending potentially 

creditable hazardous waste 

pharmaceuticals to a pharmaceutical 

reverse distributor, or if a 

pharmaceutical reverse distributor is 

sending potentially creditable 

hazardous waste pharmaceuticals to 

another pharmaceutical reverse 

distributor. Further, DOT shipping 

requirements continue to apply to 

shipments of potentially creditable 

hazardous waste pharmaceuticals. 

In lieu of requiring a hazardous waste 

manifest and the use of hazardous waste 

transporters, EPA is proposing an 

alternate type of tracking for potentially 

creditable hazardous waste 

pharmaceuticals—with two 

requirements. First, for each shipment, 

healthcare facilities and pharmaceutical 

reverse distributors must provide in 

writing (via letter or electronic 

communication), advance notice of the 

shipment to the pharmaceutical reverse 

distributor. Second, for each shipment, 

the receiving pharmaceutical reverse 

distributors must provide confirmation 

to the healthcare facility or 

pharmaceutical reverse distributor that 

initiated the shipment that the shipment 

of potentially creditable hazardous 

waste pharmaceuticals has arrived. One 

way to comply with this requirement 

would be for the receiving reverse 

distributor to require the healthcare 

facility or pharmaceutical reverse 

distributor that initiates the shipment of 

potentially creditable hazardous waste 

pharmaceuticals to utilize some form of 

‘‘delivery confirmation’’ mechanism 

that is provided by the shipper that 

confirms that a shipment to a reverse 

distributor has reached its destination 

and is under the custody and control of 

the recipient (e.g. delivery confirmation 

tracking with return receipt). This 

‘‘delivery confirmation’’ notice can be 

paper-based or electronic. As part of the 

delivery confirmation system, a 

signature (paper or electronic) or other 

confirmation from a representative of 

the receiving pharmaceutical reverse 

distributor would be required. The 

signature by the pharmaceutical reverse 

distributor would provide assurance 

that the shipment was received by the 

reverse distributor. Without the 

signature or other confirmation of a 

representative of the pharmaceutical 

reverse distributor, it is possible for the 

shipper to state that delivery to the 

location has occurred, but it would not 

necessarily indicate that the recipient 

was there to receive the shipment. This 

proposed requirement is in direct 

response to concerns expressed by 

commenters over the lack of tracking of 

pharmaceuticals in the 2008 

Pharmaceutical Universal Waste 

proposal. 

Alternatively, EPA has learned that 

some stakeholders use bar-coding on the 

pharmaceuticals or on the boxes to track 

shipments. The barcodes contain 

detailed information, including the 

exact quantities and types of 

pharmaceuticals included in the 

shipment. Typically, when a reverse 

distributor receives a barcoded 

shipment, it will scan in the shipment 

and the sender will receive electronic 

notification that the shipment has 

arrived. This type of bar-code tracking 

would meet the delivery confirmation 

requirement of this proposed rule, but 

other mechanisms of ‘‘delivery 

confirmation’’ that are offered by 

common carriers, such as the U.S. Postal 

Service, FedEx or United Parcel Service 

(UPS), would also be acceptable. 

Under this proposal, healthcare 

facilities and reverse distributors may 

use common carriers, such as the U.S. 

Postal Service, United Parcel Service, or 

FedEx 139 for shipments of potentially 

creditable hazardous waste 

pharmaceuticals to and between 

pharmaceutical reverse distributors. 

EPA believes that common carriers are 

able to provide safe shipment since 

these potentially creditable hazardous 

waste pharmaceuticals present low 

transportation risk. We note that 

healthcare facilities and pharmaceutical 

reverse distributors must meet the 

applicable Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA) Hazardous Materials 

Regulation (HMR; 49 CFR parts 171– 

180) shipping requirements, including 

preparing proper shipping papers when 

shipping potentially creditable 

hazardous waste pharmaceuticals. A 

RCRA hazardous waste that does not 

meet DOT hazard classes 1–8 in the 

HMR, are only Class 9 hazardous 

materials when defined as a RCRA 

hazardous wastes that requires a 

manifest. As a result, the DOT shipping 

requirements will apply when 

potentially creditable hazardous waste 

pharmaceuticals are shipped to 

pharmaceutical reverse distributors only 

when the hazardous wastes are DOT 

class 1–8 hazardous materials. 

EPA notes that a pharmaceutical 

reverse distributor is not required to sort 

the potentially creditable hazardous 

waste pharmaceuticals from the 

potentially creditable non-hazardous 

waste pharmaceuticals when they are 

destined for another reverse distributor. 

However, if the potentially creditable 

pharmaceuticals are not sorted, the 

pharmaceutical reverse distributor must 

follow the tracking procedures in this 

proposal for the entire shipment. On the 

other hand, if a pharmaceutical reverse 

distributor chooses to sort the 

potentially creditable hazardous waste 

pharmaceuticals from the creditable 

non-hazardous waste pharmaceuticals 

prior to shipping to another reverse 

distributor, only the potentially 

creditable hazardous waste 

pharmaceutical portion would have to 

be shipped according to these proposed 

standards. EPA asks for comment on 

whether the proposed tracking system 

and controls are sufficient to protect 

human health and the environment. 

a. What Happens if a Healthcare Facility 

or Pharmaceutical Reverse Distributor 

Initiates a Shipment and Does Not Get 

Confirmation of Delivery? 

If a healthcare facility or 

pharmaceutical reverse distributor 

initiates a shipment of potentially 

creditable hazardous waste 

pharmaceuticals to a reverse distributor 

and does not receive delivery 

confirmation from the intended 

recipient within seven calendar days, 

EPA is proposing that the healthcare 

facility or pharmaceutical reverse 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58059 

140The Controlled Substances Import and Export 

Act prohibits controlled substances from being 

imported or exported unless permitted by DEA, 

even when the controlled substances are wastes. 

See 21 U.S.C. 952 and 953. 

distributor that initiated the shipment 

must contact the shipper and the 

intended recipient promptly to (1) 

report that the confirmation was not 

received and (2) to determine the status 

and whereabouts of the potentially 

creditable hazardous waste 

pharmaceuticals that were shipped. The 

Agency requests comment on whether 

any additional requirements, such as 

reporting to the implementing agency, 

are necessary in such cases. 

b. Importing/Exporting Potentially 

Creditable Hazardous Waste 

Pharmaceuticals 

If a healthcare facility or 

pharmaceutical reverse distributor 

imports potentially creditable hazardous 

waste pharmaceuticals, then it must 

comply with the proposed requirements 

for the shipment of potentially 

creditable hazardous waste 

pharmaceuticals. The proposed 

requirements would be in lieu of those 

for manifested hazardous waste imports 

found at 40 CFR part 262, subpart F. 

EPA requests comment on whether 

potentially creditable hazardous waste 

pharmaceuticals are imported into the 

U.S. and, if so, how they are currently 

declared to customs when imported. 

If a healthcare facility or 

pharmaceutical reverse distributor 

exports potentially creditable hazardous 

waste pharmaceuticals then it must 

generally comply with 40 CFR part 262, 

subpart E, except that it is not required 

to manifest the potentially creditable 

hazardous waste pharmaceuticals.140

c. Recordkeeping for Shipments of 

Potentially Creditable Hazardous Waste 

Pharmaceuticals 

EPA is proposing to require 

healthcare facilities and reverse 

distributors to keep records of the 

shipments of potentially creditable 

hazardous waste pharmaceuticals to 

reverse distributors. Specifically, we are 

proposing that healthcare facilities and 

reverse distributors that initiate a 

shipment to another pharmaceutical 

reverse distributor keep (1) records of 

advance notification regarding 

shipments of potentially creditable 

hazardous waste pharmaceuticals, (2) 

shipping papers, and (3) confirmation of 

receipt of shipment for three years after 

the shipment was initiated. These 

records are necessary to ensure that 

potentially creditable hazardous waste 

pharmaceuticals are reaching their 

intended destination and not diverted. 

In most cases, retaining records for 3 

years should be sufficient for inspection 

purposes; however, we are proposing 

that the periods of retention are 

automatically extended during 

unresolved enforcement activity, or at 

the request of the EPA Regional 

Administrator. The Agency seeks 

comment on whether additional 

recordkeeping is necessary to document 

the cases when the pharmaceutical 

reverse distributor does not receive a 

shipment of potentially creditable 

pharmaceuticals within 7 calendar days 

and the steps must be taken to locate the 

shipment. 

G. What are the proposed standards for 

pharmaceutical reverse distributors? 

1. Background on Pharmaceutical 

Reverse Distributor Operations 

Pharmaceutical reverse distributors 

act as intermediaries between healthcare 

facilities and pharmaceutical 

manufacturers. They receive shipments 

of potentially creditable hazardous 

waste pharmaceuticals from healthcare 

facilities and, on behalf of 

manufacturers, facilitate the process of 

crediting healthcare facilities for these 

pharmaceuticals. From stakeholder 

input and EPA site visits, EPA’s 

understanding is that when a 

pharmaceutical reverse distributor 

receives a shipment of potentially 

creditable hazardous waste 

pharmaceuticals, the reverse distributor 

sorts through the shipment and often 

uses barcodes to scan items into its 

computer system. Based on 

manufacturers’ return goods policies, 

the pharmaceutical reverse distributors 

determine which potentially creditable 

hazardous waste pharmaceuticals can be 

credited, as well as which must be sent 

on to another reverse distributor for 

completion of the crediting process. 

In many cases, there is more than one 

reverse distributor involved in 

establishing and verifying 

manufacturer’s credit for a particular 

potentially creditable hazardous waste 

pharmaceutical. For instance, reverse 

distributors may have contracts with 

specific pharmaceutical manufacturers 

such that only a specific pharmaceutical 

reverse distributor may facilitate credit 

for a particular manufacturer’s 

pharmaceuticals. If the receiving reverse 

distributor has a contract with the 

healthcare facility, but not with the 

pharmaceutical manufacturer, then the 

receiving pharmaceutical reverse 

distributor sends the returned 

pharmaceutical on to the reverse 

distributor that has a contract with the 

pharmaceutical manufacturer in order to 

facilitate the credit process. 

Because manufacturers’ return goods 

policies change over time, sometimes a 

pharmaceutical reverse distributor 

receives a potentially creditable 

hazardous waste pharmaceutical that is 

not eligible for credit immediately, and 

the pharmaceutical reverse distributor 

retains the potentially creditable 

hazardous waste pharmaceutical on-site 

until it is credit eligible. EPA requests 

comment on how often this happens 

and how long the potentially creditable 

hazardous waste pharmaceuticals are 

kept on-site at reverse distributors to 

await changes in manufacturers’ return 

goods policies. 

In some cases, even after the 

pharmaceutical reverse distributor has 

awarded credit, a pharmaceutical 

manufacturer may request that the 

hazardous waste pharmaceuticals be 

transported back to the manufacturer to 

inventory and verify the amount of 

pharmaceuticals and credit. In 

developing this proposed rule, EPA 

considered all of the previous scenarios 

as part of the crediting process. 

On the other hand, if the potentially 

creditable hazardous waste 

pharmaceuticals are not sent onward to 

another pharmaceutical reverse 

distributor, the pharmaceutical reverse 

distributor awards the manufacturer’s 

credit to the healthcare facility and then 

manages the hazardous waste 

pharmaceuticals on-site until they are 

sent off-site for treatment and disposal. 

As discussed previously in this 

proposal, after a potentially creditable 

hazardous waste pharmaceutical has 

been evaluated and either credited or 

deemed non-creditable and no 

additional pharmaceutical reverse 

distributors will be involved in the 

crediting process, EPA proposes to use 

the term ‘‘evaluated hazardous waste 

pharmaceutical.’’ This is to distinguish 

between the potentially creditable 

hazardous waste pharmaceuticals 

awaiting determination within the 

reverse distribution system versus 

credited and non-creditable hazardous 

waste pharmaceuticals that have been 

through the reverse distributor process 

and are destined to be managed by a 

permitted or interim status TSDF. Both 

are considered hazardous waste 

pharmaceuticals, but they are managed 

differently under the proposed 

regulations. 

EPA is not aware of any 

pharmaceutical reverse distributors that 

facilitate manufacturer’s credit that also 

has interim status or a permit to treat or 

dispose of hazardous waste on-site. 

Therefore, EPA anticipates that 

pharmaceutical reverse distributors 

eventually send all evaluated hazardous 

waste pharmaceuticals off-site for 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58060 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

141Barnes, K. K., Christenson, S. C., Kolpin, D. 

W., Focazio, M. J., Furlong, E. T., Zaugg, S. D., 

Meyer, M. T. and Barber, L. B. (2004), 

Pharmaceuticals and Other Organic Waste Water 

Contaminants Within a Leachate Plume 

Downgradient of a Municipal Landfill. 

Groundwater Monitoring & Remediation, 24: 119– 

126. 

142Buszka, P.M., Yeskis, D.J., Kolpin, D.W., 

Furlong, E.T., Zaugg, S.D., and Meyer, M.T. (2009), 

Waste-Indicator and Pharmaceutical Compounds in 

Landfill-Leachate-Affected Ground Water near 

Elkhart, Indiana, 2000–2002. Bulletin of 

Environmental Contamination and Toxicology, 

82.6:635–659. 

143See EPA’s request of information from reverse 

distributors, as well as their responses to EPA in the 

docket for this rulemaking: EPA–HQ–RCRA–2007– 

0932. 

144Meeting with representatives from CVS/

Caremark (November 8, 2012); see the docket for 

meeting notes (EPA–HQ–RCRA–2007–0932). 

treatment and disposal. EPA requests 

comment on whether the processes 

described previously are representative 

of the pharmaceutical reverse 

distribution process. 

2. EPA’s Rationale for Proposing New 

RCRA Management Standards for 

Pharmaceutical Reverse Distributors 

This proposed rule is establishing 

standards for the management of both 

potentially creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals that 

pharmaceutical reverse distributors 

receive and manage. The Agency notes 

that the management standards 

discussed in this section apply only to 

reverse distributors of potentially 

creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals and 

do not apply to reverse distribution or 

reverse logistics systems that may exist 

for other consumer products. 

The current federal RCRA hazardous 

waste regulations at 40 CFR part 262 

provide that only RCRA- permitted and 

interim status TSDFs may receive 

hazardous waste from off-site for 

treatment, storage, or disposal. 

However, the Agency does not believe it 

is necessary for pharmaceutical reverse 

distributors to obtain permits or have 

interim status to store hazardous waste 

pharmaceuticals in order to protect 

human health and the environment. 

Thus, EPA proposes a new category 

under RCRA called a ‘‘pharmaceutical 

reverse distributor,’’ which we proposed 

to define as any person that receives and 

accumulates potentially creditable 

hazardous waste pharmaceuticals for 

the purpose of facilitating or verifying 

manufacturer’s credit. The definition 

specifies that any person, including 

forward distributors and pharmaceutical 

manufacturers, which processes 

pharmaceuticals for the facilitation or 

verification of manufacturer’s credit is 

considered a pharmaceutical reverse 

distributor. EPA is proposing that 

pharmaceutical reverse distributors are 

not required to have interim status or a 

RCRA permit to accumulate hazardous 

waste pharmaceuticals and they may 

only accept potentially creditable 

hazardous waste pharmaceuticals from 

off-site provided they comply with the 

proposed standards in this rule. 

Pharmaceutical reverse distributors may 

not treat or dispose of hazardous waste 

on-site unless authorized to do so as a 

RCRA-permitted or interim status TSDF. 

As discussed previously, EPA’s 

existing interpretation allows 

pharmaceutical reverse distributors to 

be generators of hazardous waste 

pharmaceuticals after a decision is made 

about whether the pharmaceuticals will 

be repurposed. As a generator, a 

pharmaceutical reverse distributor 

currently must comply with the LQG, 

SQG, or CESQG generator requirements, 

depending on the total volume of 

hazardous waste generated in a calendar 

month. Some smaller pharmaceutical 

reverse distributors might stay under the 

hazardous waste quantity limits for 

CESQGs, which would mean that under 

the federal RCRA requirements, these 

CESQG pharmaceutical reverse 

distributors would not have to notify 

EPA as a generator and their hazardous 

waste pharmaceuticals could be 

disposed of with municipal and nonmunicipal solid waste (see § 261.5). 

However, the Agency has concerns with 

CESQG pharmaceutical reverse 

distributors not notifying EPA that they 

are managing hazardous waste. EPA is 

even more concerned about 

pharmaceutical reverse distributors that 

currently qualify as CESQGs placing the 

hazardous waste pharmaceuticals into 

the municipal and non-municipal solid 

waste stream and sending them to nonhazardous waste landfills. Some limited 

studies have shown active 

pharmaceutical ingredients present in 

landfill leachate that is collected in 

municipal solid waste landfill leachate 

systems.141 142 Landfill leachate is 

generally transported to a wastewater 

treatment plant to be treated before 

discharge; however, some 

pharmaceutical compounds pass 

through treatment and are discharged, 

becoming a potential contributor of the 

pharmaceutical compounds detected in 

our nation’s waters. 

EPA is proposing to revise its position 

regarding potentially creditable 

hazardous waste pharmaceuticals, such 

that they will be first considered 

discarded at the healthcare facilities, not 

at the reverse distributors. This revision 

is based on new information 

demonstrating to EPA that 

pharmaceuticals returned to a reverse 

distributor are rarely, if ever, recycled or 

reused, and therefore the decision to 

send a potentially creditable hazardous 

waste pharmaceutical to a 

pharmaceutical reverse distributor is a 

decision to discard the pharmaceutical 

(as discussed previously in Section 

V.D.1). Other comments on the 

December 2008 Pharmaceutical 

Universal Waste proposal indicated that 

notification to EPA by pharmaceutical 

reverse distributors and tracking of 

shipments of potentially creditable 

hazardous waste pharmaceuticals are 

critical and must be included in any 

regulatory scheme to ensure the safe 

management of potentially creditable 

hazardous waste pharmaceuticals. 

As previously discussed, only 

between 2–6 percent of the potentially 

creditable hazardous wastes that are 

received by pharmaceutical reverse 

distributors are listed or characteristic 

hazardous wastes.143 Therefore, the vast 

majority of the potentially creditable 

pharmaceutical waste that a 

pharmaceutical reverse distributor 

receives is not considered a 

characteristic or listed hazardous waste 

pharmaceutical under the existing 

definition of hazardous waste. This 

stands in contrast to a typical TSDF, 

which primarily manages hazardous 

waste. As a result, a pharmaceutical 

reverse distributor generally manages a 

smaller volume of hazardous waste than 

a typical permitted TSDF. 

In addition, because the 

pharmaceuticals in the reverse 

distribution system are receiving credit, 

they are moved through the system 

efficiently. In fact, one national 

pharmacy retail chain informed EPA 

that the value of the credit they receive 

from manufacturers for returned 

pharmaceuticals is approximately $1 

billion a year.144 Healthcare facilities 

and reverse distributors have a vested 

interest in having potentially creditable 

hazardous waste pharmaceuticals 

processed and credited quickly and 

managed appropriately so money is not 

lost in the process. 

Furthermore, potentially creditable 

hazardous waste pharmaceuticals 

generally present a low risk of release to 

the environment as they typically are 

still in the manufacturer’s packaging. 

Since there is a low human health and 

environmental risk of release associated 

with the low volumes of potentially 

creditable hazardous waste 

pharmaceuticals shipped to reverse 

distributors for crediting purposes, and 

because EPA is not aware of any 

incidents of mismanagement resulting 


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in environmental harm or releases of 

hazardous waste pharmaceuticals by 

reverse distributors, EPA believes that is 

not necessary to require reverse 

distributors to obtain RCRA hazardous 

waste storage permits with respect to 

typical reverse distribution operations, 

such as receiving, sorting, consolidating, 

and reshipping potentially creditable 

hazardous waste pharmaceuticals. 

Thus, EPA is proposing to take a 

‘‘middle-of-the-road’’ approach to 

regulating pharmaceutical reverse 

distributors by regarding them as a new 

type of RCRA hazardous waste entity— 

a pharmaceutical reverse distributor. 

This proposed approach addresses 

comments that EPA received on the 

December 2008 Pharmaceutical 

Universal Waste proposal and reflects 

EPA’s proposed revised interpretation 

that the point of generation for 

potentially creditable hazardous waste 

pharmaceuticals is at the healthcare 

facility, not the reverse distributor. 

EPA proposes to establish 

management standards for 

pharmaceutical reverse distributors in 

40 CFR part 266, subpart P. These 

entities would not be subject to 40 CFR 

parts 262, 264, or 265. Generally, EPA 

is proposing that pharmaceutical reverse 

distributors comply with standards that 

are similar to the current federal LQG 

standards, in combination with certain 

requirements that permitted or interim 

status hazardous waste TSDFs must 

meet. We are establishing one set of 

requirements for all pharmaceutical 

reverse distributors, regardless of the 

amount of potentially creditable 

hazardous waste pharmaceuticals they 

receive. EPA believes this uniform set of 

standards will make it easier for 

pharmaceutical reverse distributors to 

comply with the new proposal, since 

the burden of having to count hazardous 

waste pharmaceuticals on a monthly 

basis, especially the 1 kg of acute 

hazardous waste pharmaceuticals, will 

be removed. 

EPA proposes that a pharmaceutical 

reverse distributor will not be required 

to have a hazardous waste permit or 

interim status for on-site accumulation 

of creditable and evaluated hazardous 

waste pharmaceuticals provided it 

follows the proposed pharmaceutical 

reverse distributor standards. However, 

for activities such as treatment or 

disposal of hazardous waste 

pharmaceuticals or other hazardous 

waste, a pharmaceutical reverse 

distributor must either obtain a RCRA 

permit or have interim status. This 

proposal requires pharmaceutical 

reverse distributors to comply with 

standards that are similar to LQG 

standards for on-site accumulation of 

hazardous waste that are found in 

§ 262.34(a) and (b). We are proposing 

these requirements because, as 

discussed prevoiusly, the value of the 

potentially creditable pharmaceuticals 

creates an incentive for proper 

management and the risk of release is 

low. Furthermore, many pharmaceutical 

reverse distributors are already LQGs 

and therefore this proposed rule should 

not represent a large shift in current 

practices or increased burden. However, 

once credit is provided, the value of the 

pharmaceuticals is eliminated and 

therefore the evaluated hazardous waste 

pharmaceuticals have a greater potential 

for mismanagement. As a result, we are 

proposing that pharmaceutical reverse 

distributors have additional standards 

for the management of evaluated 

hazardous waste pharmaceuticals. Note 

that while the LQG accumulation 

standards are found in §§ 262.34(a) and 

(b), these generator regulations reference 

many interim status TSDF standards in 

part 265. However, in the regulatory text 

and preamble for this rule, we reference 

the standards in part 265 directly for the 

applicable accumulation standards for 

pharmaceutical reverse distributors 

(rather than § 262.34(a) which would 

then simply refer the reader to part 265). 

However, the Agency requests comment 

as to whether we should include the 

regulatory standard directly in 40 CFR 

part 266, subpart P, instead of providing 

a cross-reference to the standard in 40 

CFR part 265 in an effort to make the 

rules easier to follow and comply with. 

3. Detailed Discussion of Proposed 

Pharmaceutical Reverse Distributor 

Standards 

The proposed standards for 

pharmaceutical reverse distributors are 

organized into three sections. The first 

section applies to the pharmaceutical 

reverse distributor for the management 

of all potentially creditable hazardous 

waste pharmaceuticals and evaluated 

hazardous waste pharmaceuticals. The 

second section includes additional 

standards that would apply to the 

management of the potentially 

creditable hazardous waste 

pharmaceuticals that will be sent to 

another pharmaceutical reverse 

distributor for further evaluation or 

verification of credit and therefore 

continue to be regulated as potentially 

creditable hazardous waste 

pharmaceuticals. The third section 

includes additional standards that apply 

to the management of the evaluated 

hazardous waste pharmaceuticals that 

will not be sent to another 

pharmaceutical reverse distributor, but 

instead will be sent to a permitted or 

interim status TSDF. 

a. Standards for Pharmaceutical Reverse 

Distributors 

This portion of the preamble 

discusses the proposed standards that 

apply to pharmaceutical reverse 

distributors for the management of all 

hazardous waste pharmaceuticals onsite. Unlike the following two sections, 

the standards discussed in this section 

apply to all pharmaceutical reverse 

distributors, regardless of the 

subsequent destination of the hazardous 

waste pharmaceuticals. We note that a 

pharmaceutical reverse distributor must 

follow the proposed standards for the 

management of hazardous waste 

pharmaceuticals even if it generates 

other, non-pharmaceutical hazardous 

waste that is managed under 40 CFR 

part 262. 

i. Notification. The first proposed 

requirement is that a pharmaceutical 

reverse distributor must notify EPA of 

its hazardous waste pharmaceutical 

activities via the Site ID form (EPA form 

8700–12). Under the current RCRA 

Subtitle C program, both LQGs and 

TSDFs must submit a Site ID form to 

EPA. Thus, EPA believes it is 

appropriate, and in line with comments 

received on the 2008 Pharmaceutical 

Universal Waste proposal, to require 

pharmaceutical reverse distributors to 

notify EPA. A pharmaceutical reverse 

distributor that does not have an EPA ID 

number will be required to submit the 

Site ID form to obtain one. If this 

proposal is finalized, the Agency plans 

on revising the Site ID form to include 

a box to allow notifications by 

pharmaceutical reverse distributors. For 

those pharmaceutical reverse 

distributors that already have an EPA ID 

number, they will need to re-notify EPA 

as a pharmaceutical reverse distributor. 

Some pharmaceutical reverse 

distributors may also be generators of 

other types of hazardous waste (e.g., 

from cleaning and maintenance 

operations). Therefore, it is possible that 

a pharmaceutical reverse distributor 

may notify on the same notification 

form as both a generator of hazardous 

waste and as a pharmaceutical reverse 

distributor. 

ii. Inventory. EPA is proposing a new 

provision that is specific to 

pharmaceutical reverse distributors: the 

requirement is to keep an inventory of 

the potentially creditable hazardous 

waste pharmaceuticals and evaluated 

hazardous waste pharmaceuticals that 

are on-site. The inventory must include 

the identity (e.g., name or national drug 

code (NDC)) and quantity of each 

potentially creditable hazardous waste 

pharmaceutical and evaluated 

hazardous waste pharmaceuticals. EPA 


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145See all the responses EPA received from 

pharmaceutical reverse distributors in the docket 

for this proposed rulemaking (EPA–HQ–RCRA– 

2007–0932). 

146 ‘‘Pharmacies Besieged by Addicted Thieves’’ 

by Abby Goodnough Published: February 6, 2011 

http://www.nytimes.com/2011/02/07/us/

07pharmacies.html. 

also recommends as a best management 

practice that pharmaceutical reverse 

distributors also keep an inventory of 

their non-hazardous waste 

pharmaceuticals as well. An inventory 

is a key requirement to protect public 

health by helping to prevent the 

diversion of hazardous waste 

pharmaceuticals. An inventory will 

allow the pharmaceutical reverse 

distributor to know which 

pharmaceuticals they have on-site at 

any time. The Agency believes that in 

many cases, pharmaceutical reverse 

distributors already maintain 

inventories and this proposed 

requirement is not expected to be 

burdensome for the pharmaceutical 

reverse distributors to implement. In 

fact, according to responses from 

pharmaceutical reverse distributors to a 

request for information, four out of eight 

of them indicated that they already keep 

inventories as best management 

practices or because it is required by the 

Board of Pharmacy in their state.145

However, EPA requests comment on 

whether this practice is already 

commonly followed. 

iii. Security of the pharmaceutical 

reverse distributor. EPA is proposing 

that pharmaceutical reverse distributors 

must meet a performance-based security 

requirement which is based on the 

existing interim status TSDF security 

requirements found at § 265.14. 

Specifically, due to increased thefts of 

narcotics from pharmacies reported in 

recent years in major media outlets,146

EPA is concerned that pharmaceutical 

reverse distributors could also face such 

thefts since they accumulate unused 

pharmaceuticals or those that have 

exceeded their expiration date. Further, 

commenters on the 2008 Pharmaceutical 

Universal Waste proposal suggested that 

pharmaceutical universal waste 

handlers should meet the TSDF facility 

security requirement. EPA agrees with 

the commenters that the requirements 

that appear in the interim status TSDF 

security regulations would be 

appropriate to adopt and apply to 

pharmaceutical reverse distributors to 

prevent the illicit use of these 

pharmaceuticals and safeguard human 

health and thus, has included this 

requirement for pharmaceutical reverse 

distributors. The security of the facility 

requirement of § 265.14(a) requires a 

facility to ‘‘prevent the unknowing 

entry, and minimize the possibility for 

the unauthorized entry, of persons or 

livestock onto the active portion of his 

facility.’’ EPA is proposing a similar 

requirement for pharmaceutical reverse 

distributors: they must prevent 

unknowing entry, and minimize the 

possibility for the unauthorized entry 

into the portion of the facility where 

potentially creditable and evaluated 

hazardous waste pharmaceuticals are 

kept (e.g., a receiving area and 

accumulation area). 

Based on site visits, EPA recognizes 

that many pharmaceutical reverse 

distributors may already meet the 

proposed security standard through the 

use of key cards that allow only 

authorized personnel into specific areas 

of the pharmaceutical reverse 

distributor, camera surveillance 

systems, and cages for storing 

pharmaceuticals. Some pharmaceutical 

reverse distributors may use fences and 

signs. EPA is including several 

examples of acceptable security 

measures in the regulatory text, but 

pharmaceutical reverse distributors are 

not limited to the examples provided. 

Further, if a pharmaceutical reverse 

distributor already meets the 

performance-based security standard by 

complying with other regulations, such 

as DEA’s regulations, then the 

pharmaceutical reverse distributor 

would not need to install additional 

security. 

iv. Maximum 90 days for on-site 

accumulation and petition for an 

extension of accumulation time. 

EPA is proposing that, like LQGs, 

pharmaceutical reverse distributors may 

accumulate potentially creditable 

hazardous waste pharmaceuticals and 

evaluated hazardous waste 

pharmaceuticals on-site for up to 90 

calendar days without having interim 

status or a permit. However, because of 

the value of the potentially creditable 

hazardous waste pharmaceuticals, and 

the low risk these materials present, the 

Agency has decided not to propose 

specific container management 

standards. 

The 90-day time limit begins when 

the potentially creditable hazardous 

waste pharmaceuticals initially arrive at 

the pharmaceutical reverse distributor. 

The 90-day time limit follows the 

potentially creditable pharmaceutical, 

even after it becomes an evaluated 

hazardous waste pharmaceutical. That 

is, there is a single 90-day accumulation 

limit for the hazardous waste 

pharmaceutical at each pharmaceutical 

reverse distributor. However, some 

potentially creditable hazardous waste 

pharmaceuticals travel through more 

than one pharmaceutical reverse 

distributor to receive manufacturer’s 

credit. In such cases, each 

pharmaceutical reverse distributor that 

receives the potentially creditable 

hazardous waste pharmaceuticals has a 

new 90-day accumulation limit. EPA 

requests comment on the 90-day 

timeframe and whether this timeframe 

is sufficient, or whether an alternative 

timeframe should be allowed. 

As discussed previously, EPA is 

proposing that a pharmaceutical reverse 

distributor must inventory potentially 

creditable hazardous waste 

pharmaceuticals upon arrival. Many 

pharmaceutical reverse distributors 

utilize barcoding and scanners to log 

potentially creditable pharmaceuticals 

into a database upon arrival or soon 

after a shipment arrives. Current 

inventory systems may be adapted to 

provide verification of the time limits. 

For example, if a pharmaceutical reverse 

distributor includes the date of arrival 

in the inventory, then the 

pharmaceutical reverse distributor will 

be able to use the inventory to verify 

that potentially creditable hazardous 

waste pharmaceuticals and evaluated 

hazardous waste pharmaceuticals are 

not accumulated on-site for more than 

90 calendar days. EPA is not proposing 

a specific method that pharmaceutical 

reverse distributors must use to 

document that accumulation does not 

exceed 90 calendar days. We anticipate 

that most pharmaceutical reverse 

distributors would use the inventory 

system to verify the 90-calendar day 

timeframe rather than using an 

additional requirement of labeling 

containers with dates for verification, 

but we request comment on this issue. 

We also request comment on whether 

EPA needs to specify a method of 

documenting that 90 calendar days is 

not exceeded. 

Pharmaceutical reverse distributors 

have informed EPA that there are times 

when pharmaceutical returns may need 

to be consolidated for longer periods 

because they are subject to litigation and 

the pharmaceutical reverse distributor is 

not allowed to move them. 

Pharmaceutical reverse distributors may 

also need to handle large recalls of 

hazardous waste pharmaceuticals and 

might not be able to process all of the 

returned items within 90 calendar days. 

Therefore, EPA is proposing to allow a 

pharmaceutical reverse distributor to 

request from EPA an extension of the 

90-day accumulation time limit for 

situations when the hazardous waste 

pharmaceuticals are involved in 

litigation, a recall, or in unforeseen 

circumstances beyond the control of the 

pharmaceutical reverse distributor. A 

pharmaceutical reverse distributor 


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seeking an extension must submit a 

written request to the EPA Regional 

Administrator (in writing or 

electronically), explaining the reason for 

the extension, the approximate volume 

or weight of the hazardous waste 

pharmaceuticals that will be stored for 

more than 90-days and the amount of 

additional time requested. Under the 

existing RCRA subtitle C regulations, 

the extension of time typically allowed 

is limited to an extra 30 days for LQGs. 

However, due to the complex nature of 

pharmaceutical litigation and recalls, 

EPA is proposing to allow the EPA 

Regional Administrator to grant a time 

extension at their discretion on a caseby-case basis. EPA requests comment on 

whether it is necessary to place a limit 

on the length of time for which an 

extension may be granted. 

v. Contingency plan and emergency 

procedures. The Agency is proposing to 

require that pharmaceutical reverse 

distributors meet standards that are the 

same as those that appear in the federal 

LQG regulations for developing a 

contingency plan and emergency 

procedures at 40 CFR part 265, subpart 

D. EPA believes that a pharmaceutical 

reverse distributor should be prepared 

to respond to potential emergencies just 

like LQGs and TSDFs. Since many 

pharmaceutical reverse distributors are 

already LQGs, they should already have 

contingency plans to address the 

hazards on-site. It may be possible that 

the pharmaceutical reverse distributors 

will have to amend their contingency 

plans to include the potentially 

creditable hazardous waste 

pharmaceuticals, which have been 

considered products, not hazardous 

waste, but we believe that such 

modifications should not impose much 

burden. 

vi. Closure. Due to the generally low 

risk of release of the hazardous waste 

pharmaceuticals that pharmaceutical 

reverse distributors will accumulate onsite, as well as the value of the 

hazardous waste pharmaceuticals, EPA 

is proposing to require a performancebased closure standard that is based on 

the federal LQG closure standard found 

at § 265.111. Specifically, when a 

pharmaceutical reverse distributor 

closes its operations related to 

hazardous waste pharmaceuticals, it 

must control or minimize post-closure 

releases of hazardous waste constituents 

into the environment. This will entail 

removing the containers of hazardous 

waste pharmaceuticals (both potentially 

creditable hazardous waste 

pharmaceuticals as well as evaluated 

hazardous waste pharmaceuticals) from 

the facility before closure. 

vii. Reporting. In some instances, a 

pharmaceutical reverse distributor may 

receive a shipment from a healthcare 

facility that includes items that are not 

potentially creditable pharmaceuticals. 

These shipments can include wastes 

that are clearly not eligible to receive 

credit, such as patient care waste (e.g., 

IV tubing), contaminated personal 

protective equipment (PPE), medical 

waste, or other inappropriate wastes. 

Pharmaceutical reverse distributors are 

not the appropriate waste management 

facility for medical or infectious wastes 

and these wastes must be managed and 

transported from the healthcare facility 

directly to an appropriate waste 

disposal facility. In some cases, these 

non-creditable wastes may be hazardous 

waste. These non-creditable hazardous 

wastes are prohibited from being 

transported from a healthcare facility to 

a pharmaceutical reverse distributor; 

rather they should be manifested to a 

designated facility, such as a permitted 

or interim status TSDF. Nevertheless, a 

healthcare facility might incorrectly 

ship non-creditable hazardous wastes to 

a pharmaceutical reverse distributor. 

EPA is proposing that if a 

pharmaceutical reverse distributor 

receives a shipment from a healthcare 

facility that includes hazardous waste 

that it is not authorized to receive, such 

as non-creditable hazardous waste or 

hazardous waste that is not a 

pharmaceutical, the pharmaceutical 

reverse distributor must submit an 

unauthorized waste report to the EPA 

Regional Administrator within 15 days 

of receiving the hazardous waste. We 

have adapted the existing requirement 

for situations when permitted and 

interim status TSDFs receive 

unmanifested hazardous waste (§ 264.76 

and § 265.76, respectively) to make it 

appropriate for pharmaceutical reverse 

distributors that receive unauthorized 

hazardous waste. However, we are also 

proposing two additional requirements 

for pharmaceutical reverse distributors 

that receive inappropriate hazardous 

waste. First, the pharmaceutical reverse 

distributor must send a copy of the 

unauthorized hazardous waste report to 

the healthcare facility that sent the 

unauthorized hazardous waste. This 

requirement is intended to alert the 

healthcare facility of its mistake in order 

to prevent further shipments of noncreditable hazardous waste or nonpharmaceutical hazardous waste. 

Second, the pharmaceutical reverse 

distributor must manage the 

unauthorized hazardous waste that it 

receives in accordance with all 

applicable regulations. The Agency 

expects that the pharmaceutical reverse 

distributor will likely pass these 

additional costs (e.g., medical waste 

incineration) on to the healthcare 

facility for the management of the 

hazardous waste and this will act as an 

incentive for the healthcare facility to 

take measures to prevent further 

shipments of unauthorized hazardous 

waste. We request comment on whether 

EPA’s understanding regarding this type 

of situation is representative. 

In order to prevent exposing 

employees to unnecessary risk, EPA 

recommends as a best management 

practice that pharmaceutical reverse 

distributors avoid sorting through 

shipments that contain non-creditable 

waste since the shipment may include 

hazardous waste, including infectious or 

radioactive healthcare waste. As a 

result, it is possible that a 

pharmaceutical reverse distributor 

receiving a shipment that includes noncreditable waste may be unsure whether 

the shipment includes hazardous waste. 

In such cases, EPA recommends that the 

pharmaceutical reverse distributor 

assume the shipment includes 

hazardous waste and submit an 

unauthorized waste report. Further, we 

recommend that pharmaceutical reverse 

distributors work with their clients to 

reduce the occurrence of inappropriate 

shipments. 

viii. Recordkeeping. EPA is proposing 

three recordkeeping requirements to 

provide transparency for the movement 

of potentially creditable hazardous 

waste pharmaceuticals and as a means 

of verification upon inspection. First, a 

pharmaceutical reverse distributor must 

keep a copy of its notification (EPA form 

8700–12) to EPA to indicate that it is a 

pharmaceutical reverse distributor 

operating under 40 CFR part 266, 

subpart P. A pharmaceutical reverse 

distributor must keep the record of 

notification for as long as it is subject to 

these requirements. Second, a 

pharmaceutical reverse distributor must 

keep copies of the records associated 

with shipments of potentially creditable 

hazardous waste pharmaceuticals that it 

receives. This includes a copy of the 

advance notification from the healthcare 

facility or other pharmaceutical reverse 

distributor, a copy of delivery 

confirmation, shipping papers and any 

unauthorized waste reports. We propose 

that these shipping records must be kept 

for three years from the date the 

pharmaceutical reverse distributor 

receives the shipment. We request 

comment on whether additional 

recordkeeping is necessary to document 

cases when shipments of potentially 

creditable hazardous waste 

pharmaceuticals do not reach their 

intended destination within 7 calendar 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58064 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

147A healthcare facility or pharmaceutical reverse 

distributor also has the option of sending its 

hazardous waste pharmaceuticals to a RCRA 

permitted or interim status TSDF. 

days. Third, a pharmaceutical reverse 

distributor must keep a copy of its 

current inventory at all times as long as 

the pharmaceutical reverse distributor 

remains in operation. The inventory is 

a living document that will constantly 

be updated and must be available for 

inspection. Finally, we propose that 

periods of record retention indicated 

previously for a pharmaceutical reverse 

distributor will be automatically 

extended during an enforcement action, 

or as requested by the EPA Regional 

Administrator to ensure that the 

appropriate records are available and 

can be reviewed as part of any 

enforcement action. 

Note that additional recordkeeping 

requirements may also pertain to 

pharmaceutical reverse distributors. For 

example, a pharmaceutical reverse 

distributor that manifests its nonpharmaceutical hazardous waste is 

subject to the manifest recordkeeping 

requirements of § 262.40. Further, as 

discussed in subsequent sections, there 

are additional recordkeeping 

requirements that apply to 

pharmaceutical reverse distributors for 

the management of potentially 

creditable hazardous waste 

pharmaceuticals destined for another 

pharmaceutical reverse distributor and 

others that apply to pharmaceutical 

reverse distributors for the management 

of evaluated hazardous waste 

pharmaceuticals. 

ix. Evaluating potentially creditable 

hazardous waste pharmaceuticals 

within 21 days. Based on stakeholder 

input and site visits, EPA has learned 

that when a pharmaceutical reverse 

distributor receives a shipment of 

potentially creditable hazardous waste 

pharmaceuticals, the reverse distributor 

sorts through the shipment and often 

uses barcodes to scan items into its 

system. The pharmaceutical reverse 

distributor then determines which 

potentially creditable hazardous waste 

pharmaceuticals must be transported to 

another reverse distributor and which 

ones will be credited and then sent offsite for treatment and disposal. EPA is 

proposing that this evaluation process 

must be completed within 21 days of 

arriving at the pharmaceutical reverse 

distributor. Likewise, if the 

pharmaceutical reverse distributor is a 

manufacturer, EPA is proposing that the 

manufacturer must finish verifying the 

appropriate credit within 21 calendar 

days of receiving the shipment of 

potentially creditable hazardous waste 

pharmaceuticals. 

EPA has chosen to propose 21 

calendar days to ensure that the 

pharmaceutical reverse distributor has a 

long enough of time to make the 

evaluation, yet a short enough time to 

ensure that potentially creditable 

hazardous waste pharmaceuticals do not 

linger awaiting evaluation. The Agency 

requests comment on this timeframe 

and whether it should be shortened or 

lengthened. We also want to emphasize 

that the 21 calendar days for evaluating 

the potentially creditable hazardous 

pharmaceuticals counts as part of the 

total 90 calendar days that the 

hazardous waste pharmaceuticals are 

allowed to accumulate on-site. 

Once an evaluation is made on the 

incoming potentially creditable 

hazardous waste pharmaceuticals, if 

they are destined for another 

pharmaceutical reverse distributor, they 

are still considered potentially 

creditable hazardous waste 

pharmaceuticals. There are additional 

regulations in this proposal at 

§ 266.510(b) that pertain to these 

potentially creditable hazardous waste 

pharmaceuticals (discussed in Section 

V.G.3.b.). If, however, they are destined 

for an interim status or permitted TSDF, 

they are considered ‘‘evaluated 

hazardous waste pharmaceuticals.’’ 

There are additional regulations in this 

proposal at § 266.510(c) that pertain to 

these evaluated hazardous waste 

pharmaceuticals (discussed in Section 

V.G.3.c.). 

b. Additional Standards for 

Pharmaceutical Reverse Distributors 

Managing Potentially Creditable 

Hazardous Waste Pharmaceuticals 

Destined for Another Pharmaceutical 

Reverse Distributor 

This section discusses the additional 

standards that apply to a 

pharmaceutical reverse distributor for 

the management of potentially 

creditable hazardous waste 

pharmaceuticals that require further 

evaluation or verification of 

manufacturer’s credit at another 

pharmaceutical reverse distributor. 

These hazardous waste pharmaceuticals 

continue to be considered potentially 

creditable hazardous waste 

pharmaceuticals. Until manufacturer’s 

credit is finalized, the potentially 

creditable hazardous waste 

pharmaceuticals retain their value and 

there is greater incentive to manage 

them carefully in order to receive full 

manufacturer’s credit. Therefore, EPA is 

proposing few regulatory standards for 

the management of the potentially 

creditable hazardous waste 

pharmaceuticals that are destined for 

another pharmaceutical reverse 

distributor. 

i. Where potentially creditable 

hazardous waste pharmaceuticals can 

be sent. The proposed regulations for 

pharmaceutical reverse distributors are 

structured so that there is a limit to the 

number of transfers of potentially 

creditable hazardous waste 

pharmaceuticals that may occur before 

they are ultimately transported to a 

TSDF for treatment and disposal. 

Stakeholders expressed concern that the 

2008 Pharmaceutical Universal Waste 

proposal would have allowed hazardous 

waste pharmaceuticals to be shipped 

repeatedly and indefinitely from one 

universal waste handler to another. 

From discussions with pharmaceutical 

reverse distributors and reviewing 

information submitted via EPA’s request 

for information, the Agency believes a 

reasonable limit is three transfers of 

potentially creditable hazardous waste 

pharmaceuticals before the 

pharmaceutical hazardous waste is 

ultimately transported to a TSDF. The 

three possible types of transfers are: 147

(1) a healthcare facility may send 

potentially creditable hazardous waste 

pharmaceuticals to a pharmaceutical 

reverse distributor, which may or may 

not be a manufacturer; 

(2) the first pharmaceutical reverse 

distributor may send the potentially 

creditable hazardous waste to another 

pharmaceutical reverse distributor, 

which may or may not be a 

manufacturer 

(3) the second pharmaceutical reverse 

distributor can only send the potentially 

creditable hazardous waste 

pharmaceuticals on to a pharmaceutical 

reverse distributor that is a 

manufacturer. 

EPA anticipates that healthcare 

facilities that are CESQGs will send 

their potentially creditable hazardous 

waste pharmaceuticals directly to 

pharmaceutical reverse distributors, and 

that the accumulation mechanism that 

we are proposing will be used to send 

only non-creditable hazardous waste 

pharmaceuticals to off-site healthcare 

facilities (see Section V.C.15.). However, 

EPA requests comment on whether 

CESQG healthcare facilities would 

benefit from being able to consolidate 

potentially creditable hazardous waste 

pharmaceuticals off-site, as well. 

Depending on comments, EPA will 

consider allowing a fourth transfer (for 

this limited situation) when potentially 

creditable hazardous waste 

pharmaceuticals are sent from a CESQG 

healthcare facility to an off-site 

healthcare facility for accumulation, as 

would also be allowed by proposed 

§ 266.504(a). 


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This chain of transfers ensures that 

the potentially creditable hazardous 

waste pharmaceuticals will be 

accumulated for no more than 270 days 

in total after leaving a healthcare facility 

and before being transported to a RCRApermitted or interim status TSDF for 

treatment and disposal (assuming no 

accumulation time extensions are 

granted). EPA requests comment as to 

whether the three-transfer and 90-day 

limits are appropriate and whether more 

or fewer transfers are necessary for 

verification of manufacturer’s credit. 

Put another way, if a pharmaceutical 

reverse distributor receives potentially 

creditable hazardous waste 

pharmaceuticals from a healthcare 

facility, the pharmaceutical reverse 

distributor must send those potentially 

creditable hazardous waste 

pharmaceuticals to another 

pharmaceutical reverse distributor 

(which may or may not be a 

manufacturer) or must manage them as 

evaluated hazardous waste 

pharmaceuticals under proposed 

§ 266.510(c). However, a pharmaceutical 

reverse distributor that receives 

potentially creditable hazardous waste 

pharmaceuticals from another 

pharmaceutical reverse distributor is 

more limited in where it can send the 

potentially creditable hazardous waste 

pharmaceuticals. It can send potentially 

creditable hazardous waste 

pharmaceuticals to a pharmaceutical 

reverse distributor that is the 

manufacturer or else must manage them 

as evaluated hazardous waste 

pharmaceuticals under § 266.510(c). 

Regardless of the destination, each 

pharmaceutical reverse distributor must 

make an evaluation of the hazardous 

waste pharmaceuticals within 21 

calendar days and may only accumulate 

the hazardous waste pharmaceuticals 

on-site for a maximum of 90 calendar 

days, unless an extension is granted by 

the Regional Administrator before it 

ships them off-site to another 

pharmaceutical reverse distributor or a 

RCRA-permitted or interim status TSDF. 

In addition, all shipments of evaluated 

hazardous waste pharmaceuticals are 

subject to proposed § 266.508 and 

shipments of all potentially creditable 

hazardous waste pharmaceuticals are 

subject to proposed § 266.509. 

ii. Recordkeeping for pharmaceutical 

reverse distributors shipping of 

potentially creditable hazardous waste 

pharmaceuticals to another 

pharmaceutical reverse distributor. 

Pharmaceutical reverse distributors 

must keep records (paper or electronic) 

for each shipment of potentially 

creditable hazardous waste 

pharmaceuticals that it initiates to 

another pharmaceutical reverse 

distributor (whether it is a manufacturer 

or not). This includes a copy of the 

advance notification provided to the 

other pharmaceutical reverse 

distributor, a copy of delivery 

confirmation, as well as shipping papers 

or bill of lading. We propose that these 

shipping records must be kept for 3 

years from the date it initiates the 

shipment. 

c. Additional Standards for 

Pharmaceutical Reverse Distributors 

Managing Evaluated Hazardous Waste 

Pharmaceuticals 

This section discusses the additional 

standards that apply to a 

pharmaceutical reverse distributor for 

the management of evaluated hazardous 

waste pharmaceuticals (i.e., a hazardous 

waste pharmaceutical that was a 

potentially creditable hazardous waste 

pharmaceutical but has been evaluated 

by a pharmaceutical reverse distributor 

to establish whether it is eligible for 

manufacturer’s credit and will not be 

sent to another pharmaceutical reverse 

distributor for further evaluation or 

verification). Evaluated hazardous waste 

pharmaceuticals have been through the 

entire crediting process. In order to 

minimize the potential for their 

mismanagement, EPA believes it is 

necessary to have additional standards 

for the evaluated hazardous waste 

pharmaceuticals. 

i. Accumulation area. As discussed 

previously, EPA is proposing that a 

pharmaceutical reverse distributor must 

complete its evaluation of a potentially 

creditable hazardous waste 

pharmaceuticals within 21 calendar 

days of arriving at the pharmaceutical 

reverse distributor. Once the evaluation 

has been completed and the 

pharmaceutical reverse distributor 

knows that it is destined for treatment 

and disposal at a RCRA-permitted or 

interim status TSDF, rather than another 

pharmaceutical reverse distributor, the 

pharmaceutical is considered an 

evaluated hazardous waste 

pharmaceutical. Under the proposal, a 

pharmaceutical reverse distributor must 

establish an on-site accumulation area 

where it will accumulate these 

evaluated hazardous waste 

pharmaceuticals. An on-site 

accumulation area is needed so that the 

evaluated hazardous waste 

pharmaceuticals are segregated and 

clearly distinguished from the 

potentially creditable hazardous waste 

pharmaceuticals. 

ii. Weekly inspections. EPA is 

proposing that the accumulation area for 

evaluated hazardous waste 

pharmaceuticals must be inspected at 

least weekly to ensure containers are not 

leaking and that diversion of the 

hazardous waste pharmaceuticals is not 

occurring. Under the recordkeeping 

requirements for pharmaceutical reverse 

distributors, we are proposing that a 

pharmaceutical reverse distributor must 

keep a log of the weekly inspections of 

the on-site accumulation area and that 

the log must be retained for at least 

three years from the date of inspection. 

The log is necessary to validate the 

weekly inspections. 

iii. Personnel training. EPA is 

proposing to require that 

pharmaceutical reverse distributors 

meet the same federal classroom or onthe-job personnel training requirements 

that LQGs must meet (§ 265.16). 

However, we specify in this proposal 

that the personnel that need to be 

trained are those persons who handle 

the evaluated hazardous waste 

pharmaceuticals in the on-site 

accumulation area. EPA believes that 

these personnel are the individuals 

handling and managing the hazardous 

waste pharmaceuticals and must have 

appropriate hazardous waste training. 

The Agency requests comment on 

whether the training standards are 

appropriate for the specific reverse 

distributor personnel. 

iv. Labeling and management of 

containers in on-site accumulation area. 

EPA is proposing container labeling 

similar to what was proposed under the 

2008 pharmaceutical universal waste 

proposed rule. While containers of 

hazardous waste pharmaceuticals are in 

the accumulation area, they must be 

marked with the words, ‘‘Hazardous 

Waste Pharmaceuticals.’’ We are 

proposing this term in order to 

distinguish them from the nonhazardous waste pharmaceuticals and 

from the hazardous waste 

pharmaceuticals that are still considered 

potentially creditable. We are not 

proposing to require an accumulation 

start date on the label for the containers, 

because the reverse distributor’s 

inventory will likely be used to verify 

the accumulation start date. However, a 

pharmaceutical reverse distributor may 

choose an alternate method, such as 

marking the date on each container as 

it arrives, to ensure that the hazardous 

waste pharmaceuticals are not 

accumulated at the pharmaceutical 

reverse distributor for more than 90 

days, provided an extension is not 

granted. As explained previously, EPA 

prefers to allow a performance-based 

standard that allows flexibility to verify 

the 90-day accumulation time rather 

than require dating on the container 

labels, but we request comment 

regarding this requirement and whether 


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58066 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

it is necessary to specify a method for 

how a pharmaceutical reverse 

distributor must verify that the 90-day 

maximum accumulation time is not 

exceeded. 

In terms of container management 

standards, the Agency is proposing 

requirements that are similar to the 

container management standards for 

LQGs—that is, the standards in 40 CFR 

part 265, but the Agency is also 

proposing to include some additional 

management requirements specific to 

hazardous waste pharmaceuticals. 

Specifically, under 40 CFR 

262.34(a)(1)(i), LQGs must comply with 

the container management standards in 

40 CFR part 265, subpart I, which 

includes a requirement that containers 

of hazardous waste must be kept closed, 

except when adding or removing waste. 

In this document, EPA is proposing to 

require that only containers with 

hazardous waste pharmaceuticals that 

are liquids or gels be kept closed during 

accumulation due to the low potential 

for release for those hazardous waste 

pharmaceuticals that are in a solid form. 

However, because most potentially 

creditable hazardous waste 

pharmaceuticals are in their original 

packaging, if the original packaging for 

gels or liquids is intact and sealed or the 

pharmaceuticals have been repackaged 

(e.g., for unit dosing) and the 

repackaged packaging for gels and 

liquids is intact and sealed, they are 

considered to meet the closed container 

standard. EPA requests comment on 

whether additional forms of hazardous 

waste pharmaceuticals (other than 

liquids and gels) need to be specified in 

the regulations and subject to the closed 

container requirement. 

EPA is also proposing that containers 

of hazardous waste pharmaceuticals 

must be maintained in good condition 

to prevent leaks and the container 

material must be compatible with the 

hazardous waste pharmaceuticals 

placed in the container. In addition, we 

are proposing to require that a 

pharmaceutical reverse distributor that 

manages ignitable or reactive evaluated 

hazardous waste pharmaceuticals or 

that mixes or comingles incompatible 

evaluated hazardous waste 

pharmaceuticals must manage the 

container to prevent dangerous 

situations, such as fire, explosion, or 

release of toxic fumes. 

Similar to healthcare facilities that 

accumulate non-creditable hazardous 

waste pharmaceuticals, pharmaceutical 

reverse distributors that accumulate 

evaluated hazardous waste 

pharmaceuticals must segregate the 

pharmaceuticals that are prohibited 

from being combusted because of the 

dilution prohibition of § 268.3(c) and 

accumulate them in separate containers 

from other evaluated hazardous waste 

pharmaceuticals. 

There are also several existing LQG 

accumulation unit management 

standards in § 262.34(a) that EPA 

believes are not necessary to include for 

the management of evaluated hazardous 

waste pharmaceuticals. For instance, 

this proposal only sets standards for the 

accumulation of evaluated hazardous 

waste pharmaceuticals in containers. 

EPA does not think it is necessary to 

include accumulation units such as 

tanks, containment buildings, or drip 

pads because pharmaceutical reverse 

distributors do not currently use these 

types of accumulation units. However, if 

EPA is mistaken in this understanding 

and commenters indicate they would 

like to be able to use tanks, containment 

buildings, or drip pads, EPA would 

consider including in this proposal the 

LQG standards for accumulation in 

these units. The Agency solicits 

comment on this matter. 

In addition, the Agency is not 

proposing to require pharmaceutical 

reverse distributors to meet the air 

emission standards found in 40 CFR 

part 265, subpart CC as required in 

§ 262.34(a)(1)(i) because we anticipate 

that they will not be applicable. 

Specifically, § 265.1083(c) exempts 

tanks, surface impoundments, and 

containers from the organic air emission 

standards if the hazardous waste 

entering the accumulation unit has an 

average volatile organic concentration of 

less than 500 parts per million by 

weight, while § 265.1080(b)(2) exempts 

containers with a capacity of less than 

0.1 m3 (26 gallons) from the standards. 

EPA understands that the only 

evaluated hazardous waste 

pharmaceuticals that have the potential 

for air emissions are liquids and gels, 

but they generally do not contain 

volatile organics. Thus, they do not 

release organic air emissions, which is 

what the 40 CFR part 265, subpart CC, 

air emission standards for tanks, surface 

impoundments, and containers were 

promulgated to control. Moreover, 

because hazardous waste 

pharmaceuticals are often in their 

original packaging, and we are 

proposing to require that liquid and gel 

hazardous waste pharmaceuticals must 

be in intact, sealed packaging or 

otherwise in closed containers, EPA 

believes that the container air emission 

standards are unnecessary. In addition, 

the Agency anticipates that the 

packaging and containers for hazardous 

waste pharmaceuticals will often have a 

capacity less than 0.1 m3 (26 gallons) 

further limiting the applicability of the 

container air emission standards. 

Similarly, EPA does not anticipate 

that the 40 CFR part 265, subpart AA— 

air emissions standards for process 

vents—and subpart BB—air emission 

standards for equipment leaks—are 

applicable to the activities of a 

pharmaceutical reverse distributor and 

its management of hazardous waste 

pharmaceuticals. Therefore, like 40 CFR 

part 265, subpart CC discussed 

previously, EPA is not proposing to 

require that 40 CFR part 265, subparts 

AA and BB apply to pharmaceutical 

reverse distributors. EPA requests 

comments on whether its current 

understanding is correct and whether 

the 40 CFR part 265, subparts AA, BB, 

and CC RCRA air emission standards 

should be applied to pharmaceutical 

reverse distributors. 

v. Hazardous waste numbers (codes). 

EPA is proposing to require that the 

containers of evaluated hazardous waste 

pharmaceuticals be labeled with the 

appropriate RCRA hazardous waste 

numbers. The hazardous waste numbers 

may be placed on the container label at 

any time during on-site accumulation, 

but they must be added prior to when 

the evaluated hazardous waste 

pharmaceuticals are transported off-site. 

The hazardous waste numbers must be 

marked on the container label in order 

to ensure that it is readily visible and 

cannot be separated from the hazardous 

waste. The hazardous waste numbers 

are necessary so that transporters, 

transfer facilities, and TSDFs to know 

how to properly transport, consolidate, 

treat, store and dispose of the hazardous 

waste in compliance with the applicable 

RCRA regulations. We are not requiring 

that the pharmaceutical reverse 

distributor be the party that adds the 

hazardous waste numbers to the 

containers. The proposed regulations 

allow a vendor to perform this duty on 

behalf of the pharmaceutical reverse 

distributor. In practice, however, if a 

vendor is responsible for assigning 

hazardous waste numbers, personnel 

from the pharmaceutical reverse 

distributor may need to assist in the 

process. 

vi. Shipping evaluated hazardous 

waste pharmaceuticals. Although it is 

already stated in § 266.508(a) under the 

section of the regulations that pertains 

to shipping standards, for clarity, we 

propose to repeat in § 266.510 (the 

pharmaceutical reverse distributor 

section of the regulations) the 

requirement that pharmaceutical reverse 

distributors that ship evaluated 

hazardous waste pharmaceuticals offsite must do so in accordance with the 

proposed shipping requirements in 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58067 

§ 266.508(a). This includes the 

applicable DOT packaging, marking and 

labeling requirements, as well as the 

requirement to utilize the hazardous 

waste manifest when shipping the 

evaluated hazardous waste to a 

designated facility. 

vii. Rejected shipments. The Agency 

is proposing to require in § 266.510(c)(7) 

that pharmaceutical reverse distributors 

meet the same procedures as LQGs must 

meet for rejected shipments in 

§ 262.42(c). If a designated permitted or 

interim status TSDF identified on the 

hazardous waste manifest cannot accept 

a shipment of evaluated hazardous 

waste pharmaceuticals from a 

pharmaceutical reverse distributor and 

the TSDF returns the shipment to the 

pharmaceutical reverse distributor, the 

pharmaceutical reverse distributor must 

sign the applicable item on the manifest. 

In addition, the pharmaceutical reverse 

distributor may consolidate the rejected 

hazardous waste pharmaceuticals onsite for up to 90 days provided they are 

managed in the on-site accumulation 

area and in accordance with this 

proposal’s pharmaceutical reverse 

distributor standards for evaluated 

hazardous waste pharmaceuticals. The 

reporting requirements associated with 

rejected shipments are discussed 

separately under the reporting section. 

viii. Land disposal restrictions. EPA is 

proposing in § 266.510(c)(8) that 

pharmaceutical reverse distributors are 

subject to the same land disposal 

restrictions (LDRs) that apply to LQGs 

with respect to their evaluated 

hazardous waste pharmaceuticals. In 

addition, EPA is proposing to amend the 

testing, tracking, and recordkeeping 

requirements for generators, treaters and 

disposal facilities at § 268.7 to add the 

words, ‘‘pharmaceutical reverse 

distributors’’ to the title of that section 

to make the applicability of the 

treatment standards clear. 

ix. Reporting by a pharmaceutical 

reverse distributor for evaluated 

hazardous waste pharmaceuticals. 

(1) Biennial report. EPA is proposing 

that pharmaceutical reverse distributors 

submit a BR for the evaluated hazardous 

waste pharmaceuticals that are 

transported to a TSDF in order for the 

Agency to have as complete a picture of 

the amount of hazardous waste 

generated, treated, stored, or disposed of 

annually. However, the BR should only 

include the evaluated hazardous waste 

pharmaceuticals, and not the potentially 

creditable hazardous waste 

pharmaceuticals that a pharmaceutical 

reverse distributor sends to another 

pharmaceutical reverse distributor. 

Specifically, we are proposing in 

§ 266.510(c)(9)(i) that a pharmaceutical 

reverse distributor comply with the LQG 

BR requirements in § 262.41, except for 

§ 262.41(a)(7), which includes the 

requirement to report changes in 

volume and toxicity of waste achieved 

during the year in comparison to 

previous years. The reason we are not 

requiring the pharmaceutical reverse 

distributor to provide such information 

is that they do not have control of the 

volume or toxicity of the hazardous 

waste pharmaceuticals it receives from 

the healthcare facility, and thus have no 

ability to reduce the volume or toxicity 

of the hazardous waste pharmaceuticals. 

Thus, EPA is not requiring the 

pharmaceutical reverse distributor to 

report this information in its BR. 

(2) Exception reporting. For the 

reasons that EPA requires exception 

reporting generally—that is, to maintain 

the cradle to grave tracking system, EPA 

is proposing in § 266.510(c)(9)(ii)(A) 

that pharmaceutical reverse distributors 

provide an exception report when a 

TSDF does not return the hazardous 

waste manifest to the pharmaceutical 

reverse distributor for shipments of 

hazardous waste pharmaceuticals to a 

designated facility. Likewise, we are 

proposing in § 266.510(c)(9)(ii)(B) that 

pharmaceutical reverse distributors 

meet LQG exception reporting when a 

shipment from a pharmaceutical reverse 

distributor is rejected by the designated 

facility and forwarded onto an alternate 

facility. 

x. Recordkeeping by a pharmaceutical 

reverse distributor for evaluated 

hazardous waste pharmaceuticals. 

Many of the proposed recordkeeping 

requirements that pertain to evaluated 

hazardous waste pharmaceuticals have 

been discussed in the sections 

previously, but for clarity, it is useful to 

restate them in this recordkeeping 

section, so that pharmaceutical reverse 

distributors can refer to one section to 

determine their recordkeeping 

requirements related to evaluated 

hazardous waste pharmaceuticals. In 

particular, we are proposing five 

recordkeeping requirements that pertain 

to evaluated hazardous waste 

pharmaceuticals at pharmaceutical 

reverse distributors. First, EPA is 

proposing that a pharmaceutical reverse 

distributor keeps a log (written or 

electronic) of its weekly inspections of 

the on-site accumulation area. The other 

four recordkeeping requirements that 

we are proposing in § 266.510(c)(10) for 

pharmaceutical reverse distributors are 

the same as the LQG recordkeeping 

requirements that appear in §§ 262.40– 

42 and § 265.16; these include 

hazardous waste manifest records, 

records of biennial reports, exception 

reporting and training documentation. 

EPA believes that these recordkeeping 

requirements are appropriate for 

pharmaceutical reverse distributors, 

many of whom are currently LQGs, but 

requests comment on this requirement. 

EPA asks commenters to review the 

standards EPA is proposing for 

pharmaceutical reverse distributors and 

provide specific comment on whether 

the standards are appropriate and 

sufficient to protect human health and 

the environment. 

d. When a Pharmaceutical Reverse 

Distributor Must Have a RCRA 

Hazardous Waste Permit 

EPA is proposing to not require that 

a pharmaceutical reverse distributor 

have a RCRA permit or interim status 

for accumulating potentially creditable 

and evaluated hazardous waste 

pharmaceuticals, provided that the 

pharmaceutical reverse distributor 

follows all the conditions of the 

permitting exemption in § 266.510. In 

other words, a pharmaceutical reverse 

distributor would be subject to 

regulation as a TSDF and require a 

RCRA permit (or interim status) if it 

does not meet the conditions of 

§ 266.510. In addition, a pharmaceutical 

reverse distributor must have a RCRA 

permit (or interim status) if it treats or 

disposes of hazardous waste on-site or 

if it accepts manifested hazardous waste 

from off-site. A pharmaceutical reverse 

distributor is required to reject 

shipments of manifested hazardous 

waste that it may inadvertently receive 

from off-site because a pharmaceutical 

reverse distributor is not a designated 

facility and therefore is not eligible to 

receive hazardous waste via a manifest. 

EPA believes that this approach to 

regulation of pharmaceutical reverse 

distributors that accumulate hazardous 

waste pharmaceuticals strikes an 

appropriate balance because it 

recognizes that pharmaceutical reverse 

distributors are different from typical 

hazardous waste TSDFs for permitting 

purposes, while it still imposes certain 

conditions for exemption from 

permitting requirements that provide 

the necessary environmental protection. 

VI. Implementation and Enforcement 

A. Healthcare Facilities 

1. Determining Whether a Healthcare 

Facility is Subject to Part 266, 

Subpart P 

EPA is proposing that healthcare 

facilities that are currently considered 

LQGs or SQGs are subject to the new 40 

CFR part 266, subpart P requirements 

for the management of hazardous waste 

pharmaceuticals. Thus, a healthcare 

facility that generates (or accumulates) 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58068 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

148EPA is examining the reverse logistics of nonpharmaceutical hazardous wastes as part of its 

analysis of comments received on the Retail Notice 

of Data Availability that was published on February 

14, 2014 (79 FR 8926). 

more than 100 kg hazardous waste per 

calendar month, or more than 1 kg of 

acute hazardous waste per calendar 

month, or more than 100 kg of any 

residue or contaminated soil, waste, or 

other debris resulting from the clean-up 

of a spill, into or on any land or water, 

of any acute hazardous wastes listed in 

§§ 261.31, or 261.33(e), must manage its 

hazardous waste pharmaceuticals in 

compliance with the 40 CFR part 266, 

subpart P requirements. In addition, 

healthcare facilities that are CESQGs are 

subject to the prohibition on sewering 

hazardous waste pharmaceuticals in 

§ 266.5052. 

To determine whether a healthcare 

facility is a subject to 40 CFR part 266, 

subpart P, or a CESQG regulated under 

§ 261.5, a healthcare facility must count 

all the hazardous waste— 

pharmaceutical and nonpharmaceutical—it generates in a 

calendar month. In counting the amount 

of hazardous waste generated per 

calendar month, we note that EPA is 

proposing to change which 

pharmaceuticals will be considered 

hazardous wastes (i.e., potentially 

creditable hazardous waste 

pharmaceuticals). Specifically, EPA is 

proposing that potentially creditable 

hazardous waste pharmaceuticals 

transported to a pharmaceutical reverse 

distributor will be considered solid 

waste from the point of generation at the 

healthcare facility and therefore must be 

counted when determining whether the 

healthcare facility is a CESQG regulated 

under § 261.5, or whether it is regulated 

under 40 CFR part 266, subpart P. This 

differs from current practice where, 

although a healthcare facility must 

count the non-creditable hazardous 

waste pharmaceuticals it generates each 

calendar month toward its hazardous 

waste generator category, it does not 

count the potentially creditable 

hazardous waste pharmaceuticals it 

sends to a pharmaceutical reverse 

distributor. Therefore, although a 

healthcare facility currently may be 

considered a CESQG, when it begins 

counting its potentially creditable 

hazardous waste pharmaceuticals, it 

may no longer be a CESQG. In that case, 

the healthcare facility would be subject 

to the 40 CFR part 266, subpart P 

requirements. 

2. Healthcare Facilities Managing 

Hazardous Waste Pharmaceuticals 

Under Part 266, Subpart P 

EPA is proposing that all healthcare 

facilities, with the exception of CESQGs, 

will be subject to the same regulations 

for the management of their hazardous 

waste pharmaceuticals, regardless of the 

quantity of hazardous waste 

pharmaceuticals generated. A healthcare 

facility that generates both 

pharmaceutical and non-pharmaceutical 

hazardous waste must manage the nonpharmaceutical hazardous waste 

pursuant to part 262, but need not count 

its hazardous waste pharmaceuticals 

toward the facility’s monthly hazardous 

waste generator category. In addition, if 

a healthcare facility does not want to 

keep track of the amount of hazardous 

waste it generates to ensure it does not 

exceed the CESQG quantity limits, it 

could choose to operate under this 

proposed rule. If it chooses to operate 

under this proposed rule, however, a 

healthcare facility must comply with all 

the requirements of this subpart for the 

management of its hazardous waste 

pharmaceuticals. 

B. Pharmaceutical Reverse Distributors 

1. Pharmaceuticals Sent to 

Pharmaceutical Reverse Distributors Are 

Solid Wastes 

One difference between this proposal 

and the 2008 Pharmaceutical Universal 

Waste proposal is how RCRA would 

apply to pharmaceuticals returned to 

pharmaceutical reverse distributors to 

obtain manufacturer’s credit. EPA is 

proposing to change its existing position 

on this issue. If this rule is finalized, 

this change would mean that the 

decision by a healthcare facility to send 

a pharmaceutical to a pharmaceutical 

reverse distributor is the decision to 

discard the pharmaceutical. Therefore, 

under this proposed rule, once the 

healthcare facility makes the decision to 

send a pharmaceutical to a 

pharmaceutical reverse distributor for 

credit, it is a solid waste at the 

healthcare facility. It is likely that a 

portion of the potentially creditable 

solid waste pharmaceuticals at 

healthcare facilities that are destined for 

a pharmaceutical reverse distributor 

will also meet the definition of 

hazardous waste and as a result, these 

potentially creditable hazardous waste 

pharmaceuticals would need to be 

managed in accordance with the 

standards proposed in this document. 

However, until this rule is final and 

effective, EPA’s current position will 

remain in effect. 

In addition, the Agency notes that the 

proposed change in EPA’s position 

concerning reverse distribution and the 

management standards discussed in this 

document pertain only to the reverse 

distribution of hazardous waste 

pharmaceuticals and does not apply to 

reverse distribution or reverse logistics 

systems that may exist for other 

consumer products. This limitation is 

because EPA has studied and collected 

data for reverse distribution systems for 

hazardous waste pharmaceuticals, and 

not all consumer products.148

2. Pharmaceutical Reverse Distributors 

Managing Hazardous Waste 

Pharmaceuticals Under Part 266, 

Subpart P 

Under this proposal, all 

pharmaceutical reverse distributors are 

subject to 40 CFR part 266, subpart P 

and will be subject to the same 

standards with respect to their 

hazardous waste pharmaceuticals, 

regardless of the amount of hazardous 

waste pharmaceuticals they manage. 

Even pharmaceutical reverse 

distributors that are currently CESQGs 

will be regulated under 40 CFR part 266, 

subpart P for the management of their 

hazardous waste pharmaceuticals. 

Therefore, as with healthcare facilities, 

a pharmaceutical reverse distributor 

subject to 40 CFR part 266, subpart P 

will no longer have to keep track of the 

amount of hazardous waste 

pharmaceuticals that it generates on a 

monthly basis. 

C. Healthcare Facilities and 

Pharmaceutical Reverse Distributors 

Managing Non-Pharmaceutical 

Hazardous Waste in Accordance With 

40 CFR Part 262 or Part 273 

Most, if not all, healthcare facilities 

and pharmaceutical reverse distributors 

generate hazardous wastes other than 

pharmaceuticals. These, nonpharmaceutical hazardous wastes will 

continue to be regulated under 40 CFR 

part 262 (and other applicable Subtitle 

C regulations). However, because a 

healthcare facility or pharmaceutical 

reverse distributor operating under 40 

CFR part 266, subpart P no longer has 

to count its hazardous waste 

pharmaceuticals, including acute 

hazardous waste pharmaceuticals such 

as warfarin, it could result in a change 

in the facility’s overall generator 

category and thus change how its nonpharmaceutical hazardous waste must 

be managed. For example, the generator 

category for a healthcare facility or 

pharmaceutical reverse distributor may 

be reduced from an LQG to an SQG or 

even a CESQG, when it stops counting 

its hazardous waste pharmaceuticals, 

especially acute hazardous waste 

pharmaceuticals, toward its generator 

category. 

If finalized, the standards established 

by this rulemaking apply only to the 

management of hazardous waste 


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Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58069 

149http://www.calepa.ca.gov/enforcement/orders/

2012/CVSStipFinal.pdf and http://

www.calepa.ca.gov/enforcement/orders/2012/

CostcoFinal.pdf or see the docket for this 

rulemaking EPA–HQ–RCRA–2007–0932. 

150http://www.ct.gov/deep/lib/deep/enforcement/

consentorder/COWSWDH13005.pdf. or see the 

docket for this rulemaking EPA–HQ–RCRA–2007– 

0932. 

151See the interim enforcement policy in the 

docket for this rulemaking (EPA–HQ–RCRA–2007– 

0932) or see it online at https://fortress.wa.gov/ecy/ 

publications/documents/0704024.pdf. 

152See the guidance document in the docket for 

this rulemaking (EPA–HQ–RCRA–2007–0932) or 

see it online at http://www.pca.state.mn.us/

index.php/view-document.html?gid=4004. 

pharmaceuticals at healthcare facilities 

and pharmaceutical reverse distributors. 

Healthcare facilities and pharmaceutical 

reverse distributors likely generate or 

manage other types of wastes. For 

example, hospitals may generate nonpharmaceutical hazardous wastes, such 

as solvents in their diagnostic 

laboratories; those hazardous wastes 

must still be managed in accordance 

with the RCRA Subtitle C requirements 

(such as the RCRA satellite 

accumulation regulations (§ 262.34(c)), 

or if it is a teaching hospital, the 

Academic Laboratories Rule (if it has 

opted into part 262, subpart K). Retail 

pharmacies in retail stores and grocery 

stores may have non-pharmaceutical 

hazardous wastes on-site as well, which 

must be managed in accordance with 

the 40 CFR part 262 requirements and 

all other applicable RCRA Subtitle C 

regulations. For example, fluorescent 

bulbs may be managed under the 

universal waste program (40 CFR part 

273). For pharmaceutical reverse 

distributors, this proposed rule only 

applies to the management of 

potentially creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals. Some 

pharmaceutical reverse distributors may 

generate other non-pharmaceutical 

hazardous wastes from activities, such 

as cleaning and maintenance; other 

RCRA requirements will apply to those 

non-pharmaceutical hazardous wastes. 

D. State Enforcement Activities and 

Interpretations 

States have taken a variety of 

approaches regarding pharmaceutical 

hazardous wastes. One major goal of 

this proposed rule is to provide clarity 

on this topic, and thereby promote 

national consistency, which, in turn, 

should promote better compliance 

among healthcare facilities, including 

pharmacies. 

California has taken numerous 

enforcement actions against national 

retail chains with pharmacies for not 

complying with the RCRA hazardous 

waste regulations. In recent years, the 

state took enforcement actions and 

imposed fines on the following chains: 

Kmart (2009), Walmart (2010), Target 

(2011), CVS (2012), Costco (2012), 

Walgreens (2012) and Rite-Aid (2013). 

In at least two settlement agreements, 

California directed the defendants (CVS 

and Costco) to ‘‘initiate work with 

appropriate stakeholders from business 

and government, including the U.S. 

Environmental Protection Agency, the 

U.S. Food and Drug Administration, and 

the DTSC [Department of Toxic 

Substances Control], and thereafter 

either directly or through trade 

associations or informal coalitions of 

interested parties, undertake to promote 

federal regulatory reform regarding the 

proper management of nondispensable 

pharmaceuticals, including over-thecounter medications, through ‘‘reverse 

distribution.’’ 149 Through these 

settlement agreements, California is 

seeking clarity from EPA about its 

longstanding interpretation about the 

regulatory status of pharmaceuticals that 

are routed through pharmaceutical 

reverse distribution systems. 

In 2012, Connecticut’s Department of 

Energy and Environmental Protection 

(DEEP) took enforcement actions at 

seven CVS stores for violations of the 

RCRA hazardous waste regulations. 

Consent orders from Connecticut DEEP 

direct CVS stores in the state to follow 

a set of best management practices.150 A 

number of the practices developed in 

these consent orders mirror some of the 

practices we are proposing in this rule, 

particularly with regard to 

pharmaceuticals destined for a 

pharmaceutical reverse distributor. 

Connecticut DEEP asserts RCRA 

jurisdiction over the pharmaceuticals 

destined for pharmaceutical reverse 

distributors by applying specific 

practices to their management. For 

example, CVS must maintain records of 

each shipment of non-dispensable 

pharmaceuticals to a pharmaceutical 

reverse distributor, including 

confirmation of receipt of the nondispensable pharmaceuticals from the 

pharmaceutical reverse distributor 

receiving them. The best practices also 

include procedures for addressing 

situations when CVS does not receive 

delivery confirmation of shipment to a 

pharmaceutical reverse distributor. 

Further, the consent order sets out 

separate, more comprehensive practices 

for the non-dispensable pharmaceuticals 

that are not suitable for pharmaceutical 

reverse distribution. 

Aside from best management 

practices developed by Connecticut as 

part of a consent order, at least two 

other states have developed guidance 

documents that apply conditions to the 

management of hazardous wastes 

pharmaceuticals in exchange for 

enforcement discretion. In particular, in 

2008, the Washington State Department 

of Ecology issued guidance titled, 

Interim Enforcement Policy: 

Pharmaceutical Waste in Healthcare.151

Like Connecticut’s consent orders with 

CVS, this enforcement discretion policy 

has some elements in common with this 

proposed rule for hazardous waste 

pharmaceuticals. For instance, a 

healthcare facility must notify the 

Department of Ecology that it is 

operating under the policy and must 

train its staff involved in 

pharmaceutical waste management. 

Only a time limit, rather than a quantity 

limit, applies to the accumulation of the 

hazardous waste pharmaceuticals onsite. Of particular note is that 

Washington State prohibits disposing of 

most hazardous waste pharmaceuticals 

down the toilet or drain. 

In 2011, Minnesota’s Pollution 

Control Agency (MPCA) issued a fact 

sheet titled Reverse Distribution of 

Pharmaceuticals: Guidance for 

Minnesota Healthcare Providers.152 In 

this guidance, Minnesota states, 

‘‘Whether a pharmaceutical is eligible 

for return credit does not affect its 

product or waste status. In Minnesota, if 

a pharmaceutical is not used or reused 

for its intended purpose, it is a waste. 

The MPCA considers health care 

practitioners and pharmacies to be 

generators of these pharmaceutical 

wastes. Nevertheless, the MPCA 

believes that the established reverse 

distribution system provides an 

environmentally protective method for 

handling waste pharmaceuticals. 

Therefore, it will allow Minnesota 

health care practitioners and 

pharmacies to manage certain 

pharmaceuticals through reverse 

distribution, subject to additional 

requirements discussed in this fact 

sheet.’’ This is similar to the approach 

that EPA is proposing for potentially 

creditable hazardous waste 

pharmaceuticals. For example, like 

EPA’s proposed rule, MPCA does not 

require hazardous waste 

pharmaceuticals destined for a 

pharmaceutical reverse distributor to be 

counted toward determining a 

healthcare facility’s generator category, 

and MPCA does not require hazardous 

waste pharmaceuticals to be 

accompanied by a hazardous waste 

manifest when shipped to a 

pharmaceutical reverse distributor. By 

adopting a rule that is consistent with 

state approaches, EPA is bringing 

national consistency to the management 


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153May 19, 1980 Federal Register (45 FR 33084) 

and November 25, 1980 Federal Register (45 FR 

78525). 

154See NIOSH’s Preventing Occupational 

Exposures to Antineoplastic and Other Hazardous 

Drugs in Healthcare Settings (http://www.cdc.gov/

niosh/docs/2004-165/) and OSHA Technical 

Manual Section VI: Chapter 2—Controlling 

Occupational Exposure to Hazardous Drugs 

(https://www.osha.gov/dts/osta/otm/otm_vi/otm_

vi_2.html). Note that the ‘‘hazardous’’ classification 

used by NIOSH and OSHA is not the same as the 

definition of hazardous under the RCRA subtitle C 

regulations. 

155 § 261.11(a)(2) states ‘‘The Administrator shall 

list a solid waste as a hazardous waste only upon 

determining that the solid waste . . . has been 

found to be fatal to humans in low doses or, in the 

absence of data on human toxicity, it has been 

shown in studies to have an oral LD 50 toxicity (rat) 

of less than 50 milligrams per kilogram, an 

inhalation LC 50 toxicity (rat) of less than 2 

milligrams per liter, or a dermal LD 50 toxicity 

(rabbit) of less than 200 milligrams per kilogram or 

is otherwise capable of causing or significantly 

contributing to an increase in serious irreversible, 

or incapacitating reversible, illness. (Waste listed in 

accordance with these criteria will be designated 

Acute Hazardous Waste.)’’ 

156The Agency cannot list hazardous wastes 

under section § 261.11(a)(3) based on inherent 

toxicity alone without considering exposure factors, 

particularly the likelihood of mismanagement. That 

is, EPA needs to examine each of the 10 factors and, 

to the extent it does not use one or more of them, 

must explain why they are irrelevant or 

unimportant. See Dithiocarbamate Task Force v. 

EPA (No. 95–1249). 

157EPA emphasizes that this finding reflects the 

manner in which EPA defines acute hazardous 

waste under the RCRA subtitle C program; the 

NIOSH/OSHA lists are based upon different criteria 

related to preventing occupational exposure to 

these drugs. 

of hazardous waste pharmaceuticals, 

while avoiding disruption to practices 

already in place. 

VII. Request for Comment on EPA’s 

Efforts To Identify Additional 

Pharmaceutical Hazardous Wastes 

Some of the comments EPA received 

in response to the 2008 Universal Waste 

proposal recommended that EPA add 

additional pharmaceutical wastes to the 

P and U hazardous waste lists (see 

§ 261.33). Some commenters suggested 

that EPA assess the hazards from all 

discarded pharmaceuticals (especially 

chemotherapy drugs) that have come 

into the market since the promulgation 

of the original P and U hazardous waste 

lists 153 and that EPA update these lists 

to include discarded pharmaceuticals 

that are hazardous. In response to these 

comments, the Agency began gathering 

and reviewing information related to 

pharmaceuticals that may exhibit 

hazardous properties. EPA identified 

204 drugs, which include 172 drugs that 

the National Institute for Occupational 

Safety and Health (NIOSH) and the 

Occupational Safety and Health 

Administration (OSHA) identified as 

hazardous, and 32 drugs that NIOSH 

proposed for addition to its hazardous 

drug list.154 EPA also collected toxicity 

data and other information for these 204 

drugs. These findings, along with 

additional information regarding the 

management of pharmaceutical wastes, 

are presented in the final report entitled 

Data Collection on the Toxicity, Use, 

and Disposal of Hazardous Drugs 

Report (September 2011) placed in the 

docket for this proposed rulemaking 

(EPA–HQ–RCRA–2007–0932). 

Commenters specifically referred to 

EPA’s P and U hazardous waste lists 

under the RCRA subtitle C regulations. 

Generally, in its hazardous waste 

determinations, EPA has evaluated both 

‘‘production wastes’’ (from specific or 

non-specific sources; see §§ 261.31 and 

261.32) and ‘‘commercial chemical 

products’’ that, when discarded, become 

wastes (§ 261.33). This latter category 

(commercial chemical products that are 

discarded) is the most relevant of the 

listed hazardous wastes to the 

pharmaceuticals wastes discussed 

elsewhere in this preamble, and to 

which commenters referred in the 2008 

Universal Waste proposal. As discussed 

in Section IV.A.of this preamble, 

commercial chemical products listed in 

§ 261.33 are (when discarded) defined 

as either P-listed ‘‘acute’’ hazardous 

wastes, or U-listed (non-acute) 

hazardous wastes. The criteria for listing 

a solid waste as hazardous under RCRA 

Subtitle C are described in § 261.11. A 

waste may be identified as a P-listed 

waste if it is shown to be fatal to 

humans or animals at low doses (see 

§ 261.11(a)(2)). Thus, lethality data for 

any chemical is the principal factor for 

making a determination that a discarded 

commercial chemical product is a Plisted hazardous waste.155

In contrast, a waste may be identified 

as a U-listed waste if it contains any of 

the toxic constituents listed in 

Appendix VIII of 40 CFR part 261, and 

if, after examining each of 10 factors in 

§ 261.11(a)(3), it is determined that the 

waste is capable of posing a ‘‘substantial 

present or potential hazard to human 

health or the environment when 

improperly treated, stored, transported, 

or disposed of, or otherwise 

managed.’’ 156 Examples of these 10 

factors include the toxicity and 

concentration of the hazardous 

constituent in the waste, the plausible 

types of improper management to which 

the waste could be subjected, the 

quantities of the waste generated at 

individual generation sites or on a 

regional or national basis, the nature 

and severity of the human health and 

environmental damage that has 

occurred as a result of the improper 

management of wastes, and action taken 

by other governmental agencies or 

regulatory programs based on the health 

or environmental hazard posed by the 

waste or waste constituent. EPA may 

only revise either of these lists of 

commercial chemical products through 

notice-and-comment rulemaking. 

In its September 2011 report, EPA 

found that 11 drugs on the NIOSH or 

OSHA lists of hazardous drugs meet the 

specific criteria for acute toxicity in 

§ 261.11(a)(2) (identified as ‘‘Tier 1’’ 

drugs in the report). An additional 114 

drugs on the NIOSH or OSHA lists did 

not meet the specific criteria in 

§ 261.11(a)(2) for acute toxicity, but did 

have lethal doses for other animals or 

humans (‘‘Tier 2’’ drugs). The remaining 

79 drugs had limited human or animal 

toxicity data, and no lethality data, and 

were designated ‘‘Tier 3’’ in the report. 

Thus, the vast majority of the NIOSH/ 

OSHA hazardous drugs evaluated in the 

EPA 2011 report do not meet the criteria 

for listing as acute hazardous waste 

under RCRA subtitle C.157 As discussed 

previously, to include a drug on the Ulist, the Agency must demonstrate that 

a discarded drug would be ‘‘capable of 

posing a substantial present or potential 

hazard to human health or the 

environment when improperly treated, 

stored, transported, or disposed of, or 

otherwise managed.’’ Therefore, for the 

NIOSH/OSHA drugs that do not meet 

the listing criteria for inclusion on the 

P-list, the Agency would have to 

examine the 10 factors in § 261.11(a)(3) 

to determine whether a drug meets the 

criteria to be included on the U-list. In 

addition to toxicity data (which is 

lacking in particular for the drugs 

identified as Tier 3), the types of 

information that would be relevant 

include waste volumes, plausible 

management scenarios, exposure 

potential, damage cases, and actions 

taken by other governmental agencies or 

regulatory programs. To obtain this 

information for this class of materials 

poses a challenge. While EPA has some 

information—the September 2011 report 

includes summaries of drug 

management practices and references to 

others—there remain significant gaps. 

In addition, as discussed in Section 

IV.D. of this preamble, the EPA’s OIG 

has recommended that EPA identify and 

review existing pharmaceuticals to 

determine whether they qualify for 

regulation as hazardous waste, and 

establish a process to review new 

pharmaceuticals to determine whether 

they qualify for regulation as hazardous 

waste. While EPA has an existing 

process generally for defining whether 

or not a solid waste is a listed hazardous 


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158EPA’s policy statement on hazardous waste 

listing determinations is contained in the Federal 

Register preamble to the first proposed Dyes and 

Pigments Listing Determination (59 FR 66072, 

December 22, 1994). 

159See EPA’s listing Background Document for 

Section 261.33, April 1981, in the docket for this 

proposed rule (EPA–HQ–RCRA–2007–0932). 

waste (i.e., EPA has regulatory criteria 

for defining listed hazardous waste 

described previously; EPA has 

established policies for evaluating risk 

and other factors in making listing 

determinations; 158 and EPA must use 

the notice-and-comment rulemaking 

process when proposing listing 

determinations), the OIG observed that 

EPA’s hazardous waste program has not 

kept pace with the large number of 

pharmaceuticals that have been 

developed since 1980. EPA plans to 

regularly review the NIOSH/OSHA lists 

of hazardous drugs, as they represent a 

source of valuable information on 

pharmaceuticals that have already been 

identified as having the possibility of 

posing risks that might warrant 

regulation as hazardous waste. 

EPA is also exploring ways to identify 

new sources of information, along with 

alternative approaches that can most 

efficiently address these concerns. EPA 

is using the opportunity in this 

preamble to seek stakeholders’ input on 

the best course of action concerning 

regulation of additional pharmaceuticals 

as hazardous wastes. It is also an 

opportunity for stakeholders to provide 

additional information that they may 

have about potentially hazardous 

pharmaceuticals. Thus, before deciding 

on a possible proposal to list additional 

pharmaceuticals as hazardous wastes, 

we request comment on the September 

2011 final report, and solicit 

information regarding additional 

potentially hazardous pharmaceuticals. 

We request information on the sources 

and identity of additional potentially 

hazardous pharmaceuticals along with 

annual product generation data, annual 

waste generation data, use information, 

toxicity data, waste storage and 

handling information, and disposal 

information. 

In addition, we request stakeholder 

input for alternative approaches to 

making hazardous waste listing 

determinations for pharmaceuticals that 

do not meet the acute hazardous 

criteria. Based on the existing listing 

determination process described 

previously for non-acute wastes, there is 

no single toxicity effect (e.g., LD50) to 

readily determine whether or not the 

waste is hazardous under RCRA subtitle 

C. As such, we are seeking ideas on 

alternative approaches to more 

efficiently evaluate potentially 

hazardous non-acute discarded 

pharmaceuticals. For example, should 

EPA develop and promulgate new 

criteria specific to discarded 

pharmaceuticals that would allow it to 

establish a single hazardous waste 

listing for all discarded pharmaceuticals 

that meet the new criteria? Such 

approaches could also include 

consideration of whether discarded 

pharmaceuticals are already managed 

under a regulatory scheme that prevents 

mismanagement that a hazardous waste 

designation would otherwise address 

(similar to the hazardous waste listing 

factor that takes into account ‘‘actions 

taken by other governmental agencies or 

regulatory programs’’). We also are 

seeking information on any innovative 

processes or programs that states may 

have for identifying, reviewing, and 

making a hazardous waste 

determination for discarded 

pharmaceuticals. 

The Agency emphasizes that no 

regulatory action is being proposed with 

respect to expanding the number of 

pharmaceuticals that are considered 

hazardous waste. We will use the 

comments we receive to help inform 

how to proceed with evaluating 

discarded pharmaceuticals as listed or 

characteristic hazardous wastes. Any 

action taken would be part of a separate, 

proposed rulemaking in the future. 

VIII. Request for Comment on EPA’s 

Efforts To Amend the Acute Hazardous 

Waste Listing for Nicotine and Salts 

(Hazardous Waste No. P075) 

A. Background 

In 1980, as part of its final and interim 

final regulations implementing Section 

3001 of RCRA, EPA promulgated the list 

of commercial chemical products or 

manufacturing chemical intermediates 

(40 CFR 261.33) that are hazardous 

wastes if they are discarded or intended 

to be discarded, which included 

nicotine and salts (45 FR 33124; May 19, 

1980). The phrase ‘‘commercial 

chemical product or manufacturing 

chemical intermediate’’ refers to a 

‘‘chemical substance which is 

manufactured or formulated for 

commercial or manufacturing use which 

consists of the commercially pure grade 

of the chemical, any technical grades of 

the chemical that are produced or 

marketed, and all formulations in which 

the chemical is the sole active 

ingredient’’ (see the Comment following 

40 CFR 261.33(d)). A chemical 

substance is listed in 40 CFR 261.33(e) 

as an acutely hazardous waste if it meets 

any of the criteria in 40 CFR 

261.11(a)(2), which states that the waste 

‘‘has been found to be fatal to humans 

in low doses or, in the absence of data 

on human toxicity, it has been shown in 

studies to have an oral LD 50 toxicity 

(rat) of less than 50 milligrams per 

kilogram, an inhalation LC 50 toxicity 

(rat) of less than 2 milligrams per liter, 

or a dermal LD 50 toxicity (rabbit) of 

less than 200 milligrams per kilogram or 

is otherwise capable of causing or 

significantly contributing to an increase 

in serious irreversible, or incapacitating 

reversible, illness.’’ 

B. Basis for Original Listing 

EPA listed nicotine and salts (referred 

to commonly as just nicotine) as acutely 

hazardous waste (P075) in § 261.33(e) 

based on an estimated oral LD50 

toxicity to humans of 1 mg/kg and a 

dermal LD50 toxicity to rabbits of 50 

mg/kg.159 As discussed previously, for 

humans, the standard in the regulations 

for acute toxicity is ‘‘fatal to humans in 

low doses’’ (see § 261.11(a)(2)). EPA’s 

Background Document for Section 

261.33 from 1981 provides a basis for 

what is meant by ‘‘fatal to humans in 

low doses’’ for chemicals that have been 

given through the oral route (‘‘fatal to 

humans upon ingestion of ≤100 mg/

kg’’). The estimated oral LD50 to 

humans of 1 mg/kg falls within the 

criteria for ‘‘fatal to humans in low 

doses.’’ However, the background listing 

document and its references do not 

provide sufficient detail to determine 

the concentration of nicotine that was 

used to establish the estimated oral 

LD50 in humans. 

C. Rationale for EPA’s Efforts To Amend 

the P075 Listing 

On February 14, 2014, EPA published 

a Notice of Data Availability (NODA) 

and Request for Comment (79 FR 8926) 

entitled ‘‘Hazardous Waste Management 

and the Retail Sector: Providing and 

Seeking Information on Practices to 

Enhance Effectiveness to the RCRA 

Program.’’ EPA received 44 comments 

in response to this NODA, many of 

which included comments related to 

pharmaceuticals, in particular 

comments concerning expired or 

returned low-concentration nicotinecontaining smoking cessation products 

and e-cigarettes. The most detailed 

comments concerning the unsold lowconcentration nicotine products were 

jointly submitted by the Retail Industry 

Leaders Association (RILA), the Food 

Marketing Institute (FMI), the National 

Association of Chain Drug Stores 

(NACDS), the National Retail 

Federation, and their members (referred 

to as the retail associations, retailers, or 


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160See comments by the retail associations in 

response to EPA’s Retail NODA in the docket for 

the Retail NODA (EPA–HQ–RCRA–2012–0426– 

0019). 

161See memo from Dellinger to Smith, dated 

August 23, 2010, RCRA Online # 14817 regarding 

unused patches, gums and lozenges http://

yosemite.epa.gov/osw/rcra.nsf/

0c994248c239947e85256d090071175f/

209444BADDA4ECDC852577ED00624E8F/$file/

14817.pdf. 

162See memo from Johnson to DeWitt, May 8, 

2015, regarding e-cigarettes, RCRA Online # 17850. 

commenters).160 In their comments, the 

retail associations, representing a broad 

range of retailers within the retail 

industry, asked EPA to undertake a 

rulemaking to remove lowconcentration nicotine products from 

the acute hazardous waste P075 

classification under RCRA. The retailers 

believe these products do not meet 

RCRA’s requirements for acute 

hazardous waste. Thus, according to the 

retailers, the acute hazardous 

classification is inappropriately making 

them subject to RCRA’s LQG 

requirements, which become applicable 

when someone generates more than 1 

kg/month of acute hazardous waste. The 

retailers also expressed concern that 

they are subject to increased economic 

burdens and reporting requirements 

because they are subject to RCRA’s LQG 

requirements. 

The commenters, to support their 

request to EPA, state that EPA’s listing 

for nicotine and salts warrants a 

reevaluation, because in more recent 

literature concerning nicotine toxicity, 

doubts have been expressed about the 

estimated oral LD50 toxicity to humans 

of 1 mg/kg, used as a key basis for the 

listing. According to information 

provided by commenters, the estimated 

oral LD50 toxicity to humans of 1 mg/ 

kg was based on extrapolations from 

toxicological effects observed as result 

of ‘‘self-experiments’’ performed with 

nonfatal doses of nicotine. However, 

according to the commenters, there are 

doubts about the 1 mg/kg estimate 

because people have survived after 

ingesting much larger amounts of 

nicotine. 

The commenters also state that in 

1980, when EPA listed nicotine and 

salts as acute hazardous wastes, the 

nicotine products in the market 

contained a high concentration of the 

chemical (e.g., pesticides which 

contained 40 percent nicotine sulfate), 

but that these products are no longer on 

the market. The commenters stressed 

that the current nicotine products on the 

market are low-concentration nicotine 

products that do not meet the regulatory 

criteria for acutely hazardous wastes. 

The low-concentration nicotinecontaining products that are currently 

on the market were identified by 

commenters as nicotine replacement 

therapy products (e.g., gums, lozenges, 

patches, inhalers, and nasal sprays) and 

e-cigarettes. These products, according 

to the commenters, generally contain 

less than 3 percent nicotine. 

While it may be reasonable for the 

commenters to conclude that toxicity is 

higher at higher concentrations of a 

chemical and lower at lower 

concentrations of a chemical, EPA 

currently lacks sufficient information to 

conclude that low-concentration 

nicotine-containing products are not 

acutely toxic as defined under 40 CFR 

261.11(a)(2). In addition, except for 

warfarin and zinc phosphide, the 

listings for commercial chemical 

products under 40 CFR 261.33(e) are not 

concentration-based listings. The 

warfarin and zinc phosphide listings 

were changed to concentration-based 

listings because companies using 

products containing lower 

concentration formulations of warfarin 

and zinc phosphide petitioned EPA to 

amend the listings and provided LD50 

data for animals for the lower 

concentration products to support their 

petition (see 49 FR 19922; May 10, 

1984). The Agency does not think that 

linear extrapolations from toxicity levels 

determined using higher-concentration 

nicotine products can be used to 

characterize the acute toxicity of lowconcentration nicotine-containing 

products. Furthermore, although 

nicotine pesticides are no longer 

available, high concentration nicotine 

products still exist. For example, 

manufacturers of nicotine-containing 

products, such as e-cigarettes, buy 

concentrated nicotine solutions and 

dilute them for consumer use. 

In summary, nicotine and salts are 

P075 listed acute hazardous wastes if 

the waste arises from the discard of an 

unused commercial chemical product, 

manufacturing chemical intermediate, 

or off-specification material. 

Additionally, the P075 waste code 

applies only if the nicotine is present in 

pure or technical grade form, or is the 

sole active ingredient in the chemical 

formulation when discarded. As such, 

unused (unsold, expired, or returned) 

nicotine-containing products, including 

patches, gums, lozenges,161 inhalers, 

nasal sprays and e-cigarettes,162 are 

classified as P075 listed acute hazardous 

wastes when discarded. When 

discarded, these unsold products are 

causing many retailers to notify and 

operate as LQGs, which has resulted in 

increased economic burdens and 

reporting requirements for retailers. EPA 

is aware that this is an issue of great 

concern to the retail associations and 

their members and would like to 

address the issue, if possible, by 

amending the P075 listing to 

conditionally exempt certain lowconcentration nicotine-containing 

products. The Agency is considering 

two possible approaches, described 

below, for amending the P075 listing. 

D. Two Possible Approaches for 

Amending the P075 Listing 

1. Exemption from P075 Listing for 

FDA-Approved Over-the-Counter 

Nicotine-Containing Smoking Cessation 

Products 

The over-the-counter (OTC) nicotinecontaining smoking cessation products, 

referred to also as nicotine replacement 

therapy (NRT) products (i.e., nicotine 

patches, gums, and lozenges) are 

approved by the Food and Drug 

Administration (FDA), which ensures 

that the risk to the public using these 

products have been evaluated. EPA is 

currently trying to obtain the risk 

evaluation data for these products from 

FDA, which may provide data on the 

exact concentration of nicotine in the 

NRT products and any animal and/or 

human toxicity data associated with use 

of these products. The Agency is also 

trying to gather any publicly available 

animal and/or human toxicity data for 

these products, in particular toxicity 

data that could be compared to EPA’s 

acute toxicity criteria under 

§ 261.11(a)(2). If the Agency is 

successful in obtaining the toxicity data 

to support the conclusion that FDAapproved over-the-counter nicotinecontaining smoking cessation products 

do not meet the criteria for listing as an 

acutely hazardous waste, then the 

Agency will propose to exempt these 

products from the P075 listing. 

Since e-cigarettes have not been 

approved by the FDA as smoking 

cessation products, we do not anticipate 

being able to obtain animal or human 

toxicity data from the FDA on nicotine 

concentrations in e-cigarettes. To 

complicate matters, the concentration of 

nicotine in e-cigarettes is not limited by 

any regulation or approval process and 

is therefore unpredictable. As a result, 

this option would likely be limited to 

excluding FDA-approved over-thecounter nicotine-containing smoking 

cessation products from the P075 listing 

and would not include e-cigarettes. 

2. Concentration-Based Exemption From 

P075 Listing for Low-Concentration 

Nicotine-Containing Products 

The comments from the retail 

associations have stressed that the low 


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163EPA notes that decisions regarding whether a 

state rule is more stringent or broader in scope than 

the federal program are made when the Agency 

authorizes state programs. 

concentration nicotine products 

currently in the market (generally 

containing less than 3 percent nicotine) 

should not be classified as acutely 

hazardous wastes under RCRA. 

However, they did not submit any 

human toxicological data or animal 

LD50 data for these products to 

demonstrate that these products are not 

acutely toxic as defined under 

§ 261.11(a)(2). Without these data, it is 

difficult for the Agency to justify 

exempting these products from the P075 

listing. Furthermore, in order for the 

Agency to consider a concentrationbased exemption for low-concentration 

nicotine-containing products from the 

P075 listing, the Agency needs human 

toxicological data and animal LD50 data 

for nicotine-containing products at 

maximum concentrations of nicotine in 

these products (e.g., 3 percent nicotine). 

If the toxicological data for nicotinecontaining products at maximum 

concentrations of nicotine in these 

products show that these products are 

not acutely toxic as defined under 

§ 261.11(a)(2), then the Agency could 

propose a concentration-based 

exemption for these products (including 

e-cigarettes) from the P075 listing. 

However, depending on the toxicity 

data, the Agency may also propose to 

list the P075 exempt nicotine-containing 

products as non-acute hazardous wastes 

(U-listed wastes) under 40 CFR 

261.33(f). In that case, the 

concentration-based exemption for 

nicotine-containing products from the 

P075 listing would be similar to what 

the Agency proposed for warfarin and 

zinc phosphide listings (see 48 FR 7714; 

February 23, 1983). 

E. Request for Comments 

EPA invites comments on all possible 

approaches to amend the acute 

hazardous waste listing for nicotine and 

salts, including the two approaches 

discussed above in Section VIII.D. We 

also request toxicity information for 

low-concentration nicotine-containing 

products that could help determine 

whether or not these products meet the 

criteria for acute hazardous wastes 

under § 261.11(a)(2). The Agency 

emphasizes that no regulatory language 

is currently being proposed with respect 

to amending the P075 listing to exempt 

the low-concentration nicotinecontaining products. However, 

depending on the information received 

during the comment period, EPA could 

finalize one of the approaches discussed 

previously without a separate proposed 

rulemaking in the future. 

In addition, we request comments on 

whether we should exempt other lowconcentration nicotine-containing 

smoking cessation products, such as 

inhalers and nasal sprays, from the P075 

listing under approach 1, described in 

the Section VIII.D, above. These 

products are also FDA-approved, but 

require a prescription to purchase. The 

nicotine-containing patches, gums, and 

lozenges are sold over-the-counter, so 

they do not require a prescription for 

purchase. We are interested in finding 

out what the differences are between 

nicotine-containing smoking cessation 

products requiring a prescription and 

those products that do not require a 

prescription (e.g., in concentrations of 

nicotine, amount of nicotine delivered 

over time, health effects). 

Finally, we request comment on 

whether we should include e-cigarettes 

and nicotine-containing e-liquids for the 

e-cigarettes within the scope of the 

definition of pharmaceutical. As 

described in this proposal, 

pharmaceutical hazardous wastes do not 

count toward generator category. 

Therefore, since e-cigarettes and 

nicotine-containing e-cigarette refill 

liquids (sometimes referred to as eliquids or e-juice) are P075, if they are 

considered pharmaceuticals, they would 

not impact the hazardous waste 

generator category of the retailers. The 

retailers, however, would have to 

manage e-cigarettes and nicotinecontaining liquids as hazardous waste 

pharmaceuticals under part 266, subpart 

P. We will use the comments we receive 

to help us decide whether and how to 

proceed with amending the scope of the 

definition of pharmaceutical to include 

e-cigarettes and nicotine-containing eliquids. 

IX. State Authorization 

A. Applicability of Rules in Authorized 

States 

Under Section 3006 of RCRA, EPA 

may authorize a qualified State to 

administer its own hazardous waste 

program within the State in lieu of the 

Federal program. Following 

authorization, EPA retains enforcement 

authority under Sections 3008, 3013, 

and 7003 of RCRA, although authorized 

States have primary enforcement 

responsibility. The standards and 

requirements for State authorization are 

found at 40 CFR part 271. 

Prior to enactment of the Hazardous 

and Solid Waste Amendments of 1984 

(HSWA), a State with final RCRA 

authorization administered its 

hazardous waste program entirely in 

lieu of EPA administering the Federal 

program in that State. The federal 

requirements no longer applied in the 

authorized State, and EPA could not 

issue permits for any facilities in that 

State, since only the State was 

authorized to issue RCRA permits. 

When new, more stringent federal 

requirements were promulgated, the 

State was obligated to enact equivalent 

authorities within specified time frames. 

However, the new federal requirements 

did not take effect in an authorized State 

until the State adopted the federal 

requirement as State law. 

In contrast, under RCRA Section 

3006(g) (42 U.S.C. 6926(g)), which was 

added by HSWA, new requirements and 

prohibitions imposed under HSWA 

authority take effect in authorized States 

at the same time that they take effect in 

unauthorized States. The statute directs 

EPA to implement these requirements 

and prohibitions in authorized States, 

including the issuance of permits, until 

the State is granted authorization to do 

so. While the State must still adopt 

HSWA related provisions as State law in 

order to retain final authorization, EPA 

implements the HSWA provisions in 

authorized States until the States do so. 

Authorized States are required to 

modify their program only when EPA 

enacts federal requirements that are 

more stringent or broader in scope than 

the existing federal requirements. RCRA 

Section 3009 allows the States to 

impose standards more stringent than 

those in the federal program (see also 

§ 271.1).163 Therefore, authorized States 

may, but are not required to, adopt 

federal regulations, both HSWA and 

non-HSWA, that are considered less 

stringent than previous federal 

regulations. 

B. Effect on State Authorization 

This action proposes to add a new 

subpart P to 40 CFR part 266, and it is 

being proposed in part under the 

authority of HSWA and in part under 

non-HSWA authority. The bulk of 40 

CFR part 266, subpart P is being 

proposed under non-HSWA authority. 

Thus, when finalized, the amendments 

promulgated under non-HSWA 

authority would be applicable on the 

effective date only in those states that 

do not have final authorization of their 

base RCRA programs. However, the 

prohibition of sewering pharmaceutical 

hazardous wastes (§ 266.504) is being 

proposed under HSWA authority in 

section 3018 of RCRA. Thus, when 

finalized, the amendments promulgated 

under the authority of HSWA would be 

applicable on the effective date of the 

final rule in all states. Moreover, 

authorized states are required to modify 


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their programs only when EPA 

promulgates federal regulations that are 

more stringent or broader in scope than 

the authorized state regulations. This 

proposed rule is considered, on the 

whole, to be more stringent than the 

current federal standards. Therefore, 

authorized states will be required to 

modify their programs to adopt the 

amendments, when finalized. When a 

state adopts this new subpart, if 

elements of the state program are more 

stringent than this new subpart, the 

state has the option of retaining those 

more stringent elements. Likewise, 

when a state adopts this new subpart, 

the state has the option of adding 

elements that are more stringent or 

broader in scope than this new subpart. 

C. Effect on State Authorization in 

States That Have Added 

Pharmaceuticals to the Universal Waste 

Program 

The Universal Waste program allows 

states to add wastestreams to their own 

state program, even when the waste 

stream has not been added to the federal 

Universal Waste program, provided the 

state has adopted and been authorized 

for the petition process in §§ 260.20 and 

260.23. Two states have added 

hazardous waste pharmaceuticals to 

their Universal Waste programs: Florida 

and Michigan. Because this proposed 

rule is considered more stringent than 

either the ‘‘traditional RCRA’’ standards 

or the Universal Waste program, both 

Florida and Michigan will be required 

to modify their programs to adopt an 

approach at least as stringent as the 

amendments, if this rule is finalized. 

Furthermore, because the Agency has 

determined that it is not appropriate to 

add hazardous waste pharmaceuticals to 

the Universal Waste program, both 

Florida and Michigan must remove 

hazardous waste pharmaceuticals from 

their Universal Waste program when 

they adopt this new subpart, although 

they may continue to regulate nonhazardous waste pharmaceuticals under 

the Universal Waste program, to the 

extent allowed under state law. In 

addition, states may not add hazardous 

waste pharmaceuticals to their 

Universal Waste program in the future. 

X. Adding and Reserving Part 266, 

Subpart O 

In addition to proposing new 

standards for the management of 

hazardous waste pharmaceuticals at 

healthcare facilities and pharmaceutical 

reverse distributors, EPA is proposing to 

add and reserve 40 CFR part 266, 

subpart O. Specifically, on May 22, 

2001, EPA finalized a Project XL rule in 

40 CFR part 266, subpart O (66 FR 

28066) for US Filter Recovery Services. 

However, on July 2, 2008, EPA 

published a rule that withdrew 40 CFR 

part 266, subpart O (73 FR 37858). 

Generally, in order to avoid the 

potential for confusion that might be 

caused by reusing a subpart, EPA 

reserves a subpart that has already been 

used and removed. In 2008, when we 

removed 40 CFR part 266, subpart O, we 

neglected to reserve it. Consequently, 

we are proposing to add and reserve 40 

CFR part 266, subpart O. 

XI. Summary of Regulatory Impact 

Analysis 

In order to meet the Office of 

Management and Budget (OMB) 

Circular A–4 requirement that EPA 

analyze the costs and benefits of 

regulations, we conducted an economic 

analysis of the proposed rule. The 

economic analysis follows OMB 

guidelines and estimates the costs and 

benefits of the rule. The economic 

analysis is titled ‘‘Regulatory Impact 

Analysis for EPA’s Proposed Healthcare 

Facility-Specific Regulations for the 

Management of Hazardous Waste 

Pharmaceuticals’’ and is hereafter 

referred to as the Regulatory Impact 

Analysis (RIA). The RIA is summarized 

here while the full RIA can be found at 

regulations.gov under docket number 

EPA–HQ–RCRA–2007–0932. 

This 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, other ambulatory 

care services, and pharmaceutical 

reverse distributors. Based on data from 

the 2007 Economic Census and a 

limited number of states, the RIA 

estimates that the rule will affect 

approximately 174,000 facilities. Table 

12 lists the number of facilities (by 

NAICS code) expected to be affected by 

the proposed rule. The vast majority of 

these (83.6%) are CESQGs, followed by 

SQGs (13.4%), and LQGs (3.0%). 


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We estimate that there is a total of 

approximately 139,000 tons of RCRA 

hazardous waste generated by 

healthcare facilities annually. 

Approximately 36,200 tons (26%) of 

this total are hazardous waste 

pharmaceuticals. 

A. Costs of the Proposed Rule 

The estimated costs of the proposed 

rule are the incremental costs over and 

above the ‘‘baseline’’ (i.e., assumptions 

about the way in which healthcare 

facilities currently dispose of their 

hazardous waste pharmaceuticals). The 

base case set of baseline assumptions 

reflects ‘‘full compliance’’ with the 

current RCRA hazardous waste 

requirements for the management of 

hazardous waste pharmaceuticals. A 

sensitivity analysis of baseline 

assumptions was also conducted that 

reflects only ‘‘partial compliance’’ with 

current regulations. To see the results 

for the partial compliance baseline 

sensitivity analysis, please see the RIA. 

The estimated cost of the proposed 

rule, including the proposed prohibition 

on sewering of hazardous waste 

pharmaceuticals is estimated at $37 

million annually under the full 

compliance baseline. However, there are 

also significant cost savings under the 

proposed rule: $24.3 million annually 

under the full compliance baseline. 

Therefore the net cost of the rule is $13 

million annually ($37million cost minus 

$24.3 million cost savings = $13 million 

net costs). Please see the RIA for more 

detailed analysis and results regarding 

the cost of the rule and the regulatory 

options analyzed. 

B. Benefits of the Proposed Rule 

The proposed rule for the 

management of hazardous waste 

pharmaceuticals is expected to yield a 

range of environmental benefits as 

hospitals, medical clinics, and other 

healthcare facilities divert hazardous 

waste pharmaceuticals currently 

disposed in sewers, municipal solid 

waste landfills (MSWLFs), municipal 

waste combustors (MWCs), and medical 

waste autoclaves and incinerators, to 

hazardous waste incinerators. The rule 

reduces the amount of hazardous waste 

pharmaceuticals sewered into 

waterways, provides regulatory clarity 

for industry and provides healthcare 

facilities and pharmaceutical reverse 

distributors with cost savings. 

The largest quantified benefit is from 

avoided sewering of hazardous waste 

pharmaceuticals. Disposal of hazardous 

waste pharmaceuticals through 

sewering is believed to be a widespread 

practice of disposal. Sewering is 

believed to be one of the most 

deleterious disposal methods because 

active pharmaceutical ingredients (APIs) 

entering surface waters, often untreated 

by municipal wastewater treatment 

plants, pose the potential for adverse 

human health and environmental effects 

since they may be absorbed by humans 

and other organisms. Under the 

proposed rule, the Agency anticipates 

preventing approximately 6,400 tons of 

hazardous waste pharmaceuticals 

annually into waterways via a sewering 

ban. While the Agency was not able to 

quantify the human health and 

environmental benefits of reducing or 

eliminating the sewering of hazardous 

waste pharmaceuticals, EPA did 

estimate the cost savings of eliminating 

the wastewater treatment costs 

associated with sewering such 

pharmaceuticals. The estimated cost 

savings of eliminated wastewater 

treatment related to the prevented 

sewering of hazardous waste 

pharmaceuticals is estimated to be $4.3 

million annually. 

The proposed rule will yield other 

benefits beyond the reduction in 

sewering of hazardous waste 

pharmaceuticals. For example, under 

the proposed rule, healthcare facilities 

will no longer be required to count 

hazardous waste pharmaceuticals 

toward their RCRA generator category. 

This, in turn, will lead to changes in a 

healthcare facility’s generator category, 


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enabling them to realize an additional 

cost savings. The extent to which such 

changes in generator category will occur 

under the proposed rule is uncertain, 

but these changes would be most likely 

for those healthcare facilities for which 

hazardous waste pharmaceuticals make 

up a large portion of their overall 

hazardous waste generation. Please see 

the RIA for a breakout of cost savings by 

regulatory requirement. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

Under Executive Order 12866 (58 FR 

51735; October 4, 1993), this action is a 

‘‘significant regulatory action’’ because 

it is likely to raise novel legal or policy 

issues under section 3(f)(4). 

Accordingly, EPA submitted this action 

to the Office of Management and Budget 

(OMB) for review under Executive 

Orders 12866 and 13563 (76 FR 3821; 

January 21, 2011) and any changes made 

in response to OMB recommendations 

have been documented in the docket for 

this action (EPA–HQ–RCRA–2007– 

0932). 

Findings for the RIA indicate that the 

rule, as proposed, is projected to result 

in an aggregate annual cost of 

approximately $37 million based on a 

discount rate of 7%. However, the 

proposed rule will also achieve an 

annual cost savings, which is estimated 

to be $24.3 million. Therefore, the net 

cost of the rule is estimated at $13 

million annually. The costs, which 

represents annualized incremental costs 

relative to the full compliance baseline, 

is below the $100 million threshold 

established under part 3(f)(1) of the 

Order. 

In addition to calling for an 

assessment of regulatory costs, 

Executive Order 12866 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.’’ As discussed 

previously, the cost savings for the rule 

are estimated to be $24.3 million 

annually. These cost savings are 

considered benefits of the rule. Also, 

EPA estimates that the proposed rule 

will lead to the diversion of 

approximately 6,440 tons annually of 

hazardous waste pharmaceuticals from 

sewer disposal to alternate forms of 

disposal. 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. Please see the RIA for more 

details on the benefits of the proposed 

rule. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

in this proposed rule have been 

submitted for approval to the Office of 

Management and Budget (OMB) under 

the PRA. The Information Collection 

Request (ICR) document that the EPA 

prepared has been assigned EPA ICR 

number 2486.01. You can find a copy of 

the ICR in the docket for this rule, and 

it is briefly summarized here. 

EPA is proposing in this rule, under 

a new subpart P to 40 CFR part 266, new 

and revised reporting and recordkeeping 

requirements for healthcare facilities 

and pharmaceutical reverse distributors 

managing hazardous waste 

pharmaceuticals. These proposed 

requirements, which are also identified 

in the ICR supporting this action, will 

enable EPA and state regulatory 

agencies to identify the universe of 

healthcare facilities managing 

hazardous waste pharmaceuticals. The 

healthcare facilities must keep records 

of any test results, waste analyses or 

other determinations made on 

hazardous waste pharmaceuticals for 

three years from the date of analyses. In 

addition, the proposed requirements 

include provisions for improved 

tracking of hazardous waste 

pharmaceuticals that are routed through 

pharmaceutical reverse distributors. 

EPA will use the collected 

information to ensure that hazardous 

waste pharmaceuticals are being 

managed in a protective manner. The 

tracking requirements ensure that these 

wastes arrive at their intended 

destinations rather than diverted for 

illicit purposes or managed at 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. In addition, during 

a facility inspection, information kept in 

facility records will help EPA and state 

environmental regulatory agencies 

determine whether or not regulatory 

requirements are being followed. 

Information marked on containers of 

hazardous waste pharmaceuticals will 

assist handlers and transporters in 

ensuring proper management during 

storage and shipment. 

EPA has carefully considered the 

burden imposed upon the regulated 

community by the proposed regulations. 

EPA is confident that those activities 

required of respondents are necessary 

and, to the extent possible, has 

attempted to minimize the burden 

imposed. EPA believes strongly that if 

the minimum requirements specified 

under the proposed regulations are not 

met, neither the facilities nor EPA can 

ensure that hazardous waste 

pharmaceuticals are managed in a 

manner protective of human health and 

the environment. 

EPA estimates that the total annual 

respondent burden for the new 

paperwork requirements in the 

proposed rule is approximately 54,857 

hours, and the annual respondent cost 

for the new paperwork requirements in 

the rule is approximately $3,457,478. 

The estimated annual hourly burden 

ranges from 0.1 to 3.5 hours per 

response for the 28,637 respondents. 

However, in addition to estimating the 

annual respondent burden associated 

with new paperwork requirements in 

the proposed rule, the Agency also 

estimated the annual benefits (hours 

and cost savings) to respondents from 

the new paperwork requirements in 

comparison to complying with the 

existing RCRA hazardous waste 

information collection requirements for 

hazardous waste pharmaceuticals (e.g., 

preparation of biennial reports, 

recordkeeping, etc.). Taking both the 

new proposed and existing RCRA 

requirements into account, EPA expects 

the proposed rule would result in a net 

annual paperwork burden to the 28,637 

respondents of approximately 28,660 

hours or $2,301,873. The net cost to 

EPA of administering the rule is 

expected to be negligible, since the 

Agency is not required to review and 

approve any information submitted by 

respondents. Burden is defined at 5 CFR 

1320.3(b). 

Respondents/affected entities: Private 

entities. 

Respondent’s obligation to respond: 

Mandatory per 40 CFR part 266, subpart 

P. 

Estimated number of respondents: 

28,637. 

Frequency of response: Once. 

Total estimated burden: 54,857 hours. 

Total estimated cost: $3,457,478, 

includes $1,038,856 annualized capital 

or operation & maintenance costs. 

An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for the EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. Submit 

your comments on the Agency’s need 

for this information, the accuracy of the 


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provided burden estimates and any 

suggested methods for minimizing 

respondent burden to the EPA using the 

docket identified at the beginning of this 

rule. You may also send your ICRrelated comments to OMB’s Office of 

Information and Regulatory Affairs via 

email to oria_submissions@

omb.eop.gov, Attention: Desk Officer for 

the EPA. Since OMB is required to make 

a decision concerning the ICR between 

30 and 60 days after receipt, OMB must 

receive comments no later than October 

26, 2015. The EPA will respond to any 

ICR-related comments in the final rule. 

C. Regulatory Flexibility Small Business 

Analysis 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA. The small entities 

subject to the requirements of this 

action are indicated in Table 13. The 

Agency has determined that costs of the 

regulation for a facility are less than 1 

percent of annual revenue. 

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 

SBA’s threshold for consideration as 

small. Entities in revenue categories 

above the SBA threshold are not 

considered small. See Table 12 for the 

SBA thresholds and revenues. 

The percentage of facilities that 

qualify as small under SBA’s thresholds 

were estimated for each industry 

affected by the proposed rule. These 

percentages were applied to the number 

of facilities in the regulatory universe, 

as presented in the RIA. After estimating 

the number of small entities by NAICS 

code, the average cost per small entity 

was estimated based on the model 

facility costs presented in the RIA. Next, 

the EPA determined whether the per 


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164 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. 

facility costs incurred by small entities 

represent more than 1% of annual 

revenues, which required estimating 

small entities’ average annual revenues. 

For each NAICS code, the average per 

facility revenue of entities considered 

small under the SBA standard was 

estimated based on data from the 2007 

Economic Census. 

The proposed rule is expected to 

impact a total of 144,228 small entities 

(1,634 hospitals, 142,566 other 

healthcare facilities (i.e., healthcare 

facilities that are not hospitals) and 28 

pharmaceutical reverse distributors). 

The highest cost impact to small entities 

is estimated to be 0.013% of revenues at 

other healthcare facilities and 0.002% of 

revenues at hospitals. Because 

pharmaceutical reverse distributers are 

in various NAICS codes, the Agency 

was not able to obtain revenue data for 

pharmaceutical reverse distributors. 

However the estimated cost impact to 

small entity pharmaceutical reverse 

distributors is estimated at $5,300 

annually, which the Agency does not 

anticipate will cause significant 

hardship on pharmaceutical reverse 

distributors that are small entities. 

However, the Agency requests comment 

on the cost impacts on small entity 

pharmaceutical reverse distributors that 

process creditable hazardous waste 

pharmaceuticals. 

In the RIA, small entity impacts are 

presented incremental to the full 

compliance baseline. The annual per 

facility costs incremental to both 

baselines are estimated to be much less 

than 1% of average annual revenues. 

Since the incremental impact to the 

smallest healthcare facilities in terms of 

revenue is less than 1% of average 

annual revenues, the proposed rule is 

not expected to cause a significant 

impact to a substantial number of small 

businesses. Please see the RIA for a 

detailed analysis of cost impacts on 

small entities. 

Although this proposed rule will not 

have a significant economic impact on 

a substantial number of small entities, 

EPA nonetheless has tried to reduce the 

impact of this rule on small entities. We 

continue to be interested in the 

potential impacts of the proposed rule 

on small entities and welcome 

comments on issues related to such 

impacts. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This rule does not contain an 

unfunded mandate of $100 million or 

more as described in UMRA, 2 U.S.C. 

1531–1538, and does not significantly or 

uniquely affect small governments. As 

indicated previously, the annual net 

cost is estimated to be $13 million 

annually after cost savings ($37 million 

cost minus $24.3 million in cost 

savings). Thus, this proposed rule is not 

subject to the requirements of sections 

202 or 205 of UMRA. 

This proposed rule is also not subject 

to the requirements of section 203 of 

UMRA because it contains no regulatory 

requirements that might significantly or 

uniquely affect small governments. 

While some hospitals and coroners’ 

offices are publicly owned, the 

requirements affecting those facilities 

are not unique in that they are the same 

as those affecting all facilities in the 

proposed rule. Also, using data on 

revenues of hospitals owned by state 

and local governments, EPA estimated 

that the costs of the rule borne by state 

and local governments represent less 

than 0.001% of their revenues. 

Therefore, the costs incurred by small 

governments are not expected to be 

significant. 

E. Executive Order 13132: Federalism 

This action does not have federalism 

implications. It will not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or on the 

relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action may have tribal 

implications. However, it will neither 

impose substantial direct compliance 

costs on tribal governments, nor 

preempt tribal law. 

To assess the potential tribal 

implications of the proposed rule, EPA 

compiled data on the number of tribally 

run healthcare facilities in the U.S. and 

estimated the costs of the proposed 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 Table 14.164

Data were not readily available on the 

size or hazardous waste generation 

amounts for the tribally run healthcare 

facilities identified by the IHS. To 

estimate the potential costs of each 

regulatory option, per facility costs 

derived in the RIA were applied to the 

IHS facility counts. Based on these 

values, Table 14 summarizes the costs 

that tribally run healthcare facilities are 

expected to incur under the proposed 

rule. OMB has not issued guidance on 

what constitutes a substantial burden on 

tribal governments under this executive 

order. The relatively low costs estimated 

for tribally run healthcare facilities in 

Table14, however, suggest that the 

proposed rule will not impose a 

substantial burden on tribal 

governments. EPA welcomes comments 

on the proposed rule’s impact on tribal 

governments. EPA specifically solicits 

additional comment on this proposed 

action from tribal officials. 


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The EPA consulted with tribal 

officials under the EPA Policy on 

Consultation and Coordination with 

Indian Tribes early in the process of 

developing this regulation to permit 

them to have meaningful and timely 

input into its development. A summary 

of that consultation is provided in the 

docket for this proposed rule (see EPA– 

HQ–RCRA–2007–0932). 

As required by section 7(a), the EPA’s 

Tribal Consultation Official has certified 

that the requirements of the executive 

order have been met in a meaningful 

and timely manner. A copy of the 

certification is included in the docket 

for this proposed rule (see EPA–HQ– 

RCRA–2007–0932). 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This proposed rule is not subject to 

Executive Order 13045 because it is not 

economically significant as defined in 

Executive Order 12866, and because the 

Agency does not believe the 

environmental health or safety risks 

addressed by this action present a 

disproportionate risk to children. 

To examine whether the proposed 

rule has a disproportionate impact on 

children, the RIA uses a geographic 

analysis of demographics near 

wastewater treatment plants and 

hazardous waste combustion facilities. 

Table 15 summarizes the results of this 

analysis. As indicated in the table, this 

analysis finds that children (i.e., 

individuals under the age of 18) account 

for a slightly larger share of the 

population (28.5%) in the one-mile 

radius around wastewater treatment 

plants than they account for nationally 

(25.3%). Among the catchment zones of 

wastewater treatment plants, however, 

children make up a much smaller 

portion of the population (9.8%). 

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 proposed 

rule will not result in a disproportionate 

adverse impact on children. Because the 

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 

proposed rule is unlikely to have a 

significant disproportionate impact on 

children’s health. The data in Table 15 

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. See Table 15 for the 

demographics of children surrounding 

wastewater treatment plants and 

hazardous waste combustion facilities. 

Please see the RIA for a detailed 

methodology of the children’s health 

analysis. 


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H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution or Use 

This action is not a ‘‘significant 

energy action’’ as defined in Executive 

Order 13211, (66 FR 28355 (May 22, 

2001)), because it is not likely to have 

a significant adverse effect on the 

supply, distribution, or use of energy. 

The proposed rule does not directly 

regulate energy production or 

consumption. 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 proposed 

rule will have minimal impact on 

energy consumption (e.g., from 

transporting hazardous waste 

pharmaceuticals that otherwise would 

have been sewered). Because the 

changes in energy production and 

consumption under the proposed rule 

are likely to be minimal, 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. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This proposed rulemaking does not 

involve technical standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes the human health or 

environmental risk addressed by this 

action will not have potential 

disproportionately high and adverse 

human health or environmental effects 


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on minority, low-income or indigenous 

populations. The results of this 

evaluation are summarized in the 

following paragraphs. The evaluation is 

contained in the Regulatory Impact 

Analysis (RIA), which can be found at 

regulations.gov under docket number 

EPA–HQ–RCRA–2007–0932. 

To meet the requirements of 

Executive Order 12898, EPA analyzed 

potential environmental justice impacts 

associated with the diversion of 

hazardous waste pharmaceuticals from 

sewer disposal to hazardous waste 

combustion facilities. Populations living 

near and downstream from wastewater 

treatment plants may also benefit from 

the elimination of sewering of 

hazardous waste pharmaceuticals. To 

the extent that minority and/or lowincome populations near or downstream 

from wastewater treatment plants make 

up a disproportionately high portion of 

the overall population, the proposed 

rule may result in positive 

environmental justice impacts. See 

Table 16 for the results of the 

Environmental Justice analysis. 

Overall, EPA expects that the 

proposed rule may positively affect U.S. 

environmental justice populations, 

although the size of the impact will vary 

by wastewater treatment plant. As 

suggested by Table 16, 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 

environmental justice populations near 

these combustion 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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58082 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

List of Subjects 

40 CFR Part 261 

Environmental protection, Hazardous 

waste, Recycling, Reporting and 

recordkeeping requirements. 

40 CFR Part 262 

Environmental protection, Exports, 

Hazardous materials transportation, 

Hazardous waste, Imports, Labeling, 

Packaging and containers, Reporting 

and recordkeeping requirements. 

40 CFR Part 266 

Environmental protection, Energy, 

Hazardous Waste, Recycling, Reporting 

and recordkeeping requirements. 


tkelley on DSK3SPTVN1PROD with PROPOSALS3EP25SE15.012</GPH>

Wastewater treatment plants, 

one-mile radius 

Wastewater treatment plants, 

catclnnent areas 

Hazardous waste combustion 

facilities, one-mile radius 

Wastewater treatment plants, onemile radius 

Wastewater treatment plants 

catclnnent areas 

Hazardous waste combustion 

facilities, one-mile radius 

Wastewater treatment plants, onemile radius 

Wastewater treatment plants, 

catclnnent areas 

Hazardous waste combustion 

facilities, one-mile radius 

Hazardous waste combustion 

facilities, three-mile radius 

Notes: 

6.2 million 

(22.6%i 

3.8 million 

(14.0%i 

NA'I'ION"AL AVG. MINORltY6/o. 

3,233 

3,151 

6 

7 

3,596 

3,562 

7 

8 

;MINORITIES 

24.7% 11.4% 

7,886 

7,358 

4 

4 

7,949 

7,391 

13 

16 

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. 
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58083 

40 CFR Part 268 

Environmental protection, Hazardous 

waste, Reporting and recordkeeping 

requirements. 

40 CFR Part 273 

Environmental protection, Hazardous 

materials transportation, Hazardous 

waste. 

Dated: August 31, 2015. 

Gina McCarthy, 

Administrator. 

For the reasons stated in the 

preamble, Title 40, chapter I, of the 

Code of Federal Regulations is proposed 

to be amended as follows: 

PART 261—IDENTIFICATION AND 

LISTING OF HAZARDOUS WASTE 

■ 1. The authority citation for part 261 

continues to read as follows: 

Authority: 42 U.S.C. 6905, 6912(a), 6921, 

6922, 6924(y) and 6938. 

■ 2. Amend § 261.5 by adding paragraph 

(c)(8) to read as follows: 

§ 261.5 Special requirements for 

hazardous waste generated by conditionally 

exempt small quantity generators. 

* * * * * 

(c) * * * 

(8) Is a hazardous waste 

pharmaceutical managed under 40 CFR 

part 266, subpart P. 

* * * * * 

■ 3. Amend § 261.7 by adding paragraph 

(c) to read as follows: 

§ 261.7 Residues of hazardous waste in 

empty containers. 

* * * * * 

(c) Healthcare facilities and 

pharmaceutical reverse distributors 

operating under 40 CFR part 266, 

subpart P are subject to § 266.507 for the 

management of hazardous waste 

pharmaceutical residues in containers, 

in lieu of this section. 

PART 262—STANDARDS APPLICABLE 

TO GENERATORS OF HAZARDOUS 

WASTE 

■ 4. The authority citation for part 262 

continues to read as follows: 

Authority: 42 U.S.C 6906, 6912, 6922– 

6925, 6937, and 6938. 

■ 5. Amend § 262.10 by adding 

paragraphs (m) and (n) to read as 

follows: 

§ 262.10 Purpose, scope and applicability. 

* * * * * 

(m) All pharmaceutical reverse 

distributors (as defined in § 266.500) are 

subject to 40 CFR part 266, subpart P for 

the management of hazardous waste 

pharmaceuticals in lieu of this part. 

(n) Each healthcare facility (as defined 

in § 266.500) must determine whether it 

is subject to 40 CFR part 266, subpart P 

for the management of hazardous waste 

pharmaceuticals, based on the total 

hazardous waste it generates per 

calendar month (including 

pharmaceutical hazardous waste and 

non-pharmaceutical hazardous waste). 

Healthcare facilities that generate (or 

accumulate) more than 100 kg (220 

pounds) of hazardous waste per 

calendar month, or more than 1 kg (2.2 

pounds) of acute hazardous waste per 

calendar month, or more than 100 kg 

(220 pounds) per calendar month of any 

residue or contaminated soil, waste, or 

other debris, resulting from the clean-up 

of a spill, into or on any land or water, 

of any acute hazardous wastes listed in 

§ 261.31 or § 261.33(e), are subject to 40 

CFR part 266, subpart P for the 

management of hazardous waste 

pharmaceuticals in lieu of this part. 

PART 266—STANDARDS FOR THE 

MANAGEMENT OF SPECIFIC 

HAZARDOUS WASTES AND SPECIFIC 

TYPES OF HAZARDOUS WASTE 

MANAGEMENT FACILITIES 

■ 6. The authority citation for part 266 

continues to read as follows: 

Authority: 42 U.S.C. 1006, 2002(a), 3001– 

3009, 3014, 3017, 6905, 6906, 6912, 6921, 

6922, 6924–6927, 6934, and 6937. 

Subpart O—[Reserved] 

■ 7. Add reserved subpart O: 

■ 8. Add subpart P to read as follows: 

Subpart P — Hazardous Waste 

Pharmaceuticals 

Sec. 

266.500 Definitions for this subpart. 

266.501 Applicability. 

266.502 Standards for healthcare facilities 

managing non-creditable hazardous 

waste pharmaceuticals. 

266.503 Standards for healthcare facilities 

managing potentially creditable 

hazardous waste pharmaceuticals. 

266.504 Healthcare facilities that are 

conditionally exempt small quantity 

generators (CESQGs). 

266.505 Prohibition of sewering hazardous 

waste pharmaceuticals. 

266.506 Conditional exemption for 

hazardous waste pharmaceuticals that 

are also controlled substances. 

266.507 Management of hazardous waste 

pharmaceutical residues in containers. 

266.508 Shipping non-creditable hazardous 

waste pharmaceuticals from a healthcare 

facility or evaluated hazardous waste 

pharmaceuticals from a pharmaceutical 

reverse distributor. 

266.509 Shipping potentially creditable 

hazardous waste pharmaceuticals from a 

healthcare facility or a pharmaceutical 

reverse distributor to a pharmaceutical 

reverse distributor. 

266.510 Standards for the management of 

potentially creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals at 

pharmaceutical reverse distributors. 

Subpart P—Hazardous Waste 

Pharmaceuticals 

§ 266.500 Definitions for this subpart. 

The following definitions apply to 

this subpart: 

Evaluated hazardous waste 

pharmaceutical means a hazardous 

waste pharmaceutical that was a 

potentially creditable hazardous waste 

pharmaceutical but has been evaluated 

by a pharmaceutical reverse distributor 

to establish whether it is eligible for 

manufacturer’s credit and will not be 

sent to another pharmaceutical reverse 

distributor for further evaluation or 

verification. 

Hazardous waste pharmaceutical 

means a pharmaceutical that is a solid 

waste, as defined in § 261.2, and is 

listed in part 261, subpart D, or exhibits 

one or more characteristics identified in 

part 261, subpart C. 

Healthcare facility means: 

(1) Any person that: 

(i) Provides preventative, diagnostic, 

therapeutic, rehabilitative, maintenance 

or palliative care, and counseling, 

service, assessment or procedure with 

respect to the physical or mental 

condition, or functional status, of a 

human or animal or that affects the 

structure or function of the human or 

animal body; or 

(ii) Sells or dispenses over-thecounter or prescription 

pharmaceuticals. 

(2) This definition includes, but is not 

limited to, hospitals, psychiatric 

hospitals, ambulatory surgical centers, 

health clinics, physicians’ offices, 

optical and dental providers, 

chiropractors, long-term care facilities, 

ambulance services, coroners and 

medical examiners, pharmacies, longterm care pharmacies, mail-order 

pharmacies, retailers of over-the-counter 

medications; and veterinary clinics and 

hospitals. 

Household waste pharmaceutical 

means a pharmaceutical that is a solid 

waste, as defined in § 261.2, but is 

exempt from being a hazardous waste 

under § 261.4(b)(1). 

Long-term care facility means a 

licensed entity that provides assistance 

with activities of daily living, including 

managing and administering 

pharmaceuticals to one or more 

individuals at the facility. This 

definition includes, but is not limited 

to, assisted living, hospices, nursing 

homes, skilled nursing facilities, and the 

assisted living and skilled nursing care 


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58084 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

portions of continuing care retirement 

communities. Not included within the 

scope of this definition are group 

homes, independent living 

communities, and the independent 

living portions of continuing care 

retirement communities. 

Non-creditable hazardous waste 

pharmaceutical means a hazardous 

waste pharmaceutical that is not 

expected to be eligible for 

manufacturer’s credit. 

Non-hazardous waste pharmaceutical 

means a pharmaceutical that is a solid 

waste, as defined in § 261.2, and is not 

listed in 40 CFR part 261, subpart D, 

and does not exhibit a characteristic 

identified in 40 CFR part 261, subpart 

C. 

Non-pharmaceutical hazardous waste 

means a solid waste, as defined in 

§ 261.2, that is listed in 40 CFR part 261, 

subpart D, or exhibits one or more 

characteristics identified in 40 CFR part 

261, subpart C, but is not a 

pharmaceutical, as defined in this 

section. 

Pharmaceutical means any chemical 

or biological product that is intended for 

use in the diagnosis, cure, mitigation, 

care, treatment, or prevention of disease 

or injury of a human or other animal; or 

any chemical or biological product that 

is intended to affect the structure or 

function of the body of a human or other 

animal. This definition includes, but is 

not limited to: dietary supplements as 

defined by the Federal Food, Drug and 

Cosmetic Act, prescription drugs, overthe-counter drugs, residues of 

pharmaceuticals remaining in 

containers, personal protective 

equipment contaminated with 

pharmaceuticals, and clean-up material 

from spills of pharmaceuticals. 

Pharmaceutical reverse distributor 

means any person that receives and 

accumulates potentially creditable 

hazardous waste pharmaceuticals for 

the purpose of facilitating or verifying 

manufacturer’s credit. Any person, 

including forward distributors and 

pharmaceutical manufacturers, that 

processes pharmaceuticals for the 

facilitation or verification of 

manufacturer’s credit is considered a 

pharmaceutical reverse distributor. 

Potentially creditable hazardous 

waste pharmaceutical means: 

(1) A hazardous waste pharmaceutical 

that has the potential to receive 

manufacturer’s credit and is: 

(i) Unused or un-administered; and 

(ii) Unexpired or less than one year 

past expiration date. 

(2) The term does not include 

‘‘evaluated hazardous waste 

pharmaceuticals,’’ residues of 

pharmaceuticals remaining in 

containers, contaminated personal 

protective equipment, and clean-up 

material from the spills of 

pharmaceuticals. 

§ 266.501 Applicability. 

(a) A healthcare facility that is a 

conditionally exempt small quantity 

generator remains subject to § 261.5 and 

is not subject to this subpart, except for 

§§ 266.504, 266.505, and 266.507(a) and 

(b). 

(b) A healthcare facility that is a 

conditionally exempt small quantity 

generator has the option of complying 

with this subpart for the management of 

its hazardous waste pharmaceuticals, as 

an alternative to complying with the 

conditional exemption of § 261.5. 

(c) A healthcare facility or 

pharmaceutical reverse distributor 

remains subject to all applicable 

hazardous waste regulations with 

respect to the management of its nonpharmaceutical hazardous waste. 

(d) With the exception of healthcare 

facilities identified in subsection (a), a 

healthcare facility is subject to: 

(1) Sections 266.502 and 266.504 

through 266.508 of this subpart with 

respect to the management of: 

(i) Non-creditable hazardous waste 

pharmaceuticals, and 

(ii) Potentially creditable hazardous 

waste pharmaceuticals if they are not 

destined for a pharmaceutical reverse 

distributor. 

(2) Sections 266.503 through 266.507 

and 266.509 of this subpart with respect 

to the management of potentially 

creditable hazardous waste 

pharmaceuticals that are destined for a 

pharmaceutical reverse distributor. 

(e) A pharmaceutical reverse 

distributor is subject to §§ 266.505 

through 266.510 of this subpart with 

respect to the management of hazardous 

waste pharmaceuticals. 

(f) This subpart does not apply to the 

management of hazardous waste 

pharmaceuticals that are generated or 

managed by entities other than 

healthcare facilities and pharmaceutical 

reverse distributors. 

§ 266.502 Standards for healthcare 

facilities managing non-creditable 

hazardous waste pharmaceuticals. 

(a) Notification and withdrawal from 

this subpart for healthcare facilities 

managing non-creditable hazardous 

waste pharmaceuticals—(1) 

Notification. A healthcare facility must 

notify the EPA Regional Administrator, 

using the Site Identification Form (EPA 

form 8700–12), that it is a healthcare 

facility operating under this subpart. A 

healthcare facility is not required to fill 

out Box 11 (Description of Hazardous 

Waste) of the Site Identification Form 

with respect to its hazardous waste 

pharmaceuticals. A healthcare facility 

must submit a separate notification (Site 

Identification Form) for each site or EPA 

Identification Number. 

(i) A healthcare facility that already 

has an EPA identification number must 

re-notify the EPA Regional 

Administrator, using the Site 

Identification Form (EPA form 8700– 

12), that it is a healthcare facility as part 

of its next Biennial Report, if it is 

required to submit one; or if not 

required to submit a Biennial Report, 

within 60 days of the effective date of 

this subpart, or within 60 days of 

becoming subject to this subpart. 

(ii) A healthcare facility that does not 

have an EPA identification number 

must obtain one by notifying the EPA 

Regional Administrator, using the Site 

Identification form (EPA form 8700–12), 

that it is a healthcare facility as part of 

its next Biennial Report, if it is required 

to submit one; or if not required to 

submit a Biennial Report, within 60 

days of the effective date of this subpart, 

or within 60 days of becoming subject 

to this subpart. 

(iii) A healthcare facility must keep a 

copy of its notification on file for as long 

as the healthcare facility is subject to 

this subpart. 

(2) Withdrawal. A healthcare facility 

that operated under this subpart but is 

no longer subject to this subpart, 

because it is a conditionally exempt 

small quantity generator under § 261.5, 

and elects to withdraw from this 

subpart, must notify the appropriate 

EPA Regional Administrator using the 

Site Identification Form (EPA form 

8700–12) that it is no longer operating 

under this subpart. A healthcare facility 

is not required to fill out Box 11 

(Description of Hazardous Waste) of the 

Site Identification Form with respect to 

its hazardous waste pharmaceuticals. A 

healthcare facility must submit a 

separate notification (Site Identification 

Form) for each EPA Identification 

Number. 

(i) A healthcare facility must submit 

the Site Identification Form notifying 

that it is withdrawing from this subpart 

before it begins operating under the 

conditional exemption of § 261.5(b). 

(ii) A healthcare facility must keep a 

copy of its withdrawal on file for three 

years from the date of signature on the 

notification of its withdrawal. 

(b) Training of employees managing 

non-creditable hazardous waste 

pharmaceuticals at healthcare facilities. 

A healthcare facility must ensure that 

all employees that manage noncreditable hazardous waste 

pharmaceuticals are thoroughly familiar 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58085 

with proper waste handling and 

emergency procedures relevant to their 

responsibilities during normal facility 

operations and emergencies. 

(c) Hazardous waste determination for 

non-creditable hazardous waste 

pharmaceuticals at healthcare facilities. 

A healthcare facility that generates a 

solid waste that is a pharmaceutical 

must determine whether the solid waste 

pharmaceutical is a hazardous waste 

pharmaceutical (i.e., it exhibits a 

characteristic identified in 40 CFR part 

261, subpart C or is listed in 40 CFR part 

261, subpart D) in order to determine 

whether the waste is subject to this 

subpart. A healthcare facility may 

choose to manage its solid waste 

pharmaceuticals as hazardous waste 

pharmaceuticals under this subpart 

even if the solid waste pharmaceuticals 

do not exhibit a characteristic identified 

in 40 CFR part 261, subpart C and are 

not listed in 40 CFR part 261, subpart 

D. 

(d) Standards for containers used to 

accumulate non-creditable hazardous 

waste pharmaceuticals at healthcare 

facilities. (1) A healthcare facility must 

place non-creditable hazardous waste 

pharmaceuticals in a container that is 

structurally sound, compatible with its 

contents, and that lacks evidence of 

leakage, spillage, or damage that could 

cause leakage under reasonably 

foreseeable conditions. 

(2) A healthcare facility that manages 

ignitable or reactive hazardous waste 

pharmaceuticals, or that mixes or 

commingles incompatible hazardous 

waste pharmaceuticals must manage the 

container so that it does not have the 

potential to: 

(i) Generate extreme heat or pressure, 

fire or explosion, or violent reaction; 

(ii) Produce uncontrolled toxic mists, 

fumes, dusts, or gases in sufficient 

quantities to threaten human health; 

(iii) Produce uncontrolled flammable 

fumes or gases in sufficient quantities to 

pose a risk of fire or explosions; 

(iv) Damage the structural integrity of 

the container of hazardous waste 

pharmaceuticals; or 

(v) Through other like means threaten 

human health or the environment. 

(3) A healthcare facility must keep 

containers of non-creditable hazardous 

waste pharmaceuticals closed and 

secured in a manner that prevents 

unauthorized access to its contents. 

(4) A healthcare facility may 

accumulate hazardous waste 

pharmaceuticals and non-hazardous 

pharmaceutical waste in the same 

container, except that hazardous waste 

pharmaceuticals prohibited from being 

combusted because of the dilution 

prohibition of § 268.3(c) must be 

accumulated in separate containers. 

(e) Labeling containers used to 

accumulate non-creditable hazardous 

waste pharmaceuticals at healthcare 

facilities. A healthcare facility must 

label or clearly mark each container of 

hazardous waste pharmaceuticals with 

the phrase ‘‘Hazardous Waste 

Pharmaceuticals.’’ 

(f) Maximum accumulation time for 

non-creditable hazardous waste 

pharmaceuticals at healthcare facilities. 

(1) A healthcare facility may accumulate 

non-creditable hazardous waste 

pharmaceuticals on-site for one year or 

less without a permit or having interim 

status. A healthcare facility may 

accumulate for more than one year 

without a permit or having interim 

status, only if the requirements of 

paragraph (f)(3) of this section are met. 

(2) A healthcare facility that 

accumulates non-creditable hazardous 

waste pharmaceuticals on-site must 

demonstrate the length of time that the 

hazardous waste pharmaceuticals have 

been accumulating, starting from the 

date it first becomes a waste. A 

healthcare facility may make this 

demonstration by any of the following 

methods: 

(i) Marking or labeling the container 

of non-creditable hazardous waste 

pharmaceuticals with the date that 

hazardous waste pharmaceuticals 

became a waste; 

(ii) Maintaining an inventory system 

that identifies the date the noncreditable hazardous waste 

pharmaceutical being accumulated first 

became a waste; 

(iii) Placing the non-creditable 

hazardous waste pharmaceuticals in a 

specific area and identifying the earliest 

date that any of the non-creditable 

hazardous waste pharmaceuticals in the 

area became a waste; or 

(iv) Any other method which clearly 

demonstrates the length of time that the 

non-creditable hazardous waste 

pharmaceuticals have been 

accumulating from the date it first 

became a waste. 

(3) A healthcare facility may request 

from the EPA Regional Administrator an 

extension beyond the one year 

accumulation time limit for noncreditable hazardous waste 

pharmaceuticals involved in litigation, a 

recall, or unforeseen circumstances 

beyond the control of the healthcare 

facility. 

(i) A request must be sent to the EPA 

Regional Administrator in writing 

(paper or electronic). The request for an 

extension must include an explanation 

of the reason an extension is requested, 

the approximate volume or weight of 

the hazardous waste pharmaceuticals 

that will be accumulated more than 90 

days, and the amount of additional time 

requested. 

(ii) The amount of time extension 

granted is at the discretion of the EPA 

Regional Administrator on a case-bycase basis. 

(g) Land disposal restrictions for noncreditable hazardous waste 

pharmaceuticals. The hazardous waste 

pharmaceuticals generated by a 

healthcare facility are subject to the 

Land Disposal Restrictions of 40 CFR 

part 268. A healthcare facility that 

generates hazardous waste 

pharmaceuticals must comply with the 

land disposal restrictions in accordance 

with § 268.7(a) requirements, except 

that it is not required to identify the 

hazardous waste numbers (codes). 

(h) Procedures for healthcare facilities 

for managing rejected shipments of noncreditable hazardous waste 

pharmaceuticals. A healthcare facility 

that sends a shipment of non-creditable 

hazardous waste pharmaceuticals to a 

designated facility and later receives 

that shipment back as a rejected load in 

accordance with the manifest 

discrepancy provisions of § 264.72 or 

§ 265.72 of this chapter, may 

accumulate the returned hazardous 

waste pharmaceuticals on-site for up to 

an additional 90 days provided the 

rejected or returned shipment is 

managed in accordance with paragraphs 

(d) and (e) of this section. Upon receipt 

of the returned shipment, the healthcare 

facility must: 

(1) Sign either: 

(i) Item 18c of the original manifest, 

if the original manifest was used for the 

returned shipment; or 

(ii) Item 20 of the new manifest, if a 

new manifest was used for the returned 

shipment; 

(2) Provide the transporter a copy of 

the manifest; 

(3) Within 30 days of delivery of the 

rejected shipment, send a copy of the 

manifest to the designated facility that 

returned the shipment to the healthcare 

facility; and 

(4) Transport or offer for transport the 

returned shipment in accordance with 

the shipping standards of § 266.508(a). 

(i) Reporting by healthcare facilities 

for non-creditable hazardous waste 

pharmaceuticals—(1) Biennial report by 

healthcare facilities. Healthcare 

facilities are not subject to biennial 

reporting requirements under § 262.41, 

with respect to non-creditable 

hazardous waste pharmaceuticals 

managed under this subpart. 

(2) Exception report by healthcare 

facilities for a missing copy of the 

manifest. (i) For shipments from a 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58086 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

healthcare facility to a designated 

facility: If a healthcare facility does not 

receive a copy of the manifest with the 

handwritten signature of the owner or 

operator of the designated facility 

within 60 days of the date the noncreditable hazardous waste 

pharmaceuticals were accepted by the 

initial transporter, the healthcare facility 

must submit: 

(A) A legible copy of the original 

manifest, indicating that the healthcare 

facility has not received confirmation of 

delivery, to the EPA Regional 

Administrator for the Region in which 

the healthcare facility is located, and 

(B) A handwritten or typed note on 

the manifest itself, or on an attached 

sheet of paper, stating that the return 

copy was not received and explaining 

the efforts taken to locate the noncreditable hazardous waste 

pharmaceuticals and the results of those 

efforts. 

(ii) For shipments rejected by the 

designated facility and shipped to an 

alternate facility: If a healthcare facility 

does not receive a copy of the manifest 

for a rejected shipment of the noncreditable hazardous waste 

pharmaceuticals that is forwarded by 

the designated facility to an alternate 

facility (using appropriate manifest 

procedures), with the handwritten 

signature of the owner or operator of the 

alternate facility within 60 days of the 

date the waste was accepted by the 

initial transporter forwarding the 

shipment of non-creditable hazardous 

waste pharmaceuticals from the 

designated facility to the alternate 

facility, the healthcare facility must 

submit: 

(A) A legible copy of the original 

manifest, indicating that the healthcare 

facility has not received confirmation of 

delivery, to the EPA Regional 

Administrator for the Region in which 

the healthcare facility is located, and 

(B) A handwritten or typed note on 

the manifest itself, or on an attached 

sheet of paper, stating that the return 

copy was not received and explaining 

the efforts taken to locate the noncreditable hazardous waste 

pharmaceuticals and the results of those 

efforts. 

(3) Additional reports. The EPA 

Regional Administrator may require 

healthcare facilities to furnish 

additional reports concerning the 

quantities and disposition of noncreditable hazardous waste 

pharmaceuticals. 

(j) Recordkeeping by healthcare 

facilities for non-creditable hazardous 

waste pharmaceuticals. (1) A healthcare 

facility must keep a copy of each 

manifest signed in accordance with 

§ 262.23(a) for three years or until it 

receives a signed copy from the 

designated facility which received the 

non-creditable hazardous waste 

pharmaceuticals. This signed copy must 

be retained as a record for at least three 

years from the date the waste was 

accepted by the initial transporter. 

(2) A healthcare facility must keep a 

copy of each exception report for a 

period of at least three years from the 

date of the report. 

(3) A healthcare facility must keep 

records of any test results, waste 

analyses, or other determinations made 

to support its hazardous waste 

determination(s) for at least three years 

from the date of the test, analysis, or 

other determination. 

(4) The periods of retention referred to 

in this section are extended 

automatically during the course of any 

unresolved enforcement action 

regarding the regulated activity, or as 

requested by the EPA Regional 

Administrator. 

(k) Response to releases of noncreditable hazardous waste 

pharmaceuticals at healthcare facilities. 

(1) A healthcare facility must 

immediately contain all releases of noncreditable hazardous waste 

pharmaceuticals and other residues 

from non-creditable hazardous waste 

pharmaceuticals. 

(2) A healthcare facility must 

determine whether any material 

resulting from the release is a noncreditable hazardous waste 

pharmaceutical, and if so, must manage 

the non-creditable hazardous waste 

pharmaceutical residues and spill cleanup materials in accordance with the 

requirements of this subpart. 

(l) Long-term care facilities that 

manage non-creditable hazardous waste 

pharmaceuticals. A healthcare facility 

that is a long-term care facility and that 

has individuals that administer their 

own pharmaceuticals must collect any 

unused non-creditable hazardous waste 

pharmaceuticals from those selfadministering individuals and manage 

them in accordance with this subpart. 

(m) Accepting creditable and noncreditable hazardous waste 

pharmaceuticals from an off-site 

healthcare facility that is a CESQG. A 

healthcare facility may accept creditable 

and non-creditable hazardous waste 

pharmaceuticals from an off-site 

healthcare facility that is a conditionally 

exempt small quantity generator under 

§ 261.5, without a permit or without 

having interim status, provided the 

receiving healthcare facility: 

(1) Is under the control of the same 

person, as defined in § 260.10, as the 

conditionally exempt small quantity 

generator healthcare facility that is 

sending the hazardous waste 

pharmaceuticals off-site or has a 

contractual relationship whereby the 

receiving healthcare facility supplies 

pharmaceuticals to the conditionally 

exempt small quantity generator 

healthcare facility, 

(2) Is operating under this subpart for 

the management of its hazardous waste 

pharmaceuticals, 

(3) Manages the non-creditable 

hazardous waste pharmaceuticals that it 

receives from off-site in compliance 

with this subpart, and 

(4) Keeps records of the hazardous 

waste pharmaceuticals shipments it 

receives from off-site for 3 years from 

the date that the shipment is received. 

§ 266.503 Standards for healthcare 

facilities managing potentially creditable 

hazardous waste pharmaceuticals. 

(a) Hazardous waste determination for 

creditable hazardous waste 

pharmaceuticals at the healthcare 

facility. A healthcare facility that 

generates a solid waste that is a 

potentially creditable pharmaceutical 

must determine whether the potentially 

creditable solid waste pharmaceutical is 

a potentially creditable hazardous waste 

pharmaceutical (i.e., it listed in 40 CFR 

part 261, subpart D or exhibits a 

characteristic identified in 40 CFR part 

261, subpart C). A healthcare facility 

may choose to manage its potentially 

creditable solid waste pharmaceuticals 

as potentially creditable hazardous 

waste pharmaceuticals under § 266.509 

even if the solid waste pharmaceuticals 

do not exhibit a characteristic identified 

in 40 CFR part 261, subpart C and are 

not listed in 40 CFR part 261, subpart 

D. 

(b) Healthcare facilities are prohibited 

from sending hazardous wastes other 

than potentially creditable hazardous 

waste pharmaceuticals to a 

pharmaceutical reverse distributor. 

(c) Biennial Report by healthcare 

facilities. Healthcare facilities are not 

subject to biennial reporting 

requirements under § 262.41, with 

respect to potentially creditable 

hazardous waste pharmaceuticals 

managed under this subpart. 

(d) Recordkeeping. (1) A healthcare 

facility that initiates a shipment of 

potentially creditable hazardous waste 

pharmaceuticals to a pharmaceutical 

reverse distributor must keep the 

following records (paper or electronic) 

for each shipment of potentially 

creditable hazardous waste 

pharmaceuticals for 3 years from the 

date of shipment: 


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(i) A copy of the advance notification 

provided to the pharmaceutical reverse 

distributor; 

(ii) The confirmation of delivery; and 

(iii) The shipping papers or bill of 

lading. 

(2) The periods of retention referred to 

in this section are extended 

automatically during the course of any 

unresolved enforcement action 

regarding the regulated activity, or as 

requested by the EPA Regional 

Administrator. 

§ 266.504 Healthcare facilities that are 

conditionally exempt small quantity 

generators (CESQGs). 

(a) Potentially creditable hazardous 

waste pharmaceuticals. A healthcare 

facility that is a conditionally exempt 

small quantity generator may send its 

potentially creditable hazardous waste 

pharmaceuticals to a pharmaceuticals 

reverse distributor. 

(b) Off-site collection of hazardous 

waste pharmaceuticals generated by a 

healthcare facility that is a CESQG. A 

healthcare facility that is a conditionally 

exempt small quantity generator may 

send its hazardous waste 

pharmaceuticals off-site to another 

healthcare facility, provided the 

receiving healthcare facility meets the 

conditions in § 266.502(m) of this 

subpart. 

(c) Long-term care facilities that are 

CESQGs. A long-term care facility that 

is a conditionally exempt small quantity 

generator may dispose of its hazardous 

waste pharmaceuticals in a collection 

receptacle of an authorized collector (as 

defined by the Drug Enforcement 

Administration) that is registered with 

the Drug Enforcement Administration 

provided the contents are collected, 

stored, transported, destroyed and 

disposed of in compliance with all 

applicable Drug Enforcement 

Administration regulations for 

controlled substances. 

§ 266.505 Prohibition of sewering 

hazardous waste pharmaceuticals. 

All healthcare facilities and 

pharmaceutical reverse distributors are 

prohibited from discharging hazardous 

waste pharmaceuticals to a sewer 

system that passes through to a 

publicly-owned treatment works. The 

exclusion in § 261.4(a)(1)(ii) for 

mixtures of domestic sewage and other 

wastes that pass through a sewer system 

to a publicly-owned treatment works 

does not apply to a hazardous waste 

pharmaceutical. 

§ 266.506 Conditional exemption for 

hazardous waste pharmaceuticals that are 

also controlled substances. 

(a) The following are exempt from 40 

CFR parts 260 through 273, provided 

the conditions of paragraph (b) of this 

section are met: 

(1) A hazardous waste pharmaceutical 

that is also listed on a schedule of 

controlled substances by the Drug 

Enforcement Administration in 21 CFR 

part 1308, and 

(2) An authorized collector (as 

defined by the Drug Enforcement 

Administration) registered with the 

Drug Enforcement Administration that 

collects controlled substances collected 

from an ultimate user (as defined by the 

Drug Enforcement Administration) and 

co-mingles them with hazardous waste 

pharmaceuticals that are exempt as a 

household waste under § 261.4(b)(1). 

(b) Conditions for exemption. The 

hazardous waste pharmaceuticals must 

be collected, stored, transported, 

destroyed and disposed of in 

compliance with all applicable Drug 

Enforcement Administration regulations 

for controlled substances, and 

combusted at one of the following: 

(1) A permitted large municipal waste 

combustor (LMWC), subject to 40 CFR 

part 62, subpart FFF for existing 

LMWCs, or 40 CFR part 60, subparts Ea 

and Eb for new LMWCs, or 

(2) A permitted small municipal 

waste combustor (SMWC), subject to 40 

CFR part 62, subpart JJJ for existing 

SMWCs, or 40 CFR part 60, subparts 

AAAA and BBBB for new SMWCs, or 

(3) A unit that has a permit or interim 

status to burn hazardous waste and is 

covered by 40 CFR part 63, subpart EEE. 

A unit that is exempt from 40 CFR part 

63, subpart EEE as specified in 

§ 63.1200(b) of this chapter is not 

covered by subpart EEE. 

§ 266.507 Management of hazardous waste 

pharmaceutical residues in containers. 

(a) Dispensing and unit-dose 

containers. A dispensing bottle, vial, or 

ampule (not to exceed 1 liter or 1000 

pills); or a unit-dose container, (e.g., a 

unit-dose packet, cup, wrapper, blister 

pack, or delivery device) is considered 

empty and the residues are not 

regulated as hazardous waste provided: 

(1) All pharmaceuticals have been 

removed from the dispensing bottle, vial 

or ampule; or the unit-dose container, 

(e.g., unit-dose packet, cup, wrapper, 

blister pack, or delivery device) using 

the practices commonly employed to 

remove materials from that type of 

container, and 

(2) Any dispensing bottle or unit-dose 

container that is an original 

manufacturer’s product package is 

destroyed prior to disposal in such a 

manner as would prevent further use of 

the container. 

(b) Dispensed syringes. The residues 

remaining in a syringe are not regulated 

as hazardous waste provided: 

(1) The syringe has been used to 

administer the pharmaceutical to a 

patient, and 

(2) The syringe is placed in a sharps 

container that is managed in accordance 

with all applicable federal, state, and 

local medical waste requirements. 

(c) Other containers, including 

delivery devices. The residues 

remaining in all other types of unused 

or used containers that once held 

pharmaceuticals must be managed as 

hazardous waste pharmaceuticals, if the 

residues are listed in 40 CFR part 261, 

subpart D or exhibit a characteristic 

identified in 40 CFR part 261, subpart 

C. This includes, but is not limited to, 

the residues in intravenous (IV) bags 

and tubing, inhalers, aerosols, 

nebulizers, tubes of ointment, gels or 

creams. 

§ 266.508 Shipping non-creditable 

hazardous waste pharmaceuticals from a 

healthcare facility or evaluated hazardous 

waste pharmaceuticals from a 

pharmaceutical reverse distributor. 

(a) A healthcare facility or 

pharmaceutical reverse distributor that 

ships either non-creditable hazardous 

waste pharmaceuticals or evaluated 

hazardous waste pharmaceuticals, 

respectively, off-site to a designated 

facility (such as a permitted or interim 

status treatment, storage, or disposal 

facility), must comply with: 

(1) The following pre-transport 

requirements, before transporting or 

offering for transport off-site: 

(i) Packaging. Package the waste in 

accordance with the applicable 

Department of Transportation 

regulations on hazardous materials 

under 49 CFR parts 173, 178, and 180. 

(ii) Labeling. Label each package in 

accordance with the applicable 

Department of Transportation 

regulations on hazardous materials 

under 49 CFR part 172, subpart E. 

(iii) Marking. (A) Mark each package 

of hazardous waste pharmaceuticals in 

accordance with the applicable 

Department of Transportation 

regulations on hazardous materials 

under 49 CFR part 172, subpart D; 

(B) Mark each container of 119 gallons 

or less used in such transportation with 

the following words and information in 

accordance with the requirements of 49 

CFR 172.304: 

HAZARDOUS WASTE—Federal Law 

Prohibits Improper Disposal. If found, 

contact the nearest police or public safety 


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58088 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

authority or the U.S. Environmental 

Protection Agency. 

Healthcare Facility’s or Pharmaceutical 

Reverse Distributor’s Name and Address__. 

Healthcare Facility’s or Pharmaceutical 

Reverse Distributor’s EPA Identification 

Number__. 

Manifest Tracking Number__. 

(iv) Placarding. Placard or offer the 

initial transporter the appropriate 

placards according to Department of 

Transportation regulations for 

hazardous materials under 49 CFR part 

172, subpart F. 

(v) Shipping papers. Prepare shipping 

papers in accordance with 49 CFR part 

172, subpart C. 

(2) The manifest requirements of 40 

CFR part 262, subpart B, except that: 

(i) A healthcare facility shipping noncreditable hazardous waste 

pharmaceuticals is not required to list 

hazardous waste codes in box 13 of EPA 

Form 8700–22. 

(ii) A healthcare facility shipping noncreditable hazardous waste 

pharmaceuticals must write the words 

‘‘hazardous waste pharmaceuticals’’ in 

Box 14 (the special handling 

instructions and additional information) 

of EPA Form 8700–22. 

(b) Exporting non-creditable 

hazardous waste pharmaceuticals or 

evaluated hazardous waste 

pharmaceuticals. A healthcare facility 

or pharmaceutical reverse distributor 

that exports non-creditable hazardous 

waste pharmaceuticals or evaluated 

hazardous waste pharmaceuticals is 

subject to 40 CFR part 262, subpart E. 

(c) Importing non-creditable 

hazardous waste pharmaceuticals or 

evaluated hazardous waste 

pharmaceuticals. Any person that 

imports non-creditable hazardous waste 

pharmaceuticals or evaluated hazardous 

waste pharmaceuticals is subject to 40 

CFR part 262, subpart F. A healthcare 

facility or pharmaceutical reverse 

distributor may not accept imported 

non-creditable hazardous waste 

pharmaceuticals or evaluated hazardous 

waste pharmaceuticals, unless they have 

a permit or interim status that allows 

them to accept hazardous waste from 

off-site. 

§ 266.509 Shipping potentially creditable 

hazardous waste pharmaceuticals from a 

healthcare facility or a pharmaceutical 

reverse distributor to a pharmaceutical 

reverse distributor. 

(a) A healthcare facility or a 

pharmaceutical reverse distributor who 

transports or offers for transport 

potentially creditable hazardous waste 

pharmaceuticals off-site to a 

pharmaceutical reverse distributor must: 

(1) Provide advance notice (paper or 

electronic) to the pharmaceutical 

reverse distributor of the intent to ship 

potentially creditable hazardous waste 

pharmaceuticals to the receiving 

pharmaceutical reverse distributor 

before each shipment of potentially 

creditable hazardous waste 

pharmaceuticals is sent, and 

(2) Comply with the pre-transport 

requirements of § 266.508(a)(1)(i) 

through (v). 

(b) Upon receipt of each shipment of 

potentially creditable hazardous waste 

pharmaceuticals, the receiving 

pharmaceutical reverse distributor must 

provide confirmation (paper or 

electronic) to the healthcare facility or 

pharmaceutical reverse distributor that 

initiated the shipment that the shipment 

of potentially creditable hazardous 

waste pharmaceuticals has arrived. 

(c) If a healthcare facility or 

pharmaceutical reverse distributor 

initiates a shipment of potentially 

creditable hazardous waste 

pharmaceuticals to a pharmaceutical 

reverse distributor and does not receive 

delivery confirmation within seven 

calendar days from the date that the 

shipment of potentially creditable 

hazardous waste pharmaceuticals was 

sent, the healthcare facility or 

pharmaceutical reverse distributor that 

initiated the shipment must contact the 

shipper and the intended recipient (i.e., 

the pharmaceutical reverse distributor) 

promptly to report that the confirmation 

was not received and to determine the 

status of the potentially creditable 

hazardous waste pharmaceuticals. 

(d) Exporting potentially creditable 

hazardous waste pharmaceuticals. (1) A 

healthcare facility or pharmaceutical 

reverse distributor that sends potentially 

creditable hazardous waste 

pharmaceuticals to a foreign destination 

must comply with the following 

requirements in addition to paragraphs 

(a) through (c) of this section: 

(i) Comply with the requirements 

applicable to a primary exporter at 40 

CFR 262.53, 262.56(a)(1) through (4), 

(a)(6), and (b) and 262.57; 

(ii) Export such potentially creditable 

hazardous waste pharmaceuticals only 

upon consent of the receiving country 

and in conformance with the EPA 

Acknowledgement of Consent as 

defined in 40 CFR part 262, subpart E; 

and 

(iii) Provide a copy of the EPA 

Acknowledgement of Consent for the 

shipment to the transporter transporting 

the shipment for export. 

(2) A transporter of potentially 

creditable hazardous waste 

pharmaceuticals to a foreign destination 

other than those OECD countries 

specified 40 CFR 262.58(a)(1) (in which 

case the transporter is subject to the 

requirements of 40 CFR part 262, 

subpart H) may not accept a shipment 

if the transporter knows the shipment 

does not conform to the EPA 

Acknowledgment of Consent. In 

addition the transporter must ensure 

that: 

(i) A copy of the EPA 

Acknowledgment of Consent 

accompanies the shipment; and 

(ii) The shipment is delivered to the 

facility designated by the person 

initiating the shipment. 

(e) Importing potentially creditable 

hazardous waste pharmaceuticals. Any 

person that imports potentially 

creditable hazardous waste 

pharmaceuticals into the United States 

is subject to paragraphs (a) through (c) 

of this section in lieu of 40 CFR part 

262, subpart F. 

§ 266.510 Standards for the management 

of potentially creditable hazardous waste 

pharmaceuticals and evaluated hazardous 

waste pharmaceuticals at pharmaceutical 

reverse distributors. 

A pharmaceutical reverse distributor 

may accept potentially creditable 

hazardous waste pharmaceuticals from 

off-site and accumulate potentially 

creditable hazardous waste 

pharmaceuticals or evaluated hazardous 

waste pharmaceuticals on-site without a 

permit or without having interim status, 

provided that it complies with the 

following conditions: 

(a) Standards for pharmaceutical 

reverse distributors managing 

potentially creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals. 

(1) Notification. A pharmaceutical 

reverse distributor must notify the EPA 

Regional Administrator, using the Site 

Identification Form (EPA form 8700– 

12), that it is a pharmaceutical reverse 

distributor operating under this subpart. 

(i) A pharmaceutical reverse 

distributor that already has an EPA 

identification number must re-notify the 

EPA Regional Administrator, using the 

Site Identification Form (EPA form 

8700–12), that it is a pharmaceutical 

reverse distributor, as defined in 

§ 266.500, within 60 days of the 

effective date of this subpart, or within 

60 days of becoming subject to this 

subpart. 

(ii) A pharmaceutical reverse 

distributor that does not have an EPA 

identification number must obtain one 

by notifying the EPA Regional 

Administrator, using the Site 

Identification Form (EPA form 8700– 

12), that it is a pharmaceutical reverse 

distributor, as defined in § 266.500, 

within 60 days of the effective date of 

this subpart, or within 60 days of 

becoming subject to this subpart. 


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Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58089 

(2) Inventory by the pharmaceutical 

reverse distributor. A pharmaceutical 

reverse distributor must maintain an 

inventory of all the potentially 

creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals that 

are accumulated on-site. 

(i) A pharmaceutical reverse 

distributor must inventory each 

potentially creditable hazardous waste 

pharmaceutical upon arrival at the 

pharmaceutical reverse distributor. 

(ii) The inventory must include the 

identity (e.g., name or national drug 

code (NDC)) and quantity of each 

potentially creditable hazardous waste 

pharmaceutical and evaluated 

hazardous waste pharmaceutical. 

(3) Security at the pharmaceutical 

reverse distributor facility. A 

pharmaceutical reverse distributor must 

prevent unknowing entry and minimize 

the possibility for the unauthorized 

entry into the portion of the facility 

where potentially creditable hazardous 

waste pharmaceuticals and evaluated 

hazardous waste pharmaceuticals are 

kept. 

(i) Examples of methods that may be 

used to prevent unknowing entry and 

minimize unauthorized entry include, 

but are not limited to: 

(A) 24-hour continuous monitoring 

surveillance system; 

(B) An artificial barrier such as a 

fence; or 

(C) Means to control entry, such as 

keycard access. 

(ii) If the pharmaceutical reverse 

distributor already meets the security 

requirements of this paragraph because 

of other regulatory requirements, such 

as Drug Enforcement Administration 

regulations, the facility is not required 

to provide separate security measures 

pursuant to this section. 

(4) Maximum accumulation time for 

hazardous waste pharmaceuticals at a 

pharmaceutical reverse distributor. A 

pharmaceutical reverse distributor may 

accumulate potentially creditable 

hazardous waste pharmaceuticals and 

evaluated hazardous waste 

pharmaceuticals on-site for 90 calendar 

days or less. The 90 days start when the 

potentially creditable hazardous waste 

pharmaceutical arrives at the 

pharmaceutical reverse distributor and 

applies to all hazardous waste 

pharmaceuticals accumulated on-site, 

regardless of whether they are destined 

for another pharmaceutical reverse 

distributor (i.e., potentially creditable 

hazardous waste pharmaceuticals), or a 

permitted or interim status treatment, 

storage or disposal facility (i.e., 

evaluated hazardous waste 

pharmaceuticals). 

(5) Extension of 90-day accumulation 

time limit at a pharmaceutical reverse 

distributor. A pharmaceutical reverse 

distributor may request an extension of 

its 90-day accumulation time limit for 

hazardous waste pharmaceuticals from 

the EPA Regional Administrator due to 

unforeseen circumstances beyond the 

control of the pharmaceutical reverse 

distributor, or if the potentially 

creditable hazardous waste 

pharmaceuticals or evaluated hazardous 

waste pharmaceuticals are involved in 

litigation or a recall. 

(i) A written request must be sent to 

the EPA Regional Administrator (paper 

or electronic). The request for an 

extension must include an explanation 

of the reason an extension is requested, 

the approximate volume or weight of 

the hazardous waste pharmaceuticals 

that will be accumulated more than 90 

days, and the amount of additional time 

requested. 

(ii) The amount of time granted for an 

extension is at the discretion of the EPA 

Regional Administrator on a case-bycase basis. 

(6) Contingency plan and emergency 

procedures at a pharmaceutical reverse 

distributor. A pharmaceutical reverse 

distributor that accepts potentially 

creditable hazardous waste 

pharmaceuticals from off-site must 

prepare a contingency plan and comply 

with the other requirements of 40 CFR 

part 265, subpart D. 

(7) Closure of a pharmaceutical 

reverse distributor. When closing an 

area where a pharmaceutical reverse 

distributor accumulates potentially 

creditable hazardous waste 

pharmaceuticals or evaluated hazardous 

waste pharmaceuticals, the 

pharmaceutical reverse distributor must 

control, minimize, or eliminate to the 

extent necessary to protect human 

health and the environment, postclosure escape of hazardous waste, 

leachate, contaminated run-off, or 

hazardous waste decomposition 

products to the ground or surface waters 

or to the atmosphere. 

(8) Reporting by a pharmaceutical 

reverse distributor—(i) Unauthorized 

waste report. A pharmaceutical reverse 

distributor must submit an 

unauthorized hazardous waste report if 

the pharmaceutical reverse distributor 

receives hazardous waste from off-site 

that it is not authorized to receive (e.g., 

non-creditable hazardous waste 

pharmaceuticals, non-pharmaceutical 

hazardous waste). The pharmaceutical 

reverse distributor must prepare and 

submit an unauthorized waste report to 

the EPA Regional Administrator within 

15 days after receiving the unauthorized 

hazardous waste and the 

pharmaceutical reverse distributor must 

send a copy of the unauthorized waste 

report to the healthcare facility (or other 

entity) that sent the unauthorized 

hazardous waste. The pharmaceutical 

reverse distributor must manage the 

unauthorized hazardous waste in 

accordance with all applicable 

regulations for generators of nonpharmaceutical hazardous waste. The 

unauthorized waste report must be 

signed by the owner or operator of the 

pharmaceutical reverse distributor, or 

his authorized representative, and 

contain the following information: 

(A) The EPA identification number, 

name and address of the pharmaceutical 

reverse distributor; 

(B) The date the pharmaceutical 

reverse distributor received the 

hazardous waste; 

(C) The EPA identification number, 

name and address of the healthcare 

facility that shipped the hazardous 

waste, if available; 

(D) A description and the quantity of 

each unauthorized hazardous waste the 

pharmaceutical reverse distributor 

received; 

(E) The method of treatment, storage, 

or disposal for each unauthorized 

hazardous waste; and 

(F) A brief explanation of why the 

waste was unauthorized, if known. 

(ii) Additional reports. The EPA 

Regional Administrator may require 

pharmaceutical reverse distributors to 

furnish additional reports concerning 

the quantities and disposition of 

potentially creditable hazardous waste 

pharmaceuticals and evaluated 

hazardous waste pharmaceuticals. 

(9) Recordkeeping by pharmaceutical 

reverse distributors. A pharmaceutical 

reverse distributor must keep the 

following records (paper or electronic): 

(i) A copy of its notification on file for 

as long as the facility is subject to this 

subpart; 

(ii) A copy of the advance 

notification, delivery confirmation, the 

shipping papers or bill of lading for 

each shipment of potentially creditable 

hazardous waste pharmaceuticals that it 

receives, and a copy of each 

unauthorized waste report, for at least 

three years from the date it receives the 

shipment; 

(iii) A copy of its inventory for as long 

as the facility is subject to this subpart; 

and 

(iv) The periods of retention referred 

to in this section are extended 

automatically during the course of any 

unresolved enforcement action 

regarding the regulated activity, or as 

requested by the EPA Regional 

Administrator. 


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58090 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

(10) A pharmaceutical reverse 

distributor that is not a pharmaceutical 

manufacturer must evaluate a 

potentially creditable hazardous waste 

pharmaceutical within 21 calendar days 

of arriving at the pharmaceutical reverse 

distributor to establish whether it is 

destined for another pharmaceutical 

reverse distributor for further evaluation 

or verification of manufacturer’s credit 

or for a permitted or interim status 

treatment, storage or disposal facility. 

This 21 calendar days is part of the 90 

calendar days allowed for on-site 

accumulation. 

(i) A potentially creditable hazardous 

waste pharmaceutical that is destined 

for another pharmaceutical reverse 

distributor is still considered a 

‘‘potentially creditable hazardous waste 

pharmaceutical’’ and must be managed 

in accordance with paragraph (b) of this 

section. 

(ii) A potentially creditable hazardous 

waste pharmaceuticals that is destined 

for a permitted or interim status 

treatment, storage or disposal facility is 

considered an ‘‘evaluated hazardous 

waste pharmaceutical’’ and must be 

managed in accordance with paragraph 

(c) of this section. 

(11) A pharmaceutical reverse 

distributor that is a pharmaceutical 

manufacturer must evaluate a 

potentially creditable hazardous waste 

pharmaceutical to verify manufacturer’s 

credit within 21 calendar days of 

arriving at the facility and must manage 

the evaluated hazardous waste 

pharmaceuticals in accordance with 

paragraph (c) of this section. This 21 

calendar days is part of the 90 calendar 

days allowed for on-site accumulation. 

(b) Additional standards for 

pharmaceutical reverse distributors 

managing potentially creditable 

hazardous waste pharmaceuticals 

destined for another pharmaceutical 

reverse distributor. A pharmaceutical 

reverse distributor that does not have a 

permit or interim status must comply 

with the following conditions, in 

addition to the requirements in 

paragraph (a) of this section, for the 

management of potentially creditable 

hazardous waste pharmaceuticals that 

are destined for another pharmaceutical 

reverse distributor for further evaluation 

or verification of manufacturer’s credit: 

(1) A pharmaceutical reverse 

distributor that receives potentially 

creditable hazardous waste 

pharmaceuticals from a healthcare 

facility must send those potentially 

creditable hazardous waste 

pharmaceuticals to another 

pharmaceutical reverse distributor 

within 90 days from when the 

potentially creditable hazardous waste 

pharmaceuticals arrived or follow 

paragraph (c) of this section for 

evaluated hazardous waste 

pharmaceuticals. 

(2) A pharmaceutical reverse 

distributor that receives potentially 

creditable hazardous waste 

pharmaceuticals from another 

pharmaceutical reverse distributor must 

send those potentially creditable 

hazardous waste pharmaceuticals to a 

pharmaceutical reverse distributor that 

is a pharmaceutical manufacturer 

within 90 days from when the 

potentially creditable hazardous waste 

pharmaceuticals arrived or follow 

paragraph (c) of this section for 

evaluated hazardous waste 

pharmaceuticals. 

(3) A pharmaceutical reverse 

distributor must ship potentially 

creditable hazardous waste 

pharmaceuticals destined for another 

pharmaceutical reverse distributor in 

accordance with § 266.509. 

(4) Recordkeeping. A pharmaceutical 

reverse distributor must keep the 

following records (paper or electronic) 

for each shipment of potentially 

creditable hazardous waste 

pharmaceuticals that it initiates to 

another pharmaceutical reverse 

distributor, for at least three years from 

the date of shipment: 

(i) A copy of the advance notification 

provided to the pharmaceutical reverse 

distributor; 

(ii) The confirmation of delivery; and 

(iii) The shipping papers or bill of 

lading. 

(c) Additional standards for 

pharmaceutical reverse distributors 

managing evaluated hazardous waste 

pharmaceuticals. A pharmaceutical 

reverse distributor that does not have a 

permit or interim status must comply 

with the following conditions, in 

addition to the requirements of 

paragraph (a) of this section, for the 

management of evaluated hazardous 

waste pharmaceuticals: 

(1) Accumulation area at the 

pharmaceutical reverse distributor. A 

pharmaceutical reverse distributor must 

designate an on-site accumulation area 

where it will accumulate evaluated 

hazardous waste pharmaceuticals. 

(2) Weekly inspections of on-site 

accumulation area. A pharmaceutical 

reverse distributor must inspect its onsite accumulation area at least weekly, 

looking at containers for leaks and for 

deterioration caused by corrosion or 

other factors, as well as for signs of 

diversion. 

(3) Personnel training at a 

pharmaceutical reverse distributor. 

Personnel at a pharmaceutical reverse 

distributor that handle evaluated 

hazardous waste pharmaceuticals are 

subject to the training requirements of 

§ 265.16. 

(4) Labeling and management of 

containers at on-site accumulation area. 

A pharmaceutical reverse distributor 

accumulating evaluated hazardous 

waste pharmaceuticals in containers in 

an on-site accumulation area must: 

(i) Label the containers with the 

words, ‘‘hazardous waste 

pharmaceuticals’’; 

(ii) Ensure the containers are in good 

condition and managed to prevent leaks; 

(iii) Use containers that are made of 

or lined with materials which will not 

react with, and are otherwise 

compatible with, the evaluated 

hazardous waste pharmaceuticals, so 

that the ability of the container to 

contain the waste is not impaired; 

(iv) Keep containers closed, if holding 

liquid or gel evaluated hazardous waste 

pharmaceuticals. If the liquid or gel 

evaluated hazardous waste 

pharmaceuticals are in their original, 

intact, sealed packaging; or repackaged, 

intact, sealed packaging, they are 

considered to meet the closed container 

standard; 

(v) A pharmaceutical reverse 

distributor that manages ignitable or 

reactive evaluated hazardous waste 

pharmaceuticals, or that mixes or 

commingles incompatible evaluated 

hazardous waste pharmaceuticals must 

manage the container so that it does not 

have the potential to: 

(A) Generate extreme heat or pressure, 

fire or explosion, or violent reaction; 

(B) Produce uncontrolled toxic mists, 

fumes, dusts, or gases in sufficient 

quantities to threaten human health; 

(C) Produce uncontrolled flammable 

fumes or gases in sufficient quantities to 

pose a risk of fire or explosions; 

(D) Damage the structural integrity of 

the container of hazardous waste 

pharmaceuticals; or 

(E) Through other like means threaten 

human health or the environment; and 

(vi) Accumulate evaluated hazardous 

waste pharmaceuticals that are 

prohibited from being combusted 

because of the dilution prohibition of 

§ 268.3(c) (e.g., arsenic trioxide (P012)) 

in separate containers from other 

evaluated hazardous waste 

pharmaceuticals at the pharmaceutical 

reverse distributor. 

(5) Hazardous waste numbers. 

Containers of evaluated hazardous 

waste pharmaceuticals must be marked 

with the applicable hazardous waste 

number(s) (i.e., hazardous waste 

code(s)) prior to transport off-site. 

(6) Shipments. A pharmaceutical 

reverse distributor must ship evaluated 

hazardous waste pharmaceuticals that 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 58091 

are destined for a permitted or interim 

status treatment, storage or disposal 

facility, in accordance with § 266.508(a). 

(7) Procedures for a pharmaceutical 

reverse distributor for managing rejected 

shipments. A pharmaceutical reverse 

distributor who sends a shipment of 

evaluated hazardous waste 

pharmaceuticals to a designated facility 

with the understanding that the 

designated facility can accept and 

manage the waste, and later receives 

that shipment back as a rejected load in 

accordance with the manifest 

discrepancy provisions of § 264.72 or 

§ 265.72 of this chapter, may 

accumulate the returned hazardous 

waste pharmaceuticals on-site for up to 

an additional 90 days in the on-site 

accumulation area provided the rejected 

or returned shipment is managed in 

accordance with paragraph (a) of this 

section. Upon receipt of the returned 

shipment, the pharmaceutical reverse 

distributor must: 

(i) Sign either: 

(A) Item 18c of the original manifest 

if the original manifest was used for the 

returned shipment; or 

(B) Item 20 of the new manifest if a 

new manifest was used for the returned 

shipment; 

(ii) Provide the transporter a copy of 

the manifest; 

(iii) Within 30 days of delivery of the 

rejected shipment of the evaluated 

hazardous waste pharmaceuticals, send 

a copy of the manifest to the designated 

facility that returned the shipment to 

the pharmaceutical reverse distributor; 

and 

(iv) Transport or offer for transport the 

returned shipment of evaluated 

hazardous waste pharmaceuticals in 

accordance with the shipping standards 

of § 266.508(b). 

(8) Land disposal restrictions. 

Evaluated hazardous waste 

pharmaceuticals are subject to the Land 

Disposal Restrictions of 40 CFR part 

268. A pharmaceutical reverse 

distributor that accepts potentially 

creditable hazardous waste 

pharmaceuticals from off-site must 

comply with the land disposal 

restrictions in accordance with 

§ 268.7(a) requirements. 

(9) Reporting by a pharmaceutical 

reverse distributor for evaluated 

hazardous waste pharmaceuticals. (i) 

Biennial report by a pharmaceutical 

reverse distributor. A pharmaceutical 

reverse distributor that ships evaluated 

hazardous waste pharmaceuticals offsite must prepare and submit a single 

copy of a biennial report to the EPA 

Regional Administrator by March 1 of 

each even numbered year in accordance 

with § 262.41, except § 262.41(a)(7). 

(ii) Exception reporting by a 

pharmaceutical reverse distributor for a 

missing copy of the manifest. (A) For 

shipments from a pharmaceutical 

reverse distributor to a designated 

facility: 

(1) If a pharmaceutical reverse 

distributor does not receive a copy of 

the manifest with the handwritten 

signature of the owner or operator of the 

designated facility within 35 days of the 

date the evaluated hazardous waste 

pharmaceuticals were accepted by the 

initial transporter, the pharmaceutical 

reverse distributor must contact the 

transporter or the owner or operator of 

the designated facility to determine the 

status of the evaluated hazardous waste 

pharmaceuticals. 

(2) A pharmaceutical reverse 

distributor must submit an exception 

report to the EPA Regional 

Administrator for the Region in which 

the pharmaceutical reverse distributor is 

located if it has not received a copy of 

the manifest with the handwritten 

signature of the owner or operator of the 

designated facility within 45 days of the 

date the evaluated hazardous waste 

pharmaceutical was accepted by the 

initial transporter. The exception report 

must include: 

(i) A legible copy of the manifest for 

which the pharmaceutical reverse 

distributor does not have confirmation 

of delivery; and 

(ii) A cover letter signed by the 

pharmaceutical reverse distributor, or 

its authorized representative, explaining 

the efforts taken to locate the evaluated 

hazardous waste pharmaceuticals and 

the results of those efforts. 

(B) For shipments rejected by the 

designated facility and shipped to an 

alternate facility: 

(1) A pharmaceutical reverse 

distributor that does not receive a copy 

of the manifest with the handwritten 

signature of the owner or operator of the 

alternate facility within 35 days of the 

date the evaluated hazardous waste 

pharmaceutical was accepted by the 

initial transporter must contact the 

transporter or the owner or operator of 

the alternate facility to determine the 

status of the hazardous waste. The 35 

day timeframe begins the date the waste 

is accepted by the transporter 

forwarding the hazardous waste 

shipment from the designated facility to 

the alternate facility. 

(2) A pharmaceutical reverse 

distributor must submit an Exception 

Report to the EPA Regional 

Administrator for the Region in which 

the pharmaceutical reverse distributor is 

located if it has not received a copy of 

the manifest with the handwritten 

signature of the owner or operator of the 

alternate facility within 45 days of the 

date the hazardous waste was accepted 

by the initial transporter. The 45-day 

timeframe begins the date the hazardous 

waste is accepted by the transporter 

forwarding the hazardous waste 

shipment from the designated facility to 

the alternate facility. The Exception 

Report must include: 

(i) A legible copy of the manifest for 

which the generator does not have 

confirmation of delivery; and 

(ii) A cover letter signed by the 

pharmaceutical reverse distributor, or 

its authorized representative, explaining 

the efforts taken to locate the evaluated 

hazardous waste pharmaceuticals and 

the results of those efforts. 

(10) Recordkeeping by a 

pharmaceutical reverse distributor for 

evaluated hazardous waste 

pharmaceuticals. (i) A pharmaceutical 

reverse distributor must keep a log 

(written or electronic) of the weekly 

inspections of the on-site accumulation 

area, required by paragraph (c)(2) of this 

section. This log must be retained as a 

record for at least three years from the 

date of the inspection. 

(ii) A pharmaceutical reverse 

distributor must keep a copy of each 

manifest signed in accordance with 

§ 262.23(a) for three years or until it 

receives a signed copy from the 

designated facility which received the 

evaluated hazardous waste 

pharmaceutical. This signed copy must 

be retained as a record for at least three 

years from the date the evaluated 

hazardous waste pharmaceutical was 

accepted by the initial transporter. 

(iii) A pharmaceutical reverse 

distributor must keep a copy of each 

biennial report for at least three years 

from the due date of the report. 

(iv) A pharmaceutical reverse 

distributor must keep a copy of each 

exception report for at least three years 

from the submission of the report. 

(v) A pharmaceutical reverse 

distributor must keep records to 

document personnel training, in 

accordance with § 265.16. 

(d) When a pharmaceutical reverse 

distributor must have a permit. A 

pharmaceutical reverse distributor is an 

operator of a hazardous waste treatment, 

storage or disposal facility and is subject 

to the requirements of 40 CFR parts 264, 

265, and 267 and the permit 

requirements of 40 CFR part 270, if the 

pharmaceutical reverse distributor: 

(1) Does not meet the conditions of 

this section; 

(2) Accepts manifested hazardous 

waste from off-site; or 

(3) Treats or disposes of hazardous 

waste on-site. 


tkelley on DSK3SPTVN1PROD with PROPOSALS3
58092 Federal Register / Vol. 80, No. 186 / Friday, September 25, 2015 / Proposed Rules 

PART 268—LAND DISPOSAL 

RESTRICTIONS 

■ 9. The authority citation for part 268 

continues to read as follows: 

Authority: 42 U.S.C. 6905, 6912(a), 6921, 

and 6924. 

■ 10. Amend Section 268.7 by revising 

the section heading and the paragraph 

(a) subject heading to read as follows: 

§ 268.7 Testing, tracking, and 

recordkeeping requirements for generators, 

pharmaceutical reverse distributors, 

treaters, and disposal facilities. 

(a) Requirements for generators and 

pharmaceutical reverse distributors: 

* * * 

* * * * * 

■ 11. Amend § 268.50 by adding 

paragraphs (a)(4) and (5) to read as 

follows: 

§ 268.50 Prohibitions on storage of 

restricted wastes. 

(a) * * * 

(4) A healthcare facility accumulates 

such wastes in containers on-site solely 

for the purpose of the accumulation of 

such quantities of hazardous waste 

pharmaceuticals as necessary to 

facilitate proper recovery, treatment, or 

disposal and the healthcare facility 

complies with the requirements in 

§ 266.502 of this chapter. 

(5) A pharmaceutical reverse 

distributor accumulates such wastes in 

containers on-site solely for the purpose 

of the accumulation of such quantities 

of hazardous waste pharmaceuticals as 

necessary to facilitate proper recovery, 

treatment, or disposal and the 

pharmaceutical reverse distributor 

complies with § 266.510 of this chapter. 

* * * * * 

PART 273—STANDARDS FOR 

UNIVERSAL WASTE MANAGEMENT 

■ 12. The authority citation for part 273 

continues to read as follows: 

Authority: 42 U.S.C. 6922, 6923, 6924, 

6925, 6930, and 6937. 

■ 13. Amend § 273.80 by revising 

paragraph (a) and adding paragraph (d) 

to read as follows: 

§ 273.80 General. 

(a) Except as provided in paragraph 

(d), any person seeking to add a 

hazardous waste or category of 

hazardous waste to this part may 

petition for a regulatory amendment 

under this subpart and 40 CFR 260.20 

and 260.23. 

* * * * * 

(d) Pharmaceutical hazardous waste is 

regulated by 40 CFR part 266, subpart P 

and may not be added as a category of 

hazardous waste for management under 

this part. 

[FR Doc. 2015–23167 Filed 9–24–15; 8:45 am] 

BILLING CODE 6560–50–P 


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