Management Standards for Hazardous Waste Pharmaceuticals

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 Once submitted, comments cannot be edited or withdrawn.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

s.

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 Once submitted, comments cannot be edited or withdrawn.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

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

rs 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 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 non-creditable 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

rmaceuticals? 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

xecutive 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

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, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. If finalized, healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all pharmaceutical reverse distributors, regardless of 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

zardous 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. Non-creditable 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 off-site, 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

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

ed 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

ral 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.

1 RCRA also governs the disposal of non-hazardous solid wastes; however, state and/or local environmental regulatory agencies predominantly administer the regulations pertaining to the management of non-hazardous wastes.

2 For more information on RCRA State Authorization, see: http://www.epa.gov/osw/laws-regs/state/index.htm .

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

tries 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

3 For more information on hazardous waste generators, please see: http://www.epa.gov/waste/hazard/generation/index.htm .

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:

4 See 40 CFR 261.2 for the definition of solid waste.

5 The 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-, P- or 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)

e 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-, P- or 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).

• 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 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). 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

ng 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 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).

6 EPA 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.

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

egulatory 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.

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.

7 For 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 .

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)

l 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).

8 Commercial 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)).

9 The 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.

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

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.

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).

10 The 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.

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)

he 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

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.)

12 Memo from Devlin to RCRA Division Directors, February 17, 2012 (RCRA Online #14831) http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/A5C07D01188ECA59852579EA0067CDB1/$file/14831.pdf .

13 Memo December 1, 1994 (RCRA Online #13718) http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/1C1DEB3648A62A868525670F006BCCD2/$file/13718.pdf .

14 Memo from Dellinger to Smith, March 18, 2003 (RCRA Online #14654) http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/7ACFEC572DE8897F85256D1600748BCB/$file/14654.pdf .

15 Memo from Brandes to Knauss, April 6, 1998 (RCRA Online #14175) http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/7417D2556AD322FA852568E300468198/$file/14175.pdf

2/$file/13718.pdf .

14 Memo from Dellinger to Smith, March 18, 2003 (RCRA Online #14654) http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/7ACFEC572DE8897F85256D1600748BCB/$file/14654.pdf .

15 Memo from Brandes to Knauss, April 6, 1998 (RCRA Online #14175) http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/7417D2556AD322FA852568E300468198/$file/14175.pdf .

16 Memo from Dellinger to Smith, August 23, 2010 (RCRA Online #14817) http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/209444BADDA4ECDC852577ED00624E8F/$file/14817.pdf .

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, state-specific 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 17

17 Anyone 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 .

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

ind 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.

18 Executive 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.

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

ublic comments related to 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

wer, 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

19 P-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)).

20 On 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

he 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 .

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

ng 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, 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

rmine whether any should be modified, 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.

21 For a copy of Executive Order 13563, please see: http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf .

22 US EPA. Improving Our Regulations: Final Plan for Periodic Retrospective Reviews of Existing Regulations. http://www.epa.gov/regdarrt/retrospective/documents/eparetroreviewplan-aug2011.pdf .

23 See 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 .

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)

ns 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 nicotine-containing 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)

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.

24 The current federal universal wastes include hazardous waste batteries, certain hazardous waste pesticides, mercury-containing equipment, and hazardous waste lamps.

25 The 5,000 kilogram accumulation criterion applies to the quantity of all universal wastes accumulated.

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

in 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, mercury-containing 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

sal wastes (batteries, mercury-containing 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.

26 See docket EPA-HQ-RCRA-2007-0932 at www.regulations.gov for public comments: http://www.regulations.gov/#!docketDetail;D=EPA-HQ-RCRA-2007-0932;dct=FR%252BPR%252BN%252BO%252BSR .

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

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)

euticals 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

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

h 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

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):

27 For a copy of the report, please see: http://www.epa.gov/oig/reports/2012/20120525-12-P-0508.pdf or see the docket for this proposed rule: EPA-HQ-RCRA-2007-0932.

(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 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.

28 For a copy of OSWER's full response to OIG, please see: http://www.epa.gov/oig/reports/2012/12-P-0508_Agency%20Response.pdf .

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

OIG, please see: http://www.epa.gov/oig/reports/2012/12-P-0508_Agency%20Response.pdf .

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,” “non-creditable 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.

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azardous 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-the-counter 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

inal dermal patches, with the primary purpose to deliver or dispense the pharmaceutical. As a rule of thumb, if an over-the-counter 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

s 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.

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

or prescribed by healthcare providers to patients. 29 Further, retail pharmacies routinely sell vitamins and other medicinal minerals and supplements.

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.

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 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.

30 The substance of the definition is: a product (other than tobacco) intended to supplement the http://www.gpo.gov/fdsys/pkg/USCODE-2013-title21/pdf/USCODE-2013-title21-chap9-subchapII-sec321.pdf .

31 For 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

tended to supplement the http://www.gpo.gov/fdsys/pkg/USCODE-2013-title21/pdf/USCODE-2013-title21-chap9-subchapII-sec321.pdf .

31 For 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.

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 clean-up 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

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.

33 See 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 .

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

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

34 For additional information about RCRA hazardous waste listings and characteristics, see: http://www.epa.gov/osw/hazard/wastetypes/index.htm .

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.

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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

rough 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

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 non-creditable 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

t are shipped to reverse distributors for manufacturer's credit, while also ensuring that non-creditable 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.

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ives 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

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

rdous 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 non-pharmaceutical hazardous waste to help us delineate what is and what is not regulated under this new subpart. We are proposing to define the term “non-pharmaceutical 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 non-

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)

nerating 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.

35 45 CFR part 160 http://aspe.hhs.gov/admnsimp/final/pvctxt01.htm .

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

ceuticals on its premises.

35 45 CFR part 160 http://aspe.hhs.gov/admnsimp/final/pvctxt01.htm .

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

36 For 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 .

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

ion 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

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

ore 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

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.

37 As 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

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.

37 As 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.

38 Through 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.

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

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

39 On 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.”

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 DEA-registered reverse distributor may or may not meet EPA's definition of a pharmaceutical reverse distributor and vice versa

or 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 DEA-registered 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 DEA-registered 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.

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.

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

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.

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.

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.”

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

d 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 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

nder 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 long-term 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

evaluation 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.

42 See November 13, 1984; 49 FR 44978.

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

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.

43 AARP 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-july-2012-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.

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

ered 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 47 Therefore, EPA is providing notice that if this rule is finalized, long-term care facilities may no longer use the household hazardous waste exemption. If this rule is finalized, long-term 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 long-term 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)

, 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 long-term 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.

46 Net 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).

47 Memo 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.

48 See 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.

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

g for data about long-term care facilities which was developed using data in the economic analysis: EPA-HQ-RCRA-2007-0932.

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.

49 Not 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.

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

alify 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.

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 non-creditable 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

nerated 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

gulatory 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

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

usehold 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.

50 See 49 FR 44978; November 13, 1984.

51 See memo November 1, 1988, from Porter to Regions (RCRA Online #11377). http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/2FD51915214EF63C8525670F006BDC88/$file/11377.pdf.

52 See memo September 26, 2012, Rudzinski to the Regional RCRA Division Directors (RCRA Online# 14833)

to a requirement for pharmaceutical collection programs.

50 See 49 FR 44978; November 13, 1984.

51 See memo November 1, 1988, from Porter to Regions (RCRA Online #11377). http://yosemite.epa.gov/osw/rcra.nsf/0c994248c239947e85256d090071175f/2FD51915214EF63C8525670F006BDC88/$file/11377.pdf.

52 See 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.

53 Since 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.

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-by-step 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

cals. 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

armaceuticals.

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 non-retrievable 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 Conditional Exemption for Hazardous Waste Pharmaceuticals that are also Controlled Substances.

54 See 21 CFR 1308 for a complete list of controlled substances.

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

56 Proposed rule: December 21, 2012; 77 FR 75784, see page 75803; and final rule: September 9, 2014; 79 FR 53520, see page 53548).

ii. Hazardous waste pharmaceuticals that are also medical wastes

l Exemption for Hazardous Waste Pharmaceuticals that are also Controlled Substances.

54 See 21 CFR 1308 for a complete list of controlled substances.

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

56 Proposed rule: December 21, 2012; 77 FR 75784, see page 75803; and final rule: September 9, 2014; 79 FR 53520, see page 53548).

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

rd 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.

57 The NRC regulates radioactive wastes generated by commercial or non-DOE facilities, whereas DOE regulates radioactive wastes generated by DOE facilities.

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

facilities, whereas DOE regulates radioactive wastes generated by DOE facilities.

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 non-hazardous wastes or non-pharmaceutical 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

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, non-hazardous 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 non-hazardous 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.

58 Published 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

i

not regulated as hazardous waste under RCRA Subtitle C.

58 Published 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

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 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.

59 As 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 U-listings even if one, two or all of the active ingredients are listed on the P- and/or U-lists.

60 The descriptions “bulk” and “trace” when applied to chemotherapeutic wastes are industry terms and are not defined by the federal RCRA regulations.

61 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012

ctive ingredient do not meet the specifications of the P- and U-listings even if one, two or all of the active ingredients are listed on the P- and/or U-lists.

60 The descriptions “bulk” and “trace” when applied to chemotherapeutic wastes are industry terms and are not defined by the federal RCRA regulations.

61 NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. http://www.cdc.gov/niosh/docs/2012-150/.

62 OSHA Technical Manual, Section VI: Chapter 2, Appendix VI: 2-1. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html.

ii. Recommended best management practices for other non-hazardous pharmaceutical wastes ( i.e., those not possessing hazardous waste like-qualities). 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

ample, 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).

63 Barnes, 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.

64 Buszka, 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.

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 non-pharmaceutical hazardous wastes is often more routine and does not trigger the same concerns that healthcare facilities experience when managing hazardous waste pharmaceuticals

s 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 non-pharmaceutical 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 non-creditable 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 non-creditable hazardous waste pharmaceuticals;

tandards for healthcare facilities that manage non-creditable 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 non-creditable hazardous waste pharmaceuticals;

(2) personnel training requirements for healthcare facilities managing non-creditable 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 non-creditable hazardous waste pharmaceuticals;

(5) container standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(6) labeling standards on containers for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(7) accumulation time limits for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(8) land disposal restrictions for non-creditable hazardous waste pharmaceuticals;

(9) procedures for shipping non-creditable 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 non-creditable hazardous waste pharmaceuticals;

(12) recordkeeping requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(13) procedures for responses to releases by healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(14) special requirements for long-term care facilities managing non-creditable hazardous waste pharmaceuticals;

editable hazardous waste pharmaceuticals;

(12) recordkeeping requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(13) procedures for responses to releases by healthcare facilities managing non-creditable hazardous waste pharmaceuticals;

(14) special requirements for long-term care facilities managing non-creditable 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 Non-Creditable 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

cal 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

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.

65 A 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.

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

ill 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.

66 For information on the current Site Identification Form, please see: http://www.epa.gov/wastes/inforesources/data/form8700/8700-12.pdf .

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.

67 The 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)

ection 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.

67 The 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.

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

l hazardous wastes. So while the notification requirement ensures that the environmental regulatory a

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