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5816 Federal Register / Vol 5816 Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Rules and Regulations ENVIRONMENTAL PROTECTION some information is not publicly B. What facilities are not subject to the AGENCY available, e.g., CBI or other information final rule? whose disclosure is restricted by statute. C. Scope of Hazardous Wastes Addressed 40 CFR Parts 261, 262, 264, 265, 266, Certain other material, such as by This Final Rule 268, 270, and 273 D. Wastes Generated at Healthcare copyrighted material, is not placed on Facilities That Are Not Included in the [EPA–HQ–RCRA–2007–0932; FRL–9988–26– the internet and will be publicly Scope of this Final Rule OLEM] available only in hard copy form. VIII. What terms are defined in this final Publicly available docket materials are rule? (§ 266.500) RIN 2050–AG39 available electronically through https:// A. Definition of Pharmaceutical www.regulations.gov. B. Definition of Hazardous Waste Management Standards for Hazardous Pharmaceutical FOR FURTHER INFORMATION CONTACT: Waste Pharmaceuticals and C. Definition of Reverse Distributor Amendment to the P075 Listing for Kristin Fitzgerald, Materials Recovery D. Definition of Potentially Creditable Nicotine and Waste Management Division, Office Hazardous Waste Pharmaceutical of Resource Conservation and Recovery E. Definition of Non-Creditable Hazardous AGENCY: Environmental Protection (5304P), Environmental Protection Waste Pharmaceutical Agency (EPA). Agency, 1200 Pennsylvania Ave. NW, F. Definition of Evaluated Hazardous ACTION: Final rule. Washington, DC 20460; telephone Waste Pharmaceutical number: (703) 308–8286; email address: G. Definition of Household Waste SUMMARY: Some pharmaceuticals are [email protected], or Brian Pharmaceutical H. Definition of Non-Hazardous Waste regulated as hazardous waste under the Knieser, Materials Recovery and Waste Resource Conservation and Recovery Pharmaceutical Management Division, Office of I. Definition of Non-Pharmaceutical Act (RCRA) when discarded. This final Resource Conservation and Recovery Hazardous Waste rule adds regulations for the (5304P), Environmental Protection J. Definition of Healthcare Facility management of hazardous waste Agency, 1200 Pennsylvania Ave. NW, K. Definition of Long-Term Care Facility pharmaceuticals by healthcare facilities Washington, DC 20460; telephone IX. Applicability (§ 266.501) and reverse distributors. Healthcare number: (703) 347–8769; email address: A. What facilities are subject to the final facilities (for both humans and animals) [email protected]. Also see the rule? and reverse distributors will manage EPA’s website at https://www.epa.gov/ B. What facilities or pharmaceuticals are not subject to the final rule? their hazardous waste pharmaceuticals hwgenerators/management- under this new set of sector-specific (§§ 266.501(c) and 266.501(f) and pharmaceutical-hazardous-waste. 266.501(g)) standards in lieu of the existing SUPPLEMENTARY INFORMATION: C. Do Not Count Hazardous Waste hazardous waste generator regulations. Pharmaceuticals Managed Under Among other things, these new Table of Contents Subpart P Toward Determining regulations prohibit the disposal of The information presented in this Generator Category (§§ 262.13(c)(9)) hazardous waste pharmaceuticals down preamble is organized as follows: X. Standards for Healthcare Facilities That the drain and eliminates the dual Manage Non-Creditable Hazardous I. General Information regulation of RCRA hazardous waste Waste Pharmaceuticals (§ 266.502) A. Does this action apply to me? A. Notification/Withdrawal Requirements pharmaceuticals that are also Drug B. What action is the Agency taking? for Healthcare Facilities Managing Non- Enforcement Administration (DEA) C. What is the Agency’s statutory authority Creditable Hazardous Waste for taking this action? controlled substances. The new rules Pharmaceuticals (§ 266.502(a)) D. What are the incremental costs and also maintain the household hazardous B. Personnel Training Requirements for benefits of this action? waste exemption for pharmaceuticals Healthcare Facilities Managing Non- collected during pharmaceutical take- II. List of Acronyms III. Rationale for the Final Rule Creditable Hazardous Waste back programs and events, while IV. Background Pharmaceuticals (§ 266.502(b)) ensuring their proper disposal. The new A. Summary of the Proposal C. Healthcare Facilities Making a rules codify Environmental Protection B. Retail Sector Notice of Data Availability Hazardous Waste Determination for Non- Agency (EPA)’s prior policy on the (NODA) Creditable Pharmaceuticals (§ 266.502(c)) regulatory status of nonprescription C. Retail Strategy D. No Central Accumulation Area and D. EPA Inspector General Report Satellite Accumulation Area pharmaceuticals going through reverse Requirements for Healthcare Facilities logistics. Additionally, EPA is excluding V. Amendment to the Acute Hazardous Waste Listing for Nicotine and Salts Managing Non-Creditable Hazardous certain U.S. Food and Drug (Hazardous Waste No. P075) Waste Pharmaceuticals Administration (FDA) approved over- A. Background E. Container Standards for Healthcare the-counter (OTC) nicotine replacement B. Summary of the Proposal Facilities Managing Non-Creditable therapies (NRTs) from regulation as C. Summary of Comments Hazardous Waste Pharmaceuticals hazardous waste and is establishing a D. Final Rule Provisions (§ 266.502(d)) policy on the regulatory status of unsold E. Comments and Responses F. Labeling Standards on Containers for retail items that are not pharmaceuticals VI. Reverse Distribution and Reverse Healthcare Facilities Managing Non- Creditable Hazardous Waste and are managed via reverse logistics, Logistics A. Summary Pharmaceuticals (§ 266.502(e)) fulfilling the commitment we made in B. Background G. Accumulation Time Limits for the Retail Strategy of September 2016. C. EPA’s Proposed Regulations for Reverse Healthcare Facilities Managing Non- DATES: This final rule is effective on Distribution of Pharmaceuticals Creditable Hazardous Waste August 21, 2019. D. EPA’s Final Reverse Distribution Pharmaceuticals (§ 266.502(f)) H. Land Disposal Restrictions for ADDRESSES: The EPA has established a Regulation and Reverse Logistics Policy Healthcare Facilities Managing Non- docket for this action under Docket ID E. Applicability of the Household Hazardous Waste Exemption to Retail Creditable Hazardous Waste No. EPA–HQ–RCRA–2007–0932. All Items Pharmaceuticals (§ 266.502(g) and documents in the docket are listed on VII. Scope of the Final Rule § 266.502(d)(4)) the https://www.regulations.gov A. What facilities are subject to the final I. Procedures for Healthcare Facilities website. Although listed in the index, rule? Managing Rejected Shipments of Non- VerDate Sep<11>2014 17:24 Feb 21, 2019 Jkt 247001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\22FER2.SGM 22FER2 Federal Register / Vol. 84, No. 36 / Friday, February 22, 2019 / Rules and Regulations 5817 Creditable Hazardous Waste B. Summary of Proposal Order 13563: Improving Regulation and Pharmaceuticals (§ 266.502(h)) C. Summary of Comments Regulatory Review J. Reporting Requirements for Healthcare D. Final Rule Provisions B. Executive Order 13771: Reducing Facilities Managing Non-Creditable E. Comments and Responses Regulations and Controlling Regulatory Hazardous Waste Pharmaceuticals XIV. Conditional Exemptions for Hazardous Costs (§ 266.502(i)) Waste Pharmaceuticals That Are Also C. Paperwork Reduction Act K. Recordkeeping Requirements for Drug Enforcement Administration D. Regulatory Flexibility Act Healthcare Facilities Managing Non- Controlled Substances and Household E. Unfunded Mandates Reform Act Creditable Hazardous Waste Waste Pharmaceuticals Collected in F. Executive Order 13132: Federalism Pharmaceuticals (§ 266.502(j)) Take-Back Programs (§ 266.506) G. Executive Order 13175: Consultation L. Response to Spills for Healthcare A. Summary of Proposal With Tribal Governments Facilities Managing Non-Creditable B. Summary of Comments H. Executive Order 13045: Children’s Hazardous Waste Pharmaceuticals C. Final Rule Provisions Health (§ 266.502(k)) D. Comments and Responses I. Executive Order 13211: Energy Supply M. Management of Non-Creditable XV. Management of Residues in J. National Technology Transfer and Hazardous Waste Pharmaceuticals by Pharmaceutical Containers (§ 266.507) Advancement Act Long-Term Care Facilities That Collect A. Regulatory Background K. Executive Order 12898: Environmental Them From Individuals Who Self- B. Stock, Dispensing and Unit-Dose Justice Administer Containers (§ 266.507(a)) L. Congressional Review Act N. Healthcare Facilities That Accept C. Syringes (§ 266.507(b)) Hazardous Waste Pharmaceuticals From D. Other Containers, Including Delivery I. General Information Off-Site Very Small Quantity Generator Devices (§ 266.507(c) & (d)) Healthcare Facilities (§ 266.502(l)) XVI. Shipping Standards for Hazardous A. Does this action apply to me? XI. Standards for Healthcare Facilities That Waste Pharmaceuticals (§§ 266.508 and This final rule applies to healthcare Accumulate Potentially Creditable 266.509) facilities that generate, accumulate, or Hazardous Waste Pharmaceuticals Prior A. Shipping Non-Creditable Hazardous otherwise handle hazardous waste to Shipment To Reverse Distributors Waste Pharmaceuticals From Healthcare pharmaceuticals and reverse (§ 266.503) Facilities to Treatment, Storage, and A. Healthcare Facilities Making a Disposal Facilities (§ 266.508(a)) distributors engaged in the management Hazardous
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