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EPA Finalizes Universal Waste Rule for Hazardous Aerosol Can Wastes, Streamlining Requirements for Their Management

Written by Aaron H. Goldberg, Principal, Beveridge & Diamond

On November 15, 2019, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a final rule to classify and regulate hazardous aerosol can wastes as “universal wastes” under the federal Resource Conservation and Recovery Act (RCRA) hazardous waste rules. Once the rule becomes effective, hazardous aerosol can wastes will be subject to substantially reduced requirements for collection and transport, in order to facilitate and encourage environmentally sound recycling or disposal. However, the ultimate recycling and disposal facilities will remain subject to essentially the same requirements as currently apply. As discussed below, even though the final rule is largely consistent with existing requirements for other universal wastes, and even though EPA has finalized the proposal with only limited changes, there are several aspects of the rule that warrant special attention.

The final rule builds on existing universal waste requirements for other ubiquitous hazardous wastes, such as batteries, lamps, mercury-containing equipment, and certain pesticides. See generally 40 C.F.R. Part 273. Among other things, the aerosol can wastes will no longer have to be labeled as hazardous wastes (although they will be subject to reduced marking requirements), they may be stored for up to one year or even longer in some cases (rather than just 90 days for large quantity generators), they may be transported offsite without a hazardous waste transporter or hazardous waste manifest, and collection facilities not engaged in treatment or disposal will not have to be permitted as hazardous waste storage facilities. In addition, only large handlers of universal wastes (e.g., facilities that accumulate 5000 kg or more of total universal wastes at any time) will be required to notify EPA and track shipments of the hazardous aerosol can wastes. Aerosol can wastes generated by households and Very Small Quantity Generators (VSQGs) meeting applicable requirements will remain exempt from the RCRA regulations. However, all aerosol wastes will remain subject to applicable requirements under the U.S. Department of Transportation (DOT) Hazardous Materials Regulations (HMR) (although under those rules, if aerosol cans are classified as universal wastes, they will not be subject to the enhanced DOT requirements that normally apply to RCRA hazardous wastes). See 49 C.F.R. § 171.8 (defining “hazardous wastes” for purposes of the HMR as materials subject to federal hazardous waste manifest requirements).

Several key aspects of the final rule are discussed below. We note that the discussion here is based solely on the pre-publication version of the final rule and preamble. It is possible (though unlikely) that there may be some substantive changes in the rule when it is published in the Federal Register. In addition, EPA’s Response-to-Comments document and economic assessment for the rule (neither of which are currently publicly available) may provide a further gloss on some of the issues addressed here.

Definition of Aerosol Can

The proposed rule would have limited the definition of “aerosol cans” subject to the rule to containers that use gas to “aerate and dispense any material … in the form of a spray or foam.” In this way, the proposal would have excluded cans that dispense products without aeration (e.g., shaving gels) and cans that release only gas (e.g., spray dusters or aerosol horns). In response to comments, EPA modified the definition in the final rule so that it is more inclusive and consistent with DOT rules. Under the final rule, cans that dispense products without aeration will be eligible for management as universal wastes. However, gas-only products will be excluded. DOT is currently considering a petition to revise its definition to include these products, consistent with international rules for dangerous goods transport. See Petition of the Consumer Specialty Products Association, et al. to DOT (September 28, 2017). Unfortunately, the preamble to EPA’s final rule does not mention this petition, and it is unclear if the Agency would amend the definition in the universal waste rule if/when DOT changes its definition.

Status of Aerosol Cans with Evidence of Leakage/Damage

The proposed rule would have excluded from the scope of the universal waste rule any aerosol cans that “show evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.” Commenters expressed concern that this proposed limitation was highly ambiguous, could effectively eviscerate the rule and was unnecessary from an environmental perspective (since EPA could simply require more protective packaging for leaking aerosol cans). In the final rule, the Agency agreed with the commenters and added new provisions specifying that “[u]niversal waste aerosol cans that show evidence of leakage must be packaged in a separate closed container or overpacked with absorbents, or immediately punctured and drained.” EPA also modified the definition of aerosol can so that it no longer requires that cans be “intact” to be classified as universal wastes.

Status of Empty Aerosol Cans

The final rule, like the proposed rule, excludes aerosol cans that meet the regulatory definition of an empty container. This exclusion raises a number of issues, as discussed below:

  • Commenters on the proposed rule asked EPA for clarification about when aerosol cans are properly deemed empty. They noted that it is unclear how the regulatory definition of empty and related Agency guidance applies to aerosol cans. EPA largely side-stepped this issue in the final rule. It merely restated the regulations and guidance and said that further clarifications or modifications to the relevant rules were outside the scope of the rulemaking.
  • Commenters raised questions about the relationship of the exclusion for empty cans with past EPA statements that such cans may sometimes exhibit the characteristic of reactivity. See EPA, RCRA Hotline Report (September 1987) (RCRA Online #13027) (“Irrespective of the lack of contained waste, [empty] aerosol cans would be a RCRA hazardous waste [to the extent] they demonstrate the hazardous characteristic of reactivity”). Neither the final rule nor the preamble addresses this issue.
  • The proposal left open the question as to whether empty cans could voluntarily be managed as universal wastes. In the preamble to the final rule, EPA clarified that empty cans may be managed as universal wastes, even though they do not have to be.

Other Issues Related to the Applicability of RCRA to Aerosol Cans

Commenters on the proposed rule asked EPA for guidance on several fundamental issues associated with the applicability of RCRA to aerosol cans in the first instance. For example, they requested guidance on the extent (if any) to which aerosol cans destined for recycling are properly classified as solid wastes (and thus potentially hazardous wastes). The commenters also asked the Agency for guidance about when (if ever) waste aerosol cans (empty or non-empty) might be classified as reactive hazardous wastes, and (as noted above) when aerosols cans qualify as empty. However, the final rule and preamble are essentially silent on these issues. Moreover, even though EPA had previously committed to providing such guidance as part of its 2016 strategy for addressing the applicability of RCRA to the retail sector, the preamble to the final rule states that “EPA has [now] completed all commitments made in the Retail Strategy,” which suggests that the guidance may not be forthcoming. See EPA, “Strategy for Addressing the Retail Sector under the Resource Conservation and Recovery Act’s Regulatory Framework” (September 12, 2016) at 6 (“EPA is developing a guide on how to recycle aerosol cans under the existing Subtitle C recycling exclusions”).

Allowance of Certain Processing Activities by Handlers

The final rule allows handlers of universal waste aerosol cans to perform certain limited activities, “as long as each individual aerosol can is not breached and remains intact”:

  • Sorting aerosol cans by type.
  • Mixing intact cans in one container.
  • Removing actuators to reduce the risk of accidental release.

Although there may be some uncertainty, it appears that these activities may only be performed with intact containers, even though (as noted above) EPA has modified the definition of aerosol can to eliminate the “intact” requirement. For these purposes, it appears that a can with a removed (or possibly missing) actuator would still be viewed as intact, assuming the integrity of the can has not otherwise been compromised.

Special Rules for Puncturing and Draining of Aerosol Cans

Even though puncturing and draining of hazardous aerosol cans is currently exempt from RCRA regulation if performed as part of a recycling process, the final rule imposes new requirements for puncturing and draining by handlers of universal waste aerosol cans (whether they are processing their own aerosol can wastes or those generated by others). For example, these activities will have to be performed using a device (commercial or “homemade”) that is specifically designed to do so in a safe manner that effectively contains residual contents and emissions. The handler will have to develop and follow written procedures to ensure proper operation of the equipment (including segregating incompatible wastes and preventing fires/releases) and to respond to any spills or releases, and it will have to ensure relevant employees are adequately trained. The contents drained from the aerosol cans will have to be “immediately” transferred to a tank or container meeting applicable hazardous waste generator requirements (e.g., the requirements for 90-day accumulation units or satellite accumulation units). A hazardous waste determination will have to be performed on the drained contents, and the materials will have to be managed accordingly. The drained cans will have to be recycled, and since they will be eligible for the RCRA exemption for recycled scrap metal, they will not have to be subjected to a hazardous waste determination. EPA notes that all of these activities must be conducted in compliance with all applicable federal, state, and local laws and regulations related to solid or hazardous wastes, as well as occupational safety and health.

Adoption by the States

EPA states that the final rule is “less stringent than the current federal program” and thus “states … will not have to adopt the universal waste regulations for aerosol cans.” However, as noted above, the new rules for puncturing and draining are more stringent than current rules (because those activities are currently exempt from regulation if performed as part of a recycling process), which casts doubt on the Agency’s claim that the final rule (in its entirety) is less stringent.

Shipments Between States

Despite requests from commenters for EPA to address this issue, the final rule and preamble are silent on the requirements that will apply to aerosol cans shipped from, to, or through states that do not adopt (or have not yet adopted) a universal waste rule for aerosols. In prior universal waste rules for other wastes, EPA has claimed that, in such circumstances, the waste would have to be transported in the non-universal-waste states by a hazardous waste transporter and with a hazardous waste manifest. See, e.g., 64 Fed. Reg. 36,466, 34,483 (July 6, 1999) (universal waste rule for lamps) (“[if] a [federal universal waste is] transported across a State in which it is subject to the full hazardous waste regulations … [t]ransport through the State must be conducted by a hazardous waste transporter and must be accompanied by a manifest”); 70 Fed. Reg. 45,508, 45,517 (August 5, 2005) (universal waste rule for mercury-containing equipment) (same). However, there appears to be a strong argument under the Hazardous Materials Transportation Act (HMTA) that state rules requiring a manifest are preempted if (as would be the case here) federal law does not require a manifest. See, e.g., Letter from Michael Shapiro, Director, Office of Solid Waste, EPA, to Richard J. Barlow, Chair, Northeast Waste Management Officials’ Association (June 11, 1996) (RCRA Online #14135) (“[although] preemption authorities are [generally] quite foreign to RCRA … they are introduced into the transporter area by the statutory directive in RCRA to maintain consistency with the DOT framework”); 49 Fed. Reg. 10,490, 10,492 (March 20, 1984) (federal law “prohibit[s] States from requiring separate State manifests or other information to accompany waste shipments”); id. at 10,494 (“States are not precluded from setting up another system of forms . . . as long as the system does not interfere with the actual shipment of waste [and] transporters [are] not . . . required to carry these forms”). Similar arguments may apply with respect to state requirements to use a hazardous waste transporter for a federally designated universal waste.

Next Steps

The final rule is expected to be published in the Federal Register in the next few weeks and will become effective at the federal level six months later, or approximately in early June 2020. The rule will not become effective in most states unless and until they act to adopt the rule, which (as discussed above) EPA says they will not be required to do (on the ground that the rule is less stringent than existing requirements). However, because several states have previously classified hazardous aerosol can wastes as universal wastes (e.g., California, Colorado, Utah, New Mexico, and Ohio) and another is poised to do the same (i.e., Minnesota), it can be reasonably expected that virtually all states will eventually follow EPA’s lead on this issue (possibly with some variations).

For more information about the final rule and its potential implications, please contact Aaron Goldberg or any other members of our Waste and Recycling practice group.

This article has been republished with permission of the author.  It was first published on the Beveridge & Diamond website.  


 

About the Author

Aaron applies his encyclopedic knowledge of hazardous waste regulatory law to help companies comply under federal and state laws—throughout all 50 states—and abroad.

He holds an advanced degree in chemistry, has extensive training in economics, and is a former U.S. Environmental Protection Agency consultant. His unique, multidisciplinary background—law, science, economics, and government—informs nearly every aspect of his work and makes him a useful bridge between attorneys, engineers, business managers, consultants, and regulators.

Aaron has focused on hazardous waste issues since the beginning of the federal regulatory program in 1980. With this historical experience, he offers clients comprehensive regulatory counsel on hazardous waste matters, including compliance strategy, advocacy, rulemaking challenges, end-of-life product management, permits, variances, and enforcement action response. His clients consist of companies and trade associations in the chemicals, electronics, recycling, petroleum, pharmaceuticals, retail, steel, and mining industries.

Hazardous Waste & Environmental Response Conference – November 25th & 26th

The Hazardous Waste & Environmental Response Conference is scheduled for November 25th & 26th at the Mississauga Convention Centre in Mississauga, Ontario.  The event is co-hosted by the Ontario Waste Management Association and Hazmat Management Magazine.

This 2-day conference provides an essential and timely forum to discuss the management of hazardous waste and special materials, soils and site remediation, hazmat transportation, spill response and cutting-edge technologies and practices. Valuable information will be provided by leading industry, legal, financial and government speakers to individuals and organizations that are engaged in the wide range of services and activities involving hazardous and special materials.

Attendees can expect an informative and inspiring learning and networking experience throughout this unique 2-day event. Session themes provide an essential and timely forum to discuss the management of hazardous waste and special materials, soils and site remediation, hazmat transportation, spill response and cutting-edge technologies and practices.

As the only event of its kind in Canada, delegates will receive valuable information from leading industry, legal, financial and government speakers who are actively engaged in a wide range of services and activities involving hazardous waste and special materials.

Company owners, business managers, plant managers, environmental professionals, consultants, lawyers, government officials and municipalities – all will benefit from the opportunity to learn, share experiences and network with peers.

CONFERENCE SCHEDULE

MONDAY, NOVEMBER 25 – GENERAL SESSIONS

8:00 am – Registration

8:45 am – Opening and Welcome Address

9:00 am – 9:40 am

OPENING KEYNOTE – Lessons Learned from Hazmat Incidents

Jean Claude Morin, Directeur General, GFL Environmental Inc.

Dave Hill, National Director Emergency Response, GFL Environmental Inc.

Jean Claude and Dave will discuss lessons learned from hazmat incidents in Canada, including, train derailments, truck turn-overs, and hazardous materials storage depot explosions. This presentation will also provide an overview of some of the more serious incidents in Canada and discuss the valuable lessons learned regarding best practices in hazmat response.

9:40 am – 10:10 am

Legal Reporting Requirements

Paul Manning, LL.B., LL.M, Certified Specialist in Environmental Law and Principal, Manning Environmental Law

Paul will provide an overview of the Canadian federal and Ontario legislation as it relates to the reporting requirements in the event of a hazmat incident and/or spill. Included in the discussion will be an examination of the case law related to hazmat incidents and failure to report.

10:10 am – 10:45 am – Refreshment Break             

10:45 am – 11:15 am

Hazmat and Spill Response Actions and the Utilization of Countermeasures

Kyle Gravelle, National Technical Advisor, QM Environmental

Kyle will be speaking on hazmat and spill response actions and countermeasures to prevent contamination. Included in the presentation will be real-world examples of incidents in Canada and advice on preparations and hazmat management.

11:15 am – 12:00 pm

PANEL DISCUSSION: Utilization of New Technologies for HazMat Emergency Response

Moderator:  Rob Cook, CEO, OWMA

James Castle, CEO & Founder, Terranova Aerospace

Bob Goodfellow, Manager, Strategic Accounts & Emergency Response, Drain-All Ltd.

Ross Barrett, Business Development/Project Manager, Tomlinson Environmental Services Ltd.

The hazmat and environmental response sector is quickly evolving. During this discussion, panelists will share their experiences on new technologies and methodologies for the management of hazmat and environmental incidents and provide advice on what companies should do to be better prepared for hazmat incidents.

12:00 pm – 1:30 pm – Luncheon Speaker

From Hacking to Hurricanes and Beyond – The New Era of Crisis Communications

Suzanne bernier, CEM, CBCP, MBCI, CMCP, President, SB Crisis Consulting, Founder & Author of Disaster Heroes

During any crisis, communicating effectively to all key stakeholders is key. This session, delivered by a former journalist and now award-winning global crisis communications consultant, will look at the evolution of crisis management and crisis communications over the past 15 years. Specific case studies and lessons learned from events like the recent terror and mass attacks across North America, as well the 2017 hurricane season will be shared, including Texas, Florida and Puerto Rico communications challenges and successes. The session will also review traditional tips and tools required to ensure your organization can communicate effectively during any crisis, while avoiding any reputational damage or additional fall-out that could arise.

1:35 pm – 2:15 pm

Fire Risk in Hazmat and Hazardous Waste Facilities – The Impact and Organizational Costs 

Ryan Fogelman, Vice President of Strategic Partnerships, Fire Rover

Fire safety is an important responsibility for everyone in the hazardous materials & waste sector. The consequences of poor fire safety practices and not understanding the risk are especially serious in properties where processes or quantities of stored hazmat and waste materials would pose a serious ignition hazard.

In an effort to prevent fires and minimize the damage from fires when they occur, owners, managers and operators of hazmat and related facilities will learn about fire safety and how to develop plans to reduce the risk of fire hazards.

Learn about:

  • Data and statistics on waste facility fire incidents
  • Materials and processes that create a fire risk
  • Planning and procedures to reduce fire risk
  • Tools and practices to detect, supress and mitigate fire damage.

2:15 pm – 2:45 pm

Implementation of Land Disposal Restrictions (LDR) in Ontario – Treatment Requirements & Associated Costs

Erica Carabott, Senior Environmental Compliance Manager, Clean Harbours Inc.

The field of hazardous waste management in Ontario is complex and places an onus on all parties involved, including, generators, carriers, transfer and disposal facility operators. Initiatives such as pre-notification, mixing restrictions, land disposal restrictions, recycling restrictions and the requirements of the Hazardous Waste Information Network (HWIN) all add to the cumbersome task. The Landfill Disposal Restrictions (LDR) place responsibilities on generators and service providers alike. This presentation aims to navigate the implementation of LDR in Ontario, with specific emphasis on the Clean Harbors Sarnia facility to accommodate LDR treatment and the significant costs associated with it.

2:45 pm – 3:15 pm – Refreshment Break

3:15 pm – 4:00 pm

New Requirements on the Shipment of Hazardous Goods – Provincial, Federal and International   

Eva Clipsham, A/Safety Policy Advisor for Transport Canada

Steven Carrasco, Director, Program Management Branch, Ontario Ministry of the Environment, Conservation and Parks (MOECP)

Current federal and provincial frameworks for regulating the movement of hazardous waste and materials are currently undergoing change. Manifesting systems are being upgraded and refocused as electronic systems that will provide efficiencies to both generators and transporters. Learn about the current federal and provincial systems and the changes that are anticipated to be implemented in the near future.

4:00 pm – 5:00 pm – All attendees are invited to attend the Tradeshow Reception!

TUESDAY, NOVEMBER 26

8:30 am – Registration

8:45 am – Opening & Welcome Address

9:00 am – 9:45 am

Management of contaminated sites & increasing complexity and cost

Carl Spensieri, M.Sc., P.Eng., Vice President Environment, Berkley Canada (a Berkley Company)

This presentation will explore the various elements contributing to the increasing complexity and cost of managing contaminated sites. Carl will examine emerging risks and speak to potential strategies we can use to mitigate them. This presentation will also highlight opportunities for conference participants to offer new services that help owners of contaminated sites best respond to existing and emerging challenges.

9:45 am – 10:10 am – Refreshment Break

TRACK 1: HAZARDOUS WASTE GENERATION, TRANSPORTATION, TREATMENT AND DISPOSAL

10:15 am – 10:55 am

A National Perspective on the Hazardous Waste

Michael Parker, Vice President, Environmental Compliance, Clean Harbours Inc.

Hear about the challenges and opportunities facing the hazardous waste, hazmat and emergency response sector from an industry leader with a national view. The industry is evolving and the business fundamentals are ever changing. Government administrative and technical burdens are increasing and the volume of hazardous waste is declining – what will the future hold?

11:00 am – 11:40 am

PANEL DISCUSSION: Hazardous Waste & Special Materials – Transportation & Transit Challenges

Jim Halloran, Regional Manager, Heritage – Crystal Clean Inc.

Doug DeCoppel, EH&S Manager, International Permitting and Regulatory Affairs, GFL Environmental Inc.

Frank Wagner, Vice President Compliance, Safety-Kleen Canada Inc.

This panel will discuss key transportation issues and compliance challenges faced by hazardous waste generators and service providers, including significant changes to the documentation, labelling, packaging, emergency planning, and reporting requirements for hazardous waste and special materials shipments resulting from updated regulations and proposed initiatives. The panel will also review key considerations when selecting service providers to manage hazardous waste and special materials.

Topics included in this discussion: E-manifests (provincial and federal – lack of e-data transfer capabilities), HWIN fees (300% increase in fees but no increase in service), Transboundary Permits (lack of e-data transfer capabilities), container integrity and generator awareness.

11:45 am – 12:25 pm

Factors Influencing Treatment and Disposal Options for Hazardous Waste in Ontario

Ed Vago, Director of Operations, Covanta Environmental Solutions

Dan Boehm, Director of Business Development, Veolia ES Canada Industrial Services Inc.

Learn about the many recycling, treatment and disposal options for hazardous waste and hazardous materials in Ontario. Hear about the regulatory and operational factors to consider when deciding on the best management approach.

TRACK 2: SITE REMEDIATION

10:15 am – 10:55 am

Soils – Dig and Dump vs. On-Site Remediation: Factors to Consider & Case Studies

Devin Rosnak, Senior Client Manager & Technical Sales Manager, Ground Force Environmental

D. Grant Walsom, Partner, XCG Consulting Limited, Environmental Engineers & Scientists

Mark Tigchelaar, P. Eng., President and Founder of GeoSolv Inc.

Developers of brownfield site are faced with decisions around how to manage excavated soils. Impacted soils and soils with hazardous characteristics as tested at the site of generation can be managed through on-site remediation, or can be removed from the site to a variety of remediation and/or disposal options. Learn about the key options and factors that contribute to determining the optimum approach to managing soils.

11:00 am – 11:40 am

The Legal Framework for the Management of Contaminated Sites and Materials      

John Tidball, Partner, Specialist in Environmental Law, Miller Thomson LLP

The management of contaminated sites and related materials, including soils, are constrained by both regulatory and legal framework. Hear from a legal expert with unparalleled experience about the regulatory and legal issues that all developers/excavators transporters and service providers should be aware of as the legal liabilities in this area can be significant.

11:45 am – 12:25 pm

Anaerobic Bioremediation & Bioaugmentation – from the Lab to the Field

Dr. Elizabeth Edwards (Professor), Dr.Luz Puentes Jacome, Dr. Olivia Molenda, Dr. Courtney Toth, Dr. Ivy Yang (all Post doctoral fellows in the lab), Chemical Engineering & Applied Chemistry, University of Toronto

Together with her Post-Doctoral team, Dr. Edwards will present an overview of anaerobic bioremediation and bioaugmentation with some examples from their research and its application to the field.

12:30 pm – 2:00 pm

CLOSING KEYNOTE & LUNCHEON SPEAKER

Andrea Khanjin, MPP Barrie-Innisfil, Parliamentary Assistant, Ministry of the Environment, Conservation and Parks (MOECP)


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U.S.: New Hazardous Waste Pharmaceuticals Rule: Significant Changes Coming for Health Care Facilities, Particularly Long-Term Care Facilities

by Brooke F. Dickerson and Jennifer L. Hilliard,
Arnall Golden Gregory (AGG)

Health care facilities that provide a host of health care-related services or distribute, sell, or dispense pharmaceuticals will need to learn a whole new set of regulations thanks to a finalized new rule promulgated by the United States Environmental Protection Agency (EPA). The new rule revises management standards for hazardous waste pharmaceuticals (HWPs) such as urine drug tests for health care facilities, including nursing, skilled nursing, and inpatient hospice facilities, more than three years following the close of comments for the EPA’s initial proposed rule. The revised regulations will take effect six months following publication in the Federal Register.

The Resource Conservation Recovery Act (RCRA) governs the generation, management, storage, treatment, and disposal of hazardous wastes. Before the new rule was promulgated, certain health care facilities, such as hospitals and reverse distributors were subject to the same hazardous waste requirements under the RCRA as most industries. The management of HWPs at long-term care facilities, however, was excluded from the RCRA and treated the same as HWPs at residential households. EPA makes clear in this new rule that because nursing, skilled nursing, and inpatient hospice facilities are more akin to hospitals, their management of any hazardous waste, including HWPs, will also be subject to RCRA requirements.

The final rule revises some of the regulations and management standards for HWPs under the RCRA and sets them apart in a separate section of the RCRA regulations, to be codified at 40 C.F.R. Part 266, Subpart P (“Subpart P”), that are applicable specifically to health care facilities and reverse distributors. According to the EPA, this is necessary because hazardous waste generation and management practices at health care facilities differ significantly from those encountered in industry generally. As a result, regulating HWPs under the standard provisions of RCRA Subtitle C has been unnecessarily difficult. The EPA maintains that the new management standards are more streamlined and tailored specifically for healthcare HWPs and thus will promote proper management of HWPs by healthcare workers and pharmacy employees.

The final rule does not increase the universe of pharmaceuticals that are considered hazardous waste. However, it does accomplish four significant and practical changes in the management of pharmaceuticals: (1) HWPs that are to be sent off-site for reverse distribution will be regulated as hazardous wastes under the RCRA while still at the health care facility, (2) HWPs are banned from being disposed of down a drain or in a toilet, thereby reducing the amount of pharmaceutical ingredients that contaminate drinking water and endanger the environment, (3) it is easier to make a HWP container legally “empty,” and (4) nicotine replacement therapies are no longer considered potential hazardous wastes. Some of the components of the final rule will relieve the existing burdens on generators of HWPs, while other components may make the management of HWPs more onerous, at least initially.

Applicability to Long-Term Care Facilities

As noted above, the final rule applies to health care facilities. The definition of “health care facility” specifically includes long-term care facilities. A “long-term care facility,” in turn, is defined as:

[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, Hospice Cincinnati facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, assisted living facilities and the independent and assisted living portions of continuing care retirement communities. (emphasis added).

The exclusion of assisted living from the definition of long-term care facility in the rule avoids many of the practical issues with control over medications taken directly by patients and use of multiple pharmacies that flow from the functional differences between nursing homes and assisted living facilities. The distinction constitutes a welcome change from the 2015 proposed rule, which sought to include such facilities in the definition of long-term care facility. The EPA stated unequivocally that HWPs that are in (a) the custody of the long-term care facility on behalf of the resident, or (b) an in-house pharmacy maintained by such facility (if any), must be managed under Subpart P.

Definitions and Analysis

The analysis necessary to determine whether a given substance is considered a HWP involves three questions:

Question 1 – Is it a Pharmaceutical? Under the final rule, a pharmaceutical includes, but is not limited to, the following:

  • Dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act;
  • Prescription drug, as defined by 21 C.F.R. § 203.3(y);
  • Over-the-counter drugs;
  • Homeopathic drugs;
  • Compounded drugs;
  • Investigational new drugs;
  • Pharmaceuticals remaining in non-empty containers;
  • Personal protective equipment contaminated with pharmaceuticals; and
  • Clean-up material from spills of pharmaceuticals.

The definition also includes any electronic nicotine delivery system and liquid nicotine packaged for retail sale. Excluded from the definition are sharps and dental amalgam.

Question 2 – Is it a Solid Waste? A solid waste is any discarded material that is not otherwise excluded under the regulations that implement RCRA. What constitutes a RCRA solid waste, however, is not limited to wastes that are physically solid. Many solid wastes are liquid, semi-solid, or gaseous material. A material is considered “discarded” once the facility has decided to discard it, and must be managed appropriately at that point in time. A material that is legitimately going to be used, reused or reclaimed is not discarded and is not a solid waste. Note, however, that under the final rule, EPA has pre-determined that a health care facility’s decision to reverse distribute a pharmaceutical constitutes a decision to discard the pharmaceutical.

Question 3 – Is it a HWP? Solid wastes that are pharmaceuticals are only considered hazardous waste under RCRA if they are either listed as hazardous wastes or exhibit one of the characteristics of hazardous waste. There are four lists–F , K , P and U –based on either manufacturing and industrial processes, or chemical designations. The F and K lists are based on manufacturing and industrial processes, none of which apply to pharmaceuticals for humans. The P and U lists are based on chemical products. The EPA notes that there are approximately 30 “Commercial Chemical Products” on the P and U lists that have uses in multiple pharmaceuticals. A Commercial Chemical Product is only a waste if (i) it has not been used or used as intended, and (ii) consists of the commercially pure grade of the chemical, any technical grades of the chemical that are produced or marketed or the chemical is the sole active ingredient in the formulation. If these criteria are not met, then the pharmaceutical is not a HWP, even if included in the P or U list.

As noted above, even if a pharmaceutical waste is not listed on any of the lists, it may also qualify as a hazardous waste if it exhibits one of the four characteristics of hazardous waste:

  • Ignitability (something flammable) – for example, solutions containing more than 24% alcohol,
  • Corrosivity (something that can rust or decompose) – for example, certain compounding chemicals,
  • Reactivity (something explosive), and
  • Toxicity (something poisonous).

The answer to all three of the foregoing questions must be yes for the material to qualify as a HWP, though the final rule does contain certain exceptions that may apply to exclude a pharmaceutical from being considered a HWP for purposes of RCRA Subpart P. A long-term care facility that determines that it does generate HWPs must then conduct further analysis to determine the nature of its obligations under Subpart P.

Scope of Obligations under Subpart P – Amount of Waste Generated

Once the determinations have been made that a long-term care facility is covered by the final rule and has HWPs, the analysis shifts from the type of facility and nature of the waste to the amount of the waste, to determine the scope of the facility’s obligations under Subpart P. Specifically, the next inquiry is the amount of HWPs that the facility generates. Under RCRA, a “Generator” is a person whose act or process produces hazardous waste or whose act first causes a hazardous waste to become subject to regulation. Therefore, a facility that makes the determination to “discard” a pharmaceutical becomes a Generator. A facility that generates less than or equal to any of the following per calendar month qualifies as a Very Small Quantity Generator (VSQG) :

  • 100 kg (220 pounds) of hazardous waste; or
  • 1 kg (2.2 pounds) of acute hazardous waste.

Under the final rule, long-term care facilities with 20 or fewer beds are presumed to be VSQGs, thereby shifting the burden of proof to the EPA Administrator to establish that a facility is not a VSQG. Facilities with more than 20 beds, however, bear the responsibility of demonstrating that they qualify as a VSQG.

If a facility generates total hazardous waste in amounts exceeding the VSQG thresholds, it must treat its HWPs in accordance with the management standards of Subpart P. While VSQGs may opt to handle their HWPs in accordance with the management standards of Subpart P, they are not required to do so except for the sewering ban and empty container provisions of Subpart P. If a VSQG does not opt to comply with the management standards of Subpart P, its HWPs are subject to the general hazardous waste provisions of 40 C.F.R. § 262.14, which may be less than the requirements of Subpart P. Further, a long-term care facility that is a VSQG may dispose of its HWPs (other than contaminated personal protective equipment or clean-up materials) in an on-site collection receptacle of an authorized collector that is registered with the Drug Enforcement Administration (DEA), provided the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable regulations for controlled substances.

Whether a long-term care facility that qualifies as a VSQG opts to treat its HWPs in accordance with the management standards of Subpart P likely will depend on (1) the willingness of the facility to undertake the monthly calculations, monitoring and recordkeeping required to demonstrate that their hazardous waste is within the limits established for VSQGs, or (2) whether the decision not to comply with Subpart P would render the facility subject to more onerous requirements on other hazardous waste that it generates. If a facility also generates non-pharmaceutical RCRA hazardous waste, such as lab wastes for example, those wastes are not regulated under Subpart P but under the existing RCRA regulations. The standard regulations become more stringent as the amount of applicable waste increases. Facilities could decrease the overall amount of waste and thus lessen the impact of the standard regulations by not including the HWPs that are managed instead under Subpart P.

Scope of Obligations under Subpart P – Prescription HWPs versus Non-Prescription HWPs and Non-Creditable Prescription HWPs versus Potentially Creditable Prescription HWPs

Once the determination has been made that a long-term care facility is subject to the management standards of Subpart P, the requirements vary based on whether or not the pharmaceutical required a prescription. For prescription drugs, a facility must determine if it is managing a potentially creditable HWP or a non-creditable HWP. A “potentially creditable hazardous waste pharmaceutical” is a prescription HWP that has a “reasonable expectation to receive manufacturer credit through reverse distribution and is (1) in original manufacturer packaging (except pharmaceuticals that were subject to a recall) even if opened; (2) undispensed; and (3) unexpired or less than one year past expiration date.”

A non-creditable HWP is a prescription pharmaceutical that does not meet the above three criteria and therefore is not likely to receive credit back through reverse distribution. Non-prescription HWPs that do not have a reasonable expectation to be legitimately used, reused or reclaimed are also considered non-creditable HWPs. On the other hand, non-prescription over the counter pharmaceuticals that go through reverse logistics because they have a reasonable expectation of being recycled are not “Solid Waste” under RCRA at all, and therefore are not subject to Subpart P either. The management standards for potentially creditable HWPs are not as stringent as those for non-creditable HWPs.

Because of the requirement that the pharmaceutical be undispensed, it is likely that only long-term care facilities that have an in-house long-term care pharmacy will be managing potentially creditable HWPs. Those long-term care facilities that contract for their pharmacy services with a long-term care pharmacy will be managing non-creditable HWPs because pharmaceuticals are considered to be dispensed when the order is filled by the external pharmacy.

Unlike the existing general RCRA standards for the management of hazardous wastes, standards for HWPs under the new Subpart P are the same regardless of the amounts generated or the places where they are accumulated.

Management Standards for Non-Creditable HWPs

Notification – A long-term care facility that is subject to the requirements of Subpart P must notify the EPA Regional Administrator within 60 days of the effective date of Subpart P (or within 60 days of becoming subject to Subpart P) that it is a healthcare facility operating under Subpart P, even if the facility already has an EPA Identification Number. Notification may be filed electronically. The facility must keep a copy of the notification on file for as long as the facility is subject to Subpart P. If the facility subsequently qualifies as a VSQG and elects to withdraw from Subpart P, it must so notify the EPA Regional Administrator and may not begin operating under the conditional exemption applicable to VSQGs generally under RCRA until notification has been made. Withdrawal notifications must be kept on file for a period of three (3) years.

Training – All facility personnel that manage HWPs must be trained and be “thoroughly familiar” with proper waste handling and emergency procedures relative to their responsibilities. EPA has not stated whether the agency will offer compliance assistance or training materials to facilities. As a result, because the final rule will become effective six months following publication in the Federal Register, facilities should begin exploring their options for training as early as possible.

Hazardous Waste Determination – The facility must determine whether a non-creditable pharmaceutical is a HWP. In lieu of making such a determination, the facility may choose to manage all waste pharmaceuticals as HWPs under Subpart P.

Containers – Because a facility will likely accumulate HWPs for some period of time before shipping them off-site, the final rule prescribes standards for containers that will be used to store HWPs. Generally, any container used to accumulate HWPs must be structurally sound, compatible with its contents, and lack evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. Such container must be kept closed and secured so as to prevent unauthorized access to its contents.

Labeling Containers – All containers used to accumulate HWP must be labeled or clearly marked with the phrase “Hazardous Waste Pharmaceuticals.”

Maximum Accumulation Time – A facility may accumulate non-creditable HWPs on-site for a period not to exceed one year without a permit. The period begins on the date the pharmaceutical first becomes a waste, and the facility is responsible for demonstrating how long HWPs have been accumulating. The final rule allows the facility to make this demonstration by marking/labeling the container, maintaining an inventory system or by placing the HWPs in a specific area and identifying the earliest date that any of the HWPs in that area became a waste. To the extent that any HWPs are able to be commingled safely in a container, the date on which the very first HWP was deposited in the container would start the one year clock running.

Land Disposal Restrictions – A facility must comply with extensive requirements pertaining to land disposal restrictions at 40 C.F.R. Section 268.7(a), but these have been relaxed to the extent that the individual waste codes no longer need to be identified on the land disposal restriction notification.

Shipping – As noted above, a long-term care facility may accumulate non-creditable HWPs on-site only for a limited time before it must ship them off-site to a pre-designated authorized facility for treatment, storage or disposal. The final rule includes specific requirements for such shipments.

  • Pre-Transport
    • Packaging, Labeling and Marking – Generally, all waste must be packaged, labeled and marked in accordance with applicable Department of Transportation (DOT) regulations.
      • Containers of 119 gallons or less must be marked with specific words and information, including “HAZARDOUS WASTE.”
      • With limited exceptions specified in the final rule, lab packs that will be incinerated are not required to be marked with EPA Hazardous Waste Numbers.
    • Placarding – A long-term care facility must placard or offer the initial transporter the appropriate placards as specified under DOT regulations.
  • Manifests – A facility must use a uniform manifest and comply with applicable manifest requirements except that instead of listing the individual waste codes, the facility should write “PHARMS” on the form.
  • Facilities may ship HWPs across state lines, but will only be able to use the provisions in Subpart P if both states have adopted the same regulations (see below).

Managing Rejected Shipments – A long-term care facility will need to ship any rejected shipments of non-creditable HWPs to a new designated and authorized facility within 90 days of their return.

Reporting – There is no requirement to report the amounts of HWPs generated at a facility unless specifically requested by the EPA. Other than the initial notification, the only report required under the new rule is when the facility does not receive back a copy of a fully received manifest from the receiving facility in connection with a shipment.

Record keeping – A health care facility must keep a copy of each manifest, exception report, and hazardous waste determination test result and analysis for three years. All records must be readily available during an inspection.

Response to Spills – Spills of HWPs must be immediately contained and the cleanup materials managed themselves as HWPs.

Accepting Non-Creditable HWPs from an Off-Site Facility that is a VSQG – A facility may accept non-creditable HWPs from a VSQG, such as when a health care facility returns drugs back to a pharmacy, even though the receiving facility does not have a RCRA permit, if the receiving facility (i) is under the same control as the transferring facility or has a business relationship, (ii) is operating under Subpart P, (iii) manages the new wastes under Subpart P, and (iv) keeps records of the shipment for three years.

Management Standards for Potentially Creditable HWPs

As noted above, because the definition of a potentially creditable HWP requires that a pharmaceutical be undispensed, and the use of a third party long-term care pharmacy results in medication being dispensed to a resident by the pharmacy rather than the facility, most long-term care facilities will not be managing potentially creditable HWPs. However, for those facilities that maintain their own in-house long-term care pharmacy, the requirements of the final rule with respect to potentially creditable HWPs are relevant as the facility is likely to have undispensed prescription medications on hand that can qualify as potentially creditable HWPs that can be sent to a reverse distributor.

  • Accepting Potentially Creditable HWPs from an Off-Site Facility that is a VSQG – A facility may accept potentially creditable HWPs from a VSQG, such as when a care facility returns drugs back to a pharmacy, even though the receiving facility does not have a RCRA permit, if the receiving facility (i) is under the same control as the transferring facility or has a business relationship, (ii) is operating under Subpart P, (iii) manages the new wastes under Subpart P, and (iv) keeps records of the shipment for three years.
  • Only Potentially Creditable HWPs – A facility is prohibited from sending hazardous wastes other than potentially creditable HWPs to a reverse distributor.
  • Reporting – There is no requirement to report the amounts of HWPs generated at a facility unless specifically requested by EPA.
  • Recordkeeping – A facility that initiates a shipment of potentially creditable HWPs to a reverse distributor must retain for a period of three years paper or electronic records of (i) the confirmation of delivery, and (ii) shipping papers prepared in accordance with DOT regulations. All records must be readily available during an inspection.
  • Response to Spills – Spills of potentially creditable HWPs must be immediately contained and the cleanup materials managed as non-creditable HWPs.
  • Shipping – Unlike with respect to a non-creditable HWP, a manifest is not required for shipping potentially creditable HWPs to a reverse distributor. Nevertheless, the facility must comply with all applicable DOT regulations in 49 C.F.R. Parts 171 through 180 for any HWP that meets the definition of “hazardous material” in 49 C.F.R. Section 171.8. Also, the receiving reverse distributor must provide confirmation to the facility that it has received the shipment. If the facility has not received such confirmation within 35 calendar days from the date the potentially creditable HWPs were sent, the facility must contact the carrier and the reverse distributor promptly to report that the confirmation was not received and to determine the status of the potentially creditable HWPs.

Conditional Exemption for HWPs that are Controlled Substances:

The final rule includes a conditional exemption from RCRA requirements for HWPs that are listed on a schedule of controlled substances by the DEA. The conditional exemption will apply if the HWPs are collected, stored, transported, and disposed of in compliance with all applicable DEA regulations for controlled substances, and will be destroyed by a method that DEA has publicly deemed in writing to meet their non-retrievable standard of destruction or combusted at one of five types of combustion facilities.

Generally Applicable Provisions of Subpart P to all HWPs:

The following provisions apply to all health care facilities, regardless of whether the facilities are managing creditable or non-creditable HWPs or are required to comply with the other provisions of Subpart P.

  • Sewering Ban – All health care facilities covered by the rule are prohibited from discharging HWPs to a sewer system that passes through to a publicly-owned treatment works.
  • Empty Containers – Under the new regulations, certain stock, dispensing and unit-dose containers are considered “empty” and therefore not regulated as hazardous waste under RCRA, even if minor pharmaceutical residue remains, if they have been emptied using the practices commonly employed to remove materials from that type of container. This also applies to syringes provided that the contents have been removed by fully depressing the plunger into the patient, another delivery device such as an intravenous bag, or a hazardous waste collection container. Intravenous bags avoid RCRA regulation provided the pharmaceuticals inside have been fully administered to a patient. All other types of containers—whether partially or completely empty—are to be managed as non-creditable HWPs unless they meet the general RCRA empty test for non-acute hazardous wastes.

Over the Counter Nicotine Replacement Therapies:

Nicotine and salts are currently included in the hazardous waste listed code P075 . The new rule exempts FDA approved over the counter nicotine replacement therapies, specifically patches, gums, and lozenges, from waste code P075. The rule does not exempt e-cigarettes, nicotine-containing e-liquids or prescription nicotine replacement therapies because they are not regulated in the same way as the exempted methods. Nevertheless, any nicotine replacement therapy that has been used in the manner initially intended is not a “solid waste” under RCRA and therefore is not a “hazardous waste” either.

Effective Date; Authorized State RCRA Programs:

The final rule will become effective six months following publication in the Federal Register; however, many states operate their own hazardous waste program. Once authorized by EPA, state hazardous waste programs operate in lieu of the RCRA regulations, though authorized states are required to adopt new regulations that are more stringent than existing rules. Most provisions of the pharmaceutical waste final rule are more stringent than the current RCRA generator regulations. Accordingly, authorized state programs will be required to adopt those provisions such that the new rule will not take effect in any of those states until it has been adopted and the state regulations updated. In contrast, the ban against HWP disposal in a drain or a toilet will be effective in every state as soon as it is effective under Federal law because the sewering prohibition component of the new rule, also more stringent than existing requirements, was adopted under separate legal authority. States are not required to adopt the part of the rule exempting over-the-counter nicotine replacement therapies from the hazardous waste requirements because it is less stringent. Also, facilities should be aware that states may include more stringent requirements than those included in the final rule. As a result, facilities will need to monitor adoption and implementation efforts in those states very closely.

Conclusion:

There can be no doubt that EPA’s final rule will require health care facilities, particularly long-term care facilities other than assisted living facilities, to navigate the new regulatory framework provided in Subpart P, while still potentially being subject to many other RCRA-related provisions and to regulations from other Federal agencies including the DOT. Additionally, facilities in states that have their own authorized hazardous waste program will need to monitor their state agency to determine exactly which rules apply and when. With an effective date only six months following publication of the final rule in the Federal Register, no guarantees of education or compliance assistance from EPA other than three webinars scheduled for February and March, 2019, and steep fines for violations, facilities will be hard-pressed to come up to speed in time. Health care facilities are well advised to begin their efforts now to understand the requirements, draft and implement effective policies and procedures, develop a staff training program, and enter into such contractual relationships as may be necessary to ensure compliance.

This article has been republished with the permission of the authors. It was first published on the AGG website. A pdf version, with footnotes can be found at AGG Legal Insight.


About the Authors

Brooke F. Dickerson focuses her practice on transaction, regulatory, compliance and permitting matters. With regards to environmental work, she has significant experience with Superfund (CERCLA), hazardous waste (RCRA and HWMA), the Georgia Hazardous Site Response Act (HSRA), solid waste, Brownfields, wetlands, and site evaluation, assessment and remediation issues. She also advises clients on stormwater compliance, green leasing issues and green/sustainable building practices. With regards to construction work, Ms. Dickerson advises owners and developers on the drafting and negotiation of architect, construction and construction management agreements. She has represented clients in connection with the construction of office, multi-family, mixed use and tenant improvement projects. She also advises clients on OSHA matters and has represented several companies in obtaining reduced or dismissed penalties in settlement negotiations.

Jennifer Hilliard is Of Counsel in the Healthcare Practice. Ms. Hilliard focuses her practice on long-term care and aging services issues generally. She has extensive experience with nursing home regulatory matters, compliance and operations. Additionally, she has significant experience with Federal public policy and government affairs in such related areas as Medicare and Medicaid regulation, home health and hospice regulation, DEA controlled substances regulation, OSHA and other labor and employment issues affecting aging services providers, and federal non-profit tax issues. Prior to joining AGG, Ms. Hilliard served for over 18 years in a variety of legal and advocacy-related capacities at LeadingAge, a Washington, DC based trade association for non-profit long-term care and aging services providers.

Cost of Nuclear Waste Clean-up in the U.S. estimated at $377 Billion

A new report by the United States General Accounting Office (GAO) estimates the total cleanup cost for the radioactive contamination incurred by developing and producing nuclear weapons in the United States at a staggering $377 billion (USD), a number that jumped by more than $100 billion in just one year.

The United States Department of Energy (DoE) Office of Environmental Management (EM) is responsible for cleaning up radioactive and hazardous waste left over from nuclear weapons production and energy research at DoE facilities. The $377 billion estimate largely reflects estimates of future costs to clean up legacy radioactive tank waste and contaminated facilities and soil. 

The U.S. GAO found that EM’s liability will likely continue to grow, in part because the costs of some future work are not yet included in the estimated liability. For example, EM’s liability does not include more than $2.3 billion in costs associated with 45 contaminated facilities that will likely be transferred to EM from other DOE programs in the future.

In 1967 at the height of the U.S.–Soviet nuclear arms race, the U.S. nuclear stockpile totaled 31,255 weapons of all types. Today, that number stands at just 6,550. Although the U.S. has deactivated and destroyed 25,000 nuclear weapons, their legacy is still very much alive.

Nuclear weapons were developed and produced at more than one hundred sites during the Cold War. Cleanup began in 1989, and EM has completed cleanup at 91 of 107 nuclear sites, Still, according to the GAO, “but 16 remain, some of which are the most challenging to address.” 

EM relies primarily on individual sites to locally negotiate cleanup activities and establish priorities. GAO’s analysis of DOE documents identified instances of decisions involving billions of dollars where such an approach did not always balance overall risks and costs. For example, two EM sites had plans to treat similar radioactive tank waste differently, and the costs at one site—Hanford—may be tens of billions more than those at the other site. 

Each of the 16 cleanup sites sets its own priorities, which makes it hard to ensure that the greatest health and environmental risks are addressed first.
This is not consistent with recommendations by GAO and others over the last two decades that EM develop national priorities to balance risks and costs across and within its sites. 

By far the most expensive site to clean up is the Hanford site, which manufactured nuclear material for use in nuclear weapons during the Cold War. In 2017, the DoE estimated site cleanup costs at $141 billion.

Environmental liabilities are high risk because they have been growing for the past 20 years and will likely keep increasing.

EM has not developed a program-wide strategy that determines priority sites. Instead, it continues to prioritize and fund cleanup activities by individual site. Without a strategy that sets national priorities, EM lacks assurance that it is making the most cost-effective cleanup decisions across its sites.

The GAO is made three recommendations to DOE: (1) develop a program-wide strategy that outlines how it will balance risks and costs across sites; (2) submit its mandated annual cleanup report that meets all requirements; and (3) disclose the funding needed to meet all scheduled milestones called for in compliance agreements, either in required annual reports or other supplemental budget materials.

Canadian Federal Government Proposing New Regulations on Cross-border movement of Hazardous Waste

Environment Canada and Climate Change (ECCC), which is the Canadian equivalent of the U.S. Environmental Protection Agency, recently released draft regulations to control the cross-border movement of hazardous waste and hazardous recyclable material. The regulations, if eventually promulgated, would repeal and replace the Export and Import Regulations, the Interprovincial Movement Regulations, and the PCB Waste Export Regulations. Although the proposed Regulations would maintain the core permitting and movement tracking requirements of the former regulations, the regulatory provisions would be amended to ensure greater clarity and consistency of the regulatory requirements.

Electronic Tracking System

The proposed Regulations would provide flexibility for the electronic movement tracking system by no longer prescribing the specific form required for tracking shipments of hazardous waste and hazardous recyclable material. Instead, the proposed Regulations would require specific information to be included in a movement document (that can be generated electronically) and would allow movement document information to be passed on to different parties in parallel to facilitate the tracking rather than prescribing the handover of copies from one party to another.

Furthermore, given that movement documents would be able to be managed electronically, the proposed Regulations would no longer require that the movement document and permit physically accompany the shipment. The proposed Regulations would instead require parties to immediately produce the movement document and the permit upon request. Similar simplifications would be included in the provisions related to the movement document for interprovincial movements of hazardous waste and hazardous recyclable material.

The proposed Regulations would clarify the responsibility of a receiving (importing) facility to pass on information regarding the origin of the hazardous waste and hazardous recyclable material being transferred to a subsequent authorized facility for final disposal or recycling. As the safety of everyone is important and so is protecting the environment, it would make sense to find a contact for consultation if you need help with your company’s regulatory needs.
Clarifications would also be made to the provisions for the return and rerouting of shipments to better align those requirements with current practice and ensure that confirmation of disposal from the alternative facility is also required in order to properly complete the tracking of those shipments.

Definitions of hazardous waste and hazardous recyclable material

With respect to interprovincial movements, under the proposed regulations, the definitions of hazardous waste and hazardous recyclable material would be aligned with those of international movements. In addition, proposed changes to those definitions would ensure a more consistent application of regulatory provisions for all types of transboundary movements and would better align definitions with other jurisdictions and international agreements. Some of these proposed changes are listed below.

Toxicity characteristic leaching procedure

The proposed Regulations would reference the toxicity characteristic leaching procedure (TCLP), in its entirety. This procedure is a standard test method used to evaluate the mobility of a number of contaminants that may be found in waste and recyclable material and, therefore, their potential for release. While making reference to the TCLP, the Export and Import Regulations exclude a step requiring that the size of particles in a sample be reduced to fit into the testing apparatus. In order to ensure that the method is used consistently, hazardous waste and hazardous recyclable material undergoing testing would need to be shredded to meet the TCLP’s specific particle size requirement.

Electrical and electronic equipment

Electrical and electronic equipment (EEE) is not currently listed as hazardous under the Export and Import Regulations and must meet other criteria to fall under the definitions of hazardous waste or hazardous recyclable material, which can be difficult to ascertain. The proposed Regulations would clearly designate “circuit boards and display devices and any equipment that contains them” as hazardous waste or hazardous recyclable material to be controlled when destined for specific disposal or recycling operations. The proposed Regulations would maintain the exclusion currently under the Export and Import Regulations for this type of hazardous waste and hazardous recyclable material moving within OECD countries (including moving between provinces and territories in Canada).

Mercury

The proposed Regulations would remove the small quantity exclusion for hazardous waste and hazardous recyclable material containing mercury. Any waste or material containing any amount of mercury that meets the definitions of hazardous waste or hazardous recyclable material would be subject to the regulatory provisions for both international and interprovincial movements.

Batteries

Batteries are not currently listed as hazardous under the Export and Import Regulations and must meet other criteria to fall under the definitions of hazardous waste or hazardous recyclable material. Some types of batteries are clearly covered by the definitions; however, for some other types it is not clear. The proposed Regulations would clarify that all types of batteries (i.e. rechargeable and non-rechargeable) being shipped internationally or interprovincially for disposal or recycling are included in the definitions of hazardous waste and hazardous recyclable material.

Terrapure Battery Recycling Facility

Waste and recyclable material generated on ships

The proposed Regulations would add a new exclusion to clarify that waste or recyclable material generated from the normal operations of a ship is not captured by the definitions of hazardous waste and hazardous recyclable material. This exclusion would further harmonize the proposed Regulations with the Basel Convention (which excludes this waste) and the Canada Shipping Act, 2001 where this waste is already covered.

Residual quantities

The proposed Regulations would add a new exclusion for waste or recyclable material that is to be transported in a container after the contents of that container have been removed to the maximum extent feasible and before the container is either refilled or cleaned of its residual content. This exclusion would clarify that such waste or recyclable material is not captured by the definitions of hazardous waste and hazardous recyclable material.

Recycling operation R14

Over the years, ECCC has received numerous questions regarding recycling operation R14 found in Schedule 2 of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations. Section 2 R14 reads as follows : “Recovery or regeneration of a substance or use or re-use of a recyclable material, other than by any of operations R1 to R10”. This recycling operation is not included in the Basel Convention or the OECD Decision. ECCC is proposing to delete this part of operation R14 to remove uncertainty about its application. This change may result in some recyclable material no longer being captured and defined as hazardous. For example, a used material that is to be used directly in another process that is not listed as a recycling operation would no longer be captured.
This change would further align regulatory provisions with international guidelines under the Basel Convention.

Exports, Imports and Transits of Hazardous Waste and Hazardous Recyclable Material 2003-2012

Proposed changes regarding waste containing PCBs

The regulatory provisions for the export of waste containing PCBs would be streamlined and integrated into those for hazardous waste and hazardous recyclable material. This would include removing the partial prohibition on exports of waste containing PCBs in a concentration equal to or greater than 50 mg/kg to allow controlled exports beyond the United States. Therefore, waste and recyclable material containing PCBs in a concentration equal to or greater than 50 mg/kg would be able to be exported provided a permit is obtained and all of the conditions of the proposed Regulations are met.

Proposed changes to improve the permitting process

The proposed Regulations would no longer require the name of the insurance company and the policy number for the exporter, the importer and carriers with the notification (i.e. permit application). In addition, copies of the contracts would no longer need to be provided with the notification. In both cases, the applicant would be required to provide a statement to the effect that valid insurance policies and contracts are in place and to keep proof of insurance coverage and copies of contracts at their place of business in Canada for five years.

The proposed Regulations would require a new notification for any changes in information, other than correcting clerical errors, on a permit.

The proposed Regulations would increase the maximum duration of a permit from 12 months to 3 years, consistent with international agreements, for the movement of hazardous recyclable material directed to pre-consented facilities within OECD countries.

The proposed Regulations would set out conditions under which a permit may be refused, suspended or revoked.

Impacts on Business – Costs and Operations

According to the consultation documents prepared by ECCC, the proposed Regulations, if promulgated, would affect 295 companies, 281 of which would be considered small businesses. For these small businesses, the proposed Regulations are expected to result in incremental compliance and administrative costs of $296,000 in average annualized costs, that is, $1,070 per small business.

If the proposed Regulations are implemented, it would result in an clarifications to the definitions of hazardous waste and would ensure a more consistent application of regulatory provisions. In addition, the proposed Regulations would help minimize environmental impacts outside Canada by ensuring that exported hazardous waste and hazardous recyclable material reach the intended disposal or recycling facilities. For any company that performs hazardous operations, the idea to try and find flexible safety doors is one that could benefit industries such as transportation and the medical field, as this helps increase safety in this process and acts as a security barrier between any hazards. The present value of compliance and administrative costs of the proposed Regulations would be $2.5 million in 2017 Canadian dollars, discounted at 3% to 2018 over a 10-year period between 2021 and 2030.

The proposed Regulations would impose incremental administrative costs on industry attributable to the completion of additional movement documents for interprovincial movements of hazardous waste and hazardous recyclable material. Provincial and territorial authorities that are using a tracking system would achieve small savings if they decided not to request movement document information. The present value of administrative costs of the proposed Regulations are expected to be $460,000 in 2017 Canadian dollars, discounted at 3% to 2018, over a 10-year period between 2021 and 2030.

Public Consultation

Public comments to the proposed Regulations are being accepted by ECCC until up to mid-February. Any person may file with the Minister of the Environment comments with respect to the proposed Regulations or a notice of objection requesting that a board of review be established under section 333 of the Canadian Environmental Protection Act, 1999 and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent by mail to Nathalie Perron, Director, Waste Reduction and Management Division, Environmental Protection Branch, Department of the Environment, 351 Saint-Joseph Blvd., Gatineau, Quebec K1A 0H3 (fax: 819-938-4553; email: [email protected]).

Insight into the Hazardous Waste Management Industry – A Profile of Clean Harbors Facilities

by David Nguyen – Staff Writer

Clean Harbors is a hazardous waste management company operating across North America. Their location in Mississauga is a hazardous waste terminal and transfer station, receiving, handling, and transporting flammable solids destined to the U.S. for incineration. Non-flammable solids and liquid hazardous waste is sent to their facility in Lambton, Ontario. The Lambton facility includes a hazardous waste landfill and a liquid hazardous waste incinerator, with some facilities using machines to help with their odour control while trying to improve the air quality.

Clean Harbors coordinates hazardous waste management solutions across the Canada-U.S. border with the help of something similar to this waste management software which could help keep things in order. It is makes business sense for the company to transport flammable solids that are hazardous to its U.S. incinerator instead of having a facility in Canada. “Liquid injection incinerators are a lot cheaper,” says Mike Parker, Vice President, Canadian Environmental Compliance. “There really isn’t a strong enough market to support [hazardous solid incineration] in Canada.”

Mississauga Site Activities

Carriers bring the hazardous waste to the transfer station, where the manifests and documentation are reviewed to ensure that the facility is permitted to receive the material. This is different to regular waste removal companies such as BestDealDumpsters.com who get rid of all types of household waste. Receiving times are typically planned ahead of time to prevent surges of shipments on site. Once off loaded, the waste is sampled to confirm the material profile noted in the manifest and then staged for further processing. The entire staging area is built over sealed drains leading to a blind sump to prevent any spills from leaving the site. “All the liquids from our sumps, even if it’s just rain water… get put into tanks and go down for incineration,” says Parker.

Every drum the facility receives has its contents verified, sampled, and tested. Samples are analyzed for PCBs, pH, ignitability/ flashpoint, sulfide, chloride, oxidation, cyanide, and water reactivity in order to get a profile for the waste, after which a code is attached to the drum to indicate its destination and disposal.

Staging Area (photo by David Nguyen)

This information is stored in their management system that tracks the inventory at their various facilities, including the shipping information and profiles of all items. The information is removed for approval to be received on site. The system also tracks the manifests for the generator, carrier, receiver, and the ministry, internal inspections, and monthly reports to be sent to the ministry.

After sorting and sampling, the waste is safely sorted into various streams for consolidation, bulking, or blending.

“It has to be in the same waste class to mix and match. We can’t mix something flammable with something non-flammable,” says Parker.

“Even if they are in the same waste class, we take samples from each drum, mix it together, and if nothing happens, we can do it” says Erica Carabott, Facility Compliance Manager.

Liquid waste is bulked in tank farms until there is enough to fill a taker truck to be sent to Lambton for incineration. Solid waste is loaded into pits where the material is shredded up, bulked, and mixed with a solidifying agent to take up any free liquids in the solid waste streams.

Lambton Facility Activities

Many of the materials received at the Mississauga Transfer station are transported to the Clean Harbors Lambton facility offers services including waste neutralization, incineration of hazardous waste, inorganic pre-treatment of hazardous waste, thermal desorption of solid and sludge, and landfill disposal of hazardous waste.

Liquid waste is blended in a controlled neutralization process at the acid and alkali plant before being fed to the incinerator. The liquid waste injection incinerator operates 24 hours a day, 7 days a week, consisting of a fix unit incinerator, a semi-dry spray dryer absorber, and a four-compartment baghouse. The site capacity is about 100 000 tonnes per year and can process pumpable material that does not contain PCBs, pathogens, radioactives, and cylinders.

Lambton Incinerator (Photo Credit: Clean Harbors)

The landfill is situated in natural clay, and accepts a variety of hazardous waste excluding explosives, PCBs, radioactive, pathological wastes, or compressed gasses. Due to the Land Disposal Restriction prohibiting the disposal of untreated hazardous waste on land, Clean Harbors has an inorganic solid pre-treatment processing plant which mixes inorganic waste (primarily metal bearing solids) with reagents to prevent the metals from becoming leachable.

Furthermore, a thermal desorption unit is used to condense and recover water and organics from organic solid waste. The waste is fed into a kiln that heats the waste to 400-450 degrees Celsius to strip the organics from the waste. The vapours are condensed to remove liquid organics during the process, with the remaining emissions vented to the incinerator. The residual solids are then tested for any remaining organics or metals, and then disposed of in the hazardous landfill on site.

“You can understand why it takes a lot of money to treat the stuff in the landfill. It cooks it for about a half hour – that’s a lot of heat and a lot of money” says Parker. “With testing at the front and testing at the end,” adds Carabott .

Clean Harbor’s Lambton Hazardous Waste Landfill (Courtesy: Clean Harbors)

These facilities and processes allow Clean Harbors to work with their clients to develop cost effective solutions to handling and disposing of hazardous waste materials throughout the Great Lakes Basin in both Canada and the United States. In addition, Clean Harbors conducts regular outreach programs with the local community regarding the safe operations and reporting conducted at the Lambton facility.

Special thanks to Mike Parker and Erica Carabott for taking the time to speak with me and show me around the Mississauga Transfer station.

New U.S. EPA e-Manifesting System Took Effect June 30th

By Laura Ragozzino, Cohen & Grigsby P.C.

The U.S. Environmental Protection Agency (the “EPA”) launched its new Hazardous Waste Electronic Manifest (“e-Manifest”) System on June 30, 2018. The new requirements impact all U.S. companies that handle waste requiring a Resource Conservation and Recovery Act (“RCRA”) manifest, a regulated universe that includes approximately 150,000 entities across at least 45 industry segments. Under the new rules, regulated waste handlers will need to use the new paper or electronic EPA manifest form and waste receiving facilities will have to submit the new manifests to the e-Manifesting system, incurring a processing fee.

The goal of the new e-Manifesting system is to reduce costs and improve regulatory oversight and data quality. The EPA estimates that the manual processing and documentation of paper manifests costs regulators and companies $193 million to $400 million annually.

RCRA is the federal law that creates the framework for managing hazardous and non-hazardous solid waste. Since 1980, the EPA has required a RCRA manifest, a multi-copy paper form, to track hazardous waste from the time it leaves the generating facility until it reaches the off-site waste management facility that will store, treat, or dispose of it. The manifest helps the EPA verify proper waste handling.

E-Manifest requirements are effective in all states on June 30, 2018. These requirements apply to domestic hazardous waste (as defined at the federal and state level) and state-only regulated waste subject under state law to RCRA hazardous waste manifesting. The e-Manifesting system is a product of the 2012 Hazardous Waste Electronic Manifest Establishment Act and subsequent February 2014 and January 2018 final rulemakings. Starting June 30, receiving facilities are required to submit copies, whether electronic or paper, of RCRA waste manifests to the EPA within 30 days of receipt. Receiving facilities will also incur a processing fee for manifest submittal. In three years, paper manifests will be phased out of use.

The new requirements fall under RCRA enforcement policy. Noncompliance with RCRA, including improper manifesting, exposes waste handers to substantial civil penalties.

Before this e-Manifesting system’s implementation, shipments of waste across state borders could create jurisdictional issues for states with enhanced regulatory requirements. Some states impose manifesting requirements that are more stringent than RCRA’s rules, or define hazardous waste more broadly than under RCRA. When waste generated in these more stringent states was disposed of in less stringent states, the generating state lacked the ability to enforce the receipt of manifest copies from out-of-state receiving facilities. For example, if a disposal site in Ohio received waste oil from Connecticut that was classified as hazardous under Connecticut law but not classified as hazardous under Ohio law, then the Ohio disposal facility may or may not have submitted the manifest to Connecticut, and Connecticut did not have the ability to enforce its collection.

Now, under the 2012 Hazardous Waste Electronic Manifest Establishment Act, federal and state regulators can access complete cradle-to-grave waste manifesting records from the e-Manifest system because submitting manifests is compulsory. For example, as of June 30, 2018, if a disposal site in Ohio receives waste oil from Connecticut that is classified as hazardous under Connecticut law but not classified as hazardous under Ohio law, then the Ohio disposal facility must submit the manifest to the e-Manifest system, even if Ohio law does not require such submittal.

On or after June 30, waste generators, transporters, receivers, and disposers of waste regulated by the new regulations must track the waste on the new paper or electronic manifest, U.S. EPA Form 8700-22, and submit the manifest to the e-Manifest system. The EPA granted an initial extension of the 30-day manifest-receipt deadline for paper manifests received from June 30, 2018 through September 1, 2018. With this extension, receiving facilities may submit those manifests on or before September 30, 2018.

What Generators and Transporters Need to Know

Waste handling facilities should review the waste and manifest requirements that pertain to their business. It is important to understand the laws and regulations of the generating and receiving state. Any waste defined as hazardous by the generating or receiving state, or any waste requiring tracking on a RCRA manifest (i.e., a hazardous waste manifest), is subject to the e-Manifesting requirements.

Generators have the option to create and submit manifests electronically or to submit paper manifests to the e-Manifest system. The existing 6-copy manifest is being replaced with a new 5-copy form that must be ordered from a registered printer.

What Receiving and Disposal Facilities Need to Know

The new manifesting requirements will impact both RCRA-permitted disposal facilities (i.e., Treatment, Storage, and Disposal Facilities (“TSDFs”)) and non-TSDFs when such facilities receive waste that is either (1) non-hazardous but requires a RCRA manifest, or (2) is hazardous under the generating state’s laws and regulations. Therefore, the new e-Manifesting system extends the scope of regulatory obligations under federal law even if the law of the receiving state does not require a RCRA manifest for the waste at issue.

Receiving and disposal facilities must submit all RCRA manifests, paper or electronic, to the EPA. Receiving facilities need to obtain an EPA Identification number to use the e-Manifest system. To obtain an EPA ID number, facilities must submit EPA’s Site Identification form (U.S. EPA form 8700-12). EPA will charge receiving facilities a fee for each manifest submitted. Fees, which are differentiated based on how the manifest is submitted, are projected to range from $4 to $20. Late payments are subject to interest penalties.

EPA Resources:

This article was first published at the Cohen & Grigsby website.  To help its clients better understand the most efficient and cost-effective means of compliance, Cohen & Grigsby will continue to monitor this issue. If you have any questions, please contact Laura Ragozzino at (412) 297-4713 or [email protected].

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About the Author

Laura Ragozzino is regulatory compliance and environmental attorney for Cohen & Grigsby P.C.  She practices out of the firm’s Pittsburgh offices.

Ms. Ragozzino is an energetic counselor with proven success mitigating compliance risk. She practices in the areas of administrative law, energy law, EHS law, and government and regulatory affairs. She is passionate about building a compliance culture based on mutual respect for engineering, operations, and the regulations that govern their activities.

Ms. Ragozzino manages complex issues with federal, state, and local agencies to achieve results exceeding her business clients’ expectations. She brings creative, detail-oriented, and tactical thinking to the table to find effective and appropriate compliance solutions across industry sectors.

Nano-Scale Selective Ion Exchange used to Remove Radioactive Contamination from Water

Researchers from the University of Helsinki in Finland recently reported that they have developed a new method to remove radioactive contamination from water.  They claim their method of nano-scale selective ion exchange is faster than the conventional method and more environmentally-friendly as less radioactive solid waste is produced.

Risto Koivula, researcher at the University of Helsinki

The new method of selective ion exchange uses electrospun sodium titanate.  Electrospinning is a fibre production method which uses electric force to draw charged threads of polymer solutions or polymer melts up to fiber diameters in the order of some hundred nanometers  “The advantages of electrospun materials are due to the kinetics, i.e. reaction speed, of ion exchange,” says Risto Koivula, a scientist in the research group Ion Exchange for Nuclear Waste Treatment and for Recycling at the Department of Chemistry at the University of Helsinki.

One conventional method of removing radioactive ions from water is using granular sodium titanate as an ion exchange medium.  It is currently used to treat the 120,000 cubic meters of radioactive wastewater generated as a result of the Fukushima, Japan nuclear accident.  As radioactive wastewater is run through the ion exchanger, the radio-active ions are exchanged with the sodium in the sodium titantate.  The radioactive pollutants remain bound by the granules in the ion exchange unit.

Sodium Titanate fibres

The advantage of sodium titanate over other ion exchange media is that it is selective, which means that it is picks out only the radioactive ions from the water.  One disadvantage of ion exchange is that a water pollution problem is being transferred into a waste management problem.  When the ion exchange capacity is filled, the filtering material has to be switched out.  This leaves solid radio-active waste which must be managed.

The utilization of electrospun sodium titanate results in nano-scale spindles.  The result is an ion exchange solution that occupies less space but provides an equal treatment capability.  “Since less electrospun material is needed from the start of the process, the radio-active waste requiring a permanent repository will also fit in a smaller space,” says Koivula.

The electrospinning equipment at the University of Helsinki was developed and built in the Centre of Excellence for Atomic Layer Deposition, led by Mikko Ritala. The researchers successfully tried this quite simple method for working sodium titanate into fibre.  Koivula’s team studied the ion exchange features of fibre produced this way and found it worked like the commercially produced ones.

The utilization of this selective ion exchange method could be applied to the sites with groundwater contaminated with radioactive ions.

In Canada, the Town of Port Hope (located approximately 100 km east to Toronto) has over 1 million cubic metres of low-level radioactive waste as well as radioactive waste in treatment ponds.  The source of the radioactive contamination is the historic operation of the former radium and uranium refining activities of Eldorado Nuclear.  The wastewater treatment facility at Port Hope is a two-stage process that removes salts, heavy metals, and contaminants such as radium and arsenic.  The process involves chemical precipitation with clarification followed by reverse osmosis.

Couple admits illegally storing 4,500 tons of hazardous waste in warehouse

As reported in the St. Louis Post-Dispatch, a husband and wife recently plead guilty to a U.S. federal charge and admitted improperly transporting 4,500 tons of hazardous waste and storing it in a warehouse near St. Louis, Missouri.

The couple, both in their 60’s, pleaded guilty in U.S. District Court in St. Louis to a misdemeanor charge of placing someone in danger of death or serious bodily injury from a hazardous waste.

Green Materials LLC facility in Missouri (Photo Credit: Robert Patrick, Post Dispatch)

Their company, Missouri Green Materials LLC, Missouri Green Materials LLC stored a large quantity of spent sandblasting materials inside a warehouse located in the town of Berger, approximately 70 miles west of St. Louis. They couple admitted that they arranged for the transport and storage of the hazardous waste from Mississippi, and failed to tell both the trucking companies that hauled the waste and the personnel that unloaded it of the danger. Their storage facility was not properly permitted was not registered as a permitted hazardous waste storage or recycling facility. It is important to note that there are many waste removal services around to dispose of this for you. Firms range from Bulldog Rubbish Removal to a wide-variety of other waste removal services. (Bulldog Rubbish Removal is a great example, they maybe located in Melbourne, Australia but… with great customer reviews, these are the companies to make sure you keep an eye out for).

The sandblasting waste materials are considered to be hazardous because they contain amounts of certain metals, including cadmium, that exceed regulatory limits established by the Missouri Department of Natural Resources and the U.S. Environmental Protection Agency (U.S. EPA).

The materials were stored in a warehouse in a flood plain for more than four years. There are no indications of any release of the materials from the warehouse.

When it comes to storing products in a warehouse you need to ensure that all of the resources kept are correct under the laws of the area. It should also be kept to the correct health and safety regulations to ensure none of the workers are hurt. If everything is kept safely then it will also increase productivity. If you would like to increase productivity then you should take a look at Fishbowl Inventory.

The couple have agreed to pay $1.5 million to the U.S. EPA for the costs of dealing with the waste. They could face probation or a sentence of six months behind bars for the crime under federal sentencing guidelines.

The source of the sandblasting waste was for a site in Mississippi. An Ohio company, U.S. Technology Corp had been buried the waste. The company was repeatedly ordered by regulators to remove it.

In 2016, the U.S. EPA and U.S. Technology signed a consent agreement whereby the company agreed to remove the waste from Green Material’s facility in Missouri and test the site for soil contamination. According to prosecutors, this work was never performed.

U.S. Technology and president Raymond Williams, 71, both pleaded not guilty in the case. A hearing has been scheduled to change both pleas later in June.

Some sandblasting waste is classified as hazardous

All Hazards Waste Management Planning (WMP) Tool

The U.S. EPA recommends that communities have a Waste Management Plan (WMP) that addresses the management of waste generated by all hazards, particularly from homeland security incidents ranging from natural disasters and animal disease outbreaks to chemical spills and nuclear incidents to terrorist attacks involving conventional, chemical, radiological, or biological agents.

This tool is intended to assist emergency managers and planners in the public and private sectors in creating or updating a comprehensive plan for managing waste generated from man-made and natural disasters. The tool walks the user through the process of developing and implementing a plan. The tool also contains many resources that can be used as aids to various aspects of the planning process. View and use at https://wasteplan.epa.gov.