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COVID-19

UN3291 Regulated Medical Waste

FAQ: Are wastes associated with COVID-19 a hazardous waste?

No.  Wastes such as used medical equipment or personal protective equipment contaminated with the coronavirus are not regulated as a hazardous waste under USEPA regulations.

Regulations codified under the Resource Conservation and Recovery Act (RCRA) identify solid waste as a any discarded material not excluded by regulation.  The used medical equipment, personal protective equipment (PPE), or COVID-19 test kits generated in connection with the diagnosis, treatment, or immunization of persons infected – or suspected of being infected – with SARS-CoV-2 (the virus that causes COVID-19) will be a solid waste.

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To meet the criteria of a hazardous waste, a solid waste must be one – or both – of the following according to USEPA regulations:

  • Identified on one of the lists of hazardous waste at 40 CFR 261, subpart D; i.e., a listed hazardous waste.
  • Display one of the characteristics of a hazardous waste identified at 261, subpart C; i.e., a characteristic hazardous waste.
Lists of hazardous waste:UN3291 Regulated Medical Waste
  • F001-F039 – Hazardous waste from non-specific sources.
  • K001-K181 – Hazardous waste from specific sources.
  • U001-U411 – Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof (toxic).
  • P001-P205 – Discarded commercial chemical products, off-specification species, container residues, and spill residues thereof (acutely toxic).
Characteristics of hazardous waste:
  • D001 – Characteristic of Ignitability.  Liquid, solid, or gas that can self-ignite and burn vigorously or is capable of ignition at a temperature below a regulatory threshold.  It also includes oxidizers.
  • D002 – Characteristic of Corrosivity.  Liquid of low (acid) or high (alkaline) pH or liquid capable of corroding steel.
  • D003 – Characteristic of Reactivity.  Includes: waste that is unstable and readily undergoes violent change without detonation; waste that reacts violently with water; waste that emits toxic levels of cyanide or sulfide gas, waste that is capable of detonation.
  • D004-D043 – Characteristic of Toxicity. Waste that contains an identified toxin that is leachable from the waste and is above a regulatory threshold.

Contact me with any questions you may have about the generation, identification, management, and disposal of hazardous waste

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USEPA regulations do not define wastes as hazardous due to their infectious nature, including those contaminated by the novel coronavirus which causes COVID-19.  It is up to the generator of the waste to complete the hazardous waste determinationHowever, I can, with some confidence, write that it is unlikely a solid waste contaminated with SARS-CoV-2 will either be a listed hazardous waste or display a characteristic of a hazardous waste.

Non-hazardous solid waste – including waste contaminated with SARS-CoV-2 – is subject to state regulatory programs.  This includes states that lack RCRA authorization, e.g., Iowa, Alaska, and Puerto Rico.  State regulations for the management of medical waste vary between the states.  For example, not all states refer to this waste as medical waste, but I will for this article.  This website is a great place to start to determine the regulations of your state for the management of medical waste.
BioHazard red bag

The Centers for Disease Control and Prevention (CDC) has helpful guidance for medical waste generated by healthcare facilities:

Medical waste (trash) coming from healthcare facilities treating COVID-2019 patients is no different than waste coming from facilities without COVID-19 patients. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures. There is no evidence to suggest that facility waste needs any additional disinfection.

More guidance about environmental infection control is available in section 7 of CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed COVID-19 or Persons Under Investigation for COVID-19 in Healthcare Settings.

If you are a healthcare provider, medical facility, hospital, community-based testing site, or some other commercial or government facility generating a waste potentially contaminated with the SARS-CoV-2 virus, you should do the following regarding that waste:

  1. Conduct a documented hazardous waste determination.
  2. If a hazardous waste (unlikely), manage it according to USEPA and state regulations as a hazardous waste.  Be sure to inform the transporter and designated facility it may be contaminated with the coronavirus.
  3. If not a hazardous waste, research your state regulations to determine your cradle-to-grave responsibility for its on-site and off-site management as a medical waste.
  4. Follow CDC and OSHA guidelines to ensure worker protection.
  5. Comply with USDOT/PHMSA regulations for its off-site transportation as a Division 6.2 Infectious Substance.
  6. Keep records of all activities.
  7. Be safe.

Daniels Training Services, Inc.

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https://dev.danielstraining.com/

USEPA and most states do not regulate the wastes generated by a homeowner.  Even California does not currently regulate home-generated medical waste, with the exception of sharps (i.e., needles).  Therefore, household waste that has come in contact with someone who has COVID-19 should be managed with prudence but is not subject to regulation.  This fact sheet from the Illinois EPA contains information helpful to any homeowner for management of this waste and related items.

Good Storage of Hazardous Waste Containers

FAQ: Can a hazardous waste generator exceed their on-site accumulation volume limit due to the COVID-19 public health emergency?

Yes.  USEPA allows for an exceedance of the hazardous waste generator volume threshold / limit if due to the COVID-19 public health emergency.

Pursuant to Federal USEPA regulations some generators of hazardous waste are limited to the volume of hazardous waste they may accumulate on-site at one time.  Generators that exceed this limit / threshold either lose their allowance to accumulate hazardous waste without a permit (SQG) or must comply with the regulations of the higher generator category (VSQG to SQG).  Those thresholds / limits:

  • Large quantity generator (LQG) has no volume threshold or limit.
  • Small quantity generator (SQG) may not exceed 6,000 kg (13,200 lb) of hazardous waste on-site at one time.
  • Very small quantity generator (VSQG) may not exceed 1,000 kg (2,200 lb) of hazardous waste on-site at one time.

Unlike the on-site accumulation time limit for hazardous waste accumulated by LQGs and SQGs, USEPA regulations do not provide for an exceedance to these volume thresholds / limits.

Not sure of your hazardous waste generator category?

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That has changed due to USEPA’s Temporary Enforcement Discretion Policy in Light of COVID-19.  Part I.D.4 reads (emphasis added):

If a facility is a generator of hazardous waste and, due to disruptions caused by the COVID-19 pandemic, is unable to transfer the waste off-site within the time periods required under RCRA to maintain its generator status, the facility should continue to properly label and store such waste and take the steps identified under Part I.A, above. If these steps are met, as an exercise of enforcement discretion, the EPA will treat such entities to be hazardous waste generators, and not treatment, storage and disposal facilities. In addition, as an exercise of enforcement discretion, the EPA will treat Very Small Quantity Generators and Small Quantity Generators as retaining that status, even if the amount of hazardous waste stored on site exceeds a regulatory volume threshold due to the generator’s inability to arrange for shipping of hazardous waste off of the generator’s site due to the COVID-19 pandemic.

Note1:  The reference to Part I.A in the above quotation is to the General Conditions of the enforcement discretion which pretty much says:

  • Generators should make every effort to comply with their environmental compliance obligations, and;
  • If compliance is not reasonably practical, generators should act responsibly to minimize the effects and duration of the non-compliance, return to compliance ASAP, and document everything.

Please refer to this article if you are interested in the first part of the above quotation that refers to the enforcement discretion available for the on-site accumulation time limits of a LQG and SQG

USEPA’s temporary policy clearly allows for an enforcement discretion if a VSQG or SQG exceeds their on-site accumulation volume limit / threshold as long as other conditions of the policy are met.

Daniels Training Services, Inc.

815.821.1550

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https://dev.danielstraining.com/

So, what’s a hazardous waste generator to do?

  1. Contact your regional USEPA (if you operate in a state lacking RCRA authorization) or your state environmental agency (if your state has RCRA authorization) to inform them you will – or have – exceeded your on-site accumulation volume threshold / limit.  This notification is not required by the regulations or the enforcement discretion, but I recommend you do it anyway.  Read: RCRA State Authorization
  2. Comply with all other Federal and state regulations applicable to your hazardous waste generator category to the best of your ability during the COVID-19 public health emergency.
  3. Non-compliance with other regulatory requirements (e.g., weekly inspections) due to the COVID-19 public health emergency must be addressed separately.
  4. Document your activities and correspondence and maintain as a record.
  5. Return to compliance as soon as you are able.
Two closed & labeled Haz Waste containers

FAQ: Can a hazardous waste generator receive an extension to their on-site accumulation time limits due to the COVID-19 public health emergency?

Yes.  USEPA allows for an extension to accumulation time limits due to the COVID-19 public health emergency.

Pursuant to Federal USEPA regulations at 40 CFR 262.16(d) for a small quantity generator of hazardous waste (SQG) and §262.17(b) for a large quantity generator (LQG), an extension to the standard on-site accumulation time limit (180 or 270 days for a SQG, 90 days for a LQG) of up to 30 days may be granted by USEPA (or your state if it has an authorized hazardous waste program).  This extension may be granted if…

…hazardous wastes must remain on site for longer than 90 days (or 180 or 270 days for an SQG) due to unforeseen, temporary, and uncontrollable circumstances.  An extension of up to 30 days may be granted at the discretion of the Regional Administrator on a case-by-case basis.

I believe the current COVID-19 public health emergency qualifies for this extension.

Not sure of your hazardous waste generator category?

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Also, from USEPA’s Temporary Enforcement Discretion Policy in light of COVID-19.  Part I.D.4 reads:

If a facility is a generator of hazardous waste and, due to disruptions caused by the COVID-19 pandemic, is unable to transfer the waste off-site within the time periods required under RCRA to maintain its generator status, the facility should continue to properly label and store such waste and take the steps identified under Part I.A, above. If these steps are met, as an exercise of enforcement discretion, the EPA will treat such entities to be hazardous waste generators, and not treatment, storage and disposal facilities. In addition, as an exercise of enforcement discretion, the EPA will treat Very Small Quantity Generators and Small Quantity Generators as retaining that status, even if the amount of hazardous waste stored on site exceeds a regulatory volume threshold due to the generator’s inability to arrange for shipping of hazardous waste off of the generator’s site due to the COVID-19 pandemic.

Note1:  The reference to Part I.A in the above quotation is to the General Conditions of the enforcement discretion which pretty much says:

  • Generators should make every effort to comply with their environmental compliance obligations, and;
  • If compliance is not reasonably practical, generators should act responsibly to minimize the effects and duration of the non-compliance, return to compliance ASAP, and document everything.

Note2:  The reference to amount of hazardous waste accumulated by a VSQG or SQG in the above quotation will be addressed in a separate article. 

USEPA’s temporary policy clearly allows for an enforcement discretion if an SQG or LQG exceeds their on-site accumulation time limits as long as other conditions of the policy are met.

The language on USEPA’s website of FAQ’s related to hazardous waste generators and COVID-19 are less clear than the above.  But there also it states that generators may request an extension to their on-site accumulation time limits from USEPA or their state as is allowed by §262.16(d) and §262.17(b).

Daniels Training Services, Inc.

815.821.1550

Info@DanielsTraining.com

https://dev.danielstraining.com/

So, what’s a hazardous waste generator to do?

  1. Contact your regional USEPA (if you operate in a state lacking RCRA authorization) or your state environmental agency (if your state has RCRA authorization) to request an extension to the on-site accumulation time limit.  Read: RCRA State Authorization
  2. Comply with all other Federal and state regulations applicable to your hazardous waste to the best of your ability during the COVID-19 public health emergency.
  3. Non-compliance with other regulatory requirements (e.g., weekly inspections) due to the COVID-19 public health emergency must be addressed separately.
  4. Document your activities and correspondence and maintain as a record.
  5. Return to compliance as soon as you are able.
UN Performance Oriented Packaging Mark

USDOT Notice of Enforcement Discretion for the Manufacturing of Packaging Designs Beyond Periodic Retesting Dates

The Bullet:

Due to the COVID-19 public health emergency, USDOT/PHMSA issued a notice of enforcement discretion for the continued manufacturing of United Nations (UN) Performance Oriented Packaging used in the transportation of hazardous materials (HazMat) which have exceeded their periodic retesting dates.  USDOT/PHMSA is providing temporary relief from enforcement action if packaging manufacturers are unable to conduct periodic design qualification retesting within 90-days of a retest date due to COVID-19 operational disruptions.

See the Notice of Enforcement Discretion for the Continued Manufacturing of Performance Oriented Packaging Designs Exceeding Their Periodic Retesting Date for more details.

Who:
  • William S. Schoonover / Associate Administrator for Hazardous Materials Safety
  • The agency: the Pipeline and Hazardous Materials Safety Administration within the U.S. Department of Transportation (USDOT/PHMSA).
  • The affected:  manufacturers of United Nations Performance Oriented Packaging.
What does the HMR require?
  • The Hazardous Materials Regulations (HMR, 49 CFR Parts 171-180) prescribe that UN Performance Oriented Packaging design types be subjected to periodic retesting every twelve (12) to twenty-four (24) months, depending on the design type (see §178.601(e), §178.801(e), §178.955(e), and §178.1035(e)).
  • Periodic design testing is required to recertify the design type for continued production of a UN Performance Oriented Packaging.

Daniels Training Services, Inc.

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What is the relief?
  • PHMSA gives notice that it will not take enforcement action against any company that continues to manufacture a UN Performance Oriented Packaging conforming to a tested design that is not more than 90 days beyond its periodic retest date.
  • The relief applies to manufacturers of:
    • Non-bulk packagings.
    • Intermediate bulk containers (IBCs).
    • Large packagings.
    • Flexible bulk containers.
  • This relief only applies to designs tested and certified for Packing Group (PG) II (Y-marked) or PG III (Z-marked) hazardous materials.  PG I (X-marked) designs are not eligible for this enforcement discretion.
  • All production tests required under the HMR must still be met during the manufacturing process.  As such, relief from production testing is not being granted.  For example, the requirements in §178.604 and §178.813 for leakproofness testing of non-bulk packages and IBCs continue to apply.
  • The following packaging types are eligible for relief from the periodic retest requirement:
    • UN Specification non-bulk packagings manufactured in accordance with part 178, subpart L and M to PG II and III performance standards.
    • UN Specification IBCs manufactured in accordance with part 178, subpart N and O to PG II and III performance standards.
    • UN Specification large packagings manufactured in accordance with part 178, subpart P and Q to PG II and III performance standards.
    • UN Specification flexible bulk containers manufactured in accordance with part 178, subpart R and S.
  • To qualify for this enforcement discretion, a manufacturer must document the reasons why compliance is not possible prior to manufacturing packagings which are not more than 90 days beyond the required periodic retesting date.
  • The packaging manufacturer must maintain a copy of the document stating why compliance is not possible and the most recent test report (design qualification or periodic retest, as appropriate) until the packaging is again successfully retested.
  • USDOT/PHMSA expects manufacturers to complete missing tests in a timely manner as soon as testing capability is regained.
  • No other relief from HMR requirements (e.g., production leakproofness testing) is provided in this notice.
Where:

This relief applies to manufacturers of UN Performance Oriented Packaging regardless of whether they are domestic (within U.S.) or foreign (manufactured outside of U.S.).

Note:  UN standard packaging manufactured outside the U.S. is an authorized packaging subject to the conditions and limitations of §173.24(d)(2).

When:
Virus Image COVID-19
Photo by Martin Sanchez on Unsplash
Why:
  • Due to the Coronavirus Disease 2019 (COVID-19) public health emergency, the USDOT/PHMSA) has received several inquiries from members of the regulated community requesting an extension of periodic retest date requirements for packaging used in the transportation of hazardous materials.
  • Industry stakeholders state that, absent an extension of these periods, continued manufacturing of packagings that conform to tested designs would be inhibited, and a shortage of available UN Specification packagings may develop.
  • Non-bulk packaging design types such as drums, jerricans, pails, IBCs, large packagings, and flexible bulk containers are subject to frequent quality control testing in production to verify conformance with design specifications.  Additionally, all liquid-rated non-bulk packagings and IBCs as well as IBCs intended to be discharged under pressure are subjected to production leakproofness testing in accordance with HMR requirements prior to filling.

Note:

Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60% ethanol or 70% isopropanol.

How:
  • USDOT/PHMSA’s mission is to protect people and the environment by advancing the safe transportation of energy and other hazardous materials that are essential to our daily lives.  To do this, the agency establishes national policy, sets and enforces standards, educates, and conducts research to prevent incidents.
  • This document is a temporary notice of enforcement discretion.  Regulated entities may rely on this notice as a safeguard from departmental enforcement as described herein.  To the extent this notice includes guidance on how regulated entities may comply with existing regulations, it does not have the force and effect of law and is not meant to bind the regulated entities in any way.
Conclusion:

As the COVID-19 public health emergency continues to affect the world’s economy through its manufacturing and transportation industries (and many others), USDOT/PHMSA and other U.S. regulatory agencies will continue to offer reliefs of this kind.  Refer to my blog for other instances of regulatory relief offered by USDOT/PHMSA and USEPA.

Notice as well that this relief came after petitioning by “industry stakeholders”; ‘the squeaky wheel gets the grease!”  If you find your industry hindered by compliance with the HMR during the COVID-19 public health emergency, be sure to ask USDOT/PHMSA for relief.

USDOT Offers Relief From Regulation for Transport of Sanitizers and Disinfectants During COVID-19 Public Health Emergency

The Bullet:

During this public health emergency, USDOT/PHMSA is providing relief for certain hazardous materials (HazMat), e.g., sanitizing and disinfecting materials, transported for the purpose of protecting the health and safety of employees – and contractors – directly supporting the logistical operations of transportation companies.  The relief – as an enforcement discretion – mirrors the relief provided for HazMat transported under the materials of trade exception at 49 CFR 173 .6.

Carrier MOTS Relief Notice

Who:
  • Pipeline and Hazardous Materials Safety Administration within the U.S. Department of Transportation (USDOT/PHMSA).
  • Transportation companies within the U.S.

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What is the materials of trade exception?

The materials of trade exception exempts certain hazardous materials and quantities in motor vehicle shipments from the requirements of the Hazardous Materials Regulations (HMR).  Under the HMR, a material of trade means a hazardous material that is carried on a motor vehicle for one of three reasons:

  • Protecting the health and safety of the motor vehicle operator or passengers.
  • Supporting the operation or maintenance of a motor vehicle.
  • By a private motor carrier in direct support of a principal business that is other than transportation by motor vehicle.

Sanitizing and disinfecting products transported by a logistics company’s own transportation network to support the health and safety of employees at the company’s facilities do not meet any of these three definitions.  Therefore, the materials of trade exception will not address this specific need which is the intent of this relief.

For more information about the materials of trade exception, read: 49 CFR 173.6 – The Materials of Trade Exception

What is the relief?
Person with Hand Sanitizer Pump
Photo by Kelly Sikkema on Unsplash

USDOT/PHMSA gives notice that it will not take enforcement action against any carrier transporting sanitizing and disinfecting materials carried on a motor vehicle for the purposes of protecting the health and safety of employees of the carrier – this includes contractors working for the carrier – provided the following criteria are met:

  • The sanitizing and disinfecting materials, such as hand sanitizers and spray disinfectants, are intended to allow employees to adhere to Centers for Disease Control and Prevention guidelines for protecting against COVID-19.
  • The sanitizing and disinfecting materials are being provided to protect the health and safety of employees and eligible contractors who directly support the operations of the carrier, such as by sorting packages, loading and unloading packages, and driving delivery vehicles.
  • The sanitizing and disinfecting materials are transported by motor vehicle.
  • The shipment complies with the hazard class, quantity, packaging, hazard communication, and aggregate gross weight requirements specified in 49 CFR § 173.6 Materials of Trade provisions.
  • Transport of these materials for purposes other than use by employees or contractors of the carrier (e.g., retail sale) is not authorized.

Contact me with any questions you may have about the transportation of hazardous materials by air, highway, vessel, or rail

International and Domestic

Daniels Training Services, Inc.

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Where:
  • This relief applies to transportation within the United States.
Fork truck loading vehicle
Photo by Elevate on Unsplash
When:
Why:

Because of the ongoing Coronavirus Disease 2019 (COVID-19) public health emergency, there has been a notable increase in the demand for products used for sanitization and disinfection purposes – many of which may be classified as HazMat for transportation as defined by the HMR.

  • An alcohol-based sanitizer may be a Class 3 Flammable Liquid.
  • A disinfectant may be a Class 8 Corrosive Material.
How:

PHMSA’s mission is to protect people and the environment by advancing the safe transportation of energy and other hazardous materials that are essential to our daily lives. To do this, the agency establishes national policy, sets and enforces standards, educates, and conducts research to prevent incidents. We also prepare the public and first responders to reduce consequences if an incident does occur.

Conclusion:Hand Sanitizer Wipes

This relief represents USDOT/PHMSA’s latest attempt to facilitate the transportation of hazardous materials in response to the COVID-19 public health emergency.  An earlier example:  Temporary Policy for the Transportation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) provides relief for new manufacturers and subsequent transporters of alcohol-based hand sanitizer.