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My Watershed

  Frequently Asked Questions

Purpose of the interim enforcement policy

Generator status

Proper pharmaceutical waste management

Household hazardous pharmaceutical waste



Purpose of the interim enforcement policy
Q: Why is Ecology picking on hospitals and the healthcare industry?  Why the new regulations?

A: The healthcare industry may feel that Ecology has come up with new regulations and requirements for them, but in reality these requirements have been in effect for more than two decades.  The Dangerous Waste Regulations [Chapter 173-303 WAC] apply to all businesses in Washington State that generate dangerous waste such as small family owned businesses, large international manufacturers and government/military facilities.  In the realm of healthcare, this includes hospitals, retail pharmacies, healthcare clinics, doctor’s offices, dental offices, and veterinary clinics and hospitals.  These state regulations have been in effect since 1982.  The Resource Conservation and Recovery Act (RCRA) is the federal regulation, which became effective in 1976, that encompasses all solid waste and hazardous waste. 

The Interim Enforcement Policy for Pharmaceutical Waste in Healthcare (Policy) clarifies the requirements as they pertain specifically to pharmaceutical waste.  Within its enforcement discretion, Ecology will refrain from enforcing portions of the Dangerous Waste Regulations [Chapter 173-303 WAC] at facilities meeting the conditions of this policy.
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Q: Why is Ecology making us implement such onerous and costly waste management?

A: Ecology’s technical assistance visits have shown that many patient care facilities are not in compliance with the Dangerous Waste Regulations.  This Policy recognizes some unique challenges and conflicts in regulations surrounding pharmaceuticals and pharmaceutical waste management.  Patient-care facilities work with multiple regulatory agencies for the dispensing, storage, and disposal of pharmaceutical wastes.  The intent of the Policy is to clarify how the Dangerous Waste Regulations interact with the requirements of the Washington State Board of Pharmacy and the US Drug Enforcement Administration (US DEA). Each facility may choose to implement different methods to meet the compliance requirements. 
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Q: Are state regulations different than federal regulations for hazardous waste?

A: Yes, Washington State Department of Ecology is delegated by the US Environmental Protection Agency (EPA) to enforce RCRA.  Delegated authorities can choose to be more stringent than EPA, but cannot be less stringent.  Washington State’s Dangerous Waste Regulations are more stringent than RCRA and are the regulations you must follow.  For more information, please refer to the Dangerous Waste Regulations and Pub # 96-401: State and Federal Rule Differences – Highlights
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Q: Can I still manage my State-only pharmaceutical waste under the Conditional Exclusion in WAC 173-303-071(3)(nn) ?

A: Yes, you can choose to segregate the State-only pharmaceutical wastes and manage these under the Conditional Exclusion.  If you do this, you may benefit from lower disposal costs.  However, you may have increased internal costs, such as educating your staff on proper segregation, and ensuring compliance.  Conditionally excluded pharmaceutical waste must be disposed of at either a permitted municipal solid waste incinerator or an incinerator that meets the following criteria: heat input greater than 250 million btu (British thermal units) per hour or a combustion zone greater than 1500°F. 

If you choose to mix the State-only pharmaceutical waste with the RCRA hazardous pharmaceutical waste, then you must manage the combined wastes according to the Dangerous Waste Regulations or according to the Policy.  If the wastes are managed according to the Policy, Ecology will refrain from enforcing portions of the Dangerous Waste Regulations within its enforcement discretion.
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Q: Why can’t I take these wastes to my Moderate Risk Waste (MRW) facility?

A: MRW facilities can only accept dangerous wastes from Small Quantity Generators (SQG) of dangerous waste and households.  Individual MRW facilities can decide the type of waste they accept and whether they will accept waste from businesses. Many MRW facilities are not licensed to handle pharmaceutical waste by either the Washington State Board of Pharmacy or the US DEA, and they may not be capable of handling this waste stream. 

Many businesses believe they are SQGs when in fact they may be Medium Quantity Generators (MQGs) or Large Quantity Generators (LQGs) depending on the amount of pharmaceutical waste they generate.  If you generate more than 2.2 pounds (or 1 quart) of epinephrine or other P-listed waste in 1 month, you are an LQG.  MRW facilities cannot accept waste from MQGs or LQGs.  If a business chooses to manage pharmaceutical waste according to the Dangerous Waste Regulations, they would have to prove that they are an SQG and that the appropriate MRW facility can accept the waste.  If a business chooses to manage pharmaceutical waste according to the Policy, wastes must be shipped to a RCRA approved incinerator, regardless of generator status. 
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Generator status
Q: How can I prove my facility is a Small Quantity Generator?

A: You need to show an inspector that you generate less than 2.2 pounds of either P-listed acutely hazardous waste or WT01 extremely hazardous waste per month and less than 220 pounds of all other dangerous waste per month.  The easiest way is to keep logs to show the generation locations and rates.  The monthly generation rates apply throughout your facility.  If your generation is close to the limit or you fluctuate, you may want to consider managing your waste at the higher MQG or LQG status to ensure compliance in any given month. 

Example 1: If you have a lab that generates 200 pounds of hazardous waste per month, and your dangerous pharmaceutical waste is 30 pounds per month, you are not an SQG, but rather an MQG and must follow all pertinent requirements in the Dangerous Waste Regulations (Chapter 173-303 WAC).

Example 2:  The total dangerous waste from your facility is 150 pounds per month but you generate 3 pounds of epinephrine P-listed waste.  You have exceeded the 2.2 pound Quantity Exclusion Limit (QEL) for P-listed waste and are an LQG. 

Example 3:  Your facility generates no more than 200 pounds of dangerous waste per month and you have no P-listed or WT01 wastes.  But you have accumulated more than 2200 pounds of dangerous waste on-site at your facility to minimize disposal costs.  You are now an LQG.

To learn more about generator status and the different requirements, please refer to the Dangerous Waste Regulations, the Guide for Dangerous Waste Generators in Washington State or call your regional Hazardous Waste and Toxics Reduction Program for assistance.

To compare compliance conditions between the Dangerous Waste Regulations and the Policy please refer to the Guide for Dangerous Pharmaceutical Waste Generators in Washington State.
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Q: How do I determine my generator status if I implement the Interim Enforcement Policy for my pharmaceutical wastes?

A: If you are managing your pharmaceutical waste under the Policy, you must follow the management and disposal requirements as prescribed.  By implementing the Policy, the amount of pharmaceutical waste does not count toward the grand total of dangerous waste generated throughout the remainder of your facility. 

If the amount of non-pharmaceutical dangerous waste is less than 2.2 pounds of either P-listed acutely hazardous waste or WT01 extremely hazardous waste per month, and less than 220 pounds of all other dangerous waste per month, and you never accumulate greater than 2200 pounds on-site at any one time, your facility is an SQG.  You may then manage the non-pharmaceutical waste as an SQG and the pharmaceutical waste according to the Policy

If the grand total of dangerous waste, not including the pharmaceutical waste, is greater than the 2.2, 220, and 2200 pounds, your facility is a MQG or LQG and you must manage and dispose the waste according to the Dangerous Waste Regulations.   

To compare compliance conditions between the Dangerous Waste Regulations and the Policy please refer to the Guide for Dangerous Pharmaceutical Waste Generators in Washington State.
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Proper pharmaceutical waste management
Q: Why can’t I put pharmaceutical waste in my red bags?

A:  Most red bags in Washington State are sterilized and sent to a landfill for disposal.  This is not an approved disposal method for dangerous waste pharmaceuticals.  This management is in violation of the Dangerous Waste Regulations and does not meet the requirements of the Interim Enforcement Policy.

Red bags are designated for biomedical, biohazardous, and infectious materials.  These biomedical solid wastes are regulated by the Washington State Department of Health and defined in RCW 70.95K.  The criterion for the management and disposal of biomedical solid waste do not meet the more stringent requirements for management and disposal of dangerous waste.  Companies that collect and dispose of regulated medical waste are not licensed to transport or store dangerous waste. 

Even if the biomedical waste is sent for incineration, the red bags will be sent to either a permitted municipal incinerator or a medical waste incinerator.  Neither are permitted to accept dangerous wastes.  Therefore disposal of pharmaceutical wastes into red bags is illegal disposal of a dangerous waste.
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Q: Why can’t I put pharmaceutical waste in my sharps containers?

A: Most sharps containers in Washington State are either microwaved or autoclaved to sterilize the contents and then sent to landfills.  This is not an approved disposal method for dangerous waste pharmaceuticals.  This management is in violation of the Dangerous Waste Regulations and does not meet the requirements of the Interim Enforcement Policy.
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Q: Why can’t I send all my expired or unused pharmaceuticals to a reverse distributor?

A:  Pharmaceuticals that are returned to a manufacturer, wholesaler, or reverse distributor for credit are considered a product or a viable pharmaceutical and are not regulated by Ecology’s Dangerous Waste Regulations.  The non-viable pharmaceuticals that cannot receive a credit are considered a waste.  Since pharmaceuticals commonly designate as a dangerous waste, each generator must manage the dangerous pharmaceutical waste properly. 

Most reverse distributors are not licensed to transport or accept dangerous wastes.  It is a violation of the Dangerous Waste Regulations and the Interim Enforcement Policy to send non-viable pharmaceuticals to a reverse distributor unless they are a licensed hazardous waste transporter or a RCRA licensed Treatment, Storage and Disposal (TSD) facility. 
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Q: What is wrong with disposing waste pharmaceuticals to a sanitary sewer?

A: Most pharmaceutical waste designates as either federal RCRA hazardous waste or State-only dangerous waste.  The Publicly Owned Treatment Works (POTWs) are not allowed to accept RCRA hazardous wastes and may choose to not accept state-only dangerous wastes because these wastes are not readily treatable by the wastewater treatment process.  The treatment methods that most POTWs use fail to remove these pharmaceutical compounds from either the wastewater or the biosolids.  Therefore pharmaceutical compounds pass through the treatment plant into the receiving waters or remain in the biosolids that are land applied across the state, which has a potential impact on human health and the environment.

As a result, this is an illegal disposal option unless you have authorization from either your delegated POTW or Ecology’s Water Quality program to discharge specific pharmaceuticals.  The Conditional Exclusion to the Dangerous Waste Regulations [WAC 173-303-071(3)(nn)] excludes state-only pharmaceutical wastes if they are incinerated at a permitted municipal solid waste incinerator or an incinerator that meets the following criteria: heat input greater than 250 million btu/hour or a combustion zone greater than 1500°F.  Sewer disposal is not allowed under the exclusion so any disposal of pharmaceuticals in this manner is a violation of Chapter 173-303 WAC.
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Household hazardous pharmaceutical waste
Q: What do we do with pharmaceutical waste that is abandoned, confiscated, or dropped off at the hospital?

A: You can elect to keep the collected household pharmaceuticals separate from their business waste.  Returned household-exempt pharmaceutical waste that is collected in a separate container can be managed as moderate risk waste under 173-350-360 WAC.  Your business waste cannot be included with this waste, and clear procedures and labeling will need to be demonstrated.  Hospital pharmacies who offer a separate medicine return collection program can be classified as a Product Take-Back Center under the definition of 173-350-100 WAC, and are exempt from solid waste permitting if the waste is managed under specific criteria.
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Q: If the hospital hosts a community take-back for pharmaceutical waste, how would we have to manage this waste?

A: A hospital or pharmacy that chooses to host a community take-back event for pharmaceutical wastes has two options for managing this waste.

Option 1:  The hospital can choose to mix this household pharmaceutical waste with their waste and manage appropriately.  Under the Dangerous Waste regulations, these collected pharmaceuticals would have to be designated and counted towards your generator status. If you are an SQG, you may become a MQG or LQG and trigger the additional compliance requirements.  If you are managing the pharmaceutical wastes under the Interim Policy, you just need to continue managing according to the policy requirements. 

Option 2:  The hospital or pharmacy can choose to keep the collected household pharmaceuticals separate from their business waste.  Returned household-exempt pharmaceutical waste that is collected in a separate container can be managed as moderate risk waste under 173-350-360 WAC.  Your business waste cannot be included with this waste, and clear procedures and labeling will need to be demonstrated.  Hospital pharmacies who offer a separate medicine return collection program can be classified as a Product Take-Back Center under the definition of 173-350-100 WAC, and are exempt from solid waste permitting if the waste is managed under specific criteria.
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