Administering a medical laboratory waste management program is a complicated process, and proper stewardship requires understanding and application of the most current regulations. There are multiple waste streams created in the laboratory setting, the three most common of which are:
Among these, hazardous (chemical) waste is by far the most complicated to manage effectively and efficiently. In some circumstances, chemical waste can be neutralized and sent down the drain, or it will require on-site storage and must be removed from the facility by a contracted vendor. While some laws that govern these processes apply at the national level, such as those enacted by the Environmental Protection Agency (EPA), others are state- or county-specific.
Generator Improvements Rule
In October of 2016, the EPA Administrator signed the final Hazardous Waste Generator Improvements Rule, and it was published in the United States Federal Register one month later.1 This rule (we will refer to it as GIR) creates changes to complicated waste regulations in part so that laboratories and health care facilities are more easily able to manage their particular types of waste. When the original Resource Conservation and Recovery Act (RCRA) was passed in 1976, industrial facilities were the focus, and traditionally, that has made it difficult for health care facilities to understand and comply with those older regulations.
The GIR updates EPA waste chemical regulations, and while they have been adopted in some states in 2018 and 2019, not all states are impacted by the changes as yet (see TABLE 1). Nonetheless, no matter where your state may be in the adoption process, it is important to understand the waste process changes the new rule requires.
Waste Storage & Labeling
Laboratories and hospital facilities are permitted to store hazardous waste in designated areas at or near the point of generation. These areas are called Satellite Accumulation Areas (SAA), and up to 55 gallons of waste may be stored in each area. This waste may be moved to another storage location within the facility known as a Central Accumulation Area (CAA). A CAA can be a waste storage shed, for example, where a contracted transporter can pick up the waste for disposal off site.
Hazardous waste stored in a SAA or CAA has always needed to be labeled, but the GIR has augmented the labeling requirements for such containers. Now, every receptacle used to store chemical waste must be clearly labeled with the words “Hazardous Waste.” There should be a description of the waste (such as xylene waste or stainer waste, etc) for the sake of the waste hauler (although this is no longer required), but there must be some sort of symbolic hazard warning on the label. The EPA does not specify what type of warning label must be used on container labels, so labs may choose their own methods of displaying this information. Warning pictograms can be used, or NFPA or HMIS warning conventions can be used to convey the particular hazard(s) of the contents (see FIGURE 1).
The GIR does not change where and when waste containers should have collection dates placed on them. However, small quantity generators and large quantity generators must mark or label containers in SAAs with the date that maximum volumes (or mass) are exceeded, while both generator types must mark or label containers in CAAs with the date the hazardous waste first began accumulating.1
Waste Generator Status Changes
Every facility in the United States that generates more than 100 kg (220 lbs) of hazardous waste in a given month must have an EPA identification number. Those waste amounts should include laboratory waste and any other chemical waste that is created in the same facility (ie, by pharmacy, radiopharmacy, environmental services, etc). The EPA provides each registered facility a designated generator status based on how much waste is generated and stored on site. These statuses include: Very Small Quantity Generator (VSQG), Small Quantity Generator (SQG), and Large Quantity generator (LQG). See TABLE 2 for more information on the differences. The former designation of Conditionally Exempt Small Quantity Generator, which was established years ago under RCRA, has now changed to VSQG under the GIR.
Furthermore, in an effort to reorganize hazardous waste generator regulations, those governing VSQG facilities were moved from section 261.5 of Title 40 of the Code of Federal Regulations (CFR) into section 262 of 40 CFR, where the regulations for SQGs and LQGs are located. The move simplifies and standardizes the waste regulations such that stakeholders are better able to locate specific information and understand the designations as a whole.
The GIR also added a new requirement specifically for SQG sites. Previously, an SQG site was required to give an initial notification to the EPA (or the authorized state agency) before it managed, stored, or treated hazardous wastes. After this first notification, the SQG did not need to re-notify the agency unless there was a change to the facility waste status. GIR provisions now expect all SQGs to re-notify once every four years. This re-notification must be submitted by September 1st of each year in which re-notifications are required, and it will be required of all SQGs beginning in 2021. Facilities will use EPA form 8700-122 to perform this task.
Under the previous regulations, any facility listed as a VSQG or SQG was limited to generating and disposing of the specific volumes of waste allowed by its status, each month. If that limit was exceeded, even if one time only during the calendar year, the EPA required the facility to change its generator status to the next higher category for that year. Understandably, a status change involves time-consuming paperwork and reporting. In addition, if the status changes to an LQG, there are associated fees, and requirements for the submission of a biennial waste report and the development of a contingency plan, in addition to other increased regulations that must be followed.
Changes in the GIR grant some flexibility to VSQG and SQG waste generators. The updated regulations allow each site to have two waste volume overages per year without having to increase their status with the EPA. This can benefit laboratories and their associated facilities by saving the time and money that would otherwise be spent on a status change, and by allowing facilities to continue to operate under the less stringent standards of their current waste status.
However, although the GIR allows a total of two waste overages per year, only one overage may be unplanned, whereas the other must be planned (two planned or two unplanned events in the same year are not permitted). By way of example, if an SQG hospital needs to treat a cancer patient with arsenic trioxide (an EPA-listed hazardous substance) and if the volume of the resulting waste creates an unexpected waste overage for the facility, that incident would now be considered an unplanned event (see SIDEBAR for more information about recent drug waste regulation changes). Such events must be reported to the EPA or state representative, and the proper paperwork must be filed, but the hospital may keep its current SQG status. An example of a planned waste overage event might include a laboratory relocation or construction that involves the need to dispose of extra waste chemicals.
Waste Movement Within the Facility
RCRA regulations allow for some movement of hazardous waste within a facility, but that waste cannot be moved off facility grounds unless done so by a licensed transporter. Contracted waste haulers remove hazardous waste from a facility, and they typically charge the organization fees based on the number of visits, the waste volumes, and time spent at the facility.
The GIR revisions permit a VSQG site to move hazardous waste to a LQG-designated location provided the LQG site is under the control of the same person or organization as the VSQG. The waste can be moved by an organization representative rather than a contracted hauler. If a reference laboratory is associated with smaller VSQG labs, the ability to move the waste could potentially save an organization money by reducing the number of stops and pick-ups required of the waste transporter.
Other Regulation Updates
As mentioned previously, LQG sites must have a contingency plan in place; an emergency operations plan must enable the facility to handle situations such as an accidental release of large amounts of chemical waste, fires, or even explosions involving chemical or hazardous waste. The required plan must include a designated emergency coordinator by name, a list of emergency equipment and its storage location(s), and an evacuation plan. There also must be a description of arrangements made with local police and fire departments, emergency service contractors, and emergency response teams to coordinate a response in the event of a waste-related incident.
The GIR now requires that LQG sites also include Local Emergency Planning Committees (LEPC) among their emergency planning organizations to help organize response actions. A LEPC is a community-based organization created to assist in preparing for hazardous waste emergencies. LQG locations must now submit “quick reference guides” in order to communicate key information to those local responders so they know what to do during an emergency incident.
The GIR contains many other changes, although not all of them affect laboratory waste operations. Some are technical corrections, such as the removal of obsolete rules and unclear citations. Other updates clarify inconsistent guidance on which generator category applies when a generator generates both acute and non-acute hazardous waste in a calendar month. Lastly, corrections were made to the regulations for completing the RCRA/LQG biennial report. All of the GIR changes result from the EPA’s goal to create a waste management program that better protects the environment and human health across the country.
Ensuring Compliance with GIR
Under the EPA regulations, staff training requirements are dependent on generator status. There are no staff training requirements for VSQG locations; similarly, SQG sites are not required to have a training program, but they must ensure that employees handling hazardous waste are familiar with proper handling and emergency procedures. The training requirements for LQG waste management staff are more rigorous (see FIGURE 2), but all laboratory employees who handle hazardous waste should have thorough training regarding safe handling procedures, labeling, storage, and spill clean-up. Proper training and education regarding current waste regulations will help to ensure the department remains compliant with federal and state waste laws.
Another method to ensure compliance is conducting audits of the laboratory waste management program. Review polices to confirm they are up to date with the GIR as it becomes applicable in your state. Determine your facility’s waste generator status and check for compliance with appropriate regulations. Check for proper segregation and storage of laboratory wastes, and review labels on all stored containers. Make sure spill clean-up supplies are readily available and that waste records are up to date and complete.
The Generator Improvement Rule has introduced multiple changes that affect how clinical laboratories should manage chemical waste. However, these changes are intended to both clarify and ease overall management of waste in health care facilities. One thing that has not changed is the EPA’s view of waste ownership: The generator has responsibility for the waste it produces until it reaches its final disposal location (not simply once it has left the facility). Understanding all pertinent waste regulations will help the laboratory maintain regulatory compliance, and more importantly, the safety of all who handle lab waste from its creation to its final disposition.
Daniel J. Scungio, MT(ASCP)SLS, CQA(ASQ), has over 25 years of experience as a certified medical technologist. He worked as a laboratory generalist in hospitals ranging from 75 to 800 beds before becoming a laboratory manager, a position in which he served for 10 years. Dan is now the laboratory safety officer for Sentara Healthcare, a system of more than seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. As “Dan the Lab Safety Man,” he also serves as a professional speaker, trainer, and lab safety consultant. Dan received his BS in medical technology from the State University of New York at Buffalo.
The Pharmaceutical Rule
In February 2019, the EPA published the Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine, better known as the “Pharmaceutical Rule.”* While the updates created by these new laws do not affect laboratories directly, they can significantly reduce a hospital’s waste volumes, which in turn, can change the waste generator status of the facility. This can have a direct impact on lab waste management operations.
The Pharmaceutical Rule was developed to better assist health care facilities in implementing cost-effective and sensible pharmaceutical waste practices. The rule is essentially composed of three sets of regulations which focus on separate drug waste practices:
Hazardous Waste Management Resources
CLSI. Clinical Laboratory Waste Management; Approved Guideline—Third Edition. CLSI document GP05-A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.
US Department of Transportation. Pipeline and Hazardous Materials Safety Administration. Transportation. 49 CFR 171-179.
US Department of Labor, Occupational Safety and Health Administration (OSHA). Occupational Safety and Health Standards.
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