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Failure to comply with RCRA while disposing of waste could prove costly

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August 1, 2018

 Until about a decade ago, inspectors from the federal EPA and comparable state agencies did not venture onto healthcare campuses very often, said Darrell J. Oman, program manager of consulting services for Stericycle Environmental Solutions.

That changed, he said, once the EPA “looked at revisiting the pharmaceutical hazardous waste world” and saw that many healthcare facilities were not fully complying with the Resource Conservation and Recovery Act (RCRA), which has been in effect since the 1970s.

“They started asking questions of [hazardous waste] generators and vendors like us about what the issues were. And I think the agency realized healthcare in general was probably not managing all their waste streams correctly,” Oman said in November 2017 while cohosting an HCPro webinar on RCRA compliance. “So I think that was an awakening for them.” 

These days, the probability of an RCRA-related inspection varies from state to state. Oman, who is based in Blaine, Minnesota, has been in some facilities that have never been inspected by any agency. Meanwhile, in his home turf of Minneapolis and St. Paul, hospitals are often inspected annually on hazardous waste management, Oman said.

“We have seen recently that some states are becoming more active,” he said. “They are finding a good audience in the healthcare facilities because they had not had these kinds of inspections, but they also are generators of a variety of these hazardous wastes. So it’s a target for many of the agencies.” 

And according to Marge McFarlane, PhD, MT(ASCP), CHSP, CHFM, HEM, MEP, CHEP, principal of Superior Performance in Eau Claire, Wisconsin, and Oman’s co-host during our November webinar, an unexpected inspection could prove costly if your facility is found to not be RCRA compliant.

“The bottom line is that [RCRA] provides legal and financial liability for hazardous wastes from the cradle to the grave—from the moment they come into your facility until you have properly disposed of them,” McFarlane said. “So we have regulations, we have fines, we have criminal and civil penalties associated with the handling of waste, and this is why this topic is so important for us as healthcare providers.”

Developed by the EPA and passed into law in 1976, RCRA was created, McFarlane said, to protect human health and the environment by stopping open dumping and preventing hazardous waste from being buried in landfills and seeping into groundwater. Also aiming to eliminate waste, RCRA ushered in the “Reduce, Reuse, Recycle” era. 

“These laws were written for industries where they had one, two, maybe five hazardous waste streams—large amounts, easy to manage. Now we’re talking about healthcare, with multiple waste streams from multiple departments,” McFarlane said. “It’s very, very difficult to understand and manage.”

With their recent RCRA revisions—which Oman believes will be adopted by every state within the next couple of years—the EPA hopes to have made the hazardous waste generator regulations easier to understand while also “providing greater flexibility in how hazardous waste is managed to better fit today's business operations.” 

But for the healthcare industry, compliance with RCRA remains a challenge, said McFarland and Oman. Both stressed that the EPA considers your entire campus as the generator of hazardous waste, tying your generator status and resulting compliance requirements to a physical address. So you must properly manage hazardous waste in all departments.

While making that point, McFarlane noted that a typical 200-bed hospital has approximately 500–1,000 hazardous substances in its clinical and pathology laboratories, 1,000–3,000 pharmaceuticals on hand, and another 200–500 hazardous substances used by facilities staff, cleaning crews, sterile processing, etc.

“The number adds up, and it can be difficult and complex to determine,” McFarland said. “Hazardous waste is not located in just one location on campus. You need to take a look at every place waste may be generated, and you want to make sure you evaluate all streams to determine whether they are RCRA hazardous or not.”

That, Oman said, is the first and most important step in his five-step plan for implementing an effective hazardous waste management program in your facility.

Step 1: Identification and evaluation of all waste streams 

What Oman calls “the waste determination process” begins by figuring out whether each hazardous waste stream is “listed” or “characteristic” hazardous waste. (McFarland reminds us that regulated medical waste such as sharps, tissues, and bloodborne pathogens are considered biohazardous waste, not hazardous.)

Listed hazardous wastes were established with the passing of RCRA legislation in 1976. Many pharmaceuticals fall on the “U list” (such as acetone, mitomycin, and methanol) or the “P list” (such as warfarin, nicotine, and arsenic trioxide). The other list Oman says you need to know, the “F list,” is processed wastes. 

If a substance is not on one of those lists, it could be a characteristic waste. In order to be considered a characteristic hazardous waste, the waste stream, said Oman, has to have one of the following four characteristics:

  • If the flashpoint is below 140°F, it is considered a flammable hazardous waste. 
  • If the pH level is less than or equal to 2 or greater than or equal to 12.5, it is a corrosive hazardous waste. 
  • Dissolved heavy metals such as silver or chromium get designated as a toxic hazardous waste. 
  • Unstable chemicals that react with water, such as nitrates or peroxides, are reactive hazardous waste.

Packaging for a chemical or a safety data sheet might have a description of the properties to help determine if something is a characteristic waste. Pharmacists and lab technicians should also know the chemical properties of the products they use, so you can lean on them. For difficult determinations, Oman said a physical sample could be tested in an environmental analytical testing laboratory.

Once you identify and evaluate your facility’s waste streams, start adding up the poundage to determine your hazardous waste generator status. The lower the generator status, the looser the requirements.

Any facility that generates 2,200 pounds or more of hazardous waste or more than 2.2 pounds of acutely hazardous waste per calendar month is considered a large quantity generator (LQG) and is subject to the strictest RCRA compliance requirements. Acutely hazardous waste, per the EPA, “contains such dangerous chemicals that it could pose a threat to human health and the environment even when properly managed.” 

Small quantity generators (SQG) generate between 220 and 2,200 pounds of hazardous waste per month. Very small quantity generators (VSQG) generate fewer than 220 pounds of hazardous waste or fewer than 2.2 pounds of acutely hazardous waste per month, Oman said.

One welcome change resulting from the final Hazardous Waste Generator Improvements Rule, approved by the EPA in October 2016, allows “a hazardous waste generator to avoid increased burden of a higher generator status when generating episodic waste provided the episodic waste is properly managed,” according to the EPA website. 

(Another change, adding Hazardous Waste Pharmaceuticals to RCRA as subpart P, could be finalized in 2018 and adopted by all states by 2020 or 2021, Oman said. Among the potential rule changes is that pharmaceutical waste would not count against generator status.)

Oman said accurately completing the waste determination process, and backing it up with proper documentation, “really sets the basis for the whole program.”

“A generator really would have a difficult time managing compliance with training employees, collecting and storing the waste properly, preparing and saving documentation, or even knowing what their spill response procedures are if they have not done an adequate job in step No. 1,” Oman said.

Step 2: Collecting and storing that hazardous waste properly 

When should you first consider something to be hazardous waste?

“The moment you decide you no longer need it,” McFarland said. “I have been part of many lab clean sweeps where we have changed our process and now have chemicals that may be perfectly good but I no longer need them. Once I no longer need them, they become hazardous waste.”

If an unneeded substance cannot be repurposed in another department, that waste must be documented and then stored away for disposal. Oman said that hazardous waste collection containers must be controlled by the staff that generates the waste, near the point of waste generation, closed unless being used, and labeled properly, including a clear description of the contents.

Once a collection container is full or nearly full, it must be moved from that Satellite Accumulation Area near the point of waste generation to a Central Accumulation Area, which many hospitals call a “hazardous waste storage room.” 

Containers should be stored there in a secure manner until a shipper or a vendor picks it up, Oman said. At an LQG, they typically must be shipped off-site within 90 days, though some states have different requirements for that time frame. At an SQG or VSQG, they have 180 days. However, “those time frames usually never get triggered,” Oman said, often due to storage space constraints.

Another change enacted in the Hazardous Waste Generator Improvements Rule, which went into effect this past May, is that a VSQG can ship hazardous waste to an LQG of the same controlling entity to be stored there for collection. But Oman has yet to see anyone from the healthcare industry do that.

Step 3: Training employees who handle the hazardous waste 

Any employee who handles hazardous waste must receive proper training. The type of training required depends on individual job responsibilities, and the content and delivery of the training is determined by the generator, Oman said. But federal guidelines say that any worker who is starting employment or changing job requirements is required to undergo training within six months. 

Employees who handle hazardous waste are also required to do refresher courses after that, at a frequency based on the facility’s generator status.

Oman advises against training all your employees at once while covering the responsibilities of each individual. That is “just too complicated,” he said.

“For example, nurses would need to know about identifying and managing pharmaceutical hazardous wastes. If the nurses do not transport the waste or do any recordkeeping, they wouldn’t need training on those elements,” he said. 

The RCRA-mandated training is considered to be different from OSHA’s Hazard Communication annual training and the Department of Transportation’s Hazardous Materials Safety training, despite some overlap in the respective subject matters.

Step 4: Preparing and saving documentation for hazardous waste 

Oman said that generators must submit annual or biennial hazardous waste reports based on their generator status. They must also store all of their Uniformed Hazardous Waste Manifest forms, a uniquely numbered, multi-copy shipping form “that rides with that waste from cradle, which is the generator, to the grave, which is the end facility that disposes of the waste.”

The end facility will mail you signed copies of those forms, which require multiple signatures throughout the disposal process. You are required to keep them in your records for a minimum of three years, Oman said.

Generators also must conduct a weekly inspection of their Central Accumulation Area—aka their “hazardous waste storage room”—and maintain records for that, too. Among the things to check for, Oman said, are that the aisle space between storage containers is adequate and they are properly labeled and dated.

Oman recommends doing your own self-inspections and self-audits on your facility because you never know when EPA inspectors could show up. 

Their unannounced inspections usually take a day or two, he said, and can focus on a particular waste stream or your whole facility. He added that the agency can ask any employee about his or her role in the handling of waste. 

Oman is aware of a number of recent inspections that resulted in fines ranging up to $340,000. But in his experience, “most inspectors, most agencies want to teach; they want to help the generator become compliant.”

“If you have one, you should use it as an opportunity to learn,” he said.

Among the common violations Oman listed were hazardous wastes that were not properly identified or evaluated, waste stored for too long, inadequate storage space, incomplete records, and outdated contingency plans.

Step 5: Implementing emergency and spill response procedures 

Speaking of contingency plans, LQGs are required by RCRA to have handy a written contingency plan, which would include set emergency coordinators and their contact information, communications with local emergency response services, emergency equipment required, and an evacuation plan.

While not technically required for SQGs and VSQGs, the implementation of a contingency plan is recommended by Oman, who has found that “about half the time” facility leaders are not on the same page when questioned about which departments would do what in the event of a hazardous spill.

“Employees who handle, manager, store, or transport hazardous waste need to know what actions they have to take if there’s a spill,” Oman said.




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