Don't Get Waste-Deep
By Joey Berlin Texas Medicine October 2017

Regulations on Hazardous Material Pose Pitfalls, Potential Costly Fines

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Law Feature — October 2017 

Tex Med. 2017;113(10);37-41. 

By Joey Berlin
Associate Editor

Wichita Falls pathologist Susan Strate, MD, knows how difficult it is to follow regulations on disposing hazardous and medical waste.

There are safety rules to follow, documentation requirements, and contracts with a disposal vendor. Those requirements are a challenge even for a large enterprise like Texoma Independent Physicians, the 200-practitioner group for which Dr. Strate serves as president and chief executive officer. Setting up an office and training personnel to comply with medical waste disposal regulations is "time-consuming and costly," she says. 

And she knows the regulations are much harder for a smaller facility to follow.

"It's a lot for an individual physician's office to keep track of. In fact, it's way too much," Dr. Strate said. "Like complying with the other regulations, it is very difficult for a small doctor's office to keep track of all this."

The U.S. Environmental Protection Agency (EPA) and the Texas Commission on Environmental Quality (TCEQ) both have roles in regulating waste that physician practices generate, and it's not all about proper handling and disposal. Registration and paperwork negligence can land practices in big trouble as well. 

Hazardous waste enforcement has been increasing in recent years throughout EPA Region 6, which includes Texas, and medical lab owners and operators should be aware of it, says Grand Rapids, Mich., attorney John Ferroli. In August, Mr. Ferroli was representing a Texas pathology practice that EPA had flagged for violation of hazardous waste regulations involving improper registration and documentation. Mr. Ferroli was in the process of negotiating a settlement for the facility with EPA.

Along with the safety implications of noncompliance, EPA scrutiny can lead to steep fines. And the nature of the recent EPA investigations means much of its work is done before the facility under scrutiny gets wind of it.

"By the time that the lab will hear about a violation from EPA, the EPA has already obtained all the documents it needs to determine that there's a violation. The labs are being blindsided by these enforcement notifications and demands by EPA," Mr. Ferroli said. "They don't even see it coming."

Big Fines for Big Facilities

There's a difference between hazardous waste, which EPA has a role in regulating, and medical waste, which EPA says is primarily state-regulated.

TCEQ regulates the management and disposal of medical waste, which includes animal waste, bulk human blood and body fluids, microbiological waste, and needles. TCEQ's website, tma.tips/tceqmedwaste, has information on proper medical waste management and disposal. 

"Basically, where the work comes in is having to train staff so that they know what is categorized as a biomedical waste and which category it goes into, whether it's soft waste or it's sharps, and then how to dispose of each kind," Dr. Strate said. "And there are a lot of regulations on the different containers that they must be put in, and the labeling of the containers and how they must be stored. And then you must have a contract with a vendor for pickup, transport, and offsite disposal."

On the federal side, EPA defines hazardous waste as having "properties that make it dangerous or capable of having a harmful effect on human health or the environment," according to EPA's website. Hazardous waste is always some type of solid waste, under the EPA's regulatory definition. It's divided into listed waste, which specifically appears on one of four regulatory lists; and characteristic waste, which can be ignitable, corrosive, reactive, or toxic.

Two of the waste lists, the P and U lists, contain chemical waste that may come from pharmaceutical products. (See "The P and U Lists.")

"Hospitals in general have been out of compliance, and the reason they have been has to do with their size, to some extent, and laboratories on site," said Jeff Yurk, a toxicologist for EPA Region 6. "So essentially, what pops up first [in an investigation] … is they tend to have some really acute, very toxic-type chemicals."

Those chemicals typically include nicotine, the blood-thinning drug warfarin, and "several different cancer drugs that you can't just dispose of in the ordinary way," he said. "As little as 26 pounds a year of this stuff is going to put you in the category of a large quantity generator, because they're that toxic."

The federal Resource Conservation and Recovery Act (RCRA) sets the standards for producers of hazardous waste ― known in regulatory lingo as "generators." Texas' statute effectively follows federal law. 

TCEQ has been delegated RCRA authority, and its program "is as stringent as EPA's," according to TCEQ spokeswoman Andrea Morrow. Other federal agencies have medical waste regulations, EPA says, including the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration.

Some of Texas' well-known medical institutions have drawn EPA hazardous waste fines in 2017. For example, EPA hit Memorial Hermann Health System with a fine of nearly a quarter-million dollars, according to a consent agreement signed by Memorial Hermann and released in February.

The order said EPA had conducted an investigation of Memorial Hermann from December 2015 to March 2016, naming five of the system's hospitals in the order. Memorial Hermann violated RCRA and federal regulations, the order said, by "failing to comply with the RCRA notification requirements, managing waste without an EPA ID number, failing to operate within its stated generator status, and failing to perform adequate hazardous waste determination." For example, according to the order, in 2015 four of the hospitals had produced more than 2,205 pounds (1,000 kilograms) of hazardous waste per month, placing them into the large quantity generator category. But the system failed to file notification that the status of those hospitals had changed from small quantity to large quantity generators, the order said.

Memorial Hermann was ordered to pay a civil penalty of $248,497 and to certify that it had implemented procedures to comply with RCRA, including notification requirements. 

No-Boots Investigations

Investigations don't typically start with EPA knocking on the door, and they may not show up at all. EPA has been finding noncompliant waste generators through shipment data from treatment storage and disposal facilities, according to Mr. Yurk and Mark Potts, chief of the waste enforcement branch for EPA Region 6.

"If we see [in the data] shipments that indicate a large quantity generator but we don't see that the generator itself has registered properly, that's a flag for us," Mr. Potts said.

Most of those investigations and enforcement actions don't involve "boots-on-the-ground" inspections at the offending facility, Mr. Potts says, although Mr. Yurk added it does happen.

"We'll send them a letter, we'll call them up, we'll tell them what data we have, they supply us with what they're doing, and we walk through their process and let them know where they're kind of missing some stuff," Mr. Yurk said. "But we have had inspectors go out and confirm all these things with eyes on, too, so we're not just guessing at this. It's pretty evident when you [inspect] when things aren't set up properly."

EPA says penalties for violations like failure to register or a facility operating out of its waste generator status have an upper-end range of $125,000 to $230,000, with adjustments for factors such as culpability and good-faith effort. But Mr. Yurk says EPA works with small businesses and uses a methodology to determine whether they can pay a certain fine, offering discounts if they can't.

"We don't try to put anybody out of business. We try to get them into compliance," he said. 

Get Help Staying Compliant

In Mr. Ferroli's mind, facilities get in trouble because of a simple lack of awareness. He says many hazardous waste-generating physicians assume if there's a requirement they need to meet, they'll hear about it from the people who haul away their waste.

"I think many physicians are completely unaware of these requirements, and I believe that is a major problem," Mr. Ferroli said. "Their waste transporters they've retained have not been telling the physicians that they have other requirements that they need to meet. I think many of the physicians are being disserved by their waste transporters."

He recommends laboratories hire a consultant or have someone in the office who can competently characterize the lab's waste streams. And the state even offers some protection for noncompliant facilities if they're proactive about policing themselves. The Texas Environmental, Health, and Safety Audit Privilege Act allows facilities to perform voluntary self-audits on their environmental compliance. The facility must notify TCEQ of its intent to perform a self-audit before it begins, and must disclose to TCEQ any violations found in the audit and correct them in a timely manner. In exchange for that, the lab can earn certain immunities from administrative or civil penalties. TCEQ's guide to the Audit Privilege Act can be found at tma.tips/auditprivilege.

"That's something that many of our clients in Texas are taking advantage of," Mr. Ferroli said. 

On the medical waste front, TMA's publication Policies and Procedures: A Guide for Medical Practices can help facilities set office policy. The Exposure Control chapter of the guide contains examples of proper policy on biomedical waste and sharps disposal. The manual also addresses business associate agreements with third parties involved in waste disposal. (See "Policies and Procedures.")

"I think if a physician's office looks at the TMA manual and goes through that information, and perhaps has someone with expertise help them with training of their staff, the requirements can be handled quite effectively," Dr. Strate said. "But I think a small office that's trying to do it on their own can very easily run afoul of some detail about the regulations ― very easily."

Joey Berlin can be reached by phone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email.

Legal articles in Texas Medicine are intended to help physicians understand the law by providing legal information on selected topics. These articles are published with the understanding that TMA is not engaged in providing legal advice. When dealing with specific legal matters, readers should seek assistance from their attorneys.

SIDEBAR

EPA Waste Categories

Environmental Protection Agency (EPA) regulations divide generators of hazardous waste, such as medical laboratories, into three categories ― very small quantity, small quantity, and large quantity ― based on how much waste they generate each month. Those categories then determine what regulations they must follow. Selected examples of the requirements in all three categories are shown here. For more information on the categories, visit tma.tips/epagenerators.

Very Small Quantity Generators

  • Hazardous waste per month: up to 220 pounds (100 kg), or up to 2.2 pounds (1 kg) of acute hazardous waste
  • EPA ID number: not required
  • On-site accumulation without a permit: up to 2,205 pounds (1,000 kg), or up to 2.2 pounds (1 kg) of acute hazardous waste, or up to 220 pounds (100 kg) of acute spill residue/soil
  • Accumulation time limits: none
  • Personnel training: not required
  • Tracking hazardous waste shipments by manifest: not required 

Small Quantity Generators

  • Hazardous waste per month: more than 220 pounds (100 kg) but less than 2,205 pounds (1,000 kg)
  • EPA ID number: required
  • On-site accumulation without a permit: up to 13,228 pounds (6,000 kg)
  • Accumulation time limits: up to 180 days, or 270 days if transporting more than 200 miles
  • Personnel training: basic training required
  • Tracking hazardous waste shipments by manifest: not required 

Large Quantity Generators

  • Hazardous waste per month: at least 2,205 pounds (1,000 kg), or more than 2.2 pounds (1 kg) of acute hazardous waste
  • EPA ID number: required
  • On-site accumulation without a permit: no limit
  • Accumulation time limit: up to 90 days
  • Tracking hazardous waste shipments by manifest: not required 

SIDEBAR

Policies and Procedures

TMA's Policies and Procedures: A Guide for Medical Practices is a practical, easy-to-use guide containing more than 200 sample policies and procedures, tools, sample letters, and forms you can customize to fit your practice's needs. The guide is specific to Texas medicine and Texas law and comes with a customizable CD containing policies and procedures on:  

  • Regulations compliance, 
  • Human resources,
  • Front desk operations,
  • Business office operations,
  • Management,
  • Clinical operations,
  • Medical records,
  • Safety, and
  • HIPAA.

For more information and to order the guide, visit the TMA website

The Texas Commission on Environmental Quality (TCEQ) also offers state compliance help for small businesses through its EnviroMentor program. According to TCEQ, EnviroMentors are "qualified professionals with technical or legal expertise on environmental issues" who help small businesses, independent school districts, and local governments as volunteers. EnviroMentors provide confidential help without the threat of enforcement, so their assistance doesn't lead to inspections, citations, or fines. Businesses with 100 or fewer employees who are unable to hire a consultant can qualify for the program. For more information, call (800) 447-7827 or visit www.texasenvirohelp.org

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SIDEBAR

The P and U Lists

Much of what the Environmental Protection Agency classifies as hazardous waste is categorized in four lists. Two of those, known as the P and U lists, contain unused commercial-grade chemicals, including chemicals used in pharmaceuticals. Examples of pharmaceutical waste on the P and/or U lists include: 

  • Arsenic trioxide,
  • Cyclophosphamide,
  • Epinephrine,
  • Mercury,
  • Nicotine,
  • Nitroglycerin,
  • Selenium sulfide, and
  • Warfarin. 

Find more information on listed wastes

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Last Updated On

October 19, 2017

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Joey Berlin

Associate Editor

(512) 370-1393
JoeyBerlinSQ

Joey Berlin is associate editor of Texas Medicine. His previous work includes stints as a reporter and editor for various newspapers and publishing companies, and he’s covered everything from hard news to sports to workers’ compensation. Joey grew up in the Kansas City area and attended the University of Kansas. He lives in Austin.

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