U.S. Mining Sites – Legacy of Contamination Needs to be Addressed

https://www.thechronicleherald.ca/news/world/us-mining-sites-dump-50m-gallons-of-fouled-wastewater-daily-285939/

Rimini, Montana – Every day many millions of gallons of water loaded with arsenic, lead and other toxic metals flow from some of the most contaminated mining sites in the U.S. and into surrounding streams and ponds without being treated, The Associated Press has found.

That torrent is poisoning aquatic life and tainting water supplies in Montana, California, Colorado, Oklahoma and at least five other states.

The pollution is a legacy of how the mining industry was allowed to operate in the U.S. for more than a century. Companies that built mines for silver, lead, gold and other “hardrock” minerals could move on once they were no longer profitable, leaving behind tainted water that still leaks out of the mines or is cleaned up at taxpayer expense.

Using data from public records requests and independent researchers, the AP examined 43 mining sites under federal oversight, some containing dozens or even hundreds of individual mines.

The records show that at average flows, more than 50 million gallons of contaminated wastewater streams daily from the sites. In many cases, it runs untreated into nearby groundwater, rivers and ponds — a roughly 20-million-gallon daily dose of pollution that could fill more than 2,000 tanker trucks.

The remainder of the waste is captured or treated in a costly effort that will need to carry on indefinitely, for perhaps thousands of years, often with little hope for reimbursement.

The volumes vastly exceed the release from Colorado’s Gold King Mine disaster in 2015, when a U.S. Environmental Protection Agency cleanup crew inadvertently triggered the release of 3 million gallons (11.4 million liters) of mustard-colored mine sludge, fouling rivers in three states.

At many mines, the pollution has continued decades after their enlistment in the federal Superfund cleanup program for the nation’s most hazardous sites, which faces sharp cuts under President Donald Trump.

Federal officials have raised fears that at least six of the sites examined by AP could have blowouts like the one at Gold King.

Mine waste mixes with runoff at the Gold King Mine. (Provided by the U.S. Environmental Protection Agency)

Some sites feature massive piles or impoundments of mine waste known as tailings. A tailings dam collapse in Brazil last month killed at least 169 people and left 140 missing. A similar 2014 accident in British Columbia swept millions of cubic yards of contaminated mud into a nearby lake, resulting in one of Canada’s worst environmental disasters.

But even short of a calamitous accident, many mines pose the chronic problem of relentless pollution.

AP also found mining sites where untreated water harms the environment or threatens drinking water supplies in North and South Carolina, Vermont, Missouri and Oregon.

Tainted wells

In mountains outside the Montana capital of Helena, about 30 households can’t drink their tap water because groundwater was polluted by about 150 abandoned gold, lead and copper mines that operated from the 1870s until 1953.

The community of Rimini was added to the Superfund list in 1999. Contaminated soil in residents’ yards was replaced, and the EPA has provided bottled water for a decade. But polluted water still pours from the mines and into Upper Tenmile Creek.

“The fact that bottled water is provided is great,” said 30-year Rimini resident Catherine Maynard, a natural resources analyst for the U.S. Department of Agriculture. “Where it falls short is it’s not piped into our home. Water that’s piped into our home is still contaminated water. Washing dishes and bathing — that metal-laden water is still running through our pipes.”

Estimates of the number of such abandoned mine sites range from 161,000 in 12 western states to as many as 500,000 nationwide. At least 33,000 have degraded the environment, according to the Government Accountability Office, and thousands more are discovered every year.

Officials have yet to complete work including basic risk analyses on about 80 percent of abandoned mining sites on federal lands. Most are controlled by the Bureau of Land Management, which under Trump is seeking to consolidate mine cleanups with another program and cut their combined 2019 spending from $35 million to $13 million.

An abandoned mining site in Clear Creek County. (Jesse Paul, The Colorado Sun)

Perpetual pollution

Problems at some sites are intractable. Among them:

  • In eastern Oklahoma’s Tar Creek mining district, waterways are devoid of life and elevated lead levels persist in the blood of children despite a two-decade effort to clean up lead and zinc mines. More than $300 million has been committed since 1983, but only a small fraction of the impacted land has been reclaimed and contaminated water continues to flow.
  • At northern California’s Iron Mountain Mine, cleanup teams battle to contain highly acidic water that percolates through a former copper and zinc mine and drains into a Sacramento River tributary. The mine discharged six tons of toxic sludge daily before an EPA cleanup. Authorities now spend $5 million a year to remove poisonous sludge that had caused massive fish kills, and they expect to keep at it forever.
  • In Colorado’s San Juan Mountains, site of the Gold King blowout, some 400 abandoned or inactive mine sites contribute an estimated 15 million gallons (57 million liters) of acid mine drainage per day.

AP also found mining sites where untreated water harms the environment or threatens drinking water supplies in North and South Carolina, Vermont, Missouri and Oregon.

This landscape of polluted sites occurred under mining industry rules largely unchanged since the 1872 Mining Act.

State and federal laws in recent decades have held companies more accountable than in the past, but critics say huge loopholes all but ensure that some of today’s mines will foul waterways or require perpetual cleanups.

To avoid a catastrophe like Gold King, EPA officials now require advance approval for work on many mining sites. But they acknowledge they’re only dealing with a small portion of the problem.

“We have been trying to play a very careful game of prioritization,” said Dana Stalcup, deputy director of the Superfund program. “We know the Superfund program is not the answer to the hundreds of thousands of mines out there, but the mines we are working on we want to do them the best we can.”

The 43 sites examined by AP are mining locations for which officials and researchers have reliable estimates of polluted water releases. Officials said flow rates at the sites vary.

Average flows were unavailable for nine sites that only had high and low estimates of how much polluted water flowed out. For those sites, the AP used the lower estimates for its analysis.

Questions over who should pay

To date, the EPA has spent an estimated $4 billion on mining cleanups. Under Trump, the agency has identified a small number of Superfund sites for heightened attention after cleanup efforts stalled or dragged on for years. They include five mining sites examined by AP.

Former EPA assistant administrator Mathy Stanislaus said more money is needed to address mining pollution on a systematic basis, rather than jumping from one emergency response to another.

“The piecemeal approach is just not working,” said Stanislaus, who oversaw the Superfund program for almost eight years ending in 2017.

Democrats have sought unsuccessfully to create a special cleanup fund for old hardrock mine sites, with fees paid by the mining industry. Such a fund has been in place for coal mines since 1977, with more than $11 billion in fees collected and hundreds of sites reclaimed.

The mining industry has resisted doing the same for hardrock mines, and Republicans in Congress have blocked the Democratic proposals.

Montana Mining Association director Tammy Johnson acknowledged abandoned mines have left a legacy of pollution, but added that companies still in operation should not be forced to pay for those problems.

“Back in the day there really wasn’t a lot known about acid mine drainage,” she said. “I just don’t think that today’s companies bear the responsibility.”

In 2017, the EPA proposed requiring companies still operating mines to post cleanup bonds or offer other financial assurances so taxpayers don’t end up footing cleanup bills. The Trump administration halted the rule , but environmental groups are scheduled to appear in federal court next month in a lawsuit that seeks to revive it.

“When something gets on a Superfund site, that doesn’t mean it instantly and magically gets cleaned up,” said Earthjustice attorney Amanda Goodin. “Having money immediately available from a responsible party would be a game changer.”

City of Brantford gets loan for completed brownfield project

As reported by Susan Gamble in the Brantford Expositor, The City of Brantford, Ontario is securing a $4.6 million load to cover the expenses related to the remediation of the Sydenham Pearl Brownfield Site.

The site has already been remediated. City Councillors recently voted in favour of the $4.6 million debenture from the Ontario Infrastructure and Lands Corporation with a 20-year interest rate of 3.4 per cent. The agreement will mean the city repays the loan at a rate of $322,878 a year.

The debenture was approved, along with the project, in 2012 and the remediation at the site is complete, but the money has to be returned to the city’s capital project fund, which has been fronting the money.

Joelle Daniels, the city’s director of finance, explained to the Brantford Expositor that the city had been able to finance the costs of the project over the last six years from working capital since the cash flow was available.

“Typically we have an interim balance and that allows us to not issue the debenture until we know the final cost of the project. We wouldn’t have wanted to borrow the money up front and then carry the interest longer.”

The city has about a dozen outstanding debentures, most of them with the Ontario Infrastructure Lands Corporation but others through the Federation of Canadian Municipalities or regular lending institutions.

The Sydenham-Pearl Brownfield Site is a 6 acre property that had most recently owned by two industrial companies, namely Domtar and Crown Electric, which is surrounded by residential properties, a public playground, a vacant school property, and a rail line.

Crown Electric Manufacturing 17 Sydenham Street
Image Source: (City of Brantford Records Department)

Prior to remediation, soil testing and groundwater testing had shown high levels of industrial chemicals, including but not limited to trichloroethylene and its breakdown products, ethylbenzene and vinyl chloride. 

As is the case with many brownfields, the Sydenham-Pearl Brownfield site has its history rooted in industrial purposes.  The properties have changed hands many times over the course of several decades, and have survived many changes in environmental policies.  Policies including the disposal of hazardous waste and even what chemicals are considered to be hazardous in the first place.

The remediation took 8 weeks to complete and included: the removal of underground storage tanks; excavation and offsite disposal of petroleum hydrocarbons in soil; and in situ soil mixing to break down volatile organic compounds in soil and groundwater.

With remediation activities complete, Phase 3 soil capping and berm construction began. Installation of the soil cap was a requirement of the Ontario Environment Ministry in accordance with the Risk Assessment completed for these properties. Milestone Environmental Contracting completed soil capping and berm construction.

Work at the Sydenham Pearl Brownfield Remediation project was completed in 2017 with required certificates received from the province last spring. The city is currently finishing off sampling and monitoring of the site as required by the Ministry of Environment Conservation and Parks.

The project, which took in 17 and 22 Sydenham, involved removing more than 3,000 cubic metres of contaminated soil to a provincial landfill.

Formerly the site of Crown Electric and Domtar, which made roofing materials, the site was an eyesore, inhabited by squatters and an invitation for fires.

Large fires in 2001 and 2004 meant the city spent hundreds of thousands of dollars to level buildings and clear the area. The properties were seized for tax sales and a remediation plan was created.

Milestone Environmental Contracting spent $2.4 million of the budget on the remediation and another $2.2 million was set aside for the greening process and contingency funding.

Ontario: Trucking Company Fined $250,000 over hazmat incident

Titanium Trucking Services Inc., headquartered in Ontario, was recently convicted of one violation under the Ontario Environmental Protection Act and was fined $250,000 plus a victim fine surcharge of $62,500 and was given 24 months to pay the fine. Luckily, no one was h The fine was the result of a hazmat incident in which a fluorosilicic acid spilled from a tanker truck into the natural environment, which caused adverse effects. No one can predict anything like this to happen, which is why it is important to always stay focused on the road no matter what vehicle you drive. Luckily no one was hurt in this collision. Saying this though, if you have been involved in a trucking accident and were not sure what to do next, getting some assistance from a personal injury lawyer springfield il could be the answer you need that can help you get your life back on track after this incident. There’s nothing wrong in asking for help.

Fluorosilicic acid is corrosive and causes burns. It decomposes when heated, with possible emanation of toxic hydrofluoric acid vapours. It is used in fluoridating water and in aluminum production. In the aquatic environment, an accidental spillage of fluorosilic acid would suddenly reduce pH level due to the product’s acidic properties.

At the time of the offence, Titanium Trucking Services Inc., which is located in Bolton (just northwest of Toronto) had a contract with a Burlington, Ontario area chemical company to provide drivers and vehicles on a dedicated basis for chemical product transportation.

In January 2017, the Burlington area chemical company placed an order for 81,000 kg of 37-42% fluorosilicic acid, which was required for pickup in Montreal for transport to Burlington. Fluorosilicic acid is a corrosive liquid, classified as a dangerous good.

On the date of the planned chemical pick-up, Environment Canada had issued weather advisories relating to a major winter storm and the public was instructed to consider postponing non-essential travel.

The chemical pick-up occurred as planned on March 14, 2017, and within four hours after leaving Montreal, the truck and the driver were involved in a multi-vehicle collision while traveling westbound on Highway 401. As a result of the collision 15 totes of fluorosilicic acid ejected through the front wall of the trailer and also came to rest in the roadside ditch.

Eight of the totes of acid that ejected from the trailer were punctured and spilled approximately 8,000 litres of acid into the ditch and onto the truck cab, dousing the driver, which eventually resulted in his death later in hospital.

March 14, 2017 incident on Highway 401 near Mallorytown. Several first responders were exposed and needed to be decontaminated. (XBR Traffic)

The acid discharge caused further adverse effects. a total of 13 First responders and another sixteen members of the public had to be decontaminated, the 401 highway was closed in both directions, and the OPP officer who initially attempted to extract the truck driver from the cab on scene experienced significant health effects. In addition, adverse impacts to the roadside soil ecosystem occurred.

Ontario: Consultant fined $22,500 for submitting false information to Environment Ministry

Stephen Harold Arkell, an environmental consultant and owner of CR Consulting in Markham, was recently convicted on three violations under the Ontario Environmental Protection Act and was fined $22,500 plus a victim fine surcharge of $5,625 with 18 months to pay the fine. As part of the conviction an 18 month Probation Order was issued by the court.

The convictions relate to submitting false information electronically to the Ontario Environment Ministry’s Environmental Activity and Sector Registry.

Stephen Harold Arkell has an office in Markham and during the time of the violations, provided consulting services by preparing environmental application submissions for the purpose of obtaining Ontario Environment Ministry approvals and registering on the Environmental Activity Sector Registry. Mr. Arkell is not and has never been a licenced engineering practitioner.

Before conducting an activity that may discharge contaminants into the natural environment (other than water) legislation requires that the business or individual obtain a ministry approval or register on the Environmental Activity and Sector Registry. A licenced engineer is needed to complete these requirements.

During the period, Mr. Arkell prepared and submitted registrations to the Environmental Activity and Sector Registry on behalf of clients engaged in activities that required a registration due to their potential to emit contaminant(s) to the air. 

In all cases, the registrations that Mr. Arkell prepared and submitted indicated that the required documents had been prepared by an engineer and also indicated an engineer licence number. However, this information was false. By committing these offences, Mr. Arkell impacted the registrations of three separate companies between July 2017 and January 2018.

The ministry’s Investigations and Enforcement Branch investigated and laid charges resulting in three convictions.

Mr. Arkell’s LinkedIn indicates that he has been the owner of CR Consulting since 2010. It states that his company prepares air emission applications for industries who are required to register with the Ministry of the Environment for Certificates of Approval (air). As part of the application process, the company prepares Emission Summary and Dispersion Modeling reports.

Ontario: Fertilizer Producer fined $90,000 for Ammonia Spill

Terra International (Canada) Inc., was recently was convicted of one offence under the Ontario Environmental Protection Act (EPA) and was fined $90,000 plus a victim fine surcharge of $22,500. The conviction stems from an incident that occurred on August 11, 2016 when the company reported an ammonia gas release to the Ontario Environment Ministry’s Spills Action Centre. It was subsequently determined that approximately 8.57 tonnes of liquid ammonia was released and contained, which resulted in a release of 997 kilograms of ammonia gas to the air over a two-hour period.

The ammonia release resulted in various adverse effects including the closure of nearby roads for approximately one hour. In addition, two reports were received alleging odours, with one of those alleging irritation; a third report alleged irritation, nausea and difficulty breathing; and employees at one neighbouring company reported evacuating for approximately two hours.

Upon discovery of the ammonia gas release, personnel from Terra conducted a root cause analysis which concluded that a previously unknown mechanical deficiency in an ammonia pump resulted in the failure of a vent pipe containing liquid ammonia.

Terra International (Canada) Inc. is a wholly owned subsidiary of CF Industries and operates a facility in St. Clair Township, Ontario (30 km south of Sarnia, Ontario) where it produces ammonia and urea products. To produces up to 1.0 million tons of nitrogen products for agricultural and industrial use each year. Approximately 200 people work at the facility.

Pyrolysis makes oil-soaked soil fertile again

As reported by David Ruth in Physics.org, researchers at Rice University in Texas have developed a method of decontaminating soil impacted with heavy oil and making it fertile again. Rice engineers Kyriacos Zygourakis and Pedro Alvarez and their colleagues have fine-tuned their method to remove petroleum contaminants from soil through pyrolysis. The technique gently heats soil while keeping oxygen out, which avoids the damage usually done to fertile soil when burning hydrocarbons cause temperature spikes.

While large-volume marine spills get most of the attention, 98 percent of oil spills occur on land, Alvarez points out, with more than 25,000 spills a year reported to the Environmental Protection Agency. That makes the need for cost-effective remediation clear, he said.

“We saw an opportunity to convert a liability, contaminated soil, into a commodity, fertile soil,” Alvarez said.

The key to retaining fertility is to preserve the soil’s essential clays, Zygourakis said. “Clays retain water, and if you raise the temperature too high, you basically destroy them,” he said. “If you exceed 500 degrees Celsius (900 degrees Fahrenheit), dehydration is irreversible.”

The researchers put soil samples from Hearne, Texas, contaminated in the lab with heavy crude, into a kiln to see what temperature best eliminated the most oil, and how long it took.

Their results showed heating samples in the rotating drum at 420 C (788 F) for 15 minutes eliminated 99.9 percent of total petroleum hydrocarbons (TPH) and 94.5 percent of polycyclic aromatic hydrocarbons (PAH), leaving the treated soils with roughly the same pollutant levels found in natural, uncontaminated soil.

The paper appears in the American Chemical Society journal Environmental Science and Technology. It follows several papers by the same group that detailed the mechanism by which pyrolysis removes contaminants and turns some of the unwanted hydrocarbons into char, while leaving behind soil almost as fertile as the original. “While heating soil to clean it isn’t a new process,” Zygourakis said, “we’ve proved we can do it quickly in a continuous reactor to remove TPH, and we’ve learned how to optimize the pyrolysis conditions to maximize contaminant removal while minimizing soil damage and loss of fertility.

“We also learned we can do it with less energy than other methods, and we have detoxified the soil so that we can safely put it back,” he said.

Heating the soil to about 420 C represents the sweet spot for treatment, Zygourakis said. Heating it to 470 C (878 F) did a marginally better job in removing contaminants, but used more energy and, more importantly, decreased the soil’s fertility to the degree that it could not be reused.

“Between 200 and 300 C (392-572 F), the light volatile compounds evaporate,” he said. “When you get to 350 to 400 C (662-752 F), you start breaking first the heteroatom bonds, and then carbon-carbon and carbon-hydrogen bonds triggering a sequence of radical reactions that convert heavier hydrocarbons to stable, low-reactivity char.”

The true test of the pilot program came when the researchers grew Simpson black-seeded lettuce, a variety for which petroleum is highly toxic, on the original clean soil, some contaminated soil and several pyrolyzed soils. While plants in the treated soils were a bit slower to start, they found that after 21 days, plants grown in pyrolyzed soil with fertilizer or simply water showed the same germination rates and had the same weight as those grown in clean soil.

Lettuce growing in once oil-contaminated soil revived by a process developed by Rice University engineers. The Rice team determined that pyrolyzing oil-soaked soil for 15 minutes at 420 degrees Celsius is sufficient to eliminate contaminants while preserving the soil’s fertility. The lettuce plants shown here, in treated and fertilized soil, showed robust growth over 14 days. Credit: Wen Song/Rice University

“We knew we had a process that effectively cleans up oil-contaminated soil and restores its fertility,” Zygourakis said. “But, had we truly detoxified the soil?”

To answer this final question, the Rice team turned to Bhagavatula Moorthy, a professor of neonatology at Baylor College of Medicine, who studies the effects of airborne contaminants on neonatal development. Moorthy and his lab found that extracts taken from oil-contaminated soils were toxic to human lung cells, while exposing the same cell lines to extracts from treated soils had no adverse effects. The study eased concerns that pyrolyzed soil could release airborne dust particles laced with highly toxic pollutants like PAHs.

”One important lesson we learned is that different treatment objectives for regulatory compliance, detoxification and soil-fertility restoration need not be mutually exclusive and can be simultaneously achieved,” Alvarez said.

The Uses of 3D Modeling Technology in the Environmental Remediation Industry

By: Matt Lyter (Senior Staff Geologist at St-John-Mitterhauser & Associates, A Terracon Company) and Jim Depa (Senior Project Manager/3D Visualization Manager at St-John-Mitterhauser & Associates, A Terracon Company)

Three-dimensional (3D) modeling technology is used by geologists and engineers in the economic and infrastructure industries to help organize and visualize large amounts of data collected from fieldwork investigations. In the oil and gas industry, petroleum geologists use 3D models to visualize complex geologic features in the subsurface in order to find structural traps for oil and natural gas reserves. In the construction industry, engineers use 3D maps and models to help predict the mechanics of the soil and the strength of bedrock for construction projects. Consequently, where construction projects are concerned, it is also advisable to start with design build, so it follows that these predictions can make the eventual construction process easier in the long term. Furthermore, In the mining industry, economic geologists use high resolution 3D models to estimate the value of naturally occurring ore deposits, like gold, copper, and platinum, in a practice known as resource modeling.

All of the models are built in almost the same exact way: 1) By collecting and analyzing soil samples and/or rock cores; 2) Using a computer program to statistically analyze the resulting data to create hundreds or even thousands of new (or inferred) data points; and 3) Visualizing the actual and inferred data to create a detailed picture of the ground or subsurface in three dimensions. These models can be used in the economic and infrastructure industries to help predict the best locations to install an oil or gas well, predict the size of an oil or natural gas reserve, assist in the design of a road, tunnel, or landfill, calculate the amount of overburden material needing to be excavated, or help to predict the economic viability of a subsurface exploration project.

However, because of the significant amount of computing power needed to create the models, usage of the technology by regulatory driven industries has been limited. But continuing technological advancements have recently made 3D modeling technology more accessible and affordable for these regulatory driven industries, including the environmental investigation and remediation industry. Complex 3D models that previously may have taken several days to create using expensive high-end computers, can now be made in several hours (or even minutes) using the technology present in most commercially available desktops. Because of these advancements, subsurface contamination caused by chemical spills can be visualized and modeled in 3D by environmental geologists at a reasonable price and even in near real-time.

3D Models of Soil Contamination

Some of the applications of 3D modeling technology in the environmental investigation and remediation industry are only just beginning to be utilized, but they have already helped to: 1) Identify data gaps from subsurface investigations, 2) Describe and depict the relationship between the geologic setting of a site and underground migration of a contaminant, and 3) Provide a more accurate estimate of the amount of contamination in the subsurface. The models have also helped contractors design more efficient remediation systems, assisted governmental regulators in decision making, and aided the legal industry by explaining complex geologic concepts to the non-scientific community. This is especially true when short animations are created using the models, which can show the data at multiple angles and perspectives – revealing complexities in the subsurface that static two-dimensional images never could.

The consultants at St. John-Mittelhauser and Associates, a Terracon Company (SMA), have used 3D modeling technology on dozens of sites across the United States, most recently, at a large-scale environmental remediation project in the Midwestern United States. Contamination from spills of trichloroethylene (TCE), a once widely used metal degreaser, were identified at a former auto parts manufacturer during a routine Phase 2 investigation. Dozens of soil samples were collected and analyzed in order to define the extent of contamination, and once completed, traditional 2D maps and a series of cross-sections were created. One of the cross sections is shown in the image below:

Cross-section of soil contamination

Traditional Cross-section Showing Geologic Units and Soil Sample Results

The maps and cross sections were presented to remediation contractors with the purpose of designing a remediation system precisely based on treating only the extent of the contaminated soil. The lowest bid received was for $4.2 million dollars (USD), however, it was evident to SMA that all of the proposed designs failed to take into account the complexity of the subsurface contamination. Specifically, large portions of the Site, which were not contaminated, were being proposed to be treated. Therefore, using a 3D dimensional modeling program, SMA visualized the soil sample locations, modeled the extent of the contaminated soil in 3D, and created an animation showing the model at multiple perspectives and angles, at a cost of $12,000 (USD). A screenshot of the model is provided below:

3D dimensional modeling program results

3D Side View of TCE Contamination in Soil (15 PPM in Green, 250 PPM in Orange)?

The project was resubmitted to the remediation contractors with the 3D models and animation included, resulting in a guaranteed fixed-price bid of $3.1 million dollars – a cost savings of over $1.1 million dollars for the client. Additionally, an animation showing both the remedial design plan and confirmatory sampling plan was created and presented to the United States Environmental Protection Agency (the regulatory agency reviewing the project) and was approved without any modifications. To date, the remediation system has removed over 4,200 pounds of TCE from the subsurface and completion of the project is expected in 2019. A short animation of the 3D model can be viewed on YouTube.

3D Models Showing PCE Contamination in Soil

The 3D modeling software has also been used to help determine the most cost-effective solution for other remediation projects, and has been able to identify (and clearly present) the sources of chemical spills.  The following link is an animation showing three case studies involving spills of perchloroethene (a common industrial solvent) at a chemical storage facility, ink manufacturer, and former dry cleaner: https://www.youtube.com/watch?v=0IlN_TIXkGk

The most cost-effective remediation option was different for each site and was based on the magnitude of the contamination, maximum depth of contaminated soil, geologic setting, and the 3D modeled extent of contamination.  Specifically, the contamination at the chemical storage facility was treated using electrical resistance heating technology, chemical oxidants were used to treat the soils at the ink manufacturer, and soil vapor extraction technology was used at the dry cleaner.

However, several barriers remain which prevent the wide-spread use of 3D modeling technology. The various modeling programs can cost upwards of $20,000, as well as yearly fees for software maintenance. There are also costs to organize large datasets, build the necessary files, and create the models and animations. It also must be noted that the 3D models are only statistical predictions of site conditions based on the available data, and the accuracy of the models is wholly dependent on the quantity, and more importantly, the quality of the data. Even so, 3D modeling technology has proven to play an important role in the environmental remediation industry by helping project managers to understand their sites more thoroughly. It has also provided a way to disseminate large amounts information to contractors, regulators, and the general public. But, perhaps, most-importantly, it has saved money for clients.


About the Authors

Matt Lyter (Senior Staff Geologist at St-John-Mitterhauser & Associate, A Terracon Company) provides clients with a wide range of environmental consulting services (Environmental litigation support; acquisition and transaction support; site specific risk assessment, etc.), conventional and state-of-the-art environmental Investigation services, and traditional to advanced environmental remediation services.

Jim Depa (Senior Project Manager/3D Visualization Manager at St-John-Mitterhauser & Associate, A Terracon Company) has over 12 years of experience as a field geologist, project manager, and 3D modeler. He is well-versed with a variety of computer programs including: C-Tech’s Earth Volumetric Studio (EVS), Esri’s ArcGIS, AQTESOLV, MAROS, Power Director 16, and Earthsoft’s EQuIS

Bioremediation: Global Markets and Technologies to 2023

A report issued by BCC Research provides an overview of the global markets and technologies of the bioremediation industry. The report predicts that the global bioremediation market should grow from $91.0 billion in 2018 to $186.3 billion by 2023, increasing at a compound annual growth rate (CAGR) of 15.4% from 2018 through 2023.

One of the finding of the report is that the application of bioremediation technology in the water bodies sector held the largest market share in 2017, and it is expected to remain the market leader throughout the forecast period.

The report predicts an ever-increasing use of bioremediation techniques for treating sewage, lakes, rivers and streams, ponds and aqua culture is anticipated to create huge growth opportunities for the market in the coming years. In recent years, however, the rise in the agriculture industries has augmented the growth of hazardous pollutants in the environment, and thus the application of bioremediation methods in the agricultural sector is expected to be the fastest-growing segment.

Redox zones of a typical contaminant plume (Source: Parsons 2004)

The report breaks down and analyzes the bioremediation market into three categories:

  • By type: In situ and ex situ bioremediation.
  • By application: Water bodies, mining, oil and gas, agriculture, automotive and other industries.
  • By region: North America is segmented into the U.S., Canada and Mexico; Europe is segmented into the U.K., Germany, France, Russia and Rest of Europe; the Asia-Pacific region is segmented into Japan, India, China and Rest of Asia-Pacific; and the Rest of the World (ROW) covers Latin America, Middle East and Africa.

The report provides estimated values used are based on manufacturers’ total revenues. Projected and forecast revenue values are in constant U.S. dollars unadjusted for inflation.

This report also includes a patent analysis and a listing of company profiles for key players in the bioremediation market.

Similar Reports

In 2014, a team of United Kingdom researchers at University of Nottingham and Heriot-Watt University issued the results of a global survey on the use of bioremediation technologies for addressing environmental pollution problems. The findings of the survey were quite interesting.

Preferred vs. Actual Treatment Method

One of the findings of the UK survey was the difference between the preferred vs. actual treatment method. More than half of respondents (51%) stated that they would prefer to use environmentally friendly approaches including microbial remediation (35%) and phytoremediation (16%). However, historical information suggests the opposite has actually been the case. Considering the relative low cost and low energy requirements of bioremediation technologies, the gulf between aspiration and practice might be due to various factors involving the risk-averse nature of the contaminated-land industry, or difficulties in project design. The latter include identifying appropriate organisms for removing specified contaminants, optimizing environmental conditions for their action, ascertaining extents of eventual clean-up, and the incomplete understanding of all the mechanisms and processes involved. These lead to difficulties in modeling, simulating and/or controlling these processes for improved outcomes.

Application of Bioremediation Techniques

The Figure below compares the broad bioremediation methods being employed within industry according to the 2014 survey, namely monitored natural attenuation (MNA), bio-augmentation and bio-stimulation. The use of low-cost in situ technologies (like MNA) featured quite prominently, particularly in North America and Europe, where it accounts for over 60% of the bioremediation methods being used. This finding points to a strong concern within the developed countries for better maintenance of ecological balance and preventing a disruption of naturally occurring populations.

MNA has been shown to require 1) elaborate modeling, 2) evaluation of contaminant degradation rates and pathways, and 3) a prediction of contaminant concentrations at migration distances and time points downstream of exposure points. This is to determine which natural processes will reduce contaminant concentrations below risk levels before potential courses of exposure are completed, and to confirm that degradation is proceeding at rates consistent with clean-up objectives. These results appear to suggest that regions which employ computational and modeling resources are better able to use low-cost bioremediation technologies like MNA, whereas the others tend to use the more traditional and less cost-effective technologies. In all the continents, researchers were found to favor the use of bio-stimulation methods. Less disruption of ecological balance is apparently a global concern.

Background on Bioremediation

Bioremediation is a method that uses naturally occurring microorganisms such as bacteria, fungi and yeast to degrade or break down hazardous substances into non-toxic or less-toxic substances.Microorganisms eat and digest organic substances for energy and nutrients.

There are certain microorganisms that can dissolve organic substances such as solvents or fuels that are hazardous to the environment.These microorganisms degrade the organic contaminants into less-toxic products, mainly water and carbon dioxide.

The microorganisms must be healthy and active for this to occur.

Bioremediation technology helps microorganisms grow and boosts microbial population by generating optimum environmental conditions. The particular bioremediation technology utilized is determined by various factors, including the site conditions, the presence of type of microorganisms, and the toxicity and quantity of contaminant chemicals.

Bioremediation takes place under anaerobic and aerobic conditions.In the case of aerobic conditions, microorganisms utilize the amount of oxygen present in atmosphere to function.

With a sufficient amount of oxygen, microorganisms transform organic contaminants into water and carbon dioxide. Anaerobic conditions help biological activity in which oxygen is not present so that the microorganisms degrade chemical compounds present in the soil to release the required amount of energy.

Factors of influence in bioremediation processes

Bioremediation technology is used to clean up contaminated water and soil.There are two main types of bioremediation: in situ and ex situ.

The in situ bioremediation process treats the contaminated groundwater or soil in the location where it is found. The ex situ process requires the pumping of groundwater or the excavation of contaminated soil before it can be treated.

In situ bioremediation type is typically segmented as phytoremediation, bioventing, bioleaching, bioslurping, biostimulation and bioaugmentation. The ex situ bioremediation type is typically segmented as composting, controlled solid-phase treatment and slurry-phase biological treatment.

Biodegradation is a cost-effective natural process that is useful for the treatment of organic wastes.The extent of biodegradation is greatly dependent upon the initial concentrations and toxicity of the contaminants, the properties of the contaminated soil, their biodegradability and the specific treatmentsystem selected.

In biodegradation treatment, the targeted contaminants are semi-volatile and nonhalogenated volatile organics and fuels. The benefits of bioremediation, however, are limited at sites with highly chlorinated organics and high concentrations of metals, as they may be harmful to the microorganisms.

https://www.researchandmarkets.com/publication/mkvz6uj/4752244

HAZMAT Labels Market: global industry analysis by 2028

Future Markets Inc. recently published a research report on the Hazmat Labels Market. The report, entitled Global HAZMAT Labels Market: Overview – HAZMAT Labels, provides an overview of the market and predicts the growth of the industry.

The report is a compilation of first-hand information, qualitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides in-depth analysis of parent market trends, macroeconomic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

Regional analysis includes – North America, Latin America, Eastern Europe, Asia Pacific excluding Japan (APEJ), Middle East & Africa (MEA), and Japan.

Report Highlights include a detailed overview of the following:

  • market, changing market dynamics in the industry;
  • In-depth market segmentation;
  • Historical, current, and projected market size regarding volume and value;
  • Recent industry trends and developments;
  • Competitive landscape;
  • Strategies for key players and products offered’
  • Potential and niche segments; and
  • Geographical regions exhibiting promising growth

Hazmat Labels – Requirements

Hazmat labels must have excellent durability and cannot be impaired by other labels, markings & attachments. HAZMAT labels are categorized into nine classes for different purposes such as explosives, flammable gases, flammable liquids, inhalation hazards, organic peroxides etc. HAZMAT Labels for each class have a specific size & color. Most of the HAZMAT labels have contrasting background & a dotted line border. HAZMAT labels have text & symbols either in white or black.

It is important to choose the correct HAZMAT labels for shipments, as labelling a material incorrectly can result in costly shipping delays, injuries & fines. HAZMAT labels must be printed or attached to any one side of product offered for transport. It is mandatory for HAZMAT labels to be attached alongside UN numbers.

Transport Canada and the US Department of Transportation (DOT) has developed certain specifications for labels, markings and placards that must be prominently displayed on each package or container, including transport vehicles in order to safeguard health, safety, and property. The global market of HAZMAT labels is anticipated to grow rapidly during the forecast period, due to growing demand from chemical, pharmaceutical and various other end use industries.

Stringent labeling regulations by governments regarding the transportation of hazardous material accelerates market growth of HAZMAT labels, globally. Rising popularity of interactive packaging where end users can directly track the packaging using HAZMAT labels with technologies such as
radio-frequency identification (RFID) is considered a new opportunity for growth of the HAZMAT labels market.

Global HAZMAT Labels Market: Segmentation

On the basis of material, global HAZMAT labels market has been segmented as: Paper, Plastic ( Polyolefin, Vinyl, Others ). On the basis of product type, global HAZMAT labels market has been segmented as: DOT HAZMAT labels and U.S. EPA HAZMAT labels. On the basis of end use, global HAZMAT labels market has been segmented as: Pharmaceutical, Electrical & Electronics, Chemical and Petrochemicals, and Agriculture & Allied Industries.

Geographic Market

The global HAZMAT labels market has been segmented based on the region like North America, Latin America, Western Europe, Eastern Europe, MEA, APEJ, and Japan. Asia Pacific and MEA. U.S. has strong market in HAZMAT labels accounting for highest refineries & chemical producing nation in the world. The U.S. accounts for the largest share in HAZMAT labels market, owing to a large petrochemical industry. MEA region and other Asia Pacific countries such as China, India etc. are expected to witness moderate growth in the HAZMAT labels market, during the forecast period.

Key Players

Some of the key players in the HAZMAT labels market are as follows: Emedco Inc., J.Keller & Associates Inc., Brimar Industries, Inc., Air Sea Containers, Inc., National Marker Company, Labelmaster Services Inc., BASCO, Inc., LPS Industries, LLC.;

Many local and unrecognized players are expected to contribute to the global HAZMAT labels market during forecast period.

Key Developments

Some of the key developments in the HAZMAT labels market are as follows:

  • HSE Inc. has introduced HAZMAT labels with pictograms alert in order to describe presence of a hazardous chemical.
  • In February 2018, Labelmaster Services Inc. announced that it has been named the exclusive label manufacturer and distributor for CHEMTREC.

U.S.: New Hazardous Waste Pharmaceuticals Rule: Significant Changes Coming for Health Care Facilities, Particularly Long-Term Care Facilities

by Brooke F. Dickerson and Jennifer L. Hilliard,
Arnall Golden Gregory (AGG)

Health care facilities that provide a host of health care-related services or distribute, sell, or dispense pharmaceuticals will need to learn a whole new set of regulations thanks to a finalized new rule promulgated by the United States Environmental Protection Agency (EPA). The new rule revises management standards for hazardous waste pharmaceuticals (HWPs) such as urine drug tests for health care facilities, including nursing, skilled nursing, and inpatient hospice facilities, more than three years following the close of comments for the EPA’s initial proposed rule. The revised regulations will take effect six months following publication in the Federal Register.

The Resource Conservation Recovery Act (RCRA) governs the generation, management, storage, treatment, and disposal of hazardous wastes. Before the new rule was promulgated, certain health care facilities, such as hospitals and reverse distributors were subject to the same hazardous waste requirements under the RCRA as most industries. The management of HWPs at long-term care facilities, however, was excluded from the RCRA and treated the same as HWPs at residential households. EPA makes clear in this new rule that because nursing, skilled nursing, and inpatient hospice facilities are more akin to hospitals, their management of any hazardous waste, including HWPs, will also be subject to RCRA requirements.

The final rule revises some of the regulations and management standards for HWPs under the RCRA and sets them apart in a separate section of the RCRA regulations, to be codified at 40 C.F.R. Part 266, Subpart P (“Subpart P”), that are applicable specifically to health care facilities and reverse distributors. According to the EPA, this is necessary because hazardous waste generation and management practices at health care facilities differ significantly from those encountered in industry generally. As a result, regulating HWPs under the standard provisions of RCRA Subtitle C has been unnecessarily difficult. The EPA maintains that the new management standards are more streamlined and tailored specifically for healthcare HWPs and thus will promote proper management of HWPs by healthcare workers and pharmacy employees.

The final rule does not increase the universe of pharmaceuticals that are considered hazardous waste. However, it does accomplish four significant and practical changes in the management of pharmaceuticals: (1) HWPs that are to be sent off-site for reverse distribution will be regulated as hazardous wastes under the RCRA while still at the health care facility, (2) HWPs are banned from being disposed of down a drain or in a toilet, thereby reducing the amount of pharmaceutical ingredients that contaminate drinking water and endanger the environment, (3) it is easier to make a HWP container legally “empty,” and (4) nicotine replacement therapies are no longer considered potential hazardous wastes. Some of the components of the final rule will relieve the existing burdens on generators of HWPs, while other components may make the management of HWPs more onerous, at least initially.

Applicability to Long-Term Care Facilities

As noted above, the final rule applies to health care facilities. The definition of “health care facility” specifically includes long-term care facilities. A “long-term care facility,” in turn, is defined as:

[A] licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes, but is not limited to, Hospice Cincinnati facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, assisted living facilities and the independent and assisted living portions of continuing care retirement communities. (emphasis added).

The exclusion of assisted living from the definition of long-term care facility in the rule avoids many of the practical issues with control over medications taken directly by patients and use of multiple pharmacies that flow from the functional differences between nursing homes and assisted living facilities. The distinction constitutes a welcome change from the 2015 proposed rule, which sought to include such facilities in the definition of long-term care facility. The EPA stated unequivocally that HWPs that are in (a) the custody of the long-term care facility on behalf of the resident, or (b) an in-house pharmacy maintained by such facility (if any), must be managed under Subpart P.

Definitions and Analysis

The analysis necessary to determine whether a given substance is considered a HWP involves three questions:

Question 1 – Is it a Pharmaceutical? Under the final rule, a pharmaceutical includes, but is not limited to, the following:

  • Dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act;
  • Prescription drug, as defined by 21 C.F.R. § 203.3(y);
  • Over-the-counter drugs;
  • Homeopathic drugs;
  • Compounded drugs;
  • Investigational new drugs;
  • Pharmaceuticals remaining in non-empty containers;
  • Personal protective equipment contaminated with pharmaceuticals; and
  • Clean-up material from spills of pharmaceuticals.

The definition also includes any electronic nicotine delivery system and liquid nicotine packaged for retail sale. Excluded from the definition are sharps and dental amalgam.

Question 2 – Is it a Solid Waste? A solid waste is any discarded material that is not otherwise excluded under the regulations that implement RCRA. What constitutes a RCRA solid waste, however, is not limited to wastes that are physically solid. Many solid wastes are liquid, semi-solid, or gaseous material. A material is considered “discarded” once the facility has decided to discard it, and must be managed appropriately at that point in time. A material that is legitimately going to be used, reused or reclaimed is not discarded and is not a solid waste. Note, however, that under the final rule, EPA has pre-determined that a health care facility’s decision to reverse distribute a pharmaceutical constitutes a decision to discard the pharmaceutical.

Question 3 – Is it a HWP? Solid wastes that are pharmaceuticals are only considered hazardous waste under RCRA if they are either listed as hazardous wastes or exhibit one of the characteristics of hazardous waste. There are four lists–F , K , P and U –based on either manufacturing and industrial processes, or chemical designations. The F and K lists are based on manufacturing and industrial processes, none of which apply to pharmaceuticals for humans. The P and U lists are based on chemical products. The EPA notes that there are approximately 30 “Commercial Chemical Products” on the P and U lists that have uses in multiple pharmaceuticals. A Commercial Chemical Product is only a waste if (i) it has not been used or used as intended, and (ii) consists of the commercially pure grade of the chemical, any technical grades of the chemical that are produced or marketed or the chemical is the sole active ingredient in the formulation. If these criteria are not met, then the pharmaceutical is not a HWP, even if included in the P or U list.

As noted above, even if a pharmaceutical waste is not listed on any of the lists, it may also qualify as a hazardous waste if it exhibits one of the four characteristics of hazardous waste:

  • Ignitability (something flammable) – for example, solutions containing more than 24% alcohol,
  • Corrosivity (something that can rust or decompose) – for example, certain compounding chemicals,
  • Reactivity (something explosive), and
  • Toxicity (something poisonous).

The answer to all three of the foregoing questions must be yes for the material to qualify as a HWP, though the final rule does contain certain exceptions that may apply to exclude a pharmaceutical from being considered a HWP for purposes of RCRA Subpart P. A long-term care facility that determines that it does generate HWPs must then conduct further analysis to determine the nature of its obligations under Subpart P.

Scope of Obligations under Subpart P – Amount of Waste Generated

Once the determinations have been made that a long-term care facility is covered by the final rule and has HWPs, the analysis shifts from the type of facility and nature of the waste to the amount of the waste, to determine the scope of the facility’s obligations under Subpart P. Specifically, the next inquiry is the amount of HWPs that the facility generates. Under RCRA, a “Generator” is a person whose act or process produces hazardous waste or whose act first causes a hazardous waste to become subject to regulation. Therefore, a facility that makes the determination to “discard” a pharmaceutical becomes a Generator. A facility that generates less than or equal to any of the following per calendar month qualifies as a Very Small Quantity Generator (VSQG) :

  • 100 kg (220 pounds) of hazardous waste; or
  • 1 kg (2.2 pounds) of acute hazardous waste.

Under the final rule, long-term care facilities with 20 or fewer beds are presumed to be VSQGs, thereby shifting the burden of proof to the EPA Administrator to establish that a facility is not a VSQG. Facilities with more than 20 beds, however, bear the responsibility of demonstrating that they qualify as a VSQG.

If a facility generates total hazardous waste in amounts exceeding the VSQG thresholds, it must treat its HWPs in accordance with the management standards of Subpart P. While VSQGs may opt to handle their HWPs in accordance with the management standards of Subpart P, they are not required to do so except for the sewering ban and empty container provisions of Subpart P. If a VSQG does not opt to comply with the management standards of Subpart P, its HWPs are subject to the general hazardous waste provisions of 40 C.F.R. § 262.14, which may be less than the requirements of Subpart P. Further, a long-term care facility that is a VSQG may dispose of its HWPs (other than contaminated personal protective equipment or clean-up materials) in an on-site collection receptacle of an authorized collector that is registered with the Drug Enforcement Administration (DEA), provided the contents are collected, stored, transported, destroyed and disposed of in compliance with all applicable regulations for controlled substances.

Whether a long-term care facility that qualifies as a VSQG opts to treat its HWPs in accordance with the management standards of Subpart P likely will depend on (1) the willingness of the facility to undertake the monthly calculations, monitoring and recordkeeping required to demonstrate that their hazardous waste is within the limits established for VSQGs, or (2) whether the decision not to comply with Subpart P would render the facility subject to more onerous requirements on other hazardous waste that it generates. If a facility also generates non-pharmaceutical RCRA hazardous waste, such as lab wastes for example, those wastes are not regulated under Subpart P but under the existing RCRA regulations. The standard regulations become more stringent as the amount of applicable waste increases. Facilities could decrease the overall amount of waste and thus lessen the impact of the standard regulations by not including the HWPs that are managed instead under Subpart P.

Scope of Obligations under Subpart P – Prescription HWPs versus Non-Prescription HWPs and Non-Creditable Prescription HWPs versus Potentially Creditable Prescription HWPs

Once the determination has been made that a long-term care facility is subject to the management standards of Subpart P, the requirements vary based on whether or not the pharmaceutical required a prescription. For prescription drugs, a facility must determine if it is managing a potentially creditable HWP or a non-creditable HWP. A “potentially creditable hazardous waste pharmaceutical” is a prescription HWP that has a “reasonable expectation to receive manufacturer credit through reverse distribution and is (1) in original manufacturer packaging (except pharmaceuticals that were subject to a recall) even if opened; (2) undispensed; and (3) unexpired or less than one year past expiration date.”

A non-creditable HWP is a prescription pharmaceutical that does not meet the above three criteria and therefore is not likely to receive credit back through reverse distribution. Non-prescription HWPs that do not have a reasonable expectation to be legitimately used, reused or reclaimed are also considered non-creditable HWPs. On the other hand, non-prescription over the counter pharmaceuticals that go through reverse logistics because they have a reasonable expectation of being recycled are not “Solid Waste” under RCRA at all, and therefore are not subject to Subpart P either. The management standards for potentially creditable HWPs are not as stringent as those for non-creditable HWPs.

Because of the requirement that the pharmaceutical be undispensed, it is likely that only long-term care facilities that have an in-house long-term care pharmacy will be managing potentially creditable HWPs. Those long-term care facilities that contract for their pharmacy services with a long-term care pharmacy will be managing non-creditable HWPs because pharmaceuticals are considered to be dispensed when the order is filled by the external pharmacy.

Unlike the existing general RCRA standards for the management of hazardous wastes, standards for HWPs under the new Subpart P are the same regardless of the amounts generated or the places where they are accumulated.

Management Standards for Non-Creditable HWPs

Notification – A long-term care facility that is subject to the requirements of Subpart P must notify the EPA Regional Administrator within 60 days of the effective date of Subpart P (or within 60 days of becoming subject to Subpart P) that it is a healthcare facility operating under Subpart P, even if the facility already has an EPA Identification Number. Notification may be filed electronically. The facility must keep a copy of the notification on file for as long as the facility is subject to Subpart P. If the facility subsequently qualifies as a VSQG and elects to withdraw from Subpart P, it must so notify the EPA Regional Administrator and may not begin operating under the conditional exemption applicable to VSQGs generally under RCRA until notification has been made. Withdrawal notifications must be kept on file for a period of three (3) years.

Training – All facility personnel that manage HWPs must be trained and be “thoroughly familiar” with proper waste handling and emergency procedures relative to their responsibilities. EPA has not stated whether the agency will offer compliance assistance or training materials to facilities. As a result, because the final rule will become effective six months following publication in the Federal Register, facilities should begin exploring their options for training as early as possible.

Hazardous Waste Determination – The facility must determine whether a non-creditable pharmaceutical is a HWP. In lieu of making such a determination, the facility may choose to manage all waste pharmaceuticals as HWPs under Subpart P.

Containers – Because a facility will likely accumulate HWPs for some period of time before shipping them off-site, the final rule prescribes standards for containers that will be used to store HWPs. Generally, any container used to accumulate HWPs must be structurally sound, compatible with its contents, and lack evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. Such container must be kept closed and secured so as to prevent unauthorized access to its contents.

Labeling Containers – All containers used to accumulate HWP must be labeled or clearly marked with the phrase “Hazardous Waste Pharmaceuticals.”

Maximum Accumulation Time – A facility may accumulate non-creditable HWPs on-site for a period not to exceed one year without a permit. The period begins on the date the pharmaceutical first becomes a waste, and the facility is responsible for demonstrating how long HWPs have been accumulating. The final rule allows the facility to make this demonstration by marking/labeling the container, maintaining an inventory system or by placing the HWPs in a specific area and identifying the earliest date that any of the HWPs in that area became a waste. To the extent that any HWPs are able to be commingled safely in a container, the date on which the very first HWP was deposited in the container would start the one year clock running.

Land Disposal Restrictions – A facility must comply with extensive requirements pertaining to land disposal restrictions at 40 C.F.R. Section 268.7(a), but these have been relaxed to the extent that the individual waste codes no longer need to be identified on the land disposal restriction notification.

Shipping – As noted above, a long-term care facility may accumulate non-creditable HWPs on-site only for a limited time before it must ship them off-site to a pre-designated authorized facility for treatment, storage or disposal. The final rule includes specific requirements for such shipments.

  • Pre-Transport
    • Packaging, Labeling and Marking – Generally, all waste must be packaged, labeled and marked in accordance with applicable Department of Transportation (DOT) regulations.
      • Containers of 119 gallons or less must be marked with specific words and information, including “HAZARDOUS WASTE.”
      • With limited exceptions specified in the final rule, lab packs that will be incinerated are not required to be marked with EPA Hazardous Waste Numbers.
    • Placarding – A long-term care facility must placard or offer the initial transporter the appropriate placards as specified under DOT regulations.
  • Manifests – A facility must use a uniform manifest and comply with applicable manifest requirements except that instead of listing the individual waste codes, the facility should write “PHARMS” on the form.
  • Facilities may ship HWPs across state lines, but will only be able to use the provisions in Subpart P if both states have adopted the same regulations (see below).

Managing Rejected Shipments – A long-term care facility will need to ship any rejected shipments of non-creditable HWPs to a new designated and authorized facility within 90 days of their return.

Reporting – There is no requirement to report the amounts of HWPs generated at a facility unless specifically requested by the EPA. Other than the initial notification, the only report required under the new rule is when the facility does not receive back a copy of a fully received manifest from the receiving facility in connection with a shipment.

Record keeping – A health care facility must keep a copy of each manifest, exception report, and hazardous waste determination test result and analysis for three years. All records must be readily available during an inspection.

Response to Spills – Spills of HWPs must be immediately contained and the cleanup materials managed themselves as HWPs.

Accepting Non-Creditable HWPs from an Off-Site Facility that is a VSQG – A facility may accept non-creditable HWPs from a VSQG, such as when a health care facility returns drugs back to a pharmacy, even though the receiving facility does not have a RCRA permit, if the receiving facility (i) is under the same control as the transferring facility or has a business relationship, (ii) is operating under Subpart P, (iii) manages the new wastes under Subpart P, and (iv) keeps records of the shipment for three years.

Management Standards for Potentially Creditable HWPs

As noted above, because the definition of a potentially creditable HWP requires that a pharmaceutical be undispensed, and the use of a third party long-term care pharmacy results in medication being dispensed to a resident by the pharmacy rather than the facility, most long-term care facilities will not be managing potentially creditable HWPs. However, for those facilities that maintain their own in-house long-term care pharmacy, the requirements of the final rule with respect to potentially creditable HWPs are relevant as the facility is likely to have undispensed prescription medications on hand that can qualify as potentially creditable HWPs that can be sent to a reverse distributor.

  • Accepting Potentially Creditable HWPs from an Off-Site Facility that is a VSQG – A facility may accept potentially creditable HWPs from a VSQG, such as when a care facility returns drugs back to a pharmacy, even though the receiving facility does not have a RCRA permit, if the receiving facility (i) is under the same control as the transferring facility or has a business relationship, (ii) is operating under Subpart P, (iii) manages the new wastes under Subpart P, and (iv) keeps records of the shipment for three years.
  • Only Potentially Creditable HWPs – A facility is prohibited from sending hazardous wastes other than potentially creditable HWPs to a reverse distributor.
  • Reporting – There is no requirement to report the amounts of HWPs generated at a facility unless specifically requested by EPA.
  • Recordkeeping – A facility that initiates a shipment of potentially creditable HWPs to a reverse distributor must retain for a period of three years paper or electronic records of (i) the confirmation of delivery, and (ii) shipping papers prepared in accordance with DOT regulations. All records must be readily available during an inspection.
  • Response to Spills – Spills of potentially creditable HWPs must be immediately contained and the cleanup materials managed as non-creditable HWPs.
  • Shipping – Unlike with respect to a non-creditable HWP, a manifest is not required for shipping potentially creditable HWPs to a reverse distributor. Nevertheless, the facility must comply with all applicable DOT regulations in 49 C.F.R. Parts 171 through 180 for any HWP that meets the definition of “hazardous material” in 49 C.F.R. Section 171.8. Also, the receiving reverse distributor must provide confirmation to the facility that it has received the shipment. If the facility has not received such confirmation within 35 calendar days from the date the potentially creditable HWPs were sent, the facility must contact the carrier and the reverse distributor promptly to report that the confirmation was not received and to determine the status of the potentially creditable HWPs.

Conditional Exemption for HWPs that are Controlled Substances:

The final rule includes a conditional exemption from RCRA requirements for HWPs that are listed on a schedule of controlled substances by the DEA. The conditional exemption will apply if the HWPs are collected, stored, transported, and disposed of in compliance with all applicable DEA regulations for controlled substances, and will be destroyed by a method that DEA has publicly deemed in writing to meet their non-retrievable standard of destruction or combusted at one of five types of combustion facilities.

Generally Applicable Provisions of Subpart P to all HWPs:

The following provisions apply to all health care facilities, regardless of whether the facilities are managing creditable or non-creditable HWPs or are required to comply with the other provisions of Subpart P.

  • Sewering Ban – All health care facilities covered by the rule are prohibited from discharging HWPs to a sewer system that passes through to a publicly-owned treatment works.
  • Empty Containers – Under the new regulations, certain stock, dispensing and unit-dose containers are considered “empty” and therefore not regulated as hazardous waste under RCRA, even if minor pharmaceutical residue remains, if they have been emptied using the practices commonly employed to remove materials from that type of container. This also applies to syringes provided that the contents have been removed by fully depressing the plunger into the patient, another delivery device such as an intravenous bag, or a hazardous waste collection container. Intravenous bags avoid RCRA regulation provided the pharmaceuticals inside have been fully administered to a patient. All other types of containers—whether partially or completely empty—are to be managed as non-creditable HWPs unless they meet the general RCRA empty test for non-acute hazardous wastes.

Over the Counter Nicotine Replacement Therapies:

Nicotine and salts are currently included in the hazardous waste listed code P075 . The new rule exempts FDA approved over the counter nicotine replacement therapies, specifically patches, gums, and lozenges, from waste code P075. The rule does not exempt e-cigarettes, nicotine-containing e-liquids or prescription nicotine replacement therapies because they are not regulated in the same way as the exempted methods. Nevertheless, any nicotine replacement therapy that has been used in the manner initially intended is not a “solid waste” under RCRA and therefore is not a “hazardous waste” either.

Effective Date; Authorized State RCRA Programs:

The final rule will become effective six months following publication in the Federal Register; however, many states operate their own hazardous waste program. Once authorized by EPA, state hazardous waste programs operate in lieu of the RCRA regulations, though authorized states are required to adopt new regulations that are more stringent than existing rules. Most provisions of the pharmaceutical waste final rule are more stringent than the current RCRA generator regulations. Accordingly, authorized state programs will be required to adopt those provisions such that the new rule will not take effect in any of those states until it has been adopted and the state regulations updated. In contrast, the ban against HWP disposal in a drain or a toilet will be effective in every state as soon as it is effective under Federal law because the sewering prohibition component of the new rule, also more stringent than existing requirements, was adopted under separate legal authority. States are not required to adopt the part of the rule exempting over-the-counter nicotine replacement therapies from the hazardous waste requirements because it is less stringent. Also, facilities should be aware that states may include more stringent requirements than those included in the final rule. As a result, facilities will need to monitor adoption and implementation efforts in those states very closely.

Conclusion:

There can be no doubt that EPA’s final rule will require health care facilities, particularly long-term care facilities other than assisted living facilities, to navigate the new regulatory framework provided in Subpart P, while still potentially being subject to many other RCRA-related provisions and to regulations from other Federal agencies including the DOT. Additionally, facilities in states that have their own authorized hazardous waste program will need to monitor their state agency to determine exactly which rules apply and when. With an effective date only six months following publication of the final rule in the Federal Register, no guarantees of education or compliance assistance from EPA other than three webinars scheduled for February and March, 2019, and steep fines for violations, facilities will be hard-pressed to come up to speed in time. Health care facilities are well advised to begin their efforts now to understand the requirements, draft and implement effective policies and procedures, develop a staff training program, and enter into such contractual relationships as may be necessary to ensure compliance.

This article has been republished with the permission of the authors. It was first published on the AGG website. A pdf version, with footnotes can be found at AGG Legal Insight.


About the Authors

Brooke F. Dickerson focuses her practice on transaction, regulatory, compliance and permitting matters. With regards to environmental work, she has significant experience with Superfund (CERCLA), hazardous waste (RCRA and HWMA), the Georgia Hazardous Site Response Act (HSRA), solid waste, Brownfields, wetlands, and site evaluation, assessment and remediation issues. She also advises clients on stormwater compliance, green leasing issues and green/sustainable building practices. With regards to construction work, Ms. Dickerson advises owners and developers on the drafting and negotiation of architect, construction and construction management agreements. She has represented clients in connection with the construction of office, multi-family, mixed use and tenant improvement projects. She also advises clients on OSHA matters and has represented several companies in obtaining reduced or dismissed penalties in settlement negotiations.

Jennifer Hilliard is Of Counsel in the Healthcare Practice. Ms. Hilliard focuses her practice on long-term care and aging services issues generally. She has extensive experience with nursing home regulatory matters, compliance and operations. Additionally, she has significant experience with Federal public policy and government affairs in such related areas as Medicare and Medicaid regulation, home health and hospice regulation, DEA controlled substances regulation, OSHA and other labor and employment issues affecting aging services providers, and federal non-profit tax issues. Prior to joining AGG, Ms. Hilliard served for over 18 years in a variety of legal and advocacy-related capacities at LeadingAge, a Washington, DC based trade association for non-profit long-term care and aging services providers.