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What are the pros and cons of simulators for radiation safety training?

Written by Steven Pike, Argon Electronics

Electronic radiation simulators provide trainees with realistic first-hand experience of handling detector equipment that is identical to that which they will use in the field.

But while the use of simulator detectors can offer significant advantages for both student and instructor, as with any form of training method there may be some compromises.

In this blog post we explore some of the pros and the cons of radiation safety training using simulator detectors.

The Pros

Practicality

Ionizing radiation is a powerful, invisible force – which can make creating realistic scenarios a challenge.

By incorporating the use of simulator detectors into training exercises students have the opportunity to both understand and ‘trust’ the values displayed on their instruments.

In doing so they can also develop an understanding of the relationship between the measurements on their survey meter and their own personal dose readings as well as the effects of time, distance and shielding.

Safety

Safe and environmentally friendly radiation training systems can be used in a variety of scenarios – whether indoors, outdoors in confined areas or in public spaces.

With simulators incurring zero safety risk there are no Health & Safety restrictions – and the administrative burden for instructors is vastly reduced.

Immersion

Simulator detectors offer the opportunity for a truly authentic and immersive training experience.

Scenarios can be planned to replicate all the crucial elements of real-life incidents, which in turn exposes trainees to the psychological challenges they may well encounter in high-stress incidents.

Repeatability

With the use of simulators, radiation training exercises can be quickly and easily set up – and repeated as many times as required.

Outcomes

Powerful after action review (AAR) ensures that trainees have followed clearly set out procedures and that they understand when mistakes have been made.

Efficiency

Using simulators can provide some significant time-saving advantages for training exercises.

The costly and time-consuming administrative effort normally associated with the transport, deployment and safe handling of radionuclides is completely removed – and the need to secure specialist facilities where ionizing radiation sources is no longer an issue.

The cons

With any form of training, some compromises will inevitably have to be accepted. The key, however, is to find the happy medium between the optimum training outcome and what is practical and achievable.

Dynamic ranges

The dynamic ranges associated with radiation readings are extremely large, which can contribute to challenges in implementing simulations.

Instructor intensiveness

Simulation training can also be very instructor-intensive – with the trainer finding that too much of their attention is focused on creating the “effect” for their student and not enough on observing the student’s actions.

In these cases, alternative techniques which involve the temporary placement of a means to simulate the presence of radioactivity may be more practical – selection of the ideal simulation equipment is essential.

Shielding

It is the simulation of the effects of shielding where there is the potential for the greatest compromise.

The reality is that safe alternatives won’t be subjected to the same degree of attenuation (or reduction in force) as actual ionizing radiation.

But new technology now means that shielding can be represented to a realistic enough level to enable students to appreciate its importance for protection.

Instructors will of course need to clarify the differences, where appropriate, for the lesson being delivered – and these are likely to vary depending upon the operational responsibilities of the trainees.

While training with simulator detectors has both advantages and limitations, there is no doubt that it is an effective method of ensuring successful training outcomes while at the same time maintaining the safety of student and instructor.


About the Author

Steven Pike is the Founder and Managing Director of Argon Electronics, a leader in the development and manufacture of Chemical, Biological, Radiological and Nuclear (CBRN) and hazardous material (HazMat) detector simulators. He is interested in liaising with CBRN professionals and detector manufacturers to develop training simulators as well as CBRN trainers and exercise planners to enhance their capability and improve the quality of CBRN and Hazmat training.

Meat Packing Plant facing major fines for exposing workers to hazardous chemicals

The U.S. Department of Labor’s Occupational Safety and Health Administration (U.S. OSHA) has cited 7 S Packing LLC – operating as Texas Packing Company in San Angelo, Texas – for exposing workers to releases of hazardous chemicals. The company faces $615,640 in penalties.

The U.S. OSHA determined that the meat-packing facility failed to implement a required Process Safety Management (PSM) program for operating an ammonia refrigeration unit containing over 10,000 pounds of anhydrous ammonia. The employer also failed to provide fall protection, guard machines and equipment, control hazardous energy, and implement a respiratory protection program.

The PSM Covered Chemical Facilities National Emphasis Program focuses on reducing or eliminating workplace hazards at chemical facilities to protect workers from catastrophic releases of highly hazardous chemicals. PSM standards emphasize the management of hazards associated with highly hazardous chemicals, and establishes a comprehensive management program that integrates technologies, procedures, and management practices to prevent an unexpected release.

The company has 15 business days from receipt of the citations and penalties to comply, request an informal conference with OSHA’s area director, or contest the findings before the independent Occupational Safety and Health Review Commission.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to help ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance.

Global Crisis, Emergency and Incident Management Platforms Market 2019

Persistence Market Research recent market report on Global Crisis, Emergency and Incident Management Platforms estimates that it will be worth $102 billion (USD) by the end of 2024.

A 2017 market analysis by Persistence Market Research on the market in North America predicted the year-over-year growth the Global Crisis, Emergency and Incident Management Platforms to increase at a CAGR of 7.2%. through to 2023. The 2017 report estimated that the North America market accounted for a relatively high market share and be valued at more than US$ 20 Billion in 2017. The report estimated that the North American regional market would continue to remain dominant in terms of value during the forecast period (2017 – 2024).

The latest market report from Persistence Market Research predicts that the global market or crisis, emergency & incident management platforms will be fragmented across various systems and platforms. Among which, the demand for web-based emergency management software, geospatial technology, emergency notification system, hazmat technology, seismic warning systems, and remote weather monitoring systems is expected to gain traction throughout the forecast period. These systems are also predicted to be demanding greater incorporation of communication technologies. Through 2024, satellite phone, vehicle-ready gateways, and emergency response radars will be the most dominant type of communication technologies used in working of any crisis, emergency & incident management platform.

Likewise, the report also expects that during the stipulated forecast period, professional services such as consulting and emergency operation center (EOC) design & integration will be in great demand. By the end of 2024, crisis, emergency & incident management platforms will be actively adopted across industry verticals such as BFSI, energy & utility, government & defense, and telecommunication and IT.

A regional analysis of the global crisis, emergency & incident management platform market indicates that North America will dominate by accounting for over US$ 36 Billion revenues by 2024-end. Adoption for such platforms will also be high in Asia-Pacific, and the region is expected to showcase a 6% value CAGR.

Leading providers of crisis, emergency & incident management platforms in the world include Honeywell International, Inc., Lockheed Martin Corporation, Motorola Solution, Inc., Rockwell Collins, Inc., Siemens AG, Iridium Communication Inc., Guardly, Environmental System Research Institute, Inc., and Intergraph Corporation.

Get Rid of Outdated Hazmat Compliance Materials

Written by Hazmat University

Spring is in the air! And along with that comes the pleasant and incessant urge to clean closets, declutter the house, and scrub the whole thing down!  Something that we may overlook, however, is that Spring is also a perfect time to do a Hazardous Materials refresh – and it doesn’t involve washing walls!  

Spring Clean and Keep Current Hazmat Compliance Materials

Spring is also an ideal time to do a Hazardous Materials refresh. Many people avoid this kind of clean-up because they don’t know what they should keep and for how long. But hazmat compliance is dependent on maintaining current knowledge and current practices. Now really is an excellent time to make sure that your hazardous materials are current, relevant, and not overly burdensome for the people that need them to properly do their jobs.

Out With The Old, Hold On to the Current

Do you have a tendency to hold on to outdated materials, forms, or labels? If you are, stop immediately. Hazmat compliance materials are detail-oriented to begin with, so the simpler, clearer and less cluttered, the better. You’ll be happy you did it. Outdated materials present the danger of actually being used by someone and causing an issue. Good riddance, old subsidiary risk labels!

Which Important Documents Should You Keep?

As regulations for shipping dangerous goods increase in complexity, there’s no reason to keep information laying around that could increase your risk for non-compliance, including stopped shipments, supply chain delays, fines and more.

The industry makes sweeping changes all the time, making it all the more important to only have up-to-date regulations on hand. If your printed copies of 49 CFR, IATA DGR, or the IMDG Code are outdated, it may be time to move on to online resources. An example of an online resource is Title 49 CFR   “e-CFR” which is available online, and the Government Publishing Office maintains it so that it is always up-to-date.

Compliance is dependent on maintaining current knowledge and current practices, and this is a perfect time to ensure that your hazardous materials

  • regulations;
  • policies;
  • practices;
  • employee training;
  • training content;
  • training records;
  • packaging closure instructions;
  • internal audits;
  • emergency response provider product information;
  • and more

are current, relevant, and not overly burdensome for the people that rely on them to properly do their job. Hazardous materials transportation compliance is detail-saturated to begin with, so the simpler you can make it, the better – and you’ll be happy that you did.

Making sure you discard old training and compliance documents is crucial, especially if you have new or inexperienced hazmat employees. Remembering all the regulations for various shipping transportation processes can be difficult. That’s part of the reason why it’s crucial to stay up-to-date on regulations.

It’s also critical that hazmat employees have access to transportation regulations at all times in case they need to refer to them. Remembering the most essential aspects of hazmat compliance becomes second nature for most employees, but that happens over time.

Stay Up-to-Date with Hazmat University

Everyone involved in the transportation of hazardous materials in commerce is required by law to be aware and comply with the appropriate regulations. Hazmat University offers several training programs for shipping and handling hazmat by air, ground, and sea. Courses include initial training for novices, recurrent training for those with more experience.

Now we can take a breath of that fresh spring air, and just maybe we have inspired you to clean out those closets too! Happy Spring from the Bureau of Dangerous Goods!

Tesla Fire Is A Reminder For Businesses Storing Hazardous Materials

Written by Dawn DeVroom, IDR Environmental Services

fire broke out on Saturday, February 17 at Tesla’s car plant in Fremont, California. This isn’t anything new, because we do hear about businesses that have fires from time to time.

But, what makes this fire different is that it happened in an area where the company stores some of its hazardous materials outside. And, because of this, Tesla was forced to call the local Fremont Fire Department and required a hazardous materials unit.

According to reports, Tesla has a history of fires at this facility. This includes a fire in their paint shop in April 2018 and another outdoor fire in August 2018.

Add to this, Tesla was already under investigation by Cal-OSHA cited in January and fined $29,000 for allegedly violating six different worker safety regulations in their general assembly 4 (GA4) production line.

According to the Silicon Valley Business Journal:

“Tesla allegedly didn’t obtain a building permit or inspect the tent for safety violations, train workers on how to get out of the building in an emergency, or protect themselves from heat illness. Cal-OSHA also claims the tent had exposed metal rods and rebar that workers could potentially impale themselves on, and failed to cover a hole in the floor that was 22 inches wide, 14 inches wide and 8 inches deep.”

Suffice it to say…this fire isn’t helping Tesla’s safety record with OSHA.

So, what can businesses who store hazardous materials do to avoid Tesla’s potential catastrophe with that fire. Here are some very important things you should do.

Store Hazardous Waste In Proper Containers

storing hazardous materials

As a hazardous waste generator, you must satisfy safety, environmental and regulatory guidelines and have a solid base of knowledge and experience in using and handling hazardous materials in your facility.

Using the right storage containers for different types of hazardous waste is the key to safety and compliance. All hazardous waste generators must insure that their containers are built to specification according to the most current codes and regulations.

Following is a list of the different types of hazardous waste storage containers according to the Environmental Protection Agency website.   

  • Containers – portable device in which hazardous waste is stored, transported, or otherwise handled.
  • Tanks – stationary device of man-made materials used to store hazardous waste, either open or closed.
  • Drip Pads – wood drying structure used by the pressure treated wood industry to collect excess wood preservative and drippings.
  • Containment Buildings – completely enclosed self-supporting structures used to store or treat non-containerized hazardous waste.
  • Waste Piles – open, uncovered pile used for treating or storing hazardous waste.
  • Surface Impoundments – a natural topographical depression, man-made excavation or diked area such as a holding pond, storage pit or settling lagoon.

Proper storage and disposal requires you to understand which materials are toxic, what they do, the types of containers needed for storing the material and the type of personal protective equipment (PPE) that must be used.

You can learn more about which container is right for you waste by reading our article, How To Choose The Right Hazardous Waste Storage Container.

Label Hazardous Waste Correctly

Identification of properties and the regulatory status of waste that you generate is vital in maintaining compliance with state and federal regulations.

Hazardous waste generators that accumulate hazardous waste on-site in containers must be aware of the Resource Conservation and Recovery Act (RCRA) regulations regarding the proper labeling, marking and placarding requirements for hazardous waste containers.

The California Department of Toxic Substances Control (DTSC) provides the following guidance for the proper labeling requirements for California hazardous waste generators as outlined in Title 22, California Code of Regulations (Cal. Code Regs.):

  • Date – The date upon which each period of accumulation begins must be clearly marked and visible for inspection on each accumulation unit.
  • Hazardous Waste Notice – Each generator tank or container must be labeled or clearly marked with the words, “Hazardous Waste”.
  • Name and Address – Name and address of the generator.
  • Composition and State – Chemical composition (chemicals in the waste) and physical state of the waste (e.g. solid, liquid, etc.)
  • Properties of Waste – Statement or statements that call attention to the particular hazardous properties of the waste (e.g. flammable, reactive, etc.)
  • Accumulation Dates – If waste is collected or consolidated in containers or tanks, the initial date of the accumulation must be marked, as well as the “90-day or 180-day period” dates, whichever applies to your company. If waste from an older container is added, the initial accumulation date will need to be changed.
  • Recurring Waste Labels – “Recurring use” labels may be used on containers where same waste streams are initially collected and emptied into larger accumulation containers. The labels can revise the initial accumulation and “90-day period” dates (without having to change the other labeling information). If the container is emptied at least once each day, the word “daily” may be used in the date area of the label. 

You can learn more in our article, How To Properly Label Hazardous Waste Containers.

Prepare a Hazardous Waste Contingency Plan

According to federal and state regulations, every hazardous waste generator is required to have an emergency contingency plan. This plan outlines the company’s program to minimize hazards to human health and the environment from fires, explosions or an unplanned sudden release of a hazardous waste.

Failure to implement a plan can lead to hefty fines with the California Department of Toxic Substances Control (DTSC) and the Environmental Protection Agency (EPA)

Your Hazardous Waste Contingency Plan should include:

Small Quantity Generators (SQG’s)

  • Designate an emergency coordinator and post contact information
  • Post the location of emergency equipment
  • Post emergency telephones
  • Ensure employees are familiar with emergency procedures

Contingency Plan Requirements for Large Quantity Generators (LQG’s)

  • Create a written plan on-site and make sure the it is up-to-date and reviewed frequently
  • Designate an emergency coordinator(s) and post contact information
  • Post the location of emergency equipment
  • Post emergency telephones
  • Create an emergency evacuation plan
  • Ensure employees are familiar with emergency procedures
  • List name, address and phone number (s) (home and office) for designated emergency coordinator
  • Submit written plan to local authorities

You must maintain at least one copy of the contingency plan at the facility, but multiple copies is even better. In addition, copies must be submitted to local police departments, fire departments, hospitals, and state and local emergency response teams that may provide emergency services to the facility.

Even if a facility will be providing its own responders, the contingency plan should still be sent to appropriate authorities in the local community in case of an off-site release or major emergency that requires their assistance.

You can read more about how not having a hazardous waste contingency plan affected another company in our article, No Hazardous Waste Contingency Plan Leads To Big Fine For Manufacturer.

Consider a HazMat Emergency Response Team

storing hazardous materials

The risks of working with hazardous substances and generating hazardous waste are great, and the consequences of a release, fire or spill can be dire.

Many companies choose to outsource their emergency response as an alternative to training, equipping and maintaining an emergency response team in-house. And, some companies will have more than one company at their disposal to ensure availability when an event occurs.

Emergency response companies have a fully-staffed, fully-trained hazmat emergency response team that are available 24 hours a day, 365 days per year.

It is important to establish a relationship in advance to allow for fast response times, with experienced supervisors who coordinate with all responsible agencies (such as local fire and rescue) to limit liability and costs.

Whether you need to control a situation or stop a potentially dangerous one, having an outside HazMat emergency response team provides the following benefits:

  • Save Lives
  • Protect Property
  • Preserve the environment
  • Limit Liability

You can learn more about using a HazMat emergency response team in our article, What A HazMat Emergency Response Team Can Do For Your Business.

Final Thoughts

Tesla serves as an example of what could happen to companies that use, generate and require storage of hazardous materials. Although nothing serious happened in Tesla’s recent fire, it could be much worse for your company if you don’t have the above procedures in place.

If you need assistance with putting together your program, contact a hazardous materials company that specializes in helping companies create and maintain their program.


About the Author

Dawn DeVroom is the CFO at IDR Environmental Services based in California. The company specializes in hazardous waste disposal.

Hazardous industry leaders give insight on the keys to operational excellence

A global survey of hazardous industries and Operational Index was recently published by Sphera. The annual Operational Excellence Index (OEI) survey report which highlights trends in digital transformation and OE strategies across the hazardous industries.

Previously conducted by Petrotechnics, now a Sphera company, the index is in its third year of surveying oil and gas, chemical, energy and industry manufacturing professionals to gauge attitudes around OE and the measures taken towards its adoption. Year after year respondents agree, OE programs help reduce risk, cut costs, and improve productivity. The 2018/2019 survey reveals senior leaders are relying on technologies to support their OE initiatives and identifies where they are coming up short and what they could do to improve.

Ninety percent of respondents agree digital transformation will accelerate their ability to achieve OE – not just as a one-off target but as an ongoing business objective. This is a significant increase from last year’s report where 73% of leaders agreed that going digital was key to achieving OE. Implementing digital technologies is now aligned with overall business goals with 55% leveraging technology to reduce operational risk and 55% to improve asset availability and uptime.

Paul Marushka, President and CEO at Sphera, commented, “As the third-annual Operational Excellence Index shows, digital transformation is upon us. As companies look for new ways to keep their people safe, their operations productive and their products sustainable, being able to tap into and monitor data from Industry 4.0 solutions will be a major differentiator for organizations looking to separate themselves from the competition. It’s not surprising that 90% of respondents agree that digital technology will accelerate operational excellence. We couldn’t agree more. Sphera believes digital is the wave of the future for operational risk mitigation.”

But while industry leaders agree digital is essential to OE, more than half are still trying to figure out what ‘digital transformation’ means for them, and 69% are just beginning their digital journey. The approach to digital matters, according to 83% of survey respondents, who admit they have relied on legacy systems to improve their business agility but had not embedded operational best practices cross-functionally.

The good news is the industry is on the brink of a major step forward when it comes to achieving OE through digitalization. Seventy-five percent of leaders recognize the need to create new, insight-driven business processes across enterprise functions. Advanced analytics and digital twins were highlighted as key solutions to help operators understand how to make better, safer planning and operational decisions. 

Scott Lehmann, VP, Product Management, ORM for Operations at Sphera, said, “This year’s survey clearly illustrates the challenges digital leaders face within their own organizations to understand what digital transformation means or could mean practically and tangibly to their company. While the pace of digital transformation and ROI is still in its early days, the survey points strongly to a rapid acceleration on the horizon. Digital leaders understand digital integration and the adoption of new technologies must focus on creating actionable insights to help underpin new cross-functional business processes that enhance decision-making and the way people work together.”

One survey respondent suggested: “The best approach to digital is not to use technologies to close gaps that you know already exist. Rather, start with a blank sheet of paper and define what you need – and then assess the available technologies.”

Petrotechnics, now a Sphera company, conducted the survey between October and November 2018, collecting 116 responses from a broad representation of functions, demographics and industries across the hazardous industries, including: oil, gas, chemicals, manufacturing, utilities, mining, engineering and other sectors. The survey included respondents from each major region – specifically Middle East (29%), Europe (28%), North America (28%), Asia Pacific (11%), Africa (3%) and South America (1%).

View the full report and results from the 2018/2019 Operational Excellence Index.

What are the core requirements of wide area CBRNe training?

Written by Steven Pike, Argon Electronics

When you are required to conduct wide area emergency preparedness training – be it in the setting of a chemical, biological, radiological, nuclear, and explosive (CBRNe) school, a dedicated military center or an industrial facility – the ongoing challenge for any CBRNe instructor is to be able to create a scenario that is realistic, safe, reliable and cost effective.

Trainees need to be equipped with the practical knowledge and skills to respond with confidence to an enormous variety of potential live incidents. And each threat brings with it a unique set of practical, physical and psychological tasks that need to be ‘experienced’ in order to be understood.

So what is the recommended approach to help instructors implement a realistic but safe CBRNe training environment?

Overcoming regulatory obstacles

While the spreading of chemical simulants can still occasionally be an option, strict environmental regulations generally make it unfeasible – and the use of any form of radiological source is almost always going to be unrealistic for all but the most high specialized of training facilities.

Simulant training also brings with it the problem of being very location-dependent, which restricts the ability to create scenarios in public settings or confined spaces. And there is the added difficulty of it not being able to be readily integrate simulant training with other conventional live training methods.

Wide-area instrumented training systems

When the highest degree of realism is required, a powerful modular exercise control system such as PlumeSIM enable instructors to take their CBRNe training exercises to an entirely new level. And it especially comes into its own in the context of counter terrorism scenarios, nuclear training drills and HazMat emergency exercises.

So what benefits does the PlumeSIM training system offer?

Portability – Plume-SIM is highly portable making it quick to set up and to use in any environment. The inclusion of a planning mode also means that instructors can easily prepare exercises on a laptop or PC without the need for any form of system hardware.

Realism – Students are equipped with simulators and GPS enabled players, to enable them to take part in large area exercises that can include sequential multi-threat releases or that integrate with third-party live training systems.

Instructor control – The instructor retains complete control of the exercise including the ability to decide the type, quantity, location and nature of the source.

Environment – Specific environmental conditions can also be easily defined by the user, including temperature and changes in wind direction.

Repeatability – The Plume-SIM’s exercise parameters can be saved so the identical scenario can be repeated as many times as required.

Real-time action -The trainees’ movements, progress and instrument usage can be monitored in real time from a central control station.

After action review – The recording of student activity in real-time provides useful after action review (AAR). This can be used to encourage discussions about the effectiveness of an exercise and to facilitate further improvements.

Data capture – All recorded exercise data can also be exported and emailed to external personnel for future analysis.

Pre-exercise capability – The table-top planning mode uses standard gamepad controllers which enables trainees to undertake pre-exercise practice to take place within the classroom environment. The exercise can also be recorded and analysed prior to heading for the live field training area.

Versatility – If environmental conditions preclude the ability to obtain or maintain continuous long-range radio communication then the scenario can be pre-loaded on the player unit for timed activation.

Compatibility – The Plume-SIM system is compatible with a wide variety of simulator equipment including the M4 JCAD-SIMCAMSIMAP2C-SIMAP4C-SIMRDS200-SIMEPD-Mk2-SIMAN/PDR-77-/VDR-2 and RDS100-SIM.

Room to grow – The modular system gives instructors the flexibility to expand their range of training equipment as and when their budgets allow.

Achieving the highest level of realism in CBRNe training is paramount – and assuring personnel safety will always be key.

A flexible, modular simulator-based training solution such as the PlumeSIM system can provide trainees with the opportunity to practice and perfect their response to a wide variety of highly-realistic simulated threats in a completely safe environment.


About the Author

Steven Pike is the Founder and Managing Director of Argon Electronics, a leader in the development and manufacture of Chemical, Biological, Radiological and Nuclear (CBRN) and hazardous material (HazMat) detector simulators. He is interested in liaising with CBRN professionals and detector manufacturers to develop training simulators as well as CBRN trainers and exercise planners to enhance their capability and improve the quality of CBRN and Hazmat training.

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. 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.

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.

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 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.

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