Environmental response activities conducted within the first few hours following a spill or a release are critical, as they can have significant impact on the extent of damages and the overall cost of cleanup/remediation. Regardless of the magnitude of the event, environmental incident response generally includes four steps: incident/hazard communication, spill control, spill containment, and cleanup/remediation. Successful management and execution of these steps depends on pre-incident planning and preparation.

Incident/Hazard Communication

It is essential that the nature of an environmental incident is quickly and effectively communicated to key personnel as soon as a release or spill is discovered. In cases involving injuries, fire or other catastrophic events, the first call should be to local emergency response services or 911. Releases may also need to be reported to the National Response Center (NRC) and/or appropriate federal/state regulatory agencies.

When a release or spill is initially reported, the following information, at a minimum, should be communicated: location, date, and time that the incident occurred; name and contact information for the responsible party; source and cause of the release/spill; types and quantities of spilled or released materials; medium (e.g., soil, water, air) impacted by the release; and weather conditions. This and other pertinent information are important in assembling and dispatching the appropriate personnel to respond to the incident.

After an incident response team is established, Safety Data Sheets for the released material should be obtained and distributed – so that responding personnel can select appropriate personal protective equipment (PPE) and that other necessary emergency response equipment can be dispatched to the incident site.

During an incident, well-planned and effective communications with the affected community – such as alerts and warnings; directives about sheltering-in-place, evacuation and curfews; information about the response status; etc. – can help ensure public safety, protect property, elicit cooperation, and instill public confidence.

All of these incident/hazard communication activities are often conducted simultaneously.

Spill Control

After the hazards have been assessed and conditions are determined to be safe, it may be possible to take certain actions to control and secure the scene before the incident response team arrives. Whenever possible and appropriate, shutting off potential sources of ignition and/or isolating heat sources could prevent fire; and, if safe, closing a valve, placing a container under the leak, or straightening a tipped container may be a simple  action that can reduce the magnitude of the incident. After the incident response team has appeared onsite, if the source of the spill is still leaking and cannot be controlled, it may be necessary to stop the source by transferring the materials into appropriate, safe containers.

Spill Containment

Spill containment includes actions to prevent the spread of released materials. These activities are commonly employed by response team personnel and hazardous waste technicians, and include deployment of neutralizers or absorbent materials – such as pads, pillows and booms – starting at the perimeter and working toward the center of the spill. Particular attention should be paid to pathways leading to environmentally sensitive areas, such as floor drains, water supply and drainage conduits which may need to be plugged or bermed.

Cleanup/Remediation

After the spill has been contained, cleanup/remediation of impacted environmental media can begin. While the cleanup technology implemented at any spill site must be designed for that specific incident, remediation of smaller releases often includes excavation and  disposal of impacted soil, while impacted surface water is frequently collected using vacuum trucks. Recovered impacted media is often disposed at approved facilities (landfills, wastewater treatment plants, etc.). As part of remediation activities, a certain amount of restoration, such as soil backfilling, re-paving, and/or re-seeding may be necessary.

Depending on local regulations, follow-up investigations may be necessary to assess potential soil, surface water or groundwater impacts. These investigations are generally not performed by the response team but rather by environmental consultants and specialists.

Pre-Incident Planning Program

Pre-incident planning and preparation is a crucial step in the effective response to environmental incidents. A well-planned response will help minimize environmental damages and liabilities, as well as limit potential business losses.

It takes considerable time and resources to perform a risk assessment, review hazards or threat scenarios, identify and vet external incident response teams, determine regulatory requirements, develop protective actions, develop emergency procedures, and train personnel. Additionally, after response protocols are developed, the plans must be periodically updated to assure that regulatory requirements are satisfied and that the availability and capabilities of incident response vendors are still in place. To further complicate matters, there has been much consolidation in the emergency environmental response industry in recent years. New vendors have entered the arena, while others no longer exist.

For these reasons, many companies opt to engage incident/spill response management consultants that typically maintain working relationships with a network of multi-disciplined response specialists (emergency environmental spill responders, disaster recovery experts, restoration specialists, environmental consultants, industrial hygienists and indoor air quality consultants, and waste management/disposal experts).

When outsourcing the incident/spill management function of the Pre-Incident Planning Program, one should look for the following offerings:

▪ 24/7 spill notification call number

▪  Immediate call back by a spill response project manager

▪ On-scene coordination – fast response times to site with qualified staff

▪ Established relationships with emergency response contractors

▪ Expertise with federal/state/local regulations

▪ Waste profiling and disposal coordination

▪ Regulatory agency liaison

▪  Engineering evaluation cost analysis

▪  Documentation and report preparation

Emergency Response Services from HETI

HETI has 30-plus years of experience providing emergency response services. Through our special emergency response department, supported by a toll-free hotline, we provide full-service capabilities involving all aspects of incident/spill management – including 24-hour, seven-day-a-week intervention to deal with    environmental emergencies and to mitigate potential environmental impacts. HETI’s staff is supplanted, as required, by a national network of reputable subcontractors with whom we have established working relationships.

We all have learned behavioral health and safety habits like tooth brushing, putting your seat belt on as soon as you get in the car, or looking both ways before crossing a street. The reward for developing these behavioral habits over the years is your health and safety.

Today, somewhere between 80 to 90% of all work accidents are triggered by unsafe behaviors or human error. Risky behaviors at work increase the likelihood of injury, while safe behaviors promote injury prevention. So, implementing behavioral safety practices in the workplace can help prevent hazardous situations from occurring.

A recent study conducted by Cambridge University and published in the Journal of                Organizational Behavior Management as “Behavior-based Safety 2022: Today’s Evidence” found that having a limited number of dedicated observers is more effective than encouraging all employees to participate and that being observed once a month is more useful than more frequent observations.

Take safe driving behavior as an example. One can judge drivers based on how they adjust their vehicle speed and position relative to other drivers, how they maneuver safely if a hazardous situation develops, and how considerate they are while passing other vehicles or changing lanes. Similar to drivers that do not pay attention to road conditions or text while driving, employees can become distracted if they do not focus on their behavioral safety. Their actions could then result in accidents or near misses.

Behavior-Based Safety Programs

There are two categories of unsafe behavior: violations and errors. Violations are deliberate choices made by workers not to follow safety rules, due to carelessness or lack of consequences. Errors are unintentional errors (making mistakes without realizing it) and habitual errors (due to routine or a “we’ve always done it that way” mentality). Note that unintentional errors are not intentional errors made by employees which need to be dealt with by the human resources department.

A Behavior-Based Safety Program informs management and employees regarding general safety issues in the workplace through safety observations gathered from workers’ focus on their own and their colleagues’ daily safety behavior. Safety management personnel know that promoting safe behavior in the workplace is a key element in building and maintaining a positive safety culture within any organization.

Behavior-Based Safety Programs have four key elements:

Observation

Here the observer gathers information about workers’ behavioral habits, analyzes injury history, and identifies how the habits affect the work-related safety challenges for the tasks the workers are performing. The observer categorizes safe and unsafe behaviors in order to find all opportunities for safety improvement. Be aware of the observation bias (Hawthorne effect) where workers being observed change their behavior because they are aware of being watched – significantly impacting their safety behaviors.

Checklists

A behavior-based safety checklist is a direct-observation tool used to recognize safe behavior and eliminate the root cause of unsafe acts. Checklists usually contain the following elements:

> Personal Protective Equipment – like head, eye, hearing, hand, respiratory and foot protection.

> Body Usage and Positioning – commonly including ergonomics and pinch point hazards

> Vehicle &Tools Selection and Inspection

> Travel Paths – which may include identifying the least potential incident incurring route of travel

Feedback

Behavior-Based Safety Programs are actually continuous feedback loops where the   workers and observers require response from each other to improve overall safety. By  discussing how the employees can perform their jobs safer, the observers learn a little more about the tasks, while at the same time the workers become extra aware of their  behavior. Positive feedback is especially encouraged. Once problem areas are identified and agreed upon, it’s crucial to find solutions to reduce or eliminate the safety hazards. Keep in mind that every workplace is unique and that the solutions need to be specially designed for that workplace. There are no one-size-fits-all solutions.

Goals

The goal of the Behavior-Based Safety Program is observing and correcting habits – focusing on preventing safety incidents, not just responding to them. For an average person, it takes a couple of months to break a bad behavioral habit or to form a new good one.

There are several approaches that have kindled urgent success in encouraging safe behaviors in the workplace – such as safety-oriented training, supportive peer guidance and surveillance, developing procedures that workers must follow, and rewarding safe behaviors.

Behavioral Safety Services from HETI

HETI can help clients implement Behavior-Based Safety Programs in the workplace by conducting on-site safety reviews, recording safe and unsafe behaviors, sharing the findings, and providing feedback. A well-implemented Behavior-Based Safety Program can significantly increase productivity levels within a company and raise the work environment morale – by reducing workdays lost due to workplace injuries, workers’ compensation payments, investigations, training of the replacement worker, and product/line damage.

References:

Jim Spigener, Gennifer Lyon & Terry McSween (2022), Behavior-Based Safety 2022: Today’s Evidence, Journal of Organizational Behavior Management, 42:4, 336-359, DOI: 10.1080/01608061.2022.2048943

¨ 

Microplastics have become ubiquitous in natural and built environments, which has caused concern regarding potential harm to human and aquatic life. Microplastics – plastic particles ranging in size from five millimeters (mm) to one nanometer (nm) – have been found in every ecosystem on the planet from the Antarctic tundra to tropical coral reefs.¹

Microplastics are microscopic pieces of plastic that break down from common plastic materials – such as food wrapping, tires, and synthetic fabrics – and end up in our environment. They vary in shape, size and morphology. The majority of these microplastics get washed away by rain, enter watersheds, and eventually end up in marine sediments. Sediments are under almost every water body and are primarily organic and mineral matter. They are important ecosystems and a major sink for contaminants but are often overlooked because they exist below the surface.²

According to one recent article from Remediation Technology “microplastics from tires can account for 30-40% of plastics pollution in the environment.” ⁴

Environmental Contamination

The plastics are often present in composites with nanomaterials such as carbon nanotubes or graphene oxide that maximize desirable properties like strength, conductivity, and antibacterial activity. Assuming current trends in production and no improvements in waste management, releases of microplastics into the environment may grow to 90 metric tons per year by 2030.⁵

Microplastics can occur as primary plastics that are introduced into the environment by  industrial spills. However, most microplastic environmental contamination comes from the mechanical breakdown of plastic products such as pipes, plastic cups and bottles, carpet, and other plastic consumer and industrial products. These are known as secondary microplastics. Studies suggest that some bottled drinking water may even contain miniscule plastic particles introduced by the container and cap. ⁶

Health Concerns/Effects

Definitive evidence linking microplastic consumption to human health is currently lacking. However, results from correlative studies in people exposed to high concentrations of microplastics and model animal/cell culture experiments suggest that effects of microplastics could include provoking immune and stress responses and inducing reproductive and developmental toxicity. Further research is required to explore the potential implications of this recent contaminant in our environment in more rigorous clinical studies.⁷

The accumulation of microplastics worldwide has led to increasing amounts in not only marine life and nature, but also is now highly suspected in humans as well. A study was recently published that claimed microplastics were found within human blood.⁶

The health concern of microplastics for humans occurs from the ingestion of chemicals used in their manufacture or of pollutants that concentrate on the porous surface of the particles.⁶ Particles (<150 micrometers) can be ingested by living organisms, migrate through the intestinal wall and reach lymph nodes and other body organs. The primary pathway of human exposure to microplastics has been identified as gastrointestinal ingestion, pulmonary inhalation, and dermal infiltration.

Microplastics may pollute drinking water, bioaccumulate in the food chain, and release toxic chemicals that may cause disease, including certain cancers. They may pose acute toxicity, (sub) chronic toxicity, carcinogenicity, genotoxicity, and developmental toxicity. In addition, microplastics may pose chronic toxicity (cardiovascular toxicity, hepatotoxicity, and neurotoxicity). The toxicity of microplastics primarily depends on the particle size distribution and monomeric composition/characteristics of polymers.⁸

“Given the variety in plastics, there is no standard or ‘one size fits all’ method for quantifying microplastics in environmental samples. It makes it difficult to compare data and results of various studies when there are hundreds of methods used across the world.” What concerns us is that everywhere we look – arctic, deep-sea trenches, human plasma – we find plastic. The more we look, the more we find,” says Environmental  Protection Agency (EPA) chemist Michaela Cashman, Ph.D., the lead author on a recent EPA-led study that developed a new method for identifying microplastics.²

Conclusions

Microplastics have infiltrated every part of the planet. They have been found buried in Antarctic sea ice, within the guts of marine animals inhabiting the deepest ocean trenches, and in drinking water around the world. Plastic pollution has been found on beaches of remote, uninhabited islands and has shown up in sea water samples across the planet. One study estimated that there are around 24.4 trillion microplastic fragments in the upper regions of the world’s oceans. Microplastics are spread widely in soils on land too and can even end up in the food we eat. Unwittingly, we may be consuming tiny fragments of plastic with almost every bite we take.⁹

EPA and other organizations are actively researching microplastics; however, there is admittedly much more work to be done including determining the short- and long-term effects on human health and the environment.

Additional Resources

HETI’s Certified Industrial Hygienists, Professional Engineers and Environmental Specialists are available to assist clients with a variety of services to help assess and/or characterize the safety and impact of microplastics in their organizations.

References:

¹ Microplastics Research | US EPA

² Making Microplastic Identification More Accessible | US

⁴ RemediationTechnology@products-bnp.com,

⁵ Assessing Effects of Nano- and Microplastics in Aquatic Environments | Science Inventory | US EPA

⁶ Microplastics – Eurofins USA

⁷ The potential effects of microplastics on human health: What is known and what is unknown – PubMed (nih.gov)

⁸ Human health concerns regarding microplastics in the aquatic environment-From marine to food systems – PubMed    (nih.gov)

⁹ How microplastics are infiltrating the food you eat – BBC Future

Under Title VI of the Toxic Substances Control Act (TSCA,) formaldehyde emissions are regulated for three types of composite wood products: hardwood plywood, medium-density fiberboard (MDF), and particleboard. To reduce formaldehyde emissions from these composite wood products, TSCA Title VI and the implementing regulations were created. By doing so, human exposure to formaldehyde was reduced, resulting in health benefits for workers and consumers.

The U.S. Environmental Protection Agency (EPA) Formaldehyde Standards for Composite Wood Products was originally published in the Federal Register on December 12, 2016, at 40 CFR Part 770. The standards require formaldehyde emissions limits, testing, third-party certifications, reporting, recordkeeping, and labeling. Compliance deadlines are also set forth.

An EPA-recognized third-party certifier (TPC) must confirm that any composite wood product, covered by TSCA Title VI, complies with the formaldehyde emission standards. To obtain certification by a TPC, the  manufacturer must submit such information as emissions tests results, quality control tests findings, linear regression equation and correlation data, etc. The TPC will grant certification to products that demonstrate compliance with the emission standards and their quality control requirements. To maintain the certification for a product, the manufacturer must conduct quality control testing and submit to quarterly testing and inspections by its TPC.

New Final Rule

On November 1, 2018, the EPA proposed amending 40 CFR 770 to improve regulatory clarity and better align with the Airborne Toxic Control Measures Phase II program of the California Air Resources Board (CARB).

EPA held a public consultation in March 2022 to propose technical updates to 40 CFR 770. A pair of technical updates were proposed for the standards in September 2022. And a final rule (88 FR 10468) for amending the Formaldehyde Standards for Composite Wood Products was published on February 21, 2023.

The final rule, which became effective March 23, 2023, contains several important changes to the Act – including:

TPCs can now utilize external evaluation resources to complete the certification process, such as contracted inspection. However, evaluation activities should only be outsourced to competent (normally accredited) facilities – used and managed in a way that provides confidence in the results, as well as records that support that confidence.

When unsafe conditions prevent TPCs from physically visiting the area, remote inspections may be conducted. A government entity must certify that unsafe conditions were identified during the inspection by the TPC. For example, the COVID-19 global pandemic prevented some TPCs from visiting composite wood product manufacturing facilities to conduct on-site inspections and sample collection. So EPA provided its interpretation of its regulation – allowing TPCs and composite wood product manufacturing panel producers to conduct the required quarterly inspections and sample collection via teleconference.

Ten voluntary consensus standards have been updated to reflect the editions currently in use by regulated entities and industry stakeholders. The purpose is to ensure that standards are in line with industry requirements and better align with CARB requirements.

This update also clarifies timing of panel tests after production, corrections to equivalency determinations, and data requirements for no-added formaldehyde-based resins and ultra-low-emitting formaldehyde resins.

Who is Affected?

Manufacturers, importers, sellers, suppliers, and/or providers of hardwood plywood, medium-density fiberboard, particleboard, and/or products containing composite wood materials are affected by this final rule. Those who test or work with companies that certify such materials may also be affected by this final rule.

Note: The August 2020 edition of HETI Horizons, entitled “Regulating Formaldehyde In Wood Products”, discussed what is formaldehyde, formaldehyde exposure, and the key steps to minimizing exposures. Please see our website or request a copy from development@hetiservices.com.

Services from HETI

HETI’s staff continually reviews new and proposed changes to regulations and standards to make sure we have current knowledge of compliance and environmental health & safety (EHS) issues. We have extensive experience in supporting our clients through a comprehensive range of regulatory support and other services. So whether there’s a need for hazard recognition, exposure monitoring, or other regulatory support, HETI’s EHS professionals are ready to help.

References:

EPA’s Formaldehyde Emission For Composite Wood Products available at:

https://www.epa.gov/formaldehyde/formaldehyde-emission-standards-composite-wood-products

CFR PART 770 – Formaldehyde Standards For Composite Wood Products available at:

https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-770

¨ 

This is the second of a two-part update summary of technologies used for treating “infectious” waste generated at healthcare facilities, research and clinical laboratories, biotechnology and pharmaceutical laboratories, and the like. In the January 2023 issue of HETI Horizons, Part 1 reviewed what are considered currently viable technologies. Part 2 presents a recommended method and criteria for evaluating and selecting the best, most cost-effective system for a facility-specific application.

Proven vs. Innovative Technologies

A 2001 paper by an environmental activist group identified 49 potentially viable, non-incineration medical waste treatment technologies that included 36 thermal processes,10 chemical disinfection processes, and two irradiation processes. Before 2010, virtually all of those technologies proved to be failures and were no longer commercially available.

Today, the only long-proven, viable, medical waste treatment technologies are incineration, steam autoclaving, and possibly pyrolysis. However, somewhat unique, “innovative” technologies are periodically introduced and heavily promoted as being quintessential treatment systems having minimal costs, negligible or “zero” emissions, and simple trouble-free operations. Such “groundbreaking” technologies appear very appealing on vendor websites and marketing materials – particularly to those unfamiliar with the historical and technical aspects of medical waste treatment technologies – but they are all basically reincarnations of failed technologies from decades ago. In addition, marketing and promotional materials for such “innovations” are invariably misleading and replete of useful operating and performance data. In fact, most if not all of them are only conceptual or under development with none in actual, full-scale operation.

Determining the Best Alternative

The process of evaluating and determining the best medical waste treatment technology for any particular facility-specific application could be a relatively difficult, perplexing task – whether for evaluating and comparing an array of different technologies or for determining the best system offered by different vendors within a specific treatment category, such as incineration or autoclaving. The bigges difficulty is being able to filter through vendor marketing propaganda and claims and to fill in the gaps of missing data and information. A recommendation for facilitating such evaluations is to apply each of the seven criteria below to each technology or vendor under consideration – thereby deriving a quantitative comparison and ranking that should identify what could be considered the best alternative or a short-list of the best or top two to three technologies for selection or further evaluations.

Recommended Evaluation Criteria

1.    Demonstrated Performance Criteria

Should focus on the overall viability and degree of demonstrated success for each particular technology or system. Relevant factors for consideration include the number of full-scale operational systems in place and the duration of successful operation for each. For example, technologies that are still under development with no full-scale operational systems in place should be ranked lower than those having long-term successful installations.

2. Technical & Performance Criteria

Should focus on the operational and processing capabilities and performance for each particular technology or system. Relevant factors for consideration include daily and hourly process rates; weight and volumetric reductions or increases; degree of disinfection or sterilization; recognizability of treated residues; and waste container size limitations. For example, technologies that can process large volumes of waste at a high hourly rate without requiring special handling should be ranked higher than small-capacity systems requiring special or additional waste handling measures.

3. Vendor Qualification Criteria

Should focus on the ability and resources of each particular treatment system vendor to provide support services during initial planning and permitting, during system installation and commissioning, and during the course of long-term operations inclusive of routine maintenance and emergency repair work. Relevant factors for consideration include the number of years in business in manufacturing the specific technology; financial stability; and location. For example, vendors that have been in business for many years in manufacturing and servicing their waste treatment systems should be ranked higher than those having limited resources, a small support staff, and a minimal track-record of successful installations.

4. Environmental & Permitting Criteria

Should focus on the ability of each particular treatment system to comply with applicable, site-specific environmental regulations and permit requirements without unacceptable risks to the environment or public health. Relevant factors for consideration include potential air pollutant emissions from stacks and vents and possible need to install air pollution control equipment; liquid effluent discharges and contaminants and the possible need to install wastewater treatment equipment; and the acceptability of treated waste residues for off-site transport and disposal.

5.    Occupational Safety & Health Criteria

Should focus on the ability of facility personnel to operate, maintain, and service each particular system and piece of equipment without being exposed to unacceptable safety and health risks or the need for unusual, specialized personnel protection measures. 

6.    Facility & Infrastructure Requirement Criteria

Should focus on such parameters as overall space and elevation requirements, infrastructure and general construction requirements, and utility and commodity usage requirements for each particular system and component.

7. Economic Assessment Criteria

Should include the preparation of budgetary cost estimates and preliminary economic analysis for each potentially viable or selected treatment technology or system inclusive of:

• Estimated total capital cost requirements inclusive of system procurement and installation, site and general construction work, utility connections, commissioning, compliance testing, etc.
• Estimated total annual operating and maintenance costs inclusive of operating labor, utility and consumable usage, maintenance and repair, residue disposal, and compliance costs, such as periodic testing, certifications and reporting
• Lifecycle costing analyses inclusive of annualized owning and operating costs, unit costs, and return-on-investment (ROI)  comparisons

Using these criteria as recommended may be a bit time-consuming but it is a relatively simple process and well worth the effort. It should serve to quickly identify and eliminate those technologies unworthy of consideration. The assignment of a priority-specific rating value to each of the above criteria based on facility-specific considerations should provide a definitive comparative, numerical ranking of each technology and system under consideration.

HETI Services

HETI has extensive expertise, experience, and full-service capabilities involving all aspects of medical waste management, treatment and disposal – including feasibility evaluations, engineering and design, permitting, construction administration, and ongoing compliance support. HETI staff have provided such services to more than 500 healthcare, university and biomedical research facilities throughout the U.S. and internationally.

The July 2021 issue of HETI Horizons provided an overview of anticipated changes in the 2021 update to American Society for Testing and Materials (ASTM) E1527, “Standard Practice for Environmental Site Assessments: Phase I Environmental Site Assessment Process”. In this edition, some 18 months later, we present some of the major final revisions – which become effective this month.

In March 2022, the Environmental Protection Agency (EPA) issued a direct final rule (87 FR 14174) stating that it would continue to recognize the old ASTM Standard E1527-13 as well as the new Standard as satisfying the All Appropriate Inquiries (AAI) provision in the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Then in May, EPA withdrew the direct final rule after receiving objections to continued use of ASTM E1527-13. Commenters argued that ASTM E1527-21 was developed with input from industry professionals, users, and regulators; and since it represents “good commercial and customary business practice” it should, therefore, replace ASTM E1527-13 altogether. Furthermore, commenters stated that using both the 2013 and 2021 Standards could generate confusion and add a level of complexity for users – as they would have to evaluate differences in costs/benefits of using one Standard over the other when reviewing multiple bids from environmental consultants.

In response to the concerns raised by commenters, EPA issued a new direct final rule (87 FR 76578) on December 15, 2022, stating that only the newer Standard should be used moving forward. However, to allow users to become accustomed to the new Standard, EPA is providing a sunset period of one year for ASTM E1527-13. The effective date of publication of EPA’s final rule is February 13, 2023 – meaning that the 2013 Standard will continue to satisfy AAI until February 13, 2024.

Definition Changes

The definition of a “Recognized Environmental Condition” (REC) was revised in an effort to clarify the term as it relates to the presence of hazardous substances or petroleum products at a property. A REC is now defined as (1) the presence of hazardous substances or petroleum products in, on, or at the subject property due to a release to the environment; (2) the likely presence of hazardous substances or petroleum products in, on, or at the subject property due to a release or likely release to the environment; or (3) the presence of hazardous substances or petroleum products in, on, or at the subject property under conditions that pose a material threat of a future release to the environment.

The new Standard now describes circumstances that elevate a “data gap” to the level of “significant data gap,” which is now defined as “a data gap that affects the ability of the environmental professional to identify a recognized environmental condition.” It also clarifies that a “data gap” – defined as “a lack of or inability to obtain information required by this practice despite good faith efforts by the environmental professional to gather such information” – is not inherently significant. Therefore, if a data gap does not affect the environmental professional’s ability to identify a REC, it does not constitute a “significant data gap.”

ESA Report Content & Viability Changes

ASTM E1527-21 now promotes the consistent use of “Subject Property” in a Phase I ESA report when referring to the property that is the subject of the environmental site assessment. Many environmental consultants use various terms like “subject property”, “site”, “target”, or “property” interchangeably in their reports; so, referring to the property undergoing the Phase I as “subject property” will reduce confusion among report readers and users.

The revised Standard requires the environmental professional to document in the report whether or not the features and conditions specified in the Site Reconnaissance section of the new Standard (§9.4.1 through 9.4.28) were observed. A blanket statement that “no RECs were observed at the Subject Property” will not meet the site description requirements in the revised Standard. This change in the ASTM Standard promotes good business practices as it shows the user or reader of the report that the environmental professional searched for all of the features and conditions specified in the Standard, and clearly describes their presence or absence in the ESA report.

The new Standard also clarifies the time frame for continued viability of an ESA report. The validity of a report, or the report’s expiration, depends on the earliest date at which certain components of the ESA were conducted. These include (1) interviews with owners, operators, and occupants; (2) searches for recorded environmental cleanup liens (a user responsibility); (3) reviews of federal, tribal, state, and local government records; (4) visual inspection of the Subject Property; and (5) declaration by the environmental professional. These components must be conducted within 180 days prior to the transaction date, and the dates at which they were conducted (except for environmental lien searches which are the user’s responsibility) must be identified in the report. This update to ASTM 1527-21 means that an ESA report is valid for 180 days from the date at which the first of these components was completed.

Although many environmental consultants have been including site plans in their ESA reports prior to the 2021 update, the new Standard now explicitly requires the inclusion of a site plan. The update further specifies that the following features must be included in the site plan: a north arrow; the approximate scale; all major structures; occupant/business names or land uses; and locations of features, activities, and conditions at the subject property and adjoining properties.

The old ASTM Standard stated that the environmental professional should exercise professional judgement in determining what historical sources should be reviewed to identify historical uses of the Subject Property. The new Standard specifically requires the review of four Standard Historical Sources – identified as aerial photographs, local street directories, topographic maps, and fire insurance maps – if reasonably ascertainable, likely to be useful, and applicable to adjacent properties. The environmental professional should exercise professional judgement and review additional historical sources to identify past uses that may indicate a REC in connection with the subject property.

ASTM E1527-21 clarifies that environmental lien and activity and use limitation (AUL) searches are to be completed by users and searches for land title records must be completed from the present back to 1980.

The new Standard addresses the growing concern regarding “emerging contaminants” such as per- and polyfluoroalkyl substances (PFAS), by indicating that once these emerging contaminants are classified by EPA as hazardous substances under CERCLA, they will be evaluated within the scope of ASTM E1527. This suggests that users may want to consider the risks of emerging contaminants at the subject property, and request that the environmental professional address the potential for emerging contaminants in the ESA report as a non-scope issue.

What It All Means

Overall, the aim of the new Standard is to strengthen the framework for environmental due diligence by clarifying the scope and the depth of review for an ESA and revising certain terms and definitions to make them more concise and eliminate potential confusion.

For a property owner, lender, consultant, or other interested party, it is important to be aware of these changes and to understand the new requirements set forth in ASTM E1527-21. Effective implementation of this ASTM Standard plays a critical role in managing                 environmental liability and financial risk. Ultimately, adherence to E1527-21 will assist a   property owner with qualifying for landowner liability protections (LLPs) against contamination and remediation requirements under CERCLA; and promote increased uniformity and transparency of Environmental Site Assessment reports prepared by environmental professionals.

HETI staff are well-versed in the ASTM Standard for environmental assessment of commercial real estate and are ready to support our clients as questions arise regarding the usage and interpretation of the new ASTM 1527-21.

¨ 

This is the first of a two-part update summary of technologies used for treating “infectious” waste generated at healthcare facilities, research and clinical laboratories, biotechnology/pharmaceutical laboratories, and the like. Part 1 reviews what are considered currently viable technologies. Part 2 will provide recommendations for evaluating, selecting and implementing the best, most cost-effective system for a facility-specific application.

Starting Point – Properly Describe and Define the Waste

Evaluation, decision-making and the implementation of any facility-specific waste management, treatment and disposal program should always begin with the establishment of a clear, precise description and characterization of the waste stream, along with a compositional breakdown of its main constituents. Failure to do so could result in any number of problems – ranging from management difficulties to the procurement of an inadequate, noncompliant, or overly costly waste treatment system.

It is also important that proper, clear terminology be used to describe or define the waste as opposed to vague, generic terms – such as “medical waste” – which provide no useful information about the waste itself. There are at least a dozen terms often used when referring to “medical waste” – including “infectious waste”, “contaminated waste”, and “clinical waste”. But such terms have different meanings and are subject to varying interpretations.

Use of the term “infectious waste” is a prime example where clarification is recommended; simply because only a small fraction of medical waste is actually infectious. Technically, infectious waste comprises disposed items that have been contaminated by a pathogenic microorganism or pathogens (such as bacteria, viruses, or fungi) capable of causing an infectious disease in healthy humans. The primary source for such contamination is contact with blood or body fluids from medical procedures. However, since it’s problematic to know with certainty whether any such contacted fluids actually contain viable pathogens, it is standard practice for such contaminated waste to be designated as being “infectious” and collected in red-colored containers having a universal biohazard symbol. All such color-coded containers are assumed to be filled with “infectious” waste, but published data have shown that upwards of 95% of the waste is not “infectious” and poses a negligible risk of transmitting an infectious disease.

Viable Medical Waste Treatment Technologies

Terminology

Waste Processing vs. Waste Treatment

The terms “waste processing” and “waste treatment” are often used interchangeably; but they are different. Waste processing involves the application of equipment, such as shredders and compactors, to change the physical characteristics of a waste for a particular purpose; while waste treatment involves the application of processes and equipment to convert wastes having hazardous characteristics or properties to a residue that is safe for handling and disposal.

Disinfection vs. Sterilization

The terms “disinfection” and “sterilization” are also often used interchangeably, but they also have different meanings. Disinfection involves processes for eliminating harmful microorganisms from objects and surfaces to an acceptable level, while sterilization involves processes for killing all microorganisms. Only a few medical waste treatment technologies, such as high-temperature incineration, are capable of providing sterilization. But other technologies provide a sufficiently high level of disinfection (typically 99.99% or higher) to be considered acceptable in accordance with most state         regulations.

Evolutionary Development

Until the early 1990s, incineration and steam autoclaving were widely considered the only proven, viable medical waste treatment technologies. But a series of national events, including fears associated with the AIDS epidemic, triggered the rapid proliferation of non-incineration treatment technologies – with more than 200 different technologies developed by the early 2000s. Within a few years virtually all of them proved unsuccessful and became no longer available. Today, the only proven, viable, medical waste treatment technologies are again incineration, steam autoclaving, and possibly pyrolysis. A few other technologies – including ozonation and        microwaving – continue to be promoted; but none of them have demonstrated proven success and basically reflect failed technologies from decades ago.

Incinerator Systems & Equipment

Incineration is a high-temperature combustion process suitable for destroying virtually all types of waste. A properly designed, controlled, and operated incinerator system readily converts medical waste (and almost all other types of waste generated at healthcare facilities) to an inert, sterile, non-hazardous, unrecognizable ash residue that is safe for disposal in a sanitary landfill. Incinerator systems typically reduce the weight and volume of medical waste by upwards of 95 percent or more, and provide the opportunity to recover useful energy from the waste in the form of steam via heat recovery boilers.

The most widely used incinerator technology for disposing of medical waste is termed controlled air type incineration – because of the way air for combustion is introduced and controlled. However, regardless of incinerator type, the key to procuring a successful, reliable, compliant system involves the application or specification of widely recognized design, construction and operational criteria for the incinerator itself and all associated components (such as the waste loading system, ash removal system, burners and blowers, stack and breechings, controls and instrumentation, and air pollution control devices).

Steam Autoclave Systems & Equipment

Steam autoclaving uses pressurized, saturated steam injection within a chamber for inactivating or killing pathogenic microorganisms. It is suitable for treating or disinfecting most types of medical waste; but they are not considered acceptable for treating pathological waste, waste containing bulk quantities of fluids, or hazardous waste and chemicals. Autoclaving effectiveness or efficiency is a function of steam temperatures, the ability of the steam to contact                  microorganisms within loaded waste containers, and the duration of steam contact with contaminated items. Since most autoclaved waste remains recognizable and because sharps within the waste containers remain as potential puncture hazards, it is often necessary to shred the autoclaved waste to render it unrecognizable and safe for  handling and off-site disposal. 

Pyrolysis Treatment Technologies

Pyrolysis technologies use indirect heating sources – without the introduction of air or oxygen – to heat the waste to high temperatures. This process drives off volatile gases from the waste, but such gases need to be combusted in a fuel-fired afterburner prior to stack discharge. The solid residues after pyrolysis have high percentages of carbonaceous, recognizable items that require additional special processing such as shredding or encapsulation prior to disposal.

HETI Services

HETI has extensive expertise, experience, and full-service capabilities involving all aspects of medical waste management, treatment and disposal – including feasibility evaluations, engineering and design, permitting, construction administration, and ongoing compliance support. HETI staff have provided such services to more than 500 healthcare, university and biomedical research facilities throughout the United States and internationally.