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Developing Standards for Degradation, Destruction, and Neutralization

Defense Human Health

Effectiveness Key to Chemical Threat Remediation

The collection and subsequent cleanup of illicit production, distribution, and use sites is a risky operation for law enforcement and the contractors typically hired to perform such site remediation. The use of products proven through rigorous and standardized testing will enable a safe, expedited, and more thorough cleaning of these types of sites and provide a more rapid return to normal for the civilians who reside in adjacent areas. That is why the development of such standards for the degradation, destruction, and neutralization of these products is so important.  

There is not a regulatory body charged with dictating standards and providing oversight for decontamination of most organic chemical threats. The OSHA, FDA, and EPA do make recommendations for biological pathogens, heavy metals, and a few other industrial chemicals. For chemical warfare agents (CWAs), there are some rigorous standards developed and overseen by the military such as Test Operations Procedure (TOP) 08-2-061A, which has also been applied to TICs (toxic industrial chemicals) and TIMs (toxic industrial materials). Most, if not all guides provide information on the overall process and the items to be used, not the methods by which those items have been validated. 

Unfortunately, such standards do not exist for several other materials, including drugs of abuse. In recent years, the prevalence and severity of the opioid crisis has significantly increased demand for more decontamination solutions. This has prompted companies to introduce products onto the market and make claims about their efficacy but lack publicly available data to support these claims. These products, including some used in opioid and clandestine cleanup, that market themselves as “effective” in the degradation, destruction, and neutralization of chemical and biological agents are often prone to overstatements, misunderstanding, and misinterpretation. That is because of an ambiguity in how these terms are defined. This can make the use of these products ineffective at best, and at their worst, dangerous to those entering the environment after their use because the contamination threat has not necessarily been adequately removed from the area. This can pose a health threat to first responders and others responsible for working in an environment that may be contaminated. 

Why are standards important?
By supporting the development of standards, we can help ensure that products designed to decontaminate an environment are actually effective at doing so. This helps protect first responders and others who may otherwise come into contact with these harmful substances.  

When designing a study to assess the efficacy of decontamination products, which can be utilized in established standards, there are several variables to be considered. These parameters help guide our work in determining what meets the needs of our client and what does not. Specifically, we look at variables that include:  

  • What phase of development is the product in? Has it been around for years and is now being tested against a new substance or on a new material? Or is it a new product that is being evaluated for the first time?  
  • What type of test material is available? If it is a drug of abuse or biological agent, is it available for use in our testing? In the quantity necessary to replicate an actual use-case?  
  • What type of test material is applicable? Is what is being tested applicable to real-world scenarios?  
  • What are the expected operational scenarios? Is the product expected to clean the surface? Decontaminate the surface? Capture the threat? Chemically neutralize the threat?  

Establishing these initial variables will support an effective study design.   

Establishing Standards for Efficacy
To establish standards for efficacy, we’ve developed a multi-step testing and evaluation process.   

  1. Concept testing – If a new product is being evaluated, it will go through formulation development and proof-of-concept testing. In brief, our scientists will ask “Is this concept going to work?” Using stoichiometry, we calculate theoretical degradation values for varied candidate formulations. 
  2. Quantitative testing – We will then develop and validate methods for testing. This is a rigorous and selective process that requires complex laboratory equipment, methods, and highly accurate measurements. Often, custom methods are required in order to accommodate the wide variety of sample types (product formulations) that may be tested. 
  3. Operational testing – In a laboratory, we then replicate realistic scenarios, contaminate the test environment with the substance in question, and apply the decontamination method being evaluated to determine its efficacy.  

By answering questions like “How much product should be used?,” “How long should it be on the surface?,” “What surfaces does it work on?,” and “What is the hazard level?,” we can then recommend remediation thresholds that are based on how the product will likely be used in the field and variables that may be encountered. 

The sensitivity of the measurement technique used is important to understanding the degradation of a substance. Though colorimetric and nuclear magnetic resonance spectroscopy imaging (NMR) are traditionally more affordable, they may not provide the integrity of data that is useful. They are also not as sensitive in relevant detection limits, especially with opioids, which can be harmful in very small amounts. Using a technique with greater selectivity and sensitivity, like analytical GC-or LC mass spectroscopy (MS), can help us better understand degradation and even destruction, which can lead to development of a product claim that is backed by science.  

Test Trial Controls
Through a series of quality control and assurance measures, our scientists ensure that data captured are of the highest caliber. All test trials should include negative control samples used to monitor system, process, and overall cleanliness. Few routine negative control types (blanks) are described below. 

  • Solvent Blank: A volume of solvent equal to the initial volume of target solution used. The sample is analyzed to verify a non-detection at the start of each testing day and/or for each solvent. 
  • Instrument Blank: A volume of solvent equal to the final volume of the sample. The sample is analyzed to verify a non-detection at the start of each testing day and/or for each solvent. 
  • Decon Matrix Blank: A volume of decon solution/product equal to the volume of decon solution used in test trials (sans analyte). The sample is analyzed to verify a non-detection at the start of each testing day and/or for each test condition. 

All test trials should also include a variety of positive control samples used to verify the presence and quantity of the target compounds, as well as method limitations (recoveries, accuracy, precision) 

  • Continuing Calibration Verification (CCV): A mid-level (usually C2-C4) calibration standard is periodically analyzed to verify system performance and sustained accuracy. 
  • Sensitivity Verification Standard (SVS): The low level (C1) calibration standard is periodically analyzed to verify system sensitivity. 
  • Positive Control Spikes: A volume of target solution equal to the volume of target solution used in samples is transferred into a container, a volume of solvent equal to the volume of decon solution used is transferred into the same container, mixed briefly, and analyzed to verify system performance and recovery. 

This process provides us with a better understanding of the efficacy of individual products, which then provides manufacturers with verifiable claims they can make in marketing those products. Though that is progress, there still needs to be standardized and formal definitions regarding the degradation, destruction, and neutralization for these substances that is rooted in scientific research. This will provide manufacturers with a better basis for making such claims while providing those responsible for cleaning contaminated sites the necessary assurance that their job has been done effectively. Read more about our work at “Testing and Evaluation with Decades of Expertise, World-Class Laboratories.”

 

GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal to learn more about our work in defense against chemical and biological threats. We partner with our clients to test and evaluate current methods to detect, prevent, decontaminate, protect, and destroy these materials. 

If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started. 

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