According to Airports Council International, airlines served over 6.3 billion passengers globally in 2013, a 4.6% increase over 2012, and carried 96 million metric tons of freight. These numbers are expected to continue to grow. On top of the logistical difficulties inherent in so much traffic, airlines are expected to manage many occupational and consumer risks. We help those in the airline industry assess whether there is a risk to passengers and crew caused by chemicals in aircraft.
We have worked with airlines, aircraft manufacturers, and non-profits for more than 15 years to chart key health factors in the workplace. The industry calls on us to measure and evaluate chemical exposure, as well as to detail steps to reduce potential risk.
Our work helps airlines know how well they meet Environmental Health and Safety standards. Airlines today must be able to manage health risks to workers, cabin crew, and passengers. Those risks might come from exposure to fuels, pesticides, cleaners, fabrics, foods, and paints, among other chemicals. And as the industry works to reduce its impact on the environment, new issues surface. Will using more sustainable and “green” chemicals affect the health of workers, crew, and passengers? We help our clients find the answers.
Case Study: Intertox helped an airline determine how to talk about foul odors on aircraft. Some chemicals have odors. Others don’t. Odor does not mean the air is toxic. The lack of odor doesn’t mean it’s safe to breathe. Our work helped reduce concerns among crew members about foul odors.
Case Study: An airline’s ground crew expressed concerns about breathing the fumes of jet engines. Intertox evaluated the potential risks to runway workers who were exposed to the fumes. We measured exposures, then compared the data to scientific studies on the chemical agents of concern. Our work addressed concerns with the best available science.
- Determine if new sustainable, “green” chemicals pose health risks
- Develop chemical safety programs that align with the law
- Conduct exposure assessments/audits
- Develop custom EHS training programs
- Conduct chemical safety assessments/audits
Every worksite in America has its own chemical profile, whether it’s a warehouse, an airplane, a farm, or an office building. Any chemical found there might be a potential health and safety risk to workers. At Intertox, our scientists have tested chemical and biological agents in the workplace for more than 20 years. Our work helps our clients rigorously evaluate potential safety concerns, and workers’ compensation claims, according to the best science.
Clients often ask us to perform workplace safety audits. With an audit, we are able to tell a company if there are risks before a worker makes a claim. We give the company science-based data with which it can make sound choices about what, if anything, it should do. Our services go beyond doing workplace audits. We build programs to train staff in how to reduce their risks brought on by the chemicals in their workplace. And we also assess workers’ compensation claims on a case by case basis as well.
Our team uses the best state, federal and global practices to set up testing methods. We help our clients create workplace data-based exposure limits (OELs and PELs). Our reports, while steeped in science, are easy to read, act upon, and share with those who need to know.
Case Study: In some parts of the world, air pollution is an ongoing risk to health. One client with worksites around the world found that its workers at some locations feared that their health, and that of their families, was at risk. It asked Intertox to help it tackle the issue. Working with our client, we created a program to teach its overseas workers about the health risks of air pollution. We also showed workers what they could do to lessen their risks. Part of the job was to develop material for the company’s internal website explaining the ABCs of air pollution. The site acquainted the workers to the field of toxicology, how scientists can predict risk, and standards and limits for indoor and outdoor air pollution in a way that was easy to understand. A popular function also let workers compare air pollution at their workplace with that in other cities across the globe.
Case Study: A client asked if workers in one of its offices might be exposed to unhealthy levels of volatile organic chemicals. We sampled the air in the workplace and compared the results with the guidelines set by OSHA and various state agencies. We then provided the client with findings based on science that spelled out exactly what its risk was and how it might lessen that risk.
- Develop custom environmental health and safety training programs
- Conduct occupational exposure assessments/audits
- Develop chemical safety programs that meet regulatory requirements
Intertox has helped companies improve the safety of consumer products for more than 20 years. Intertox uses science-based principles to help our clients manage any risks to human health that emerge. The experts on our staff study each step of the process from manufacturing to delivery. We study the potential risk for both workers and end-users.
Our deep knowledge of chemicals and the conditions under which they should be handled allows us develop protective, cost-effective safety programs that comply with regulations. Our experts review the risks of chemicals both in initial and continuing use. This ensures that when our clients “go green,” for instance, they truly reduce chemical risk.
We have built strong relationships with testing laboratories. This enables us to work seamlessly with clients and labs to identify extractables and leachables in products and their packaging. We can then assess what, if any, risk they might pose. If they do pose risks, we are there to find ways to address them.
Through the years, we have worked with clients to measure and assess chemical health risks associated with a wide variety of products and their packaging. Among them have been inhalers, sealed toys, insulin pumps, candy wrappers, IV bags, and inks on containers
Case Study: Cell phone carriers are challenged often on whether their phones may make people sick. One asked us to find answers. We assembled a random selection of their phones to test. We looked at two things. First, we checked the chemicals found on or in the phones themselves. Then we looked at the packaging. Our client wanted to know whether users may be harmed by inhaling chemicals that might have no odor. They also asked us to find out if simply holding or touching a phone poses a risk. We developed a forensic program to assess the source of the exposure and then evaluate any likely health outcomes. With this information, our client was able to address concerns directly and with science-based facts.
Case Study: A client asked Intertox to conduct human and ecological risk assessments of ethylene vinyl alcohol, the chemical used to make shipping packaging commonly known as “peanuts.” Using U.S. EPA guidelines as benchmarks, we reviewed laboratory data, the current scientific literature, and the use of the material as a consumer product. Our report included a risk assessment of potential cancer and non-cancer endpoints.
- Conduct exposure and chemical safety assessments of manufacturing processes
- Coordinate laboratory testing for leachable compounds and analyze the results
- Design and implement scientific studies to assist in product liability litigation case development
- Serve as expert witness/consulting expert
We make science talk. We put science into English, and into images, that most anyone can understand. Sometimes we’re asked to produce a written report. We might be called on to provide sworn testimony. In either case, our scientists have a gift for stating the facts in a way that judges and jurors can easily follow.
We have worked side-by-side with legal teams for more than 20 years. Lawyers have turned to us to evaluate scientific evidence for large-scale class actions. Others have used us to assess the science behind health and workers’ compensation claims. We have worked on a broad range of cases. Some have been environmental in nature. Others were chemical. We have also worked on cases involving pharmaceuticals, as well as biological agents. We have the command of the science needed to tackle them all.
Our scientists tell the lawyers we work with if the cases have technical merit based on science. With a team that spans disciplines, we can dot every i and cross every t in order to give lawyers the fullest picture possible. Nothing is too complex. When there are gaps in the evidence, we can explain exactly what is uncertain. If warranted, we can conduct further study to shed light on an unknown.
When others make science-based claims, we can see what’s supported and what isn’t. We evaluate their data and methodology with rigor. When it’s called for, we create science-based arguments to refute what they say. This allows the lawyers we work with to examine evidence with clarity. Armed with the data we give them, they can evaluate and strengthen their case’s legal position.
Case Study: A law firm’s client ran a large kiln that deposited chemicals in soil near the facility. It had been approved to do so, as long as the calculated level met standards deemed safe to human health. We assessed how the level was set, whether it complied with U.S. EPA risk assessment practices, and if it was based on the best and most current scientific data. Our expert report summarized our research. In our report, we rebutted the claims by showing that the opposing findings incorrectly assessed the case.
Case Study: Manure has been used safely on farms for generations. There are times, though, when the manure contaminates source water. In one case, a law firm asked us to evaluate several expert reports that appeared to condemn the client. We found critical methodological flaws and data gaps that made the opposition’s conclusions unscientific. We briefed the attorneys on our findings and summarized our research in an expert report.
- Serve as an expert witness
- Serve as a consulting expert
- Conduct human and environmental health risk assessments based on the facts of the case
- Evaluate expert reports according to the best practices of toxicology
- Review and interpret medical and laboratory data
Food and Beverage
At Intertox, we help clients assess and reduce risks posed by food and beverages. Microbial spoilage and chemical contamination have become big issues for the food and beverage industry. Intertox helps producers find the cause of their problem and put together a plan to fix it.
We identify, test, assess, and monitor food contaminants. We help clients learn if chemical uptake into crops from soil and water poses a risk to human health. We also assess whether packaging may contribute to risk.
When a client needs to track down the source of off-flavor in food or beverages, we work alongside them to develop protocols that apply scientific rigor to taste-testing under different conditions. For clients that need it, we develop Environmental Health and Safety employee education and training programs designed to control and reduce the chances of contamination
Case Study: When soil is contaminated, the food that grows in it may be, too. At Intertox, we have done more than 30 multi-pathway risk assessments to identify the possible source of contamination. Chemicals of concern have included metals, dioxins, furans, polyaromatic hydrocarbons, nitrogen oxides, and sulfur oxides. Depending on the situation, we focus on specific endpoints, such as neuroanatomical effects, and on vulnerable subpopulations, such as the developing fetuses of local pregnant women.
Case Study: A client was concerned that a drinking water dispenser at one of its offices might be contaminated and that its staff put at risk. Intertox conducted a water sampling program to test water for 107 chemicals and 3 biological agents. Based on the results, Intertox identified 27 chemicals of interest (COIs) and performed a toxicological risk assessment on the COIs for cancer and non-cancer endpoints. Our assessment clarified and explained potential risks to staff due to contamination, allowing our client to take mitigating steps.
- Conduct farm-to-table food contaminant risk assessments along with remedial consultation
- Work with risk managers and corporate counsel to develop risk strategies, along with EHS education and training programs
- Conduct chemical safety assessments/audits
- Develop chemical safety programs that meet regulatory requirements
Intertox works with utilities to define and manage potential risks caused by an array of chemicals found in water supply systems. We help utilities decide what to track and how to do it, set acceptable exposures levels, and report findings to the proper agencies and the public.
Intertox has helped utilities protect and improve drinking water for more than 15 years. We partner with utilities to create dynamic ways to track ongoing potential risks. Clients turn to us to develop top-flight Environmental Health and Safety programs. And when there is something that must be reported, we help our clients find the best ways to tell it to the key agencies and the public. Moreover, we’ve done pioneering work in the study of endocrine disrupting chemicals in drinking water, and are at the forefront in setting acceptable daily intakes relating to contaminants of emerging concern.
From the treatment plant to the faucet, Intertox staff are experts in evaluating whether chemicals pose risks to human health. We are known for our scientific rigor, creative use of visuals, and clear presentation of facts.
Case Study: Intertox has helped school systems learn if lead in their drinking water posed a risk to their staff and students. We used computer modeling to predict blood lead levels resulting from past and current exposures. When called for, we gave focus to those groups who might be more at risk. When risks were identified, we helped schools clearly and factually explain the issue to parents.
Case Study: A water district asked Intertox to use visuals on the district’s website to show contamination data in a way that would be easy for a lay person to grasp. Intertox developed a simple graphic that showed what contaminants were found, and in what quantity. The public could easily compare the maximum amounts found against Accepted Daily Intakes (ADI’s), levels considered safe by regulators. Intertox updated the graphic based on new quarterly data as it became available. Finally, Intertox created a brochure and other materials that taught district customers how monitoring data are gathered and interpreted.
- Identify chemicals to monitor
- Compute acceptable exposure levels
- Develop the right laboratory approach
- Provide results to the public and government
Manufacturing and Construction
Manufacturing and building trades are under greater safety scrutiny today than ever before. We are all more keenly aware that manufacturing and construction materials can pose a risk to human health. And the risk is not limited to those who make the products. It extends to anyone who might use a product or visit a building.
Over the past two decades, Intertox has worked with a wide range of manufacturing and construction clients. Our clients range from wood treatment facilities to thermoplastic extrusion plants. We have taken on projects for trade associations and construction companies. The industry turns to us because our experts know how to assess how chemical and biological agents might affect human health.
We know how to design protocols that comply with state, federal, and international standards, such as ADIs (Acceptable Daily Intakes). We also develop state-of-the-science Environmental Health and Safety (EHS) programs that review the risks of chemicals that are already being used, or are in the pipeline to be used in the future. Our work can include site or facility testing.
Case Study: A client came to Intertox worried that materials they were using might present a risk of potentially harmful fungus. We designed and conducted a sampling program. Our testing looked for both fungal spores and hyphal fragments. Analyses included both direct microscopy to identify any fungal spores to the genus level, as well as culture of viable samples. With our report in hand, the client could modify its protocols to avoid risk.
Case Study: Intertox evaluated the potential health impact of cutting fluids used when making aircraft. Workers worried that the fluids might be harmful. We reviewed exposure data and conducted a detailed toxicological assessment of the cutting fluids, their constituents, and their use in the workplace. At our client’s request, we summarized the results of this research to convey key facts about safety and risk to workers.
- Conduct exposure assessments/audits for facility design and permitting
- Develop chemical safety programs to meet regulatory requirements
- Serve as expert witness/ consulting expert in workers compensation claims
- Develop EHS training programs for staff
Medical Device Regulatory Services
Intertox helps clients comply with FDA rules through all phases of developing new medical products and bringing them to market. Our A to Z services include strategy, planning and, when needed, oversight to ensure that the medical product meets or surpasses what the FDA requires of it. We also provide marketing, authorization and product life cycle management programs.
Clients often ask us to help them with the various stages to develop:
- Medical devices,
- In vitro diagnostics,
- Companion diagnostics,
- Pharmaceuticals, and
- Combination products.
Intertox helps clients with regulatory approval through all stages of product development. Among our services are:
- Strategic Planning – We help clients build a plan to win FDA approval, including Chemistry Manufacturing and Controls and non-clinical and clinical programs.
- FDA Liaison – At times, clients need us to serve as a direct liaison with the FDA or to provide guidance to coordinate Prescription Drug User Fee Act meetings.
- Non-clinical Regulatory Support – Clients needing investigational new drug applications turn to us. We conduct toxicity studies, associated non-clinical safety studies and biological activity programs.
- Clinical Regulatory Support – We design and stage clinical trials to show safety, proof-of-concept and efficacy in order to win approval to begin sales.
Getting to Market
Once a product is ready to be submitted to the FDA, we offer services to help them at every step, including:
- Regulatory Submission – Our team prepares documents that comply with Common Technical Documents (CTD) requirements, including electronic CTD submission.
- Prior Approval Inspections – We help clients prepare for and be part of FDA prior approval reviews. When the FDA orders changes, we guide the client through the process and what it must do.
- Labeling Negotiations – We help clients through the each step to win approvals for product labeling, advertising and promotional materials.
Our work with clients continue after the product has been launched. We provide services in two key areas:
- Post-approval commitments – Once a product has won FDA approval, we help maintain compliance, including CMC and Phase IV Clinical Trials.
- Post approval supplements – When changes come after approval, we step in to help manage the process
Global Regulatory Support
We help our clients take their products global. We also work with foreign companies who need regulatory help in the US.
- International registration dossiers – We help clients take their products global. We work with them to develop and submit materials to gain international regulatory marketing authorizations.
- FDA Agent – Foreign clients sometimes ask us to act as a U.S. Regulatory Designated Agent. As such, we serve as a direct liaison with the FDA. In that role, we also manage and submit key documents.
Nanotechnology presents a new set of chemical risks that requires analysis, study, and regulatory oversight. Millions of tons of nano-scale material are made each year, and the increasing number of new nanomaterials developed each year is staggering. With them come new barriers for risk assessment. Intertox scientists are skilled at helping clients identify potential risks in this special class of products. Our managing director, Dr. Richard C. Pleus, is known for his ground-breaking work on how to assess risk in this quickly evolving field.
We guide clients through a process to find ways to test and analyze how they plan to use nanomaterials, and how doing so may affect workers, customers, and the environment. As our clients adopt nanotechnology, they often need to update their corporate policies. When that’s the case, we help draft and revise them according to global standards. And because nanomaterial development is at the cutting edge, many nano-products fall outside existing rules for safety. When that’s the case, we help clients set science-based standards and work with them to win regulatory approval through science-derived data.
Intertox is a global leader in the Environmental Health and Safety community’s research into nanotechnology risk assessment. Dr. Pleus led the U.S. ISO/TC 229 Working Group 3 to set physical and chemical parameters of engineered nano-objects relevant for toxicological assessment. Dr. Pleus works with leading laboratories around the world to transform those insights into in silico testing techniques. Those methods can be used to predict nanomaterial risk at lesser cost than traditional testing. He is currently a co-editor of a scientific textbook on physico-chemical properties of nanomaterials. With Dr. Pleus’ research in hand, Intertox has developed groundbreaking systems that use the best scientific data to evaluate engineered nanomaterial risks.
Case Study: A global insurance company asked that Intertox help develop a way to include risk assessments of nanomaterials into how it would evaluate insurance applications. Intertox designed, developed and deployed an in silico model that the insurer could use to predict nano-risk. The model blends scientific data with information specific to a product to create health risk reports. Underwriters proceeded to review those reports as part of their product appraisals.
Case Study: A client needed to know if its workers were being exposed to airborne nanoparticles, and, if so, whether there was a risk to the workers’ health. Part of the client’s process was to sand or grind composite materials that contained carbon nanotubules. Intertox evaluated potential exposure through inhalation, ingestion, and dermal routes.
- Develop human-health risk assessment programs for new nanomaterials
- Help draft corporate policy for the use and adoption of nanomaterials
- Conduct exposure assessments and audits to compare to international or national standards
- Develop custom EHS training programs
- Identify physico-chemical properties of new materials