People, Product, Planet

When AIHA founded the Product Stewardship Society in 2012, it sought to create a home for a growing, underserved group of professionals. Over the last seven years, product stewardship has become an increasingly viable career path for industrial hygienists and other professionals engaged in sustainability as well as occupational and environmental health and safety. To get a sense of the ways IH, sustainability, and product stewardship intersect, The Synergist interviewed three professionals with experience in each of these vocations:

Mitch Fonda is the director of Global Trade and Stewardship for Waters Corporation in Golden, Colo. He is a frequent presenter at the Product Stewardship Society’s annual conference.
Kevin Gara, CIH, FAIHA, is based in Indianapolis and serves as chief product steward officer for the Roche Group’s corporate EHS department. Roche is a leading provider of medicines and in vitro diagnostics. Gara is a former director of AIHA and incoming director of the Product Stewardship Society.
John Hott, PhD, is the director of Global Product Stewardship and Regulatory Affairs for Eastman Chemical Company in Kingsport, Tenn. He serves on the Product Stewardship Society’s Board of Directors.

The following excerpts are edited transcripts of interviews conducted in July 2019.

WHAT WERE THE MAIN EVENTS IN YOUR CAREER THAT LED YOU FROM ONE CAREER STAGE TO ANOTHER? HOTT: I’ve always been fascinated with learning new things. I was a chemist who made the leap from a role in manufacturing to a role in R&D. When I was approached with an environmental health and safety challenge, I read the regulations and became an internal advocate for making changes to our hazard communication plan, which led me to a future role in EHS and then on to regulatory affairs. In a way, when I look back at my career, it is a blur as to when I became a “product steward.” That is because, in the regulatory arena, it is a relatively new term and it means different things to different people. If I had to pinpoint a time, it would be somewhere between the transition between EHS and regulatory affairs (although EHS functions in many companies encompass both areas).

GARA: When I was looking to get into college, I thought I might want to be a physician. And then I looked at a ten-year educational path, and I didn’t want to invest that much time before knowing if that’s what I really wanted to do. The industrial hygiene field was entering a period of rapid growth. This was back in 1976. Quinnipiac College, which is now Quinnipiac University, had just launched the first bachelor of science industrial hygiene program in the country. I applied and was accepted. I saw it as working in the medical health profession. Rather than just helping people who are sick, I thought, this is a great way to keep people from getting sick. One of my professors left the college to work for a pharma company, and he needed a couple of students to do some technical work—air sampling and analysis, dust sampling, and noise profiling at one of his plants in Puerto Rico. He hired me and my college IH buddy, Jon Nelson, to do it. That’s how I got my start in the pharma industry: as an intern. Some years later I joined the diagnostics division at Roche, and for ten years worked in Indianapolis as the site safety, health, and environmental officer. This was Roche’s diagnostics headquarters for North America, so it’s a pretty big operation and we had a very dedicated and talented team. Roche puts a strong emphasis on sustainability and, as a company, has been named the most sustainable healthcare company in the Dow Jones Sustainability Indices for ten years in a row. I found that Roche has a way of integrating sustainability principles into the business that really works to deliver results. I also saw that we got a lot of questions about our products. And sometimes I would wonder, why did we do the packaging a certain way, or how could sustainability principles be better applied in the product realm? Three years ago I joined the corporate team for EHS and they asked me if I would be interested in taking on product stewardship full-time. This seemed like a great opportunity to influence the global organization to bring EHS principles more fully into our products, so I said yes. FONDA: I have an undergraduate degree in chemistry from Rochester Institute of Technology and wound up working at Eastman Kodak in the R&D section. It turned into a technician job. I wanted to make a bigger impact, so I went from a technician to a process chemist. And then my department turned the Genesee River a bright green one day, and I was told by the director of manufacturing, “Never let this happen again.” And that’s how I got into environmental work with Kodak’s environmental health and safety organization. I met one of the two directors of EHS, and he and I struck a deal that I would become an industrial hygienist and work in his organization if he would fund my master’s degree in industrial hygiene. I got my master’s from the University of Rochester School of Medicine and Dentistry and became an industrial hygienist. A month and a half after my thesis defense, I was sitting in California as EHS manager for Kodak’s California operations. The satisfaction I got there was from being able to change the way the company operates for the better. Soon I understood that the quality organization is just like the EHS organization: quality prevents the defects in products, and EHS prevents the defects in people and the environment. And there can be a balance between that and what business needs to do. After successive downswings at Kodak, I worked for an EHS management consulting firm out of California. Then I had the opportunity to work for Novartis, and then on to Millipore in Massachusetts, where I became the director of EHS. I worked on a huge project for sustainability. We were trying to take a look at how you run a profitable business and also reduce the impact of the company. How do you get that balance? My family and I made a decision to move to Colorado. In the meantime I got a job in product development at Waters, and people started asking me, based on my EHS background, “What about the Globally Harmonized System? What about the Restriction of Hazardous Substances directives? What about REACH?” I had suggested that we form a product stewardship group. We decided the focus areas would be GHS, ROHS, and chemical registration, and we started to expand from there. Along the way someone asked me, “Since you’re doing so well at product stewardship, why don’t you take on compliance?” My epiphany was that business is all about trade and meeting requirements. We have all these products that meet all these requirements around the world. In product stewardship, we facilitate trade. We make seamless borders. We do that by abiding by all these rules and regulations and requirements. If you do that, it’s good for business, it’s good for the environment, and it’s good for human health.

WHAT ARE THE MOST IMPORTANT ISSUES FACING PRODUCT STEWARDS TODAY? HOTT: First, staying abreast of the changes in regulations and trends, especially those affecting your customers’ use of your company’s products. These changes are happening on a more frequent basis, and it’s becoming more and more complicated. Second, understanding all of your customers’ needs—for example, do they need a product that is less toxic, better for the environment, less expensive—and knowing the tradeoffs they are willing to make. And third is staying healthy, not burning out, and keeping your calm. So much is coming at you, and there will always be a “fire” of the day. Many times we take an issue personally, because we care so deeply about what we do. In the end, how we address problems is what defines us, so let’s make it a positive journey. Companies are constantly challenged to do more with less. This is no different for product stewardship functions. With regulations changing and becoming more complicated, coupled with the success of product stewardship in being viewed internally as a necessary and desired function, we must build the case to add additional resources. This is not an easy task, especially in challenging economic years. We have to show the monetary value of what the additional resources would bring to the company—and conversely, what the company would lose if they don’t add resources. Once you have trust from your organization, it becomes easier to make the case for more resources.

“Circular design offers the chance to get maximum value from the materials we use and reduce the negative impacts associated with linear material flows.”

GARA: First would be transparency. More and more, people want to know what’s in the things they buy, how to use them safely, and how to dispose of them properly. There are different levels of transparency. Our company strives for the highest level of transparency, full material declaration, or as full as practical. If we know what’s in an article that we buy to include in our product, and if there’s a standardized way to access that information, we can make choices that result in safer, more environmentally friendly products. This information also enables us to be more efficient at regulatory compliance and provide greater transparency to our stakeholders, including patients and others who want to know what’s in our products and packaging. The next issue is proliferation of product-related health, safety, and environmental regulations. You’ll have a regulation or legislation in one country or one economic area, and then people in another country want to develop their own. It takes a lot of effort for a product steward to stay current on regulations and legislation around the world. Is it relevant to the product we’re making? And if it is, what do we need to do about that? And if you address the compliance issue in one jurisdiction, how do you adapt your approach to deal with similar, but not identical, regulations that pop up in other jurisdictions? Product stewards help businesses navigate this complex regulatory landscape and succeed by avoiding regulatory roadblocks. As a company, compliance for us is the bare minimum. We’re really interested in going beyond compliance. We’re asking questions like, “How do we make products that are truly safer for people and better for the environment?” Different techniques can be used. For example, a product steward may use a lifecycle analysis to look holistically at the potential impacts of that product, and use that analysis to design the product to minimize those impacts. They may also conduct a human health risk assessment. Or they may bring value by applying traditional IH principles for risk reduction—hazard elimination, substitution, and engineering controls. Another topic gaining momentum is circularity of material flows. The old way of doing things can be described as “take-make-waste.” It represents a linear material flow. You pull the resources out of the ground, use a bunch of energy, water, and chemicals to make something, people use it, and then they throw it in the landfill or it gets incinerated. The idea behind circularity is to design products in ways that allow valuable materials to be reused multiple times, either in something resembling the original product, or as raw material for a different type of product. Circular design is not possible for medicines and diagnostic reagents because they are consumed during use, but there are possibilities for ancillary components such as packaging and certain parts of diagnostic instruments. Circular design offers the chance to get maximum value from the materials we use and reduce the negative impacts associated with linear material flows. FONDA: The first issue is to understand how the world is changing. It’s not just the number of regulations, it’s the rate of implementation of the regulations that’s also increasing. If you’re in a growing company, those two things are going to bump up against each other. Take a look at the United States: every couple weeks you see something new with the Toxic Substances Control Act. You look at the European Union directives—we’re on ROHS 3 now. REACH changes every six months or so. How do you find all the information that’s applicable? How do you digest all the information, and then how do you tactically apply that to the business you’re responsible for? The second biggest issue is, how do we get the business to listen? How do I prove the business case for product stewardship? How do I be viewed as a business partner rather than as the business prevention department? And the third issue is that product stewardship is going to change with artificial intelligence. For example, at Waters we maintain over a quarter of a million safety data sheets in 21 different languages and 13 or 14 different country formats. And we do that with one person, part time. We don’t have a toxicologist on hand. We don’t have technical writers on hand. We use an outsourced service that uses algorithms to generate our safety data sheets for us. We upload data in a simple spreadsheet, and we get a safety data sheet out the other side. We do a quality check, and then ask them to put it in these formats for these languages, and it’s done automatically. That’s a taste of where our jobs our going. Companies are looking at toxicology extrapolation methodologies for new chemicals, and that’s all through algorithms. So, who do we need to have on our staffs? What we did five years ago is not going to work five years from now.

HOW ARE INDUSTRIAL HYGIENE, SUSTAINABILITY, AND PRODUCT STEWARDSHIP RELATED, AND HOW ARE THEY DIFFERENT?

HOTT: All three areas overlap, as they are each based on science. For example, the same toxicological endpoint might be used by all three areas, yet in different ways. IH uses it to make sure the employee population is protected. Product stewardship uses the same data to make governmental submittals and to make sure downstream users are protected. And EHS might use the same information for air and water regulations covering a facility. Within Eastman, these three areas are all within the same department, yet we reside in separate groups (that work very well together). GARA: To me, sustainability is about protecting people, the planet, and economic prosperity. And product stewardship is about applying EHS principles to our products, taking into account the entire product lifecycle, and improving products in all three dimensions of sustainability. Sustainability and stewardship are very closely related. They’re like different sides of the same coin. And here’s where the IH piece comes in, because our problem-solving paradigm of anticipate, recognize, evaluate, and control works well in both sustainability and stewardship. I like to say that I put on my sustainability lenses to see a sustainability problem clearly, but I use my IH skills to solve it. The same is true for product stewardship. I use a different set of lenses but the same IH skills to solve stewardship problems. FONDA: Industrial hygiene is protecting the worker from the workplace, from physical and chemical impacts. Sustainability looks at how to protect the environment from the same things. And product stewardship is looking at the lifecycle of the end product. You would think at the outset that they are not related, but they are intertwined because all are impacted by the supply chain: what you buy, where you buy it, how you use it, how you manufacture it. All three are intimately tied to that product lifecycle. You cannot take one out of the equation. And if you only think of one, you’re missing huge opportunities to do good in helping achieve the balance between the business and the impact on human health and the environment. MITCH FONDA is the director of Global Trade and Stewardship for Waters Corporation in Golden, Colo. KEVIN GARA, CIH, FAIHA, is the chief product stewardship officer for the Roche Group’s corporate EHS department.

JOHN HOTT, PhD, is the director of Global Product Stewardship and Regulatory Affairs for Eastman Chemical Company in Kingsport, Tenn.

ED RUTKOWSKI is editor in chief of The Synergist. Send feedback to The Synergist.

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“Whiteboard” Animation Connects IH, Product Stewardship, and Sustainability

A new animation created by AIHA and released this month encourages industrial hygienists to explore the possibility of expanding their professional roles to encompass product stewardship and sustainability. The animation uses the popular “whiteboard” video style, which depicts the drawing of static images on the screen. During the animation, an artist’s hand sketches a series of images depicting an industrial hygienist using her IH skills to contribute to product stewardship and sustainability. “Through the product stewardship and sustainability lenses,” a narrator says, “the IH can help an organization increase transparency and develop, deliver, and use products in a manner that minimizes the negative impacts on the workers who make the products, the people who use the products, and the communities in which the products are finally disposed.” The animation is the brainchild of AIHA’s Stewardship and Sustainability Committee. A team led by committee member Paul Harper developed the concept, wrote the script, and worked with a vendor to create the final video. The animation encourages IHs interested in becoming involved in product stewardship and sustainability to consider joining AIHA’s Stewardship and Sustainability Committee as well as the Product Stewardship Society. For more information, visit AIHA's volunteer groups page and www.productstewards.org.

The Confluence of Industrial Hygiene, Product Stewardship, and Sustainability

BY ED RUTKOWSKI

An Interview with Mitch Fonda, Kevin Gara, and John Hott

People, Product, Planet

the Synergist