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Product Stewardship Services

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Comprehensive Product Stewardship Solutions for Health,
Environment, and Sustainability

In the dynamic world of product stewardship, we deliver insights and strategies to support industry sectors—such as apparel, cosmetics, food, chemical, petroleum, and pesticides—across all phases of a product’s life cycle. We work collaboratively with our clients to determine the health, safety, and environmental profile of products and communicate this information to customers and other stakeholders.

REGULATORY COMPLIANCE

Integral can help when you hit barriers with registration dossiers, are challenged by competent authorities on marketed ingredients, need guidance on reporting, labeling, and sales restrictions across jurisdictions, or wish to submit comments on proposed rulemakings. Our scientists have national and international experience working with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), state regulatory agencies, European Chemicals Agency (ECHA), European Medicines Agency (EMA), and Swissmedic.

We are well-versed in the intricacies of regulations such as California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and the work of committees such as the European Commission’s Scientific Committee on Consumer Safety (SCCS). Our scientific expertise will help ensure that your products are compliant and safe, their continued use is supported, and that safe new products can be introduced to the market without unnecessary delays.

Pharmaceuticals | Cosmetics | Cleaning Products | Human Health | Environmental Safety

Heather Lynch, MPH, DABT

Kristian Fried, Ph.D., Dr. rer. nat., DABT, ERT

ENVIRONMENTAL SAFETY

Consumers, shareholders, and regulators increasingly focus on environmental safety, such as down-the-drain impacts of products and pharmaceuticals. A product’s safety is no longer just about the safety of its intended use; it’s also about environmental footprint it may leave. Product ingredients inevitably enter wastewater, surface water, groundwater, air, or soil, and their effects on the environment depend greatly on mobility and migration pathways, persistence, or transformations and interactions, exposure, uptake by organisms, and toxicity. We can help you understand and prioritize potential risks by modeling exposure concentrations, identifying sensitive species, and deriving predicted no-effect concentrations (PNECs).

When multiple ingredients or products require environmental assessment, we apply fast and reliable tools to screen for risks and prioritize ingredients for further assessment. Our data scientists, toxicologists, and chemists collaborate to assess large volumes of products and ingredients for environmental fate and effects. This approach to streamlining assessments makes it easy for you to prioritize products and ingredients.

Ecotoxicity | Wastewater | Environmental Receptors

Morgan Willming, Ph.D., DABT

Annaleise Conway

ENVIRONMENTAL FATE

Our assessments can inform business decision-making, whether a release is accidental, permitted during manufacturing, or occurs at the end of a product’s life cycle. Clear documentation and written environmental safety and fate assessments for drugs, chemicals, and product ingredients are critical to regulatory compliance and a successful discourse with competent authorities, advocacy groups, and the news media. We evaluate environmental concerns such as ecotoxicity and persistence to help mitigate adverse environmental impacts. We can customize testing approaches to address your products’ properties and predict environmental behavior in benchtop tests. We also model occurrence in surface waters to predict environmental concentrations after release and close the loop on environmental safety by comparing that data to PNECs.

Biodegradation | Bioaccumulation | Risk Quotient

Dan Dawson, Ph.D.

Morgan Willming, Ph.D., DABT

PRODUCT SAFETY ASSESSMENTS

Responsible companies care deeply about the safety of their products and ingredients. In addition to the obvious concerns for human health, safety concerns can translate to product recalls, reputational risk, and business and legal issues. Whether the driver is occupational health and safety, consumer health, or patient health (human and veterinary), our bespoke solutions facilitate seamless integration of the safety assessments into internal document management systems and regulatory submissions. Whether you need safety substantiation to employ safer chemistries or for compliance with the Modernization of Cosmetics Regulation Act (MoCRA), the European Union Regulation on Cosmetic Products, or other regulatory drivers, we can help you bring safe products to global markets.

Margin of Safety | SCCS Notes of Guidance | Risk Assessment | Biocompatibility | Medical Devices

Kristian Fried, Ph.D., Dr. rer. nat., DABT, ERT

Ernest Fung, Ph.D., DABT

PRODUCT VULNERABILITY ASSESSMENTS

Even when companies do everything right with respect to regulatory compliance, bringing a new product to market introduces business risk. Existing key technologies that have been providing critical consumer benefits and a competitive edge may be questioned. We help you identify and mitigate business risks posed by your products now and in the future. We focus on product risks posed by evolving regulatory landscapes, retailer sustainability policies, shareholder activism, and public relations trends. Anticipating such challenges allows you to make wise investments in ingredient defense and research and development projects that can help keep your products on the market.

Sustainability | Advocacy | Reformulation

Heather Lynch, MPH, DABT

Claire M. Hamaji, MPH

STUDY DESIGN AND OVERSIGHT

There is a lot on the line when companies contract studies on their products and ingredients. Whether chemicals are well established or of emerging concern, ingredients must pass rigorous testing before entering the market. Integral’s scientists understand what is at stake. We design customized approaches to in silico modeling, in vitro testing or new approach methods, as well as biodegradability, environmental fate, ecotoxicity, nonclinical, and clinical studies. We can support you in designing and executing the right study for the right reasons to cost-effectively ensure compliance and safety and support marketing claims.

Organisation for Economic Co-operation and Development (OECD) Test Guidelines | Irritation, Sensitization, Genotoxicity, Acute Toxicity | Aquatic and Mammalian

Kristian Fried, Ph.D., Dr. rer. nat., DABT, ERT

Elizabeth Hofstetter

ASSESSMENTS ALONG THE LIFE CYCLE

Understanding the environmental impacts of each phase of a product’s life cycle is not always a simple matter. Because different phases interact with one another, holistic considerations are critical. Integral supports safety and compliance in all phases of a product’s life cycle and addresses competing challenges as they arise. From impurities in your supply chain to documentation of strategies, we identify potential hazards and design solutions every step of the way.

Raw Materials | Production | End of Life

M. Andrew Maier, Ph.D., CIH, DABT, Fellow AIHA

Heather Lynch, MPH, DABT

LITIGATION SUPPORT AND PRODUCT DEFENSE

You have invested time and money into the sustainability and safety of the products you sell, but they nonetheless may be subject to litigation risk. You want your products in the marketplace and we want to provide the scientific defense to keep them there. When a dispute arises, Integral’s highly experienced and credentialed experts form opinions, write reports, and testify in depositions, affidavits, and trials. We will work with you to provide robust, sound, and clearly communicated arguments to defend the science.

Defendant | Plaintiff | Communication

M. Andrew Maier, Ph.D., CIH, DABT, Fellow AIHA

Ernest Fung, Ph.D., DABT

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