January 2019

Good Morning, Let’s talk NAMs!

I remember watching Mr. Spock on Star Trek glancing down at his tricorder and providing a near instantaneous analysis of environment and hazards, all while having no impacts on the indigenous inhabitants of a newly discovered planet. Wouldn’t it be nice if we all had one of these devices as an alternative to animal testing or in the current vernacular, New Approach Methodologies (NAMs)?

I know what you are thinking, “Why should I care? I don’t currently test my products on animals.” Unfortunately, it’s not that simple. Animal research has had a vital role for science. Many areas of science depend on the use of animal testing, such as medical and biological research, and there are regulatory drivers such as getting new chemicals to market or ensuring pesticidal products meet public health requirements which are used by the household and commercial products industry. Certain products are required to have animal testing performed before a product can enter the market—both in the U.S. and overseas.

There has long been interest in reducing requirements for animal testing for a variety of reasons, including animal welfare, reducing variability to increase reliability, lowered use of resources, and more recently, regulatory requirements to reduce reliance upon or ban animal testing. There has also been significant global strategic direction to reduce animal testing, mainly led by Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the Organisation for Economic Co-operation & Development (OECD), whose collective embrace of 21st century approaches are beginning to show benefits.

You may be asking yourself, “What exactly are these NAMs?” Unfortunately, it’s not that simple to explain. NAMs include in silico approaches, in chemico and in vitro assays, as well as the incorporation of chemical exposure information to refine hazard or risk assessment. This includes a variety of new testing tools, such as high-throughput screening and high-content methods, along with conventional methods envisioned to improve the understanding of toxic effects through improved toxicokinetic or toxicodynamic knowledge for substances with methods such as read-across methods. Or more succinctly, NAMs is a broad encompassing term that captures many different methods for evaluating toxicity and sensitization of ingredients or products.

Many have long grappled with Europe’s Registration, Evaluation, Authorisation & Restriction of Chemicals (REACh) and the Globally Harmonized System of Classification & Labeling of Chemicals (GHS) requirements that have unfortunately led to additional testing requirements and has largely been the impetus for alternatives. However, policymakers and government agencies have recently passed laws and created regulations to drive the transition.

Since 2013, all member countries of the European Union have banned the testing of cosmetic products and individual ingredients on animals. More recently, California passed the California Cruelty-Free Cosmetics Act, which prohibits manufacturers to “import for profit, sell, or offer for sale” any cosmetic product that was developed or made using an animal test, if the test occurs after the law takes effect on Jan. 1, 2020. While these are certainly success stories for advocates against the use of animal testing, China currently has cosmetic testing laws which require all foreign cosmetic products to be tested on animals before they can be sold in the country.

While we have not yet seen similar laws and regulations banning the use of animal testing on household and commercial products, there have long been efforts to avoid unnecessary use of time and resources, data generation costs and animal testing to the extent possible. More recently, the revised Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to develop a list of alternative test methods or strategies that are scientifically reliable, relevant and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing. Products registered under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) must similarly ensure there is sufficient information to reliably support registration decisions that are protective of public health and the environment. However, significant efforts are under way to minimize animal testing and expand acceptance of alternative methods. For example, EPA now allows the bridging of data to better utilize previously generated data, and earlier this year announced a draft policy to accept alternative approaches for identifying skin sensitization hazard.

Even if policymakers and government agencies don’t extend the outright ban of animal testing to household and commercial products, companies may be asked to certify that their products and the ingredients used in those products were not tested on animals. There are many non-governmental organizations (NGOs) that are pushing to ban all animal testing outright, so you should know if your supply chain is ready to answer such questions. Even if you can’t certify your ingredients today, because many chemical suppliers sell into the personal care, household, commercial and industrial markets, you might be able to tomorrow, so it is critical to have open communication throughout your supply chain.

The Household & Commercial Products Association (HCPA) has made it a focal point to promote NAMs and minimize the use of animal testing. HCPA has collaborated with other stakeholders towards our common goal and has hosted joint programs to educate others. Just this last month at HCPA’s Annual Meeting, we brought together experts from EPA, industry and animal health advocates to detail the latest opportunities and challenges to minimize animal testing and promote NAMs.

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While I remain hopeful for Mr. Spock’s tricorder, I look forward to the broader utilization, acceptance and advancement of NAMs in the future. If you would like to learn more about NAMs, please contact me at [email protected].    SPRAY