Pressure Points
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 that 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
with conventional methods envisioned to improve the understanding
or toxicodynamic knowledge for substances with methods
such as read-across methods. Or more succinctly, NAMs is
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
led to additional testing requirements and
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
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 that
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
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.
(HCPA) has made it a focal point to promote NAMs and
collaborated
with other stakeholders towards our common
others. Just last month at HCPA’s Annual
Meeting, we brought together experts from
EPA, industry and animal health advocates
to detail the latest opportunities and
promote NAMs.
While I remain hopeful for Mr.
Spock’s tricorder, I look forward to the
advancement of NAMs in the future.
If you would like to learn more about
NAMs, please contact me at:
org. Spray
Good Morning, Let’s talk NAMs!
10 Spray January 2019
Steven Bennett, PhD
Senior VP, Scientific Affairs, HCPA
high-throughput screening and high-content methods, along
of toxic effects through improved toxicokinetic
a broad, encompassing term that captures many different
ingredi-
(GHS) requirements that have unfortunately
has largely been the impetus for alternatives.
dients passed the California Cruelty-Free Cosmetics Act,
chain is ready to answer such questions. Even if you can’t certify
The Household & Commercial Products Association
minimize the use of animal testing. HCPA has collabo
rated goal and has hosted joint programs to educate
challenges to minimize animal testing and
broader utilization, acceptance and
sbennett@thehcpa.org