The Future of Animal Testing in the USA Depends on YOU!

Two proposed US laws have been big on our radar lately. One, the Humane Cosmetics Act (HCA), would ban animal testing of cosmetics in the US, similar to bans already in effect in the European Union and other countries. The other, the Safe Cosmetics and Personal Care Products Act (SCPCPA), would dramatically increase animal testing of cosmetics, making it impossible for cruelty-free brands to exist or be sold in the US.

It’s clear what the different approaches mean for animals, but what do they mean for consumer safety? It helps to first have a little background on today’s safety testing.

How are ingredients tested for safety now?

Ingredients usually undergo a basic “six-pack” of safety tests, which today are almost always done without using animals (thanks to the EU’s ban on animal testing for this!):
– Eye irritation
– Skin irritation
– Skin sensitization (potential to trigger an allergic reaction)
– Acute toxicity (from a single dose – this is the single dose that produces a toxic effect)
– Skin penetration
– Genotoxicity (potential for an ingredient to cause changes to our genes)

The first four tests evaluate short-term effects that are the usual concerns for cosmetics. The last two, skin penetration and genotoxicity, are used both to provide that specific information and also to screen for potential long-term, systemic effects. When you hear about endocrine disruptors and carcinogens, these are all in the group of potential systemic effects.

If an ingredient tests positive for genotoxicity (indicating a potential problem), it usually is dropped immediately as an ingredient. Only rarely would such an ingredient get further considered, and then only if a full carcinogenicity test were available. A carcinogenicity test might be available, for instance, if the ingredient was developed by the drug industry, which routinely conducts such tests.

The skin penetration test is a more general screening tool. If an ingredient penetrates skin significantly, then the ingredient is examined for its potential for biological or chemical activity. When you think about it, it makes sense: an ingredient can’t affect your system unless it can both penetrate into your system and also have the ability to react with your system.

If an ingredient both penetrates and is active, then it typically undergoes further tests, called repeated-dose tests, for potential systemic toxicity. About 2% of cosmetics ingredients fall into this category. This is where the animal testing comes in today.

Repeated-dose tests are always animal tests, and the animals are always killed at the end and autopsied to examine their organs for any systemic effects. The tests are called repeated-dose because the animals receive a dose each day for the length of the test. The most common tests are the 28 day, the 90 day, and the prenatal developmental toxicity test. In the prenatal test, pregnant animals are dosed daily throughout their pregnancy and then killed immediately before delivery, and the mothers and babies are autopsied. Typically, a 90-day test and prenatal developmental toxicity test might be done, the first to assess general systemic toxicity and the second to look at potential toxicity during early development.

This tiered strategy, where substances are first screened for potential concerns and then only those of potential concern have the more animal-intensive tests, has been standard for many years. Before that, the same rote checklist of tests tended to be used for all substances. A landmark paper, called Toxicity Testing in the 21st Century, A Vision and a Strategy (National Research Council, 2007), affirmed the tiered strategy and, noting the limits of animal methods, recommended new non-animal methods based on human biology and advanced computational biology. Major US and EU agencies are working to develop these, but alternatives to repeated-dose tests are especially hard to develop and are about 10 years away.

With this backdrop, let’s look at both the SCPCPA and HCA and how they would change this.

How would safety testing change under the SCPCPA?

First, the SCPCPA would go back to the old checklist approach. It scraps screening ingredients to see if they are potentially concerning and instead requires the same level of safety evaluations for all ingredients. The SCPCPA’s authors don’t give the reason, but likely it’s the precautionary principle, which basically holds that, if you don’t have complete information, you assume the worst case. This isn’t unusual: the EU uses the precautionary principle in its cosmetics legislation, too. Unlike the SCPCPA, though, the EU bans animal testing to achieve it and embraces the tiered screening/testing approach.

Second, the SCPCPA requires that a No Observed Adverse Effect Level (NOAEL) be determined for every ingredient. The NOAEL has a specific toxicological meaning, and it can be derived only through a repeated-dose test, typically the 90-day test. The SCPCPA also could require the prenatal developmental toxicity test. Remember that only 2% of ingredients probably have these tests now. That means about 98% of existing ingredients – those least likely to be a problem – would need new repeated-dose tests under the SCPCPA. With over 20,000+ known ingredients, 80 animals/test for the 90-day test, and 750 animals/test for the prenatal test, you can see how the animal numbers quickly add up. This would be one of the most profound differences under the SCPCPA – it would dramatically increase animal testing.

Would this provide greater safety for consumers? Maybe, but likely by only a small amount. On the one hand, some potential problem ingredients may slip through the screening tests of today. On the other hand, the SCPCPA’s animal tests are poor predictors of human response, so problem ingredients could slip through those, too. In drug testing, for example, most drugs that successfully undergo animal tests must be withdrawn from the market because of human responses the animal tests didn’t detect.
How would safety testing change under the HCA?

The HCA has just one requirement: It bans animal testing of cosmetics. It doesn’t address any other aspect of cosmetic safety testing. Under the HCA, repeated-dose animal tests would be banned for cosmetics.

How would ingredients that penetrate skin be assessed for systemic safety then? For existing ingredients, it wouldn’t be an issue, because those that penetrate skin and are active have likely already undergone such testing. For new ingredients, new methods will soon be available for determining the absence of toxicological concern, which should allow companies to evaluate the safety of new ingredients (and any existing ingredients of concern) without the use of animals.

This is a key difference between the HCA and the SCPCPA. The HCA would require the use of such non-animal methods. The SCPCPA would require the use of animal methods, because it requires the No Observed Adverse Effect Level to be determined for each ingredient; and that particular level requires a repeated-dose animal test. The new methods available soon won’t change that. By requiring the No Observed Adverse Effect Level, the SCPCPA locks the US into animal testing until replacements for repeated-dose tests are available, about 10 more years.

What YOU can do!

Fight to save these animals! Ask your US Representative to support the Humane Cosmetics Act and oppose the Safe Cosmetics and Personal Care Products Act. They pay most attention to letters, so if you write even a short 3-sentence email letter, that will have a big impact. You can find your representative’s email address at bunnyarmy.org, a web site developed by small-animal rescue groups to fight for their companions. That site has sample letters, too.

This is a long-haul fight and will require continual pressure from all of us, the grassroots, to convince Congress and the FDA to listen. When you see other calls to action, please act if you can. If you have already written a letter to your representative, for example, maybe write to the FDA commissioner this time (Dr. Margaret Hamburg is the commissioner, email her at consumer@fda.gov).

Written by Jean of White Rabbit Beauty – Jean has been an environmental consultant for over 25 years, working for the US EPA and engineering consulting firms and as an independent contractor. She has a BS in Civil Engineering from MIT (Environmental Engineering specialty) and an MS in Civil Engineering from Stanford University. Her favorite project, though, is White Rabbit Beauty, a store she started in 2004 to give people a place to buy cruelty-free products. It’s probably the only store whose business goal is to close the store because it is no longer needed!