Talk about over-reaching: Anti-REACH screed gets nearly everything wrong

Richard Denison, Ph.D., is a Senior Scientist.

In an opinion piece titled "Chemical regulators have overreached" in the August 27, 2009 issue of Nature, two prominent animal welfare advocates claim that vastly larger numbers of chemicals will have to be tested under the European Union's REACH regulation than previously estimated, and hence that 20 times more laboratory animals will be sacrificed.  They call for a moratorium on some animal tests.  Well, a closer look reveals that it's the opiners themselves that have greatly overreached.

[Update 8/28:  The European Chemicals Agency (ECHA) has just issued this press release also disputing the findings of this new study.]

The authors of the Nature opinion piece are Thomas Hartung and Costanza Rovida.  Hartung is the director of the Center for Alternatives to Animal Testing (CAAT), while Rovida is identified as a private consultant, but was formerly affiliated with the European Centre for the Validation of Alternative Methods (ECVAM), as was Hartung.

The Nature piece cites a longer, 22-page report by the same authors released by the Trans-Atlantic Think Tank for Toxicology (t4).  t4 is a creation of CAAT.

The report is laid out to look like a peer-reviewed journal article but is self-published (more later on what the authors claim to be the expert review conducted of the report).  [Note added 8/27: The report is to be published in a journal called ALTEX.  According to its website, ALTEX is "the official journal of CAAT ... and t4, the transatlantic think tank of toxicology."  According to an article appearing in today's BNA Daily Environment Report (p. A-4):  "The study was prepared with funding from the Transatlantic Think Tank for Toxicology, which works with [CAAT]."  Hence my characterization of the report as "self-published" is quite appropriate.]

This study has used numerous demonstrably false or highly questionable assumptions, one piled on another, to grossly inflate the number of chemicals requiring testing under REACH, and the number of animals involved.

Both the opinion piece and the accompanying report reflect a fundamental misunderstanding of the basics of REACH and an apparent willingness to inflate every number in long chains of calculations to yield the largest possible estimates for the number of animals to be sacrificed under REACH.

In this post, I will address in detail some of the more egregious claims.  They include:

  • Vastly overstating the number of chemicals in commerce, to be registered and required to tested under REACH.
  • Vastly overstating the number of high-production-volume chemicals in the EU.
  • Overstating the number of animals required for at least certain tests.
  • Claiming expert review of its report, when 7 of the 8 reviewers are either close colleagues of the authors or representatives of the chemical industry.  Not a single representative of the European Commission or the European Chemicals Agency reviewed the report.

Prepare for a fairly deep dive, with lots of numbers, because that's what the authors have based their claims on.

Some context

But first, some context.  During the nearly decade-long debate over the final text of REACH, animal welfare advocates extracted major concessions from the EU.  In addition to peppering REACH with statements to the effect that animal testing would be done only as a "last resort," the changes forced by animal welfare advocates included elimination of all animal testing for existing chemicals produced below 10 tons per year per manufacturer, and a requirement that only testing proposals, not test data, be submitted at the time of registration for any tests involving laboratory animals.

Most notably, an entire Title of REACH is devoted to "Data Sharing and Avoidance of Unnecessary Testing," setting in motion the mandatory formation of so-called Substance Information Exchange Forums (SIEFs) among makers and users of a chemical that have become the latest poster child for the chemical industry's ongoing gripes about REACH.

Let me be clear:  I personally, and EDF organizationally, strongly support taking all possible measures consistent with good science and sound chemicals safety policy to reduce unnecessary animal testing.  That includes unearthing and utilizing all available data, allowing and facilitating the appropriate use of alternatives to animal testing, including in vitro methods, read-across within chemical categories, and estimation models based on structure-activity relationships (SARs).  It also means aggressively developing more alternatives, including high-throughput screening methods and computational toxicology – approaches that form the core of the long-term vision embodied in the National Academy of Sciences' seminal report Toxicity Testing in the 21st Century.

But we also need to address the fact that tens of thousands of chemicals are in active use today that have never been sufficiently tested or assessed for safety, due to policies put in place decades ago that simply presumed them to be safe.  That is a very deep hole to dig ourselves out of.

But it's not nearly as deep as Hartung and Rovida would have us believe.  Let's examine some of their claims:

Claim #1:  "More than 100,000 synthetic chemicals are used in consumer products."

That's the very first sentence in the Nature opinion piece, and it's flat wrong.  This number is derived from the number of chemicals listed in the EU's inventory of all chemicals that were in commerce in the EU at the time the inventory was developed in 1981.  It is not an accurate count of chemicals currently in commerce.

In the US, about 84,000 chemicals are listed on the cumulative TSCA Inventory, first set in 1979, but again not all of those are currently in commerce.  EPA's latest count of those manufactured or imported above 25,000 pounds/year is less than 7,000 chemicals.  While that is clearly an underestimate as there are many chemicals below this threshold, and the reporting system has a number of exemptions, nowhere near 84,000 chemicals are in active commerce in the U.S.  Given the global nature of the chemicals market, it seems highly unlikely that the situation is radically different in the EU.

Claim #2.  "Our report … is based on the pre-registration of chemicals [under REACH]."

The authors' primary analysis is based on the gross number of substances that were pre-registered under REACH last year.  However, as the European Chemicals Agency (ECHA), which administers and oversees REACH, has made clear, pre-registration is not an accurate representation of the number of chemicals to be registered under REACH.

ECHA's press release from March of this year states:

  • "ECHA does not expect all of these [preregistered] substances to be registered."
  • "In ECHA’s opinion the list contains many preparations and substances that did not require registration."

ECHA has already found that the list of pre-registered substances contains many substances (as well as items such as articles) that are duplicates or are entirely exempt from or inapplicable under REACH and will not need to be registered at all.  Pre-registrations were filed not only by chemical makers and importers, but by downstream users, as well as contract testing labs, consultants and others, mining for business opportunities.

Bizarrely, Hartung and Rovida acknowledge "a large abuse of preregistration" as well as significant duplicative entries.  Yet they proceed unfazed to base much of their analysis on the inflated pre-registration numbers.

Claim #3.  "The latest published list of REACH chemicals contains 143,835 substances that are supposed to be fully registered, each requiring a chemical safety report."

     AND

There are a total of "140,008 substances that may require extensive testing for registration."

These sentences contain several significant errors.  First, they reflect the gross number of pre-registered substances.  It is true that ECHA's pre-registration list contains more than 140,000 entries.  But as noted above, that number is highly inflated and the number of substances to be registered under REACH is expected by ECHA to be far lower.

In a statement sent to Nature by ECHA in response to Hartung and Rovida's study (referred to in NatureNews here), ECHA reiterates that, based on its review of the pre-registration lists, it still believes its original estimates for the number of unique substances to be registered under REACH (about 30,000) is quite close to accurate.

Second, only those registered substances above 10 tonnes/year are required to have chemical safety reports (CSRs).  The EU estimates that the large majority (about two-thirds) of all registered substances will fall under this threshold and not require CSRs.  For these chemicals, no animal testing is to be required under REACH.

Claim #4.  We estimate "68,000 chemicals falling under REACH, and this is the lower (optimistic) estimate in our study."

The authors characterize the estimate they derived from pre-registration lists as "worst-case," yet they use it as the primary basis for their analysis.

But even their "best case" number of 68,000 chemicals is also highly inflated.  Its derivation is frankly, laughable:

  • They start with the EU's own estimate that about 30,000 chemicals will be registered under REACH.  That number was derived by data collected by the EU in the mid-1990s, compelling the authors to seek to "update" it.
  • First they note that chemical production as measured by sales volume has increased substantially in the EU, nearly doubling between the mid-1990s and today.  I have no reason to doubt this.
  • Second, they point out that the EU itself has grown by accepting into its ranks a number of new countries.  They put that growth at about 20%.  Again, all fine.
  • But then, astoundingly, they assume that the number of chemicals produced in the EU has increased in direct proportion to these growth factors.  That leads them to multiply the 30,000 EU estimate by about 2 and then again by about 1.2, to yield the 68,000.

The notion that recent growth in the sales and volumes of chemicals in the EU was derived entirely by introduction of new chemicals, and not primarily by increases in production of existing chemicals, is contradicted by all empirical evidence – including the statistics cited by the authors themselves in the very first paragraph of the Nature opinion piece.

They point out that "existing 'old' chemicals represent about 97% of those in use today and 99% of the production volume."  I'll let you do the math to conclude that there is simply no way that 38,000 new REACH-eligible chemicals have been introduced in the EU since the mid-1990s.  OK, I'll do the math:  That would mean, among other things, that the "old" chemicals would account for well under half of those in use today, not 97%!

Indeed, the actual number of new chemicals registered in the EU since 1981 (which is cited by the authors elsewhere but ignored here!) is about 4,400.

Claim #5.  After going through more arcane calculations, the authors finally arrive at the following numbers of chemicals that they claim will require extensive animal testing:

  • 47,858 chemicals marketed above 1000 tonnes/year, to which a 2010 registration deadline applies
  • 53,040 chemicals marketed above 100 tonnes/year, to which a 2013 registration deadline applies

The former of these numbers represents what the EU calls high-production-volume (HPV) chemicals.  The authors claim there are nearly 48,000 such HPV chemicals.  The EU estimates there are only a few thousand.  Who's right?

The Organization for Economic Cooperation and Development (OECD) maintains a list of HPV chemicals produced in its 33 member countries.  OECD includes not only all of the EU, but also the U.S., Japan, Australia, Canada, Korea and all of the rest of the developed world.

How many HPV chemicals does the OECD list?  About 5,000.

So yet again, Hartung and Rovida grossly overstate reality:  They are off by at least an order of magnitude.

Claim #6.  "The two-generation study for reproductive toxicity … consumes an average of 3,200 rats per chemical."

The authors zero in on this particular test as a primary culprit, calling for a moratorium on such testing under REACH.  Let's look at the claim.

The authors claim this "average" number was calculated in a paper by Höfer et al (2004).  That paper, however, merely asserts the number and provides no calculation.  It does, however, characterize the number as a "maximum" number, and includes it in a table of "theoretical extrapolation of a maximum number of animals to be used."

The authors allude to a second paper by Cooper et al. (2006) that estimates only 2,600 rats per test, but doggedly stick with the higher number for all of their calculations.  Even that number seems high to experts we have contacted.  The Cooper et al. estimate assumed an average of 15 offspring per mated pair of rats; Hartung and Rovida themselves cited data that the average litter size for rats is only 8.2 offspring, while others put it at around 10.  Yet the authors appear unaware of and certainly never flag this major discrepancy.

There are, of course, many reasons why understanding a chemical's effects on reproduction is critical, and there is a large number of chemicals for which we are already finding such effects.  ECHA's statement summarizes the need for this test as follows:

"The two generation study is the only study where functional fertility (including mating, fertility, number of implantations and litter size) is investigated in parental animals exposed during vulnerable life stages from conception, in utero up to puberty. Such an exposure design may be of special importance, e.g., for endocrine disrupting chemicals. This is not covered by any other reproductive study, including one-generation study protocols, as long as mating of the F1 generation [offspring of the exposed parents] is not performed."

Claim #7.  "The plausibility of our assumptions and calculations was checked by eight experts from industry, academia and regulatory authorities."

This paper has not been peer-reviewed in any normal sense of the term.

A footnote on the first page identifies two reviewers.  One is the current Chair of the Board and former director of CAAT, the organization Hartung now directs.  The other is a colleague of Hartung's at the University of Konstanz in Germany, where Hartung has a joint appointment.

Six other expert reviewers are cited in the Acknowledgement section of the paper.  Five of the six work for the chemical industry or its trade associations:  ECETOC (a trade association "financed by its membership, which comprises 50 of the leading companies with interests in the manufacture and use of chemicals"), Dupont, Shell, Exxon-Mobil and BASF.  CAAT's advisory board is also well-stocked with industry representatives.

This is no accident:  There is, shall we say, a strongly shared interest between the chemical industry and animal welfare advocates in undercutting chemical testing programs.  This isn't the first instance of such close cooperation, and I very much doubt it will be the last.

A single reviewer was drawn from government (a German federal agency).

The paper received no review whatsoever from anyone from the European Commission or ECHA.  Perhaps had that occurred, some of the huge errors might have been caught before publication.

Conclusion

As noted at the start, this study has used numerous demonstrably false or highly questionable assumptions, one piled on another, to grossly inflate the number of chemicals requiring testing under REACH, and the number of animals involved.

Why?  One need only look at the last concluding sentence of the author's study for what I think is at least part of the answer:

"It is be­yond dispute that the primary aim of REACH is protecting hu­man health and the environment from unwanted consequences of exposure to chemicals.  The challenge will be to do it sensibly within the context of REACH while using all the information and experience we have and recognizing that most chemicals have been produced and used safely for many years without ex­tensive testing on animals.  (emphasis added)

That naïve assumption – that what we haven't tested can't hurt us – is what got us into this mess in the first place.  I cited many sources of information that demolish that argument  in the Introduction to my 2007 report, Not That Innocent.

There is a near-total absence in either the Nature piece or the accompanying study of mention of concern for the need to protect human health from the effects of toxic chemicals.  More striking, given the animal welfare orientation of the authors, is their utter failure to recognize or acknowledge that gaining a better understanding of chemical hazards is essential to protecting animals in the wild from toxic chemicals.

Our knowledge of the endocrine-disrupting effects of chemicals originated with studies of animals in the wild.  DDT's devastating effects first came to light through witnessing the dramatic declines in reproductive success of ospreys and eagles in the wild.  Growing evidence indicates that the widespread and increasing deformations and gender-bending effects seen in wild fish and amphibians are the result of chemical exposures.  We now know that wildlife in the remotest parts of the Earth carry dangerous levels of persistent substances in their bodies.

All of these impacts of untested and under-assessed chemicals affect untold billions or trillions of animals in the wild.

Doesn't that matter?

[My EDF colleague and toxicologist, Dr. Cal Baier-Anderson, helped with some aspects of the content of this post.]

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5 Comments

  1. Richard Wiles
    Posted August 26, 2009 at 6:47 pm | Permalink

    Great post.

    By far the scariest aspect of the hard core animal rights point of view is their willingness to assume that the thousands of chemicals to which we are all exposed, are safe, even with no data to support their position.

    There are any number of steps that can be taken to use far fewer animals to attain far more meaningful data on chemical risks. And they should be. But assuming untested chemicals are safe is not one of them.

    Increased test animal welfare and protection of human health go hand in hand, but animal studies will have to be a significant part of any plan to reform US chemical policy and protect the public from the thousands of poorly tested compounds on the market today.

    There is simply no petri dish test or computer model that can match the extraordinary complexity of the human body. The challenge is to create a system that modernizes study designs, incorporates the appropriate use of non-animal techniques, minimizes study duplication and incentives for duplication, and stops industry's use of animal studies as a delay tactic.

    These reforms would radically improve animal welfare and save thousands if not millions of animals. They are well within our reach.

  2. Costanza Rovida
    Posted August 27, 2009 at 9:06 am | Permalink

    Thank you for the detailed analysis and for giving me the opportunity to reply.
    First of all I would like stress that human health must be at the top of the priorities in all our activities. And this is beyond dispute.
    Moreover, I would like to add that I have supported REACH since the very beginning and that is why I am happy to rise a debate about its feasibility now, with the only aim to aid its final applicability.
    Our main concern is not about whether chemicals need to be tested, but how the testing strategy is built to give us confidence about their safety (see “Toxicology for the 21st Century” by T.Hartung published by Nature Vol. 460, 9 July 2009). This will be one of the key subject during the 7th World Congress on Alternatives and Animal use in the Life Sciences (Rome, August 30 – September 3, 2009).
    Regarding the number of chemicals, it is clear that not all pre-registered substances (143,835) will be registered. The number of 47,858 (2010 deadline) and 53,040 chemicals (2013 deadline) is not the result of an arcane calculation but simply the total number of pre-registered substances without the ELINCS substances and without substances with no EC number. This is the number of pre-registered Phase-in substances and can represent the highest number of chemicals that need registration.
    The reasoning leading to the assumption that about 68,000 chemicals will need a full registration is definitely more complex and I invite you to read both our full report and Pedersen report. The latter was fully correct when it was published in 2003, but it is normal to update it 6-year later. This is exactly what we have tried to do by studying some public available data. The number of chemicals that fall under REACH provisions has increased mainly because the total volume of chemicals marketed in the EU is higher and because the published version of REACH is more demanding.

  3. Erica Dahl
    Posted August 27, 2009 at 9:31 am | Permalink

    Interesting post.

    Please remember that a lot of the animal tests were developed in the 50s and are used only because that's what everybody is used to doing. They are not infallible, and the field of toxicology has moved on. Many of us who are working to promote alternative testing methods are motivated by promoting science that does a better job of predicting toxicity, not by the "hardcore animal rights point of view".

  4. Posted August 27, 2009 at 11:23 am | Permalink

    Thanks for these comments.

    I can assure you, Erica, that EDF strongly supports the modernization of toxicology and raises the very concern you do: reliance on outdated methods. We also support the development and implementation of alternatives to current animal tests wherever possible. We are involved with EPA's ToxCast effort and actively advocate for more funding directed toward realizing the vision articulated in the NAS 21st Century report. But overstating the extent of animal testing needed under REACH and calling for testing moratoria do not help in this regard.

    Costanza: I have read your full report in detail, and understand but disagree with the methodology you used, as explained clearly in my post. Relying on pre-registration numbers that are clearly heavily inflated (as ECHA itself has indicated) cannot be justified. And it is clearly incorrect to attempt to update the data in the Pederson study (with which I am also familiar) by assuming that increases in EU chemical production measured by sales or volume translate directly into comparable increases in the number of chemicals produced in the EU.

    Regards, Richard

  5. Posted August 28, 2009 at 5:19 pm | Permalink

    We all can agree that REACh is an ambitious law with a number of shortcomings. The current debate highlights one of the many reasons not to institute a similar program in the United States — an incomplete picture of how many chemicals are now in commerce.

    This is all the reason why TSCA deserves a closer examination and a program like ChAMP should continue, rather than prematurely aborting this program in favor of draconian legislation. One of the ChAMP enhancements, the Inventory Reset, is an excellent approach towards providing a clearer picture of the TSCA inventory. As you pointed out the inventory of 80,000+ chemicals does not even come close to the actual number of chemicals in commerce. Furthermore, this incomplete picture provides political fodder and consequently the public pays the price for it.

    Disputes over the numbers of chemicals in commerce do not bolster arguments in favor of programs like REACh. Instead, they further support SOCMA’s position that the US must proceed carefully to gain a clearer picture of the current market through programs such as ChAMP and use existing and analogous data to fill information gaps, rather than investing untold resources in another flawed program like REACh.

    Lastly, as animal rights groups have pointed out, REACh will require the use of animals, and while alternatives to animal tests do exist, this is an example of policy getting ahead of a still-developing science.
    -Dan Newton
    Society of Chemical Manufacturers and Affiliates (SOCMA)

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